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CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of U.S. application Ser. No. 654,661 filed on Feb. 15, 1991 entitled "Implantable Infusion Device" now U.S. Pat. No. 5,180,365 which is a continuation-in-part of U.S. Pat. application Ser. No. 539,793, filed Jun. 18, 1990, which issued as U.S. Pat. No. 5,053,013, which is a continuation-in-part of application Ser. No.487,541, filed Mar. 1, 1990, which issued as U.S. Pat. No. 5,057,084.
BACKGROUND AND SUMMARY OF THE INVENTION
This invention is related to a patient access device and particularly to one which permits the introduction of an external filament such as a needle, external catheter, guide wire, or optical fiber transcutaneously.
This invention relates to a device to enable multiple patient access procedures including infusing a therapeutic agent to a desired site within a patient, feeding a filament to a desired internal site, or withdrawing a fluid from a patient; and more particularly, to such a device which is implanted such that no portion is transcutaneous. Its access portion is subcutaneous but designed so as to facilitate repeated access by the percutaneous route.
In current human and animal medical practice, there are numerous instances where therapeutic agents must be delivered to a specific organ or tissue within the body. An example is the infusion of chemotherapy into a central vein on a recurring basis over a lengthy treatment period for widespread sites of malignant tumor. Without an access device for intravenous drug infusion, multiple vein punctures over a lengthy period can result in progressive thrombosis, venous sclerosis, and destruction of small diameter peripheral vessels. In other cases, it may be desirable to infuse chemotherapy to a localized malignant tumor site. It may be difficult or impossible to deliver an agent specifically to such a site on a regular repetitive basis without surgically implanting an access system. Similarly, repeated arterial access is occasionally needed for injection of an X-ray dye or contrast agent into an artery for diagnostic purposes. In other situations, there is a need to remove a body fluid from a remote body site repetitively for analysis. Finally, sensing and physiological measuring devices incorporated into small diameter catheters and small diameter optical fibers are increasingly being utilized for monitoring body processes and could be more easily implemented through a properly designed access device with an adequate internal diameter.
In prior medical practice, percutaneous catheters have been used to provide vascular or organ access for drug therapy or removing body fluids. Although such systems generally performed in a satisfactory manner, numerous problems were presented by such therapy approaches, including the substantial care requirements by patients, e.g. dressing changes with sterile techniques, a significant rate of infection of the catheter because of its transcutaneous position, and a high rate of venous thrombosis, particularly if the catheter was located within an extremity vein.
Implantable infusion devices or "ports" have recently become available and are a significant advance over transcutaneous catheters. Presently available infusion ports have a number of common fundamental design features. The ports themselves comprise a housing which forms a reservoir which can be constructed from a variety of plastic or metal materials. A surface of the reservoir is enclosed by a high-density, self-sealing septum, typically made of silicone rubber. Connected to the port housing is an outflow catheter which communicates with a vein or other site within the patient where it is desired to infuse therapeutic agents. Implantation of such devices generally proceeds by making a small subcutaneous pocket in the patient under local anesthesia. The internal outflow catheter is tunnelled to the desired infusion site and is connected to the infusion port. When the physician desires to infuse or remove material through the port, a hypodermic needle is used which pierces the skin over the infusion port and is placed into the port.
Although presently available implantable infusion ports generally operate in a satisfactory manner, they have a number of shortcomings. Since these devices rely on a compressed rubber septum for sealing, there are limitations in the diameter of needles which can be used to penetrate the septum, since large diameter needles can seriously damage the septum. These diameter limitations severely restrict the flow rate of fluids passing through the port. Moreover, the needles used must be of a special design which minimizes septum damage.
For prolonged infusion using a conventional port, the infusion needle is taped to the patient's skin to hold it in position. Conventional ports do not allow the needle to penetrate deeply into the port; and consequently, a small displacement of the needle can cause it to be pulled from the port, allowing extravasation. In cases where locally toxic materials are being infused, extravasation of such materials can cause local tissue damage which can lead to a requirement for corrective surgery such as skin grafting or removal of tissue.
Presently available implantable infusion devices must also have a significant size to provide an acceptable target surface area for the physician who must locate the port and penetrate the septum properly with a needle. The port housing becomes bulky as the septum size increases since structure is required to maintain the septum in compression to provide self-sealing after the needle is removed. Moreover, presently available infusion ports are difficult to clear if thrombosis occurs within them or in the implanted outflow catheter, since it is difficult if not impossible to feed a cleaning wire through the penetrating hypodermic needle in a manner which will clear the infusion device and the internal outflow catheter. Present infusion ports have a space which contains a retained fluid volume beneath the self-sealing septum which increases the volume of drug which must be administered to enable a desired quantity to reach the infusion site. This retained volume also poses problems when a physician desires to deliver different drugs to the same infusion site which are incompatible or rendered less effective when mixed. In addition, when it is desired to withdraw blood through the port, the retained volume of the prior art infusion ports is an area where blood clotting can occur, thus interfering with future access to the site. And finally, for present infusion ports, there is a risk that the physician attempting to pierce the port septum will not properly enter it, leading to the possibility of extravasation which can cause significant undesirable consequences as mentioned previously.
In applicants' related patent application and issued patents, various approaches toward permitting transcutaneous access to implanted catheter are described. In accordance with those devices, multiple sealing members are used to provide an adequate fluid seal across the access device, both when an external filament is introduced into the device and after it is removed. The access ports in accordance with this invention achieve simplicity in construction and reduce the number of components necessary to provide the necessary fluid seal. In those applications where it is desired to access a port using a sharp needle, damage to elastomeric sealing elements can occur over repeated entries to the port in prior port designs. In accordance with this invention, the implanted port has an articulating valve mechanism in which the accessing needle (or other filament) contacts a hard material such as a metal to open the valve. Accordingly, a durable device is provided which is not damaged through long term use.
The features of the present invention are primarily achieved through use of a valve assembly in which a sealing element is normally maintained in contact with a valve seat. When introducing an external filament, which may be a needle, catheter, wire, optical fiber etc., the filament engages the sealing element forcing it from engagement with the valve seat. Once fully inserted into the access device, features are provided to assure a fluid seal around the introduced filament.
Additional benefits and advantages of the present invention will become apparent to those skilled in the art to which this invention relates from the subsequent description of the preferred embodiments and the appended claims, taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross-sectional view through an access port in accordance with a first embodiment of this invention shown in a normal condition in which an external filament is not present within the device.
FIG. 2 is a somewhat enlarged cross-sectional view of the access port of FIG. 1 shown with an accessing needle penetrating the device.
FIG. 3 is an exploded pictorial view of the valve assembly of the port shown in FIGS. 1 and 2.
FIG. 4 is a cross-sectional view through an access port according to a second embodiment of this invention showing a valve assembly comprising metal seal elements affixed to a multi-leaf elastomeric valve disk.
FIG. 5 is a frontal view of the valve assembly of the port shown in FIG. 4.
FIG. 6 is an exploded pictorial view of a valve assembly in accordance with a third embodiment of this invention incorporating a unitary seal member for sealing against the valve seat formed by a sealing disk.
FIG. 7 is a cross-sectional view of an access port incorporating the valve assembly shown in FIG. 6 and further showing an accessing needle penetrating the device.
FIG. 8 is a cross-sectional view taken through an access port in accordance with a fourth embodiment of this invention shown with an accessing needle partially penetrating the device.
FIG. 9 is a cross-sectional view of the access port shown in FIG. 8 but showing the accessing needle penetrating the valve assembly to permit access to an implanted catheter.
DETAILED DESCRIPTION OF THE INVENTION
An access device in accordance with this invention is shown in FIGS. 1 and 2, and is generally designated by reference number 10. As shown, access port 10 is similar to that described in applicant's issued U.S. Pat. Nos.: 5,053,013 and 5,057,084, to which the present application is related. Access port 10 is designed to allow a sharp needle to access the device for purposes including infusing drugs or other fluids in the patient or withdrawing fluids from the patient. Access port 10 generally has housing 12 which defines a generally funnel shaped entranoe orifice 14. Entrance orifice 14 has a decreasing cross-sectional area which ends at housing passageway 16. The shape of entrance orifice 14 serves to guide a needle into passageway 16. To that end, the surface of housing 12 forming orifice 14 is a hardened material such as titanium which has been found to be acceptable for this application.
Housing 12 together with outlet plug 18 define valve chamber 20 located between passageways 16 and 22. As shown, the protruding catheter connector tube 24 of outlet plug 18 is bent to provide a positive means for preventing an introduced needle from passing entirely through the device and potentially damaging a soft elastomeric implanted catheter 26. Connector tube 24 does, however, permit more flexible filaments such as a catheter, guide wire or optical fiber to pass into implanted catheter 26. Mounting pad 28 enables the device to be conveniently mounted to subcutaneous support tissue preferably using sutures, staples, or other fasteners.
Valve assembly 34 is disposed within valve chamber 20 and is best described with reference to FIG. 3. Valve disk 36 is made from an elastomeric material such as silicone rubber and is positioned in valve chamber 20 closest to entrance orifice 14. Disk 36 has a central aperture 38 defining a valve seat which is intended to seal against the introduced needle or filament upon insertion into access port 10, as will be described in more detail as follows. Stacked directly against disk 36 is sealing member 40 which is preferably made, at least partially, of a hard material such as a metal. Sealing member 40 as shown in FIGS. 1, 2 and 3 is a circular metal disk having three cuts intersecting at the center of the disk and extending radially to the outer perimeter but stopping short of the perimeter, thus defining three separate cantilever supported leaves 42. Each of leaves 42 is locally deflected from the plane of the disk at the disk center to define a segment 43 which combine to define conical sealing plug 44. Plug 44 has an external generally conical surface 46 with its center defining a concave surface 48. Sealing member 40 can be made from a flat sheet metal stock which is locally deflected at the center area to define plug 44. Alternatively, the disk can be machined or cast such that the plug 44 is defined by a locally thickened region of the disk.
Valve assembly 34 also incorporates an additional leaflet valve element 52 formed from a flat sheet of elastomeric material. Valve element 52 defines radial cuts which join at the geometric center of the disk, defining separate valve leaves 54.
As shown in FIGS. 1 and 2, the three elements comprising valve assembly 34 namely, valve disk 36, sealing member 40 and leaflet valve 52 are stacked directly against one another and are trapped in position between access port housing 12 and outlet plug 18. As shown in the Figures, housing 12 defines a relatively small diameter passageway on the side of valve assembly 34 closest to entrance passageway 16. In this manner, seal element 36 is constrained against deflecting toward entrance orifice 14 except at near its central area defining aperture 38. On the opposite side of valve assembly 34, outlet plug 18 defines a large diameter area for the deflection of the leaves of valve elements 40 and 52.
The operation and cooperation of the elements defining access port 10 will now be described with particular reference to FIGS. 1 and 2. FIG. 1 shows the configuration of valve assembly 34 when access port 10 is in its normal condition, implanted within the patient and not being used for access. In that condition, the segments of sealing member 40 making up sealing plug 44 project into and seal against disk aperture 38 which acts as a valve seat. Plug 44, having a conical outside surface 46, presses against disk aperture 38, causing it to be stretched and enlarged. Due to the contact between disk 36 and sealing member 40, a seal against fluid leakage is provided.
Leaflet valve element 52 is provided to enhance the level of sealing by preventing fluid leakage between sealing member leaves 42. In the normal condition of the device as shown in FIG. 1, the valve leaves 54 meet to provide a fluid seal. As shown in FIG. 3, as a means of providing enhanced fluid sealing, the orientation of the cuts defining leaflet valve leaves 54 and the cuts defining the individual sealing member leaves 42 are off-set or indexed so that they are not in registry.
FIG. 2 shows the orientation of the elements of access port 10 upon insertion of accessing external needle 58. Housing orifice 14 and passageway 16 serve to direct and orient needle 58 such that the sharp point of the needle strikes concave surface 48 of plug 44. Due to the enlargement of valve disk aperture 38 through its interaction with plug 44, the sharp point of the needle does not strike valve disk 36. As needle 58 is forced through the device, sealing member leaves 42 are forced to deflect in the direction of the outlet plug passageway 22. This movement of leaves 42 causes the segments defining plug 44 to move from engagement with disk aperture 38 which is allowed to contract in diameter. The undeformed diameter of aperture 38 is selected so that it will form a fluid seal against needle 58 (or another introduced filament such as a catheter around the needle which can be left in the device after the needle is removed). Continued deflection of leaves 42 allows free passage of the needle 58. Such deflections also causes valve leaves 54 to separate, allowing passage of needle 58 but without being damaged by contact with the needle point.
As is evident from the above description of the operation of access port 10, repeated access using needle 58 will not damage the device since the needle repeatedly strikes the hard material forming plug 44. Access port 10 also permits the introduction of the external filaments, such as an external catheter, optical fiber or guide wire, provided that it has sufficient rigidity to deflect the valve elements in the manner previously described. Access port 10 could also enable external filaments to be introduced via needle 58 either as fed through its center passageway, or introduced around the needle like a typical angiography catheter.
FIG. 4 illustrates an access port 60 incorporating a valve assembly 62 in accordance with the second embodiment of this invention. This embodiment, along with those described elsewhere in this specification have elements and features identical to those of the first embodiment, and are identified with like reference numbers. FIG. 5 illustrates valve assembly 62 which includes a valve disk 36 identical to that previously described. The distinction of this embodiment over valve assembly 34 is that the sealing member 64 which defines plug 70 is a composite structure. Sealing element 64 is formed from an elastomeric or flexible base disk 66 having a number of radically projecting cuts defining individual leaves 68 as in the case of sealing member 40 described previously. Attached to leaves 68 near the center of base disk 66 are plug segments 70 which together define a sealing plug 72 as in the prior embodiment which are made of a hard material such as a metal. Plug elements 70 are bonded or otherwise structurally affixed to disk 66.
In use, valve assembly 62 operates in a manner consistent with the description of valve assembly 34. A principle advantage of the configuration of valve assembly 62 is that sealing element disk 66 performs the combined functions of sealing as with the leaflet valve element 52 of the first embodiment, and further supports plug segments 70.
FIGS. 6 and 7 illustrate an access port 78 in accordance with a third embodiment of this invention. Access port 78 has valve assembly 80 with a valve disk 36 identical to that present in the first and second embodiments. In this embodiment, however, sealing member 82 is a unitary structure which includes plug element 84 attached to a mounting ring 86 via a cantilever arm 88. As with the prior embodiments, plug 84 defines an external conical surface 90 and a central concave surface 92. In this design, however, the plug 84 is a unitary element.
In operation, valve assembly 80 operates as like those of the prior embodiments in that in a normal condition without an external filament inserted within the access device, plug 84 is in sealing engagement with disk aperture 38. Upon the introduction of an external filament such as needle 58, engagement between the needle and sealing plug 84 urges it out of engagement with disk aperture 38, and deflects it sufficiently to allow passage of the needle, as shown in FIG. 7. This process also results in the contraction of the diameter of aperture 38, causing it to constrict around the introduced filament. A significant benefit of valve assembly 80 results from the fact that plug 84 is a unitary structure and, therefore, does not provide a fluid leakage path. In the normal condition with plug 84 against disk aperture 38, a fluid seal is provided, and therefore, additional sealing elements such as a leaflet valve 52 shown in the first embodiment are unnecessary.
FIGS. 8 and 9 provide an illustration of access port 102 in accordance with a fourth embodiment of this invention. This embodiment features a modified housing 104 and outlet plug 106. Housing 104 forms a small diameter counterbore 108 extending toward entrance orifice 14. Piston element 110 is positioned within housing cavity 112 and includes a central filament passageway 114. Piston 110 butts against elastomeric bushing 116 having passageway 117, which is trapped within counterbore 108. The head of piston 110 forms a dished concave surface 118 which supports valve ball 120. Piston surface 118 is formed to position ball 120 such that it is displaced from alignment with piston passageway 114. Outlet plug 106 forms a generally flat surface 122 within housing cavity 112 which provides for movement of ball 120, as is described in more detail below.
Operation of access port 102 will be described with reference to FIGS. 8 and 9. FIG. 8 represents the orientation of the elements comprising the device while inserting access needle 58. As is shown in FIG. 8, access needle 58 engages ball 120 off-center. Continued insertion of needle 58 causes ball 120 to be displaced upward to the position shown in FIG. 9. During such displacement, piston 110 is caused to move toward entrance orifice 14 as ball 120 "rides out" of concave surface 118. This displacement of piston 110 compresses bushing 116. Since bushing 116 is trapped within counterbore 108 its axial compression causes bushing passageway 117 to constrict, thus causing it to seal against the introduced needle or other filament. As shown in FIG. 9, once ball 120 is fully displaced, free passage to the exit passageway 124 is provided. When needle 58 is completely removed from the device, ball 120 reseats in position within concave surface 118 which provides a fluid seal. It would be possible to enhance the fluid seal provided by ball 120 in its normal position by providing an O-ring or other elastomeric valve seat (not shown) installed either on outlet plug 106 or a piston 110 and engaging the ball.
While the above description constitutes the preferred embodiments of the present invention, it will be appreciated that the invention is susceptible of modification, variation and change without departing from the proper scope and fair meaning of the accompanying claims.
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An infusion device which permits transcutaneous access to an implanted catheter for use in introducing an external filament such as a optical fiber, external catheter, guide wire or rigid needle. In accordance with this invention the device includes a valve assembly including a first valve element defining an aperture with a sealing member which is normally to engage and seal against the aperture. The sealing element is made from a hard material such as a metal. Upon introduction of a rigid external introducer such as a needle, the needle directly contacts the sealing member plug unsealing it from the valve element aperture which then closes against the external element. The device enables repeated access using a sharp introduced element such as a needle without it contacting soft sealing elements which could be degraded by such repeated access.
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This application is a Continuation of application Ser. No. 08/696,899, filed Aug. 22, 1996 which application is in National Stage of PCT/ES95/00149 which is published as WO96/19473 on Jun. 27, 1996.
TECHNICAL FIELD OF THE INVENTION
The present invention falls within the field of Immunology and, specifically, the modifiers of the biological immune response, "immunomodulators".
Specifically, this invention provides a new generation of biological immune response modifiers very useful in the therapy of chronic diseases, especially cancer and AIDS.
STATE OF THE ARTPRIOR TO THE INVENTION
The natural or acquired resistance of individuals can be seriously affected by multiple intrinisic and extrinsic factors such as genetics, age, general bad nutrition, environment, stress, alcohol, drug addiction, chronic diseases (cancer, diabetes mellitus, sarcoidosis, etc.) chemotherapy agents (cytostatic, antibiotics, etc.) ionizing radiations, severe traumatism and burns, etc. . . .
For many years, many researchers have tried to manipulate the "Immunological Response" (RI) in order to enhance the resistance of patients to pathological processes, the prognosis of which depends to a large extent on the status of their own "Immunological System" (IS). In 1985, J. Hericourt and C. Richet tried to manipulate the RI in patients with melanoma through the heterologous passive Immunotherapy. In 1902 and 1893 to 1929 respectively, E. Von Leyden and F. Blumenthal tested the active Immunotherapy with homologous tumoral cells and W. B. Coley with bacterial toxins, in oncological patients. Afterwards, the administration of serum or blood plasma of donors "immunized" with cancerous cells, "sensitized" autologous or allogeneic lymphocytes, intradermic injection of tumoral cells, etc., in general was very disappointing (M F A Woodruff, 1980). However, the positive results obtained in 24 random studies performed during the 70s (published by W. D. Terry and S. A. Rosenberg 1982) evidence the efficiency of Immunotherapy as a procedure and questions the adequacy of biological crudes and that of the protocols used (R. K. Oldham and R. V. Smalley, 1983).
The recent advances made in Cellular and Molecular Biology, specifically the arrival of monoclonal antibodies (Ac.Mo.) after the hybridomae technology of G. Kolher and C. Milstein in 1975, the individualized clonation and the passage by genetic engineering of eukariotic genes to bacterias, yeasts and even eukariotic cells and the advance with respect to the possibilities offered by new working equipments, either jointly or separately, have made possible the emergence in the market of virtually pure products known as biological response modifiers (BRM), i.e. modifiers of the biological response, currently used mainly in human oncological clinic with different success.
The availability of such products offers new ways to act on the RI and to enhance the resistance of individuals, which is the main objective of the positive Immunomodulation, a term conceptually more precise than that of Biotherapy and broader than that of Immunotherapy itself. The administration of Interferon-alpha (IFN-α) or Interleukin-2 (IL-2) with LAK cells (Lymphokine Activated Killer Cells) as a kind of non-specific Immunomodulation way can cause the regression of tumor metastases (renal carcinoma, no-Hodgkin lymphoma) in patients with favourable prognosis factors (S. A. Rosenberg, 1988).
The adjuvant specific Immunomodulation, either active, passive or adoptive, combined or not with BCG ("Bacillus Calmette-Guerin") and or heterologous monoclonal antibodies (Ac.Mo.) or sensitized lymphocytes can prolong the survival of patients with cancer. However, its use has been seriously limited to a reduced number of institutions and researchers, mainly due to technological difficulties almost impossible to overcome in non-specialized hospitals. The number of cancer patients who benefit from the use of heterologous Ac.Mo. and their conjugated compounds along with toxins ("Immunotoxins") or radionuclides (Radioactive antibodies) is very small yet (F. A. Waldmann, 1991).
The National Biotherapy Study Group of the U.S.A. recommends a selection of patients prior to a continued treatment with IL-2 considering the high toxicity and the low response index observed in 788 patients included between 1985 and 1990 in fifteen clinical trails with high doses of IL-2 associated to LAK cells, TIL (Tumour Infiltrating Lymphocytes) IFNs, TNF (Tumour Necrosis Factor), etc. (R. O. Dillman, 1992). The toxicity seems to be directly proportional to the dose administered. In one series of S. A. Rosenberg 1989, where high doses of IL-2 alone, with LAK cells or TIL were administered to 435 patients with advanced cancer, in 679 occasions there were nine deaths related with the treatment and five patients suffered a myocardial infarction. In 60% of the therapeutical actions hypotension was detected and anemia in 61%, requiring treatment with vasopressors and blood transfusions, respectively. 38% of the patients suffered somnolence, disorientation and coma. Most patients needed symptomatic treatment of fever, emesia, diarrhea, etc. (J. S. Rubin and M. T. Lotze, in Biomodulation, M. S. Mitchell, editor, 1993) and among other rare complications, perforations of colon and of the small intestine were included (D. H. Schwartzentruber et al., 1988 and R. Rahman et al., 1991).
The thymic extracts or factors can restore the RI of patients with primary or secondary immunodeficiencies by promoting cellular differentiation thus expanding the range of T quiescent helper and effector lymphocytes. In "high risk" immunodepressed patients, the THF (Thymus Humoral Factor) and TP-1 (Thymostimulin), respectively, decrease the morbidity and mortality due to severe viral infections (N. Trainin et al., 1984) or post-surgical bacterial sepsis (A. Terrizi et al., 1985; A. Solans et al., 1990, etc). Furthermore, the TFV ("Thymosin Fraction V") combined with Chemotherapy (M. H. Cohen et al., 1979) or Radiotherapy (A. L. Goldstein et al., 1984) in lung cancer, and the TP-1 as adjuvant after surgery in melanoma (M. G. Bernengo et al., 1984) have succeeded to prolong the survival of such patients. TFV obtained from the thymus of calves contains polypeptides with a molecular weight of 1-15 KDa, is practically devoid of toxicity and can cause hyperargic reactions of anaphylactic type (T. Low et al., 1979).
Recently, the agents of several human hematopoietic growth factors have been cloned of which the two most deeply studied have been the rhG-CSF ("recombinant human Granulocyte Colony Stimulating Factor"), and the rhMG-CSF ("recombinant human Macrophage Granulocyte Colony Stimulating Factor") which is currently available for clinical use under three main recombinant forms derived from the "E. coli" (Schering Labs.), yeasts (Immunex Labs.) and "CHO" mammal cells (Sandoz Labs.), respectively (L. M. Souza et al., 1986; J. L. Gabrilove and A. Jakubowski in "Biomodulation" M. S. Mitchell ed., 1993). Their administration to cancer patients in the absence of a myelodepression causes a great increase in the number of circulating (peripheral blood) polymorphonuclear neutrophile (rhG-CSF) or neutrophiles and eosinophile (rhMG-CSF) granulocytes they have managed to decrease the morbidity of the neutorpenia (G. Morstyn et al., 1989; H. F. Oettgen, 1991). Especially, the rhMG-CSF drastically decreases systemic bacterial and viral infections in patients with severe chronic neutropenia (A. Ganser et al., 1989) or after the transplant of bone marrow in patients with malignant lymphoproliferative processes (G Schulz et al., 1991). Its administration prior to chemotherapy notably reduces the duration of the neutropenia. However, 2 out of 14 patients who received rhMG-CSF died from sepsis (K. S. Antheman et al., 1989). The most significant side effects are fever, bone ache, pericarditis, hypotension (G. Morstyn et al., 1989, etc.), nausea and emesis (F. Herrmann et al., 1989, etc.), generalized edema, thrombophlebitis, acute renal failure in one case (K. S. Antman et al., 1989), etc.
The "in vivo" activation of macrophages has not been successful since the life of lymphokines administered intravenously is extremely short (E. S. Kleinerman et al., 1989) while their "in vitro" activation has been successfully achieved through the use of liposomes that contain MDP (Muramil Dipeptide), MTP-PE (analogous lipophilic analogue of MDP), IFNs, etc. Liposomal-MTP-PE (Ciba-Geigy, Ltd., Basel, Switzerland) at the maximum dose of 6 mg/m 2 is well tolerated and the main side effects noticed during a phase I trail were chill and fever (80%), fatigue (60%), nausea and emesis (55%), hypo- or hypertension, etc. (J. J. Killion and I. J. Fidler in "Biomodulation", M. S. Mitchell, ed., 1993).
Therefore, the efficacy of experimental immunomodulation has been completely demonstrated. However, the success achieved in oncological clinics, for instance, with the use of the BRM currently available in the market has been, in general, limited to selective populations, sporadic and non-foreseeable, as previously stated.
The manipulation of RI with the exogenous contribution of "cytokines" is not an easy task. In practice, the existing uncertainty regarding the precise regulating role of each cytokine by itself and the (apparent) existence of multiple alternatives pathways for the "in vivo" lymphocyte expansion (M. T. Lotze et al., 1992); the unequivocal cellular and humoral requisites for the effective activation of the primigenial (naive) regulating T lymphocytes (CD 4 cells), which would be the first and unavoidable step to obtain a response, and the factors determining the polarized responses (Th0, Th-1 and Th-2 patterns) of the CD4 T cells (S. L. Swain, 1993), etc. . . . would together make it difficult to select a strategy up to the point that the pretention to guess the adequate BRM, dose and time in each case as well as to predict the results is just an utopia. The toxicity of some BRM, similar to that of the cytotoxic agents common in antineoplastic chemotherapy; the frequent production of anti-IFNα, anti-Ac.Mo., anti-TFV, anti-TP-1, etc. specific antibodies that apart from interfering with their bioavailability and efficacy provoke hyperergic type reactions; the technological difficulties and the financial cost--sometimes unsurmountable--of certain protocols etc., make it necessary to develop and incorporate more effaceous and safer new immunomodulators.
The present invention overcomes the different therapeutical limitations that the above-mentioned BRM currently have. Some of them are due to the biological activity, the bioavailability and their indications; others to the systemic toxicity (in some cases similar to that of cytotoxic pharmaceutical products) and the production of specific antibodies such as anti-IFNα, anti-Ac.Mo., anti-TFV, etc. that can provoke severe anaphylactic type hyperergic reactions, etc.
The BRM-BLAS products afforded by the present invention represent a peerless new generation of BRM-synthetic agents. Such compounds overcome the natural limitations of thymic extracts and factors, i.e. "immunorestorers", by potentiating the RLP-I (Non-specific Lymphoproliferative Response) and by increasing the number of circulating (peripheral) blood lymphocytes in normal individuals so that they exceed the physiological basal values and are perfectly tolerated. As it will be seen below, these products have been repeatedly used during the last two years in the same animals without impairing their normal activity and with a complete absence of undesired side effects. Furthermore, the administration of Swiss mice of a dose thousand of times higher than the therapeutical or biological effective doses in the case of rabbits--without any noteworthy evidence of pathological signs--also guarantee their satisfactory tolerance.
Finally, with respect to the "CSFs", the complementary, non-competitive or substitute use of them should logically be considered. Each has its precise indications in different clinic situations.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1.--It shows the IR spectrum of the basic crude product.
FIG. 2.--It shows the 1 H-NMR spectrum of the BRM-BLAS 236 (Cl) compounds.
FIG. 3.--It shows the 13 C-NMR spectrum of the BRM-BLAS 236 (Cl) compounds.
FIG. 4.--It shows the EM spectrum of the BRM-BLAS 236 (Ac) compounds.
FIG. 5.--It shows the IR spectrum of the BRM-BLAS 236 (Cl) and BRM-BLAS 236 (Ac) compounds for comparison purposes.
FIG. 6.--It shows the IR spectra of the BRM-BLAS 278 (Cl) and BRM-BLAS 278 (Ac) compounds for comparison purposes.
FIG. 7.--It shows the EM spectrum of the BRM-BLAS 278 (Ac) compounds.
FIG. 8.--It shows the 1 H-NMR spectrum of the isomeric BRM-BLAS 320 (Ac) compounds.
FIG. 9.--It shows the EM spectrum of the BRM-BLAS 320 (Ac) compounds.
FIG. 10.--It shows the IR spectrum of the BRM-BLAS 320 (Cl) and BRM-BLAS 320 (Ac) compounds.
FIG. 11.--It shows the EMAR spectrum of the BRM-BLAS 320 (Ac) compounds.
FIG. 12.--It shows the graphs corresponding to the leukocyte kinetics after the immunomodulation with BRM-BLAS 236 (Cl) compounds.
FIG. 13.--It shows the graphs corresponding to the lymphocyte kinetics after the immunomodulation with BRM-BLAS 236 (Cl) compounds.
FIG. 14.--It shows the graphs corresponding to the lymphocyte response after the immunomodulation with BRM-BLAS 320 (Ac) and 278 (Cl) compounds.
FIG. 15.--It shows the graphs corresponding to the leuko-lymphocyte response after the immunomodulation with BRM-BLAS 320 (Ac) and 278 (Cl) compounds.
FIG. 16.--It shows the graphs corresponding to the lymphocyte kinetics after the immunomodulation with BRM-BLAS 278 (Ac) and BRM-BLAS 320 (Ac) compounds.
FIG. 17.--It shows the graphs corresponding to the leukocyte kinetics after the immunomodulation with BRM-BLAS 278 (Ac) and BRM-BLAS 320 (Ac) compounds.
FIG. 18.--It shows the graphs corresponding to the leuko-lymphocyte response after the immunomodulation with BRM-BLAS 278 (Ac) and BRM-BLAS 320 (Ac) compounds expressed as relative values (percentages).
FIG. 19.--It shows the graphs corresponding to the leukocyte-lymphocyte response after the immunomodulation with BRM-BLAS 278 (Ac) and BRM-BLAS 320 (Ac) compounds expressed as absolute values.
DETAILED DESCRIPTION OF THE INVENTION
This invention affords a new generation of BRM agents, biological response modifiers with a marked positive immunomodulator activity, more efficaceous and safer that those currently available in the market. They are new original derivatives of the pyroglutamic acid, obtained from chemical synthesis either with chloride (CL--) or acetate (CH 3 COO--) anions, as pyridine salts.
The basic molecular structure, the cation, is formed of a pyridine ring (N-methylpyridine) and another dissubstituted lactamic ring (pyroglutamic acid) with two stereogenous centres and three potentially acetylable groups, two of them nitrogenous, that give rise to different stereoisomeric compounds and their acetylatable derivatives, all of which are included within the scope of the present invention. The exact molecular mass corresponding to the main stable compounds, excluding the anion, is 236.10385 (average of nine measures), 278.11387 (average of eleven measures) and 320.12480 (average of eight measures). The respective molecular formulae are: C 11 H 14 N 3 O 3 (theoretical exact mass: 236.10357; δ-1.4 ppm), C 13 H 16 N 3 O 4 (theoretical exact mass: 278.11408; δ 0.8 ppm) and C 15 H 18 N 3 O 5 (theoretical exact mass: 320.12465; δ-0.5 ppm).
Purified dry products are crystalline, white, very hygroscopic, deliquescant and when heated they become caramel-like and are decomposed without melting above 180° C. They are water and alcohol soluble and practically insoluble in acetone and ether among other organic solvents. In an aqueous solution their maximum UV absorption peak between 259-260 nm.
The most peculiar and outstanding biological characteristics of such BRM agents are their marked "in vivo" and "in vitro" immunomodulating activity along with their perfect tolerance. All of them increase the non-specific lymphoproliferative response (RLP-I) to the phytohemagglutinin (PHA) in "in vitro" cultures of human lymphocytes (healthy persons--blood donors) and the absolute values of the circulating peripheral blood leukocytes, especially of lymphocytes, in experimental animals (New Zealand's albino and giant rabbits), asymptomatic, which effect is biologically and statistically significant.
In summary, this invention covers different original BRM compounds, indistinctly described as salts of 1-(1-amino-3-aza-4-carboxyl-2-oxycyclopentyl) methylpyridinium or derivatives of 4-amino-4-(pyridiniomethyl) pyroglutamic acid with the following general formula (I): ##STR2## wherein R 1 , R 2 and R 3 are independently selected between H and COR 4 , where R 4 is a lower alkyl or aryl and A-- is an anion selected between Cl--, CH 3 COO--, OH--; and the undulated line means that the relevant substituent may occupy any of the possible spatial positions, without excluding oligomeric products of the basic structure. Their more outstanding common denominator or biological activity is a significative enhancement of the "in vitro" RLP-I induced by the PHA and of the absolute number of circulating peripheral blood lymphocytes in healthy individuals, exceeding the physiological baseline values.
Therefore, they have been jointly designated by the generic name of "BLAS" (Blood Lymphocyte Augmenting Substances) followed, in each case, for their specific identification by the number of the nominal value of the molecular mass of the cation and, in brackets, the signs (Cl) and (Ac) of their respective chloride and acetate anions.
The procedure of this invention to obtain the said products incorporates an original method for the initial chemical synthesis of the basic crude and the concatenated preparation from it of the new BRM-BLAS compounds.
The experimental conditions for the synthesis of the crude product are broad with regard to the quantities and proportions of the reagents used, reaction time, temperature, etc. Briefly, the selected quantity of L-serine is mixed with a molar excess of acetic anhydride (5.6-4.4 moles/mol) and pyridine (1.6-1.9 moles/mol). The reaction can be performed between time and temperature intervals that respectively vary from 15 minutes to 18 hours and from 35° C. to the reflux temperature of the mixture, although it is preferable to heat it during 20-30 minutes at 80°-90° C. with a continuous agitation. Once the mixture of the reaction is cool, the crude product is precipitated with ethylic ether, washed with it or with a mixture of ether-acetone, dried and it can be stored at room temperature during several years without noticeable alterations or damages. Even though the experimental conditions are essentially the same than those of the Dankin-West reaction ("alpha-aminoacids with acetic anhydride with the presence of a base"; H. D. Dankin and R. West, 1928), the presence of a methyl ketone is not detected in the product. Instead, a mixture of the compounds that constitute the principal crude product of this invention appears. The crude product dry powder is of a creme-beige colour, soluble in water and alcohol and from such solutions it can be obtained in a crystallized form. The UV spectrum has no defined peak and shows a plateau between 256-259 nm. However, the IR (KBr) spectrum shows many characteristics and intense bands at 1286, 1373, 1538, 1635, 1665, 1702 and 1747-1756 cm -1 (Table I and FIG. 1), fully coincident with the general formula (I) given for the BRM-BLAS compounds.
The purification of the crude product can be performed by the usual adsorption chromatography techniques with activated carbon in a matrix either of cellulose, silica gel, pevikone, etc. or a combination of all. The molecular structure of such compounds has been elucidated by Nuclear Magnetic Resonance ( 1 H and 13 C-NMR) on D 2 O solutions in BRUKER AC-200 and AMX-300 spectrometers; Mass spectrometry (EM and EMAR) with Cs ions on a matrix of m-nitrobenzylic alcohol, "LSIMS" ("Liquid Secondary Ion Mass Spectrometry") method, in an VG-AutoSpec spectrometer; Infra-red (IR) spectroscopy in a solid medium (KBr) tablet with the FTIR spectrophotometer, BRUKER brand, IFS 85 model and Elemental Analysis with a PERKIN ELMER 2400 CHN elemental analyzer.
TABLE 1______________________________________INFRA-RED SPECTROSCOPY (II) BIOLOGICAL RESPONSE MODIFIERSPRINCIPAL B CRUDE BLAS - 236 BLAS - 278 BLAS - 320∞-1 PRODUCT (Cl) (Ac) (Cl) (Ac) (Cl) (Ac)______________________________________1182-1195 d d d d d d d 1290-1304 FF d d/m d/m m/f f F 1373-1390 FF === F === f/F F F 1391-1399 === m === m/f === === === 1490-1491 f f/F f/F f/F f/F f/F F 1538-1550 F === === === === F F 1601-1611 F === FF FF FF === FF 1631-1636 FF F FF FF FF FF FF 1660-1665 FF === === FF FF FF FF 1698-1709 FF === FF FF FF FF FF 1727 === FF === === === === === 1745-1765 F === === === === F F 2955-3050 d m/f === m/f === === d 3200-3500 d m/f m/f m/f m/f m/f m/f______________________________________ FF: very strong; F: strong; f: moderately strong; m: moderate; d: weak
PREFERRED EXECUTION MODES OF THIS INVENTION
In the following examples the present invention is illustrated with more detail, making reference to the specific compounds covered by it and to one specific case of the preparation procedure.
EXAMPLE NO. 1
BRM-BLAS 236 (Cl)
This name covers the A and B isomer compounds called (IUPAC-386.3) "1-(1-ammonium-3-aza-4-carboxyl-2-oxycyclopentyl) methylpyridinium" dichloride or "4-ammonium-4-(1-pyridiniomethyl) pyroglutamic acid dichloride" with the molecular formula C 11 H 15 Cl 2 N 3 O 3 .H 2 O, their elemental analysis of which, theoretical versus found, (in brackets) is C 40.51% (40.94%), H 5.25% (5.57%), N 12.88% (12.93%), Cl 21.74% and O 19.62%. In aqueous solution they have a maximum UV absorption peak at 259.5 nm and follow the Lambert-Beer Law for concentrations ranging between 10-100 micrograms/ml.
They can be obtained as a hydrochloride, monohydrated, by acid hydrolysis of the purified acetylated derivatives or directly from the crude product. The experimental conditions of hydrolysis are very broad. It can be performed with hydrochloric acid from 0.6N to 3.0N at 100°-115° C. during 2 to 16 hours, or at lower temperatures during longer reaction times. From a sample with 1.0 g of the semipurified acetylated derivatives dissolved in 40 ml of a 0.9N solution of hydrochloric acid and heated at 105° C. during 165 minutes, 250 mg of a mixture of A (40%) and B (60%) pure compounds can be obtained without any other sign in the 1 H-NMR and 13 C-NMR spectra that could correspond to impurities of another organic compound (FIGS. 2 and 3). They are mainly recovered from the chromatographic column hydrophilic phase eluate.
The spectroscopic data and the elemental analysis of the A and B diastereoisomer compounds fully confirm their molecular structure represented in the formula (II). ##STR3## The tabulated data of the 1 H-NMR and 13 C-NMR of Table II are self-explaining.
TABLE II______________________________________BRM - BLAS 236 (Cl) - A, B DIASTEREOISOMERS .sup.1 H--RMN .sup.13 C--RMNδ (ppm) Multiplicity.sub.W,H.sbsb.2.sub.) Integral δ (ppm) Assignment (Dept)______________________________________8.66 A m.sup.a 2H 174.0 C 8.63 B m.sup.b 2H 173.7 C 8.44 A,B m.sup.a 1H + 1H 173.1 C 7.96-7.87 A,B m 2H + 2H 172.5 C 5.03 A,B d(14.0) 1H + 1H 147.0 CH 4.73 A d(14.0) 1H 145.5 CH 4.62 B d(14.0) 1H 145.1 CH 4.18 B dd(10.3; 8.8) 1H 123.6 CH 4.06 A dd(10.4; 9.0) 1H 65.9 CH2 2.82 A dd(15.5; 9.0) 1H 65.0 CH2 2.75 B dd(14.0: 8.8) 1H 64.8 C 2.28 B dd(14.0; 10.3) 1H 49.5 CH2 1.92 A dd(13.5; 14.4) 1M 34.0 CH233.3 CH2______________________________________ .sup.a pseudoublet; .sup.b pseudotriplet
In synthesis, the protonic spectrum clearly evidences a CH--CH 2 aliphatic fragment linked by the first carbon to a heteroatom. The isolated AB system, strongly dis-screened and with a high coupling constant corresponds to a methylene group, having discarded a double CH═CH link through the experiment of correlation 1 H/ 13 C to a link. The 13 C-NMR spectrum corroborates such groupings and the CH signs respectively assigned to the aromatic carbons are in line with the values tabulated for the N-methylpyridine cation by Hans-Oto Kalinowski et al. (1988) (Refer to Table II). The EM mass spectrum confirms the presence of the pyridinium ring in the molecular structure of such compounds and their nominal mass, fragments at m/z 80 (protonated adduct of the pyridine) and at m/z 236, respectively, as shown in Table III.
TABLE III______________________________________MASS SPECTROSCOPY (EM) BIOLOGICAL RESPONSE MODIFIERSRELEVANT PEAKS BLAS - 236 BLAS - 278 BLAS - 320(m/z) (Cl) (Ac) (Cl) (Ac) (Cl) (Ac)______________________________________80 9% 40% 25% 37% 39% 96% 199 === === 7% 28% 15% 50% 236 33% 100% 36% === === === 241 === === === === 6% 12% 278 === === 53% 100% 58% 24% 320 === === === === 100% 100% 513 === === 3% === === === 553 === === 3% 7% === === 597 === === === === 5% === 639 === === === === 5% ===______________________________________ (%): Relative intensities of signals/The BRMBLAS 320 (Ac) spectrum includes only up to m/z 500
Likewise, the exact mass of the cation obtained in the high resolution EMAR spectrum fully coincides with the theoretical of the molecular formula inferred from the exact mass (δ-1.4 ppm), excluding the anion.
The data of the IR spectrum are also concordant. The wide and structured band between 2,200 and 3,500 cm -1 is characteristic of the aminoacid hydrochlorides and the single non-resolved band at 1,727 cm -1 of the carbonyl, lactamic and carboxylic groups (Table I). The different stereochemistry around one or both chiral centres would be the main reason for the existence of the A and B isomeric compounds, diastereoisomers.
EXAMPLE NO. 2
BRM-BLAS 236 (Ac)
These compounds come from the BRM-BLAS 236 (Cl) described above where the chloride molecular anion (Cl--) has been replaced by the acetate (CH.sub. COO--). They are called "1-(1-amino-3-aza-4-carboxyl-2-oxycyclopentyl) methyl]pyridinium acetate" or "4-amino-4-(1-pyridiniomethyl) pyroglutamic acid acetate". The molecular formula is C 13 H 17 N 3 O 5 .
The exchange of the molecular anion can be made at room temperature from a 2% aqueous solution of the BRM-BLAS 236 (Cl) compounds to which first NaOH ( 1 N) is added in an amount enough to obtain a pH>9 and then acetic acid until returning the solution to a pH<4. The BRM-BLAS 236 (Ac) compounds purified by chromatography can be obtained free from other salts with an approximate yield of 80% of the sample.
In aqueous solution, their maximum UV absorption peak is at 259.5 nm and they follow the Lambert-Beer law for concentrations between 10-100 micrograms/ml.
Their molecular structure or linkage formula is represented in the formula (III) ##STR4## Without it being possible to discard their corresponding ammoniacal salt.
The spectroscopic data of 1 H-NMR and 13 C-NMR are fully concordant or can be referred to those of the previously described BRM-BLAS 236 (Cl) compounds from which they derive (Table II; FIGS. 2 and 3).
Obviously, the EM spectra--since they have all the same molecular cation--are exactly the same (Table III; FIG. 4). However, the IR spectrum of the BRM-BLAS 236 (Ac) compounds shows strong and very strong bands at 1388 cm -1 and between 1500-1700 cm -1 , which are the characteristics of the methyl and carbonyl groups of their own molecular anion, which obviously are absent in the original compounds from which they derive (Table I; FIG. 5).
EXAMPLE NO. 3
BRM-BLAS 278 (Cl)
This name includes the monoacetylated derivatives of the BRM-BLAS 236 (Cl) compounds described above. They are called "1-(3-acetyl-1-ammonium-3-aza-4-carboxy-2-oxycyclopentyl) methyl]pyridinium dichloride" or "1-acetyl-4-ammonium-4-(1-pyridiniomethyl) pyroglutamic acid dichloride", of the molecular formula C 13 H 17 Cl 2 N 3 O 4 .
They can be directly obtained as main product in the form of hydrochlorides by partial acid hydrolysis of the diacetylated compounds or of the crude product and indirectly as a subproduct in the preparation of the BRM-BLAS 236 (Cl) compounds. They are mainly recovered from the chromatographic column mainly in the lipophilic phase eluate. The experimental conditions of the partial hydrolysis are somewhat narrow. It can be made with hydrochloric acid from 0.03 N to 0.07 N at 100-115° C. during 16 to 24 hours. From a sample of 2 g of the crude product dissolved in 100 ml of a 0.05 N solution of hydrochloric acid, heated at 105° C. during 18 hours, approximately 600 mg of the purified product (30%) can be obtained.
In aqueous solution, their maximum UV absorption peak is at 259.5-260 nm and they follow the Lambert-Beer law for concentrations between 10-100 micrograms/ml.
In general, the 1 H-NMR and 13 C-NMR spectra are referrable to those of the BRM-BLAS 236 (Cl) already described with the exception of the presence of four isomeric compounds with an additional methyl group for each of them, and the molecular structure of which corresponds to the structural formula (IV) ##STR5##
The identification of up to six isomers in some sample could be due to the presence of acyclic or dimeric nature compounds derived from the opening of the lactamic ring.
The exact cation mass obtained in the high resolution spectrum EMAR of the isomeric mixture, practically coincides with the theoretical calculated from the molecular formula obtained for the exact mass (δ 0.8 ppm), excluding the anion.
The comparative study of the respective EM spectra of the BRM-BLAS 278 (Cl) and BRM-BLAS 236 (Cl) compounds evidences their the inter-relationship. The highest intensity peak at m/z 278 corresponding to the mass of the molecular cation of the BRM-BLAS 278 (Cl) compounds takes place after losing 42 uam at m/z 236, precisely the nominal mass of the molecular cation of the BRM-BLAS 236 (Cl) compounds. Therefore, the former are undoubtedly monoacetylated derivatives of these compounds.
On the other hand, the loss of 79 uam from the m/z 278 main peak giving rise to the m/z 199 along with the signal at m/z 80 (protonated pyridine adduct) clearly reveals the presence of the pyridinium ring in their molecular structures (Table III).
The IR spectrometry is concordant with the position assigned to the acetyl group of the BRM-BLAS 278 (Cl) compounds, since such compounds lack the strong band at 1540 cm -1 (band II, in solid phase) characteristic of the N--H band combination and M--C tension in the amides and "R 1 --CO--NH--R 2 " related compounds and which, on the other hand, is evident in the diacetylated compounds from which they derive by partial acid hydrolysis (Table I; FIG. 6).
EXAMPLE NO. 4
BRM-BLAS 278 (Ac)
Under this name the monoacetylated derivatives of the BRM-BLAS 236 (Ac), described above, are included. They are called "1-(3-acetyl-1-amino-3-aza-4-carboxyl-2-oxycyclopentyl) methyl]pyridinium acetate" or "1-acetyl-4-amino-4-(1-pyridiniomethyl) pyroglutamic acid acetate", of the molecular formula C 15 H 19 N 3 O 6 . In an aqueous solution, their maximum UV absorption peak is at 259.5-260 nm and they follow the Lambert-Beer law for concentrations between 10-100 micrograms/ml.
They can be indistinctly obtained through heating the crude product during a long period of time in an aqueous solution (pH 4) or by replacement of the molecular anion of the BRM-BLAS 278 (Cl) compounds described above, by the acetate ion.
From a sample of 2 g of the crude product dissolved powder in 100 ml of water, after 18 hours at 110° C., approximately 500-600 mg (25-30%) of purified product can be obtained from the chromatographic column mainly in the lipophilic phase eluate, immediately after the hydrophilic phase.
The molecular structure or the structural formula of these compounds is represented in the formula (V). ##STR6## Without it being possible to discard their corresponding ammoniacal salt.
The spectroscopic data of these compounds are also concordant with the molecular structure shown. In general, they show the same type of compounds than the BRM-BLAS 278 (Cl) with the exception of a greater number of signals corresponding to the acetate molecular anion. The pattern of the IR spectrum is practically identical to that of such compounds (FIG. 6), both having the same number of bands (Table I).
The EM spectrum shows a main peak at m/z 278 which represents the nominal mass of the molecular cation and another two at m/z 199 and m/z 80 resulting from the fragmentation of the main one in two (FIG. 7). However, there is no trace of the peak at m/z 236, a contaminant that can appear with the BRM-BLAS 278 (Cl) compounds when they are obtained as a byproduct from the preparation of the BRM-BLAS 236 (Cl) compounds (Table III).
EXAMPLE NO. 5
BRM-BLAS 320 (Ac)
Under this name the diacetylated derivatives of the BRM-BLAS 236 (Ac) are included. The are called "1-(3-acetyl-1-acetylamino-3-aza-4-carboxy-2-oxycyclopentyl) methyl]pyridinium acetate" or "1-acetyl-4-acetylamino-4-(1-pyridiniomethyl) pyroglutamic acid acetate", of the molecular formula C 17 H 21 N 3 O 7 . In aqueous solution, their maximum UV absorption peak is at 260 nm and they follow the Lambert-Beer law for concentrations between 10-100 micrograms/ml.
They can be directly obtained from the crude product and if wanter from the BRM-BLAS 320 (Cl) purified compounds by replacing the molecular anion by the acetate ion. From a sample of 2 g of the crude product dry powder in a 2% aqueous solution, approximately 500-600 mg (25-30%) of purified product can be obtained from the chromatographic column mainly in the lipophilic phase eluate.
The molecular structure or the structural formula of these compounds is represented in the formula (VI). ##STR7##
The pattern of the 1 H-NMR spectra of the BRM-BLAS 320 (Ac) compounds, with regard to the multiplicities of signals and chemical shifts at which they appear, is totally referrable to that of the BRM-BLAS 236 (Cl) and BRM-BLAS 278 (Cl) compounds described above, except that it presents a greater number of signals corresponding to the methyl and carboxyl groups of the molecular anion and to the acetyl residues. Their analysis by 13 C-NMR, including DEPT, also supports the presence of the fragments observed in the most simple monoacetylated and disacetylated compounds. Structurally, they are in fact the same kind of compounds, four isomers being observed (FIG. 8), with the presence therein of two groups of acetyl signals.
The EM mass spectrum of shows multiple interrelated molecular fragments that, once again, confirm the presence of the pyridine ring and the acetyl residues as an integral part of the molecular structure of such compounds (Table III and FIG. 9). The IR spectrum shows the intense (strong) bands which are a characteristic of the carbonyl groups, between 1750-1600 cm -1 and the band II in solid phase (a combination of N--C tension and N--H flection) of the amides R 1 --CO--NH--R 2 at 1547-1549 cm -1 (FIG. 10) absent in the monoacetylated and disacetylated compounds (Table I).
EXAMPLE NO. 6
BRM-BLAS 320 (Cl)
Under this name the diacetylated derivatives of the BRM-BLAS 236 (Cl), described above, are included. They are called "1-(3-acetyl-1-acetylamino-3-aza-4-carboxy-2-oxycyclopentyl) methyl]pyridinium chloride" or "1-acetyl-4-acetylamino-4-(1-pyridiniomethyl) pyroglutamic acid chloride", the molecular formula being C 15 H 18 ClN 3 O 5 . In an aqueous solution they present a maximum UV absorption peak at 260 nm and they follow the Lambert-Beer law for concentrations between 10-100 micrograms/ml.
They can be indistinctly obtained from the crude product or from the BRM-BLAS 320 (Ac) compounds by treating them with a 0.05 N solution of hydrochloric acid, at room temperature, during a few minutes. The performance when the BRM-BLAS 320 (Ac) compounds are used is optimal (90%) If the Crude Product is used for the reaction of the molecular anion exchange, the product is recovered from the chromatographic column mainly in the lipophilic phase eluate. The molecular structure or the structural formula of these compounds is represented in the formula (VII). ##STR8##
The spectroscopic data of the BRM-BLAS 320 (Cl) compounds are completely similar to those of the BRM-BLAS 320 (Ac) which they come from, with the exception of the signals corresponding to their molecular acetate anion. The IR spectrum is practically identical for the compounds of both products, (Table I) and the same can be said in the case of the EM spectrum and those of the EMARs, (FIG. 11), since the exact mass found in both cases is practically identical, 320, 12465 and 320, 12480 for the compounds with the acetate and chloride anion, respectively; exact theoretical mass calculated for the molecular formula interred, 320, 12465.
EXAMPLE NO. 7
Procedure
50 g of L-serine, 200 ml of acetate anhydride and 60 ml of pyridine were reacted at 85° C. during 25 minutes and 40 g of the crude product powder were obtained.
Preclinical Studies
The preclinical study on the lymphocyte Response and Kinetics reveals a marked immunomodulator effect of the above-mentioned BRM-BLAS compounds, which inoculation to normal individuals is perfectly tolerated and followed by a significative increase of the biological response, above the mean physiological baseline of the group.
A.--"In Vitro" Tests
The "in vitro" lymphocyte response has been assessed in samples of circulating and peripheral venous blood from asymptomatic blood donor adults of both sexes. In general, the lymphocyte cultures include in each case six experimental models called witnesses, and incorporate progressive doses between 0.25-6.0 units (20-500 ng) of the BRM-BLAS compounds and PHA. The RLP-I of each one has been morphologically determined and is expressed in absolute values of lymphoblasts/10,000.
Systematically, in all the cases it has been tabulated the RLP-I to the PHA, basal, of the PHA models; to the PHA+BRM-BLAS, of the "witness" models and the maximum individual response of the witness models (RMC), in each case. The distribution of the sample is shown in Table IV.
TABLE IV______________________________________DISTRIBUTION OF THE SAMPLE GROUPS CONSIDERED - BRM BLAS - 236 BLAS - 278 BLAS - 320TESTS (Cl) (Ac) (Cl) (Ac) (Cl) (Ac) TOTAL______________________________________Number of cases 11 15 16 9 16 14 81 PHA Model alone 11 15 16 9 16 14 81 PHA + BRM-BLAS 66 90 93 54 96 82 481 TOTAL TESTS 77 115 109 63 112 96 562______________________________________
77% of the witness models globally show a RLP-I super-added to that of the respective basal PHA which varies among the groups from 70% [BRM-BLAS 236 (Cl) and BRM-BLAS 320 (Cl)] to 83% [BRM-BLAS 278 (Cl)], Table V.
TABLE V__________________________________________________________________________INTERMODEL GLOBAL ANALYSISEXPERIMENTAL GROUPS CONSIDERED - BRMMODEL BLAS - 236 BLAS - 278 BLAS - 320 TOTALPHA (A) VERSUS (Cl) (Ac) (Cl) (Ac) (Cl) (Ac) CASOS PHA + BRM-BLAS (B) Num. (%) Num. (%) Num. (%) Num. (%) Num. (%) Num. (%) Num. (%)__________________________________________________________________________RLP-I B > A 46(70) 73(81) 77(83) 40(74) 67(70) 65(70) 368(77) RLP-I B < A 20(30) 17(19) 16(17) 14(26) 29(30) 17(21) 113(23) TOTAL 66(100) 90(100) 93(100) 54(100) 96(100) 82(100) 481(100)__________________________________________________________________________
The intragroup individual analysis reveals, in turn, that the RLP-I to the PHA, basal, is exceeded in all cases, at least by 33%-50% of the respective witness models; in 74% by 67% of them, and in 30% by all, Table VI. These response patterns discard any randomized results and fully confirmed the cause-effect relation between the incorporation of BRM-BLAS compounds to the witness models and the RLP-I super-added to that of their PHA, basal.
TABLE VI__________________________________________________________________________INTRAGROUP RLP-1 INTERMODEL INDIVIDUAL ANALYSISEXPERIMENTAL GROUPS CONSIDERED - BRMMODELS BLAS - 236 BLAS - 278 BLAS - 320 TOTALPHA (A) VERSUS (Cl) (Ac) (Cl) (Ac) (Cl) (Ac) CASOS PHA + BRM-BLAS (B) Num. (%) Num. (%) Num. (%) Num. (%) Num. (%) Num. (%) Num. (%)__________________________________________________________________________RLP-I B > A(33-50%)# 11(100) 15(100) 16(100) 9(100) 16(100) 14(100) 81(100) RLP-I B > A(67%)# 9(82) 12(82) 13(81) 6(67) 11(69) 9(64) 60(74) RLP-I B > A(100%)# 2(18) 6(40) 6(37) 3(33) 2(13) 5(36) 24(30)__________________________________________________________________________ %: Percentage of the witness models with a RLPI B > A
The statistical assessment of the groups is also concluding. The RLP-I mean of each witness model of the group, irrespective of the relevant BRM-BLAS dose, exceeds that of the respective basal PHA (Table VII). Such response depends on the dose and the maximum values of the mean are distributed among the witness models with the higher experimental doses, corresponding 50%, 33% and 17% of such values to the models with three (210 ng), six (420 ng) and two units (140 ng) respectively (Table VII). The RLP-I super-added to that of the basal PHA of the group is statistically significant in 81% of the witness models and exceeds one standard deviation in 36% of them.
However, the most representative measure or indicator of the potential immunomodulating activity of such compounds could probably be the RMC individual or that of the group, which finally would be conditioned by the (limited) number of witness models. In this context, the intragroup values of the individual RMC reveal in most cases (50%-60%) a very significant increase of the RLP-I super-added to that of the respective basal PHA (100%) that oscillate within groups from 167% to 227% [BRM-BLAS 278 (Ac)] and from 191% to 298% [BRM-BLAS 320 (Ac)]. The highest mean of the groups prepared on the basis of the RMC individual represents a statistically and biologically significant increase, of the RLP-I super-added to that of the PHA, which in 83% is higher than two or three standard deviations, Table VII.
TABLE VII______________________________________"IN VITRO" RLP-I ADDED TO THAT OF THE PHA STATISTICAL ASSESSMENT GROUPS CONSIDERED______________________________________ #STR9## - #STR10## - ##STR11##______________________________________ MD represents the average of the total number of lymphoblasts/10.000 ##STR12## B. "In Vivo" Tests
The pharmacodynamic study to assess the leuko-lymphocyte kinetics has been carried out in New Zealand's albino, giant, female, adult, asymptomatic (healthy) rabbits. The blood samples with EDTA (ethylene-diamino-tetraAcetic acid), non-coagulable, for the periodical weekly controls, have been obtained by aseptic puncture from the marginal vein of the outer ear. The count and the differential cytologic survey of the white series has been routinely performed in a "Coulter" (Coulter Cientifica, S.A., STKs model) differential analyzer, within the two hours following the extraction.
Hereinafter, there is a summary of the most significant results of the preclinical protocols which include different experimental conditions, different BRM-BLAS products and doses which vary in vary of their concentration of the product, frequency and number.
I. Successive Doses (BRM-BLAS 236 (Cl))
The administration every 21 days of three successive intravenous doses of the BRM-BLAS 236 (Cl) compounds, each one of 5 U/Kg (300 ng/Kg) to 3-year old asymptomatic rabbits, without any other immunomodulating treatment during the previous months, was followed in all cases by an increase in the number of leukocytes which affect granulocytes as well as lymphocytes in the same way. The leuko-lymphocyte mean values of the group run parallelly during the study, in general above the respective basal values before the treatment to which they return in the last two assessments. They reach the higher ones 7, 16 and 20 days after the first, second and third dose, FIG. 12, FIG. 13 and Table VIII (assessments: 3, 8 and 13).
Statistically, the leukocyte (FIG. 12) and lymphocyte (FIG. 13) mean values of the group exceed the basal ones over the standard deviation in 55% and 75% of the assessments; by more than two in 20%, and an by more than three in 5% and 10% respectively. Furthermore the difference between them is statistically significant, in 70% of the assessments in the case of the leukocytes and in 35% in the case of the lymphocytes. Their highest values correspond to the assessment 8 of the study (37th day) and represent an increase over the basal ones of 169% and 157% respectively. Once the results have been grouped, the difference between the leuko-lymphocyte mean values of the "first" period (3rd to 31st Day; 24 assessments) and the "second" period (37th to 64th day; 24 assessments) during the treatment versus those of the "third" period (71st to 92nd day; 16 assessments) and "fourth" period (102nd to 122nd day; 16 assessments) post-treatment, is statistically significantly surpassing the mean values of the "first" period exceed those of the "fourth" period and the basal ones, practically by two standard deviations, Table VIII.
TABLE VIII__________________________________________________________________________LEUKO-LYMPHOCYTE KINETICS AFTER THE IMMUNOMODULATION SUCCESSIVE DOSES OF BRM-BLAS 236 (Cl) 5 U/Kg - I.V. Significance Levels - "p" Values EXPERIMENTAL TIMESEXPERIMENT- LEUKOCYTES LYMPHOCYTESAL TIMES BASAL FIRST SECOND THIRD FOURTH BASAL FIRST SECOND THIRD FOURTH__________________________________________________________________________ ##STR13##__________________________________________________________________________ Probability levels from the "Statistical tables for Biological, Medical and Agricultural Research, Fisher & Yates, Bdienburgh, Oliver and Lloyd, Liod. 1931"-
II. Progressive Doses (BRM-BLAS 320 (Ac))
The intravenous administration of the BRM-BLAS 320 (Ac) compounds in progressive doses of 5, 10, 15, 20, 25 and 30 units/Kg (0.4-2.4 mcg/Kg), the days 0, 21st, 43rd, 64th, 109th and 153rd of the survey to 31/2 year old asymptomatic rabbits and without any other immunomodulating treatment during the months prior to the first dose, was followed in all cases by a selective and significant increase in the number of lymphocytes that starts after the third dose and reaches its maximum level after the sixth, FIG. 14 and Table IX.
A total number of 225 individual assessments and 45 of the group assessments have been performed, grouped in four evolutive periods moments. The "first" one includes the 40 individual assessments (8 of the group) after the two first doses, days 0 to 43rd; the "second", the 85 (17 of the group) after the third, fourth and fifth doses, days 46th to 147th; the "third", the first 50 (10 of the group) after the sixth, days 153rd to 213th, and the "fourth", the last 50 (10 of the group), days 220th to 282nd, respectively. The assessment of the group prior to the third dose (43rd day), the lymphocyte mean of which has been the lowest during the survey, has been taken as the natural reference baseline for the comparative analysis of punctual and grouped data.
Logically, the lymphocyte mean of the group in all the assessments exceeds the selected basal (100%). However, there are large variations among the moments under consideration. In the "first" one, the relative values of such mean in each assessment oscillate from 103% to 117% of the basal, and in all of them the difference is lower than one standard deviation. In the "second" one, the values vary from 108% to 141% of the basals, 41% exceed one standard deviation and 43% reveal a statisitically significant difference. In the "third" and "fourth", the response is statistically and biologically more significant (Table IX). 80% of the assessment of the group in the "third" one and 100% in the "fourth" one exceed the mean of the lymphocyte basal values by more than one, two or three standard deviations and in all of them the difference is statistically significant. The highest average values reach a 178% over the basal values on the 92nd day after the sixth dose (day 241st of the study) "fourth" moment, FIG. 14.
The lymphocyte mean of the group, obtained from the results grouped in the four evolutive periods described above, increases from the baseline, in a progressive and uninterrupted way, from 110% on the "first" one to 120% on the "second", 131% on the "third" and 152% on the "fourth" (FIG. 15). The difference between the mean values of such groupings is statistically significant and that of the "fourth" moment exceeds that of the "first" one by more than one standard deviation. Moreover, the difference between the individual lymphocyte mean of each animal of the group at the "fourth" moment versus the "first" is statistically significant and higher in two or three standard deviations in 40% and 60% of the animals, respectively.
Paradoxically, the leukocyte mean values of punctual assessments of the group exceeds by one standard deviation of the basal values only in two occasions (4.4%), 227 th , (129%) and 241st (136%) day and during the study the difference is never became statistically significant. However, the group mean obtained from the data gathered shows differences that are statistically significant between the "fourth" versus the "first" or "third" moment and the "second" versus the "third" one but it never exceeds one standard deviation (Table IX). Finally, two animals (40%), individually, exceed at the "fourth" moment the respective figures of the mean values in the "first" one by two or three standard deviations, and the difference is statistically significant in both cases.
TABLE IX__________________________________________________________________________LEUKO-LYMPHOCYTE KINETICS AFTER THE IMMUNOMODULATION Significance Levels - "p" Values EXPERIMENTAL TIMESEXPERIMENT- LEUKOCYTES LYMPHOCYTESAL TIMES FIRST SECOND THIRD FOURTH FIFTH FIRST SECOND THIRD FOURTH FIFTH__________________________________________________________________________"BRM" BLAS 320 (Ac) #STR14##"BRM" BLAS 278 (Cl) SubcutaneousFIFTH 0.0050 0.0228 0.0002 0.2420 #### 0.0001 0.0001 0.0035 0.3446 ####__________________________________________________________________________ (*) Probability levels from the "Introduction to biostatistics"; Libers & (HULDAH BANCROFT); Page 72, table XIV
III. Unique Dose, High (BRM-BLAS 278 (Cl))
This trail is subsequent to the protocol previously described and corresponds to the "fifth" moment of the global study, FIG. 14 and FIG. 15.
After the subcutaneous administration of a dose of 30 u/Kg (2.1 mcg/Kg) of the BRM-BLAS 278 (Cl) compounds 137 days after the sixth dose of the BRM-BLAS 320 (Ac) compounds, in the presence of high figures of the lymphocyte mean of the group, at the "fourth" moment, such figures were specifically exceeded by the 4th and 5th punctual weekly assessments of the "fifth" moment, 24th (184%) and 31st (180%) days, respectively, FIG. 14. Globally, 28% of the assessment exceed basal values by one or two standard deviations; 57% in three, and the difference is statistically in all of them. The resulting mean of the data gathered for the "fifth" moment with a 158% of the basal values, exceed those of the four previous moments, and the difference is statistically significant compared with those of the "first", "second" and "third", and exceeds that of the "first" in more than one standard deviation, FIG. 15 and (Table IX).
Individually, the difference between the lymphocyte mean values of each one of the animals at the "fifth" moment versus the "first" one is statistically significant and higher than two or three standard deviations in 20% and 80% of the animals, respectively.
The leukocyte mean of 57% of the routine weekly assessments of the group exceeds the basal figures by one standard deviation and the difference is statistically significant in 29%.
The leukocyte mean of the group resulting from the data collected at the "fifth" moment shows statistically significant differences when compared with the "first", "second" and "third" moments which in all cases, is lower than one standard deviation (Table IX). Finally, and on individual basis, the mean at the "first" moment of 40% of the animals is exceeded at the "fifth" moment by more than two standard deviations and the difference between them is statistically significant.
IV. Single Low Dose, Versus Single High Dose, BRM-BLAS 278 (Ac) and BRM-BLAS 320 (Ac), Respectively
This study comprises three concatenated experimental situations. The first one is focused on the vicissitudes of the leuko-lymphocyte kinetics occurred during a pause, "first" moment, that takes place months after several doses, mainly of BRM-BLAS 236 (Cl) compounds and includes 30 individual assessments (6 of the group) days 0 to 39. The second "second" moment, is centered on the successive changes occurred after the administration on the 39th day of an intravenous dose of 8 u/Kg (0.6 mcg/Kg) of the BRM-BLAS 278 (Ac) compounds and includes a total of 25 individual assessments (5 of the group), days 43rd to 68th. The third one, moments "third" to "seventh", analyzes the changes induced after the intravenous administration on the 68th day of 22 u/Kg (1.8 mcg/Kg) of BRM-BLAS 320 (Ac) compounds and includes 150 individual assessments (6 of the group×5 times), days 75th to 287th of the study. The assessment prior to the last dose, the lymphocyte average of which is the lowest of the group during the study, has been selected as the common baseline (100%) for reference of the comparative analysis between the assessments.
Regarding the mean of the lymphocyte number, the peaks of the second and fifth assessment of the first block stand out ostensibly--pause between the treatments--which due to the "weight" of an outliner reach 157% and 164% of the baseline values, respectively, but are not statistically significant. After the low dose of the BRM-BLAS 278 (Ac) compounds, second block, the group mean in the fifth assessment appears in the basal line of the histogram, after some mere fluctuations, FIG. 16.
On the contrary, twenty days after the high dose of the BRM-BLAS 320 (Ac) compounds, such mean starts a scaling which surpasses the baseline by two or three standard deviations from the 53rd day and is statistically significant uninterruptedly, until the 213th day, the end of the study. Its highest values in respect of the basal ones reach 212%, on the 88th (fourth block) and 202nd days (seventh block) after the above-mentioned dose, the precise moment at which repeatedly the maximum biological response of all animals coincided--a synchronization of the response due "a priori" to the treatment, FIG. 16.
The lymphocyte mean resulting from the grouped data of the group in the seven evolutive moments reveals differences between them that are statistically significant, specifically the "fourth", "fifth", "sixth" and "seventh" moments over the "first", "second" and "third" ones, despite the relatively limited number of their assessments (Table X). The individual mean at the "seventh" moment exceeds that of the "first" one by one, two or three standard deviations in 80% of the cases and is statistically significant in all of them.
The leukocyte mean of the group exceeds the baseline by one standard deviation in 39% of the assessments; by two, in 24%, and by three in 5% (FIG. 17), and the difference is statistically significant in 12% of them. The leukocyte mean derived from the grouped data of the group shows statistically significant differences between the "fourth" and "sixth" moments versus the "second" and "third" ones (Table X), and that never exceeds one standard deviation. On the contrary, individually, no significant differences are observed between the different experimental moments.
Finally, the separated assessment of the relative and absolute figures of lymphocytes versus granulocytes and monocytes together, clearly shows a sustained and selective immunomodulating activity or effect of the BRM-BLAS 320 (Ac) compounds on subpopulations of lymphocytes without detriment to the number of granulocytes and monocytes, FIG. 18 and FIG. 19 (histograms include the 8th moment that follows the response pattern of the previous ones, FIG. 16 and FIG. 17).
The action mechanism is not known yet; however, it is assumed that the common mechanism of both "in vitro" and "in vivo" experimental models is a modulation on the cell differentiation (Ontogeny and the subsequent increase of the (absolute) number of mature and quiescent T lymphocytes (T Repertoire, available). Such subpopulations sensitive to the PHA, would be on the one hand recruited for the "in vitro" RLP-I and, on the other hand, would "in vivo" induce (peripheral) regulating signals inducing the increase in the number of circulating peripheral lymphocytes above the basal figures.
V. Toxicity
The intraperitoneal administration to Swiss, male and female, adult, healthy mice of a single dose of the BRM-BLAS 236 (Cl), BRM-BLAS 278 (Ac) and BRM-BLAS 320 (Ac) compounds, thousand of times higher than the protocols described above (800 mcg/Kg, 4.2 mg/Kg and 4.8 mg/Kg, respectively) was perfectly tolerated without evidences of toxicity. The necropsy made after 14 days merely reveals a slight decrease in the white pulp of the spleen, without apparent alterations of the hepatic, renal parenchyma, bone marrow, thymus, suprarenal glands, etc.
TABLE X__________________________________________________________________________LEUKO-LYMOHOCYTE KINETICS AFTER THE IMMUNOMODULATION GROUP ASSESSEMENT AT DIFFERENT EVOLUTION TIMES Significance Levels - "p" ValuesEXPERIMENTAL TIMES (Unique low dose 278 (Ac) vs. UNIQUE HIGH DOSE320 (Ac))EXPERI-LEUKOCYTES LYMPHOCYTESMENTAL SEC- SEV- SEC- SEV- TIMES FIRST OND THIRD FOURTH FIFTH SIXTH ENTH FIRST OND THIRD FOURTH FIFTH SIXTH ENTH__________________________________________________________________________ ##STR15##__________________________________________________________________________ Probability levels from the "Statistical tables for Biological, Medical and Agricultural Research, Fisher & Yates, Bdienburgh, Oliver and Lloyd, Liod. 1931"- @; PAUSE $; LOW DOSE 278 (Ac); #; HIGH DOSE 320 (Ac)
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The new derivatives of pyroglutaminic acid have the formula (I) wherein R 1, R 2 and R 3 are H or COR 4, R 4 being lower alkyl or aryl, A - is Cl -, CH 3 COO - and OH - and the ondulated line means that the substituent occupies any of the possible spatial positions. The process comprises the reaction of serine with pyridine and acetic anhydrid. These compounds may be applied in immunology as modifiers of the biological immune response, in the "integral" treatment of cancer and prevention or treatment of serious systemic infections in "high risk" patients suffering of chronical diseases and secondary immunodeficiency (cancer, AIDS, Diabetes Mellitus), or primary immunodeficiency (syndromes of DiGeorge, Down). ##STR1##
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This application is a division of Ser. No. 07/985,301, filed Dec. 4,1992, now abandoned, which is a continuation-in-part of copending application Ser. No. 07/802,628, filed Dec. 5, 1991, and entitled Non-Reusable Syringe now U.S. Pat. No. 5,181,912.
FIELD OF THE INVENTION
This invention relates generally to hypodermic syringes, and more particularly, to a hypodermic syringe having a part that is removable after use to serve as a needle guard.
BACKGROUND OF THE INVENTION
It is frequently necessary to use hypodermic syringes for intravenous administration of fluids, or to withdraw fluids from the veins of a person during the course of treatment of an illness, or in routine diagnostic examinations. Hypodermic syringes used for this purpose are generally disposable, and are intended to be discarded after a single use by trained medical personnel.
However, unless they are properly disposed of, these used syringes present a serious health hazard to persons subsequently handling them. For instance, if the needle is left intact and is not sheathed in a protective guard, it is possible that someone could be accidentally pricked with the needle during subsequent handling of it. If the syringe has been used to make an injection or withdraw body fluid from a person having an infectious disease, the consequences could be very serious to someone accidentally pricked with the needle.
One of the more serious concerns of health care workers is the danger of becoming accidentally infected with HIV-infected blood or other materials. Acquired Immune Deficiency Syndrome (AIDS) is now recognized as an epidemic of global proportion. In addition, there is an increasing recognition of a broad spectrum of severe HIV-associated diseases, including pneumonia, endocarditis, and pulmonary tuberculosis.
Medical and rescue personnel are aware of these risks, and when possible, take precautions to avoid unnecessary exposure or contact with infectious materials.
However, if a used syringe has been left intact and not properly disposed of, medical and rescue personnel, custodial workers, and others, are exposed to the danger of being accidentally pricked with the contaminated needle in spite of the precautions that they might normally take. Such a needle could be mingled with soiled linens, bandages or other materials, and when these materials are gathered for disposal, the needle has the distinct potential of penetrating the skin of anyone handling the materials.
To prevent such accidents from occurring, the needles should be broken from the used syringes, and/or encased in a protective sheath, and devices have been provided in the prior art for accomplishing this.
For instance, needles have been joined to the syringe body through frangible connections so that the doctor, nurse or other medical personnel can easily break the needle from the syringe after it is used. Unfortunately, this is not always done during the urgency of medical treatment, or if it is, there still remains an exposed needle body.
Similar shortcomings exist with respect to guards or sheaths that have been provided to encase the used needle. Such guards generally comprise separate sleeves or cap members that enclose the needle before it is used and which must be removed and set aside during use of the syringe. It is intended that after use of the needle, the guard will again be placed over the needle. However, the guard may become misplaced during the medical procedure being performed and therefore not available for reuse. Even if it is not misplaced, the person responsible for safe handling of the syringe may not have the time, or take the time, to retrieve the guard and place it over the needle.
A further problem exists with respect to syringes that are not properly disposed of or rendered inoperative after use. Used syringes of conventional construction are capable of reuse, and are thus liable to spread infectious diseases.
Although the medical community has long used disposable syringes a single time and then disposed of the used syringe, these syringes are sometimes stolen from hospitals, or from medical equipment suppliers, or are not properly disposed of after being used by authorized personnel, and ultimately come into the possession of drug abusers. Intravenous drug abusers consistently use the same syringe over-and-over again and share them with other drug abusers. This practice has led to the rapid spread of HIV, Hepatitis and other infectious diseases in the illicit drug use population.
Intravenous drug use is believed to account for most AIDS-related diseases in heterosexual men and women. This disease may also be transmitted to the children of infected adults, and to the sex partners of the infected persons, or to others, such as medical workers and rescue personnel, who may be inadvertently exposed to the blood of the infected person.
As AIDS-related diseases continue to grow, it is becoming increasingly more important to control the means by which these diseases are transmitted. Medical personnel, for example, should have reasonable assurance that they can perform their procedures without unnecessary risk of exposure to such infectious diseases, and without requiring time-consuming steps to render used syringes safe for subsequent handling.
Some examples of prior art syringes that utilize needle guards are shown in U.S. Pat. Nos. 2,550,394, 2,551,339, 2,566,428, 2,607,341, 4,365,626, 4,778,453, 4,782,841, 5,064,419 and 5,088,985. However, none of these patents teach the use of the plunger as a needle guard after the syringe has been used. U.S. Pat. No. 5,064,419 has a retractable needle that is displaced into the syringe barrel and piston following use of the syringe. U.S. Pat. No. 5,088,985 discloses an arrangement in which a needle remover (28) is normally fitted within the plunger body, but which may be removed and placed over the needle to separate it from the syringe. U.S. Pat. Nos. 2,550,394, 2,551,339, 2,566,428 and 2,607,341 all disclose arrangements in which a needle guard used during shipment and handling of the syringe is removed and inserted into the barrel to serve as a plunger when the needle is ready to use. In order to reuse the plunger as a guard following its use in any of these patents would require separation of the plunger from the piston, and would require an inventive step not suggested in any of the prior art.
In addition to an effective needle guard, a means is needed to prevent sharing and reuse of syringes by intravenous drug abusers, and thereby to prevent the spread of infectious diseases caused by use of contaminated syringes. Since the major cause of spread of HIV, Hepatitis and similar diseases is through the repeated and/or shared use of contaminated hypodermic syringes and needles, a significant preventive measure would be the elimination of the ability of intravenous drug abusers to acquire syringes that could be used more than one time.
Examples of some prior art efforts to provide non-reusable syringes are disclosed in U.S. Pat. Nos. 3,478,937, 3,951,146, 4,367,738, 4,391,272, 4,493,703, 4,731,068 and 4,781,684. Most of these patented devices involve some type of catch mechanism which becomes engaged upon full or partial travel of the syringe piston to lock the piston in place and prevent either its withdrawal or its insertion into the syringe barrel. Other devices disclosed in these patents include pistons which become separated from the plunger or stem after an operating cycle to eject a fluid from the syringe. For instance, U.S. Pat. Nos. 4,391,272, 4,731,068 and 4,781,684 disclose arrangements in which both some type of catch mechanism and a separable piston and stem structure are used.
All of the prior art devices known to applicant are either excessively complicated and expensive in construction or are not adequately reliable in operation. Further, many prior art devices require either modification of the barrel, or the use of separate collars, adapters or sleeves to connect the piston to the plunger or stem. Moreover, it is possible in some of these devices to reassemble them after use, whereby they may then be repeatedly used.
Accordingly, it would be desirable to have a disposable hypodermic syringe that is reliable in operation, simple and economical in construction, and in which a part of the syringe assembly, itself, is adapted as a needle guard after the syringe has been used for its intended purpose. It would further be desirable to provide a disposable syringe that is not capable of being reused after a single use.
SUMMARY OF THE INVENTION
The disposable syringe of the invention comprises a conventional cylindrical syringe barrel having a suitable conventional fitting on one end, such as a Luer lock adapter, or other means, for attaching a needle, and an open opposite end. A plunger or stem is reciprocable in the barrel and carries a piston on its inner end for developing vacuum or pressure, depending upon the direction of reciprocation of the piston and plunger in the barrel.
An essential feature of the present invention is the use of the plunger, itself, as a guard for the needle after the syringe has been used. To this end, the plunger has a cavity formed in it, shaped to receive the needle and to remain securely attached to the syringe after it has been placed over the needle. In use, the plunger is simply removed from the barrel after the syringe has been used, and placed over the needle. There is no separate member which must be retrieved and used for this purpose. Moreover, in a preferred embodiment, a small quantity of glue is positioned in the plunger/guard to adhesively secure the plunger/guard to the needle after it is placed in operative position on the needle.
Further in accordance with the invention, the syringe is automatically rendered inoperable after a single use, so that it cannot be used again. In a conventional-syringe, the piston is attached to the end of the plunger so that it will not become displaced from the plunger during use, even though the plunger and piston may be reciprocated many times in the barrel of the syringe. However, in the present invention, the piston is releasably attached to the end of the plunger by movable latch arms that move through an over center position so that the piston becomes displaced from the plunger after the plunger and piston are reciprocated through one cycle rearwardly and then forwardly in the barrel. A subsequent reciprocal movement of the plunger rearwardly in the barrel results in the piston becoming separated from the plunger so that it cannot be reattached to the plunger without the use of a special tool used during its manufacture, thus rendering the syringe incapable of further use.
In the present invention the piston is preferably made of a synthetic plastic material, whereas in conventional syringe constructions the piston is normally made of a rubber material. In an alternate construction, however, the piston used in the system of the invention may be made of rubber and still incorporate the novel features of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing and other objects and advantages of the invention will become apparent from the following detailed description when considered in conjunction with the accompanying drawings, wherein like reference characters refer to like parts throughout the several views, and wherein:
FIG. 1 is an enlarged perspective view of a syringe incorporating the built-in needle guard feature of the invention;
FIG. 2 is a view in elevation of the syringe of FIG. 1;
FIG. 3 is an exploded view, with parts broken away, of the syringe of FIG. 1, showing the plunger removed from the barrel and depicting how the plunger may be placed over the exposed needle to serve as a needle guard;
FIG. 4 is an enlarged view in elevation of the syringe of FIG. 1, showing the plunger removed from the barrel and applied to the end of the barrel to form a sheath for the needle;
FIGS. 5 and 6 are transverse sectional views taken along lines 5--5 and 6--6, respectively, in FIG. 2;
FIG. 7 is a greatly enlarged perspective view, with portions shown in section and portions broken away, of a syringe assembly incorporating both the built-in needle guard of FIG. 1 and an automatically separable piston and plunger arrangement to render the syringe incapable of reuse after a single use;
FIG. 8 is an enlarged, exploded, fragmentary perspective view of the automatically detachable piston and associated end of the plunger in the form of the invention shown in FIG. 7;
FIG. 9 is a greatly enlarged vertical sectional view of the piston and forward end of the plunger in the form of the invention shown in FIG. 7;
FIG. 10 is an enlarged, longitudinal sectional view of the plunger in a further modified form of the invention, wherein a small envelope containing an adhesive is placed in the bore of the plunger to adhesively secure the plunger/guard to the needle after the syringe has been used for its intended purpose;
FIG. 11 is a view similar to FIG. 10, showing how the adhesive-containing envelope is pierced by the needle when the plunger is placed in operative relationship over the needle;
FIG. 12 is a transverse sectional view, taken along line 12--12 in FIG. 11, showing how the adhesive forms a mechanical lock with the needle in the plunger bore after the envelope is pierced with the needle;
FIG. 13 is an exploded view in elevation of another form of the invention, wherein the forward end of the plunger from which the piston has become separated is inserted over the needle; and
FIGS. 14 and 15 are transverse sectional views taken along lines 14--14 and 15--15, respectively, in FIG. 13.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring more specifically to the drawings, a first form of syringe in accordance with the invention is indicated generally at 10 in FIGS. 1-6. In this form of the invention, a conventional syringe barrel 11 has a forward end 12 with a suitable means, such as a Luer lock adapter 13 for attachment of a needle 14, and an open rearward end 15.
An elongate plunger 16 is reciprocable in the barrel between a forward position inserted fully into the barrel, and a rearward position retracted or withdrawn in the barrel, and has a forward end 17 and rearward end 18. In this form of the invention, the plunger may have a generally X-shaped transverse cross-section, with a central body 19 and oppositely extending flanges 20, 21, 22 and 23 along diametrically opposite sides edge of the body to slidably support the plunger in the barrel. The rearward end of the plunger has a radially enlarged, generally bow-tie-shaped operating flange 24 which may be gripped with the fingers and used to reciprocate the plunger in the barrel, and a piston 25 is secured on the forward end of the plunger. The piston may either be releasably attached to the plunger, as in the later-described forms of the invention, or it may be permanently attached thereto as in conventional syringe constructions.
An essential feature of the present invention is the construction of the body 19 so that it is hollow and has a stepped configuration, including a larger cylindrical entry portion 19a adapted to snugly receive the forward end 12 of the syringe barrel, an intermediate tapered portion 19b adapted to lock onto the Luer Lock fitting 13 of the syringe barrel, and a reduced diameter portion 19c adapted to closely receive the needle 14.
After the syringe 10 has been used, it is a simple matter for the doctor, nurse or other medical personnel to simply withdraw the plunger 16 from the barrel 11 and place the plunger over the needle, with the tapered portion 19b locking onto the Luer Lock adapter 13 of the syringe barrel, as shown in FIGS. 3 and 4. There is no need for the doctor, nurse or other person using the syringe to search for and retrieve a separate needle guard, as is presently necessary in the prior art.
A second form of the invention is indicated generally at 30 in FIGS. 7-9. In this form of the invention, a detachable piston 31 is carried on the forward end of plunger 32 by an automatically releasable latching mechanism 33.
The forward end of the plunger has a reduced transverse dimension and defines an elongate, forwardly extending attaching post 34 with a plurality of radially outwardly projecting latching arms 35 integrally pivotally connected to the post at hinge areas 36. Four such latching arms are shown in the specific example described herein, but it is contemplated that a different number of arms could be used, if desired.
Each arm includes a thickened outer end portion defining detents 37 that are arranged in outwardly spaced, confronting relationship to a radially outwardly projecting retaining ring 38 formed on the post forwardly of the point of attachment of the arms to the post.
The piston 31 is carried on the post 34 at the forward end of the plunger, and as shown in FIGS. 7-9, is made of a synthetic plastic material. This plastic piston has a pair of oppositely axially projecting sealing flanges 39a and 39b, each flared radially outwardly and having a radially enlarged sealing bead 40 thereon for effecting a sliding seal with the inner surface of the barrel. Thus, during forward motion of the piston in the barrel, pressure of fluid in the barrel acting under the sealing flange 39a causes that flange to expand radially outwardly, making a tight sliding seal with the inner surface of the barrel. Conversely, rearward movement of the piston in the barrel causes lowered pressure in the forward end of the barrel to pull the sealing flange 39b outwardly to effect a tight sliding seal with the inner surface of the barrel.
The piston is held on the forward end of the plunger by a plurality of detents 41 on the end of the piston adjacent the plunger, spaced radially inwardly from the sealing flange 39a, and clamped between the latching arms 35 and retaining ring 38. These detents are molded with a natural, unbiased position as shown in FIG. 8, spaced radially outwardly out of contact with the retaining ring 38, and in the operative position of the invention are held inwardly behind the retaining ring by the latching arms 35.
As seen best in FIGS. 8 and 9, the outer ends of the arms 35, the retaining ring 38 and the detents 41 are uniquely shaped to cooperate with one another and with the inner surface of the barrel during reciprocal movement of the plunger in the barrel to either maintain the piston latched to the plunger, or to disengage the piston from the plunger.
With particular reference to FIG. 9, a first of these surfaces 42 defines a relatively narrow annular cylindrical band around the outer perimeter of the latching arms, which is parallel to the inner surface of the barrel and is adapted to slide along the inner barrel surface when the arms are in their normal, operatively latched position with respect to the detents on the piston. Thus, with the piston beginning in its forwardmost position at the forward end of the syringe, as seen in FIG. 7, this surface 42 is in parallel, sliding contact with the inner surface of the barrel.
At the same time, a second, latching surface 43 on a radially inner portion of each latching arm is in parallel, mating contact with a complemental latching surface 44 on an upper outer end portion of the detents 41 on the piston to hold the detents inwardly behind the retaining ring 38 and therefore latch the piston to the plunger, as shown in FIGS. 7 and 9.
After the piston and plunger have been withdrawn in the barrel, .and forward motion thereof is then initiated, the frictional drag between the outer ends of the latching arms and the inner surface of the barrel causes the arms to pivot rearwardly, as depicted in dashed lines in FIG. 9, through an over-center position to a rearwardly flexed inoperative position. The over center action results from the difference in diameter of the latching arms in comparison with the diameter of the inner surface of the barrel. Thus, when the arms are in their latched, operative position as shown in full lines in FIG. 9, the first surface 42 is on essentially the same diameter as the inner diameter of the barrel, and this surface is in close, sliding contact with the inner surface of the barrel. However, when the arms pivot rearwardly upon forward movement of the piston in the barrel, the outer ends thereof swing through an arc that places the outer ends of the arms on a greater diameter than the diameter of the inner surface of the barrel. Continued forward movement of the piston in the barrel results in the arms pivoting to their unlatched position shown in dashed lines at the left hand side of FIG. 9. In this position, a third surface 45 on the outer end of the latching arms is in parallel, sliding contact with the inner surface of the barrel. This surface 45 has substantial width in relationship to the first surface 42, and maintains the latching arms in this unlatched position, regardless of the direction of motion of the piston in the cylinder.
The operating relationship between a fourth surface 46 on the underside of the latching arm and the upper end of the detents 41 will become apparent. The upper end of the detents has a slightly tapered surface 47 that extends between a heel 48 at the radially outermost end thereof, to a nose 49 at the innermost end. Thus, when the plunger and piston have been retracted in the barrel, and forward motion thereof is then initiated, the heel 48 begins pushing upwardly against surface 46 on the latching arm, and, combined with the frictional drag of the Outer end of the arm against the inner surface of the barrel, begins upward flexing movement of the arm. Continued movement in this direction causes the nose 49 to begin sliding upwardly along a fifth surface 50 on the post immediately below the point of attachment of the arms, resulting in radially outward pivoting movement of the detents and continued upward pushing action of the heel against the surface 46. The latching arms are thus pivoted completely through this "over-center" motion to their fully unlatched position shown in dashed lines on the left side of FIG. 9, where the end surface 47 on the detents is in parallel contact with the undersurface 46 of the latching arms, securely holding the latching arms in their unlatched position during downward movement of the plunger and piston in the barrel and providing a large contact area between the plunger and piston for pushing the piston forwardly in the barrel.
When the plunger is again retracted in the barrel, the surfaces 45 on the outer ends of the latching arms easily slide along the inner surface of the barrel, whereby the latching arms are maintained in their unlatched position, regardless of the direction of reciprocation of the plunger in the barrel.
Upon subsequent withdrawal of the plunger in the barrel, the unlatched piston remains in its forwardmost, previously pushed position in the barrel.
During assembly of the syringe of the invention, the piston is first inserted into the barrel through the open rearward end thereof, and the plunger is next inserted to bring the post and latching arms into juxtaposition with the piston. A special tool (not shown) is then inserted through the open end of the barrel and into contact with the latching arms, and is used to force the latching arms through their over-center position into the latched position shown in FIG. 9.
The plunger 32 in this form of the invention also has a hollow central body 19, as in the previous form of the invention, with stepped diameter portions 19a, 19b and 19c for the same purposes as described in connection with the previous embodiment. However, rather than the X-shaped cross-section as previously described, the plunger in this form of the invention has a pair of laterally projecting webs 55 and 56 with oppositely directed circumferentially extending flanges 57 and 58 on their outer edges. In all other respects, and with the two exceptions noted above, this form of the invention functions the same and has all the advantages of the previous form of the invention.
A further form of the invention is indicated generally at 60 in FIGS. 10-12. This form of the invention is essentially the same as that form illustrated in FIGS. 7-9. However, in this form a small envelope 61 containing an adhesive 62 is located in the hollow bore portion 19c of the syringe in a position to be pierced by the needle 14 as the plunger is placed over the needle. The envelope 61 is roughly the size of a BB and is located at a point in the bore where small openings 63 and 64 are formed during the molding process. When the needle pierces the envelope, the adhesive 62 escapes and flows into the space surrounding the needle and into the two small openings 63 and 64, thereby forming a mechanical lock between the needle and the plunger and preventing removal of the plunger after the adhesive has cured. It should also be noted that it is anticipated that a small quantity of the adhesive will enter the end of the needle as it passes through the envelope of adhesive, plugging the needle and preventing its use even if access to it should be gained.
Yet another modification of the invention is indicated generally at 70 in FIGS. 13-15. In this form of the invention, the piston-receiving end 17 of the plunger is shaped with a tapered recess 71 for locking engagement on the Luer Lock adapter 13 of the syringe barrel, and a reduced diameter elongate opening 72 extends from the end of the tapered section to receive the needle 14. The major difference between this form of the invention and that previously described is that the plunger may be grasped by the flanged end 25, pulled from the syringe barrel, and pushed over the needle without inverting it end-for-end.
While the piston has been described herein as made of plastic, it should be understood that it may equally as well be made of rubber, as described in copending application Ser. No. 07/802,628. In such event, the piston itself is constructed differently in the area where it seals with the barrel, but the latching mechanism is substantially identical to that previously described, and the hollow body for encasing the needle are the same as before.
In a specific example of the invention, and with the latching arms in their natural, as-molded position, the first surface 42 is disposed at an angle of 15° relative to the longitudinal axis of the syringe, the third surface 45 is disposed at an angle of 25° relative to the longitudinal axis, and the fourth surface 46 is inclined 20° with respect to the transverse axis of the syringe. Further, there are four substantially uniformly circumferentially spaced latching arms and eight substantially uniformly circumferentially spaced detents, with each latching arm arranged to press against two of the detents.
The syringe of the invention is simple and economical in construction, and does not require any more parts than a conventional syringe, i.e., the barrel, plunger and piston. Yet, it provides an entirely different structure and function as compared with a conventional syringe, i.e., the plunger doubles as a needle guard after the syringe has been used. Further, as described in somewhat greater detail in the parent application, the piston is connected to the plunger through a latched construction that automatically disables the syringe after a single use.
While the invention has been illustrated and described in detail herein, it is to be understood that various modifications may be made therein without departing from the spirit and scope of the invention, as defined by the appended claims.
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A disposable hypodermic syringe having a barrel with an adapter on one end for attachment of a needle, and a piston and plunger reciprocable in the barrel. The plunger has a longitudinally extending hollow bore therein and is removable from the barrel and lockable on the adapter in enclosing relationship to the needle to serve as a needle guard. In one form of the invention, the piston and plunger are automatically separable upon use to prevent reuse of the syringe.
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BACKGROUND OF THE INVENTION
[0001] Potassium citrate is used clinically to treat kidney stones by alkalizing the urinary pH and increasing urinary citrate concentration. However, its therapeutic efficacy is limited by its gastrointestinal complications such as irritation and ulcerations. Extended-release tablets of potassium citrate could minimize these side effects and have been shown to lead to sustained elevation of urinary pH and citrate concentration (Pak et al., 1984).
[0002] Considerable difficulties have been encountered in the preparation of extended-release matrix tablets containing potassium citrate. Potassium citrate is very soluble in water and the dosage required is very high. The only way to extend the release of potassium citrate tablet while keeping the tablet size acceptable for swallowing is to use a hydrophobic wax matrix, wherein the total amount of inactive ingredients is below 25% w/w.
[0003] Mission Pharmacal (San Antonio, Tex., USA) sells an extended-release potassium citrate tablet, Urocit-K, in three strengths: 5-meq, 10-meq, and 15-meq tablets. The daily dose of Urocit-K is 30-60 meq, which requires 6-12 tablets of the 5-meq, 3-6 tablets of the 10-meq, and 2-4 tablets of the 15-meq. Urocit-K is a wax matrix tablet containing potassium citrate, carnauba wax as extended-release agent, and magnesium stearate as, lubricant.
[0004] When the drug content is low, the carnauba wax can be dry mixed with the drug and other inactive ingredients prior to compression. For example, U.S. Pat. No. 4,904,478 teaches an extended-release wax matrix tablet of a highly water-soluble drug, sodium fluoride, wherein the carnauba wax, present at 35-70% w/w of the tablet weight, is dry mixed with the drug and other inactive ingredients prior to compression.
[0005] In the case of potassium citrate, because the drug dosage is high, the inactive ingredients including the extended-release agent(s) must be kept below 25% w/w to keep the tablet size acceptable for swallowing. If carnauba wax is used at less than 25% w/w, prior art teaches that the drug and carnauba wax should be heated until the carnauba wax liquefies, as described in Example 1 of US 2008/0131504 A1, to give an acceptable extended-release profile and abrasion. Abrasion is a measure of the durability of the tablet from the time it is compressed, to packaging, and to the time of use.
[0006] The process for making extended-release potassium citrate tablet containing carnauba wax is difficult. Heating until the carnauba wax liquefies requires a lot of time and then there is the problem of discharging the molten potassium citrate-carnauba wax mixture from the mixer. The cooled mass is extremely hard; therefore the molten mass must be poured into molds so that the cooled mixture is of appropriate size for feeding into a comminuting machine. There is a need for a simpler process to make extended-release potassium citrate wax matrix tablet.
SUMMARY OF THE INVENTION
[0007] We have surprisingly found that extended-release potassium citrate tablets containing carnauba wax can be produced without melting the wax. The potassium citrate-carnauba wax mixture is heated to a temperature below the temperature at which carnauba wax liquefies, and then discharged from the mixer as granules. The temperature is preferably higher than 55° C., and most preferably higher than 60° C. The cooled granulate can then be fed directly into a comminuting machine for size reduction. The tablet of this instant invention has the same dissolution profile as prior art tablet produced by totally melting the wax. This instant invention reduces the production time and eliminates the complexities related to melting and cooling the wax.
DETAILED DESCRIPTION OF THE INVENTION
[0008] Extended-release potassium citrate tablet must comply with USP 35. Dissolution is performed in 900 ml water, apparatus 2 at 50 rpm, and must comply with the following dissolution specifications:
[0000]
TABLE 1
(dissolution, 12 units)
Time
All Units
Average
30
min
30-60%
35-55%
1
hour
45-75%
50-70%
3
hour
≧75%
≧80%
[0009] Abrasion was measured in an Erweka TAR20. Briefly, ten tablets were placed inside a baffled 190 mm ID drum. The drum was rotated at 25 rpm for 4 minutes. The difference in the total tablet weight before and after rotating the drum divided by the initial tablet weight is the abrasion. The desired abrasion for extended-release potassium citrate tablet is not more than 1.5%.
COMPARATIVE EXAMPLE 1
[0010] 10-meq tablets of Urocit-K (Mission Pharmacal, lot 9L038) were purchased. The tablet hardness was 9 kp, and abrasion was 0.3%. The dissolution was performed according to USP 35. The result is as follows:
[0000]
TABLE 2
(dissolution, 12 units)
Time
Range
Average
30
min
43.6-47.6%
45.2%
1
hour
57.9-61.1%
60.4%
3
hour
87.9-97.4%
91.7%
[0011] The product complies with the USP 35 requirement for extended-release potassium citrate tablet.
EXAMPLE 2
[0012] A 10-meq tablet was prepared by dry mixing potassium citrate and carnauba wax. The formulation is given in Table 3.
[0000]
TABLE 3
Ingredient
mg/tablet
% w/w
Tripotassium citrate monohydrate
1080
85
Carnauba wax
177
14
Magnesium stearate
13
1
[0013] Potassium citrate was sieved through mesh 18, and then mixed with carnauba wax for 5 minutes in a sigma mixer. Magnesium stearate was passed through mesh 30, added to the potassium citrate-carnauba wax mixture, and mixed for 1 minute. The granule was compressed into 18.9×8.6 mm elliptical tablet in a Stokes-Pennwalt rotary tablet press model 900. Tablet hardness was 7 kp, and the abrasion of the tablet was 1.8%, which is not acceptable. The dissolution profile is as follows:
[0000]
TABLE 4
(dissolution, 12 units)
Time
Range
Average
30
min
47.8-62.0%
53.7%
1
hour
66.9-74.9%
68.5%
3
hour
89.7-95.6%
92.7%
[0014] The product fails the dissolution requirement of USP 35. This example illustrates that dry mixing carnauba wax at 14% w/w to produce granules for direct compression does not produce tablet that complies with the USP requirements for potassium citrate extended-release tablet. Further, the abrasion is not acceptable.
EXAMPLE 3
[0015] A 10-meq tablet was prepared by dry mixing potassium citrate and carnauba wax. The formulation is given in Table 5.
[0000]
TABLE 5
Ingredient
mg/tablet
% w/w
Tripotassium citrate monohydrate
1080
79
Carnauba wax
272
20
Magnesium stearate
14
1
[0016] Potassium citrate was sieved through mesh 18, and then mixed with carnauba wax for 5 minutes in a sigma mixer. Magnesium stearate was passed through mesh 30, added to the potassium citrate-carnauba wax mixture, and mixed for 1 minute. The granule was compressed into 18.9×8.6 mm elliptical tablet in a Stokes-Pennwalt rotary tablet press model 900. Tablet hardness was 7 kp, and the abrasion of the tablet was 2%, which is not acceptable. The dissolution profile is as follows:
[0000]
TABLE 6
(dissolution, 12 units)
Time
Range
Average
30
min
49.4-54.5%
52.5%
1
hour
64.3-69.1%
67.1%
3
hour
90.2-94.5%
92.4%
[0017] This example illustrates that dry mixing carnauba wax at 20% w/w to produce granules for direct compression, while passing the compendial dissolution requirement, does not produce tablet of acceptable abrasion.
EXAMPLE 4
[0018] A 10-meq tablet with the same formulation as Example 2 was prepared by fully melting the carnauba wax. The procedure is as follows:
[0019] 1. The potassium citrate was comminuted in a Fitzmill D6, knives forward, using perforated screen mesh 8.
[0020] 2. The comminuted potassium citrate from #1 was mixed with carnauba wax in a sigma mixer for 20 minutes.
[0021] 3. The granule from #2 was comminuted in a Fitzmill D6, knives forward, using perforated screen mesh 12.
[0022] 4. The granule from #3 was heated in a jacketed sigma mixer, with continued mixing. Heating was continued until the carnauba wax was fully melted (above 80° C.), and for an additional 10 minutes thereafter.
[0023] 5. The liquid mass from #4 was poured into 2″×2″×2″ molds, and allowed to cool to room temperature.
[0024] 6. The blocks from #5 were comminuted in a Fitzmill D6, knives forward, using perforated screen mesh 16.
[0025] 7. Magnesium stearate was passed through mesh 30 and mixed with the comminuted granule of #6 in a sigma mixer for 2 minutes.
[0026] 8. The granule from #7 was compressed into 18.9×8.6 mm elliptical tablet in a Stokes-Pennwalt rotary tablet press model 900.
[0027] Tablet hardness was 12 kp, and the abrasion of the tablet was 0.5%. The dissolution profile is as follows:
[0000]
TABLE 7
(dissolution, 12 units)
Time
Range
Average
30
min
46.8-53.3%
48.2%
1
hour
61.7-69.1%
63.1%
3
hour
91.3-98.3%
92.7%
[0028] This tablet produced according to prior art method has good abrasion and passes the dissolution requirement of USP 35.
EXAMPLE 5
[0029] A 10-meq tablet of this instant invention was prepared. The formulation is the same as Example 2. The procedure is as follows:
[0030] 1. The potassium citrate was comminuted in a Fitzmill D6, knives forward, using perforated screen mesh 8.
[0031] 2. The comminuted potassium citrate from #1 was mixed with carnauba wax in a sigma mixer for 20 minutes.
[0032] 3. The granule from #2 was comminuted in a Fitzmill D6, knives forward, using perforated screen mesh 12.
[0033] 4. The granule from #3 was heated in a jacketed sigma mixer, with continued mixing. Heating was continued until the temperature reached 70° C., which is below the melting point of carnauba wax.
[0034] 5. The granule from #4 was discharged into plastic drums and allowed to cool to room temperature.
[0035] 6. The cooled granule from #5 was comminuted in a Fitzmill D6, knives forward, using perforated screen mesh 16.
[0036] 7. Magnesium stearate was passed through mesh 30 and mixed with the comminuted granule of #6 in a sigma mixer for 2 minutes.
[0037] 8. The granule from #7 was compressed into 18.9×8.6 mm elliptical tablet in a Stokes-Pennwalt rotary tablet press model 900.
[0038] Tablet hardness was 12 kp, and the abrasion of the tablet was 0.6%. The dissolution profile is as follows:
[0000]
TABLE 8
(dissolution, 12 units)
Time
Range
Average
30
min
43.5-48.7%
46.8%
1
hour
59.6-63.8%
61.9%
3
hour
89.9-94.7%
92.8%
[0039] The tablet produced according to this instant invention has good abrasion and similar dissolution profile with tablets produced using prior art method whereby the carnauba wax is fully melted (Example 4). This is surprising because it was previously believed that extended-release potassium citrate tablet containing carnauba wax can only be produced by fully melting the carnauba wax. The method of this instant invention significantly simplifies the production of extended-release potassium citrate tablet, with reduction in production time and elimination of manufacturing complexities related to melting and cooling the wax.
COMPARATIVE EXAMPLE 6
[0040] 15-meq tablets of Urocit-K (Mission Pharmacal, lot 2A012) were purchased. The tablet hardness was 12 kp, and abrasion was 1%. The dissolution was performed according to USP 35. The result is as follows:
[0000]
TABLE 9
(dissolution, 12 units)
Time
Range
Average
30
min
35.2-40.2%
38.0%
1
hour
49.9-61.0%
53.1%
3
hour
79.7-82.8%
81.1%
[0041] The product complies with the USP 35 requirement for extended-release potassium citrate tablet.
EXAMPLE 7
[0042] A 15-meq tablet was prepared by fully melting the carnauba wax. The formulation is given in Table 10.
[0000]
TABLE 10
Ingredient
mg/tablet
% w/w
Tripotassium citrate monohydrate
1620
84
Carnauba wax
289
15
Magnesium stearate
19
1
[0043] The tablets were made as described in Example 4 except that the granule was compressed into 22.5×9.3 mm elliptical tablets with a hardness of 13 kp and abrasion of 0.3%. The dissolution is as follows:
[0000]
TABLE 11
(dissolution, 12 units)
Time
Range
Average
30
min
35.9-41.2%
38.5%
1
hour
48.9-62.0%
53.5%
3
hour
79.5-84.6%
82.2%
[0044] This tablet produced according to prior art method has good abrasion and passes the dissolution requirement of USP 35.
EXAMPLE 8
[0045] A 15-meq tablet of this instant invention was prepared. The formulation is the same as Example 7. The procedure is as follows:
[0046] 1. The potassium citrate was comminuted in a Fitzmill D6, knives forward, using perforated screen mesh 8.
[0047] 2. The comminuted potassium citrate from #1 was mixed with carnauba wax in a sigma mixer for 20 minutes.
[0048] 3. The granule from #2 was comminuted in a Fitzmill D6, knives forward, using perforated screen mesh 12.
[0049] 4. The granule from #3 was heated in a jacketed sigma mixer, with continued mixing. Heating was continued until the temperature reached 60° C., which is below the melting point of carnauba wax.
[0050] 5. The granule from #4 was discharged into plastic drums and allowed to cool to room temperature.
[0051] 6. The cooled granule from #5 was comminuted in a Fitzmill D6, knives forward, using perforated screen mesh 16.
[0052] 7. Magnesium stearate was passed through mesh 30 and mixed with the comminuted granule of #6 in a sigma mixer for 2 minutes.
[0053] 8. The granule from #7 was compressed into 22.5×9.3 mm elliptical tablet in a Stokes-Pennwalt rotary tablet press model 900.
[0054] Tablet hardness was 12 kp, and the abrasion of the tablet was 0.8%. The dissolution profile is as follows:
[0000]
TABLE 12
(dissolution, 12 units)
Time
Range
Average
30
min
38.8-41.0%
40.1%
1
hour
53.1-56.3%
55.0%
3
hour
84.7-90.9%
87.6%
[0055] The tablet produced according to this instant invention has good abrasion and passes the USP 35 dissolution specs. This is surprising because it was previously believed that extended-release potassium citrate tablet containing carnauba wax can only be produced by fully melting the carnauba wax. The method of this instant invention significantly simplifies the production of extended-release potassium citrate tablet, with reduction in production time and elimination of manufacturing complexities related to melting and cooling the wax.
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The present invention relates to a method for producing extended-release potassium citrate tablet containing camauba wax, wherein the method comprises heating the potassium citrate-carnauba wax mixture to a temperature below the temperature at which carnauba wax liquefies. This invention simplifies the production of extended release potassium citrate wax-matrix tablet.
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CROSS REFERENCE TO RELATED APPLICATION
This application is a continuing application Ser. No. 07/597,418, filed Oct. 15, 1990, now abandoned.
BACKGROUND OF THE INVENTION
The present invention relates to oxidation of green and Oolong tea leaves to alter the organoleptic and aesthetic characteristics of extracts obtained therefrom.
As is accepted in the art, green tea is tea which has been freshly picked and which generally has undergone treatment, such as a heat treatment, to inactivate enzymes contained in the tea which oxidize chemical substances contained in the tea. As is also known in the art, Oolong tea is tea which has been subject to some enzymatic oxidation.
Black tea is prepared conventionally by subjecting freshly picked tea leaves to various processing steps which include a fermentation step which employs enzymes naturally present in the tea to effect enzymatic oxidation of chemical substances contained in the tea which results in providing the organoleptic and aesthetic characteristics, i.e., aroma, flavor and color, associated with aqueous beverage extracts obtained from black tea. Extracts of black tea may be consumed as a hot beverage or may be chilled to provide a cold beverage, or the extracts may be processed further to provide an instant water-soluble product for preparation of hot and cold beverages.
Although beverages prepared from green and Oolong teas are appreciated by consumers in various parts of the world, in some localities, particularly in the United States, consumer preferences dictate that tea beverages have the organoleptic and aesthetic characteristics of beverage extracts obtained from black tea. In contrast to the distinctive reddish coloration of extracts obtained from black tea, aqueous extracts obtained from green tea, in particular, have a yellowishgreen coloration which tends to reinforce a perception in consumers that the extracts have a "grassy" flavor and aroma and a "bitter" taste. Oolong teas have organoleptic and aesthetic characteristics which fall in between those of green and black teas.
Efforts have been undertaken in the art to treat fresh and green teas to obtain a product having characteristics which at least approach those of black tea obtained by enzymatic oxidation of fresh tea. Illustrative of such efforts are Seltzer, et al., U.S. Pat. No. 2,975,057, ("Seltzer") Gurkin, et al., U.S. Pat. No. 3,445,236, ("Gurkin") and Moore, et al., U.S. Pat. No. 3,484,246, ("Moore").
Seltzer discloses a process said to enable obtaining fermented black tea and partially fermented tea of more uniform quality from green tea. To obtain this objective, the process is carried out by extracting green tea leaves with water and then combining the aqueous extract with what is described as a "relatively small amount" of "bruised" fresh tea leaves and then heating the mixture of the extract and bruised leaves in the presence of oxygen at a temperature not to exceed 43° C. for a period of time after which the reaction mixture is heated to inactivate the enzymes. The extract obtained is said to have characteristics of black tea.
Gurkin discloses treating an aqueous extract of green tea in the presence of oxygen or treating green tea leaf in the presence of water and oxygen at a temperature above 50° C., and preferably, at a temperature of from 75° C. to 125° C., under a pressure of at least 100 psig (7.03 kg/cm 2 ), and preferably at a pressure of from 14.06 kg/cm 2 to 56.24 kg/cm 2 . Times of treatment may range from 2 mins to 30 mins. It is taught that, preferably, the pH of the reaction media be above a pH of 7 prior to the treatment. In addition to demonstrating the effects of variables of pressure, time, pH and concentration of tea solids when treating aqueous extracts, Gurkin discloses treating macerated leaves in water in a ratio of water to leaf of 9:1. Gurkin also posits that the treatment may be carried out by adding a "small amount" of water to the green leaf and converting it to black tea leaf under the disclosed conditions.
Moore, which was assigned commonly with Seltzer and Gurkin, also discloses a process for treating water-soluble constituents of green tea leaves, particularly aqueous extracts thereof, in the manner of Gurkin. Moore, however, differs from Gurkin in that the process requires that the reaction media have a pH of at least 7.5. It is disclosed that such a pH was found to be a "major" factor affecting the color of the final product and that such a pH is necessary to produce a "practical degree of conversion within a commercially feasible time". When leaves are to be treated, Moore teaches that they are to be treated in an alkaline solution in which the majority of the solution is absorbed by the leaf.
Other efforts which teach treating tea leaves and tea solids in aqueous solution media include U.S. Pat. No. 3,484,247 in which heat and ozone are employed to treat an aqueous media having a pH above about 6.0.
As also is known in the art, polyphenolic substances, of which tannin compounds are included, play a significant role in providing the characteristic organoleptic and aesthetic characteristics of tea extracts. In that regard, to obtain a water-soluble oxidized tea extract having a higher tannin content for obtaining a tea beverage said to be of higher quality than is said to be obtainable in extracts obtained from enzymatically oxidized black tea, U.S. Pat. No. 2,863,775 discloses extracting fresh tea leaves, as plucked from the tree, and oxidizing the extract obtained with the aid of an inorganic catalyst, such as potassium permanganate, while heating the extract at 80° C. to 90° C.
Additionally, efforts have been undertaken to reduce what is known in the art as "turbidity" of tea extracts, which is believed due in large part to the polyphenolic substances present in the extracts. Although polyphenolic substances are readily soluble in hot water, i.e., boiling water, at beverage concentrations and at temperatures when the beverage is consumed hot, when the extracts are cooled to room temperature and below, these substances are, at most, only partially soluble in the water of the extract. Thus, the cooled extracts have a "cloudiness", known in the art as turbidity, which is not aesthetically acceptable but which, if removed from an extract result in loss of flavor and production yield losses.
U.S. Pat. No. 3,903,306 addresses the problem of turbidity by teaching a controlled pH reaction which employs hydrogen peroxide to treat an aqueous suspension of green tea. Nagalakshmi, et al. Food Chemistry 13 (1984) 69-77 disclose treating green tea by incorporating various carbohydrates into green leaves and then fermenting the treated leaves to obtain black tea having reduced cold water insoluble solids. U.S. Pat. No. 4,051,264 discloses a process for treating green tea with tannase which is said to, after a traditional fermentation process, provide an extract having a reduced level of cold water insoluble solids as compared with an extract prepared from like leaves not so treated.
SUMMARY OF THE INVENTION
The present invention is characterized in that polyphenolic substances contained in moist green and/or Oolong tea leaves having a moisture content of at least 17% by weight based upon the dry weight of tea solids contained in the moist leaves ("by weight dry tea solids") are oxidized at an elevated temperature and at a pressure greater than the water vapor pressure at the elevated temperature. The reaction is characterized further in that the moist leaves are contacted at the elevated temperature with an oxidizing agent which provides an amount of molecular oxygen sufficient to the moist leaves to oxidize polyphenolic substances contained in the moist leaves.
With more particularity, the present invention is characterized in that moist green tea leaves, such as Japanese tea leaf fannings, and/or Oolong tea leaves having a moisture content of from about 17% to about 25% by weight dry tea solids are heated to an elevated temperature of from about 110° C. to about 130° C. and contacted with an oxidizing agent which provides molecular oxygen to the moist leaves in an amount of from about 0.3 moles 0 2 /kg of tea based upon the dry weight of the tea solids contained in the moist leaves ("0 2 /kg dry tea solids") to about 2.0 moles 0 2 /kg dry tea solids for a time sufficient and at a pressure greater than a water vapor pressure at the elevated temperature for oxidizing polyphenolic substances contained in the moist leaves.
The treated leaves may be processed immediately for preparing water-soluble instant tea products, or they may be dried for subsequent extraction for preparation of a beverage.
It has been discovered that the amount of moisture employed in the oxidizing treatment of the present invention is a very critical variable. By reason of the amount of moisture employed in the process of the present invention, the leaves to be treated are only moist which is believed to facilitate the permeation of the leaves by the oxidizing agent.
For purposes of this disclosure, the term "moist" is intended to mean and is used to mean that there is no free water present between or amongst the leaves during the oxidation step which would occur if the leaves are saturated with water which would tend to cause extraction of the leaves or result in a slurry and result in providing oxidized leaves which provide extracts which have a low pH and poor flavor and color characteristics.
Thus, in the process of the present invention, by reason of the leaves being only moist and thereby having no free water present, the oxidation reaction takes place in localized sites on and within the tea leaf structure. Therefore, the pH changes which occur due to the oxidation reaction occur substantially only at the localized sites and do not substantially affect neighboring oxidation reaction sites, which would occur if free water were present. Thus, the present invention affords a method to control the pH of the oxidation reaction and avoids the need for employing alkaline compounds in the reaction to control pH or the need for significant, if any, pH adjustment of extracts obtained from the oxidized leaves.
Additionally, it has been discovered that although a broad range of moisture contents can be employed to obtain leaves which provide extracts which have substantially reduced turbidity, extracts having a desirable aroma, flavor and color are obtained only when treating leaves having a moisture content of from about 17% to about 25% by weight dry tea solids.
In carrying out the process of the present invention, the moist tea leaves, and hence the various oxidizable substances of the tea leaves, are contacted with molecular oxygen. Although various oxidizing agents can be employed to provide the molecular oxygen for the reaction, various chemical agents such as hydrogen peroxide or permanganate, for example, may be deemed undesirable because residues of the same in the treated leaves may be considered to be food additives, and thus, the final product therefore would not be considered to be 100% tea. Thus, gaseous oxidizing agents are most preferred. Suitable gaseous oxidizing agents include ozone or ozone-containing gases, but more advantageously, an oxygen-containing gas, including air and oxygenenriched air may be employed. For most efficient results, however, oxygen gas is employed as the oxidizing agent.
In addition, when carrying out the present invention with gaseous oxidizing agents, it has been discovered that for obtaining extracts having desirable aroma, flavor and color characteristics, together with minimal turbidity, the amount of molecular oxygen employed is critical in relation to the amount of the tea solids being treated. If too little molecular oxygen is present, the green aroma, flavor and color characteristics of extracts obtained from the treated leaves are not substantially altered and substantial reduction of turbidity will not be realized. If too much oxygen is employed, although a substantial reduction of turbidity is realized, the aroma, flavor and color properties of the treated leaves are affected adversely in that the oxidized leaves will provide extracts having burnt aromatic and flavor characteristics, and the color will be too dark.
In carrying out the oxidation reaction, elevated temperatures sufficient for obtaining the desired results are on the order of from about 110° C. to about 130° C., the reaction being difficult to control at temperatures above 130° C. The amount of time sufficient for carrying out the reaction is on the order of from about 5 mins to about 30 mins and is inversely proportional to the temperature and the amount of molecular oxygen employed. Thus, generally, at higher temperatures and with higher amounts of molecular oxygen, shorter times are employed. On the other hand, at lower temperatures and with lesser amounts of molecular oxygen, longer times are employed. As noted above, pressures at least greater than the water vapor pressure of the oxidizing reaction temperature of the moist tea are employed which thereby enables maintaining the reaction temperature.
DESCRIPTION OF PREFERRED EMBODIMENTS
When the tea leaves to be treated in accordance with the present invention are in a dry state having a stable moisture content, which conventionally is in a range of from about 5% to about 7% by weight dry tea solids, the leaves first are moistened with water, conveniently in the vessel in which the oxidation step is to be performed. Dependent, of course, upon inherent characteristics of the tea, moisture contents on the order of about 40% by weight dry tea solids and greater should be avoided since such amounts, generally, will result in saturation of the leaves and the presence of free water, if not an identifiable aqueous phase.
An object of the moistening step is to moisten the leaves uniformly, and to that end, preferably, the leaves are moistened by spraying them with water by means such as with a series of nozzles contained in the vessel. Preferably, the leaves being moistened are agitated, such as with a stirrer, by tumbling, or by a fluidized bed, or other such agitating means. Should a continuous system be employed which has, for example, zones for performing the various treating steps which are separated by such as surge means, a screw device may be employed for moving the leaves to be treated in and through the zones and for thereby agitating the leaves in the treating zones. In such a system, it would be preferred that the moist leaves and molecular oxygen be contacted in a countercurrent flow.
For best results, after adding water to the leaves, the moisture is allowed to equilibrate throughout the leaves, preferably while agitating the leaves, so that the moisture is substantially uniformly imbibed by and distributed in the leaves and so that there is no free water between and amongst the moist leaves to be treated in the oxidizing step.
In carrying out preferred embodiments of the present invention, specified amounts of molecular oxygen are supplied to the moist leaves, most preferably in the form of substantially pure oxygen gas as hereinafter exemplified, for obtaining particular ratios of molecular oxygen in relation to dry tea solids. Thus, a known quantity of oxygen gas is contacted with moist leaves having a known amount of dry tea solids. In cases when other sources of molecular oxygen, e.g., ozone, air, or oxygen-enriched air are employed, the available molecular oxygen may be calculated to determine the quantity of the gas required to practice the process of the present invention. As is evident, lesser quantities of molecular oxygen in the gas will require greater absolute amounts of gas.
Prior to contacting the leaves with the desired amount of molecular oxygen, for best control of the process, the moist leaves are pre-heated in the reaction vessel to the reaction temperature which is desired to be employed in the oxidizing step. To effect the heating of the moist leaves, the vessel may be jacketed for providing the heat and should contain a probe for measuring the temperature of the moist leaves. To obtain uniform heating, preferably, the moist leaves are agitated by means such as noted above.
Likewise, preferably, for enabling best control of the process, the temperature of the oxygen is increased to the desired reaction temperature prior to its introduction into the reaction vessel. In addition, for best process control, moisture is introduced into the oxygen while it is being heated so that the oxygen will be substantially saturated with moisture at the reaction temperature and pressure. To effect heating and moistening of the oxygen, most conveniently, the oxygen may be sparged through heated water, for example.
The oxidizing step may be carried out in the reaction vessel in either an open or closed mode, i.e., a system open or closed to the atmosphere, the closed system having been found to provide a better quality final product. In either system, to obtain the objective of obtaining substantially uniform contact of the oxygen with the heated moist leaves most effectively, again preferably, the heated moist leaves are agitated in the oxidizing step by means as noted above.
When the oxidizing step is carried out in a closed system, preferably, the entire quantity of the preheated moist oxygen gas required for obtaining the desired ratio of molecular oxygen to dry tea solids is introduced into the vessel containing the preheated moist tea. In the closed system, the pressure is dependent, primarily, upon the amount of oxidizing gas employed with respect to the range of temperatures employed and the void volume of the vessel.
In an open system, the reaction vessel has a vent to the atmosphere, and the desired amount of preheated moist oxygen gas is fed at a fixed rate with respect to the desired time of treatment so that the desired amount of molecular oxygen contacts the heated moist tea during the time of treatment. The vessel is vented at a fixed rate so that a pressure is maintained in the vessel which is a pressure which is at least slightly above the water vapor pressure at the elevated temperature, preferably a pressure of from about 0.35 kg/cm 2 to about 1 kg/cm 2 greater than the elevated temperature water vapor pressure. This enables maintenance of the reaction temperature.
It has been found that somewhat lesser amounts of molecular oxygen may be employed in a closed system than in an open system. That is, in the closed system, the entire quantity of oxygen gas required to obtain the desired molecular oxygen to tea solids ratio may be introduced at once, and therefore, the initial concentration of the available molecular oxygen is higher than is in the case when the entire quantity of oxygen gas is not introduced for contact with the tea leaves all at once.
To achieve the objects of the present invention in a closed system, the oxygen gas is supplied and introduced into the vessel containing the tea to be treated in an amount of from about 0.3 moles 0 2 /kg dry tea solids to about 1.3 moles 0 2 /kg dry tea solids, preferably in an amount of 0.5 moles 0 2 /kg dry tea solids to about 1.3 moles 0 2 /kg dry tea solids and most preferably in an amount of from about 0.6 moles 0 2 /kg dry tea solids to about 1.1 moles 0 2 /kg dry tea solids.
Preferably, the temperatures employed in a closed system are on the order of about 115° C. to about 120° C.
As is the case with all embodiments of the present invention, at lower reaction temperatures, the reaction may not proceed as efficiently and may require longer times, on the order of approaching up to 30 mins to obtain the desired changes of aroma, flavor, color and reduction of turbidity. On the other hand, at higher temperatures, shorter times, which may be on the order of about 5 mins to about 20 mins, may be utilized to avoid obtaining a product having burnt aroma and flavor characteristics and having a dark gray/brown color which is distinctly different from the color of conventional black teas.
In the closed system, in reactions in which preferred amounts of molecular oxygen and preferred temperatures are employed, reaction times on the order of about 10 mins to about 20 mins are preferred.
As mentioned above, in the open system, the oxygen gas is not generally as concentrated during the reaction, particularly initially, as may be provided in the closed system. Thus, the lowest amount of molecular oxygen which should be provided to realize optimal benefits of the present invention is somewhat higher than that which is employed in the closed system, and likewise, the upper extent of the range which may be employed may be somewhat higher. Hence, in the open system, oxygen gas is supplied and introduced into the reaction vessel containing the tea to be treated to contact the tea in an amount, over the desired period of the reaction time, of from about 1.0 mole 0 2 /kg dry tea solids to about 2.0 moles 0 2 /kg dry tea solids and preferably, in an amount of from about 1.0 mole 0 2 /kg dry tea solids to about 1.3 moles 0 2 /kg dry tea solids.
In the open system, times on the order of from about 15 mins to about 30 mins may be employed, but it has been found that the reaction in the open system is not as sensitive to conditions of temperature and time as in the closed system. Thus, employing an open system allows obtaining the desired results by treating the heated moist leaves over a range of preferred temperatures and times on the order of from about 115° C. to about 120° C. for about 20 mins to about 25 mins.
After the desired period of treatment, preferably, the treated tea is cooled, preferably rapidly, such as by means of introducing a cooling fluid in the jacket of the treatment reaction vessel while, preferably, continuing to agitate the treated tea. After cooling, the pressure in the vessel is released. Volatiles from the reaction may be recovered from gases released from the vessel by conventional methods known in the art.
Most efficiently, particularly for preparing tea products which will be extracted directly by the consumer, preferably in a blend with black teas, or even Oolong teas, which have been produced by conventional fermentation, the treated tea may be transferred immediately to a dryer, which preferably is a fluidized bed dryer, to dry it to a stable moisture content, at which time the collected volatiles may be added back to the dried tea by means known in the art.
For preparation of instant water-soluble tea, advantageously, the treated tea is transferred directly to an extraction vessel and processed in any of the various ways well-known to those skilled in the art for making soluble instant tea, and the collected volatiles are added back subsequently.
Thus, the present invention provides an efficient process for treating green and Oolong teas for altering the aroma, flavor and color characteristics of extracts obtained therefrom and for providing extracts having little or no noticeable turbidity, particularly in cold water.
EXAMPLES
The following examples are illustrative of the present invention and parts and percentages are by dry weight unless otherwise indicated.
DESCRIPTION OF COLOR TEST
I. 200 ml deionized water having a temperature of about 100° C. is added to 3 g of tea leaves which then are steeped for 21/2 mins. The infusion then is mildly agitated for 10 secs and then allowed to stand for 2 mins, 20 secs. The extract is separated from the leaves through a 270 U.S. standard mesh NYTEX screen. The solids concentration of the extract is adjusted with deionized water to 0.3% solids by weight, and the solids adjusted extract then is allowed to cool to room temperature.
II. Following dilution to 0.3%, the color is measured using a Minolta CT 100 colorimeter with a submersible probe. The color of the extract is evaluated on the L* a* b* scale, known to those skilled in the art. Final color results are expressed in L*, i.e., lightness, and C*, i.e., chromaticity, wherein C* equals the square root of the sum of the squares of a* and b*.
With regard to the values obtained, an extract having an L* value greater than that of another extract is lighter in color. With regard to chromaticity, which also may be characterized as hue and saturation of color, the "a" value is a measure of red to green color, the hues, and the saturation of those hues, and "b" is a measure of yellow to blue color, the hues, and the saturation of those hues. The "a" and "b" values indicate whether the extract has a grayish hue and therefor lacks color or whether the extract has a greater color and is thus more vivid. Thus, an extract having a greater C* value than that of another extract has a more vivid color which is a characteristic of extracts obtained from black tea.
For purposes of comparison, extracts of green tea generally lack color and have a grey-green hue. For comparison with the following experimental data, extracts of conventional black tea when tested in the foregoing manner generally have a L* value of about 75 and C* value of about 90.
DESCRIPTION OF TURBIDITY TEST
Testing for turbidity is performed as follows:
I. The first step of the turbidity test is performed in the same manner as the first step of the color test except that instead of allowing the solids adjusted extract to cool to room temperature, it is cooled to 10° C.
II. Turbidity of a portion of the cooled extract then is measured with a HACH ratio turbidmeter, model 18900.
For purposes of comparison with the following experimental data, conventional black tea extracts tested in the foregoing manner generally will be found have a turbidity of about 26 NTU.
EXAMPLE I
A portion of about 0.35 kg of a sample from a batch of dry Japanese green tea leaves are moistened in a vessel to a moisture content of about 23% by weight dry tea solids by spraying them with water while agitating them. After adding the water, agitation is continued for enabling the moisture to equilibrate throughout the leaves.
A jacketed pressure vessel having a void volume of about 2.8 l is preheated to a temperature of about 90° C. and then the moist leaves are placed in the vessel. The vessel then is closed to the atmosphere and heated to about 115° C. to heat the moist leaves to about 115° C., as determined by a temperature probe in the vessel, while agitating the leaves by stirring with paddles which extend through the vessel.
While heating and agitating the moist leaves in the vessel, oxygen is introduced into another vessel which has a void volume of about 2.0 l to purge the vessel of atmospheric air so that the vessel will contain substantially only oxygen and be under a pressure which is about 10 kg/cm 2 greater than the pressure in the jacketed vessel containing the heated moist leaves.
When the moist leaves attain a temperature of about 115° C., the pressurized oxygen is directed through a water bath heated to about 115° C. for heating and moistening the oxygen. The heated moist oxygen then is introduced into the vessel containing the heated moist leaves such that about 0.7 moles 0 2 /kg dry tea solids are present with the heated moist leaves in the reaction vessel. Then the reaction vessel is closed off to the oxygen.
The temperature of the heated moist leaves is maintained at about 115° C. for about 20 mins while agitating the leaves, after which time the temperature is reduced to about 90° C. by introducing cold water in the jacket of the reaction vessel for chilling the vessel while still agitating the treated leaves. The pressure of the vessel then is released, and the volatiles are condensed and collected. The treated tea is removed from the vessel and then dried and the collected volatiles are then added back to the dried treated leaves.
An infusion extract obtained from the treated leaves for preparing a 0.3% by weight extract has a pH of 4.0. Upon performing the color and turbidity tests, as described above, it is found that the 0.3% extract has a color of L* 74 and C* 66 and a turbidity of 18 NTU.
COMPARISON EXAMPLE I
For comparison, an infusion extract is obtained from a portion of the sample of untreated tea leaves employed in Example 1. The extract has a pH of 5. Color and turbidity tests, as described above, are performed upon a 0.3% solids by weight extract. The 0.3% extract has a color of L* 82 and C* 28 and a turbidity of 65 NTU.
Thus, the treated leaves of Example I provide a distinctly more colorful and less turbid extract than the untreated leaves.
EXAMPLE II
Water is added, as in Example I, to about a 0.35 kg portion of a sample from a batch of Japanese green tea leaves to moisten the leaves to a moisture content of about 23% by weight dry tea solids.
A jacketed pressure vessel, as employed in Example I, is preheated to about 90° C., and then the moist leaves are placed in the vessel. The vessel then is closed to the atmosphere and heated to heat the moist leaves to about 120° C., as indicated by a temperature probe in the vessel, while agitating the leaves. While the moist leaves are being heated to the 120° C. reaction temperature, oxygen is introduced into another vessel having a void volume of about 2.8 l in an amount to obtain a pressure of about 9 kg/cm 2 greater than the pressure in the jacketed vessel containing the heated moist leaves.
When the moist leaves attain a temperature of about 120° C., the pressurized oxygen is directed through a water bath heated to about 120° C for heating and moistening the oxygen. The heated moist oxygen then is introduced into the bottom of the jacketed vessel at which time a venting device on this reaction vessel is opened to the atmosphere to allow flow of gases out of the vessel while maintaining a pressure in the vessel of about 2 kg/cm 2 which assists in maintaining the reaction temperature at about 120° C. A condenser is provided to collect volatiles released from the vent.
The flow of oxygen is supplied for about 30 mins, at about 320 cc/min, at standard temperature and pressure, using an in-line flow meter, which provides molecular oxygen in an amount of about 1.25 moles 0 2 /kg dry tea solids, after which the gas supply is sealed off from the reaction vessel and the vent valve of the reaction vessel is closed. The reaction vessel is cooled by introducing cold water into the jacket, and then the pressure in the vessel is released. The treated leaves are removed from the vessel and dried. Collected volatiles then are added back to the dried treated leaves.
An infusion brew extract obtained for preparing a 0.3% extract for the color and turbidity tests has a pH of 5. The color and turbidity tests are performed. The 0.3% extract has a color of L* 76 and C* 64 and has a turbidity of 30 NTU.
COMPARATIVE EXAMPLE II
A color and turbidity test is performed upon an infusion extract of a portion of the sample from the batch of the leaves of Example II except that the leaves are not treated in accordance with the present invention of Example II. The extract has a pH of 5.7. A 0.3% extract has a color of L* 77, C* 33 and a turbidity of 74 NTU.
EXAMPLE III
About 0.35 kg portions of a sample from a batch of Japanese green tea leaves having a moisture content of 4.9% by weight dry tea solids are employed in each of several trials in a closed system mode. The reaction temperature of each trial is about 120° C., and each reaction is carried out for about 20 mins. The amount of oxygen employed in each trial is about 0.7 moles 0 2 /kg dry tea solids. The moisture content of the leaves is the variable manipulated.
A 0.3% control extract obtained from another portion of the sample of the untreated leaves has a color of L* 77 and C* 33, a turbidity of 74 NTU. The control extract has a pH of 5.6 and a greenish flavor.
______________________________________ Moisture ContentPortion % Dry Basis L* C* NTU pH Flavor______________________________________(1) 4.9 77 65 30 5.6 greenish/harsh(2) 8.7 74 68 17 5.4 greenish/harsh(3) 12.9 73 67 13 5.2 greenish/harsh(4) 14.3 74 65 11 5.2 greenish/ flat(5) 16.4 76 69 12 4.9 greenish/cooked(6) 17.0 76 73 13 4.8 slight Oolong(7) 17.9 73 70 8 4.9 slight Oolong/ astringent(8) 19.3 76 73 12 4.8 Oolong/astringent(9) 21.7 75 73 13 4.6 Oolong/slightly cooked(10) 23.8 76 70 9 4.6 slightly cooked(11) 25.0 76 70 9 4.6 acid(12) 26.1 70 67 10 4.6 burnt(13) 27.2 78 68 10 4.6 burnt/acid(14) 28.0 73 66 7 4.7 cooked/acid(15) 38.9 75 65 7 4.6 burnt/poor______________________________________
From the foregoing, it is clear that at all moisture contents, turbidity is reduced but that a moisture content of at least about 17% must be employed to obtain flavor differentiation of significance and that less desirable flavor characteristics result when treating leaves having a moisture content above about 25%.
EXAMPLE IV
The relationship of temperature and time is demonstrated by the following table reflecting trials of treating about 0.35 kg portions of a sample from a batch of Japanese green tea leaves moisturized to about 23% by weight dry tea solids. The samples are treated with about 1.0 mole 0 2 /kg dry tea solids in a closed system.
A control extract obtained from another portion of the sample of the untreated leaves has a pH of 5.0. A 0.3% control extract has a color of L* 82 and C* 28 and a turbidity of 65 NTU.
______________________________________ Time Temp.Portion (mins) (°C.) L* C* NTU pH Flavor______________________________________(1) 10 110 78 61 24 4.1 greenish/slight Oolong(2) 10 120 76 65 25 4.1 Oolong(3) 30 110 78 65 16 3.8 cooked(4) 30 120 68 66 7 3.6 burnt/acid______________________________________
The results show that at higher temperatures and over longer times better color and turbidity results may be obtained but less desirable flavor and pH characteristics result.
EXAMPLE V
The following table shows results of trials with about 0.35 kg portions of a sample from a batch of Japanese green tea leaves in which reaction temperature and time in an open system are varied. The leaves treated have a moisture content of about 23% by weight dry tea solids and are contacted with about 1.25 moles 0 2 /kg dry tea solids.
A control extract obtained from another portion of the sample of the untreated leaves has a pH of 5.7. A 0.3% control extract has a color of L* 77 and C* 33 and a turbidity of 74 NTU.
______________________________________ Time Temp.Portion (mins) (°C.) L* C* NTU pH Flavor______________________________________(1) 15 120 83 65 26 5.5 grassy(2) 20 120 80 67 26 5.3 slight Oolong/ astringent(3) 30 120 76 64 30 5.0 Oolong(4) 10 130 80 63 24 5.0 cooked Oolong(5) 20 130 72 68 14 4.7 burnt/acid______________________________________
These results show that higher temperatures and longer times may be employed in open system than in the closed system and that the effect upon pH by the open system is not as great as in the closed system.
EXAMPLE VI
The following table shows results of varying the amount of oxygen and temperature and time in a closed system and shows results with the lower end of the usable range of the amount of oxygen. The trials are run with about 0.35 kg portions of a sample from a batch of Japanese green tea leaves having a moisture content of about 23% by weight dry tea solids.
A control extract obtained from another portion of the sample of the untreated leaves has a pH of 5.0, and a 0.3% control extract has a color of L* 82 and C* 28 and a turbidity of 65 NTU.
__________________________________________________________________________ Time Temp. Moles O.sub.2 /kg dryPortion (mins) (°C.) tea solids L* C* NTU pH Flavor__________________________________________________________________________(1) 10 110 0.4 79 65 38 4.4 green/grassy(2) 10 110 1.0 78 61 24 4.1 slight Oolong/astringent(3) 10 120 0.4 77 67 25 3.9 slight Oolong(4) 10 120 1.0 76 65 25 4.1 Oolong(5) 20 115 0.7 74 66 18 4.0 slight cooked(6) 30 110 0.4 75 66 18 4.0 cooked(7) 30 110 1.0 78 65 16 3.8 cooked/acid(8) 30 120 0.4 74 67 18 4.0 burnt(9) 30 120 1.0 68 66 7 3.6 burnt__________________________________________________________________________
The foregoing results again show that effects of the interaction of the variables of time and temperature and also that the amount of oxygen employed and in particular, the effect of oxygen upon flavor development and pH.
EXAMPLE VII
The following shows results of varying the effect of the amount of oxygen and temperature and time in an open system wherein trials are run with about 0.35 kg portions of a sample from a batch of Japanese green tea leaves having a moisture content of about 23% by weight dry tea solids.
A control extract obtained from another portion of the sample of untreated leaves has a pH of 5.7 and a color of L* 77 and C* 33 and a turbidity of 74 NTU.
__________________________________________________________________________ Time Temp. Moles O.sub.2 /kg dryPortion (mins) (°C.) tea solids L* C* NTU pH Flavor__________________________________________________________________________(1) 15 115 1.8 82 65 34 5.4 green/slight cooked(2) 20 115 0.6 80 62 31 5.4 green/cooked(3) 30 115 1.0 81 64 27 5.1 harsh/astringent(4) 15 120 0.6 82 63 28 5.4 green/slight cooked(5) 15 120 1.3 83 65 26 5.5 green/slight cooked(6) 20 120 1.3 80 67 26 5.3 slight Oolong(7) 30 120 0.6 80 60 21 4.9 slight Oolong/astringent(8) 30 120 1.3 76 64 30 5.0 Oolong/good astringent(9) 10 130 0.6 83 58 25 5.1 slight green/harsh(10) 10 130 1.3 80 63 24 5.0 Oolong cooked(11) 20 130 1.3 72 68 14 4.7 burnt/acid__________________________________________________________________________
In addition to showing the effect of the amount of oxygen and its interrelation with temperature and time, these results again show that the open system has a lesser effect upon the pH of an extract obtained from the product than is the case in the closed system.
EXAMPLE VIII
A portion of about 0.25 kg of a sample of Oolong commercial grade tea leaves are moistened to a moisture content of about 24% by weight dry tea solids. A jacketed pressure vessel having a void volume of about 2.8 l is preheated to a temperature of about 90° C. and then the moist leaves are placed in the vessel which then is closed to the atmosphere and heated to about 115° C. while the leaves are agitated.
Oxygen gas is introduced into a second vessel having a void volume of about 2.0 l to obtain an atmosphere in the second vessel comprised substantially of only oxygen which then is charged to a pressure of about 6.5 kg/cm 2 greater than the pressure in the heated jacketed vessel. The pressurized oxygen gas then is heated to about 115° C. as in the prior Examples and directed to the jacketed vessel such that heated oxygen is introduced into the jacketed vessel in an amount of about 0.5 moles/kg dry tea solids.
After introduction of the heated oxygen into the jacketed vessel, the temperature of about 115° C. is maintained for about 5 mins, and then the heated leaves are cooled to about 90° C. while agitation of the leaves is continued as in the prior Examples. After cooling the leaves, the pressure in the jacketed vessel is released, and volatiles are condensed and collected.
An infusion extract of the 0.3% by weight extract has a pH of 4.7. Upon performing the color and turbidity tests described above, it is found that the 0.3% extract has a color of L* 75 and C* 69 and a turbidity of 21 NTU.
In comparison, an infusion extract of another portion of the sample of the Oolong leaves not treated in accordance with the present invention has a pH of 4.9. A 0.3% extract prepared from the infusion extract has a color of L* 68 and C* 61 and a turbidity of 30 NTU.
As is clear from the foregoing, various modifications of the present invention may be without departure from the spirit and scope of the invention as defined by the following claims.
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Green and Oolong tea leaves are oxidized to alter the organoleptic and aesthetic characteristics of aqueous extracts obtained therefrom and to provide extracts which have minimal turbidity, particularly when cooled. The oxidation reaction is performed on leaves which contain moisture only in an amount such that the oxidation reaction occurs at localized sites on and within the tea leaf structure.
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FIELD OF THE INVENTION
This invention relates to a system and methods for interventional medicine, and more specifically to computer assisted navigation and imaging of medical devices within a subject body.
BACKGROUND OF THE INVENTION
Interventional medicine is the collection of medical procedures in which access to the site of treatment is made through one of the subject's blood vessels, body cavities or lumens. For example, angioplasty of a coronary artery is most often performed using a catheter which enters the patient's arterial system through a puncture of the femoral artery in the groin area. Other interventional medical procedures include the assessment and treatment of tissues on the inner surface of the heart (endocardial surfaces) accessed via peripheral veins or arteries, treatment of vascular defects such as cerebral aneurysms, removal of embolic clots and debris from vessels, treatment of tumors via vascular access, endoscopy of the intestinal tract, etc.
Interventional medicine technologies have been applied to manipulation of instruments which contact tissues during surgical procedures, making these procedures more precise, repeatable and less dependent of the device manipulation skills of the physician. Some presently available interventional medical systems for directing the distal tip of a medical device from the proximal end of the medical device use computer-assisted navigation and a display means for providing a visual display of the medical device along with anatomical images obtained from a separate imaging apparatus. Such systems can provide a visual display of blood vessels and tissues, obtained from a Fluoroscopy (X-ray) imaging system for example, and can display a projection of the medical device being navigated to a target destination using a computer that controls the orientation of the distal tip of the medical device.
In some cases, it may be difficult for a physician to become oriented in a three dimensional setting using a display of a single-plane X-ray image projection. Enhancement or augmentation of the single-plane X-ray image may be required to aid the physician in visualizing the orientation of the medical device and blood vessels. A method is therefore desired for enhancing a display image of the anatomical surfaces and the orientation of a medical device in real time to improve navigation through the blood vessels and tissues.
SUMMARY OF THE INVENTION
According to the principles of the present invention, a system and method are provided for control of a navigation system for deploying a medical device within a subject, and for enhancement of a display image of anatomical features for viewing the current location and orientation of a medical device moving through the subject body. The display of the X-ray imaging system information is augmented in a manner such that a physician can more easily become oriented in three dimensions with the use of a single-plane X-ray display. A typical X-ray imaging system comprises a source for emitting a beam through a three dimensional space and onto a plane, where a point within a subject body in the three dimensional space is projected onto the plane. The projection of a point within the subject body onto the imaging plane can be obtained using an orthographic projection matrix derived from the point-to-image plane distance and the source-to-image plane distance. Thus, a point location within the subject body having known coordinates, properly registered to the frame of reference of the X-ray system, can be projected onto the X-ray image plane of the live X-ray image in the same manner.
In accordance with one aspect of the invention, a method of projection can be used to graphically overlay a representation of the actual medical device location and orientation onto the X-ray image. One or more desired target points within the subject can also be projected onto the X-ray image, as well as one or more reference markers on the subject to track patient movement. A graphical representation of a virtual medical device can be overlaid to show a visual reference of a predicted new location and orientation of the actual medical device that corresponds to a desired navigational configuration. A mathematical model of the medical device can be used to define the configuration of the virtual medical device, which can model the behavior of the device corresponding to a change in navigation control variables to predict deflection and rotation of the medical device. A desired direction for steering the medical device within the plane of the X-ray image can be graphically represented, and surface shapes within the subject may also be rendered and graphically represented on the X-ray image display. All the graphically overlaid information is also updated in real time as the X-ray imaging system is rotated or moved, to augment the image display and enhance visualization of the orientation of a medical device in a three dimensional space using a single-plane X-ray image displayed on the control system.
It is thus an object of the invention to provide a system and method for augmenting the displayed anatomical image of a subject with graphically overlaid objects to provide enhanced visualization of medical devices, anatomical locations, shapes, markers, and other objects and annotations in a three dimensional space for aiding in the orientation and navigation of the medical device through the subject body.
It is a further object of the invention to provide a system and method for enabling virtual representation of the medical device, for providing a visual reference of a predicted orientation and location of the medical device corresponding to a desired configuration or movement to a desired target.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic diagram of an automated system for navigating a medical device through the lumens and cavities in the operating regions in a patient in accordance with the principles of this invention;
FIG. 2 is an illustration of the projection geometry for projecting a location point onto an imaging plane in accordance with the principles of the present invention;
FIG. 3 is an illustration of an anatomical image display comprising images of the actual medical device, graphically overlaid images of a virtual medical device configuration and a series of target locations according to the principles of the present invention;
FIG. 4A is a schematic diagram of a navigation system and imaging system combination, in which the navigation system determines the where objects in the operating region should appear based upon information from the imaging system;
FIG. 4B is a schematic diagram of a navigation system and imaging system combination, in which the imaging system determines where objects in the operating region should appear based upon position information from the navigation system;
FIG. 5 is a view of the screen of a magnetic navigation system, with imported images from an imaging system in accordance with the principles of this invention;
FIG. 6A is an x-ray image of an anatomic model of a human heart along an axis 26° on the LAO side, showing objects overlaid on the image in accordance with the principles of operation;
FIG. 6B is an x-ray image of the anatomic model of the human heart along an axis 26° on the RAO side;
FIG. 7A is an x-ray image of an anatomic model of a human heart along an axis 25° on the LAO side, showing objects overlaid on the image in accordance with the principles of operation;
FIG. 7B is an x-ray image of the anatomic model of the human heart along an axis 27° on the RAO side;
FIG. 8A is an x-ray image of an anatomic model of a human heart along an axis 25° on the LAO side, showing objects overlaid on the image in accordance with the principles of operation;
FIG. 8B is an x-ray image of the anatomic model of the human heart along an axis 8° on the RAO side;
FIG. 8C is an x-ray image of the anatomic model of the human heart along an axis 27° on the RAO side;
FIG. 9A is an x-ray image of an anatomic model of a human heart along an axis 25° on the LAO side, showing objects overlaid on the image in accordance with the principles of operation;
FIG. 9B is an x-ray image of an anatomic model of a human heart along an axis 16° on the LAO side;
FIG. 9C is an x-ray image of an anatomic model of a human heart along an axis 6° on the LAO side;
FIG. 9D is an x-ray image of an anatomic model of a human heart along an axis 17° on the RAO side;
FIG. 9E is an x-ray image of an anatomic model of a human heart along an axis 27° on the RAO side.
DETAILED DESCRIPTION OF THE INVENTION
An automated system for navigating a medical device through the lumens and cavities in an operating region in a patient in accordance with the principles of this invention is indicated generally as 20 in FIG. 1 . The system 20 comprises an elongate medical device 22 , having a proximal end and a distal end adapted to be introduced into the operating region in a subject. The system 20 also comprises an imaging system 30 for displaying an image of the operating region on a display 32 , including a representation of the distal end of the medical device 22 in the operating region.
The system also includes a navigation system for manipulating the distal end of the medical device 22 . In this preferred embodiment the navigating system is a magnetic navigation system 50 . Of course, the navigation system could alternatively be a piezoelectric or electrostrictive system or a mechanical control system with pull wires or servo motors, or other suitable system for orienting the distal tip of the medical device. The magnetic navigation system 50 orients the distal end of the medical device 22 in a selected direction through the interaction of magnetic fields associated with the medical device 22 inside the operating region and at least one external source magnet outside the subject's body. The catheter may then be advanced in the selected direction, to reach the target destination through the successive reorientation stepwise process and advancement.
A preferred embodiment of the present invention describes a method for a navigation system associated with an elongate flexible catheter or medical device and an X-ray imaging system, for providing a suitable projection of a graphic overlay of the medical device and target locations within the subject body. The control or actuation means used to steer or navigate the medical device with a computer controlled navigation system may be any of a variety of method known to those skilled in the art, such as mechanical, magnetic, electrostrictive, hydraulic, or others. One preferred embodiment is one where an externally applied magnetic field is used to steer the device, while device advancement and retraction is mechanically driven. Such a navigation system is typically used in conjunction with an X-ray system such as a Fluoroscopy Imaging system, with a mutually known registration between the systems. Other anatomical features such as curves, ridge lines, ablation lines, surface portions, landmark locations, marker locations as reference, and so on, possibly including data from preoperative or intraoperative three dimensional images, can be overlaid on the live X-ray display. Past device configurations can also be displayed as a reference so that any changes in configuration such as patient shift can be monitored during the course of the procedure.
Likewise reconstructed features such as blood vessels reconstructed from contrast agent injection and subsequent imaging and image processing, or other path reconstructions as defined by a user to produce a three dimensional path could be overlaid on the live X-ray display.
A typical X-ray imaging system comprises a source for emitting a beam through a three dimensional space and onto an imaging plane, where a point within a subject body in the three dimensional space is projected onto the plane. In a preferred embodiment, the X-ray imaging system is preferably a Fluoroscopy imaging system capable of providing images on at least two separate planes, which together can provide the three dimensional coordinates for a location displayed in the two separate planes. FIG. 2 shows a geometric illustration of an X-ray source point of origin 60 for emitting a beam towards the subject and the imaging plane 62 . The projection of {right arrow over (x)}, a point 64 in a three dimensional space, onto the imaging plane 62 as a perspective projection {right arrow over (x)} p , can be obtained using an orthographic projection matrix. The orthographic projection matrix can be derived from h the point-to-image plane distance 72 , and d the source-to-image plane distance 70 , or distance to the center {right arrow over (x)} c of the plane 62 . A vector {right arrow over (q)} from a point in space {right arrow over (x)} to the center of the plane {right arrow over (x)} c may be defined as {right arrow over (q)}=({right arrow over (x)}−{right arrow over (x)} c ):. The source-to-image distance 70 is defined as d. The orthographic projection of {right arrow over (q)} onto the imaging plane 72 is:
{right arrow over (y)} =( I−nn T ) {right arrow over (q)} or
{right arrow over (y)}=A{right arrow over (q)}=A ( {right arrow over (x)}−{right arrow over (x)} c )
where nn T is the 3×3 outer product constructed from the normal {right arrow over (n)} to the X-ray image plane, I is the 3×3 identity matrix, and (I−nn T ) is the orthographic projection matrix. From FIG. 2 , it can be seen that:
x → P - x → C d = y → ( d - h ) , where h = ( q → · n → ) ( 1 ) Since ( x → P - x → C ) = x → P - x → C · y → y → , ( 2 )
Equation (1) may be rewritten as:
( x → P - x → C ) = ⅆ ( ⅆ - h ) y → = ⅆ ( ⅆ - n → · ( x → - x → C ) ) A ( x → P - x → C ) ( 3 )
Equation (3) above defines the perspective projection {right arrow over (x)} p of point {right arrow over (x)} onto the imaging plane, so {right arrow over (x)} p may be rewritten in the form:
x
→
P
=
x
→
C
+
ⅆ
(
ⅆ
-
n
→
·
(
x
→
-
x
→
C
)
)
A
(
x
→
P
-
x
→
C
)
(
4
)
For any given point {right arrow over (x)} in a three dimensional space, a corresponding perspective projection point {right arrow over (x)} p on the X-ray image plane can be determined using equation (4) above. Thus, for any point location within the imaging volume, a corresponding graphic overlay object may be suitably projected onto the X-ray image display. Such graphic overlay objects that may be suitably projected onto a display as illustrated in FIG. 3 may include objects such as the actual medical device 100 and target locations 102 , 104 , 106 and 108 within the operating region of the subject. Other objects that can be usefully overlaid on the live X-ray display include anatomical features such as curves, ridge lines, ablation lines, surface portions, landmark locations, marker locations used as reference, and so on, possibly including data from preoperative or intraoperative three dimensional images. Likewise, previously marked or identified device configurations can also be displayed as a reference so that any changes in configuration due to factors such as patient shift can be monitored during the course of the procedure. Additionally, reconstructed features such as blood vessels reconstructed from contrast agent injection and subsequent imaging and image processing, or other path reconstructions as defined by a user to produce a three dimensional path, or a variety of path-like or other features extracted from three dimensional image data could be overlaid on the live X-ray display.
As the Fluoroscopic imaging system is moved or rotated about the subject, the graphically overlaid objects may be continuously updated and displayed along with the continuously updated X-ray images to provide projection images in real time to improve visualization of the orientation of the medical device and target locations.
Other graphic overlay objects that can be suitably projected onto the display may include one or more reference markers 110 on the subject body to provide a reference for the movement of the medical device 100 . In the preferred embodiment, the medical device 100 is preferably deployed from the distal end of a relatively stiff sheath inserted within the subject body. The distal end of such a sheath functions as a base for the distal end of a medical device 100 deployed therefrom. One efficient method to mark the pivot or base of the medical device as a reference marker 110 is to position the tip of the medical device 110 at the intended base, for example at the distal tip of a sheath, and then record the current location of the tip as a reference marker, as illustrated in FIG. 3 at 110 . Reference markers could also be used to indicate target locations for the tip of the medical device to access, and text or other graphic annotations could be used to distinguish and identify various locations. A pre-operative anatomical three-dimensional data set, of an endocardial surface for example, could also be graphically rendered and projected onto the display at 118 , after a suitable registration of the coordinates to the frame of reference of the X-ray is performed. Likewise, an intra-operative three-dimensional data set could also be graphically rendered and projected onto the image display.
In the preferred embodiment where a magnetic navigation system is employed for controlling the orientation of the distal tip of the medical device, a graphic annotation of the current magnetic field direction 116 could be projected onto the live Fluoroscopy Image display as a steering reference. Where a localization system for determining the position of the medical device in a frame of reference translatable to the displayed image of the Fluoroscopy system is also included, a graphical rendition of portions of the medical device as determined from the localization information obtained from the localization system can be overlaid on the X-ray image display. Rates of change of control variables such as the magnetic field, or the rate of movement of the medical device may also be determined and displayed on the X-ray image display.
A graphical representation of a virtual medical device 112 can be overlaid to show a visual reference the medical device 100 being rotated or moved before initiating actual movement of the medical device. A mathematical model of the medical device can be used to define the configuration of the virtual medical device 112 , which can model the behavior of the device relative to a desired navigation rotation to predict movement of the medical device 110 . Thus, a desired rotation or re-orientation of the tip of the medical device 110 may be evaluated through a visual representation of a virtual medical device 112 in advance of re-orientation of the actual medical device 110 . The model of the virtual medical device 112 can account for the deflective behavior of the medical device 110 relative to changes in navigation control variables such as the applied magnetic field direction, and can provide a representation of the resulting changes in configuration of the device. A graphic indication 114 of a direction for steering the medical device within the plane of the X-ray image may also be graphically overlaid onto the display for coordination with a joystick that is mapped to the X-ray plane. Likewise, a desired target such as location point 102 may be entered, and the model of the virtual medical device 112 configuration can be used to determine the appropriate change in navigation control variables to steer the tip of the medical device to the desired target destination 102 .
The imaging display of the present invention may be further augmented by the use of gated location data, for example where the gating is performed with respect to ECG (electro cardiograph) data, so that the device location is always measured at the same phase of a periodic cycle of anatomical motion such as the cardiac cycle. In a preferred embodiment, this data is input into the navigation system together with the real-time location data in a manner such that the location data may be projected onto the X-ray image display.
It should be noted that the overlay of the medical device and various objects could be controlled by a user input from an input device such as a joystick, mouse, or hand-held localized stylus, or it could automatically be controlled by a computer. Alternatively, a joystick could also be used to control the direction or steering of the medical device within the subject body. Additional design considerations such as the above modifications may be incorporated without departing from the spirit and scope of the invention. More particularly, the system and method may be adapted to medical device guidance and actuation systems other than magnetic navigation systems, including electrostrictive, mechanical, hydraulic, or other actuation technologies. Likewise, a variety of medical devices such as catheters, cannulas, guidewires, microcatheters, endoscopes and others known to those skilled in the art can be remotely guided according to the principles taught herein. Accordingly, it is not intended that the invention be limited by the particular form described above, but by the appended claims.
Operation
In operation, the imaging system of the various embodiments of the present invention display an image of an operating region together with an overlay of representations of various objects in the operating region to facilitate the user's orientation within the image. For example these objects can include points that the user has identified or marked, or which have been identified or marked for the user. The objects can alternatively or additionally include shapes, for example closed loops identifying openings in the operating region. The objects can also be reconstructions of medical devices in the operating region, based upon mathematical models of the devices or position information from a localization system. The positions and shapes of the representations automatically change as the imaging plane changes when the imaging beam and imaging plate move about the operating region. Thus the user does not lose the points of reference and landmarks that he or she may have been using prior to the reorientation of the imaging system. This reorientation can occur frequently during medical procedures as the imaging system is moved to accommodate other equipment in the procedure room (e.g. a magnetic navigation system), or when the user desires a different imaging angle to better observe the procedure.
In one embodiment the imaging system consists of an imaging beam source, an imaging plate, an imaging processor, for processing the imaging data collected by the imaging plate, and a display for displaying the image from the processed imaging data. This imaging system can be used in conjunction with another system, such as a navigation system for orienting the a medical device in the operating region in the subject, or a medical localization system for determining the location of a medical device in the operating region in the subject. Whether using the navigation system or the localization system, the user can generally identify points of interest, for example anatomical land marks or points of physiological interest. Representations of these points can be displayed on the image of the operating region from the imaging system, to help the user visualize the operating region and the procedure. However, in addition to overlaying the representation on a static image from the imaging system, the overlay can be dynamically adjusted as the imaging plane changes so that the objects not only remain on the display, but the remain in the correct position and orientation relative to the displayed image and the displayed image changes.
The method can be implemented in several ways as illustrated by FIGS. 4A and 4B . In one embodiment, shown schematically in FIG. 4A , the navigation or localization system receives information about the location of the imaging beam source and the imaging receiver, and uses this information to determine where objects of known locations in the operating region should appear on the image generated by the imaging system. More specifically, the imaging system 100 can provide the navigation system (or localization system) 102 with information about the position/orientation of the imaging beam source 104 and the imaging receiver 106 . (This is represented by arrow 108 ). Using this information the navigation system (or localization system) 104 can determine where an object of known position in the operating region should appear in an image generated by the imaging system. This information can be communicated back to the imaging system 100 so that the selected objects can be overlaid in the proper location and orientation on the image generated by the imaging system, and displayed on the display 110 . (This is represented by arrow 112 )
As the imaging beam source 104 and imaging receiver 106 move, the information provided by the imaging system to the navigation system (or the localization system), and the resulting information provided by the navigation system (or the localization system) to the imaging system is updated. (This is represented by arrow 114 ). So that representations of the selected objects can be overlaid on the images from the imaging system are updated as the imaging system moves about the operating region.
As shown in FIG. 4B , the navigation system (or the localization system) 102 can provide the imaging system with the positions of objects in the operating region. The imaging system 100 can use this information to determine where the objects should appear in an image generated by the imaging system, using the known position of the imaging beam source 104 and imaging receiver 106 , and then overlay representations of the objects on the image generated by the imaging system on the display 110 .
As the positions of the imaging beam source and imaging receiver change, the imaging system can redetermine where the objects should appear in an image generated by the system in the new configuration, and overlay the representations of the object on the image generated by the imaging system, so that the representations of the objects are updated as the imaging system moves about the operating region.
An example of a display from a graphical user interface from a magnetic navigation system is shown in FIG. 5 . The interface in FIG. 5 allows the user to import images from an x-ray imaging system, and display them in windows in the display. The magnetic navigation system allows the user to identify points in the operating region and show these points on an overlay on the image from the imaging system. The overlay becomes “persistent” such that as the imaging system is moved about the operating region, and another image is made of the operating region, the overlay is adjusted in position and/or orientation so that it correctly shows the points on the new image. This is illustrated in FIG. 5 in which two images from the operating region in different directions are depicted in side by side panes on the interface, and the overlaid objects are properly positioned and oriented in each,
FIG. 6A shows an x-ray image of an anatomical model of a human heart taken in a direction 26° to the left anterior side. An object, and more specifically a representation of a ring 200 constructed from a plurality of points 202 is overlaid on the x-ray image. FIG. 6B shows an x-ray image of the anatomical model taken in a direction 26° to the right anterior side (i.e., rotated 52° from FIG. 6A ). The representation of the ring 200 and constituent points 202 in FIG. 6B have been rotated from FIG. 6A in accordance with the principles of this invention, to remain in the proper orientation with respect to the image in the new imaging direction.
FIG. 7A shows an x-ray image of an anatomical model of a human heart taken in a direction 25° to the left anterior side. Objects, and more specifically a plurality of annotations including an “E” 204 , an “F” 206 , and a “G” 208 are overlaid on the x-ray image. FIG. 7B shows an x-ray image of the anatomical model taken in a direction 27° to the right anterior side (i.e., rotated 52° from FIG. 7A ). The representation of the annotations “E” 204 , “F” 206 , and “G” 208 in FIG. 7B have been rotated from FIG. 7A in accordance with the principles of this invention, to remain in the proper orientation with respect to the image in the new imaging direction.
FIG. 8A shows an x-ray image of an anatomical model of a human heart taken in a direction 25° to the left anterior side. An object. and more specifically a catheter 210 is overlaid on the x-ray image. The representation of catheter 210 can be generated from localization data of one or more points on the corresponding real catheter in the operating region. Alternatively, the representation of the catheter 210 can be generated from a mathematical model of the actual catheter in the operating region (for example using the control variable from the navigation system).
FIG. 8B shows an x-ray image of the anatomical model taken in a direction 8° to the right anterior side (i.e., rotated 33° from FIG. 8A ). The representation of the catheter 210 in FIG. 8B has been rotated from FIG. 8A in accordance with the principles of this invention, to remain in the proper orientation with respect to the image in the new imaging direction. FIG. 8C shows an x-ray image of the anatomical model taken in a direction 27° to the right anterior side (i.e., rotated 19° from FIG. 8B ). The representation of the catheter 210 in FIG. 8C has been rotated from FIG. 8B in accordance with the principles of this invention, to remain in the proper orientation with respect to the image in the new imaging direction.
FIG. 9A shows an x-ray image of an anatomical model of a human heart taken in a direction 25° to the left anterior side. Objects, and more specifically representations of points 212 , 214 , and 216 in the operating region are overlaid on the x-ray image. FIG. 9B shows an x-ray image of the anatomical model taken in a direction 16° to the right anterior side (i.e., rotated 9° from FIG. 9A ). The representation of the points 212 , 214 and 216 in FIG. 8B have been rotated from FIG. 9A in accordance with the principles of this invention, to remain in the proper orientation with respect to the image in the new imaging direction. FIG. 9C shows an x-ray image of the anatomical model taken in a direction 6° to the left anterior side (i.e., rotated 3° from FIG. 9B ). The representation of the points 212 , 214 , and 216 in FIG. 9C has been rotated from FIG. 9B in accordance with the principles of this invention, to remain in the proper orientation with respect to the image in the new imaging direction. FIG. 9D shows an x-ray image of the anatomical model taken in a direction 17° to the right anterior side (i.e., rotated 23° from FIG. 9C ). The representation of the points 212 , 214 , and 216 in FIG. 9D has been rotated from FIG. 9C in accordance with the principles of this invention, to remain in the proper orientation with respect to the image in the new imaging direction. FIG. 9E shows an x-ray image of the anatomical model taken in a direction 27° to the right anterior side (i.e., rotated 10° from FIG. 9D ). The representation of the points 212 , 214 , and 216 in FIG. 9E has been rotated from FIG. 9D in accordance with the principles of this invention, to remain in the proper orientation with respect to the image in the new imaging direction.
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A system and method are provided for control of a navigation system for deploying a medical device within a subject, and for enhancement of a display image of anatomical features for viewing the projected location and movement of medical devices, and projected locations of a variety of anatomical features and other spatial markers in the operating region. The display of the X-ray imaging system information is augmented in a manner such that a physician can more easily become oriented in three dimensions with the use of a single-plane X-ray display. The projection of points and geometrical shapes within the subject body onto a known imaging plane can be obtained using associated imaging parameters and projective geometry.
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[0001] This application is a Continuation-in-Part of application Ser. No. 08/511,076, filed Aug. 3, 1995, the disclosure of which is hereby incorporated by reference.
FIELD OF THE INVENTION
[0002] This invention relates to an endoprosthesis device for implantation within a body vessel, typically a blood vessel. More specifically, it relates to a tubular expandable stent of improved longitudinal flexibility.
BACKGROUND OF THE INVENTION
[0003] Stents are placed or implanted within a blood vessel for treating stenoses, strictures or aneurysms therein. They are implanted to reinforce collapsing, partially occluded, weakened, or dilated sections of a blood vessel. They have also been implanted in the urinary tract and in bile ducts.
[0004] Typically, a stent will have an unexpanded (closed) diameter for placement and an expanded (opened) diameter after placement in the vessel or the duct. Some stents are self-expanding and some are expanded mechanically with radial outward force from within the stent, as by inflation of a balloon.
[0005] An example of the latter type is shown in U.S. Pat. No. 4,733,665 to Palmaz, which issued Mar. 29, 1988, and discloses a number of stent configurations for implantation with the aid of a catheter. The catheter includes an arrangement wherein a balloon inside the stent is inflated to expand the stent by plastically deforming it, after positioning it within a blood vessel.
[0006] A type of self-expanding stent is described in U.S. Pat. No. 4,503,569 to Dotter which issued Mar. 12, 1985, and discloses a shape memory stent which expands to an implanted configuration with a change in temperature. Other types of self-expanding stents not made of shape memory material are also known.
[0007] This invention is directed to stents of all these types when configured so as to be longitudinally flexible as described in detail hereinbelow. Flexibility is a desirable feature in a stent so as to conform to bends in a vessel. Such stents are known in the prior art. Examples are shown in U.S. Pat. No. 4,856,516 to Hillstead; U.S. Pat. No. 5,104,404 to Wolff; U.S. Pat. No. 4,994,071 to MacGregor; U.S. Pat. No. 5,102,417 to Palmaz; U.S. Pat. No. 5,195,984 to Schatz; U.S. Pat. No. 5,135,536 to Hillstead; U.S. Pat. No. 5,354,309 to Shepp-Pesch et al.; EPO Patent Application 0 540 290 A2 to Lau; EPO Patent Application No. 0 364 787 B1 to Schatz, and PCT Application WO 94/17754 (also identified as German Patent Application 43 03 181).
[0008] Generally speaking, these kinds of stents are articulated and are usually formed of a plurality of aligned, expandable, relatively inflexible, circular segments which are interconnected by flexible elements to form a generally tubular body which is capable of a degree of articulation or bending. Unfortunately, a problem with such stents is that binding, overlapping or interference can occur between adjacent segments on the inside of a bend due to the segments moving toward each other and into contact or on the outside of a bend the segments can move away from each other, leaving large gaps. This can lead to improper vessel support, vessel trauma, flow disturbance, kinking, balloon burst during expansion, and difficult recross for devices to be installed through already implanted devices and to unsupported regions of vessel.
[0009] A diamond configuration with diagonal connections between each and every diamond of each segment is also known but such closed configurations lack flexibility.
[0010] It is an object of this invention to provide a longitudinally flexible stent of open configuration that avoids these problems and exhibits improved flexibility (radially and longitudinally) in the stent body segments thereof rather than in flexible joints between the segments.
[0011] It is a further object of the present invention to provide a stent that is flexible yet also allows for side branch access.
SUMMARY OF THE INVENTION
[0012] It is a goal of the present invention to provide a flexible stent formed of interconnected bands which provides for side branch access and which further avoids the problem of pinching or overlap between adjacent bands. Pinching or overlap is avoided where peaks and troughs of adjacent bands are circumferentially displaced relative to each other. The stents of the present invention accomplish this goal by having different bands characterized by different wavelengths over the length of the stent and/or disposing the interconnecting members in such a way that after expansion of the stent, the phase relationship between adjacent bands is altered with the peaks and troughs displaced circumferentially relative to each other.
[0013] The inventive expandable stents are formed of a plurality of interconnected band-like elements characterized by alternating peaks and troughs. The ends of the interconnecting members which join adjacent bands are circumferentially offset and optionally, longitudinally offset. Peaks and troughs in adjacent bands are circumferentially offset as well so that the stent, in an expanded state, will have minimal overlap of peaks and troughs.
[0014] To this end, the invention provides a tubular, flexible, expandable stent, comprising a plurality of undulating band-like elements of a selected wavelength or wavelengths. The band-like elements have peaks and troughs and are aligned on a common longitudinal axis to define a generally tubular stent body. The peaks and troughs take a generally longitudinal direction along the stent body. Adjacent band-like elements may be in phase or out of phase with each other. The inventive stents further comprise a plurality of interconnecting elements having first ends and second ends. The first and second ends extend from adjacent band-like elements and are displaced from one another in a longitudinal direction and in a radial direction along the stent. Desirably, upon expansion of the stent, at least some of the peaks and troughs of a given band-like element are displaced relative to each other about the periphery of the stent to accommodate longitudinal flexing of the stent within the band-like elements and without interference between adjacent band-like elements.
[0015] In one embodiment, two different types of band-like elements are present in the stent, first band-like elements with a first selected wavelength and second band-like elements with a second selected wavelength exceeding the first selected wavelength. The first and second band-like elements preferably alternate over the length of the stent. Although the terminology of ‘first band-like element’ and ‘second band-like element’ is used, it is not intended to convey the relative order of appearance of the elements in the inventive stents.
[0016] In another embodiment, two different types of band-like elements are present, first and second band-like elements, each of which has peaks and troughs. The first band-like elements have more peaks (or troughs) than the second band-like elements. Similarly, the invention is also directed to embodiments having first and second band-like elements with peaks and troughs where the peaks (or troughs) of the first band-like elements are spaced closer together than the peaks (or troughs) of the second band-like elements.
[0017] In another embodiment in which band-like elements of only one wavelength are present, adjacent bands are about 180° out of phase with one another. Interconnecting elements extend at an oblique angle relative to the longitudinal axis from a peak to a trough on an adjacent band.
[0018] In another embodiment in which band-like elements of only one wavelength are present, peaks from which interconnecting elements emanate are elongated relative to the peaks which are not connected to troughs and similarly, the troughs from which interconnectors emanate are elongated relative to troughs which are not connected to peaks. Further, each interconnecting element extends from the side of a peak to the side of a trough on an adjacent band.
[0019] In yet another embodiment in which band-like elements of only one wavelength are present, adjacent bands are about 90° out of phase with one another. Each interconnecting element extends between a peak and a trough and the ends of the interconnecting member are circumferentially offset from one another and, optionally, longitudinally offset.
[0020] The invention further provides a tubular, flexible, expandable stent having a longitudinal axis, comprising one or more cylindrical shaped first segments having first struts, the first segment being defined by a member formed in an undulating pattern of interconnected paired first struts and in which adjacent pairs of first struts in a given first segment are interconnected at opposite ends and one or more cylindrical shaped second segments defined by a member formed in an undulating pattern of interconnected paired second struts and in which adjacent pairs of second struts in a given second segment are interconnected at opposite ends. The first struts are shorter than the second struts. The first segments are formed of a number of first struts and the second segments are formed of a number of second struts with the number of first struts in a first segment exceeding the number of second struts in a second segment. The first and second segments, present and desirably alternating along the stent body, are aligned on a common longitudinal axis to define a generally tubular stent body. Adjacent first and second segments are connected by a plurality of interconnecting elements, each interconnecting element extending from an end of paired first struts on a first segment to an end of paired second struts on an adjacent second segment. The ends of interconnecting elements are circumferentially offset relative to each other, and optionally, longitudinally offset. Desirably, upon expansion of the stent, the paired struts of the adjacent segments are displaced relative to each other about the periphery of the stent body to accommodate longitudinal flexing of the stent within the segments and without interference between adjacent segments.
BRIEF DESCRIPTION OF THE FIGURES
[0021] [0021]FIG. 1 a shows a band-like element used in the inventive stents.
[0022] [0022]FIG. 1 b shows a schematic of a peak region which contains a double peak and a trough region containing a double trough.
[0023] [0023]FIG. 2 shows a flat view of a stent configuration according to the invention.
[0024] [0024]FIG. 3 shows the pattern of FIG. 2 in a tubular stent.
[0025] [0025]FIG. 4 a shows a flat view of a stent configuration according to the invention.
[0026] [0026]FIG. 4 b shows a flat view of a stent configuration according to the invention.
[0027] [0027]FIG. 5 a shows a flat view of a stent configuration according to the invention.
[0028] [0028]FIG. 5 b shows a flat view of a stent configuration according to the invention.
[0029] [0029]FIG. 6 shows a flat view of a stent configuration according to the invention.
[0030] [0030]FIG. 7 shows a flat view of a stent configuration according to the invention.
[0031] [0031]FIG. 8 shows a flat view of a stent configuration according to the invention.
[0032] [0032]FIG. 9 shows a flat view of a stent configuration according to the invention.
[0033] [0033]FIG. 10 shows a flat view of a stent configuration according to the invention.
[0034] [0034]FIG. 11 shows a flat view of a stent configuration according to the invention.
[0035] [0035]FIG. 12 shows a flat view of a stent configuration according to the invention.
[0036] [0036]FIG. 13 shows the pattern of FIG. 12 in a tubular stent.
[0037] [0037]FIG. 14 shows an expanded stent of the configuration shown in FIG. 12.
[0038] [0038]FIG. 15 shows a flat view of an alternate stent configuration according to the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0039] While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated.
[0040] For the sake of consistency, the terms ‘peak’ and ‘trough’ shall be defined with respect to the proximal and distal ends of the stent. Each of the stents has a proximal end 91 and a distal end 93 and a longitudinal axis 95 , as seen in FIG. 1 a . Peaks 36 are generally concave relative to the proximal end of the stent and generally convex relative to the distal end of the stent. Troughs 40 , on the other hand, are generally convex relative to the proximal end of the stent and generally concave relative to the distal end of the stent. Notwithstanding this definition, the term peak is also intended to extend to regions 48 that are generally peak-like which may, nevertheless, contain trough-like regions within the peak-like region as seen in FIG. 1 b . Similarly the term trough is also intended to extend to regions 52 that are generally trough-like which may, nevertheless, contain peak-like regions within the trough-like region as seen in FIG. 1 b.
[0041] Corresponding to each peak 36 is an inner diameter peak 38 where the inner diameter of the band-like element reaches its peak. The set of points on a given band-like element which are distal to inner diameter peak 38 is denoted peak region 48 . Similarly, corresponding to each trough 40 is an inner diameter trough 42 where the inner diameter of the band-like element reaches its trough. The set of points on a given band-like element which are proximal to inner diameter trough 42 is denoted trough region 52 . For the sake of clarity, unless otherwise indicated, analogous portions of stents will be similarly labeled, using three digit reference numerals to distinguish among the various embodiments shown.
[0042] Also included within this definition of peak regions and trough regions are peak regions which are comprised of multiple peaks as well as trough regions which are comprised of multiple troughs such as those shown schematically in FIG. 1 b . Peak 36 is seen to consist of two sub-peaks 36 a,b and trough 40 is similarly seen to consist of two sub-troughs 40 a,b . In the case of peaks containing sub-peak and troughs containing sub-troughs, the peak region 48 includes all of the points along the band-like element between the sub-peaks that make up the peak and similarly, the trough region 52 includes all of the points along the band-like element between the sub-troughs that make up the trough.
[0043] The inventive stents may incorporate one or more bands of a chosen wavelength. In some embodiments, the inventive stents include one or more small amplitude, short wavelength bands to provide for flexibility and one or more large amplitude, long wavelength bands to give side branch access or to provide for sections of alternative strengths such as soft and/or stiff sections.
[0044] Turning to the Figures, FIG. 2 shows a flat view of a stent configuration and FIG. 3 shows the stent of FIG. 2 in tubular form. That is, the stent is shown for clarity in FIG. 2 in the flat and may be made from a flat pattern 110 (FIG. 2) which is formed into a tubular shape by rolling the pattern so as to bring edges 112 and 114 together (FIG. 2). The edges may then joined as by welding or the like to provide a cylindrical configuration such as that shown generally at 115 in FIG. 3.
[0045] A more preferred method of manufacture begins with a thin walled tube which is then laser cut to provide the desired configuration. It may also be chemically etched or EDM'd (electrical discharge machined) to form an appropriate configuration.
[0046] The configuration can be seen in these Figures to be made up of one or more spaced first band-like elements 120 . First band-like elements have a generally serpentine configuration to provide continuous waves to the first band-like elements. The waves are characterized by a plurality of peaks 124 and troughs 128 taking a generally longitudinal direction along the cylinder such that the waves in first band-like elements 120 open as the stent is expanded from an unexpanded state having a first diameter to an expanded state having a second diameter.
[0047] The stent further comprises a plurality of spaced second band-like elements 132 having a generally serpentine configuration to provide continuous waves to the second band-like elements. The waves are characterized by a plurality of peaks 136 and troughs 140 taking a generally longitudinal direction along the cylinder such that the waves in the second band-like elements open as the stent is expanded from an unexpanded state having a first diameter to an expanded state having a second diameter. First and second band-like elements are characterized by respective wavelengths and amplitudes with the wavelength and amplitude of the second band-like elements exceeding the wavelength and amplitude of the first band-like elements.
[0048] Adjacent first band-like elements 120 and second band-like elements 132 are interconnected via a plurality of interconnecting elements 144 . The ends of interconnecting element are circumferentially offset from each other.
[0049] In an embodiment, as shown in FIGS. 2 and 3, first band-like elements 120 and second band-like elements 132 alternate over the length of the stent. Optionally, as shown in FIGS. 2 and 3, each end 152 of the stent may terminate in a first band-like element. The invention also, however, contemplates each end terminating in a second band-like element, or further, one end terminating in a first band-like element and the other end terminating in a second band-like element.
[0050] While a minimum of one connecting element is required to join adjacent band-like elements, two or more interconnecting elements are preferred. In one embodiment, as shown in FIGS. 2 and 3, adjacent first and second band-like elements 120 and 132 are connected with three interconnecting elements 144 . Further, in one embodiment, adjacent interconnecting elements 144 extending from peaks 136 on a first band-like element 120 are spaced five peaks apart on the first band-like element while adjacent interconnecting elements 144 extending from troughs 140 on a second band-like element 132 are spaced three troughs apart on the second band-like element.
[0051] It is a further feature of the present invention that peaks 124 on first band-like elements 120 are circumferentially displaced on the periphery of the stent from troughs 140 on adjacent second band-like elements 132 . It is desirable that peaks and troughs be displaced in the expanded state of the stent to minimize the possibility of pinching or overlap between adjacent band-like elements.
[0052] Although the stent of FIG. 2 is comprised of two different wavelength band-like elements, the invention contemplates stents with a plurality of different wavelength band-like elements. As such, other stents may have three, four or more different wavelength band-like elements.
[0053] In another embodiment, the inventive stent is comprised of band-like elements of a single wavelength, interconnected by interconnecting elements. Turning to FIGS. 4 a and 4 b , band-like elements 220 a,b are interconnected by interconnecting elements 244 a,b . Adjacent band-like elements 220 a,b are 180° out of phase with one another. In the compressed state, the band-like elements consist of a plurality of peaks 236 a,b and troughs 240 a,b . Peak region 248 a,b and trough region 252 a,b have been shaded in one instance for illustrative purposes.
[0054] In the embodiment shown in FIG. 4 a , each interconnecting element 244 a extends between a peak region 248 a and a trough region 252 a . Rectilinear interconnecting elements 244 a consist of a first shank 280 a , a second shank 284 a and a link 288 a disposed in-between the first and second shanks 280 a and 284 a . First shank 280 a extends in a longitudinal direction from peak region 248 a and is substantially perpendicular to link 288 a . Second shank 284 a extends in a longitudinal direction from trough region 252 a and is perpendicular to link 288 a.
[0055] In the embodiment shown in FIG. 4 b , the stent differs from the embodiment of FIG. 4 a in that interconnecting element 244 b extending between a peak region 248 b and a trough region 252 b is curvilinear rather than rectilinear.
[0056] In both FIGS. 4 a and 4 b , the interconnecting elements are seen to emanate from the middle of the peak and trough regions.
[0057] In another embodiment, as shown in FIG. 5 a , the inventive stent is comprised of band-like elements 320 a of a single wavelength, interconnected by interconnecting elements 344 a . Adjacent band-like elements 320 a are 180° out of phase with one another. The band-like elements consist of a plurality of peaks 336 a and troughs 340 a . Interconnecting elements 344 a extend between a peak region 348 a and a trough region 352 a . The peak regions 348 a and trough regions 352 a from which interconnecting elements 344 a emanate on a given band-like element 320 a are seen to extend longitudinally beyond adjacent peak regions 348 a ′ and trough regions 352 a ′ from which no interconnecting elements extend. The extension is such that at least a portion of peak regions 348 a overlap longitudinally along the stent with at least a portion of trough region 352 a on an adjacent band-like element 320 a ′. Of course, the overlap is limited to the longitudinal direction and not to the circumferential direction.
[0058] In another embodiment, as shown in FIG. 5 b , interconnecting elements 344 b extend between peak region 348 b and a second closest trough region 352 b on an adjacent band-like element. Interconnecting elements 344 b are seen to be perpendicular to the longitudinal axis. As in the stent of FIG. 5 a , peak regions 348 b from which interconnecting elements 344 b extend and trough regions 352 b from which interconnecting elements 344 b extend may extend beyond adjacent peak regions 348 b ′ and trough regions 352 b ′ from which no interconnecting elements 344 b emanates.
[0059] In another embodiment, as shown in FIG. 6, adjacent band-like elements 420 are in phase with each other. As in previous FIGS., band-like elements 420 are of a single wavelength, interconnected by interconnecting elements 444 . The band-like elements consist of a plurality of peaks 436 and troughs 440 . Interconnecting elements 444 extend at an oblique angle relative to the longitudinal axis of the stent between a peak region 448 and a trough region 452 . As such, ends of interconnecting elements 444 are circumferentially offset relative to each other. The exact angle will, of course, depend on the region from which the interconnecting elements extend, as well as on whether interconnecting elements interconnect nearest peaks and troughs, next nearest peaks and troughs or peaks and troughs that are further separated.
[0060] In FIGS. 5 a , 5 b and 6 , the interconnecting elements are seen to emanate from the sides of the peak and trough regions.
[0061] Although for the embodiments of FIGS. 1-6, the interconnecting elements extend from peak regions on band-like elements to trough regions on adjacent band-like elements, the invention further contemplates interconnecting elements extending from a position between a peak region and an adjacent trough region on a band-like element to a position intermediate a trough region and a peak region on an adjacent second band-like element as in FIG. 7.
[0062] In the embodiment of FIG. 7, interconnecting elements are seen to extend from a region between the peak region and the trough region on a band-like element. The stent is formed of adjacent band-like elements 520 which are 180° degrees out of phase with one another. Interconnecting elements 544 extend from a region intermediate a peak region 548 and a trough region 552 on a band-like element to a region intermediate a peak region 548 and a trough region 552 on an adjacent band-like element. Interconnecting elements 544 consist of a first shank 560 , a second shank 564 , and an intermediate member 568 disposed in-between first and second shanks 560 and 564 . First shank 560 and second shank 564 are substantially perpendicular to intermediate member 568 which extends in the longitudinal direction. Although not depicted, the region from which interconnecting elements 544 emanate may be midway between peaks and troughs.
[0063] The embodiment of FIG. 7 also differs from the embodiments of FIGS. 2-6 in the orientation of the interconnecting elements. Whereas the interconnecting elements in FIGS. 2-6 are all similarly oriented, in the embodiment of FIG. 7, the orientation of interconnecting elements alternates between adjacent pairs of adjacent band-like elements. Specifically, second shanks 564 ′ of interconnecting elements 544 ′ are seen to be displaced in a clockwise circumferential direction along the stent relative to first shanks 560 ′, and seconds shank 564 ″ of interconnecting elements 544 ″ are seen to be displaced in a counterclockwise circumferential direction along the stent relative to while first shank 560 ″.
[0064] This feature is also seen in the embodiment of FIG. 8 in which adjacent in-phase band-like elements 620 are interconnected by interconnecting elements 644 . Interconnecting elements 644 extend at an oblique angle relative to the longitudinal axis of the stent between a peak region 648 and a trough region 652 . As in FIG. 7, the orientation of interconnecting elements alternates between adjacent pairs of adjacent band-like elements. Specifically, the distal ends of interconnecting elements 644 ′ are seen to be oriented in a counterclockwise circumferential direction along the stent relative to the proximal end of the interconnecting elements while the distal ends of interconnecting elements 644 ″ are seen to be displaced in a clockwise circumferential direction along the stent relative to the proximal ends.
[0065] Although in the embodiments of FIGS. 2-8, adjacent bands are connected by five interconnecting elements, additional or fewer interconnecting elements may be used. Further, while interconnecting elements are shown spaced three peaks apart and three troughs apart, other separations are contemplated as well.
[0066] In the embodiment of FIG. 9, each band-like element 720 is seen to comprise peaks 736 of more than one amplitude and troughs 740 of more than one amplitude. Large amplitude peaks 736 a and small amplitude peaks 736 b alternate as do large amplitude troughs 740 a and small amplitude troughs 740 b . As in the previous embodiments, the interconnecting elements are oriented at an oblique angle relative to the longitudinal axis 795 of the stent. More generally, the invention is directed at stents comprising band-like elements whose amplitude varies along the band-like element.
[0067] In another embodiment of the invention, as shown in FIG. 10, each band-like element 820 is seen to comprise peaks 836 of more than one amplitude and troughs 840 of more than one amplitude, however, peaks of the same amplitude are grouped together within a band-like element as are troughs of the same amplitude. It is further noted that in the embodiment of FIG. 10, the location of a group of peaks of given amplitude in a band-like element varies circumferentially along the length of the stent. Interconnecting elements 844 connect peaks 836 and troughs 840 in adjacent band-like elements 820 . Where several peaks of different amplitudes are present in a band-like element, the invention further contemplates the possibility of interconnecting elements extending from the large peaks 836 a to large troughs 840 a as in FIG. 9 as well as the possibility of interconnecting elements extending from large peaks to small troughs or from small peaks 836 b to large troughs 840 a as in FIG. 10. Further, the interconnecting elements between any two adjacent band-like elements may be of different lengths from one another as seen in FIG. 10 and commence at different longitudinal positions within a band-like element and terminate at different longitudinal positions within a band-like element. Interconnecting element 844 a is seen to be longer than interconnecting element 844 b . As in the previous embodiments, the interconnecting elements are oriented at an oblique angle relative to the longitudinal axis 895 of the stent. In the embodiment of FIG. 10, interconnecting element 844 a is seen to be oriented at a smaller oblique angle relative to the longitudinal axis of the stent than interconnecting element 844 b . As is apparent from FIG. 10, the invention is also directed to stents comprised of band-like elements whose wavelength varies along a given band-like element. Region 898 and region 899 of band-like element are characterized by different wavelengths.
[0068] It is also noted that in the embodiment of FIG. 10, all of the troughs 840 a,b in a given band-like element 820 are aligned longitudinally along the stent and differ only in their circumferential position along the stent.
[0069] It is further noted in the embodiment of FIG. 10, the stent comprises a first group of interconnecting elements 844 a and a second group of interconnecting elements 844 b . The interconnecting elements of the first group are all parallel to one another and disposed at a different oblique angle relative to the longitudinal axis than the members of the second group which are all parallel to one another. As such, the invention contemplates stents having several different groups of obliquely disposed interconnecting elements where the oblique angle differs from group to group.
[0070] In another embodiment of the invention, as shown in FIG. 11, each band-like element 920 is seen to comprise peaks 936 a,b of different amplitudes and troughs 940 of different amplitudes, however, peaks of the same amplitude are grouped together within a band-like element as are troughs of the same amplitude. It is further noted that in the embodiment of FIG. 11 the location of groups of peaks of given amplitude in a band-like element varies circumferentially along the length of the stent. Interconnecting elements 944 connect large amplitude peaks 936 a and small amplitude troughs 940 b in adjacent band-like elements 920 . Similarly, interconnecting elements 944 also connect small amplitude peaks 936 b and large amplitude troughs 940 a.
[0071] The invention also contemplates stents similar to that shown in FIG. 11 in which interconnecting elements extend from large peaks 936 a to large troughs 940 a , as in FIG. 9. Similarly, interconnecting elements may extend from small peaks 936 b to small troughs 940 b.
[0072] Further, the interconnecting elements between any two adjacent band-like elements may be of different lengths from one another and disposed at different oblique angles.
[0073] As is apparent from FIG. 11, the invention is also directed to stents comprised of band-like elements whose wavelength varies along a given band-like element. Region 998 and region 999 of band-like element 920 are characterized by different wavelengths.
[0074] It is also noted that in the embodiment of FIG. 1 the large amplitude portions 999 of band-like element 920 are symmetrically disposed about the center 1001 of the band-like element as are the small amplitude portions 998 . The center 1001 of the band-like element is defined as a ring that runs along a path that is midway between the large peaks 936 a and large troughs 940 a of the band-like element. This feature may also be seen in the embodiment of FIG. 9.
[0075] The invention is also directed to a tubular, flexible, expandable stent having a longitudinal axis, comprising one or more cylindrical shaped first segments. Cylindrical shaped first segments 20 as seen in FIG. 1, have first struts 23 having first 25 and second 27 ends. First segments 20 are defined by a member formed in an undulating pattern of interconnected paired first struts 23 , in which adjacent pairs of first struts 29 ′ and 29 ″ in a given first segment 20 are interconnected at opposite ends 31 ′ and 31 ″, respectively. Adjacent segments are interconnected.
[0076] The stent may be seen more clearly in FIGS. 2-8. As shown, the stent of FIG. 3, in addition to comprising first segments 120 which are defined by an undulating pattern of interconnected paired first struts 123 in which adjacent pairs of first struts 129 ′ and 129 ″ in a given first segment 120 are interconnected at opposite ends 131 ′ and 131 ″, respectively, the stent further comprises one or more cylindrical shaped second segments 132 , each second segment being defined by a member formed in an undulating pattern of interconnected paired second struts 135 and in which adjacent pairs of second struts 137 ′ and 137 ″ in a given second segment 132 are interconnected at opposite ends 139 ′ and 139 ″, respectively. First struts 123 are shorter than second struts 135 . First segments 120 are formed of a number of first struts 123 and second segments 132 formed of a number of second struts 135 , the number of first struts in a first segment exceeding the number of second struts in a second segment. First and second segments 120 and 132 are aligned on a common longitudinal axis 195 to define a generally tubular stent body, shown generally at 115 . First and second segments 120 and 132 alternate along the stent body. Adjacent first and second segments 120 and 132 are connected by a plurality of interconnecting elements 144 . Each interconnecting element 144 extends from an end 131 ″ of paired first struts on a first segment 120 to an end 139 ″ of paired second struts on an adjacent second segment 132 . The ends of interconnecting elements 144 are circumferentially offset relative to each other.
[0077] Desirably, upon expansion of stent 115 , paired struts 129 ″ and 137 ″ of adjacent segments 120 and 132 are displaced relative to each other about the periphery of the stent body to accommodate longitudinal flexing of the stent within the segments and without interference between adjacent segments.
[0078] In the embodiments as shown in FIGS. 4 a, b , cylindrical shaped segments 220 a,b are formed of interconnected struts 223 a,b having first 225 and second 227 ends. Adjacent pairs of struts 229 a,b ′ and 229 a,b ″ in a given segment 220 a,b are interconnected at opposite ends 231 a,b ′ and 231 a,b ″, respectively. Adjacent segments are connected by a plurality of interconnecting elements 244 a,b . Each interconnecting element 244 a,b extends from an end of paired struts 231 a,b ″ on a segment to an end of paired struts 231 a,b ′ on an adjacent segment. First end 245 a,b and second end 247 a,b of interconnecting elements 244 a,b are seen to be circumferentially displaced along the stent.
[0079] Similar structure, denoted by similar reference numerals may be found in the stents of FIGS. 5 a,b , and 6 - 8 .
[0080] In particular, in the embodiment as shown in FIG. 8, cylindrical shaped segments 620 are formed of interconnected struts 623 , having first 625 and second 627 ends. Segments 620 are defined by a member formed in an undulating pattern of interconnected paired struts 623 in which adjacent pairs of struts 629 ′ and 629 ″ in a given segment 620 are interconnected at opposite ends 631 ′ and 631 ″, respectively. Segments 620 are aligned on a common longitudinal axis 695 to define a generally tubular stent body. Adjacent segments are connected by a plurality of interconnecting elements 644 (and 644 ′) having first 645 ( 645 ′) and second 647 ( 647 ′) ends, each interconnecting element 644 ( 644 ′) extending from an end of paired struts 631 ″ on a segment to an end of paired struts 631 ′ on an adjacent segment. First end 645 ( 645 ′) and second end 647 ( 647 ″) are seen to be circumferentially displaced along the stent.
[0081] Additional embodiment of the stents are shown in FIGS. 12-15. FIG. 12 and FIG. 13 show a fragmentary flat view of an unexpanded stent configuration and the actual tubular stent (unexpanded), respectively. That is, the stent is shown for clarity in FIG. 12 in the flat and may be made from a flat pattern 1110 (FIG. 12) which is formed into a tubular shape by rolling the pattern so as to bring edges 1112 and 1114 together (FIG. 12). The edges may then joined as by welding or the like to provide a configuration such as that shown in FIG. 13.
[0082] The configuration can be seen in these Figures to be made up of a plurality of adjacent segments generally indicated at 1116 , each of which is formed in an undulating flexible pattern of substantially parallel struts 1118 . Pairs of struts are interconnected at alternating end portions 1119 a and 1119 b . As is seen in FIG. 12, the interconnecting end portions 1119 b of one segment are positioned opposite interconnecting end portions 1119 a of adjacent segments. The end portions as shown are generally elliptical but may be rounded or square or pointed or the like. Any configuration of end portions is acceptable so long as it provides an undulating pattern, as shown. When the flat form 1110 is formed into an unexpanded tube as shown in FIG. 13, the segments are cylindrical but the end portions 1119 of adjacent segments remain in an opposed position relative to each other.
[0083] A more preferred method of manufacture begins with a thin walled tube which is then laser cut to provide the desired configuration. It may also be chemically etched or EDM'd (electrical discharge machined) to form an appropriate configuration.
[0084] Interconnecting elements 1120 extend from one end portion 1119 of one segment 1116 to another end portion 1119 of another adjacent segment 1116 but not to an oppositely positioned end portion 1119 of an adjacent segment 1116 . There are at least three struts included between the points on each side of a segment 1116 at which an interconnecting element 1120 contacts an end portion 1119 . This results in the interconnecting elements 1120 extending in an angular direction between segments around the periphery of the tubular stent. Interconnecting elements 1120 are preferably of the same length but may vary from one segment to the other. Also, the diagonal direction may reverse from one segment to another extending upwardly in one case and downwardly in another, although all connecting elements between any pair of segments are substantially parallel. FIG. 12, for example shows them extending downwardly, right to left. Upwardly would extend up left to right in this configuration.
[0085] As a result of this angular extension of the interconnecting elements 1120 between adjacent segments and loops, upon expansion of the stent as seen in FIG. 14, the closest adjacent end portions 1119 between segments 1116 are displaced from each other and are no longer opposite each other so as to minimize the possibility of binding or overlapping between segments, i.e., pinching.
[0086] The number of interconnecting elements 1120 may vary depending on circumstances in any particular instance. Three per segment are satisfactory for the configuration shown and at least three will be used typically.
[0087] The alternate design shown in FIG. 15 includes longer struts 1118 a in the two end segments 1116 a than in the intermediate segments 1116 . This allows the end segments ( 1116 a ) to have less compression resistance than the intermediate segments ( 1116 ), providing a more gradual transition from the native vessel to the support structure of the stent. Otherwise, the configuration is the same as that shown in FIG. 12.
[0088] As indicated in the Figures, the invention contemplates a variation of interconnecting element shapes ranging from rectilinear to curvilinear. The invention further contemplates embodiments in which all interconnecting elements are similarly oriented as well as embodiments in which adjacent sets of interconnecting elements extending between adjacent pairs of segments are oppositely oriented (e.g., FIGS. 7 and 8). The invention also contemplates the use of interconnecting elements which extend from a range of positions along the segments, ranging from various positions in the area in which paired struts are interconnected to other positions along the struts.
[0089] The invention also contemplates the possibility of interconnecting elements extending at an oblique angle relative to the longitudinal axis of the stent and connecting adjacent peaks and troughs on adjacent segments as well as peaks and troughs on adjacent segments which are separated by one or more peaks and/or troughs.
[0090] The invention also contemplates reversing the orientation of interconnecting elements as shown in FIGS. 7 and 8.
[0091] Finally, there are preferably at least three interconnecting elements joining adjacent first and second segments although fewer or additional interconnecting elements are also contemplated.
[0092] It is understood that the peaks and troughs of the present invention need not be rounded, as shown in the Figures. The peaks and troughs may be bulbous, triangular, square, pointed, or otherwise formed of interconnected straight sections.
[0093] As already indicated, this invention is applicable to self-expanding configurations, mechanically expandable configurations and to a wide variety of materials, including both metal and plastic and any other material capable of functioning as an expandable stent. For example, the stent may be of metal wire or ribbon such as tantalum, stainless steel or the like. It may be thin-walled. It may be of shape memory alloy such as Nitinol or the like, etc. The interconnecting elements may be formed integrally with the band-like elements (or segments) or may be bonded thereto via such methods as adhesive bonding, welding or any other known method of bonding.
[0094] The above Examples and disclosure are intended to be illustrative and not exhaustive. These examples and this description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the attached claims. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims attached hereto.
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Segmented articulatable stent of open structure comprised of end-connected struts of first and second lengths making up first and second segments with angular interconnects between adjacent first and second segments.
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BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to an application member for the application of a product, particularly a cosmetic or dermatological product, to a surface such as the skin, and to an application assembly containing the product and equipped with an application member of this type.
2. Discussion of the Background
The assembly envisaged by the present invention is of the type comprising a reservoir containing the product and provided with an open end over which a stopper acting as a gripping member is removably fastened. The stopper is integral with the application member, generally by means of a wand, so that the application member, in the closed position of the assembly, is permanently immersed in the product.
The reservoir is intended, in particular, to contain a dermatological product, a make-up product or a product for specific treatment of the body and more particularly of the face, such as a liquid foundation, a blusher or an eyeshadow. More specifically, the application member is designed for the application of a product for treating the signs of skin aging, such as wrinkles and small wrinkles and the signs of fatigue, particularly those of the face, neck or décolletage.
A number of products have been proposed in the past with the aim of erasing or blurring the signs of skin aging. More recently, in Patent Applications FR-A-2 758 083 and FR-A-2 759 084, the Applicant has described novel products intended for treating signs of aging and of fatigue, based on particularly effective “tightening agents”. During aging, the skin has an increasingly irregular micro relief and exhibits wrinkles and small wrinkles.
In the case of tightening agents, these are compounds which are capable of tightening the skin and, through this tightening effect, smoothing the skin and immediately reducing or even erasing wrinkles and small wrinkles thereof. These products have a particular texture and have rapid drying properties.
The direct application of this type of product using the fingers is unsuitable. In fact, even with the lightest massaging, finger friction suffices to break up the product's texture.
Thus, the problem posed by the present invention consists in providing an application member capable of:
depositing just the necessary quantity of product;
having a geometry to suit the surface to be treated;
being flexible, supple and soft, given the sensitivity of the skin of the eye contour area and of the fragility of the product's texture;
spreading the product rapidly, particularly in a single stroke, before the product dries.
The areas of the face particularly targeted by the invention are wrinkles in the eye contour area, such as “crow's feet” at the outer corner of the eyes, dark rings and bags under the eyes, wrinkles at the corners of the mouth, etc.
FR-A-2 506 580 discloses a flat, supple applicator, in the form of a spatula, for applying a make-up product. This applicator, intended to be loaded with a very fluid product by capillary effect, cannot be used for the products envisaged by the present invention. Moreover, its shape is not particularly suited to the application of the said products to the areas of the body targeted by the invention.
SUMMARY OF THE INVENTION
Thus, a first object of the present invention is to provide an application member adapted to the treatment of the skin, particularly of the aforesaid areas of the face.
A second object of the invention consists in an application member capable of conferring as gentle an application as possible to the skin whilst still guaranteeing a high level of precision during application.
A further object of the invention consists in an application member capable of selectively treating a single wrinkle or a “bundle” of wrinkles.
A yet further object of the invention consists in an application assembly including a treatment-product reservoir and provided with an application member of this type.
The application assembly according to the invention is intended for carrying in the user's handbag or it may be used for renewing the treatment during the day, particularly whilst travelling.
Thus, the subject of the present invention is an application member, for the application of a product to the skin, including a gripping element and an application element, integral with the said gripping element, the said application element being flexible, and having at least a first substantially planar face, the width of which in a direction perpendicular to an axis of the gripping element decreases in the direction of a free end located opposite the said gripping element, the said first face being delimited by two lateral edges, at least one of which is of concave form. Thus, when the application member is loaded with product, the first face may be used as an application surface. The lateral edge of concave form is adapted particularly to the shape of the lower part of the eyes. To this end, the concave lateral edge advantageously has a radius of curvature of between 16 mm and approximately 30 mm.
In the sense of the present invention, the term “flexible” is used to denote the ability of the application element to curve, in response to a stress, and to resume its initial form by means of elasticity when the stress ceases. The ability of a material of this type to flex may be characterized by its flexural modulus in flexure. Generally, the materials envisaged by the invention have a flexural modulus of flexure which is at least equal to 200 MPa (Young's modulus in flexure). The flexibility may be the result of the nature of the material forming the application element and/or its configuration.
According to a particularly preferred embodiment, one of the lateral edges is of concave shape, the other of the lateral edges being of convex shape. In this case, the two lateral edges may have different radii of curvature. Advantageously, the radius of curvature of the convex lateral edge is greater than the radius of curvature of the concave lateral edge. Alternatively, the two lateral edges may be concave.
Thus, the user, holding the gripping element in the right hand, applies the planar face to the area to be treated, located, for example, below the right eye, the concave edge of the application element matching the edge of the lower eyelid.
In order to be able to carry out the same treatment on the lower part of the left eye, using the same hand or the left hand, the second face of the application element, opposite the first one, is also preferably substantially planar.
Preferably, at least the free end of the application element is of rounded form. In this case, the curvature of this free end has a radius of between approximately 1 mm and approximately 3 mm.
As regards the application element, it may be produced from natural or synthetic rubber, particularly from polyurethane or from thermoplastic elastomer. It may consist of a foam with closed or semi-open cells or include a flocked covering. Advantageously, the application element has a mean thickness of between approximately 1 mm and approximately 3 mm.
By virtue of the choice of these materials and of the thickness of the application element, the latter has a flexibility such that, as it brushes against the skin, a portion of the corresponding face of the application element is applied tangentially to the surface of the skin, without giving rise to notable deformation of the latter.
According to a preferred embodiment, the application element has a length of approximately 20 mm measured along the axis of the gripping element. Advantageously, this gripping element is connected to the application element by means of a wand of small diameter, which makes it easier to handle the application member.
Advantageously, the application element has a mean width of approximately 7 mm measured in a direction perpendicular to the axis of the gripping element. This width is adapted to cover the essential part of the wrinkles in the targeted wrinkled areas.
In practice, the application member is associated with a reservoir intended to contain a product, for example an anti-wrinkle treatment product, thus forming an application assembly. This reservoir includes an open end defining an opening over which a closure element is removably fastened. Advantageously, this closure element consists of a generally cylindrical stopper, which forms the gripping element integral with the application element described above.
In order to be able to guarantee correct metering of the product and its homogeneous distribution on the application element, a drying member is advantageously provided, located in the vicinity of the open end of the reservoir. This drying member is capable of metering the quantity of product taken up by the application member. Preferably, this drying member consists of an elastomeric material and has at least one slit extending over a substantial part of the section of the drying member. In the storage position of the assembly, the wand carrying the application element passes through the slit.
According to one embodiment, the drying member may comprise a plurality of slits intersecting in the vicinity of the center of the drying member. According to an advantageous aspect of the invention, each end of the slit or slits may be extended by at least one portion oriented in a different direction from the axis of the corresponding slit. In particular, each end ends in a “V” portion centred on the axis of the corresponding slit and the apex of which is adjacent to the corresponding slit. The free ends of the “V” portion may be oriented away from the corresponding slit or, alternatively, towards the corresponding slit. The angle of opening of the “V” slit may be between 30° and 180° and preferably between 30° and 90°.
Alternatively, each end of a slit ends in an opening, the form of which is advantageously circular. Typically, the diameter of this opening is of the order of 1 mm.
The application member which has just been described can be used, in particular, for the application of a product capable of treating wrinkles and small wrinkles, particularly of the eye contour area and of the corners of the mouth, based on a product containing tightening agents of the type mentioned above.
BRIEF DESCRIPTION OF THE DRAWINGS
Further objects of the invention will become apparent in a detailed manner upon reading the following description of an embodiment of the invention which is given by way of purely illustrative and non-limiting example, shown in the appended drawing.
In this drawing:
FIG. 1 shows a view in axial section of an application assembly according to the invention;
FIG. 2 is an enlarged view of the application member of the assembly of FIG. 1;
FIG. 3 a shows an enlarged top view of a drying member according to a first embodiment;
FIG. 3 b shows a view in axial section of the drying member of FIG. 3 a:
FIG. 4 a shows an enlarged top view of a drying member according to a second embodiment;
FIG. 4 b shows a view in axial section of the drying member of FIG. 4 a:
FIG. 5 shows an enlarged top view of a drying member according to a third embodiment;
FIG. 6 illustrates the application of an anti-wrinkle product to the face, using the application member according to the invention;
FIG. 7 illustrates an enlarged view of a second embodiment of the application member of the assembly of the present invention;
FIG. 8 shows as enlarged top view of a drying member according to a fourth embodiment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
With reference to FIGS. 1 and 2, an application assembly 1 can be seen, of axis X, for the application of a product P and equipped with an application member 2 . The application member 2 includes a stopper 4 serving as a gripping element and a closure element, and capable of being fastened, by screwing, onto the neck 21 of a bottle 20 of cylindrical form. The bottle 20 forms a reservoir containing the product P of liquid to pasty or gel consistency. The neck 22 includes an outer screw thread 23 capable of interacting with a complementary screw thread 5 on the lower portion inside the stopper 4 , thereby allowing the stopper 4 to act as a closure element. The stopper 4 acts as a gripping element since the stopper has a general elongate cylindrical form, allowing easy gripping. The stopper 4 is provided with a central wand 6 emerging from the lower side of the stopper 4 . This wand 6 has a lower end 6 a to which an application element 8 is fastened, for example by adhesive bonding, interlocking or heat welding.
The application element has two ends, a first end 8 a adjacent to the wand 6 and a second free end 8 b . The two ends have a rounded form, the radius of curvature R 4 of the first end 8 a being greater than the radius of curvature R 3 of the second free end 8 b . According to the example in question, R 4 is approximately 4 mm R 3 being approximately 1 mm. The distance between the two ends 8 a and 8 b , measured along the axis X, is approximately 20 mm.
The two ends 8 a , 8 b are separated from each other by two edges 9 a , 9 b . The edge 9 a is concave and has a radius of curvature R 1 . The edge 9 b is convex and has a radius of curvature R 2 . In the embodiment illustrated, R 1 is greater than R 2 . This makes it possible to obtain good convergence of the lateral edges 9 a , 9 b in the direction of the free end 8 b.
R 1 is adapted to the curvature of the lower eyelid. Typically, R 1 is of the order of 20 mm. R 2 is of the order of 16 mm. The mean distance l separating the two lateral edges 9 a and 9 b , measured in a direction perpendicular to the axis X of the wand, is of the order of 7 mm. In its widest portion, the application element 8 has a width of approximately 8 mm.
The application element has two principal faces 10 which are substantially planar and parallel to each other. The distance between these two surfaces defines the thickness of the application element, this thickness being chosen as a function of the flexibility of the material used for producing the application element 8 . Generally, this thickness is between approximately 1 mm and approximately 3 mm.
FIG. 7 depicts a second embodiment of the application element 8 where the later edge 9 a 1 , and the lateral edge 9 b 1 , are both concave.
The material forming the application element 8 is a material which is elastically deformable, particularly in flexure. It may be chosen from natural or synthetic rubbers and preferably from thermoplastic elastomers. Advantageously, a closed-cell or semi-open-cell elastomer foam is chosen. Optionally, the surface of the application element 8 may be flocked, which makes it possible to increase its capacity to retain product P and thus to increase its autonomy.
The neck 21 of the bottle has a free circular edge 22 defining an opening 24 . A drying member 26 (FIG. 1) formed from an elastically deformable material is fitted in this opening. The drying member has the form of a thin membrane and has a circular peripheral edge 27 resting on the free edge 22 of the neck of the bottle. The central portion 25 of the drying member is shaped as a dish, the bottom of which faces the reservoir 20 . The drying member has one or more slits 28 (FIGS. 3 a , 3 b ), 28 a- 28 d (FIGS. 4 a , 4 b ). When several slits are present, these intersect at a central point C. In a storage position, the wand 6 passes through this slit or these slits.
As may be seen in FIGS. 3 a and 3 b , a single rectilinear slit 28 is made, the terminal portions 29 of which are extended by means of two branches 30 a , 30 b arranged as a “V” and together defining an angle α of approximately 60°.
FIGS. 4 a and 4 b show a further embodiment of a drying member 26 b , according to which the bottom 25 is provided with four slits 28 a - 28 d intersecting at the center C of the membrane. In a similar manner to the embodiment of the slit of FIG. 3 a , the slits 28 a - 28 d shown in FIGS. 4 a and 4 b have a terminal part 29 extended by two branches 30 a , 30 b in the form of a “V”.
The structure of the slits with their “V” terminal part allows supple opening of the edges of the slit 28 , 28 a - 28 d during removal of the application element 8 from the bottle 20 or during its insertion into it. Moreover, the edges of the slit or slits ensure correct spreading of the product P on the application element during removal of the application member, removing any excess of product P and ensuring homogeneous distribution over the application surface 10 .
FIG. 5 shows a third embodiment of a drying member 26 c , according to which the bottom 25 is provided with four slits 28 a - 28 d intersecting at the center C of the membrane in a similar manner to the embodiment of the slits of FIG. 4 a . Each slit 28 a - 28 d shown in FIG. 5 has two terminal parts formed by an opening 29 a . Typically, each opening 29 a is circular and has a diameter of approximately 1 mm.
FIG. 6 illustrates the application of an anti-wrinkle product using the application member 2 according to the invention to the wrinkled areas of the contour area of the eyes Y and of the corners of the mouth Z. By lightly applying just the free end 8 b of the application element, it is possible to spread the product P over a single wrinkle, ensuring homogeneous and precise smoothing of the product over the wrinkle in question without deposition of excess product at the edge of the wrinkle. The product is applied gently, without detrimental effect on the product's texture. In this application mode, the user holds the application member so that an angle of approximately 30° to 60° is formed between the wand 6 and the surface of the skin.
In order to treat a more extensive wrinkled area, for example the wrinkled area below the eye, the application element 8 is applied with a greater bearing force than in the previous case. This gives rise to flexing of the application element so that a larger and particularly wider surface area of the application element comes into contact with the skin. In this case, the surface 10 of the application element comes into contact with the skin tangentially. By following the area to be treated with the application element, product is spread just in the depths of the wrinkles where, through the action of the tightening agent present in the product, blurring and even erasing of the wrinkles is produced after drying.
The form of the application element is particularly adapted to the treatment of rings under the eyes. The product may be spread in a single operation. Thus, a first face of the application element is used to apply the product to the rings under the right eye, using the right hand, whilst the other face is applied to the rings under the left eye, using the left hand.
FIG. 8 depicts a fourth embodiment of a drying member 26 d having at least one slit 28 with terminal portions 29 of which are extended by means of two branches 30 a 1 , 30 b 1 arranged as a “V”. The branches 30 a 1 , 30 b 1 are oriented such that the free ends thereof are oriented in a direction towards the slit 28 .
In the above detailed description, reference has been made to particular embodiments of the invention. Obviously, variations may be made to it without departing from the spirit of the invention as claimed hereinbelow.
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Application member for the application of a product to the skin, including a gripping element and an application element, integral with the gripping element, the application element being flexible, and having at least a first substantially planar face, the width of which in a direction perpendicular to an axis of the gripping element decreases in the direction of a free end located opposite the gripping element, the first face being delimited by two lateral edges, at least one of which is of concave form. Further included herein is an application assembly equipped with such an application member and a method to the use of this application member for the treatment of wrinkles.
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This application on claims the benefit of Provisional Application No. 60/082,067 filed Apr. 17, 1998.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a process for improving the utilization of feedstuffs by ruminants, especially during the transition from a roughage diet to a feedlot diet, and more particularly to a process for administering to a ruminant a feed additive composition which includes Propionibacteria jensenii strain P-63, preferably in combination with a lactic acid producing bacteria for improving the production from, and feed conversion efficiency of, a high grain or concentrate feedlot diet. The composition also may be used to reduce scours in swine.
2. Technology Description
Acute indigestion resulting from the transition from a predominantly roughage diet to a feedlot diet could be fatal to ruminants. The purpose of a feedlot operation is to fatten a ruminant, such as beef cattle, for sale or slaughter. The most common and efficient method of fattening ruminants is to feed them a high grain or high energy concentrate diet. However. this abrupt conversion from a roughage or pasture diet of plant food, mainly cellulose, to a feedlot diet predominantly composed of grains and starches can cause decreased production to feedlot cattle and even death from acidosis. Similar diet transitions can result in a decrease in milk production for dairy cows as well as death.
As discussed in Diseases of Feedlot Cattle , Second Edition, Lea & Febiger, p 292-293 (1971), acute indigestion in cattle is caused by sudden consumption of large amounts of grain, green corn, green apples or other easily fermentable feeds. During a roughage diet, cellulosic bacteria predominates in ruminal microflora. Volatile fatty acids are usually formed in the following proportions: acetic, 67%; propionic, 19%; and butyric, 14%. These acids constitute an important nutrient from cellulose digestion. However, during the fattening process at the feedlot, cattle are placed on a high grain diet. On a high grain diet the ruminal microflora ferment the new feed and produce 100 or more milli-moles per liter of lactic acid resulting in the rumen becoming immobilized. A large portion of the lactic acid accumulated may be the D(−) isomer which is an unavailable energy source for the ruminant and thus builds up in the rumen. Absorption of the acid into the blood lowers the blood pH and diminishes the content of bicarbonate and glucose bringing about acidosis. Compensation for the acidic condition occurs by excretion of carbonic acid through rapid respiration and by excretion of hydrogen ions through urine. Affected cattle may survive through compensation, however, severe acidosis is fatal. Additionally, the increase in acidity of the rumen damages the mucosa which may result in necrosis of the epithelium which enables bacteria such as Spherophorus necrophorus to enter the veins and be conveyed to the liver where liver abscesses may form in surviving animals.
Lactic acid and products containing lactic acid have been found to enhance gains in the starting period of cattle (first 28 days) and reduce liver abscesses when given prior to the transition from a roughage diet to a feedlot diet. Various strains of Lactobacillus acidophilus have been isolated which restore and stabilize the internal microbial balance of animals. Manfredi et al, U.S. Pat. No. 4,980,164, is such a strain of Lactobacillus acidophilus which has been isolated for enhancing feed conversion efficiency. The Lactobacillus acidophilus strain of the Manfredi et al patent has been designated strain BT1386 and received accession number ATCC No. 53545 from the American Type Culture Collection in Rockville, Md. Strain ATCC 53545 demonstrates a greater propensity to adhere to the epithelial cells of some animals which would increase the bacteria cultures' ability to survive. initiate and maintain a population within an animal intestine. Thus, the primary mode of action as previously understood relative to Lactobacillus acidophilus occurs post-ruminally.
Another strain of Lactobacillus acidophilus isolated for restoring and stabilizing the internal microbial balance of animals is disclosed in Herman et al, U.S. Pat. No. 5,256,425. The
Lactobacillus acidophilus strain of the Herman et al patent has been designated strain BT1389 and received accession number ATCC No. 55221 from the American Type Culture Collection in Rockville, Md. Strain ATCC 55221 is a further improvement on strain ATCC 53545 in that it is easily identified and quantified due to its resistance to antibiotics such as erythromycin and streptomycin.
The above-mentioned strains of Lactobacillus acidophilus are perfectly good lactic acid producing organisms. However, more than a lactic acid producing organism is needed to improve the utilization of feedstuffs by ruminants, especially during the transition from a roughage diet to a feedlot diet. The problem with the increase of D-lactate in the rumen must also be resolved in order to facilitate the transition of ruminants from a roughage diet to a feedlot diet.
Administration of bacteria to cattle is also problem due to the extreme sensitivity of organisms like Lactobacillus acidophilus which are difficult to maintain in a viable state at ambient temperatures. Also, lactic acid is corrosive to feedlot and feedmill equipment and metallic components
U.S. Pat. Nos. 5,534,271 and 5,529,793 suggest that both a lactic acid producing culture as well as a lactate utilizing bacterial culture be combined with a typical animal feedlot diet to assist in the transition of a ruminant diet from roughage to feedlot while minimizing the risk of acidosis. These patents list several classes of materials from each of the producing and utilizing categories which may be selected for combination with the animal feedstock. Unfortunately, these patents; do not give much guidance as to which of these specific cultures should be selected in order to gain efficacious results. The only lactate utilizing cultures which are specifically enabled by the examples are Propionibacterium P-5, Propionibacterium P-42 and Propionibacterium P-99 and the only lactic acid producing cultures enabled by the examples are Lactobacillus acidophilus ATCC 53545 and Lactobacillus acidophilus strain LA45. The reference fails to disclose or suggest that amongst the thousands of permutations possible presented by their proposed combination of cultures, that synergistic results can occur by selecting a very specific strain of lactate utilizing culture not specifically enabled in these patents. The inventors of the instant invention have discovered such a specific lactate utilizing culture, namely Propionibacterium P-63.
Despite the above teachings, there still exists a need in the art for a direct fed microbial for ruminants having a specifically defined lactic acid utilizing culture which, when combined with lactic acid producing cultures, can demonstrate unexpected results in terms of efficacy against acidosis.
In addition, there exists a need in the art for a direct fed microbial which may reduce scours in swine and companion animals as the above technology has been more specifically directed against treatment of acidosis in ruminants.
BRIEF SUMMARY OF THE INVENTION
In accordance with the present invention a novel direct fed microbial for ruminants having a specifically defined lactic acid utilizing culture which, when used alone as a direct fed microbial or combined with lactic acid producing cultures, can demonstrate unexpected results in terms of resistance against acidosis is provided. More specifically, the lactic acid utilizing culture composes Propionibacterium P-63. This increased resistance can enable the ruminant to be superior producers of milk, if dairy ruminants, or experience greater weight gain, if beef ruminants. This culture may also be used to reduce scours in swine.
A first embodiment of the present invention comprises a ruminant direct fed microbial composition of matter comprising an acidosis inhibiting effective amount of Propionibacterium P-63. In most embodiments, the microbial composition is combined with an animal feed material selected from the group consisting of corn, dried grain, alfalfa, corn meal and mixtures thereof.
In the preferred embodiment, the direct fed microbial composition further comprises a lactic acid producing bacterial culture, and even more preferably Lactobacillus acidophilus ATCC 53545.
A second embodiment comprises a swine direct fed microbial composition of matter comprising a scour inhibiting effective amount of Propionibacterium P-63.
Still another embodiment of the present invention comprises a process for reducing acidosis when converting a ruminant diet from a roughage diet to a grain diet by administering to a ruminant a direct fed microbial comprising an acidosis inhibiting effective amount of Propionibacterium P63.
In most embodiments, the microbial composition is combined with an animal feed material selected from the group consisting of corn, dried grain, alfalfa, corn meal and mixtures thereof.
Yet another embodiment comprises a process for reducing scours in swine by administering to a swine a direct fed microbial comprising an scour inhibiting effective amount of Propionibacterium P-63.
In a preferred embodiment, the direct fed microbial composition further comprises a lactic acid producing bacterial culture for administration to the ruminant, and even more preferably Lactobacillus acidophilus ATCC 53545.
An object of the present invention is to provide a novel direct fed microbial for ruminants or swine.
Still another object of the present invention is to provide a process for reducing acidosis in ruminants when converting from a roughage diet to a grain diet.
A further object of the present invention is to provide a synergistic combination of lactic acid producing cultures with lactate utilizing cultures to reduce acidosis in ruminants when converting from a roughage diet to a grain diet.
Another object of the present invention is directed to a method for reducing scours in swine.
These, and other objects, will readily be apparent to those skilled in the art as reference is made to the detailed description of the preferred embodiment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
In describing the preferred embodiment, certain terminology will be utilized for the sake of clarity. Such terminology is intended to encompass the recited embodiment, as well as all technical equivalents which operate in a similar manner for a similar purpose to achieve a similar result.
Propionibacterium P-63 is a culture of the species Propionibacterium jensenii , strain designation PJ54. This information is obtained from Communicable Disease Laboratory, in Atlanta, Ga., U.S.A. Genetic equivalents of this strain are expressly considered to be covered within the scope of the present invention.
The use of lactate utilizing bacteria in ruminant feeds, even those feeds designed to aid in the conversion of the ruminant from a roughage diet to a grain diet is not considered novel. The prior art is replete with listings of many genus/species and strains of materials suggested for ruminant feeds. Prior to the present invention it is not believed that the use of Propionibacterium P-63 has been disclosed or suggested for use in animal feeds. The inventors have surprisingly discovered that this specific strain demonstrates superior ant-acidosis properties as compared to other lactate utilization bacteria. While not wishing to be bound to any specific scientific theory, use of this strain of bacteria during conversion of the ruminant feed from a roughage diet to a feedlot diet does not result in an appreciable production of lactic acid in the rumen, allowing it to remain at a relatively constant pH.
It is also believed that P-63 can be effectively used to treat scours in swine by administering a scour inhibiting amount of P-63 to a swine.
In practice, the amount of Propionibacterium P-63 which should be administered to the animal ranges between about 1×10 6 cfu/animal/day to about 1×10 12 cfu/animal/day. Higher amounts of the bacterium are preferably used, i.e., greater than about 1×10 9 cfu/animal/day when the bacterium is the sole acidosis or scours control agent whereas lesser amounts, i.e., less than about 1×10 8 cfu/animal/day may be administered when a lactic acid producing bacterium culture is added in combination with the P-63.
The bacterium culture may be administered to the ruminant in one of many ways. The culture can be administered in a solid form as a veterinary pharmaceutical, may be distributed in an excipient, preferably water, and directly fed to the animal, may be physically mixed with feed material in a dry form, or, in a most preferred embodiment, the culture may be formed into a solution and thereafter sprayed onto feed material. The method of administration of the culture to the animal is considered to be within the skill of the artisan.
When used in combination with a feed material, the feed material is preferably grain based. Included amongst such feed materials are corn, dried grain, alfalfa, and corn meal and mixtures thereof.
The bacteria cultures of the novel process may optionally be admixed with a dry formulation of additives including but not limited to growth substrates, enzymes, sugars, carbohydrates, extracts and growth promoting micro-ingredients. The sugars could include the following: lactose; maltose; dextrose; malto-dextrin; glucose; fructose; mannose; tagatose; sorbose; raffinose; and galactose. The sugars range from 50-95%, either individually or in combination. The extracts could include yeast or dried yeast fermentation solubles ranging from 5-50%. The growth substrates could include: trypticase, ranging from 5-25%; sodium lactate, ranging from 5-30%; and, Tween 80, ranging from 1-5%. The carbohydrates could include mannitol, sorbitol, adonitol and arabitol. The carbohydrates range from 5-50% individually or in combination. The micro-ingredients could include the following: calcium carbonate, ranging from 0.5-5.0%; calcium chloride, ranging from 0.5-5.0%; dipotassium phosphate, ranging from 0.5-5.0%; calcium phosphate, ranging from 0.5-5.0%; manganese proteinate, ranging from 0.25-1.00%; and, manganese, ranging from 0.25-100%.
While the P-63 culture may be used alone in a method to prevent acidosis or scours, because of the high levels of administration required and the desire for even better resistance against disease, it is optionally combined with a lactic acid producing culture. Despite the above, it is hypothesized that one does not need a lactate producer in a beef direct fed microbial (DFM) to prevent/reduce acidosis. If the reason (or at least primary contributor) acidosis occurs is lactate production, adding a lactate producing organism with the DFM may likely be inconsequential. It is further hypothesized that a lactic acid producing culture may not be required when using P-63 to prevent scours in swine.
If added, the lactic acid producing bacteria could include, but is not limited to, the following: Lactobacillus acidophilus; Lactobacillus plantarum; Streptococcuus faecium; Lactobacillus casel; Lactobacillus lactis: Lactobacillus enterli; Lactobacillus fermentum; Lactobacillus delbruckii; Lactobacillus helveticus; Lactobacillus curvatus; Lactobacillus brevis; Lactobacillus bulgaricus; Lactobacillus cellobiosuus; Streptococcus lactis; Streptococcus thermophilus; Streptococcus cremoris; Streptococcus diacetylactis; Streptococcus intermedius; Bifidobacterium animalis; Bifidobacterium adolescentis; Bifidobacterium bifidum; Bifidobacterium infantis; Bifidobacterium longum; Bifidobacterium thermephilum; Pediococcus acidilactici ; and, Pediococcus pentosaceus . Particularly preferred is the use of Lactobacillus acidophilus , and most preferably the strain corresponding to ATCC 53545.
When a lactic acid producing culture is utilized in combination with P-63, In practice, the amount of lactic acid producing culture which should be administered to the animal ranges between about 1×10 6 cfu/animal/day to about 1×10 12 cfu/animal/day, with amounts ranging from about 1×10 7 cfu/animal/day to about 1×10 9 , cfu/animal/day being most preferred.
The invention is described in greater detail by the following non-limiting examples.
EXAMPLE 1
Bacterial strains. Propionibacterium cultures used in this study are obtained from the culture collection of Agtech Products, Inc., Waukesha, Wis. Cultures are maintained at −75° C. in a sodium lactate broth (NLB) supplemented with 10% glycerol (Hofherr and Glatz, 1983). The specific Propionibacterium strains used in this study are listed in Table 1.
TABLE 1
Propionibacterium strains
Strain
Strain
number
Species designation
designation
Source
P2
P. acidipropionici
128
B
P3
P. acidipropionici
E14
A
P4
P. thoenii
TH25
A
P5
P. acidipropionici
E214
A
P9
P. acidipropionici
129
B
P10
P. thoenii
R9611
A
P15
P. thoenii
TH20
A
P20
P. thoenii
TH21
A
P21
P. thoenii
R6
A
P25
P. jensenii
J17
A
P26
P. thoenii
8266
B
P31
P. freudenreichii
1294
E
P35
P. acidipropionici
1505
E
P38
P. acidipropionici
13
D
P41
P. jensenii
14
D
P42
P. acidipropionici
10
D
P44
P. jensenii
363
E
P46
P. jensenii
E.1.2
F
P48
P. freudenreichii
E.11.3
F
P49
P. freudenreichii
E.15.01
F
P50
P. acidipropionici
E.7.1
F
P52
P. acidipropionici
E.5.1
F
P53
P. acidipropionici
E.5.2
F
P54
P. jensenii
E.1.1
F
P63
P. jensenii
PJ54
G
P68
P. jensenii
PJ53
G
P69
P. jensenii
PJ23
G
P74
P. jensenii
PZ99
G
P78
P. acidipropionici
PA62
G
P79
P. thoenii
PT52
G
P81
P. acidipropionici
PP798
G
P85
P. thoenii
20
H
P86
P. jensenii
11
H
P88
P. jensenii
22
H
P89
P. freudenreichii
5571
I
P90
P. acidipropionici
5578
I
P96
P. freudenreichii
8903
I
P99
P. freudenreichii
ATCC 9615
J
P101
P. freudenreichii
ATCC 9617
J
P104
P. freudenreichii
ATCC 6207
J
P105
P. thoenii
ATCC 4871
J
P106
P. jensenii
ATCC 4964
J
P108
P. acidipropionici
ATCC 14072
J
P111
P. acidipropionici
O
Sources:
A Cornell University, Ithaca, NY;
B Iowa State University, Ames IA;
C Dr. K. W. Sahli, Station Federate D'Industrie Laitiere Liebefeld-Bern, Switzerland;
D Dr. W. Kundrat, University of Munich, Munich, Germany;
E Dr. V. B. D. Skerman, University of Queensland, Brisbane, Australia;
F Dr. C. B. van Neil, Hopkins Marine Station, Pacific Grove, CA;
G Communicable Disease Laboratory, Atlanta, GA;
H Isolated from Gruyere cheese imported from France:
J American Type Culture Collection, Rockville, MD;
O Origin unknown.
Culture conditions. Strains are activated by placing a portion of the frozen suspension in 10 ml of NLB and incubating at 32° C. for 36-48 hours. Strains are sub-cultured by transferring a 1% volume of the culture at mid-log growth to fresh NLB. Cultures are transferred a minimum of three times before being tested. The purity of tested strains is monitored by regularly streaking cultures onto a sodium lactate agar (NLA).
In vitro acidified and neutralized broth medium. Primary strain selection involves testing the growth and lactic acid utilization of cultures in a basal broth media. The acidified medium is prepared by including 80 mM L(+) lactic acid in a basal broth containing 1% yeast extract, 1% tryptone, dipotassium phosphate and distilled water. The pH of the broth medium is raised to pH 5.0 using 5.0 M NaOH. Following filter sterilization (Gelman Sciences, Ann Arbor, Michigan), the medium is dispensed at a volume of 10 ml into sterile screw cap test tubes. Neutralized broth medium is prepared the same as acidified media except that the pH of broth is raised to 7.0 with 5.0 M NaOH prior to filter sterilization.
Rumen fluid simulation medium. Ruminal fluid is collected via ruminal cannula 2 h post feeding from a cross-bred beef heifer fed a high roughage diet. The ruminal fluid is strained through four layers of cheesecloth and transported to the laboratory in an insulated container. Test ruminal fluid media contains 250 ml of strained ruminal fluid, 62.5 ml McDougall's buffer (McDougall, 1948), and 1.5% dextrose. The added dextrose serves as a readily fermented carbohydrate to simulate conditions found in the rumen of animals following grain engorgement. Strained ruminal fluid, buffer, and dextrose are dispensed into sterilized 500 ml bottles and allowed to equilibrate in a water bath at 39° C. for approximately 15 minutes prior to inoculation. Initial pH of the rumen fluid model ranged from 6.6 to 6.9 depending on date of collection.
High Pressure Liquid Chromatography. Samples are prepared for HPLC analysis by aseptically removing 1.0 ml from the test medium at the appropriate sampling times. Samples are placed in a 1.5 ml microcentrifuge tube and the cells are pelleted by centrifugation (10 minutes, at 12,500 rpm). A sample of the supematant fluid (0.5 ml) is transferred to a clean tube and acidified with an equal volume of 0.01 M sulfuric acid solution to stop fermentation. These samples are stored at −20° C. until analysis is performed. For analysis, frozen tubes are allowed to thaw at room temperature and filtered through 0.2 um filters directly into 2 ml HPLC autosampler vials and capped.
Samples are analyzed using a Hewlett Packard 1090 HPLC system equipped with a diode-array detector (Hewlett Packard, Atlanta, Ga.). The sample is injected into 0.005 M H 2 SO 4 mobile phase heated to 65° C. and separated using a BioRad HPX-87H column (Bio-Rad Laboratories, Inc., Hercules, Calif.). The peaks are detected with a diode array detector at 210 nm. Other wavelengths are recorded and examined for peak purity, but 210 nm is the optimum setting for determining peak height with minimum background noise. Peak areas are used to determine compound concentrations by comparison with external standards. Peak purity is monitored by UV scanning techniques as an aid in identifying abnormal wavelength patterns present in a single peak.
Rumen model experimental procedures. Duplicate bottles are inoculated with the appropriate propionibacteria strain to be tested at a level of 1×10 7 cfu/ml. Bottles are flushed with CO 2 , capped, and incubated at 39° C. for 48 h. Every 6 h during the 48 h incubation period, samples are collected and analyzed for pH, lactic acid and volatile fatty acid (VFA) concentrations. Additional samples are collected at 16 h and 48 h for use in microbiological analysis. Lactic acid and VFA samples are prepared by aseptically collecting a 1 ml sample in a 1.5 ml microcentrifuge tube. Cells are pelleted by centrifugation (10 minutes at 12,500×g). One-half ml of supernatant is mixed with an equal volume of 10 mM H 2 SO 4 and filtered through a 0.2 um membrane filter.
Microbiological analysis consists of plating serial dilutions (10 −3 , 10 −4 and 10 −5 ) of the in vitro rumen fluid medium on a propionibacteria selective-differential medium (PSA). Colonies with typical propionibacteria morphology are confirmed using pulsed-field gel electrophoresis (PFGE).
Differences in pH and lactic acid concentration between inoculated and uninoculated controls at each sampling time are calculated and regressed against incubation time up to 24 h in order to select the best lactic acid utilizing strains. Strains for which a change over time in lactate or pH was detected (an R>0.50 against sampling time) are compared using Duncan's Multiple Range procedures (SAS, 1985). Additionally, Gompertz equation is used to analyze the sigmoidal curves for pH decrease and lactic acid concentration increase (Zwietedng et al. 1990).
Results. The rate of change in pH and lactic acid concentration is determined by regressing the difference between inoculated and control rumen fluid incubations against time. Only when the regression coefficient for rate of change in pH and lactate was greater than 0.50 for an inoculated flask was the data included in the statistical analysis (Table 2).
TABLE 2
Impact of added Propionibacterium strains on rates of change in
pH and lactate concentration of incubated rumen fluid models.
pH elevation,
Lactate decrease
Strain
(Units/h)
(mM/h)
42
.03770
1.61
63
.03627
1.30
54
.02433
1.26
25
.02380
1.12
41
.02372
1.55
111
.01691
1.05
81
.01064
.71
104
.00923
.88
89
.00785
.53
88
.00590
.76
49
.00425
.65
48
.00366
NA
99
.00051
−.17
31
.00926
−.22
90
−.00917
−.32
Calculatcd by regressing the difference between inoculated and control fluid against incubation time. Means in a column with the same superscript are not different (P < .05).
Compared with other strains, P42 has the highest rate of pH increase (0.0377 units/h), but is not statistically (P<0.05) different from strains P63, P54, P25, and P41. Strain P42 also has the heighest rate of lactic acid utilization (1.61 mM/h) compared to others but is not statistically (P<0.05) different from strains P63, P54, P25, P41, P111, P81, and P104. Since linear regression analysis does not adjust for differences in lag times, other non-linear methods were employed.
Ruminal fluid simulation data is analyzed using the Gompertz non-linear equation technique. up to 24 h are used in the analysis since a decrease in lactic acid concentration is observed after 24 h in all controls. Flasks inoculated with strains P54 and P63 have significantly lower rates of hydrogen ion accumulation (Table 3).
TABLE 3
Contrasts of maximum lactate accumulation and
mininium pH of rumen models inoculated with
various propionibacteria strains.
Lactate
H+
Time lag
Time lag
production
increase
of lactate
of H+
rate
rate
production
increase
Strain
(mM/h)
(×10 −5 )
(h)
(h)
P25
18.87
4.65
4.41+
4.20
P31
38.85
11.63
5.15
3.81
P41
23.31
11.15
4.65
3.29
P42
24.42
7.46
5.52
3.99
P48
38.85
1.45
5.45
3.27
P49
6.67
6.45
5.89
3.28
P54
21.09
−1.45**
8.08**
3.56
P63
9.99
2.18*
6.47+
2.68
P78
12.21
9.34
5.30
3.02
P81
1.11
9.86
4.91
2.99
P88
14.43
11.49
5.76
2.87
P89
9.99
13.57
5.71
3.13
P90
14.43
5.18
5.00
3.28
P99
4.44
7.87
4.94
3.59
P104
−2.22
8.02
4.94
2.67
P111
14.43
5.17
4.97
5.74*
Control
38.85
17.99
5.45
4.72
*Values significantly different when compared to controls (P < .05)
+Values significantly different when compared to controls (P < .01)
**Values significantly differcnt when compared to controls (P < .001)
When the rate of H + increase of inoculated flasks is compared to the control (0.00018), only strains P54 and P63 have significantly different values of −1.45 and 2.18 respectively. Strains P54, P63 and also P25 have a significant impact on the lactic acid production lag time. P54 and P63 increase the lag time of lactic acid accumulation by 2.06 and 2.63 (h) respectively, thereby slowing the accumulation of acid. On the other hand, strain P25 decreases the lag time of inoculated samples thus resulting in faster lactic acid accumulation. Strain P111 is the only strain found to significantly increase the lag time of H + .
The viable plate counts of strains at 16 h and 48 h of incubation in the rumen simulation model in Table 4. Nine strains maintain a population of at least 1.0×10 4 cfu/ml for 48 the nine strains exceed 1.0×10 5 cfu/ml; strains P25 and P63 have the highest al at 6.0×10 5 and 1.0×10 6 cfu/ml, respectively.
TABLE 4
Survival of Propionibacterium strains in the
rumen model after 16 and 48 hours of incubation.*
Propionibacterium (cfu/ml)
Strain
16 h
48 h
63
7.4 × 10 6
1.0 × 10 6
25
2.5 × 10 5
6.0 × 10 5
81
5.0 × 10 6
3.0 × 10 5
90
1.0 × 10 4
1.0 × 10 5
88
8.3 × 10 6
1.0 × 10 5
54
1.0 × 10 5
1.0 × 10 5
111
2.0 × 10 6
1.0 × 10 4
99
1.0 × 10 4
1.0 × 10 4
41
4.7 × 10 6
1.0 × 10 4
104
5.0 × 10 6
1.0 × 10 3
89
1.0 × 10 3
1.0 × 10 3
48
1.0 × 10 5
1.0 × 10 3
42
1.1 × 10 6
1.0 × 10 3
31
1.0 × 10 3
1.0 × 10 3
*Propionibacteria count at 0 hour was 1 × 10 7 cfu/ml
EXAMPLE 2
Seventy-five cross-bred, post weaned calves weighing 650-750 pounds are randomly assigned to one of three treatments: 1.) no treatment, 2.) Propionibactenum strain P63 treated at 3.0×10 11 cfu/hd. or 3.) Propionibacterium strain P63 at 1.0×10 9 cfu/hd and Lactobacillus acidophilus strain 53545 at 1.0×10 8 cfu/hd. A total of 15 pens with 5 calves per pen are blocked by sex, weight and breed prior to treatment assignment. Calves are given free access to the feed bunk and water source during the course of the experiment.
Each treatment group, consisting of steers and heifers are fed a 50:50 ration (cracked corn, cottonseed meal, alfalfa pellets and balanced for minerals) at 1.5 to 2% of BW for 14 days. During this period the appropriate treatment is added directly to the feed. The treatment dose for each individual pen is added to 600 ml of water and completely mixed with the daily ration at the time of feeding throughout the entire feeding study.
On the day following the 14-day establishment period, cattle do not receive any feed for a 24 h period. This procedure is performed in order to stimulate the engorgement of the next meal. Following the 24 hour fasting period, cattle are given a 90% concentration ration (75% cracked wheat and 25% cracked corn). This ration is fed for a total of 10 days. During this time, treatments are administered as stated above and cattle are closely monitored for signs of severe stress due to ruminal indigestion. Following the 10 day challenge period, cattle are fed a 90% concentrate diet consisting of 100% cracked corn. Cattle are fed to final weights of approximately 1,200 pounds (approx. 120 days).
All cattle are weighed at receiving and approximately every 28 days during the feeding period. Feed intake and animal health are monitored daily. Following the finishing period, cattle are transported to a packing plant at which time hot carcass weights, quality grades, yield grades, and carcass characteristics were determined.
Results. The only significant differences (p<0.05) in live weights are observed during the first 10 days of the study. Control cattle are 18 pounds heavier than cattle receiving the combination and 25 to 30 pounds heavier than cattle in the group which is fed P63 alone during this period. By day 27 no differences in live weight are observed (P<0.05). To reduce the variation resulting from bulk fill differences, final weights are determined using hot carcass weights and dressing percentages. Control carcass weights are 13 pounds heavier compared to cattle fed the combination and 18 pounds heavier than cattle fed P63 alone, however these differences are not statistically different and considered to be animal variation.
Feeding intake is reduced in cattle being fed the combination inoculum by 7.8% when compared to control animals during the first 83 days (p<0.02). Overall feed intake is 6.8% lower for the combination treatment (P<0.08) and only 2.8% lower when animals received P63 alone (not significant) when compared to controls.
The only significant difference in average daily gain is observed during the initial 10 days of the trial when cattle are abruptly switched from a 50% concentrate ration to a 90% concentrate diet containing 75% ground wheat. Cattle receiving the combination treatment gain 1.13 LB more than control cattle during this intensive adaptation period (p<0.04). Recall feed intakes during this period are not statistically different between treatment groups. Given the utilization of lactic acid and glucose by the combined inoculum the improvement in gain during this initial feeding period is expected since cattle are the most effected by ruminal indigestion at this time.
Average daily gains are slightly higher for cattle fed the combination during the first and last 30 days of the study. However, these differences are not significant. Cattle receiving P63 alone have slightly lower gains compared to control and cattle fed the combination inoculum during the entire study. Overall average daily gain (ADG) is almost identical during the 120 day feeding period.
Cattle which is fed the combination inoculum has significantly improved feed efficiencies over the entire 120 day feeding study when compared to controls. During the first 10 days of feeding, efficiency is improved by 38.4% (P<0.06) and by 10.4% (P<0.03) in the first 30 days when comparing cattle fed the combination to control cattle. The percent difference between treatments declines in the later periods of the feeding trial, however the significant treatment response of the combination inoculum during the initial period results in a significant treatment difference over the entire 120 day study (P<0.04).
No significant differences in carcass quality and composition are observed. The incidence of liver abscesses is relatively insignificant as compared to industry standards. Control and cattle fed P63 both have incidences of 8%. Cattle fed Lactobacillus acidophilus strain 53545 with Propionibacterium strain P63 have no liver abscesses. Generally, feedlot finished cattle will have a liver incidence of approximately 30%. Dressing percents, ribeye area, yield grades, and quality grades are similar for all treatments.
Having described the invention in detail and by reference to the preferred embodiments thereof, it will be apparent that modifications and variations are possible without departing from the scope of the appended claims.
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A ruminant direct fed microbial composition of matter comprising an acidosis inhibiting effective amount of Propionibacterum P-63 is provided. Also disclosed is a process for reducing acidosis in ruminants or scours in swine by administration of the bacterium to the ruminant or swine. The microbial composition may be administered by itself, or combined with animal feed and/or lactic acid producing cultures.
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TECHNICAL FIELD
This invention relates to a hand-held electronic game.
BACKGROUND
The game Operation by Milton Bradley is well known. In that game, a player holds a pair of tweezers and tries to grab and remove misplaced anatomy parts from a simulated human body cavity without touching the body cavity. If the player touches the body cavity or drops an anatomy part, the game buzzes and flashes a light.
SUMMARY
The invention provides a hand-held electronic game that includes a housing, a display mounted on the housing, the input device mounted within the housing, and a processor positioned in the housing and connected to the display and the input device. The processor is programmed to cause the display to display (1) a body cavity, (2) one or more hazardous cells in the body cavity, (3) one or more anatomy parts in the body cavity, and (4) a game piece that moves relative to the body cavity in response to signals from the input device, and, when positioned near an anatomy part, removes the anatomy part from the body cavity.
Embodiments may include one or more of the following features. For example, the housing may be shaped like a human body.
The game may include a second input device (e.g., a laser button). The game piece may destroy hazardous cells in response to signals from the second input device. Furthermore, the game may include special cells in the body cavity that replenish, when the game piece is maneuvered over them, an ability for the game piece to destroy hazardous cells.
Hazardous cells may remain stationary or move relative to the body cavity. Hazardous cells may block movement of the game piece. An anatomy part may remain in the body cavity until a hazardous cell overtakes and destroys it. The body cavity may scroll across the housing.
The housing may include a light connected to the processor and controlled by the processor. The processor may be programmed to flash the light when hazardous cells strike the game piece. Furthermore, the light may protrude from the housing. The housing may include a mechanism that permits retraction of the light when the light is pushed.
The display may be a liquid crystal display screen.
The processor also may be programmed to display a game update that provides game information to a player. The game update may display the amount of time that the player has played the game. The game update also may display a tally of anatomy parts that have been removed from the body cavity. The game update also may display a number of laser shots that are available for use by the game piece to destroy hazardous cells in the body cavity.
An anatomy part may remain in the body cavity until a player removes it, or for a predetermined time period.
The game piece may be displayed as tweezers.
The processor may be programmed to remove one of a player's lives when a hazardous cell strikes the game piece. The game may include a vibrator mounted in the housing, connected to the processor, and controlled by the processor. The processor may be programmed to vibrate the game using the vibrator when a hazardous cell strikes the game piece.
The game may further include a speaker mounted in the housing, connected to the processor, and controlled by the processor. The processor may be programmed to play one or more sounds from the speaker when an anatomy part is removed from the body cavity, when the game piece moves through the body cavity, or when all anatomy parts are removed from the body cavity.
Other features and advantages will be apparent from the following description, including the drawings, and from the claims.
DESCRIPTION OF DRAWINGS
FIG. 1 is a front view of a hand-held electronic game.
FIG. 2 is a block diagram of operating components of the game of FIG. 1.
FIG. 3 is a flow chart of game play using the game of FIG. 1.
FIG. 4 is a detail of a display screen of the game of FIG. 1.
FIGS. 5-7 are details of elements displayed by the display screen of FIG. 4.
DETAILED DESCRIPTION
Referring to FIG. 1, a hand-held, electronic game 100 includes a housing 105 in the shape of a human body. The housing 105 may be made of a rigid plastic material and formed of two pieces that fit together to form a hollow volume to house components of the game. A liquid crystal display (LCD) screen 110 is positioned at the front of the housing 105. The LCD screen 110 displays both a body cavity 115 (designed to simulate a human body cavity) and a game update 120. Control buttons 125-150 are positioned on the housing 105 at easy-to-reach locations. For example, an operate button 125 is positioned at a portion of the housing 105 corresponding to a hand such that use of the operate button 125 is eased when a player holds and plays the game 100. An indicator light 155 (for example, a light-emitting diode) is positioned at and acts as the nose of the human body represented by the housing 105.
Briefly, game play consists of moving a pair of tweezers 160 depicted on the LCD screen 110 through the body cavity 115. The body cavity 115 may scroll to simulate movement of the tweezers 160 through the body cavity 115. The tweezers 160 are moved (for example, up, down, right, or left) by the player using the operate button 125. The player's goals are to avoid touching hazardous cells 165 which are depicted in the body cavity 115 of the LCD screen 110, and to obtain "funatomy" parts 170, such as a "rubber band" or a "funny bone", left in the body cavity 115. Points, designated as money, are awarded for collecting the funatomy parts 170.
Referring also to FIG. 2, the housing 105 contains an electronic controller 200 which connects to and controls other game components. A power source 205 (for example, a battery) is contained by the housing 105 and provides electrical power for the controller 200. Switches 210-250, which connect to the control buttons 125-150, provide inputs from the player to the controller 200.
Using input from the switches 210-250, the controller 200 controls the image displayed on the LCD screen 110. As game play requires, the controller 200 also may flash the indicator light 155, vibrate a vibrator 255 contained by the housing 105 and configured to shake the game 100, or send an audio signal to a speaker 260 contained by the housing 105. The controller 200 performs these tasks using additional information obtained from a processor 265, memory 270, a clock 275, and a counter 280.
Referring also to FIG. 3, game play proceeds according to a procedure 300 that is initiated when the player presses a start/laser button 130 (step 305) to turn on the game 100. Game play 300 initially defaults to a demonstration mode which helps the player get acquainted with the game 100. A reset button 150 may be pressed at this time to place the game 100 in game mode. Additionally, the reset button 150 may be pressed at any time if the game 100 malfunctions. A sound button 135 may be pressed at any time during game play to turn off or turn on the sound from the speaker 260.
A skill level is set to zero when a new game button 145 is pressed (step 310). The skill level ranges from zero (easy play) to a maximum level L max (difficult play). As a player completes each skill level, an increasingly more difficult skill level is introduced. For example, difficulty may be altered by changing a funatomy part appearance time or adding hazardous cells 165 to the body cavity 115. As a player advances to higher skill levels, the game update 120 saves information until the new game button 145 is pressed again and a new game begins. The game update 120 includes a time indicator 170 and a tally 175 of collected funatomy parts 170. When a high score button 140 is pressed at any time during game play 300, the time indicator 170 displays the money earned by the player for that game. Furthermore, at higher skill levels, the time indicator 170 may display accumulated laser shots which are used in the higher-skilled games to destroy hazardous cells 165.
When the player presses the start/laser button 130 another time, the controller 200 begins a game of basic OPERATION (step 315) with the player having a fixed number of lives. Referring also to FIG. 4, during basic OPERATION, the player moves the tweezers 160 through a stationary body cavity 115 using the operate button 125 on the game body 105. The body cavity 115 includes hazardous cells 165 that must be avoided by the tweezers 160. When funatomy parts 170, such as a "butterfly in the stomach" shown in the body cavity 115 or a "broken heart" shown in the tally 180, appear along edges of the body cavity 115 and between the hazardous cells 165, the player maneuvers, using the operate button 125, the tweezers 160 to "operate" on that funatomy part 170. A successful operation causes the part 170 to be removed from the body cavity 115 and placed in the tally 180. Every time the player removes a funatomy part 170, money is accumulated and the controller 200 causes the speaker 260 to play a brief song. If the tweezers 160 strike a hazardous cell 165 at any time during the game, the controller 200 vibrates the game 100 using the vibrator 255, flashes the indicator light 155, and removes one of the player's lives.
Referring again to FIG. 3, the controller 200 next determines if the player has successfully completed the game (step 320). The player successfully completes the basic game by collecting all of the available funatomy parts while still retaining at least one life. Lack of success causes the controller to return game play to the game of basic OPERATION (step 315).
If success has been achieved, the controller 200 increments the skill level (step 325) to a more difficult skill level. The controller 200 then determines if the skill level is at a first threshold L 1 (step 330). If the skill level has not reached the first threshold, the controller 200 returns game play to the game of basic OPERATION at step 315.
If the skill level has reached the first threshold, the controller 200 advances to a game of moving OPERATION (step 335). This new game incorporates all the aspects of basic OPERATION in addition to new features which make the game more difficult. Referring also to FIG. 5, the hazardous cells 165 begin to scroll in a direction indicated by double arrows 505. Thus, a funatomy part 170, which appears in the body cavity 115 and remains "stationary", will disappear if the player fails to operate on the part 170 before it is captured by the hazardous cells 165. For example, after the funatomy part 170 appears in the body cavity 115, the player advances the tweezers 160 to operate on the part 170. If, however, the hazardous cell 510 reaches the part 170 (since the hazardous cells are scrolling) before the tweezers 160 arrive, then the part is captured by the cell 510 and the player cannot operate on that part 170 until the part 170 reappears at a later time. If the tweezers 160 strike a hazardous cell 165 at any time during the game of moving OPERATION, the controller 200 vibrates the game 100 using the vibrator 255, flashes the indicator light 155, and removes one of the player's lives.
Referring again to FIG. 3, the controller 200 then determines if the player has successfully completed the game of moving OPERATION (step 340) by collecting all of the funatomy parts 170 while retaining at least one life. Lack of success causes the controller 200 to return game play to the game of moving OPERATION (step 335).
If success has been achieved, the controller 200 increments the skill level (step 345) to a more difficult skill level. The controller 200 then determines if the skill level is at a second threshold L 2 (step 350). If the skill level has not reached the second threshold, the controller 200 returns game play to the game of moving OPERATION at step 335.
If the skill level has reached the second threshold, the controller advances to a game of basic laser surgery OPERATION (step 355). Basic laser surgery OPERATION incorporates all the aspects of moving OPERATION in addition to new features which make the game more difficult. Referring also to FIG. 6, the player may now fire (using the start/laser button 130) laser shots 600 from the tweezers 160 at hazardous cells 165 to destroy them. The player begins with a preset number of laser shots 600. Additional laser shots may be obtained by capturing special cells 605 that flash and remain stationary during basic laser surgery is OPERATION. When the player maneuvers the tweezers 160 to a flashing cell 605, a supply of laser shots is replenished by a preset number of laser shots 600. Laser shots 600 are used to clear a way through crowded areas of hazardous cells 165. For example, each laser shot 600 may be able to destroy one hazardous cell 165. A number 610 of laser shots 600 collected by the player is displayed in the time indicator 175. The controller 200 may be configured to hold a maximum number 610 of laser shots. Thus, the player should attempt to conserve laser shots 600 to use at just the right time. Furthermore, the player must be careful not to destroy, using a laser shot 600, flashing cells 605 which appear during the game. If the tweezers 160 strike a hazardous cell 165 at any time during the game of basic laser surgery OPERATION, the controller 200 vibrates the game 100 using the vibrator 255, flashes the indicator light 155, and removes one of the player's lives.
Referring again to FIG. 3, the controller 200 then determines if the player has successfully completed basic laser surgery OPERATION (step 360) by collecting all of the funatomy parts 170 while still retaining at least one life. Lack of success causes the controller 200 to return game play to basic laser surgery OPERATION (step 355).
If success has been achieved, the controller 200 increments the skill level (step 365) to a more difficult skill level. The controller 200 then determines if the skill level is at a third threshold L 3 (step 370). If the skill level has not reached the third threshold, the controller 200 returns to the game of basic laser surgery OPERATION at step 355.
If the skill level has reached the third threshold, the controller 200 advances to a game of advanced laser surgery OPERATION (step 375). Advanced laser surgery OPERATION incorporates all the aspects of basic laser surgery OPERATION in addition to new features which make the came more difficult. The hazardous cells 165 may now completely block a path of the tweezers 160 and thus require the player to fire at least one laser shot 600 to avoid touching the hazardous cells 165. If the tweezers 160 strike a hazardous cell 165 at any time during the game of advanced laser surgery OPERATION, the controller 200 vibrates the game 100 using the vibrator 255, flashes the indicator light 155, and removes one of the player's lives.
Referring again to FIG. 3, the controller 200 determines if the player has successfully completed advanced laser surgery OPERATION (step 380) by collecting all of the funatomy parts 170 while still retaining at least one life. Lack of success causes the controller 200 to return game play to the game of advanced laser surgery OPERATION (step 375).
If success has been achieved, the controller 200 increments the skill level (step 385) to a more difficult skill level. The controller 200 then determines if the skill level is at a fourth threshold L 4 (step 390). If the skill level has not reached the fourth threshold, the controller 200 returns to the game of advanced laser surgery OPERATION at step 375.
If the skill level has reached the fourth threshold, the controller 200 advances to a game of avoid virus OPERATION (step 395). Avoid virus OPERATION incorporates all the aspects of advanced laser surgery OPERATION in addition to new features which make the game more difficult. Referring also to FIG. 7, virus cells 700 begin moving through the body cavity 115 in a free-floating manner; that is, they don't scroll with the hazardous cells 165. Initially, a virus cell 700 briefly flashes as a warning to the player. Then the virus cell 700 detaches from the rest of the scrolling hazardous cells 165 and tries to attack the tweezers 160. The player must try to get the tweezers 160 away from the virus cell 700 quickly. If the tweezers 160 "catch" a virus (that is, if the tweezers 160 are struck by a virus cell 700), the player loses a life. The player may use laser shots 600 to blast the virus cells that move in the tweezers'path to ensure success. If the tweezers 160 strike a hazardous cell 165 at any time during the game of avoid virus OPERATION, the controller 200 vibrates the game 100 using the vibrator 255, flashes the indicator light 155, and removes one of the player's lives.
Referring again to FIG. 3, the controller 200 determines if the player has successfully completed avoid virus OPERATION (step 400) by collecting all of the funatomy parts 170 while still retaining at least one life. Lack of success causes the controller 200 to return game play to the beginning of avoid virus OPERATION (step 395).
If success has been achieved, the controller 200 determines if the skill level is at the maximum value L max (step 405). If the skill level has not reached the maximum value, the controller 200 increments the skill level (step 410) to a more difficult skill level and returns game play to the game of avoid virus OPERATION at step 395. Otherwise, the controller 200 returns game play 300 to the game of avoid virus OPERATION at step 395.
Other implementations also are contemplated. For example, the game 100 may be timed by the clock 275, so that the player is required to remove all funatomy parts 170 from the body cavity 115 within a preset interval. At the end of the preset interval, the player's money is determined from the number of parts 170 removed and placed in the tally 180. Alternately, if the player removes all the funatomy parts 170 within the preset interval, the player's money may be determined from the time remaining in the preset interval.
Funatomy parts 170 may have different monetary prizes for removal. For example, the player may receive $30 for removing an "Adam's apple" and $60 for removing a "wishbone." Prizes may be based on a location in the body cavity 115 in which the funatomy part appears. For example, a "bread basket" which appears in a lower corner of the body (cavity 115 may be more difficult to operate on than a "funny bone" which appears in an upper corner of the cavity 115. Therefore, the prize would be greater for the "bread basket" than for the "funny bone." A player may receive bonus money based on how many laser shots 600 remain at the end of a skill level.
The game may default to a maximum number of lives. When a player loses the last life during a game, the controller 200 may be configured to take all money and laser shots 600 from the player, and to end the game.
The game 100 may be configured to automatically shut off after a predetermined interval of inactivity. Then, to finish a previous level, the player may press the start/laser button 130. Alternately, the player may start back at skill level zero by pressing the new game button 145.
The indicator light 155 is configured to protrude like a nose from the housing 105. The light 155 may be mounted internally on springs to permit the light 155 to be pushed into the housing 105. This configuration serves to prevent breakage which may occur if the light 155 is accidentally struck by, for example, dropping the game.
Other embodiments are within the scope of the following claims.
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A hand-held electronic game includes a housing shaped like a human body, a display mounted on the housing, an input device mounted within the housing, and a processor positioned in the housing. The processor is connected to the display and the input device. The processor is programmed to cause the display to display a body cavity, one or more hazardous cells in the body cavity, one or more anatomy parts in the body cavity, and a game piece in the body cavity. The game piece moves relative to the body cavity in response to signals from the input device, and, when positioned near an anatomy part, removes the anatomy part from the body cavity.
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BACKGROUND
[0001] Infections are a significant problem in many fields where sanitary conditions are important, such as in healthcare. Problematic infections may arise from bacterial, fungal, amoebic, protozoan and/or viral organisms. Challenges are encountered both in preventing infection, and in reducing or eliminating the infection once it is established. Infected environments may include surfaces of objects, fluids and fluid conduits and/or humans or animals.
[0002] Alcohol solutions and isopropyl alcohol wipes are commonly used to disinfect surfaces and have been shown to have antibacterial activity. The most effective inhibitory anti-microbial effect is seen with 70% isopropanol solutions. Alcohol solutions at this concentration are quite expensive and rapidly evaporate, which substantially diminishes their efficacy and increases their cost. Moreover, although isopropanol solutions may be used for surfaces, including human skin, and in a variety of medical applications, alcohol solutions of this concentration cannot be administered to humans, for medical purposes, other than topically.
[0003] In the healthcare field, infections of various types and causes are common and often result in longer hospital stays, producing higher hospital costs. Even worse, over 90,000 patient deaths annually are attributed to nosocomial infections—that is, infections acquired at a hospital or in another healthcare environment. Surveillance for nosocomial infection has become an integral part of hospital practice. Studies conducted more than 20 years ago by the Centers for Disease Control and Prevention (CDC) documented the efficacy of these surveillance activities in reducing nosocomial infection occurrence. Despite the attention paid to problems of nosocomial infection, however, infection rates have not been dramatically reduced, and nosocomial infections remain a substantial risk and a substantial health concern.
[0004] One problematic source of infections in the medical and veterinary fields is found in catheters, and particularly in in-dwelling catheters. Catheters have become essential in the management of critical care patients, yet the inside of a catheter is often the major source of infection. Catheters are used for delivery of fluids, blood products, drugs, nutrients, hemodialysis, hemofiltration, peritoneal dialysis, retrieval of blood samples, monitoring of patient conditions, etc. Transcutaneous catheters often become infected through skin penetration of the catheter. It has been found that seventy percent (70%) of all nosocomial bloodstream infections occur in patients with central venous catheters. Daouicher et al. 340, 1-8, NEW ENGLAND JOURNAL OF MEDICINE (1999).
[0005] In particular, during some procedures, a catheter must be implanted in, and remain implanted in, a patient for a relatively long period of time, e.g. over thirty days. Intravenous (IV) therapy catheters and urinary catheters typically remain implanted for a substantial period of time. As a result of trauma to the areas of insertion, and pain to the patients, such catheters can't be removed and implanted frequently. Catheter-borne bacteria are implicated as a primary source of urinary tract infections. Patients who receive a peripherally inserted central catheter during pregnancy have also been found to be at significant risk for infectious complications. “Complications Associated With Peripherally Inserted Central Catheter Use During Pregnancy” AM. J. OBSTET. GYCOL. 188(5):1223-5 May 2003. In addition, central venous catheter infection, resulting in catheter related sepsis, has been cited as the most frequent complication during home parenteral nutrition. CLINICAL NUTRITION, 21(1):33-38, 2002. Because of the risk of infections, catheterization may be limited to incidences when the procedure is absolutely necessary. This seriously compromises patient health.
[0006] After most prescribed access medical procedures involving a catheter, the catheter is flushed with saline and then filled with a liquid, such as saline or a heparin solution, to prevent blood from clotting inside of the catheter, to inhibit the patient's blood from backing up into the catheter, and to prevent gases from entering the catheter. The liquid that is used to flush the catheter is referred to as a “lock-flush,” and the liquid used to fill the catheter following flushing or during periods of non-use is referred to as a “lock” solution.
[0007] Traditionally, catheters have been locked with normal saline or heparin solutions. Heparin and saline are sometimes used in combination. Normal saline is generally used to lock short term peripheral intravenous catheters, but saline has no anticoagulant or antimicrobial activity. Heparin solutions are generally used to lock vascular catheters. Heparin has anticoagulant activity but it does not function as an antimicrobial and does not prevent or ameliorate infections. There are also strong indications that heparin in lock solutions may contribute to heparin-induced thrombocytopenia, a serious bleeding complication that occurs in a subset of patients receiving heparin injections.
[0008] Catheter locking solutions comprising taurolidine, citric acid and sodium citrate have been proposed. A recent publication (Kidney International, September 2002) describes the use of a 70% alcohol solution as a lock solution for a subcutaneous catheter port. The use of alcohol as a lock solution is questionable, since it is not an anticoagulant, and since there would be risks associated with this solution entering the bloodstream. There is also no evidence that the inventors are aware of that indicates that a 70% alcohol solution has any biofilm eradication activity.
[0009] An emerging trend and recommendation from the Center for Infectious Disease (CID) is to treat existing catheter infections systemically with either a specific or a broad range antibiotic. Use of an antibiotic in a lock solution to prevent infection is not recommended. The use of antibiotics to treat existing catheter infections has certain risks, including: (1) the risk of antibiotic-resistant strains developing; (2) the inability of the antibiotic to kill sessile, or deep-layer biofilm bacteria, which may require the use of antibiotics at toxic concentrations; and (3) the high cost of prolonged antibiotic therapy. Catheters coated with a disinfectant or antibiotic material are available. These coated catheters may only provide limited protection for a relatively short period of time.
[0010] In general, free-floating organisms may be vulnerable to antibiotics. However, bacteria and fungi may become impervious to antibiotics by attaching to surfaces and producing a slimy protective substance, often referred to as extra-cellular polymeric substance (EPS), polysaccharide covering or glycocalyx. As the microbes proliferate, more than 50 genetic up or down regulations may occur, resulting in the formation of a more antibiotic resistant microbial biofilm. One article attributes two-thirds of the bacterial infections that physicians encounter to biofilms. SCIENCE NEWS, 1-5 Jul. 14, 2001.
[0011] Biofilm formation is a genetically controlled process in the life cycle of bacteria that produces numerous changes in the cellular physiology of the organism, often including increased antibiotic resistance (of up to 100 to 1000 times), as compared to growth under planktonic (free floating) conditions. As the organisms grow, problems with overcrowding and diminishing nutrition trigger shedding of the organisms to seek new locations and resources. The newly shed organisms quickly revert back to their original free-floating phase and are once again vulnerable to antibiotics. However, the free-floating organism may enter the bloodstream of the patient, creating bloodstream infections, which produce clinical signs, e.g. fever, and more serious infection-related symptoms. Sessile rafts of biofilm may slough off and may attach to tissue surfaces, such heart valves, causing proliferation of biofilm and serious problems, such as endocarditis.
[0012] To further complicate matters, conventional sensitivity tests measure only the antibiotic sensitivity of the free-floating organisms, rather than organisms in a biofilm state. As a result, a dose of antibiotics is administered to the patient, such as through a catheter, in amounts that rarely have the desired effect on the biofilm phase organisms that may reside in the catheter. The biofilm organisms may continue to shed more planktonic organisms or may go dormant and proliferate later as an apparent recurrent infection.
[0013] In order to eradicate biofilm organisms through the use of antibiotics, a laboratory must determine the concentration of antibiotic required to kill the specific genetic biofilm phase of the organism. Highly specialized equipment is required to provide the minimum biofilm eradication concentration. Moreover, the current diagnostic protocols are time consuming, and results are often not available for many days, e.g. five (5) days. This time period clearly doesn't allow for prompt treatment of infections. The delay and the well-justified fear of infection may result in the overuse of broad-spectrum antibiotics and continued unnecessary catheter removal and replacement procedures. Overuse of broad-spectrum antibiotics can result in the development of antibiotic resistant bacterial strains, which cannot be effectively treated. Unnecessary catheter removal and replacement is painful, costly and may result in trauma and damage to the tissue at the catheter insertion site.
[0014] The antibiotic resistance of biofilms, coupled with complications of antibiotic use, such as the risk of antibiotic resistant strains developing, has made antibiotic treatment an unattractive option. As a result, antibiotic use is limited to symptomatic infections and prophylactic antibiotics are not typically applied to prevent contamination. Because the biofilm can act as a selective phenotypic resistance barrier to most antibiotics, the catheter must often be removed in order to eradicate a catheter related infection. Removal and replacement of the catheter is time consuming, stressful to the patient, and complicates the medical procedure. Therefore, there are attempts to provide convenient and effective methods for killing organisms, and especially those dwelling inside of catheters, without the necessity of removing the catheter from the body.
[0015] In addition to bacterial and fungal infections, amoebic infections can be very serious and painful, as well as potentially life threatening. Several species of Acanthamoeba, for example, have been found to infect humans. Acanthamoeba are found worldwide in soil and dust, and in fresh water sources as well as in brackish water and sea water. They are frequently found in heating, venting and air conditioner units, humidifiers, dialysis units, and in contact lens paraphernalia. Acanthamoeba infections, in addition to microbial and fungal infections, may also be common in connection with other medical and dental devices, including toothbrushes, dentures and other dental appliances, and the like. Acanthamoeba infections often result from improper storage, handling and disinfection of contact lenses and other medical devices that come into contact with the human body, where they may enter the skin through a cut, wound, the nostrils, the eye, and the like.
[0016] There is a need for improved methods and substances to prevent and destroy infections in catheters. Such disinfectant solutions should have a broad range of antimicrobial properties. In particular, the solutions should be capable of penetrating biofilms to eradicate the organisms comprising the biofilms. The methods and solutions should be safe enough to be use as a preventive measure as well as in the treatment of existing infections.
[0017] Poly(hexamethylenebiguanide) (PHMB) is a broad spectrum, fast acting disinfectant. It is used as a preservative for make-up removers, moisturizing toners, facial cleansers, wet wipes and offers antibacterial and deodorant properties. It is available as Poly(hexamethylenebiguanide) hydrochloride (commonly known as polihexanide) in a solution form at a concentration of 20%. It is sold under the name of Cosmocil CQ via Avecia/Arch Chemicals.
[0018] Ethylene diamine tetraacetic acid (EDTA) has been used for systemic detoxification treatment and as an anticoagulant in blood samples for some time. Thus its use for medical treatment and applications is established. The use of disodium EDTA and calcium disodium EDTA in combination with other compounds to enhance anti-microbial properties of these other compounds has been studied and practiced. It has been discovered that many stand-alone salts of Ethylenediamine-tetraaceticacid (EDTA) are effective anti-microbial agents and that specific salts are more effective than others. In particular, it has been discovered that certain salts of EDTA exhibit anti-microbial (both antifungal and antibacterial) properties superior to those of the disodium salt in common use. In particular, dipotassium and ammonium EDTA are superior to disodium EDTA, and tetrasodium EDTA (TEDTA) has been found to be preferred to disodium, ammonium, and dipotassium.
OBJECTS AND SUMMARY
[0019] In the following discussion, the terms “microbe” or “microbial” will be used to refer to microscopic organisms or matter, including fungal and bacterial organisms, and possibly including viral organisms, capable of infecting humans. The term “anti-microbial” will thus be used herein to refer to a material or agent that kills or otherwise inhibits the growth of fungal and/or bacterial and possibly viral organisms.
[0020] The term “disinfect” will be used to refer to the reduction, inhibition, or elimination of infectious microbes from a defined system. The term “disinfectant” will be used herein to refer to a one or more anti-microbial substances used either alone or in combination with other materials such as carriers, solvents, or the like.
[0021] The term “bactericidal activity” is used to refer to an activity that at least essentially kills an entire population of bacteria, instead of simply just reducing or inhibiting their growth. The term “fungicidal activity” is used to refer to an activity that at least essentially kills an entire population of yeast, instead of simply just reducing or inhibiting their growth. Contamination of conduits, e.g., catheters, poses serious and substantial health risks and bactericidal disinfection is a significant priority.
[0022] The term “infected system” will be used herein to refer to a defined or discrete system or environment in which one or more infectious microbes are or are likely to be present. Examples of infected systems include a physical space such as a bathroom facility or operating room, a physical object such as food or surgical tool, a biological system such as the human body, or a combination of a physical object and a biological system such as a catheter or the like arranged at least partly within a human body. Tubes and other conduits for the delivery of fluids, in industrial and healthcare settings, may also define an infected system.
[0023] A solution that consists essentially of PHMB and EDTA salt(s) in a solvent, such as water or saline, is substantially free from other active substances having antimicrobial and/or anti-fungal activity.
[0024] The present disclosure involves disinfectant solutions comprising, or consisting essentially of, or consisting of, PHMB and EDTA salt(s) at a prescribed concentration and/or pH. The inventors have discovered, unexpectedly, that certain PHMB and EDTA salt(s) formulations provide enhanced disinfectant activities. PHMB and EDTA salt(s) formulations act as enhanced, fast acting catheter lock/flush solutions. PHMB and EDTA salt(s) formulations of the present disclosure are also highly effective in killing pathogenic biofilm organisms, and are expected to be effective in reducing existing biofilms, in eliminating existing biofilms as well as preventing biofilm formation. PHMB and EDTA salt(s) formulations function as broad-spectrum anti-microbial agents, as well as fungicidal agents against many strains of pathogenic yeast. PHMB and EDTA salt(s) formulations are expected to exhibit anti-protozoan activity and also exhibit anti-amoebic activity.
[0025] The PHMB and EDTA salt(s) formulations of the present disclosure are safe for human administration and are biocompatible and non-corrosive. The disinfectant solutions of the present disclosure have applications at least as lock and lock flush solutions for various types of catheters. The efficacy of the PHMB and EDTA salt(s) formulations of the present disclosure is superior to many disinfectant compositions conventionally used as catheter lock/flush solutions. The disclosed PHMB and EDTA salt(s) formulations do not contribute to antibiotic resistance, which provides yet another important benefit.
[0026] The PHMB and EDTA salt(s) formulations of the present disclosure are also have improved anticoagulant properties and are thus especially beneficial as catheter lock-flush solutions and other related uses.
[0027] In one embodiment, disinfectant compositions of the present disclosure have some of the following properties: anticoagulant properties; inhibitory and/or bactericidal activity against a broad spectrum of bacteria in a planktonic form; inhibitory and/or fungicidal activity against a spectrum of fungal pathogens; inhibitory and/or bactericidal activity against a broad spectrum of bacteria in a sessile form; inhibitory activity against protozoan infections; inhibitory activity against Acanthamoeba infections; safe and biocompatible, at least in modest volumes, in contact with a patient; and safe and biocompatible, at least in modest volumes, in a patient's bloodstream.
[0028] Methods for inhibiting the growth and proliferation of microbial populations and/or fungal pathogens are provided that comprise contacting an infected or suspected infected object, or surface, e.g., catheter, with a disinfectant composition of the present disclosure. Methods for inhibiting the growth and proliferation of protozoan populations are also provided, comprising contacting an infected or suspected infected object, or surface, e.g., catheter, with a disinfectant composition of the present disclosure.
[0029] Methods for inhibiting the growth and proliferation of amoebic populations, and for preventing amoebic infection, particularly Acanthamoeba infections, are provided, comprising contacting an object, or a surface, e.g., catheter, with a disinfectant composition of the present disclosure. Methods for substantially eradicating microbial populations are also provided and comprise contacting an infected or suspected infected object, or surface, e.g., catheter, with a disinfectant composition of the present disclosure. Methods for substantially eradicating an Acanthamoeba population are provided and comprise contacting an infected or suspected infected object, or surface, e.g., catheter, with a disinfectant composition of the present disclosure. Depending on the disinfectant composition used in the various methods, various compositions and contact time periods may be required to inhibit the formation and proliferation of various populations, and/or to substantially eradicate various populations. Suitable contact time periods for various compositions may be determined by routine experimentation.
[0030] Importantly, in most embodiments, disinfectant compositions and methods of the present disclosure do not employ traditional antibiotic agents and thus do not contribute to the development of antibiotic resistant organisms.
[0031] In one embodiment, disinfectant compositions consisting of, consisting essentially of, or comprising PHMB and EDTA salt(s) at a greater than physiological pH are provided as disinfectant compositions of the present disclosure. Such disinfectant compositions have application as lock solutions and lock flush solutions for various types of in-dwelling access catheters, including vascular catheters used for delivery of fluids, blood products, drugs, nutrition, withdrawal of fluids or blood, dialysis, monitoring of patient conditions, and the like. Disinfectant solutions of the present disclosure may also be used as lock and lock flush solutions for urinary catheters, nasal tubes, throat tubes, and the like. The general solution parameters described below are suitable for these purposes. In one embodiment, a disinfectant solution consisting of, consisting essentially of, or comprising PHMB and EDTA salt(s) at a greater than physiological pH is provided to maintain the patency of in-dwelling intravascular access devices. Methods for disinfectant catheters and other medical tubes, such as nasal tubes, throat tubes, and the like, are also provided and involve contacting the catheter or other medical tube with a disinfectant composition of the present disclosure.
BRIEF DESCRIPTION OF THE DRAWING(S)
[0032] FIG. 1 shows the results of experiments of a PHMB MIC test with P. aeruginosa. The data suggests that the MIC value for PHMB is <5 PPM.
[0033] FIG. 2 shows the results of experiments of a PHMB MIC test with S. aureus. The data suggests that the MIC value for PHMB is <1.25 PPM.
[0034] FIG. 3 shows the results of experiments of a PHMB MIC test with C. Albicans. The data suggests that the MIC value for PHMB is <1.25 PPM.
[0035] FIG. 4 shows the results of experiments of a PHMB MBC test with C. Albicans. The data suggests that the MBC value for PHMB is <1.25 PPM.
[0036] FIG. 5 shows the results of experiments of a EDTA(Na 4 ) MIC test with P. aeruginosa. The data suggests that the MIC value for EDTA(Na 4 ) is <0.25 wt %.
[0037] FIG. 6 shows the results of experiments of a EDTA(Na 4 ) MIC test with S. aureus. The data suggests that the MIC value for EDTA(Na 4 ) is <0.03125 wt %.
[0038] FIG. 7 shows the results of experiments of a EDTA(Na 4 ) MIC test with C. Albicans. The data suggests that the MIC value for EDTA(Na 4 ) is <0.03125 wt %.
[0039] FIG. 8 shows the results of experiments of a EDTA(Na 4 ) MBC test with C. Albicans. The data suggests that the MBC value for EDTA(Na 4 ) is <0.0625 wt %.
[0040] FIG. 9 shows the results of experiments of a Checkerboard Titration with S. aureus. The data suggests that the FIC index=0.8 for EDTA(Na 4 )+PHMB Combination.
[0041] FIG. 10 shows the results of experiments of a Checkerboard Titration with P. aeruginosa. The data suggests that the FIC index=0.5 for EDTA(Na 4 )+PHMB Combination.
[0042] FIG. 11 shows the results of experiments of a Checkerboard Titration with C albicans. The data suggests that the FIC index=0.6 for EDTA(Na 4 )+PHMB Combination.
[0043] FIG. 12 shows the results of experiments of a Rate Kill Assay for S. aureus. The data clearly suggest the synergistic action against S. Aureus by EDTA(Na 4 )+PHMB combination.
[0044] FIG. 13 shows the results of experiments of a Rate Kill Assay for P. aeruginosa. The data clearly suggest the synergistic action against P. aeruginosa by EDTA(Na 4 )+PHMB combination.
[0045] FIG. 14 shows the results of experiments of a Rate Kill Assay for C. albicans. The data does not suggest the synergistic action against C. albicans by EDTA(Na 4 )+PHMB combination. However, the data suggests the combination is very effective against C. albicans with PHMB being the dominant component.
[0046] FIG. 15 shows the results of experiments of a PHMB MIC and MBC test with S. aureus at a pH of 7. The data suggests that the MIC value for PHMB at a pH of 7 is <5 PPM. The data suggests that the MBC value for PHMB at a pH of 7 is <5 PPM.
[0047] FIG. 16 shows the results of experiments of a PHMB MIC and MBC test with P. aeruginosa at a pH of 7. The data suggests that the MIC value for PHMB at a pH of 7 is <5 PPM. The data suggests that the MBC value for PHMB at a pH of 7 is <5 PPM.
[0048] FIG. 17 shows the results of experiments of a PHMB MIC and MBC test with C. albicans at a pH of 7. The data suggests that the MIC value for PHMB at a pH of 7 is <10 PPM. The data suggests that the MBC value for PHMB at a pH of 7 is <10 PPM.
[0049] FIG. 18 shows the results of experiments of a EDTA MIC and MBC test with S. aureus at a pH of 7. The data suggests that the MIC value for EDTA at a pH of 7 is <0.03 wt %. The data suggests that the MBC value for EDTA at a pH of 7 is <0.13 wt %.
[0050] FIG. 19 shows the results of experiments of a EDTA MIC and MBC test with P. aeruginosa at a pH of 7. The data suggests that the MIC value for EDTA at a pH of 7 is <0.25 wt %. The data suggests that the MBC value for EDTA at a pH of 7 is <4.00 wt %.
[0051] FIG. 20 shows the results of experiments of a EDTA MIC test with C. albicans at a pH of 7. The data suggests that the MIC value for EDTA at a pH of 7 is >4.0 wt %. The MBC value for EDTA at a pH of 7 could not be determined.
[0052] FIG. 21 shows the results of experiments of a Checkerboard Titration with S. aureus at a pH of 7. The data suggests that the FIC index=0.6 for PHMB-EDTA Combination at a pH of 7.
[0053] FIG. 22 shows the results of experiments of a Checkerboard Titration with P. aeruginosa at a pH of 7. The data suggests that the FIC index=0.5 for PHMB-EDTA Combination at a pH of 7.
[0054] FIG. 23 shows the results of experiments of a Checkerboard Titration with C. albicans at a pH of 7. The data suggests that there is no synergy against C. ablicans for PHMB-EDTA Combination at a pH of 7.
[0055] FIG. 24 shows the results of experiments (raw data) of a Prothrombin Time (PT) Assay.
[0056] FIG. 25 shows the results of experiments (processed data) of a Prothrombin Time (PT) Assay.
[0057] FIG. 26 shows the graph of the International Normalized Ratio (INR) for EDTA(Na 4 ) from a Prothrombin Time (PT) Assay.
[0058] FIG. 27 shows the graph of the International Normalized Ratio (INR) for PHMB from a Prothrombin Time (PT) Assay.
[0059] FIG. 28 shows the graph of the International Normalized Ratio (INR) for combined EDTA(Na 4 ) and PHMB formulations from a Prothrombin Time (PT) Assay.
DETAILED DESCRIPTION
[0060] Disinfectant compositions of the present disclosure may comprise concentrations of PHMB and EDTA salt(s) at a pH higher than physiological. PHMB and EDTA salt(s) may be used in compositions with water as the solvent.
[0061] Some properties of PHMB are:
[0062] Physical Properties
Color—Colorless to slightly pale yellow Solubility—Miscible with water, ethanol, glycerine and propylene glycol Specific Gravity at 25° C.-1.04 pH—5.0-5.5 Shelf Life—greater than two year storage stability Stability—Effective and stable over a broad pH range (4-10) active agent heat stable to >140° C. UV stable odorless, non-foaming Chemically stable and non-volatile
[0073] Chemical Properties
Zero Volatile Organic Compound Compatible with a wide range of cosmetic raw materials Compatible with cationic, amphoteric and non-ionic surfactants Incompatible with strongly anionic systems
[0078] Antimicrobial Properties
Unique biguanide chemistry Novel non-specific mode of action No known evidence of development of organism resistance Contains no formaldehyde and is not a formaldehyde donor Broad spectrum of activity high activity vs. tough Gram (negative) organisms, e.g., Pseudomonas Extensively studied mammalian toxicity Low acute toxicity via dermal and oral routes Low skin and eye irritancy potential at in-use concentration Slow toxicity following long term exposure Not teratogenic and shows no reproductive effects when studied over two generations Non-genotoxic in a range of studies Not considered carcinogenic in humans.
[0091] Compositions comprising PHMB have a well established safety profile in connection with medical usage and administration to humans. Acute Oral LD 50 of 1617 mg/kg (see table below for further info).
[0000]
Guideline
Toxicity
No.
Study Type
MRID #(s)
Results
Category
Acute Toxicity
870.1100
Acute Oral
00030330
LD50 = 2747 mg/kg
III
44940701
LD50 = 1831 mg/kg (M) LD50 =
1617 mg/kg (F)
45916505
LD50 = 1049 mg/kg (F)
870.1200
Acute Dermal
00065124
LD50 > 2.0 ml/kg
III
44940702
LD50 > 2000 mg/kg
45916506
LD50 > 5000 mg/kg
IV
870.1300
Acute Inhalation
44970403
LC50 = 1.76 mg/L
III
870.2400
Primary Eye Irritation
00046789
Moderate irritant
II
00065120
44963902
870.2500
Primary Skin Irritation
00046789
Moderate irritant
II
00065120
44949704
Slight irritant
IV
45916509
870.2600
Dermal Sensitization
42674201
Moderate sensitizer
NA
44940705
Mild sensitizer
Notes:
LC = Lethal Concentration;
LD = Lethal Dose;
NA = Not Applicable
[0000]
Special FQPA SF*
and Level of
Exposure
Dose Used in Risk
Concern for Risk
Scenario
Assessment, UF
Assessment
Study and Toxicological Effects
Acute Dietary
NOAEL = 20 mg/kg/day
FQPA SF = 1
Rabbit Developmental Study
(Females 13-50
UF = 100
aPAD = acute RfD
(MRID 42865901)
years of age)
Acute RfD = 0.2 mg/kg/day
FQPA SF =
LOAEL = 40 mg/kg/day based on reduced
0.2 mg/kg/day
number of litters and skeletal
abnormalities.
Acute Dietary
No Appropriate single dose effects can be selected for general population
(General population
including infants and
children)
Chronic Dietary (All
NOAEL = 20 mg/kg/day
FQPA SF = 1 cPAD =
Rabbit Developmental Study (MRID
populations)
UF = 100
chronic RfD FQPA
42865901) LOAEL = 40 mg/kg/day
Chronic RfD = 0.2 mg/kg/day
SF = 0.2 mg/kg/day
Based on the increased mortality, reduced
food consumption, and clinical toxicity;
Mouse Developmental Study (Report No.
CTL/P/335, 1977 (cited in Report No.
003810, 1978. Section C-9))
LOAEL = 40 mg/kg/day;
Based on reduced body weight gain; and
Rat Developmental Study (Report No.
CTL/P/1262, 1976 (cited in Report No.
003810, 1978. Section C-11))
LOAEL = 50 mg/kg/day
Based on reduced food consumption.
Cancer (Oral,
The HED Cancer Assessment Review Committee (CARC) classified PHMB as
dermal, Inhalation)
“Suggestive Evidence of Carcinogenicity, but not sufficient to Assess Human Carcinogenic
Potential” by the oral and dermal routes. Quantification of human cancer risk is not
required.
Notes:
UF = uncertainty factor,
FQPA SF = Food Quality Protection Act safety factor,
NOAEL = no observed adverse effect level,
LOAEL = lowest observed adverse effect level,
PAD = population adjusted dose (a = acute, c = chronic)
RfD = reference dose
Reference —Re-registration Eligibility Decision for PHMB, September 2005.
[0092] PHMB is also present, in combination with other components, in many solutions used in medical and human health applications, and has been established as safe for human use, both in vitro and in vivo. PHMB is readily available at a reasonable cost, and is stable over time in solution.
[0093] Soluble salts of EDTA are used in compositions of the present disclosure. Sodium salts of EDTA are commonly available and generally used, including di-sodium, tri-sodium and tetra-sodium salts, although other EDTA salts, including ammonium, di-ammonium, potassium, di-potassium, cupric di-sodium, magnesium di-sodium, ferric sodium, and combinations thereof, may be used, provided they have the antibacterial and/or fungicidal and/or anti-protozoan and/or anti-amoebic properties desired, and provided that they are sufficiently soluble in the solvent desired. Various combinations of EDTA salts may be used and may be preferred for particular applications.
[0094] The British Pharmacopoeia (BP) specifies that a 5% solution of di-sodium EDTA has a pH of 4.0 to 5.5. The BP also specifies a pH range of 7.0 to 8.0 for solutions of tri-sodium EDTA. At physiological pH, the sodium salts of EDTA exist as a combination of di-sodium and tri-sodium EDTA, with the tri-sodium salt of EDTA being predominant. In the U.S., pharmaceutical “di-sodium” EDTA prepared for injection has generally been titrated with sodium hydroxide to a pH of 6.5 to 7.5. At this pH, the EDTA solution actually comprises primarily tri-sodium EDTA, with a lesser proportion of the di-sodium salt. Other compositions comprising sodium salts of EDTA that are used in medical or healthcare applications are generally adjusted to a pH that is substantially physiological.
[0095] Compositions comprising EDTA have a well established safety profile in connection with medical usage and administration to humans. Doses of up to 3000 mg EDTA disodium are infused over 3 hours, on a daily basis, for the treatment of hypercalcemia in humans. This dose is well tolerated. EDTA salts are also present, in combination with other components, in many solutions used in medical and human health applications, and have been established as safe for human use, both in vitro and in vivo. EDTA salts are readily available at a reasonable cost, and are stable over time in solution.
[0096] The combination of PHMB and EDTA salt(s) has an anti-coagulant effect. The anti-coagulant effect is further detailed in FIG. 28 .
[0097] Embodiments of the disclosed composition may comprise at least 0.1 PPM PHMB and up to 400 PPM PHMB. Embodiments comprising at least 5 PPM PHMB and less than 200 PPM PHMB are preferred for many applications, and compositions comprising about 10-50 PPM PHMB are especially preferred.
[0098] Embodiments of the disclosed composition may comprise at least 0.0125% EDTA salt(s), by weight per volume solution (w/v) and up to 12.0% (w/v) EDTA salt(s). Embodiments comprising at least 0.25% (w/v) EDTA salt(s) and less than 8% (w/v) EDTA salt(s) are preferred for many applications, and compositions comprising about 0.5-4 (w/v) EDTA salt(s) are especially preferred.
[0099] Embodiments of the disclosed composition may comprise between 0 and 25% (v/v) ethanol and water. Other embodiments of the disclosed composition may comprise between 0 and 20% (v/v) ethanol and water, between 0 and 15% (v/v) ethanol and water, or between 0 and 10% (v/v) ethanol and water.
[0100] The desired PHMB and EDTA salt(s) concentrations for various applications may depend on the type of infection being treated and, to some degree, on the solvent used for disinfectant compositions. When aqueous solvents comprising ethanol are used, for example, the concentrations of PHMB and EDTA salt(s) required to provide the desired level of activity may be reduced compared to the PHMB and EDTA salt(s) concentrations used in compositions having water as the solvent. “Effective” concentrations of PHMB and EDTA salt(s) in disinfectant compositions of the present disclosure for inhibitory, bactericidal, fungicidal, biofilm eradication and other purposes, may be determined by routine experimentation.
[0101] In certain embodiments, disinfectant compositions of the present disclosure comprise, or consist essentially of, or consist of, PHMB and EDTA salt(s) in solution at a pH higher than physiological, preferably at a pH of > or >8.0, or at a pH > or >8.5, or at a pH> or >9, or at a pH> or >9.5, or at a pH>or >10.0, or at a pH> or >10.5. Compositions comprising PHMB and EDTA salt(s) that are used in medical or healthcare applications may be adjusted to a pH that is substantially physiological. In one embodiment, disinfectant compositions of the present disclosure comprise, or consist essentially of, or consist of, PHMB and a sodium EDTA salt (or combination of sodium salts) in solution at a pH in the range between 8.5 and 12.5 and, in another embodiment, at a pH of between 9.5 and 11.5 and, in yet another embodiment, at a pH of between 10.5 and 11.5. When used herein, the term “EDTA salt” may refer to a single salt, such as a di-sodium or tri-sodium or tetra-sodium salt, or another EDTA salt form, or it may refer to a combination of such salts. The composition of EDTA salt(s) depends both on the EDTA salts used to formulate the composition, and on the pH of the composition. For disinfectant compositions of the present disclosure comprising sodium EDTA salt(s), and at the desired pH ranges (specified above), the sodium EDTA salts are predominantly present in both the tri-sodium and tetra-sodium salt forms.
[0102] Disinfectant compositions comprising, or consisting essentially of, or consisting of PHMB and EDTA salt(s) have different “effective” pH ranges. “Effective” pH ranges for desired EDTA salt(s) in disinfectant compositions of the present disclosure for inhibitory, bactericidal, fungicidal, biofilm eradication and other purposes, may be determined by routine experimentation.
[0103] In some embodiments, disinfectant compositions of the present disclosure consist of PHMB and EDTA salt(s), as described above, and disinfectant solutions consist of PHMB and EDTA salt(s) dissolved in a solvent, generally an aqueous solvent such as water or saline. In other embodiments, disinfectant compositions of the present disclosure consist essentially of PHMB and EDTA salt(s), as described above, generally in an aqueous solvent such as water or saline.
[0104] In some embodiments, disinfectant compositions of the present disclosure comprise PHMB and EDTA salt(s) having specified concentrations, at specified pH ranges, and may contain materials, including active components, in addition to the PHMB and EDTA salt(s) described above. Other antimicrobial or biocidal components may be incorporated in disinfectant compositions of the present disclosure comprising PHMB and EDTA salt(s), although the use of traditional antibiotics and biocidal agents is generally discouraged as a result of the potential dire consequences of the development of antibiotic- and biocidal-resistant organisms. In some embodiments, disinfectant compositions of the present disclosure comprising PHMB and EDTA salt(s) having specified concentration(s), at specified pH ranges, are substantially free from other active substances having substantial antimicrobial and/or anti-fungal activity.
[0105] Other active and inactive components may also be incorporated in disinfectant compositions of the present disclosure comprising PHMB and EDTA salt(s), preferably provided that they don't deleteriously affect the activity and/or stability of the PHMB and EDTA salt(s). Proteolytic agents may be incorporated in disinfectant compositions for some applications. Disinfectant compositions formulated for topical application have various creams, emollients, skin care compositions such as aloe vera, and the like, for example. Disinfectant compositions of the present disclosure provided in a solution formulation may also comprise other active and inactive components, preferably provided they don't interfere, deleteriously, with the activity and/or stability of the PHMB and EDTA salt(s).
[0106] The compositions of the present disclosure may be used in a solution or a dry form. In solution, the PHMB and EDTA salt(s) are preferably dissolved in a solvent, which may comprise an aqueous solution, such as water or saline, or another biocompatible solution in which the PHMB and EDTA salt(s) are soluble. Other solvents, including alcohol solutions, may also be used. In one embodiment, PHMB and EDTA salt(s) compositions of the present disclosure may be formulated in a mixture of water and ethanol. Such solutions are expected to be highly efficacious and may be prepared by making a concentrated PHMB and EDTA salt(s) stock solution in water and then introducing the desired concentration of ethanol. Ethanol concentrations of from more than about 0.5% and less than about 10%, v/v, are expected to provide effective disinfectant compositions. In some embodiments, bio-compatible non-aqueous solvents may also be employed, provided the EDTA salt(s) can be solubilized and remain in solution during storage and use.
[0107] PHMB and EDTA salt(s) solutions of the present disclosure are preferably provided in a sterile and non-pyrogenic form and may be packaged in any convenient fashion. In some embodiments, disinfectant PHMB and EDTA salt(s) compositions of the present disclosure may be provided in connection with or as part of a medical device, such as in a pre-filled syringe or another medical device. The compositions may be prepared under sterile, aseptic conditions, or they may be sterilized following preparation and/or packaging using any of a variety of suitable sterilization techniques. Single use vials, syringes or containers of PHMB and EDTA salt(s) solutions may be provided. Multiple use vials, syringes or containers may also be provided. Systems of the present disclosure include such vials, syringes or containers containing the PHMB and EDTA salt(s) solutions of the present disclosure. Catheters contemplated for use include peripherally inserted catheters, central venous catheters, peritoneal catheters, hemodialysis catheters and urological catheters.
[0108] The compositions of the present disclosure may also be provided in a substantially “dry” form, such as a substantially dry coating on a surface of tubing, or a conduit, or a medical device such as a catheter or conduit, or a container, or the like. Dry forms of the disinfectant compositions of the present disclosure may include hydrophilic polymers such as PVP, which tend absorb water and provide lubricity, surfactants to enhance solubility and/or bulking and buffering agents to provide thermal as well as pH stability. Such substantially dry forms of PHMB and EDTA salt(s) compositions of the present disclosure may be provided in a powder or lyophilized form that may be reconstituted to form a solution with the addition of a solvent. Substantially dry forms of PHMB and EDTA salt(s) compositions may alternatively be provided as a coating, or may be incorporated in a gel or another type of carrier, or encapsulated or otherwise packaged and provided on a surface as a coating or in a container. Such substantially dry forms of PHMB and EDTA salt(s) compositions of the present disclosure are formulated such that in the presence of a solution, the substantially dry composition forms an PHMB and EDTA salt(s) solution having the composition and properties described above. In certain embodiments, different encapsulation or storage techniques may be employed such that effective time release of the PHMB and EDTA salt(s) is accomplished upon extended exposure to solutions. In this embodiment, the substantially dry PHMB and EDTA salt(s) solutions may provide disinfectant activity over an extended period of time and/or upon multiple exposures to solutions.
[0109] Formulation and production of disinfectant compositions of the present disclosure are generally straightforward. In one embodiment, desired disinfectant compositions of the present disclosure are formulated by dissolving PHMB and EDTA salt(s) in an aqueous solvent, such as purified water, to the desired concentration and adjusting the pH of the solution to the desired pH. In alternative embodiments, desired disinfectant compositions of the present disclosure are formulated by dissolving PHMB and EDTA salt(s) in a solvent in which the PHMB and EDTA salt(s) are soluble to provide a concentrated, solubilized solution, and additional solvents or components may then be added, or the solubilized composition may be formulated in a form other than a solution, such as a topical preparation. The disinfectant solution may then be sterilized using conventional means, such as filtration and/or ultrafiltration, and other means. The preferred osmolarity range for PHMB and EDTA salt(s) solutions is from 240-500 mOsm/Kg, more preferably from 300-420 mOsm/Kg. The solutions are preferably formulated using USP materials.
[0110] A PHMB and EDTA salt(s) solution can be used as a treatment for catheters defining an infected system. The PHMB and EDTA salt(s) solution may inhibit microbe colonization by treating the catheter with the solution at the prescribed concentration using a liquid lock prior to and in between infusions and/or by surface coating of catheter devices. A further application is the treatment of colonized or infected catheters by use of a liquid lock containing the PHMB and EDTA salt(s) solution in the preferred concentration and pH.
[0111] Typically, the PHMB and EDTA salt(s) solution, when used to treat catheters, are dissolved in water as a carrier, although other carriers may be used. Substances such as thrombolytics, sodium, alcohol, or reagents may also be added to the basic water/PHMB and EDTA salt(s) solution.
Minimum Inhibitory Concentration (MIC) Experiments
[0112] The minimum concentration of a composition required to inhibit growth is known as the minimum inhibitory concentration (MIC). In order to determine MIC and MBC (minimum bactericidal concentration) a National Committee on Clinical Laboratory Standards (NCCLS) micro-dilution procedure was followed. According to the procedure each formulation must be exposed to 6 log concentration (or the highest achievable concentration) of organism. In the current protocol 100 μL of MHB was mixed with 90 μL of formulation and 10 μL of log 8 concentration organism (or the highest achievable concentration). The concentration of the formulation was adjusted to obtain the required concentration in the final solution. The mixture was incubated at 37 degree C for 16-24 hrs. After 16-24 hours the absorbance value was read at 600 nm. The obtained data was corrected by subtracting the appropriate blanks. Finally, the wells having an absorbance >0.1 were marked + and <0.1 were marked −. The +symbol indicated growth while −symbol indicates no growth. The positive growth controls must have a corrective absorbance value of >0.5 and negative controls must have a corrected absorbance value of <0.1. In cases where the positive growth controls corrected absorbance is lower than 0.5, an alternate rule is utilized which is “absorbance <than 20% of positive growth control is marked as −growth, while absorbance >than 20% of positive growth control is marked as +growth”.
[0113] Staphylococcus aureus (Organism #25923), Pseudomonas aeruginosa (Organism #27853), and Candida Albicans (Organism #10231) was obtained from ATCC. PHMB was used (Avecia, Lot #1L15-038). EDTA, tetrasodium salt hydrate, was used (Alfa Aesar, Catalogue #A17385, Lot #J9570A). A 200 PPM PHMB solution in water was prepared. A 8 wt % EDTA(Na 4 ) solution in water was prepared. These solutions were then diluted as necessary to obtain the required concentrations. A minimum concentration of EDTA(Na 4 ) and PHMB that inhibited the growth of Staphylococcus aureus and P. aeruginosa was found. As per experiments conducted, EDTA(Na 4 ) has a MIC of <0.03% (w/v) for S. aureus, PHMB has a MIC of <1.25 PPM for S. aureus, EDTA(Na 4 ) has a MIC of <0.25% (w/v) for P. aeruginosa, PHMB has a MIC of <5 PPM for P. aeruginosa, EDTA(Na 4 ) has a MIC of <0.03125% (w/v) for C. albicans, PHMB has a MIC of <1.25 PPM for C. albicans, EDTA(Na 4 ) has a MBC of <0.0625% (w/v) for C. albicans, PHMB has a MBC of <1.25 PPM for C. albicans. See FIGS. 1-8 for MIC and MBC results.
Synergism Experiment
[0114] Two sets of experiments were conducted to show an unexpected synergism of the disinfectant activity of a composition that includes both EDTA(Na 4 ) and PHMB.
[0115] The first experiment conducted was a screening experiment using checkerboard titration to assess if the combinations fall within a range having an FIC index value of <1. The method used was a NCCLS micro-dilution procedure
[0116] The second experiment conducted was a “rate of kill” assay. A rate of kill assay can confirm whether combinations are synergistic or not. In this assay the formulations are first exposed to organisms for a desired time (the current formulations readings were taken at 0, 1, 2, 3 and 24 hrs). Then a sample of the organisms and formulation mixture is serially diluted and plated to assess the log recovery. The organisms are allowed to grow and are checked for growth/log recovery after 24 hrs. The log recovery values obtained for individual components were compared with the combinations. Any combinations having >2 log reduction when compared with the most active compound used in the combination at any time point tested were labeled as synergistic (Comparison of methods for assessing synergic antibiotic interactions, International journal of antimicrobial agents, 15 (2000) 125-129).
[0117] According to the first and second experiments described above, experiments were conducted to investigate the effect of PHMB on the antimicrobial activity of EDTA(Na 4 ). PHMB was used (Avecia, Lot #1L15-038). EDTA, tetrasodium salt hydrate, was used (Alfa Aesar, Catalogue #A17385, Lot #J9570A).
Checkerboard Titration Experiment— S. Aureus
[0118] The Checkerboard Titration method was used to assess the interactions between EDTA(Na 4 ) and PHMB. The Checkerboard Titration method is a frequently used technique where, for example, each agent (EDTA(Na 4 ) and PHMB) was tested at multiple dilutions lower than the MIC. During this experiment, EDTA(Na 4 ) and PHMB were tested in the combinations to assess if the combinations have an FIC index of <1. The following concentrations were tested:
[0000]
Concentration
Concentration PHMB
Combination
EDTA(Na 4 ) (wt %)
(PPM)
0.5 MIC + 0.5 MIC
0.0156
0.625
0.4 MIC + 0.4 MIC
0.0125
0.5
0.35 MIC + 0.35 MIC
0.01093
0.4375
0.3 MIC + 0.3 MIC
0.0093
0.375
0.25 MIC + 0.25 MIC
0.00781
0.3125
0.125 MIC + 0.125 MIC
0.0039
0.15625
[0119] Fraction Inhibitory Concentration (FIC) is defined as the MIC of the compound in combination divided by the MIC of the compound alone. If the FIC index is <0.5, the combination is interpreted to be synergistic; <1 but >0.5—as partially synergistic; =1 as additive; >1 but <4 as indifferent; and ≧4 as antagonistic. In order to calculate the FIC index the following calculations are performed for compounds A and B:
FIC-A=(MIC of A in combination)/(MIC of A alone) FIC-B=(MIC of B in combination)/(MIC of B alone) FIC-combination=FIC-A+FIC-B
[0123] The MIC-PHMB (MIC of PHMB in combination with EDTA(Na 4 )), a minimum concentration of PHMB, while in combination with EDTA(Na 4 ), that inhibited the growth of S. aureus in MHB was found. In order to determine the MIC-EDTA(Na 4 ) (MIC of EDTA(Na 4 ) in combination with PHMB ), a minimum concentration of EDTA(Na 4 ), while in combination with PHMB, that inhibited the growth of S. aureus in MHB was found. See FIG. 2 , 6 and 9 for results.
[0124] Thus, the FIC-PHMB is 0.4. The FIC-EDTA(Na 4 ) is 0.4. Thus, the FIC-combination is 0.4+0.4, which equals 0.80. See FIG. 9 for results. Accordingly, the combination of PHMB and EDTA(Na 4 ) unexpectedly has partial synergistic results. That is, embodiments of the combination of PHMB and EDTA(Na 4 ) provides results that are, unexpectedly, greater than the total effects of each agent operating by itself.
[0000] Checkerboard Titration Experiment— P. aeruginosa
[0125] The Checkerboard Titration method was used to assess the interactions between EDTA(Na 4 ) and PHMB. The Checkerboard Titration method is a frequently used technique where, for example, each agent (EDTA(Na 4 ) and PHMB) was tested at multiple dilutions lower than the MIC. During this experiment, EDTA(Na 4 ) and PHMB were tested in the combinations to assess if the combinations have an FIC index of <1. The following concentrations were tested:
[0000]
Concentration
Concentration PHMB
Combination
EDTA(Na 4 ) (wt %)
(PPM)
0.5 MIC + 0.5 MIC
0.125
2.5
0.4 MIC + 0.4 MIC
0.1
2
0.35 MIC + 0.35 MIC
0.0875
1.75
0.3 MIC + 0.3 MIC
0.075
1.5
0.25 MIC + 0.25 MIC
0.0625
1.25
0.125 MIC + 0.125 MIC
0.03125
0.625
[0126] The FIC-PHMB is 0.25. The FIC-EDTA(Na 4 ) is 0.25. Thus, the FIC-combination is 0.25+0.25, which equals 0.5. See FIG. 10 for results. Accordingly, the combination of PHMB and EDTA(Na 4 ) unexpectedly has full synergistic results. That is, embodiments of the combination of PHMB and EDTA(Na 4 ) provides results that are, unexpectedly, greater than the total effects of each agent operating by itself.
[0000] Checkerboard Titration Experiment— C. albicans
[0127] The Checkerboard Titration method was used to assess the interactions between EDTA(Na 4 ) and PHMB. The Checkerboard Titration method is a frequently used technique where, for example, each agent (EDTA(Na 4 ) and PHMB) was tested at multiple dilutions lower than the MIC. During this experiment, EDTA(Na 4 ) and PHMB were tested in the combinations to assess if the combinations have an FIC index of <1. The following concentrations were tested:
[0000]
Concentration
Concentration PHMB
Combination
EDTA(Na 4 ) (wt %)
(PPM)
0.5 MIC + 0.5 MIC
0.0156
0.625
0.4 MIC + 0.4 MIC
0.0125
0.500
0.35 MIC + 0.35 MIC
0.0109
0.438
0.3 MIC + 0.3 MIC
0.0090
0.375
0.25 MIC + 0.25 MIC
0.0078
0.313
0.125 MIC + 0.125 MIC
0.0039
0.156
[0128] The FIC-PHMB is 0.3. The FIC-EDTA(Na 4 ) is 0.3. Thus, the FIC-combination is 0.3+0.3, which equals 0.6. See FIG. 11 for results. Accordingly, the combination of PHMB and EDTA(Na 4 ) unexpectedly has partial synergistic results for C. albicans. That is, embodiments of the combination of PHMB and EDTA(Na 4 ) provides results that are, unexpectedly, greater than the total effects of each agent operating by itself.
[0000] Rate Kill Assay— S. aureus
[0129] As discussed above, EDTA(Na 4 ) has a MIC of <0.03% (w/v) for S. aureus and PHMB has a MIC of <1.25 PPM for S. aureus. Accordingly, the following solutions were prepared:
[0000] Composition Concentration MIC EDTA(Na 4 ) 0.015 wt % 0.5 PHMB 0.625 PPM 0.5 EDTA(Na 4 ) 0.007 wt % 0.25 PHMB 0.31 PPM 0.25 EDTA(Na 4 ) + PHMB 0.015 wt % + 0.625 PPM 0.5 + 0.5 EDTA(Na 4 ) + PHMB 0.007 wt % + 0.31 PPM 0.25 + 0.25
Each solution was then combined with S. aureus and the log recovery of the S. aureus was measured initially, after 0 hour, 1 hour, 2 hours, 3 hours and 24 hours. The difference in log recovery for the 0.5 MIC concentrations and for the 0.25 MIC concentrations is shown in FIG. 12 . The data shows that EDTA(Na 4 ) and PHMB solutions are synergistic. That is, embodiments of the combination of EDTA(Na 4 ) and PHMB provides results that are, unexpectedly, greater than the total effects of each agent operating by itself.
Rate Kill Assay— P. aeruginosa
[0130] As discussed above, EDTA(Na 4 ) has a MIC of <0.25% (w/v) for P. aeruginosa, and PHMB has a MIC of <5 PPM for P. aeruginosa. Accordingly, the following solutions were prepared:
[0000] Composition Concentration MIC EDTA(Na 4 ) 0.125 wt % 0.5 PHMB 2.5 PPM 0.5 EDTA(Na 4 ) 0.0625 wt % 0.25 PHMB 1.25 PPM 0.25 EDTA(Na 4 ) + 0.125 wt % + 2.5 PPM 0.5 + 0.5 PHMB EDTA(Na 4 ) + 0.0625 wt % + 1.25 PPM 0.25 + 0.25 PHMB
Each solution was then combined with P. aeruginosa and the log recovery of the P. aeruginosa was measured initially, after 0 hour, 1 hour, 2 hours, 3 hours and 24 hours. The difference in log recovery for the 0.5 MIC concentrations and for the 0.25 MIC concentrations is shown in FIG. 13 . The data shows that EDTA(Na 4 ) and PHMB solutions are synergistic. That is, embodiments of the combination of EDTA(Na 4 ) and PHMB provides results that are, unexpectedly, greater than the total effects of each agent operating by itself.
Rate Kill Assay— C. albicans
[0131] As discussed above, EDTA(Na 4 ) has a MIC of <0.3125% (w/v) for C. albicans, and PHMB has a MIC of <1.25 PPM for C. albicans. Accordingly, the following solutions were prepared:
[0000] Composition Concentration MIC EDTA(Na 4 ) 0.007 wt % 0.25 PHMB 0.31 PPM 0.25 EDTA(Na 4 ) 0.0035 wt % 0.125 PHMB 0.15 PPM 0.125 EDTA(Na 4 ) 0.00525 wt % 0.1875 PHMB 0.2325 PPM 0.1875 EDTA(Na 4 ) + PHMB 0.007 wt % + 0.31 PPM 0.25 + 0.25 EDTA(Na 4 ) + PHMB 0.0035 wt % + 0.15 PPM 0.125 + 0.125 EDTA(Na 4 ) + PHMB 0.00525 wt % + 0.2325 PPM 0.1875 + 0.1875
Each solution was then combined with C. albicans and the log recovery of the C. albicans was measured initially, after 0 hour, 1 hour, 2 hours, 3 hours and 24 hours. The difference in log recovery for the solutions is shown in FIG. 14 . The data does not show that EDTA(Na 4 ) and PHMB solutions are synergistic. However, the data suggests the combination is very effective against C. ablicans with PHMB being the dominant component.
[0132] The synergistic effect (via rate kill assay and checkerboard titration for P. aeruginosa ), partial synergistic effect (via checkerboard titration for S. Aureus and C. Albicans ), and synergistic effect (via rate kill assay for S. Aureus ) provides significant, practical advantages for uses of embodiments of the combination of PHMB and EDTA salt(s). Thus, embodiments of the present invention should prevent the overuse of broad-spectrum antibiotics and continued unnecessary catheter removal and replacement procedures.
pH Experiments
[0133] Further experiments were conducted to measure the effects of pH on PHMB and EDTA formulations. In order to determine MIC (minimum inhibitory concentration) and MBC (minimum bactericidal concentration) a National Committee on Clinical Laboratory Standards (NCCLS) micro-dilution procedure was followed. According to the procedure each formulation must be exposed to 6 log concentration of organism or the highest achievable concentration. In the current protocol 100 μL of MHB was mixed with 90 μL of formulation and 10 μL of log 8 organism or the highest achievable concentration. The concentration of the formulation was adjusted to obtain the required concentration in the final solution. The mixture was incubated at 37 degree C. for 16-24 hrs. After 16-24 hours the absorbance value was read at 600 nm. The obtained data was corrected by subtracting the appropriate blanks. Finally, the wells having an absorbance >0.1 were marked + and <0.1 were marked −. The +symbol indicated growth while −symbol indicates no growth. The positive growth controls must have a corrective absorbance value of >0.5 and negative controls must have a corrected absorbance value of <0.1. In cases where the positive growth controls corrected absorbance is lower than 0.5, an alternate rule is utilized which is “absorbance<than 20% of positive growth control is marked as −growth, while absorbance≧than 20% of positive growth control is marked as +growth”. pH was adjusted to the stated value using NaOH or HCl.
[0134] Staphylococcus aureus (Organism #25923), Pseudomonas aeruginosa (Organism #27853), and Candida Albicans (Organism #10231) was obtained from ATCC. PHMB was used (Avecia, Lot #1L15-038). EDTA, tetrasodium salt hydrate, was used (Alfa Aesar, Catalogue #A17385, Lot #J9570A). A 20 PPM PHMB solution in water was prepared at a pH of 7. A 8 wt % EDTA solution in water was prepared at a pH of 7. These solutions were then serially diluted as necessary to obtain the required concentrations. The MIC and MBC concentrations of PHMB and EDTA at a pH of 7 was found for each of S. aureus, P. aeruginosa, and C. albicans. See FIGS. 15-20 for results.
[0135] Based on the above, a further experiment conducted was a screening experiment using checkerboard titration to assess if the combinations at a pH of 7 fall within a range having an FIC index value of ≦1. The method used was a NCCLS micro-dilution procedure. The results of this experiment are shown in FIGS. 21-23 . Based on the results the FIC index for PHMB and EDTA at a pH of 7 is 0.6 for S. aureus, 0.5 for P. aeruginosa and greater than 1 for C. albicans.
Anticoagulant Experiments
[0136] Experiments were conducted to assess the anticoagulant capacities of PHMB, EDTA and combinations of PHMB and EDTA via a Prothrombin Time (PT) Assay. A PT assay (TM-4339-063) was conducted using a Coagulation Analyzer to obtain PT instead of manually recording the PT.
[0137] Tetrasodium EDTA (TEDTA) was used (Alfa Aesar, Catalog #A17385, Lot #J9570A). PHMB was used (Arch Biocides, Catalogue #84312, Lot #1L15-038). TriniCHECK 1 (Normal Control) was used (Trinity Biotech). TriniCHECK 2 (Abnormal Control) was used (Trinity Biotech). A KC4 Amelung Coagulizer was used (Trinity Biotech).
[0138] FIG. 24 shows the results (raw data) of the PT assay. The concentrations stated in the concentration column are the final concentrations of the reagents. TriniCHECK 1 is a normal control that provides the PT time in the range of what a normal blood sample would take to coagulate. TriniCHECK 2 is an abnormal control that provides the PT time above the range of what a normal blood sample would take to coagulate. INR (International Normalized Ratio) is a system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation (clotting) tests. INR is calculated as:
[0000] INR =( PT test sample /PT normal control ) ISI
[0000] ISI (International Sensitivity Index) indicates the sensitivity of individual thromboplastin. The value of ISI utilized herein was 1.89.
[0139] FIG. 25 shows the results (processed data) of the PT assay. All the PTs greater than 3×the TriniCHECK 1 (normal control) were replaced with 32 seconds. This was done for the following reasons: Instrument used does not provide reproducible readings at PTs greater than 45 seconds; PTs greater than 3×the normal control results in INR greater than 6 if the ISI is 1.89. Any INR value higher than 5.5 indicates very high anticoagulant capacity and any higher value is of very little or no clinical significance; and for better assessment of data.
[0140] FIG. 26 shows the graph of the International Normalized Ratio (INR) for TEDTA from a Prothrombin Time (PT) Assay. From FIG. 26 it is evident that (within the tested range) that at a concentration of TEDTA of 4 wt %, the INR is greater than 7.25.
[0141] FIG. 27 shows the graph of the International Normalized Ratio (INR) for PHMB from a Prothrombin Time (PT) Assay. From FIGS. 24 , 25 & 27 is it evident that (within the tested range) than an increase in concentration of PHMB results in no significant increase in INR.
[0142] FIG. 28 shows the graph of the International Normalized Ratio (INR) for combined TEDTA and PHMB formulations from a Prothrombin Time (PT) Assay. From FIG. 28 , and comparing results from FIGS. 26 and 27 , it is evident that (within the tested range) that the addition of PHMB does not significantly promote or enhance the anticoagulant activity of TEDTA, but also does not negatively affect the anticoagulant activity of TEDTA. Accordingly, TEDTA (4 wt %) mixed with PHMB at 50, 75 or 100 ppm provides very good anticoagulant activity.
[0143] From the foregoing, it should be clear that the present disclosure may be embodied in forms other than those discussed above; the scope of the present disclosure should be determined by the following claims and not the detailed discussion presented above.
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Disinfectant compositions comprising PHMB and EDTA salt(s) are disclosed. The disinfectant compositions have also demonstrated activity as enhanced, fast acting catheter lock/flush solutions. They are safe for human and medical uses and may be used as prophylactic preparations to prevent infection, or to reduce the proliferation of and/or eliminate existing or established infections.
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PRIORITY
This application claims the priority date of the provisional application entitled EKG Recording Accessory System (EKG RAS) filed by Alireza Nazeri on Mar. 4, 2003, with serial No. 60/452,483, the disclosure of which is incorporated herein.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally relates to an EKG contact electrode pad, and more particularly relates to EKG contact pads with temperature sensors, sizing selection, and placing means.
2. Background Information
Electrocardiography (EKG, ECG) is a medical test for recording the electrical activity of the heart. In the standard twelve lead EKG there are twelve (12) different wires that carry electrical signals from the area of the body to which they are attached. Certain leads are attached to the person's chest in six standard areas. These are known as precordial leads. Four of the twelve leads are the four limb electrodes: right wrist, left wrist, right ankle and left ankle. In some cases, the placing of two extra lead electrodes in the right side of the patient's chest allows the possibility to record the EKG of the right heart. The limb leads are designated RL, RF, LL, and LF, and attach respectively to the two ankles and the two wrists of the patient. The precordial leads are designated as V1, V2, V3, V4, V5, and V6, and the leads for the right side of the heart are designated VR1 and VR2. The limb leads can be placed in an “adjusted” position, rather than on the extremities. The adjusted position for the limb leads are on the torso of the patient.
From the time of the invention of EKG to present usage, each electrode is generally connected separately to the EKG recorder by wire. This means that, for the routine twelve lead EKG, we need at least ten (10) separate electrodes attached to standard anatomical positions and ten (10) wires that go separately to the EKG machine. In the configurations including the right heart EKG, they will become twelve (12) separate electrodes. These standard electrode placements can also be used for electrodes for an external pacemaker, a defibrillation device, and for real time heart monitoring of the patients in critical care units.
The results of the EKG will be printed as a graph on standard paper or shown on the monitor. EKG is the most commonly used diagnostic test in medicine for evaluating the function of the heart. Reading the EKG is very important in patient management, as the difference between a normal and an abnormal reading can be measured in millimeters on the chart. Correct placement of electrodes in the standard positions, attachment to the skin, perfect conductivity, and the least artifacts as possible in the recording are the keys in the repeatability, accuracy, and reliability of this procedure. For the best performance, a skilled physician or technician should place the electrodes. With the currently available methods of electrode placement, there can be significant errors produced in the EKG recordings. For example, one person may place the electrodes in a different position than another person, and the same person can place them in another position at a different time. Even if placed predictability, it could be placed in a wrong anatomical position.
Thus, in the conventional placement of the electrodes, the repeatability, accuracy, and reliability of the data are suspect, especially in emergency situations when procedures are carried out rapidly and in difficult situations.
Therefore, what is needed are repeatability, consistency, and accuracy in the placement of electrodes for an EKG recording on the same patient with different users, or on different patients by the same user.
Additional objects, advantages, and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims
SUMMARY OF THE INVENTION
These objects, as well as others, are accomplished by the EKG pad of the invention. The repeatability is provided by an array of electrodes that are mounted in a disposable precordial pad. The precordial pad of the invention has an array of EKG electrodes and a temperature sensor distributed on a flexible, multi-layer material. The flexible material forms a pad body, which has an outer surface and a body surface. The body surface of the precordial pad body includes an adhesive layer, which stabilizes the pad on a person's torso and ensures that the readings are taken during a test from one, and only one, position on the patient's chest. The adhesive layer of the precordial pad is covered until it is ready for use. The precordial pad is covered by an adhesive cover, which is stripped off to expose the adhesive surface when the pad is ready to be used. The body surface also includes conductive electrodes and a temperature sensor, which will contact the patient's skin.
The pad also has a middle layer, which is the main circuit layer. The circuit layer includes a printed circuit that collects all data from all applicable electrodes, sensors, and attachments of the pad and brings them to the one area on the outer surface of the pad. The circuit layer is designed and made to be capable of tolerating higher voltages that may be used for defibrillation. The printed circuit can be made of copper, conductive ink, or other electrically conductive material.
The outer surface pad also includes a signal export area. This is where the data-transmitting module attaches to the pad and carries all of the signals from one point to the EKG machine. The signal export module can be a wireless transmitter that transmits data from the precordial pad to the EKG machine via the system adaptor. The module is also capable of transmitting data via a conventional wiring harness, as single cable includes a bundle of wires leaving the main precordial pad to a designed universal adaptor of the invention, which is connected to an EKG machine.
The invention is also a system for taking the EKG of a patient, which has a capability of performing defibrillation, external pacing, and monitoring the patient's heart at the same time and with the same precordial pad. The system includes a disposable EKG precordial pad as described above, as well as some additional components. The additional components include a measuring device, which is used to measure the size of the patient's test area such as his chest or torso. Depending on the size of the patient's test area, a size of precordial pad is selected based on the testing system of the invention. For instance, sizes 1, 2, 3, and 4 may be available for various sizes of patients. Sizing can also include consideration for gender, as pads for males are likely to be larger than those for females. Pad sizes can also be designated as Small, Medium, Large, Extra Large, etc. Other designations are obviously possible and would be related to an indication on the measuring device of the invention. The correct size of the pad can also be determined based on the patient's gender and shirt size.
The system includes a positioning device, which can be used to measure a patient for pad size, as well as aid the caregiver in positioning a pad correctly on a patient. The positioning device of the system is used with the well-known anatomical marker on the human chest called the Supra Sternal Notch. By placing a curved edge of the positioning device on the patient's supra sternal notch, the precordial pad can be placed accurately and consistently in the anatomically correct position, with the electrodes thus placed correctly. This feature allows non-professional users to place the EKG electrodes on themselves with high accuracy. This has not been possible with EKG electrodes in the prior art.
The pad is also composed of materials to be translucent to the X-Ray so patients can wear the pad while they are being x-rayed. The pad is also designed and composed of materials to be water resistant and waterproof. The pad is also from biocompatible material to make the least allergic reaction for the patients. The pad may also be worn while the patient is getting an MRI.
The Signal Export Module is another part of this system. This has an interface for connection to the signal export area of the pad. The signal export module receives signals from the related electrodes and sensors. It can include a connection site for connection of a single cable, which can be used to transmit the data to the universal adaptor. The cable can be regular wire or fiber optic. The module also can contain a micro-transmitter to transmit data wirelessly to the universal adaptor. This will have the benefit of wireless transmission and can utilize bluetooth, infrared, wi-fi, or other wireless technologies. One way to select between wireless and wired transmission is to activate the wireless mode, unless a cable is connected to the module. It would typically have a rechargeable long life lithium battery, or another suitable battery type. The signal export module can also have a data recognition sensor to sense the EKG signals and send an alarm if the patient has certain preprogrammed changes in his or her EKG, such as arrhythmias. The wireless feature of the pad allows the patient to wear the pad, put the module on wireless mode, and be able to move around, go to the bathroom, go to the lunchroom, move in a wheelchair, etc. The pattern recognition ability of the system will automatically send an alarm signal if an abnormal event happens.
The Universal Adaptor/Receiver is another part of the invention. Its features will include compatibility with all of the current or future EKG recorders in the market. It includes an input site for the wires from the recorder and a site for connection of the wires from the pad and limb electrodes. This part will be used for the wire transmission of data from the pad to the EKG machine. The adaptor/receiver also contains a receiver for receiving data wirelessly from the micro-transmitter and transferring them to the recorder. It also includes a digital display to show body temperature. A switch will allow the adaptor/receiver to select wire or wireless transmission mode, and to change output to the selected format for the EKG machine in use, or for a defibrillator, external heart pacing system, or for real time monitoring.
The pad is disposable so that it will be used for only one patient. This will limit the risk of transmitting skin disorders from one person to another, which is a concern in the currently available method.
An important feature of the pad is that the electrodes embedded in the pad extend from the pad surface for better contact. Rather than being flush with the pad, the electrode layer of the pad includes a device that causes the electrodes to extend away from the pad by two to five millimeters. The electrode-extending device would also exert a small amount of pressure so that when the pad is attached to the patient's chest, the extended electrodes press harder against the patient's skin than they would otherwise. The electrode extension device can be some type of biased device, such as a coiled spring or some other type of spring. The electrode extension device can also be a biased member made of foam. The foam structure would be compressed under the electrode when the adhesive cover is applied. When the adhesive cover is removed, the compressed foam would force the electrode to extend out from the body surface of the pad by two to five millimeters or more, preferably.
A foam pad or other biased device would also apply the correct pressure that would be transmitted to the electrode and thus, to the patient's skin. This will produce the highest quality contact and conductivity, which is directly related to the performance of the recording.
The body surface of the pad includes an adhesive layer made from biocompatible and non-allergic materials. This will be attached to the skin upon removal of the cover. Another feature of the invention is that the electrodes may be pre-coated with a transmitting gel, which would be sandwiched between the electrode and the cover of the adhesive layer. When the adhesive cover is removed, the transmitting gel would remain on the electrode contact surface and be available to improve the connection between the electrode and the patient's skin. All of these features result in a precordial pad that can improve the repeatability of test results, which can stabilize the pad during a particular test, which can read low temperatures and send that information to the EKG machine, and which facilitates rapid, accurate, and repeatable placement of the precordial pad of the invention. This pre-application of gel also eliminates a possible route of cross contamination.
The precordial pad of the invention also includes a temperature sensor built into the pad body. The temperature sensor measures a low range of body temperatures. It is when a patient's body temperature is in a low range that the electrical pattern of the heart will be affected. Knowing this factor in the recording is key to distinguishing the pattern of a normal from an abnormal EKG, as an EKG taken from a patient who is at a below normal temperature will have altered the readings. If that EKG is reviewed at a later time, a full interpretation of the EKG readings would not be possible without knowledge of the patient's temperature at the time the reading was taken. For that reason, a temperature sensor is built into the pad body. The temperature sensor would also be linked to the data-transmitting module, and sent to the EKG machine for recording with other data.
The micro-transmitter for the limb electrodes uses the same technology for the four electrodes of the limb leads. This can be associated with each single electrode for wireless transmission, if applicable.
Added features of the precordial pad of the invention are connection points to the four limb electrodes. These sensing sites are on the four limb of the patient, including the right arm, left arm, the right ankle, and the left ankle, or their adjusted positions on the chest of the patient. The designed sets of limb electrodes of this invention are also capable of attachment on the chest, rather than on the limb, to simplify the installation of electrodes for EKG test if the user chooses. The pad body of the invention would include sites to allow electrodes from the four limb to connect to the pad body and be routed with the information from the other electrodes of the pad body to the EKG machine.
Further, the purpose of the foregoing abstract is to enable the United States Patent and Trademark Office and the public generally, and especially the scientists, engineers, and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measure by the claims, nor is it intended to be limiting as to the scope of the invention in any way.
Still other objects and advantages of the present invention will become readily apparent to those skilled in this art from the following detailed description, wherein I have shown and described only the preferred embodiment of the invention, simply by way of illustration of the best mode contemplated by carrying out my invention. As will be realized, the invention is capable of modifications in various obvious respects all without departing from the invention. Accordingly, the drawings and description of the preferred embodiment are to be regarded as illustrative in nature, and not as restrictive in nature.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view of the surface of the precordial pad, which would face away from the patient.
FIG. 2 is a view of the circuit layer of the precordial pad, with detachable limb leads.
FIG. 3 is a view of the circuit layer of the precordial pad with detachable limb leads in the attached position.
FIG. 4 is a view of the precordial pad with limb leads attached, showing the surface which contacts the patient.
FIG. 5 is a view of the precordial pad that does not have limb leads, showing the side which contacts the patient.
FIG. 6 is a view of the attachable limb leads.
FIG. 7 is a view of a positioning device detached from the pad.
FIG. 8 is a view of the electrodes in closed and opened positions.
FIG. 9 shows various configurations of the universal adaptor.
FIG. 10 shows internal structure of the universal adaptor.
FIG. 11 is a view of the data transmitting module.
FIG. 12 shows the pad of the invention with optional attachment to an EKG machine and selected non-EKG devices.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
While the invention is susceptible of various modifications and alternative constructions, certain illustrated embodiments thereof have been shown in the drawings and will be described below in detail. It should be understood, however, that there is no intention to limit the invention to the specific form disclosed, but, on the contrary, the invention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined in the claims.
While there is shown and described the present preferred embodiment of the invention, it is to be distinctly understood that this invention is not limited thereto but may be variously embodied to practice within the scope of the following claims.
Several preferred embodiments of the invention are shown in FIGS. 1-12 . FIG. 1 shows a disposal EKG precordial pad of the invention, which is designated as 10 . This embodiment of the invention includes a pad body 12 , which includes a sliding site for module attachment 14 and a temperature window 16 . The pad body includes an outer surface 18 and a body surface 20 . FIG. 1 is a view of the outer surface, with the body surface 20 being located on the opposite side of this view of the pad body 12 . In this view of the precordial pad body 10 , the embedded electrodes are not visible. A data-transmitting module 22 interfaces with the sliding site for module attachment 14 . This will be discussed further in other figures. A temperature sensor 24 is also present in the device, with data from the temperature sensor 24 being displayed in the temperature window 16 . The precordial pad 10 includes a positioning extension 26 . In the embodiment shown in FIG. 1 , the position extension 26 is attached to the pad body 12 . Other embodiments of the device could include a positioning extension 26 which is detachable or not attached at all, to the pad body 12 .
A doctor, technician or any professional or non-professional user uses the positioning extension 26 on a patient to determine the correct placement of the precoridal pad 10 . The positioning extension 26 includes a supra sternal notch 28 . The supra sternal notch 28 is meant to be placed adjacent the manubrium, which is the bone adjacent to the jugular notch directly above the ribcage and at a patient's throat. By placing the supra sternal notch 28 of the precordial pad 10 adjacent the jugular notch of the patient, the electrodes of the precordial pad are assured of being placed in the proper anatomical position on a patient. Also included in the precordial pad 10 , shown in FIG. 1 , is an upper right limb lead 30 . Although this is on the left hand side of FIG. 1 , it would be associated with the patient's right side. Also, in the embodiment in FIG. 1 is a lower right limb lead 32 , an upper left limb lead 34 , and a lower left limb lead 36 .
Shown in FIG. 2 is another favored embodiment of the invention. In this embodiment, the limb leads are available as attachments to the pad body 12 . This embodiment includes a right limb lead assembly 38 and a left limb lead assembly 40 . The embodiment shown in FIG. 2 shows the circuit layer 42 of the pad body 12 . In the circuit layer 42 , the electrical connections which are associated with each electrode are visible. The electrodes include an upper right limb lead connection 44 and a lower right limb lead connection 46 , to which the upper right limb lead 30 and the lower right limb lead 32 are connected when the right limb lead assembly 38 is attached to the pad body 12 . The electrical connections would be sufficient to carry higher voltages if to be used with a defibrillation option. In such a case, only certain predetermined electrodes would be used for defibrillation.
Similarly, an upper left limb lead connection 48 is provided, as well as a lower left limb lead connection 50 . These are provided so that a connection can be made with the upper left limb lead 34 and the lower left limb lead 36 , which are part of the left limb lead assembly 40 . These limb lead assemblies 38 and 40 can optionally be snapped into place, or the pad body may be used without limb leads. Electrode 52 is the V1 electrode, electrode 54 is the V2 electrode, the electrode 56 is the V3 electrode, electrode 58 is the V4 electrode, electrode 60 is the V5 electrode, and electrode 62 is the V6 electrode. The positions of these electrodes, V1 through V6, correspond to known electrode geometries and provide an accurate EKG reading when positioned on the patient's body correctly.
As in FIG. 1 , the embodiment of FIG. 2 includes a positioning extension 26 . As can be seen in FIG. 2 , electrical connection between each of the electrodes is made with the module attachment site 14 . A data-transmitting module 22 , not shown in FIG. 2 , is utilized to transmit the data from each of the electrodes to the EKG machine. Electrode 64 is provided to obtain a temperature reading, which is conveyed to the site for module attachment 14 and to the data-transmitting module 22 .
FIG. 3 shows the right limb lead assembly 38 and the left limb lead assembly 40 attached in place on the pad body 12 , showing the circuit layer 42 and the temperature sensor 24 .
The embodiment shown in FIG. 4 is the same as that in FIG. 3 . However, what is shown is the body surface of the pad body, also called the body surface layer. This is the view of the device, as it would contact the patient's body. The electrodes 52 , 54 , 56 , 58 , 60 , 62 , and 64 are shown. They are connected by the electrical connection shown in FIG. 3 , which is not visible in this view. The right and left limb lead assemblies 38 and 40 are shown in their attached configuration, attached to the connections 44 , 46 , 48 , and 50 . Shown around each electrode is a zone of adhesive material. Adhesive material may also optionally be placed on the pad body 12 in various locations.
FIG. 5 is a view of the second surface 20 of the pad body, the surface which contacts the patient's skin. This version of the device does not have the right or left limb lead assembly, and shows an optional configuration of the precordial pad 10 .
FIG. 6 shows view of the right limb lead assembly 38 and the left limb lead assembly 40 , which may be optionally used with the versions of the precordial pad 10 which are shown in FIGS. 2-4 . FIG. 7 shows the positioning extension 26 which can be detachable from, or used as a separate piece with the precordial pad 10 .
FIG. 8 shows a cross-sectional and enlarged view of an electrode 72 in the precordial pad. Also shown, are the first surface of the pad body 18 and the second surface of the pad body 20 . The second surface of the pad body 20 would be positioned against the skin of the patient. Between the electrode 72 and the first surface 18 , is a biased member 74 . The biased member 74 is a device which is stored under some degree of compression and, when released, expands and causes the electrodes 72 to move away from the first surface 18 . The biased member 74 can be a spring, such as a coil spring, or it can be a compressible substance such as foam. When released, either the spring or the foam would expand and cause the electrode 72 to move away from the first surface 18 . On the electrode 72 , the surface opposite the biased member 74 is a conductive gel 76 . The conductive gel 76 is added to the surface of the electrode 72 during manufacture. On the second surface 20 a layer of adhesive 68 is located. A cover layer 78 covers the adhesive 68 . When the cover layer 78 is removed, as shown in the lower corner of FIG. 8 , the biased member 74 expands and pushes the electrode 72 away from the first surface 18 . Removal of the cover layer 78 exposes the adhesive surface 68 and the gel 76 .
FIG. 9 shows a number of configurations by which the EKG system of the invention would transmit information to any EKG machine. Shown in FIG. 9 is the universal adaptor/receiver of the accessory system. The universal adaptor/receiver is numbered 66 . The universal adaptor can take several configurations, which are shown in FIG. 9 . In the upper left corner of FIG. 9 is an example of the adaptor/receiver 66 of the invention configured for wireless reception of information from electrodes from the precordial pad. It is also configured for hardwired input of data from the limb electrodes. Shown on the adaptor/receiver 66 is a temperature window 70 , which is a separate window from the temperature window 16 , which is located on the precordial pad. From the adaptor/receiver 66 , wires extend to the EKG machine. From the foregoing description, it will be apparent that various changes may be made without departing from the spirit and scope of the invention as defined by the following claims.
In the lower left corner of FIG. 9 is a depiction of a universal adaptor/receiver 66 of the invention, which is configured for hardwire transmission of data from the precordial pad and from the limb electrodes.
In the upper right corner of FIG. 9 is a depiction of the adaptor/receiver 66 , which is configured to receive wireless transmission from both the electrodes of the precordial pad and limb electrodes.
In the lower right corner of FIG. 9 is a universal adaptor/receiver 66 configured to receive hardwired information from the electrodes of the precordial pad and wireless data from the limb electrodes. Any of these configurations of the universal adaptor/receiver 66 of the invention are possible.
FIG. 10 is a view of some of the details of the universal adaptor/receiver 66 . Shown, are inputs for the four limb electrodes as well as inputs for the precordial cable. A wireless switch 80 is shown for switching the unit from wireless to wired operation. Also shown, is an antenna 82 for receiving a wireless signal from the precordial pad of the invention. The antenna 82 is connected to a receiver 84 that receives, processes, and transmits the information from the precordial pad to outlet jacks 86 . Outlet jacks 86 are available for connection to the EKG machine. This would typically be by a wired connection, but using wireless technology for this connection would also be possible. Thermometer window 70 is also shown.
FIG. 11 shows a system transmitting module, which has also been called the signal export device 22 . It has a first surface 86 and a second surface 88 . The second surface 88 includes contact points 90 which provide electrical connection with the electrodes or the precordial pad. The signal export device 22 connects to the precordial pad 10 by means of the sliding site for module attachment 14 . The signal export devices include sliding borders 92 , which allow it to slide into a positive engagement with the sliding site for module attachment 14 . Although brackets on the side of the unit are shown, attachment could be accomplished by a number of configurations, as are well known in the industry. This unit could be operated with a cable 94 or could operate by wireless transmission.
FIG. 12 shows a pad of the invention and possible connections with which it can be used. These include an EKG machine, a defibrillator, a real time heart monitoring system, and an external heart pacing machine.
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The invention is a precordial pad for positioning EKG electrodes on a patient for anatomically correct and repeatable placement. Data can be transmitted from the EKG pad of the invention by wire or wireless means. The pad includes a sizing aid, and a positioning device. The invention is also a system for obtaining and sending EKG data.
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BACKGROUND ART
Many improvements have been applied to this fishing rod art. After reviewing patents residing in this field, it has become apparent the present invention has solved many problems for the common fisherman. The principles that surround the prior arts are as follows: "The basic fishing rod balances mass, inertia and spring when casting. In theory the prime function of the common fishing rod is to bend or flex, and the ability to send a weight through the air is called recoil power. Recoil power has been defined as stiffness or moment of inertia, this united with proper weight distribution is referred to as the theory of rod function, having velocity the end product of casting. Velocity which you achieve through muscular impulse (acceleration) multiplied by the time of the cast. The action of the rod to a large extent determines the time factor (fast or slow). The action is controlled by the rods taper, thus the ideal rod is one that is harmonically sound and whose effective bending length is longest for the weight being propelled. This does not mean that long rods are better than short ones or light rods are better than heavy ones. It does mean that the slowest rod to reach any hypothetical maximum of recoil power is close to if not perfection". The present invention exaggerates common fishing rod dynamics by combining with simple mechanics. The present invention uses a short well balanced rod less its handle, this is then placed in a ferrule tipped cylindrical housing or appendage. The appendage having a means to mount and adjust a pulley. The pulley is to support an elastomer and/or cable and communicate with adjustable pulley or pulleys of a second appendage. This appendage being of a flexible variety. The first said cylindrical appendage is mounted on a rotating spool. The spool is provided with a means to set and adjust the limits of its clockwise rotation. The spool is placed on a fishing rod butt section by means of its axle, said rod butt section also supports the flexible appendage. Upon the muscular impulse of a crisp backcast, the spool rotates in a clockwise direction resulting in a pivoting motion of attached cylindrical appendage and rod blank; as the pulley supported elastomer and/or cable system is storing its energy, the spool's clockwise rotation is abruptly stopped and reversed by said means of adjusting and limiting the spool's clockwise rotation. This abrupt stopping and reversing action combined with the releasing of energies contained in the pulley systems, along with a means to abruptly arrest the spool's counter-clockwise rotation has induced an exaggeration in the bending length of the rod blank, resulting in an increase in the rods recoil power and velocity. The present invention is capable of a substantially longer cast than its conventional counterparts residing in the prior arts. The device, through use of its adjustments and options is capable of accommodating all fishing projectiles regardless of their varing weights.
SUMMARY OF THE INVENTION
It is a major objective of the present invention to provide the fisherman with a fishing rod which is capable of a substantial increase in the distance one may cast a common fishing projectile. This is important so as he may reach out to more aquatic feeding areas by covering a larger volume of water. A second major objective is to provide an option of two new energy storing modes, to be a part of and effectively unite the mechanics of the present invention with common fishing rod dynamics. It is a third and equally important objective to provide a totally adjustable rod, capable of various power altering arrangements to accommodate the varying weights of common fishing projectiles. Generally, the objectives of this invention are carried out by a fishing rod butt section, attached near its tip is a flexible appendage, said appendage extending outward from, and then parallel to a projected line of the rod butt section. This appendage is provided with a plurality of mounting holes to receive a means to attach and adjust a pulley or pulleys. Located at the extreme tip of the rod butt section is a hole provided to accommodate a pin. The pin serves as an axle for two rotating discs or spool. The spool is provided with a centered hole to accommodate said axle, and a plurality of holes allowing an option of pin placements to adjust and set the limits of the spool's clockwise rotation. The spool also has an insular hole to receive a pin to limit its counter-clockwise rotation. The spool includes a means to attach a cylindrical appendage. The cylindrical appendage has a narrow slot running through its top to bottom diameter to receive a pulley. By a means for attachment, said pulley is mounted through one of a number of openings placed along and through the side diameter of said cylindrical appendage. This provides options to the pulleys location along the appendage. The adjustable pulley of the cylindrical appendage is to communicate with the adjustable pulley or pulleys of the flexible appendage by means of an elastomer and/or cable, thereby providing an option of two energy storing modes. The cylindrical appendage has an opening at its tip, said opening serves as a sleeve type ferrule to accept interchangeable fast, medium or slow fishing rod blanks. Upon the muscular impulse of a crisp backcast, the spool rotates in a clockwise direction resulting in a pivoting motion of attached cylindrical appendage and rod blank; as the pulley supported elastomer and/or cable system is storing its energy, the spool's clockwise rotation is abruptly stopped and reversed by said means of adjusting and limiting the spool's clockwise rotation. This abrupt stopping and reversing action combined with the releasing of energies contained in the pulley systems, along with a means to abruptly arrest the spool's counter-clockwise rotation has induced an exaggeration in the effective bending length of the rod blank while adding time to the cast. This results in an increase in the rods recoil power and velocity. The present invention is capable of a substantially longer cast than its conventional counterparts residing in the prior arts. The device, through use of its adjustments and options is capable of accommodating all fishing projectiles regardless of their varing weights. These and other objects, features and advantages of the present invention will become more apparent in the following description of a preferred embodiment with reference to the accompanying drawings, in which
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of the major components comprising the invention. The device is in a disassembled state, with enlargements therein.
FIG. 2 is a plan view of the invention, including enlargements of components used in the cable or mode A system. The rod is shown in a relaxed and stressed state.
FIG. 3 is a plan view of the invention, illustrating enlargements of components used in the elastomer or mode B option. The rod is shown in a relaxed and stressed state.
BACKGROUND OF THE INVENTION
The present invention relates to an adjustable breakdown fishing rod, capable of a more efficient use of the energy applied to the act of casting common fishing projectiles, resulting in an increase in the distance these projectiles can obtain. The device unites common fishing rod dynamics with mechanical advantages of the present invention.
TECHNICAL FIELD
The technical field in which the present invention resides is believed to be of group art 325 and references to be cited may be found in class 43 and subclass 18.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
In reference to FIG. (1) in this a side view of the components, a fishing rod butt section denoted by numeral 1 having an end tapered and sized to receive the sleeve portion of a flexible appendage 2. The sleeve portion of the flexible appendage 2, firmly slides over and beyond the tip portion of the fishing rod butt section 1. Flexible appendage 2 having holes 3 and mounting pins 4 to place and adjust a pulley or pulleys 5. The pulley or pulleys 5 are provided with optional mounting holes 30 and 31 for said placement. The tip portion of fishing rod butt section 1 has an attached rubber pad 6, an indentation 7 and a hole 8. Hole 8 is placed through the side diameter of said rod butt section to accommodate a pin 9 serving as an axle and placed through a centered hole 10 in a pair of rotating discs or spool 11. The spool 11 supports a plurality of holes 12 to be chosen from to place a spool rotation adjustment pin 13. Pin 13 is placed to adjust and set the limits of the spool's clockwise rotation by making contact with said rubber pad 6, thereby abruptly stopping and reversing the spool's clockwise rotation. Spool 11 also has an insular hole 14 to receive a second rotational control pin 15 to communicate with said indentation 7 to abruptly limit the counter-clockwise rotation of spool 11. Two final holes 16 have been placed through spool 11 for accommodating two fasteners 17 for attachment of a cylindrical appendage 18. The cylindrical appendage 18 is provided with two holes 19 for said attachment. Cylindrical appendage 18 also having a number of openings 20 placed along and through its side diameter and a narrow continuous slot 21 running through its top to bottom diameter. A pulley 5 is placed through said slot 21 then positioned at a chosen side opening 20 and attached there by means of a mounting pin 4 placed through center axis pulley hole 30. This mounting system allows pulley 5 a degree of longitudinal freedom along cylindrical appendage 18. The cylindrical appendage 18 and its adjustable pulley 5 is to communicate with flexible appendage 2 and its adjustable pulley or pulleys 5 by means of varying types of interchangeable O-ring style elastomers 22 or a cable 23. Slotted ring 28 and rubber connector 29 serve as links to adjust the union of cable 23 and pulley 5 of said cylindrical appendage 18. The cylindrical appendage 18 has an opening in its tip end to serve as a sleeve type ferrule 24, said ferrule is capable of accepting interchangeable fast, medium and slow fishing rod blanks, denoted by numerals 25, 26 and 27 respectfully. FIG. (2) is a plan view of the optional use of the cable energy storing system, referred to as mode (A). Placed on flexible appendage 2 at optional mounting holes 3 are two pulleys 5, each pulley has a hole 30 placed at their center axis and a second hole 31 located approximately at half the measurement radius to the pulleys out-ward most curving edge. Using said pulley hole 31, pulleys 5 are attached at optional mounting holes 3 by means of mounting pins 4. Pulleys 5 are of a double grooved variety where as a small pulley wheel is molded to a larger pulley wheel. Cable 23 is used in conjunction with said pulleys 5 and is threaded as follows; beginning at pulley hole 31 and looped around mounting pin 4 and protected by bushings 32, cable 23 runs at a slight downward angle to the base or bottom of the small wheel of a second pulley 5, here the cable enters a channel 33 and runs through the interior of the pulley then exits at the top of the larger wheel of said pulley 5. The cable 23, while controlled by the groove of said larger wheel, runs counter-clockwise along the wheel's circumference to fully run its perimeter. Cable 23 then runs on a level line to the larger wheel of first said pulley 5, here the cable runs counter-clockwise along the larger wheel's circumference to fully run its perimeter. Cable 23 then enters channel 33 at the top of said larger wheel. The cable then runs through the interior of first said pulley 5 and exits at the base or bottom of the small wheel of said pulley 5. Cable 23 then runs at a slight angle upward to pulley hole 31 of second said pulley 5, here the cable is looped around mounting pin 4 and protected by bushings 32 to complete said threading. Placed through slot 21 of the cylindrical appendage 18 and positioned at a coordinating side opening of said appendage, a third pulley 5 is mounted through its center axis hole 30 by means of mounting pin 4. This pulley supports a rubber connector 29. The connector is placed on either the large or small wheel of pulley 5 providing an option to its functional length. A slotted ring 28 is to receive cable 23 and rubber connector 29 thus completing the union of the cylindrical appendage 18 and its adjustable pulley with the flexible appendage 2 and the adjustable pulleys therein. This mode A cable system is used when casting projectiles of considerable weight such as those used when fishing in and around salt water. The system functions as follows; Upon the muscular impulse of a crisp backcast, the spool 11 rotates in a clockwise direction resulting in a pivoting motion of attached cylindrical appendage 18 and rod blank 25. As the cylindrical appendage 18 and its attached pulley 5 apply pressure to cable 23, the pulleys 5 of flexible appendage 2, are forced to rotate in a pivoting motion on their offset axis, as the small wheel of each pulley collects cable material the larger wheels are releasing material of cable 23, resulting in an approximate 270 degree flop or pivotal rotation of each of the two pulleys 5 of the said flexible appendage. This allows a reduction in the tension of cable 23, thus allowing an increase in the rotational speed of spool 11. The clockwise rotation of spool 11 is then abruptly stopped and reversed by means of a rotational adjustment pin 13 making contact with rubber pad 6. This abrupt stopping and reversing action combined with the abrupt releasing of energies stored in the said pivot pulley system, along with a pin 15 making contact with indentation 7 to abruptly arrest the spool's counter-clockwise rotation has induced an exaggeration in the effective bending length of the rod blank while adding time to the cast. This results in an increase in the rods recoil power and velocity. The mode A system is one of two energy storing modes the fisherman may choose from to increase the distance one may cast common fishing projectiles.
FIG. (3) is a plan view of the optional use of the interchangeable elastomer energy storing system, referred to as mode (B). In this mode, a simple union of the cylindrical appendage 18 with the flexible appendage 2 has been accomplished by mounting two pulleys 5. One pulley is to be mounted on each appendage through the use of mounting pins 4 and center axis pulley holes 30. On the cylindrical appendage 18, a pulley 5 is placed through slot 21 then positioned and mounted at a chosen side opening 20. On the flexible appendage 2, a pulley 5 is mounted at a selected mounting hole 3. An elastomer has been chosen from interchangeable elastomers 22 and placed at either sized wheels of said pulleys 5 or any combination of pulley wheel sizes or elastomers therein. A fishing rod blank is chosen from optional fast, medium or slow varieties, and placed in the ferrule tip 24 of said cylindrical appendage 18. The system functions as follows; upon the muscular impulse of a crisp backcast, the spool 11 rotates in a clockwise direction resulting in a pivoting motion of attached cylindrical appendage 18 and its accompanying rod blank. As the pulley supported elastomer 22 is storing its energy, the spool's clockwise rotation is abruptly stopped and reversed by means of a rotational adjustment pin 13 making contact with rubber pad 6. This abrupt stopping and reversing action combined with the releasing of energies contained in the pulley elastomer system, along with a pin 15 engaging with indentation 7 to abruptly arrest the spool's counter-clockwise rotation, has induced an exaggeration in the effective bending length of the rod blank while adding time to the cast. This results in an increase in the rods recoil power and velocity. In both the mode A and mode B energy storing systems, adjustments may be made in the angle and location of applied energy by means of said various mounting holes and openings along the length of the cylindrical and flexible appendages. Various other power altering adjustments are found in the various sized wheels of a pulley 5, the size and elasticity specifications of elastomer or elastomers 22, the adjustable clockwise rotation pin 13 of spool 11 and a choice of fast, medium or slow fishing rod blanks, denoted by numerals 25, 26 and 27 respectfully. The present invention effectively unites common fishing rod dynamics with the mechanics of this device to provide a substantially longer cast of common fishing projectiles. This is accomplished by its increased power and further advandaged by said options and adjustments to accommodate varying weights of commonly used fishing projectiles. It should be known, the scope of this invention is not limited to the fishing rod types of the accompanying drawings.
The materials holding preference in the manufacturing of this, a lightweight innovative fishing rod include plastics or aluminum for the spool and pulleys. The appendages would benefit by use of a fiberglass or graphite material as would the rod blanks and the rod butt section. A nylon or an equivalent material would suit the needs of the fasteners, pins and axle.
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A device relating to a breakdown sport fishing rod, to better utilize the energy applied to casting a weight. The device having a fishing rod butt section supporting an adjustable rotating spool at its tip end. The spool has an attached cylindrical appendage capable of receiving interchangeable rod blanks. The appendage also adapted to support and provide adjustments for a pulley. The pulley communicating by means of elastomers and or cables with one or a pair of pulleys placed in a second adjustable environment on an additional appendage. This appendage is one of a flexible variety and supported by said rod butt section. The present invention induces an exaggeration of rod action, resulting in an increase in the rods recoil power and velocity, providing a longer cast of common fishing projectiles.
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This is a continuation of application(s) Ser. No. 08/ 790,050 filed on Jan. 28, 1997, now abandoned which is a continuation of application Ser. No. 08/390,446 filed on Feb. 17, 1995, abandoned.
FIELD OF THE INVENTION
The invention relates to systems and methods for pacing and mapping the heart for diagnosis and treatment of cardiac conditions.
BACKGROUND OF THE INVENTION
Normal sinus rhythm of the heart begins with the sinoatrial node (or "SA node") generating a depolarization wave front. The impulse causes adjacent myocardial tissue cells in the atria to depolarize, which in turn causes adjacent myocardial tissue cells to depolarize. The depolarization propagates across the atria, causing the atria to contract and empty blood from the atria into the ventricles. The impulse is next delivered via the atrioventricular node (or "AV node") and the bundle of HIS (or "HIS bundle") to myocardial tissue cells of the ventricles. The depolarization of these cells propagates across the ventricles, causing the ventricles to contract.
This conduction system results in the described, organized sequence of myocardial contraction leading to a normal heartbeat.
Sometimes aberrant conductive pathways develop in heart tissue, which disrupt the normal path of depolarization events. For example, anatomical obstacles in the atria or ventricles can disrupt the normal propagation of electrical impulses. These anatomical obstacles (called "conduction blocks") can cause the electrical impulse to degenerate into several circular wavelets that circulate about the obstacles. These wavelets, called "reentry circuits," disrupt the normal activation of the atria or ventricles. As a further example, localized regions of ischemic myocardial tissue may propagate depolarization events slower than normal myocardial tissue. The ischemic region, also called a "slow conduction zone," creates errant, circular propagation patterns, called "circus motion." The circus motion also disrupts the normal depolarization patterns, thereby disrupting the normal contraction of heart tissue.
The aberrant conductive pathways create abnormal, irregular, and sometimes life-threatening heart rhythms, called arrhythmias. An arrhythmia can take place in the atria, for example, as in atrial tachycardia (AT) or atrial flutter (AF). The arrhythmia can also take place in the ventricle, for example, as in ventricular tachycardia (VT).
In treating arrhythmias, it is essential that the location of the sources of the aberrant pathways (called arrhthymia substrate) be located. Once located, the tissue in the arrthymia substrate can be destroyed, or ablated, by heat, chemicals, or other means. Ablation can remove the aberrant conductive pathway, restoring normal myocardial contraction.
Today, physicians examine the propagation of electrical impulses in heart tissue to locate the arrhthymia substrate. The techniques used to analyze the substrate, commonly called "mapping," identify regions in the heart tissue, which can be ablated or otherwise altered, such as by injection of cells or genes, to treat the arrhythmia.
One form of conventional cardiac tissue mapping techniques uses multiple electrodes positioned in contact with epicardial heart tissue to obtain multiple electrograms. The physician stimulates myocardial tissue by introducing pacing signals and visually observes the morphologies of the electrograms recorded during pacing, which this Specification will refer to as "paced electrograms." The physician visually compares the patterns of paced electrograms to those previously recorded during an arrhythmia episode to locate tissue regions appropriate for ablation. These conventional mapping techniques require invasive open heart surgical techniques to position the electrodes on the epicardial surface of the heart.
Conventional epicardial electrogram processing techniques used for detecting local electrical events in heart tissue are often unable to interpret electrograms with multiple morphologies. Such electrograms are encountered, for example, when mapping a heart undergoing ventricular tachycardia (VT). For this and other reasons, consistently high correct foci identification rates (CIR) cannot be achieved with current multi-electrode mapping technologies.
Another form of conventional cardiac tissue mapping technique, called pace mapping, uses a roving electrode in a heart chamber for pacing the heart at various endocardial locations. In searching for the VT foci, the physician must visually compare all paced electrocardiograms (recorded by twelve lead body surface electrocardiograms (ECG's)) to those previously recorded during an induced VT. The physician must constantly relocate the roving electrode to a new location to systematically map the endocardium.
These techniques are complicated and time consuming. They require repeated manipulation and movement of the pacing electrodes. At the same time, they require the physician to visually assimilate and interpret the electrocardiograms.
There thus remains a real need for cardiac mapping and ablation systems and procedures that simplify and automate the analysis of electrograms and the use of electrograms to locate appropriate arrhythmogenic substrate.
SUMMARY OF THE INVENTION
A principal objective of the invention is to provide improved probes and methodologies to examine heart tissue morphology quickly and accurately.
The invention provides systems and methods for determining appropriate ablation sites by comparing electrograms obtained during an arrhythmia episode to those obtained during pacing and mapping.
One aspect of the invention provides an analog or digital processing element and associated method for analyzing electrograms. The element and method input a first number of electrogram samples over time during a cardiac event of known diagnosis, such as, for example, VT or AT. The element and method also input a second number of paced electrogram samples over time. The element and method cross-correlate the first number of event-specific electrogram samples with the second number of paced electrogram samples. The element and method generate an output based upon the cross-correlation. The output aids in identifying potentially appropriate tissue sites for ablation.
In a preferred embodiment, the element and method use an array of multiple electrodes supported within a heart chamber in operative association with a region of endocardial tissue. The element and method condition the electrode array to record at each electrode a first number of electrogram samples over time during the cardiac event of known diagnosis. The element also sequentially conditions different ones of the multiple electrodes on the array to emit a pacing signal and to record at each electrode on the array a second number of paced electrogram samples over time. In this implementation, the element and method individually cross-correlate, for each different one of the pacing signal-emitting electrodes, the first number of event-specific electrogram samples with the second number of paced electrogram samples. The element and method generate an output for each electrode on the array.
In a preferred embodiment, the output comprises a numerical set of cross-correlation functions.
Another aspect of the invention provides an analog or digital element and associated method for analyzing electrocardiograms. The element and associated method input a first number of electrocardiogram samples recorded over time during a cardiac event of known diagnosis using multiple body surface electrodes. The element and method also input a second number of paced electrocardiogram gram samples recorded over time using the multiple body surface electrodes. The element and method cross-correlate the first number of event-specific electrocardiogram samples with the second number of paced electrocardiogram samples and generate an output based upon the cross-correlation. The output aids in identifying site or sites potentially appropriate for ablation.
In a preferred embodiment, the output comprises a numerical cross-correlation function.
Other features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended Claims.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1A is a diagrammatic view of a system, which embodies the features of the invention, for accessing a targeted tissue region in the body for diagnostic or therapeutic purposes;
FIG. 1B is a diagrammatic view of the system shown in FIG. 1A, with the inclusion of a roving pacing probe and additional features to aid the physician in conducting diagnosis and therapeutic techniques according to the invention;
FIG. 2 is an enlarged perspective view of a multiple-electrode structure used in association with the system shown in FIG. 1;
FIG. 3 is an enlarged view of an ablation probe usable in association with the system shown in FIGS. 1A and 1B;
FIG. 4A is a diagrammatic view of the process controller shown in FIGS. 1A and 1B, which locates by electrogram matching a site appropriate for ablation;
FIG. 4B is a schematic view of a slow conduction zone in myocardial tissue and the circular propagation patterns (called circus motion) it creates;
FIG. 5 is a flow chart showing a cross correlation technique that the process controller shown in FIG. 4A can employ for cross-correlating electrograms according to the invention; and
FIGS. 6A and 6B and 6C are representative electrogram morphologies;
FIG. 7A is the result of cross-correlating the electrogram shown in FIG. 6A with the electrogram shown in FIG. 6B in accordance with the cross correlation coefficient technique shown in FIG. 5; and
FIG. 7B is the result of cross-correlating the electrogram shown in FIG. 6A with the electrogram shown in FIG. 6C in accordance with the cross correlation coefficient technique shown in FIG. 5.
The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIG. 1A shows the components of a system 10 for analyzing body tissue biopotential morphologies for diagnostic or therapeutic purposes. The illustrated embodiment shows the system 10 being used to examine the depolarization of heart tissue that is subject to an arrhythmia. In this embodiment, the system 10 serves to locate an arrhythmogenic substrate for removal by ablation. The invention is well suited for use in conducting electrical therapy of the heart.
Still, it should be appreciated that the invention is applicable for use in other regions of the body where tissue biopotential morphologies can be ascertained by analyzing electrical events in the tissue. For example, the various aspects of the invention have application in procedures for analyzing brain or neurologic tissue.
FIG. 1A shows the system 10 analyzing endocardial electrical events, using catheter-based, vascular access techniques. Still, many aspects of the invention can be used in association with techniques that do not require any intrusion into the body, like surface electrocardiograms or electroencephalograms. Many of the aspects of the invention also can be used with invasive surgical techniques, like in open chest or open heart surgery, or during brain surgery.
In particular, FIG. 1A shows the system 10 analyzing electrical events within a selected region 12 inside a human heart. FIGS. 1A and 1B generally show the system 10 deployed in the left ventricle of the heart. Of course, the system 10 can be deployed in other regions of the heart, too. It should also be noted that the heart shown in the FIG. 1 is not anatomically accurate. FIGS. 1A and 1B show the heart in diagrammatic form to demonstrate the features of the invention.
The system 10 includes a mapping probe 14 and an ablation probe 16. In FIG. 1A, each is separately introduced into the selected heart region 12 through a vein or artery (typically the femoral vein or artery) through suitable percutaneous access. Alternatively, the mapping probe 14 and ablation probe 16 can be assembled in an integrated structure for simultaneous introduction and deployment in the heart region 12.
Further details of the deployment and structures of the probes 14 and 16 are set forth in pending U.S. patent application Ser. No. 08/033,641, filed Mar. 16, 1993, entitled "Systems and Methods Using Guide Sheaths for Introducing, Deploying, and Stabilizing Cardiac Mapping and Ablation Probes."
The mapping probe 14 has a flexible catheter body 18. The distal end of the catheteribody 18 carries a three dimensional multiple-electrode structure 20. In the illustrated embodiment, the structure 20 takes the form of a basket defining an open interior space 22 (see FIG. 2). It should be appreciated that other three dimensional structures, or one dimensional or two dimensional arrays, could also be used.
As FIG. 2 shows, the illustrated basket structure 20 comprises a base member 26 and an end cap 28. Generally flexible splines 30 extend in a circumferentially spaced relationship between the base member 26 and the end cap 28.
The splines 30 are preferably made of a resilient, biologically inert material, like Nitinol metal or silicone rubber. The splines 30 are connected between the base member 26 and the end cap 28 in a resilient, pretensed, radially expanded condition, to bend and conform to the endocardial tissue surface they contact. In the illustrated embodiment (see FIG. 2), eight splines 30 form the basket structure 20. Additional or fewer splines 30 could be used.
The splines 30 carry an array of electrodes 24. In the illustrated embodiment, each spline 30 carries eight electrodes 24. Of course, additional or fewer electrodes 24 can be used. Similary, surface electrodes 24' also be used.
A slidable sheath 19 is movable along the axis of the catheter body 18 (shown by arrows in FIG. 2). Moving the sheath 19 forward causes it to move over the basket structure 20, collapsing it into a compact, low profile condition for introducing into the heart region 12. Moving the sheath 19 rearward frees the basket structure 20, allowing it to spring open and assume the pretensed, radially expanded position shown in FIG. 2. The electrodes are urged into contact against the surrounding heart tissue.
Further details of the basket structure are disclosed in pending U.S. patent application Ser. No. 08/206,414, filed Mar. 4, 1994, entitled "Multiple Electrode Support Structures."
In use, the electrodes 24 sense electrical events in myocardial tissue for the creation of electrograms. The electrodes 24 are electrically coupled to a process controller 32 (see FIG. 1A). A signal wire (not shown) is electrically coupled to each electrode 24. The wires extend through the body 18 of the probe 14 into a handle 21, in which they are coupled to an external multiple pin connector 23. The connector 23 electrically couples the electrodes to the process controller 32.
Alternatively, multiple electrode structures can be located epicardially using a set of catheters individually introduced through the coronary vasculature (e.g., retrograde through the aorta or coronary sinus), as disclosed in PCT/US94/01055 entitled "Multiple Intravascular Sensing Devices for Electrical Activity."
The ablation probe 16 (see FIG. 3) includes a flexible catheter body 34 that carries one or more ablation electrodes 36. For the sake of illustration, FIG. 3 shows a single ablation electrode 36 carried at the distal tip of the catheter body 34. Of course, other configurations employing multiple ablation electrodes are possible, as described in pending U.S. patent application Ser. No. 08/287,310, filed Aug. 8, 1994, entitled "Systems and Methods for Ablating Heart Tissue Using Multiple Electrode Elements."
A handle 38 is attached to the proximal end of the catheter body 34. The handle 38 and catheter body 34 carry a steering mechanism 40 for selectively bending or flexing the catheter body 34 along its length, as the arrows in FIG. 3 show.
The steering mechanism 40 can vary. For example, the steering mechanism can be as shown in U.S. Pat. No. 5,254,088, which is incorporated herein by reference.
A wire (not shown) electrically connected to the ablation electrode 36 extends through the catheter body 34 into the handle 38, where it is electrically coupled to an external connector 45. The connector 45 connects the electrode 36 to a generator 46 of ablation energy. The type of energy used for ablation can vary. Typically, the generator 46 supplies electromagnetic radio frequency energy, which the electrode 36 emits into tissue. A radio frequency generator Model EPT-1000, available from EP Technologies, Inc., Sunnyvale, Calif., can be used for this purpose. Alternatively, genes or cells could be injected to improve conduction.
In use, the physician places the ablation electrode 36 in contact with heart tissue at the site identified for ablation. The ablation electrode emits ablating energy to heat and thermally destroy the contacted tissue.
According to the features of the invention, the process controller 32 employs electrogram cross-correlation to automatically locate for the physician the site or sites potentially appropriate for ablation.
I. Electrogram Cross-Correlation
The process controller 32 is operable to sense electrical events in heart tissue and to process and analyze these events to achieve the objectives of the invention. The process controller 32 is also selectively operable to induce electrical events by transmitting pacing signals into heart tissue.
More particularly, the process controller 32 is electrically coupled by a bus 47 to a pacing module 48, which paces the heart sequentially through individual or pairs of electrodes to induce depolarization. Details of the process controller 32 and pacing module 48 are described in copending U.S. patent application Ser. No. 08/188,316, filed Jan. 28, 1994, and entitled "Systems and Methods for Deriving Electrical Characteristics of Cardiac Tissue for Output in Iso-Characteristic Displays."
The process controller 32 is also electrically coupled by a bus 49 to a signal processing module 50. The processing module 50 processes cardiac signals into electrograms. A Model TMS 320C31 processor available from Spectrum Signal Processing, Inc. can be used for this purpose.
The process controller 32 is further electrically coupled by a bus 51 to a host processor 52, which processes the input from the electrogram processing module 50 in accordance with the invention to locate arrhythmogenic substrate. The host processor 32 can comprise a 486-type microprocessor.
According to the invention, the process controller 32 operates in two functional modes, called the sampling mode and the cross-correlation mode.
In the sampling mode, the physician deploys the basket structure 20 in the desired heart region 12. To assure adequate contact is made in the desired region 12, the physician may have to collapse the basket structure 20, rotate it, and then free the basket structure 20. The degree of contact can be sensed by the process controller 32 in various ways. For example, the process controller 32 can condition the pacing module 48 to emit pacing signals through a selected electrode 24 or pair of electrodes 24. The process controller 32 conditions the electrodes 24 and processing module 50 to detect electrograms sensed by a desired number of the electrodes 24. The processing module can also ascertain the desired degree of contact by measuring tissue impedance, as described in copending patent application Ser. No. 08/221,347, filed Mar. 31, 1994, and entitled "Systems and Methods for Positioning Multiple Electrode Structures in Electrical Contact with the Myocardium."
Once the basket structure 20 is properly positioned, the process controller 32 conditions the electrodes 24 and signal processing module 50 to record electrogram samples during a selected cardiac event having a known diagnosis. In the sampling mode, the process controller 32 typically must condition the pacing module 48 to pace the heart until the desired cardiac event is induced. Of course, if the patient spontaneously experiences the cardiac event while the structure 20 is positioned, then paced-induction is not required.
The processor controller 32 saves these electrogram samples in the host processor 52. At the end of the sampling mode, the process controller 32 typically must condition the pacing module 48 to pace terminate the cardiac event, or the physician may apply a shock to restore normal sinus rhythm.
The cross-correlation mode is begun without altering the position of the multiple electrode structure 20 in the heart region 12, so that the electrodes 24 occupy the same position during the cross-correlation mode as they did during the sampling mode.
In the cross-correlation mode, the process controller 32 first conditions the pacing module 48 to pace the heart in a prescribed manner without inducing the cardiac event of interest, while conditioning the signal processing module 50 to record a number of the resulting electrograms. The process controller 32 then operates the host processor 52 to cross-correlate all or a selected number of the resulting paced electrogram samples to all or a selected number of the electrogram samples collected during the sampling mode. Based upon this comparison, the host processor 52 generates an output that identifies the location of the electrode or electrodes 24 on the structure 20 that are close to a potential ablation site.
A. The Sampling Mode
As before generally described, the process controller 32 operates in the sampling mode while the heart is experiencing a selected cardiac event of known diagnosis and the basket structure 20 is retained in a fixed location in the region 12. In the illustrated and preferred embodiment, the selected event comprises an arrhythmia that the physician seeks to treat, for example, ventricular tachycardia (VT), or atrial tachycardia (AT), or atrial fibrillation (AF).
As FIG. 4A shows, during the sampling mode, the signal processing module 50 processes a selected number of event-specific electrogram samples obtained from each electrode during the known cardiac event (designated for the purpose of illustration as El to E3 in FIG. 4A). The event-specific electrogram samples (designated for the purpose of illustration in FIG. 4A as SI to S3) may be recorded unipolar (between an electrode 24 and a reference electrode, not shown) or bipolar (between electrodes 24 on the structure 20). The samples S1 to S3 can comprise one heart beat or a specified number of heart beats. Multiple beats may be averaged to reduce noise, if desired.
The host processor 52 retains the set of event-specific electrogram samples Si to S3 in memory. The processor 52 can, for an individual patient, retain sets of event-specific electrogram samples for different cardiac events. For example, a patient may undergo different VT episodes, each with a different morphology. The processor 52 can automatically detect different VT morphologies and store samples for each VT episode for analysis according to the invention. The samples can be downloaded to external disk memory for off-line cross-correlation at a subsequent time, as will be described later.
B. The Cross-Correlation Mode
In the cross-correlation mode, the process controller 32 operates the pacing module 48 to apply pacing signals sequentially to each of the individual electrodes. The pacing electrode is designated Ep in FIG. 4A.
The pacing signal induces depolarization, emanating at the location of the pacing electrode Ep. The process controller 32 operates the signal processing module 50 to process the resulting paced electrogram samples sensed at each electrode (again designated El to E3 for the purpose of illustration in FIG. 4A) during pacing by the selected individual electrode Ep. The processed paced electrogram samples are designated P1 to P3 in FIG. 4A.
The paced morphology P1 to P3 at each electrode can be from one heart beat or a specified number of heart beats, provided that the length of the morphologies P1 to P3 are not shorter than the length of the event-specific samples Si to S3 for the same electrodes El to E3 obtained during the sampling mode.
Different conventional pacing techniques can be used to obtain the paced morphologies P1 to P3. For example, conventional pace mapping can be used, during which the pace rate is near the arrhythmia rate, but arrhythmia is not induced.
For reasons that will be explained later, conventional entrainment or reset pacing is the preferred technique. During entrainment pacing, the pacing rate is slightly higher than and the period slightly lower than that observed during the arrhythmia event, thereby increasing the rate of the induced arrhythmia event. Further details of entrainment pacing are found in Almendral et al., "Entrainment of Ventricular Tachycardia: Explanation for Surface Electrocardiographic Phenomena by Analysis of Electrograms Recorded Within the Tachy-cardia Circuit," Circulation, vol. 77, No. 3, March 1988, pages 569 to 580, which is incorporated herein by reference.
Regardless of the particular pacing technique used, the pacing stimulus may be monophasic, biphasic, or triphasic.
In the cross-correlation mode, while pacing at an individual one of the electrodes Ep, the host processor 52 cross-correlates the paced morphology P1 to P3 obtained at each electrode El to E3 to the event-specific samples SI to S3 for the same electrode El to E3. The cross-correlations are designated Cl to C3 in FIG. 4A.
Alternatively, the paced morphologies P1 to P3 can be retained in memory or downloaded to external disk memory for cross-correlation at a later time. To accommodate off-line processing, the host processor 52 preferably includes an input module 72 for uploading pregenerated event-specific samples and/or paced samples recorded at an earlier time. The input module 72 allows event specific samples and paced morphologies to be cross-correlated off-line by the host processor 52, without requiring the real time presence of the patient. Alternatively, recorded paced samples can be cross-correlated in real time using event-specific samples generated earlier.
For each pacing electrode Ep(j), the host processor 52 preferably generates a cross-correlation coefficient M COEF (i) for each electrode E(i) from the comparison C(i) of the pacing morphology P(i) to the event-specific morphology S(i) for the same electrode E(i). Preferably, both j and i=1 to n, where n is the total number of electrodes on the three dimensional structure (which, for the purpose of illustration in FIG. 4A, is 3).
The value of the cross-correlation coefficient M COEF (i) is indicative for that electrode E(i) how alike the pacing morphology P(i) is to the event-specific sample S(i) for that electrode E(i). The value of M COEF (I) for each electrode E(i) varies as the location of the pacing electrode Ep(j) changes. Generally speaking, the value of the cross-correlation coefficient M COEF (i) for a given electrode E(i) increases in relation to the closeness of the pacing electrode Ep(j) to the arrhythmogenic foci.
In the illustrated and preferred embodiment (as FIG. 4A shows), while pacing at an individual one of the electrodes Ep(j), the host processor 52 generates from the cross-correlation coefficients M COEF (i) for each electrode E(i) an overall cross-correlation factor M PACE (j) for the pacing electrode Ep(j). The value of the overall cross-correlation factor M PACE (i) for the pacing electrode Ep(j) is indicative of how alike the overall propagation pattern observed during pacing at the electrode Ep(j) is to the overall propagation pattern recorded on the associated event-specific samples.
The process controller 32 operates the pacing module 48 to apply a pacing signal sequentially to each electrode Ep(j) and processes and compares the resulting electrogram morphologies at each electrode E(i) (including Ep(j)) to the event-specific samples, obtaining the cross-correlation coefficients M COEF (i) for each electrode E(i) and an overall cross-correlation factor M PACE (j) for the pacing electrode Ep(j), and so on, until every electrode E(i) serves as a pacing electrode Ep(j).
M PACE (j) for each pacing electrode can be derived from associated cross-correlation coefficients M COEF (i) in various ways.
For example, various conventional averaging techniques can be used. For example, M PACE (j) can be computed as a first order average (arithmetic mean) of M COEF (i) as follows: ##EQU1## where i=1 to n; or as a weighted arithmetic mean, as follows:
M.sub.PACEY(i ) =ΣW(i)M.sub.COEF(i)
where i=1 to n; ΣW(i)=1. If W(i)=1/n, for each i, then the arithmetic mean is obtained.
Generally speaking, the value of the overall cross-correlation factor M PACE (j) increases in relation to the proximity of the particular pacing electrode Ep(j) to a potential ablation site.
By way of overall explanation, for VT, the site appropriate for ablation typically constitutes a slow conduction zone, designated SCZ in FIG. 4B. Depolarization wave fronts (designated DWF in FIG. 4B) entering the slow conduction zone SCZ (at site A in FIG. 4B) break into errant, circular propagation patterns (designated B and C in FIG. 4B), called "circus motion." The circus motions disrupt the normal depolarization patterns, thereby disrupting the normal contraction of heart tissue to cause the cardiac event.
The event-specific samples S(i) record these disrupted depolarization patterns. When a pacing signal is applied to a slow conduction zone, the pacing signal gets caught in the same circus motion (i.e., paths B and C in FIG. 4B) that triggers the targeted cardiac event. A large proportion of the associated pacing morphologies P(i) at the sensing electrodes E(i) will therefore cross-correlate with the associated event-specific samples S(i) recorded during the targeted cardiac event. This leads to a greater number of larger cross-correlation coefficients M COEF (i) and thus to a larger overall cross-correlation factor M PACE (j).
However, when a pacing signal is applied outside a slow conduction zone, the pacing signal does not get caught in the same circus motion. It propagates free of circus motion to induce a significantly different propagation pattern than the one recorded in the event-specific samples S(i). A large proportion of the pacing morphologies P(i) at the sensing electrodes E(i) therefore are not well cross-correlated with the event-specific samples S(i). This leads to a smaller number of larger cross-correlation coefficients M COEF (i) and thus to a smaller overall cross-correlation factor M PACE (j).
This is why the overall cross-correlation factor M PACE (j) becomes larger the closer the pacing electrode Ep(j) is to the slow conduction zone, which is the potential ablation site. The difference in propagation patterns between pacing inside and outside a slow conduction zone is particularly pronounced during entrainment pacing. For this reason, entrainment pacing is preferred.
Ablating tissue in or close to the slow conduction zone prevents subsequent depolarization. The destroyed tissue is thereby "closed" as a possible path of propagation. Depolarization events bypass the ablated region and no longer become caught in circus motion. In this way, ablation can restore normal heart function.
The cross-correlation of pacing morphologies P(i) to event-specific samples S(i) to create the coefficient M COEF (i) and the overall factor M PACE (i) can be accomplished using conventional cross correlation techniques. FIG. 5 shows a cross correlation technique that embodies features of the invention.
For example, when the data sequences of the event-specific samples are time aligned with the data sequences of the paced samples, the cross correlation technique can comprise calculating a cross correlation coefficient. For N pairs of time aligned data {x(n), y(n)}, where x(n) is the event-specific electrogram and y(n) is the paced electrogram, the cross-correlation coefficient can be calculated as follows: ##EQU2##
Any columnar alignment technique can be used to time align the samples. For example, the electrograms could be aligned about the point of largest positive slope.
M COEF (i) is equal to rxy computed for the individual electrode E(i).
When the data sequences between the eventspecific and paced samples are not time aligned, the cross-correlation technique can comprise calculating a cross-correlation function.
This technique uses an appropriate algorithm to calculate for each electrode a cross correlation function between the event-specific samples of electrogram and the samples of the paced electrograms. For identical electrograms, the largest excursion of the cross correlation function will equal 1.0.
Various conventional methods for determining the cross correlation function can be used. For example, for M pairs of data {x(m), y(m)}, where x(m) is the event-specific electrogram and y(m) is the paced electrogram, the correlation function can be calculated as follows: ##EQU3## where m=1 to M; -M≦K≦M, and x and y are the means of the sequences {x} and {y}.
M COEF (i) is equal to the largest excursion of the sequence {rxy(k)} computed for the individual electrode E(i) (i.e., the largest excursion can be either negative or positive, depending upon the degree of intercorrelation).
FIG. 7A shows the cross correlation function for the electrograms of FIG. 6A and FIG. 6B. These electrograms are quite similar, and the cross correlation technique detects this. The largest excursion of the cross correlation function in FIG. 7A is near 1.0 (i.e., it is 0.9694).
Refer now to FIG. 7B, which shows the cross correlation function for the unlike electrograms shown in FIGS. 6A and 6C. The cross correlation technique detects this lack of similarity. The largest excursion in FIG. 7B is negative (i.e., it is -0.7191).
Using either a cross-correlation coefficient or a cross-correlation function to calculate M COEF (i), the pacing electrode Ep(j) having an overall factor M PACE (j) closest to 1.0 is designated to be close to a potential ablation site. When using the cross-correlation function technique, additional information may be contained in the shift parameter k for each electrode.
In one implementation (see FIG. 4A), the host processor 52 sets a target N, which numerically establishes a factor M PACE (j) at which a high probability exists that the pacing electrode is close to a potential ablation site. In a preferred implementation, N=0.8. When M ACE (j) >N, the host processor 52 deems the location of the pacing electrode Ep(j) to be close to a potential site for ablation. When this occurs (as FIG. 4 shows), the host processor 52 transmits a SITE signal to an associated output display device 54 (see FIG. 1A). Through visual prompts, the display device 54 notifies the physician of the location of the pacing electrode Ep(j) and suggests that location as a potential ablation site.
In the preceding embodiments, the endocardially positioned basket structure 20 both paces and senses the resulting electrograms. In an alternative implementation, the process controller 32 can condition the pacing module 48 in the sampling mode to pace the heart and record resulting electrocardiograms using body surface electrodes electrically coupled to the process controller 32.
In this implementation, during the cross-correlation mode, the process controller 32 paces the heart and records resulting paced electrocardiograms with the same body surface electrodes (located in the same position as during the sampling mode) and compared to the event-specific electrocardiogram samples in the manner above described.
In this implementation, the process controller 32 generates the location output based upon comparing the event-specific electrocardiogram samples with the paced electrocardiograms.
The electrograms may or may not be filtered before analysis. A 1 to 300 Hz bandpass filter may be used for filtering. If a filter is used to reduce the noise for an electrogram that is used as a event-specific sample, the same filter must also be used for the paced electrograms, since filtering may alter the electrogram morphology.
The implementation of the system 10 described herein is based largely upon digital signal processing techniques. However, it should be appreciated that a person of ordinary skill in this technology area can easily adapt the digital techniques for analog signal processing.
Various features of the invention are set forth in the following claims.
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An analog or digital processing element and associated method analyses electrograms or electrocardiograms to locate sites potentially appropriate for ablation. The element and method compares a first number of electrogram or electrocardiogram samples recorded over time during a cardiac event of known diagnosis with a second number of paced electrogram or electrocardiogram samples recorded over time. The comparison cross-correlates the first number of electrogram samples with the second number of paced electrogram samples. The element and method generate an output based upon the cross-correlation. The element and method compare the output to a predetermined value to determine whether a pacing site for the paced electrogram or electrocardiogram samples is near to a potential ablation site.
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TECHNICAL FIELD
The present invention relates to the field of medical aid devices. More particularly, the invention relates to a device for treatment of depression, anxiety and pain.
BACKGROUND ART
According to the World Health Organization, 121 million people worldwide suffer from depression, only 25% of whom have access to effective treatment.
The majority of patients are treated with medication, although about 60% of these patients are not helped by the medication. Approximately 29% of Americans suffer from anxiety at some point in their lives.
A further approximately 15% of patients suffering depression are helped with magnetic field and electroconvulsive therapy. A small percentage of people suffer from Seasonal Affective Disorder (SAD), and can be helped with light therapy.
Currently accepted medical treatments for depression include medication, psychotherapy, transcranial magnetic stimulation (TMS—therapy using magnetic fields); electroconvulsive therapy (ECT), and light treatment for SAD.
There is also scientific evidence to back up the use of alternative methods such as meditation and yoga, but there is no conclusive scientific evidence that proves any benefit from reflexology or acupuncture on such illnesses.
ECT and TMS are very expensive treatments, costing tens of thousands of dollars as an ambulatory care treatment using a technician and a doctor. Use of a light therapy device costs the patient US$100-400; it only helps 1-10% of the patient population; and it is only useful for seasonally affected patients.
In a patent search carried out by the Applicant in Google Patents, and other patent databases, no patent publication has been found that intends to solve depression and anxiety problems.
It is an object of the present invention to provide a solution for the abovementioned problems, and other problems of the prior art.
The present invention will help people who have no access to an effective treatment, as well as patients who are not helped by currently existing medications and treatments.
Other objects and advantages of the invention will become apparent as the description proceeds.
SUMMARY OF THE INVENTION
A device ( 100 ) for the treatment of depression, anxiety and pain, the device comprising:
a plurality of adjacent dots ( 11 ) or other shapes, each comprising means for providing a signal being sensible by a touch sense, the signal comprising mechanical signal and/or electrical signal and/or temperature signal and/or magnetic signal; and a controller ( 32 ) for executing each of the means independently, for providing pre-programmed shapes ( 30 , 40 , 40 A, 40 B, 42 , 46 , 48 , 50 , 52 , 54 ) being sensible by the touch sense,
thereby allowing treating the depression, anxiety and pain by generating to the brain, signals resembling the pre-programmed shapes ( 30 , 40 , 40 A, 40 B, 42 , 46 , 48 , 50 , 52 , 54 ) through the signals being sensible by the touch sense.
The pre-programmed shapes ( 30 , 40 , 40 A, 40 B, 42 , 46 , 48 , 50 , 52 , 54 ) being sensible by the touch sense may comprise a procedure of increasing resolution of lines ( 40 , 40 A, 40 B, 42 ) or of other shapes,
thereby utilizing the touch sense for brain discrimination exercises, rather than brain discrimination exercises applied by meditation treatment.
The procedure of increasing resolution of lines ( 40 , 40 A, 40 B, 42 ) or of other shapes may comprise maintaining a constant number of lines.
The procedure of increasing resolution of lines ( 40 , 40 A, 40 B, 42 ) or of other shapes may comprise providing a single distance at each step.
The procedure of increasing resolution of lines ( 40 , 40 A, 40 B, 42 ) or of other shapes may comprise providing a plurality of distances at each step.
The pre-programmed shapes ( 30 , 40 , 40 A, 40 B, 42 , 46 , 48 , 50 , 52 , 54 ) being sensible by the touch sense may comprise a procedure of providing shapes ( 46 ) comprising empty segments ( 48 ) thereof,
thereby utilizing the touch sense for brain completion exercises.
The pre-programmed shapes ( 30 , 40 , 40 A, 40 B, 42 , 46 , 48 , 50 , 52 , 54 ) being sensible by the touch sense may comprise a procedure of
providing a line or shape ( 50 ),
then of providing a portion ( 52 ) of the line or shape ( 50 ), and
then of providing the said line or shape ( 54 ),
thereby utilizing the touch sense for producing an expectation, produced by the line or shape ( 50 ) and by the portion ( 52 ), and for producing a fulfillment of the expectation, produced by said line or shape ( 54 ) again.
The plurality of adjacent dots ( 11 ) or other shapes may comprise one or more groups ( 10 ) of shiftable and retractable pins ( 11 ), each of the pins ( 11 ) being substantially perpendicular to a surface on which the pins are disposed; and
the controller ( 32 ) is adapted for controlling the operation of shifting and retracting each of the pins ( 11 ) individually; and the device ( 100 ) may further comprise a computerized mechanism ( 34 ) for instructing the controller ( 32 ) to shift/retreat each of the pins individually, according to a script, being a group of timed instructions; thereby generating mechanical stimulation signal/pulse to a human organ, according to a script.
The device may further comprise a mechanism for heating the plurality of adjacent dots ( 11 ) or other shapes, for allowing the device to produce a heating pulse/signal.
The device may further comprise a mechanism for chilling the plurality of adjacent dots ( 11 ) or other shapes, for allowing the device to produce a chilling pulse/signal.
The device may further comprise a mechanism for electrifying the plurality of adjacent dots ( 11 ) or other shapes, for allowing the device to produce an electric pulse/signal.
The device may further comprise an electromagnetic mechanism, for magneticizing the plurality of adjacent dots ( 11 ) or other shapes, thereby allowing the device to produce a magnetic pulse/signal.
Each command of the script may define a form of the pulse/signal.
The form may be an intensity and/or duration and/or rhythm and/or a cycle.
Each of the dots ( 11 ) or other shapes may be heated individually.
All of the pins may be heated together by a heated liquid disposed around the pins when being in their retreated state.
Each of the pins may be chilled individually.
All of the pins may be chilled together by a chilling liquid disposed around the pins when being in their retreated state.
The surface may correspond to a surface of a human organ.
The human organ may constitute a palm and/or a foot and/or a sole, and/or a back, and/or a face.
The more sensitive a region of the human organ, the higher the density of the members of the group ( 10 ) of shiftable and retractable pins ( 11 ).
The pins may be shifted out in a geometric form.
The pins may be shifted in a partial geometric form, thereby allowing a patient's brain to complete the full form.
The members of the group ( 10 ) of shiftable and retractable pins ( 11 ) may be arranged in a matrix form.
The device may further comprise:
a first perforated plate ( 12 ) wherein the pins ( 11 ) are shiftable through the perforation; a second plate ( 14 ); a closed space ( 38 ) between the plates, filled with a liquid ( 42 ); and a heating/chilling body ( 40 ) disposed in the liquid ( 42 ), for heating/chilling the liquid ( 42 ), thereby heating/cooling all of the pins when dipped in the liquid.
The plurality of adjacent dots ( 11 ) or other shapes may comprise an electrical mask comprising a plurality of electrical outputting dots or of other shapes.
The reference numbers have been used to point out elements in the embodiments described and illustrated herein, in order to facilitate the understanding of the invention. They are meant to be merely illustrative, and not limiting. Also, the foregoing embodiments of the invention have been described and illustrated in conjunction with systems and methods thereof, which are meant to be merely illustrative, and not limiting.
BRIEF DESCRIPTION OF DRAWINGS
Preferred embodiments, features, aspects and advantages of the present invention are described herein in conjunction with the following drawings:
FIG. 1 pictorially illustrates a device for treatment of depression and anxiety, according to one embodiment of the invention.
FIG. 2 further details the pin matrix of FIG. 1 , by focusing the “magnifying glass” on pins of a matrix.
FIG. 2A . is similar to FIG. 2 , except that the shape of each pin is of a line.
FIG. 3 further details the pins matrix of FIG. 2 .
FIG. 3A depicts steps of a first procedure for applying the treatment.
FIG. 3B depicts a second procedure for applying the treatment.
FIG. 3C depicts a third procedure for applying the treatment.
FIG. 4 is a sectional view that illustrates the cross-section A-A defined in FIG. 1 . In FIG. 4 the pins are lifted up.
FIG. 5 is a sectional view that focuses on the electromechanical mechanism of shifting the pins.
FIG. 6 is a sectional view that focuses on the heating mechanism of the pins.
It should be understood that the drawings are not necessarily drawn to scale.
DESCRIPTION OF EMBODIMENTS
The present invention will be understood from the following detailed description of preferred embodiments (“best mode”), which are meant to be descriptive and not limiting. For the sake of brevity, some well-known features, methods, systems, procedures, components, circuits, and so on, are not described in detail.
The present invention is directed to a device for treating depression, anxiety and pain.
The term “synapse” refers herein to a structure that permits a neuron (or nerve cell) to pass an electrical or chemical signal to another neuron
The term “somato-sensory” refers herein to touch sense.
One of possible explanations for the development of depression is disturbance in the plasticity of the brain. The present invention is directed to improve the plasticity in synaptic activity of the brain, by transmitting touchable signals to the synapses.
Research studies in the field of neurobiology and clinical experiments have shown that by increasing somatosensory discrimination activity, it is possible to improve the condition of patients suffering from clinical depression and anxiety. This is supported also by initial clinical observations.
Through stimulation with special modulated signals to human organs such as foot sole, palm, and so on, the present invention gradually reduces the patient's nervous system's discrimination threshold.
By reducing the “noise” of sensoric and by using sensomotoric signals, a device thereof will improve the condition of patients suffering clinical depression and anxiety.
The technical innovation is introduced by activating a variable modality of generating pulses to sensitive parts of the patient's body. Such a device includes algorithms in the form of software files that will be stored to an electronic card as a result of tests conducted on the patient.
The terms “pulse” and “signal” refer herein to a time period of stimulation. For example, “an electric pulse” is an electric impact that takes a duration such as hundredths of a second, tenth of a second, etc, while “an electric signal” takes at least seconds.
The object is obtained by a device that generates stimulation signals/pulses on sensitive region(s) of the body of a patient, such as palms, hands, feet, soles, face, etc.
The stimulation signal can be controlled by a control system, which may be operated by computer software.
The stimulation signal can be in a form of mechanical force, electrical current, temperature (heat/cold), magnetic, and so on.
The stimulation signal may be sequential, intermittent, repeatable, non-repeatable, in a single pattern or a plurality of patterns, and so on.
According to one embodiment of the invention, the device is adapted to perform a plurality of stimulation signals simultaneously, such as electric pulse along with a heat pulse.
According to one embodiment of the invention, the stimulation device is adapted to incorporate a plurality of stimulation forms into the same device to stimulate the aforesaid sensitive areas of a patient's body.
The device may be designed as a mobile device, as well as a fixed device.
The device can be used by doctors, as well as a self-treatment device.
As a result of treatments with the stimulation device, an improvement may be seen in the condition of a patient suffering from depression, anxiety or pain.
According to one embodiment of the invention, the device uses a group of pins movable by a control system (which may be a computerized mechanism), wherein the end thereof is used as a stimulation terminal, such as means for producing a physical hit, a contact for generating electric pulse, a heating body for generating heat, and so on.
The group of movable pins may be ordered in a form of a matrix, i.e., a group of elements uniformly arranged in rows and columns, or in a different form, not necessarily with uniform dispersal. For example, in sensitive areas of a human body, the dispersal may be more condensed than in less sensitive areas of the human body.
According to one embodiment of the invention, the patient lies on a bed, with his lap flex by a bar that lifts them up. In this situation his feet are approached to the device (or the device is approached to the patient's foot soles. In the first stage, the device resets the pins by approaching each of the pins to the surface of the patient's foot sole. In this situation the stimulation takes place.
The stimulation may be in a form of a physical contact, electric current, magnetic field, heat/cold signal, through the pins, in different geometrical forms, intensities, resolutions, rhythms, repeatable, and so on, according to commands of a computerized command that runs algorithms thereof.
FIG. 1 pictorially illustrates a device for treatment of depression and anxiety, according to one embodiment of the invention.
The device, which is marked herein by reference numeral 100 , is adapted to stimulate the foot soles of a patient.
The device comprises a casing 16 , wherein at the top side thereof are disposed two panels 26 and 28 , correspondingly to human feet soles. In each panel is installed a matrix of movable pins, their movement being controlled by a control, as will be further detailed. The pins of the panels are depressed in order to allow placing thereon a human foot sole.
FIG. 1 also defines a cross-section A-A, the result of which is illustrated in FIG. 4 .
FIG. 2 further details the pin matrix of FIG. 1 , by focusing the “magnifying glass” on pins of a matrix.
In this example pins 11 are dispersed uniformly, but it should be noted that the pins arrangement may not be uniform as a result of treatment and/or technical considerations.
According to the embodiment of FIG. 2 , the shape of each pin 11 is of a dot.
FIG. 2A is similar to FIG. 2 , except that the shape of each pin is of a line.
According to another embodiment, the shape of each pin 11 may be a line or another shape.
In FIGS. 2 and 2A , all the illustrated pins 11 are elevated, but as will be described hereinafter, each of the pins 11 is movable and its state is changeable by a control system.
FIG. 3 further details the pins matrix of FIG. 2 .
The plurality of pins 11 may provide a plurality of pre-selected shapes. In the example of FIG. 3 , the plurality of pins 11 form a triangle 30 , which is generated by elevating the corresponding pins 11 , by a controlling mechanism thereof (not illustrated in this figure). Thus, each of pins 11 can be elevated and lowered by a control mechanism, according to commands from a computerized mechanism that runs algorithms thereof.
Triangle 30 may be generated by other means, rather than by mechanical means applied by pins 11 , such as by electrical means, for supplying electrical current to the skin, or temperature means for heating or cooling dots or other shapes on the skin. The electrical means may apply an electrical mask including a plurality of electrical outputting dots or of other shapes. The temperature means may apply a plurality of heat or cool outputting dots or other shapes.
In general, the patient must sense by somato-sensory thereof, pre-determined shapes produced as a function of time.
A pre-selected procedure is executed, for applying the treatment. One procedure is somato-sensory discrimination, for transmitting to the brain of the patient, through touchable signals, such as of physical, electrical, or temperature signals, discrimination of lines or dots or other shapes in various resolutions.
FIG. 3A depicts steps of a first procedure for applying the treatment.
The discrimination of lines or other shapes may be applied by increasing the resolution of the lines or of the shapes from step to step. According to one embodiment, the number of lines is constant along the steps, for example 1 or 2 or 3 or 4, and the resolution being constant at every step, increases from one step to the next step, as exemplified below
For example, at the first day (1.1.14) of treatment pins 11 within panel 28 may produce one line 40 or another shape, disposed at various locations of panel 28 . Line 40 is not permanently produced, but rather is produced and cancelled repeatedly, e.g., produced for 20 seconds, cancelled for 10 seconds, the produced for 20 seconds or for 18 seconds, etc.
At the second day (2.1.14) of the treatment, pins 11 within panel 28 may produce two lines 42 or another shape, disposed at various locations of panel 28 , wherein at the first step, the distance between lines 42 is 2.5 centimeters one from the other; at the second step, the distance between lines 42 is 2 centimeters one from the other; at the third step, the distance between lines 42 is 1.5 centimeters one from the other; and at the fourth step, the distance between lines 42 is 1 centimeters one from the other. Preferably, lines 42 are not permanently produced, but rather are produced and cancelled repeatedly.
At the third day (3.1.14) of the treatment, pins 11 within panel 28 may produce three lines 40 A or another shape, disposed at various locations of panel 28 , wherein at the first step, the distance between lines 40 A is 2.5 centimeters one from the other; at the second step, the distance between lines 40 A is 2 centimeters one from the other; at the third step, the distance between lines 40 A is 1.5 centimeters one from the other; and at the fourth step, the distance between lines 40 A is 1 centimeters one from the other. Preferably, lines 40 A are not permanently produced, but rather are produced and cancelled repeatedly.
At the fourth day (4.1.14) of the treatment, pins 11 within panel 28 may produce four lines 40 B or another shape, disposed at various locations of panel 28 , wherein at the first step, the distance between lines 40 B is 2.5 centimeters one from the other; at the second step, the distance between lines 40 B is 2 centimeters one from the other; at the third step, the distance between lines 40 B is 1.5 centimeters one from the other; and at the fourth step, the distance between lines 40 B is 1 centimeters one from the other. Preferably, lines 40 B are not permanently produced, but rather are produced and cancelled repeatedly.
According to one embodiment, the distance between the lines may be different within the same set of lines.
For example, at the fifth day (5.1.14) of the treatment, pins 11 within panel 28 may produce a set of five lines 40 C including from left to right the lines 40 C 1 , 40 C 2 , 40 C 4 , 40 C 4 and 4005 , or another shape, disposed at various locations of panel 28 , wherein at the first step, the distance between line 40 C 1 and 40 C 2 is 2.5 centimeters; the distance between line 40 C 2 and 40 C 3 is 2 centimeters; the distance between line 40 C 3 and 40 C 4 is 1.5 centimeters; and the distance between line 40 C 4 and 4005 is 1 centimeters.
At the second step, the distance between line 40 C 1 and 40 C 2 is 2 centimeters; the distance between line 40 C 2 and 40 C 3 is 1.6 centimeters; the distance between line 40 C 3 and 40 C 4 is 1.2 centimeters; and the distance between line 40 C 4 and 4005 is 0.8 centimeters;
And at the following steps, the distances decrease in relation to the previous step accordingly.
This signaling to the brain through the touchable signals, is applied for exercising brain discrimination in an improved manner, since it applies physical means, rather than brain discrimination exercises applied by pure cognitive affecting means applied by known meditation treatments.
FIG. 3B depicts a second procedure for applying the treatment.
According to another procedure of treatment, for being applied by device 100 , device 100 produces shapes, for being completed by the brain. For example, the shape for being completed by the brain may constitute a triangle 46 or a rectangle 46 , each having an empty segment 48 . Empty segment 48 is produced for being completed by the brain.
FIG. 3C depicts a third procedure for applying the treatment.
According to another procedure of treatment, for being applied by device 100 , device 100 produces expectations for being fulfilled. The embodiment includes producing sequenced shapes, for producing expectations, and for being later completed by device 100 .
For example, at the first step, device 100 produces a line 50 ; at the second step, device 100 produces one or more dots or other segments 52 being a portion of line 50 . The patient expects the remainder of line 50 . Then device 100 fulfils, at the third step, the expectation by producing a line 54 being similar to line 50 .
Preferably, the shapes produced by device 100 are not permanently produced, but rather are produced and cancelled repeatedly.
A physical hit can be generated by elevating a pin, and then immediately retreating to its lowered state.
The pins may provide a plurality of stimulation forms. For example, the pin which is designed to generate a physical hit may also comprise a heating body which heats the pin. As a result, the pin not only hits the sole, but also provides a heat pulse.
A pin may also generate an electrical current. Thus, each pin may be used for generating a pulse of: physical, electrical, and temperature nature, in combination or not.
FIG. 4 is a sectional view that illustrates the cross-section A-A defined in FIG. 1 . In
FIG. 4 the pins are lifted up.
FIG. 5 is a sectional view that focuses on the electromechanical mechanism of shifting the pins.
FIG. 5 illustrates two pins, the left one being lowered down, and the right one lifted up. Reference numeral 36 denotes a hole of the perforation of plate 12 , from which the pin thereof has been “removed”.
As mentioned, reference numeral 12 denotes a perforated plate. Each of the holes 36 of the perforated plate is a conduit used for passing therethrough a pin 11 . It should be noted that each of the pins is perpendicularly shiftable to the surface of the panel at the pin's location.
Reference numeral 14 denotes a lower plate (in the figure's orientation). Reference numeral 20 denotes an upper electromagnet and reference numeral 22 denotes a lower electromagnet (in the figure's orientation). Reference numeral 24 denotes a ferric element, attached to pin 11 .
It should be noted that one of the electromagnets 20 or 22 may be replaced by a spring, thereby obtaining a simplified mechanism. When using a spring instead of an electromagnet, each pin has two states: an idle state, wherein the spring pushes the pin towards on of the plates 12 , 14 ; and an active state, where the pin is pulled to the opposite direction.
When the upper electromagnet 20 is activated, it pulls up the ferric element 24 , and therefore the pin is lifted up. When the lower electromagnet 22 is activated, it pulls down the ferric element 24 , and therefore the pin is lowered down.
As illustrated, the ferric element 24 is larger than the width of hole 36 , and therefore the perforated plate 12 limits the movement of pin 11 upwards. In addition, plate 14 limits the movement of the pin downwards.
It should be noted that in FIG. 5 , each of the pins has a tip in a conic form. This structure provides a tingle, which is a form of stimulation. Of course, the pin's tip may be dull.
Referring again to FIG. 4 , each of the electromagnets is controlled by a controller 32 . Thus, the controller is in charge of providing power to the upper electromagnet 20 and the lower electromagnet 22 of each of the pins.
The computerized mechanism 34 is in charge of instructing controller 32 to which electromagnet of the pins to provide power. The commands from the computerized mechanism to controller 32 , and therefrom to the pins of matrix 10 are transferred via a bus 18 .
The term “script” refers herein as to a group of timed instructions (to perform a physical operation by a machine).
The computerized mechanism may use scripts for activating the pins, and the stimulation thereof (heating, chilling, electrifying, etc.). For example, the triangle form 30 of the pins which is illustrated in FIG. 3 can “move” forth and back in a repeatable manner, while each of the pins is heated. Thus, the computerized mechanism “decides” when to lift up a pin, and when to lower a pin, and the controller is the mechanism that provides the power to the required electromagnets to perform the computerized mechanism's commands
While the term “controller” refers herein to a mechanism for carrying out a physical operations, the term “computerized mechanism” refers herein a group of instructions to the controller. A computerized mechanism may include a CPU and memory for executing a program (which is a group of commands stored in the memory). Of course, presently a computerized mechanism can be implemented merely by a circuitry.
Preferably, the computerized mechanism may comprise a user interface, by which a user (doctor, therapist, the patient, etc.) selects the stimulation treatment (script), sets parameters of the treatment (such as the duration, the intensity of the pulses, etc). Using the user interface, the user also may determine the script, may define new stimulation scripts, and so on.
Preferably, the surface form of each of plates 12 that forms each of the panels 26 and 28 should correspond to a human foot sole, and in general to a human organ to be stimulated. However, in order to facilitate the understanding of the invention, in the accompanying figures the plate 12 is flat.
A magnetic pulse/signal can be generated by an electromagnetic mechanism. An electric pulse/signal can be generated by a circuitry for this purpose, which presently is well known.
As per a magnetic pulse/signal, the device can be designed such that when a pin is lifted up, it closes a circuit which generates an electric/magnetic pulse/signal. Thus, the same mechanism that moves the pins may also be used for generating a physical hit, a heat/chill pulse/signal, and so on.
FIG. 6 is a sectional view that focuses on the heating mechanism of the pins.
According to this embodiment of the invention, the space 38 between the upper and lower plate can be filled with liquid 42 , which can be heated by a heating body 40 . As a result, when the pins are in their lower state, i.e., dipped in the heated liquid 42 , they are heated, and when they are lifted up, the heat is propagated to the human body at the contact points. This mechanism is simpler than heating each of the pins by its individual heating body. The same mechanism can be applied to chilling the pins.
In the figures and/or description herein, the following reference numerals (Reference Signs List) have been mentioned:
numeral 100 denotes a device for treatment of depression and anxiety, according to one embodiment of the invention; numeral 10 denotes a group of pins 11 ; numeral 11 denotes a movable pin, controllable by a controller 32 by a computerized mechanism 34 ; numeral 12 denotes a perforated plate; numeral 14 denotes a lower plate, which limits the movement of each of the pins downwards (in the figures' orientation); numeral 16 denotes a casing, wherein at the top side thereof are disposed two panels 26 and 28 , correspondingly to human feet soles; numeral 18 denotes a bus (a data communication channel) that passes commands from the computerized mechanism 34 , to the controller 32 ; numeral 20 denotes an upper electromagnet (in the figures' orientation); numeral 22 denotes a lower electromagnet (in the figures' orientation); numeral 24 denotes a ferric element; numeral 26 denotes a left panel, correspondingly to a human left foot sole; numeral 28 denotes a right panel, correspondingly to a human right foot sole; numeral 30 denotes a triangle form, generated from the pins 11 of matrix 10 ; numeral 32 denotes a controller; numeral 34 denotes a computerized mechanism (e.g., that includes a CPU and memory); numeral 36 denotes a hole in a perforation in plate 12 ; numeral 38 denotes a space between plate 12 and plate 14 ; numerals 40 , 40 A, 40 B, 40 C, and 42 denote lines or set of lines produced; numerals 40 C 1 , 40 C 2 , 40 C 3 , 40 C 4 and 4005 denote single lines within a set of lines produced; numeral 46 denotes a shape, such as a triangle or a rectangle or a circle, having an empty segment; numeral 48 denotes an empty segment of the produced line or shape; numeral 50 denotes a line or shape to be produced; numeral 52 denotes a dot or another segment of the line or the other produced shape; and numeral 54 denotes difference between two produced shapes.
The foregoing description and illustrations of the embodiments of the invention has been presented for the purposes of illustration. It is not intended to be exhaustive or to limit the invention to the above description in any form.
Any term that has been defined above and used in the claims, should to be interpreted according to this definition.
The reference numbers in the claims are not a part of the claims, but rather used for facilitating the reading thereof. These reference numbers should not be interpreted as limiting the claims in any form.
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A device ( 100) for the treatment of depression, anxiety and pain, the device comprising: a plurality of adjacent dots ( 11) or other shapes, each comprising means for providing a signal being sensible by a touch sense, the signal comprising mechanical signal and/or electrical signal and/or temperature signal and/or magnetic signal; and a controller ( 32) for executing each of the means independently, for providing pre-programmed shapes ( 30, 40, 40 A, 40 B, 42, 46, 48, 50, 52, 54) being sensible by the touch sense, thereby allowing treating the depression, anxiety and pain by generating to the brain, signals resembling the pre-programmed shapes ( 30, 40, 40 A, 40 B, 42, 46, 48, 50, 52, 54) through the signals being sensible by the touch sense.
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BACKGROUND OF THE INVENTION
[0001] The invention concerns a conveyor arrangement for shock-sensitive products, such as eggs or the like, and includes a conveyor apparatus for conveying the products, an intermediate storage region which is adapted to receive products temporarily by virtue of discontinuous feed or discharge, and a control device for increasing the discharge and/or for reducing the feed of products into the intermediate storage region of the conveyor apparatus when a predetermined critical number of products is exceeded in the intermediate storage region.
[0002] Conveyor arrangements are generally used for transporting eggs away from a laying area and feeding them to a packaging station. That purpose is served by using particular conveyor arrangements which include a transverse conveyor belt which conveys products to a processing station and a plurality of longitudinal conveyor belts which are so arranged that they convey products from various, mutually spaced locations onto the transverse conveyor belt. In such devices, the longitudinal conveyor belts extend along a row of henhouses or aviaries and are generally provided individually for each level or tier. The transverse conveyor belts are typically mounted at a right angle to the longitudinal conveyor belts which are disposed in a parallel relationship, and receive the eggs which are transported by the longitudinal conveyor belts out of the laying areas.
[0003] A first problem arising with such prior conveyor arrangements is that conveyance of the eggs on the longitudinal conveyor belts, which extends over a period of time, causes the feed of the eggs by way of the transverse conveyor belt to the processing station to be discontinuous, and in an amount which is insufficient to make full use of the processing capacity of the processing station. To avoid this problem, it is known for a plurality of longitudinal conveyor belts to be simultaneously activated to supply the transverse conveyor belt with an adequate amount of eggs. A problem with that procedure, however, is that the spaced points of entry of the longitudinal conveyor belts mean that the transverse conveyor belt cannot be filled uniformly, and the transverse conveyor belt capacities are exceeded locally, which usually leads to damage to the eggs.
[0004] A further problem with such prior conveyor arrangements is that only low egg conveyor rates are achieved at both the beginning of the conveyor cycle or operation, and at the end of the cycle, since an excessively low level of supply to the transverse conveyor belt occurs by virtue of starting up the first longitudinal conveyor belt and allowing the last longitudinal conveyor belt to run down. That increases or prolongs the processing time at the processing station, which is disadvantageous for cost reasons.
[0005] Particularly in relatively large henhouse installations, it is often desirable for the eggs to be collected in batches or groups from given locations, for example because certain henhouses involve the administration of a different feed from other henhouses, and the eggs produced in that way are to be supplied as an interrelated assembly to the processing station in order to be jointly processed, for example packaged. It is in precisely such situations where the egg collecting operation, with for example up to 15 different groups, takes place in succession. However, it is not possible to achieve full utilization of the processing capacity of the processing station at all times with the previously known measures of simultaneously switching on different longitudinal conveyor belts so that, in such situations of use, considerably longer operating times in the processing station and consequently longer collecting times and higher operating costs have to be tolerated.
[0006] A further problem with such prior conveyor arrangements involves in particular keeping laying hens in an aviary in animal-friendly conditions. In such a situation, the animals are provided with a nest in which the animals preferably lay their eggs. The eggs roll onto the longitudinal conveyor belt from the nest. However, the locally concentrated accumulation of the laid eggs results in overfilling of the longitudinal conveyor belt in the nest region, and that can lead to damage to the eggs. In contrast, keeping the hens in cages leads to the laid eggs being distributed over the entire cage width, and consequently, one-off or sequential activation of the longitudinal conveyor belts per day would be sufficient to collect the laid eggs, it being necessary when keeping the birds in animal-friendly aviaries for the collecting operation to be carried out a number of times daily by virtue of local overfilling of the longitudinal conveyor belts.
[0007] Yet a further problem with such prior conveyor arrangements is that a build-up can occur due to congestion or processing problems upstream of or in the processing station, and as a result, high damaging forces can act on the eggs. To avoid that problem, it is known to provide a limit switch which is actuated by the egg collection, and which switches off the transverse conveyor belt when an inadmissibly high force occurs. However, from the point of view of utilizing the full capacity of the processing station, a certain build-up or accumulation upstream of the processing station is desired as a buffer, switching off the transverse conveyor belt in that way results in the transverse conveyor belt being very frequently switched on and off, and that can cause increased wear and premature failure.
[0008] Finally, a further problem with known conveyor apparatuses is that, when supplying products from a plurality of conveyor belts to a common collecting conveyor belt, damage to the products often occurs if the additionally supplied products first have to displace the products which are already on the collecting conveyor belt, and in that case, unacceptably high forces are operative between the products. To avoid such damage, it is known to provide product guide devices which are stationarily fixed in position relative to the movement of the collecting conveyor belt, and which guide the products already on the collecting conveyor belt upstream of the entry regions of further products in such a way that they are guided away from the entry region and space is thus made available for the products which are additionally arriving. Those product guide devices have to be regularly repositioned and set to accommodate changing delivery conditions, either due to delivery from different delivery conveyor belts or due to varying delivery conveyor quotas, and that makes handling thereof more difficult.
SUMMARY OF THE INVENTION
[0009] One object of the present invention is to provide a conveyor arrangement which avoids one, and preferably a plurality, of the aforementioned problems.
[0010] In accordance with one aspect of the invention, a force measuring device is provided which is adapted and arranged to detect a force which is exerted by the products disposed in an intermediate storage region, and which represents a measurement of the number of products in the intermediate storage region, and a control device adapted to process the force detected by the force measuring device as an input parameter, and to increase or reduce the discharge and/or feed of the products from/to the intermediate storage region in accordance with the force value.
[0011] The invention makes it possible for the first time to achieve differentiated actuation of the discharging and feeding conveyor apparatuses, in accordance with the force responsible for damage to the products. In that way, the filling of the intermediate storage region that is sought to be achieved, for example to supply a processing station or to receive products from a product region, can be effected in a very much more specific and targeted fashion, and it is thus possible to achieve an intermediate storage region filling effect, without the frequent starting and stopping of the conveyor apparatus as is required in the state of the art.
[0012] In that embodiment, it is particularly preferred that the control device is adapted to actuate the conveyor apparatus at a first and a second conveyor speed, wherein the second speed is higher than the first speed. In that way, it is possible to select a suitable speed depending upon on the force measurement value in order to increase or reduce the number of products in the intermediate storage region. Thus, upon a reduction in the detected force, the second speed can be selected while upon an increase in the detected force, the first speed can be selected. Furthermore, the first and second speeds can be set when the force values fall below or exceed predetermined force limit values.
[0013] It is further preferred that the control device is adapted to adjust the conveyor apparatus preferably steplessly in accordance with the force detected by the force measuring device. Stepless control of the conveyor apparatus allows highly precise regulation of the number of products in the intermediate storage region or the force occurring between the products.
[0014] It is further preferred that the control device is adapted to reduce the feed of products to the intermediate storage region and/or to increase the discharge from the intermediate storage region when a predetermined force value is exceeded. That provides for simple and reliable control or regulation of product conveyance.
[0015] In a particularly preferred embodiment of the conveyor arrangement, the force measuring device is arranged beneath the products in the intermediate storage region in order to measure in a vertical direction and to detect the total or cumulative force due to weight of the products in the intermediate storage region. This arrangement is particularly suitable for use in the region of a nest when animals are being kept in an aviary situation. In that respect, the force measuring device can be so arranged that it measures the force due to weight of the eggs on the longitudinal belt in the region of the nest, and causes a conveying movement on the part of the longitudinal conveyor belt when a predetermined force due to weight is exceeded in order to prevent a build-up of the eggs.
[0016] In that embodiment, it is particularly preferred that the force measuring device is coupled to a horizontally arranged weighing plate arranged beneath a conveyor belt on which the products are arranged in the intermediate storage region. Weighing of all the products in the intermediate storage region is thus achieved in a reliable and structurally robust fashion.
[0017] In particular, it is preferable that the control device is adapted to actuate the conveyor apparatus from a stopped condition when a predetermined cumulative force due to weight of the products in the intermediate storage region is exceeded, so that the products are further conveyed to such an extent that all products are conveyed out of the intermediate storage region. In that way, a conveying action, partial or complete, is implemented in accordance with the products in the intermediate storage region, and it is possible to avoid a build-up.
[0018] It is particularly preferred that the conveyor apparatus includes a conveyor belt on which the intermediate storage region extends by a given length, and the control device is adapted so that the conveyor belt is further conveyed by precisely the length of the intermediate storage region when a predetermined cumulative force caused by the weight of the products in the intermediate storage region is exceeded. That arrangement provides that, upon complete filling of the intermediate storage region, the conveyor belt is advanced, only to such an extent that the subsequent filling of the conveyor belt occurs in a region directly adjoining or adjacent to the previously filled region, and in that way, complete filling of the longitudinal conveyor belt is progressively achieved over a large region.
[0019] Thus, in one aspect of the conveyor arrangement, a plurality of mutually spaced intermediate storage regions are arranged along the conveyor belt, and the control device is so adapted that when a predetermined cumulative force caused by the weight of the products is first exceeded in an intermediate storage region, the conveyor belt is further conveyed by the length of the intermediate storage means. When a predetermined cumulative force due to the weight of the products is subsequently exceeded in the intermediate storage region, the conveyor belt is conveyed further once again by the length of the intermediate storage means, and that procedure is optionally repeated up to a predetermined number of repetitions until the conveyor belt is full. The conveyor belt is then driven until the products are conveyed from the conveyor belt onto a second conveyor apparatus or into a storage space.
[0020] In this embodiment, when using the conveyor arrangement as a longitudinal conveyor belt, a multiple advance movement of the longitudinal conveyor belt is effected in a stepwise fashion over a discrete advance distance which corresponds to the length of the intermediate storage region. In that way, adjacent regions on the longitudinal conveyor belt are filled in succession over time. A plurality of nest regions are usually arranged along the longitudinal conveyor belt, and then after a given number of such discrete advance movements, a longitudinal conveyor belt portion, which is filled up by an adjacent nest region, would be conveyed into the nest region of a juxtaposed aviary, and in that case, there would be the danger of a build-up of eggs occurring, as there is no longer any free longitudinal conveyor belt region available. Therefore, when the longitudinal conveyor belt is typically completely filled, continuous activation of the longitudinal conveyor belt is implemented in order to convey the eggs toward a storage space, for example onto a transverse conveyor belt.
[0021] A further development of the conveyor arrangement includes providing a plurality of conveyor belts, each having at least one respective intermediate storage region, arranged so that at least one intermediate storage region includes a force sensor for measuring the force due to the weight of the products in the intermediate storage region, and the control device is so adapted that all conveyor belts are further conveyed by the length of the intermediate storage means when a predetermined cumulative force due to the weight of the products in that intermediate storage region is exceeded. That arrangement is suitable in particular for a plurality of henhouses, and is based on the realization that typically each aviary has a similar laying capacity, so that it is sufficient if the laid eggs are weighed only in the region of the nest of one aviary, and then all conveyor belts are advanced when a given force or weight value in that region is exceeded.
[0022] A further aspect of that arrangement includes providing a plurality of conveyor belts, each having at least one respective intermediate storage region with a force sensor for measuring the force caused by the weight of the products in the intermediate storage region, and a control device adapted so that all conveyor belts are further conveyed by the length of the intermediate storage means when the force due to the weight of the products in one intermediate storage region with force sensor, or the mean value of the force due to the weight of the products in all intermediate storage regions with force sensor, exceeds a predetermined force due to the weight of the products. With this embodiment, a greater degree of security or precision in relation to irregularities in the laying capacity is achieved, insofar as the laid eggs of a plurality of aviaries are measured, and then all longitudinal conveyor belts are advanced in dependence on those measurement values.
[0023] In a second particularly preferred configuration of the conveyor arrangement according to the invention, the force measuring device is coupled to a movable wall portion to detect the horizontal surface pressure exerted by the products on the movable wall portion as a pressing force on the movable portion. This feature is particularly suitable for monitoring the eggs conveyed by the transverse conveyor belt in the region upstream of a packaging station to avoid damage to those eggs if build-ups occur in the packaging station. Detection of a differentiated pressing force allows precise control of the supply of eggs and avoids damage or frequently recurring stopping and starting of the transverse conveyor belt.
[0024] In that embodiment, it is particularly preferred that the force measuring device is coupled to a movable wall portion to detect the horizontal surface pressure exerted by the products on the movable wall portion as a pressing force on the movable portion. That feature provides for precise measurement of the pressing force, and thus generates an input parameter which is reliable for the control or regulating action. In that embodiment, it is alternatively possible to provide a plurality of force measuring devices, each having a respective movable wall portion, which for example, can lie laterally and in opposite relationship to the products which are being conveyed therethrough, or which can also be arranged in the form of a measuring island in the flow of products.
[0025] A further development in the embodiments with a horizontally measuring force sensor is providing the movable wall portion with a first wall surface region which faces in opposite relationship to the feed conveyor device into the intermediate storage region, and a second wall surface region which faces parallel to the feed conveyor device. It has been found that the provision of two such wall surface regions provides for detection, which is desirable in terms of ascertaining the actual product loading of the conveyor force in the conveyor direction and the transverse force produced thereby with respect to the conveyor direction, which represents an input parameter directly related to the risk of product damage, for the regulating or control action.
[0026] In that embodiment, the movable wall portion can be of a half-round shape. Thus, a preferred structure is a half-round wall portion, which is mounted pivotably at one end, and spaced from that mounting is coupled to the force sensor and transmits a force to the sensor.
[0027] In accordance with a second aspect of the invention, to avoid the above-discussed disadvantages of known conveyor arrangements, there is proposed a conveyor arrangement, comprising a conveyor apparatus for conveying the products, an intermediate storage region which is adapted to receive products which are to be put temporarily into intermediate storage by virtue of discontinuous feed or discharge, a control device for increasing the discharge and/or for reducing the feed of products into the intermediate storage region of the conveyor apparatus when a predetermined critical number of products is exceeded in the intermediate storage region, wherein the conveyor arrangement is distinguished in that a measuring device is arranged in the intermediate storage region, which is adapted and arranged to detect the number of products standing up in the intermediate storage region, and which represents a measurement of the horizontal force between the products in the intermediate storage region, and the control device is adapted to process the number detected by the measuring device as an input parameter and to increase or reduce the discharge and/or feed of the products from/to the intermediate storage region as a function thereof.
[0028] This aspect of the invention represents an alternative for direct measurement of the force in the intermediate storage region, and is based on the realization that the products accumulated in the intermediate storage region, when a given horizontal pressing force among each other is exceeded, have a tendency to stand up or be arranged in a mutually superposed relationship in the intermediate storage region. The number of the products which project in that way beyond the products, which are lying flat on the base surface of the intermediate storage region, whether that occurs by virtue of the products standing up or by virtue of their being supported on an adjacent product, is a measurement of the magnitude of the horizontal forces between the products in the intermediate storage region, and can therefore be used as an input parameter for the control device. That conveyor arrangement is suitable in particular for conveying eggs which typically, when an increased conveyor pressure is involved, tend to stand up, and accordingly afford a reliable indication in the form of a plurality of eggs standing on their rounded ends, when a predetermined critical horizontal force has been exceeded.
[0029] In that way, the conveyor arrangement can be used in the same fashion as previously discussed for effecting stepless or dynamic transverse belt regulation, which can be regulated as a function of the number of products which are standing up in the intermediate storage region, in a closed regulating circuit.
[0030] The measuring device can be for example in the form of a plurality of light barrier arrangements, which measure horizontally over the products which are lying flat in the intermediate storage region, wherein preferably mutually crossing light paths are used in order to ensure coverage and detection over the area involved.
[0031] It is further preferred that the intermediate storage region is arranged in the transfer region between a first feeding conveyor apparatus and a second discharging conveyor apparatus, and the control device is so adapted that when a predetermined pressing force between the products, or the number of products standing up in the intermediate storage region is exceeded, the conveyor rate of the feeding conveyor apparatus is reduced and/or the conveyor rate of the discharging conveyor apparatus is increased.
[0032] In that embodiment, the predetermined pressing force, or the number of products which are standing up, is selected for example in dependence on the pressure sensitivity of the products being conveyed, and can be stored in table form for typical conveyed products in a memory of the control device or can be input by the user of the conveyor arrangement by way of an operating unit.
[0033] It is further preferred that the conveyor rate of the conveyor apparatus or apparatuses can be altered by a preferably stepless or dynamic alteration in the conveyor speed. A stepless change in the conveyor speed, for example by means of frequency converters and electric drive motors for conveyor belts or bar belt conveyors, makes it possible to achieve particularly precise regulation of the conveyor apparatuses in a closed regulating circuit, and on the one hand, reliably avoids damage to the products, while on the other hand, ensuring that the products are permanently held in readiness in the intermediate storage region.
[0034] In accordance with one aspect of the invention, to avoid the above-mentioned disadvantages, there is further proposed a conveyor arrangement comprising a transverse conveyor belt which conveys products to a processing station, and a plurality of longitudinal conveyor belts which are so arranged that they convey products onto the transverse conveyor belt at various, mutually spaced locations, wherein a development of the conveyor arrangement provides a device for detecting the conveyor advance of the transverse conveyor belt, and a regulating device which is coupled to said device, and which is adapted at the beginning of a conveyor operation of the conveyor arrangement to set the longitudinal conveyor belts in operation in time-displaced relationship as a function of the spacing between the entry points onto the transverse conveyor belt, the processing station, and the advance of the transverse conveyor belt.
[0035] Such conveyor arrangements are used for example to collect the products from production units which are distributed over a large area, and convey them to a common processing station. For that purpose, there are typically provided a plurality of longitudinal conveyor belts which are arranged parallel, and in displaced relationship with each other, and which meet a common transverse conveyor belt at mutually spaced points and convey the products onto the transverse conveyor belt. A problem with such conveyor arrangements is that in discontinuous operation of the longitudinal conveyor belts, a discontinuous feed of the products to the processing station is also realized. Moreover, due to the spatial arrangement involved, full utilization of the capacity of the processing station, and the conveyor capacity of the transverse conveyor belt, which is typically matched to that capacity of the processing station, is not possible. The aforementioned aspect of the invention remedies that disadvantage, insofar as the conveyor advance of the transverse conveyor belt is detected, for example by means of a synchronizing timing means, and a regulating device is used, which regulates the discontinuous activation of the longitudinal conveyor belts on the basis of the conveyor advance and the arrangement of the points of entry of the longitudinal conveyor belts onto the transverse conveyor belt. That regulation can involve on the one hand, activation of the longitudinal conveyor belts (binary regulation), or regulation of the conveyor speed of the longitudinal conveyor belts. Consequently, it is typically possible to implement time-displaced actuation of the longitudinal conveyor belts in such a fashion that the products are conveyed in a closed front, and make full use of the capacity of the transverse conveyor belt, and consequently the capacity of the processing station is also fully utilized. Also, in a situation involving diminishing conveyance of products from an individual longitudinal conveyor belt, another longitudinal conveyor belt, or the other longitudinal conveyor belts, can be increased in their conveying action in order to compensate for that condition, and to initiate compensation in positionally resolved relationship to the transverse conveyor belt at the location at which the deficit has occurred. The regulation of the conveyor arrangement is proposed in a way that makes it possible for the first time to fully utilize the capacity of the processing station in any operating state, and in that respect, to be able to accommodate interruptions in the transverse conveyor belt, and fluctuations in the conveyor efficiency of the longitudinal conveyor belts into the regulating and control procedures.
[0036] In particular, the noted conveyor arrangement can be combined with counting devices for the products, which are arranged at the points of entry of the longitudinal conveyor belts onto the transverse conveyor belt, and which detect and count the products which are delivered from each individual longitudinal conveyor belt. The degree of precision of regulation can be further increased by using or exploiting the numerical data ascertained in that way.
[0037] One particularly preferred feature for the above-described conveyor arrangement is to provide that the regulating device is adapted to first set in operation a first longitudinal conveyor belt, which is most remote from the processing station, and to set in operation a second conveyor belt arranged closer to the processing station at a time at which the transverse conveyor belt has advanced to such an extent that the products delivered by the first longitudinal conveyor belt have reached the entry region of the second longitudinal conveyor belt. That feature provides that, after a stoppage of the installation, in particular after the conveyor arrangement has become completely empty, the transverse conveyor belt is loaded from the plurality of longitudinal conveyor belts in such a way as to avoid only isolated products being arranged over a longer transverse conveyor belt portion, but instead providing that a front of loaded-on products involving the full capacity of the processing station is formed on the transverse conveyor belt, whereby full utilization of the processing station can be implemented at a predeterminable moment in time. That is highly advantageous, for example, for collecting eggs from a plurality of different locations which are spaced from each other to feed the eggs to a packaging station in such a way that the packaging station can be operated in a fully utilized condition when the operating personnel start work.
[0038] Furthermore, in the aforementioned conveyor arrangements, it is advantageous if at least two groups of longitudinal conveyor belts are provided, and the regulating device is adapted to arrange the products of the longitudinal conveyor belts of a first group on the transverse conveyor belt before the products of the longitudinal conveyor belts of a second group. It is often desirable for conveyor arrangements to be operated in such a way that the products are jointly collected from given regions, in particular a plurality of mutually spaced regions. It is only after that collecting operation is completed that the products are collected from other, mutually spaced regions. In that way, two or more groups of production regions can be defined, from which products are collected sequentially or in succession with respect to time. Ensuring constant or efficient utilization of the capacity of the processing station cannot be achieved precisely when using prior art conveyor arrangements and collection strategies. The conveyor arrangement according to the present invention now makes it possible for the first time also to implement such groupwise collection, and achieve constant or full utilization of the capacity of the processing station, by virtue of regulation of the longitudinal conveyor belts as a function of their point of entry, and the transverse belt advance. As in the case of joint collection and processing of all production regions, operation is based on the principle of feeding the production regions of a group to the transverse conveyor belt by way of the corresponding longitudinal conveyor belts in such a way that a closed front is formed using the full processing capacity, and after complete collection of the group, the next closed front of the next group is formed immediately behind the end of the preceding group, and so forth.
[0039] In this embodiment, it is particularly preferred that the regulating device is adapted to actuate first in each group the longitudinal conveyor belt most remote from the processing station. This provides that the groups achieve full levels of utilization of the capacity of the processing station, thereby avoiding longer lagging of the transverse conveyor belt at a low level of utilization of the potential capacity.
[0040] It is further preferred that the regulating device is adapted to actuate the longitudinal conveyor belts of the group, with the longitudinal conveyor belt most remote from the processing station as the last group. That has turned out to be advantageous, as otherwise there would be a major gap on the transverse conveyor belt, which would interfere with full utilization of the processing station, in the event one of the front longitudinal conveyor belts in a front group is collected, and following that, the last longitudinal conveyor belt is actuated, whereby the transverse conveyor belt remains product-free over a length corresponding to the distance between the front and last longitudinal conveyor belts. As an alternative thereto, the longitudinal conveyor belt most remote from the processing station in the last group could be activated, and that activation could occur at a predetermined period of time prior to termination of the activation of the last longitudinal conveyor belt of the previous group. In that case, the conveyor end of the previous group is predicted, and the most remote longitudinal conveyor belt can be started in such a way as to avoid a gap forming between the two groups.
[0041] Groupwise collection can be further optimized if the regulating device is adapted to determine the moment of stopping the last longitudinal conveyor belt of a group, and activating the first longitudinal conveyor belt of a subsequent group as a function of the spacing between the point of entry of the last longitudinal conveyor belt, and the first longitudinal conveyor belt on the transverse conveyor belt, and the transverse conveyor belt advance. With this feature, it is possible for the regulating device to leave between two groups a defined—positive or negative—spacing, by stopping and starting of the corresponding longitudinal conveyor belts being controlled in such a way that the groups specifically overlap or do not overlap, or are at a given spacing from each other.
[0042] In that case, it is particularly preferred that the regulating device is adapted to stop the longitudinal conveyor belts and the transverse conveyor belt when the last product of a group has been conveyed into the processing apparatus. In that way, the regulating device affords the possibility of implementing conversion at the processing station, in order to process products of different groups in different ways. In that respect, the last product of a group, or the first product of a following group, can be referred to as a criterion for initiating stopping of the transverse conveyor belt.
[0043] It is further preferred that the regulating device is adapted to determine the number of times the last products of the last longitudinal conveyor belt of the first group, and the first products of the first longitudinal conveyor belt of the second group, are deposited on the transverse conveyor belt in a joint mixed region. That produces a mixed region, which for example, contains products of different quality levels, and in the processing of which it is therefore necessary to accept that products of a higher quality level are sorted into a packaging which is classified with a lower quality level. With this feature, it is possible to achieve the advantage that the capacity of the processing station is fully utilized without interruption, and a fluent change takes place between the products in the first and second groups. In that case, the mixed region is treated in the processing station like the group with the products of the lower quality, and accordingly prior to or after the beginning of the mixed region, conversion of the processing mode is effected at the processing station, depending on whether the products are worse or better from one group to another in terms of their quality.
[0044] Finally, it is also preferred that, in the groupwise collection of the products, the regulating device is adapted to determine the number of times the longitudinal conveyor belts of the successive groups are started and stopped in such a way to form an intermediate space on the transverse conveyor belt between the products of the first group and the second group. In that way, a period of time for conversion of the processing station can be afforded without interrupting the conveyor procedure.
[0045] The conveyor arrangement according to one aspect of the invention can be designed so that the regulating device is adapted to activate so many longitudinal conveyor belts and/or to regulate the conveyor speed of the activated longitudinal conveyor belts in such a way that so many products are fed to each region of the transverse conveyor belt that a predetermined capacity of the processing station is achieved. In that way, full utilization of the capacity of the processing station is achieved by activation and/or speed regulation of the longitudinal conveyor belts, at any moment in time.
[0046] It is further preferred that the regulating device is adapted to allocate a fraction of the transverse conveyor belt width to each activated longitudinal conveyor belt, and to regulate the conveyor speed of each longitudinal conveyor belt in such a way that the respectively allocated width of the transverse conveyor belt is filled up with products by the respective longitudinal conveyor belt. That allocation means that each individual longitudinal conveyor belt can be regulated with respect to the conveyor capacity in such a way that the fraction of the transverse conveyor belt width that is allocated thereto is fully utilized. That makes it possible for longitudinal conveyor belts, which are to be emptied in a particularly rapid manner, to be provided with a large fraction of the transverse conveyor belt width, and therefore to preferably collect products therefrom. Also, longitudinal conveyor belts, which are collected over a longer period of time, provide only a small fraction of the transverse conveyor belt width and implement correspondingly slower collection.
[0047] In particular, in that respect, it is preferable that each longitudinal conveyor belt pre-stores a given number of products, and the regulating device is coupled to sensors for detecting the products still stored on each longitudinal conveyor belt, and is adapted to allocate to a longitudinal conveyor belt with few products, a smaller fraction of the transverse conveyor belt width than is allocated to a longitudinal conveyor belt with more products so that emptying of all longitudinal conveyor belts is finished or terminated at the same time, or in a time-displaced relationship by a given amount. This development of the invention provides that, besides full utilization of the capacity of the processing station from the beginning of the conveyor operation, which is possible with the conveyor arrangement according to the invention, the arrangement also provides for full utilization of the processing station up to the end of the conveyor operation. The sensors for detecting the products still stored on each longitudinal conveyor belt can, in a simple version, comprise travel sensors, which detect the conveyor belt advance of the longitudinal conveyor belt. An improved version is achieved by additionally ascertaining the product density on the longitudinal conveyor belt, for example by counting the products at the discharge. Particularly, if sensors for detecting the force due to the weight of the products of the above-described kind are installed, it is possible to infer the total eggs disposed on the longitudinal conveyor belt, from the measured weights.
[0048] A typical problem with prior conveyor arrangements is that the longitudinal conveyor belts have different amounts of products in readiness, and as a result, the longitudinal conveyor belts which have more products in readiness than others must still lag behind after termination of the conveyor operation of all other longitudinal conveyor belts. As a result, only a small amount of products is delivered onto the transverse conveyor belt from the individual longitudinal conveyor belt which is still continuing to convey products. Because of that small amount, the processing station cannot be utilized to its full capacity over a prolonged period of time. That causes time-intensive rectification at the processing station. With the development according to the present invention, it is possible for a large fraction of the transverse conveyor belt width to be allocated to such longitudinal conveyor belts, whereby the longitudinal conveyor belts with a larger number of products can be emptied as quickly as the other longitudinal conveyor belts. In that respect, the regulating device according to the present invention permits dynamic regulation of the respectively allocated transverse conveyor belt widths, that is to say, as soon as a greater transverse conveyor belt width is allocated to a longitudinal conveyor belt which is entirely filled, the transverse conveyor belt width of the other longitudinal conveyor belts is dynamically reduced to such a degree that in total the proportion attributed to the one longitudinal conveyor belt is attained. The aim of modified regulation of this kind is to operate the processing station at full capacity up to the end of the processing operation, and avoid the processing station lagging behind for isolated subsequently delivered products, at a low level of utilization of its capacity. For that purpose, it will typically be necessary to stop the longitudinal conveyor belts in a time-displaced relationship, as the longitudinal conveyor belts which are closest to the processing station have to be stopped last, and the most remote longitudinal conveyor belt has to be stopped first in order to achieve the desired abrupt termination of product accumulation on the transverse conveyor belt.
[0049] It is particularly preferred that the regulating device is coupled to a force sensor arranged at the exit region of the transverse force conveyor belt or a counting sensor of the above-described kind and is adapted to regulate the conveyor speed of the transverse conveyor belt as a function of the sensor signal.
[0050] Implementation of such a force sensor, in particular in conjunction with the conveyor arrangement according to one aspect of the present invention with a regulating device, permits reliable, comfortable and convenient regulation, as the variation in the conveyor speed of the transverse conveyor belt that is caused by virtue of the force sensor, is incorporated into the regulation action in the form of the transverse conveyor belt advance, and can thus be taken into consideration. In other words, for the first time it is possible with the conveyor arrangement according to one aspect of the invention to achieve full utilization of the processing station at any time in the conveyor operation, and to avoid repeated starting and stopping of the transverse conveyor belt, insofar as stepless regulation of the transverse conveyor belt is effected, and at the same time, the width of the transverse conveyor belt is completely filled up with products from the longitudinal conveyor belts at any time and at any location on the transverse conveyor belt.
[0051] Finally, a further development of the conveyor arrangement according to one aspect of the invention provides a display device, which is coupled to the regulating device to obtain from the regulating device signals for positionally resolved representation of the number of products on the transverse conveyor belt. The subject display device makes it possible for a user or operator of the conveyor arrangement to recognize full utilization of the individual conveyor belt lines and the processing station at a glance, and if necessary, modify and optimize the regulating procedures by means of parameter selection.
[0052] In accordance with a further aspect of the invention, there is proposed a conveyor arrangement comprising a transverse conveyor belt and a plurality of longitudinal conveyor belts leading onto the transverse conveyor belt, with at least one movable product guide device which is arranged above the transverse conveyor belt, and which is coupled to an actuator, wherein the actuator can move the product guide device into at least two positions at the support region of the transverse conveyor belt. The product guide device is laterally placed on the transverse conveyor belt in such a way that it guides the products on the transverse conveyor belt away from the entry region of at least one longitudinal conveyor belt. With this conveyor arrangement, it is possible to avoid a collision between products which are already on the transverse conveyor belt and products which are arriving from the longitudinal conveyor belt. The actuator can be actuated electrically, pneumatically, hydraulically or in another fashion. The product guide device can be a pivotably mounted plate.
[0053] In that embodiment, it is particularly preferred that there are a plurality of movable product guide devices, which are respectively arranged upstream of the entry regions of a plurality of longitudinal conveyor belts in the conveyor direction of the transverse conveyor belt. This feature permits variable product guidance in dependence on the conveyor state and the activated longitudinal conveyor belts.
[0054] It is further preferred that the actuator of each product guide device is coupled to a central control device, and is actuated as a function of the degree of filling of the transverse conveyor belt as calculated by the control device from supplied products and transverse belt advance upstream of the respective product guide device, in order to guide the products away from the entry region of the longitudinal conveyor belts to the degree permitted by the degree of filling. It is possible in that way to prevent the products from being damaged or laterally pushed away by the transverse conveyor belt. The product guide device can be so set that the maximum possible deflection is achieved, or only a fraction thereof, to achieve a deflection which is precisely sufficient to provide space on the transverse conveyor belt for the products which are still to be added thereto.
[0055] In addition, in the situation involving groupwise collection, it is preferable that the actuator of each product guide device is actuated in relation to the collected group. Pre-programmed actuator actuation can be effected in that way, and can be set in a group-dependent relationship when the respective group is collected.
[0056] The above-described conveyor arrangement according to one aspect of the invention is preferably used for conveying eggs on a longitudinal conveyor belt on which a plurality of mutually spaced, stationary intermediate storage regions is provided, which are so arranged that they receive the eggs laid in nest regions in cages arranged in a row along the longitudinal belt.
[0057] The above-described conveyor arrangement according to one aspect of the invention can further be used for conveying eggs on a transverse conveyor belt in order to convey eggs into an intermediate storage region, which is arranged in the conveyor direction upstream of an installation for further processing, such as a packaging installation.
[0058] The conveyor arrangement according to one aspect of the invention is preferably operated with a method of conveying eggs in the region of a henhouse comprising a plurality of cage units, comprising the steps:
a. temporarily storing or collecting the eggs laid in a first nest region of a cage or in a first cage on a first intermediate storage region of a static or stationary conveyor belt, b. measuring the cumulative force due to the weight of the eggs in the first intermediate storage region, c. conveyance of the longitudinal conveyor belt by a predetermined distance, such that a conveyor belt portion which is not occupied with eggs is provided as the first intermediate storage region, d. repetition of steps a to c up to a time at which further conveyance of the longitudinal conveyor belt by the predetermined distance would provide a conveyor belt portion already occupied with eggs due to an adjacent second intermediate storage region of a nest region of an adjacent second cage or a second cage as the first intermediate storage region, and e. further conveyance of the conveyor belt until the eggs deposited thereon have been transferred completely onto a second conveyor belt or into a storage means.
[0064] Another preferred method to operate the above-described conveyor arrangement comprises the steps:
a. conveying the eggs on a first conveyor apparatus into an intermediate storage region, b1. measuring the cumulative pressing force exerted by the eggs on a lateral boundary wall portion of the intermediate storage region, or b2. measuring the eggs standing up in the intermediate storage region, c. further conveying the eggs out of the intermediate storage region by means of a second conveyor apparatus, and d. regulating the conveyor speed of the first or second conveyor apparatus in dependence on the measured pressing force or the measured number of eggs standing up.
[0070] In accordance with a further aspect the present conveyor arrangement, the same can be operated with a method comprising the steps: conveying products on a transverse conveyor belt to a processing station, and delivering products by means of a plurality of longitudinal conveyor belts onto the transverse conveyor belt at various, mutually spaced locations, wherein the conveyor advance of the transverse conveyor belt is detected, and at the beginning of the conveyor operation, the longitudinal conveyor belts are set in operation in a time-displaced relationship as a function of the spacing between their point of entry onto the transverse conveyor belt and the processing station, and the conveyor advance of the transverse conveyor belt.
[0071] It is preferred that the first longitudinal conveyor belt most remote from the processing station is set in operation first, and a second conveyor belt arranged closer to the processing station is set in operation at a time at which the transverse conveyor belt has advanced to such an extent that the products conveyed by the first longitudinal conveyor belt have reached the entry region of the second longitudinal conveyor belt.
[0072] It is preferred that before the beginning of the conveyor operation, at least two groups of longitudinal conveyor belts are defined, and the longitudinal conveyor belts of a first group are activated first, and the longitudinal conveyor belts of a second group are activated subsequently.
[0073] It is preferred that in each group, the longitudinal conveyor belt furthest away from the processing station is activated first.
[0074] It is preferred that the longitudinal conveyor belts of the group with the longitudinal conveyor belt furthest away from the processing station are activated as the last group.
[0075] It is preferred that the time of stopping the last longitudinal conveyor belt of a group and activating the first longitudinal conveyor belt of a subsequent group is determined as a function of the spacing between the point of entry of the last longitudinal conveyor belt and the first longitudinal conveyor belt to the transverse conveyor belt, and the transverse conveyor belt advance.
[0076] It is preferred that the longitudinal conveyor belts and the transverse conveyor belt are stopped when the last product of a group has been conveyed into the processing apparatus.
[0077] It is preferred that the last product of the last longitudinal conveyor belt of the first group and the first products of the first longitudinal conveyor belt of the second group are deposited in a common mixed region on the transverse conveyor belt.
[0078] It is preferred that an intermediate space is provided on the transverse conveyor belt between the products of the first group of longitudinal conveyor belts and the products of the second group of longitudinal conveyor belts.
[0079] It is preferred that so many longitudinal conveyor belts are activated and/or the conveyor speed of the activated longitudinal conveyor belts is regulated, such that so many products are fed to each region of the transverse conveyor belt that a predetermined capacity of the processing station is attained.
[0080] It is preferred that a fraction of the transverse conveyor belt width is allocated to each activated longitudinal conveyor belt, and the conveyor speed of each longitudinal conveyor belt is so regulated that the respectively allocated width of the transverse conveyor belt is filled with products by the respective longitudinal conveyor belt.
[0081] It is preferred that each longitudinal conveyor belt pre-stores a given number of products, and the products stored on each longitudinal conveyor belt are detected by sensors, and a smaller fraction of the transverse conveyor belt width is allocated to a longitudinal conveyor belt with fewer products than the longitudinal conveyor belt with more products, in order to achieve termination of emptying of all longitudinal conveyor belts at the same time, or in time-displaced relationship by a given amount.
[0082] It is preferred that a force sensor arranged at the discharge region of the transverse conveyor belt measures the pressing force prevailing horizontally between the products at the discharge region, and the conveyor speed of the transverse conveyor belt is regulated in accordance with the force sensor signal.
[0083] It is preferred that the conveyor speed of the transverse conveyor belt is reduced if the measured pressing force exceeds a predetermined value.
[0084] It is preferred that the conveyor speed of the transverse conveyor belt is increased if the measured pressing force falls below a predetermined value.
[0085] It is preferred that the conveyor speed of the longitudinal conveyor belts and/or the transverse conveyor belt is steplessly or dynamically altered or varied.
[0086] It is preferred that a processing starting time is input, and activation and conveyor speed of the longitudinal conveyor belts and the transverse conveyor belt are started at a time ascertained as a function of the spacing between the longitudinal conveyor belt entry onto the transverse conveyor belt, and the transverse conveyor belt advance, in order to feed products to the processing station in a predetermined capacity at the start time of the processing station.
[0087] The invention can further be implemented using a computer program product for execution on a computer, which is so programmed that it performs the steps required for regulation of the conveyor arrangement according to the invention when it is executed on a computer.
[0088] These and other advantages of the invention will be further understood and appreciated by those skilled in the art by reference to the following written specification, claims and appended drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0089] A preferred embodiment of the invention is described with reference to the Figures in which:
[0090] FIG. 1 shows a diagrammatic view of a conveyor arrangement having six henhouse buildings, longitudinal conveyor belts and a transverse conveyor belt,
[0091] FIG. 1 a shows a view on an enlarged scale of an individual henhouse building as shown in FIG. 1 ,
[0092] FIG. 2 shows a diagrammatic plan view of the region of a row of henhouses with aviaries arranged in a mutually juxtaposed relationship,
[0093] FIG. 3 shows a side view in cross section of the region of the longitudinal conveyor belt and the region of rolling out of a nest of an aviary,
[0094] FIG. 4 a shows a first embodiment of the entry region of a transverse conveyor belt into a packer with a force pickup device,
[0095] FIG. 4 b shows a second embodiment as shown in FIG. 4 a,
[0096] FIG. 4 c shows a third embodiment as shown in FIG. 4 a,
[0097] FIG. 5 shows a side view of a variant of the embodiments of FIGS. 4 b and 4 c,
[0098] FIG. 6 shows a plan view of a fourth embodiment as shown in FIG. 4 a with a transverse conveyor belt regulator,
[0099] FIG. 7 shows a diagrammatic view of a visualization of the conveyor advance of a transverse conveyor belt in a start-up phase of the conveyor operation,
[0100] FIG. 8 shows a portion from FIG. 7 at a time of termination of the conveyor operation,
[0101] FIG. 9 shows a diagrammatic view of a further embodiment of the conveyor arrangement according to the invention with two transverse conveyor belts,
[0102] FIG. 10 shows a diagrammatic view of the visualization of the conveyor belt advance of the arrangement shown in FIG. 9 , and
[0103] FIG. 11 shows a diagrammatic plan view of a portion of a transverse conveyor belt with five longitudinal conveyor belts entering the same and four controllable product guide devices.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0104] For purposes of description herein, the terms “upper”, “lower”, “right”, “left”, “rear”, “front”, “vertical”, “horizontal” and derivatives thereof shall relate to the invention as oriented in FIGS. 1 and 1 a . However, it is to be understood that the invention may assume various alternative orientations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise.
[0105] FIG. 1 shows an egg farm with six henhouse buildings 1 - 6 , each of which has four double rows 1 a - 1 d with a plurality of tiers of aviaries or cage systems arranged in rows one behind the other.
[0106] The henhouse buildings 1 - 6 are arranged in mutually juxtaposed relationship in such a way that a transverse conveyor belt 10 can pass in a straight line at the end of the henhouse buildings. The transverse conveyor belt 10 is oriented at a right angle to the rows of aviaries 1 a - 1 d in the region of the henhouse buildings.
[0107] As can be clearly seen in particular from FIG. 1 a , longitudinal conveyor belts 11 a - 11 d and 12 a - 12 d are arranged in a mutually parallel relationship, and are respectively disposed at each side of the rows of aviaries 1 a - 1 d . Each tier of the rows of aviaries has its own longitudinal conveyor belts so that, for the five tiers of the rows of aviaries as shown in FIGS. 1 and 1 a , there are total of ten longitudinal conveyor belts for each row of aviaries, and forty longitudinal conveyor belts for each henhouse building. The longitudinal conveyor belts 11 a - 11 d and 12 a - 12 d of the individual rows of aviaries communicate alternatively with an elevator (not shown) at the end of each row of aviaries, which lifts the eggs out of the ten longitudinal conveyor belts of a row of aviaries onto the transverse conveyor belt 10 , or alternatively, the transverse conveyor belt 10 is displaced in height and the five tiers of the rows of aviaries are collected sequentially or in succession with respect to time.
[0108] The transverse conveyor belt 10 conveys from right to left in FIGS. 1 and 1 a , and opens into a packaging station 20 in which the eggs are packaged.
[0109] A central control and regulating unit 30 is connected to peripheral control and regulating units in each henhouse building, and carries out the control and regulating procedures according to the invention for the longitudinal conveyor belts 11 a - 11 d and 12 a - 12 d and the transverse conveyor belt 10 .
[0110] A central farm control system 40 permits a selection of parameters, as well as visualization of the egg collection procedure and the degree of utilization of the individual conveyor belts.
[0111] FIG. 2 shows a plan view of a portion of a double row of aviaries with four aviaries in an adjoining relationship to the left and the right, respectively, and two further partially illustrated aviaries. An individual aviary extends over a length L 1 of the longitudinal conveyor belts 11 a , 12 a. A fraction L 2 of the length L 1 is occupied by a nest region L 3 in the aviary. In the region of the length L 2 , over 90 percent of the eggs are laid by the hens in the aviary, so that the longitudinal conveyor belt 11 a is filled in the region L 2 in the stopped or static condition in a relatively short period of time during the laying period.
[0112] Two nest regions 13 of adjacent aviaries are in a directly adjoining relationship, as can be seen from FIG. 2 . Therefore, when the longitudinal conveyor belt in the region of the nest is filled with eggs, the longitudinal conveyor belts 11 a , 12 a must be advanced at least by double the length L 2 in order to move a portion of the conveyor belt which is empty into the nest region 13 . As the length L 2 in the present example is a quarter of L 1 , that advance movement on the part of each longitudinal conveyor belt 11 a , 12 a can be effected three times. On the fourth occasion, the filled region of each longitudinal conveyor belt 11 a , 12 a would be conveyed out of the nest region 13 into the nest region 14 . As in that situation, the longitudinal conveyor belt is therefore full, and the longitudinal conveyor belt must be continuously operated after it has advanced three times by the length 2×L 2 until all eggs are conveyed from the longitudinal conveyor belt 11 a , 12 a onto the transverse conveyor belt 10 .
[0113] FIG. 3 shows an arrangement of the force sensor according to the invention, which is adapted to control the advance of the longitudinal conveyor belts 11 a - 11 d and 12 a - 12 d as shown as a function of the number of eggs which have rolled from the nest region 13 onto the longitudinal conveyor belt. The eggs roll on an inclined plane 15 out of the nest region 13 to the longitudinal conveyor belt 11 a . The upper run of the longitudinal conveyor belt 11 a runs above a weighing pan 16 which is coupled to a force sensor 18 by means of two L-shaped members 17 a, 17 b. The force sensor 18 is fixedly connected to the frame of the aviaries by means of a U-shaped member 19 . The force sensor 18 ascertains the weight of the eggs arranged on an intermediate storage region 16 ′ on the conveyor belt 11 a above the weighing pan 16 .
[0114] The force sensor 18 can be in the form of a pressure sensor, but preferably it is in the form of a flexural beam sensor acting at one side, which represents a robust structure, which at the same time is also reliable.
[0115] The procedure involved in the conveyor method of the arrangement shown in FIG. 3 is as follows. The eggs roll on the inclined plane 15 to a stop wire outside the aviary frame (not shown). The stop wire slows down the eggs and thus prevents those eggs from colliding with eggs which are already lying on the longitudinal conveyor belt 11 a , and it is cyclically lifted to allow the eggs to pass through onto the conveyor belt 11 a at a low speed. The greater the number of eggs on the conveyor belt 11 a in the region above the weighing pan 16 , the correspondingly greater weight is detected by the force sensor 18 . Upon the attainment of a given limit value, which on the basis of an average egg weight, indicates complete filling of the longitudinal conveyor belt 11 a in the region of the nest, the longitudinal conveyor belt is advanced by double the magnitude of the nest length in order to move an empty region of the longitudinal conveyor belt 11 a into the nest region 13 . That procedure is repeated three times, and on the fourth occasion, complete collection of the eggs from the longitudinal conveyor belt 11 a is implemented by the longitudinal conveyor belt being operated until it has covered at least a total lengthwise extent of the conveyor belt (that is to say half the length of the conveyor belt) and all eggs have been conveyed onto the transverse conveyor belt 10 .
[0116] FIG. 4 a shows another embodiment of the force sensor according to the invention in the entry region to a packaging station 20 . The eggs are passed to the packaging station 20 by one or more transverse conveyor belts 10 by way of a funnel table 10 ′, and are brought together to the width of the packaging station 20 on the table by means of wall guide elements 21 . That provides for compacting the distribution of the eggs in an intermediate storage region 21 ′ between the two wall guide elements 21 . In the entry region of the packaging station 20 , the eggs must be introduced into guide passages 22 a, 22 b, etc. In those regions, a build-up and congestion or accumulation of eggs may occur by virtue of transversely disposed eggs, which can lead to further compacting of the egg distribution. That compacting effect can mean that the horizontal pressure between the eggs in the entry region upstream of the packaging station can become so great that hair cracks are produced in the eggshells, or the eggs are completely destroyed.
[0117] In order to detect such a situation before damage occurs, arranged laterally in the entry region are two pressure sensors 23 a, 23 b coupled to two half-round pressure pickup plates 24 a , 24 b. The pressure pickup plates 24 a and 24 b project into the flow of eggs and detect a superposed, horizontally acting force component in transverse relationship with the conveyor direction and in opposite relationship to the conveyor direction. In relation to the level of the force detected by the force sensors 23 a, 24 b, the conveyor speed of the transverse conveyor belt 10 is regulated. If the measured force rises, the transverse conveyor belt speed is reduced, while if the force falls, the transverse conveyor belt speed is increased.
[0118] FIG. 4 b shows an alternative to the arrangement of FIG. 4 a. In the FIG. 4 b arrangement, the force sensors 23 a, 24 b are replaced with light barrier devices 25 a, 25 b which pass transversely over the entry region of the packaging station 20 . The light barrier devices are so oriented that they measure over the eggs which are lying flat on the bottom surface of the packaging station, as can be seen from FIG. 5 . As soon as an egg stands up on end, or the eggs come to lie one upon the other, they break the light beam of the light barrier device 25 a, 25 b. The number of such detected eggs is a measurement which reflects the horizontal pressure between the eggs in the entry region, and can once again serve to regulate the transverse belt conveyor speed, as described hereinbefore.
[0119] FIG. 4 c shows a further variant of the embodiment with light barrier devices as shown in FIG. 4 b. In FIG. 4 c, there are a total of four light barrier elements 26 a - 26 d which monitor the entry region of the packaging station 20 over the area thereof, and thus ensure more precise detection of eggs which are standing up or which are arranged one upon the other.
[0120] FIG. 6 shows a variant of the embodiment of FIG. 4 a with force sensors. The transverse conveyor belt 110 conveys the eggs by way of a funnel table 110 ′ into a reaction region 122 in front of a packaging station 120 . Side wall elements 121 a, 121 b guide the eggs together and compress the distribution thereof. Arranged at each of the side wall elements 121 a, 121 b is a respective pressure pickup 123 a, 123 b coupled to a half-round deflection and pressure pickup plate 124 a, 124 b. The pressure pickup plate 124 a, 124 b is respectively pivotably mounted in a hinge mounting 125 a, 125 b arranged on the side facing towards the conveyor direction and as a result can freely movably transmit a pressing force exerted by the eggs to the pressure pickup 123 a, 123 b.
[0121] Placed centrally in the reaction region 122 , in the form of an island arrangement, are two further pressure sensors 123 c, 123 d which are again supported by means of two half-round pressure pickup plates 124 c, 124 d mounted pivotably in a common pivot mounting 125 c in order to detect the horizontal egg pressure in the central region. The use of four pressure pickups at mutually spaced locations with a differing measurement direction ensures that even local compression phenomena, indicative of egg distribution with unacceptably high horizontal forces, are detected, and the transverse belt conveyor speed can be appropriately regulated.
[0122] The pressure pickups 123 a - 123 d are connected to a central transverse conveyor belt control 126 , coupled in turn to a frequency converter 127 for actuating the drive motor 128 for transverse belt conveyance.
[0123] A timing device 129 is also connected to the central control unit 126 and indicates the advance of the transverse conveyor belt.
[0124] FIG. 7 shows an example of a display screen that provides visualization of the full utilization and advance of the transverse conveyor belt 210 . The transverse conveyor belt 210 is divided into a plurality of transverse strips, each respective one of each represents a transverse conveyor belt length of 1 m.
[0125] Along the transverse conveyor belt 210 , six longitudinal conveyor belts 211 a - 211 f communicate at spaced locations with the transverse conveyor belt 210 . The longitudinal conveyor belts are illustrated by box symbols 211 a - 211 f in which are shown parameters relating to the conveyor properties of the longitudinal conveyor belt.
[0126] The left-hand end the transverse conveyor belt 210 leads to a packaging station 220 .
[0127] FIG. 7 shows a conveyor arrangement state in which the collection operation from the longitudinal conveyor belts 211 was begun a short time ago. That is represented by black bars in the transverse conveyor belt regions downstream in the conveyor direction of the point of entry of the longitudinal conveyor belt 211 f . The black bar region 212 symbolically represents the eggs deposited on the transverse conveyor belt 210 . In addition, a hatched rectangular region in the region of the entry of the longitudinal conveyor belt 211 f symbolically represents the transverse conveyor belt width allocated to the longitudinal conveyor belt 211 f.
[0128] FIG. 8 shows the arrangement of FIG. 7 at a later time in the operation of transverse conveyor 123 . In region 213 f filled to a reference value, the transverse conveyor belt picks up eggs to a transverse conveyor belt capacity of 80 percent, which includes a safety margin in relation to utilization at full capacity. In the region 214 , it is possible to see the discharge of the collection of the first group of eggs, which can be seen by virtue of the fact that the width of the transverse conveyor belt is utilized in a diagonally decreasing fashion. The first group, in the direction of conveyor travel, is followed by a second group of eggs, which is put onto the transverse conveyor belt by activation of the longitudinal conveyor belt 211 e . A gap 216 is left between the group 213 , 214 , and the group 215 , wherein the gap allows a short period of time for conversion of the packaging station 220 .
[0129] FIG. 9 shows a diagrammatic plan view of a conveyor arrangement having two transverse conveyor belts 310 , 312 , and FIG. 10 shows a diagrammatic view of a display screen that provides visualization of that conveyor arrangement. As can be seen, arranged at each transverse conveyor belt 310 , 312 are a plurality of longitudinal conveyor belts 311 a - 311 e , 313 a - 313 e, which lead onto the transverse conveyor belt 310 and 312 , respectively, at spaced locations. Each longitudinal conveyor belt 311 a - 311 e , 313 a - 313 e has its own local control, which actuates the longitudinal conveyor belt as a function of a weighing sensor, as shown in FIG. 3 , and at the command of a higher order central control system 330 , which causes total emptying of the longitudinal conveyor belt onto the corresponding transverse conveyor belt.
[0130] Both transverse conveyor belts 310 , 312 open to a packaging station 320 .
[0131] As can be seen from FIG. 10 , the eggs collected on the transverse conveyor belt are placed thereon in a locally displaced relationship from four activated longitudinal conveyors 331 c - 331 f, and are fed in the form of an interconnected block corresponding to the capacity of the packaging station 320 , to the packaging station 320 . On the transverse conveyor belt 312 , only the longitudinal conveyor belts 313 d - 331 f are active, and it is only after a further advance of the transverse conveyor belt 312 that the further longitudinal conveyor belts 313 a - 313 f are switched on.
[0132] FIG. 11 shows a portion of a transverse conveyor belt 410 with a plurality of longitudinal conveyor belts 411 a - 411 e which connect with the transverse conveyor belt 410 at locations of entry of which are spaced from each other in the conveyor direction. A plurality of eggs, which are symbolically represented by circles on the conveyor belt, are conveyed on the transverse conveyor belt in the conveyor direction shown by the arrow.
[0133] As will be seen, the products pass into the illustrated portion of the transverse conveyor belt at the right-hand edge, as viewed in the direction of the transverse conveyor belt, and would therefore impede the feed of further eggs from the longitudinal conveyor belts 411 a - 411 e , as they would first have to press the eggs, which are already on the transverse conveyor belt, in the direction of the left-hand edge, as seen in the direction of conveying movement of the transverse conveyor belt, with a considerable horizontal pressure. In that situation, the eggs can suffer damage.
[0134] Arranged upstream of longitudinal conveyor belt 411 e in the conveyor direction of transverse conveyor belt 410 is an egg guide device 420 a, which includes an egg guide plate 421 a mounted pivotably in a laterally and stationarily supported pivot mounting 422 a. The egg guide plate 421 a can be pivoted into or out of the region above the transverse conveyor belt 410 by means of an actuator, which in this case, is an electrical linear drive 423 a with position feedback signaling.
[0135] Arranged in a similar fashion and of a similar structure, between the longitudinal conveyor belts 411 d and 411 e , between the longitudinal conveyor belts 411 c and 411 d and between the longitudinal conveyor belts 411 b and 411 c , are respective egg guide devices 420 b - 420 d, which are of the same structure as the egg guide device 420 a.
[0136] In the illustrated conveyor condition, additional eggs are conveyed from the longitudinal conveyor belts 411 a - 411 e to add to the eggs which are already on the transverse conveyor belt 410 . In order to avoid damage to the additional eggs which are being supplied thereto, or the eggs which are already on the transverse conveyor belt, in that conveyor condition, the egg guide device 420 a is pivoted into the region above the transverse conveyor belt 410 to such an extent that the eggs are deflected from the right-hand side to the left-hand side, so that space is provided for the eggs additionally arriving from the longitudinal conveyor belts 411 a - 411 e . The egg guide devices 420 b and 420 c are not pivoted out.
[0137] The egg guide device 420 d is pivoted out by a lesser amount than the egg guide device 420 a in order to guide the eggs which are additionally arriving from the longitudinal conveyor belts 411 d , 411 e away from the right-hand edge of the transverse conveyor belt, and thus provide space for the eggs which are being added from the longitudinal conveyor belts 411 a , 411 b , without guiding the entire flow of eggs on the transverse conveyor belt excessively far in the direction of the left-hand edge of the transverse conveyor belt, as that would cause damage to the eggs which are already on the transverse conveyor belt 410 .
[0138] The electrical linear drives 423 a - 423 d and the position feedback signaling units of those drives of the egg guide devices 420 a - 420 d are coupled to the central control system, and are actuated as a function of the number of eggs already on the transverse conveyor belt, their arrangement, and possibly the conveyor rate of the longitudinal conveyor belts which are additionally feeding eggs, and are extended to such an extent that neither damage to the deflected eggs nor damage to the eggs which are being added can occur.
[0139] The conveyor method according to the invention operates as follows.
[0140] At a time about three hours after the beginning of laying, the longitudinal conveyor belt 311 f which is most remote from the packaging station is activated and conveys the eggs onto the transverse conveyor belt 310 . The transverse conveyor belt 310 is also activated and conveys the eggs in the direction of the packaging station 320 . As soon as the eggs moved onto the transverse conveyor belt 310 by the longitudinal conveyor belt 311 f reach the point of entry of the longitudinal conveyor belt 311 e , the longitudinal conveyor belt 311 e is also activated and conveys the eggs onto the transverse conveyor belt 310 . In that way, the eggs on the two longitudinal conveyor belts 311 e , 311 f are added to give a total transverse conveyor belt width. As soon as that region reaches the point of entry of the longitudinal conveyor belt 311 d , longitudinal conveyor belt 311 d is also activated, and so forth, until activation of the longitudinal conveyor belt 311 a occurs. In that way, full utilization of capacity is achieved over the full width of the transverse conveyor belt, and at the beginning of the work done by the packers at the packaging station 320 , the transverse conveyor belt is completely filled, and the eggs are positioned just upstream of the packaging station 320 .
[0141] The eggs supplied by each longitudinal conveyor belt are counted in the region of the mouth opening of the respective longitudinal conveyor belts to provide a check concerning the laying output of the respective henhouse or the respective rows of aviaries. Furthermore, the egg counting operation makes it possible to precisely determine the eggs disposed on the transverse conveyor belt. As soon as it is recognized that a longitudinal conveyor belt contains a very high number of eggs, for example by a high number of eggs already being counted with a short advance movement of the longitudinal conveyor belt, a greater transverse conveyor belt width is allocated to that longitudinal conveyor belt, and a correspondingly reduced width is allocated to the other longitudinal conveyor belts. This ensures that even the longitudinal conveyor belt which is filled to an above-average extent is emptied within a period of time in which the other longitudinal conveyor belts are also emptied. This dynamic regulation can possibly be further adapted if other longitudinal conveyor belts emerge as being emptied belatedly or prematurely.
[0142] The method according to the invention is the first to make it possible to provide for automatic regulation and full utilization of the capacity of the packaging station as a function of the eggs supplied by the individual longitudinal conveyor belts and the individual spacing thereof from the packaging station, as well as the respective currently prevailing transverse conveyor belt advance.
[0143] In the foregoing description, it will be readily appreciated by those skilled in the art that modifications may be made to the invention without departing from the concepts disclosed herein. Such modifications are to be considered as included in the following claims, unless these claims by their language expressly state otherwise.
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A conveyor for shock-sensitive products includes a conveyor member with at least one intermediate storage region adapted to receive a predetermined number of the products placed thereon when the conveyor is a static condition for temporary intermediate storage. A force measuring member determines the weight force of the products in the intermediate storage region. A control member, adapted to increase and decrease the rate of feed of the shock-sensitive products in the conveyor member, processes the weight force detected by the force measuring member as an input parameter, and increases or reduces the rate of feed of the products toward and away from the intermediate storage region as a function of the weight force.
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FIELD OF THE INVENTION
This invention relates to the field of operating room surgical instruments and devices for handling such instruments during and after surgical procedures.
BACKGROUND OF THE INVENTION
There are a wide variety of surgical tools and instruments which are used in modern surgical procedures. Many specialized surgical procedures that are now routinely performed, including less invasive laproscopic/endoscopic surgery, involve instruments that are longer or larger and more cumbersome to handle than instruments used in the past. An example of these would be laproscopic cutting, grasping and stapling instruments, etc. and certain orthopedic and abdominal surgical instruments, to name a few.
During surgical procedures, once instruments are used, operating room nurses typically place them into round surgical basins filled with a sterile solution. These basins sit into the ring portion of conventional surgical ring stands. The instruments remain in these basins on the ring stands until after the surgical procedure is concluded when the instruments are then transported to a separate decontamination area and sterilized.
With many surgical procedures, the used instruments do not fit completely into the round surgical basins because either the instruments are too long to fit into the basins or the basins simply cannot accommodate the number of instruments that have been used. In such cases, the instruments may not be safely kept in the basins. Presently, there are several types of larger soaking trays, some including an inner strainer, which are used to transport contaminated surgical instruments from an operating room to a decontamination area.
Utilizing any of these soaking trays requires the transfer, by hand, of the contaminated instruments from the round surgical basins into a soaking tray filled with enzyme pre-soak and decontamination solution and then the later transfer, by hand, of the same instruments from the soaking tray into, for example, a sink in a decontamination area. Because of this extra handling of the instruments, the current practice is inefficient and increases the likelihood of both injuries to hospital personnel and damage to the instruments.
In addition, it is also a typical practice for the soaking tray to be lifted from its transport cart onto, for example, a counter in the decontamination area. This requires the lifting of an often very heavy tray containing solution and contaminated surgical instruments. Once the instruments have been removed from the soaking tray, the solution remaining in the tray is then typically poured into a sink which requires still further lifting and tilting of the tray and creates the risk of splashing contaminated solution. Such lifting and splashing also increases the likelihood of workplace injuries.
Accordingly, there is a need for a system of handling operating room surgical instruments which can easily accommodate the larger instruments typical of today's modern surgical procedures and at the same time provide a more efficient and safer way of handling such instruments.
SUMMARY OF THE INVENTION
To these ends, in a system and method for handling operating room surgical tools and instruments, whereby both safety and efficiency in handling are improved, a rectangular porous strainer is preferably provided which is sufficiently large to fully contain a quantity of contaminated operating room surgical instruments of various shapes and sizes. A waterproof rectangular basin is advantageously sized and shaped to receive the porous strainer. The basin is adapted to fit onto a conventional surgical ring stand, either alone or with the use of an adapter.
In use, sterile surgical items, such as sponges, needle counters and instruments, can be delivered to an operating room in the sterile basin and strainer.
The basin with the strainer inside is advantageously adapted to fit onto or into a conventional surgical ring stand, in place of a traditional round basin.
When the surgical procedure is completed, the basin with the inner strainer containing contaminated instruments and enzyme pre-soak and decontamination solution is preferably covered and taken to a decontamination area, thereby eliminating the necessity of manually transferring the instruments into a separate soaking tray. The strainer provides a safer and easier way of removing the instruments from the contaminated solution. Furthermore, a drains is advantageously provided on the rectangular basin to permit hospital personnel to quickly drain the contaminated solution from the basin without having to lift the basin to pour out the liquid. The surgical ring stand is preferably used to transport the basin and strainer containing the instruments and solution. Thus handling of the surgical instruments is reduced. Furthermore, lifting of heavy trays or basins filled with contaminated surgical instruments and solution is also most desirably avoided.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings wherein similar reference characters denote similar elements throughout the several views:
FIG. 1 is an exploded perspective view of a preferred embodiment of the present invention which includes a rectangular porous strainer which fits into a waterproof rectangular basin, and a cover which can be used when the system is being transported. In the embodiment shown, the basin is adapted to fit stably onto a conventional surgical ring stand without the need for a separate adapter.
FIG. 2 is a plan view of a rectangular basin in an embodiment which includes a rim and an internal drain fitting and further includes bottom supports by which the basin fits stably onto a conventional surgical ring stand.
FIG. 3 is a section view of the basin of FIG. 2 taken along line 3--3.
FIG. 4 is an end view of the basin of FIG. 2.
FIG. 5 is a plan view of a rectangular strainer.
FIG. 6 is a section view of the strainer of FIG. 5 taken along lines 6--6.
FIG. 7 is an end view of the strainer of FIG. 5.
FIG. 8 is a plan view of a cover in an embodiment which includes an integral handle and a rim.
FIG. 9 is a section view of the cover of FIG. 8 taken along lines 9--9.
FIG. 10 is a section view of the cover of FIG. 8 taken along lines 10--10.
FIG. 11 is an exploded perspective view of an alternative embodiment of the present invention utilizing a conventional surgical ring stand with an adapter for stably holding a rectangular basin that does not have bottom supports.
FIG. 12 is an exploded perspective view of another embodiment which includes a basin stand capable of stably holding a rectangular basin without bottom supports and without using an adapter.
FIG. 13 is an exploded perspective view of yet another embodiment having two narrow basin and strainer combinations which can replace a single wider rectangular basin and strainer.
FIG. 14 is an exploded view depicting the internal drain fitting and basin of FIG. 3.
FIG. 15 is a section view of the internal drain fitting of FIG. 14.
FIG. 16 is an exploded view showing an alternative embodiment of the drain fitting.
FIG. 17 is a section view of yet another embodiment of the drain spout.
DETAILED DESCRIPTION OF THE INVENTION
Turning in detail to the drawings, FIG. 1 shows a preferred embodiment of the invention comprising a rigid rectangular porous strainer 50, which fits within a rectangular waterproof basin 30, and a cover 60 which fits onto the assembled basin 30 and strainer 50. The basin 30 in this embodiment includes integral bottom supports 48 which, as will be discussed in more detail below, enable the basin 30 to stably fit onto a ring 23 on a conventional surgical ring stand 22. Furthermore, the basin 30 shown in FIG. 1 has an integral rim 42 which provides additional strength and rigidity as well as a convenient feature of lifting the basin 30.
The basin 30 is shown in greater detail in FIGS. 2-4. The basin 30 has a rectangularly shaped floor 32, having a top surface 34 and a bottom surface 36 and four integral side walls 38 extending upwardly from the floor 32 and substantially perpendicular to the floor 32. The floor 32 and sidewalls 38 together form the waterproof rectangular basin 30.
The basin 30 also includes an internal drain fitting 150 on the floor 32 at a position near a shorter sidewall 38a. The drain fitting 150 allows solution within the basin 30 to be easily drained. It is preferred that the geometry and position of the drain fitting 150 be such that the presence of the porous strainer 50 fitted within the basin 30 would not interfere with the draining function. The drain fitting 150 is sized to permit the attachment of a length of tube 170 such as surgical tubing to aid in draining. An adapter 168 can be used to facilitate the connection of the tube 170 to the fitting 150. As seen in FIG. 15, a removable cap 172 is provided for the tube 170 to prevent accidental drainage. A hook 174 is located on sidewall 38a to securely hold the tube 170 in an upright position to prevent accidental drainage.
FIG. 15 shows the internal drain fitting of FIG. 3 in greater detail. The fitting 150 has a generally circular flange 152 having a, bottom surface 155. Extending downwardly from the flange 152 is a neck 154 with an internal bore 158. A short tubular drain spout 156 extends substantially perpendicular to the neck 154 and in fluid connection with the internal bore 158.
FIG. 14 illustrates the installation of the internal drain fitting 150 of FIGS. 3 and 15. A generally circular recess 160 corresponding in size to the flange 152 on the fitting 150 is located on the top surface 34 of the floor 32 of the basin 30. A circular opening 162 through the floor 32 is located in the center of the recess 160. The opening 162 is sufficiently large so that the drain spout 156 and neck 154 of the drain fitting 150 can pass through the opening 162. The drain fitting 150 is attached to the basin floor 32 by a sealing mechanism such as an ultrasonic seal or a glue between the recess 160 and the bottom surface 155 of the flange 152.
FIGS. 16-17 illustrate alternative embodiments of the drain. An external drain fitting 190 is shown in FIG. 16. The external drain fitting 190 has a generally circular flange 192 having a top surface 193. Extending downwardly from the flange 192 is a neck 194 with an internal bore 198. Substantially perpendicular to the neck 194 is a tubular drain spout 196 which is in fluid connection with the internal bore 198. The spout 196 is sized to permit the attachment of a tube 170, either alone or with an adapter 168.
When the external drain fitting 190 is used, the basin 30 has a generally circular recess 180 on the bottom surface 36 of the floor 32. The recess 180 corresponds in size to the flange 192. Protruding downward from the center of the recess 180 is a neck 182 with an internal bore 184 through the floor 32 of the basin. The neck 182 is sized to fit within the internal bore 198 of the fitting 190. The fitting 190 is attached to the basin floor 32 by a sealing mechanism such as an ultrasonic seal or a glue between the recess 180 and the top surface 193 of the flange 182.
FIG. 17 shows an embodiment of a drain spout 44 which is integral to the floor 32 and sidewall 38a of the basin 30.
As seen in FIGS. 2-4, bottom supports 48 extend downwardly from the bottom surface 36 of the basin floor 32 to enable the basin 30 to stably fit onto a conventional surgical ring stand 22. The bottom supports 48 are positioned and shaped such that they fit within the ring 23 on a surgical ring stand 22, thus providing stability to the basin 30 sitting on the ring stand 22 by restricting lateral movement of the basin 30 relative to the ring stand 22. In the embodiment shown in FIGS. 2-4, there are two bottom supports 48 which are integral to the bottom surface 36 of the floor 32 and which are each,partial circular arcs adapted to securely fit within the ring 23 of the ring stand 22.
A preferred embodiment of the strainer 50 is shown in greater detail in FIGS. 5-7. The strainer 50 comprises a rectangularly shaped floor 52 with a plurality of holes 54, and four integral side walls 56 extending upwardly from the floor 52 and substantially perpendicular to the floor 52. The size and shape of the strainer 50 corresponds to that of the basin 30 so that the strainer 50 can be nested within the basin 30.
The basin 30 and strainer 50 are large enough to fully contain several surgical instruments of various shapes and sizes that are typically used in modern surgical procedures.
The holes 54 allow solution in the strainer 50 to rapidly drain out into the basin 30 when the strainer 50 is lifted out of the basin 30, thereby exposing any surgical instruments within the basin 30. The number and size of the holes are selected to allow the solution to rapidly drain out without interfering with holding or containing the instruments.
As shown in FIGS. 5-7, the strainer 50 includes a rim 58 integral to the sidewalls 56 and opposite the floor 52. The rim 58 provides a convenient way for lifting the strainer 50 as well as providing additional strength and rigidity.
As shown in FIGS. 8-10, the cover 60 has a rectangularly shaped top 62 and an integral rim 64 extending downwardly and substantially perpendicularly to the top 62. The cover 60 includes a handle 66 which is integral to the top 62. The size and shape of the cover 60 correspond to that of the basin 30 and the strainer 50 such that the cover 60 ideally fits over them both. The cover 60 can be either be rigid or flexible. It can also be a shower-cap type cover of the type commonly used in current surgical practice.
As shown in FIG. 11, an alternate embodiment has a generally rectangular porous strainer 82, which fits within a rectangular waterproof basin 80. A cover 84 fits onto the assembled basin 80 and strainer 82. An adapter 70 fits onto a conventional surgical ring stand 22 and provides a way for adapting a conventional ring stand 22 for use with the rectangular basin 80. The basin 80 need not include integral bottom supports 48, as in FIG. 1, to fit stably onto the ring stand 22 when the adapter 70 is used.
The adapter 70 shown in FIG. 11 includes a rectangular frame 72 having four cross-members 76 joined together perpendicularly to each other to form the rectangular frame 72. The adapter 70 further includes vertical risers 74 which extend downwardly from the frame 72 and are substantially perpendicular to the frame 72. Each vertical riser 74 includes a leg 78 and a foot 79. The leg 78 is an elongated member having a first end 75 and a second end 77. The first end 75 of the leg 78 is attached to the rectangular frame 72. The foot 79 is attached to the second end 77 of the leg 78 opposite the frame 72. The foot 79 is shaped to fit around a horizontal member 24 on the conventional ring stand 22. In use the adapter 70 is set onto the horizontal members 24 of a ring stand 22 and restricts the lateral movement of the rectangular basin 80 placed onto the ring stand 22 inside the adapter frame 72.
A cross member 76a of the adapter frame 72 can be made to be easily removable, to permit the basin 80 to be slid off of the ring stand 22 without having to lift the basin 80 over the adapter 70 or without having to first remove the adapter 70 from the ring stand 22. Cross member 76a can be made to fit within notches or slots within the adapter frame 72 which would hold the member 76a in place, but would allow the member 76a to be advantageously removed when desired. Alternatively, one end of the cross member 76a can be pivotally attached to the adapter frame 72 to allow the member 76a to swing away from the frame 72 to permit the basin 80 to be slid off the ring stand 22.
As shown in FIG. 12, yet another alternate embodiment uses a surgical basin stand 90 adapted to stably hold a rectangular basin 100. An adapter 70 is not required. The basin 100 need not have bottom supports 48 to stably support the basin 100. The basin stand includes a plurality of rigid basin supports 92. The basin supports 92 are advantageously shaped and arranged to support the rectangular basin 100 from the bottom surface 36 of the basin 100.
The basin stand 90 may also include a removable restraining member 94. When the restraining member 94 is attached to the basin stand 90, lateral movement of the basin 100 in the direction of arrow A in FIG. 12 with respect to the basin stand 90 is restrained. When the restraining member 94 is removed, the basin 100 may be easily slid off of the basin stand 90 with a minimal amount of lifting required. Restraining member 94 can be made to fit within notches or slots within the basin stand 90 which would hold the member 94 in place, but would allow the member 94 to be advantageously removed when desired. Alternatively, one end of the restraining member 94 can be pivotally attached to the basin stand 90 to allow the member 94 to swing away from the stand 90 to permit the basin 100 to be slid off the basin stand 90. In yet another alternative, the restraining member 94 could be positioned low enough on the basin stand 90 such that the basin 100 will sit stably on the basin stand 90, but can still be slid off of the basin stand 90 when desired without removing the restraining member 94 and without an excessive amount of lifting required.
FIG. 13 shows yet still another embodiment having two narrow rectangular basins 110 in place of a single wide rectangular basin. Each narrow basin 110 includes the same preferred features of the single wide basin, including an integral rim 116 and drain tubes 170. A narrow rectangular strainer 120 nests within each basin 110. Each strainer includes holes 122 and an integral rim 124. Additionally, this embodiment includes two narrow covers 130 which fit onto the assembled strainer and basin combinations.
In the embodiment shown in FIG. 13, the two narrow basins 110 sit adjacent to one another on a surgical basin stand 90 that is adapted to stably hold a single wide rectangular basin. However, the two narrow basins 110 could also be used with a conventional surgical ring stand 22, either alone or with an adapter 70. If the narrow basins 110 are used with a conventional ring stand 22 without an adapter 70, the basins should include bottom supports similar to those shown in FIGS. 1-4.
In addition, although the embodiments depicted herein utilize a single ring stand 22, it is anticipated that a double ring stand could also be utilized, either with an adapter similar to the adapter 70 shown, or with a basin with bottom supports similar to those shown in FIGS. 1-4. Yet another rigid support that could be used with the present system is a stainless steel table which typically would be draped with sterile covers before use.
Thus, while several embodiments have been shown and described, various other modifications may be made without departing from the spirit and scope of the invention.
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A system and method for handling contaminated operating room surgical instruments includes a rectangular porous strainer which is sufficiently large to fully contain a variety of surgical tools and instruments and a waterproof rectangular basin, sized to receive the strainer. The basin is adapted to fit stably onto a conventional surgical ring stand either alone, or with a separate adapter. The system replaces conventional round surgical basins which are not capable of safely containing the larger or longer surgical instruments typical of many modern surgical procedures. Utilizing the system eliminates the current practice of manually transferring contaminated instruments from the round surgical basins into larger soaking trays for transportation to the decontamination area.
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RELATED APPLICATIONS
[0001] The present application is a continuation-in-part application of U.S. provisional patent application, Ser. No. 61/663,630, filed Jun. 25, 2012, for TENNIS BAG AND BALL PICKUP UNIT, by Tiffany Tong Zhang, Ching Qing Guo, included by reference herein and for which benefit of the priority date is hereby claimed.
FIELD OF THE INVENTION
[0002] The present invention relates to a portable tennis apparatus and, more particularly, to a portable tennis bag that is also a tennis ball retrieving and dispensing device.
BACKGROUND OF THE INVENTION
[0003] To play a tennis game, the players must at least use a ball container, such as a tennis bag, to transport the balls to and from a tennis court. During a tennis game, tennis balls are often widely scattered on the ground in a court or field. Without a ball retrieving and dispensing device, one must frequently bend down and stand up to pick up the balls from the ground and to serve the balls. This action consumes the player considerably more energy in addition to game playing, it also tends to cause back strain and back pain. The player may also need a handy container to carry all the balls.
[0004] The tennis bags and ball retrieving devices of prior art are separate apparatus. The tennis bags of prior art are either hand-held or carried over shoulders, which can be quite heavy if containing large number of balls. The tennis ball retrieving devices of prior art, are either with small capacity (only contains a few balls), or space-occupying large and heavy equipment. Some of the basket type of ball retrieving devices of prior art do have the capacity of reversing the top handles to increase the height of the basket for ball dispensing, but they are all “one-height-fit-all” type, especially the tall players still need to bend down to pick out the balls. One also needs to lift and carry the heavy basket off ground between scattered balls on the tennis court. Sometimes one needs to transfer the balls from a retrieving device to a ball dispensing device, which can be time-consuming and tiring.
PRIOR ART
[0005] TENNIS BALL RETRIEVING MACHINES, which are large, complex and expensive, not suitable for personal use, such as:
[0006] Tennis ball vacuum collector patented by Mailman in 2012, U.S. Pat. No. 8,313,396B1
[0007] Tennis practice machine patented by Phillip A Torbet in 1977, U.S. Pat. No. 4,021,037A.
[0008] Ball retrieval device patented by Edward B Frankel 1992, U.S. Pat. No. 5,147,100.
[0009] Tennis ball retriever patented by Kurt G Beranek in 1995, U.S. Pat. No. 5,407,242.
[0010] Tennis ball retrieving device by John Meyer in 1978, U.S. Pat. No. 4,077,533.
[0011] Tennis ball retriever with hinged gate by Leonard Falitz et al. in 1975, U.S. Pat. No. 3,902,749.
[0012] Portable ball retriever, holder and carrier apparatus by Dennis K Stotts in 1988, U.S. Pat. No. 4,735,544.
[0013] Tennis ball receptacle and dispenser by Bill Richter in 1990, U.S. Pat. No. 4,978,041.
[0014] BASKET TYPE OF TENNIS BALL RETRIEVERS, which are rigid in shape, space-occupying, heavy to carry by hand, such as:
[0015] Portable ball retriever patented by Zats in 2012, U.S. Pat. No. 8,328,254B1.
[0016] Ball retrieving apparatus patented by Gwin and Pearson in 2011 U.S. Pat. No. 8,075,030B2, which also has very small capacity of a few balls.
[0017] Other wire basket with handles were patented by Stap in 1968 (U.S. Pat. No. 3,371,950), Seewagen and Markisz in 1974 U.S. Pat. No. 3,820,836),
[0018] Madrazo in 1995 (U.S. Pat. No. 5,464,262), Podejko in 2002 (U.S. Pat. No. 6,354,643), and Nestable basket type of ball retrieval and storage device by Christina E Turdo in 2012, U.S. Pat. No. 8,141,919, Ball picker dolly by Lynn L Ray in 1983, U.S. Pat. No. 4,383,695.
[0019] TUBE TYPE OF TENNIS BALL RETRIEVERS, which have very limited capacity of just a few balls, such as:
[0020] Ball delivery retrieval and storage system by Kenneth W Loerop et al, in 2001, U.S. Pat. No. D442658.
[0021] Tennis ball retrieval, storage and dispensing device by Jonathan C Shoham in 2011, U.S. Pat. No. 7,922,608.
[0022] Ball retrieval, storage and discharge device by Ryan L Nelson in 1998, U.S. Pat. No. 5,775,751.
SUMMARY OF THE INVENTION
[0023] In accordance with the present invention, there is provided a portable device and method for transporting and retrieving tennis balls easily and quickly. More particularly, the invention is a device that includes a tennis bag, a tennis ball retrieving unit, a stretchable back handle with an end hand-grip, and a rolling mean, and a bag stand. The invention is truly an “all-in-one” and handy tennis apparatus. The ball retrieving unit retries balls quickly and easily from the ground directly into the tennis bag; the flexible and compressible bag makes it very easy to carry and transport large or small number of balls; the top opening of the bag provides easy access to pick out balls from the bag for replay. The hand-grip and the stretchable back bar can be pulled up and pushed the unit with rolling means on the ground in any direction easily. The extendable stand with adjustable height can raise the tennis bag at a desirable level, according to the player's height, for dispensing balls so that the player does not have to bend down to pick the balls. The stretchable back bar and the stand can be put back to their original position during the transportation of the apparatus, such as between tennis court and player's home. The entire apparatus is light-weight and easily carry-on and operated single-handed.
[0024] It is an object of the invention to provide a tennis apparatus.
[0025] It is an object of the invention to provide a tennis apparatus for storing and transporting tennis balls; retrieving and dispensing tennis balls during game play.
[0026] It is a further object of the invention to provide a convenient carry-on tennis bag which is also a tennis ball retrieving device and a tennis ball dispensing device.
[0027] It is an object of the invention to provide a tennis bag that has the feature of conventional sports bag and pull-up traveling suitcase such as stretchable handle and rolling wheels.
[0028] It is an object of the invention to provide a core mean of ball retrieving unit comprised of stretchable back bar, the side-stick and the bottom retrieving grid.
[0029] It is an object, of the invention to provide an end hand-grip that gear the direction of the device and to deliver the pressure or energy for ball retrieval.
[0030] It is an object of the invention to provide an adjustable stand that raises the top opening of the tennis bag to a desirable level, such as to player's waistline, so that the player of different height can easily reach into the tennis bag, without bending down, to pickout a ball for replay.
[0031] It is an object of the invention to provide a locking system on the bag stand to prevent the shifting of the level of the bag.
[0032] It is an object of the invention to provide light-weighted bag which is compressible with small number of balls, and expandable with large number of balls.
[0033] It is an object of the invention to provide a tennis apparatus that can be carried on and operated with just one hand.
[0034] It is an object of the invention to provide options of adding more pockets to the bag for personal accessories, such as keys, cell phone and water bottles and etc.
[0035] It is an object of the invention to provide option of a side hook or loop to hold a tennis racket.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] A complete understanding of the present invention may be obtained by reference to the accompanying drawings, when considered in conjunction with the subsequent, detailed description, in which:
[0037] FIG. 1 is a perspective view of a tennis bag with tennis ball retrieving and dispensing unit in accordance with the present invention;
[0038] FIG. 2 is a front perspective view of the tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ;
[0039] FIG. 3 is a rear perspective view of the tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ;
[0040] FIG. 4 is a bottom exploded view of a tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ;
[0041] FIG. 5 is a top perspective view of the tennis ball retrieving frame of the tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ;
[0042] FIG. 6 is a top exploded view of the tennis ball retrieving frame, while in use, of the tennis bag with tennis retrieving and dispensing unit in FIG. 1 ;
[0043] FIG. 7 is a bottom plan view of the bottom tennis ball retrieving panel of the tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ;
[0044] FIG. 8 is a left perspective view of a tennis bag with the stand extended of the tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ;
[0045] FIG. 9 is a plan view of a bottom part of the stand of the tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ;
[0046] FIG. 10 is a left partial view of an of an alternative stand (detached) in extended position, and the tennis bag sitting on top of the stand, of the tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ;
[0047] FIG. 11 is a rear partial view of a storage of the alternative stand (same as in FIG. 10 ) of the tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ;
[0048] FIG. 12 is a rear elevation view of a shoulder strap exposed when the pocket cover the shoulder strap is unzipped of the tennis bag with tennis ball retrieving and dispensing unit in FIG. 1 ; and
[0049] FIG. 13 is an exploded view of a lock of side bars of the stand of the tennis bag with tennis ball retrieving unit in FIG. 1 .
[0050] For purposes of clarity and brevity, like elements and components will bear the same designations and numbering throughout the Figures.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0051] FIG. 1 is a perspective view of the Tennis bag 20 with tennis ball 16 retrieving unit in accordance with the present invention.
[0052] FIG. 2 is a front perspective view of the the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1 .
[0053] FIG. 3 is a rear perspective view of the the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1
[0054] FIG. 4 is a bottom exploded view of the of the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1
[0055] FIG. 5 is a top perspective view of the the tennis ball 16 retrieving frame of the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1
[0056] FIG. 6 is a top exploded view of the the tennis ball 16 retrieving frame, while in use, of the tennis bag 20 with tennis retrieving unit in FIG. 1
[0057] FIG. 7 is a bottom plan view of the the bottom tennis ball 16 retrieving panel of the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1
[0058] FIG. 8 is a left perspective view of the tennis bag 20 with the stand 25 extended of the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1
[0059] FIG. 9 is a plan view of the bottom part of the stand 25 of the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1
[0060] FIG. 10 is a left partial view of the of an alternative stand (detached) in extended position, with the tennis bag 20 sitting on top of the stand 25 , of the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1 .
[0061] FIG. 11 is a rear partial view of the storage of the alternative stand (same as in FIG. 10 ) of the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1
[0062] FIG. 12 is a rear elevation view of the shoulder strap 23 exposed when the pocket cover the shoulder strap 23 is unzipped
[0063] FIG. 13 is an exploded view of the lock 24 of side bars of the stand 25 of the tennis bag 20 with tennis ball 16 retrieving unit in FIG. 1
[0064] FIG. 1 is a sketch illustration of the perspective view of the tennis bag 20 with tennis ball 16 retrieving unit. The details of the apparatus is not revealed in this figure, but will be described in the following figures.
[0065] FIG. 2 is the front view of the tennis bag 20 with tennis ball 16 retrieving unit, that shows the tennis bag 20 ; the stretchable back bar 1 in its stretched position; end hand-grip 2 at the top end of stretchable back bar 1 , and the stand 25 .
[0066] The tennis bag 20 may be made of durable, light-weighted and water prove fabric or similar materials. The bottom panel 9 of the bag is the embodiment of the tennis ball 16 retrieving unit (not showing in this picture). The bag has the capacity of storing at least 50 balls. There is a zipper at the upper part of the bag where the player can unzip the zipper to open the top zippered flap, and reach inside of the tennis bag 20 , then take out of retrieved tennis balls to play again.
[0067] FIG. 2 also shows the stand 25 in its original position during transportation or ball retrieving mode. The stand 25 is comprised of top panel bar and bottom panel 9 bar of the stand 25 ; side-bar of the stand 8 connect the top panel bar of the stand 5 and the bottom panel 9 bar of the stand 25 .
[0068] The stretchable back bar 1 is made of light-weighted rigid material, such as metal or glass-fiber, or any other material with the similar quality. The end hand-grip 2 is made of semi-rigid, light-weighted material, such as plastic, in a shape of easy grip with hand. The end hand-grip 2 and stretchable back bar 1 are to ease the transportation of the unit on ground when it is at its stretched position. The player can grip the end hand-grip 2 , then gear and push the unit on the ground. When it is in its original position, i.e. unstretched position, the player can carry the unit by top hand strap 3 or shoulder strap 23 .
[0069] There is an additional pocket 7 (or more additional pockets) for convenience of carrying more stuff or accessories.
[0070] FIG. 3 is the rear view of the tennis bag 20 with tennis retrieving unit, that shows the rolling means 12 , the stretchable back bar 1 in stretched position, and the pocket cover of shoulder strap 23 in zipped or closed position.
[0071] The rolling means 12 can be wheels, and are for transporting the unit on the ground. The rolling means 12 are designed to rotate up to 360 degree, so that the unit can be easily moved to any direction.
[0072] Under the pocket cover of shoulder strap 23 are the shoulder straps. When the cover is closed, it prevents the shoulder straps get in the way of players, such as during ground transportation, or during game play, or any, other situations when shoulder straps are not needed. When the cover is unzipped or opened, the player can carry the unit by shoulders (not shown in FIG. 3 ).
[0073] FIG. 4 is the bottom view of the tennis bag 20 with tennis ball 16 retrieving unit, that shows the means of tennis ball 16 retrieving, such as during and after a tennis game. It shows a tennis ball 16 is slightly compressed in between the rigid grid bars, on its way from ground to be pushed into the bag when forward then downward pressure applied to the bag end hand-grip 2 by the player, as will be described in FIG. 6 .
[0074] FIG. 5 is a sketch of tennis ball 16 retrieving mean, comprised of a hand grip and a vertical bar (i.e. the end hand-grip 2 and the stretchable back bar 1 ), a short side-stick molded to between the front of near bottom of the stretchable back bar 1 and the mid-portion of the rear bar of the grid in the bottom panel 9 .
[0075] The side stick is to assist in keeping the ball retrieving frame and the stretchable back bar 1 in a pre-determined and fixed angle during the ball retrieving process, and also to save energy of the player when applying forward and downward pressure against ball.
[0076] It also shows a tennis ball 16 is slightly compressed in between the rigid grid bars, on its way from ground to be pushed into the bag
[0077] FIG. 6 is another sketch of tennis ball 16 retrieving mean, demonstrating the mechanism of action when the tennis ball 16 retrieving frame is on top of a tennis ball 16 , the end hand-grip 2 is pushed forward then downward, forcing the ball to be compressed in between the grid bars into the tennis bag 20 . Solid lines demonstrate the mean in a neutral position. Dotted lines demonstrate the position of mean when forward and downward pressure is applied to .
[0078] FIG. 7 is the sketch of bottom panel 9 , either oval or rectangle shape. There are multiple parallel grid bars (either horizontal or vertical in relation to the longer outer sides of the panel), The bars are directly or indirectly fixed to the outer sides of the bottom panel 9 . The distance between the bars, or between bar and outer sides of panel is slightly smaller than the diameter of a tennis ball 16 , such width as to prevent the balls falling out from the bag once retrieved in.
[0079] The bottom, panel 9 is made of rigid, durable, light-weighted material, such as metal, or fiber glass, or any other material with the similar quality.
[0080] FIG. 8 is a left perspective view of a tennis bag 20 with tennis ball 16 retrieving unit, when the stand 25 is in use, i.e. in extended position. The stand 25 is comprised of a top panel, side bars or rods, and bottom panel 9 . The top panel is circumferential in shape and perpendicular in relation to the longitudinal axis of the tennis bag 20 , positioned at about mid-level of the tennis bag 20 . The side bars are located on both left and right side of the bag between about midway of top and bottom panel 9 . The side bars connect and fix the distance between top and bottom panels. There is a lock 24 on either side of the side bars that secures the bars in place when in original position (i.e. not in use). When the lock 24 is open, it allows the bottom part of the stand 25 automatically drops out by gravity, then re-lock 24 to secure the bars in extended position.
[0081] When it is time to dispense or serve the ball, the player will unlock the lock 24 to let the bottom part of the stand 25 drops out until it reaches desirable height, then the player will re-lock 24 the lock 24 . When it is time to have the bag on ground level, the player will unlock the lock 24 and the bag will drop automatically to the ground level, and the player will then re-lock 24 the lock 24 to secure it in its original position.
[0082] The stand 25 is comprised of small caliber tubes made of light-weighted metal, or durable rigid fiber glass, or any other material with similar quality. The bottom side bars are slightly smaller in diameter than the top side bar, so the bottom bar can be inserted into the top side bar (original position) when not in use (i.e. not in extended position).
[0083] FIG. 9 is a plan illustration of the bottom part of the stand 25 when it is pulled out of the top part of stand, shows the bottom side bars and the U-shaped bottom panel 9 for stabilization of the unit when set on ground.
[0084] FIG. 10 shows an alternative option of the stand 25 , which is detached from the bag, at an extended mode and in use. The tennis bag 20 unit sits on top of the stand 25 . The height of the stand 25 can be adjusted to the desired level by the player.
[0085] The alternative stand is comprised of small caliber tubes or narrow linear plate, made of light-weighted metal, or durable rigid fiber glass, or any other material with similar quality.
[0086] FIG. 11 is the same stand as in FIG. 10 , but is in a folded mode when not in use, which is easily stored in the back pocket of the bag.
[0087] FIG. 12 is the elevated rear view of the tennis bag 20 with tennis retrieving unit, that is similar to FIG. 3 , except the pocket cover of the shoulder strap 23 is unzipped or open, showing the shoulder straps are exposed, and can be used to carry the unit by shoulders.
[0088] FIG. 13 is the exploded view of the lock 24 on either side of the side bars. The actual design of the lock 24 may change. The lock 24 is located at the lower end of the top side bar and is made of durable and rigid plastic material or similar material.
[0089] Since other modifications and changes varied to fit particular operating requirements and environments will be apparent to those skilled in the art, the invention is not considered limited to the example chosen for purposes of disclosure, and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention.
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A portable tennis apparatus comprising a tennis bag, a tennis ball retrieving unit, a stretchable back bar and an extendable bottom stand. The ball retrieving unit retrieves balls on the ground directly to the bag; the stretchable back bar can be pulled up and pushed around with rolling means on the ground easily. The top opening of the bag made it easy to reach the balls for replay. The extendable stand can raise the tennis bag at a desirable level for dispensing balls so that the player does not have to bend down. The stretchable back bar and the stand can be put back to their original position during the transportation of the apparatus, such as between tennis court and player's home. The entire apparatus is light-weighted, easily carried and operated single-handed. This apparatus is truly an "all-in-one" tennis apparatus, and a revolution in the field of tennis equipment.
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CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. application Ser. No. 10/535,918, filed Mar. 16, 2006, which is a U.S. National Phase of PCT/US2002/37948, filed Nov. 26, 2002, the disclosures of which are incorporated herein by reference in their entirety.
FIELD OF INVENTION
[0002] The present invention relates to materials and methods for preventing or treating microbe-mediated epithelial disorders, such as gut-derived sepsis.
BACKGROUND
[0003] Microbe-mediated epithelial disorders, or abnormal conditions, present a significant threat to the health of man and animals, imposing a burden on healthcare systems worldwide. One example of such disorders, gut-derived sepsis, is a major cause of mortality among organisms, such as human patients, that suffer from any of a variety of diseases, disorders or afflictions, such as burn injuries, neonatal enterocolitis, severe neutropenia, inflammatory bowel disease, and organ rejection following transplantation. The intestinal tract reservoir has long been recognized to be a potentially lethal focus of bacterial-mediated sepsis in, e.g., critically ill, hospitalized patients. The ability of microbial pathogens such as the Pseudomonads (e.g., Pseudomonas aeruginosa ) to perturb the regulatory function of the intestinal epithelial barrier may be a defining characteristic among opportunistic organisms capable of causing gut-derived sepsis. In many of these infections, Pseudomonas aeruginosa has been identified as the causative pathogen. Significantly, the intestinal tract has been shown to be the primary site of colonization of opportunistic pathogens such as P. aeruginosa.
[0004] Conventional therapeutic approaches to the prevention or treatment of microbe-mediated epithelial disorders such as gut-derived sepsis have met with incomplete success. Antibiotic-based approaches are compromised by the difficulty in tailoring antibiotics to the intestinal pathogen in a manner that does not impact the remaining intestinal flora. In addition, many of the intestinal pathogens, as typified by P. aeruginosa , often become resistant to antibiotic challenges, resulting in a costly, ongoing and incompletely successful approach to prevention or treatment. Problems also plague immunotherapeutic approaches. Particularly, many intestinal pathogens such as P. aeruginosa , are immunoevasive, rendering such approaches minimally effective.
[0005] Another approach to the prevention or treatment disorders such as gut-derived sepsis is intestinal lavage. In the past several years, intestinal lavage using polyethylene glycol (PEG) solutions has been attempted, with some anecdotal reports suggesting that PEG may show some promise in treating gut-derived sepsis across a variety of clinical and experimental circumstances. The PEG in these solutions has an average molecular weight of 3,500 daltons and the solutions are commercially available (e.g., Golytely). The mechanisms by which these relatively low molecular weight (LMW) solutions of PEG provide a therapeutic benefit in treating or preventing gut-derived sepsis is unknown. Typically, these solutions are used to wash or flush the intestinal tract of organisms at risk of developing, or suffering from, gut-derived sepsis. As a result of administering these LMW PEG solutions to the intestinal tract, there is a variable change in the floral composition of the treated intestine depending on the method of concentration and the molecular weight of the compounds used. For example, solutions having concentrations of PEG higher than about 20% can result in a microbiocidal action resulting in the elimination of potentially protective microorganisms in the intestinal tract of a stressed host. Also, solutions of low molecular weight PEG can lose their efficacy in attenuating the virulence capacity of certain organisms, despite preserving them. Therefore, a need exists in the art for a solution that inhibits microbial virulence expression (the harmful properties of a microbe) while not killing the microbe or neighboring microbes, thereby providing the benefit of preserving the natural ecosystem of the intestinal microflora. For example, preservation of the native floral composition would provide competition for opportunistic pathogens that might otherwise colonize the intestine.
[0006] Concomitant with a change in floral composition is a change in the physiology of the organism. These physiological changes may be monitored by assaying any number of characteristic enzymatic activities, such as lactate dehydrogenase levels. Consequently, LMW PEG treatments of the intestine produce significant changes in the physiology of the treated organisms, with unpredictable, and thus potentially deleterious, longer-term consequences for the health and well-being of the treated organism. Moreover, such treatments provoke physically demanding reactions in the form of massive intestinal voiding in critically ill organisms such as hospitalized human patients.
[0007] Thus, there remains a need in the art to provide a composition effective in preventing, or treating, a microbe-mediated epithelial disorder (e.g., gut-derived sepsis) and/or a symptom associated with such a disorder, along with methods for achieving such benefits, without creating the potential for further complications through significant alteration of the physiology of the treated organism.
SUMMARY OF THE INVENTION
[0008] The present invention satisfies the aforementioned need in the art by providing a high molecular weight (HMW) polyethylene glycol composition that provides effective protection against an abnormal condition characterized by an epithelial surface at risk of developing a microbe-mediated disorder. Exemplary abnormal conditions include gut-derived sepsis, and other intestinal disorders/diseases associated with intestinal flora, due to intestinal pathogens including, but not limited to, P. aeruginosa . The HMW PEG inhibits or prevents contact of such pathogens as P. aeruginosa with the intestinal epithelial surface. In addition, high molecular weight PEG suppresses virulence expression in these pathogens (e.g., P. aeruginosa ) responsive to a variety of signals that may involve quorum sensing signaling networks. The ability of HMW PEGs to interdict at the infectious interface between the intestinal pathogen and the intestinal epithelium provides an alternative approach to preventing or treating gut-derived sepsis, e.g., following catabolic stress. Importantly, treatments with HMW PEGs would be cost effective and relatively simple to perform on human patients as well as a variety of other organisms such as agriculturally significant livestock (e.g., cattle, pigs, sheep, goats, horses, chickens, turkeys, ducks, geese, and the like), pets, and zoo animals.
[0009] One aspect of the invention provides a method of reducing the likelihood of mortality in an animal with an abnormal condition, including a disease condition, comprising an epithelial surface at risk of developing a microbe-mediated disorder selected from the group consisting of gut-derived sepsis, a burn injury, neonatal necrotizing enterocolitis, severe neutropenia, toxic colitis, inflammatory bowel disease, enteropathy, transplant rejection, pouchitis, and pig belly, comprising administering an effective dose of polyethylene glycol (PEG) to an animal in need thereof, wherein the PEG has an average molecular weight of at least 5,000 daltons. Suitable animals include, but are not limited to, dog, cat, sheep, goat, cow, pig and human. In the aforementioned method, the PEG preferably has an average molecular weight of at least 15,000 daltons, and is preferably between 5,000 and 20,000 daltons, or between 15,000 and 20,000 daltons. Also preferred is PEG having an average molecular weight of 6,000, of 7,000, of 8,000, of 9,000, of 10,000, of 11,000, of 12,000 of 13,000, of 14,000, and of 25,000 daltons. Further, the PEG may be in an aqueous solution comprising 5-20% PEG, and preferably 10-20% PEG (e.g., 10% PEG). In one embodiment of the method, the condition is associated with the presence of a Pseudomonas aeruginosa organism in the intestine and the cell membrane integrity of such P. aeruginosa is not detectably altered. In another embodiment of the method, the growth pattern of Pseudomonas aeruginosa is not detectably altered.
[0010] Another aspect of the invention is a method of inhibiting gut-derived sepsis comprising contacting a mammalian epithelium, such as an intestine, with polyethylene glycol (PEG), wherein the PEG has an average molecular weight of at least 5,000 daltons, and preferably at least 15,000 daltons. In one embodiment of this method, the mammalian intestine contacts the PEG for at least 30 minutes.
[0011] Further aspects of the invention include a method of inhibiting PA-I lectin/adhesin expression in a pathogen of the epithelia, e.g., an intestinal pathogen, comprising administering an effective dose of polyethylene glycol to an animal in need thereof; a method of inhibiting epithelium-induced (e.g., intestinal epithelium-induced) activation of PA-I lectin/adhesin comprising administering an effective dose of polyethylene glycol to an animal in need thereof; a method of inhibiting C4-HSL-induced morphological change of a pathogen of the epithelia (e.g., an intestinal pathogen) comprising administering an effective dose of polyethylene glycol to an animal in need thereof; a method of reducing virulence expression in a pathogen of the epithelia (e.g., an intestinal pathogen) comprising administering an effective dose of polyethylene glycol to an animal in need thereof; a method of reducing or preventing interaction of an epithelial surface with a microbial virulence factor comprising administering an effective dose of polyethylene glycol to an animal in need thereof; a method of ameliorating epithelial (e.g., intestinal) pathogenesis by preventing formation of pathogenic quorum-sensing activation comprising administering an effective dose of polyethylene glycol to an animal in need thereof; and a method of inhibiting interaction between epithelium (e.g., intestinal epithelium) of a vertebrate and a bacterium, such as a Pseudomonad (e.g., Pseudomonas aeruginosa ), comprising contacting the epithelium with polyethylene glycol. In all of these aspects of the invention, the PEG has an average molecular weight of at least 5,000 daltons, and preferably at least 15,000 daltons.
[0012] A still further aspect of the invention is a method of inhibiting a Pseudomonas aeruginosa -induced reduction in the transepithelial electrical resistance of a mammalian epithelial layer, such as an intestinal epithelial layer, comprising contacting the (intestinal) epithelial layer with polyethylene glycol, wherein the PEG has an average molecular weight of at least 5,000 daltons, and preferably at least 15,000 daltons. Preferably, the PEG has an average molecular weight of 15,000 to 20,000 daltons. In a preferred embodiment, the integrity of the membrane of the microbe (e.g., P. aeruginosa ) is not detectably altered.
[0013] Yet another aspect of the invention is a method of inhibiting adherence of a bacterial cell to a mammalian epithelium, such as a mammalian intestine, comprising contacting the intestine with polyethylene glycol, wherein the PEG has an average molecular weight of at least 5,000 daltons, and preferably at least 15,000 daltons. With this method as well, it is preferred that the PEG has an average molecular weight of 15,000 to 20,000 daltons. The PEG may be in an aqueous solution comprising 5-20% PEG, and preferably 5-10% PEG. An exemplary bacterial cell contemplated as amenable to inhibition of adherence by this method is a Pseudomonad, such as P. aeruginosa.
[0014] Another aspect of the invention is a method of reducing the expression of PA-I lectin/adhesin in a bacterial cell comprising contacting the bacterial cell with polyethylene glycol, wherein the PEG has an average molecular weight of at least 5,000 daltons, and preferably 15,000 daltons, and is preferably between 15,000 and 20,000 daltons. Again, the PEG may be in an aqueous solution comprising 5-20% PEG, and preferably 5-10% PEG.
[0015] In another aspect, the invention provides a method of reducing the likelihood of mortality in an animal exhibiting a microbe-mediated epithelial disorder selected from the group consisting of gut-derived sepsis, a burn injury, neonatal necrotizing enterocolitis (NEC), severe neutropenia, toxic colitis, inflammatory bowel disease, enteropathy (e.g., in the critically ill), transplant rejection, pouchitis and pig belly comprising administering an effective amount of a compound (e.g., PEG) that adheres to a cell selected from the group consisting of a mammalian intestinal epithelial cell and an intestinal bacterial cell, wherein the compound adheres to the cell in a topographically asymmetrical manner, thereby inhibiting interaction of the mammalian intestinal epithelial cell and the bacterial cell. A preferred compound is a surfactant. In one embodiment of this method, the compound is PEG, preferably having an average molecular weight of at least 15,000 daltons. In another embodiment of this method, the inhibition is determined by atomic force microscopy. In yet another embodiment of this method, the bacterial cell is an intestinal pathogen and there is no detectable modification of its growth characteristics. In related aspects, this method further comprises introducing an effective amount of dextran into the intestine of the animal and/or introducing an effective amount of L-glutamine, dextran-coated L-glutamine, dextran-coated inulin, dextran-coated butyric acid, one or more fructo-oligosaccharides, N-acetyl-D-galactosamine, dextran-coated mannose and galactose, lactulose and balancing buffers and stabilizing agents, known in the art, into the intestine of the animal. When administered together as a single composition, this multicomponent single-solution administration will treat and prepare the intestinal tract in anticipation of a disruption in the intestinal flora and barrier function of the intestine, such as occurs following severe catabolic-, surgical- and traumatic-type stresses.
[0016] Another aspect of the invention is a method of ameliorating a symptom associated with any disease or condition arising from, or characteristic of, an abnormal condition of the epithelium, such as gut-derived sepsis, comprising administering polyethylene glycol to the intestine, wherein the PEG has an average molecular weight of at least 5,000 daltons, preferably at least 15,000 daltons, and is preferably between 15,000 and 20,000 daltons. The PEG may be in an aqueous solution comprising 5-20% PEG, and preferably 5-10% PEG. The invention comprehends ameliorating a symptom associated with any disease or condition disclosed herein.
[0017] Still another aspect of the invention is a method of preventing loss of lactating capacity in an animal exhibiting an abnormal condition in the form of an epithelial surface of a mammary gland at risk of developing a microbe-mediated disorder affecting milk output, comprising administering, e.g., topically, an effective dose of a polyethylene glycol of at least 5,000 daltons, and preferably at least 15,000 daltons, to the epithelial surface of a mammary gland. Exemplary animals include mammals, such as sheep, goats, cows, pigs, horses and humans. In a related aspect, the invention provides a method of treating a loss of lactating capacity in an animal characterized by a microbe-mediated disorder of an epithelial surface of a mammary gland affecting milk output, comprising administering, e.g., topically, an effective dose of a polyethylene glycol of at least 5,000 daltons and, preferably, at least 15,000 daltons to a mammary gland. In another related aspect, the invention provides a method of preventing development of a microbe-mediated epithelial disorder in an animal of nursing age comprising administering an effective dose of polyethylene glycol of at least 5,000 daltons, and preferably at least 15,000 daltons, to the animal. Suitable animals include mammals, such as humans, livestock, domesticated pets, and zoo animals. In one embodiment, the PEG is admixed with any infant formula known in the art.
[0018] A related aspect of the invention is a composition comprising infant formula and polyethylene glycol (PEG), wherein the PEG has an average molecular weight of at least 5,000 daltons. Again, any infant formula known in the art may be used, including formulas based on the milk of a mammal, such as cow's milk, goat's milk, and the like, as well as formulas based on soy milk. The formula may also be enriched with any vitamin and/or element, including fortification with iron. The PEG preferably has an average molecular weight of at least 15,000 daltons, and is preferably present in the range of 5-20% upon reconstitution or hydration of the infant or baby formula. The invention further provides a method of providing nutrition to an animal, preferably of nursing age, comprising administering an effective dose of the composition comprising infant formula and PEG to the animal.
[0019] Yet another aspect of the invention is a pharmaceutical composition comprising polyethylene glycol of at least 5,000 daltons, and preferably 15,000 daltons, average molecular weight and a suitable adjuvant, carrier or diluent. In a related aspect, the composition further comprises a compound selected from the group consisting of dextran-coated L-glutamine, dextran-coated inulin, dextran-coated butyric acid, one or more fructo-oligosaccharides, N-acetyl-D-galactosamine, dextran-coated mannose and galactose, lactulose and balancing buffers and stabilizing agents known in the art.
[0020] An additional aspect of the invention is a kit for the therapeutic treatment or prevention of an abnormal condition characterized by an epithelial surface at risk of developing a microbial-mediated disorder, such as gut-derived sepsis, comprising one of the above-described pharmaceutical compositions and a protocol describing use of the composition in therapeutic treatment or prevention of the abnormal condition. Protocols suitable for inclusion in the kit describe any one of the therapeutic or preventive methods disclosed herein.
[0021] Still other aspects of the invention are drawn to methods of preventing an abnormal condition characterized by an epithelial surface at risk of microbe-mediated disorder, including diseases. For example, the invention comprehends a method of preventing a disease or an abnormal condition comprising administering a composition comprising an effective dose of polyethylene glycol (PEG) to an animal, wherein the PEG has an average molecular weight of at least 5,000 daltons. A suitable disease or abnormal condition, amenable to the preventive methods of the invention, is selected from the group consisting of swimmer's ear, acute otitis media, chronic otitis media, ventilator-associated pneumonia, gut-derived sepsis, necrotizing enterocolitis, antibiotic-induced diarrhea, pseudomembranous colitis, an inflammatory bowel disease, irritable bowel disease, neutropenic enterocolitis, pancreatitis, chronic fatigue syndrome, dysbiosis syndrome, microscopic colitis, a chronic urinary tract infection, a sexually transmitted disease, and infection. An animal suitable as a subject for such preventive methods is selected from the group consisting of dog, cat, sheep, goat, cow, pig, chicken, horse and human. The PEG preferably has an average molecular weight of at least 15,000 daltons; also preferred is PEG having an average molecular weight between 15,000 and 20,000 daltons. Further, the PEG may be an aqueous solution comprising 10-20% PEG, and preferably 10% PEG. The composition being administered may further comprise a vehicle selected from the group consisting of a liquid solution, a topical gel, and a solution suitable for nebulizing. Additionally, the composition may further comprise a compound selected from the group consisting of dextran-coated L-glutamine, dextran-coated inulin, dextran-coated butyric acid, a fructo-oligosaccharide, N-acetyl-D-galactosamine, dextran-coated mannose, galactose and lactulose. In one embodiment, the composition comprises PEG, dextran-coated L-glutamine, dextran-coated inulin, dextran-coated butyric acid, a fructo-oligosaccharide, N-acetyl-D-galactosamine, dextran-coated mannose, galactose and lactulose.
[0022] Yet another aspect of the invention is a method of preventing skin infection comprising the step of applying a composition comprising an effective amount of polyethylene glycol (PEG) to an animal, wherein the PEG has an average molecular weight of at least 5,000 daltons. The composition may further comprise a vehicle selected from the group consisting of an ointment, a cream, a gel and a lotion. The invention contemplates that an agent causing the infection is selected from the group consisting of Bacillus anthracis , Small Pox Virus, enteropathogenic E. coli (EPEC), enterohemorrhagic E. coli (EHEC), enteroaggregative E. coli , (EAEC), Clostridium difficile , rotavirus, Pseudomonas aeruginosa, Serratia marcescens, Klebsiella oxytocia, Enterobacteria cloacae, Candida albicans and Candida globrata.
[0023] Another aspect of the invention is a method of preventing respiratory infection comprising the step of administering an effective amount of polyethylene glycol (PEG) to an animal, wherein the PEG has an average molecular weight of at least 5,000 daltons. A respiratory infection amenable to the preventive methods of the invention may arise from contact with an infectious agent via any route known in the art, including pneumonias associated with ventilators (e.g., ventilator-associated pneumonia), air-borne infectious agents, infectious agents dispersed in a nebulized fluid such as by sneezing, and the like. In some embodiments, the method prevents respiratory infection by an agent selected from the group consisting of Bacillus anthracis and Small Pox Virus.
[0024] Yet another aspect of the invention is a method for irrigating at least a portion of the urinary tract in order to prevent a chronic urinary tract infection, comprising the step of delivering an effective amount of a composition comprising PEG to a urethra, wherein the PEG has an average molecular weight of at least 5,000 daltons. In one embodiment, the composition is administered to a portion of the urinary tract that includes at least the bladder.
[0025] Another aspect of the invention is a method of preventing a sexually transmitted disease comprising the step of applying polyethylene glycol (PEG) to a condom, wherein the PEG has an average molecular weight of at least 5,000 daltons. A related aspect of the invention is a condom comprising at least a partial coating with PEG having an average molecular weight of at least 5,000 daltons. Yet another related aspect is a kit comprising a condom and polyethylene glycol (PEG) having an average molecular weight of at least 5,000 daltons.
[0026] The invention also comprehends a method of preventing a digestive tract disorder comprising administering an effective dose of a composition comprising polyethylene glycol (PEG) to an animal in need thereof, wherein the PEG has an average molecular weight of at least 5,000 daltons. Exemplary digestive tract disorders amenable to the preventive methods of the invention may be selected from the group consisting of neonatal necrotizing enterocolitis, antibiotic-induced diarrhea, pseudomembranous colitis, an inflammatory bowel disease, irritable bowel disease, neutropenic enterocolitis, pancreatitis, dysbiosis syndrome and microscopic colitis.
[0027] Another aspect of the invention is a method for monitoring the administration of polyethylene glycol (PEG) to an animal in need thereof, comprising administering an effective amount of a composition comprising labeled PEG, wherein the PEG has an average molecular weight of at least 5,000 daltons, to an animal in need thereof, and detecting the labeled PEG, whereby the quantity and/or location of the labeled PEG (e.g., associated with a microbe) provides information useful in assessing the efficacy of administration. In one embodiment of the monitoring method, the label is a fluorophore (e.g., fluorescein, rhodamine, Cy3, Cy5). In another embodiment of the method, detecting the labeled PEG comprises endoscopic inspection. The monitoring method also contemplates that the labeled PEG is detected in a stool sample (i.e., the labeled PEG associates with a component such as a microbe, whose source is a stool sample). In addition, the monitoring method may further comprise administering a second label specific for a microbe and detecting the second label. “Specific” as used in this context means that the label is detectably associable with at least one microbe.
[0028] Another aspect of the invention is a method for monitoring the administration of polyethylene glycol (PEG) to an animal in need thereof, comprising obtaining a sample from an animal receiving polyethylene glycol, wherein the PEG has an average molecular weight of at least 5,000 daltons, contacting the sample with an epithelial cell, and measuring the adherence of a microbe in the sample to the epithelial cell, whereby the quantity and/or location of the PEG provides information useful in assessing the efficacy of administration. The measuring may be accomplished by microscopic examination.
[0029] Another monitoring method according to the invention is a method for monitoring the administration of polyethylene glycol (PEG) to an animal in need thereof, comprising obtaining a sample from an animal receiving polyethylene glycol, wherein the PEG has an average molecular weight of at least 5,000 daltons, contacting the epithelial cell layer with the sample, and measuring a trans-epithelial electrical resistance of the epithelial layer, whereby effective administration is indicated by a reduced decrease in trans-epithelial electrical resistance relative to a control value. The control value may be internal (i.e., measuring the TEER prior to PEG administration) or external (i.e., a value developed in other studies that is reliably used for comparison).
[0030] Yet another monitoring method of the invention is a method for monitoring the administration of polyethylene glycol (PEG) to an animal in need thereof, comprising obtaining a sample from an animal receiving polyethylene glycol, wherein the PEG has an average molecular weight of at least 5,000 daltons, isolating a microbe from the sample, and measuring the hydrophobicity of the cell surface of the microbe, whereby the hydrophobicity of any microbe in the sample provides information useful in assessing the efficacy of administration. “Isolating,” as used in this context, means separated from other components of the sample (e.g., solid matter) sufficiently to permit hydrophobicity measurements, as would be understood in the art.
[0031] A related aspect of the invention is a kit for monitoring the administration of polyethylene glycol, comprising a labeled PEG and a protocol describing use of the labeled PEG in monitoring administration thereof. Suitable protocols include any of the methods disclosed herein or known in the art relating to the administration, delivery or application of PEG. In some embodiments of this aspect of the invention, the kit further comprises a free label.
[0032] Still another monitoring method of the invention is a method for monitoring the administration of polyethylene glycol (PEG) to an animal in need thereof, comprising obtaining a sample from an animal receiving polyethylene glycol, wherein the PEG has an average molecular weight of at least 5,000 daltons, and detecting PA-I lectin/adhesin activity in the sample, whereby the PA-I lectin/adhesin activity provides information useful in assessing the efficacy of administration. In one embodiment of this method, the PA-I lectin/adhesin is detected by binding to a PA-I lectin/adhesin binding partner, such as any known form of a specific anti-PA-I lectin/adhesin antibody or a carbohydrate to which the lectin/adhesin specifically binds. A related aspect of the invention is a kit for monitoring the administration of polyethylene glycol (PEG) comprising a PA-I lectin/adhesin binding partner and a protocol describing use of the binding partner to detect PA-I lectin/adhesin in the sample. Suitable protocols include any of the methods disclosed herein or known in the art relating to the use of PEG.
[0033] Other features and advantages of the present invention will be better understood by reference to the following detailed description, including the drawing and the examples.
BRIEF DESCRIPTION OF THE DRAWING
[0034] FIG. 1 provides mortality rates in mice at 48 hours subjected to either sham laparotomy or 30% surgical hepatectomy followed by direct injection of P. aeruginosa PA27853 into the cecum. Mice underwent a 30% bloodless left lobe hepatectomy immediately, followed by direct cecal injection of 1×10 7 cfu/ml of PA27853. Each group contained 7 mice. Control mice underwent sham laparotomy followed by injection of equal amounts of PA27853 into the cecum. For mice in the PEG groups, 1×10 7 cfu/ml of PA27853 was suspended in either PEG 3.35 (LMW PEG 3,350) or PEG 15-20 (HMW PEG 15,000 to 20,000 daltons) prior to cecal injection. Dose response curves for PEG 15-20 are seen in panel b. a. A statistically significant protective effect of PEG 15-20 was determined by the Fisher Exact Test (P<0.001). b. The minimum protective concentration of PEG 15-20 was determined to be 5% (P<0.05). c. Quantitative bacterial cultures of cecal contents (feces), washed cecal mucosa, liver, and blood 24 hours following 30% surgical hepatectomy and direct cecal injection of 1×10 7 cfu/ml of PA27853. One-way ANOVA demonstrated a statistically significant increase in bacterial counts in cecal contents, mucosa, liver, and blood in mice following hepatectomy (P<0.001). A significant decrease (P<0.05) in the liver and blood bacterial counts was observed for PEG 3350, while PEG 15-20 completely prevented PA27853 from disseminating to the liver and blood of mice.
[0035] FIG. 2 shows the protective effect of PEG 15-20 against PA27853-induced epithelial barrier dysfunction as assessed by transepithelial electrical resistance (TEER). a. Data represent the mean±SEM % maximal fall in TEER from baseline of triplicate cultures (n=7) observed during 8 hours of apical exposure to 1×10 7 cfu/ml of PA27853. A statistically significant decrease in TEER was demonstrated (one-way ANOVA (P<0.001)) in Caco-2 cells exposed to PA27853. A statistically significant protective effect on the fall in TEER induced by PA27853 was demonstrated for PEG 15-20 (P<0.001). b. Image of Caco-2 cells in the presence of PEG 3.35 and apical exposure to PA27853. Images taken after 4 hours of co-culture demonstrated loss of monolayer integrity with cells floating 30-40 microns above the cell scaffolds displaying adherence of PA27853 to cell membranes. c. Caco-2 cells apically exposed to PA27853 after 4 hours in the presence of PEG 15-20 showed no evidence of floating cells in any of the planes examined.
[0036] FIG. 3 illustrates the inhibitory effect of PEGs on PA-I expression in PA27853. a. Western blot analysis. Exposure of PA27853 to 1 mM of the quorum-sensing signaling molecule C4-HSL resulted in a statistically significant increase (P<0.001 one-way ANOVA) in PA-I protein expression that was partially inhibited in the presence of 10% PEG 3.35 and much more inhibited with 10% PEG 15-20. a′. The minimum inhibitory concentration of PEG 15-20 on C4-HSL induced PA-I expression was 5% (P<0.01). b. Electron microscopy of individual bacteria cells exposed to C4-HSL in the presence and absence of PEGs, demonstrated that C4-HSL caused a morphological change in the shape and pili expression of P. aeruginosa . The C4-HSL-induced morphological effect was completely eliminated in the presence of PEG 15-20, but not PEG 3.35. A halo-type effect can be seen surrounding PA27853 exposed to PEG 15-20. c. Northern hybridization. Exposure of PA27853 to 0.1 mM of C4-HSL resulted in a statistically significant increase (P<0.001 one-way ANOVA) in PA-I mRNA expression that was greatly inhibited with 10% PEG 15-20. d. The increase in PA-I mRNA induced by 4 hours exposure to Caco-2 cell was inhibited in the presence of PEG 15-20, but not PEG 3.35 (P<0.001 one-way ANOVA).
[0037] FIG. 4 shows the effect of PEG solutions on bacterial membrane integrity arid growth patterns of PA27853. a. The effect of the two PEG solutions on bacterial membrane integrity was assessed by a staining method consisting of SYTO 9 and propidium iodide. Neither PEG solution had any effect on bacterial membrane permeability. b. PA27853 growth patterns appeared identical in the two PEG solutions relative to the PEG-free TSB medium (control).
[0038] FIG. 5 presents Atomic Force Microscopy (AFM) images of Caco-2 cells and bacterial cells exposed to PEGs. a-c. AFM images of Caco-2 cells in the presence of medium alone (a), medium with PEG 3.35 (b), and medium with PEG 15-20. PEG 3.35 was seen to form a smooth carpet over the Caco-2 cells (b), whereas PEG 15-20 formed a more topographically defined covering (c). d-f. AFM images of PA27853 in PEG 3.35 and PEG 15-20. PEG 3.35 formed a smooth envelope around individual bacterial cells (e) whereas PEG 15-20 not only tightly hugged the individual cells (f), but also increased the polymer/bacterial diameter (g,h), thereby distancing individual bacteria from one another.
[0039] FIG. 6 shows the effect of PEG solution on the dispersion/clumping pattern of PA27853. The dispersion pattern of bacterial cells in dTC3 dishes was observed directly with an Axiovert 100 TV fluorescence inverted microscope using DIC and GFP fluorescence filter, at an objective magnification of 63×. Temperature was adjusted with a Bioptechs thermostat temperature control system. Tungsten lamps (100 V) were used for both DIC and the GFP excitation. The 3D imaging software (Slidebook) from intelligent Imaging Innovations was used to image the bacterial cell dispersion pattern in the Z plane using the GFP filter. Uniformly dispersed planktonic P. aeruginosa cells in the medium without Caco-2 cells were seen on DIC image ( 6 a 1 ) and Z plane reconstruction ( 6 a 2 ). In the presence of Caco-2 cells, bacterial cells developed a clumped appearance ( 6 b 1 ) and were seen adherent to the Caco-2 cells ( 6 b 2 ). 10% PEG 3350 decreased the motility of bacteria and induced immediate formation of mushroom-shaped bacterial microcolonies ( 6 c 1 ) adhering to the bottom of the well ( 6 c 2 ). In the presence of Caco-2 cells, bacterial microcolonies were on the order of 8 microns above the plane of the epithelial cells ( 6 d 1,2 ). 10% PEG 15-20 greatly diminished the motility of P. aeruginosa cells. Nevertheless, for the first 0.5-1 hours of incubation in PEG 15-20-containing medium, bacterial cells formed spider-shaped microcolonies that were close to the bottom of the well ( 6 e 1,2 ). Within several hours, spider leg-shaped microcolonies occupied the entire space/volume of the medium (not shown). In the presence of Caco-2 cells, P. aeruginosa cells lost the spider-like configuration and were seen elevated high above the plane of the epithelium (30-40 microns) ( 6 f 1,2 ).
DETAILED DESCRIPTION OF INVENTION
[0040] The invention provides products and methods that collectively present simple and economical approaches to the treatment and/or prevention of a variety of microbe-mediated epithelial disorders, i.e., abnormal conditions and diseases, that afflict many mammals, including humans. By administering high molecular weight polar polymers such as HMW polyethylene glycol to an animal in need, including those at risk, any of a number of health- or life-threatening abnormal conditions, i.e., epithelial disorders and diseases, including gut-derived sepsis, can be treated with minimal cost and minimal training of practitioners. Without wishing to be bound by theory, the benefits provided by the invention are consistent with the principle that microbe-mediated epithelial disorders can be successfully prevented, ameliorated or treated by facilitating an environment conducive to the survival of such microbes. An understanding of the following more detailed description of the invention is facilitated by initially establishing the following meanings for terms used in this disclosure.
[0041] An “abnormal condition” is broadly defined to include mammalian diseases, mammalian disorders and any abnormal state of mammalian health that characterized by an epithelial surface at risk of developing a microbial-mediated disorder. The abnormal conditions characterized by an epithelial surface at risk of developing a microbial-mediated disorder include conditions in which the epithelial surface has developed a microbial-mediated disorder. Exemplary conditions include human diseases and human disorders requiring, or resulting from, medical intervention, such as a burn injury, neonatal enterocolitis, severe neutropenia, inflammatory bowel disease, enteropathy (e.g., of the critically ill) and transplant (e.g., organ) rejection.
[0042] “Burn injury” means damage to mammalian tissue resulting from exposure of the tissue to heat, for example in the form of an open flame, steam, hot fluid, and a hot surface.
[0043] “Severe” neutropenia is given its ordinary and accustomed meaning of a marked decrease in the number of circulating neutrophils.
[0044] “Transplant rejection” refers to any development of transplanted material (e.g., an organ) recognized as being associated with ultimate rejection of that material by the host organism.
[0045] “Administering” is given its ordinary and accustomed meaning of delivery by any suitable means recognized in the art. Exemplary forms of administering include oral delivery, anal delivery, direct puncture or injection, topical application, and spray (e.g., nebulizing spray), gel or fluid application to an eye, ear, nose, mouth, anus or urethral opening.
[0046] An “effective dose” is that amount of a substance that provides a beneficial effect on the organism receiving the dose and may vary depending upon the purpose of administering the dose, the size and condition of the organism receiving the dose, and other variables recognized in the art as relevant to a determination of an effective does. The process of determining an effective dose involves routine optimization procedures that are within the skill in the art.
[0047] An “animal” is given its conventional meaning of a non-plant, non-protist living being. A preferred animal is a mammal, such as a human.
[0048] In the context of the present disclosure, a “need” is an organismal, organ, tissue, or cellular state that could benefit from administration of an effective dose to an organism characterized by that state. For example, a human at risk of developing gut-derived sepsis, or presenting a symptom thereof, is an organism in need of an effective dose of a product, such as a pharmaceutical composition, according to the present invention.
[0049] “Average molecular weight” is given its ordinary and accustomed meaning of the arithmetic mean of the molecular weights of the components (e.g., molecules) of a composition, regardless of the accuracy of the determination of that mean. For example, polyethylene glycol, or PEG, having an average molecular weight of 3.5 kilodaltons may contain PEG molecules of varying molecular weight, provided that the arithmetic mean of those molecular weights is determined to be 3.5 kilodaltons at some level of accuracy, which may reflect an estimate of the arithmetic mean, as would be understood in the art. Analogously, PEG 15-20 means PEG whose molecular weights yield an arithmetic mean between 15 and 20 kilodaltons, with that arithmetic mean subject to the caveats noted above. These PEG molecules include, but are not limited to, simple PEG polymers. For example, a plurality of relatively smaller PEG molecules (e.g., 7,000 to 10,000 daltons) may be joined, optionally with a linker molecule such as a phenol, into a single molecule having a higher average molecular weight (e.g., 15,000 to 20,000 daltons).
[0050] “Cell membrane integrity” means the relative absence of functionally significant modifications of a cell membrane as a functional component of a living cell, as would be understood in the art.
[0051] “Detectably altered” is given its ordinary and accustomed meaning of a change that is perceivable using detection means suitable under the circumstances, as would be understood in the art.
[0052] “Growth pattern” refers collectively to the values of those properties of a cell, or group of cells (e.g., a population of cells), that are recognized in the art as characterizing cell growth, such as the generation or doubling time of the cell, the appearance of topography of a nascent group of cells, and other variables recognized in the art as contributing to an understanding of the growth pattern of a cell or group of cells.
[0053] “Inhibiting” is given its ordinary and accustomed meaning of inhibiting with, reducing or preventing. For example, inhibiting morphological change means that morphological change is made more difficult or prevented entirely.
[0054] “PA-I, or PA-I lectin/adhesin, expression means the production or generation of an activity characteristic of PA-I lectin/adhesin. Typically, PA-I lectin/adhesin expression involves translation of a PA-I lectin/adhesin-encoding mRNA to yield a PA-I lectin/adhesin polypeptide having at least one activity characteristic of PA-I lectin/adhesin. Optionally, PA-I lectin/adhesin further includes transcription of a PA-I lectin/adhesin-encoding DNA to yield the aforementioned mRNA.
[0055] “Epithelium-induced activation” refers to an increase in the activity of a given target (e.g., PA-I lectin/adhesin) through direct or indirect influence of an epithelial cell. In the context of the present invention, for example, epithelium-induced activation of PA-I lectin/adhesin refers to an increase in that polypeptide's activity attributable to the indirect influence of an epithelium manifested through the direct contact of an epithelial cell or cells with an intestinal pathogen.
[0056] “Morphological change” is given its ordinary and accustomed meaning of an alteration in form.
[0057] “Intestinal pathogen” means a pathogenic microbe capable of causing, in whole or part, gut-derived sepsis in an animal such as a human. Intestinal pathogens known in the art are embraced by this definition, including gram negative bacilli such as the Pseudomonads (e.g., Pseudomonas aeruginosa ).
[0058] “Ameliorating” means reducing the degree or severity of, consistent with its ordinary and accustomed meaning.
[0059] “Pathogenic quorum” means aggregation or association of a sufficient number of pathogenic organisms (e.g., P. aeruginosa ) to initiate or maintain a quorum sensing signal, as would be known in the art.
[0060] “Interaction” is given its ordinary and accustomed meaning of interplay, as in the interplay between or among two or more biological products, such as molecules, cells, and the like.
[0061] “Transepithelial Electrical Resistance,” or TEER, is given the meaning this phrase has acquired in the art, which refers to a measurement of electrical resistance across epithelial tissue, which is non-exclusively useful in assessing the status of tight junctions between epithelial cells in an epithelial tissue.
[0062] “Adherence” is given its ordinary and accustomed meaning of physically associating for longer than a transient period of time.
[0063] “Topographically asymmetrical” refers to an image, map or other representation of the surface of a three-dimensional object (e.g., a cell) that is not symmetrical.
[0064] “Atomic force microscopy,” also known as scanning force microscopy, is a technique for acquiring a high-resolution topographical map of a substance by having a cantilevered probe traverse the surface of a sample in a raster scan and using highly sensitive means for detecting probe deflections, as would be understood in the art.
[0065] “Pharmaceutical composition” means a formulation of compounds suitable for therapeutic administration, to a living animal, such as a human patient. Preferred pharmaceutical compositions according to the invention comprise a solution balanced in viscosity, electrolyte profile and osmolality, comprising an electrolyte, dextran-coated L-glutamine, dextran-coated inulin, lactulase, D-galactose, N-acetyl D-galactosamine and 5-20% PEG (15,000-20,000).
[0066] “Adjuvants,” “carriers,” or “diluents” are each given the meanings those terms have acquired in the art. An adjuvant is one or more substances that serve to prolong the immunogenicity of a co-administered immunogen. A carrier is one or more substances that facilitate the manipulation, such as by translocation of a substance being carried. A diluent is one or more substances that reduce the concentration of, or dilute, a given substance exposed to the diluent.
[0067] “HMW PEG” refers to relatively high molecular weight PEG defines as having an average molecular weight greater than 3.5 kilodaltons. Preferably, HMW PEG has an average molecular weight greater than 5 kilodaltons and, in particular embodiments, HMW PEG has an average molecular weight at least 8 kilodaltons, at least 15 kilodaltons, and between 15 and 20 kilodaltons.
[0068] The following examples illustrate embodiments of the invention. Example 1 describes the protection against gut-derived sepsis provided to hepatectomized mice by high molecular weight PEG. Example 2 discloses how HMW PEG prevents pathogen adherence to intestinal epithelial cells. Example 3 reveals how HMW PEG inhibits pathogenic virulence expression generally, and PA-I lectin/adhesin expression specifically. Example 4 shows that PEG does not affect growth, or cell membrane integrity, of pathogens. Example 5 illustrates the unique topographical conformation of HMW PEG-coated pathogens using Atomic force microscopy. Example 6 describes the cell-cell interactions affected by HMW PEG. Example 7 describes preventive methods using the compositions of the invention. Example 8 discloses methods for monitoring administration of HMW PEG, such as in the treatment methods of the invention, and corresponding kits.
Example 1
HMW PEG Protects Against Gut-Derived Sepsis Following 30% Hepatectomy
[0069] Male Balb/c mice were anesthetized and subjected to hepatectomy using a conventional protocol. A 30% bloodless excision of the liver along the floppy left lobe was performed. Control mice underwent manipulation of the liver without hepatectomy. The experimental and control groups each contained seven mice. In all mice, a volume of 200 μl of 10 7 cfu/ml of Pseudomonas aeruginosa PA27853 was injected into the base of the cecum by direct needle puncture diluted in either saline, PEG 3.350 or PEG 15-20 (PEGs). The relatively low molecular weight PEGs are commercially available; PEG 15-20, having an average molecular weight of 15,000 to 20,000 daltons, is a combination of PEG 7-8 and PEG 8-10 covalently joined to a phenol ring. The PEG 7-8 has an average molecular weight of 7,000 to 8,000 daltons and the PEG 8-10 has an average molecular weight of 8,000 to 10,000 daltons. One of skill in the art will realize that HMW PEGs include compounds having any of a variety of PEG subunits with each subunit having any of a variety of average molecular weights joined, preferably covalently, to each other or to one or more linker molecules, which are relatively small molecules having functional groups suitable for joinder of PEG molecules. Suitable linkers substantially preserve the biological activity of HMW PEG (preservation of sufficient biological activity to realize a beneficial prophylactic or therapeutic effect as disclosed herein).
[0070] In order to provide a constant source of PEG for the 48-hour duration of the experiment, the needle was directed into the small bowel (ileum) and 1 ml of saline, PEG 3.35 or PEG 15-20 was injected retrograde into the proximal bowel. The puncture site was tied off with a silk suture and the cecum swabbed with alcohol. Mice were returned to their cages and were given H 2 O only for the next 48 hours.
[0071] Dose response curves for PEG 15-20 are seen in panel b of FIG. 1 . a. A statistically significant protective effect of PEG 15-20 was determined by the Fisher Exact Test (P<0.001). b. The minimum protective concentration of PEG 15-20 was determined to be 5% (P<0.05). c. Quantitative bacterial cultures of cecal contents (feces), washed cecal mucosa, liver, and blood 24 hours following 30% surgical hepatectomy and direct cecal injection of 1×10 7 cfu/ml of PA27853. One-way ANOVA demonstrated a statistically significant increase in bacterial counts in cecal contents, mucosa, liver, and blood in mice following hepatectomy (P<0.001). A significant decrease (P<0.05) in the liver and blood bacterial counts was observed for PEG 3350, while PEG 15-20 completely prevented PA27853 from disseminating to the liver and blood of mice.
[0072] Pseudomonas aeruginosa strain ATCC 27853 (PA27853) is a non-mucoid clinical isolate from a blood culture. Direct cecal injection of strain PA27853 in mice previously subjected to a 30% bloodless surgical hepatectomy resulted in a state of clinical sepsis and no survivors at 48 hours. Mice subjected to sham laparotomy without hepatectomy (controls), who are similarly injected with P. aeruginosa , survive completely without any clinical signs of sepsis ( FIG. 1 a ). To determine the ability of PEG solutions to prevent or lower mortality in this model, 200 μl of PA27853 at a concentration of 1×10 7 cfu/ml, was suspended in one of two 10% (w/v) solutions of polyethylene glycol (PEG-3.35 versus PEG-15-20). PEG-3.35 was chosen as it represents the molecular weight of PEGs that have been available for clinical use for the last 25 years (Golytely®). In comparison, PEG solutions according to the invention that were used had molecular weights varying between 15-20 kDa. Suspended strains were introduced into the cecum by direct puncture. PEG 3.35 had no effect on mortality in mice following hepatectomy, whereas PEG 15-20 was completely protective. In fact, PEG 15-20 had a statistically significant protective effect, as determined by the Fisher Exact Test (P<0.001). Dose-response experiments demonstrated a 5% solution to be the minimal concentration of PEG 15-20 that was completely protective (P<0.05; see FIG. 1 b ), although one of skill in the art will recognize that HMW PEG solutions of less than 5% would be expected to provide some protection and, thus, fall within the scope of the present invention. With respect to bacterial counts in the experimental and control mice, a one-way analysis of variance (ANOVA) demonstrated a statistically significant increase in bacterial counts in the cecal contents, mucosa, liver, and blood in mice following hepatectomy (P<0.001). A significant decrease (P<0.05) in the liver and blood bacterial counts was observed for PEG 3350, while PEG 15-20 completely prevented PA27853 from disseminating to the liver and blood of mice. PEG 15-20 completely inhibited the dissemination of intestinal PA27853 to the liver and bloodstream ( FIG. 1 c ). The data indicate that the action of PEG solutions involves mechanisms that are non-microbiocidal. Given at PEG concentrations non-toxic to mammalian cells (i.e. ≦about 10%), no effect on bacterial growth patterns can be demonstrated.
[0073] The example demonstrates that HMW PEG reduces the mortality rate attributable to gut-derived sepsis in mice subjected to surgical intervention in the form of a partial hepatectomy. This mouse model indicates that HMW PEG therapy is useful in reducing the mortality rate of an animal species (i.e., reducing the likelihood of mortality in any given organism), such as a mammal like man, subjected to a physiological stress such as invasive surgery (e.g., partial hepatectomy). It is expected that HMW PEG therapy will be effective in methods of preventing death or serious illness associated with sepsis when implemented following the physiological stress (e.g., during post-operative care). Further, HMW PEG therapy may be used prior to physiological stressing (e.g., pre-operative care), under circumstances where introduction of the stress is predictable, to lower the risk of serious illness or death. HMW PEG therapy is also useful in ameliorating a symptom associated with a disease or abnormal condition associated with gut-derived sepsis.
Example 2
HMW PEG Prevents Pathogen Adherence to Intestinal Epithelia
[0074] Tight junctions are dynamic elements of the epithelial cell cytoskeleton that play a key role in the barrier function of the mammalian intestinal tract. P. aeruginosa results in a profound alteration in tight junctional permeability as measured by the transepithelial electrical resistance (TEER) of both Caco-2 cells and T-84 cells. Caco-2 cells are well-characterized human colon epithelial cells that maintain a stable TEER in culture, and this cell line provides a recognized in vitro model of the in vivo behavior of intestinal pathogens. To determine the protective effect of PEG on P. aeruginosa PA27853-induced decreases in TEER of cultured Caco-2 monolayers, 1×10 7 cfu/ml of PA27853 was apically inoculated onto two Caco-2 cell monolayers in the presence of 10% PEG 3.35 or 10% PEG 15-20. TEER was serially measured for 8 hours and the maximal fall in TEER recorded.
[0075] Only PEG 15-20 protected significantly against the P. aeruginosa -induced decrease in TEER ( FIG. 2 a ). The data presented in FIG. 2 represent the mean±SEM % maximal fall in TEER from baseline of triplicate cultures (n=7) observed during 8 hours of apical exposure to 1×10 7 cfu/ml of PA27853. A statistically significant decrease in TEER, as demonstrated in Caco-2 cells exposed to PA27853, was revealed by one-way ANOVA (P<0.001). A statistically significant protective effect on the fall in TEER induced by PA27853 was demonstrated for PEG 15-20 (P<0.001). FIG. 2 b shows Caco-2 cells in the presence of PEG 3.35 and with apical exposure to PA27853. After 4 hours of co-culture in the presence of PEG 3.35, disruption of the Caco-2 cell monolayers displaying focally adherent bacteria was observed, with cells floating 30-40 microns above the monolayer scaffolds ( FIG. 2 b ). In contrast, FIG. 2 c , showing images of Caco-2 cells apically exposed for 4 hours to PA27853 in the presence of PEG 15-20, shows no evidence of floating cells in any of the planes examined. The protective effect of PEG 15-20 on Caco-2 cell integrity was associated with less bacterial adherence, reflected by a 15-fold higher recovery of bacteria in the cell supernatants following a 4-hour exposure to 1×10 6 cfu/ml of PA27853.
[0076] The resistance of PEG-cultured human intestinal epithelial cells to the barrier-disrupting effects of P. aeruginosa , as judged by the maintenance of TEER, offers a practical approach to stabilizing tight junctional barrier function in the face of a challenge from invading pathogens. Further evidence of the therapeutic value of PEG 15-20 is that epithelial transport function (Na + /H + exchange, glucose transport) is unaffected by this compound.
[0077] Thus, HMW PEG is relatively inert to, and has a stabilizing effect on, the intestinal epithelial barrier. The invention comprehends methods of treating intestinal barrier abnormalities associated with intestinal pathogens such as P. aeruginosa by administering HMW PEG to an animal such as a mammal and, preferably, a human. An intestinal barrier abnormality may be revealed by any diagnostic technique, or other means, known in the art. It is not necessary to identify an intestinal barrier abnormality prior to HMW PEG treatment, however. The low cost and high degree of safety associated with HMW PEG treatment make this approach suitable for both prophylactic applications, preferably directed towards at-risk organisms, as well as treatment methods applied to animals exhibiting at least one symptom characteristic of an intestinal barrier abnormality. The HMW PEG treatment methods would ameliorate a symptom associated with an intestinal barrier abnormality; preferably, the methods would reduce or eliminate the effects of gut-derived sepsis from a treated organism.
Example 3
HMW PEG Inhibits Virulence Expression in Pathogens
[0078] The expression of the PA-I lectin/adhesin in P. aeruginosa PA27853 was increased in the cecum of mice following hepatectomy and played a key role in the lethal effect of P. aeruginosa in the mouse intestine. PA-I functions as a significant virulence determinant in the mouse intestine by facilitating the adherence of PA27853 to the epithelium as well as by creating a significant barrier defect to the cytotoxins, exotoxin A and elastase. PA-I expression in P. aeruginosa is regulated by the transcriptional regulator RhIR and its cognate activator C4-HSL. Expression of PA-I in PA27853 was not only increased by exposure to C4-HSL, but also by contact with Caco-2 cells, Caco-2 cell membrane preparations, and supernatants from Caco-2 cell cultures.
[0079] Northern hybridization was used to analyze the expression of PA-I at the transcriptional level. Total RNA of P. aeruginosa was isolated by the modified three-detergent method. Probes were generated by PCR using PA-I primers: F(ACCCTGGACATTATTGGGTG) (SEQ ID NO: 1), R(CGATGTCATTACCATCG-TCG) (SEQ ID NO: 2) and 16S primers: F(GGACGGGTGAGTAATGCCTA) (SEQ ID NO: 3), R(CGTAAGGGCCATGATGACTT) (SEQ ID NO: 4), and cloned into the pCR2.1 vector (Invitrogen, Inc.). The inserts were sequences that matched the sequence of either PA-I or 16S. Specific cDNA probes for PA-I and 16S were radiolabeled with α 32 P-dCTP. The specific radioactivity was measured by a Storm 860 phosphorimager (Molecular Dynamics, CA), and relative percent changes compared to control were calculated based on the intensity ratio of PA-I and 16S. Western blot was used for PA-I protein analysis, using rabbit affinity-purified polyclonal anti-PA-I antibodies. One ml of P. aeruginosa cells was washed with PBS and heated at 100° C. in lysis buffer (4% SDS, 50 mM Tris-HCl, pH 6.8); immunoblot analysis was performed by electrotransfer of proteins after Tricine SDS-PAGE. The PA-I lectin was detected by the ECL reagent (Amersham, N.J.).
[0080] Exposure of P. aeruginosa PA27853 to 1 mM of the quorum-sensing signaling molecule C4-HSL resulted in a statistically significant increase (P<0.001, one-way ANOVA) in PA-I protein expression that was partially inhibited in the presence of 10% PEG 3.35 and inhibited to a much greater extent by 10% PEG 15-20 ( FIG. 3 ). The minimum completely inhibitory concentration of PEG 15-20 on C4-HSL-induced PA-I expression was 5% (P<0.01, one-way ANOVA). Electron microscopic examination of individual bacterial cells exposed to C4-HSL in the presence and absence of PEG, demonstrated that C4-HSL caused a morphological change in the shape and pili expression of P. aeruginosa ( FIG. 3 b ). The C4-HSL-induced morphological effect was completely eliminated in the presence of PEG 15-20, but not completely eliminated in the presence of PEG 3.35. A halo-type effect was seen surrounding PA27853 exposed to PEG 15-20 ( FIG. 3 b ). Exposure of PA27853 to 0.1 mM of C4-HSL resulted in a statistically significant increase (P<0.001, one-way ANOVA) in PA-I mRNA expression assessed using Northern blots. The PA-I expression was greatly inhibited by 10% PEG 15-20. FIG. 3 d shows that the increase in PA-I mRNA induced by a 4-hour exposure to Caco-2 cells was inhibited by PEG 15-20, but not by PEG 3.35 (P<0.001 one-way ANOVA).
[0081] The data presented herein show that a significant attenuation (3-4-fold decrease) of PA-I expression (protein and mRNA) in PA27853, induced by 100 μM-1 mM of C4-HSL, was observed when bacteria were pre-treated with 10% PEG 15-20. This effect was not observed with PEG 3.35 ( FIG. 3 a ). Attenuation of C4-HSL-induced PA-I expression was also observed for 10% PEG 3.35, although the degree of attenuation was significantly less than that for 10% PEG 15-20. The minimum concentration of PEG 15-20 that inhibited C4-HSL induced expression of PA-I protein was 5% ( FIG. 3 b ). Electron microscopy of individual bacterial cells exposed to C4-HSL demonstrated that C4-HSL caused a morphological change in the shape and pili expression of PA27853 ( FIG. 3 b ). The C4-HSL-induced morphological effect was completely eliminated in the presence of PEG 15-20, but not PEG 3.35 ( FIG. 3 b ). PA-I expression (mRNA), induced by 4 hours exposure to Caco-2 cells, was inhibited in the presence of PEG 15-20 but not PEG 3.35 ( FIG. 3 b ). The protective effect of Caco-2 cell-induced PA-I expression with PEG 15-20 persisted in experiments of overnight exposure.
[0082] HMW PEG also affects the virulence expression of P. aeruginosa in response to known stimuli. The attenuation of C4-HSL-induced PA-I expression in PA27853 may be a major protective effect of PEG 15-20, given that quorum-sensing signaling is a well-established mechanism of virulence expression for this pathogen. The PEG 15-20-induced interference with Caco-2 cell-induced expression of PA-I is expected to be an important aspect of the protective effect of PEG 15-20. PEG 15-20 was found to have a protective effect on host animals through the attenuation of P. aeruginosa (PA27853) PA-I expression in response to filtered cecal contents (feces) from mice following 30% hepatectomy. The ability of PEG 15-20 to shield P. aeruginosa from host factors that increase its virulence expression is expected to be yet another mechanism by which organisms are protected from gut-derived sepsis.
[0083] Accordingly, the invention includes materials in the form of kits and corresponding methods of administering an HMW PEG to an animal to prevent or treat a condition characterized by the expression of a virulence factor or determinant by an intestinal pathogen such as one of the Pseudomonads. A virulence determinant may contribute to virulence directly, or indirectly. An example of an indirect contribution is the effect of the PA/I lectin/adhesin of P. aeruginosa on intestinal pathogen adhesion to intestinal epithelia and/or the generation of a barrier defect to the cytotoxins, exotoxin A and elastase.
Example 4
PEG does not Affect Cell Growth, or Cell Membrane Integrity, of Pathogens
[0084] The effect of the two PEG solutions (PEG 3.35 and PEG 15-20) on bacterial membrane integrity was assessed by a staining method consisting of SYTO 9 and propidium iodide. Neither PEG solution had any effect on bacterial membrane permeability ( FIG. 4 a ). Membrane integrity was determined using a live/dead bacterial viability kit L-3152 (Molecular Probes). Bacteria were quantified and counts expressed as cfu/ml by plating 10-fold dilutions of samples taken at different incubation times. Growth curves for P. aeruginosa grown overnight in TSB media containing either of the two PEG solutions demonstrated no inhibitory effect by either PEG solution on bacterial quantity ( FIG. 4 b ). In fact, the growth pattern in each of the PEG-containing media was indistinguishable from the growth pattern in PEG-free TSB medium. The activity of a housekeeping enzyme involved in energy metabolism, lactate dehydrogenase (LDH), was measured at various time points during the exponential and stationary phases of growth. LDH activity was measured in a coupled diaphorase enzymatic assay using a substrate mix from CytoTox 96 (Promega). Protein concentration was determined using the BCA Protein Assay (Pierce). No change in LDH activity in cell-free supernatants of P. aeruginosa grown in the presence of PEGs was observed. The results of this experiment indicate that HMW PEG has a negligible effect on bacterial growth patterns.
[0085] The methods of the invention, and corresponding products (e.g., kits), provide the benefit of preventing or treating diseases or abnormal conditions associated with gut-derived sepsis without significantly influencing the composition of the intestinal flora. Similarly, the methods and products of the invention may be used to ameliorate a symptom associated with such diseases or abnormal conditions without significant change to the microbial composition of the intestine. One of skill in the art recognizes that methods (and kits) that do not significantly disturb the composition of the intestinal flora are desirable insofar as such methods would not be expected to lead to secondary health complications arising from such a disturbance.
Example 5
Atomic Force Microscopy of PEG-Coated Pathogen
[0086] One percent aliquots of a culture of PA27853 grown overnight were subcultured in tryptic soy broth (TSB), with or without 10% HMW PEG, for 4 hours at 37° C. One drop of each subculture was withdrawn and the P. aeruginosa PA27853 cells were extensively washed with PBS, dried on top of mica in blowing air for 10 minutes, and imaged immediately. Imaging of the dried bacteria with tapping-mode AFM was performed in air with a Multimode Nanoscope IIIA Scanning Probe Microscope (MMAFM, Digital Instruments). Subconfluent Caco-2 cells were treated with 10% HMW PEG for 4 hours and washed with PBS extensively. AFM imaging of the cells was performed in PBS without using an O-ring. For electron microscopy, PA27853 was inoculated in TSB with or without 1 mM C4-HSL and 10% HMW PEG and incubated overnight. One drop of 1% P. aeruginosa was stained with uranyl acetate and washed with 0.5M NaCl before examination under the electron microscope.
[0087] Atomic force microscopy of Caco-2 cells demonstrated a classical non-uniform surface with brush border microvili, while Caco-2 cells exposed to PEG 3.35 demonstrated a smooth planar appearance on the surface of the epithelial cells ( FIGS. 5 a, c ). PEG 15-20 appears to carpet the Caco-2 cells by filling the asymmetries along a topographically defined plane ( FIG. 5 e ), yielding a more complex topographically defined covering. In somewhat similar fashion, PA27853 cells exposed to PEG 3.35 demonstrate a pattern of smooth coating of the polymer to bacterial cells in a diffuse flat pattern ( FIG. 6 d ), whereas PEG 15-20 appears to surround and hug the bacteria circumferentially in a more topographically asymmetric fashion. Cross-sectional analysis of the atomic force measurement of the bacterial diameter in PEG 15-20 demonstrates a significant increase in the bacteria/PEG envelope within the PEG solution ( FIG. 5 e, f ). In other words, PEG 3.35 forms a smooth envelope around individual bacterial cells ( FIG. 5 e ), whereas PEG 15-20 tightly hugs individual cells ( FIG. 5 f ) and increases the polymer/bacterial diameter ( FIGS. 5 g , 5 h ), thereby distancing individual bacterial cells from each other.
[0088] Without wishing to be bound by theory, HMW PEG may exert its beneficial effect by the mere physical distancing of P. aeruginosa away from the intestinal epithelium. Alternatively, HMW PEG may provide benefits by preventing formation of a pathogenic quorum-sensing activation signal arising from cell-cell interaction of the pathogenic cells. Again without wishing to be bound by theory, it is possible that the coating of biological surfaces with HMW PEG results in loss of conformational freedom of the coating PEG chains and the repelling of approaching proteins. Polar-polar interactions between HMW PEG and Caco-2 cells could affect the elasticity of the PEG chains, constraining certain HMW PEG side chains to a molecular construct which repels protein. Data presented herein support the conclusion that HMW PEG-coated Caco-2 cells are more repellant to P. aeruginosa than uncoated Caco-2 cells, perhaps owing to a loss of “conformational entropy” as a result of some dynamic interaction of HMW PEG with Caco-2 cells.
[0089] The results of this experiment establish that HMW PEG treatment has an effect on treated cells, notably affecting the surface topology of such cells. Moreover, the effect of HMW PEG exposure on such cells is different from the effect that PEG 3.35 has on such cells. Although not wishing to be bound by theory, the results disclosed herein do provide a physical correlate for the markedly different effect on cells exhibited by HMW PEG relative to lower molecular weight PEGs, such as PEG 3.35.
Example 6
HMW PEG Affects Cell-Cell Interactions
[0090] To directly observe the effect of PEG solutions on the spatial orientation of P. aeruginosa , experiments were performed with live strains of P. aeruginosa PA27853/EGFP harboring the egfp gene encoding the green fluorescent protein. Experiments were performed in the presence and absence of Caco-2 cells. In order to image the effect of PEGs on both the bacteria and their interaction with the cultured epithelia, differential interference contrast (DIC) microscopy and GFP imaging were used.
[0091] The EGFP gene encoding green fluorescent protein was amplified using the pBI-EGFP plasmid (Clontech) as a template. XbaI and PstI restriction sites were introduced using primers TCTAGAACTAGTGGATCCCCGCGGATG (SEQ ID NO: 5) and GCAGACTAGGTCGACAAGCTTGATATC (SEQ ID NO: 6). The PCR product was cloned directly into the pCR 2.1 vector using a TA-cloning kit (Invitrogen), followed by transformation of the pCR2.1/EGFP construct into E. coli DH5a. The EGFP gene was excised from this construct by digestion with XbaI and PstI and the fragment containing the excised gene was cloned into the E. coli - P. aeruginosa shuttle vector pUCP24, which had been digested with the same restriction enzymes. The resulting construct (i.e., pUCP24/EGFP), containing the EGFP gene in the shuttle vector, was electroporated at 25 μF and 2500 V into PA27583 electro-competent cells. PA27853/EGFP-containing cells were selected on LB-agar plates containing 100 μg/ml gentamicin (Gm).
[0092] Cells harboring PA27853/EGFP were grown overnight in LB containing 100 μg/ml Gm, and 1% of the culture was used to inoculate fresh LB containing 50 μg/ml Gm. After 3 hours of growth, Isopropyl-β-D-thiogalactopyranoside (IPTG) was added to a final concentration of 0.5 mM, and cultures were incubated for 2 additional hours. 100 μl of the bacterial culture was mixed with 1 ml of HDMEM media (Gibco BRL) buffered with HEPES and containing 10% fetal bovine serum (HDMEM HF) and 10% HMW PEG. One ml of bacterial suspension was poured into a 0.15 mm-thick dTC3 dish (Bioptech). Four-day-old Caco-2 cells (p10-p30) grown in 0.15 mm-thick dTC3 dishes (Bioptech) in HDMEM HF were washed once in HDMEM HF with or without HMW PEG. One ml of bacterial suspension prepared as above was added to a dTC3 dish containing Caco-2 cells. The dispersion pattern of bacterial cells in dTC3 dishes was observed directly with an Axiovert 100 TV fluorescence inverted microscope using DIC and GFP fluorescence filters, at an objective magnification of 63×. The temperature was adjusted with a Bioptechs thermostat temperature control system. Tungsten lamps (100 V) were used for both DIC and the GFP excitation. The 3D imaging software (Slidebook) from Intelligent Imaging Innovations was used to image the bacterial cell dispersion pattern in the Z plane using the GFP filter. Uniformly dispersed planktonic P. aeruginosa cells in the medium without Caco-2 cells were seen on a DIC image ( FIG. 6 a 1 ) and Z plane reconstruction ( FIG. 6 a 2 ). In the presence of Caco-2 cells, bacterial cells developed a clumped appearance ( FIG. 6 b 1 ) and were seen adhering to the Caco-2 cells ( FIG. 6 b 2 ). A solution of 10% PEG 3350 decreased the bacterial motility and induced immediate formation of mushroom-shaped bacterial microcolonies ( FIG. 6 c 1 ) adhering to the bottom of the well ( FIG. 6 c 2 ). In the presence of Caco-2 cells, bacterial microcolonies were approximately 8 microns above the plane of the epithelial cells ( FIG. 6 d 1,2 ). A solution of 10% PEG 15-20 greatly diminished the motility of P. aeruginosa cells. Nevertheless, for the first 0.5-1 hour of incubation in PEG 15-20-containing medium, bacterial cells formed spider leg-shaped microcolonies that were close to the bottom of the well ( FIG. 6 e 1,2 ). Within several hours, spider leg-shaped microcolonies occupied the entire space/volume of the medium. In the presence of Caco-2 cells, P. aeruginosa cells lost the spider leg-like configuration and were seen elevated high above the plane of the epithelium (30-40 microns) ( FIG. 6 f 1,2 ).
[0093] To determine the spatial orientation of the bacterial-epithelial cell interactions in three dimensions, Z plane re-constructions were performed. Images demonstrated that the two PEG solutions had different effects on the clumping behavior of P. aeruginosa and differentially affected the spatial orientation of the bacteria depending on the presence or absence of Caco-2 cells. In experiments with medium only, P. aeruginosa were seen to display a uniformly dispersed pattern ( FIG. 6 a ). Bacterial cells examined in the presence of Caco-2 cells, however, developed a clumped appearance and were seen adjacent to the plane of the epithelial cells at the bottom of the wells ( FIG. 6 b ). Bacterial cells examined in the presence of PEG 3.35 alone formed large clumped aggregates and remained in the bottom of the culture well ( FIG. 6 c ), whereas bacterial cells examined with Caco-2 cells in medium containing PEG 3.35, remained suspended above the plane of the epithelial cells (about 8 microns), maintaining their clumped appearance ( FIG. 6 d ). Bacterial cells examined in the presence of PEG 15-20 alone displayed a uniform pattern of microclumping ( FIG. 6 e ), whereas bacterial cells examined in the presence of Caco-2 in medium containing PEG 15-20 were suspended higher above the plane of the epithelium (˜32 microns) in clumped formation ( FIG. 6 f ). In timed experiments, bacterial motility was observed to be decreased by PEG 3.35 and, to an even greater degree, with PEG 15-20.
[0094] In a manner analogous to the experiment disclosed in Example 5, this Example provides a physical correlate for the observed effect of HMW PEG on cell-cell interaction, consistent with its beneficial prophylactic and therapeutic activities as disclosed herein. It is expected that use of HMW PEG will reduce or eliminate deleterious cell-cell interactions in the intestine (e.g., between intestinal epithelial cells and intestinal pathogens such as the Pseudomonads), reducing the risk of diseases and/or abnormal conditions associated with gut-derived sepsis.
Example 7
Methods of Preventing Disease/Abnormal Conditions
[0095] The invention also provides methods of preventing a variety of diseases and/or abnormal conditions in humans and other animals, particularly other mammals. In these methods, an effective amount of HMW PEG is administered to a human patient or an animal subject in need thereof. The PEG may be administered using a schedule of administration that is determined using routine optimization procedures known in the art. Preferably, the PEG has an average molecular weight of 5,000-20,000 daltons, and more preferably between 10,000-20,000 daltons. It is contemplated that at least 5% HMW PEG is administered. The HMW PEG may be administered in any suitable form, e.g., as a solution, as a gel or cream, as a solution suitable for nebulizing (e.g., for inhalational use), in a pharmaceutical composition comprising the HMW PEG, and in a sterile, isotonic solution suitable for injection into an animal. administration may be accomplished using any conventional route; it is particularly contemplated that the HMW PEG is administered orally or topically. In some embodiments, the HMW PEG composition being administered further comprises a compound selected from the group consisting of dextran-coated L-glutamine, dextran-coated inulin, dextran-coated butyric acid, a fructo-oligosaccharide, N-acetyl-D-galactosamine, dextran-coated mannose, galactose and lactulose. In another embodiment, the administered HMW PEG composition further comprises dextran-coated L-glutamine, dextran-coated inulin, dextran-coated butyric acid, one or more fructo-oligosaccharides, N-acetyl-D-galactosamine, dextran-coated mannose, galactose and lactulose.
[0096] The invention provides methods of preventing a variety of diseases and abnormal conditions, such as swimmer's ear, acute or chronic otitis media, ventilator-associated pneumonia, gut-derived sepsis, necrotizing enterocolitis, antibiotic-induced diarrhea, pseudomembranous colitis, inflammatory bowel diseases, irritable bowel disease, neutropenic enterocolitis, pancreatitis, chronic fatigue syndrome, dysbiosis syndrome, microscopic colitis, chronic urinary tract infection, sexually transmitted disease, and infection (e.g., exposure to an environment contaminated by a bioterror agent such as Bacillus anthracis , Small Pox Virus, enteropathogenic E. coli (EPEC), enterohemorrhagic E. coli (EHEC), enteroaggregative E. coli , (EAEC), Clostridium difficile , rotavirus, Pseudomonas aeruginosa, Serratia marcescens, Klebsiella oxytocia, Enterobacteria cloacae, Candida albicans, Candida globrata , and the like). In a preferred embodiment of the method of preventing chronic urinary tract infection, or treating such an infection, the HMW PEG is delivered in the form of a bladder irrigant. For sexually transmitted disease prevention, a composition of the invention is preferably used to lubricate a condom. In a preferred embodiment of a method of preventing infection by a bioterror agent, the composition according to the invention is provided in the form of a gel or cream, suitable for topical application. It is expected that such topical application will be useful in preventing a variety of diseases/abnormal conditions associated with any of the bioterror agents or associated with a variety of chemical or physico-chemical agents that pose a threat to man or animal in terms of survival, health or comfort. Such chemical or physico-chemical agents include those agents capable of burning or otherwise injuring skin and which are rendered inactive or are poorly soluble in the compositions of the invention.
[0097] In one embodiment of the preventive methods, male Balb/c mice are anesthetized and an aqueous 5% solution of PEG 15-20 is injected into the base of the cecum by direct needle puncture. In order to provide a constant source of PEG for the 48-hour duration of the experiment, the needle is directed into the small bowel (ileum) and 1 ml of the PEG 15-20 is injected retrograde into the proximal bowel. The puncture site is tied off with a silk suture and the cecum swabbed with alcohol. Mice are returned to their cages and are given H 2 O only. Forty-eight hours later, the mice are subjected to a conventional hepatectomy procedure involving a 30% bloodless excision of the liver along the floppy left lobe. Control mice will experience manipulation of the liver without hepatectomy. The preventive treatment involving administration of HMW PEG is expected to reduce or eliminate the incidence of surgery-associated gut-derived sepsis in mice.
[0098] These methods are applicable beyond the preventive care of such pets as mice, guinea pigs, dogs and cats to such agriculturally significant animals as cattle, horses, goats, sheep, pigs, chickens, turkeys, ducks, geese, and any other domesticated animal. Moreover, these preventive methods are expected to be applicable to humans, improving the health, and life expectancy, of many patients or candidates at risk of developing a disease and/or an abnormal condition, such as swimmer's ear, acute or chronic otitis media, ventilator-associated pneumonia, gut-derived sepsis, necrotizing enterocolitis, antibiotic-induced diarrhea, pseudomembranous colitis, an inflammatory bowel disease, irritable bowel disease, neutropenic enterocolitis, pancreatitis, chronic fatigue syndrome, dysbiosis syndrome, microscopic colitis, chronic urinary tract infections, sexually transmitted diseases, and infectious agents (e.g., bioterror compositions) that include, but are not limited to, anthrax and small pox. As noted above, the preventive methods comprise administration of a composition comprising at least 5% HMW PEG (5-20 kDa), by any known or conventional administration route, to man or another animal. Preferably, the preventive methods are practiced on those individuals at risk of developing one or more of the aforementioned diseases and/or abnormal conditions, but it is contemplated that the compositions and methods of the invention will be useful in either a prophylactic or therapeutic role to broadly treat or prevent such diseases or abnormal conditions in entire populations or sub-populations of man or other animals.
Example 8
Methods of Monitoring Administration of HMW PEG
[0099] The invention also contemplates methods for monitoring administration of HMW PEG, e.g., in a method of treatment. In such monitoring methods, labeled HMW PEG is administered, alone or in combination with unlabeled HMW PEG, and the label is detected during treatment on a continuous or intermittent schedule, including simple endpoint determinations. The term “labeled” HMW PEG means that a label, or detectable compound, is directly or indirectly attached to HMW PEG, or the HMW PEG is attached to a reporter compound that is capable of associating a label with HMW PEG (of course, labels not attached to HMW PEG or designed to be associated therewith are also contemplated by the invention, as noted below). The HMW PEG is labeled using any detectable label known in the art, and the PEG is labeled to a level sufficient to detect it. Those of skill in the art will recognize that the level will vary depending on the label and the method of detection. One of skill in the art will be able to optimize the degree of labeling using routine optimization procedures. The label is chemically bound to the HMW PEG by a non-covalent or a covalent bond that is stable in use and, preferably, in storage. Label covalently bound to HMW PEG is preferred. The density of label attachment is adjusted to substantially preserve the biological activity of HMW PEG (preservation of sufficient biological activity to realize a beneficial prophylactic or therapeutic effect as disclosed herein). This is typically achieved by adjusting the HMW PEG:label ratio, as would be known in the art. Given the relative size of the average molecule of HMW PEG, it is expected that a wide variety of labels will be suitable for attachment to HMW PEG with substantial preservation of the biological activity thereof.
[0100] Labels contemplated by the invention are those labels known in the art, which include a radiolabel, a chromophore, a fluorophore, and a reporter (including an enzyme that catalyzes the production of a detectable compound and a binding partner such as an antibody that localizes a detectable compound in the vicinity of the reporter). Exemplary enzyme reporters include an enzymatic component of a luminescence system and a catalyst of a colorimetric reaction. More particularly, exemplary reporter molecules include biotin, avidin, streptavidin, and enzymes (e.g., horseradish peroxidase, luciferase, alkaline phosphatases, including secreted alkaline phosphatase (SEAP); β-galactosidase; β-glucuronidase; chloramphenicol acetyltransferase). The use of such reporters is well known to those of skill in the art and is described in, e.g., U.S. Pat. No. 3,817,837, U.S. Pat. No. 3,850,752, U.S. Pat. No. 3,996,345, and U.S. Pat. No. 4,277,437. Exemplary enzyme substrates, which may be converted to detectable compounds by reporter enzymes, include 5-bromo-4-chloro-3-indolyl β-D-galactopyranoside or Xgal, and Bluo-gal. Enzyme substrates, as compounds capable of conversion to detectable compounds, may also be labels in certain embodiments, as would be understood in the art. U.S. patents teaching labels, and their uses, include U.S. Pat. No. 3,817,837; U.S. Pat. No. 3,850,752; U.S. Pat. No. 3,939,350 and U.S. Pat. No. 3,996,345. Exemplary radiolabels are 3 H, 14 C, 32 P, 33 P, 35 S, and 125 I; exemplary fluorophores are fluorescein (FITC), rhodamine, Cy3, Cy5, aequorin, and green fluorescent protein. A preferred label is a fluorophore such as fluorescein.
[0101] The monitoring methods of the invention may also involve more than one label. In one embodiment, one label serves to identify the location of the HMW PEG following or during treatment, while a second label is specific for one or more microbes insofar as the label detectably associates with at least one microbe. For example, a monitoring method may include fluorescein attached to HMW PEG in a manner that substantially preserves the biological activity of the HMW PEG, and free (i.e., unattached) Xgal or bluo-gal for detection of prokaryote-specific β-galactosidase activity. The fluorescein localizes the HMW PEG, while a colored (blue) product indicates the presence of a lactose-metabolizing prokaryotic microbe, such as a Pseudomonad. The invention also includes monitoring methods wherein a single label provides this information (i.e., the location of HMW PEG and an indication of the presence of a microbe).
[0102] Any detection technique known in the art may be used in the monitoring methods of the invention. Several factors will influence the detection technique chosen, including the type of label, the biomaterial subjected to monitoring (e.g., epidermal cells of the skin, ear canal, or intestine; stool, mucus or tissue samples), the level of discrimination desired, whether quantitation is expected, and the like. Suitable detection techniques include simple visual inspection with the unaided eye, visual inspection with an instrument such as an endoscope, optionally equipped with a suitable light source and/or camera for recordation, the conventional use of Geiger counters, x-ray film, scintillation counters, and the like, and any other detection technique known in the art.
[0103] One of skill will recognize that the monitoring methods of the invention are useful in optimizing the treatment methods. For example, a monitoring method may be used to optimize the quantity and/or concentration of HMW PEG (e.g., to achieve a desired viscosity for a solution or mixture of HMW PEG), which is delivered to an epithelial cell, such as the epithelial cells of the ear canal to prevent or to treat swimmer's ear. By way of additional examples, optimization of bowel or intestinal treatments may be facilitated by endoscopic inspection of an intestinal tract exposed to labeled HMW PEG or by monitoring stool samples.
[0104] The monitoring methods of the invention include a stool assay for a microbe capable of adhering to an intestinal epithelial cell comprising contacting a microbe and an intestinal epithelial cell and detecting adherence of the microbe to the epithelial cell using any technique known in the art. In a preferred embodiment, the intestinal epithelial cell is immobilized on a suitable surface, such as the bottom and/or sides of a microtiter well. In another preferred embodiment, a direct label, or an indirect label such as a reporter capable of generating a detectable product, is added prior to, or during, the detecting step. The monitoring methods may further comprise addition of free label. For example, free Bluo-gal is added to a sample suspected of containing a lactose-metabolizing prokaryotic microbe; if present, the microbial enzyme β-galactosidase will cleave Bluo-gal to yield a detectable blue product.
[0105] In one embodiment, commercially available intestinal epithelial cells (e.g., Caco-2 cells, ATCC HTB 37, and/or IEC-6 cells, ATCC CRL 1952) are fixed to the wells of a microtiter dish using a conventional technique. A stool sample is collected and mixed with a fluid such as phosphate-buffered saline. The liquid phase of the mixture, containing suspended microbes, is obtained (e.g., by suitable filtration (i.e., separation of gross solids from bacteria in fluid suspension), decanting, or the like) and diluted 1:100 in PBS. Bluo-gal is added to the live microbial suspension. The microbial suspension is added to microtiter wells for 1 hour at 24° C., followed by washing of the wells with a suitable fluid (e.g., PBS) to remove unbound microbes. Microbes unbound and/or bound to the immobilized epithelial cells are detected, e.g., by counting using polarized light microscopy. In alternative embodiments, an immunoassay is used to detect adherence, with suitable immunological reagents being a microbe(s)-specific monoclonal or polyclonal antibody, optionally attached to a label such as a radiolabel, a fluorophore or a chromophore.
[0106] One of skill in the art will recognize that neither the intestinal epithelial cell nor the microbe is required to be immobilized, although such immobilization may facilitate accurate detection of microbes adhering to epithelial cells. For example, in one embodiment, an immobilized stool microbe is brought into contact with an intestinal epithelial cell that is not immobilized. Further, one of skill would recognize that any suitable fluid known in the art may be used to obtain the microbial suspension, with preferred fluids being any of the known isotonic buffers. Also, as noted above, any known label may be used to detect cell adherence.
[0107] In a related aspect, the invention provides a kit for assaying for microbial cell adherence comprising an epithelial cell and a protocol for assaying microbial cell adherence to the epithelial cell. The protocol describes a known method for detecting a microbe. A preferred kit includes an intestinal epithelial cell. Other kits of the invention further comprise a label, such as a fluorophore or a reporter.
[0108] Another monitoring method contemplated by the invention is an assay for microbial hydrophobicity. In this method, the relative or absolute hydrophobicity of a microbial cell is determined using any conventional technique. An exemplary technique involves exposure of any microbe to hydrophobic interaction chromatography, as would be known in the art. Ukuku et al., J. Food Prot. 65:1093-1099 (2002), incorporated herein by reference in its entirety. Another exemplary technique is non-polar:polar fluid partition (e.g., 1-octanol:water or xylene:water) of any microbe. See Majtan et al., Folia Microbiol (Praha) 47:445-449 (2002), incorporated herein by reference in its entirety.
[0109] In one embodiment of a hydrophobicity assay for monitoring PEG administration, a stool sample is suspended in 50 mM sodium phosphate buffer (pH 7.4) containing 0.15 M NaCl. Microbes in the suspension are collected by centrifugation and resuspended in the same buffer, and the centrifugation-resuspension cycle is repeated. If feasible, the microbes are resuspended in the same buffer to an absorbancy of 0.4 at 660 nm, which will permit monitoring spectrophotometrically, without using labeled PEG. The microbial suspension is treated with xylene (2.5:1, v/v, Merck), the suspension is vigorously mixed for two minutes, and the suspension is allowed to settle for 20 minutes at room temperature. The presence of microbes in the aqueous phase is then determined, for example by spectrophotometric determination of absorbancy at 660 nm. A blank containing the sodium phosphate buffer is used to eliminate background.
[0110] In obtaining microbial cells from stool samples for use in these methods, it is preferred that the HMW PEG be relatively insoluble in the fluid used to obtain the microbial suspension and any fluid used to dilute the microbial suspension.
[0111] The invention further provides a kit for performing the monitoring method comprising an assay for microbial hydrophobicity, which comprises an intestinal epithelial cell and a protocol describing the determination of microbial hydrophobicity. A preferred kit includes an intestinal epithelial cell. Related kits further comprise a label, such as a fluorophore or a reporter.
[0112] Still further, the invention provides a monitoring method comprising obtaining a sample of intestinal flora and detecting PA-I lectin/adhesin activity. Any technique for detecting PA-I lectin/adhesin activity known in the art may be used. For example, PA-I lectin/adhesin may be detected using an antibody (polyclonal, monoclonal, antibody fragment such as a Fab fragment, single chain, chimera, humanized or any other form of antibody known in the art) that specifically recognizes PA-I lectin/adhesin. The immunoassay takes the form of any immunoassay format known in the art, e.g., ELISA, Western, immunoprecipitation, and the like. Alternatively, one may detect a carbohydrate-binding capacity of PA-I lectin/adhesin or the intestinal epithelial barrier breaching activity of PA-I lectin/adhesin may be measured, e.g., by monitoring the trans-epithelial electrical resistance or TEER of an epithelial layer prior to, and/or during, exposure to a sample. In related kits, the invention provides a PA-I lectin/adhesin binding partner and a protocol for detecting PA-I lectin/adhesin activity (e.g., binding activity). Other kits according to the invention include any carbohydrate known to bind PA-I lectin/adhesin and a protocol for detecting PA-I lectin/adhesin activity (e.g., binding activity).
[0113] Numerous modifications and variations of the present invention are possible in view of the above teachings and are within the scope of the invention. The entire disclosures of all publications cited herein are hereby incorporated by reference.
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The present invention provides pharmaceutical compositions in the form of relatively high molecular weight biocompatible polymers such as polyethylene glycol, optionally supplemented with a protective polymer such as dextran and/or essential pathogen nutrients such as L-glutamine. Also provided are methods for preventing or treating gut-derived sepsis attributable to intestinal pathogens such as Pseudomonas aeruginosa by administering high molecular weight polyethylene glycol as well as methods for monitoring the administration of high molecular weight polyethylene glycol, such as in methods of preventing, ameliorating or treating microbe-induced epithelial disorders, as exemplified by gut-derived sepsis. Frequently, gut-derived sepsis arises as a complication in mammals recovering from surgical intervention or suffering from a disease or disorder, providing indications of suitable animals to receive preventative treatment. Finally, the invention provides a composition comprising infant formula and polyethylene glycol and methods for using that composition.
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RELATED APPLICATIONS
[0001] This application is a divisional of co-pending application Ser. No. 11/199,715, filed Aug. 9, 2005, which is a divisional of application Ser. No. 10/747,547, filed 29 Dec. 2003, now U.S. Pat. No. 6,981,981, which is a divisional of application Ser. No. 10/411,573, filed Apr. 10, 2003, now abandoned, which is a divisional of application Ser. No. 10/200,674, filed Jul. 22, 2002, now U.S. Pat. No. 6,663,647, which is a divisional of Ser. No. 09/059,796, filed Apr. 13, 1998, now U.S. Pat. No. 6,423,083, which is a divisional of application Ser. No. 08/788,786, filed Jan. 23, 1997, now U.S. Pat. No. 6,235,043, which is a continuation of application Ser. No. 08/188,224, filed on Jan. 26, 1994 (now abandoned).
FIELD OF THE INVENTION
[0002] This invention relates to improvements in the surgical treatment of bone conditions of the human and other animal bone systems and, more particularly, to an inflatable balloon-like device for use in treating such bone conditions. Osteoporosis, avascular necrosis and bone cancer are diseases of bone that predispose the bone to fracture or collapse. There are 2 million fractures each year in the United States, of which about 1.3 million are caused by osteoporosis. Avascular necrosis and bone cancers are more rare but can cause bone problems that are currently poorly addressed.
BACKGROUND OF THE INVENTION
[0003] In U.S. Pat. Nos. 4,969,888 and 5,108,404, an apparatus and method are disclosed for the fixation of fractures or other conditions of human and other animal bone systems, both osteoporotic and non-osteoporotic: The apparatus and method are especially suitable for use in the fixation of, but not limited to, vertebral body compression fractures, Colles fractures and fractures of the proximal humerus.
[0004] The method disclosed in these two patents includes a series of steps which a surgeon or health care provider can perform to form a cavity in pathological bone (including but not limited to osteoporotic bone, osteoporotic fractured metaphyseal and epiphyseal bone, osteoporotic vertebral bodies, fractured osteoporotic vertebral bodies, fractures of vertebral bodies due to tumors especially round cell tumors, avascular necrosis of the epiphyses of long bones, especially avascular necrosis of the proximal femur, distal femur and proximal humerus and defects arising from endocrine conditions).
[0005] The method further includes an incision in the skin (usually one incision, but a second small incision may also be required if a suction egress is used) followed by the placement of a guide pin which is passed through the soft tissue down to and into the bone.
[0006] The method further includes drilling the bone to be treated to form a cavity or passage in the bone, following which an inflatable balloon-like device is inserted into the cavity or passage and inflated. The inflation of the inflatable device causes a compacting of the cancellous bone and bone marrow against the inner surface of the cortical wall of the bone to further enlarge the cavity or passage. The inflatable device is then deflated and then is completely removed from the bone. A smaller inflatable device (a starter balloon) can be used initially, if needed, to initiate the compacting of the bone marrow and to commence the formation of the cavity or passage in the cancellous bone and marrow. After this has occurred, a larger, inflatable device is inserted into the cavity or passage to further compact the bone marrow in all directions.
[0007] A flowable biocompatible filling material, such as methylmethacrylate cement or a synthetic bone substitute, is then directed into the cavity or passage and allowed to set to a hardened condition to provide structural support for the bone. Following this latter step, the insertion instruments are removed from the body and the incision in the skin is covered with a bandage.
[0008] While the apparatus and method of the above patents provide an adequate protocol for the fixation of bone, it has been found that the compacting of the bone marrow and/or the trabecular bone and/or cancellous bone against the inner surface of the cortical wall of the bone to be treated can be significantly improved with the use of inflatable devices that incorporate additional engineering features not heretofore described and not properly controlled with prior inflatable devices in such patents. A need has therefore arisen for improvements in the shape, construction and size of inflatable devices for use with the foregoing apparatus and method, and the present invention satisfies such need.
Prior Techniques for the Manufacture of Balloons for in-Patient Use
[0009] A review of the prior art relating to the manufacture of balloons shows that a fair amount of background information has been amassed in the formation of guiding catheters which are introduced into cardiovascular systems of patients through the brachial or femoral arteries. However, there is a scarcity of disclosures relating to inflatable devices used in bone, and none for compacting bone marrow in vertebral bodies and long bones.
[0010] In a dilatation catheter, the catheter is advanced into a patient until a balloon is properly positioned across a lesion to be treated. The balloon is inflated with a radiopaque liquid at pressures above four atmospheres to compress the plaque of the lesion to thereby dilate the lumen of the artery. The balloon can then be deflated, then removed from the artery so that the blood flow can be restored through the dilated artery.
[0011] A discussion of such catheter usage technique is found and clearly disclosed in U.S. Pat. No. 5,163,989. Other details of angioplasty catheter procedures, and details of balloons used in such procedures can be found in U.S. Pat. Nos. 4,323,071, 4,332,254, 4,439,185, 4,168,224, 4,516,672, 4,538,622, 4,554,929, and 4,616,652.
[0012] Extrusions have also been made to form prism shaped balloons using molds which require very accurate machining of the interior surface thereof to form acceptable balloons for angioplastic catheters. However, this technique of extrusion forms parting lines in the balloon product which parting lines are limiting in the sense of providing a weak wall for the balloon itself.
[0013] U.S. Pat. No. 5,163,989 discloses a mold and technique for molding dilatation catheters in which the balloon of the catheter is free of parting lines. The technique involves inflating a plastic member of tubular shape so as to press it against the inner molding surface which is heated. Inflatable devices are molded into the desired size and shape, then cooled and deflated to remove it from the mold. The patent states that, while the balloon of the present invention is especially suitable for forming prism-like balloons, it can also be used for forming balloons of a wide variety of sizes and shapes.
[0014] A particular improvement in the catheter art with respect to this patent, namely U.S. Pat. No. 4,706,670, is the use of a coaxial catheter with inner and outer tubing formed and reinforced by continuous helical filaments. Such filaments cross each other causing the shaft of the balloon to become shorter in length while the moving portion of the shank becomes longer in length. By suitably balancing the lengths and the angle of the weave of the balloon and moving portions of the filaments, changes in length can be made to offset each other. Thus, the position of the inner and outer tubing can be adjusted as needed to keep the balloon in a desired position in the blood vessel.
[0015] Other disclosures relating to the insertion of inflatable devices for treating the skeleton of patients include the following:
[0016] U.S. Pat. No. 4,313,434 relates to the fixation of a long bone by inserting a deflated flexible bladder into a medullary cavity, inflating the balloon bladder, sealing the interior of the long bone until healing has occurred, then removing the bladder and filling the opening through which the bladder emerges from the long bone.
[0017] U.S. Pat. No. 5,102,413 discloses the way in which an inflatable bladder is used to anchor a metal rod for the fixation of a fractured long bone.
[0018] Other references which disclose the use of balloons and cement for anchoring of a prosthesis include U.S. Pat. Nos. 5,147,366, 4,892,550, 4,697,584, 4,562,598, and 4,399,814.
[0019] A Dutch patent, NL 901858, discloses a means for fracture repair with a cement-impregnated bag which is inflated into a preformed cavity and allowed to harden.
[0020] It can be concluded from the foregoing review of the prior art that there is little or no substantive information on inflatable devices used to create cavities in bone. It does not teach the shape of the balloon which creates a cavity that best supports the bone when appropriately filled. It does not teach how to prevent balloons from being spherical when inflated, when this is desired. Current medical balloons can compress bone but are too small and generally have the wrong configuration and are generally not strong enough to accomplish adequate cavity formation in either the vertebral bodies or long bones of the body.
[0021] U.S. Pat. Nos. 4,969,888 and 5,108,404 disclose a checker-shaped balloon for compressing cancellous bone, but does not provide information on how this balloon remains in its shape when inflated.
[0022] Thus, the need continues for an improved inflatable device for use with pathological bones and the treatment thereof.
SUMMARY OF THE INVENTION
[0023] The present invention is directed to a balloon-like inflatable device or balloon for use in carrying out the apparatus and method of the above-mentioned U.S. Pat. Nos. 4,969,888 and 5,108,404. Such inflatable devices, hereinafter sometimes referred to as balloons, have shapes for compressing cancellous bone and marrow (also known as medullary bone or trabecular bone) against the inner cortex of bones whether the bones are fractured or not.
[0024] In particular, the present invention is directed to a balloon for use in treating a bone predisposed to fracture or to collapse. The balloon comprises an inflatable, non-expandable balloon body for insertion into said bone. The body has a predetermined shape and size when substantially inflated sufficient to compress at least a portion of the inner cancellous bone to create a cavity in the cancellous bone and to restore the original position of the outer cortical bone, if fractured or collapsed. The balloon body is restrained to create said predetermined shape and size so that the fully inflated balloon body is prevented from applying substantial pressure to the inner surface of the outer cortical bone if said bone is unfractured or uncollapsed.
[0025] In addition to the shape of the inflatable device itself, another aspect of importance is the construction of the wall or walls of the balloon such that proper inflation the balloon body is achieved to provide for optimum compression of all the bone marrow. The material of the balloon is also desirably chosen so as to be able to fold the balloon so that it can be inserted quickly and easily into a bone using a guide pin and a cannula, yet can also withstand high pressures when inflated. The balloon can also include optional ridges or indentations which are left in the cavity after the balloon has been removed, to enhance the stability of the filler. Also, the inflatable device can be made to have an optional, built-in suction catheter. This is used to remove any fat or fluid extruded from the bone during balloon inflation in the bone. Also, the balloon body can be protected from puncture by the cortical bone or canula by being covered while inside the canula with an optional protective sleeve of suitable material, such as Kevlar or PET or other polymer or substance that can protect the balloon. The main purpose of the inflatable device, therefore, is the forming or enlarging of a cavity or passage in a bone, especially in, but not limited to, vertebral bodies.
[0026] The primary object of the present invention is to provide an improved balloon-like inflatable device for use in carrying out a surgical protocol of cavity formation in bones to enhance the efficiency of the protocol, to minimize the time prior to performing the surgery for which the protocol is designed and to improve the clinical outcome. These balloons approximate the inner shape of the bone they are inside of in order to maximally compress cancellous bone. They have additional design elements to achieve specific clinical goals. Preferably, they are made of inelastic material and kept in their defined configurations when inflated, by various restraints, including (but not limited to) use of inelastic materials in the balloon body, seams in the balloon body created by bonding or fusing separate pieces of material together, or by fusing or bonding together opposing sides of the balloon body, woven material bonded inside or outside the balloon body, strings or bands placed at selected points in the balloon body, and stacking balloons of similar or different sizes or shapes on top of each other by gluing or by heat fusing them together. Optional ridges or indentations created by the foregoing structures, or added on by bonding additional material, increases stability of the filler. Optional suction devices, preferably placed so that if at least one hole is in the lowest point of the cavity being formed, will allow the cavity to be cleaned before filling.
[0027] Among the various embodiments of the present invention are the following:
[0028] 1. A doughnut (or torus) shaped balloon with an optional built-in suction catheter to remove fat and other products extruded during balloon expansion.
[0029] 2. A balloon with a spherical outer shape surrounded by a ring-shaped balloon segment for body cavity formation.
[0030] 3. A balloon which is kidney bean shaped in configuration. Such a balloon can be constructed in a single layer, or several layers stacked on top of each other.
[0031] 4. A spherically shaped balloon approximating the size of the head of the femur (i.e. the proximal femoral epiphysis). Such a balloon can also be a hemisphere.
[0032] 5. A balloon in the shape of a humpbacked banana or a modified pyramid shape approximating the configuration of the distal end of the radius (i.e. the distal radial epiphysis and metaphysis).
[0033] 6. A balloon in the shape of a cylindrical ellipse to approximate the configuration of either the medial half or the lateral half of the proximal tibial epiphysis. Such a balloon can also be constructed to approximate the configuration of both halves of the proximal tibial epiphysis.
[0034] 7. A balloon in the shape of sphere on a base to approximate the shape of the proximal humeral epiphysis and metaphysis with a plug to compress cancellous bone into the diaphysis, sealing it off.
[0035] 8. A balloon device with optional suction device.
[0036] 9. Protective sheaths to act as puncture guard members optionally covering each balloon inside its catheter.
[0037] The present invention, therefore, provides improved, inflatable devices for creating or enlarging a cavity or passage in a bone wherein the devices are inserted into the bone. The configuration of each device is defined by the surrounding cortical bone and adjacent internal structures, and is designed to occupy about 70-90% of the volume of the inside of the bone, although balloons that are as small as about 40% and as large as about 99% are workable for fractures. In certain cases, usually avascular necrosis, the balloon size may be as small as 10% of the cancellous bone volume of the area of bone being treated, due to the localized nature of the fracture or collapse. The fully expanded size and shape of the balloon is limited by additional material in selected portions of the balloon body whose extra thickness creates a restraint as well as by either internal or external restraints formed in the device including, but not limited to, mesh work, a winding or spooling of material laminated to portions of the balloon body, continuous or non-continuous strings across the inside held in place at specific locations by glue inside or by threading them through to the outside and seams in the balloon body created by bonding two pieces of body together or by bonding opposing sides of a body through glue or heat. Spherical portions of balloons may be restrained by using inelastic materials in the construction of the balloon body, or may be additionally restrained as just described. The material of the balloon is preferably a non-elastic material, such as polyethylene tetraphthalate (PET), Kevlar or other patented medical balloon materials. It can also be made of semi-elastic materials, such as silicone or elastic material such as latex, if appropriate restraints are incorporated. The restraints can be made of a flexible, inelastic high tensile strength material including, but not limited, to those described in U.S. Pat. No. 4,706,670. The thickness of the balloon wall is typically in the range of 2/1000ths to 25/1000ths of an inch, or other thicknesses that can withstand pressures of up to 250-400 psi.
[0038] A primary goal of percutaneous vertebral body augmentation of the present invention is to provide a balloon which can create a cavity inside the vertebral body whose configuration is optimal for supporting the bone. Another important goal is to move the top of the vertebral body back into place to retain height where possible, however, both of these objectives must be achieved without fracturing the cortical wall of the vertebral body. This feature could push vertebral bone toward the spinal cord, a condition which is not to be desired.
[0039] The present invention satisfies these goals through the design of inflatable devices to be described. Inflating such a device compresses the calcium-containing soft cancellous bone into a thin shell that lines the inside of the hard cortical bone creating a large cavity.
[0040] At the same time, the biological components (red blood cells, bone progenitor cells) within the soft bone are pressed out and removed by rinsing during the procedure. The body recreates the shape of the inside of an unfractured vertebral body, but optimally stops at approximately 70 to 90% of the inner volume. The balloons of the present invention are inelastic, so maximally inflating them can only recreate the predetermined shape and size. However, conventional balloons become spherical when inflated. Spherical shapes will not allow the hardened bone cement to support the spine adequately, because they make single points of contact on each vertebral body surface (the equivalent of a circle inside a square, or a sphere inside a cylinder). The balloons of the present invention recreate the flat surfaces of the vertebral body by including restraints that keep the balloon in the desired shape. This maximizes the contacts between the vertebral body surfaces and the bone cement, which strengthens the spine. In addition, the volume of bone cement that fills these cavities creates a thick mantle of cement (4 mm or greater), which is required for appropriate compressive strength. Another useful feature, although not required, are ridges in the balloons which leave their imprint in the lining of compressed cancellous bone. The resulting bone cement “fingers” provide enhanced stability.
[0041] The balloons which optimally compress cancellous bone in vertebral bodies are the balloons listed as balloon types 1, 2 and 3 above. These balloons are configured to approximate the shape of the vertebral body. Since the balloon is chosen to occupy 70 to 90% of the inner volume, it will not exert undue pressure on the sides of the vertebral body, thus the vertebral body will not expand beyond its normal size (fractured or unfractured). However, since the balloon has the height of an unfractured vertebral body, it can move the top, which has collapsed, back to its original position.
[0042] One aspect of the invention provides a device for insertion into a vertebral body to apply a force capable of compacting cancellous bone and moving fractured cortical bone. The device includes a catheter extending along an axis and having a distal end sized and configured for insertion through a cannula into the vertebral body. The catheter carries near its distal end an inflatable body having a wall sized and configured for passage within the cannula into the vertebral body when the inflatable body is in a collapsed condition. The wall is further sized and configured to apply the in response to expansion of the inflatable body within the vertebral body. The wall includes, when inflated, opposed side surfaces extending along an elongated longitudinal axis that is substantially aligned with the axis of the catheter. The inflatable body has a height of approximately 0.5 cm to 3.5 cm, an anterior to posterior dimension of approximately 0.5 cm to 3.5 cm, and a side to side dimension of approximately 0.5 cm to 5.0 cm.
[0043] In a representative embodiment, the inflatable body comprises a balloon and the cannula is a percutaneious cannula.
[0044] In another aspect of the invention, the wall includes changes in wall thickness which restrain the opposed sided surfaces from expanding beyond a substantially flat condition.
[0045] According to another aspect of the invention, the wall includes an internal restraint which restrains the opposed side surfaces from expanding beyond a substantially flat condition. The internal restraint may include a mesh material, a string material, a woven material, a seam, or an essentially non-elastic material.
[0046] In yet another aspect of the invention, the wall includes an external restraint which restrains the opposed side surfaces from expanding beyond a substantially flat condition. The internal restraint may include a mesh material, a string material, a woven material, a seam, or an essentially non-elastic material.
[0047] A primary goal of percutaneous proximal humeral augmentation is to create a cavity inside the proximal humerus whose configuration is optimal for supporting the proximal humerus. Another important goal is to help realign the humeral head with the shaft of the humerus when they are separated by a fracture. Both of these goals must be achieved by exerting pressure primarily on the cancellous bone, and not the cortical bone. Undue pressure against the cortical bone could conceivably cause a worsening of a shoulder fracture by causing cortical bone fractures.
[0048] The present invention satisfies these goals through the design of the inflatable devices to be described. Inflating such a device compresses the cancellous bone against the cortical walls of the epiphysis and metaphysis of the proximal humerus thereby creating a cavity. In some cases, depending on the fracture location, the balloon or inflatable device may be used to extend the cavity into the proximal part of the humeral diaphysis.
[0049] Due to the design of the “sphere on a stand” balloon (described as number 7 above), the cavity made by this balloon recreates or approximates the shape of the inside cortical wall of the proximal humerus. The approximate volume of the cavity made by the “spherical on a stand balloon” is 70 to 90% that of the proximal humeral epiphysis and metaphysis, primarily, but not necessarily exclusive of, part of the diaphysis. The shape approximates the shape of the humeral head. The “base” is designed to compress the trabecular bone into a “plug” of bone in the distal metaphysis or proximal diaphysis. This plug of bone will prevent the flow of injectable material into the shaft of the humerus, improving the clinical outcome. The sphere can also be used without a base.
[0050] A primary goal of percutaneous distal radius augmentation is to create a cavity inside the distal radius whose configuration is optimal for supporting the distal radius. Another important goal is to help fine tune fracture realignment after the fracture has been partially realigned by finger traps. Both of these goals must be achieved by exerting pressure primarily on the cancellous bone and not on the cortical bone. Excessive pressure against the cortical bone could conceivably cause cortical bone fractures, thus worsening the condition.
[0051] The present invention satisfies these goals through the design of inflatable devices either already described or to be described.
[0052] The design of the “humpbacked banana”, or modified pyramid design (as described as number 5 above), approximates the shape of the distal radius and therefore, the cavity made by this balloon approximates the shape of the distal radius as well. The approximate volume of the cavity to be made by this humpbacked banana shaped balloon is 70 to 90% that of the distal radial epiphysis and metaphysis primarily of, but not necessarily exclusive of, some part of the distal radial diaphysis. Inflating such a device compresses the cancellous bone against the cortical walls of the epiphysis and metaphysis of the distal radius in order to create a cavity. In some cases, depending on the fracture location, the osseous balloon or inflatable device may be used to extend the cavity into the distal part of the radial diaphysis.
[0053] A primary goal of percutaneous femoral head (or humeral head) augmentation is to create a cavity inside the femoral head (or humeral head) whose configuration is optimal for supporting the femoral head. Another important goal is to help compress avascular (or aseptic) necrotic bone or support avascular necrotic bone is the femoral head. This goal may include the realignment of avascular bone back into the position it previously occupied in the femoral head in order to improve the spherical shape of the femoral head. These goals must be achieved by exerting pressure primarily on the cancellous bone inside the femoral head.
[0054] The present invention satisfied these goals through the design of inflatable devices either already described or to be described.
[0055] The design of the spherical osseous balloon (described as balloon type 4 above) approximates the shape of the femoral head and therefore creates a cavity which approximates the shape of the femoral head as well. (It should be noted that the spherical shape of this inflatable device also approximates the shape of the humeral head and would, in fact, be appropriate for cavity formation in this osseous location as well.) Inflating such a device compresses the cancellous bone of the femoral head against its inner cortical walls in order to create a cavity. In some cases, depending upon the extent of the avascular necrosis, a smaller or larger cavity inside the femoral head will be formed. In some cases, if the area of avascular necrosis is small, a small balloon will be utilized which might create a cavity only 10 to 15% of the total volume of the femoral head. If larger areas of the femoral head are involved with the avascular necrosis, then a larger balloon would be utilized which might create a much larger cavity, approaching 80 to 90% of the volume of the femoral head.
[0056] The hemispherical balloon approximates the shape of the top half of the femoral (and humeral) head, and provides a means for compacting cancellous bone in an area of avascular necrosis or small fracture without disturbing the rest of the head. This makes it easier to do a future total joint replacement if required.
[0057] A primary goal of percutaneous proximal tibial augmentation is to create a cavity inside the proximal tibia whose configuration is optimal for supporting either the medial or lateral tibial plateaus. Another important goal is to help realign the fracture fragments of tibial plateau fractures, particularly those features with fragments depressed below (or inferior to) their usual location. Both of these objectives must be achieved by exerting pressure on primarily the cancellous bone and not the cortical bone. Pressure on the cortical bone could conceivably cause worsening of the tibial plateau fracture.
[0058] The present invention satisfies these goals through the design of the inflatable devices to be described. Inflating such a device compresses the cancellous bone against the cortical walls of the medial or lateral tibial plateau in order to create a cavity.
[0059] Due to the design of the “elliptical cylinder” balloon (described as balloon type 6 above) the cavity made by this balloon recreates or approximates the shape of the cortical walls of either the medial or lateral tibial plateaus. The approximate volume of the cavity to be made by the appropriate elliptical cylindrical balloon is 50 to 90% of the proximal epiphyseal bone of either the medial half or the lateral half of the tibial.
[0060] According to one aspect of the invention, a system for treating a bone having an interior volume occupied, at least in part, by cancellous bone comprises a first tool, a second tool, and a third tool. The bone may be e.g., a vertebral body. The first tool establishes a percutaneous access path to bone. The second tool is sized and configured to be introduced through the percutaneous access path to form a void that occupies less than the interior volume. The third tool places within the void through the percutaneous access path a volume of filling material.
[0061] In one embodiment, the interior volume has a maximum anterior-to-posterior dimension and the void has a dimension, measured in an anterior-to-posterior direction, that is less than the maximum anterior-to-posterior dimension of the interior volume.
[0062] In one embodiment, the interior volume has a maximum side-to-side dimension and the void has a dimension, measured in a side-to-side direction, that is less than the maximum side-to-side dimension of the interior volume.
[0063] Another aspect of the invention provides a method of treating a bone having an interior volume occupied, at least in part, by cancellous bone. The bone may be, e.g., a vertebral body. The method provides establishing a percutaneous access path to bone. A tool is introduced through the percutaneous access path and manipulated to form a void that occupies less than the interior volume. A volume of filling material is then placed within the void through the percutaneous access path.
[0064] In one embodiment, the interior volume has a maximum anterior-to-posterior dimension and the void has a dimension, measured in an anterior-to-posterior direction, that is less than the maximum anterior-to-posterior dimension of the interior volume.
[0065] In one embodiment, the interior volume has a maximum side-to-side dimension and the void has a dimension, measured in a side-to-side direction, that is less than the maximum side-to-side dimension of the interior volume.
[0066] Other objects of the present invention will become apparent as the following specification progresses, reference being had to the accompanying drawings for an illustration of the invention.
DESCRIPTION OF THE DRAWINGS
[0067] FIG. 1 is a perspective view of a first embodiment of the balloon of the present invention, the embodiment being in the shape of a stacked doughnut assembly.
[0068] FIG. 2 is a vertical section through the balloon of FIG. 1 showing the way in which the doughnut portions of the balloon of FIG. 1 , fit into a cavity of a vertebral body.
[0069] FIG. 3 is a schematic view of another embodiment of the balloon of the present invention showing three stacked balloons and string-like restraints for limiting the expansion of the balloon in directions of inflation.
[0070] FIG. 4 is a top plan view of a spherical balloon having a cylindrical ring surrounding the balloon.
[0071] FIG. 5 is a vertical section through the spherical balloon and ring of FIG. 4 .
[0072] FIG. 6 shows an oblong-shaped balloon with a catheter extending into the central portion of the balloon.
[0073] FIG. 6A is a perspective view of the way in which a catheter is arranged relative to the inner tubes for inflating the balloon of FIG. 6 .
[0074] FIG. 7 is a suction tube and a contrast injection tube for carrying out the inflation of the balloon and removal of debris caused by expansion from the balloon itself.
[0075] FIG. 8 is a vertical section through a balloon after it has been deflated and as it is being inserted into the vertebral body of a human.
[0076] FIGS. 9 and 9A are side elevational views of a cannula showing how the protective sleeve or guard member expands when leaving the cannula.
[0077] FIG. 9B is a vertical section through a vertebral bone into which an access hole has been drilled.
[0078] FIG. 10 is a perspective view of another embodiment of the balloon of the present invention formed in the shape of a kidney bean.
[0079] FIG. 11 is a perspective view of the vertebral bone showing the kidney shaped balloon of FIG. 10 inserted in the bone and expanded.
[0080] FIG. 12 is a top view of a kidney shaped balloon formed of several compartments by a heating element or branding tool.
[0081] FIG. 13 is a cross-sectional view taken along line 13 - 13 of FIG. 12 but with two kidney shaped balloons that have been stacked.
[0082] FIG. 14 is a view similar to FIG. 11 but showing the stacked kidney shaped balloon of FIG. 13 in the vertebral bone.
[0083] FIG. 15 is a top view of a kidney balloon showing outer tufts holding inner strings in place interconnecting the top and bottom walls of the balloon.
[0084] FIG. 16 is a cross sectional view taken along lines 16 - 16 of FIG. 15 .
[0085] FIG. 17A is a dorsal view of a humpback banana balloon in a right distal radius.
[0086] FIG. 17B is a cross sectional view of FIG. 17A taken along line 17 B- 17 B of FIG. 17A .
[0087] FIG. 18 is a spherical balloon with a base in a proximal humerus viewed from the front (anterior) of the left proximal humerus.
[0088] FIG. 19A is the front (anterior) view of the proximal tibia with the elliptical cylinder balloon introduced beneath the medial tibial plateau.
[0089] FIG. 19B is a three quarter view of the balloon of FIG. 19A .
[0090] FIG. 19C is a side elevational view of the balloon of FIG. 19A .
[0091] FIG. 19D is a top plan view of the balloon of FIG. 19A .
[0092] FIG. 20 is a spherically shaped balloon for treating avascular necrosis of the head of the femur (or humerus) as seen from the front (anterior) of the left hip.
[0093] FIG. 20A is a side view of a hemispherically shaped balloon for treating avascular necrosis of the head of the femur (or humerus).
DETAILED DESCRIPTION
Balloons for Vertebral Bodies
[0094] A first embodiment of the balloon ( FIG. 1 ) of the present invention is broadly denoted by the numeral 10 and includes a balloon body 11 having a pair of hollow, inflatable, non-expandable parts 12 and 14 of flexible material, such as PET or Kevlar. Parts 12 and 14 have a suction tube 16 therebetween for drawing fats and other debris by suction into tube 16 for transfer to a remote disposal location. Catheter 16 has one or more suction holes so that suction may be applied to the open end of tube 16 from a suction source (not shown).
[0095] The parts 12 and 14 are connected together by an adhesive which can be of any suitable type. Parts 12 and 14 are doughnut-shaped as shown in FIG. 1 and have tubes 18 and 20 which communicate with and extend away from the parts 12 and 14 , respectively, to a source of inflating liquid under pressure (not shown). The liquid can be any sterile biocompatible solution. The liquid inflates the balloon 10 , particularly parts 12 and 14 thereof after the balloon has been inserted in a collapsed condition ( FIG. 8 ) into a bone to be treated, such as a vertebral bone 22 in FIG. 2 . The above-mentioned U.S. Pat. Nos. 4,969,888 and 5,108,404 disclose the use of a guide pin and cannula for inserting the balloon into bone to be treated when the balloon is deflated and has been inserted into a tube and driven by the catheter into the cortical bone where the balloon is inflated.
[0096] FIG. 8 shows a deflated balloon 10 being inserted through a cannula 26 into bone. The balloon in cannula 26 is deflated and is forced through the cannula by exerting manual force on the catheter 21 which extends into a passage 28 extending into the interior of the bone. The catheter is slightly flexible but is sufficiently rigid to allow the balloon to be forced into the interior of the bone where the balloon is then inflated by directing fluid into tube 88 whose outlet ends are coupled to respective parts 12 and 14 .
[0097] In use, balloon 10 is initially deflated and, after the bone to be filled with the balloon has been prepared to receive the balloon with drilling, the deflated balloon is forced into the bone in a collapsed condition through cannula 26 . The bone is shown in FIG. 2 . The balloon is oriented preferably in the bone such that it allows minimum pressure to be exerted on the bone marrow and/or cancellous bone if there is no fracture or collapse of the bone. Such pressure will compress the bone marrow and/or cancellous bone against the inner wall of the cortical bone, thereby compacting the bone marrow of the bone to be treated and to further enlarge the cavity in which the bone marrow is to be replaced by a biocompatible, flowable bone material.
[0098] The balloon is then inflated to compact the bone marrow and/or cancellous bone in the cavity and, after compaction of the bone marrow and/or cancellous bone, the balloon is deflated and removed from the cavity. While inflation of the balloon and compaction occurs, fats and other debris are sucked out of the space between and around parts 12 and 14 by applying a suction force to catheter tube 16 . Following this, and following the compaction of the bone marrow, the balloon is deflated and pulled out of the cavity by applying a manual pulling force to the catheter tube 21 .
[0099] The second embodiment of the inflatable device of the present invention is broadly denoted by the numeral 60 and is shown in FIGS. 4 and 5 . Balloon 60 includes a central spherical part 62 which is hollow and which receives an inflating liquid under pressure through a tube 64 . The spherical part is provided with a spherical outer surface 66 and has an outer periphery which is surrounded substantially by a ring shaped part 68 having tube segments 70 for inflation of part 68 . A pair of passages 69 interconnect parts 62 and 68 . A suction tube segment 72 draws liquid and debris from the bone cavity being formed by the balloon 60 .
[0100] Provision can be made for a balloon sleeve 71 for balloon 60 and for all balloons disclosed herein. A balloon sleeve 71 ( FIG. 9 ) is shiftably mounted in an outer tube 71 a and can be used to insert the balloon 60 when deflated into a cortical bone. The sleeve 71 has resilient fingers 71 b which bear against the interior of the entrance opening 71 c of the vertebral bone 22 ( FIG. 9A ) to prevent tearing of the balloon. Upon removal of the balloon sleeve, liquid under pressure will be directed into tube 64 which will inflate parts 62 and 68 so as to compact the bone marrow within the cortical bone. Following this, balloon 60 is deflated and removed from the bone cavity.
[0101] FIGS. 6 and 6A show several views of a modified doughnut shape balloon 80 of the type shown in FIGS. 1 and 2 , except the doughnut shapes of balloon 80 are not stitched onto one another. In FIG. 6 , balloon 80 has a pear-shaped outer convex surface 82 which is made up of a first hollow part 84 and a second hollow part 85 . A tube 88 is provided for directing liquid into the two parts along branches 90 and 92 to inflate the parts after the parts have been inserted into the medullary cavity of a bone. A catheter tube 16 is inserted into the space 96 between two parts of the balloon 80 . An adhesive bonds the two parts 84 and 85 together at the interface thereof.
[0102] FIG. 6A shows the way in which the catheter tube 16 is inserted into the space or opening 96 between the two parts of the balloon 80 .
[0103] FIG. 7 shows tube 88 of which, after directing inflating liquid into the balloon 80 , can inject contrast material into the balloon 80 so that x-rays can be taken of the balloon with the inflating material therewithin to determine the proper placement of the balloon. Tube 16 is also shown in FIG. 6 , it being attached in some suitable manner to the outer side wall surface of tube 88 .
[0104] Still another embodiment of the invention is shown in FIG. 3 which is similar to FIG. 1 except that it is round and not a doughnut and includes an inflatable device 109 having three balloon units 110 , 112 and 114 which are inflatable and which have string-like restraints 117 which limit the expansion of the balloon units in a direction transverse to the longitudinal axes of the balloon units. The restraints are made of the same or similar material as that of the balloon so that they have some resilience but substantially no expansion capability.
[0105] A tube system 115 is provided to direct liquid under pressure into balloon units 110 , 112 and 114 so that liquid can be used to inflate the balloon units when placed inside the bone in a deflated state. Following the proper inflation and compaction of the bone marrow, the balloon can be removed by deflating it and pulling it outwardly of the bone being treated. The restraints keep the opposed sides 77 and 79 substantially flat and parallel with each other.
[0106] In FIG. 10 , another embodiment of the inflatable balloon is shown. The device is a kidney shaped balloon body 130 having a pair of opposed kidney shaped side walls 132 which are adapted to be collapsed and to cooperate with a continuous end wall 134 so that the balloon 130 can be forced into a bone 136 shown in FIG. 11 . A tube 138 is used to direct inflating liquid into the balloon to inflate the balloon and cause it to assume the dimensions and location shown vertebral body 136 in FIG. 11 . Device 130 will compress the cancellous bone if there is no fracture or collapse of the cancellous bone. The restraints for this action are due to the side and end walls of the balloon.
[0107] FIG. 12 shows a balloon 140 which is also kidney shaped and has a tube 142 for directing an inflatable liquid into the tube for inflating the balloon. The balloon is initially a single chamber bladder but the bladder can be branded along curved lines or strips 141 to form attachment lines 144 which take the shape of side-by-side compartments 146 which are kidney shaped as shown in FIG. 13 . The branding causes a welding of the two sides of the bladder to occur since the material is standard medical balloon material, which is similar to plastic and can be formed by heat.
[0108] FIG. 14 is a perspective view of a vertebral body 147 containing the balloon of FIG. 12 , showing a double stacked balloon 140 when it is inserted in vertebral bone 147 .
[0109] FIG. 15 is a view similar to FIG. 10 except that tufts 155 , which are string-like restraints, extend between and are connected to the side walls 152 of inflatable device 150 and limit the expansion of the side walls with respect to each other, thus rendering the side walls generally parallel with each other. Tube 88 is used to fill the kidney shaped balloon with an inflating liquid in the manner described above.
[0110] The dimensions for the vertebral body balloon will vary across a broad range. The heights (H, FIG. 11 ) of the vertebral body balloon for both lumbar and thoracic vertebral bodies typically range from 0.5 cm to 3.5 cm. The anterior to posterior (A, FIG. 11 ) vertebral body balloon dimensions for both lumbar and thoracic vertebral bodies range from 0.5 cm to 3.5 cm. The side to side (L, FIG. 11 ) vertebral body dimensions for thoracic vertebral bodies will range from 0.5 cm to 3.5 cm. The side to side vertebral body dimensions for lumbar vertebral bodies will range from 0.5 cm to 5.0 cm.
[0111] The eventual selection of the appropriate balloon for, for instance, a given vertebral body is based upon several factors. The anterior-posterior (A-P) balloon dimension for a given vertebral body is selected from the CT scan or plain film x-ray views of the vertebral body. The A-P dimension is measured from the internal cortical wall of the anterior cortex to the internal cortical wall of the posterior cortex of the vertebral body. In general, the appropriate A-P balloon dimension is 5 to 7 millimeters less than this measurement.
[0112] The appropriate side to side balloon dimensions for a given vertebral body is selected from the CT scan or from a plain film x-ray view of the vertebral body to be treated. The side to side distance is measured from the internal cortical walls of the side of the vertebral bone. In general, the appropriate side to side balloon dimension is 5 to 7 millimeters less than this measurement by the addition of the lumbar vertebral body tends to be much wider than side to side dimension then their A-P dimension. In thoracic vertebral bodies, the side to side dimension and their A-P dimensions are almost equal.
[0113] The height dimensions of the appropriate vertebral body balloon for a given vertebral body is chosen by the CT scan or x-ray views of the vertebral bodies above and below the vertebral body to be treated. The height of the vertebral bodies above and below the vertebral body to be treated are measured and averaged. This average is used to determine the appropriate height dimension of the chosen vertebral body balloon.
Balloons for Long Bones
[0114] Long bones which can be treated with the use of balloons of the present invention include distal radius (larger arm bone at the wrist), proximal tibial plateau (leg bone just below the knee), proximal humerus (upper end of the arm at the shoulder), and proximal femoral head (leg bone in the hip).
Distal Radius Balloon
[0115] For the distal radius, a balloon 160 is shown in the distal radius 152 and the balloon has a shape which approximates a pyramid but more closely can be considered the shape of a humpbacked banana in that it substantially fills the interior of the space of the distal radius to force cancellous bone 154 lightly against the inner surface 156 of cortical bone 158 .
[0116] The balloon 160 has a lower, conical portion 159 which extends downwardly into the hollow space of the distal radius 152 , and this conical portion 159 increases in cross section as a central distal portion 161 is approached. The cross section of the balloon 160 is shown at a central location ( FIG. 17B ) and this location is near the widest location of the balloon. The upper end of the balloon, denoted by the numeral 162 , converges to the catheter 88 for directing a liquid into the balloon for inflating the same to force the cancellous bone against the inner surface of the cortical bone. The shape of the balloon 160 is determined and restrained by tufts formed by string restraints 165 . These restraints are optional and provide additional strength to the balloon body 160 , but are not required to achieve the desired configuration. The balloon is placed into and taken out of the distal radius in the same manner as that described above with respect to the vertebral bone.
[0117] The dimensions of the distal radius balloon vary as follows:
[0118] The proximal end of the balloon (i.e. the part nearest the elbow) is cylindrical in shape and will vary from 0.5.times.0.5 cm to 1.8.times.1.8 cm.
[0119] The length of the distal radius balloon will vary from 1.0 cm to 12.0 cm.
[0120] The widest medial to lateral dimension of the distal radius balloon, which occurs at or near the distal radio-ulnar joint, will measure from 1.0 cm to 2.5 cm.
[0121] The distal anterior-posterior dimension of the distal radius balloon will vary from 0.5 to 3.0 cm.
Proximal Humerus Fracture Balloon
[0122] The selection of the appropriate balloon size to treat a given fracture of the distal radius will depend on the radiological size of the distal radius and the location of the fracture.
[0123] In the case of the proximal humerus 169 , a balloon 166 shown in FIG. 18 is spherical and has a base design. It compacts the cancellous bone 168 in a proximal humerus 169 . A mesh 170 , embedded or laminated and/or winding, may be used to form a neck 172 on the balloon 166 , and second mesh 170 a may be used to conform the bottom of the base 172 a to the shape of the inner cortical wall at the start of the shaft. These restraints provide additional strength to the balloon body, but the configuration can be achieved through molding of the balloon body. This is so that the cancellous bone will be as shown in the compacted region surrounding the balloon 166 as shown in FIG. 18 . The cortical bone 173 is relatively wide at the base 174 and is thin-walled at the upper end 175 . The balloon 166 has a feed tube 177 into which liquid under pressure is forced into the balloon to inflate it to lightly compact the cancellous bone in the proximal humerus. The balloon is inserted into and taken out of the proximal humerus in the same manner as that described above with respect to the vertebral bone.
[0124] The dimensions of the proximal humerus fracture balloon vary as follows:
[0125] The spherical end of the balloon will vary from 1.0.times.1.0 cm to 3.0.times.3.0 cm.
[0126] The neck of the proximal humeral fracture balloon will vary from 0.8.times.0.8 cm to 3.0.times.3.0 cm.
[0127] The width of the base portion or distal portion of the proximal numeral fracture balloon will vary from 0.5.times.0.5 cm to 2.5.times.2.5 cm.
[0128] The length of the balloon will vary from 4.0 cm to 14.0 cm.
[0129] The selection of the appropriate balloon to treat a given proximal humeral fracture depends on the radiologic size of the proximal humerus and the location of the fracture.
Proximal Tibial Plateau Fracture Balloon
[0130] The tibial fracture is shown in FIG. 19A in which a balloon 180 is placed in one side 182 of a tibia 183 . The balloon, when inflated, compacts the cancellous bone in the layer 184 surrounding the balloon 180 . A cross section of the balloon is shown in FIG. 19C wherein the balloon has a pair of opposed sides 185 and 187 which are interconnected by restraints 188 which can be in the form of strings or flexible members of any suitable construction. The main purpose of the restraints is to make the sides 185 and 187 substantially parallel with each other and non-spherical. A tube 190 is coupled to the balloon 180 to direct liquid into and out of the balloon. The ends of the restraints are shown in FIGS. 19B and 19D and denoted by the numeral 191 . The balloon is inserted into and taken out of the tibia in the same manner as that described above with respect to the vertebral bone. FIG. 19B shows a substantially circular configuration for the balloon; whereas, FIG. 19D shows a substantially elliptical version of the balloon.
[0131] The dimensions of the proximal tibial plateau fracture balloon vary as follows:
[0132] The thickness or height of the balloon will vary from 0.5 cm to 5.0 cm.
[0133] The anterior/posterior (front to back) dimension will vary from 1.0 cm to 6.0 cm.
[0134] The side to side (medial to lateral) dimension will vary from 1.0 cm to 6.0 cm.
[0135] The selection of the appropriate balloon to treat a given tibial plateau fracture will depend on the radiological size of the proximal tibial and the location of the fracture.
Femoral Head Balloon
[0136] In the case of the femoral head, a balloon 200 is shown as having been inserted inside the cortical bone 202 of the femoral head which is thin at the outer end 204 of the femur and which can increase in thickness at the lower end 206 of the femur. The cortical bone surrounds the cancellous bone 207 and this bone is compacted by the inflation of balloon 200 . The tube for directing liquid for inflation purposes into the balloon is denoted by the numeral 209 . It extends along the femoral neck and is directed into the femoral head which is generally spherical in configuration. FIG. 20A shows that the balloon, denoted by the numeral 200 a , can be hemispherical as well as spherical, as shown in FIG. 20 . The balloon 200 is inserted into and taken out of the femoral head in the same manner as that described with respect to the vertebral bone. The hemispherical shape is maintained in this example by bonding overlapping portions of the bottom, creating pleats 200 b as shown in FIG. 20A .
[0137] The dimensions of the femoral head balloon vary as follows:
[0138] The diameter of the femoral head balloon will vary from 1.0 cm to up to 4.5 cm. The appropriate size of the femoral head balloon to be chosen depends on the radiological or CT scan size of the head of the femur and the location and size of the avascular necrotic bone. The dimensions of the hemispherical balloon are the same as the those of the spherical balloon, except that approximately one half is provided.
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A vertebral body is selected for treatment. The vertebral body has a cortical wall enclosing a cancellous bone volume. The vertebral body has at least one cortical plate that is depressed due to fracture. At least one maximum dimension for the cancellous bone volume is ascertained. An expandable device is provided having an expanded configuration and an unexpanded configuration. The expandable device has a predefined dimension when substantially expanded that is less than the maximum dimension. The expandable device is introduced into the vertebral body through a percutaneous access path while in the unexpanded condition. The expandable device is expanded while disposed within the cancellous bone volume from the unexpanded configuration toward the expanded configuration to move the fractured cortical plate toward a desired anatomic position.
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[0001] This invention relates to new medical applications of alpha-ketoglutarate including an application of alpha-ketoglutarate for manufacturing of therapeutic and prophylactic preparations for use in prophylaxis and treatment of undesired conditions of human beings and animals, especially pet and/or farm animal, namely mammal, bird, amphibian, fish, molluse or arthropod, as well as the use of alpha-ketoglutarate in therapeutic and prophylactic treatment of the such living organisms.
BACKGROUND OF THE INVENTION
Alpha-Ketoglutarates—Salts of Alpha-Ketoglutaric Acid
[0002] Alpha-ketoglutarate occurs in living organisms as an endogenous molecule.
[0003] Salts of alpha-ketoglutaric acid have been known for at least 60 years, i.e. since the Krebs cycle was discovered. Endogenous alpha-ketoglutaric acid salts play in humans and in animals a fundamental role, together with the salts of oxaloacetic and pyruvic acid, in the citric acid cycle. As a result of reproducible reactions there are synthesised fatty acids, sterols, cholesterol (with involvement of citrate), porphiryn, heme, chlorophyll (activity of succinyl-CoA), glutamate, amino acids, nucleotide bases (activity of alpha-ketoglutaric acid salts).
[0004] Alpha-ketoglutaric acid anion plays a key role in metabolism, mainly in aerobic organisms. Alpha-ketoglurate is produced in a process of oxidative decarboxylation involving cellular enzyme of isocitrate dehydrogenase, and also in another metabolic pathway, by an oxidative deamination of glutamate catalyzed by glutamate dehydrogenase.
[0005] Alpha ketoglutarate—being an intermediate compound in the basic life cycle, namely the tricarboxylic acid cycle, i.e. the Krebs cycle, is a subject of intracellular permanent transformations and it is present in rather low concentrations in peripheral blood in an anion form due to its full metabolisation in the organism.
[0006] Within the organisms, alpha-ketoglutarate also plays a role of a natural scavenger—a decontaminant, through transportation of nitrogen by means of transamination in effect of a transfer of amino groups originating from catabolised amino acids. This process occurs in the liver and it is called the ornithine cycle or urea cycle.
[0007] During transamination of alpha-ketoglutarate and glutamine, a neurotransmitter named glutamate is formed. In the presence of B6 vitamin, glutamate may be decarboxylated while producing a compound referred to as GABA (gamma-aminobutyric acid) which is an inhibitor of the glutamate neurotransmitter and blocks the neurotransmitter.
[0008] It has also been shown that alpha-ketoglutarate enzymes participate in the removal of free radicals—being incompletely metabolised products and very toxic compounds, from the organism.
[0009] Besides, one of alpha-ketoglutarate-dependent oxygenases is a molecular oxygen sensor, i.e. an indicator of oxygen level in the environment.
[0010] Alpha-ketoglutarate may also be introduced into an organism through known routes of administration, for instance: orally, through inhalation, intravenously or via other routes.
[0011] The everyday diet of both humans and animals does not comprise alpha-ketoglutarate.
[0012] On the market, in particular in America, there are numerous commercially available dietary supplements containing salts of alpha-ketoglutaric acid, mainly salts of arginine, pyridoxine, ornithine, creatine, histidine and citrulline, as ready-made products intended both for humans and for household animals. Also available are sodium, potassium and calcium salts of alpha-ketoglutaric acid.
[0013] In the dietary supplements register drawn up by the National Nutritional Foods Association (NNFA), alpha-ketoglutaric acid itself and alpha-ketoglutaric acid combined with pyridoxine (vitamin B6) was listed in the group of biochemical products even before Sep. 15, 1994. Such a long presence on the market results in a large number of dietary supplements containing these chemical compounds. The main reason why derivatives or salts of alpha-ketoglutaric acid salts are present in all the products available on the market is that alpha-ketoglutarate—as an intermediate compound in the Krebs cycle—is one of the substances responsible for cellular respiration and therefore it is believed to improve quality of life.
[0014] The most numerous group among the products discussed here are the products comprising L-arginine in combination with alpha-ketoglutarate. These products, as declared by manufacturers, facilitate the maintenance of energy during and after physical activities, enhance nitrogen oxide synthesis, besides—in combination with nitrogen oxide, they increase the level of this oxide in the organism and enhance transportation of nutrients, as well as enhance metabolism in muscles. In combination with other substances, they also increase the level of energy and enhance amino acid metabolism.
[0015] The next largest group of the marketed products comprises ornithine in combination with alpha-ketoglutaric acid. In this form alpha-ketoglutarate not only increases energy production, but also protects muscles against decomposition of branched amino acids in order to generate glutamine, the energy boosting molecule. Besides, it is a compound which enhances secretion of growth hormone and optimises muscle metabolism. It increases the activity of insulin and polyamines in a safe way. It also enhances neurotransmission, thus helping to maintain a good mental status of the organism, supports endurance of muscles maximising athletic effects, influences the organism's fat burning capability, increases libido, has a beneficial influence on immunological functions and reduces oxygen stress.
[0016] Another group of food preparations used as dietary supplements comprises pyridoxine and pyridoxyl that are combined with alpha-ketoglutarate. Components of these products enhance metabolic activity within a cell, balance out the organism's efforts to produce energy and protect the liver.
[0017] On the market there are also products comprising creatine in combination with alpha-ketoglutarate. They act as glutamine precursors and participate in the synthesis of proteins.
[0018] Other, non-specified alpha-ketoglutaric acid salts stimulate fat reduction in the organism and are necessary for ensuring integrity of muscle tissue.
[0019] On the other hand, alpha-ketoglutaric acid itself is a component of another kind of preparations, namely those exhibiting a natural detoxifying function, recommended for use in chronic fatigue and in metabolic deficiencies often diagnosed by amino acids analysis. Administration of this type of preparations results in increase of stamina and boosts energy. An interesting product of this group is a calcium and magnesium salt of alpha-ketoglutaric acid. Due to the fact that alpha-ketoglutaric acid belongs to a group of strong organic acids, it irritates oesophagus and stomach when administered orally. Use of calcium and magnesium allows production of a buffered bi-component alpha-ketoglutaric acid compound that does not cause the unpleasant feeling of excessive acidity.
[0020] Numerous patents and patent applications show that alpha-ketoglutarate may be administered in metabolic brain dysfunction, in disorders of the nervous system, blood circulation and the skeletal muscle system, in order to strengthen cell mitochondrial functions.
[0021] Drinks comprising alpha-ketoglutaric acid salts are also available and are intended to supply energy to the organism, in particular before, during and after physical activity. Such a drink—as a source of energy—may be administered also in states of fasting and long-lasting demand for energy in humans and other mammals.
[0022] Furthermore, alpha-ketoglutarate may be used as a non-steroid, anabolic product increasing muscle mass without transforming muscles into fat. The effect of such a dietary supplement is similar to the effect obtained with synthetic anabolic steroids, however without the unfavourable side effects.
[0023] A supplement comprising tiamin, lipoic acid, creatine derivatives and L-arginine together with alpha-ketoglutarate may also be administered orally. This dietary supplement is intended to lower blood glucose levels and to maintain low glucose levels in the course of treatment of diabetic neuropathy, as well as to improve blood circulation and muscle efficiency.
[0024] Alpha-ketoglutaric acid salts were found to have an interesting application as agents aiming to reduce nitrogen emission in humans and animals and to maintain protein synthesis, and also in food microbiology.
[0025] In the food industry the salts are used as a component improving and enhancing aroma and taste of fermentation products (e.g. vinaigrette) and dairy products, inter alia cheese. Alpha-ketoglutaric acid salts influence lactic acid bacteria fermentation thus altering the metabolism of amino acids, levels of catabolites and activity of aminotransferases. In practice, it leads to shortening of the cheese ripening period by accelerating formation of those compounds which guarantee high commercial quality of food products. See: Williams A G, Noble J, Banks J M., The effect of alpha-ketoglutaric acid on amino acid utilization by nonstarter Lactobacillus spp. isolated from Cheddar cheese. Lett. Appl. Microbiol. 2004; 38:289-295.
[0026] Numerous patents and patent applications relate to use of alpha-ketoglutarate as a pharmaceutical preparation or as a component of a pharmaceutical preparation.
[0027] A use of alpha-ketoglutaric acid, glutamine, glutamic acid and salts thereof, as well as amides and di- and tripeptides as pharmaceutical preparations for treatment and prophylaxis of arthrosis, rheumatoid arthritis and cartilage damage due to inflammation and other reasons is known from the publication WO 2007/058612.
[0028] Publication WO 2005/123056 discloses a use of alpha-ketoglutaric acid, glutamine, glutamic acid and pharmaceutically acceptable salts, amides and di- and tripeptides thereof as a pharmaceutical preparation, as food and animal feed additive in the treatment and prophylaxis of excessive plasma levels of at least one of the following parameters: cholesterol, LDL, glycerides. The preparation may also be used to raise HDL level.
[0029] EP 0 922 459 discloses that alpha-ketoglutaric acid together with D-galactose and ornithine and such alpha-ketoglutaric acid salts as sodium, potassium, magnesium, zinc and calcium salts in a defined dosage, in form of tablets, powders, infusions, syrups may serve to raise amino acid profiles in blood, in particular in patients under metabolic stress situations. The disclosed preparation may be used in the treatment of liver diseases, in therapy and prevention of liver diseases in alcohol addicts in order to maintain the function and structure of the liver, as well as to regenerate the liver.
[0030] In the publication WO 2006/016143 it has been stated that a preparation consisting of alpha-ketoglutarates and a number of derivatives thereof—that was formerly used to activate HIFa hydroxylase in order to increase the alpha-ketoglutarate level, is now used to treat cancer and angiogenesis.
[0031] In accordance with publication WO 2006/062424 it is also possible to use 3-hydroxy-3-methylbutyrate in combination with alpha-ketoglutarate and a number of derivatives in the process of growth and mineralization of the skeleton in physiological conditions and in osteochondropathy processes in adult humans and in animals. The same product may be added to functional food and medicated food.
[0032] The publication WO 2006/016828 indicates the use of alpha-ketoglutarates and a number of derivatives thereof as a pharmaceutical preparation and also as a food and animal feed additive improving functioning of nerve cells and the whole nervous system, minimising and preventing apoptosis of nerve cells and protecting against diseases of the nervous system in adults and foetuses.
[0033] The publication WO 2007/082914 discloses a method for diagnosing higher susceptibility for diseases and conditions of the gastrointestinal tract associated with low levels of alpha-ketoglutaric acid (AKG) in a human or animal, such as among others Helicobacter pylori related gastritis, gastric and duodenal ulcers, peptic ulcer, gastric cancer, and gastric mucosa-associated lymphoid tissue lymphoma. It is suggested that humans or animals with low levels of AKG as compared to a normal average AKG levels should be treated with a pharmaceutical preparation or food or feed supplement comprising AKG, its derivatives, metabolites, analogues or salts thereof. The publication discloses some results confirming that in the control group of test animals (2-3 years old rats) those with a low blood level of AKG—below 0.1 ug/ml, did not survive the experiment whereas the test animals with similar initial blood level of AKG receiving feed with an addition of Na 2 AKG*2H 2 O survived the experiment. No evidence however has been given to demonstrate that the test animals were H. pylori infected. There is therefore also no evidence showing that low levels of AKG correlate in any respect with the above mentioned H. pylori related diseases and conditions. The data presented as an illustration of a relationship between AKG blood levels and various diseases in different age groups in humans, fail to provide a sufficient volume of data related on one hand to the health status of each individual patient and on the other—to the correlation between the low blood levels of AKG and age, sex, weight, specific disease or condition, since such relevant data were different for every patient examined. It is essential, that none of the patients examined has been categorized as showing severe signs of any one of the diseases mentioned in the test and none of the patients examined has been categorized as showing anything more severe than “mild” signs of gastritis. Besides, even for those patients who showed “mild” signs of gastritis no evidence of H. pylori colonization of the patient's gastrointestinal tract has been provided. Moreover, there is no mention in the publication how have the pathogenic strains of H. pylori been identified. The experimental data show only that the range of physiological AKG blood levels is very broad and not necessarily indicative for any of the diseases listed in the publication. The conclusions have been drawn on the basis of the test results obtained in such a small group of patients that statistical analysis can not provide any reliable data.
[0034] Pyridoxine alpha-ketoglutarate is known as an agent used in prophylaxis of acidosis in human medicine and veterinary medicine, in prophylaxis of all conditions leading to acidosis, as well as in pathologies where medicines decreasing lactic acid levels in blood are used.
[0035] Alpha-ketoglutarate is also used in medical practice as a detoxifying agent in case of intoxication of an organism. The detoxifying action of alpha-ketoglutarate was used, for instance, in treating cyanide poisonings. Alpha-ketoglutarate as an anti-toxic agent prevents post-operational muscle catabolism and it is also used in hospitals in patients with parenteral feeding recommendation, where alpha-ketoglutarate is one of the compounds of the applied bolus. Alpha-ketoglutarate is also recommended for patients that suffer cerebrovascular stroke, for patients with burn wounds, for patients with hypoxia and for those irradiated with X-rays, as well as in case of cataracts resulting from selenite poisoning.
[0036] Alpha-ketoglutarate combined with ornithine effectively protects the organism after small bowel transplantation against any translocation of bacteria, as examined in mesenteric lymph nodes, the liver and spleen. See: de Oca J, Bettonica C, Cuadrado S, Vallet J, Martin E, Garcia A, Montanes T, Jaurrieta E. Effect of oral supplementation of ornithine-alpha-ketoglutarate on the intestinal barrier after orthotopic small bowel transplantation. Transplantation. 1997; 63:636-639.
[0037] In rats in an experimentally induced post-trauma state, administration of ornithin-alpha-ketoglutarate reduces spreading of E. coli and destruction of tissue following LPS. It is assumed, that in humans after trauma, administration of this product may prevent sepsis and consequences thereof. See: Schlegel L, Coudray-Lucas C, Barbut F, Le Boucher J, Jardel A, Zarrabian S, Cynober L. Bacterial dissemination and metabolic changes in rats induced by endotoxemia following intestinal E. coli overgrowth are reduced by ornithine alpha-ketoglutarate administration. J. Nutr. 2000; 130:2897-2902.
[0038] Alfa-ketoglutarate is also used in animal breeding to improve amino acid absorption. It is administered to piglets to accelerate absorption of iron ions.
[0039] Ureolytic Bacteria
[0040] The range of nitrogen assimilating bacteria is wide: from non-pathogenic commensals, such as skin-colonising bacteria, and non-pathogenic symbionts inhabiting mucous membrane of the gastrointestinal tract, to pathogenic bacteria, including Helicobacter pylori and bacteria causing urogenital system infections.
[0041] The most common infection caused by ureolytic bacteria is the H. pylori infection.
[0042] The common feature of ureolytic bacteria is their ability to make use of urea present in their environment, by means of urease—mainly as a source of nitrogen necessary for survival live. Bacterial urease (urea aminohydrolase E.C.3.5.1.5) is a nickel-dependent multimer consisting of 2 or 3 subunits. The 3D crystallographic structure of some bacterial ureases has been discovered ( H. pylori, Klebsiella aerogenes, Bacillus pasteurii ). A high degree of similarity in amino acid sequences indicates that all types of ureases originate from one parent protein, that they probably have a similar three-dimensional structure and that they maintain catalytic activity while hydrolysing urea to ammonia and carbon dioxide.
[0043] Examples of nitrogen-assimilating bacteria by means of their own ureases are Streptococcus salivarius and Actinomyces naeslundii commonly present in the oral cavity and forming a biofilm.
[0044] The gastrointestinal tract has the biggest concentration of ureolytic bacteria. Microorganisms, including ureolytic ones, permanently colonise a surface of epithelium, and they are recognised as a natural intestinal microbiota. This means, that access to urea is one of the critical factors of microorganism ecology in the gastrointestinal tract, i.e. it influences the quantity and quality of bacteria in this area. Through the maintenance of tissue integrity, the access to urea is one of the conditions of the macroorganism's health. The same rule of homeostasis governs the occurrence of microorganisms colonising body surfaces.
[0045] Urea is also important as a substrate for pathogens' urease in the stabilisation phase of inflammation during H. pylori infection.
[0046] A common route of entry of pathogens into human and animal organisms is via the gastrointestinal tract with food, regardless of the place where infection develops further on. Infections with ureolytic microorganisms through the gastrointestinal tract show that urease plays a role in the pathogenesis of these infections. It was demonstrated that bacterial strains, for instance of the urease producing Brucella strains are resistant in the urea environment to the biocidal action of gastric juice with its strongly acidic conditions. Urease-negative mutants of these bacteria are on the other hand susceptible to such conditions, which results in a reduced number of bacteria after passage through the stomach. It may be concluded, that under such conditions urease protects brucellae against the acidic effects of the gastric juice when they enter the organism orally. Having passed the barrier of stomach, bacteria are free to invade e.g. respiratory and urogenital systems and generate symptoms typical for brucellosis.
[0047] Ureolytic bacteria, even though they are not the main etiological factor in urinary system infections in healthy organisms, they are often associated with infections in humans with urinary systems disorders. The consequence of urinary system infections with urease-producing microorganisms is staghorn calculus accompanied by supersaturation of urine with ammonium magnesium phosphate salts (struvite) and phosphate calcium salts, as well as by pathological processes within kidneys. Under physiological conditions urine does not contain these salts.
[0048] Another interesting mechanism in the pathogenesis of urogenital system infections is the maintenance of infections caused by urease-positive bacteria, such as Ureaplasma ureolyticum and other alkalophilic bacteria, e.g. Bacillus pasteurii . In the urea environment pathogens use ureolysis to generate their own ATP and thus they reproduce permanently. Even though U. urealyticum and other mycoplasmas are relatively rare, they may also cause dangerous and difficult to cure infections of the respiratory system in humans and animals, including fish.
[0049] It was also found, that urease-producing Yersinia enterocolica —a gastrointestinal tract pathogen may in some genetically handicaped people cause reactive arthritis and its reactivity is related to the chemical structure of the enzyme, specifically its subunit UreB.
[0050] It should be noted that many bacteria capable of movement are ureolytic organisms responsible for formation of biofilm and for mineralisation of deposits on catheters and other mechanical medical implements.
[0051] Urea metabolism is also believed to be related to infections in the mucous membranes of the oral cavity, including gingival diseases, formation of dental caries and tartar.
[0052] Formation of infectious stones is associated with urinary system infections caused by bacteria of the following genii: Proteus, Ureaplasma, Klebsiella, Pseudomonas, Staphylococcus, Providencia, Corynebacterium . The most common cause of formation of infectious stones is the P. mirabilis bacteria. Another factor in formation of the stones are mycoplasmas usually reported to be associated with genital tract infections, in particular with infections of the lower genital regions—mainly with vaginal infections. From the urethra in men the following organisms are isolated: Mycoplasma hominis and U. urealyticum . Colonisation of the urogenital system in both women and men by the bacteria leads to urinary system infections accompanied by formation of infectious stones in the bladder.
[0053] H. pylori Infections
[0054] H. pylori rods in humans are usually isolated from the stomach and duodenum. These Gram-negative, ureolytic, spiral-shaped bacteria formerly known as Campylobacter pylori are one of the etiological factors of gastritis and the formation of ulcers in stomach and duodenum. In 1983 Warren and Marschall, honoured in 2005 with a Nobel Prize, showed the cause-effect relationship between the occurrence of H. pylori bacteria in the gastrointestinal tract and chronic gastritis. See: Marshall B J, Warren J R. Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Lancet. 1984; 1:1311-1315. Due to the fact that long-lasting infection evidently increases the risk of intestinal type adenocarcinoma, in the recent years H. pylori rods were declared by WHO as a carcinogenic factor (IARC. Schistosomes, liver flukes and Helicobacter pylori . IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Lyon, 7-14 June 1994. IARC Monogr Eval Carcinog Risks Hum. 1994; 61:1-241.). Moreover, a relationship was found between H. pylori infection and pathologies in tissues and organs other than the stomach, for example in heart.
[0055] For a long time it was believed that stomach is free from bacteria because the permanent colonisation of mucous membrane in stomach is difficult due to the fact, that the pH is too low for growth of the majority of microorganisms. However, the urease produced by H. pylori allows this organism to form permanent colonies in stomach and intestine, while ureolysis is the main factor causing pathologies associated with H. pylori infections. Urease deposited outside of the bacteria cell may constitute even up to 20% of bacterial protein. The enzyme protects the bacteria against the acidic environment and prevents the lethal destruction of the bacterial cell envelope. Additionally, during the H. pylori infection ammonium ions released by urease during the course of urea decomposition have cytotoxic effects on stomach epithelium cells. In the presence of leukocytes and urea, bacterial urease generates monochloramine that may induce DNA mutagenesis, one of the factors involved in the development of cancer in the course of chronic H. pylori infection.
[0056] New species of ureolytic spiral bacteria are being isolated in humans and animals. However, so far it is not clear how other Helicobacter species occurring in humans should be connected with diseases of stomach (for instance H. heilmannii ), intestines (for instance H. cinaed, H. canadensis ), liver (for instance H. hepaticus, H. bilis ) or with systemic infections (for example H. pullorum, Helicobacter spp. flexispira taxon 8 “ F. rappini ”).
[0057] In recent years it has been found that the gastrointestinal tract (intestines, stomach, liver, and pancreas) in laboratory animals may be naturally colonised by bacteria of the Helicobacter genus: H. bilis, H. ganmani, H. hepaticus, H. muridarum, H. mastomyrinus, H. rappini, H. rodentium, H. typhlonius . Animals—both wild and domestic, permanently colonised with these microorganisms, do not manifest infection symptoms and no inflammatory processes are found in their internal organs in the course of autopsy. Microorganisms susceptible to environmental conditions continue to thrive due to permanent horizontal transmission of bacteria from one individual to another through feces and saliva.
[0058] It has been found that in humans H. pylori infection is present in 50% of the population and it seems to be related to the economic status and age of communities. It increases in adults, including almost entire populations in poorly developed countries. H. pylori is found in 90-100% of gastritis cases. Often chronic infection is found to be transformed into atrophic inflammation. In 10% of those infected, serious pathologies develop. Infection with H. pylori is common in both children and adults. Most often infection occurs in a childhood and the colonisation of the mucous membrane of the stomach with H. pylori rods is maintained throughout the life-time.
[0059] It is known that factors such as malnutrition, vitamin deficiency and smoking play a role in infection.
[0060] In 10% of patients, the applied conventional therapy is ineffective due to existing and increasing resistance of bacteria to standard medicines. Some patients are also found to be re-infected with drug-resistant bacteria. The other ca. 10% of patients do not tolerate preparations from the group of proton pump inhibitors. In these patients adverse side effects are manifested.
[0061] Due to the systematically decreasing effectiveness of treatment and the difficulty thereof, regional gastrological associations in Europe, following the recommendation of the “Maastricht 2-2000” report, recommend appropriate diagnostic procedures to detect H. pylori and starting a treatment only where certain disease symptoms occur, such as: gastritis, stomach and duodenal ulcers, peptic ulcer confirmed in course of interviews, surgery due to peptic ulcer, pre-cancer changes (atrophic inflammation, metaplasia, dysplasia), stomach resection due to an early cancer, stomach cancer in family (up to 2 nd level of consanguinity), gastric hyperplastic adenomatous polyposis (after removal thereof), MALT lymphoma, long-term treatment with NSAIDs.
[0062] It was noticed that in humans H. pylori infection is accompanied by certain diseases, such as peptic ulcers, gastric lymphomas, chronic atrophic gastritis with intestinal metaplasia and stomach cancer.
[0063] In diagnostics of Helicobacter infections routine invasive tests are used in combination with endoscopic examinations, as well as non-invasive tests that do not require testing of bioptates from patient's stomach mucosa.
[0064] Testing of mucosa fragments enables isolation of the microorganism (selective growing media) or application of appropriate techniques (specific and non-specific staining) that indicate the presence of H. pylori cells. Identification of H. pylori cells in the course of mucosa biopsy is subjected to verification by means of both classical microbiological methods (phenotype determination, drug resistance determination in the isolate), as well as biochemical methods (enzymatic activity of H. pylori —production of urease, catalase, oxidase), and molecular biology methods (PCR testing, Real-time PCR with specific primers for selected segment of the bacterial DNA).
[0065] The most commonly used non-invasive methods include serological tests and identification of Helicobacter antigens—stool antigen test, and the urea breath test which detects levels of urea above that which is assumed to be the standard urea concentration in the air exhaled by the patient. Routine serological tests are ELISA-type tests detecting specific G-class antibodies to H. pylori bacteria.
[0066] In humans in the first stage of H. pylori infection, an inflammation of the mucous membrane in the stomach and duodenum develops which should be fully eradicated with pharmacological measures. H. pylori infection treatment is still based on the introduction of substances which decrease secretion of gastric juice and raise pH values in stomach. Such substances include proton pump inhibitors and certain antibiotics which eliminate the bacteria—clarythromicin, amoxicillin and chemical compounds—metronidazole (from the group of nitroimidazole derivatives).
[0067] In general, current therapy of diseases caused by ureolytic bacteria involves the application of an appropriate anti-bacterial drug administered orally, intravenously, intravaginally, anally and externally, in the form of pills, ointments, suppositories and powders. Selection of a therapeutically effective drug is made after the following factors are determined: biochemical activity of ureolytic bacteria, their resistance patterns to antibiotics and chemotherapeutic agents (antibiogram), and after the structure of the cell envelope (e.g. mycoplasmas) is determined.
[0068] In Europe the list of recommendations in the “Maastricht 2—2000” report published in 2002 does not include any H. pylori therapy without anti-bacterial measures such as antibiotics, and in terms of chemotherapeutic compounds—substances other than nitroimidazole derivatives. The therapy is complex, costly, sometimes badly tolerated and not always effective. In accordance to the recommendations of European regional Gastroenterological Associations a treatment may be based on antibiotics and chemotherapeutic compounds (clarythromicin (2×500) and amoxicillin (2×1 g) or metronidazole (2×500 mg), as well as proton pump inhibitors.
[0069] For example:
[0070] First-Time Therapy. a Seven-Day Treatment Cycle:
1. Medicine reducing the secretion of gastric juice; a double dose of a compound belonging to the group of proton pump inhibitors (PPI)—for instance omeprazol 2× day, 20 mg 2. Antibiotic I—for instance amoxicillin, 2× day 1 g 3. Antibiotic II—for instance clarythromicin, 2× day 0.5 g
[0074] Second-Time Therapy.
1. Medicine reducing the secretion of gastric juice; a double dose of a compound belonging to the group of proton pump inhibitors (PPI)—for instance lanzoprazol 2× day, 30 mg 2. Antibiotic I—for instance maintain amoxicillin, 2× day 1 g 3. Antibiotic II—other antibiotic or chemical compound—for instance metronidazol, 2× day 0.5 g 4. bismuth compounds (citrate).
[0079] Due to the epidemic spread of H. pylori in different parts of the world, there is a great and permanent demand for preparations reducing pathologies associated with the infection; there is great pressure upon the medical community to identify such preparations.
[0080] The main object of the invention is to provide a new preparation for treatment and prophylaxis of diseases caused by urolytic bacteria, to be used in particular to regulate ureolytic microbiota of intestines, to regulate ureolytic microbiota of oral cavity, to inhibit passage of pathogenic ureolytic bacteria through a digesting stomach, to prevent formation of deposits and infectious stones in the urinary system—in humans and animals, in particular in dogs and cats, and in other domestic animals.
[0081] The object of the invention is to provide also a new agent for control of undesired growth of ureolytic bacteria in living organisms, including a human beings, plants and animals, especially pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod.
[0082] A specific aim of the invention is to provide a new preparation for treatment and prophylaxis of diseases caused by H. pylori.
[0083] It is also an aim of the invention to provide methods of treatment and prophylaxis of diseases caused by urolytic bacteria, in particular methods for regulation of ureolytic microbiota of intestines, for regulation of ureolytic microbiota of oral cavity, for inhibiting passage of pathogenic ureolytic bacteria through a digesting stomach, for preventing formation of deposits and infectious stones in the urinary system—in humans and animals, in particular in dogs and cats, and in other domestic animals.
[0084] Still further object of the invention is to provide a new preparation for inhibiting growth of ureolytic bacteria, in particular of Ureaplasma and other mycoplasmas causing fish diseases, for use in particular as a prophylaxis of gill inflammation caused by ureolytic bacteria in carp and carp fry and other fresh water and sea fish.
[0085] Besides, it is the object of the invention is to provide a new preparation for preventing formation of biofilm and mineralisation of deposits on catheters and other medical equipment.
[0086] It is also the aim of the invention is to provide a new preparation for reduction of tartar formation and inhibition of development of caries.
[0087] Furthermore, it is a further aim of the invention is to provide new dietary supplements, special medicated food products and food/feed additives preventing and/or inhibiting colonisation of living organisms, including a human being, pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod, by undesired ureolytic bacteria, in particular colonisation of humans and of domestic animals by H. pylori.
[0088] Taking into account beneficial effect of alpha-ketoglutarate on gut microbiota it is also an object of the present invention to provide an improved process for manufacturing organic biofuel, based on the conversion of biomass comprising of lignin and cellulose by means of bacterial enzymes.
[0089] These aims and objects are achieved by providing a solution according to the invention as presented in the appended patent claims.
[0090] The achievement of the above mentioned aims is assured in accordance with the invention—as defined in the appended patent claims, by use of alpha-ketoglutarate as an active substance in therapeutically or prophylactically effective doses to produce a therapeutic or prophylactic medical preparation or a dietary supplement, special medicated food product and food/feed additive or else a personal hygiene products for everyday use.
[0091] Therapeutic and/or prophylactically effective dosages range from 0.001 g to 0.2 g/kg of body mass/day when administered intragastrically or orally. As far as local topical administration is concerned, the effective dosages range from 0.01 to 10 g/m 2 of tissue surface/day.
[0092] Until now, it has not been reported that salts of alpha-ketoglutaric acid may be effectively used in humans or in animals to treat ureolytic bacterial infections, including H. pylori infections.
[0093] The availability of alpha-ketoglutarate, its well examined activities within the organisms, as well as the fact that this substance is approved for use in other medical and prophylactic applications contribute to numerous advantages of the present invention.
[0094] The invention is further explained in the following detail description and with reference to the enclosed drawings.
[0095] In the drawings enclosed,
[0096] FIG. 1 shows the scheme of the experimental mice infectious model with H. pylori bacteria, used to study the relationship between colonisation level of mouse stomach mucosa (n=28) by H. pylori and the mice treated intragastrically with salts of alpha-ketoglutaric acid.
[0097] FIG. 2 shows the scheme of the experimental mice infectious model with H. pylori bacteria, used to study the relationship between colonisation level of mouse stomach mucosa (n=48) by H. pylori and the mice treated intragastrically with salts of alpha-ketoglutaric acid.
[0098] FIG. 3 shows mobility of PCR products related to 16S rDNA Helicobacter genus bacteria in electrical field assayed with DGGE technique.
[0099] The terms used throughout the description and the appended patent claims have the following meaning:
[0100] The term “alpha-ketoglutarate” as used herein, refers to the compound releasing an active anion of the acid known as 2-okso-pentanedioic, 2-oksoglutaric, alpha-oksoglutaric, alpha-oksopentanedioic, 2-ketoglutaric, 2-okso-1,5-pentanedioic, 2-oksopentanedioic, or 2-okso-glutaric. The examples of such compounds are salts, additive salts, esters, amides, imides of alpha-ketoglutaric acid and prodrugs thereof. Alpha-ketoglutarate exerts an inhibitory action on colonisation and prevents mucosa colonisation by ureolytic bacteria in living organisms, including a human being, plant and animal, especially pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod. As far as the salts of alpha-ketoglutaric acid are concerned, the term alpha-ketoglutarate—as used herein, covers alkali metal salts and/or alkaline earth metal salts and/or chitosan salts of the acid, or else a mixed salts of alkali metals and alkaline earth metals and chitosan and alpha-ketoglutaric acid. Particularly preferred are sodium salt and calcium salt or a mixture thereof.
[0101] The term “medical preparation” as used herein refers to a composition comprising a therapeutically effective quantity of alpha-ketoglutarate to be used in new medical or prophylactic indications covered by this invention. The medical preparation may comprise other active ingredient(s) and/or additional beneficial pharmaceutically acceptable and compatible with the active ingredient(s) substances such as vehicles, diluents, excipients, adjuvants and auxiliary additives suitable for the selected administration route intended for the preparation. As other active ingredient(s) the present medical preparation comprising alpha-ketoglutarate may contain for example vitamins.
[0102] The term “therapeutically effective” denotes such a specific quantity of a derivative, in particular, a salt of alpha-ketoglutaric acid, that under in vivo conditions presented in this description has a therapeutic effect, i.e. reduces and inhibits colonisation of the mucous membrane by ureolytic bacteria in living organisms, including a human being, pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod. Therapeutic or prophylactic effectiveness is achieved by introducing the above mentioned medical preparation in a solid or liquid form, with or without a vehicle, diluent, additive, or else as a component of a pharmaceutical composition, into living organisms, including a human being, pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod. The preparation is administered in quantities sufficient to reduce and prevent ureolytic bacteria infections. Alternatively, therapeutically effective quantity of the medical preparation heals the infections caused by ureolytic bacteria.
[0103] Depending on the desired effects, the quantity of the preparation may differ, according to its specific action on the ureolytic bacteria in the target place. A dose of the preparation may comprise a defined quantity of a substance calculated in such a way as to bring about the expected therapeutic results. Dosage is given in terms of a pure active substance taking into account its chemical structure and presence of additional substances, such as vehicle, diluent, adjuvants and other permitted pharmaceutically acceptable additives. Desired therapeutic effect and thus the recommended dose may be determined by means of known methods by an employee of medical or veterinary service, mainly based on such parameters as age, weight, sex of the patient, other accompanying infections and diseases, in accordance with good medical practice.
[0104] The term “administration of the medical preparation” refers to prophylactic or therapeutic reaction to the abovementioned diseases with an appropriate route of administration adjusted to the place, type and intensity of infection, taking into the account the route of entry of harmful ureolytic bacteria into the organism.
[0105] The term “inhibiting of colonisation” relates to the reduction of spread and/or severity of infection within mucous membranes or other tissues, caused by ureolytic bacteria, or complete eradication of the infecting factor—leading to the reduction and/or prevention of further development of infection in living organisms, including a human being, pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod.
[0106] The term “preventing of colonisation” refers to the prevention of the development of harmful ureolytic bacteria, when the bacteria get into contact with the mucous membrane of a living organism, including a human being, pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod. In the case of an effective prevention of colonisation, infection does not occur or mucous membranes of the living organisms, including a human being, pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod—are infected with considerable delay in comparison to a scenario without preventing of colonisation.
[0107] The term “dietary supplement” means a concentrated source of nutrients or other substances with nutritious or physiological effect, the use of which contributes to supplementing everyday diet deficient in certain beneficial components. Dietary supplements are produced in an easy-to-use form, e.g. tablets, capsules or liquids, preferably in one-dose packages.
[0108] The term “medicated food product” means a food product with form and recipe typical for the product, containing an additional substance of specific therapeutic or prophylactic value.
[0109] The term “food/feed additive” relates to a product containing an active substance, pure or in a composition, in solid or liquid form, with or without vehicles, buffers, detergents, solubilizers, antioxidants, preservatives and other additives substances corresponding with the active substance profile, and approved for usage in food.
DETAILED DESCRIPTION OF THE INVENTION
[0110] The invention relates mainly to new medical applications of alpha-ketoglutarate.
[0111] In another aspect, the invention relates also to a process for manufacturing an organic biofuel, based on the conversion of biomass comprising of lignin and cellulose by means of bacterial enzymes, wherein the enzymes produced by hindgut ureolytic microbiota of wood-feeing higher termites are used in presence of alpha-ketoglutarate.
[0112] In the process alpha-ketoglutarate is used in a ratio sufficient to increase the yield of the process by at least 5%. The enzymes may be used in a purified form free of disrupted ureolytical bacterial cell fragments or in a nonpurified form, i.e. in admixture with disrupted bacterial cell fragments or released by ureolytical bacteria.
[0113] Termites are known for their wood-degradation ability. Natural colonizing bacteria of termite guts have been identified as a factor which converts wood into biofuels. It has been shown recently that there are more than 250 bacterial species found in termites' hindgut with hundreds of genes encoding enzymes that break down cellulose and xylan during lingo-cellulose degradation. A high amount of urease-positive highly motile spirochetes present in termites' intestine can take part in the initial hydrolysis of wood polysaccharides (Wernecke et al. Metagenomic and functional analysis of hindgut microbiota of a wood-feeding higher termite. 2007. Nature, 450, 7169, 560-565.)
[0114] According to the present invention alpha-ketoglutarate is proposed for speeding up and intensifying enzymatic activities of bacteria and their products determining performance of biofuels in a quality way exchanging urease-positive microbial community of symbiotic bacteria in the gut to achieve more effective and higher level of lingo-cellulose degradation.
[0115] According to the medical aspects of the invention, alpha-ketoglutarate is used in the form of a single compound or a mixture of various compounds, for manufacturing of medical preparation for use in prophylaxis and/or treatment of diseases caused by pathogenic ureolytic bacteria in living organisms, including a human being, plant and animal, especially pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod.
[0116] Prophylactic or therapeutic effect of the administration of the preparation manufactured in accordance with the invention is reached, when from 0.001 to 0.2 g of alpha-ketoglutarate is used per 1 kilogram of body mass/day. When used topically and in the body cavities, the alpha-ketoglutarate is particularly effective in the dosage from 0.01 to 10 g/m 2 of tissue surface/day.
[0117] The present invention is based on the observation that H. pylori bacteria are able to survive in the highly acidic environment of the higher organisms' stomachs.
[0118] A well known property of H. pylori is its ability to survive in low pH environment due to the activity of urease which hydrolyses urea present in the mucous membrane of stomach and in the gastric juice (Saidijam M, Psakis G, Clough J L, Meuller J, Suzuki S, Hoyle C J, Palmer S L, Morrison S M, Pos M K, Essenberg R C, Maiden M C, Abu-bakr A, Baumberg S G, Neyfakh A A, Griffith J K, Sachs G, Scott D, Weeks D, Melchers K. Gastric habitation by Helicobacter pylori : insights into acid adaptation. Trends Pharmacol Sci. 2000; 21:413-416, Sachs G, Weeks D L, Melchers K, Scott D R. The gastric biology of Helicobacter pylori . Annu Rev Physiol. 2003; 65:349-369, Sidebotham R L, Worku M L, Karim Q N, Dhir N K, Baron J H. How Helicobacter pylori urease may affect external pH and influence growth and motility in the mucus environment: evidence from in-vitro studies. Eur J Gastroenterol Hepatol. 2003; 15:395-401.). The scheme of individual reactions is as follows:
[0000] H 2 NCONH 2 +H 2 O→CO 2 +2NH 3 (1)
[0000] CO 2 +H 2 O→H 2 CO 3 (2)
[0000] H 2 CO 3 +2NH 3 →NH 4 + +HCO 3 − +NH 3 (3)
[0000] H + Cl − +NH 3 →NH 4 + +Cl − (4)
[0119] As a result of the urea decomposition process, ammonia is formed and it reacts immediately with hydrochloric acid so that in the tissue (mucous membrane of the stomach) pH of the micro-environment is locally increased. As it is known, under natural conditions, the mucous membrane of the stomach is acidic, due to the HCl production in parietal cells.
[0120] Even though H. pylori rods are sensitive organisms difficult to be grown in vitro, the low pH in the stomach—lethal to other bacteria—may paradoxically support H. pylori colonisation. This is mainly due to the presence of endogenous urea decomposed by bacterial urease (an enzyme produced by H. pylori ) to ammonia which increases pH in the micro-environment of the bacteria. Thus, the lethal influence of the acidic environment on H. pylori is eliminated. It is even believed (Nakazawa T. Growth cycle of Helicobacter pylori in gastric mucous layer. Keio J. Med. 2002; 51, S2:15-19.) that the H. pylori growth cycle in the gastric mucous layer is stimulated by the ureolytic properties of the microorganisms. It was proved, that in the cellular level, urease mRNA is stabilised and destabilised depending on pH of the environment. It was assumed that the bacteria use nutrients from degraded cells in order to grow and colonise a region where pH has already been altered. Urease activation is accompanied by the opening of a pH-dependent UreI channel in bacterial cell which facilitates urea hydrolysis (Weeks D L, Eskandari S, Scott D R, Sachs G. A H+-gated urea channel: the link between Helicobacter pylori urease and gastric colonization. Science. 2000; 287:482-485, Weeks D L, Sachs G. Sites of pH regulation of the urea channel of Helicobacter pylori . Mol. Microbiol. 2001; 40:1249-1259.). It was also noticed that H. pylori has the ability to move towards greater concentrations of urea, and this chemotaxis accelerates the urea hydrolysis process. This explains the second round of the growth cycle and in consequence the stabilisation of the infection in the stomach (Scott D R, Marcus E A, Weeks D L, Sachs G. Mechanisms of acid resistance due to the urease system of Helicobacter pylori . Gastroenterology. 2002; 123:187-195, Scott D R, Marcus E A, Weeks D L, Lee A, Melchers K, Sachs G. Expression of the Helicobacter pylori ureI gene is required for acidic pH activation of cytoplasmic urease. Infect Immun. 2000; 68:470-477, Voland P, Weeks D L, Marcus E A, Prinz C, Sachs G, Scott D. Interactions among the seven Helicobacter pylori proteins encoded by the urease gene cluster. Am J Physiol Gastrointest Liver Physiol. 2003; 284:96-106.).
[0121] On the other hand, it is known that during the course of amino acid degradation—as a result of oxidizing deamination the α-amino groups are transferred to α-keto acids and it is accompanied by the detachment of ammonium ion. Ammonium ions produced as a result of amino acid decomposition partly participate in the biosynthesis of nitrogen compounds, and the remaining ones are removed from the organism after transformation into urea. In urea one of the nitrogen atoms originates directly from the ammonium ion.
[0122] Under natural conditions urea may diffuse freely from the place where it is produced, i.e. from hepatocytes, to the entire digestive system, this is due to the low molecular mass of this compound (M r 60). Due to the strong toxicity of the ammonium ion the organism protects itself by employing the ion in the synthesis of low-toxicity compounds, such as urea (ureotelic organisms—mammals). Ureotelic organisms are not able to store nitrogen: which relates to proteins, amino acids and ammonia.
[0123] In a living organism, free ammonia occurs in insignificant quantities in spite of continuous deamination of amino acids. Some ammonia is immediately bound by glutamate and asparaginate. Some ammonia is excreted through kidneys in the form of ammonium ions. The majority of the toxic ammonia is converted into urea in the liver in the ornithine cycle.
[0124] At present it was unexpectedly found that after administering alpha-ketoglutarate to the stomach, the population of H. pylori decreases. Under conditions of an in vivo experiment the level of ammonium ions is relatively low and removal thereof by alpha-ketoglutarate (immediate binding into glutamate and asparaginate), in spite of improved anion transport to gastric mucous layer cells (through DC transporter), leads to the death of ureolytic bacteria. Production of ammonium ions from urea, necessary for survival of H. pylori in the stomach, does not cover the needs of the rods, because the ammonium ion is immediately utilised, with involvement of the administered alpha-ketoglutarate, in the synthesis of glutamate and other amino acid compounds.
[0125] It is still unclear why H. pylori produces excessive—in relation to the substrate, quantities of urease. Bacterial urease is a nickel-dependent enzyme with nickel divalent cation posttranslationally incorporated. It is assumed, that in order to maintain an appropriate quantity of active enzyme H. pylori accumulates it to safeguard ureolytic activity of descendant cells growing even under conditions of nickel deficiency. Due to the intensive up-take of alpha-ketoglutaric acid salts in the stomach, H. pylori may also compete for access to these salts which causes an intensive production of bacterial urease in the first stage of infection.
[0126] Due to the epidemic spreading of H. pylori infections, searching for preparations limiting pathologies resulting from the infection is a subject matter of numerous reports. See: El-Omar E M. Mechanisms of increased acid secretion after eradication of Helicobacter pylori infection. Gut. 2006; 55:144-146., Wotherspoon A C, Ortiz-Hidalgo C, Falzon M R, Isaacson P G. Wotherspoon A C, Ortiz-Hidalgo C, Falzon M R, Isaacson P G. Helicobacter pylori -associated gastritis and primary B-cell gastric lymphoma. Lancet. 1991; 338:1175-1176.
[0127] Alpha-ketoglutarate participates, alongside ammonium ions, in the synthesis of certain amino acids, such as glutamic acid, and then glutamine, in the following reaction:
[0000] O═C—COO − +NH 4 + →H2N—CH—COO − HCH HCH HCH HCH C═O C═O OH OH
[0000] alpha-ketoglutarate+ammonium ions→glutamate
[0132] It was this ability of alpha-ketoglutarate to bind ammonium ions that instigated the research on the present new medical applications of this well-known substance.
[0133] It was assumed that the above mentioned reaction is a pathway of binding ammonium ions competitive to synthesis of urea being a necessary source of nitrogen for H. pylori in the gastric environment or for other ureolytic bacteria, for instance in the urogenital system.
[0134] Due to the lack of reports concerning harmful actions of alpha-ketoglutarate on the mucous membrane of the stomach and small intestine in healthy volunteers, a series of experiments were conducted on healthy laboratory animals to establish the influence of alpha-ketoglutarate on H. pylori colonisation of stomach and small intestine in healthy laboratory animals.
[0135] Unexpectedly, the results confirmed the above mentioned assumptions and showed the following:
1. There were no morphological changes in the thickening of the mucosa in the stomach of mice infected with H. pylori and following inoculation with alpha-ketoglutarate, or in the thickening of the mucosa in the small intestine and in the villus width and crypt depth in animals tested. 2. There were no changes in the amount of lactic acid bacteria isolated from scraped stomach mucosa (antral part) in animals tested, including those samples from mice infected with H. pylori and following inoculation with alpha-ketoglutarate. 3. A 17% (p<0.01) reduction in the number of gastrin—gastric hormone—producing cells localised in the pyloric region of the stomach glands was observed in animals infected with H. pylori and following inoculation with alpha-ketoglutarate in contrast to the control group (challenged with phosphate buffer—PBS). In animals infected with H. pylori and following inoculation with alpha-ketoglutarate a decreasing level of blood gastrin occurred (from 21.8 pM-24.7 pM up to 12.8 pM-15.6 pM) (p<0.05), most probably as a result of the reduced number of gastrin-producing cells in stomach mucosa. This fact indicates an indirect (through histamin) inhibitory interaction between alpha-ketoglutarate and proton pomp activity. Its hyperactivity is manifesting in reflux diseases. 4. Some tendency towards a decreasing number of cholecystokinin (CCK) tissue hormone producing cells was noticed in the small intestine of animals treated with alpha-ketoglutarate. There is a slope in 30% (without statistical differences, p=0.1) as compared to this same intestine segment of mice not infected, inoculated only with PBS. There were no significant differences in the number of CCK-producing cells in the small intestine of mice infected with H. pylori , following the challenge with alpha-ketoglutarate as compared to the mice inoculated only with alpha-ketoglutarate (p=0.25). A low CCK blood level (from 3.1 pM-4.0 pM up to 1.9 pM-2.5 pM) (p<0.05) in animals infected with H. pylori and inoculated with H. pylori , and following with alpha-ketoglutarate can be connected to the decreasing number of CCK producing cells in the small intestine. Therefore the low CCK level can stimulate stomach emptying in increasing frequency; it is stated by medical service as a factor avoiding further colonisation by H. pylori and infection development.
[0140] Bactericidal Effect of Alpha-Ketoglutarate on H. Pylori Rods
[0141] It was presently unexpectedly found that the salt of alpha-ketoglutaric acid inhibits the process of H. pylori colonisation of the gastrointestinal tract of mammals. The present studies show that the average number of colonies isolated from mucosa in the pyloric part of the stomach in mice infected only with H. pylori —on the thirtieth day after administering the first dose of suspension of the bacteria cells was equal to 7.8×10 2 ±5.0×10 1 . In the group of laboratory animals which after 14 days from infection received an intragastric dose of the salt of alpha-ketoglutaric acid for 9 consecutive days, the average number of isolated colonies was only 3.8×10 2 ±5.0×10 1 . Nine intragastric administrations of alpha-ketoglutarate for nine consecutive days, which started 14 days after the last infective dose with H. pylori resulted in a 49% decrease in the gastric mucous layer colonisation by the bacteria. The results prove that the salts of alpha-ketoglutaric acid inhibit colonisation of stomach by H. pylori.
[0142] In another experiment it was found that the average number of colonies isolated from the mucosa in the pyloric part of the stomach of mice infected solely with H. pylori on the twentieth day after the first administration of suspension of bacterial cells, was equal to 4.3×10 2 ±5.0×10 1 . In the group of laboratory animals which received alpha-ketoglutarate intragastrically for 3 consecutive days, 8 days after infection, no H. pylori colonies were found. Three intragastric administrations of alpha-ketoglutarate continued for 3 consecutive days, which started 8 days after the last infective dose of H. pylori , completely stopped colonisation and fully eradicated H. pylori in mice gastric mucosa.
[0143] In course of the observation, the gastric microbiota altered and in mice infected with H. pylori DNA of H. bilis was also found; in mice additionally inoculated with alpha-ketoglutarate—only DNA of H. rodentium, H. bilis, H. hepaticus were found; in the control group of mice, to whom salts of alpha-ketoglutaric acid were administered, DNA of H. hepaticus i H. rodentium was identified. In mice treated with PBS DNA of Helicobacter bacteria was not found.
[0144] The results were obtained by means of routine diagnostic methods supported with classic techniques which assume that a living microorganism must be cultured in order to confirm the presence of bacteria in a tissue (fulfilment of Koch's postulates). Additionally the studies were supported with DNA detection methods for H. pylori and other non-pathogenic bacteria of the Helicobacter genus. PCR followed by electrophoretical separation of PCR products by means of Denaturing Gradient Gel Electrophoresis (DGGE), and sequencing of products intended to examine the DNA composition is a method for detecting changes that were described here. In practice, in course of sequencing no H. pylori DNA was found (sensitive level: ethidium bromide staining) in mice treated with alpha-ketoglutarate.
[0145] Alpha-ketoglutarate is thus an ideal active substance for a large and varied group of patients that require prophylaxis and treatment against H. pylori , and urogenital system infections caused by ureolytic bacteria.
[0146] Mechanism of bactericidal action of alpha-ketoglutarate against ureolytic bacteria—quite different from those mechanisms known so far, will allow safe eradication of these microorganisms without fear of induction of an increase of drug resistance in ureolytic bacteria. In practice, it will result in reduction of reinfections, superinfections and difficulties in treatment with antibiotics.
[0147] As it has been established so far, alpha-ketoglutarate supports, or is an alternative to, standard antibiotic treatment. Also, in cases of cachexia it may serve to balance the natural ureolytic microbiota.
[0148] In accordance with the invention, alpha-ketoglutarate and/or appropriate precursors releasing under in vivo conditions anions of alpha-ketoglutaric acid will be used to manufacture a medical preparation to be used in prophylaxis and/or treatment of diseases caused by ureolytic bacteria.
[0149] To cure infections caused by ureolytic bacteria and diseases associated with the infections it is now recommended according to the present invention, to administer alpha-ketoglutarate to patients with catheters and urinary system infections through the administration of the alpha-ketoglutarate solution into the catheter in order to ensure direct contact of the alpha-ketoglutarate with the bacteria colonizing host mucosa or with the ureolitic bacteria forming infectious stones.
[0150] As proposed in accordance with the invention it is also recommended to introduce alpha-ketoglutarate into body cavities in the case of urogenital system infections in the form of suppositories and irrigation.
[0151] Suppositories containing alpha-ketoglutarate should be, as proposed in accordance with the present invention, administered anally in anal glands infections (in animals), and also in resistant infections that form with time alongside haemorrhoids, rupture or ulceration of mucosa of the distal part of the digestive system (including the rectum).
[0152] In the case of bacteræmia (sepsis) occurring as a result of systemic infection with ureolitic bacteria it is now recommended in accordance with the present invention, to apply alpha-ketoglutarate treatment involving administering it directly into blood, for example in the form of intravenous infusion.
[0153] Externally, in places of rupture and ulceration of skin with infections caused by ureolitic bacteria alpha-ketoglutarate should be administered, as proposed in accordance with the present invention, in the form of powder, dressings and ointments.
[0154] Alpha-ketoglutarate in solid state should be administered, in accordance with the present invention, to infected fish during feeding.
[0155] In each above mentioned exemplary route of administration of alpha-ketoglutarate, one should always take necessary measures to ensure that the form of the drug and pH of preparation containing alpha-ketoglutarate as the active ingredient is not irritating to the infected tissue or organ, as irritations may lead to an increased severity of the infection.
[0156] The preparation obtained in accordance with the invention is useful in particular to prevent and/or inhibit H. pylori colonisation.
[0157] The following salts are preferably used as alpha-ketoglutarate: mono- and di-substituted salts of alpha-ketoglutaric acid and alkali metals and/or alkaline earth metals and/or chitosan. The preferred salts are sodium salt and/or calcium salt.
[0158] Alpha-ketoglutarate, in accordance with the invention, may be used in humans and animals as a medical preparation, dietary supplement, special medicated food product and/or food/feed additive, depending on conditions, for inhibition of H. pylori colonisation in humans and animals, in order to prevent H. pylori infection and consequences thereof, or in order to alleviate H. pylori infection and consequences thereof.
[0159] Alpha-ketoglutarate may be administered together with known vehicles and additives that are approved for pharmaceutical use and are compatible with the selected alpha-ketoglutarate precursors. Appropriate additives include, for instance, water, saline, dextrose, glycerol, ethanol or other similar substances or combinations thereof. Moreover, where desired, the preparation may contain additional substances such as, for instance, wetting agents, emulsifiers, pH modulators, buffers and other.
[0160] Alpha-ketoglutarate may be administered together with other known active substances that are approved for pharmaceutical use and are compatible with the selected alpha-ketoglutarate precursors. Among valuable other active ingredients are vitamins, vitamin C in particular, and many others.
[0161] In accordance with the invention, the preparation containing alpha-ketoglutarate may be solid and/or liquid, depending on the intended route of administration.
[0162] The invention relates also to the use of alpha-ketoglutarate for manufacturing preparations for treatment and prophylaxis of other ureolytic bacteria infections. Examples of further medical applications of alpha-ketoglutarate include the use of alpha-ketoglutarate to manufacture a preparation that inhibits passage of pathogenic ureolytic bacteria through the stomach, a preparation preventing formation of deposits and infectious stones in the urinary system, a preparation reducing formation of biofilm and mineralisation of deposits on catheters and other medical equipment, and also a preparation inhibiting growth of other pathogenic ureolytic bacteria in the urogenital system, to be used in the form of urethral infusions, tablets, irrigation liquids, intravaginal tablets.
[0163] In accordance with the present invention, alpha-ketoglutarate may also be used in dogs, cats and domesticated animals, in the form of bladder infusions in bacterial infections caused by ureolytic bacteria.
[0164] A further example of a new use of alpha-ketoglutarate is a use for manufacturing of a preparation regulating ureolytic microbiota of the oral cavity, reducing formation of tartar and inhibiting development of dental caries. This product may have the form of a chewing gum or a tooth paste.
[0165] Alpha-ketoglutarate finds also its further new use according to the invention, for manufacturing a preparation inhibiting growth of ureolytic bacteria, in particular Ureaplasma and other mycoplasmas causing infections in fish. In this respect, the new use of alpha-ketoglutarate is use for manufacturing a preparation for preventing inflammation of gills caused by the above mentioned ureolytic bacteria in carp and carp fry, and in other fresh water and sea fish.
[0166] The invention also covers the use of alpha-ketoglutarate in production of dietary supplements, special medicated food products, and food/feed additives used to prevent and/or inhibit H. pylori colonisation.
[0167] Examples below provide a better explanation of this invention.
Example 1
[0168] Laboratory experimental animals: twenty eight 6 week-old BALB/cA (female) mice weighing 25±2 g ( FIG. 1 ). Fourteen mice were challenged through a tube (outer diameter 1.3 mm) 3 times with one day intervals with 0.2 ml suspension of H. pylori cells, strain 119/95 at the concentration 10 9 cfu/ml. Two weeks after the last challenge, seven mice were inoculated intragastrically for nine successive days by the same method with a solution of calcium or sodium salt of alpha-ketoglutaric acid (0.2 ml, at concentration 30 mM) (group I A). The remaining seven mice were sham-treated with 0.01 M phosphorate buffer—PBS (group I B) as animals from group I A.
[0169] Further fourteen mice from group II A and II B were treated with 0.2 ml PBS according to the scheme operating by the infection of the animals with H. pylori . Two weeks after the above treatment seven mice were continuously inoculated with PBS (0.2 ml) for three consecutive days. The remaining seven mice were treated with a solution of salts of alpha-ketoglutaric acid (0.2 ml, concentration 30 mM) (group II A).
[0170] On the 30 th day of the experiment all mice were sacrificed using CO 2 . For further analyses blood and stomach samples from mice infected with H. pylori with or without the following inoculation with salts of alpha-ketoglutaric acid were collected. Scheme of the experimental mice infectious model with H. pylori bacteria has been presented in FIG. 1 . In this experiment the relationship between colonisation level of mouse stomach mucosa (n=28) by H. pylori and the mice treated intragastrically with salts of alpha-ketoglutaric acid were studied in accordance with the time regime as described above.
[0171] In FIG. 1 the following abbreviations were used. Mice from experimental groups (n=28) were inoculated intragastrically with the following preparations: suspension of H. pylori cells: #; solution of salts of alpha-ketoglutaric acid: ♦; solution of PBS: . The name of the strain, concentration and volume of inoculum ( H. pylori ) and concentrations and doses of: salts of alpha-ketoglutaric acid and PBS, correspond to the above information. Bolded figures accompanied by the S letter indicate autopsy days. Autopsies were carried out in accordance with commonly binding standards.
[0172] Blood samples from all animals tested were smeared on GAB-CAMP agar plates and incubated at temp. 37° C., under microaerophilic conditions for 7-10 days. From the half of the antrum gastric mucosa was scraped off and mixed with 500 μl PBS sterilized. After homogenate balancing it was noticed that the amount of the scraped mucosa from the half of the antrum was generally between 40 μg a 50 μg. For calculation of number of H. pylori cells, a 100 μl of gastric mucosa homogenate was smeared onto GAB-CAMP agar plates and incubated at temp. 37° C., for 5-10 days, under microaerophilic conditions. Homogenized mucosa samples from each mouse were examined in triplicate. The results are presented as the mean value±SD. The presence of H. pylori was identified by colony morphology and urease-, oxidase- and catalase tests, as well as by morphological examination of cells by Gram-staining.
[0173] There were no isolated H. pylori from tissue of animals inoculated intragastrically with PBS and with salts of alpha-ketoglutaric acid (Group II A in FIG. 1 ), or with PBS (Group II B in FIG. 1 ).
[0174] From stomach samples of animals inoculated with H. pylori and then following with salts of alpha-ketoglutaric acid (Group I A in FIG. 1 ) or PBS (Group I B in FIG. 1 ) bacteria were isolated between the 5 th and 10 th day of incubation. The number of colonies (mean±SD) isolated from the antral part of the gastric mucosa from the mice exclusively infected with H. pylori was 7.8×10 2 ±5.0×10 1 whereas after intragastric treatment of mice with salts of alpha-ketoglutaric acid, according to the protocol presented—the number of colonies (mean±SD) isolated was 3.8×10 2 ±5.0×10 1 ( FIG. 3 ). Nine times, during 9 consecutive days, intragastric induction of salts of alpha-ketoglutaric acid, which has been started after 14 days interval from the last infective dose of H. pylori bacteria for mouse, caused the reduction by 49% of a degree of gastric mucosa colonisation by H. pylori . It is interpreted as inhibitory action of salts of alpha-ketoglutaric acid on colonisation stage of stomach by H. pylori.
[0175] From the blood samples taken from the mice neither H. pylori nor any other bacteria were isolated.
[0176] Results obtained are presented below in Table 1.
[0000]
TABLE 1
H. pylori bacteria isolated from homogenates of
stomach mucosa of mice non-infected and infected
with H. pylori with or without the following inoculation
with the salts of alpha-ketoglutaric acid
H. pylori cultivated**
Number of mice
Number of bacteria
Inoculates*
infected/in group
(cfu)/mouse
H. pylori + PBS (Group I B)
7/7
7.8 × 10 2 ± 5.0 × 10 1
PBS (Group II B)
0/7
0
H. pylori + AKG (Group I A)
7/7
3.8 × 10 2 ± 5.0 × 10 1
PBS + AKG (Group II A)
0/7
0
*according to the scheme of FIG. 1.
**bacteria were cultivated on GAB-CAMP solid plates.
Animals exclusively infected with H. pylori ( H. pylori +PBS), infected with H. pylori with following inoculation of salts of alpha-ketoglutaric acid ( H. pylori +AKG) and control groups non infected animals, inoculated only with PBS or with PBS and salts of alpha-ketoglutaric acid (PBS+AKG).
Example 2
[0178] Laboratory experimental animals: forty eight, 6 weeks old BALB/cA (female) mice weighing 25±2 g ( FIG. 2 ). Twenty four mice ( FIG. 2 ) from group III B and III were challenged intragastrically 3 times with one day intervals with 0.2 ml suspension of H. pylori cells, strain 119/95 at the concentration 10 9 cfu/ml. Eight days after the last challenge, sixteen mice were inoculated intragastrically through the tube for three successive days with 0.2 ml of 30 mM solution of salts of alpha-ketoglutaric acid (group III B). The remaining eight mice were sham-treated with 0.2 ml of 0.01 M PBS (group III) according to the procedure with group III.
[0179] The remaining twenty four mice ( FIG. 2 ) were inoculated intragastrically 3 times with one day intervals with 0.2 ml 0.01 M PBS. Eight days after above treatment sixteen mice were inoculated with the tube for three consecutive days with salts of alpha-glutaric acid (0.2 ml, concentration 30 mM) (group IV B). The remaining eight mice were treated with 0.2 ml 0.01 M PBS (group IV).
[0180] On the 20 th day of the experiment all mice were sacrificed using CO 2 . Stomach and blood were samples were collected for the further studies.
[0181] In FIG. 2 the following abbreviations were used. Mice from experimental groups (n=76) were inoculated intragastrically with following preparations: suspension of H. pylori cells: #; solution of salts of alpha-ketoglutaric acid: ♦; solution of PBS: . The name of the strain, concentration and volume of inoculum ( H. pylori ) and concentrations and doses of: salts of alpha-ketoglutaric acid and PBS corresponding to the above text. Bold letters determined as the S letter indicate autopsy days. Autopsies were carried out in accordance with common principles.
[0182] From samples collected, as it is demonstrated in example 1, H. pylori bacteria were cultivated on GAB-CAMP agar plates. DNA was also isolated to perform PCR with primers (5′-CTATGACGGGTATCCGGC-3′ and 5′-CTCACGACACGAGCTGAC-3′) recognizing 16S rDNA fragment in DNA of bacteria from Helicobacter genus. Afterwards PCR products in size 470 by were separated according to denaturating gradient gel electrophoresis technique (DGGE) and sequenced. DGGE analysis was performed in 9%, polyacrylamide gel (acrylamide/bisacrylamide solution in rate 37.5:1). Electrophoresis run at a temp of 60° C. in 125 V during 16 h.
[0183] Results obtained are presented below in Table 2.
[0000]
TABLE 2
Bacteria of Helicobacter genus, including H. pylori , in homogenates of
stomach mucosa (antral part) from mice infected with H. pylori with or
without following inoculation of salts of alpha-ketoglutaric acid
H. pylori cultivated
16S rDNA PCR - Helicobacter genus
Number of
Number of mice
Number of mice
bacteria
with H. pylori
with DNA other
Inoculates*
infected/in group
(cfu)/mouse
DNA/in group
then H. pylori /in group
H. pylori + PBS
8/8
4.3 × 10 2 ±
8/8
2/8
(Group III)
5.0 × 10 1
H. pylori + AKG
0/16
0
0/16
5/16
(Group III B)
PBS + AKG
0/16
0
0/16
3/16
(Group IV B)
PBS
0/8
0
0/8
0/8
(Group IV)
*according to the scheme on FIG. 2.
Animals exclusively infected with H. pylori ( H. pylori +PBS), infected with H. pylori with following inoculation of salts of alpha-ketoglutaric acid ( H. pylori +AKG) and control groups of non infected animals, inoculated only with PBS or with PBS and salts of alpha-ketoglutaric acid (PBS+AKG).
[0185] H. pylori was isolated from 8 stomach samples of 8 mice infected with H. pylori +PBS (Group III in FIG. 2 ) (Table 2). In DNA isolated from the same stomach samples 16S rDNA H. pylori specific fragment was identified employing PCR.
[0186] From stomach samples obtained from 16 mice infected with H. pylori and treated with salts of alpha-ketoglutaric acid (Group III B in FIG. 2 ) either H. pylori culture or sequences specific for H. pylori in PCR products was not found (Table 2).
[0187] No H. pylori rods were cultured from blood samples taken from these animals. With selected primers, DNA isolated from blood and from stomach of 8 mice challenged with PBS (Group IV in FIG. 2 ) did not amplify.
[0188] In the enclosed figure FIG. 3 mobility of PCR products typical for 16S rDNA fragment of bacteria from Helicobacter genus in a field of electrical current evaluated with DGGE technique was illustrated. A: H. muridorum , B: H. bilis , C: H. pullorum , D: H. pylori , E: Helicobacter spp. flexispira taxon 8 “ F. rappini ”, F: H. hepaticus , G: H. bizzozeronii served as markers. Arrow indicates DNA of H. bilis . Letters from 1 to 8 estimate paths migrating PCR products from present example 2.
[0189] In 16 PCR products extracted from the antral part of the stomach of mice infected with H. pylori and afterwards treated or not treated with salts of alpha-ketoglutaric acid or from mice not infected, 19 DNA fragments of 470 by in size were detected. Results are shown in FIG. 3 and in Table 3 below. Sequencing of DNA segments (n=19) found in these 16 DNA fragments (separated before with DGGE) corresponded to H. pylori (n=8), as well to H. rodentium (n=4), H. bilis (n=3) and H. hepaticus (n=4) ( FIG. 3 ).
[0000]
TABLE 3
Sequencing of PCR products obtained after amplification of
homogenates of stomach mucosa scraps (antral part)
PCR
Inoculates*
products
Helicobacter spp.
H. pylori + PBS
1.
H. pylori
(Group III)
2.
H. pylori
3.
H. pylori
4.
H. pylori
5.
H. pylori , H. bilis
6.
H. pylori
7.
H. pylori , H. bilis
8.
H. pylori
H. pylori + AKG
1.
H. rodentium , H. bilis
(Group III B)
2.
H. hepaticus
3.
H. rodentium
4.
H. hepaticus
5.
H. rodentium
PBS + AKG
1.
H. hepaticus
(Group IV B)
2.
H. hepaticus
3.
H. rodentium
*according to the scheme in FIG. 2.
Animals exclusively infected with H. pylori ( H. pylori +PBS), infected with H. pylori with following inoculation of salts of alpha-glutaric acid ( H. pylori +AKG) and non infected, inoculated with salts of alpha-glutaric acid (PBS+AKG).
[0191] As it follows from above Table 3. DNA of two Helicobacter species: H. pylori and H. bilis as well as H. rodentium and H. bilis were detected in 3 different mice. In stomach samples of 2 mice from group III ( H. pylori +PBS) H. pylori and H. bilis was found. In stomach samples of mouse from group III B ( H. pylori +salts of alpha-ketoglutaric acid) H. rodentium i H. bilis was detected (Table 3). Afterwards DNA of H. hepaticus was identified in 4 animals, two mice form group III B ( H. pylori +salts of alpha-ketoglutaric acid), and in two mice inoculated with PBS+salts of alpha-ketoglutaric acid (Group IV B) (Table 3).
[0192] DNA of H. bilis did not appear separately in any PCR products, whereas DNA of H. rodentium was present in 3 samples without sequences accompanying, and in one sample together with DNA of H. bilis ( FIG. 3 . Table 3).
[0193] In summary, number of colonies (mean±SD) isolated from the antral part of the stomach mucosa of mice infected exclusively with H. pylori (Group III) was 4.3×10 2 ±5.0×10 1 whereas after additional intragastric treatment of mice with salts of alpha-ketoglutaric acid (Group III B) no H. pylori colony was cultured (Table 2). Three times, during 3 consecutive days, intragastric induction of salts of alpha-ketoglutaric acid, which has been started after 8 days interval from the last infective dose of H. pylori bacteria for the mouse, caused total inhibitory effect on bacterial colonisation and fully eradication of H. pylori bacteria from gastric mucosa.
[0194] Moreover, during the time of experiment the composition of stomach urolytic microbiota has been changed and in mice infected H. pylori (Group III) DNA of H. bilis was identified as well, whereas in mice, following inoculation with salts of alpha-ketoglutaric acid (Group III B) DNA of H. rodentium, H. bilis, H. hepaticus exclusively was found and in control mice treated with salts of alpha-ketoglutaric acid (Group IV B) DNA of H. hepaticus and H. rodentium was identified.
Example 3
[0195] Aqueous solutions of calcium and sodium salt of alpha-ketoglutaric acid in admixture or separately were prepared and used as an additive for diary products and beverages.
[0000]
Salt of alpha-ketoglutaric acid
0.001 g-0.2 g
Glucose
20 g
Water
up to 100 g
[0196] Therapeutically and/or prophylactically effective amount is from 0.001 g up to 0.2 g/kg body weight in one day dose.
[0197] Using model animals (mice) and with the participation of volunteers it has been demonstrated that the intragastrical or oral administration of sodium and/or calcium alpha-ketoglutarate in the form of an aqueous solution, a prophylactic activity, alleviation of an infection course and also diminishing of colonisation of gastrointestinal tract by H. pylori are achieved.
Example 4
[0198] In the period between September and November 10 persons (6 men, 4 women aged 45 to 60, weighing 60-95 kg) with H. pylori infection confirmed by means of microbiological methods (endoscopy), experiencing acute symptoms in the gut intestinal tract at this time of year were voluntarily taking calcium salt of alpha-ketoglutaric acid (2 g) combined with a milk drink every day at breakfast. After a two-week treatment period, symptoms of pyrosis and other features of dyspepsia disappeared in selected volunteers. Lack of dyspepsia symptoms was still maintained for one month after the end of AKG administration.
[0199] The presented examples illustrate, how ureolytic bacteria—in this case H. pylori —compete against host organism cells for access to substrate, i.e. urea. Intragastric introduction of salts of alpha-ketoglutaric acid facilitated the use of urea decomposed to ammonia by ureolytic bacteria for the needs of macroorganism, i.e. in synthesis of glutamate with alpha-ketoglutarate as one of the agents. In spite of the activity of bacterial urease, the acidic pH of the gastric environment was maintained preventing formation of a micro-niche for H. pylori . Thus, the colonisation of mucous membrane of macroorganisms by ureolytic bacteria was hindered and stopped. Use of alpha-ketoglutarate also prevents infections caused by ureolytic bacteria.
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The invention relates to a new use of alpha-ketoglutarate for manufacturing of medical preparation for prophylaxis or treatment of undesired medical conditions associated with the presence and/or activity of ureolytic bacteria in living organisms, except plants, including a human being, pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod, whereas the undesired medical conditions is a condition associated with the presence and/or activity in the gastrointestinal tract, respiratory and/or urogenital system of ureolytic bacteria from the group including Helicobacter pylori, bacterial strains from the Brucella genus, urease-positive bacteria such as Ureaplasma ureolyticum and other alkalophilic bacteria, such as for instance Bacillus pasteurii, urease-producing Yersinia enterocolica rods, ureolytic bacteria that participate in the formation of biofilm and mineralisation of deposits on catheters and other medical equipment, ureolytic bacteria causing infections of the mucous membrane in the oral cavity, gingival diseases, dental caries, causing formation of tartar, ureolytic bacteria responsible for formation of infectious stones in course of urinary system infections of the genii: Proteus, Ureaplasma, Klebsiella, Pseudomonas, Staphylococcus, Providencia, Corynebacterium, in particular P. Mirabilis, and mycoplasmas causing genital tract--in particular its lower part infections, Mycoplasma hominis and U. Urealyticum. The invention also covers new medical preparations, dietary supplements, special medicated food and food/feed additives containing alpha-ketoglutarate, useful in prophylaxis and inhibition of colonisation of living organisms, except plants, including a human being, pet and farm animal, such as mammal, bird, amphibian, fish, molluse or arthropod, by harmful ureolytic bacteria, in particular organisms of human beings and domestic animals by H. Pylori. Moreover, according to the invention alpha-ketoglutarate is used as an active ingredient in methods of prophylaxis and treatment of the a.m. Diseases and conditions associated with ureolytic bacteria, as well as in a process for the manufacture of organic biofuel, based on the conversion of biomass comprising of lignin and cellulose by means of bacterial enzymes, wherein the enzymes produced by hindgut ureolytic microbiota of wood-feeing higher termites are used in presence of alpha-ketoglutarate.
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CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Application Ser. No. 61/106,548, filed Oct. 17, 2008, the contents of which are incorporated by reference herein.
BACKGROUND
[0002] Various embodiments of the present invention are directed to a toy, in particular, a toy that stimulates the senses of a user. Games and toys that involve launching objects into the air or at a target are perennially popular games with all users, be they a child or an adult. Both children and adults also enjoy toys that stimulate other senses and have changing visual appearances and/or sound effects. Typical toy projectile launchers utilize foam darts or disks that are expelled from the launcher by any number of mechanisms. Other popular toys are housed in facsimiles of real objects. These might include, ships or planes or other police or military inspired objects. Such games are sometimes capable of launching or throwing objects or projectiles.
[0003] Accordingly, it is desirable to provide a toy that utilizes a projectile launcher while stimulating the senses of the user.
SUMMARY OF THE INVENTION
[0004] According to one aspect of the invention a toy vehicle having a main vehicle body portion and a display device rotatably mounted to the main body portion is provided. The display device is configured to create a plurality of images via a persistence of vision effect. A mechanism is also present for rotating the display device. An actuator is included and is attached to a sensor for determining when the actuator is depressed. A controller is in operable communication with the sensor and the display device; the controller changes the appearance of at least one of the plurality of images when the sensor determines the actuator has been depressed.
[0005] According to another aspect of the invention, an amusement device is provided. It comprises a main body portion having a projectile launcher and a display device rotatably mounted to the main body portion, the display device being configured to create a plurality of images via a persistence of vision effect. The amusement device includes a mechanism for rotating the display device, an actuator and a sensor for determining when the actuator is depressed. A controller is in operable communication with the sensor and the display device. The controller changes the appearance of at least one of the plurality of images when the sensor determines the actuator has been depressed.
[0006] These and other advantages and features will become more apparent from the following description taken in conjunction with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The subject matter which is regarded as the invention is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other features, and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which:
[0008] FIGS. 1A-1D show multiple illustrations of an amusement device in accordance with the invention;
[0009] FIG. 2 is a side view of the invention;
[0010] FIG. 3 is a front view of the invention;
[0011] FIG. 4 is a rear view of the invention;
[0012] FIG. 5 is a top view of the invention;
[0013] FIG. 6 is a top view of one aspect of the invention;
[0014] FIG. 7 is a view taken along section A-A of FIG. 3 ;
[0015] FIGS. 8 and 9 are side views of one aspect of the invention;
[0016] FIGS. 10 , 11 and 12 are side, top and front views of another element of the invention;
[0017] FIGS. 13A and 13B are top and side views, respectively, of one aspect of the invention;
[0018] FIGS. 14A and 14B are top and side views, respectively, of another aspect of the invention; and
[0019] FIG. 15 is a schematic illustration of yet another aspect of the invention.
DETAILED DESCRIPTION
[0020] Referring now to FIGS. 1A-1D , where the invention will be described with reference to specific embodiments, without limiting same, an amusement toy in the shape of a miniature helicopter 10 is shown. As seen in FIGS. 1A-1D , helicopter 10 includes a main body portion 11 and a display device 12 mounted to the main body portion 11 , rotational display system or display device 12 being included on individual rotors 14 and 15 of a propeller 16 . Miniature helicopter 10 includes a compartment 21 in the main fuselage 22 to house an action FIG. 23 , compartment 21 being accessed through helicopter windscreen 25 , which is pivotably mounted to main fuselage 22 .
[0021] Helicopter 10 is capable of firing in the exemplary embodiment shown, foam disc projectiles 24 from a firing portion 26 that is below fuselage 22 in main body portion 11 . It is of course, understood that the projectiles 24 may be configured to have any shape suitable for firing and the projectiles may be formed from any suitable material such as plastic, foam, etc and equivalents thereof. Helicopter 10 is held at a pistol grip 31 having a trigger 32 at a tail end 33 of main body portion 11 . In the embodiment shown, depressing trigger 32 activates both propeller 16 and firing portion 26 to launch projectiles 24 . It will be appreciated that a separate motor 222 can also drive propeller 16 . Individual rotors 14 and 15 include an electric LED display 201 , which will be described in detail herein.
[0022] Referring now to FIGS. 2 through 7 , where like numerals will be used for like elements, an alternative embodiment of helicopter 110 is shown. Main body portion 11 of helicopter 110 includes a landing gear 141 that is pivotably connected to main fuselage 22 at a pivot point 142 . Landing gear 141 includes a resting surface 143 and an upturned tip 144 to form a ski shaped surface when miniature helicopter 110 is in a display position. When it is desired to use miniature helicopter 110 , landing gear 141 as shown in FIG. 8 to a rotated position, as shown in FIG. 9 . Landing gear 141 is locked into the rotated position of FIG. 9 in order to form a support handle. FIGS. 10 , 11 and 12 include additional features of landing gear 141 . It will be appreciated that landing gear 141 may take any one of a number shapes and may include a trigger to activate or launch projectiles 24 .
[0023] Referring now specifically to FIGS. 3 and 7 details of firing portion 26 are shown. Projectiles 24 are generally launched forward from firing portion 26 above landing gear 142 . Projectiles 24 are loaded and kept in a firing position via a spring biased detent 39 , shown in FIG. 7 .
[0024] Referring now to FIGS. 13A-13B , 14 A- 14 B and 15 , an electric LED system 201 is fixed to display device 12 . The display device 12 is capable of creating a plurality of images 210 or 211 or any number of variants via a persistence of vision effect. The effect is created by a rotating display device 12 , in this instance propeller 16 of miniature helicopter 10 . LED electric elements 214 are intermittently illuminated while located on individual rotors 14 and 15 of propeller 16 . The rotation of the display device 12 , combined with rapidly changing illuminated segments on rotors 14 and 15 produces a series of flashing frames that blend together to form a recognizable image, as seen by the human eye, or series of animated images 210 , 211 that may move around the display area. Devices that utilize persistence of vision technology receive electronic information about an image to be displayed and the information is used to synchronize the illumination of individual illuminating elements 214 at specific positions during rotation of the assembly or device 12 .
[0025] As shown in FIGS. 13 and 14 , propeller 16 is rotated with the plurality of LEDs 214 disposed on the individual rotors 14 and 15 . As the propeller 16 rotates, the blur perceived by the eye makes the propeller appear to be a flat, virtual circle 216 , as seen in FIGS. 13 and 14 . This virtual circle 216 formed by the rotating propeller 16 forms visual images 210 and 211 , when brightness and timing of the LEDs 214 on sections of rotors 14 and 15 are properly synchronized.
[0026] As best seen in FIG. 15 , in order to provide a rotational force to the rotational display system and in order to provide visual images, a motor 222 is provided. Motor 222 is contained within main body portion 11 or at the base of rotating display device 12 to supply the rotational force to the display device 12 .
[0027] In the exemplary embodiment shown, the display device comprises a flexible circuit 224 with a plurality of electric LED illuminating devices 214 coupled to a power supply 227 . A controller or microcontroller 228 is in operable communication with the sensor and the plurality of illuminating devices 214 . This creates a plurality of images 210 and 211 as the rotors 14 and 15 are rotated, by microcontroller 228 selectively illuminating a plurality of illuminating devices 214 disposed on the display device 12 . The power supply 227 also provides the necessary power to motor 222 and any of the other devices requiring power, including microcontrollers 228 , a sound system 232 , illuminating devices 214 or other device add-ons.
[0028] As used herein, the term “controller” or “microcontroller” refers to an application specific integrated circuit (ASIC), electronic circuit, a processor (shared, dedicated, or group) and memory that executes one or more software or firmware programs/algorithms, a combinational logic circuit, and/or other suitable components that provide the described functionality.
[0029] For all general purposes, the term “signal” as used herein is defined as any electrical signal or any stored or transmitted value. For example, a signal can comprise a voltage, or a current. Further, a signal can comprise any stored or transmitted value such as binary values, scalar, values, or the like.
[0030] As further illustrated, display device 12 also comprises a sound system 232 for playing a plurality of sound effects through a speaker 239 . In the embodiment shown, each of the plurality of sound effects correspond to at least one of the plurality of images 210 , 211 . For example, the sound effects may simulate that of a missile launched from helicopter 10 . The sound system is controlled by the microcontroller 228 .
[0031] In one exemplary embodiment, a sensor 221 is positioned to detect the presence of a source 223 secured to helicopter 10 . Sensor 221 senses a rotational speed of the device and provides a digital or analog signal as the source 223 is sensed by the sensor 221 . Controller 228 receives the signal or frequency of sensor 226 Controller 228 then determines and/or regulates a rotational speed of the display device 12 . In the non-limiting embodiment of FIG. 15 , the sensor 221 is a hall effect sensor and source 223 is a magnet. The digital or analog signal is activated, engaged or triggered by magnet 223 and the signal or frequency thereof is used to determine and/or regulate a rotational speed of the display device 12 . Alternatively, other equivalent sensing devices are contemplated, including optical sensors, inductive sensors, etc.
[0032] As further shown in FIG. 15 , controller 228 also receives signals from a second hall effect sensor 221 a , which is positioned to detect the presence of magnet 223 a fixedly mounted to the structure, in order to determine the rotational speed of the display system 12 and for purposes of illuminating the light devices 214 in sequence to provide the desired visual effect.
[0033] In accordance with known principles, the hall effect sensor 221 a will provide a digital or analog signal to the microcontroller 228 as the magnet 223 a is detected by the sensor 221 a in a full rotation. An algorithm contained within the controller 228 is adapted to determine the rotational speed of the display device 12 . Thus, the sequence of the illuminating devices 214 can be operated (e.g., turned off and on) to provide the desired visual effect. Of course, any non-hall effect sensor or device capable of registering equivalent positional feedback and any light source, including the LEDs illustrated, is considered to be within the scope of embodiments of this invention.
[0034] In another embodiment, the helicopter 10 may further comprise a second controller 250 . Controller 250 is in operable communication with the first microcontroller 228 via a transmitter 252 and a receiver 254 to provide signals to the display device 12 which, in the embodiment illustrated, instructs display device 12 to provide certain images in accordance with the invention.
[0035] A sensor 221 detects source 223 and provides a signal to the second microcontroller 250 , which detects the rotational speed of the display device 12 by counting sensor input pulses compared to an internal timer of micro controller 250 . Sensor 221 a on the display device 12 detects source 223 a and provides a signal to the first microcontroller 228 , which detects the sensor input and uses it as a position reference to begin outputting image data to the LEDs 214 to create a correctly timed display.
[0036] The sound system 232 is also operated by signals received from the second microcontroller 250 . The images displayed by the rotational display system 12 are controlled by the first microcontroller 228 in response to the signals received from the receiver 254 . In other words, the microcontroller 228 of the display device 12 illuminates the light in illuminating devices 214 in response to the rotational speed to provide images via a persistence of vision effect. At about the same time, the second microcontroller 250 provides signals to the controller 228 indicating what images controller 228 is to provide to display device 12 . In accordance with another aspect of this embodiment, transmitter 252 and receiver 254 are infrared (IR) devices. Of course, other equivalent transmitting devices are considered to be within the scope of the present invention.
[0037] With further reference to FIG. 15 , a sensor or microswitch 270 is positioned to be actuated by depressing the trigger 32 , thereby providing a signal indicative of the movement of trigger 32 and when projectiles 24 have been launched. As shown, schematically in FIG. 15 , sensor 270 and the movement of trigger 32 are coupled to microcontroller 250 which is adapted to provide a signal indicative of when, and in what direction, the projectiles 24 are being launched. Furthermore, controller 250 will have information pertaining to the location of the target image via operational protocols resident upon the controller 250 . This information is transmitted to microcontroller 228 via transmitter 252 and receiver 254 or any other equivalent device. Accordingly, an image is displayed on display device 12 which is indicia of projectile 24 , as seen in image 210 , can correspond to the direction of projectile 24 , as seen in images 210 and 211 or can simply indicate the direction of projectile 24 , with any indicia, as seen in image 211 all created by the persistence of vision effect.
[0038] While the invention has been described in detail in connection with only a limited number of embodiments, it should be readily understood that the invention is not limited to such disclosed embodiments. Rather, the invention can be modified to incorporate any number of variations, alterations, substitutions or equivalent arrangements not heretofore described but which are commensurate with the spirit and scope of the invention. Additionally, while various embodiments of the invention have been described, it is to be understood that aspects of the invention may include only some of the described embodiments. Accordingly, the invention is not to be seen as limited by the foregoing description.
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A toy vehicle is disclosed. It has a main vehicle body portion and a display device rotatably mounted to the main body portion, the display device being configured to create a plurality of images via a persistence of vision effect. A mechanism is also present for rotating said display device. An actuator is included and is attached to a sensor for determining when the actuator is depressed. A microcontroller is in operable communication with the sensor and the display device; the microcontroller changing the appearance of at least one of the plurality of images when the sensor determines the actuator has been depressed.
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REFERENCE TO RELATED APPLICATIONS
The present application is the national stage under 35 U.S.C. 371 of international application PCT/IL99/00673, filed Dec. 9, 1999 which designated the United States, and which international application was published under PCT Article 21(2) in the English language.
FIELD OF THE INVENTION
The present invention concerns palladium-substituted bacteriochlorophyll derivatives, processes and intermediates for their preparation and pharmaceutical compositions comprising the same as well as their use in the field of in vivo photodynamic therapy and diagnosis and in vitro photodynamic killing of viruses and microorganisms.
DEFINITIONS AND ABBREVIATIONS
BChl=bacteriochlorophyll a (Mg-containing 7,8,17,18-tetrahydroporphyrin having a phytyl or geranylgeranyl group at position 17 3 , a COOCH 3 group at position 13 2 , an H atom at position 13 2 , an acetyl group at position 3 and an ethyl group at position 8).
BChlide=bacteriochlorophyllide a (the C-17 2 -free carboxylic acid derived from BChl a).
BPhe=bacteriopheophytin a (BChl in which the central Mg atom is replaced by two H atoms).
BPheid=bacteriopheophorbide a (the C-17 2 -free carboxylic acid derived from BPhe).
Pd-BPheid=Pd-bacteriopheophorbide a (the C-17 2 -free carboxylic acid derived from BPhe having a central Pd atom, a COOCH 3 group at position 13 2 , an H atom at position 13 2 , an acetyl group at position 3 and an ethyl group at position 8).
IUPAC numbering of the bacteriochlorophyll derivatives is used throughout the specification. Using this nomenclature, the natural bacteriochlorophylls carry two carboxylic acid esters at positions 13 2 and 17 2 , however they are esterifed at positions 13 3 and 17 3 .
BACKGROUND OF THE INVENTION
There has been an increasing interest in the utilization of photosensitizers for cancer therapy. According to this technique, known as photodynamic therapy (PDT), photosensitizers are applied for example to a tumor and the in situ photosentization produces compounds which intoxicate the malignant cells.
Photodynamic therapy using porphyrins and related compounds has, by now, a fairly long history. Early work, in the 1940s, demonstrated that porphyrin could be caused to fluoresce in irradiated tumor tissue. The porphyrins appeared to accumulate in these tissues, and were capable of absorbing light in situ, providing a means to detect the tumor by the location of the fluorescence. A widely used preparation in the early stages of photodynamic treatment both for detection and for therapy was a crude derivative of hematoporphyrin, also called hematoporphyrin derivative, HpD, or Lipson derivative prepared as described by Lipson and coworkers in J Natl Cancer Inst (1961) 26:1-8. Considerable work has been done using this preparation, and Dougherty and coworkers reported the use of this derivative in treatment of malignancy ( Cancer Res (1978) 38:2628-2635; J Natl Cancer Inst (1979) 62:231-237).
Dougherty and coworkers prepared a more effective form of the hematoporphyrin derivative which comprises a portion of HpD having an aggregate weight>10 kd. This form of the drug useful in photodynamic therapy is the subject of U.S. Pat. No. 4,649,151, is commercially available, and is in clinical trials.
The general principles of the use of light-absorbing compounds, especially those related to porphyrins, has been well established as a treatment for tumors when administered systematically. The differential ability of these preparations to destroy tumor, as opposed to normal tissue, is due to the homing effect of these preparations to the objectionable cells. (See, for example, Dougherty, T. J., et al., “Cancer: Principles and Practice of Oncology” (1982), V. T. de Vita, Jr., et al., eds. pp 1836-1844.). Efforts have been made to improve the homing ability by conjugating hematoporphyrin derivative to antibodies. (See, for example, Mew, D., et al., J Immunol .(1983) 130:1473-1477.). The mechanism of these drugs in killing cells seems to involve the formation of singlet oxygen upon irradiation (Weishaupt, K. R., et al., Cancer Research (1976) pp. 2326-2329).
The use of hematoporphyrin derivative or its active components in the treatment of skin diseases using topical administration has also been described in U.S. Pat. No. 4,753,958. In addition, the drugs have been used to sterilize biological samples containing infectious organisms such as bacteria and virus (Matthews, J. L., et al., Transfusion (1988): 81-83). Various other photosensitizing compounds have also been used for this purpose, as set forth, for example, in U.S. Pat. No. 4,727,027.
In general, the methods to use radiation sensitizers of a variety of structures to selectively impair the functioning of biological substrates both in vivo and in vitro are understood in the art. The compounds useful in these procedures must have a differential affinity for the target biological substrate to be impaired or destroyed and must be capable of absorbing light so that the irradiated drug becomes activated in a manner so as to have a deleterious effect on the adjacent compositions and materials.
Because it is always desirable to optimize the performance of therapeutics and diagnostics, variations on the porphyrin drugs traditionally used in treatment and diagnosis have been sought. A number of general classes of photosensitizers have been suggested including phthalocyanines, psoralen-related compounds, and multicyclic compounds with resonant systems in general. Most similar to the compounds disclosed herein are various pheophorbide derivatives whose use in photodynamic therapy has been described in EPO Application 220686 to Nihon Metaphysics Company; ethylene diamine derivatives of pheophorbide for this purpose described in Japanese Application J85/000981 to Tama Seikayaku, K.K., and Japanese Application J88/004805 which is directed to 10-Hydroxypheophorbide-a. In addition, Beems, E. M., et al., in Photochemistry and Photobiology (1987) 46:639-643 disclose the use as photosensitizers of two derivatives of bacteriochlorophyll-a—bacteriochlorophyllin-a (also known as bacteriopheophorbide-a, which lacks the phytyl alcohol derivatized in bacteriochlorophyll-a) and bacteriochlorin-a (which lacks both the phytyl group and the Mg ion). These authors direct their attention to these derivatives as being advantageous on the grounds of enhanced water solubility as compared to bacteriochlorophyll-a.
EP 584552 and WO97/19081, both to Yeda Research and Development Co. Ltd., describe chlorophyll and bacteriochlorophyll derivatives and their use as PDT agents, and metaled bacteriochrophylls and their preparation by transmetalation of the corresponding Cd-BChl derivatives, respectively.
The problem remains to find suitable photosensitizers useful in photodynamic therapy and diagnosis which are optimal for particular targets and particular contexts. Thus, the invention provides an additional group of photosensitizing compounds which becomes part of the repertoire of candidates for use in specific therapeutic and diagnostic situations.
SUMMARY OF THE INVENTION
It has now been found, in accordance with the present invention, that the compounds of formula I, I′ or I″ below wherein A as defined below represents a substituent capable of allowing an efficient plasma transfer and cell membrane penetration, are useful as PDT agents and present the advantages of enhanced solubility, stability and/or efficiency, compared with the known compounds.
The invention thus concerns the compounds of formula I, I′, or I″
wherein
A represents
OH,
OR 1 ,
—O—(CH 2 ) n —Y,
—S—(CH 2 ) n —Y,
—NH—(CH 2 ) n —Y,
—O—(CH 2 ) 2 —OH,
—NH—(CH 2 ) n — + No,X − ,
—NH—(CH 2 ) 2 —NH—BOC or
—N—(CH 2 —CH═CH 2 ) 2
wherein
R 1 represents
Na + , K + , (Ca 2+ ) 0.5 , (Mg 2+ ) 0.5 , Li + , NH 4 +
+ NH 3 —C(CH 2 OH) 3 , + NH 3 —CH 2 —(CHOH) 4 —CH 2 OH,
+ NH 2 (CH 3 )—CH 2 —(CHOH) 4 —CH 2 OH or
+ N(C n′ H 2n′+1 ) 4 ;
R 2 represents H, OH or COOR 4 , wherein R 4 is C 1 -C 12 alkyl or C 3 -C 12 cycloalkyl;
R 3 represents H, OH or C 1 -C 12 alkyl or alkoxy;
n is 1, 2, 3, 4, 5 or 6,
Y is —NR′ 1 R′ 2 or — + NR′ 1 R′ 2 R′ 3 , X − wherein R′ 1 , R′ 2 and R′ 3 independently from each other represent —CH 3 or —C 2 H 5 ;
X is F, Cl, Br or I,
n′ is 1, 2, 3 or 4,
and wherein * denotes an asymmetric carbon and — — — represents a single saturated bond or a double unsaturated bond.
Furthermore, the present invention concerns processes for the preparation of the above new compounds.
Thus, in one aspect, it is herein described a method to effect the impairment or destruction of a target biological substrate which method comprises treating the target substrate with an amount of the compound of formula I, I′ or I″ effective to photosensitize said substrate followed by irradiating said target substrate with radiation in a wavelength band absorbed by the compound of formula I, I′ or I″ for a time effective to impair or destroy the substrate.
In other aspect, the invention is therefore directed to pharmaceutical compositions comprising at least a compound of formula I, I′ or I″ as an active agent, together with a pharmaceutically acceptable carrier. The compositions are useful for in vivo photodynamic therapy and diagnosis of tumors and for killing of cells, viruses and bacteria, parasites and fungi in samples and in living tissues by well known photodynamic techniques.
Furthermore, the invention concerns the use of the compounds of formula I, I′ or I″ for the preparation of a pharmaceutical composition useful in photodynamic therapy.
The invention further concerns the use of the invention compounds for the preparation of compositions useful in diagnosis and ex vivo killing of bacteria, parasites, viruses and fungi.
The invention further concerns the acid chloride and anhydride of formulas II and III herebelow, respectively, as intermediates.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 depicts the optical absorption spectrum of Pd-BPheid in a mixture of acetone and methanol/K buffer phosphate.
FIGS. 2 and 3 depict, respectively, low and high resolution mass spectra of Pd-BPheid conducted by Fast Atom Bombardement (FAB-MS).
FIG. 4 shows time-dependent morphological changes of A431 cells with Pd-BPheid or BChl-SerOMe post PDT [In the Figures, Bchl-Ser stands for BChl-SerOMe, the seryl methyl ester of BChl].
FIG. 5 shows phototoxicity of Pd-BPheid and BChl-SerOMe tested on ECV-304 cells.
FIG. 6 shows phototoxicity of Pd-BPheid and Pd-BPheid-ethyl ester on cultured M2R mouse melanoma cells. (A) pigments dissolved in 95% ethanol and further diluted to the indicated concentrations in culture medium+10% serum to 1% ethanol. (B) pigments dissolved directly in culture medium+10% serum.
FIG. 7 shows phototoxicity of Pd-BPheid on cultured M2R mouse melanoma and human H29 colon carcinoma cells.
FIG. 8 shows PDT of M2R mouse melanoma with Pd-BPheid (2.5 mg/Kg) dissolved in Cremophor and diluted in salt solution.
FIG. 9 shows PDT of M2R mouse melanoma with Pd-BPheid (2.5 mg/Kg) dissolved in salt solution and diluted with Cremophor.
FIG. 10 illustrates cure of primary C6 glioma tumors after PDT with Pd-BPheid or Pd-BPheid-SerOMe [In the Figure, Pd-Bchl-Ser].
FIG. 11 shows appearance of C6 glioma metastases in CD1 nude mice after surgery (amputation) or after PDT with Pd-BPheid or Pd-BPheid-SerOMe [In the Figure, Pd-Bchl-Ser].
DETAILED DESCRIPTION OF THE INVENTION
In a preferred embodiment, the compounds of the invention have the following formula with the optical configuration below:
wherein A is as above.
When the dotted lines representing the bond between C7 and C8 and C17 and C18 in the above structure is a saturated single bond, the carbon atoms numbered 7, 8, 17 and 18 are asymmetric carbon atoms. When R 2 or R 3 is H, C13 2 is an asymmetric carbon atom.
In the presence of oxygen or at the ambient air and under light action, the oxidation of the above C7-C8 and C17-C18 bonds may occur, resulting in compounds with double bonds at said positions C7-C8 and C17-C18.
The compounds of formula I′ and I″ of the present invention are oxidized forms of the compounds of formula I and can be obtained by the processes described in Chlorophyll , by Scheer H. (ed.), CRC Press, 1991, pp. 147-209.
In a preferred embodiment of the invention, the compounds are those wherein A is OR 1 .
In a most preferred embodiment, the compound of the invention is Pd-PBheid (also designated herein sometimes Pd-BChl-COOH), the compound of formula I wherein A is OH, having the following structure:
One of the processes for the preparation of the compounds of formula I wherein A is OH, comprises at least the steps of:
a) combined demetalation and hydrolysis of a M-BPheid-17 3 -Z compound wherein Z is phytyl, geranylgeranyl (gg) or SerOMe (seryl O-methyl ester) and M is a metal selected from Mg, Cd, or Zn;
b) incorporation of Pd with a Pd reagent into the compound obtained in (a), thus obtaining a Pd-BPheid, and, if desired,
(c) subsequent reaction of the obtained Pd-BPheid with a corresponding compound of formula A—H, wherein A is other than OH, for forming the corresponding R 1 salt or a compound wherein A is not OH.
In one preferred embodiment, the process is directed to the preparation of Pd-BPheid and bacteriochlorophyll a (Bchla) is demetalated and hydrolyzed in step (a), and the obtained bacteriopheophorbide (BPheid) is reacted with a Pd reagent in step (b) to produce the desired Pd-BPheid.
Another process for the preparation of the compound of formula I comprises at least the steps of:
a) transmetalation of a BChlide-17 3 -Z to obtain the corresponding Pd-BPheid-17 3 -Z wherein Z is phytyl, gg or Ser OMe,
b) hydrolysis of the obtained compound, and
c) optionally subsequent reaction of the obtained Pd-BPheid with a corresponding compound of formula or A—H wherein A is other than OH, for forming the corresponding R 1 salt or a compound wherein A is not OH.
In one preferred embodiment, the process is directed to the preparation of Pd-BPheid and bacteriochlorophyll a (Bchla) is transmetalated in step (a) to replace the native central Mg atom by Pd, and the obtained Pd-BPheid-17 3 -Z wherein Z is phytyl is hydrolized in step (b) to produce the desired Pd-BPheid.
Another process for the preparation of the compound of formula I comprises at least the steps of:
a) enzymatic hydrolysis of a BChlide-17 3 -Z wherein Z is phytyl or geranylgeranyl to obtain a Bchlide;
b) acidic demetalation of said BChlide of (a);
c) incorporation of Pd with a Pd reagent into the demetalated BPheid of (b); and
d) optionally subsequent reaction of the obtained Pd-BPheid with a corresponding compound of formula A—H wherein A is other than OH, for forming the corresponding R 1 salt or a compound wherein A is not OH.
In the above processes for the preparation of compounds of formula I, the Pd reagent may be any convenient reactive compound providing Pd in such structures such as, for instance, Pd acetate and Pd chloride.
The incorporation of Pd in the procedures above can be achieved by a two-step procedure using Na ascorbate or ascorbic acid, or by a one-step procedure using 6-O-palmitoyl-L-ascorbic acid.
The compounds of the invention wherein A is different from OH and OR 1 may be obtained by reaction of the Pd-BPheid (Pd-BChl-COOH) with the corresponding A—H compound.
The compounds of formula II and III above are intermediates for the compounds of formula I of the invention. The acid chlorides of formula II, Pd-BPheid-COCl, may be obtained by using any agent suitable for forming acyl chlorides, such as for example SOCl 2 .
The acid anhydrides of formula III may be obtained by dehydration of the compounds of formula I, I′, I″ with acetic anhydride.
By reaction of these intermediates II and III with the corresponding compound AH, the compounds of formula I, I′ or I″ may be obtained.
The invention further comprises pharmaceutically acceptable salts of the free acids of formulas I, I′ and I″. The salts can be formed by methods well known in the art such as by reaction of the free acid or a salt thereof with inorganic or organic reagents such as, but not limited to, NaOH, KOH, calcium or magnesium suitable salts, LiOH, NH 4 OH, tetraalkylammonium hydroxide, e.g. tetraethylammonium hydroxide, or N-methylglucamine, glucamine and triethanolamine.
The compounds of the invention are for use in photodynamic therapy and diagnosis with respect to target biological substrates. By “target biological substrate” is meant any cells, viruses or tissues which are undesirable in the environment to which therapy or other corrective action, such as sterilization, is employed, or the location of which is desired to be known in an environment to which diagnosis is applied.
According to the present invention, the drug is injected into the subject, and permitted to reach an optimal concentration in the target substrate. Then the target substrate is exposed to radiation at a wavelength appropriate to the absorption spectrum of the compound administered. The effect of the compound can be enhanced by concomitant increase of the target substrate temperature.
For use in the method of the invention, the compounds of the invention are formulated using conventional excipients appropriate for the intended use. For systemic administration, in general, buffered aqueous compositions are employed, with sufficient nontoxic detergent to solubilize the active compound. As the compounds of the invention are generally not very soluble in water, a solubilizing amount of such detergent may be employed. Suitable nontoxic detergents include, but are not limited to, Tween-80, various bile salts, such as sodium glycholate, various bile salt analogs such as the fusidates. Alternate compositions utilize liposome carriers. The solution is buffered at a desirable pH using conventional buffers such as Hank's solution, Ringer's solution, or phosphate buffer. Other components which do not interfere with the activity of the drug may also be included, such as stabilizing amounts of proteins, for example, serum albumin, or low density- or high density-lipoprotein (LDL and HDL, respectively).
Systemic formulations can be administered by injection, such as intravenous (i.v.), intraperitoneal (i.p.), intramuscular, or subcutaneous (s.c.) injection, or can be administered by transmembrane or transdermal techniques. Formulations appropriate for transdermal or transmembrane administration include sprays and suppositories containing penetrants, which can often be the detergents described above.
For topical local administration, the formulation may also contain a penetrant and is in the form of an ointment, salve, liniment, cream, or oil. Suitable formulations for both systemic and localized topical administration are found in Remington's Pharmaceutical Sciences , latest edition, Mack Publishing Co., Easton, Pa.
For use ex vivo to treat, for example, blood or plasma for transfusion or preparations of blood products, no special formulation is necessary, but the compounds of the invention are dissolved in a suitable compatible solvent and mixed into the biological fluid at a suitable concentration, typically of the order of 1-100 μg/ml prior to irradiation.
For photodynamic therapeutic and diagnostic applications, suitable dosage ranges will vary with the mode of application and the choice of the compound, as well as the nature of the condition being treated or diagnosed. However, in general, suitable dosages are of the order of 0,01 to 50 mg/kg body weight, preferably 0,1 to 10 mg/kg. For topical administration, typically amounts on the order of 5-100 mg total are employed.
The general procedures for photodynamic ex vivo treatment are analogous to those described by Matthews, J. L., et al., Transfusion (supra).
Briefly, for systemic administration, a suitable time period after administration, typically from several minutes to two days is allowed to elapse in order to permit optimal concentration of the compounds of the invention in the target biological substrate. In general, this substrate will be a tumor vasculature, tumor cells or any other tumor component, and the localization of the compound can be monitored by measuring the optical absorption of the target tissue as compared to background. After optimization has been accomplished, the target biological substrate is irradiated with a suitable band of irradiation, in the range of 740-800 nm, or 500-600 nm or 700-900 nm at a rate of 5-750 mW/cm 2 , and a total energy of 100-1000 J/cm 2 .
For topical treatment, localization is immediate, and the corresponding radiation can be provided thereafter. For treatment of biological fluids ex vivo, radiation is applied after optimal binding/uptake by the target tissue is reached. The radiation fluence is on the order of 1-10 J/cm 2 . Because penetration of tissue is not required, lower total energy can be employed.
The compositions of the invention comprise at least one compound of formula I, I′ or I″ as defined above together with a physiologically acceptable carrier. These compositions may be in the form of a solution, a lipid emulsion or a gel or in the form of liposomes or nanoparticles. The suitable carrier is chosen to allow optimization of the concentration of the compound of the invention at the target substrate. Examples of such carriers, but not limited to, are “Tween 80”, polyethyleneglycol, e.g. PEG400, “Cremophor EL”, propylene glycol, ethanol, basil oil, bile salts and bile salts analogs and mixtures thereof. Liposome formulations can be based, for example, on dimyristoylphosphatidyl choline or phosphatidyl glycerol. The carrier may also comprise dipalmitoylphosphatidyl choline.
When nanoparticles are used, they may be in the form of PEG-coated poly(lactic acid) nanoparticles. In the form of lipid emulsions, low density lipoproteins and triglycerides are usually used.
In the composition of the invention, the invention compound(s) is (are) in an amount of 0.01 to 20%, preferably 0.05% to 5% by weight of the total weight composition.
The invention will now be illustrated by the following non-limiting examples.
EXAMPLES
Example 1
Preparation of Pd-BPheid
Pd-BPheid was prepared from BChla by the following 3-step procedure.
(a) Isolation of Bacteriochlorophyll a (BChla)
BChla was extracted form lyophilized bacteria Rhodovolum sulfidophilum as follows:
Lyophilized cells (100 gr) were ground to powder, washed 5 times with a total of 1250 ml acetone to partially wash away the carotenoids, the mixture was filtered and BChla was extracted from the solid with absolute methanol (≈1200 ml, 4-5 filtrations). After filtering, the dark blue-green solution was partly evaporated under vacuum, the concentrated solution (≈500 ml) was extracted 2-3 times with petrol ether (b.p. 80-100° C., ≈1300 ml) to further eliminate carotenoids, and the petrol ether phase was extracted twice with methanol (≈550 ml). This phase was then discarded, the combined methanol phase was evaporated under vacuum, and the bluegreen residue was redissolved in methanol-acetone (1:3, v/v) and loaded on a DEAE-Sepharose column (3×10 cm) equilibrated with methanol-acetone (1:3, v/v). The BChla was eluted with methanol-acetone (1:3, v/v), the methanol-acetone mixture was evaporated and the dry Bchla was redissolved in an exact volume (for absorption spectrum) of ether and filtered through coton wool to get rid of dissolved column material. After a final evaporation the solid pigment was stored under Argon in the dark at −20° C. Extraction yield: about 700 mg BChla per 100 g lyophilized cells.
The DEAE-Sepharose column was prepared as previously described (Omata and Murata, 1983, “Preparation of Chlorophyll a, Chlorophyll b and Bacteriochlorophyll a by column chromatography with DEAE-Sepharose C1-6B and Sepharose C1-6B”, Plant Cell Physiol., vol. 24, pp. 1093-1100). Briefly, DEAE-Sepharose was washed with distilled water and then converted to an acetate form by suspending it in a 1M sodium acetate buffer (pH=7). The slurry was washed 3 times with acetone and finally suspended in methanol-acetone (1:3, v:v) for storage at 5° C.
(b) Preparation of Bacteriopheophorbide (BPheid)
Crude Bchla extract as obtained in (a) (about 100 mg Bchla containing some residual carotenoides) was dissolved in 80% aqueous trifluoroacetic acid (about 15 ml) which had been bubbled with nitrogen for 10 min. The solution was stirred at ambient temperature for 2 h. Then the reaction mixture was poured into water (250 ml) and extracted with chloroform. The extract was washed twice with water and dried over anhydrous Na 2 SO 4 . After evaporation of the solvent the residue was chromatographed on Silica (3 cm×15 cm column, Kieselgel 60, Merck) and eluted with methanol in chloroform by step gradient: 2%, 5%, 10%, 15%. At the beginning, carotenoids and a small amount of bacteriopheophytin were washed out, followed by elution of allo-bacteriopheophytin and carotenoids. At 10% methanol in chloroform the product started to be collected and monitored by TLC (Kieselgel, chloroform-methanol, 9:1). The product (60 mg) was evaporated, and the residue taken up in CHCl 3 was filtered through UltraPore membrane to remove residual silica that could otherwise cause oxidations.
(c) Incorporation of Palladium into Bacteriopheophorbide (Bpheid)
BPheid (100 mg) as obtained in (b) and Pd-acetate (80 mg) were dissolved in dichloromethane (≈10 ml) and added to a suspension of 200 mg sodium ascorbate in 50 ml of methanol. The reaction mixture was stirred in a closed flask at room temperature, and samples from the reaction mixture were collected every 15-20 minutes and their optical absorption recorded. After about 4 hours, most of the BPheid absorption at 357 nm was replaced by the Pd-BPheid absorption at 330 and 390 nm.
The reaction mixture was transferred into a chlorofom/water solution (200 ml; 50:50 v/v) and shaken in a separatory funnel. The organic phase was collected, washed with water, dried over anhydrous sodium chloride, and evaporated. The dried material was added to 80 mg of Pd-Acetate and steps above were repeated until the residual absorption at 357 nm completely vanished and the ratio between the absorption at 765 nm (the peak of the red-most transition) and the absorption maximum at 330 nm reached the value of ≈2.4 (in chloroform).
The dried reaction mixture was solubilized in a minimal volume of 2:1 chloroform:acetone and loaded on a CM-Sepharose column (150 mm×25 mm) that had been pre-equilibrated with acetone. The column was first washed with acetone and the eluted first fraction was discarded. The column was then washed with 9:1 acetone:methanol. Two bands became prominent and were washed out—the first was the major product and the second was an allomerized by-product (discarded). The product was concentrated almost to dryness and transferred into a 50:50 chlorophorm:water system in a separatory funnel. The mixture was thoroughly shaken and the organic phase was separated, dried over anhydrous sodium sulfate (or sodium chloride) and evaporated to dryness.
Example 2
Preparation of Pd-BPheid
(a) Isolation of Bchla
This step of the procedure was carried out as in Example 1(a) above.
(b) Preparation of Pd-Bpheid
6-O-palmitoyl-L-ascorbic acid (246 mg, 593 μmol) was dissolved in MeOH (84 ml) and N 2 was passed through the solution. Bpheid (92 mg, 151 μmol) and Pd(CH 3 COO) 2 (83 mg, 370 μmol) were dissolved in CHCl 3 (34 ml, degassed with N 2 ) and added to the methanolic solution. The mixture was kept under inert atmosphere by stirring and the reaction progress was monitored by recording the absorption spectra of small reaction portions every few minutes. After ˜30 min. the reaction was completed and the solvents were evaporated.
(c) Purification of Pd-Bpheid
The crude Pd-BPheid was dissolved in CHCl 3 and loaded on a column packed with 15 g of 0.4%-Silica-Asc. Small volume of CHCl 3 (˜30 m)l was passed through the column and than the pigment was eluted using MeOH:CHCl 3 (1:99, ˜250 ml). Purity of the fractions was determined by TLC and optical absorption spectroscopy. Mass Spectroscopy and NMR detection were performed on representative samples. Yield: 82.5 mg of pure Pd-BPheid (76%).
For the preparation of the 0.4%-Silica-Asc, ascorbic acid (240 mg) was dissolved in 240 cc of EtOH:CHCl 3 :MeOH (60:60:120) mixture. Silica gel 60 (60 g, Merck, Cat. No. 107734; mesh 70-230) was added and the slurry mixture was stirred for 10 min. and then filtered at the pump. The yellowish Silica-Asc. was finally dried for ˜1 hr. at ˜50° C. This 0.4%-Silica-Asc. is ready to use as regular silica gel; its nature is less polar and it has some antioxidative properties.
Example 3
Preparation of Pd-BPheid
(a) Isolation of Bchla
This step was performed as in Example 1(a) above.
(b) Preparation of Chlorophyllase (Chlase)
Chlorophyllase (Chlase) was prepared from chloroplasts of Melia azedarach L., Chine tree leafs. Fresh leaves (50 g) were ground for 2 min. in a blender containing 350 ml of acetone cooled to −20° C. The homogenate was filtered through four layers of gauze, and the filtrate was collected and left overnight at 4° C. for further precipitation. The acetone was removed by filtration, and the remaining powder was washed a few times with cold acetone to remove traces of Chlase and carotenoids until the filtrate was colorless. The Chlase acetone powder was finally dried in a lyophilizer and further stored at −20° C. Under these conditions, the enzyme preparation was stable for over 1 year without noticeable loss of activity. Yield: 20 g Chlase per 1 kg leaves were obtained.
(c) Synthesis and Purification of Bacteriochlorophyllide (BChlide)
Ascorbic acid (70 mg; Merck) was dissolved in water (9 ml), the pH of the solution was adjusted to 7.7 using 10 M KOH aqueous solution, and 1 ml of 0.5 M, sodium phosphate buffer (pH 7.7) was added to maintain the pH during the reaction. Triton X-100 (about 80 μl) was added to achieve a final detergent concentration of 0.8% (v/v). Chlase acetone powder (200 mg) was homogenized in 6 ml of this solution using a Polytron homogenizer. The remaining solution was used to wash the instrument and was then combined with the homogenate. The enzyme solution was sonicated with 20 mg of solid BChla saturated with Argon and incubated in the dark for 6 hrs at 37° C., while stirring.
For purification, the reaction material was directly frozen (−20° C.) after 6 hrs of reaction and subsequently lyophilized. The dry residue was dissolved in acetone and sonicated and the solution was then subjected to a CM-Sepharose column equilibrated in acetone. The column was washed with acetone to elute unreacted material and then with 5% and 7% methanol (v/v) in acetone to elute Bacteriochlorophyllide (Bchlide) and Bacteriopheophorbide (Bpheid). The product was eluted with 25% methanol in acetone. The solvent was evaporated and the solid pigment was stored under Argon, at −20° C., in the dark. Reaction yield: 30-55%.
The CM-Sepharose for chromatography was prepared by first washing CM-Sepharose with water and then 3 times with acetone before packing a column and equilibrating in acetone. The chromatographic material could be reused after thorough rinsing with 2M NaCl aqueous solution until colorless, washed with water and resuspended in acetone.
(d) Incorporation of Palladium into the Bacteriopheophorbide (BPheid)
The procedure is the same as in Example 1 (c) above. HPLC of the dried material showed the main product in the form of two epimers which were chemically identical (88% of the entire mixture) and residual allomers. There was also a slight (0.5%) contamination of the starting material, BPheid.
Example 4
Characterization of the Compound Pd-BPheid
(a) Absorbance Spectra
The absorbance spectra of Pd-BPheid were determined with a UVICON spectrophotometer (1 cm pathlength) using a PM detector which is normalized to baseline. The sensitivity is 0.05.
Absorbance spectra of Pd-Bpheid in acetone and a mixture of methanol/K phosphate buffer are reported in Table 1 and in FIG. 1 .
The absorbance spectrum of Pd-BPheid in plasma was red-shifted to 763 nm.
TABLE 1
Methanol/K Phosphate 20 mM pH 6.59
Acetone
(70%/30%)
λ
Absorbance
λ
Absorbance
753 nm
2.43
758 nm
1.25
530 nm
0.49
537 nm
0.324
385 nm
1.25
384 nm
0.535
331 nm
1.45
329 nm
0.777
The pic detection revealed the following peaks according to FIG. 1 : at 758 nm: 1.2502; at 537 nm: 0.3239; at 384 nm: 0.5351; and at 329 nm: 0.7766.
(b) HPLC Detection of Pd-BPheid
A reverse phase HPLC method was developed to characterize the impurity profile and quantify the Palladium-BPheid.
Solid phase
a C 8 Inertsil 5 μm, 250 × 4.6 mm
Liquid phase
methanol:potassium phosphate buffer 20 mM
pH = 6.59 (70%:30%)
Flow rate
1 ml/min
Volume of injection
100 μl
Detection
1-Spectroflow 783, Deuterium lamp: 385 nm
2-Spectroflow 757, Tungsten lamp: 753 nm
As shown in Table 2, HPLC analysis of the product Pd-Bpheid as obtained in Example 3 exhibited 7 peaks. The major peak represented 64 to 70% of the total products.
Solutions of Pd-BPheid stored in acetone at −20° C. were stable for at least 2-month period. When the stock solution was maintained at room temperature for 18 hours, no change in the HPLC profile was observed showing that Pd-Bpheid is a stable compound.
TABLE 2
HPLC Detection of Pd-BPheid
Absorption spectra
%
%
(wavelength of maxima
Peak
Detection 385 nm
Detection 753 nm
nm)
B1
0.7
0.78
B2
3.4
4.31
754,537,384,330
C
1.07
1.25
D
2.49
2.76
758,535,384,330
E
64.11
69.98
758,537,384,329
F
9.62
3.61
753,531,358
G
13.56
14.46
758,537,384,329
(c) Characterization of Pd-BPheid by NMR
After a purification step of the Pd-BPheid prepared according to the Example 3, the percentage of the major peak was above 90%. This purification was conducted by a preparative HPLC C8. This purified compound was used for the characterization of the product by NMR and mass spectrometry.
Analysis of Pd-BPheid by NMR was carried out and the chemical shifts are listed in Table 3:
1 H NMR and 13 C NMR
2D 1 H NMR (COSY and NOESY)
2D 1 H- 13 C NMR (HMQC and HMBC: reverse detection).
TABLE 3
1 H, 13 C Chemical shifts (ppm)
proton
carbon
Methyl
1-CH 3
3.44
14.4
2-CH 3
3.07
33.1
3-CH 3
1.75
23.6
4-CH 3
1.06
10.8
5-CH 3
3.36
12.5
8-CH 3
1.65
23.9
10-CH 3
3.85
53.3
Meso
α
9.11
101.5
β
8.50
102.9
δ
8.45
98.7
C—H
3-H
4.35
47.2
4-H
4.09
55.2
7-H
4.10
49.2
8-H
4.34
49.2
10-H
5.92
65.10
Others
4-CH 2
2.08; 2.22
30.6*
7′-CH 2
2.30; 2.52
30.6*
7″-CH 2
2.15; 2.35
35*
Carbon without proton
2-CO
199
9-CO
188
17-CO 2 H
170.2
10-CO 2 Me
174.3
1-C
141
2-C
135.6
5-C
126.9
6-C
130.1
11-C
142.3
12-C
158.5
13-C
159.5
14-C
151.5
15-C
140.5
16-C
152.5
17-C
109.8
18-C
152.3
19-C
158.6
(d) Characterization of Pd-BPheid by Mass Spectrometry
The mass spectrometry analysis of Pd-BPheid resulted in the spectra depicted in FIGS. 2 and 3. It was conducted by Fast Atom Bombardment (FAB) under low and high resolutions. The spectrometer was a “ZabSpec TOF Micromass” spectrometer; ionisation mod: LSIMS with Cs + , positive, acceleration: 8 kV; source temperature: 40° C.; solvent used: mNBA (meta-nitrobenzilic alcohol); input: lateral.
Results: iontype: M+; formula: C 35 H 36 N 4 O 6 106 Pd; theory: 714.1670 Z:1 m/z theoretical 714.1670 m/z found 714.1689.
These results confirmed the NMR study: m/e=714 and confirmed the insertion of Palladium metal.
The chemical structure analyzed by NMR and mass spectrometry is the palladium derivative of the free acid form of BChl-Pd-BPheid.
Example 5
Biological Activity of Pd-Bpheid on Murine L1210 and Human HT29 Cells
(i) Cell lines. The murine leukemia cell line (L1210) was maintained in suspension culture using Fischer's medium supplemented with 10% horse serum, 1 mM glutamine, 1 mM mercaptoethanol and gentamicin. The RIF (Radiation induced Fibrosarcoma) tumor was maintained as specified by Twentyman et al. (1980, “A new mouse tumor model system (RIF-1) for comparison of end-point studies”, J. Natl. Cancer Inst., 64, 595-604). Cultures were grown in Weymouth's medium containing 10% fetal calf serum and gentamycin.
HT29 human colon adenocarcinoma cells were cultured in RPMI 1640 without phenol red and with 10% FCS. Cells were subcultured by dispersal with 0.25% trypsin in 0.02% EDTA and replated at a 1:5 split.
(ii) In vitro phototoxicity. For studies on phototoxicity involving L1210 and RIF cells, light was provided by a 600 watt quartz-halogen source filtered with 10 cm of water and a 850 nm cut-off filter to remove IR. The bandwidth was further confined to 660±5 nm by an interference filter (Oriel). Cells in suspension (L1210) or adhering to 24 mm diameter cover slips were incubated in growth medium (with 20 mM HEPES pH 7 replacing NaHCO 3 for added buffering capacity) for 15 min in the presence of specified levels of sensitizers. The cells were then washed free from the sensitizer, and transferred to fresh media. Irradiations were carried out at 10° C. For some studies, the cells were then labeled with fluorescent probes and sites of photodamage were assessed. In other studies, the cells were then incubated for 60 min at 37° C. in fresh medium to allow apoptosis to proceed. Viability studies were carried out using 96-well plates and a 72-hour MTT assay, in quadruplicate.
For HT29 model, cells were incubated for 1 hour with different concentrations of Pd-Bpheid and irradiated by an halogen lamp or a titanium sapphire laser with 300 mW/cm 2 at 10 and 25 J/cm 2 .
(iii) Cell Viability. Cell survival was assessed by the MTT reaction carried out 3 days after plating of 1,000-50,000 cells in 96 well plates. The color intensity was compared to a standard curve containing variable numbers of control cells. Absorbance at x nm was determined with a BioRad Plate reader. For L1210, growth in fresh medium was allowed to occur during the next 3 days, and cell numbers were similarly estimated using the MTT assay procedure.
(iv) Lipoprotein binding: Binding of Pd-BPheid to protein and lipoprotein compound of control human plasma was determined. Incubation of 250 μl plasma sample with 3 μM of the compound for 30 min at 37° C. Lipoprotein and protein components were then separated by density-gradient centrifugator. The gradients were fractionated, fractions diluted into 3 ml of 10 mM Triton X-100 detergent or of fluorescence at 750-800 nm determined upon excitation at 400 nm.
Results
(v) Phototoxicity Effect of Pd-BPheid on L1210 Cells
L1210 murine leukemia cells were incubated with 1 μM Pd-BPheid for 30 min at 37° C. resulting in a 50% cell killing using a 75 mJ/cm 2 dose of light at 760±5 nm. A similar degree of cell killing in the RIF line required a 215 mJ/cm 2 light dose.
(vi) Phototoxicity Effect of Pd-BPheid on HT29 Cells
The survival rate varied between 100% and 79% when HT29 cells were incubated with Pd-BPheid without light. The cellular survival rate decreased when the concentration of Pd-BPheid was higher and when the doses of energy delivered were increased. The Pd-BPheid photosensitizer dose causing a 50% death rate (also called LD 50 ) was 48 μM under an irradiation of 25 J/cm 2 . The excitation wavelength inducing the most important phototoxicity was 773 nm.
(vii) Sites of photodamage. Using mouse leukemia L1210 cells, Pd BPheid was highly specific mitochondrial photosensitizers with no detectable photodamage to the plasma membrane or to lysosomes. Such a result has been associated with rapid initiation of apoptosis.
(viii) Plasma lipoprotein binding. Studies carried out indicated that Pd-BPheid bound to HDL>LDL>>>Albumin fractions of human serum, considered to be one determinant of PDT selectivity.
Example 6
Formulations of Pd-Bpheid: Solubilization and Stability of Pd-Bpheid in Solvents Used for Animal Experiments
Solutions of Pd-BPheid were made up in different formulations to obtain a concentration of 0.05 to 2%.
(a) Cremophor formulation was prepared as follows: 40 mg of Pd-BPheid was dissolved in 2 ml of Cremophor EL in a dry tube either by slow rotation of the vial until the solution had been completely free from particles, or using short pulses of a sonic oscillator probe. The tube was cooled such that temperature did not rise above 30° C. After the drug was solubilized, 0.6 ml of propylene glycol was added and again mixed either by slow rotation or with the sonic probe. Isotonic NaCl was then added in 0.1 ml portions to a total volume of 4 ml. The mixture should be clear after each addition, with no evidence of a precipitate. The compositions were briefly treated with the sonic probe after each addition of NaCl 0.9% taking care to keep the temperature below 25-30° C. The concentration of drug was assessed by measuring the absorbance at 757 nm after dilution into ethanol.
When 20 mg/kg of Pd-BPheid were used in experimental studies, this translated into 0.4 mg per 20 gram mouse. Since no more than 0.1 ml of cremophor can be injected into a tail vein, the drug concentration was then 4 mg/ml.
(b) A modified Cremophor formulation was prepared as follows: 5 mg of Pd-BPheid was mixed with 0.4 ml of Cremophor EL. After dissolution, 0.12 ml of propylene glycol was added. Isotonic saline (1.48 ml) was then added in small portions, and the same was mixed after each addition. The final solution was completely clear and free from particles. An ultrasonic probe was used to aid in dissolving the drug, keeping the solutions below 25° C. by cooling as needed in an ice bath.
The determination of Pd-BPheid concentration in the Cremophor solution was performed by dilution into methanol. The absorbance spectrum was measured over 740-780 nm. The peak value was compared with the results from a known concentration of Pd-BPheid.
(c) Additional formulations were prepared using Tween 80 and ethanol to solubilize Pd-BPheid (1 mg Pd-BPheid/ml solution).
Example 7
In vivo Toxicity Studies—Effect of Pd-Bpheid on Murine Tumor Models
Two sets of experiments involving murine tumor models were used to assess the phototoxicity of Pd-Bpheid.
(a) The photodynamic responsiveness of Pd-BPheid was firstly evaluated in two murine tumor models: BA—mammary adenocarcinoma and radiation induced fibrosarcoma (RIF-1)
Photodynamic therapy parameters: Mice with tumors measuring 5-7 mm in diameter were entered into PDT experiments. Three Pd-BPheid drug doses (1, 5 and 10 mg/kg) and two light doses (100 and 300 Joules/sq.cm) were evaluated. A formulation of Pd-BPheid dissolved in Cremophor was administered by i.v. tail injection. PDT light exposure was started either 15 minutes, 1 hour or 4 hours following injection. Three mice were treated under each treatment condition unless initial results demonstrated lethal toxicity or non-responsiveness. A titanium sapphire laser tuned to 757 nm was used as the light source for PDT. Laser generated light was coupled into quartz fibers for delivery of light to tumors. A light power density of 75 mW/sq.cm was used. Tumor size was measured 3 days per week following PDT treatments and the percentage of tumor cures (defined as no tumor recurrence for 40 days post treatment) was determined.
In vivo PDT Response: Tables 4 and 5 hereinafter provide summaries of the PDT treatment results for C3H mice transplanted with either the BA mammary carcinoma or the RIF-1 fibrosarcoma. Each table indicates the following parameters: 1) intravenous drug dose expressed in mg/kg; 2) laser treatment parameters, including the total light dose (J/cm 2 ), the wavelength (757 nm), the light dose rate (mW/cm 2 ), and the time interval (between treated for each group, 4) toxicity (four mice died shortly after treatment), 5) tumor regrowth (consisting of the number of days between PDT treatment and tumor recurrence) and 6) the number of mice (and percentage) with Pd-BPheid PDT induced tumor cures.
As shown herein, Pd-BPheid mediated PDT was found to induce both a classical and an efficient tumoricidal response in two mouse tumor models. PDT mediated tumor responsiveness was directly correlated with drug dose, light dose and time interval between drug administration and light treatment. Specifically, higher drug doses and/or higher light doses produced enhanced responses. The BA mammary carcinoma was found to be more responsive to Pd-BPheid mediated PDT than comparable PDT treatments of the RIF-1 fibrosarcoma. Pd-BPheid mediated PDT was effective when light treatments were initiated within 1 hour of drug administration, and was not effective when a 4-hour interval between drug administration and light treatment was used.
(b) In the second set of experiments, the phototoxicity of Pd-BPheid was assessed in a mouse tumor model transplanted with HT29 human colon adenocarcinoma.
Animal and tumor model: Solid tumor tissue (diameter 2 cm) removed from donor mouse immediately after death was mechanically crushed in 1 ml of 0.9% saline solution and the solution (0.1 ml) was injected s.c. into one hind leg of each mouse. Mice were included for experiments when the tumor diameter was 8-10 mm. Tumors were grafted s.c. in 8-week aged Swiss nude mice 10 days before experiment.
Phototoxic studies: 0.15 ml Pd-BPheid was injected i.v. at 15 mg/kg. Mice were anesthetized with thiopental at 40 mg/kg just before irradiation. At 30 min, 1 h, 4 h or 24 h after injection, mice were irradiated with a titanium sapphire laser at 300 mW/cm 2 , mean diameter were measured to adjust time irradiation to obtain 200 or 300 J/cm 2 . Control mice not injected with Pd-BPheid were also irradiated in same conditions. The tumor growth delay induced by PDT was analyzed by equivalence with tests realized in experimental radiotherapy. For in vivo studies and for each separate experiment, all results were the mean of 2 or 3 separate experiments and for each separate experiment, 2 mice were used for each experimental condition.
Concerning tumoral growth studies, results are expressed as tumoral index variations with reference (=1) corresponding to tumoral index from non-treated cells. The tumoral index was calculated as follows:
Tumoral index=(largest tumoral diameter+perpendicularly opposite diameter)/2.
Temperature variation studies: to assure that the thermic effect was not excessive, temperature variation was measured for the halogen lamp and the titanium sapphire laser irradiation using non-absorbing alumin-embedded microthermocouples.
The results of this experiment are the following:
(1) 763 nm irradiation at 200 J/cm 2 :
A tumor growth decrease (as compared to controls) was observed for the conditions 30 min and 4 h after injection. A decrease of tumor index was observed up to 7 days for the conditions 1 h and 24 h after injection.
(ii) 763 nm irradiation at 300 J/cm 2 :
A tumor growth decrease was observed (as compared to controls) for the conditions 30 min and 24 h after injection. A decrease of tumor index was observed up to 7 days for the conditions 1 h and 4 h after injection.
(iii) 300 J/cm 2 irradiation 1 h after injection:
A tumor growth decrease was observed (as compared to controls) for the condition 773 nm up to 5 days and for the conditions 753 nm and 763 nm up to 12 days. The maximum tumor growth decrease was observed for 763 nm.
(iv) 300 J/cm 2 irradiation 24 h after injection:
A tumor growth decrease was observed (as compared to controls) for the condition 753 nm up to 4 days and for the conditions 763 nm and 773 nm up to 12 days. The maximum tumor growth decrease was observed for 773 nm.
No excessive temperature variation was observed during halogen lamp or titanium sapphire irradiation of mice.
In summary of this study, the optimal wavelength of irradiation was found to be 773 nm. The delay between injection and illumination had an influence on the tumor response. At 764 nm, a one hour delay was shown to be the most efficient. When using a 773 nm wavelength, the most efficient delay was 24 hours.
TABLE 4
C3H/BA mammary carcinoma response to Pd-BPheid
Number of
Animals with
Toxicity
Primary Tumor
Drug
Number of
(Treatment
Regrowth
Summary
Dose
Light
Animal
associated
(Days to
(cures)
(mg/Kg)
parameters
treated
death
Recurrence)
%
1 i.v.
300 J/cm 2
1
0
1(1 day)
−
757 nm
no response
75 mW/cm 2
15 min. interval
5 i.v.
300 J/cm 2
3
0
+
757 nm
1(41 days)
75 mW/cm 2
2(40 days)
15 min. interval
100%
5 i.v.
300 J/cm 2
3
0
1(11 days)
+
757 nm
2(41 days)
75 mW/cm 2
66.66%
1 HR interval
10 i.v.
300 J/cm 2
3
0
+
757 nm
2(41 days)
75 mW/cm 2
1(41 days)
1 HR interval
100%
10 i.v.
300 J/cm 2
2
0
2(1 day)
−
757 nm
no response
75 mW/cm 2
4 HR interval
10 i.v.
100 J/cm 2
3
0
+
757 nm
2(42 days)
75 mW/cm 2
1(41 days)
15 min. interval
100%
10 i.v.
100 J/cm 2
3
0
1(5 days)
+
757 nm
2(40 days)
75 mW/cm 2
66.66%
1 HR interval
TABLE 5
RIF-1 response to Pd-BPheid
Number
of
Animals
with
Primary
Tumor
Toxicity
Regrowth
Drug
Number
(Treat-
(Days
Dose
of
ment
to
Summary
(mg/
Light
Animal
associated
Re-
(cures)
Kg)
parameters
treated
death)
currence)
%
1 i.v.
300 J/cm 2
2
0
2(1 day)
−
757 nm
no
75 mW/cm 2
response
15 min. interval
5 i.v.
300 J/cm 2
3
0
1(5 days)
+
757 nm
1(12 days)
1(40 days)
75 mW/cm 2
33.33%
15 min. interval
5 i.v.
300 J/cm 2
3
0
1(4 days)
+
757 nm
1(2 days)
75 mW/cm 2
1(7 days)
1 HR. interval
10 i.v.
300 J/cm 2
3
2
+
757 nm
2(1 day)
1(41 days)
75 mW/cm 2
33.33%
15 min. interval
10 i.v.
300 J/cm 2
4
2
1(20 days)
+
757 nm
2(1 day)
1(40 days)
75 mW/cm 2
25.00%
1 HR interval
10 i.v.
300 J/cm 2
1
0
−
757 nm
no
75 mW/cm 2
response
4 HR interval
10 i.v.
100 J/cm 2
3
0
2(12 days)
+
757 nm
1(7 days)
75 mW/cm 2
15 min. interval
10 i.v.
100 J/cm 2
3
0
2(3 days)
+
757 nm
1(6 days)
75 mW/cm 2
1 HR interval
Example 8
Morphological Evaluation of A431 Human Epithelial Carcinoid Cells After Pd-BPheid and BChl-Ser Based PDT
This experiment was performed in order to examine the time-dependent morphological changes occurring after PDT with Pd-BPheid or BChl-SerOMe on A431 human epithelial carcinoid cells.
(i) Materials: The Pd-BPheid was prepared as in Example 1 above and the serine methyl ester BChl-SerOMe was prepared as in EP 584552.
(ii) Light source: Halogen lamp (Osram, Germany, 100 W), with 4.5 cm water filter and cut off filter>650 nm. The cells were illuminated for 10 minutes, 15 mW/cm 2 , a total energy fluency of 9 J/cm 2 . For illumination, the culture plates were placed on a glass table to provide the light from the bottom.
(iii) Phototoxicity study: A431 cells (5×10 4 cells) were seeded in 3 cm dishes in duplicates and cultured to 75% confluency in Dulbecco's modified Eagle's medium (DMEM)+F12 (1:1), buffered with HEPES (25 mM, pH 7.4), fetal calf serum (FCS) with penicillin (0.06 mg/ml) and streptomycin (0.1 mg/ml). Pd-BPheid or BChl-Ser were added to the cells at the corresponding LD 90 concentration (0.1 and 1 μM, respectively). After a 4-hour period the cells were washed with culture medium and the cells were illuminated with the light source above. Phase contrast microscopic examination was performed at different time points after illumination (0, 0.5, 4 and 24 hours post-PDT) using Zeiss Axiovert-35 light microscope (magnification X320) equipped with a Contax 35 mm SLR camera. In the second dish of every duplicate, cell viability was assessed 24 hours post-PDT using neutral red viability assay (Zhang S Z., 1990, Cell Biol Toxicol 6(2): 219-234).
(iv) Results: Both sensitizers caused significant changes in the cell morphology. Pd-BPheid caused a fast alteration in the cells membrane structure (30 minutes), the cells rapidly shrinked and fibrous connections were formed, connecting the cells membrane with the original focal adhesion points (fibrous phenotype). After 4 hours, 90% of the cells lost most of their inner volume and a large portion of them detached from the dish, no further change was observed after 24 hours (FIG. 4, right column). Bchl-Ser showed a different pattern of time dependant morphological changes that could be observed only after 4 hours. Membrane blabbing was seen as dark vesicles budding out from the cells membrane. No significant volume decrease was observed over 24 hours and after this period most of the cells were attached to the dish but appeared hollow (blabbing phenotype, FIG. 4, Left column). Twenty four hours after illumination, neutral red viability assay was performed which confirmed 90±7% cell killing in both of the experimental groups. In FIG. 4, the fibrous phenotype is represented in the right column and the blabbing phenotype is represented in the left column. The solid white arrows show the formations of the fibers or the blabs.
Example 9
Photocytotoxicity of Pd-BPheid and BChl-SerOMe on the Human Bladder Carcinoma Cell Line ECV304
This experiment was carried out for assessing the photocytotoxic effects of the photosensitizers Pd-BPheid and BChl-SerOMe on ECV304 human bladder carcinoma cells.
(i) Materials: as in Example 8(i).
(ii) Light source: as in Example 8(ii).
(iii) Phototoxicity study: ECV304 cells (2×10 4 cells per well) were cultured in M-199, 10% FCS with penicillin (0.06 mg/ml) and streptomycin (0.1 mg/ml) in 96-well to confluence (˜2×10 5 cells per well). Incubation with increasing concentrations of Pd-BPheid or BChl-SerOMe with the cells for 4 hours was followed by washing with fresh culture medium and illumination as described above Sec. 1. Twenty-four hours after illumination, cell viability was assessed using neutral red viability assay. The following controls were used: Light control: irradiated cells, not treated with sensitizer. Dark control: non-irradiated cells, treated with sensitizer in the dark. Untreated control: cells not treated with sensitizer and unirradiated were used for calculation of 100% survival (Rosenbach-Belkin V. et al., 1996, Photochem Photobiol 64(1): 174-181)
(iv) Results: Both Pd-BPheid and BChl-SerOMe exhibited dose and light dependent cytotoxicity on ECV304 cells (FIG. 5 ). The corresponding LD 50 values are 19 and 1000 nM. Morphological changes post-PDT were consistent with the observations made with A431 cells (data not shown).
Example 10
PDT of Pd-BPheid and Pd-BPheid-ethyl Ester on M2R Mouse Melanoma Cells
The aim of this experiment was to test the effect of Pd-BPheid and Pd-BPheid-ethyl ester on M 2 R cells.
(i) Materials: Pd-Bpheid was prepared as in Example 1 above and the Pd-Bacteriopheophorbide a ethyl ester (Pd-Bpheid-ethyl ester) was prepared as described in WO 97/19081.
(ii) Light source: As above in Example 8(ii) but cells were illuminated for 10 minutes, 12 mW/cm 2 , a total energy fluency of 7 J/cm 2 .
(iii) Phototoxicity study: M 2 R cells were cultured as monolayers in Dulbecco's modified Eagle's medium (DMEM)+F12 (1:1), buffered with HEPES (25 mM, pH 7.4). Fetal bovine serum (FBS) (10%), glutamine (2 mM), penicillin (0.06 mg/ml) and streptomycin (0.1 mg/ml) were included and the cells were grown at 37° C. in a humidified atmosphere containing 8% CO 2 . For phototoxicity analysis cells (1×10 4 cells/well) were cultured in 96-well plates for 24 hours to an approximate density of 2×10 4 cells/well. Pigments were dissolved directly in culture medium or in ethanol 95% and further diluted in culture medium to a final concentration of 1% ethanol. The diluted pigments were added and the cells were incubated in the dark for four hours at 37° C. Prior to illumination, the cells were washed once and replaced with fresh culture medium. The plates were then illuminated from the bottom for 10 minutes at room temperature and placed in the culture incubator at 37° C. in the dark. Cell survival was determined 24 hours later. The following control systems were used: Dark control—untreated cells kept in the dark; Light control—cells not treated with sensitizer that were illuminated; Dark toxicity—cells treated with pigment but kept in the dark. Cell survival was determined by [ 3 H]-thymidine incorporation as described earlier (WO 97/19081).
(iv) Results: As can be seen in FIG. 6A, when the pigments were dissolved in ethanol 95%, Pd-BPheid had a LD 50 of 0.03 μM, while the Pd-BPheid-ethyl ester had a LD 50 of 0.07 μM. When the pigments were dissolved directly in culture medium containing 10% serum, only the Pd-BPheid was fully active while the Pd-BPheid-ethyl ester was not active at all up to 1 μM, the highest concentration tested (FIG. 6 B).
Example 11
PDT of Pd-BPheid on M2R Mouse Melanoma and Human HT29 Colon Carcinoma Cells
These experiments were aimed at determining the phototoxic effect of Pd-BPheid toward two cell lines: M2R mouse melanoma and human HT29 colon carcinoma cells.
(i) Materials: Pd-Bpheid was prepared as in Example 1 above.
(ii) Light source: The light source was a Xenon fluorine LS3-PDT lamp (Bio-Spec, Russia), with 10 cm water filter and 720-850 nm light band. The cells were illuminated for 10 minutes, 12 mW/cm 2 , at a total energy of 7 J/cm 2 .
(iii) Phototoxicity study: Analysis was performed with the same protocol as described above (Example 10) with the following changes: Pd-BPheid was dissolved directly in medium containing 10% serum and then added to the cells. Survival of M2R cells was determined by [ 3 H]-thymidine incorporation and that of human HT29 cells with the MTT assay (Merlin J L et al., 1992 Eur. J. Cancer 28A: 1452-1458).
(iv) Results: As can be seen in FIG. 7, human colon HT-29 cells show lower sensitivity toward this pigment (LD 50 of 0.5 μM), while the M 2 R cells were about 10 times more sensitive (LD 50 of 0.03 μM).
Example 12
In vivo PDT of M2R Mouse Melanoma Tumors with Pd-BPheid
The aim of this experiment was to study PDT of M2R mouse melanoma tumors in CD1 nude mice with 2.5 mg/Kg Pd-Bpheid.
(i) Materials: Pd-Bpheid was prepared as in Example 1 above.
(ii) Mice: CD1 nude mice (25-30 g)
(iii) Anesthesia: i.p injection of 50 μl of Ketamine/Rumpon (vol/vol=85/15).
(iv) Tumor implantation: Mice were implanted with 10 6 M2R cells on the back and tumors arose to the treatment size (7-8 mm) within 2-3 weeks.
(v) Light source: Osram 150 W halogen photo-optic lamp 64643 (D. K. Keller et al 1999, Int. J. Hyperthermia 15, 467-474) equipped with λ=650-900 mn spectral window, 300 mW/cm −2 . Illumination was for 30 min.
(vi) PDT protocol: The anesthetized mouse was i.v injected with the pigment and the tumor immediately illuminated. At the end of treatment the mouse was placed back in the cage. Photographs of the tumor were taken before and at the times indicated.
Experiment 1
Preparation of sensitizer: Two mg Pd-BPheid were dissolved in 0.25 ml cremophor EL followed by 20 min sonication. 0.075 ml 1,2-propylene glycol were added and sonication was continued for another 15 min. Then 0.9 ml of 0.15 mM NaCl were added followed by 5 min sonication. The sample was centrifuged for 12 min at 13,000 rpm (Eppendorf). The final calculated concentration of Pd-BPheid based on spectrum in chloroform was 0.5 mg/ml.
PDT of tumor: Pd-BPheid 2.5 mg/kg was i.v injected to CD1-Nude mouse bearing M2R melanoma tumor. The tumor was illuminated for 30 min at 300 mW cm −2 . The temperature of the mouse skin tumor area was 37.7-38° C. The response of tumor was followed 1 and 4 days after treatment. The results are shown in FIG. 8 .
Experiment 2
Preparation of sensitizer: Two mg Pd-BPheid were dissolved in 0.1 ml methanol, 0.1 ml 0.1M KH 2 PO 4 , pH=8.0 and 0.9 ml PBS and sonicated for 10 min. The methanol was evaporated with Argon and 20% of cremophor EL: 1,2-propylene glycol (3:1) was added following by 15 min sonication. The sample was centrifuged for 8 min on 13,000 rpm the final calculated concentration of Pd-BPheid based on spectrum in chloroform was 0.5 mg/ml. PDT of tumor: Pd-BPheid 2.5 mg/kg (120 μl) was i.v administered to CD1-Nude mice bearing M2R melanoma tumor. The tumor tissue was illuminated for 30 min at 300 mW cm −2 . The temperature of the mouse skin tumor area was 37.7-38° C. The response of tumor was followed 1 and 4 days after treatment. The results are shown in FIG. 9 .
Results: As shown in FIGS. 8 and 9, PDT of M2R melanoma tumors with 2.5 mg/Kg Pd-Bpheid as described above induces severe inflammatory response with necrosis of the tumor within 24 h.
Example 13
Pd-BPheid Based PDT Reduces Rate of C6 Glioma Metastasis Formation in Mice: Advantage Over Surgery
These experiments were conducted in order to compare the therapeutic potential of Pd-BPheid and BChl-SerOMe based PDT, and the probability of metastasis spread by Pd-BPheid and BChl-SerOMe based PDT.
(i) Materials: Pd-BPheid (prepared as in Example 1) or Pd-BPpheid-SerOMe 5 mg/kg in 20% Cremophor EL.
(ii) Light source: The light source was a Xenon fluorine LS3-PDT lamp (Bio-Spec, Russia), with 10 cm water filter and 720-850 nm light band.
(iii) Mice: CD1 nude mice.
(iv) Tumors: Mice were implanted with 10 6 C6 glioma cells in the foot of the hind leg. Tumors were treated when reached a length of 7-8 mm.
(v) Anesthesia: 50 μl of Vetalar/Rumpon (vol/vol=85/15).
(vi) Analgesia: Oxycodone (12 mg/liter) added in 5% sucrose drinking water, as of treatment (amputation or PDT) for one week.
(vii) Protocol: Three groups (10 mice in each) were i.v. injected with 5 mg/Kg of sensitizer (Pd-BPheid or Pd-BPpheid-SerOMe) and immediately illuminated at 200 mw/cm 2 , for 30 minutes, and the animals were allowed to recover in the cage. Groups 1 and 2: Animals which received PDT Pd-Bpheid and Pd-BPpheid-SerOMe, respectively. Tumor response and metastasis formation in groin were followed for 4 weeks. Group 3: Animals which were amputated at the ankle joint (paired with group 1) and metastasis formation in groin was followed for 4 weeks. The parameters of response to PDT were the percent of animals with tumor necrosis and disappearance, out of the total number of treated animals. Metatstasis was manifested by appearance of tumors in the groin or elsewhere. The endpoints considered were: follow up for 4 weeks, spontaneous death, tumors reached a diameter of 2 cm, metastasis, whichever came first.
(viii) Results: The results of tumor flattening (disappearance) are shown on FIG. 10 . While on day 11 the response to Pd-BPheid was stronger than to Pd-BPheid-SerOMe (100% and 80% tumor flattening, respectively), later, on day 28, the percent of response was similar, about 60%. The decline in tumor flattening in the long term is due to some tumor re-growth in some of the treated animals, probably due to mismatch of light field and tumor area. The results of metastasis appearance are shown in FIG. 11 . The surgical treatment by leg amputation yielded a substantially higher percent of metastasis in comparison to PDT (up to 78%). In addition, the metastasis after amputation appeared much earlier. The frequency of metastasis after PDT with Pd-BPheid was the lowest (up to 23%). This result is similar to that obtained with Pd-BPheid-SerOMe and the main advantage of Pd-BPheid is delay of metastasis appearance. PDT with Pd-BPheid or Pd-BPheid-SerOMe are curative for C6 glioma tumors. Metastasis formation after PDT is substantially lower when compared with surgical treatment.
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Palladium-substituted Bacteriochlorophyll derivatives of formula (I), wherein A represents OH, OR 1, --O--(CH 2) n --Y, --S--(CH 2) n --Y, --NH--(CH 2) n --Y, --O--(CH 2) 2 --NH 2, --O--(CH 2) 2 --OH, --NH--(CH 2) n -- + N o, X--, --NH0(CH 2) 2 --NH-BOC or --N--(CH 2 --CH-CH 2) 2 ; wherein R 1 represents Na +, K +, (Ca 2+) 0, 5, (Mg 2+) 0, 5, Li +, NH 4 +, NH 3 --C(CH 2 OH) 3 + NH 3 --CH 2 --(CHOH) 4 --CH 2 OH, + NH 2 (CH 3)--CH 2 --(CHOH) 4 --CH 2 OH or + N(C N' H 2n'+1) 4 ; R 2 represents H, OH or COOR 4, wherein R 4 is C 1 -C 12 alkyl or C 3 -C 12 cycloalkl; R 3 represents H, OH or C 1 -C 12 alkyl or alkoxy; n is 1, 2, 3, 4, 5 or 6, Y is --NR' 1 R' 2 R' 3, X-wherein R' 1, R' 2 and R' 3 independently from each other represent --CH 3 or --C 2 H 5 ; X is F, Cl, Br or 1, n' is 1, 2, 3 or 4 and their oxidized forms, are useful in the field of photodynamic therapy (PDT).
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[0001] The invention relates to a device for dosing and aerosolization of aerosolizable material, in particular powdery medical substances such as, e.g., pharmaceutical preparations for inhalation. The device is particularly suited for the aerosolization of powdery lung surfactant preparations.
BACKGROUND OF THE INVENTION
[0002] Devices for aerosolization (“dry nebulization”) of aerosolizable (“nebulizable”) dry material are known to the skilled person. For example, for the aerosolization of powdery pharmaceutical preparations, so-called dry powder inhalers (DPIs) have been described. In these devices, an aerosolizable material, for example a powdery medical substance, is acted upon by a compressed gas or carrier gas in a specially provided chamber and, within this chamber, is converted to a state which is referred to as aerosol or dry mist. The particles of the material are in this case present in a preferably uniform and finely dispersed form across the entire volume of compressed gas or carrier gas and are then discharged from the chamber in this state via suitable devices.
[0003] Such devices can be used for administration of medical substances to spontaneously breathing or ventilated patients. For use in spontaneously breathing patients, the devices are generally connected to a suitable mouthpiece or a breathing mask. In invasive use, i.e. on ventilated patients, these devices feed the aerosolized medical substance into a ventilator system which then delivers the aerosolized material to the patient's lung.
[0004] In the devices known hitherto for aerosolization of powdery material, however, the problem generally found was that large amounts of medical substances could be delivered to the patient only, if at all, with considerable outlay in terms of equipment, for example using extensive mechanical dosing devices. Generally, the known devices were suitable for the aerosolization of pharmaceutical quantities in the range from approximately 1 μg up to approximately 20 mg. However, certain medical substances such as, e.g., lung surfactant preparations, require administration of large amounts, for example more than 100 mg or even in the gram range which, when using conventional DPIs, requires very long inhalation times. A second problem of devices known from the art can be the reproducibility of the amount of aerosolized material delivered to the patient. This is particularly the case when during storage or even during action of the inhaler the particles of the aerosolizable material agglomerate to larger particles with a different aerodynamic behaviour. Large particles will have a much smaller chance to reach their target, the deeper lung, since they tend to be deposited in the upper airways or throat or even somewhere in the inhaling apparatus.
[0005] The problem of administering large amounts of aerosolizable material such as lung surfactant preparations in precise doses concerns all sections of the apparatus used for inhalation: the air supply and its controller, the aerosolizing unit itself, the piping and valve system (including, where appropriate, the inner surfaces of a ventilator system), and the respiratory endpieces (mask, tube), in other words all sections in which an uncontrolled loss by unwanted deposition of aerosolized particles and thus reduction of the dose delivered to the patient and obstruction may occur.
[0006] In conventional aerosolizing units, one problem generally found was that the aerosolizable material, which is present as a loose charge in a storage container, for example a commercially available pharmaceutical vial, tends to agglomerate, by reason of its surface quality and/or its moisture content, which can result in blockage of a comparatively narrow aperture cross section of the vial. Such agglomeration may also occur in lung surfactant preparations. Such blockages can normally be obviated only by suitable mechanical means, in order to ensure a continuous dosing of the aerosolizable material over quite a long period of time. In addition, as already pointed out above, agglomerated particles of aerosolizable material, for example lung surfactant preparations, are not generally able to access the lungs with the same efficiency and following the same local distribution/deposition pattern as smaller, non-agglomerated particles.
[0007] In the prior art aerosolizing unit of GB 24 848 A, a reservoir of aerosolizable material is connected via a narrow passage to a chamber into which supply air is pressed by means of a syringe. Deagglomeration of the aerosolized particles takes place as the supplied air is further forced into the reservoir and performs a whirling action therein; where after the dispersed aerosolizable material is expelled through the chamber and out of a nozzle towards the patient. In FR 2 598 918 A the aerosolizable material is, in contrast, conveyed by an Archimedean screw into a jet of compressed air where dispersion takes place.
[0008] In many instances it is necessary to ensure rapid and high-dose administration of aerosolizable material, in a form accessible to the alveoli, into the lungs with a constant dosage, in rapid sequence and over a period of several minutes. Both above-mentioned systems cannot, however, provide administration of high doses of aerosolizable material and are, due to their geometry and dispersion mechanism, still prone to agglomeration, e.g. in the chamber or in the hopper provided with the screw, so that accurate dosing remains an issue. In fact, such administration was possible, if at all, only with considerable outlay in terms of equipment.
[0009] WO 2006/108558 A1 discloses a device for dosing and powder aerosolization in which deagglomeration of the aerosolizable material, such as a powdery lung surfactant preparation, is achieved by means of pressure compensation between the pressure pulses sent into the aerosolization channel of the device. The shear force necessary for deagglomeration is created by taking advantage of the high pressure during the pulses. While this system delivers superior results over the known prior art systems in terms of concentration of aerosolized material delivered, issues of concern remain regarding residues of aerosolizable material adhering to the inner surfaces of the system such as the reservoir walls or the bottom of the aerosolization channel.
[0010] A further issue concerns the output characteristics of a dosing device such as the one disclosed in WO 2006/108558 A1. As the dosing device uses pressure pulses to deagglomerate, the question arises about the effect these may have on the patient. The pressure pulses are of substantial magnitude and, thus, the dosing device cannot be connected directly to the patient's breathing front ends such as masks in the case of spontaneously breathing patients. For ventilated patients, the output of the dosing device must be connected to the ventilator in order to allow for both adequate and precise dosage, and for the necessary oxygen supply. In the case of infants, moreover, the volume and dosage of the supplied aerosol as well as the partial pressure of oxygen as well as the airway pressure are even more critical than in adults and need special consideration. Since for infants the conventional approach of supplying airborne drugs via pressure respirators and tubes is extremely stressful, specialized equipment and rooms are required.
SUMMARY OF THE INVENTION
[0011] It is therefore an object of the present invention to provide a device for dosing and aerosolization of aerosolizable dry material which overcomes the above problems of residues of aerosolizable material and allows essentially all the aerosolizable material present in the device to be aerosolized and delivered to the patient, thereby allowing for a yet unachieved dosing accuracy also in the case in which large volumes of dry powder need to be administered.
[0012] Since the utility of the device according to the invention is not limited to the dosing and aerosolization of substances used in a medical context, such as substances used for diagnostics and/or for treatment, it is a further object of the invention to provide a device for dosing and aerosolization of aerosolizable dry material which overcomes the above problems of residues of aerosolizable material and allows essentially all the aerosolizable material present in the device to be aerosolized.
[0013] It is also an object of the invention to provide a system for dosing and aerosolization of aerosolizable dry material which allows treatment of spontaneously breathing as well as ventilated patients and can be used both with adults and infants.
[0014] These objects are achieved by means of a device for dosing and aerosolization of aerosolizable dry material according to claim 1 . Further optional and preferred embodiments are defined in the respective dependent claims.
[0015] In a first aspect of the invention, the novel device for dosing and aerosolization of aerosolizable dry material comprises a body with an aerosolization channel having a distal attachment portion connectable to a source of pulsed carrier gas which provides pressure pulses of the gas to the aerosolization channel and a proximal attachment portion for outputting aerosolized material (the “aerosol”) towards a patient, and a reservoir for receiving aerosolized material (“proximal” and “distal” as seen from the patient). It is further preferred that the device has an attachment portion connectable to a source of non-pulsed carrier gas serving to transport the generated aerosol from the aerosolization channel or from the reservoir towards the patient. The reservoir comprises walls and is connected in a gas-tight manner to the body and is in flow connection with the aerosolization channel. At least parts of the walls are membranes that can be put into oscillation. While the latter could be realized by any sort of actuator, it is preferred that the membranes are self-exciting membranes that can be put into oscillation by the pressure pulses.
[0016] Preferably, the novel device comprises means for transferring oscillation energy between different areas of the membranes. Advantageously said means can recircle oscillation energy induced by the pressure pulses. It is preferred to transfer the oscillation energy from stronger oscillating areas of the membranes to weaker oscillating areas. This serves to compensate for pressure differences between the membranes. Thus activating weaker oscillating areas. Such a transfer can be assured for example by a tubing connecting the proximal attachment portion and/or the aerosolization channel and the distal reservoir of the device.
[0017] The term “membrane” as used herein refers to any sheet-like structure that is impermeable to gas, liquid and the aerosolizable material, and that forms at least part of the containment for the aerosolizable material in the reservoir. “Self-exciting” as used herein refers to the property of the membrane to elastically deform and oscillate in response to pressure pulses of the carrier gas supplied to the device. As such it is to be understood that, as a function of the membrane's material, the membrane needs to be thin and flexible enough in order to be deformed by the pressure pulses. Examples of membrane materials are elastic polymers such as silicone, but other materials will be apparent to the skilled person.
[0018] By being provided with membrane walls, the inventive device is capable of utilising essentially the complete amount of aerosolizable dry material stored in the reservoir and transform it into an aerosol because the oscillation of the membrane walls of the reservoir loosens up aerosolizable material, so it can fall into the dosing chamber beneath the reservoir. The process of aerosolization is, for example, described in WO 2006/108558.
[0019] According to the invention it is thus possible to have a uniformly loose charge of aerosolizable dry material available in the device for dosing and aerosolization after each pressure pulse, as a result of which a gradually increasing compaction of the material is avoided and a uniform dosing is guaranteed over a considerable time period. The device according to the invention thus easily allows aerosolizable material to be dosed in large amounts in a highly reproducible manner and preferably without moving parts. In addition, during the pressure compensation between aerosolization channel and reservoir, a loosening of the charge of the aerosolizable material is achieved. It is thus possiblethat the mixture of compressed carrier gas and material predominantly contains deagglomerated particles, preferably exclusively or almost exclusively particles having the size of the primary, non-agglomerated particles of the aerosolizable material. If the aerosolizable material is in the form of a powdery medical substance such as, e.g., powdery lung surfactant, it is possible that the primary particles of the medical substance located in the reservoir are present in the mixture of compressed gas and material. To this extent, the device according to the invention permits, preferably completely free of mechanical moving parts, optimal aerosolization of the aerosolizable dry material even down to the size of the primary particles.
[0020] In the preferred case that the device is used for dosing and aerosolization of substances for therapeutic and/or diagnostic purposes, the size of the primary particles of the aerosolizable material preferably corresponds to a mass median aerodynamic diameter (MMAD) which is such that the particles are able to access the lungs, i.e. the site of action in the airways or the alveoli of the lungs. The MMAD of particles that can access the lungs is in the range of 1 to 5 μm. The desired MMAD range, according to the invention, of the particles in the mixture of compressed gas and material is consequently 1 to 5 μm.
[0021] Preferably, a funnel portion tapered towards the aerosolization channel is provided in the body between the reservoir and the channel, and the walls of the funnel portion are self-exciting membranes. The funnel portion is where the aerosolizable material falls to and accumulates from the reservoir before entering the aerosolization channel. The differential pressure pulses generated as a result of the pressure pulses utilizing the Venturi principle create a pressure gradient which serves to suck the aerosolizable material into the aerosolization channel and entrains it into the carrier gas stream, by this generating a highly concentrated aerosol. As the walls of the funnel portion are self-exciting membranes, no material accumulated in the funnel portion will be left adhering to its walls and substantially all of it can be entrained in the carrier gas.
[0022] The reservoir may preferably be provided with a lid that comprises a membrane towards the reservoir. While the cover as such allows the reservoir to be (re)filled, the membrane on the cover will also oscillate and support a complete deagglomeration and detachment of aerosolizable material from the inner surfaces of the reservoir. If desired, between membrane and lid a gas- and/or humidity absorber can be inserted.
[0023] Additionally, a self-exciting membrane may be provided as part of the bottom of the aerosolization channel beneath the connection thereof with the reservoir. When aerosolizable material falls into the aerosolization channel, not all of it is always immediately entrained in the carrier gas stream, and some material may deposit and accumulate beneath the mentioned connection. By providing this area with a self-exciting membrane, the pressure pulses sent through the aerosolization channel excite this membrane to oscillate so that the material is reentrained in the carrier gas. This configuration can be termed a “passively controlled” membrane. It is also conceivable to dispose an actuator connected to the membrane so as to drive the membrane to oscillate. This is called “actively controlled”.
[0024] Finally, it is preferred that the reservoir and the body are integrally formed. This has the advantage that a disposable device can be provided in which the total dose of aerosolizable material is carefully controlled by the manufacturer and contamination and wrong dosage due to filling inaccuracies can be prevented.
[0025] In a second aspect of the invention, a system for dosing and aerosolizaticn of aerosolizable dry material comprises the above-described device for dosing and aerosolization of aerosolizable dry material. In addition, a first hollow spacer is connected to the proximal attachment portion of the device and comprises a distal portion having inner walls tapered towards the proximal attachment portion, and a proximal portion having inner walls tapered towards the patient, with preferably a central cylindrical portion there between.
[0026] The term “spacer” as used herein refers to an additional piece of pathway for respiratory or carrier gas/aerosol to traverse, which introduces expansion space for the pulsed gas stream. The geometry of the first hollow spacer allows to dampen the pressure pulse of the gas carrying the aerosol to the patient and to reduce at the same time the associated noise, much in the same way as a silencer. Thus, both for spontaneously breathing and for ventilated patients, the aerosol arrives more uniformly and without unacceptable pressure spikes.
[0027] According to a preferred embodiment, the inner walls of the distal portion, the central portion and/or the proximal portion of the first hollow spacer comprise self-exciting membranes. When a differential pressure pulse arrives in the system, the membranes oscillate due to their elasticity so that this construction avoids that particles from the aerosol adhere to and stay on the walls of the spacer.
[0028] It is also preferred that an annular gap is provided between the distal and the central portions of the first hollow spacer, which is connectable to an auxiliary air supply. This annular gap can be supplied with auxiliary air that rinses the inside of the spacer and makes sure no residue of aerosolizable material stays adhered to the wall. It is most preferred that the geometry of the annular gap allows formation of a sheath flow of auxiliary air along the walls of the cylindrical part of the spacer, thus ensheathing the aerosol stream entering the spacer and efficiently helping to avoid the aerosolized particles to deposit on the spacer's walls.
[0029] In a preferred embodiment, the system according to the second aspect of the invention further comprises a second hollow spacer connected to the proximal portion of the first hollow spacer and distally to a patient connector, the second hollow spacer having an ambient air inlet with a non-return valve provided at the distal end and an exhaled gas outlet provided at the proximal end of the second hollow spacer. The second hollow spacer preferably has a larger cross-section and volume than the preceding first hollow spacer, and may preferably be cylindrical, although the invention does not provide any limitation on shape.
[0030] This arrangement is particularly advantageous for administration of aerosolized material to spontaneously breathing patients. Like the first hollow spacer, the second hollow spacer serves to attenuate the differential pressure pulses coming from the supply of compressed air through the dosage and aerosolization device and to reduce the associated noise. But it also has the function of providing an intermediate storage for the aerosol, that is the aerosolized material entrained in the carrier gas. From this intermediate storage, which is connected to the patient's mouth piece, a spontaneously breathing patient can inhale the predetermined dose of aerosolized material. Due to the expanded cross-section and larger volume of the second hollow spacer with respect to the first hollow spacer, the negative respiratory pressure necessary to draw and inhale the aerosolized material from the second hollow spacer does not become excessive as would be the case if the dosage and aerosolization device and first hollow spacer were directly connected to the patient. Moreover, inhalation of aerosolized material from the first or second spacer is further facilitated by the provision of auxiliary air as described above.
[0031] In an alternative preferred embodiment, the aerosolization device is connected to a ventilator system operated as CPAP System (continuous positive airway pressure) delivering ventilatory support to a patient. In such a setup, the aerosol is introduced into a ventilator or CPAP system via a T-connector to a patient side respiratory front end. This system provides numerous advantages to patients on mechanical ventilation or on ventilatory support, in particular in case of infants and neonates. In acute situations, these little patients may need carefully controlled administration of aerosolized medical substances. By connecting the ventilator or CPAP system and the dosing and aerosolization device via a T-connector that is connecting the device in parallel to the respirator, it is possible to control both how much air or oxygen is provided from the ventilator (by controlling the air and/or oxygen pressure) and, separately, how much aerosolized material is provided to the patient. Furthermore, in contrast to delivery of the aerosol into the inspiration branch of the respirator, this configuration allows for higher aerosol concentrations in the gas delivered to the patient since dilution is minimized.
[0032] As mentioned above means can be provided to transfer oscillation energy from one area of the membranes to another.
[0033] Preferably, a compensation tubing is provided between the interior of the first hollow spacer and the interior of the funnel portion. This tubing serves to compensate for pressure differences between spacer and reservoir and at the same time to activate the funnel membrane.
[0034] The above-described systems may be integrated in standard ventilator systems for routine administration/addition of aerosolizable material, such as lung surfactant, to the respiratory gas.
[0035] It is obvious to the person skilled in the art that the aerosolization device as described hereinabove can be used in a variety of technical fields. Actually the device according to the invention will be applicable whenever efficient and uniform aerosolization of powders is desired. While preferred uses of the device according to the invention are in the field of therapy and administration of inhalable drugs, pharmaceutical preparations and other medical substances, in particular lung surfactant, the device will be useful for the aerosolization of any sort of aerosolizable substances in the range of less than 100 mg up to several grams of substance. It is even conceivable that an adequately sized version of the device allows aerosolization of even higher amounts of substances up to technical scales. The particle size or particle size distribution of the material to be aerosolized will depend on the particular application. For example, as is known from the art, particles to be administered to the lung by inhalation ideally will have a size in the range of 1-5 μm MMAD. Of course, the device according to the invention is not limited to aerosolization of particles in this size range. Rather, smaller as well as larger particles would lend themselves for aerosolization by use of this device. To give an example, powder coating of workpieces which has gained considerable importance in recent years would be a possible application where relatively large quantities of particles having a very small size (e.g., <1 μm) have to be aerosolized.
[0036] Accordingly, the present invention relates to a device for dosing and aerosolization of aerosolizable material comprising a body with an aerosolization channel having a distal attachment portion connectable to a source of carrier gas which provides pressure pulses of the gas to the aerosolization channel and a proximal attachment portion for outputting aerosolized material towards a patient, a reservoir for receiving aerosolizable material, the reservoir comprising walls and being connected in a gas-tight manner to the body and in fluid connection with the aerosolization channel, characterized in that at least part of the walls are self-exciting membranes that can be put into oscillation by the pressure pulses.
[0037] The present invention also relates to the above device, wherein a funnel portion tapered towards the aerosolization channel is provided in the body between the reservoir and the channel, and wherein walls of the funnel portion are self-exciting membranes.
[0038] The present invention also relates to any of the above devices, wherein the reservoir is provided with a top cover and the top cover comprises a self-exciting membrane towards the reservoir.
[0039] The present invention also relates to any of the above devices, wherein a self-exciting membrane is provided in a wall of the aerosolization channel beneath the connection thereof with the reservoir.
[0040] The present invention also relates to any of the above devices, wherein the reservoir and the body are integrally formed.
[0041] The present invention also relates to any of the above devices, wherein the reservoir is connected with the aerosolization channel via a valve. In one embodiment, the valve is a rotary valve.
[0042] In summary the present invention uses the energy of a pressure pulse generated for example by expansion of compressed gas to excite elastic elements. As mentioned before, these elements can be membranes, especially self-exciting membranes. By exciting the membranes energy is taken up from the original pressure pulse, thus weakening this pressure pulse. As a result the aerosolizable material is aerosolized in a more continous, constant and homogeneous form compared to a rapid output initiated by an unweakened pressure pulse. By such an attenuation of the pressure pulse the aerosole produced is comfortable breathable by a patient.
[0043] Additionally an agglomeration of the aerosolizable material, especially in the reservoir, is prevented.
BRIEF DESCRIPTION OF DRAWINGS
[0044] FIG. 1 is a longitudinal sectional view of an embodiment of a system for dosing and aerosolization according to the invention;
[0045] FIG. 2 is schematic view of an embodiment of a system for dosing and aerosolization for use with spontaneously breathing adult patients;
[0046] FIG. 3 is schematic view of an embodiment of a system for dosing and aerosolization for use with ventilated infants; and
[0047] FIG. 4 is schematic view of an embodiment of a system for dosing and aerosolization for use with ventilated adults.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0048] In FIG. 1 , a longitudinal sectional view of a first embodiment of the system for dosing and aerosolization is shown. The system 100 comprises a device 1 for dosing and aerosolization, in which an aerosolization channel 3 is arranged inside a body 2 . At its distal end (on the right in FIG. 1 ), the body 2 comprises a capillary seat 4 into which a capillary tube holder 14 supporting a capillary tube 13 is fitted. This capillary tube holder 14 can in turn be connected via connecting lines and a valve (both not shown) to a supply of pulsed compressed carrier gas. At its proximal end (on the left in FIG. 1 ), the aerosolization channel 3 opens into a dispersing nozzle 5 whose cross section increases continuously in a direction extending away from the capillary tube 13 .
[0049] Above the aerosolization channel 3 , the device 1 comprises a reservoir 9 for the powdery material to be aerosolized. The reservoir 9 comprises an outer wall 10 and an inner portion having a cylindrical wall 11 and conically tapering wall 12 . The walls 11 and 12 are self-exciting membranes made of, e.g., medical grade silicone having a wall thickness of about 0.5 mm. Between the outer wall 10 and the cylindrical and conical walls 11 and 12 , spaces 6 and 7 are respectively formed. At the bottom, the reservoir 9 forms an aperture 19 located above the aerosolization channel 3 that is partially integral part of the dosing chamber 8 . Located above this aperture 19 will be a charge of the powder to be aerosolized (not shown) which may be clumped together to such an extent that almost no grain of aerosolizable material enters the aerosolization channel 3 . The whole assembly consisting of parts 5 , 3 , 15 , 8 , 13 , and 4 may be turned by 90 degrees around the apparatus' longitudinal axis to prevent powder from falling into the chamber 8 , thus closing the reservoir. Accordingly, said assembly together with the body 2 forms a rotary valve which allows to interrupt supply of the powder stored in the reservoir 9 to the dosing chamber 8 and aerosolization channel 3 .
[0050] On top of the reservoir 9 , a lid 16 is provided that tightly closes the reservoir. At the bottom side of the lid, towards the interior of the reservoir, a self-exciting membrane 17 is provided that seals the top opening of the reservoir 9 . Above the membrane, a humidity (or generally gas) absorber 18 is included in the cover that eliminates residual humidity or other trace gases in the reservoir which otherwise could have adverse effects. Furtheron, a space is formed between the membrane 17 and the humidity absorber 18 (not shown).
[0051] In the present embodiment, the reservoir 9 and the body 2 with the aerosolization channel 3 are integrally formed, whereby complete gas-tightness and sterility is guaranteed. However, it is to be understood that they may also be separate elements that are fitted together in an gas-tight manner.
[0052] The dispersing nozzle 5 opens into a proximal attachment piece 2 a which is an integral component part of the body 2 . Onto the attachment piece 2 a , a hollow spacer 20 is fitted in a gas-tight manner. The spacer 20 comprises a cylindrical outer wall 21 , a distal portion with conical inner walls 22 tapered distally, a proximal portion with conical inner walls 24 tapered proximally, and a central portion having cylindrical walls 23 arranged there between. As with the reservoir, also the walls 22 , 23 , 24 of the spacer 20 are self-exciting membranes made of, e.g., silicone. Between the outer wall 21 and walls 22 , 23 , 24 corresponding spaces 25 , 26 , 27 are provided. An annular gap is formed between the distal and central portions of the spacer 20 and is connected to an auxiliary gas supply (not shown).
[0053] In operation, pressure pulses of carrier gas enter the aerosolization channel 3 of device 1 through the capillary 13 and, due to the pressure difference created between the gas exiting from capillary 13 and the reservoir 9 by Venturi's principle, aerosolizable material is sucked from the reservoir 9 into the aerosolization channel 3 , dispersed and entrained in the carrier gas. At the same time, this differential pressure pulse also acts on the membrane walls 11 , 12 of the reservoir 9 and the membrane walls 22 , 23 , 24 of the spacer 20 , causing them to bulge and oscillate according to the frequency of the pressure pulses. Thus, aerosolizable material adhering to the walls is reentrained into the bulk material and free to enter the carrier gas stream.
[0054] It is to be understood that in alternative embodiments only some of the inner walls of the device are carried out as self-exciting membranes. For example, in an alternative embodiment only the tapered wall 12 is a self-exciting membrane. Obviously, each inner wall of the device which is not carried out as self-exciting membrane does not require a hollow space between this inner and the corresponding outer wall. For example, when only the tapered wall 12 is carried out as self-exciting membrane, spaces 6 and 25 - 27 are dispensable.
[0055] The amount of aerosolizable material that can be administered with the devices and systems of the present invention exceeds 50 mg and is coupled with a high precision of dosage. On one hand, the precision allows the use of drugs having a very narrow “therapeutic window” and on the other hand the large volumes make the system suitable for use with substances that need to be administered in large quantities. For example, aerosolizable medical substances other than lung surfactant which can be administered by use of the device according to the invention include antibiotics, nucleic acids, retard formulas, peptides/proteins, vaccines, antibodies, insulin, osmotically active substances like mannitol, hydroxyethyl starch, sodium chloride, sodium bicarbonate and other salts, enzymes (e.g., DNAse), N-acetyl cystein, etc.
[0056] Turning now to FIG. 2 , an embodiment of a system for dosing and aerosolization 200 is shown, which is employed for large volume dry powder inhalation of spontaneously breathing patients. The system 200 comprises the device 1 for dosing and aerosolization and the first spacer 20 of the first embodiment, wherein additionally a compensation tubing 29 connects the spaces 6 , 7 of the reservoir with spaces 25 , 26 , 27 of the spacer 20 . On the upstream side, the system 200 comprises a controller 50 that is connected via a compressed air line 51 to a compressed air supply 52 (e.g., the compressed air supply of a hospital) providing the compressed air through a main connecting line 41 to the dosing and aerosolization device 1 . The main connecting line 41 is connected to the capillary holder 14 (distal attachment portion) of the device 1 . The flow of the compressed air to the device is regulated by a fast-switching solenoid valve 40 which is caused to open and close by a current pulse 43 sent from the controller so as to achieve a determined number, duration and frequency of air pressure pulses. In use, the flow of compressed air may be triggered automatically by the controller, but may also be triggered by the breathing of the patient so as to adapt the timing of aerosolization and the volume of aerosolized material provided in the second spacer to the patient's breathing characteristics.
[0057] An auxiliary connecting line 42 supplies un-pulsed air to the annular gap 28 of the spacer 20 (the connection is not shown) to thereby flush the spacer of residues of aerosolizable material. Both connecting lines 41 and 42 comprise filters F to block contamination by undesired particles.
[0058] On the downstream side, a second spacer 30 is connected to the first spacer 20 . At the same time, an ambient air inlet 31 provided with a no-return valve 32 is provided at the distal end of the second spacer 30 . At the proximal end of the second spacer 30 , a straight connector 34 with a mouth piece 35 is positioned, while an exhaled gas outlet 36 (optionally with a filter F) branches perpendicularly off the straight connector 34 .
[0059] FIG. 3 shows an embodiment of the system for dosing and aerosolization that is particularly suited for acute respiratory therapy of very young children such as infants and neonates. Several components which are the same or are equivalent to those described with respect to FIGS. 1 and 2 bear the same reference numerals and will not be discussed again. The system 300 comprises the device 1 for dosing and aerosolization and the spacer 20 , and a controller 50 which is connected to it in the same way as in the embodiment of FIG. 2 . Connected to the output of spacer 20 is a ventilator tubing 60 that in turn connects to the first port of a T-piece 61 . Further, in this embodiment a ventilator in CPAP mode 70 is provided that supplies respiratory gas via respiratory gas line 64 to a manifold 65 while keeping the ventilator pressure at a constant level. From the manifold 65 , a common ventilating line 62 connects to the second port of the T-piece 61 . The third port is connected to a nasopharyngeal tube 66 that is introduced through the infant's nose so that its tip is positioned just above the glottis.
[0060] Further, a flow rate sensor 67 is disposed at the manifold to measure the gas flow rate V 3 of the gas in common line 62 . The measurement signals are fed back to the ventilator 70 , which directly controls the pressure in line 64 and in line 63 by controlling the respective flow rates, and therefore indirectly controls V 3 . By means of this pressure control additional flow from the disperser dosing unit causes V 3 to be down regulated so that the pressure and hence total flow to the infant (V 5 ) is kept constant.
[0061] In addition, an oxygen sensor 69 is provided at the third port of the T-connector 61 , monitoring oxygen content of the respiratory gas mixture actually administered to the lungs of the infant. The respective measurement signals are fed back to the ventilator 70 , where together with the flow rate information a comprehensive picture of the properties of the supplied respiratory gas mixture is obtained. These properties are then in turn controlled by the ventilator 70 . In summary, by connecting the device 1 in parallel with the respiratory system, it becomes possible both to provide oxygen-rich respiratory gas and the correct dose of aerosolized material, such as lung surfactant.
[0062] Finally, turning to FIG. 4 , another embodiment of a system for dosage and aerosolization is shown. The system 400 is used with ventilated adult patients and comprises the device 1 for dosing and aerosolization, the controller 50 , a ventilator 71 and a hollow spacer 80 . The controller is connected in the above-described manner to a hospital air supply 52 and via a main connecting line 41 with valve 40 to the device 1 , just as described in the foregoing embodiments. However, in this embodiment, the spacer 80 is much larger than spacer 20 , both in diameter and in volume, in order to accommodate the needs of an adult ventilated patient. The spacer 80 is connected at its distal end to the proximal attachment piece 2 a of the device 1 and has at its proximal end a straight connector 84 leading to a breathing mask 85 . A respiratory gas inlet 81 with a non-return valve 82 is disposed laterally on the distal end of the spacer 80 and is connected in the usual manner via a filter and respiratory gas line 64 to the ventilator 71 . Similarly, at the proximal side an exhaled gas outlet 86 is connected via a non-return valve 82 and exhaled gas return line 63 to the ventilator.
[0063] The amount of aerosolizable material that can be administered with the devices and systems of the present invention exceeds 50 mg and is coupled with a high precision of dosage. On the one hand, the precision allows the use of drugs having a particularly narrow “therapeutic window” and on the other hand the large volumes make the system suitable for use with substances that need to be administered in large quantities. For example, aerosolizable medical substances other than lung surfactant which can be administered by use of the device according to the invention include contrast agents, antibiotics, nucleic acids, retard formulas, peptides/proteins, vaccines, antibodies, insulin, osmotically active substances like mannitol, hydroxyethyl starch, sodium chloride, sodium bicarbonate and other salts, enzymes (e.g. DNAse), N-acetyl cystein, etc.
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The claimed subject matter relates to a device for dosing and aerosolization of aerosolizable material. The device comprises: a body with an aerosolization channel with a distal attachment portion connectable to a source of carrier gas which provides pressure pulses to the aerosolization channel; a proximal attachment portion for outputting aerosolized material and a reservoir for receiving aerosolizable material. The reservoir comprises walls and is connected in a gas-tight manner to the body and in fluid connection with the aerosolization channel. At least part of the walls of the device are self-exciting membranes that can be put into oscillation by the pressure pulses.
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TECHNICAL FIELD
[0001] The present invention relates generally to stabilization systems and methods configured to stabilize at least a portion of the spinal column via the use of an interconnection mechanism for engaging two or more stabilization members to one another.
BACKGROUND
[0002] In the art of orthopedic surgery, and particularly spinal surgery, it has long been known to anchor one or more elongate stabilization members, such as spinal plates or rods, to a portion of the spinal column to provide stabilization and support across two or more vertebral levels. With regard to prior stabilization systems, in order to revise or add to an existing system, one or more stabilization components must be loosened and/or removed to allow for integration and attachment of additional stabilization members or devices to the system, thereby tending to increase the complexity and duration of the surgical procedure.
[0003] There remains a need for improved stabilization systems and methods. The present invention satisfies this need and provides other benefits and advantages in a novel and unobvious manner.
SUMMARY
[0004] The present invention relates generally to stabilization systems and methods configured to stabilize at least a portion of the spinal column. While the actual nature of the invention covered herein can only be determined with reference to the claims appended hereto, certain forms of the invention that are characteristic of the invention are described briefly as follows.
[0005] In one aspect of the present invention, a bone structure stabilization system is provided which is capable of stabilizing adjacent bone structures. The bone structure stabilization system includes an anchor member having an upper segment and a lower segment. The lower segment of the anchor member is structurally configured to be positioned in a respective bone segment. In one embodiment, the lower segment of the anchor member comprises an externally threaded segment that acts as a bone screw for securing the anchor member in a respective bone structure. A first stabilization member is connected to the upper segment of the anchor member. In one example, the first stabilization member comprises a rod and the upper segment of the anchor member includes a head defining a cradle portion in which a portion of the rod is positioned.
[0006] The bone structure stabilization system also includes a locking member that is engaged with the anchor member. The locking member is connected to the anchor member such that the first stabilization member is fixedly secured to the anchor member by a lower portion of the locking member. The lower portion of the locking member protrudes downwardly from a mounting segment of the locking member and includes an externally threaded segment. The anchor member includes an internally threaded segment within which the externally threaded segment of the locking member is threaded to engage the locking member with the anchor member. A lower surface of the externally threaded segment makes contact with a surface of the first stabilization member to thereby secure the first stabilization member to the anchor member.
[0007] The bone structure stabilization system also includes a second stabilization member that is connected to an upper portion of the locking member. In one example, the second stabilization member comprises a plate member having an elongated slot. The upper portion of the locking member includes an externally threaded segment about which the elongated slot is positioned. A portion of the externally threaded segment protrudes upwardly through the elongated slot and above an upper surface of the plate member. A cap is connected to the upper portion of the locking member to secure the second stabilization member to the locking member. In one embodiment, the cap includes an internally threaded segment that threads onto the externally threaded segment of the locking member that protrudes upwardly through the upper surface of the plate member to secure the plate member to the locking member.
[0008] Another aspect of the present invention is directed to a method of stabilizing adjacent bone structures. The method includes the step of inserting an anchor member into a portion of bone structure. The anchor member includes a threaded portion that is capable of threading into a portion of bone structure to fixedly secure the anchor member to the bone structure. A first stabilization member is then positioned within a cradle defined by the anchor member. The first stabilization member is secured in the cradle of the anchor member with a locking member that includes a lower mounting surface and an upper mounting surface. A threaded segment protrudes downwardly from the lower mounting surface and threads into an internally threaded segment of the anchor member. A second stabilization member is then placed on the upper mounting surface of the locking member. Once in place, the second stabilization member is secured on the upper mounting surface of the locking member with a locking cap. The cap threads onto a threaded segment protruding upwardly from the upper mounting surface.
[0009] Yet another aspect of the present invention is directed to a spinal stabilization apparatus. The spinal stabilization apparatus includes a plurality of bone anchor members positioned in respective vertebrae of a spinal column. A first stabilization member is positioned in a first set of the bone anchor members that spans from a beginning location in one vertebra to an ending location in another vertebra. A first locking member is positioned in each of the bone anchor members of the first set of bone anchor members except the bone anchor member at the ending location. The first locking member secures the first stabilization member in the first set of bone anchor members.
[0010] A dual thread locking member is positioned in the bone anchor member at the ending location. The dual thread locking member includes a mounting segment positioned between an upper externally threaded segment and a lower externally threaded segment. The lower externally threaded segment threads into an internally threaded portion of the bone anchor member at the ending location to secure the first stabilization member in the bone anchor member. A second stabilization member is positioned about the upper externally threaded segment of the dual thread locking member and a portion of the upper externally threaded segment protrudes above a surface of the second stabilization member. A locking cap is used to secure the second stabilization member to the upper externally threaded segment.
[0011] Another aspect of the present invention is directed to a method of revising an implanted spinal construct. The method includes removing a set screw from an anchor member that secures a first stabilization member to a respective bone segment. A lower portion of a locking member is then connected to the anchor member to once again secure the first stabilization member to the anchor member. A second stabilization member is then placed about an upper portion of the locking member such that a portion of a lower surface of the second stabilization member rests on an upper surface of a mounting segment of the locking member. A cap is then secured to the upper portion of the locking member to fixedly secure the second stabilization member to the upper surface of the mounting segment. This method allows constructs to be revised without requiring the removal of an existing construct, thereby reducing surgery time, recovery time, and the number of components required to perform the revision surgery.
[0012] Yet another aspect of the present invention is directed to a locking member for a bone stabilization apparatus having at least first and second stabilization members. The locking member includes a mounting segment having an upper engagement surface and a lower engagement surface. A lower threaded segment extends downwardly from the lower engagement surface of the mounting and is structurally configured to be connected with an anchor member to secure the first stabilization member within the anchor member. An upper threaded segment extends upwardly from the upper engagement surface of the mounting segment that is structurally configured to receive a second stabilization member such that a portion of the second stabilization member rests on the upper engagement surface. A locking cap having an internal threaded segment is structurally configured to thread onto the upper threaded segment to secure the second stabilization device to the upper engagement surface of the mounting segment.
[0013] It is one object of the present invention to provide stabilization systems and methods configured to stabilize at least a portion of the spinal column. Further objects, features, advantages, benefits, and aspects of the present invention will become apparent from the drawings and description contained herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 illustrates a stabilization system according to one embodiment of the present invention, as engaged to a portion of the spinal column.
[0015] FIG. 2 is a top view of a stabilization member according to one embodiment of the present invention.
[0016] FIG. 3 is a side view of the stabilization member illustrated in FIG. 2 .
[0017] FIG. 4 is a side perspective view of an anchor member according to one embodiment of the present invention.
[0018] FIG. 5 illustrates a stabilization assembly according to another embodiment of the present invention including an elongate stabilization member engaged with an anchor member by a locking member.
[0019] FIG. 6 is a perspective view of the locking member illustrated in FIG. 5 .
[0020] FIG. 7 illustrates a stabilization assembly according to another embodiment of the present invention including first and second stabilization members engaged with an anchor member by a locking member.
[0021] FIG. 8 is a side perspective view of a locking cap portion of the locking member illustrated in FIG. 7 .
[0022] FIG. 9 is a side view of the locking cap portion illustrated in FIG. 8 .
DETAILED DESCRIPTION
[0023] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is hereby intended, and that alterations and further modifications to the illustrated devices and/or further applications of the principles of the invention as illustrated herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
[0024] Referring to FIG. 1 , illustrated therein is a spinal stabilization system 10 according to one form of the present invention. The stabilization system 10 generally includes first supports or stabilization members 12 a , 12 b engaged to a first portion of the spinal column via a number of bone anchors 18 , which are in turn interconnected with second supports or stabilization members 14 a , 14 b engaged to a second portion of the spinal column 16 via a number of bone anchors 18 . The anchor members 18 are configured to securely anchor the stabilization members 12 a , 12 b and 14 a , 14 b to respective vertebrae 22 of the spinal column 16 . As will be set forth in greater detail below, in one embodiment of the invention, the anchor members 18 comprise bone screws, with locking members provided to engage the stabilization members to the bone screws. However, it should be understood that other types and configurations of anchor members are also contemplated as falling within the scope of the present invention including, for example, spinal hooks, staples, bolts or any other suitable bone anchor device that would occur to one of skill in the art.
[0025] Although the embodiment of the invention shown in FIG. 1 illustrates the stabilization system 10 engaged to a lateral aspect of the spinal column 16 , it should be understood that the stabilization system 10 may be engaged to other portions of the spinal column 16 , including posterior or anterior portions. Additionally, it is also contemplated that the present invention may have application in other parts of the human body including, for example, other types of joints or long bones. The particular arrangement of the stabilization members 12 a , 12 b and 14 a , 14 b is determined by the surgeon before and/or during the surgical procedure to conform the stabilization system 10 to the patient's anatomy and to provide relief for the patient's diagnosed medical condition. It should be understood, however, that the particular arrangement of the first and second stabilization members 12 a , 12 b and 14 a , 14 b is exemplary, and may be adjusted or changed to provide any desired stabilization arrangement or configuration.
[0026] In the illustrated embodiment of the invention, the first stabilization members 12 a , 12 b comprise elongate spinal rods. Although a conventional circular-shaped spinal rod is illustrated, it should be appreciated that other shapes and configurations are also contemplated, including square, rectangular, hexagonal, diamond and elliptical shaped rods, or any other suitable shape that would occur to one of skill in the art. The spinal rod 12 a , 12 b may be formed from stainless steel, titanium, polyethertherketone (PEEK), or any other suitable biocompatible material known to those of skill in the art. In the illustrated embodiment, the stabilization system 10 includes a pair of spinal rods 12 a , 12 b running substantially parallel to one another along the spinal column 16 . However, in other embodiments, a single spinal rod may be used. Additionally, it should be understood that the stabilization members 12 a , 12 b may take on other configurations including, for example, plates, wires, tethers, or any other suitable configuration known to those of skill in the art.
[0027] Referring collectively to FIGS. 2 and 3 , in one embodiment of the invention, the second stabilization members 14 a , 14 b comprise plate members. The plate members 14 a , 14 b include an elongate body 26 extending along a longitudinal axis 28 . In the illustrated embodiment, the elongate body 26 includes at least one opening in the form of an elongate slot 30 extending generally along the longitudinal axis 28 . The elongate slot 30 extends through the elongate body 26 between upper and lower surfaces 32 , 34 , thereby defining side rails 36 extending longitudinally along opposite sides of the elongate slot 30 , and a pair of end rails 38 extending transversely between the side rails 36 adjacent the ends of the elongate body 26 . The plate members 14 a , 14 b further include a flange portion 39 extending downwardly from one of the end rails 38 . As illustrated in FIG. 7 , the flange portion 39 includes a lower engagement surface 40 configured to conform to an outer surface of the spinal rods 12 a , 12 b . In the illustrated embodiment, the engagement surface 40 has a curved or concave configuration which conforms with an outer curved surface of the spinal rods 12 a , 12 b . However, other shapes and configurations are also contemplated. In the illustrated embodiment, the plate member 14 a , 14 b include a curved or angled section 42 which interconnect first and second portions of the body 26 that are offset from one another by a distance d. In other embodiments, the plate member 14 a , 14 b need not include a curved or angled section, but may instead be provided with a generally flat or planar configuration.
[0028] Although a particular configuration of the stabilization members 14 a , 14 b has been illustrated and described herein, it should be appreciated that other plate configurations are also contemplated as falling within the scope of the present invention. Additionally, it should be understood that the stabilization members 14 a , 14 b may take on other configurations including, for example, rods, wires, tethers, or any other suitable configuration known to those of skill in the art. The stabilization members 14 a , 14 b may be formed from stainless steel, titanium, polyethertherketone (PEEK), or any other suitable biocompatible material known to those of skill in the art. In the illustrated embodiment, the stabilization system 10 includes a pair of plate members 14 a , 14 b running substantially parallel to one another along the spinal column 16 . However, in other embodiments, a single plate member may be used.
[0029] The spinal rods 12 a , 12 b and the plate members 14 a , 14 b are engaged to the spinal column 16 via a plurality of anchor members 18 , which as indicated above may be configured as bone screws. Referring to FIG. 4 , shown therein is one embodiment of an anchor member 18 suitable for use in association with the present invention. The anchor member 18 extends generally along a longitudinal axis and includes a distal segment 40 , an intermediate threaded segment 42 , and a proximal fixation or connection segment 44 . The distal segment 40 may be provided with self-cutting or self-drilling capabilities, including a tip 46 defining a cutout or flute 50 providing a cutting edge 52 . The threaded segment 42 defines a helical thread 54 configured for anchoring in bone, and more particularly in cancellous bone. In the illustrated embodiment, the fixation segment 44 comprises a head 60 having a pair of generally parallel arms 62 a , 62 b that provide a cradle 68 defining a generally U-shaped channel 70 between the arms 62 a , 62 b for receiving the first stabilization member or spinal rod 12 a , 12 b . An interior surface 72 of the arms 62 a , 62 b defines inner threads 74 for receiving a set screw such as, for example, a conventional set screw 19 ( FIG. 1 ) for capturing the spinal rod 12 a , 12 b within the cradle 68 and U-shaped channel 70 of the bone anchor 18 . Although a particular configuration of a bone anchor 18 has been illustrated and described herein, it should be understood that other types and configurations are also contemplated.
[0030] Referring to FIG. 5 , shown therein is another embodiment of an anchor member 18 ′ suitable for use in association with the present invention. The anchor member 18 ′ is also configured as a bone screw and, like the bone screw 18 , includes a distal segment 40 , an intermediate threaded segment 42 defining a helical thread 54 , and a proximal fixation or connection segment 44 including a head 60 having a pair of generally parallel arms 62 a , 62 b that provide a cradle 68 defining a generally U-shaped channel 70 for receiving one of the spinal rod 12 a , 12 b . Additionally, like the bone screw 18 , the interior surfaces of the arms 62 a , 62 b define inner threads for receiving a locking member or set screw for capturing the spinal rod 12 a , 12 b within the cradle 68 and U-shaped channel 70 of the bone anchor 18 ′. However, unlike the bone screw 18 which has a single-piece configuration, the bone screw 18 ′ has a poly-axial configuration wherein the connection segment 44 is formed separately from the threaded segment 42 and is attached thereto in a manner which allows the connection segment 44 to pivot or rotate relative to the threaded segment 42 prior to being locked at a selected angular and/or rotational position. Poly-axial bone screws are well know to those of skill in the art and need not be discussed in further detail herein. Although a particular configuration of the poly-axial bone anchor 18 ′ has been illustrated and described herein, it should be understood that other types and configurations are also contemplated.
[0031] Referring collectively to FIGS. 5 and 6 , shown therein is a locking member 80 according to one embodiment of the present invention for securing one of the spinal rods 12 a , 12 b within the cradle 68 and U-shaped channel 70 of the bone anchor 18 , 18 ′, and for coupling one of the plate members 14 a , 14 b to the bone anchor 18 , 18 ′. In the illustrated embodiment, the locking member 80 comprises a dual-threaded member including a lower threaded segment 82 and an upper threaded segment 84 that are separated from one another by an intermediate contact or mounting segment 86 . The locking member 80 extends generally along an axis 87 , with the upper and lower threaded segments 82 , 84 extending axially from the mounting segment 86 in generally opposite directions.
[0032] The lower threaded segment 82 includes external threads 88 that are configured for threading engagement with the internal threads 74 formed along the arms 62 a , 62 b of the bone anchor 18 , 18 ′. The length of the lower threaded segment 82 may be sized such that a lower surface 90 of the intermediate mounting segment 86 engages an upper surfaces 66 of the arms 62 a , 62 b of the bone anchor 18 , 18 ′, while at the same time exerting sufficient force against the spinal rod 12 a , 12 b to secure the spinal rod 12 a , 12 b in position relative to the bone anchor 18 , 18 ′. The upper threaded segment 84 includes external threads 92 that are configured for threading engagement within a threaded passage formed in a locking cap or nut 110 ( FIGS. 8 and 9 ). The upper threaded segment 84 further includes a pair of opposing flat or truncated surfaces 102 that are engagable by a tool or wrench. The length of the upper threaded segment 82 is sized to extend into the elongate slot 30 defined by the plate member 14 a , 14 b , with an upper surface 100 of the intermediate mounting segment 86 engaging a lower surface 34 of the plate member 14 a , 14 b . Although the external threads 88 , 92 formed along the upper and lower threaded segments are illustrated as having a particular thread configuration, it should be understood that various thread configurations are contemplated including, for example, a buttress thread, a helical thread, a square thread, a reverse-angle thread or other thread-like structures.
[0033] Referring collectively to FIGS. 7-9 , shown therein is a locking cap or nut 110 according to one embodiment of the present invention. The locking cap 100 is generally circular in shape and extends generally along an axis 112 . In the illustrated embodiment, the locking cap 100 includes an upper portion 114 , a lower portion 116 , and an axial passage 118 extending through the upper and lower portions 114 , 116 . A first portion of the axial passage 118 extending through the upper portion 114 of the locking cap 110 has a hexagonal shape configured for engagement with a driving tool and terminates at a base or shoulder 120 . A second portion of the axial passage 118 extending through the lower portion 116 of the locking cap 110 has a circular shape and defines internal threads 122 configured for threading engagement with the external threads 92 formed along the upper threaded segment 84 of the locking member 80 . The first portion of the axial passage 118 extending through the upper portion 114 of the locking cap 110 may be provided with a series of notches or grooves 124 that provide frictional engagement with the driving tool and/or which aid in engaging or securing a lid or cover (not shown) to the locking cap 110 to close off the axial passage 118 .
[0034] As illustrated in FIG. 9 , the upper portion 114 of the locking cap 110 defines a curved or rounded upper surface 115 devoid of sharp edges or corners to avoid injury or trauma to adjacent tissue. The lower portion 116 of the locking cap 110 includes a first cylindrical portion 126 having a diameter sized somewhat smaller than the upper portion 114 of the locking cap 110 , thereby defining a lower surface or shoulder 130 . The diameter of the first cylindrical portion 126 is preferably sized in relatively close tolerance with the width of the elongate slot 30 extending through the plate members 14 a , 14 b . The lower portion 116 of the locking cap 110 further includes a second cylindrical portion 128 extending from the first cylindrical portion 126 and having a diameter sized somewhat smaller than the first cylindrical portion 126 . The end of the second cylindrical portion 128 may be provided with a tapered edge 132 . As shown in FIG. 7 , when the locking cap 110 is threaded onto the upper threaded segment 84 of the locking member 80 , the lower surface or shoulder 130 of the cap 110 engages the upper surface 32 of the plate member 14 a , 14 b , thereby forcing the plate member 14 a , 14 b into tight engagement against the upper surface 100 of the locking member 80 , and also firmly engaging the lower engagement surface 40 of the flange 39 against the outer surface of the spinal rod 12 a , 12 b . Although a particular configuration of the locking cap 110 has been illustrated and described herein, it should be understood that other configurations are also contemplated as falling within the scope of the present invention.
[0035] In one embodiment of the invention, stabilization members 12 a , 12 b may comprise a stabilization system that has previously anchored to a first portion of the spinal column 16 by a number of bone anchors 18 , 18 ′ via a prior surgical procedure. In some instances, correction or stabilization of another portion of the spinal column is required or desired. In such instances, additional stabilization members 14 a , 14 b may be engaged with the stabilization members 12 a , 12 b and anchored to another portion of the spinal column 16 by additional bone anchors 18 , 18 ′ to provide further stabilization or support to the spinal column. Such procedures are sometimes referred to as a revision procedure or technique. During a revision procedure, benefits or advantages may be realized by avoiding removal or extensive manipulation of the previously implanted stabilization system.
[0036] Referring collectively to FIGS. 1 , 5 and 7 , in one embodiment of the invention, the conventional set screws 19 may be removed from the bone anchors 18 , 18 ′ adjacent one end of the existing stabilization system. The removed set screws 19 are then replaced with locking members 80 , with the lower threaded segment 82 of each locking member 80 threadedly engaged along the internal threads 74 formed along the arms 62 a , 62 b of a respective bone anchor 18 , 18 ′ and into engagement with the spinal rod 12 a , 12 b to once again securely engage the spinal rods 12 a , 12 b to the existing bone anchors 18 , 18 ′. The plate members 14 a , 14 b are then engaged to the bone anchors 18 , 18 ′ via insertion of the upper threaded segment 84 of the locking member 80 into the elongate slot 30 , with the lower surface 34 of the plate member 14 a , 14 b resting upon the upper surface 100 of the intermediate mounting segment 86 of the locking member 80 . A locking cap 110 is then threaded onto the upper threaded segment 84 of each locking member 80 until the lower surface or shoulder 130 of the cap 110 tightly engages the upper surface 32 of the plate member 14 a , 14 b , thereby forcing the plate member 14 a , 14 b into tight engagement against the upper surface 100 of the locking member 80 , and also firmly engaging the lower engagement surface 40 of the flange 39 against the outer surface of the spinal rod 12 a , 12 b . Additional bone anchors 18 , 18 ′ are used to anchor the opposite ends of the plate members 14 a , 14 b to another portion of the spinal column. As should be appreciated, the plate members 14 a , 14 b are interconnected with the existing spinal stabilization system (including the spinal rods 12 a , 12 b and the existing bone anchors 18 , 18 ′) without extensive manipulation or removal of the components associated with the existing stabilization system.
[0037] While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character.
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A spinal stabilization system, apparatus, and method are disclosed which include an interconnection mechanism for engaging stabilization members to one another. In one embodiment, the interconnection mechanism comprises a locking member having first and second threaded segments. An anchor member is provided having an upper segment and a lower segment, wherein the lower segment is structurally configured for engagement with a respective bone segment. A first stabilization member is connected to the upper segment of the anchor member. A locking member is engaged with the anchor member such that the first stabilization member is fixedly secured to the anchor member by a lower portion of the locking member having a first threaded segment. A second stabilization member is connected to an upper portion of the locking member by a cap that is threaded onto a second threaded segment of the locking member.
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FIELD OF THE INVENTION
The present invention relates generally to an apparatus for use in an orthopedic surgery, and more particularly to an apparatus for locating the interlocking intramedullary nails.
BACKGROUND OF THE INVENTION
The U.S. Pat. No. 5,474,561 of the same applicant has disclosed an all positional and universal guiding device for interlocking intramedullary nail. Under such a prior art, the applicant devotes himself and creates a further development and precision apparatus for locating interlocking intramedullary nails.
The interlocking intramedullary nails are often used in treatment of deformities, diseases, and injuries of bones, such as humerus, femur, tibia, etc. The interlocking intramedullary nails are used in conjunction with the fixation nails for the rehabilitation of the deformed bone. Such restorative operation is often complicated by the fact that there are a variety of interlocking intramedullary nails, which are different in specification and are made by various manufacturers.
It is technically difficult to implant an interlocking intramedullary nail with precision. In order to minimize the technical difficulty that is involved in the implanting of the interlocking intramedullary nail, the X-ray machine is often used to help the surgeon to align the nail with the threaded hole. It is conceivable that the constant exposure to the X-rays is hazardous to the health of the surgeon.
SUMMARY OF THE INVENTION
The primary objective of the present invention is to provide an adjustable apparatus enabling the interlocking intramedullary nails of various specifications to be aligned with the near end and the far end threaded holes without the use of the X-ray machine.
The features and the advantages of the present invention will be more readily understood upon a thoughtful deliberation of the following detailed description of the present invention with reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows an exploded view of the present invention.
FIG. 2 shows a perspective view of the present invention in combination.
FIG. 3 shows a schematic view of the inclined near end threaded hole of the present invention.
FIG. 4 shows a schematic view of another near end threaded hole of the present invention.
FIG. 5 shows a schematic view of the far end threaded hole of the present invention.
FIG. 6 shows a schematic view of a locating embodiment of another near end threaded hole of the present invention.
FIG. 7 shows a schematic view of a drilling embodiment of another near end threaded hole of the present invention.
FIG. 8 shows a schematic view of the embodiment of the inclined near end threaded hole of the present invention.
FIG. 9 shows a schematic view of a locating embodiment of the far end threaded hole of the present invention.
FIG. 10 shows a schematic view of a drilling embodiment of the far end threaded hole of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
As shown in FIGS. 1 and 2, the present invention comprises a curved main body 10 and a vertical seat 11 , which is perpendicular to the bone nail and is provided with and inner recessed hole 12 and a plurality of fastening holes 13 . The main body 10 is provided with a parallel seat 14 which is parallel to the bone nail and is provided with a long slide slot 15 and a swaying seat 16 which is in turn provided with a locking hole 17 . The locking hole 17 is provided at the outer end thereof with a protruded pillar 18 . The inner recessed hole 12 of the vertical seat 11 of the main body 10 is provided with an extension seat 20 which is provided with an expandable rod 21 having a plurality of fitting holes 22 corresponding to the locking hole 13 . The extension seat 20 is provided at other end thereof with a carrying seat 23 which is provided in the midsegment thereof with a through hole 24 which is provided at the bottom end thereof with a locating block 25 projecting therefrom. The extension seat 20 is further provided with a near end inclined hole 26 as desired. The locking hole 13 end of the main body 10 is provided with two threaded rods 27 to cooperate with the fitting hole 22 . In light of various bone nail designs, the carrying seat 23 is provided at the bottom end thereof with a rotary connection block 30 which is in turn provided at the bottom end with an orientation locating block 32 for connecting the threaded rod 35 end of a nail connection rod 34 . The parallel seat 14 is provided with two slide blocks 40 fastened thereto. The slide block 40 is provided with two retaining holes 41 in cooperation with the slide slot 15 . The slide block 40 is provided in one side with a fixation thread 42 to cooperate with a threaded rod 43 . The swaying seat 16 is provided with an adjustment swing arm 50 which is provided with an axial hole 51 to cooperate with the locking hole 17 so as to set up a threaded rod 52 . The adjustment swing arm 50 is provided with a slide hole 53 and a locking hole 54 to cooperate a threaded rod 55 . The protruded pillar 18 of the main body 10 is provided with an arcuate restriction slot 56 . The adjustment swing arm 50 is provided at the bottom end thereof with an adjustment block 60 extending therefrom and having a locating slide shaft 61 to cooperate the slide hole 53 of the adjustment swing arm 50 . The locating slide shaft 61 is provided at one end with a retaining face 62 . The adjustment block 60 is provided at the front end with an axial hole 63 which is provided at the outer end with a recessed restriction slot 64 . The axial hole 63 of the adjustment block 60 is connected with the locking hole 72 of the rotary seat 71 of a slide seat 70 by a threaded rod 65 . The locking hole 72 is provided at the outer end with a protruded pillar 73 to cooperate with the restriction slot 64 . The slide seat 70 is provided with a slide through hole 74 and a fitting hole 75 . A threaded rod 77 is provided to fasten the locking hole 76 of the slide hole 74 in which an adjustment rod 80 is received. An opening hole 81 is corresponding to the fitting hole 75 of the slide seat 70 . The adjustment rod 80 is provided at the front end with a fitting hole 82 . Finally, the near end inclined hole 26 , the retaining hole 41 , the fitting holes 75 , 82 are provided with a guide rod 36 or drilling guide sleeve 37 .
As shown in FIGS. 3-5, in conjunction with FIGS. 6-10, the component parts of the present invention can be easily separated or combined. They can be stored separately in an orderly manner. They can be stored separately in an orderly manner. They can be put together as required in cooperation with the interlocking intramedullary nails of various specifications.
As shown in FIG. 3, in light of the near end threaded hole of the interlocking intramedullary nail being of an inclined construction, only the extension seat 20 is called for such that the locating block 25 of the extension seat 20 is fitted with the interlocking intramedullary nail of an appropriate specification, and that it is fastened with the threaded rod 35 of the nail connection rod 34 . The near end inclined hole 26 is provided with the drilling guide sleeve 37 for drilling the near end threaded hole, as shown in FIG. 8 . The expandable rod 21 of the extension seat 20 can be cooperated with the body size of a patient such that it can be fixed in the inner recessed hole 12 by two threaded rods 27 .
As shown in FIG. 4, in light of the near end threaded hole of the interlocking intramedullary nail being perpendicular to the interlocking intramedullary nail end, the slide block 40 is fastened with the parallel seat 14 of the main body 10 after being fastened onto humerus, femur, or tibia. The interlocking intramedullary nails of various specifications are thus fastened by means of two guide rods 36 and the threaded rod 43 , as shown in FIG. 6 . The near end threaded holes of various intervals of interlocking intramedullary nails of various brands are thus located. Upon completion of the implanting of the nails onto humerus, femur, or tibia, the drilling guide sleeve 37 is connected to facilitate the work of drilling the near end threaded hole, as shown in FIG. 7 .
As shown in FIG. 5, the far end threaded hole is located by the present invention. Upon completion of the fastening of the interlocking intramedullary nail, the adjustment swing arm 50 of an appropriate length is selected and then fastened by the threaded rod 55 . The far end threaded hole member is formed of the adjustment block 60 , the slide seat 70 , and the adjustment rod 70 . The far end threaded holes of the interlocking intramedullary nails are connected by two guide rods 36 in conjunction with the fitting holes 75 and 82 . As the threaded rods 65 and 52 are unfastened, the protruded pillars 18 and 73 are located in the restriction slot 56 , 64 respectively. The present invention is capable of cooperating with the curvature of the interlocking intramedullary nails. Upon completion of the fastening of the threaded rods 77 , 65 , 55 , and 52 , the parallel locating of the far end threaded holes is thus attained, as shown in FIG. 9 . After the implantation of the interlocking intramedullary nail into femur, tibia, or humerus, the drilling guide sleeve 37 is fastened to facilitate the work of drilling the far end threaded hole, as shown in FIG. 10 . In light of the interlocking intramedullary nails being various in length, it is necessary to unfasten the threaded rod 55 so as to adjust the relative positions of the locating slide shaft 61 and the slide hole 53 of the adjustment swing arm 50 . For the purpose of locating the far end threaded holes of various brands, the threaded rod 77 is first unfastened so as-to adjust the two guide rods 36 in relation to the hole interval of various far end threaded holes of the interlocking intramedullary nails. The locating of the far end threaded holes of various brands can be also attained by adjusting the sliding distance of the adjustment rod 80 in the slide hole 74 of the slide seat 70 . Finally, the threaded rod 77 is fastened to conclude the adjusting of the hole interval of the far end threaded holes of various brands.
Depending on the body size of a patient, the adjustment of the near end and the far end threaded holes of the interlocking intramedullary nails of various specifications is attained by changing the adjustment swing arm 50 and the adjustment block 60 . The locating blocks 25 of various specifications can be adjusted by means of the expandable rod 21 of the extension seat 20 . According to the bone size of the patient, the locating of the threaded holes, the drilling of the threaded holes, and the fastening of the threaded holes can be done by adjusting the distance between the deformed bone and the horizontal seat 14 of the main body 10 , without the help of the X-ray machine.
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An apparatus for locating interlocking intramedullary nails comprises a slide device which is disposed at the near end of the nails and is capable of adjustment in various directions. The slide device is provided with a locking structure, a locating rod, or drilling guide sleeve. The relative positions of the near end and the far end threaded holes of the interlocking intramedullary nails of various hole intervals and specifications are adjusted by the slide device in accordance with the body size of a patient under treatment. The drilling position of the drilling guide sleeve can be attained with precision and speed.
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REFERENCE TO RELATED APPLICATION
[0001] The present application is a continuation of U.S. patent application Ser. No. 14/815232, filed on Jul. 31, 2015, entitled “Physiological Measurement Communications Adapter,” which is a continuation of U.S. patent application Ser. No. 14/217,788, filed on Mar. 18, 2014, entitled “Wrist-Mounted Physiological Measurement Device,” now U.S. Pat. No. 9,113,832, which is a continuation of U.S. patent application Ser. No. 14/037,137, filed on Sep. 25, 2013, entitled “Physiological Measurement Communications Adapter,” now U.S. Pat. No. 9,113,831, which is a continuation of U.S. patent application Ser. No. 12/955,826, filed on Nov. 29, 2010, entitled “Physiological Measurement Communications Adapter,” now U.S. Pat. No. 8,548,548, which is a continuation of U.S. patent application Ser. No. 11/417,006, filed on May 3, 2006, entitled “Physiological Measurement Communications Adapter,” now U.S. Pat. No. 7,844,315, which claims priority benefit under 35 U.S.C. §120 to, and is a continuation of, U.S. patent application Ser. No. 11/048,330, filed Feb. 1, 2005, entitled “Physiological Measurement Communications Adapter,” now U.S. Pat. No. 7,844,314, which is a continuation of U.S. patent application Ser. No. 10/377,933, entitled “Physiological Measurement Communications Adapter,” now U.S. Pat. No. 6,850,788, which claims priority benefit under 35 U.S.C. §119(e) from U.S. Provisional Application No. 60/367,428, filed Mar. 25, 2002, entitled “Physiological Measurement Communications Adapter.” The present application also incorporates the foregoing utility disclosures herein by reference.
BACKGROUND OF THE INVENTION
[0002] Patient vital sign monitoring may include measurements of blood oxygen, blood pressure, respiratory gas, and EKG among other parameters. Each of these physiological parameters typically requires a sensor in contact with a patient and a cable connecting the sensor to a monitoring device. For example, FIGS. 1-2 illustrate a conventional pulse oximetry system 100 used for the measurement of blood oxygen. As shown in FIG. 1 , a pulse oximetry system has a sensor 110 , a patient cable 140 and a monitor 160 . The sensor 110 is typically attached to a finger 10 as shown. The sensor 110 has a plug 118 that inserts into a patient cable socket 142 . The monitor 160 has a socket 162 that accepts a patient cable plug 144 . The patient cable 140 transmits an LED drive signal 252 ( FIG. 2 ) from the monitor 160 to the sensor 110 and a resulting detector signal 254 ( FIG. 2 ) from the sensor 110 to the monitor 160 . The monitor 160 processes the detector signal 254 ( FIG. 2 ) to provide, typically, a numerical readout of the patient's oxygen saturation, a numerical readout of pulse rate, and an audible indicator or “beep” that occurs in response to each arterial pulse.
[0003] As shown in FIG. 2 , the sensor 110 has both red and infrared LED emitters 212 and a photodiode detector 214 . The monitor 160 has a sensor interface 271 , a signal processor 273 , a controller 275 , output drivers 276 , a display and audible indicator 278 , and a keypad 279 . The monitor 160 determines oxygen saturation by computing the differential absorption by arterial blood of the two wavelengths emitted by the sensor emitters 212 , as is well-known in the art. The sensor interface 271 provides LED drive current 252 which alternately activates the red and IR LED emitters 212 . The photodiode detector 214 generates a signal 254 corresponding to the red and infrared light energy attenuated from transmission through the patient finger 10 ( FIG. 1 ). The sensor interface 271 also has input circuitry for amplification, filtering and digitization of the detector signal 254 . The signal processor 273 calculates a ratio of detected red and infrared intensities, and an arterial oxygen saturation value is empirically determined based on that ratio. The controller 275 provides hardware and software interfaces for managing the display and audible indicator 278 and keypad 279 . The display and audible indicator 278 shows the computed oxygen status, as described above, and provides the pulse beep as well as alarms indicating oxygen desaturation events. The keypad 279 provides a user interface for setting alarm thresholds, alarm enablement, and display options, to name a few.
SUMMARY OF THE INVENTION
[0004] Conventional physiological measurement systems are limited by the patient cable connection between sensor and monitor. A patient must be located in the immediate vicinity of the monitor. Also, patient relocation requires either disconnection of monitoring equipment and a corresponding loss of measurements or an awkward simultaneous movement of patient equipment and cables. Various devices have been proposed or implemented to provide wireless communication links between sensors and monitors, freeing patients from the patient cable tether. These devices, however, are incapable of working with the large installed base of existing monitors and sensors, requiring caregivers and medical institutions to suffer expensive wireless upgrades. It is desirable, therefore, to provide a communications adapter that is plug-compatible both with existing sensors and monitors and that implements a wireless link replacement for the patient cable.
[0005] An aspect of a physiological measurement communications adapter comprises a sensor interface configured to receive a sensor signal. A transmitter modulates a first baseband signal responsive to the sensor signal so as to generate a transmit signal. A receiver demodulates a receive signal corresponding to the transmit signal so as to generate a second baseband signal corresponding to the first baseband signal. Further, a monitor interface is configured to communicate a waveform responsive to the second baseband signal to a sensor port of a monitor. The waveform is adapted to the monitor so that measurements derived by the monitor from the waveform are generally equivalent to measurements derivable from the sensor signal. The communications adapter may further comprise a signal processor having an input in communications with the sensor interface, where the signal processor is operable to derive a parameter responsive to the sensor signal and where the first baseband signal is responsive to the parameter. The parameter may correspond to at least one of a measured oxygen saturation and a pulse rate.
[0006] One embodiment may further comprise a waveform generator that synthesizes the waveform from a predetermined shape. The waveform generator synthesizes the waveform at a frequency adjusted to be generally equivalent to the pulse rate. The waveform may have a first amplitude and a second amplitude, and the waveform generator may be configured to adjusted the amplitudes so that measurements derived by the monitor are generally equivalent to a measured oxygen saturation.
[0007] In another embodiment, the sensor interface is operable on the sensor signal to provide a plethysmograph signal output, where the first baseband signal is responsive to the plethysmograph signal. This embodiment may further comprise a waveform modulator that modifies a decoded signal responsive to the second baseband signal to provide the waveform. The waveform modulator may comprise a demodulator that separates a first signal and a second signal from the decoded signal, an amplifier that adjusts amplitudes of the first and second signals to generate a first adjusted signal and a second adjusted signal, and a modulator that combines the first and second adjusted signals into the waveform. The amplitudes of the first and second signals may be responsive to predetermined calibration data for the sensor and the monitor.
[0008] An aspect of a physiological measurement communications adapter method comprises the steps of inputting a sensor signal at a patient location, communicating patient data derived from the sensor signal between the patient location and a monitor location, constructing a waveform at the monitor location responsive to the sensor signal, and providing the waveform to a monitor via a sensor port. The waveform is constructed so that the monitor calculates a parameter generally equivalent to a measurement derivable from the sensor signal.
[0009] In one embodiment, the communicating step may comprise the substeps of deriving a conditioned signal from the sensor signal, calculating a parameter signal from the conditioned signal, and transmitting the parameter signal from the patient location to the monitor location. The constructing step may comprise the substep of synthesizing the waveform from the parameter signal. In an alternative embodiment, the communicating step may comprise the substeps of deriving a conditioned signal from said sensor signal and transmitting the conditioned signal from the patient location to the monitor location. The constructing step may comprise the substeps of demodulating the conditioned signal and re-modulating the conditioned signal to generate the waveform. The providing step may comprise the substeps of inputting a monitor signal from an LED drive output of the sensor port, modulating the waveform in response to the monitor signal, and outputting the waveform on a detector input of the sensor port.
[0010] Another aspect of a physiological measurement communications adapter comprises a sensor interface means for inputting a sensor signal and outputting a conditioned signal, a transmitter means for sending data responsive to the sensor signal, and a receiver means for receiving the data. The communications adapter further comprises a waveform processor means for constructing a waveform from the data so that measurements derived by a monitor from the waveform are generally equivalent to measurements derivable from the sensor signal, and a monitor interface means for communicating the waveform to a sensor port of the monitor. The communications adapter may further comprise a signal processor means for deriving a parameter signal from the conditioned signal, where the data comprises the parameter signal. The waveform processor means may comprise a means for synthesizing the waveform from the parameter signal. The data may comprise the conditioned signal, and the waveform processor means may comprise a means for modulating the conditioned signal in response to the monitor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is an illustration of a prior art pulse oximetry system;
[0012] FIG. 2 is a functional block diagram of a prior art pulse oximetry system;
[0013] FIG. 3 is an illustration of a physiological measurement communications adapter;
[0014] FIGS. 4A-B are illustrations of communications adapter sensor modules;
[0015] FIGS. 5A-C are illustrations of communications adapter monitor modules;
[0016] FIG. 6 is a functional block diagram of a communications adapter sensor module;
[0017] FIG. 7 is a functional block diagram of a communications adapter monitor module;
[0018] FIG. 8 is a functional block diagram of a sensor module configured to transmit measured pulse oximeter parameters;
[0019] FIG. 9 is a functional block diagram of a monitor module configured to received measured pulse oximeter parameters;
[0020] FIG. 10 is a functional block diagram of a sensor module configured to transmit a plethysmograph;
[0021] FIG. 11 is a functional block diagram of a monitor module configured to receive a plethysmograph;
[0022] FIG. 12 is a functional block diagram of a waveform modulator;
[0023] FIG. 13 is a functional block diagram of a sensor module configured for multiple sensors; and
[0024] FIG. 14 is a functional block diagram of a monitor module configured for multiple sensors.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Overview
[0025] FIG. 3 illustrates one embodiment of a communications adapter. FIGS. 4-5 illustrate physical configurations for a communications adapter. In particular, FIGS. 4A-B illustrate sensor module configurations and FIGS. 5A-C illustrate monitor module configurations. FIGS. 6-14 illustrate communications adapter functions. In particular, FIGS. 6-7 illustrate general functions for a sensor module and a monitor module, respectively. FIGS. 8-9 functionally illustrate a communications adapter where derived pulse oximetry parameters, such as saturation and pulse rate are transmitted between a sensor module and a monitor module. Also, FIGS. 10-12 functionally illustrate a communications adapter where a plethysmograph is transmitted between a sensor module and a monitor module. FIGS. 13-14 functionally illustrate a multiple-parameter communications adapter.
[0026] FIG. 3 illustrates a communications adapter 300 having a sensor module 400 and a monitor module 500 . The communications adapter 300 communicates patient data derived from a sensor 310 between the sensor module 400 , which is located proximate a patient 20 and the monitor module 500 , which is located proximate a monitor 360 . A wireless link 340 is provided between the sensor module 400 and the monitor module 500 , replacing the conventional patient cable, such as a pulse oximetry patient cable 140 ( FIG. 1 ). Advantageously, the sensor module 400 is plug-compatible with a conventional sensor 310 . In particular, the sensor connector 318 connects to the sensor module 400 in a similar manner as to a patient cable. Further, the sensor module 400 outputs a drive signal to the sensor 310 and inputs a sensor signal from the sensor 310 in an equivalent manner as a conventional monitor 360 . The sensor module 400 may be battery powered or externally powered. External power may be for recharging internal batteries or for powering the sensor module during operation or both.
[0027] As shown in FIG. 3 , the monitor module 500 is advantageously plug-compatible with a conventional monitor 360 . In particular, the monitor's sensor port 362 connects to the monitor module 500 in a similar manner as to a patient cable, such as a pulse oximetry patient cable 140 ( FIG. 1 ). Further, the monitor module 500 inputs a drive signal from the monitor 360 and outputs a corresponding sensor signal to the monitor 360 in an equivalent manner as a conventional sensor 310 . As such, the combination sensor module 400 and monitor module 500 provide a plug-compatible wireless replacement for a patient cable, adapting an existing wired physiological measurement system into a wireless physiological measurement system. The monitor module 500 may be battery powered, powered from the monitor, such as by tapping current from a monitor's LED drive, or externally powered from an independent AC or DC power source.
[0028] Although a communications adapter 300 is described herein with respect to a pulse oximetry sensor and monitor, one of ordinary skill in the art will recognize that a communications adapter may provide a plug-compatible wireless replace for a patient cable that connects any physiological sensor and corresponding monitor. For example, a communications adapter 300 may be applied to a biopotential sensor, a non-invasive blood pressure (NIBP) sensor, a respiratory rate sensor, a glucose sensor and the corresponding monitors, to name a few.
Sensor Module Physical Configurations
[0029] FIGS. 4A-B illustrate physical embodiments of a sensor module 400 . FIG. 4A illustrates a wrist-mounted module 410 having a wrist strap 411 , a case 412 and an auxiliary cable 420 . The case 412 contains the sensor module electronics, which are functionally described with respect to FIG. 6 , below. The case 412 is mounted to the wrist strap 411 , which attaches the wrist-mounted module 410 to a patient 20 . The auxiliary cable 420 mates to a sensor connector 318 and a module connector 414 , providing a wired link between a conventional sensor 310 and the wrist-mounted module 410 . Alternatively, the auxiliary cable 420 is directly wired to the sensor module 400 . The wrist-mounted module 410 may have a display 415 that shows sensor measurements, module status and other visual indicators, such as monitor status. The wrist-mounted module 410 may also have keys (not shown) or other input mechanisms to control its operational mode and characteristics. In an alternative embodiment, the sensor 310 may have a tail (not shown) that connects directly to the wrist-mounted module 410 , eliminating the auxiliary cable 420 .
[0030] FIG. 4B illustrates a clip-on module 460 having a clip 461 , a case 462 and an auxiliary cable 470 . The clip 461 attaches the clip-on module 460 to patient clothing or objects near a patient 20 , such as a bed frame. The auxiliary cable 470 mates to the sensor connector 318 and functions as for the auxiliary cable 420 ( FIG. 4A ) of the wrist-mounted module 410 ( FIG. 4A ), described above. The clip-on module 460 may have a display 463 and keys 464 as for the wrist-mounted module 410 ( FIG. 4A ). Either the wrist-mounted module 410 or the clip-on module 460 may have other input or output ports (not shown) that download software, configure the module, or provide a wired connection to other measurement instruments or computing devices, to name a few examples.
Monitor Module Physical Configurations
[0031] FIGS. 5A-C illustrate physical embodiments of a monitor module 500 . FIG. 5A illustrates a direct-connect module 510 having a case 512 and an integrated monitor connector 514 . The case 512 contains the monitor module electronics, which are functionally described with respect to FIG. 7 , below. The monitor connector 514 mimics that of the monitor end of a patient cable, such as a pulse oximetry patient cable 140 ( FIG. 1 ), and electrically and mechanically connects the monitor module 510 to the monitor 360 via the monitor's sensor port 362 .
[0032] FIG. 5B illustrates a cable-connect module 540 having a case 542 and an auxiliary cable 550 . The case 542 functions as for the direct-connect module 510 ( FIG. 5A ), described above. Instead of directly plugging into the monitor 360 , the cable-connect module 540 utilizes the auxiliary cable 550 , which mimics the monitor end of a patient cable, such as a pulse oximetry patient cable 140 ( FIG. 1 ), and electrically connects the cable-connect module 540 to the monitor sensor port 362 .
[0033] FIG. 5C illustrates a plug-in module 570 having a plug-in case 572 and an auxiliary cable 580 . The plug-in case 572 is mechanically compatible with the plug-in chassis of a multiparameter monitor 370 and may or may not electrically connect to the chassis backplane. The auxiliary cable 580 mimics a patient cable and electrically connects the plug-in module 570 to the sensor port 372 of another plug-in device. A direct-connect module 510 ( FIG. 5A ) or a cable-connect module 540 ( FIG. 5B ) may also be used with a multiparameter monitor 370 .
[0034] In a multiparameter embodiment, such as described with respect to FIGS. 13-14 , below, a monitor module 500 may connect to multiple plug-in devices of a multiparameter monitor 370 . For example, a cable-connect module 540 ( FIG. 5B ) may have multiple auxiliary cables 550 ( FIG. 5B ) that connect to multiple plug-in devices installed within a multiparameter monitor chassis. Similarly, a plug-in module 570 may have one or more auxiliary cables 580 with multiple connectors for attaching to the sensor ports 372 of multiple plug-in devices.
Communications Adapter Functions
[0035] FIGS. 6-7 illustrate functional embodiments of a communications adapter. FIG. 6 illustrates a sensor module 400 having a sensor interface 610 , a signal processor 630 , an encoder 640 , a transmitter 650 and a transmitting antenna 670 . A physiological sensor 310 provides an input sensor signal 612 at the sensor connector 318 . Depending on the sensor 310 , the sensor module 400 may provide one or more drive signals 618 to the sensor 310 . The sensor interface 610 inputs the sensor signal 612 and outputs a conditioned signal 614 . The conditioned signal 614 may be coupled to the transmitter 650 or further processed by a signal processor 630 . If the sensor module configuration utilizes a signal processor 630 , it derives a parameter signal 632 responsive to the sensor signal 612 , which is then coupled to the transmitter 650 . Regardless, the transmitter 650 inputs a baseband signal 642 that is responsive to the sensor signal 612 . The transmitter 650 modulates the baseband signal 642 with a carrier to generate a transmit signal 654 . The transmit signal 654 may be derived by various amplitude, frequency or phase modulation schemes, as is well known in the art. The transmit signal 654 is coupled to the transmit antenna 670 , which provides wireless communications to a corresponding receive antenna 770 ( FIG. 7 ), as described below.
[0036] As shown in FIG. 6 , the sensor interface 610 conditions and digitizes the sensor signal 612 to generate the conditioned signal 614 . Sensor signal conditioning may be performed in the analog domain or digital domain or both and may include amplification and filtering in the analog domain and filtering, buffering and data rate modification in the digital domain, to name a few. The resulting conditioned signal 614 is responsive to the sensor signal 612 and may be used to calculate or derive a parameter signal 632 .
[0037] Further shown in FIG. 6 , the signal processor 630 performs signal processing on the conditioned signal 614 to generate the parameter signal 632 . The signal processing may include buffering, digital filtering, smoothing, averaging, adaptive filtering and frequency transforms to name a few. The resulting parameter signal 632 may be a measurement calculated or derived from the conditioned signal, such as oxygen saturation, pulse rate, blood glucose, blood pressure and EKG to name a few. Also, the parameter signal 632 may be an intermediate result from which the above-stated measurements may be calculated or derived.
[0038] As described above, the sensor interface 610 performs mixed analog and digital pre-processing of an analog sensor signal and provides a digital output signal to the signal processor 630 . The signal processor 630 then performs digital post-processing of the front-end processor output. In alternative embodiments, the input sensor signal 612 and the output conditioned signal 614 may be either analog or digital, the front-end processing may be purely analog or purely digital, and the back-end processing may be purely analog or mixed analog or digital.
[0039] In addition, FIG. 6 shows an encoder 640 , which translates a digital word or serial bit stream, for example, into the baseband signal 642 , as is well-known in the art. The baseband signal 642 comprises the symbol stream that drives the transmit signal 654 modulation, and may be a single signal or multiple related signal components, such as in-phase and quadrature signals. The encoder 640 may include data compression and redundancy, also well-known in the art.
[0040] FIG. 7 illustrates a monitor module 500 having a receive antenna 770 , a receiver 710 , a decoder 720 , a waveform processor 730 and a monitor interface 750 . A receive signal 712 is coupled from the receive antenna 770 , which provides wireless communications to a corresponding transmit antenna 670 ( FIG. 6 ), as described above. The receiver 710 inputs the receive signal 712 , which corresponds to the transmit signal 654 ( FIG. 6 ). The receiver 710 demodulates the receive signal to generate a baseband signal 714 . The decoder 720 translates the symbols of the demodulated baseband signal 714 into a decoded signal 724 , such as a digital word stream or bit stream. The waveform processor 730 inputs the decoded signal 724 and generates a constructed signal 732 . The monitor interface 750 is configured to communicate the constructed signal 732 to a sensor port 362 of a monitor 360 . The monitor 360 may output a sensor drive signal 754 , which the monitor interface 750 inputs to the waveform processor 730 as a monitor drive signal 734 . The waveform processor 730 may utilize the monitor drive signal 734 to generate the constructed signal 732 . The monitor interface 750 may also provide characterization information 758 to the waveform processor 730 , relating to the monitor 360 , the sensor 310 or both, that the waveform processor 730 utilizes to generate the constructed signal 732 .
[0041] The constructed signal 732 is adapted to the monitor 360 so that measurements derived by the monitor 360 from the constructed signal 732 are generally equivalent to measurements derivable from the sensor signal 612 ( FIG. 6 ). Note that the sensor 310 ( FIG. 6 ) may or may not be directly compatible with the monitor 360 . If the sensor 310 ( FIG. 6 ) is compatible with the monitor 360 , the constructed signal 732 is generated so that measurements derived by the monitor 360 from the constructed signal 732 are generally equivalent (within clinical significance) with those derivable directly from the sensor signal 612 ( FIG. 6 ). If the sensor 310 ( FIG. 6 ) is not compatible with the monitor 360 , the constructed signal 732 is generated so that measurements derived by the monitor 360 from the constructed signal 732 are generally equivalent to those derivable directly from the sensor signal 612 ( FIG. 6 ) using a compatible monitor.
Wireless Pulse Oximetry
[0042] FIGS. 8-11 illustrate pulse oximeter embodiments of a communications adapter. FIGS. 8-9 illustrate a sensor module and a monitor module, respectively, configured to communicate measured pulse oximeter parameters. FIG. 10-11 illustrate a sensor module and a monitor module, respectively, configured to communicate a plethysmograph signal.
Parameter Transmission
[0043] FIG. 8 illustrates a pulse oximetry sensor module 800 having a sensor interface 810 , signal processor 830 , encoder 840 , transmitter 850 , transmitting antenna 870 and controller 890 . The sensor interface 810 , signal processor 830 and controller 890 function as described with respect to FIG. 2 , above. The sensor interface 810 communicates with a standard pulse oximetry sensor 310 , providing an LED drive signal 818 to the LED emitters 312 and receiving a sensor signal 812 from the detector 314 in response. The sensor interface 810 provides front-end processing of the sensor signal 812 , also described above, providing a plethysmograph signal 814 to the signal processor 830 . The signal processor 830 then derives a parameter signal 832 that comprises a real time measurement of oxygen saturation and pulse rate. The parameter signal 832 may include other parameters, such as measurements of perfusion index and signal quality. In one embodiment, the signal processor is an MS-5 or MS-7 board available from Masimo Corporation, Irvine, Calif.
[0044] As shown in FIG. 8 , the encoder 840 , the transmitter 850 and the transmitting antenna 870 function as described with respect to FIG. 6 , above. For example, the parameter signal 832 may be a digital word stream that is serialized into a bit stream and encoded into a baseband signal 842 . The baseband signal 842 may be, for example, two bit symbols that drive a quadrature phase shift keyed (QPSK) modulator in the transmitter 850 . Other encodings and modulations are also applicable, as described above. The transmitter 850 inputs the baseband signal 842 and generates a transmit signal 854 that is a modulated carrier having a frequency suitable for short-range transmission, such as within a hospital room, doctor's office, emergency vehicle or critical care ward, to name a few. The transmit signal 854 is coupled to the transmit antenna 870 , which provides wireless communications to a corresponding receive antenna 970 ( FIG. 9 ), as described below.
[0045] FIG. 9 illustrates a monitor module 900 having a receive antenna 970 , a receiver 910 , a decoder 920 , a waveform generator 930 and an interface cable 950 . The receive antenna 970 , receiver 910 and decoder 920 function as described with respect to FIG. 7 , above. In particular, the receive signal 912 is coupled from the receive antenna 970 , which provides wireless communications to a corresponding transmit antenna 870 ( FIG. 8 ). The receiver 910 inputs the receive signal 912 , which corresponds to the transmit signal 854 ( FIG. 8 ). The receiver 810 demodulates the receive signal 912 to generate a baseband signal 914 . Not accounting for transmission errors, the baseband signal 914 corresponds to the sensor module baseband signal 842 ( FIG. 8 ), for example a symbol stream of two bits each. The decoder 920 assembles the baseband signal 914 into a parameter signal 924 , which, for example, may be a sequence of digital words corresponding to oxygen saturation and pulse rate. Again, not accounting for transmission errors, the monitor module parameter signal 924 corresponds to the sensor module parameter signal 832 ( FIG. 8 ), derived by the signal processor 830 ( FIG. 8 ).
[0046] Also shown in FIG. 9 , the waveform generator 930 is a particular embodiment of the waveform processor 730 ( FIG. 7 ) described above. The waveform generator 930 generates a synthesized waveform 932 that the pulse oximeter monitor 360 can process to calculate SpO 2 and pulse rate values or exception messages. In the present embodiment, the waveform generator output does not reflect a physiological waveform. In particular, the synthesized waveform is not physiological data from the sensor module 800 , but is a waveform synthesized from predetermined stored waveform data to cause the monitor 360 to calculate oxygen saturation and pulse rate equivalent to or generally equivalent (within clinical significance) to that calculated by the signal processor 830 ( FIG. 8 ). The actual intensity signal from the patient received by the detector 314 ( FIG. 8 ) is not provided to the monitor 360 in the present embodiment. Indeed, the waveform provided to the monitor 360 will usually not resemble a plethysmographic waveform or other physiological data from the patient to whom the sensor module 800 ( FIG. 8 ) is attached.
[0047] The synthesized waveform 932 is modulated according to the drive signal input 934 . That is, the pulse oximeter monitor 360 expects to receive a red and IR modulated intensity signal originating from a detector, as described with respect to FIGS. 1-2 , above. The waveform generator 930 generates the synthesized waveform 932 with a predetermined shape, such as a triangular or sawtooth waveform stored in waveform generator memory or derived by a waveform generator algorithm. The waveform is modulated synchronously with the drive input 934 with first and second amplitudes that are processed in the monitor 360 as red and IR portions of a sensor signal. The frequency and the first and second amplitudes are adjusted so that pulse rate and oxygen saturation measurements derived by the pulse oximeter monitor 360 are generally equivalent to the parameter measurements derived by the signal processor 830 ( FIG. 8 ), as described above. One embodiment of a waveform generator 930 is described in U.S. Patent Application No. 60/117,097 entitled “Universal/Upgrading Pulse Oximeter,” assigned to Masimo Corporation, Irvine, Calif. and incorporated by reference herein. Although the waveform generator 930 is described above as synthesizing a waveform that does not resemble a physiological signal, one of ordinary skill will recognize that another embodiment of the waveform generator 930 could incorporate, for example, a plethysmograph simulator or other physiological signal simulator.
[0048] Further shown in FIG. 9 , the interface cable 950 functions in a manner similar to the monitor interface 750 ( FIG. 7 ) described above. The interface cable 950 is configured to communicate the synthesized waveform 932 to the monitor 360 sensor port and to communicate the sensor drive signal 934 to the waveform generator 930 . The interface cable 950 may include a ROM 960 that contains monitor and sensor characterization data. The ROM 960 is read by the waveform generator 930 so that the synthesized waveform 932 is adapted to a particular monitor 360 . For example, the ROM 960 may contain calibration data of red/IR versus oxygen saturation, waveform amplitude and waveform shape information. An interface cable is described in U.S. Patent Application No. 60/117,092, referenced above. Monitor-specific SatShare™ brand interface cables are available from Masimo Corporation, Irvine, Calif. In an alternative embodiment, such as a direct connect monitor module as illustrated in FIG. 5A , an interface cable 950 is not used and the ROM 960 may be incorporated within the monitor module 900 itself.
Plethysmograph Transmission
[0049] FIG. 10 illustrates another pulse oximetry sensor module 1000 having a sensor interface 1010 , encoder 1040 , transmitter 1050 , transmitting antenna 1070 and controller 1090 , which have the corresponding functions as those described with respect to FIG. 8 , above. The encoder 1040 , however, inputs a plethysmograph signal 1014 rather than oxygen saturation and pulse rate measurements 832 ( FIG. 8 ). Thus, the sensor module 1000 according to this embodiment encodes and transmits a plethysmograph signal 1014 to a corresponding monitor module 1100 ( FIG. 11 ) in contrast to derived physiological parameters, such as oxygen saturation and pulse rate. The plethysmograph signal 1014 is illustrated in FIG. 10 as being a direct output from the sensor interface 1010 . In another embodiment, the sensor module 1000 incorporates a decimation processor, not shown, after the sensor interface 1010 so as to provide a plethysmograph signal 1014 having a reduced sample rate.
[0050] FIG. 11 illustrates another pulse oximetry monitor module 1100 having a receive antenna 1170 , a receiver 1110 , a decoder 1120 and an interface cable 1150 , which have the corresponding functions as those described with respect to FIG. 9 , above. This monitor module embodiment 1100 , however, has a waveform modulator 1200 rather than a waveform generator 930 ( FIG. 9 ), as described above. The waveform modulator 1200 inputs a plethysmograph signal from the decoder 1120 rather than oxygen saturation and pulse rate measurements, as described with respect to FIG. 9 , above. Further, the waveform modulator 1200 provides an modulated waveform 1132 to the pulse oximeter monitor 360 rather than a synthesized waveform, as described with respect to FIG. 9 . The modulated waveform 1132 is a plethysmographic waveform modulated according to the monitor drive signal input 1134 . That is, the waveform modulator 1200 does not synthesize a waveform, but rather modifies the received plethysmograph signal 1124 to cause the monitor 360 to calculate oxygen saturation and pulse rate generally equivalent (within clinical significance) to that derivable by a compatible, calibrated pulse oximeter directly from the sensor signal 1012 ( FIG. 10 ). The waveform modulator 1200 is described in further detail with respect to FIG. 12 , below.
[0051] FIG. 12 shows a waveform modulator 1200 having a demodulator 1210 , a red digital-to-analog converter (DAC) 1220 , an IR DAC 1230 , a red amplifier 1240 , an IR amplifier 1250 , a modulator 1260 , a modulator control 1270 , a look-up table (LUT) 1280 and a ratio calculator 1290 . The waveform modulator 1200 demodulates red and IR plethysmographs (“pleths”) from the decoder output 1124 into a separate red pleth 1222 and IR pleth 1232 . The waveform modulator 1200 also adjusts the amplitudes of the pleths 1222 , 1232 according to stored calibration curves for the sensor 310 ( FIG. 10 ) and the monitor 360 ( FIG. 11 ). Further, the waveform modulator 1200 re-modulates the adjusted red pleth 1242 and adjusted IR pleth 1252 , generating a modulated waveform 1132 to the monitor 360 ( FIG. 11 ).
[0052] As shown in FIG. 12 , the demodulator 1210 performs the demodulation function described above, generating digital red and IR pleth signals 1212 , 1214 . The DACs 1220 , 1230 convert the digital pleth signals 1212 , 1214 to corresponding analog pleth signals 1222 , 1232 . The amplifiers 1240 , 1250 have variable gain control inputs 1262 , 1264 and perform the amplitude adjustment function described above, generating adjusted red and IR pleth signals 1242 , 1252 . The modulator 1260 performs the re-modulation function described above, combining the adjusted red and IR pleth signals 1242 , 1252 according to a control signal 1272 . The modulator control 1270 generates the control signal 1272 synchronously with the LED drive signal(s) 1134 from the monitor 360 .
[0053] Also shown in FIG. 12 , the ratio calculator 1290 derives a red/IR ratio from the demodulator outputs 1212 , 1214 . The LUT 1280 stores empirical calibration data for the sensor 310 ( FIG. 10 ). The LUT 1280 also downloads monitor-specific calibration data from the ROM 1160 ( FIG. 11 ) via the ROM output 1158 . From this calibration data, the LUT 1280 determines a desired red/IR ratio for the modulated waveform 1132 and generates red and IR gain outputs 1262 , 1264 to the corresponding amplifiers 1240 , 1250 , accordingly. A desired red/IR ratio is one that allows the monitor 360 ( FIG. 11 ) to derive oxygen saturation measurements from the modulated waveform 1132 that are generally equivalent to that derivable directly from the sensor signal 1012 ( FIG. 10 ).
[0054] One of ordinary skill in the art will recognize that some of the signal processing functions described with respect to FIGS. 8-11 may be performed either within a sensor module or within a monitor module. Signal processing functions performed within a sensor module may advantageously reduce the transmission bandwidth to a monitor module at a cost of increased sensor module size and power consumption. Likewise, signal processing functions performed within a monitor module may reduce sensor module size and power consumption at a cost of increase transmission bandwidth.
[0055] For example, a monitor module embodiment 900 ( FIG. 9 ) described above receives measured pulse oximeter parameters, such as oxygen saturation and pulse rate, and generates a corresponding synthesized waveform. In that embodiment, the oxygen saturation and pulse rate computations are performed within a sensor module 800 ( FIG. 8 ). Another monitor module embodiment 1100 ( FIG. 11 ), also described above, receives a plethysmograph waveform and generates a remodulated waveform. In that embodiment, minimal signal processing is performed within a sensor module 1000 ( FIG. 10 ). In yet another embodiment, not shown, a sensor module transmits a plethysmograph waveform or a decimated plethysmograph waveform having a reduced sample rate. A corresponding monitor module has a signal processor, such as described with respect to FIG. 8 , in addition to a waveform generator, as described with respect to FIG. 9 . The signal processor computes pulse oximeter parameters and the waveform generator generates a corresponding synthesized waveform, as described above. In this embodiment, minimal signal processing is performed within the sensor module, and the monitor module functions are performed on the pulse oximeter parameters computed within the monitor module.
Wireless Multiple Parameter Measurements
[0056] FIGS. 13-14 illustrate a multiple parameter communications adapter. FIG. 13 illustrates a multiple parameter sensor module 1300 having sensor interfaces 1310 , one or more signal processors 1330 , a multiplexer and encoder 1340 , a transmitter 1350 , a transmitting antenna 1370 and a controller 1390 . One or more physiological sensors 1301 provide input sensor signals 1312 to the sensor module 1300 . Depending on the particular sensors 1301 , the sensor module 1300 may provide one or more drive signals 1312 to the sensors 1301 as determined by the controller 1390 . The sensor interfaces 1310 input the sensor signals 1312 and output one or more conditioned signals 1314 . The conditioned signals 1314 may be coupled to the transmitter 1350 or further processed by the signal processors 1330 . If the sensor module configuration utilizes signal processors 1330 , it derives multiple parameter signals 1332 responsive to the sensor signals 1312 , which are then coupled to the transmitter 1350 . Regardless, the transmitter 1350 inputs a baseband signal 1342 that is responsive to the sensor signals 1312 . The transmitter 1350 modulates the baseband signal 1342 with a carrier to generate a transmit signal 1354 , which is coupled to the transmit antenna 1370 and communicated to a corresponding receive antenna 1470 ( FIG. 14 ), as described with respect to FIG. 6 , above. Alternatively, there may be multiple baseband signals 1342 , and the transmitter 1350 may transmit on multiple frequency channels, where each channel coveys data responsive to one or more of the sensor signals 1314 .
[0057] As shown in FIG. 13 , the sensor interface 1310 conditions and digitizes the sensor signals 1312 as described for a single sensor with respect to FIG. 6 , above. The resulting conditioned signals 1314 are responsive to the sensor signals 1312 . The signal processors 1330 perform signal processing on the conditioned signals 1314 to derive parameter signals 1332 , as described for a single conditioned signal with respect to FIG. 6 , above. The parameter signals 1332 may be physiological measurements such as oxygen saturation, pulse rate, blood glucose, blood pressure, EKG, respiration rate and body temperature to name a few, or may be intermediate results from which the above-stated measurements may be calculated or derived. The multiplexer and encoder 1340 combines multiple digital word or serial bit streams into a single digital word or bit stream. The multiplexer and encoder also encodes the digital word or bit stream to generate the baseband signal 1342 , as described with respect to FIG. 6 , above.
[0058] FIG. 14 illustrates a multiple parameter monitor module 1400 having a receive antenna 1470 , a receiver 1410 , a demultiplexer and decoder 1420 , one or more waveform processors 1430 and a monitor interface 1450 . The receiver 1410 inputs and demodulates the receive signal 1412 corresponding to the transmit signal 1354 ( FIG. 13 ) to generate a baseband signal 1414 as described with respect to FIG. 7 , above. The demultiplexer and decoder 1420 separates the symbol streams corresponding to the multiple conditioned signals 1314 ( FIG. 13 ) and/or parameter signals 1332 ( FIG. 13 ) and translates these symbol streams into multiple decoded signals 1422 , as described for a single symbol stream with respect to FIG. 7 , above. Alternatively, multiple frequency channels are received to generate multiple baseband signals, each of which are decoded to yield multiple decoded signals 1422 . The waveform processors 1430 input the decoded signals 1422 and generate multiple constructed signals 1432 , as described for a single decoded signal with respect to FIGS. 7-12 , above. The monitor interface 1450 is configured to communicate the constructed signals 1432 to the sensor ports of a multiple parameter monitor 1401 or multiple single parameter monitors, in a manner similar to that for a single constructed signal, as described with respect to FIGS. 7-12 , above. In particular, the constructed signals 1432 are adapted to the monitor 1401 so that measurements derived by the monitor 1401 from the constructed signals 1432 are generally equivalent to measurements derivable directly from the sensor signals 1312 ( FIG. 13 ).
[0059] A physiological measurement communications adapter is described above with respect to wireless communications and, in particular, radio frequency communications. A sensor module and monitor module, however, may also communicate via wired communications, such as telephone, Internet or fiberoptic cable to name a few. Further, wireless communications can also utilize light frequencies, such as IR or laser to name a few.
[0060] A physiological measurement communications adapter has been disclosed in detail in connection with various embodiments. These embodiments are disclosed by way of examples only. One of ordinary skill in the art will appreciate many variations and modifications of a physiological measurement communications adapter within the scope of the claims that follow.
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An arm mountable portable patient monitoring device configured to receive physiological information from a plurality of sensors attached to a patient via wired connections for on-patient monitoring of parameter measurements and wireless transmission of parameter measurements to separate monitoring devices. The arm mountable portable patient monitoring device includes a housing, a strap, a display, a first sensor port positioned on a first side of the housing configured to face toward a hand of the patient when the housing is secured to the arm of the patient, second and third sensor ports configured to receive signals from additional sensor arrangements via a wired connections, one or more signal processing arrangements configured to cause to be displayed measurements of oxygen saturation and pulse rate, and a transmitter configured to wirelessly transmit information indicative of the measurements of oxygen saturation and pulse rate to a separate monitoring device.
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CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of International Application No. PCT/US2004/040517, filed Dec. 3, 2004, which claims the benefit of U.S. Provisional Application Ser. No. 60/526,887, filed Dec. 4, 2003. The entire contents of these applications are hereby incorporated herein by reference.
FIELD
[0002] The disclosed systems and methods relate generally to systems and methods for aortic valve annuloplasty. More specifically, the disclosed systems and methods relate to annuloplasty rings and methods for deploying annuloplasty rings.
BACKGROUND
[0003] The aortic valve is situated at the junction of the left ventricle of the heart and the root of the aorta. The valve opens to admit blood ejected from the contracting heart into the ascending aorta, and closes to prevent regurgitation of the ejected blood back into the left ventricle. The valve opens and closes by the motion of its constituent leaflets, of which there are typically three (but occasionally two or, rarely, one). When the valve is functioning properly, the leaflets seal the valve by touching one another, referred to as “co-aption” or “coaption.”
[0004] A number of pathologic conditions, however, may prevent the perfect coaption of the leaflets. The two broad categories of pathology include disorders of the leaflets themselves and disorders of the fibrous skeletal ring (“annulus”) that supports the leaflets. Leaflet disorders include scarring, fibrosis, and calcification resulting from infection (rheumatic fever), hypertension, or congenital malformation. The resulting thickening or encrustation limits the leaflets' range of motion so that they cannot fully close. Blood is then able to leak through the imperfectly coapted leaflets.
[0005] Disorders of the annulus of the aortic valve may result from inherent defects in the annulus or from stretching caused by aortic dilation. Inherent defects may result from trauma to the annulus or from genetic disorders of connective tissue. Dilation of the aorta may result from a wide variety of etiologies, including trauma, genetic disorders (Marfan syndrome and Ehlers-Danlos syndrome), congenital malformation (coarctation of the aorta), infectious disease (syphilis and mycotic infections), inflammatory disorders (rheumatoid arthritis, Takayasu's arteritis), hypertension, and atherosclerosis. When the annulus is deformed, the value leaflets may not touch, even when fully closed.
[0006] Currently, aortic valve performance is restored by replacing the valve leaflets and the annulus with a prosthetic structure. The prosthetic structure may be a biomaterial (such as a porcine valve, a human cadaveric valve, or pericardial tissue) or a metallic implant (such as a pyrolite carbon bileaflet valve). Replacement of the aortic valve is a complex procedure necessitating cardiopulmonary bypass and its attendant risks.
SUMMARY
[0007] The present disclosure provides systems and methods for restoring proper coaption of the aortic valve leaflets without subjecting a patient to valve replacement surgery. The inventors have found that the leaflets can be repositioned for proper coaption by engaging a ring around the aortic root, in a subcoronary position, to constrict the root. The applied compression may counteract the distortion of the stretched annulus. The compression can significantly ameliorate the effects of the underlying pathology and delay the need for a valve replacement. In some circumstances, compression can eliminate the need for valve replacement entirely.
[0008] In one embodiment, an aortic annuloplasty ring includes a ring, having a “C” shape and being so sized as to fit around and circumferentially engage an aortic root. The ring is formed at least in part of a biocompatible material so deformable as to permit manual adjustment of the ring but stiff enough to keep the shape into which it is adjusted.
[0009] In another embodiment, an aortic annuloplasty ring includes a collar having first and second ends that together form a fastener operable to secure the first and second ends together. The collar is thereby so shaped as to engage the aorta circumferentially. The ring further includes a flap depending from the collar for wrapping over the aorta, to prevent distal aneurismal changes. The ring is sized to fit around the aorta, and is transitionable between a first state, in which the fastener does not secure the first and second ends together, and a second state, in which the fastener so secures the first end to the second end that the collar is shaped to engage the aorta circumferentially.
[0010] In yet another embodiment, an aortic annuloplasty method includes disposing an aortic annuloplasty ring around the aortic root, and deforming the ring to circumferentially engage it. The ring has a “C” shape and is so sized as to fit around and circumferentially engage the aortic root, formed at least in part of a biocompatible material so deformable as to permit manual adjustment of the ring, and so nonresilient as to keep the shape into which it is deformed against blood pressure or the heart beat's force.
[0011] In still another embodiment, an aortic annuloplasty method includes disposing an aortic annuloplasty ring around an aorta, the ring including a collar having first and second ends, the first and second ends forming a fastener operable to secure the first and second ends together, the ring further including a flap depending from the collar; fastening the first and second ends of the collar, thereby so shaping the collar as to engage the aorta circumferentially; and wrapping the flap over the aorta.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 depicts an exemplary embodiment of an aortic annuloplasty ring, the ring lying flat.
[0013] FIG. 2 depicts an exemplary embodiment of an aortic annuloplasty ring, the ring having a substantially circular shape.
[0014] FIG. 3 is a plan view of an exemplary embodiment of an aortic annuloplasty ring having a “C” shape.
[0015] FIG. 4 is a perspective view of the ring shown in FIG. 3 .
[0016] FIGS. 5-9 depict exemplary cross sections taken at line 5 - 5 of FIG. 3 .
[0017] FIG. 10 depicts an exemplary embodiment of a ring having a groove.
[0018] FIG. 10A depicts an exemplary embodiment of a ring having more than one groove.
[0019] FIG. 11 depicts an exemplary embodiment of the deployment of a grooved ring.
[0020] FIGS. 12-14 depict exemplary modifications of ring ends.
[0021] FIGS. 15-18 depict exemplary ring adjustment systems.
[0022] FIGS. 19-20 depict exemplary ring sealing systems.
DETAILED DESCRIPTION
[0023] The disclosed systems and methods facilitate aortic annuloplasty by providing aortic annuloplasty rings that are deployed around the aorta to improve coaption of the aortic valve leaflets.
[0024] FIG. 1 shows one exemplary embodiment of such a ring. The depicted ring 10 includes a collar 11 having a first end 12 and a second end 14 that cooperate to form a fastener that secures the ends to each other. In the FIG. 1 embodiment, for example, the collar's first end removably and adjustably receives catches 18 on the collar's second end. The ring may be reversibly transitionable between a first state, shown in FIG. 1 , in which the two ends are not secured, and the fastener and the collar 11 can lie substantially flat, and a second state, shown in FIG. 2 , in which the fastener secures the collar's ends in an endless configuration. Although the FIG. 1 embodiment includes a plurality of catches 18 to make the ring adjustable, some embodiments may instead be fixed in size.
[0025] FIG. 2 depicts the ring in its second state, in which the fastener secures the ring 10 in its endless configuration. The second state may be substantially circular, but in any event it will tend to conform to the outer shape of the aorta in the vicinity of the aortic valve so as to engage the aorta circumferentially. FIG. 2 shows an aperture 16 receiving one particular catch 18 , but the ring may be adjusted to make the aperture receive a different catch 18 . As FIGS. 1 and 2 show, the catches 18 have respective inclined surfaces on one side to facilitate further tightening of the ring, but the opposite-side surfaces impede loosening of the ring; the catches act as a ratcheting mechanism. That is, the aperture 16 may have to be lifted out of contact with the catch 18 to permit loosening. Such an arrangement may be selected both for convenience and for safety. A ring with a preferential adjustment for tightening may improve deployment of the device by preventing the ring from slipping while the operator is fine-tuning its fit. Furthermore, a ring that resists loosening tends to keep its preferred shape and size and is less likely to need its fit revised after initial deployment.
[0026] In other embodiments, the catches 18 may be so shaped as to resist adjust in both directions, such as by having ends that are both raised from the surface of the collar 11 . In one embodiment, the catches 18 fit lock-and-key with the aperture 16 . Such an arrangement can facilitate precise adjustment of the ring during deployment and can also impede undesired tightening of the ring after deployment. Such tightening might otherwise occur, for example, if the ring is tugged by scar tissue.
[0027] In other embodiments, the catch 18 may facilitate continuous adjustment, as opposed to the illustrated discrete adjustment. For example, one of the collar's ends may form a slot, and a clamp that slides along the slot and affixes to the collar at a desired position may be attached to the collar's other end.
[0028] The ring shown in FIG. 1 includes three flaps 20 that depend from the collar 11 and can be wrapped over the aorta to prevent dilation of the aorta distal to the ring. Other embodiments may have more or fewer flaps; some may have only one. The flaps may be shaped to facilitate wrapping on the curved surface of the aorta. The flaps may be wrapped in a variety of patterns and directions over the aorta. For example, the flaps may wrapped helically or non-helically over the aorta, and they may overlap one another or lie separate. The flaps may define slots or grooves to avoid wrapping or disturbing the coronary arteries. In addition, the flaps can, but need not, be affixed to the aorta by, for example, tacks, sutures, or cement. Also, the tips of the flaps may in some cases be tied or stitched together after deployment. The ring and flaps may be made from a variety of materials, such as a plastic.
[0029] FIG. 2 also shows that the ring includes detents 22 (such as tacks or clips) that can provide traction to prevent ring slippage along the aorta. Detents may be positioned all around the inner surface of the ring. Other embodiments may have no or few detents.
[0030] FIG. 3 is a plan view of another embodiment of an aortic annuloplasty ring 30 . In this embodiment, the ring has a “C” shape and is sized to fit around the aortic root and engage the root circumferentially. The ring's shape may be that of a circle's arc, but it may have other overall shapes, such as a shape corresponding to a typical aortic root's outer surface. FIG. 4 is a perspective view of the embodiment of FIG. 3 . The C shape defines an gap G through which the aorta passes as the ring is deployed. The ring may be deformable. Preferably, the ring is deformable enough to permit it to be manually adjusted by, e.g., pressing the ring between an operator's fingers to narrow the gap G after the ring is positioned around the aorta. The deformation should be largely nonresilient: the ring should tend to keep its new shape when it has been thus adjusted. The ring may also be so deformable as to permit the ring to be loosened by prying its ends apart with the operator's fingers.
[0031] The ring may be formed from a variety of materials. The material is preferably biocompatible so that the ring does not provoke an immune response or other adverse reaction. The material is also preferably non-biodegradable, so that the ring persists in the body until it is deliberately removed. Preferable materials include gold, silver, titanium, nickel-titanium alloy, and combinations of these. An alloy having at least 23-karat gold is preferred for its malleability, nonresilience, and consequent ease of adjustment; indeed, pure (i.e., 24-karat) gold is best in this regard. However, lesser amounts of gold may be used instead. For example, the gold may be alloyed with silver (preferably less than 10% silver). Other possible alloys are gold and titanium; gold, silver, and titanium, or other metals. Silver may provide bacteriostasis. Barium may provide radioopacity. Nickel-titanium may provide shape memory.
[0032] The material may include a thermoplastic elastomer. The shape and/or flexibility of such a material may be temperature-dependent. For example, the thermoplastic elastomer may be selected so that it is less flexible at body temperature (typically around 37° C.) than at room temperature (for example, in the range of 15° C. to 24° C.). A ring including such a material could be flexible enough to permit adjustment before it has warmed to body temperature and then could become inflexible enough at body temperature to impede further adjustment in response to blood pressure or the heart beat's force. In some embodiments, the thermoplastic elastomer may be selected so that the ring is manually deformable at a temperature below body temperature.
[0033] The material may be selected so that the ring is so rigid at body temperature as not to deform in response to arterial blood pressure (up to about 200 mm Hg), in response to repeated heart pressure cycles (up to about 160 beats per minute), or in response to motion of the heart or aortic root (from a heartbeat).
[0034] The “C” ring will typically be an arc of about 240 degrees to about 270 degrees. In other words, the gap defined by the ring will typically account for at least one fourth but usually less than one third of the ring's circumference.
[0035] When placing a “C” ring on the aorta of a particular patient, an operator typically selects a ring size that approximates or slightly exceeds the aorta's diameter. This maximizes contact between the ring and the aorta and also minimizes the adjusting required to improve leaflet coaption. Typical human aortas have diameters in the range of about 1 cm to about 3 cm, with some aortas as large as 5 cm or, rarely, larger still. Accordingly, rings will typically be made that have a major diameter D ( FIG. 3 ) in these ranges. In some instances, a kit can be provided that includes rings having several different major diameters. The operator can measure the subject's aortic diameter and select a ring having a corresponding diameter.
[0036] The ring stiffness depends on the ring material and ring's minor diameter d ( FIG. 3 ), i.e., its thickness. For the preferred materials, the desired ring stiffness will result from a minor diameter d in the range of about 0.1 mm to about 2 mm.
[0037] The ring may have edges. The edges are preferably rounded to prevent trauma to the surrounding tissue, particularly to the nearby coronary arteries. The edges of the ring may be slightly rounded so that a cross-section of a segment of the ring (taken, for example, at line 5 - 5 of FIG. 3 ) has rounded corners, as shown in FIG. 5 . Among other possible ring cross-section shapes are the circular shape shown in FIG. 6 , the convex-concave shape shown in FIG. 7 , the concave-concave shape shown in FIG. 8 , and the convex-convex shape shown in FIG. 9 . Additionally, the ring may have different cross-sectional shapes in different regions along the length of the ring.
[0038] FIG. 10 shows an embodiment in which the ring defines a groove 32 . The groove 32 provides a contour to fit a coronary artery so that the ring may snugly engage the aortic root without impinging the coronary artery. A groove also provides a location for tying down the ring in the subcoronary position. FIG. 10A shows an embodiment in which the ring has three grooves 32 . In other embodiments, a ring may have two grooves, or more than three grooves. If a ring has multiple grooves, it is preferable to space the grooves equally around the ring to distribute forces evenly. FIG. 11 shows a side view of an aorta A having a coronary artery C branching therefrom, with a grooved ring 30 circumferentially engaging the aorta and the ring groove 32 lessening trauma to the coronary artery.
[0039] The rings described herein may be deployed in a number of ways. For example, during open thoracic surgery, the ring may be slipped around the exposed aorta. During a thoracoscopic procedure, a ring may be delivered through an endoscopic instrument and positioned using the appropriate tools. A ring may be introduced in a catheter that is advanced through the vasculature to the aorta and positioned around the aorta through an incision in the aortic wall.
[0040] Once positioned, a ring may be secured by tacking or other affixation (such as by detents 22 of FIG. 1 ) to the outer surface of the aorta. In addition, a ring may be affixed by devices that penetrate the full thickness of the aortic wall and are affixed on the inner surface of the aorta. For example, if access to the interior of the aorta is available (as by catheterization or by incision into the aorta), then a ring may be attached to the aorta by stitching, stapling, or riveting through the full thickness of the aorta.
[0041] Once deployed, the rings described herein may be adjusted in a variety of ways. As described above, a ring may be adjusted manually. For example, a ring as shown in FIG. 1 may be adjusted by pulling the second end 14 through the fastener 16 . A ring as shown in FIG. 3 may be adjusted by squeezing the ends together or by prying them apart. Attachments or accessories may also be used to adjust a ring. For example, a clamp or wrench may be applied to a ring to squeeze or pry it. Arms of a clamp may engage respective ends of a ring. The grip of the clamp may be facilitated by providing a projection or indentation on one or both ends. FIG. 12 depicts an exemplary embodiment of a ring 30 having projections 34 on the ends. FIG. 13 depicts an exemplary ring 30 having indentations 36 on the ends. As shown in FIG. 14 , one or both ends of a ring may have a combination projection/indentation 38 .
[0042] A ring may be adjusted by pulling one or more strings, sutures, guidewires, or other filaments attached to one or both ends of the ring. As shown in FIG. 15 , filaments 40 may be attached to ends of a ring 30 and be pulled in opposite directions to tighten the ring. As shown in FIG. 16 , a single filament 42 may be slideably coupled to at least one end of a ring 30 by a couple 44 . Alternatively, a filament may be secured to one end and slideably coupled to the other, so that there is one free end which may be pulled to tighten the ring. The filaments may be removable from the ring so that they may be disconnected from the ring once the ring is adjusted. Alternatively, the filaments may remain affixed to the ring to permit further adjustment after the ring is deployed. In some cases, the loose end(s) of filament(s) may be brought out to the skin surface or just below the skin surface to facilitate the further adjustment. The filaments may disposed in conduits, such as tubes, to protect the filaments from scarring or adhesion and to enable their controlled movement by an operator.
[0043] Additional adjustment systems are contemplated. For example, as depicted schematically in FIG. 17 , a ring 30 ′ may be an inflatable “C” cuff that fits around the aorta. In this embodiment, the ring may be adjusted by inflating the cuff. As the cuff inflates, it exerts the desired compressive force on the aorta. Alternatively, a ring may be as described earlier, with an inflatable cuff attached to the outside of ring. Inflating the cuff can exert compressive force on the ring, which deforms on response. The cuff may then be deflated, or it can be kept inflated to maintain the deformed state of the ring. In yet another alternative, a ring can be embedded in an inflatable cuff. When the cuff is inflated, it exerts compressive force on the aorta, and the embedded ring helps the cuff to keep its shape and remain in position.
[0044] The cuff may be inflatable by a liquid, a gas, or other fluid material. A line 46 may be coupled in fluid communication with the ring cuff 30 ′. In an embodiment, the line 46 can connect in fluid communication with a bladder 48 . The bladder 48 may be disposed in a patient subcutaneously, with a port 50 accessible just beneath the skin. A source of fluid such as a syringe 52 may be applied to the port to introduce or withdraw fluid from the bladder 48 , thereby inflating or deflating the ring 30 ′, respectively.
[0045] In yet another embodiment, depicted schematically in FIG. 18 , a ring 30 ″ may include a controller 54 coupled to an adjustment system such an electronic fulcrum or gear arrangement 56 . The controller 54 may be an RF receiver that receives commands from an external control (not shown). In response to such commands, the controller 54 may instruct the arrangement 56 to open or close the ring 30 ″. The controller 54 and/or arrangement 56 may also be responsive to magnetic signals.
[0046] Rings may be sealed shut to prevent undesired loosening or opening. A wide variety of sealing systems may be appropriate for this purpose. For example, the ends of a ring 30 may be glued together. Alternatively, as shown in FIG. 19 , once the ends of a ring 30 are brought to the final adjustment position, the ends may be tied together by, e.g., a tie 58 . ( FIG. 19 shows the ring fully closed in its final adjustment position, but it need not be.) The tie 58 may fit around projections 34 of the ends. Alternatively, or simultaneously, tie 58 may fit in an indentation 36 , such as a groove. In another embodiment, depicted in FIG. 20 , one end of a ring 30 may have a boss 60 that fits into a receptacle 62 . The boss 60 may be, for example, glued or welded into receptacle 62 . The boss 60 may be so sized as to engage the receptacle 62 in friction-tight press-fit.
[0047] A ring sizer may be provided to determine the appropriate ring size to use with a particular patient. Aortic size may be difficult to determine prior to a surgery or other procedure, so a sizing system may be used during such surgery or procedure. A sizer may be a calibrated ring or strap that can be fitted around the aorta at the appropriate position, and a size read therefrom. The sizes indicated on the sizer may correspond to sizes of rings available. A kit may be provided that includes a sizer and a selection of rings of various sizes. If appropriate, the kit may also include an adjustment tool, such as a filament, a clamp, or a line/bladder system as described for FIG. 17 .
[0048] During the deployment and/or adjustment of an aortic annuloplasty ring, it may be desirable to monitor blood flow through the aortic valve to determine whether the ring is appropriately adjusted. For example, blood flow through the valve may be monitored to determine whether the ring has sufficiently coapted the valve leaflets to eliminate aortic regurgitation. If blood flow is not adequately corrected, the ring may be further adjusted. If blood flow is overcorrected (for example, by creating aortic stenosis), the ring may be loosened. A number of methods may be employed for assessment of blood flow, such as echocardiography (transesophageal and/or transthoracic), intraoperative leak tests, direct observation (e.g., through a catheter camera), and fluoroscopy.
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An aortic annuloplasty ring may include a ring, having a "C" shape. The ring may be so sized as to fit around and circumferentially engage an aortic root. The ring may be formed at least in part of a biocompatible material so nonresiliently deformable as to permit manual adjustment of the ring. An aortic annuloplasty method may include disposing an aortic annuloplasty ring around an aorta root, the ring having a "C" shape, and the ring being so sized as to fit around and circumferentially engage the aortic root; and deforming the ring to circumferentially engage the aortic root.
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FIELD OF THE INVENTION
[0001] This invention relates cycle transportation and exercise equipment and more particularly to a four wheeled arm and foot powered cycle and exercise apparatus.
BACKGROUND OF THE INVENTION
[0002] Bicycle and other cycle devices are known in the arts including U.S. patents as follows: U.S. Pat. No. 6,485,041 to Janssen; U.S. Pat. No. 6,378,882 to Devine; U.S. Pat. No. 6,032,970 to Porter; and U.S. Pat. No. 6,190,289 to Pyles et al. The patents referred to herein are provided herewith in an Information Disclosure Statement in accordance with 37 CFR 1.97.
SUMMARY OF THE INVENTION
[0003] The quad cycle and exercise machine comprises four wheeled cycle apparatus providing foot pads interrelated to hand operated levers for the operation of a bicycle cam and derailer gear system for propulsion of the quad cycle. The operator is upstanding during operation. Standard bicycle brakes and derailer systems are employed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] The foregoing and other features and advantages of the present invention will become more readily appreciated as the same become better understood by reference to the following detailed description of the preferred embodiment of the invention when taken in conjunction with the accompanying drawings, wherein:
[0005] FIG. 1 is a perspective view of the quad cycle ( 1 ) showing the main frame ( 100 ) with frame center leg ( 140 ) and front “T” frame ( 160 ) and rear “T” frame ( 180 ). Seen is the standard bicycle derailer system ( 700 ) and standard bicycle brake assembly ( 600 ). The frame center vertical leg ( 260 ) is depicted relative to the swing arm assembly ( 400 ) which is integral with the means of propulsion and steering; also depicted are the front wheels ( 175 ) interrelated with the steering system ( 800 ).
[0006] FIG. 2 is a detail of the swing arm assembly ( 400 ) as section 2 from FIG. 1 .
[0007] FIG. 3 is a plan detail and section 3 from FIG. 1 of the front wheels ( 175 ) and steering related features.
[0008] FIG. 4 is a front elevation of the front wheel ( 175 ) assembly.
[0009] FIG. 5 is detail from FIG. 2 of the left upper swing arm section ( 415 ) and left master hub ( 470 ).
[0010] FIG. 6 is a side elevation of the left master hub ( 470 ).
[0011] FIG. 7 is a detail from FIG. 2 of the right upper swing arm section ( 435 ) and right master hub ( 480 ).
[0012] FIG. 8 is a side elevation of the right master hub ( 470 ).
[0013] FIG. 9 is a detail from FIG. 3 showing the left steering hub ( 850 ). Those of ordinary skill will recognize that the elements of the right steering hub ( 810 ) are represented in mirror image from that shown in the left steering hub ( 850 ).
[0014] FIG. 10 is a perspective showing an alternative embodiment of the quad cycle ( 1 ) rear axle ( 192 ) bearing means ( 193 ) and wheels ( 195 )
DETAILED DESCRIPTION
[0015] FIGS. 1 through 9 depicts the quad cycle ( 1 ) and systems composing the quad cycle ( 1 ). The quad cycle ( 1 ) has a frame means comprising a main frame ( 100 ) having at least one elongated center leg ( 140 ) having a center leg first end ( 144 ) and a center leg second end ( 148 ). A front “T” frame ( 160 ), generally tubular and elongated, has a front “T” frame first end ( 164 ), a front “T” frame second end ( 168 ) and is affixed by frame affixing means at the center leg first end ( 144 ); the front “T” frame ( 160 ) is comprised of a frame member generally orthogonal to the at least one center leg ( 140 ). In the preferred embodiment, the front “T” frame ( 160 ) has a front “T” frame top ( 170 ) and the elongated center leg ( 140 ) has a center leg bottom ( 146 ); the front “T” frame ( 160 ) is affixed at the front “T” frame top ( 170 ) proximal the center leg first end ( 144 ) at the center leg bottom ( 146 ).
[0016] A rear “T” frame ( 180 ), generally elongated and affixed by frame affixing means at the center leg second end ( 148 ); the rear “T” frame ( 180 ) is composed of a frame member generally orthogonal to the at least one center leg first end ( 144 ). The rear “T” frame ( 180 ) has a rear “T” frame right end ( 184 ) and a rear “T” frame left end ( 188 ). The frame members including those of the main frame ( 100 ), in the preferred embodiment, are constructed of a rigid tubular means comprised of metals, composite materials, plastics and other materials commonly recognized by those of ordinary skills in the bicycle arts for frame construction. In the preferred embodiment the main frame, and other frame members, are formed from light weight rectangular metal tubing.
[0017] Bearing, axle and wheel means are mounted at the rear “T” frame right end ( 184 ) and the rear “T” frame left end ( 188 ). Bearing, axle and wheel means are generally so mounted by affixing, by frame affixing means, a bearing mount means at the respective rear “T” frame right end ( 184 ) and rear “T” frame left end ( 188 ). In the preferred embodiment the rear “T” frame ( 180 ) has a right bearing mount ( 185 ) affixed by frame affixing means at the rear “T” frame right end ( 184 ) positioned generally orthogonal to the rear “T” frame ( 180 ) and parallel with the frame center leg ( 140 ). The rear “T” frame ( 180 ) has a left bearing mount ( 190 ) affixed by frame affixing means at the rear “T” frame left end ( 188 ) positioned generally orthogonal to the rear “T” frame ( 180 ) and parallel with the frame center leg ( 140 ). Bearing, bushing and axle means ( 192 ) are received by apertures and bearing, bushing and axle receiving means ( 186 ) to position the bearings, bushings and axle ( 192 ) orthogonal to the frame center leg ( 140 ). At least one rear wheel ( 195 ) is mounted at said axle ( 192 ) and, in the preferred embodiment there are at least two rear wheels ( 195 ) mounted at said axle ( 192 ), one at the right bearing mount ( 185 ) and one at the left bearing mount ( 190 ).
[0018] A standard bicycle brake system ( 600 ) is provided for stopping having brake means ( 640 ), including disk brakes; hand grip or lever ( 610 ) and brake cable ( 620 ) means to communicate braking commands to a caliper means ( 630 ) to urge braking forces on the brake means ( 640 ).
[0019] A standard bicycle derailer ( 700 ) assembly is mounted by derailer mounting means ( 711 ) at the frame center leg ( 140 ) and at the axle ( 192 ); a front derailer gear assembly ( 710 ) with drive cam ( 730 ) is mounted by gear mounting means at the frame center leg ( 140 ) intermediate the center leg first end ( 144 ) and the center leg second end ( 148 ); a front derailer ( 712 ) is mounted at a derailer mounting means ( 711 ) comprising a bracket support structure capable of receiving a derailer and which is provided in the disclosed invention by an upstanding tube immovably affixed to the frame center leg ( 140 ) intermediate the center leg first end ( 144 ) and the center leg second end ( 148 ). Other equivalent mounting means will be appreciated by those of ordinary skill in the bicycle gear mounting arts. A rear derailer gear assembly ( 720 ) is mounted by gear mounting means at the rear axle ( 192 ) intermediate the right bearing mount ( 185 ) and the left bearing mount ( 190 ); rear derailer ( 722 ) and rear derailer mounting means ( 721 ) is mounted at the rear “T” frame ( 180 ). Derailer hand grip or shift levers ( 750 ) are in front derailer cable ( 760 ) and rear derailer cable ( 762 ) communication with the respective front derailer ( 712 ) and the rear derailer ( 722 ). It will be appreciated that cable means including front derailer cable ( 760 ) and rear derailer cable ( 762 ), and indeed other cable means disclosed herein, will be routed from controls or source vial frame means members to point of action. A chain drive means ( 740 ), provided by endless chain or belt drives or other equivalent gear interconnection means, drive and gear shift interrelates the front derailer gear assembly ( 710 ) with the rear derailer gear assembly ( 722 ). The brake assembly means ( 600 ) and front derailer ( 712 ), rear derailer ( 722 ), gear and derailer assemblies are affixed by brake assembly and derailer gear and derailer affixing means including bushings, bearings, and other affixing means including races, bolts, screws, washers, rivets, drive cams, seals and other such affixing means as will be appreciated by those of ordinary skill in the bicycle arts.
[0020] Steering and propulsion means, driven by arm and foot power, is seen in association with a center vertical frame means ( 260 ) seen as the center vertical leg ( 260 ), swing arms ( 400 ) and foot pads ( 500 ). Again, frame means is generally formed from tubular materials including a variety of cross sections and, in the preferred embodiment, a rectangular or square cross section tube of metal or composite materials. The center vertical leg ( 260 ) is upstanding and has an upper vertical leg section ( 280 ) and a lower vertical leg section ( 290 ). The upper vertical leg section ( 280 ) has a vertical leg first end ( 282 ) and a vertical leg second end ( 287 ) with a vertical leg angle ( 284 ) intermediate the said vertical leg first end ( 282 ) and the vertical leg second end ( 287 ). The lower vertical leg section ( 290 ) has a lower leg first end ( 291 ) and a lower leg second end ( 292 ). The lower vertical leg section ( 290 ) at the lower vertical section second end ( 292 ) is sized to either receive the upper vertical leg section at the vertical leg first end ( 282 ) or the vertical leg first end ( 282 ) is sized to receive the lower vertical leg section ( 290 ) at the lower leg second end ( 292 ). Movable or immovable frame affixing means proximal the lower leg second end ( 292 ) and the vertical leg first end ( 282 ); movable frame affixing means generally aperture means ( 265 ) in the upper vertical leg section ( 280 ) proximal the vertical leg first end ( 282 ) in alignment with aperture means ( 265 )in the lower vertical leg section ( 290 ) proximal the lower leg second end ( 292 ) where said aligned aperture means ( 265 ) receive bolt/nut means ( 267 ); immovable frame affixing means includes welding. Those of ordinary skills in the frame arts will appreciate equivalent movable frame affixing means to the use of bolt/nut means ( 267 ).
[0021] Vertical leg bracket means ( 293 ) affixed by immovable means at the lower leg first end ( 291 ) and oriented to receive the frame center leg ( 140 ) intermediate the center leg first end ( 144 ) and the derailer mounting means ( 711 ).
[0022] Said vertical leg bracket means ( 293 ) is, in the preferred embodiment tubular or inverse “U” shaped and sized to receive the frame center leg ( 140 ); the center vertical leg ( 260 ) is moveably or immovably affixed at the frame center leg ( 140 ) with movable means generally aperture means in the frame center leg ( 140 ) aligned with aperture means in the frame aperture means ( 150 ) aligned with aperture means in the leg bracket means ( 293 ) and moveably affixed by bolt/nut means ( 295 ). The interconnection between the center leg ( 140 ) and the said leg bracket means ( 293 ) allows the center vertical leg ( 260 ) to be moved relative to the frame center leg ( 140 ) to accommodate various sized riders. The upper section of the vertical leg ( 280 ) is angled, at the vertical leg angle ( 284 ), towards the rider as a means of increasing rider leg clearance.
[0023] A swing arm assembly ( 400 ) provides lever means to assist with arm propulsion and steering and is comprised of an upstanding left swing arm ( 410 ) and right swing arm ( 430 ). Said left swing arm ( 410 ) is composed an left upper section ( 415 ), a left middle section ( 420 ) and a left lower section ( 425 ); said right swing arm ( 430 ) is composed an right upper section ( 435 ), a right middle section ( 440 ) and a right lower section ( 445 ).
[0024] An elongated rigid swing arm mount ( 450 ), generally comprised of cylindrical metal or composite tube or rod means interrelates the left swing arm ( 410 ), the center vertical leg ( 260 ) and the right swing arm ( 430 ). Vertical leg swing arm apertures ( 285 ), intermediate the vertical leg angle ( 284 ) and the vertical leg second end ( 287 ), are in alignment with left middle swing arm apertures ( 417 ) and right middle swing arm apertures ( 437 ); said apertures are sized to receive and do receive the swing arm mount ( 450 ). The swing arm mount ( 450 ) has a left end ( 455 ) and a right end ( 460 ) and is orthogonal to the frame center leg ( 140 ). The left middle swing arm section ( 420 ) is received at the swing arm mount ( 450 ) left end ( 455 ) and is rotatably affixed, by rotatable means, proximal the left end ( 455 ); the right middle swing arm section ( 440 ) is received at the swing arm mount ( 450 ) right end ( 440 ) and is rotatably affixed, by rotatable means, proximal the right end ( 460 ). Rotatable means comprising bearing and or bushing means at said left middle swing arm apertures ( 417 ) and right middle swing arm apertures ( 437 ) where said bearing and or bushing means in turn rotatably receives the said swing arm mount ( 450 ). Said left middle swing arm section ( 420 ) and right middle swing arm section ( 440 ) are positionally fixed by pin, set screw, or other equivalent position fixing means.
[0025] The swing arm assembly ( 400 ) is upstanding relative to the frame center leg ( 140 ).
[0026] The tubular left swing arm ( 410 ) is comprised of a left middle swing arm section ( 420 ) intermediate a left lower swing arm section ( 425 ) and a left upper swing arm section ( 415 ). FIG. 1 and 2 show the upper swing arm section ( 415 ). The left upper swing arm section ( 415 ) has a left upper swing arm upper end ( 416 ) and a left upper swing arm lower end ( 418 ). The left middle swing arm section ( 420 ) has a left middle swing arm upper end ( 421 ), a left middle swing arm lower end ( 423 ), at least one left middle swing arm adjustment aperture ( 422 ) intermediate the left middle swing arm upper end ( 421 ) and the left middle swing arm lower end ( 423 ) and at least one left middle swing arm aperture ( 424 ). The left lower swing arm section ( 425 ) has a left lower swing arm upper end ( 426 ), a left lower swing arm lower end ( 428 ), at least one left lower swing arm adjustment aperture ( 427 ) intermediate the left lower swing arm upper end ( 426 ) and the left lower swing arm lower end ( 428 ) and at least one left lower swing arm aperture ( 429 ) proximal the left lower swing arm lower end ( 428 ). The left swing arm ( 410 ) and the right swing arm ( 430 ) are composed primarily of tubular construction including but not limited to metal tubing.
[0027] The tubular left middle swing arm lower end ( 423 ) receiving or being received by the tubular left lower swing arm upper end ( 426 ) such that the at least one left middle swing arm adjustment aperture ( 422 ) and the at least one left lower swing arm adjustment aperture ( 427 ) are aligned to receive affixing means comprised generally of bolt and nut means or the equivalent. Those of ordinary skills in the interconnection of tubular arts will appreciate that there will be at least two left middle swing arm adjustment apertures ( 422 ) and at least two left lower swing arm adjustment apertures ( 427 ) which will be in alignment to receive affixing means for the purpose of adjusting the length of the entirety of the left middle swing arm section ( 420 ) and the left lower swing arm section ( 425 ) from the from the left middle swing arm upper end ( 441 ) to the left lower swing arm lower end ( 448 ).
[0028] The tubular right swing arm ( 430 ) is comprised of a right middle swing arm section ( 440 ) intermediate a right lower swing arm section ( 445 ) and a right upper swing arm section ( 435 ). The right upper swing arm section ( 435 ) has a right upper swing arm upper end ( 436 ) and a right upper swing arm lower end ( 438 ). The right middle swing arm section ( 440 ) has a right middle swing arm upper end ( 441 ), a right middle swing arm lower end ( 443 ), at least one right middle swing arm adjustment aperture ( 442 ) intermediate the right middle swing arm upper end ( 441 ) and the right middle swing arm lower end ( 443 ) and at least one right middle swing arm aperture ( 444 ). The right lower swing arm section ( 445 ) has a right lower swing arm upper end ( 446 ), a right lower swing arm lower end ( 448 ), at least one right lower swing arm adjustment aperture ( 447 ) intermediate the right lower swing arm upper end ( 446 ) and the right lower swing arm lower end ( 448 ) and at least one right lower swing arm aperture ( 449 ) proximal the right lower swing arm lower end ( 448 ). The right swing arm ( 410 ) and the right swing arm ( 430 ) are composed primarily of tubular construction including but not limited to metal tubing.
[0029] The tubular right middle swing arm lower end ( 443 ) receiving or being received by the tubular right lower swing arm upper end ( 446 ) such that the at least one right middle swing arm adjustment aperture ( 442 ) and the at least one right lower swing arm adjustment aperture ( 447 ) are aligned to receive affixing means comprised generally of bolt and nut means or the equivalent. Those of ordinary skills in the interconnection of tubular arts will appreciate that there will be at least two right middle swing arm adjustment apertures ( 442 ) and at least two right lower swing arm adjustment apertures ( 447 ) which will be in alignment to receive tubular affixing means for the purpose of adjusting the length of the entirety of the right middle swing arm section ( 440 ) and the right lower swing arm section ( 445 ) from the from the right middle swing arm upper end ( 441 ) to the right lower swing arm lower end ( 448 ). Tubular affixing means includes bolt with nut, rivet and other equivalent means.
[0030] A left master hub ( 470 ) immovably affixed by hub affixing means at the left upper swing arm lower end ( 418 ). Hub affixing means comprising generally welding, threaded means between the left master hub ( 470 ) and the left upper swing arm lower end ( 418 ), bolt/nut means, screw and other means as will be appreciated by those of ordinary skills in the mechanical arts. Left master hub bracket means ( 471 ) are immovably affixed by bracket affixing means at the left middle swing arm upper end ( 421 ). The left master hub ( 470 ) is received by the left master hub bracket means ( 471 ) and is pivotally affixed relative to the left master hub bracket means ( 471 ). The left master hub ( 470 ) has at least one left master hub bracket aperture ( 472 ) which aligns with at least one left master hub aperture ( 475 ). The at least one left master hub bracket aperture ( 472 ) and the at least one left master hub aperture ( 475 ) receive left master hubs bushing or bearing means ( 473 ) wherein said bushing or bearing means ( 473 ) comprises bearing surfaces, including bushings and or bearings, for the left master hub aperture ( 475 ). Said left master hub bushing or bearing means ( 473 ) receives a rotatable affixing means ( 474 ) between the said left master hub ( 470 ) and the left master hub bracket means ( 471 ) wherein, in the preferred embodiment, said rotatable affixing means includes a bolt and nut received by the left master hub bushing or bearing means ( 473 ). The left master hub ( 470 ) is generally disk shaped having a left master hub groove ( 476 ) at a left master hub perimeter ( 478 ) where the left master hub groove ( 476 ) is principally “V” or “U” shaped to receive cable means for steering control ( 1000 ) comprising a first left side steering cable ( 1100 ) and a first right side steering cable ( 1200 ). The said first left side steering cable ( 1100 ) fixedly terminated at the left master hub ( 470 ) at the left master hub groove ( 476 ) by a nonadjustable cable fixing means ( 477 ) which anchors the indicated cable by screw, bolt, welding or other immovable fixing means. The said first right side steering cable ( 1200 ) fixedly terminated at the left master hub ( 470 ) at the left master hub groove ( 476 ) by a nonadjustable cable fixing means ( 477 ) which nonadjustable cable fixing means or anchors comprising screw, bolt, welding or other immovable fixing means. A right master hub ( 480 ) immovably affixed by hub affixing means at the right upper swing arm lower end ( 438 ). Hub affixing means comprising generally welding, threaded means between the right master hub ( 480 ) and the right upper swing arm lower end ( 438 ), bolt/nut means, screw and other means as will be appreciated by those of ordinary skills in the mechanical arts. Right master hub bracket means ( 481 ) are immovably affixed by bracket affixing means at the right middle swing arm upper end ( 441 ). The right master hub ( 480 ) is received by the right master hub bracket means ( 481 ). The right master hub ( 480 ) has at least one right master hub bracket aperture ( 482 ) which aligns with at least one right master hub aperture ( 485 ). The at least one right master hub bracket aperture ( 482 ) and the at least one right master hub bracket aperture ( 482 ) receive right master hubs bushing or bearing means ( 483 ) wherein said bushing or bearing means ( 483 ) comprises bearing surfaces, including bushings and or bearings, for the said right master hub aperture ( 485 ). Said right master hub bushing or bearing means ( 483 ) receives a rotatable affixing means ( 484 ) between the said right master hub ( 480 ) and the right master hub bracket means ( 481 ) wherein, in the preferred embodiment, said rotatable affixing means includes a bolt and nut received by the right master hub bushing or bearing means ( 483 ). The right master hub ( 480 ) is generally disk shaped having a right master hub groove ( 486 ) at a right master hub perimeter ( 488 ) where the right master hub groove ( 486 ) is principaly “V” or “U” shaped to receive a second right side steering cable ( 1300 ) and a second left side steering cable ( 1400 ). The said second right side steering cable ( 1300 ) fixedly terminated at the right master hub ( 480 ) at the right master hub groove ( 486 ) by a nonadjustable cable fixing means ( 487 ) which anchors the indicated cable by screw, bolt, welding or other immovable fixing means. The said second left side steering cable ( 1400 ) fixedly terminated at the right master hub ( 480 ) at the right master hub groove ( 486 ) by a nonadjustable cable fixing means ( 487 ) which anchors the indicated cable by screw, bolt, welding or other immovable fixing means.
[0031] Hand grip or lever means ( 610 ) for brake assembly ( 600 ) operation positioned proximal the left upper swing arm upper end ( 416 ) or proximal the right upper swing arm upper end ( 436 ). Derailer hand grip or shift levers ( 750 ) for derailer gear operation positioned proximal the left upper swing arm upper end ( 416 ) or proximal the right upper swing arm upper end ( 436 ).
[0032] The tubular left swing arm ( 410 ) and the tubular right swing arm ( 430 ) rotate about the swing arm mount ( 450 ). The left swing arm ( 410 ) and the right swing arm ( 430 ) cycle toward the front “T” frame ( 160 ), then away from the front “T” frame ( 160 ) toward the rear “T” frame ( 180 ) and back for the complete cycle. The cycle of the left swing arm ( 410 ) and the cycle of the right swing arm ( 430 ) each ascribes a a vertical upstanding plane parallel to the frame center leg ( 140 ) and the center vertical leg ( 260 ). The left upper swing arm section ( 415 ) and the right upper swing arm section ( 435 ) rotate respectively relative to the left middle swing arm section ( 420 ) and the right middle swing arm section ( 440 ), about the respective left master hub aperture ( 475 ) and the right master hub aperture ( 485 ), ascribing a rotation plane orthogonal to the swing plane ascribed by the left swing arm ( 410 ) and the right swing arm ( 430 ). When turning forces are exerted at the left upper swing arm section ( 415 ) and the right upper swing arm section ( 435 ), it is noted that the said left upper swing arm section ( 415 ) and the right upper swing arm section ( 435 ) are never pivoting forward or backward, relative to the frame center leg ( 140 ) but remain, relative to the frame center leg ( 140 ), in a plane parallel to that of the frame center leg ( 140 ) and the center vertical leg ( 260 ).
[0033] FIGS. 1, 2 , 3 , 4 and 9 show the left upper swing arm section ( 415 ), right upper swing arm section ( 435 ), left master hub ( 470 ), right master hub ( 480 ), right steering hub ( 810 ) and left steering hub ( 850 ). The left upper swing arm section ( 415 ) and the right upper swing arm section ( 435 ), when rotated, exert forces on the left side steering cable ( 1100 ) and the right side steering cable ( 1200 ) which are in steering communication with a steering unit ( 800 ). The steering unit ( 800 ), proximal to or at the center leg first end ( 144 ), comprises a right axle ( 835 ) affixed by axle affixing means at the front “T” frame first end ( 164 ) at a right steering knuckle ( 830 ) and a left axle ( 875 ) affixed by axle affixing means at the front “T” frame second end ( 168 ) at a left steering knuckle ( 870 ). At least one front wheel ( 175 ) rotatably affixed by wheel affixing means at each of the said right axle ( 835 ) and left axle ( 875 ) respectfully distal to the front “T” frame first end ( 164 ) and the front “T” frame second end ( 168 ). The right steering knuckle ( 830 ) comprises a right steering hub ( 810 ) immovably affixed by fixing means to a right bearing mount ( 185 ); a bushing or bearing means and housing with shaft ( 186 ) received by the rotatable right bearing mount ( 185 ); the right axle ( 835 ) extending from and affixed by axle affixing means to the right bearing mount ( 185 ). The left steering knuckle ( 870 ) comprises a left steering hub ( 850 ) immovably affixed by fixing means to a left bearing mount ( 190 ); a bushing or bearing means and housing with shaft ( 168 ) received by the rotatable left bearing mount ( 190 ); the left axle ( 875 ) extending from and affixed by axle affixing means to the left bearing mount ( 190 ). A tie bar ( 890 ) interrelates the right steering hub ( 810 ) and the left steering hub ( 850 ) to insure alignment and coordinated parallel movement between the at least one front wheel ( 175 ) at each of the said right axle ( 835 ) and left axle ( 875 ). A left tie bar connection ( 892 ) and a right tie bar connection ( 894 ) affixed by immovable means respectively at the left bearing mount ( 190 ) and the right bearing mount ( 185 ) receive the tie bar ( 890 ) by rotatable connection means ( 893 ).
[0034] The steering communication means between he left upper swing arm section ( 415 ) and left master hub ( 470 ) is respectively by the first left side steering cable ( 1100 ) and second right side steering cable ( 1200 ) connection with the left steering hub ( 850 ) and the right steering hub ( 810 ) respectively; and between the right upper swing arm section ( 435 ) and right master hub ( 480 ) is respectively by second left side steering cable ( 1300 ) and second right side steering cable ( 1400 ) connection with the right steering hub ( 810 ) and the left steering hub ( 850 ) respectively. Thus the left upper swing arm section ( 415 ), when pivoted at the left master hub ( 470 ) exerts rotational forces at both the right steering hub ( 810 ) and the left steering hub ( 850 ) and the right upper swing arm section ( 435 ), when pivoted at the right master hub ( 480 ) exerts rotational forces at both the right steering hub ( 810 ) and the left steering hub ( 850 ).
[0035] In the preferred embodiment the right steering hub ( 810 ) is primarily disk sharped having a right steering hub grove ( 820 ) receiving second left side steering cable ( 1300 ) and second right side steering cable ( 1400 ) and a the left steering hub ( 850 ), primarily disk sharped and having a left steering hub grove ( 860 ) receives the first left side steering cable ( 1100 ) and the first right side steering cable ( 1200 ).
[0036] The steering cable interconnections are as follows:
1.) From the left master hub ( 470 ) thread the first left side steering cable ( 1100 ) through cable shield means to a right hub right side ( 812 ) position of the right steering hub ( 81050 ) at the right steering hub grove ( 820 ) to be secured by right steering hub cable securing means ( 845 ); 2.) from the left master hub ( 470 ) thread the first right side steering cable ( 1200 ) through cable shield means to a left hub left side ( 851 ) position of the left steering hub ( 850 ) at the left steering hub grove ( 860 ) to be secured by right steering hub cable securing means ( 885 ); 3.) from the right master hub ( 480 ) thread the second left side steering cable ( 1400 ) through cable shield means to a left hub right side ( 852 ) position of the left steering hub ( 850 ) at the left steering hub grove ( 860 ) to be secured by left steering hub cable securing means ( 885 ); 4.) from the right master hub ( 480 ) thread the second right side steering cable ( 1300 ) through cable shield means to a right hub left side ( 811 ) position of the right steering hub ( 810 ) at the right steering hub grove ( 820 ) to be secured by right steering hub cable securing means ( 845 ).
[0041] Cable guide means provided, in the preferred embodiment, by left side steering cable guide ( 1150 ) and right side steering cable guide ( 1250 ) received respectively by left middle swing arm aperture ( 424 ) and right middle swing arm aperture ( 444 ). Left side steering cable guide ( 1150 ) and right side steering cable guide ( 1250 ) have guide means to receive cable where such means includes aperture means. Right steering hub cable guide ( 840 ) and left steering hub cable guide ( 880 ) immovably affixed by means respectively at the right steering hub ( 810 ) and left steering hub ( 850 ); said right steering hub cable guide ( 840 ) and left steering hub cable guide ( 880 ) have guide means to receive cable where such means includes aperture means. First left side cable ( 1100 ), first right side cable ( 1200 ), second left side cable ( 1300 ) and second left side cable ( 1400 ) are received and guided by said cable guide means; said cables, in the preferred embodiment, are comprised of aircraft quality cable. The left master hub groove ( 476 ), right master hub groove ( 486 ), the right steering hub groove ( 820 ) and the left steering hub groove ( 860 ) are grooved to captivate said cable including air craft quality cable for steering control. It is noted that there is no rotational cable movement at the left master hub groove ( 476 ), right master hub groove ( 486 ), the right steering hub groove ( 820 ) and the left steering hub groove ( 860 ) with cable movement only through cable shield means. Cable shield means ( 841 ) is provided by plastic, metal and other tubing means. Adjustable cable shield dead heads mounted on the main frame to take slack out of steering and adjust position of the handle bars for rider comfort as desired.
[0042] The left master hub ( 470 ) and the right master hub ( 480 ), primarily disk shaped and circular have a diameter either equal to or less than the diameter of the primarily disk shaped and circular right steering hub ( 810 ) and left steering hub ( 850 ).
[0043] The front “T” frame ( 160 ) is mounted under the frame center leg ( 140 ) to maintain horizontal ground clearance and keep the right steering knuckle ( 830 ) and left steering knuckle ( 870 ) vertical to the riding surface.
[0044] The left axle ( 875 ), when axle affixing means is a threaded means, will have a left hand thread to prevent the rotation of the wheel from loosening the nut means used to captivate bearings and seals.
[0045] There are adjustable cable shield means ( 495 ) mounted on the main frame ( 100 ) primarily at the frame center leg ( 140 ) or the center vertical leg ( 260 ) allowing cable adjustment to add or remove slack from steering, brake or derailer cables as adjustments are made for operator size and preferences.
[0046] The left upper swing arm section ( 415 ) and right upper swing arm section ( 435 ) provide a handle bars function; said left upper swing arm section ( 415 ) and right upper swing arm section ( 435 ) are rotatably adjustable in position as desired by the operator.
[0047] The front wheel base ( 179 ), in the preferred embodiment, is wider from center to center than the back wheel base ( 199 ) providing greater stability in operation. The front wheels ( 175 ), in the preferred embodiment, are smaller in diameter than the rear wheels ( 195 ) with larger rear wheels preferred for operational clearance between riding surface and driving components. In the preferred embodiment, front wheels ( 175 ) will have 16″ tires and rear wheels will have 20″ tires to provide ground clearance and to allow derailer operation.
[0048] Foot pads ( 500 ) comprise an elongated substantially planar left foot pad ( 510 ) and right foot pad ( 540 ); the left foot pad ( 510 ) having a left foot pad first end ( 515 ), a left foot pad second end ( 520 ) and a left foot pad center ( 525 ); the right foot pad ( 540 ) having a right foot pad first end ( 545 ), a right foot pad second end ( 550 ) and a right foot pad center ( 555 ). Bushing and shaft receiving means at the left lower swing arm lower end ( 428 ) and at the right lower swing arm lower end ( 448 ) align with and rotatably receive bushing and shaft receiving means at the left foot pad first end ( 515 ) and right foot pad first end ( 545 ) respectively for a rotatable interaction. Bushing and shaft receiving means includes aperture means at said left foot pad first end ( 515 ) and right foot pad first end ( 545 ) and at the said left lower swing arm lower end ( 428 ) and at the right lower swing arm lower end ( 448 ) including the left lower swing arm aperture ( 429 ) and the right lower swing arm aperture ( 449 ). Bushing and shaft receiving means at the left foot pad second end ( 520 ) and at the right foot pad second end ( 550 ) align with and rotatably receive bicycle drive cam means at the right and left respectively where the drive cam means, in the preferred embodiment, is a standard bicycle drive cam ( 730 ). Arm lever action and foot action at the left 3 g 4 swing arm ( 410 ) and right swing arm ( 430 ) and at the left foot pad ( 510 ) and right foot pad ( 540 ) exert forces against the drive cam ( 730 ) and derailer gear assembly ( 705 ) to propel the quad cycle ( 1 ).
[0049] FIG. 10 is a perspective showing an alternative embodiment of the quad cycle ( 1 ) rear axle ( 192 ) bearing means ( 193 ) and wheels ( 195 )
[0050] While a preferred embodiment of the present invention has been shown and described, it will be apparent to those skilled in the art that many changes and modifications may be made without departing from the invention in its broader aspects. The appended claims are therefore intended to cover all such changes and modifications as fall within the true spirit and scope of the invention.
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This invention is a quad cycle and exercise apparatus with arm and foot power as propulsion. The rider is upstanding during operation.
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The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/313,694, filed Aug. 20, 2001, which application, including its Appendix A, is incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
The present invention relates to bionic ear implants, and more particularly to an ear level high resolution bilateral programming system for use with a bionic ear implant.
A new generation of cochlear implants, commonly referred to as a “bionic ear” implant, has recently been introduced to the cochlear implant community. A representative bionic ear implant is the CII Bionic Ear™ cochlear implant system introduced by Advanced Bionics Corporation, of Sylmar Calif. A bionic ear implant is capable of delivering electrical stimulation to a patient at rates and resolutions which surpass that of conventional cochlear implants.
Early research indicates that cochlear implant patients will benefit from additional synchronized and processed speech information conveyed to the brain via both the right and left auditory nerve pathways. Several configurations are available to implement such a system, including, e.g.: (a) bilateral implants controlled by a single master speech processor; (b) bilateral implants driven by independent external speech processors; and (c) bilateral implants driven by synchronized external speech processors. The present invention relates primarily to configurations (b) & (c).
Of significance to configuration (c) is its ability to interface with patients who use presently available technology platforms; specifically ear level early-generation speech processors. (The early-generation speech processors are referred to herein as “CI” processors, whereas the more recent bionic ear processors are referred to as the “CII” processors.) With or without a hardware change to a standalone behind-the-ear (BTE) processor, there is a need for an adapter module whereby two standalone BTE units may be synchronized both temporally and tonotopically to maximize the Cl patients listening experience. There is also a need for a peer-to-peer network and protocol consisting of two BTE units during normal operation, or two BTE units plus a host controller (PC, PDA, etc. . . . ) during a fitting session.
SUMMARY OF THE INVENTION
The present invention addresses the above and other needs by providing an adapter module that allows two standalone BTE units to be synchronized both temporally and tonotopically in order to maximize the CI patients listening experience. Further, the present invention provides a peer-to-peer network and protocol that consists of two BTE units during normal operation, or two BTE units plus a host controller (PC, PDA, etc. . . . ) during fitting.
The system provided by the invention includes (a) a communications interposer adapted to be inserted between the BTE battery and the BTE housing or modified BTE devices; (b) a communication channel over which communication takes place between the connected devices, including the protocol governing access to such channel; (c) the synchronization mechanisms used to achieve synchronization between the connected devices; and (d) a bilateral fitting paradigm. Each of these four components of the invention are summarized below.
(a) Communications Interposer. The communications interposer is a plug-in module designed for use with the Clarion® BTE (a CI device). It interfaces mechanically to the existing clinicians programming interface (CPI) contacts found on the underside of a standard platinum series BTE. The interposer module contains the interface electronics to the physical layer (any necessary antennae or connectors) and a replicated battery port on its underside to allow insertion as usual of a BTE battery.
(b) Communication Channel. The communication channel may be a wired or wireless link configured to use proprietary technology (e.g. the implantable speech processor's 10.7 MHz ITEL channel) or industry standard channels (e.g. the newly allocated 400 MHz medical band, Bluetooth, 802.11, etc. . . . ). One preferred embodiment uses wired interconnections of multiple speech processors and a fitting station via the buffered serial ports that are standard on Texas Instruments DSP products. In the case of wired links, interference is not a problem and the fundamentals of an enhanced packet protocol are utilized. For a wireless embodiment, bandwidth and interference issues bound the ultimate capability and robustness of the system. Any time there is a need to maintain communications in real time between two operating processors, there are many tradeoffs to consider, leaving certain implementations fundamentally superior to others. Conversely, developing new applications to run over an industry standard link utilizing industry standard protocols (e.g. Bluetooth) may simplify the development of new applications.
(c) Synchronization. The raw bandwidth and necessary protocol overhead of a chosen physical medium dictates the nature of information that can be passed over the network in real time. This, in turn, limits the degree to which parallel speech processors can synchronize their activities and/or share information. In a preferred embodiment, a maximally efficient data link layer is used that allows for arbitrary data exchange and device synchronization. Disadvantageously, varying degrees of reduced functionality are mandated as the system's communication bandwidth is reduced and/or as protocol overheads increase. To minimize such reduced functionality, several steps are taken. First, a fitting mechanism is used that tonotopically ranks electrode contact position in the contra-lateral cochlea, followed by assignment of audio frequency bands to those optimal contacts. Second, an operational mode is used that offers noise cancellation and directional hearing by making use of phase information available from the contra-lateral microphones. Third, an operational mode is described for listening in stereo.
(d) Bilateral fitting Paradigm. A fitting procedure, based on trans-cochlear pitch discrimination, is used so as to reduce channel interaction and optimally interleave channel information across available electrode contacts.
BRIEF DESCRIPTION OF THE DRAWINGS
The features and advantages of the present invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings, wherein:
FIG. 1 is shows a simple binaural interposer;
FIG. 2 shows a binaural programming cable suitable for use with a Clinician Programming Interface (CPI) device;
FIG. 3 depicts a BioNet BTE interposer;
FIG. 4 shows a BioNet Wireless BTE communications controller;
FIG. 5 depicts a first configuration for a binaural fitting cable;
FIG. 6 illustrates a second configuration for a binaural fitting cable;
FIG. 7 illustrates a third configuration for a binaural fitting cable;
FIG. 8 shows a fourth configuration of a fitting cable;
FIG. 9 shows a binaural standalone approach;
FIG. 10 depicts a wired binaural fitting mode;
FIG. 11 shows a BioNet Wireless fitting system.
FIG. 12 illustrates a cascaded master/slave bootload operation;
FIG. 13 shows stimulation synchronization;
FIG. 14 depicts audio synchronization;
FIG. 15 illustrates a fitting system framework; and
FIG. 16 conceptually illustrates a bilateral fitting paradigm.
Additional details regarding the CII Bionic Ear™ implant, and the BioNet, or communications network, that may be established between two bionic ears, or other biotechnology-based devices, in accordance with the present invention, including case studies and performance data, may be found in Appendix A of the earlier-referenced provisional patent application Ser. No. 60/313,694; filed Aug. 20, 2001, previously incorporated herein by reference.
Corresponding reference characters indicate corresponding components throughout the several views of the drawings.
DETAILED DESCRIPTION OF THE INVENTION
The following description is of the best mode presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention.
Turning first to FIG. 1 , there is shown a simple binaural interposer 23 that may be used as part of the invention. The BTE speech processor 22 is normally connected to a removable battery 24 . To insert the interposer 23 , the battery 24 is removed from the BTE processor 22 , and the interposer 23 is inserted between the BTE processor 22 and the battery 24 . The battery 24 may then be connected to the underneath side of the interposer 23 .
The interposer 23 has a BTE interface port 25 on the side thereof that is placed against the BTE processor. Such interface port allows electrical connections to be made with the circuits within the BTE processor. A binaural communications port 26 is on one side of the interposer 23 . This port, used for a wired implementation, allows a cable to be attached thereto that connects with another BTE processor, or to a programming device, such as a host fitting station. Power connections or terminals are also provided on the interposer 23 so as to allow the power terminals on the battery 24 to make electrical connection with the power input terminals on the BTE speech processor 22 . Thus, Power In terminals are located on a side 27 of the interposer 23 that is placed adjacent the battery terminals, and Power OUT terminals are located on a side 28 of the interposer that is placed adjacent the BTE processor, thereby allowing power to pass through the interposer from the battery to the BTE processor.
Turning next to FIG. 2 , an enhanced binaural interposer 30 is depicted that includes a binaural CPI programming cable 32 exiting from a bottom side thereof. The acronym CPI stands for “clinician programming interface”, and refers to a special interface unit that allows the clinician's programmer (usually a laptop computer) to interface with the BTE processor that is being programmed. The CPI programming cable 32 is an extension to an existing BTE/CPI Programming Cable. On one end it is terminated with a standard DB15 connector for connection to a standard CPI-2. On the other end, it is terminated with the enhanced binaural interposer 30 . The enhanced interposer 30 performs CPI signal level shifting, power distribution and BSP (body speech processor) interconnection between a Master BTE (to which the interposer is attached), a slave BTE (to which the interposer is tethered) and the CPI (host PC). This is used for wired fitting of the system. Multiple variations of the enhanced interposer 30 are possible, as described, e.g., in FIGS. 5 , 6 and 7 , below. The fitting system is embodied in a “Wired Binaural Fitting Mode”.
Next, with reference to FIG. 3 , a BioNet BTE interposer 40 is shown. The interposer 40 houses a wireless transceiver (Bluetooth, ISM, Medical Band, FIS ITEL, etc. . . . ) for wireless communication between binaurally co-joined BTE's and/or a host fitting station. The interposer 40 includes the same or similar connectors, e.g., Power In, Power Out, BTE interface port 25 , binaural cable port 26 (optional), and further includes an optional CPI programming cable port 42 . In a singular mode, the wireless link provided through the wireless transceiver can be used to fit a remote BTE. A more powerful mode provided by the interposer 40 is simultaneous fitting of synchronized BTE pairs.
A block diagram of the control subsystem necessary to implement a BioNet is shown in FIG. 4 . That which is shown in FIG. 4 functionally represents the circuitry contained within the interposer 40 . As seen in FIG. 4 , a control module 44 interfaces with the local BTE 22 and local battery 24 through the BTE interface port 25 and power connections. Internal to the interposer 40 , the control module 44 —typically realized from microprocessor circuitry—interfaces with both a wireless network interface module 43 and a wired network interface module 46 . The wireless network interface module 43 has an antenna coil 45 connected thereto. Such antenna coil 45 is advantageously embedded within the housing of the interposer 40 so that it is not obtrusively visible to a user of the BioNet, which BioNet is made possible by the interposer 40 . The wireless network interface module 43 may connect to one or more remote BTE's. The wired network interface module 46 may connect to a remote BTE through the binaural cable port 26 , or to a host fitting system through the CPI programming cable port 42 .
FIG. 5 illustrates a standalone wired interconnection of two BTE's, a master BTE 22 , and a slave BTE 22 ′, via simple binaural interposers 23 and 23 ′, and a binaural interface cable 21 . The wiring of the binaural interface cable 21 is illustrated in FIG. 9 .
FIGS. 6 , 7 and 8 respectively show variations of a master BTE 22 connected to a slave BTE 22 ′. In FIG. 6 , an enhanced interposer 30 connects the master BTE 22 to a CPI device 52 , while a binaural interface cable 21 connects the slave BTE 22 ′ to both the CPI 52 and the master BTE 22 through a simple interposer 23 ′. In FIG. 7 , a BioNet BTE interposer 40 connects the master BTE 22 to a CPI device 52 , while a binaural interface cable 21 connects the slave BTE 22 ′ to both the CPI 52 and the master BTE 22 through a simple interposer 23 ′. In FIG. 8 , two enhanced interposers 30 and 30 ′ are used to respectively connect a primary BTE 22 and a secondary BTE 22 ′ to respective CPI's 52 and 52 ′. Dual Port Fitting Software 54 interfaces with each of the respective CPI's 52 and 52 ′.
Turning next to FIG. 10 , a wired binaural fitting mode is illustrated. A slave BTE 22 ′ is connected through, e.g., a simple interposer 23 ′ and a synchronous binaural interface cable 21 to an enhanced interposer 30 . The enhanced interposer 30 is connected to a master BTE 22 . The binaural fitting cable 32 that exits from the enhanced interposer 30 (see FIG. 2 ) is connected to a CPI device 52 . The CPI device 52 , in turn, is connected to a host programming system, e.g., a laptop computer (not shown) loaded with the appropriate fitting software.
Next, with reference to FIG. 11 , a BioNet Wireless Fitting System is illustrated. FIG. 11 embodies the operational modes for fitting and operating a wireless BTE fitting system. As seen in FIG. 11 , the system consists of two BioNet BTE Interposers 40 , each connected to a respective BTE 22 , and a BioNet PC Card 56 plugged into the host fitting station 58 . As thus configured, a BioNet 60 is created that allows either BTE to be coupled to the host fitting station 58 , and that further allows either BTE to be coupled to the other BTE.
FIG. 12 illustrates the preferred cascaded Master/Slave bootload operation relative to a CPI device, a Master BTE and a Slave BTE. As seen from FIG. 12 , in keeping with the architecture of present day speech processors, a cascaded bootload scenario is presented whereby cable interconnection as per “Fitting Cable Configuration # 2 ”, FIG. 6 , is employed. The “Command/Response” handshaking is defined in the serial link protocol and is presently controlled from the PC side by PPMIF.DLL (or equivalent). First, the need to utilize multiple target addresses (destination field in the packet protocol) is required. Secondly, monitor functions running on the DSP require master & slave awareness with all incoming commands (from the host) delivered to the master for processing or forwarding (based on destination address) and all acknowledges to the PC delivered from the slave (directly or by way of forwarding from the master).
The key to the startup is a double blind bootload. That is, bootloading is a blind process, the success of which cannot be determined until the operation is complete and a PING is received from the remote kernel. In one binaural configuration, this blind operation is cascaded. For the BTE processor to become operational, a bootload to the master is performed (identical to the present day single speech processor environment). Upon completing the master bootload sequence, the slave bootload sequence is forwarded by the now operational master BTE to the slave BTE. Once both BTE's have been bootloaded, success can be determined by issuing a PING to the master BTE. The ping response is routed through the slave BTE and returned to the host PC through the CPI. Receipt of this acknowledgment indicates success.
Once a bootload has been successfully made, application programs can be loaded as per an existing packet protocol with the caveat that destination addresses will determine which BTE processor processes each command.
FIG. 13 illustrates how stimulation synchronization is obtained between the Master BTE and the Slave BTE.
FIG. 14 shows the manner in which audio synchronization is obtained between the Master BTE and the Slave BTE.
FIG. 15 depicts a fitting system platform. Such platform allows operation with the various binaural speech processor configurations described above. The platform includes a host fitting station 58 , typically comprising a laptop computer loaded with the appropriate fitting software. Also included in the platform is a BioNet PC card 56 , or equivalent, that is plugged into the fitting station 58 , thereby allowing communications with two BTE's 22 , one BTE being for the left ear and the other BTE being for the right ear. Each BTE is coupled to a headpiece 21 . The headpiece 21 , in turn, is coupled to the bionic ear implant 18 , which implant includes an electrode array 19 . A multiplicity of electrode contacts, e.g., 16 electrode contacts, are spaced apart along the length of the array 19 , thereby allowing stimulation of cochlea tissue to occur at various locations along the length of the array.
Fundamental to the platform shown in FIG. 15 are means to perform bilateral pitch ranking and channel allocation. This process of pitch ranking is illustrated in FIG. 16 , and is further explained in Appendix A of the above-referenced provisional patent application Ser. No. 60/313,694, filed Aug. 20, 2001, previously incorporated herein by reference.
While the invention herein disclosed has been described by means of specific embodiments and applications thereof, numerous modifications and variations could be made thereto by those skilled in the art without departing from the scope of the invention set forth in the claims.
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A system for allowing bilateral cochlear implant systems to be networked together. An adapter module that forms part of the system allows two standalone BTE units to be synchronized both temporally and tonotopically in order to maximize a patients listening experience. The system further allows a peer-to-peer network and protocol that includes two BTE units during normal operation, or two BTE units plus a host controller (PC, PDA, etc....) during fitting. The bilateral cochlear network includes four main components: (a) a communications interposer adapted to be inserted between the BTE battery and the BTE housing or modified BTE devices; (b) a communication channel over which communication takes place between the connected devices, including the protocol governing access to such channel; (c) the synchronization mechanisms used to achieve synchronization between the connected devices; and (d) a bilateral fitting paradigm.
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FIELD OF THE INVENTION
The invention relates to methods of manufacturing an implantable electrically conductive lead body used in such applications as cardiac pacing, intracardiac defibrillation and electrical nerve stimulation that is biocompatible upon implantation in an animal and compatible with a magnetic resonance imaging scanner for the purpose of diagnostic quality imaging.
BACKGROUND
Magnetic Resonance Imaging (MRI) is commonly used to view the internal organs of medical patients. To create an image, the patient is placed into very strong static and varying magnetic and radio frequency (RF) fields. For this reason, MRI is generally prohibited for patients with implanted ferromagnetic and/or electrically conductive objects, such as pacemakers, implantable defibrillators and nerve stimulators. Although it is feasible to minimize and even eliminate the use of ferromagnetic materials in implanted devices, these types of devices still require electrically conductive components that are affected by the fields produced by an MRI scanner.
U.S. Pat. No. 7,917,213, authored by the inventors of the present invention and incorporated herein by reference describes in detail the electrical and dimensional parameters of an MRI compatible lead body which minimizes the induced voltages and currents that can cause localized heating and/or distortion of an MRI image. This design requires that the diameter and pitch of the conductive coil within the lead body be closely controlled over its entire length.
Current methods of producing implantable lead bodies utilize various methods of polymer deposition such as spraying, dip coating, and extruding, however, these methods do not provide axial and diametric control of the conductive coil within the required tolerances and are thus unsuitable for producing MRI compatible lead bodies.
The invention as described and claimed herein details a process for manufacturing MRI compatible lead bodies which maintains close control of the helix pitch as well as the position of the coil in relation to the center line of the lead body, both of which relate to achieving the target RF performance.
SUMMARY
In one embodiment the invention discloses a method of manufacturing an MRI compatible conductive lead body. The method includes providing a mandrel defining a first end, a second end and an outer diameter and then applying a first substrate layer over the mandrel, with the first substrate layer defining an outer surface. The first substrate layer is next reflowed to conform closely to the mandrel. A conductive coil layer is wound around the outer surface of the first substrate layer and then secured to the mandrel at least at the first end and the second end. A second substrate layer is applied over the outer surface of the first substrate layer and reflowed to fuse with the first substrate layer and the conductive coil layer, permanently securing the conductive coil layer to the lead body. A third substrate layer is applied over the outer surface of the second substrate layer and reflowed causing the third substrate layer to fuse with the second substrate layer. The lead body is removed from the mandrel and trimmed to expose the conductive coil layer, allowing the lead body to be capable of electrical communication.
In another embodiment the invention discloses a method of manufacturing an MRI compatible conductive lead body. The method includes providing a mandrel defining a first end and a second end and an outer dimension substantially conforming to a desired inner dimension of a lumen defined by the lead body, with the mandrel coated with a non-stick material. A first set of blockers is placed at the first and second end of the mandrel, with the first set of blockers serving to prevent the migration of subsequently applied layers during the manufacturing process. A first substrate layer is applied between the first set of blockers, followed by the application of a first length of heat shrink material over the first substrate layer. The first length of heat shrink material is exposed to a sufficient amount of heat for a sufficient length of time to cause the first substrate layer to reflow, resulting in the first substrate layer conforming to the coated mandrel. Following reflowing of the first substrate layer, the first length of heat shrink material is removed. A conductive coil layer is wound over the outer surface of the first substrate layer and secured to the mandrel. A second set of blockers is placed at the first and second end of the lead body followed by applying a second substrate layer between the second set of blockers. A second length of heat shrink material is placed over the second substrate layer and exposed to a sufficient amount of heat for a sufficient length of time to cause the second substrate layer to reflow, resulting in the second substrate layer encapsulating the conductive coil layer and fusing with the first substrate layer. The second length of heat shrink material is removed and discarded. A third substrate material is placed over the second substrate layer. A third length of heat shrink material is applied over the third substrate and exposed to a sufficient amount of heat for a sufficient length of time to cause the third substrate layer to reflow and fuse to the second substrate layer. The third length of heat shrink material is removed and discarded. The first, second and third set of blockers are loosened from the mandrel, allowing the lead body to be removed from the mandrel. Upon removing the lead body from the mandrel the blockers are removed to expose the conductive coil layer, allowing the lead body to be capable of electrical communication.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a longitudinal cross section of a non-stick coated mandrel with a first set of blockers attached.
FIG. 2 is a longitudinal cross section of the lead body shown in FIG. 1 with a first substrate applied following reflowing of the first substrate.
FIG. 3 is a longitudinal cross section of the lead body shown in FIG. 2 following the winding of a conductive coil layer and an attached second set of blockers.
FIG. 4 is a longitudinal cross section of the lead body shown in FIG. 3 following the application of a second substrate prior to reflowing the second substrate.
FIG. 5 is a longitudinal cross section of the lead body shown in FIG. 4 following reflowing the second substrate.
FIG. 6 is a longitudinal cross section of the lead body shown in FIG. 5 following the application of a third substrate prior to reflowing the third substrate.
FIG. 7 is a longitudinal cross section of the lead body following reflowing of the third substrate.
FIG. 8 is a longitudinal cross section of the lead body following removal of the mandrel.
FIG. 9 is a longitudinal cross section of the completed lead body.
FIG. 9A is a lateral cross section of the lead body taken through the lines 9 A- 9 A of FIG. 9 .
FIG. 10 is a flow chart illustrating the steps of the method of the invention.
DETAILED DESCRIPTION
The particulars shown herein are by way of example and for purposes of illustrative discussion of the invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for the fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.
Nomenclature
10 Mandrel
10 a Tapered End of Mandrel
10 b Non-Tapered End of Mandrel
12 Coating
14 First Blocker
16 First Substrate Layer
18 Second Blocker
20 Conductive Coil Layer
22 Second Substrate Layer
26 Third Substrate Layer
28 Third Blocker
30 Lumen
50 Step of Providing Non-Stick Coated Mandrel
52 Step of Placing 1 st Set of Blockers on Mandrel
54 Step of Applying 1 st Substrate Between 1 st Set of Blockers
56 Step of Applying 1 st Length of Heat Shrink Material Over 1 st Substrate Layer
58 Step of Exposing 1 st Length of Heat Shrink Material to Sufficient Heat to Reflow 1 st Substrate Layer
60 Step of Removing 1 st Length of Heat Shrink Material
62 Step of Winding Conductive Coil Layer Over 1 st Substrate Layer
64 Step of Placing 2 nd Set of Blockers Over Conductive Coil Layer and 1 st Substrate Layer
66 Step of Applying 2 nd Substrate Layer Over Conductive Coil Layer Between 2 nd Set of Blockers
68 Step of Applying 2 nd Length of Heat Shrink Material Over 2 nd Substrate Layer
70 Step of Exposing 2 nd Length of Heat Shrink Material to Sufficient Heat to Reflow 2 nd Substrate Layer
72 Step of Removing 2 nd Length of Heat Shrink Material
74 Step of Applying 3 rd Set of Blockers
76 Step of Applying 3 rd Substrate Layer Over Reflowed 2 nd Substrate Layer, Between 3 rd Set of Blockers
78 Step of Applying 3 rd Length of Heat Shrink Material Over 3 rd Substrate Layer
80 Step of Exposing 3 rd Length of Heat Shrink Material to Sufficient Heat to Reflow 3 rd Substrate Layer
82 Step of Removing 3 rd Length of Heat Shrink Material
84 Step of Loosening 1 st , 2 nd 3 rd Blockers from Mandrel
86 Step of Removing Lead Body from Mandrel
88 Step of Trimming Away Blockers to Expose the Conductive Winding Layer at Both Ends of Lead Body
100 Conductive Lead body
Definitions
“Filar” means the number of separate conductive strands wound onto the lead body.
“Reflow” means applying sufficient pressure and temperature to a polymeric material to cause it to change configuration.
“Teflon®” is used here in its generic sense and includes PTFE, ETFE, FEP and other non-stick coatings.
Construction
As best shown in FIG. 1 , the method begins with step 50 the procurement of a mandrel 10 , which can be stainless steel, Teflon® or other materials able to withstand the temperatures and pressures of the method of the present invention. The mandrel 10 defines an outer dimension which will eventually correspond to the inner dimension of the lumen 30 of the eventually completed lead body 100 . The mandrel 10 also defines a tapered end 10 a and a non-tapered end 10 b . The tapered end 10 a serves to facilitate easier loading of the first 16 , second 22 and third 26 substrate layers onto the mandrel 10 as well as the heat shrink material (not shown) used to reflow the first 16 , second 22 and third 26 substrate layers. In this embodiment, the mandrel 10 is coated with a layer of non-stick coating 12 such as Teflon® or another compound characterized by chemical inertness as well as possessing significant non-stick characteristics. In one embodiment, the mandrel comprises a stainless steel wire with a sheet of Teflon® applied to it. A first set of blockers 14 at step 52 is placed over the Teflon® coated 12 mandrel 10 and serves to assist in preventing the migration of subsequently applied layers during the manufacturing process. In one embodiment the first set of blockers 14 comprise a heat shrink material that is heated following application causing the blockers 14 to decrease in size and closely conform to the outer contours of the mandrel 10 . The first set of blockers 14 can be made of PET (polyethylene terephthalate) heat shrink material, however, it is noted that other materials possessing similar characteristics would also work, thus the invention is not considered to be so limited.
FIG. 2 shows the lead body following step 54 and the application of a first substrate layer 16 between the first set of blockers 14 which serves to create a uniform outer diameter as well as acting to add structural strength to the eventually completed lead body 100 . In one embodiment, the first substrate layer is made of a 55 D polyurethane material such as Pellethane, made by Dow Chemical, which is relatively rigid and adds strength and integrity to the eventually completed lead body 100 . In other embodiments, the first substrate layer 16 can also be made of other urethane, silicone or other polymeric materials able to withstand the temperature and pressure requirements necessary to reflow and provide the necessary biocompatibility. The first substrate layer 16 is applied to the mandrel 10 as a tube which is slid over the tapered end 10 a of mandrel 10 followed at step 56 by sliding a tube of a first length of heat shrink material (not shown) also over the tapered end 10 a , over the not yet reflowed first substrate layer 16 . The first length of heat shrink material (not shown) is then at step 58 exposed to heat for a period of time sufficient to cause the first length of heat shrink material (not shown) to decrease in size and to reflow the first substrate layer 16 . In one embodiment, suitable heat shrink materials include FEP (fluorinated ethylene polypropylene), however, it is noted that other materials possessing similar characteristics would also work, thus the invention is not considered to be so limited. Due to variables such as the pitch of the conductive winding 20 and the thickness of the first, second and third substrate layers 16 , 22 , 26 it is difficult to characterize the heat treatment necessary to cause the first, second and third substrate layers 16 , 22 , 26 to reflow. In one embodiment, a vertical reflow system is used (not shown), which is well known to those skilled in the art. A vertical reflow system comprises a cylindrical chamber which is provided with a heat source through which the lead body is sequentially passed. It has been found that the first, second and third substrate layer 16 , 22 , 26 successfully reflow at a temperature of 450 degrees C., plus or minus 25 degrees C. when passed through a vertical reflow system at a speed of 0.1 to 0.3 centimeters per second. Following reflowing of the first substrate layer 16 the first length of heat shrink material (not shown) is removed and discarded at step 60 .
FIG. 3 illustrates step 62 and placement of a conductive coil layer 20 over the outer surface of the first substrate layer 16 . The conductive coil layer 20 in one embodiment is MP35N drawn fused tubing sold under the name DFI® but could also be any non-ferromagnetic material having sufficient conductivity to deliver electrical energy through the lead body 100 while maintaining MRI compatibility. The MP35N drawn fused tubing is an insulated conductor which could be insulated by such bio-compatible materials such as Teflon®, polyimide, urethanes or other materials. The conductive coil layer 20 may be initially secured in place using a variety of methods (e.g., crimping, swaging, heat shrink, others)(not shown). It is understood that the winding pattern for the conductive coil layer 20 shown herein is for purposes of illustration only and therefore does not limit the scope of the invention. As an example, the winding pattern as illustrated is monofilar, however, the invention is also compatible with multifilar applications. It is also understood that while a single conductive coil layer is shown in the drawings, this is for purposes of illustration only and therefore additional embodiments utilizing multiple conductive coil layers are also compatible with the method of this invention and therefore within its scope.
In one embodiment the second set of blockers 18 comprises a heat shrink material, where at step 64 , the heat shrink material is placed over the coil between the second set of blockers 18 and serves to prevent the migration of the subsequent (i.e., second 22 and third 26 ) substrate layers. In one embodiment, suitable heat shrink materials include PET (polyethylene terephthalate) heat shrink material, however, it is noted that other materials possessing similar characteristics would also work, thus the invention is not considered to be so limited. Placement of the second set of blockers 18 is followed by the application of heat to cause the heat shrink material to shrink in size.
FIG. 4 shows the application at step 66 of a second substrate layer 22 over the uncompleted lead body. In one embodiment the second substrate layer 22 comprises an 80 A polyurethane material which is a softer material than 55 D polyurethane and functions as a dampener or shock absorber. Additionally, the second substrate layer 22 serves to precisely bind the winding layer 20 to the first substrate layer 16 thus ensuring the accuracy of the intended diameter and pitch of the conductive coil layer 20 which maintains the electrical performance characteristics necessary for MRI compatibility. The second substrate layer 22 is applied to the lead body as a tube which is slid over the tapered end 10 a of the mandrel 10 and uncompleted lead body.
FIG. 5 shows the lead body following reflowing of the second substrate 22 . Reflowing is accomplished at step 68 by sliding a second length of heat shrink material (not shown) over the second substrate 22 which is then at step 70 exposed to a sufficient amount of heat for a period of time sufficient to cause the heat shrink material (not shown) to decrease in size and to reflow the second substrate layer 22 . In one embodiment, suitable heat shrink materials include an FEP (fluorinated ethylene polypropylene) heat shrink material, however, it is noted that other materials possessing similar characteristics would also work, thus the invention is not considered to be so limited. The pressure exerted on the second substrate layer 22 by the decreasing size of the heat shrink material (not shown), in combination with the exposure to heat energy causes the second substrate material 22 to reflow, resulting in the second substrate layer 22 being uniformly molded around the uncompleted lead body, resulting in the conductive winding 20 being permanently secured in place. Reflowing of the second substrate layer 22 also results in the second substrate layer 22 fusing with the first substrate layer 16 , while still maintaining separate layers. Following reflowing of the second substrate layer 22 the heat shrink material (not shown) is removed and discarded at step 72 .
As shown in FIG. 6 , a third substrate layer 26 is applied at step 76 by sliding a tube over the lead body. In one embodiment the third substrate layer 26 comprises a 55 D urethane material which is a relatively firm material, which primarily serves to add strength and an additional degree of integrity to the completed lead body 100 . Also shown in FIG. 6 is the addition of a third set of blockers 28 which can be heat shrink material placed towards the outer ends (unnumbered) of the uncompleted lead body. It should be noted that in some embodiments, the third set of blockers 28 may not be used, depending on the thicknesses of the substrate layers. Placement of the third set of blockers 28 is followed by the application of heat to cause the heat shrink material to reduce in size, thereby securing the third set of blockers at the desired position on the lead body. When used, the third set of blockers 28 functions to prevent the reflowed third substrate layer 26 from flowing beyond the third set of blockers 28 . The third set of blockers 28 can be made of PET (polyethylene terephthalate) heat shrink material, however, it is noted that other materials possessing similar characteristics would also work, thus the invention is not considered to be so limited.
FIG. 7 shows reflowing the third substrate 26 which is accomplished at step 78 by sliding a third length of heat shrink material (not shown) over the third substrate layer 26 which is then at step 80 exposed to a sufficient amount of heat for a period of time sufficient to cause the heat shrink material (not shown) to decrease in size and reflow the third substrate layer 26 . In one embodiment, suitable heat shrink materials include an FEP (fluorinated ethylene polypropylene) heat shrink material, however, it is noted that other materials possessing similar characteristics would also work, thus the invention is not considered to be so limited. Following reflowing of the third substrate layer 26 the heat shrink material (not shown) is removed and discarded at step 82 . The pressure exerted on the third substrate layer 26 by the decreasing size of the heat shrink material, in combination with the exposure to heat energy causes the third substrate material 26 to reflow, resulting in the third substrate layer 26 being uniformly molded around the lead body. Reflowing of the third substrate layer 26 also results in the third substrate layer 26 fusing with the second substrate layer 22 , while still maintaining separate layers.
FIG. 8 shows the lead body 100 following removal of the mandrel 10 . It is noted that a lumen 30 is formed where the mandrel 10 had previously been in place. Removal of the mandrel 10 at step 84 first requires loosening of the first, second and third sets of blockers 14 , 18 , 28 , which frees the mandrel 10 from the lead body 100 , allowing the mandrel 10 at step 86 to be withdrawn from the lead body 100 without damaging the lead body 100 . The function of the first, second and third sets of blockers 14 , 18 , 28 is to ensure that the first, second and third reflowed substrate layers 16 , 22 , 26 end at the same point. In one embodiment they would be perfectly aligned, but perfect alignment is not absolutely required. Following removal of the lead body 100 from the mandrel 10 , the lead body 100 is trimmed (not shown) at step 88 to expose the conductive coil layer 20 , allowing later attached electrodes and connectors to be in electrical communication with various devices.
FIG. 9A is a lateral cross section taken through the lines 9 A- 9 A of the completed lead body 100 ( FIG. 9 ) and shows the various layers built up during the manufacturing process and the lumen 30 .
FIG. 10 is a flow chart illustrating the various steps of the manufacturing process, including reflowing of the first, second and third substrate layers 16 , 22 , 26 .
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A method of manufacturing an implantable electrical lead body MRI used in such applications as cardiac pacing, electrical nerve stimulation and intracardiac defibrillation applications that is biocompatible upon implantation in an animal and compatible with a magnetic resonance imaging scanner for the purpose of diagnostic quality imaging is disclosed. The method involves a relatively rigid first substrate layer, a conductive coil layer being precisely placed over the first substrate layer, a relatively soft second substrate layer over the conductive coil layer and a relatively rigid third substrate layer over the second substrate layer.
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FIELD OF THE INVENTION
[0001] The invention relates to an unsubstituted quaternary ammonium salt that is an effective biocide in combination with a germicidal/bactericidal ingredient, alkyl-dimethyl-benzyl-ammonium chloride (Benzalkronium Chloride or BAC) and Carbamide peroxide (CH 6 N 2 O 3 ).
[0002] The invention describes a desirable effect of the chemistry combination where the creation of Hydronium Ions are known to mediate chemical reactions by attaching themselves to the hydrophilic ends of molecules, specifically sites with partial negative charges or rich in electron density. The formation of an adduct, for steric hindrance where adding Carbamide to the existing molecular chain will form a lightly bonded bi-molecule chain making the quaternary ammonia salt larger and more difficult to penetrate the skin flora while maintaining its germicidal functionality.
[0003] The described unsubstituted quaternary ammonium salt composition with other ingredients has been shown to be effective in testing against E - coli, Salmonella, Pseudomonas, Listeria, H1N1, NDM1, c-Difficile Spores, Rhinovirus, MRSA and a wide range of other bacteria and viruses, molds and spores.
[0004] Other additives such as scents, humectants, antifungal, anti-inflammatory, cicatrizants and hemostatic agents can be added to the chemistry combination to promote healing as well as other medicinal benefits.
BACKGROUND OF THE INVENTION
[0005] Hand sanitizers have been marketed and sold for decades. However, nearly all sanitizers use alcohol at a minimum of 62% concentration as both an antiseptic and a drying agent. According to Center for Disease Control (CDC) recommendations, a hand sanitizer should contain at least 60% alcohol by volume in order to be effective. Alcohol is harsh on the skin, and also is not recommended for use by people with diabetes as it can dramatically affect blood glucose readings. Certain religious beliefs restrict the use of alcohol on the hands and providing a non-alcohol based hand sanitizer with effective killing rates address s problem for a large community.
[0006] Alcohol-free hand sanitizers are available, but their effectiveness is limited by the number of active ingredients allowed under the FDA 1974 Tentative Final Monograph. Thus, it is necessary to find an ingredient, or combination of ingredients, that can significantly enhance the allowed biocides from the Monograph.
[0007] The FDA requirement for hand sanitizers must include active ingredient from a list identified in the FDA 1978 Monograph. One specific biocide listed in the Monograph is Benzalkronium Chloride (BAC) that acts as a sanitizer to disrupt the cellular membrane of micro-organisms. The biocide activity of BAC is enhanced by the action of the long chain substitutes, acting as solvents of the lipid (or other soluble) parts of the cellular membrane. This event disrupts the integrity of the cellular membrane causing the outflow of the intracellular liquid. The addition of a mineral acid as H 2 So 4 lowers the pH of the system, leading to the formation of Hydronium ions.
[0008] Hydronium ions are known to mediate chemical reactions by attaching themselves to the hydrophilic ends of molecules, specifically sites with partial negative charges or rich in electron density. H+ will bond disrupting the general characteristics of the lipid while the long chain of BAC will solvate the hydrocarbon chain.
[0009] In addition, the solution may contain other ingredients not listed as active by the FDA and may include but not limited to natural moisturizers such as Carbamide. The described unsubstituted quaternary ammonium salt composition is compatible with different aromas and fragrances, such as Rose Water, Witch Hazel, Lavender, Lilac and is not limited by one or more volatilized chemical compounds that can be added to the solution at a very low concentration that stimulates the human olfactory senses.
[0010] Carbamide is also highly water-soluble due to its ability to form multiple hydrogen bonds with the low pH hydronium ions in the chemistry composition. The natural conditioning properties of Carbamide, also called urea peroxide, urea hydrogen peroxide (UHP), and percarbamide, is an adduct of hydrogen peroxide and urea and is similar to hydrogen peroxide as an oxidizer. Carbamide has several other applications. In veterinary medicine, for instance, it is used as a topical antiseptic and a diuretic.
[0011] Carbamide appears as a white crystalline solid which dissolves in water to give free hydrogen peroxide and is readily available with the solubility of commercial samples varying from 0.05 g/ml to more than 0.6 g/ml. The chemical formula is CH 6 N 2 O 3 . As a natural skin conditioner the allergic reactions by users to dyes and chemicals found in readily available alcohol based hand sanitizers is avoided. The use of low doses of Carbamide has shown to reduce the effects of acme and psoriasis on the skin without damaging side effects found in some medications.
[0012] As documented in (www.wikipedia.org), “ Aloe vera is now widely used on facial tissues, where it is promoted as a moisturiser and/or anti-irritant to reduce chafing of the nose of users suffering hay-fever or cold. Aloe vera is also used for soothing the skin, and keeping the skin moist to help avoid flaky scalp and skin in harsh and dry weather. Aloe vera may also be used as a moisturizer for oily skin.” Aloe vera can be easily added to the described highly protonated, low pH, nondermathropic solution as a moisturizer.
[0013] Taspine is an alkaloid extracted from trees of Croton (family Euphorbiaceae) of the western Amazon region that has been used by natives and others as a vulnerary agent when purified from the tree sap. Some testing and data suggest that taspine promotes early phases of wound healing in a dose-dependent manner with no substantial modification thereafter. Its mechanism of action is probably related to its chemotactic properties on fibroblasts and is not mediated by changes in extracellular matrix. Additionally, Taspine can be added to the described highly protonated, low pH, nondermathropic solution as a natural moisturizer and wound healing ingredient.
SUMMARY OF THE INVENTION
[0014] The described invention of using a base chemistry where a high concentration of Hydronium Ions is created as a base chemistry where other ingredients described in the invention forms a composition that both reduces bacteria on the skin and a natural moisturizer with extended protection up to forty-eight hours after application to the skin.
[0015] As a result, the described skin sanitizing solution both sanitizes and moisturizes the skin on contact without the addition of harsh chemicals, such as alcohol, and without the need for skin conditioning additives that may contain objectionable chemistry, dyes and perfumes.
DETAILED DESCRIPTION OF THE INVENTION
[0016] The invention is an unsubstituted quaternary ammonium salt composition with other ingredients that comprises a composition that is non-flammable, alcohol-free, non-stinging, highly protonated, and nondermatropic. The composition has a very high Hydronium proton count and is created by a process involving the blending of a premix that comprises a highly protonated, non-corrosive, nondermatropic Hydronium carrier and a biocide, added to a predetermined quantity of water until it dissolves. The biocide comprises one or more quaternary ammonium compounds.
[0017] The described unsubstituted quaternary ammonium salt composition with other ingredients comprises a blend of an inorganic acid, a sulfate, and water or a blend of organic acid, a sulfate, and water. The quaternary ammonium compound is selected from one or more of the group consisting of Benzalkonium Chloride, Cetylpyridinium Chloride, Silver Chloride adsorbed to titanium dioxide (initially notified under silver chloride), Cetalkonium chloride, Benzyldimethyl (octadecyl) ammonium chloride, Miristalkonium chloride, Dimethyldioctylammonium chloride, Hydrogen chloride/hydrocholoric acid, Silver Chloride, Dodecylguanidine monohydrochloride, Bromine chloride, Dimethyloctadecyl [3-(trimethoxysilyl) propyl]ammonium chloride, Decyldimethyloctylammonium chloride, Benzyl dimethyloleylammonium chloride, Dimethyltetradecyl [3-(trimethoxysilyl)propyl]ammonium chloride, benzylcoco alkyldimethyl chlorides, dicocoalkyl dimethyl, chlorides, bis(hydrogenated tallow alkyl) dimethyl chlorides, benzyl-c8-18-alkyldimethyl chlorides, benzyl-c12-18-alkyldimethyl chlorides, di-C6-12-alkyldimethylchlorides, benzyl-c8-16-alkyldimethyl chlorides, di-c8-10-alkyldimethyl chlorides, benzyl-C10-16-alkyldimethylchlorides, Octenidine dihydrochloride di-C8-18 alkyldimethyl, chlorides, benzyl-C12-14-alkyldimethyl chlorides, C12-14-alkyl[(ethylphenyl)methyl]dimethyl chlorides.
[0018] The inorganic acid is selected from one or more of the group consisting of Sulfuric acid, Hydrochloric acid, Nitric acid, Phosphoric acid, Boric acid, Hydrofluoric acid, Hydrobromic acid.
[0019] The organic acid selected from one or more of the group consisting of Lactic acid, Acetic acid, Formic acid, Citric acid, Oxalic acid, Uric acid.
[0020] The solution may further comprise a skin permeation enhancer or conditioner selected from one or more of the group consisting of natural components and vitamins, minerals, urea or anti-oxidants to enhance the composition's natural skin moisturizing and protection against the spread of acme and psoriasis.
[0021] A thickener may be added to make a gel formula solution. The thickener is selected from one or more of the group consisting of Xanthan gum, Alginic acid, Sodium alginate, Ammonium alginate, Calcium alginate, Propylene glycol alginate, Propane-1,2-diol alginate, Agar, Carrageenan, Processed euchuema seaweed, Furcelleran, Aribinogalactan larch gum, Locust Bean (carob gum), Oat gum, Guar gum, Tragacanth, Acadia Gum (Gum Arabic), Karaya gum, Tara Gum, Gellan gum, Sorbitol, Mannitol, Glycerol, Konjac, Konjac gum, Polyoxethylene (8) sterate, Polyoxyl 8 stearate, Polyoxyethylene (40) stearate, Polyoxyethylene (20) sorbitan monolaurate (polysorbate 20), Polysorbate 80, Polyoxethylene sorbitan mono-oleate, Polyoxethylene sorbitan monopalminate, Polysorbate 40, Tween 40, Polyxethylene sorbitan monostearate, Polysorbate 60, Tween 60, Polyoxyethylene-20-sorbitan tristearate, Polysorbate 65, Tween 65, Pectin, Amidated pectin, Gelatine, Ammonium phosphatides, Sucrose acetate isobutyrate, SAIB, Sucrose diacetate hexaisobutyrate, Glycerol esters of wood rosins, Sodium and potassium pyrophosphates, Diphosphates, Ammonium phosphate (diabasic and monobasic), Sodium and potassium triphosphate, Triphosphate, Sodium and potassium polyphosphates, Polyphosphates, Beta-cyclodextrine, Cellulose (microcrystalline and powdered), Methyl cellulose, Ethyl cellulose, Hydroxypropyl cellulose, Hydroxypropyl methyl cellulose, Methylethylcellulose, Carboxymethyl cellulose, Sodium carboxymethyl cellulose, Crosslinked sodium carboxymethyl cellulose, Sodium caseinate, Magnesium stearate, Sodium, potassium and calcium salts of fatty acids, Magnesium salts of fatty acids, Mono- and diglycerides of fatty acids (glyceryl monostearate, glyceryl distearate), Acetic and fatty acid esters of glycerol, Acetic acid esters of mono- and diglycerides of fatty acids, Lactic and fatty acid esters of glycerol, Lactic acid esters of mono- and diglycerides of fatty acids, Citric and fatty acid esters of glycerol, Citric acid esters of mono- and diglycerides of fatty acids, Tartaric and fatty acid esters of glycerol, Tartaric acid esters of mono- and diglycerides of fatty acids, Diacetyltartaric and fatty acid esters of glycerol, mon- and diacetyl tartaric acid esters of monoand diglycerides of fatty acids, Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids, Sucrose esters of fatty acids, Sucroglycerides, Polyglycerol esters of fatty acids, Polyglycerol esters of interesterified ricinoliec acid, Propylene glycol mono- and di-esters, Propane 1,2-Diol esters of fatty acids, Lactylated fatty acid esters of glycerol and propane-1,2-diol, Thermally oxidized soy bean oil interacted with mono- and diglycerides of fatty acids, Dioctyl sodium sulphosuccinate, Sodium oleyl or stearoyl lactylate stearoyl-2-lactylate, Calcium stearoyl-2-lactylate, Stearyl tartrate, sorbitan monostearate, Sorbitan tristearate, Span 65, Sorbitan monolaurate, Span 20, Sorbitan mono-oleate, Span 80, Sorbitan monopalmitate, Span 40.
[0022] The unsubstituted quaternary ammonium salt created by the invention was tested by an independent laboratory and the results recorded for each microbe studied. It is important to note that alcohol based hand sanitizers with or without the active ingredient BZK does not offer the same results against MRSA, c-Diff spores, H1N1.
[0000]
Average
Untreated
Number
Percent
Microbe
Control
Recovered
Reduction
MRSA
(30 Seconds)
1.7 × 10 5
3.3 × 10 0
99.998%
MRSA
(180 seconds)
1.7 × 10 5
<1.0 × 10 0
99.999%
c-Diff Spores
Trial 1
3.3 × 10 3
<1.00
99.97%
Trial 2
3.3 × 10 3
<1.00
99.97%
Trial 3
3.3 × 10 3
<1.00
99.97%
Trial 4
3.3 × 10 3
<1.00
99.97%
Trial 5
3.3 × 10 3
<1.00
99.97%
NDM-1
Trial 1
9.6 × 10 5
<5.0
99.9995%
Trial 2
9.6 × 10 5
<5.0
99.9995%
Trial 3
9.6 × 10 5
<5.0
99.9995%
Trial 4
9.6 × 10 5
<5.0
99.9995%
Trial 5
9.6 × 10 5
<5.0
99.9995%
Rhinovirus 39
6.7 × 10 5
4.8 × 10 0
99.993%
Influenza A
3.1 × 10 4
<2.2
99.993%
(H1N1)
PRD-1
2.0 × 10 4
4.3 × 10 0
99.98%
Bacteriophage
E. Coli
9.10 × 10 5
<0.5
99.9999%
E. Coli
(Dry Test)
5.6 × 10 4
3.7 × 10 2
99.3%
Salmonella
1.1 × 10 6
<0.5
99.9999%
Enterica
Salmonella
(Dry Test)
1.6 × 10 5
1.6 × 10 2
99.9%
Enterica
[0023] This product is manufactured according to FDA Tentative Final Monograph (1974, 1978, 1991, 1994, 2002). All testing is performed by an independent registered laboratory, according to test methods described in AOAC Official Method 961.02 (Germicidal Spray Products as Disinfectants), ASTME 1053-97 (Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Surfaces), and from ASTM E2111-00 (Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal and Sporicidal Potencies of Liquid Chemical Germicides). The FDA does not specify testing protocols for this product. Copies of full reports are available upon request.
[0024] The solution also was graded minimally irritating at 2.8 (non-irritant) on the standardized Draize Test scale where 0 is non-irritating and 110 is severe/extreme where skin damage will occur.
[0025] According to (wwww.wikipedia.org) the Draize Test is an acute toxicity test devised in 1944 by the Food and Drug administration (FDA) toxologists John H. Draize and Jacob M. Spines. Initially used for testing cosmetics, the procedure involves applying 0.5 mL or 0.5 g of a test substance to the eye or skin of a restrained, conscious animal, and then leaving it for set amount of time before rinsing it out and recording its effects. The animals are observed for up to 14 days for signs of erythema and edema in the skin test, and redness, swelling, discharge, ulceration, hemorrhaging, cloudiness, or blindness in the tested eye. The test subject is commonly an albino rabbit, though other species are used too, including dogs. The animals are euthanized after testing if the test renders irreversible damage to the eye or skin. Animals may be re-used for testing purposes if the product tested causes no permanent damage. Animals are typically reused after a “wash out” period during which all traces of the tested product are allowed to disperse from the test site. The FDA supports the test, stating that “to date, no single test, or battery of tests, has been accepted by the scientific community as a replacement [for] . . . the Draize test”
PREFERRED EMBODIMENT
[0026] One embodiment of the invention consists of the use of the described unsubstituted quaternary ammonium salt composition with other ingredients which are fully incorporated herein by reference, as the Ionic Carrier premix. In this embodiment, 10 grams of the described highly protonated, low pH, nondermathropic solution are blended in a 1:2 ratio with water, by weight. This blend is then added to 5.5 grams of Benzalkonium Chloride, mixed with 3 grams of Urea, and 481.5 grams of water.
[0027] The amount of thickener can vary, depending upon the final intended use. 0.5% to 1% xanthan gum gives a good consistency for a hand gel. The formula is a composition, which is a highly protonated, supercharged, non-corrosive liquid proton suspending composition.
[0028] The manufacturing process to create the described unsubstituted quaternary ammonium salt with is well known and beginning as early as the 1980's various chemists and inventors have experimented with the nature of this reaction of adding acid to the water. Generally speaking, these reactions and resulting compounds have lacked stability and the manufacturing process was extremely expensive for commercialization.
[0029] However, this invention has created a compound reaction of the several elements for making the described unsubstituted quaternary ammonium salt composition with other ingredients of adding sulfuric acid of at least 88% purity in a controlled manner to water while vigorously stirring and agitating said solution to control the temperature of the exothermic reaction.
[0030] It should be understood that the preceding is merely a detailed description of one or more embodiments of this invention and that numerous changes to the disclosed embodiments can be made in accordance with the disclosure herein without departing from the spirit and scope of the invention. The preceding description, therefore, is not meant to limit the scope of the invention. Rather, the scope of the invention is to be determined only by the appended claims and their equivalents.
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A water based, alcohol-free, skin sanitizing solution with a natural skin softener, where the nature of the biocidal enhancer used in the process of making the solution significantly increases efficacy while simultaneously enabling much more economical manufacturing, processing and transportation of the product. Because it is water based, no further moisturizing additives are required, and those with sensitive skin, diabetes, allergies or religious beliefs are able to use the product without concern.
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This application is a division of U.S. patent application Ser. No. 09/329,688, filed on Jun. 10, 1999 now U.S. Pat. No. 6,221,074 and entitled FEMORAL INTRAMEDULLARY ROD SYSTEM; the contents of which are hereby incorporated by reference.
FIELD OF THE INVENTION
The present invention is directed to techniques for treating bone fractures. Specifically, but not exclusively, the invention relates to a system for treating a variety of typical femoral fractures using a uniform intramedullary rod design.
BACKGROUND OF THE INVENTION
The femur generally comprises an elongated shaft extending from the hip to the knee. The proximal end of the femoral shaft includes a neck segment connected to a head portion. The head portion fits into a concavity of the hip bone to form a ball and socket joint at the hip. The distal end of the femoral shaft engages the upper end of the tibia to form the knee joint. Overall, the femur is one of the longest and strongest bones in the human body; however, portions of the femur are extremely susceptible to fracture.
Internal fixation of femoral fractures is one of the most common orthopedic surgical procedures. Many different types of femoral fractures are encountered in practice, including fractures of the femoral neck, midshaft, and distal regions. When the femur is fractured, treatment requires that the fractured bone be substantially immobilized and held together in an abutting relationship during the healing process. Any longitudinal, transverse, or rotational movement of one section of the fractured bone relative to the other can cause substantial delay in healing time or cause improper healing to occur. In general, two different internal fixation approaches have been used to immobilize the area surrounding the fracture site.
One approach involves driving metallic pins through the two sections of bone to be joined and connecting them to one or more plates bearing against the external surface of the bones. However, such an arrangement injures the flesh and muscle surrounding the bones and a large number of pins driven through the bone tend to weaken its hard outer layer. Plates also tend to stress the bone and are not always able to bear sufficient stress for many femoral fracture applications.
Further, bone beneath the plate does not always become as strong as it would in the absence of the plate. A second approach to treating femoral fractures involves the use of an intramedullary nail which is inserted into the medullary canal of the femur and affixed therein by a number of different methods. After complete healing of the bone at the fracture site, the nail may be removed through a hole drilled in the proximal end of the femur. A wide variety of devices have been developed over the years for use in the internal fixation of femoral fractures utilizing the method of intramedullar stabilization and immobilization. While there have been a number of technological advances made within the area of intramedullary fixation of femoral fractures, several problem areas remain.
One such problem arises from the fact that most intramedullary fixation systems currently available are adapted to a specific type of femoral fracture, resulting in a large number of highly specialized configurations. This has led to the disadvantageous consequence that hospitals and trauma centers have to keep a large inventory of incremental nail lengths with varying configurations and ancillary parts in order to accommodate a random and diverse incoming patient population. Maintaining such a high level of inventory to handle all expected contingencies is not only complex, but is also very expensive. Correspondingly, the possibility of error during selection and implantation of the fixation device by the surgeon is elevated. Likewise, the inventory costs associated with varying methods of intramedullary fixation are drastically increased and, in the case of smaller medical facilities, may necessitate switching to a less costly and potentially less effective method of treating femoral fractures.
Another problem may result from intramedullary rod systems used to specifically treat fractures of the neck or head of the femur. These devices typically include a transverse fixation member (nail, pin, screw, etc.) adapted to be positioned along the longitudinal axis of the femoral neck with its leading end portion embedded in the femoral head so as to grip the femoral head and thereby stabilize the fracture site. The fixation member is operably connected to the intramedullary rod to maintain a fixed relationship between the fixation member and the rod. Unfortunately, this structural connection does not always prevent rotational or translational movement of the fixation member relative to the intramedullary rod in response to forces commonly resulting from the normal activity of a convalescing patient. Additionally, the intramedullary rods used in these devices are typically specialized for use with this single fixation application and can not be used in other applications. Therefore, the costs associated with maintaining increased levels of inventory are substantially increased. Furthermore, if it is desired to vary the angle of the fixation member relative to the rod, substantial modifications must typically be made to either the fixation member or the rod member to accommodate for such an angular variation, again driving up inventory levels and associated inventory costs.
In still another problem area, on occasion, it is necessary to use transverse locking bone screws to lock the rod into position relative to the femur. In order to prevent the screws from backing out, locking nuts can be threaded onto the distal ends of the locking screws. Unfortunately, the installation of locking nuts onto the ends of the locking screws requires additional surgical incisions and commonly causes soft tissue irritation.
In yet another problem area, when an intramedullary rod is inserted into the medullary canal and anchored to the femur by two or more bone screws, despite the best efforts of the surgeon, the fracture site may have either been over-compressed or over-distracted as a result of the insertion of the rod. Unfortunately, with conventional intramedullary rods, it is virtually impossible to adjust the amount of distraction or compression without first removing one or more of the bone screws and manually distracting or compressing the fracture site. The intramedullary rod must then be re-anchored to the femur by reinserting the bone screws at different positions along the femur.
Thus, there is a demand for bone treatment techniques to address these problems. The present invention meets this demand and provides other benefits and advantages in a novel and unobvious manner.
SUMMARY OF THE INVENTION
The present invention is directed to techniques for treating bone fractures. Various aspects of the invention are novel, nonobvious and provide various advantages. While the actual nature of the invention covered herein can only be determined with reference to the claims appended hereto, selected forms and features of the preferred embodiment as disclosed herein, are described briefly as follows.
One form of the present invention includes treating a bone fracture with a nail that defines an opening and a transverse member including a bone engaging portion and a connection portion. The connection portion defines a through-hole and the nail is sized to pass through the through-hole. A pin is adjustably coupled to the transverse member to rigidly assemble the transverse member to the nail.
In a further form of the present invention, a method of treating a bone fracture includes forming a first hole in a femur transverse to the medullary canal and introducing a transverse member through the first hole. The transverse member includes a through-hole that is positioned relative to the medullary canal of the femur, and is preferably aligned therewith. The method further includes forming a second hole intersecting the medullary canal and inserting an intramedullary nail into the medullary canal via the second hole. The nail passes through the through-hole of the transverse member. The nail may include an opening aligned with the transverse member to facilitate rigid assembly to the transverse member by positioning a pin coupled to the transverse member in the nail opening.
In still another form of the present invention, a system for treating bone fractures includes a nail having a first end portion opposite a second end portion along a longitudinal axis. The first end portion defines an opening extending through the nail and has an angled surface oriented at an oblique angle relative to the longitudinal axis of the nail. Also included is a sleeve that includes a pair of apertures positioned on opposite sides of the sleeve. The apertures and the opening align to form a passageway when the sleeve is fitted over an end portion. A bone engaging member is received within the passageway in an abutting relationship with the angled surface.
In yet another form of the present invention, a bone fracture treatment apparatus includes an elongated nail having a longitudinal axis and a transverse axis generally perpendicular to the longitudinal axis. The nail defines a transverse opening extending along the transverse axis with the opening being bound by an upper surface and an opposite lower surface. At least one of the upper or lower surface defines a projection extending in a longitudinal direction to thereby narrow a dimension of the opening within the nail. The nail opening, and projection may be arranged to cooperate with one or more other members suitable to treat a particular type of bone fracture, such as a fracture of the femur.
According to another form of the present invention, a system for treating bone fractures includes a nail defining a longitudinal axis, a transverse axis and an opening extending along the transverse axis with the opening being bound by a bearing surface. Also included is a sleeve having a pair of apertures positioned on opposite sides thereof. The apertures and the opening are aligned to form a passageway when the sleeve is fitted over the nail. A bone engaging member is sized to pass through the passageway. Additionally, the system may include a means for biasing the sleeve in a longitudinal direction to clamp the bone engaging member against the bearing surface.
Still a further form of the present invention includes a technique for treating bone fractures with a nail that defines a longitudinal axis, an elongated opening extending therethrough, and a longitudinal passage intersecting the opening. A bone engaging member passes through the opening and a positioning device is provided that may be adjusted to change position of the bone engaging member along the longitudinal axis relative to the nail when the member is positioned through the nail opening. This device may be utilized to facilitate compression or distraction of a bone fracture.
Accordingly, one object of the present invention is to provide an improved bone fracture treatment system. Preferably, this system may be used to treat fractures of the femur.
Additionally or alternatively, another object is to provide an improved method of treating bone fractures, particularly fractures of elongated bones such as the femur.
Additionally or alternatively, still another object is to reduce the complexity and inventory costs associated with treating bone fractures.
Other objects, features, forms, embodiments, aspects, advantages and benefits of the present invention will become apparent to persons of ordinary skill in the art from the following written description and accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view, partly in section, of a rod system of the present invention with a transverse member shown in an antegrade position.
FIG. 2 is a side view, partly in section, of the system of FIG. 1 with the transverse member in a retrograde position.
FIG. 3 is a partial side view of the proximal end portion of the rod of FIGS. 1 and 2.
FIG. 4 is a partial side view of the sleeve of FIGS. 1 and 2.
FIG. 5 is a partial, sectional side view of the proximal end portion of the rod shown in FIG. 3 and the sleeve of FIG. 4 assembled together with the locking member of FIGS. 1 and 2.
FIG. 6 is a side view, partly in section, of another rod system of the present invention implanted in the neck and head of a femur.
FIG. 7 is a partial, sectional side view of the proximal end portion of the system of FIG. 6 .
FIG. 8A is a side view of the fixed angle pin of FIG. 7 .
FIG. 8B is an end view of the fixed angle pin of FIG. 7 .
FIG. 9 is a partial, sectional side view of the proximal end of yet another system of the present invention having a variable angle pin positioned at 135 degrees relative to a rod.
FIG. 10A is a side view of the leading portion of the variable angle pin of FIG. 9 .
FIG. 10B is an end view of the leading portion of the variable angle pin of FIG. 9 taken along view line 10 B— 10 B of FIG. 10 A.
FIG. 11A is a side view of the trailing portion of the variable angle pin of FIG. 9 .
FIG. 11B is an end view of the trailing portion of the variable angle pin of FIG. 9 taken along view line 11 B— 11 B of FIG. 11 A.
FIG. 12 is a partial, sectional side view of the proximal end of the system of FIG. 9 showing the variable angle pin at 140 degrees relative to the rod.
FIG. 13 is a side view, partly in section, of still another rod system of the present invention illustrating implantation of an intramedullary nail inserted in a retrograde direction.
FIG. 14 is a partial, sectional side view of the proximal end portion of a farther system of the present invention.
FIG. 15 is a side view, partly in section, of another rod system of the present invention for performing distraction of a bone fracture.
FIG. 16 is a partial, sectional side view of the proximal end portion of the rod of FIG. 15 .
FIG. 17 is a partial, sectional side view of the proximal end portion of the system of FIG. 15, illustrating a first operational position.
FIG. 18 is a partial, sectional side view of the proximal end portion of the system of FIG. 15, illustrating a second operational position.
FIG. 19 is a side view, partly in section, of an additional intramedullary rod system of the present invention for performing compression of a bone fracture.
FIG. 20 is a partial, sectional side view of the proximal end portion of the system of FIG. 19, illustrating a first operational position.
FIG. 21 is a partial, sectional side view of the proximal end portion of the system of FIG. 19, illustrating a second operational position.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, any alterations and further modifications in the illustrated embodiments, and any further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
FIGS. 1-2 depict intramedullary system 10 according to one embodiment of the present invention. System 10 is shown implanted in femur 12 and includes an elongated intramedullary rod or nail 14 , sleeve 16 and bone engaging member 18 . System 10 also includes fasteners 20 and locking bone screws 22 a, 22 b. FIG. 1 illustrates system 10 as used in a first locking configuration with bone engaging member 18 placed in an antegrade direction within femur 12 . FIG. 2 illustrates a second locking configuration of system 10 ; where bone engaging member 18 is placed in a retrograde position within femur 12 . The tip of the greater trochanter 12 a, the neck 12 b, and the head 12 c of femur 12 are designated in FIGS. 1 and 2. Although system 10 is shown implanted in a human femur 12 , system 10 could also be used in conjunction with other bones as would occur to one skilled in the art, including, but not limited to, the tibia, humerus, radius, ulna and fibula.
Nail 14 includes a proximal end portion 14 a and a distal end portion 14 b. Nail 14 also defines a longitudinal centerline axis L 1 running along the length of nail 14 between proximal end portion 14 a and distal end portion 14 b. For application to an adult human femur, proximal end portion 14 a preferably has a diameter of about 11-13 millimeters. The diameter of the remainder of nail 14 may vary depending upon the requirements of the fixation procedure and the surgeon's preference. While nail 14 has a generally circular cross section, other suitable shapes are also contemplated as would occur to one skilled in the art.
Referring additionally to FIGS. 3-5, portion 14 b of nail 14 defines generally parallel transverse bores 24 a, 24 b, each sized to respectively receive locking bone screws 22 a, 22 b therein. Distal end portion 14 b also defines transverse bore 24 c, aligned generally perpendicular to transverse bores 24 a, 24 b and sized to receive locking bone screw 22 c (not shown). Proximal end portion 14 a defines an opening 26 and a threaded transverse bore 28 , both extending through nail 14 generally transverse to axis L 1 from a first side 14 c to a second side 14 d. Side 14 c generally opposes side 14 d. Proximal end portion 14 a also defines threaded longitudinal bore 29 generally extending along axis L 1 for receiving nail insertion and extraction instrumentation (not shown) used to guide nail 14 into and out of femur 12 . Nail 14 also defines a longitudinal passage 30 intersecting bore 29 and extending generally along axis L 1 to allow for the optional use of a guide wire (not shown) to aid in the insertion of nail 14 into femur 12 .
Referring more specifically to FIGS. 3 and 5, opening 26 is bound by lower surface 31 opposite upper surface 32 . Lower surface 31 includes a first angled surface 31 a oriented generally parallel to transverse axis T 1 . Upper surface 32 includes a second angled surface 32 a offset from first angled surface 31 a along axis T 1 . Angled surfaces 31 a, 32 a are generally parallel to transverse axis T 1 . Transverse axis T 1 is aligned at an oblique angle α 1 relative to longitudinal axis L 1 of nail 14 . Angle α 1 is preferably in a range of about 120-150 degrees, with the more preferred angle being about 135 degrees. First angled surface 31 a and second angled surface 32 a cooperate to define pathway 33 generally oriented at angle α 1 relative to axis L 1 . First pathway 33 is sized to receive bone engaging member 18 therethrough.
Lower surface 31 also includes a third angled surface 31 b aligned generally parallel to transverse axis T 2 . Upper surface 32 also includes a fourth angled surface 32 b generally offset from third angled surface 31 b along axis T 2 that is also generally parallel to transverse axis T 2 . Comparing to FIG. 2, transverse axis T 2 is also aligned at an oblique angle α 2 relative to longitudinal axis L 1 of nail 14 . Angle α 2 is preferably in a range of about 120-150 degrees, with the more preferred angle being about 135 degrees. Third angled surface 31 b and fourth angled surface 32 b cooperate to define pathway 34 generally oriented at angle α 2 relative to axis L 1 . Second pathway 34 is sized to receive bone engaging member 18 therethrough.
First angled surface 31 a and third angled surface 31 b cooperate to define a first projection 35 extending in a longitudinal direction which narrows a dimension of opening 26 within nail 14 along axis L 1 . Similarly, second angled surface 32 a and fourth angled surface 32 b cooperate to define a second projection 36 extending in a longitudinal direction generally opposite first projection 35 to further narrow a dimension of opening 26 within nail 14 along axis L 1 . In a preferred embodiment, each projection 35 , 36 defines an apex, resulting in a convergent-divergent throat 36 a about midway between sides 14 c and 14 d of nail 14 . However, first projection 35 and second projection 36 could alternatively define any other geometric configuration as would occur to those skilled in the art. For example, first projection 35 and second projection 36 could be rounded. Likewise, in other alternative embodiments, one or more of projections 35 , 36 may be absent. While angled surfaces 31 a, 31 b, 32 a, 32 b are generally concave to compliment member 18 , other shapes are also contemplated as would occur to those skilled in the art. For example, angled surfaces 31 a, 31 b, 32 a, 32 b could be flat or have other configurations corresponding to the outer surface of bone engaging member 18 .
Referring to FIG. 4, sleeve 16 of system 10 is illustrated therein. Sleeve 16 has a generally cylindrical shape and defines a proximal end 16 a, a distal end 16 b and a side wall 37 . Sleeve 16 is sized to fit over the proximal end of nail 14 as shown in FIG. 3 . Distal end 16 b is therefore open to allow for passage of proximal end portion 14 a therethrough. Sleeve 16 also defines an inwardly tapered edge 38 , terminating at distal end 16 b, to permit easy sliding of sleeve 16 through bone. Proximal end 16 a defines an opening 39 to permit access to threaded bore 29 , and thus allow for passage of nail insertion and extraction instrumentation (not shown). Side wall 37 defines offset apertures 40 a, 40 b positioned on opposite sides of sleeve 16 . Apertures 40 a, 40 b are generally circular and are aligned and sized to receive bone engaging member 18 therethrough. Side wall 37 further defines opposing transverse apertures 42 a, 42 b positioned on opposite sides of sleeve 16 . Apertures 42 a, 42 b are generally circular and are aligned and sized to receive fastener 20 therethrough.
Referring to FIG. 5, therein is illustrated bone engaging member 18 . Bone engaging member 18 includes a proximal end portion 18 a and a distal end portion 18 b. Bone engaging member 18 has a generally circular cross section and preferably has a diameter of about 5.5-6.5 millimeters for applications treating fractured adult human femurs. Distal end portion 18 b includes a means for fixedly engaging and gripping bone 44 . Bone engaging member 18 may be a bone screw having a threaded distal end portion 18 b as shown in FIG. 5, or a bone blade having distal end portion 18 b formed from a plate with a helical twist (not shown). Alternately, distal end portion 18 b may be otherwise configured for engaging bone as would occur to those skilled in the art.
As illustrated in FIG. 5, when sleeve 16 is fitted over proximal end portion 14 a of nail 14 , apertures 40 a, 40 b of sleeve 16 are positioned to align with opening 26 of nail 14 , and register with pathway 33 along transverse axis T 1 . Collectively, apertures 40 a, 40 b and opening 26 define passageway 50 coincident with pathway 33 . Passageway 50 is bound on one side by first angled surface 31 a and on another side by second angled surface 32 a. As bone engaging member 18 is slidably received within passageway 50 and guided along transverse axis T 1 , bone engaging member 18 forms an abutting relationship with either or both of first and second angled surface 31 a, 32 a. This relationship may be load bearing in nature. Bone engaging member 18 is sized relative to passageway 50 so that its rotational position about axis L 1 and its translational position along axis L 1 are generally fixed when positioned therethrough.
As illustrated in FIG. 5, when sleeve 16 is fitted over proximal end portion 14 a of nail 14 , apertures 42 a, 42 b of sleeve 16 are aligned with bore 28 of nail 14 . A fastener 20 is passed through aperture 42 a and threaded into bore 28 to thereby releasably secure sleeve 16 to nail 14 . Another fastener 20 is passed through aperture 42 b and threaded into bore 28 to further secure sleeve 16 to nail 14 . While two fasteners 20 are shown to releasably secure sleeve 16 to nail 14 , it is also contemplated that a single fastener may be used to sufficiently secure sleeve 16 to nail 14 . To avoid interfering with the optional use of a guide wire (not shown) to aid in the insertion of nail 14 into femur 12 , fastener 20 has a length which penetrates bore 28 far enough to secure sleeve 16 to nail 14 , but without obstructing longitudinal passage 30 . In still other embodiments, one or more of fasteners 20 , bore 28 , and apertures 42 a, 42 b may not be utilized at all.
Notably, by rotating sleeve 16 180 degrees relative to nail 14 , system 10 may be reconfigured from an antegrade orientation of bone engaging member 18 to a retrograde orientation, or vice-versa. Similarly, regardless of which locking configuration is used, the same components of system 10 can be used to treat either a left or right femur by simply rotating sleeve 16 180 degrees relative to nail 14 . As a result, apertures 40 a, 40 b of sleeve 16 are repositioned to align with pathway 34 through opening 26 of nail 14 along transverse axis T 2 . Collectively, apertures 40 a, 40 b and opening 26 define passageway 52 which is coincident with pathway 34 . Passageway 52 is bound on one side by third angled surface 31 b and on another side by fourth angled surface 32 b (see FIGS. 2 and 5 ). As bone engaging member 18 is slidably received within passageway 52 and guided along transverse axis T 2 , bone engaging member 18 forms an abutting relationship with either or both of the third and fourth angled surfaces 31 b, 32 b. Preferably, this relationship is suitable for load bearing, and generally fixes member 18 with respect to rotation about axis L 1 or translation along axis L 1 .
In other embodiments of system 10 , the angular alignment of bone engaging member 18 relative to axis L 1 may be varied by changing the configuration of sleeve 16 . More specifically, apertures 40 a, 40 b can be aligned at an angle other than α 1 . In these embodiments, first passageway 50 does not fall along transverse axis T 1 of nail 14 . Thus, as bone engaging member 18 is slidably received within first passageway 50 , bone engaging member 18 will contact either first projection 35 or second projection 36 , but will not form an abutting relationship with first angled surface 31 a or second angled surface 32 a. However, the alternative arrangement is still suitable to fix bone engaging member 18 axially and rotationally relative to nail 14 .
Referring again to FIGS. 1 and 2, a femur implantation procedure corresponding to system 10 is next described. The implant procedure generally includes forming a longitudinal hole into, and generally parallel with, the medullary canal from a position slightly medial to the tip of the greater trochanter 12 a. The longitudinal hole is sized to receive nail 14 therethrough. Preferably, the longitudinal hole is formed by drilling. Sleeve 16 is fitted over proximal end portion 14 a of nail 14 and sleeve 16 is secured to nail 14 by threading fasteners 20 into bore 28 . As discussed above, system 10 can be used in either a first or second locking configuration depending on the rotational orientation of sleeve 16 relative to nail 14 .
FIG. 1 illustrates system 10 in a first locking configuration corresponding to an antegrade configuration for the depicted femur 12 . In this first locking configuration, sleeve 16 is secured to nail 14 with apertures 40 a, 40 b positioned relative to opening 26 of nail 14 to define passageway 52 along transverse axis T 2 . Nail 14 , with sleeve 16 secured thereto, is inserted through the longitudinal hole and into the medullary canal. A transverse hole is formed through femur 12 across the medullary canal corresponding to transverse axis T 2 The transverse hole intersects the medullary canal and is sized to receive bone engaging member 18 therein. Preferably this transverse hole also is formed by drilling. Bone engaging member 18 is inserted into the transverse hole and through passageway 52 formed by nail 14 and sleeve 16 . As a result, member 18 is preferably secured against translation along axis L 1 or rotation about axis L 1 . When received in passageway 52 , member 18 generally extends between a femur entry point slightly lateral to the greater trochanter 12 a to a terminal point below the base of neck 12 b. Generally parallel bores are formed through femur 12 transverse to the medullary canal and generally perpendicular to axis L 1 to align with transverse bores 24 a, 24 b of nail 14 . Preferably these bores are also formed by drilling. Nail 14 is further locked into position by inserting locking bone screws 22 a, 22 b through femur 12 and into transverse bores 24 a, 24 b of nail 14 .
FIGS. 2 and 5 illustrates system 10 in a second locking configuration corresponding to a retrograde arrangement relative to the depicted femur 12 . In this second locking configuration, sleeve 16 is secured to nail 14 with apertures 40 a, 40 b positioned relative to opening 26 of nail 14 to define passageway 50 along transverse axis T 1 . The medullary canal is accessed in generally the same manner as described in connection with FIG. 1 . Nail 14 , with sleeve 16 secured thereto, is inserted through the longitudinal hole medial to the greater trochanter 12 a and into the medullary canal. A transverse hole is drilled into femur 12 across the medullary canal corresponding to transverse axis T 1 and sized to receive bone engaging member 18 therein. Bone engaging member 18 is inserted into the transverse hole through passageway 50 . So arranged, member 18 generally extends through neck 12 b into head 12 c. Generally parallel bores are formed through femur 12 transverse to the medullary canal and generally perpendicular to axis L 1 . These bores are generally aligned with transverse bores 24 a, 24 b of nail 14 . Nail 14 is further locked into position by inserting locking bone screws 22 a, 22 b through femur 12 and into transverse bores 24 a, 24 b of nail 14 .
Next, a preferred method of manufacturing nail 14 is described. This preferred method includes drilling a first bore through proximal portion 14 a in a direction corresponding to transverse axis T 1 (aligned at angle α 1 ). A second bore is then drilled through proximal portion 14 a corresponding to transverse axis T 2 (aligned at angle α 2 ) and intersecting the first bore at a point generally corresponding to the centerline of nail 14 . The first and second bores are each sized to receive bone engaging member 18 therethrough. The first bore thereby defines first angled surface 31 a and second angled surface 32 a, and the second bore thereby defines third angled surface 31 b and fourth angled surface 32 b. The remaining material between lower surface 31 and upper surface 32 may then be removed to form opening 26 through nail 14 , having projections 35 , 36 as depicted.
FIG. 6 depicts intramedullary system 100 according to another embodiment of the present invention; where like reference numerals represent like features previously described in connection with system 10 . System 100 is shown implanted in femur 12 and includes intramedullary rod or nail 14 , transverse member 102 , pin 103 , locking screw 104 and set crew 105 . System 100 also includes locking bone screws 22 a, 22 b. Although system 100 is shown implanted in human femur 12 , system 100 could also be used in conjunction with other bones as would occur to one skilled in the art, including the tibia, humerus, radius, ulna and fibula to name a few. While system 100 could be used to treat the same indications as system 10 in the second locking configuration, as illustrated in FIG. 2 and discussed above, it is preferably used for fractures of the proximal portion of femur 12 , and more preferably fractures between the neck 12 b and head 12 c. The same components of system 100 can be used to treat either a left or right femur by rotating transverse member 102 180 degrees relative to nail 14 .
FIGS. 7-12 provide additional details concerning the structure and assembly of system 100 . Referring to FIG. 7, various structural details of transverse member 102 and pin 103 are shown therein. Transverse member 102 defines a longitudinal centerline axis L 2 and includes a barrel connection portion 106 and a bone engaging portion 108 . Connection portion 106 is generally cylindrical and has a side wall 110 . Side wall 110 defines a passage 112 extending generally along axis L 2 . Connection portion 106 also includes a proximal portion 106 a and a distal portion 106 b. Proximal portion 106 a includes an internal threaded portion 114 extending along a portion of passage 112 . Distal portion 106 b defines an external inward taper 116 to promote ease of movement through bone when transverse member 102 is advanced into femur 12 . Distal portion 106 b also defines an inner retaining lip 118 for provisionally maintaining bone engaging portion 108 in sliding engagement with connection portion 106 , the operation of which will become apparent hereinafter.
A thru-hole 120 is formed through connection portion 106 . Thru-hole 120 is generally cylindrical and has a diameter slightly greater than the outer diameter of proximal portion 14 a of nail 14 . Alternately, thru-hole 120 could be elliptical or any other shape corresponding to proximal portion 14 a of nail 14 . Additionally, thru-hole 120 and portion 14 a of nail 14 could be asymmetrical and of similar profile to prevent rotational movement of transverse member 102 relative to nail 14 when proximal portion 14 a is received within thru-hole 120 . Similarly, if thru-hole 120 and portion 14 a of nail 14 where both tapered in the same direction and at about the same angle, the resulting tight engagement between transverse member 102 and nail 14 would aid in preventing rotational movement.
Thru-hole 120 is formed through connection portion 102 to provide a selected angular relationship with axis L 1 when nail 14 passes therethrough. This relationship corresponds to angle α 3 between axes L 1 and L 2 , and is preferably in a range of about 130-145 degrees. More preferably, for system 100 , angle α 3 is about 135 degrees and is equal to angle α 2 as depicted in FIG. 6 . As will become apparent from later discussion, angle α 3 corresponds to the angle of fixation between transverse member 102 and nail 14 .
Bone engaging portion 108 includes a proximal portion 108 a and a distal portion 108 b. A bone engaging and gripping thread 122 is formed on distal portion 108 b. Additionally or alternatively, a different bone gripping means may be utilized, such as a bone blade having distal portion 108 b formed from a plate with a helical twist, or such other means as would occur to those skilled in the art.
Proximal portion 108 a includes a hex recess 124 for receiving a driving tool (not shown), such as an Allen wrench, preferably suited to drive bone engaging portion 108 into neck 12 b and head 12 c of femur 12 . Bone engaging portion 108 defines a longitudinal passage 126 extending therethrough and generally along axis L 2 to allow for the optional use of a guide wire (not shown) to aid in the insertion of bone engaging portion 108 into bone. Proximal portion 108 a is sized to be received within passage 112 of connection portion 106 to allow slidable movement of bone engaging portion 108 generally along axis L 2 over a predetermined range. A keeper 128 is provided on, in association with, or integral to proximal portion 108 a to provisionally maintain bone engaging portion 108 and connection portion 106 in a telescopic sliding relationship. Keeper 128 is comprised of a cylindrical sleeve that is preferably laser welded onto shaft 130 of bone engaging portion 108 after it has been positioned within connection portion 106 . The outer diameter of keeper 128 is slightly smaller but in close tolerance with the inner diameter of passage 112 .
Pin 103 is shown positioned within passage 112 of connection portion 106 . FIGS. 8A and 8B additionally illustrate various structural details of pin 103 . Pin 103 has a longitudinal centerline axis L 3 and includes a leading portion 132 integrally connected to a trailing portion 134 . Leading portion 132 has a generally circular, elongated body and is sized to be received within opening 26 of nail 14 . Leading portion 132 also includes an angled, annular engaging surface 135 configured to co-act with a surface of nail 14 . Engaging surface 135 is aligned at an angle α 4 relative to axis L 3 . Angle α 4 is in a range of about 130-145 degrees. Most preferably, angle α 4 should be approximately equal to angle α 2 . Leading portion 132 additionally includes a tapered tip 136 . Trailing portion 134 is provided with an externally threaded portion 137 configured to threadedly engage threaded portion 114 of connection portion 106 . A hex recess 138 is defined by trailing portion 134 for receiving a driving tool (not shown), such as an Allen wrench, to advance pin 103 into portion 106 or remove pin 103 from portion 106 by turning in a corresponding rotational direction. In other embodiments, pin 103 additionally or alternatively has a different means for positioning relative to connection portion 106 , such as a ratcheting mechanism, a cabling arrangement, or any other method capable of advancing pin 103 along axis L 2 as would occur to those skilled in the art.
In order to prevent pin 103 from migrating once positioned in a desired position within passage 112 , system 100 includes locking screw 104 . Locking screw 104 is provided with external threads 142 configured to threadedly engage threaded portion 114 of connection portion 106 . A hex recess 144 is defined by trailing end 146 for receiving a driving tool (not shown), such as an Allen wrench, to rotationally advance locking screw 104 along connection portion 106 . Locking screw 104 is axially advanced along axis L 2 until it tightly engages trailing portion 134 of pin 103 . In other embodiments, system 100 additionally or alternatively includes another locking means as would normally occur to one skilled in the art to prevent pin 103 from migrating relative to connection portion 106 .
To further aid in preventing pin 103 from rotating, loosening or migrating once positioned in a desired axial position within passage 112 , system 100 includes set screw 105 . Set screw 105 includes a threaded portion 150 and an elongated stem portion 152 . Threaded portion 150 is configured to threadedly engage bore 29 of nail 14 . Threaded portion 150 also includes a hex recess 154 for receiving a driving tool (not shown), such as an Allen wrench, to rotationally advance set screw 105 along bore 29 . Elongated stem portion 152 is sized to be slidably received within longitudinal passage 30 of nail 14 . Stem 152 also defines a tapered or contoured end 156 conforming with an outer surface of leading portion 132 of pin 103 to provide improved mechanical interlocking between set screw 105 and pin 103 .
Referring generally to FIGS. 6, 7 , 8 A, and 8 B, another embodiment of a femur implantation procedure in accordance with the present invention is described with respect to system 100 . This femur implantation procedure generally includes forming a transverse passage into femur 12 that crosses the medullary canal and is sized to receive transverse member 102 therein. Preferably, this transverse passage is formed by drilling and begins at the lateral side of femur 12 , extends into neck 12 b and terminates in head 12 c to orient transverse member 102 as depicted in FIG. 6 . Also shown in FIG. 6, it is preferred that the transverse passage form an oblique angle approximately the same as angle α 3 with respect to axis L 1 or the medullary canal.
Next, transverse member 102 is introduced through the transverse passage with thruhole 120 positioned to at least overlap the medullary canal of femur 12 , and preferably to be generally centered with respect to the medullary canal of femur 12 . At least a portion of bone engaging portion 108 is threaded into femur 12 at this stage. Preferably, bone engaging portion 108 is threaded into a portion of head 12 c of femur 12 by engaging hex recess 124 with a suitable tool and turning portion 108 in a corresponding rotational direction generally about axis L 2 .
Notably, bone engaging portion 108 is telescopically received within passage 112 of connection portion 106 to allow axial movement of bone engaging portion 108 over a predetermined range along axis L 2 . Keeper 128 cooperates with inner retaining lip 118 to prevent disengagement of bone engaging portion 108 from connection portion 106 . The cooperation between inner retaining lip 118 and keeper 128 also acts to stabilize bone engaging portion 108 , thus aiding in the sliding motion of bone engaging portion 108 to provide the preferred telescopic functioning of transverse member 102 . Since connection portion 106 provisionally maintains bone engaging portion 108 in a captive, telescopic relationship, the alignment of bone engaging portion 108 along axis L 1 is always maintained. Thus, when the procedure includes turning thread 122 through neck 12 b of femur 12 and into head 12 c, head 12 c will become fixed in an angular relationship relative to transverse member 102 . By maintaining the angular alignment between neck 12 b and head 12 c, and allowing them to slide telescopically relative to one another, system 100 can accommodate for changes during patient movement and expedite the bone healing process.
After transverse member 102 is inserted, an opening is formed, preferably by drilling, into and generally along the medullary canal from a position slightly medial relative to the tip of the greater trochanter 12 a and sized to receive nail 14 therethrough. Nail 14 is inserted through the longitudinal and into the medullary canal. Nail 14 passes through thru-hole 120 of connection portion 106 . Thru-hole 120 of transverse member 102 receives nail 14 in a close sliding fit, thereby permitting limited axial and rotational movement of transverse member 102 along axis L 1 of nail 14 . Transverse member 102 is longitudinally positioned on nail 14 so that passage 112 of connection portion 106 registers with opening 26 of nail 14 . If desired, bone engaging portion is further advanced into the bone at this stage.
Next, pin 103 is axially advanced through passage 112 by engaging hex recess 144 with an appropriate tool and rotating in a corresponding direction. As threaded portion 137 of pin 103 engages threaded portion 114 of connection portion 106 , leading portion 132 is slidably received within opening 26 to engage one or more surfaces 31 b, 32 b. Even if passage 112 and opening 26 are misaligned, in many instances tapered tip 136 allows pin 103 to self-center, thereby aiding in the insertion of leading portion 132 within opening 26 . As pin 103 is slidably received within pathway 34 of opening 26 and guided along transverse axis T 2 , leading portion 132 forms an abutting relationship with one or both of angled surfaces 31 b, 32 b. Pin 103 thus becomes oriented at angle α 2 relative to axis L 1 , aiding in the fixation of transverse member 102 relative to nail 14 . As pin 103 is further advanced through passage 112 , engaging surface 135 is firmly pressed against nail 14 and transverse member 102 is pulled in a proximal direction. Correspondingly, an inner surface of transverse member 102 that borders thru-hole 120 is clamped against an outer surface of nail 14 while generally maintaining angle α 2 of transverse member 102 relative to axis L 1 .
After securely clamping transverse member 102 and nail 14 together, generally parallel passages are formed, preferably by drilling through femur 12 transverse to the medullary canal and aligned with transverse bores 24 a, 24 b of nail 14 . Nail 14 is further locked into position by inserting locking bone screws 22 a, 22 b through femur 12 and into transverse bores 24 a, 24 b of nail 14 .
Referring to FIG. 9, system 160 of another embodiment of the present invention is illustrated; where reference numerals like those of previous embodiments refer to like features. System 160 includes transverse member 102 ′ which is the same as transverse member 102 except that pin 103 ′ is utilized in place of pin 103 . FIGS. 10A, 10 B, 11 A and 11 B illustrate selected details of pin 103 ′. Pin 103 ′ includes a leading portion 162 and a non-integral trailing portion 164 . Leading portion 162 preferably has a generally circular, elongated body and is sized to be received within opening 26 of nail 14 . Leading portion 162 also includes an angled, annular engaging surface 165 configured to co-act with a surface of nail 14 . Engaging surface 165 is aligned at an angle α 4 relative to axis L 4 of pin 103 ′. Leading portion 162 additionally includes a tapered tip 166 .
Leading portion 162 is articulated to trailing portion 164 to facilitate pivotal movement of portion 162 relative to portion 164 . Trailing portion 164 includes externally threaded portion 167 configured to threadedly engage threaded portion 114 of connection portion 106 . A hex recess 168 is defined by trailing portion 164 for receiving a driving tool (not shown), such as an Allen wrench, to advance pin 103 ′ axially along connection portion 106 . In other embodiments, pin 103 ′ is alternatively or additionally configured with a different means to be axially advanced through connection portion 106 , such as a ratcheting mechanism or a cabling arrangement. In still other embodiments, techniques are utilized as would occur to one skilled in the art.
Leading portion 162 has a longitudinal centerline axis L 4 and trailing portion 164 has a longitudinal centerline axis L 5 . Unlike pin 103 , leading portion 162 and trailing portion 164 are not integral and are coupled to permit leading portion 162 to pivot relative to trailing portion 164 . This pivoting or articulation permits angular variation of portion 162 relative to axis L 2 . In one preferred embodiment, leading portion 162 includes a ball and socket joint 170 to provide the angular adjustment capability.
The rear portion of leading portion 162 defines a concave surface 174 generally centered about axis L 4 . Projecting proximally from concave surface 174 along axis L 4 is stem 178 . Stem 178 has a generally circular cross section, but also preferably defines a pair of parallel, opposing flats 180 a, 180 b. A ball member 182 is positioned at the end of stem 178 and is generally spherical-shaped. Trailing portion 164 defines a convex surface 184 generally centered about axis L 5 and configured to closely conform with concave surface 174 of leading portion 162 . Trailing portion 164 also defines a transverse socket 186 extending partially therethrough and aligned generally perpendicular to axis L 5 .
Transverse socket 186 has a diameter slightly larger than the diameter of ball member 182 . Transverse socket 186 terminates at concave bottom surface 188 . Concave bottom surface 188 substantially conforms with the outer surface of ball member 182 . Trailing portion 164 also defines a longitudinal bore 190 aligned with axis L 5 . Longitudinal bore 190 extends from convex surface 184 to transverse socket 186 . Longitudinal bore 190 is outwardly tapered with wide end 190 a intersecting convex surface 184 and narrow end 190 b intersecting transverse socket 186 , thus defining taper angle α 5 relative to axis L 5 . Preferably, taper angle α 5 is between about 5 degrees and 20 degrees. Most preferably, taper angle α 5 is about 10 degrees. Trailing portion 164 further defines a transverse slot 192 extending partially therethrough and substantially aligned with transverse socket 186 . Slot 192 has a width W extending along longitudinal bore 190 from convex surface 184 to transverse socket 186 . Slot 192 has a depth sufficient to intersect narrow end 190 b of transverse bore 190 . Height H of slot 192 is slightly greater than the distance between flats 180 a, 180 b of stem 190 . Collectively, socket 186 and slot 192 are configured to receive ball member 182 and stem 178 therein, respectively.
In another embodiment of pin 103 ′, a flexible, readily deformable intermediate section is positioned between leading portion 162 and trailing portion 164 that may be additionally or alternatively used to provide means for allowing angular variation between axis L 4 and axis L 5 . In still another embodiment, portion 162 is journaled to portion 164 by a shaft through a bore, permitting rotation of portion 162 relative to portion 164 . In other embodiments, another suitable means for providing angular variation between axis L 4 and L 5 may alternatively or additionally be utilized as would occur to those skilled in the art.
As illustrated in FIG. 9, pin 103 ′ operates generally in the same manner as pin 103 described in connection with system 100 . Although pin 103 ′ can be used in instances where angles α 2 and α 3 are substantially equal (as shown in FIG. 9 ), the more preferred application arises in configurations where angles α 2 and α 3 are different. The articulation of leading portion 162 relative to trailing portion 164 facilitates secure clamping to nail 14 despite a mismatch between the angled surfaces 31 a, 32 a, or 31 b, 32 b and the angular relationship of member 102 ′ to axis L 1 defined by thru-hole 120 . For example, referring additionally to FIG. 12, angles α 2 and α 3 are about 135 and 140 degrees, respectively, relative to axis L 1 . Preferably, the pivot range of leading portion 162 accommodates a range of different angular orientations of thru-hole 120 corresponding to α 3 . In one more preferred range, leading portion 162 pivots to accommodate a variation of angle α 3 from about 130 to about 145 degrees.
In one preferred implantation procedure, transverse member 102 ′ and nail 14 are implanted in accordance with the same procedure for inserting bone engaging member 108 , connection portion 106 and nail 14 , with the engagement of pin 103 ′ in place of pin 103 . For pin 103 ′, ball member 182 is inserted into socket 186 by aligning flats 180 a, 180 b of stem 178 with slot 192 and then guiding ball member 182 within transverse socket 186 until ball member 182 is positioned adjacent concave bottom surface 188 . A slight rotation or angulation of leading portion 162 relative to trailing portion 164 securely engages the two portions. As a result, leading portion 162 is rotatably coupled to trailing portion 164 by ball and socket joint 170 . Thus, leading portion 162 can rotate freely over a predetermined range within passage 112 as limited by taper angle α 5 . In one preferred embodiment, taper angle α 5 permits angular variation between leading portion 162 and trailing portion 164 of about 10 degrees in any direction. The assembly of leading portion 162 to trailing portion 164 may be performed during the implantation procedure just before insertion into passage 112 or in advance of the procedure as desired.
Once leading portion 162 and trailing portion 164 are assembled, Pin 103 ′ is advanced through passage 112 of connection portion 106 by engaging hex recess 168 and turning in the appropriate rotational direction. Pin 103 ′ is slidably received within pathway 34 of opening 26 and leading portion 162 is guided along transverse axis T 2 to form an abutting relationship with one or both of angled surfaces 31 b, 32 b. If, as mentioned above, thru-hole 120 is disposed in connection portion 106 in correspondence to a different angle α 3 relative to axis L 1 (such as 140 degrees), leading portion 162 is forced to pivot relative to trailing portion 164 and thereby aligns at angle α 2 (such as 135 degrees). As trailing portion 164 is tightened in connection portion 106 , a rigid, secure construct forms between transverse member 102 ′ and nail 14 as described in connection with the operation of system 100 , except that pin 103 ′ may pivot, contacting an inner surface of connection portion 106 as illustrated in FIG. 12 . Notably, like system 10 , system 100 and 160 may be reconfigured to accommodate either the left or right femur or an antegrade or retrograde application; however, in other embodiments of the present invention, rod 14 may be modified to define only one generally linear pathway therethrough.
Referring now to FIG. 13, system 195 according to another embodiment of the present invention is illustrated; where reference numerals of previously described embodiments refer to like features. Preferably, system 195 is implanted in femur 12 as shown, and includes intramedullary rod or nail 14 , set screw 105 , and locking bone screws 22 a, 22 b, 22 c. In other embodiments, system 195 may be used in conjunction with other bones as would occur to one skilled in the art, such as the tibia, humerus, radius, ulna, or fibula to name a few. Additionally, the same components of system 195 can be used to treat either a left or right femur by simply rotating nail 14 180 degrees relative to longitudinal axis L 1 . Unlike systems 10 , 100 and 160 ; system 195 positions nail 14 with the proximal and distal end portions reversed within femur 12 corresponding to implantation of nail 14 in a retrograde direction. Unlike existing systems, nail 14 need not be modified to operate in a retrograde direction. Indeed, nail 14 may be used in either an antegrade direction, as illustrated in connection with systems 10 , 100 , and 160 , or a retrograde direction as illustrated in FIG. 13 .
One preferred implant procedure for system 195 includes forming a longitudinal hole along femur 12 , intersecting the medullary canal from a point generally central to distal end portion 12 d. The longitudinal hole is sized to receive nail 14 therethrough and is preferably formed by drilling into femur 12 . Nail 14 is inserted through the longitudinal hole and into the medullary canal. A pair of generally parallel, transverse passageways are formed, preferably by drilling, through femur 12 transverse to and intersecting with the medullary canal. These passageways are in registry with opening 26 and transverse bore 28 , respectively. Nail 14 is locked into position by inserting locking bone screws 22 a, 22 b into the transverse passageways and correspondingly through opening 26 and transverse bore 28 . Another transverse passageway is drilled through femur 12 across the medullary canal and intersecting therewith that is generally aligned with transverse bore 24 c formed in distal portion 14 b of nail 14 . Nail 14 is further locked into position by inserting locking bone screw 22 c into this distal transverse passageway and correspondingly through transverse bore 24 c. Although system 195 does not require a sleeve to lock bone screws 22 a, 22 b into position relative to nail 14 , as discussed below, such a feature may optionally be utilized.
Referring now to FIG. 14, shown is bone treatment system 200 according to yet another embodiment of the present invention; where reference numerals of previously described embodiments refer to like features. System 200 is shown implanted in femur 12 and includes intramedullary nail 14 , sleeve 202 , bone engaging members 204 , 205 and biasing sleeve 202 . Preferably, system 200 is utilized to treat fractures of the human femur, but may be used in conjunction with any other bone as would occur to those skilled in the art. Additionally, while system 200 can be used with any nail and sleeve configuration, it is preferably used in conjunction with retrograde implantation of nail 14 as described in connection with FIG. 13 herein.
In FIG. 14, opening 26 extends generally along transverse centerline axis T 3 and transverse bore 28 extends generally along transverse centerline axis T 4 . Opening 26 is bounded by a bearing surface 26 a and bore 28 is bounded by a bearing surface 28 a. Sleeve 202 has a generally cylindrical shape and defines a proximal end 202 a, a distal end 202 b, and a side wall 208 . Sleeve 202 is sized to fit over proximal end portion 14 a of nail 14 . Distal end 202 b is therefore open to allow for passage of proximal end portion 14 a. Sleeve 202 defines an inwardly tapered edge 210 , terminating at distal end 202 b, to facilitate movement of sleeve 202 through bone. Proximal end 202 a is also open to allow for the passage of nail insertion and extraction instrumentation (not shown). The interior surface of side wall 208 immediately adjacent proximal end 202 a defines a threaded portion 211 . Side wall 208 also defines two sets of opposing apertures 212 a, 212 b and 214 a, 214 b. Apertures 212 a, 214 a oppose apertures 212 b, 214 b in a direction along axes T 3 , T 4 , respectively. Aperture sets 212 a, 212 b, and 214 a, 214 b are generally circular and are aligned and sized to respectively receive bone engaging members 204 , 205 therethrough. Apertures 212 a, 212 b define circumferential engaging surfaces 213 a, 213 b, respectively, and apertures 214 a, 214 b define circumferential engaging surfaces 215 a, 215 b, respectively.
Bone engaging member 204 includes a proximal end portion 204 a opposite a distal end portion 204 b. Bone engaging member 204 has a generally circular cross section and preferably has a diameter of about 5.5-6.5 millimeters for a femur application. Distal end portion 204 b includes thread 216 for engaging and gripping bone. Alternatively or additionally, member 204 may include a different bone engaging or gripping means such as a bone blade having distal end portion 204 b formed from a plate with a helical twist or an expansion device. Bone engaging member 205 includes a proximal end 205 a and a distal end 20 b and is preferably configured the same as bone engaging member 204 .
System 200 includes biasing end cap 220 . End cap 220 is generally circular and includes a first threaded portion 222 configured to threadingly engage threaded portion 211 of sleeve 202 . A second threaded portion 224 is configured to threadingly engage longitudinal bore 29 of nail 14 . End cap 220 proximally terminates in an enlarged, flat end portion 226 having protruding flange 228 . Flat end portion 226 also defines hex recess 230 for receiving a driving tool (not shown).
System 200 is utilized in accordance with one preferred femur implantation procedure by inserting nail 14 as described in connection with FIG. 13, except, proximal end 14 a also carries sleeve 202 thereon by loosely threading end cap 220 into sleeve 202 and rod 14 .
Accordingly, protruding flange 228 of flat end portion 226 bears against proximal end 202 a of sleeve 202 . With sleeve 202 so oriented, apertures 212 a, 212 b are generally in alignment with transverse bore 28 along axis T 4 to define passageway 232 . Correspondingly, apertures 214 a, 214 b are generally aligned with opening 26 along transverse axis T 3 to defined passageway 234 .
Once the nail 14 and sleeve 202 are in place within femur 12 , two transverse passages are formed through the bone that are in registry with passageways 232 , 234 . Next, bone engaging members 204 , 205 are received through the bone and passageways 232 , 234 , respectively. Once bone engaging members are in place. Sleeve 202 is biased by further tightening of end cap 220 . As end cap 220 is tightened, is moves sleeve 202 and nail 14 in opposite directions along axes L 1 . Correspondingly, surfaces 213 a, 213 b move to bear against bone engaging member 204 and engaging surfaces 214 a, 214 b bear against bone engaging member 205 . In turn, bone engaging member 204 is tightly clamped against bearing surface 26 a of opening 26 and bone engaging member 205 is tightly clamped against bearing surface 28 a of bore 28 . The tight engagement between bone engaging members 204 , 205 and bearing surfaces 26 a, 28 a thereby clamps bone engaging members 204 , 205 into position relative to nail 14 and prevents lateral migration. Locking nuts, which have in the past been used to prevent such lateral migration, are generally not needed for system 200 , so that additional surgical incisions normally required to engage locking nuts onto the bone engaging members need not be made and soft tissue irritation commonly associated with the presence of the locking nuts is also eliminated. Preparations and implantation of one or more bone engaging members may optionally be performed at distal end 14 b of nail 14 .
In an alternative embodiment, end cap 220 does not include first threaded portion 222 . Thus, as threaded portion 224 engages longitudinal bore 29 of nail 14 , flange 228 of flat end portion 226 contacts proximal end 202 a of sleeve 202 to advance sleeve 202 in a distal direction relative to nail 14 . In still another embodiment, end cap 220 does not include second threaded portion 224 . Thus, as threaded portion 222 engages threaded portion 211 of sleeve 202 , flat end 222 a of threaded portion 222 is forced into contact with the proximal end of nail 14 , thereby advancing sleeve 202 in a proximal direction relative to nail 14 . In yet another embodiment of system 200 , the biasing means consists of a spring member operably captured between nail 14 and sleeve 202 . The spring member is configured to urge sleeve 202 , nail 14 , or both to clamp bone engaging members 204 , 205 .
Referring now to FIG. 15, intramedullary system 300 according to still another embodiment of the present invention is illustrated; where reference numerals of previously described embodiments refer to like features. System 300 is shown implanted in femur 12 and includes elongated intramedullary nail 302 , positioning device 304 , bone engaging member 306 and locking bone screw 308 . Femur 12 includes a fracture site 301 , separating femur 12 into two portions 12 f, 12 e. Fracture site 301 is shown in a compressed state (i.e., portions 12 f, 12 e are being pushed together). Although system 300 is shown implanted in femur 12 , system 300 could also be used in conjunction with other bones such as the tibia, humerus, radius, ulna and fibula to name a few. Additionally, the same components of system 300 can be used to treat either a left or right femur by simply rotating nail 302 180 degrees relative to axis L 6 . Although FIG. 15 illustrates nail 302 implanted within femur 12 in a retrograde direction, it is understood that system 300 could also be implanted with nail 302 in an antegrade direction.
FIGS. 15 and 16 show various structural details of nail 302 . It should be understood that nail 302 can take on a number of configurations, including that of nail 14 illustrated and described above. However, in a preferred embodiment, nail 302 is configured as described below. Nail 302 includes a proximal end portion 302 a and a distal end portion 302 b. Nail 302 also defines a longitudinal axis L 6 running along the length of nail 302 between proximal end portion 302 a and distal end portion 302 b. Proximal end portion 302 a preferably has a diameter of about 11-12 millimeters for an adult human femur application. The diameter of the remainder of nail 302 can be varied depending upon the requirements of the fixation procedure and the surgeon's preference. While nail 302 has a generally circular cross section, other suitable shapes are also contemplated as would occur to one skilled in the art.
Nail 302 defines a passage 309 extending therethrough along axis L 6 line to allow for the optional use of a guide wire (not shown) to aid in the insertion of nail 302 in femur 12 . Distal end portion 302 b defines parallel transverse bores 310 b, 310 c, each sized to receive locking bone screw 308 . Distal end portion 302 b also defines transverse bore 310 a, aligned generally perpendicular to transverse bores 310 b, 310 c and also sized to receive locking bone screw 308 .
Proximal end portion 302 a defines an elongated, longitudinal opening 312 bounded by side walls 313 and sized to receive bone engaging member 306 therein. Opening 312 laterally extends through nail 302 and is elongated in the direction of longitudinal axis L 6 . Opening 312 has a first end portion 312 a and an opposing second end portion 312 b. Proximal end portion 302 a of nail 302 also defines a longitudinal passage 314 extending generally along axis L 6 and having a generally circular cross-section. Longitudinal passage 314 intersects opening 312 and terminates in a generally concave bottom surface 316 . A threaded portion 318 is defined about a portion of longitudinal passage 314 . Proximal end portion 302 a also defines a transverse bore 320 extending through nail 302 generally perpendicular to axis L 6 and aligned with opening 312 . Bore 320 is sized to receive bone engaging member 306 therein.
Referring to FIG. 17 therein is shown nail 302 , positioning device 304 and bone engaging member 306 as assembled within system 300 . Positioning device 304 is shown positioned within longitudinal passage 314 and includes a first portion 322 and a second portion 324 . First portion 322 includes a head 326 and a threaded stem 328 extending therefrom generally along longitudinal axis L 6 . Head 326 is substantially circular and has an outer diameter generally corresponding to the outer diameter of nail 302 . Head 326 also includes a hex recess 330 for receiving a driving tool (not shown), such as an Allen wrench. The diameter of threaded stem 328 is less than the diameter of head 326 , thereby defining an annular shoulder 332 .
Second portion 324 defines a generally circular, elongated body 333 having a diameter slightly less than the diameter of longitudinal passage 314 . Second portion 324 also defines an internally threaded portion 334 extending generally along longitudinal axis L 6 and configured to threadedly engage threaded stem 328 of first portion 322 . Threaded portion 334 has a depth slightly greater than the length of threaded stem 328 . The end of second portion 324 opposite threaded portion 334 terminates into a generally convex outer surface 336 that substantially corresponds to concave bottom surface 316 of longitudinal passage 314 . Second portion 324 also defines a transverse opening 338 extending therethrough generally perpendicular to longitudinal axis L 6 . Opening 338 is bounded by inner surface 339 and is sized to receive bone engaging member 306 therein.
FIG. 17 illustrates a first operational position of system 300 . Positioning device 304 (including first and second portions 322 , 324 ) is shown inserted within longitudinal passage 314 of nail 302 . Opening 338 of second portion 324 is positioned adjacent second end portion 312 b of opening 312 and generally aligned with opening 312 to define a passageway 40 . Bone engaging member 306 is shown inserted through passageway 340 . Threaded stem 328 of first portion 322 is partially threadedly engaged within threaded portion 334 of second portion 324 . First portion 322 can be rotated by placing a driving tool (not shown) within hex recess 330 and turning in a clockwise or counterclockwise direction as appropriate. Second portion 324 is prevented from rotating in correspondence with first portion 322 because of engagement between bone engaging member 306 against sidewalls 313 of opening 312 . In one embodiment, threaded stem 328 and threaded portion 334 each have right-handed threads. In this embodiment, as first portion 322 is rotated in a clockwise direction, shoulder 332 of head 326 bears against nail 302 , and second portion 324 correspondingly moves toward first portion 322 generally along longitudinal axis L 6 . As the position of second portion 324 is adjusted along axis L 6 , inner surface 339 of opening 338 bears against bone engaging member 306 and correspondingly adjusts the position of bone engaging member 306 along the length of opening 312 .
FIG. 18 illustrates a second operational position of system 300 in which first portion 322 is rotated in a clockwise direction until bone engaging member 306 is positioned adjacent first end portion 312 a of opening 312 . It should be understood, however, that bone engaging member 306 can be variably positioned anywhere along the length of opening 312 . It should further be understood that the terms “first operational position” and “second operational position” are not necessarily indicative of the initial position and adjusted position of bone engaging member 306 . For example, bone engaging member 306 could originate in a position adjacent first end portion 312 a and be variably positioned anywhere along the length of opening 312 .
In other embodiments of system 300 , nail 302 defines a keyway extending along the length of longitudinal passage 314 generally parallel with axis L 6 . Additionally, second portion 324 defines a key along its length which generally corresponds to the keyway defined in nail 302 . Preferably, the key is radially positioned so that when it is slidably received within the keyway, opening 338 of second portion 324 will correspondingly align with opening 312 of nail 302 . Alternatively, the key could be defined along the length of second portion 324 and, correspondingly, the keyway could be defined along the length of longitudinal passage 314 of nail 302 .
Having described selected structural and operational features of nail 302 and positioning device 304 , the operational characteristics of system 300 will now be described in further detail. Referring back to FIG. 15, nail 302 is shown implanted in femur 12 . Distal end 302 b of nail 302 is anchored to portion 12 e of femur 12 by inserting locking bone screw 308 into portion 12 e and through transverse bore 310 a (not shown) of nail 302 . Proximal end 302 a of nail 302 is anchored to portion 12 f of femur 12 by inserting bone engaging member 306 into portion 12 f and through passageway 340 (defined by aligning opening 338 with opening 312 ). Preferably, bone engaging member 306 is initially positioned adjacent or near second end portion 312 b of opening 312 . As first portion 322 of positioning device 304 is rotated in a clockwise direction, bone engaging member 306 is correspondingly repositioned along the length of opening 312 , and more specifically is transferred toward first end portion 312 a. Because bone engaging member 306 is anchored to portion 12 f of femur 12 , portion 12 f is correspondingly moved in the direction of arrow “A”, while portion 12 e of femur 12 remains stationery, securely anchored to distal end 302 b of nail 302 . Thus, portion 12 f of femur 12 is repositioned away from portion 12 e, thereby distracting fracture site 301 .
One preferred procedure for implanting system 300 within femur 12 includes forming a longitudinal hole along the medullary canal from a point generally central to the distal end portion 12 d of femur 12 . Preferably this hole is formed by drilling sized to receive nail 302 therethrough. Positioning device 304 is inserted in longitudinal passage 314 of nail 302 and nail 302 is inserted through the longitudinal hole and into the medullary canal. It should be understood that positioning device 304 could alternatively be inserted in longitudinal passage 314 after nail 302 has been implanted in femur 12 . A first passage is formed through femur 12 transverse to the medullary canal and generally aligned with transverse bore 310 a (not shown) formed in distal portion 302 b of nail 302 . A second passage is formed through femur 12 transverse to the medullary canal and generally aligned with passageway 340 . Preferably, these transverse passages are formed by drilling. Locking bone screw 308 is threaded into the first passage, passing through transverse bore 310 a. Bone engaging member 306 is threaded into the second passage, passing through passageway 340 . At this point, fracture site 301 can be distracted by following the operational procedure described above. Dashed line 301 a of FIG. 15 corresponds to the position of the fractured end of portion 12 f after distraction in accordance with one embodiment of the present invention.
Referring now to FIG. 19, intramedullary system 400 according to yet another embodiment of the present invention is illustrated; where like reference numerals of previously described embodiments refer to like features. System 400 is shown implanted in femur 12 and includes elongated intramedullary nail 302 , positioning device 304 ′, bone engaging member 306 and locking bone screw 308 . Femur 12 includes a fracture site 301 ′, separating femur 12 into two portions 12 f, 12 e. Fracture site 301 ′ is shown in a distracted state (i.e., portion 12 a, 12 b are spaced apart relative to one another). Although system 400 is shown implanted in femur 12 , system 400 could also be used in conjunction with other bones as would occur to one skilled in the art, including the tibia, humerus, radius, ulna and fibula, to name a few. Additionally, the same components of system 400 can be used to treat either a left or right femur by simply rotating nail 302 180 degrees relative to axis L 6 . Although FIG. 19 illustrates nail 302 implanted within femur 12 in a retrograde direction, it is understood system 400 may also be implanted with nail 302 in an antegrade direction.
Referring to FIG. 20, therein is shown nail 302 , positioning member 304 ′ and bone engaging member 306 as assembled within system 400 . Positioning member 30 ′ is shown positioned within longitudinal passage 314 and includes a first portion 402 and a second portion 404 . First portion 402 includes a threaded upper portion 406 and an elongated lower portion 408 extending therefrom along longitudinal axis L 6 . Upper portion 406 is configured to threadedly engage threaded portion 318 of longitudinal passage 314 . Upper portion 406 also includes a hex recess 410 for receiving a driving tool (not shown), such as an Allen wrench. Lower portion 408 has a generally circular body having an outer diameter slightly less than the diameter of longitudinal passage 314 . A transverse passage 412 extends through lower portion 408 and is aligned generally perpendicular to axis L 6 . The end of lower portion 408 opposite its threaded portion terminates in a generally flat surface 414 .
Second portion 404 has a circular body having an outer diameter generally corresponding to the outer diameter of lower portion 408 of first portion 402 . Second portion 404 defines an internally threaded portion 416 extending generally along axis L 6 for engaging insertion instrumentation (not shown). One end of second portion 404 defines a generally flat surface 418 , corresponding to surface 414 of lower portion 408 . The opposing end of second portion 404 terminates in a generally convex outer surface 420 substantially corresponding to concave bottom surface 316 of longitudinal passage 314 . Second portion 404 also defines a transverse opening 422 extending therethrough generally perpendicular to axis L 6 . Opening 422 is bound by inner surface 424 and is sized to receive bone engaging member 306 therein.
FIG. 20 illustrates a first operational position of system 400 . Positioning device 304 ′ including first and second portions 402 , 404 ) is shown inserted within longitudinal passage 314 of nail 302 . Opening 422 of second portion 404 is positioned adjacent first end portion 312 a of opening 312 and generally aligned with opening 312 to define a passageway 426 . Bone engaging member 306 is shown inserted through passageway 426 . Upper portion 406 of first portion 402 is partially threadedly engaged within threaded portion 318 of longitudinal passage 314 . First portion 402 can be rotated by placing a driving tool (not shown) within hex recess 410 and turning first portion 402 in a clockwise or counterclockwise direction. In one embodiment, threaded upper portion 406 and threaded portion 318 each have right-handed threads. In this embodiment, as first portion 402 is rotated in a clockwise direction, it will be advanced through longitudinal passage 314 generally along axis L 6 . As first portion 402 is advanced, surface 414 will engage surface 418 of second portion 404 , thereby correspondingly advancing second portion 404 through longitudinal passage 314 generally along axis L 6 . As the position of second portion 404 is adjusted along axis L 6 , inner surface 424 of opening 422 bears against bone engaging member 306 and correspondingly adjusts the position of bone engaging member 306 along the length of opening 312 .
FIG. 21 illustrates a second operational position of system 400 in which first portion 402 is rotated in a clockwise direction until bone engaging member 306 is positioned adjacent second end portion 312 b of opening 312 . It should be understood, however, that bone engaging member 306 can be variably positioned anywhere along the length of opening 312 . It should further be understood that the terms “first operational position” and “second operational position” are not necessarily indicative of the initial position and adjusted position of bone engaging member 306 . For example, bone engaging member 306 could originate in a position adjacent second end portion 312 b and be variably positioned anywhere along the length of opening 312 .
When bone engaging member 306 is positioned adjacent second end portion 312 b of opening 312 , transverse passage 412 of upper portion 406 will become aligned with transverse bore 320 of nail 302 , thereby defining a passageway 430 . A second bone engaging member 306 can then be inserted through passageway 430 to prevent further rotational movement of first portion 402 relative to nail 302 . However, if transverse passage 412 and transverse bore 320 cannot be aligned to form passageway 430 , a second bone engaging member 306 cannot be used. In this case, in order to prevent first portion 402 from rotating and migrating relative to nail 302 , a locking set screw can be threadedly advanced along threaded portion 318 of nail 302 until it tightly engages upper portion 406 .
Having described selected structural and operational features of positioning device 304 ′, the operational characteristics of system 400 will now be described in further detail. Referring back to FIG. 19, nail 302 is shown implanted in femur 12 and is anchored to portions 12 a and 12 b in substantially the same manner as described above in system 300 . Preferably, bone engaging member 306 is initially positioned adjacent or near first end portion 312 a of opening 312 . As first portion 402 of positioning device 304 ′ is rotated in a clockwise direction, bone engaging member 306 is correspondingly repositioned along the length of opening 312 , and more specifically is transferred toward second end portion 312 b of opening 312 . Because bone engaging member 306 is anchored to portion 12 f of femur 12 , portion 12 f is correspondingly moved in the direction of arrow “B”, while portion 12 e of femur 12 remains stationary, securely anchored to distal end 302 b of nail 302 . Thus, portion 12 f of femur 12 is repositioned toward portion 12 e, thereby compressing fracture site 301 ′. Dashed line 301 b of FIG. 19 corresponds to the fractured end of portion 12 f after compression in accordance with one embodiment of the present invention.
One preferred procedure for implanting system 400 within femur 12 is substantially identical to the procedure for implanting system 300 , except a compression operation as described above is performed instead of the distraction operation as described in connection with system 300 .
The components of systems 10 , 100 , 165 , 195 , 200 , 300 and 400 may be fabricated from any suitably strong, bio-compatible material such as stainless steel, titanium, chrome-cobalt, or any other material which would occur to those skilled in the art.
While the invention has been illustrated and described in detail in the drawings and foregoing discussion, the sane is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.
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A femoral intramedullary rod system capable of treating a variety of femoral bone fractures using a uniform intramedullary rod design. The system generally comprising an intramedullary rod defining an opening having an upper surface and a transverse member including a bone engaging portion and a connection portion defining a thru-hole with the nail sized to pass therethrough. A pin is selectively coupled to the transverse member to rigidly assemble the transverse member to the nail when the nail is passed through the thru-hole and the pin is received within the opening.
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. Provisional Application No. 60/446,711, filed Feb. 11, 2003, entitled “Removable Vena Cava Clot Filter.”
BACKGROUND OF THE INVENTION
The present invention relates to medical devices. More particularly, the invention relates to a removable vena cava clot filter that can be percutaneously placed in and removed from the vena cava of a patient.
Filtering devices that are percutaneously placed in the vena cava have been available for over thirty years. A need for filtering devices arises in trauma patients, orthopedic surgery patients, neurosurgery patients, or in patients having medical conditions requiring bed rest or non-movement. During such medical conditions, the need for filtering devices arises due to the likelihood of thrombosis in the peripheral vasculature of patients wherein thrombi break away from the vessel wall, risking downstream embolism or embolization. For example, depending on the size, such thrombi pose a serious risk of pulmonary embolism wherein blood clots migrate from the peripheral vasculature through the heart and into the lungs.
A filtering device can be deployed in the vena cava of a patient when, for example, anticoagulant therapy is contraindicated or has failed. Typically, filtering devices are permanent implants, each of which remains implanted in the patient for life, even though the condition or medical problem that required the device has passed. In more recent years, filters have been used or considered in preoperative patients and in patients predisposed to thrombosis which places the patient at risk for pulmonary embolism.
The benefits of a vena cava filter have been well established, but improvements may be made. For example, filters generally have not been considered removable from a patient due to the likelihood of endotheliosis of the filter during treatment. After deployment of a filter in a patient, proliferating intimal cells begin to accumulate around the filter struts which contact the wall of the vessel. After a length of time, such ingrowth prevents removal of the filter without risk of trauma, requiring the filter to remain in the patient. As a result, there has been a need for an effective filter that can be removed after the underlying medical condition has passed.
Moreover, conventional filters commonly become off-centered or tilted with respect to the hub of the filter and the longitudinal axis of the vessel in which it has been inserted. As a result, the filter including the hub and the retrieval hook engage the vessel wall along their lengths and potentially become endothelialized therein. This condition is illustrated in prior art FIG. 1 in which a prior art filter 13 has been delivered through a delivery sheath 25 into a blood vessel 51 . In the event of this occurrence, there is a greater likelihood of endotheliosis of the filter to the blood vessel along a substantial length of the filter wire. As a result, the filter becomes a permanent implant in a shorter time period than otherwise.
Some filters have been designed so that the filter has minimal contact with the vessel wall. Ideally, some filters can be removed after several weeks with minimal difficulty and little injury to the vessel wall. One such filter is described in U.S. Pat. No. 5,836,968. The filter is designed so that the filter wires or struts are not positioned parallel to the vessel walls or not in contact with the vessel walls for a substantial portion of the length of the filters. The ends of the struts contact the vessel walls and provide anchoring to reduce the likelihood of filter migration. When the filter is removed, a wire is docked to one end of the device while a sheath or sleeve is passed over the wire. Using counter traction by pulling the wire while pushing the sheath, the sheath is passed over the filter and the filter struts are retracted from the vessel wall. In this way, only small point lesions are created where the filter was attached to the vessel wall.
The filter of U.S. Pat. No. 5,836,968 teaches two levels of oppositely expanding filter wires or struts to insure that the filter is properly aligned in the lumen of the vessel. If the filter tilts or becomes misaligned with the central axis of the vessel, the filter wires will contact the wall of the vessel along a greater area, and become endothelialized. As a result of the two levels, removal of the filter from the blood vessel becomes impossible or at least difficult.
Additionally, the configuration of the second level of filter wires in the device of U.S. Pat. No. 5,836,968 provides a filter which may be too long for the segment of the vessel that the filter would normally be placed. The normal placement segment of a vena cava filter is between the femoral veins and the renal veins. If the lower part of the filter extends into the femoral veins, filtering effectiveness will be compromised. Moreover, it is not desirable to have filter wires crossing the origin of the renal veins, since the filter wires may interfere with the flow of blood from the kidneys. In the device disclosed in U.S. Pat. No. 5,836,968, both levels of filter wires are attached at one point as a bundle at the central axis of the filter. The resulting diameter of this bundle of filter wires results in a filter that may be too large for easy placement and becomes an obstacle to blood flow in the vena cava.
BRIEF SUMMARY OF THE INVENTION
The present invention provides a vena cava filter comprising struts configured to align the filter about the center axis of a blood vessel and minimize engagement with the blood vessel. The filter comprises a plurality of primary struts, each of which having a first end. A hub axially connects the first ends of the struts to define a central axis of the filter. Each primary strut has a curved member extending from the central axis. Each curved member terminates at an anchoring hook to engage the blood vessel at a first axial plane and secure the filter in the blood vessel. Each anchoring hook includes a barb formed at an angle relative to the strut to allow a removal sheath to be advanced over the filter and allow the hooks to be removed straight away from the vessel wall, resulting in minimal vessel damage. The filter further comprises a plurality of secondary struts. Each secondary strut is connected to one of the curved members and extends therefrom to a free end for engaging the blood vessel at a second axial plane, aligning the filter in the blood vessel.
In one embodiment, a set of at least two secondary struts are connected to the curved member of one primary strut. The set of secondary struts extend radially from each side of the primary strut, forming a netting configuration of the filter. In another embodiment, one secondary strut is connected to the curved member of one primary strut. The secondary strut extends from the primary strut and is in radial alignment with the primary strut, avoiding interference with blood flow.
In a collapsed configuration, the vena cava filter occupies a reduced diameter, since the hub is the origin to only primary struts. In an expanded configuration, the hub occupies a reduced cross-sectional area. As a result, interference with blood flow is lessened in the vena cava.
In an expanded configuration, the vena cava filter occupies a reduced length, since the secondary struts merely extend within the axial length of the primary struts. As a result, the filter can more easily be placed in the vena cava of a patient, lessening the risk of interference in the femoral and renal veins.
Further aspects, features, and advantages of the invention will become apparent from consideration of the following description and the appended claims when taken in connection with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of a prior art filter deployed in a blood vessel;
FIG. 2 is an illustration of the anatomy of the renal veins, the femoral veins, and the vena cava in which one embodiment of a vena cava filter of the present invention is deployed;
FIG. 3 is a side perspective view of one embodiment of the vena cava filter of the present invention;
FIG. 4 is a cross-sectional view of a blood vessel showing the filter of the present invention partially deployed;
FIG. 5 is a cross-sectional view of a blood vessel showing the filter of the present invention fully deployed;
FIG. 6 is a cross-sectional view of a blood vessel in which the filter of FIG. 3 has been deployed;
FIG. 7 is a cross-sectional view of the blood vessel of FIG. 6 taken along line 7 - 7 ;
FIG. 8 is a cross-sectional view of a blood vessel showing a portion of a retrieval device for the filter in FIG. 3 ;
FIG. 9 is a side perspective view of a vena cava filter in accordance with another embodiment of the present invention; and
FIG. 10 is a cross-sectional view of a blood vessel in which the filter in FIG. 9 is disposed.
DETAILED DESCRIPTION OF THE INVENTION
In accordance with a first embodiment of the present invention, FIG. 2 illustrates a vena cava filter 20 implanted in the vena cava 50 for the purpose of lysing or capturing thrombi carried by the blood flowing through the femoral veins 54 , 56 toward the heart and into the pulmonary arteries. As shown, the femoral veins from the legs merge at juncture 58 into the vena cava 50 . The renal veins 60 from the kidneys 62 join the vena cava 50 downstream of juncture 58 . The portion of the vena cava 50 , between the juncture 58 and the renal veins 60 , defines the inferior vena cava 52 in which the vena cava filter 20 has been percutaneously deployed through one of the femoral veins 54 . Preferably, the vena cava filter 20 has a length smaller than the length of the inferior vena cava 52 . If the lower part of the filter extends into the femoral veins, filtering effectiveness will be compromised and if the filter wires cross over the origin of the renal veins the filter wires might interfere with the flow of blood from the kidneys.
The first embodiment of the present invention will be discussed with reference to FIGS. 3-8 in which filter 20 is shown. FIG. 3 illustrates filter 20 comprising four primary struts 12 each having first ends that emanate from a hub 10 . Hub 10 secures the first ends of primary struts 12 together in a compact bundle to define a central or longitudinal axis of the filter. The hub 10 has a minimal diameter for the size of wire used to form the struts. Preferably, the primary struts 12 are formed from stainless steel wire, MP35N, Nitinol, or any other suitable superelastic material that will result in a self-opening or self-expanding filter. In this embodiment, the primary struts 12 are formed from wire having a round cross-section with a diameter of about 0.015 inches. Of course, it is not necessary that the primary struts have a round cross-section. For example, the primary struts could have a square shaped or other suitable shaped cross section without falling beyond the scope or spirit of the present invention.
Each primary strut 12 is formed with a first curved portion 13 that is configured to bend away from the longitudinal or central axis of the filter 20 and a second curved portion 15 that is configured to bend toward the longitudinal axis of the filter 20 . Each primary strut 12 maintains a non-parallel relationship with the longitudinal axis of the filter 20 . The primary struts 12 terminate at anchoring hooks 18 that will anchor in the vessel wall when the filter 20 is deployed at a delivery location in the blood vessel. When the filter is deployed, the anchoring hooks define a first axial plane to secure the filter in the blood vessel. The anchoring hooks 18 prevent the filter 20 from migrating from the delivery location in the blood vessel where it has been deposited. The primary struts 12 are shaped and dimensioned such that, when the filter 20 is deployed and expanded, the filter 20 has a diameter of about 35 mm and a length of about 5 cm. For example, when expanded, the filter 20 may have a diameter of between about 30 mm and 40 mm, and a length of between about 3 cm and 7 cm. The primary struts 12 have sufficient spring strength that when the filter is deployed the anchoring hooks 18 will anchor into the vessel wall.
In this embodiment, each primary strut 12 has two secondary struts 14 secured thereto by laser welding, brazing, crimping or any suitable process that will avoid damaging the material or adding to the thickness of the filter and thus the size of the delivery system. The secondary struts 14 may be made from the same type of material as the primary struts. However, the secondary struts may have a smaller diameter, e.g., about 0.012 inches, than the primary struts. Each of the secondary struts 14 is formed of a single curve and is secured to one of the primary struts 12 on its first curved portion 13 such that the secondary strut 14 becomes a continuation or an extension of the first curved portion 13 of the primary strut 12 . In this embodiment, two secondary struts 14 flare away from each side of one primary strut 12 to form a part of a netting configuration of the filter 20 .
When opened, free ends 17 of the secondary struts 14 will expand radially outwardly to a diameter of about 35 mm to engage the vessel wall. For example, the secondary struts 14 may expand radially outwardly to a diameter of between about 30 mm and 40 mm. The free ends 17 define a second axial plane where the vessel wall is engaged. The secondary struts 14 function to stabilize the position of the filter 10 about the center of the blood vessel in which it is deployed. As a result, the filter 20 has two layers or planes of struts longitudinally engaging the vessel wall of the filter. The length of the filter is preferably defined by the length of a single set of primary struts. Furthermore, the diameter of the hub 10 is defined by the size of a bundle containing the primary struts 12 . In this embodiment, the eight secondary struts, although maintaining the filter in a centered attitude relative to the vessel wall and formed as a part of the netting configuration of the filter, minimally add to the diameter of the hub or the overall length of the filter.
FIG. 4 illustrates the filter 20 partially deployed in inferior vena cava 52 . For deployment of the filter 20 , a delivery tube 24 is percutaneously inserted through the patient's vessels such that the distal end of the delivery tube is at the location of deployment. In this embodiment, a wire guide is preferably used to guide the delivery tube to the location of deployment. The filter is preferably inserted through the proximal end of the delivery tube 24 with the removal hook 16 leading and free ends of the primary struts 12 held by a filter retainer member. The filter retainer member may be connected to a pusher wire (not shown) that is fed through the proximal end of the delivery tube 24 until the filter reaches the distal end of the delivery tube 24 . For a more complete disclosure of a filter delivery system that may be used to deliver the filter 20 to a desired location, reference may be made to U.S. Pat. No. 5,324,304 which is incorporated herein by reference.
As shown in FIG. 4 , filter 20 is deployed leading with removal hook 16 from the delivery tube 24 . The secondary struts expand first. When the free ends of the secondary struts emerge from the distal end of delivery tube 24 , the secondary struts expand to an expanded position shown in FIG. 4 . The free ends engage the inner wall of the vessel in which the filter is being deployed. The free ends of the secondary struts function to stabilize the attitude of filter 20 about the center of the blood vessel. The filter is then pushed further by the pusher wire (not shown) until it is fully deployed as shown in FIG. 5 .
As shown in FIG. 5 , the ends of the primary struts 12 and the secondary struts 14 are in engagement with the vessel wall. The anchoring hooks of the primary struts have anchored the filter at the location of deployment in the vessel, preventing the filter 20 from moving with the blood flow through the vessel. As a result, the filter 20 is supported by two sets of struts that are spaced axially along the length of the filter. The struts avoid engaging the vessel wall along their lengths and thus avoid becoming endothelialized in the vessel wall.
FIGS. 6 and 7 show the filter 20 fully expanded after being deployed in inferior vena cava 52 . In FIG. 6 , the inferior vena cava 52 has been broken away so that the filter 20 can be seen. The direction of the blood flow BF is indicated in FIG. 6 by the arrow that is labeled BF. The anchoring hooks 18 at the ends of the primary struts 12 are shown as being anchored in the inner lining of the inferior vena cava 52 . The anchoring hooks 18 include barbs 19 that, in one embodiment, project toward the hub 10 of the filter. The barbs 19 function to retain the filter 20 in the location of deployment.
In this embodiment, the filter 20 is pushed in a direction BF of the blood flow by the pusher wire (not shown) during deployment. The pusher wire pushes the filter 20 from the delivery tube, causing the barbs 19 to move in the direction BF of the blood flow and secure anchoring hooks 18 in the inferior vena cava 52 . The spring biased configuration of the primary struts 12 causes the anchoring hooks 18 to puncture the vessel wall and anchor the filter at the location of deployment. After initial deployment, the pressure of the blood flow on the filter 20 contributes in maintaining the barbs 19 anchored in the inner lining of the inferior vena cava 52 . As seen in FIG. 6 , the free ends 17 of secondary struts 14 also have a spring biased configuration to engage with the vessel wall. In this embodiment, the free ends 17 of secondary struts 14 are not provided with anchoring hooks, minimizing the trauma of retrieving the filter 20 .
FIG. 7 illustrates a netting configuration formed by the primary struts 12 , secondary struts 14 , and the hub 10 . The netting configuration shown in FIG. 7 functions to catch thrombi carried in the blood stream prior to reaching the heart and lungs to prevent the possibility of a pulmonary embolism. The netting configuration is sized to catch and stop thrombi that are of a size that are undesirable to be carried in the vasculature of the patient. As shown, the hub 10 houses a bundle of first ends of the four primary struts 14 . Due to its compacted size, the hub minimally resists blood flow.
As seen in FIG. 6 , the hub 10 and removal hook 16 are positioned downstream from the location at which the anchoring hooks 18 are anchored in the vessel. When captured by the struts, thrombi remains lodged in the filter. The filter along with the thrombi may then be percutaneously removed from the vena cava. When the filter 20 is to be removed, the removal hook 16 is preferably grasped by a retrieval instrument that is percutaneously introduced in the vena cava in the direction opposite to the direction in which the filter was deployed.
FIG. 8 illustrates part of a retrieval device 65 being used in a procedure for removing the filter 20 from the inferior vena cava 52 . The retrieval device 65 is percutaneously introduced into the superior vena cava via the jugular vein. In this procedure, a removal catheter or sheath 68 of the retrieval device 65 is inserted into the superior vena cava. A wire 70 having a loop snare 72 at its distal end is threaded through the removal sheath 68 and is exited through the distal end of the sheath 68 . The wire is then manipulated by any suitable means from the proximal end of the retrieval device such that the loop snare 72 captures the removal hook 16 of the filter 20 . Using counter traction by pulling the wire 70 while pushing the sheath 68 , the sheath 68 is passed over the filter. As the sheath 68 passes over the filter 20 , the secondary struts 14 and then the primary struts 12 engage the edge of the sheath 68 and are caused to pivot at the hub 10 toward the longitudinal axis of the filter. The pivoting toward the longitudinal axis causes the ends of the struts 14 and 12 to be retracted from the vessel wall. In this way, only surface lesions 74 and small point lesions 76 on the vessel wall are created in the removal procedure. As shown, the surface lesions 74 are created by the ends of the secondary struts 14 and the small point legions 76 are created by the anchoring hooks 18 of the primary struts 12 . However, it is to be noted that any other suitable procedure may be implemented to remove the filter from the patient.
A second embodiment of the present invention will be discussed with reference to FIGS. 9 and 10 in which a filter 28 is shown. FIG. 9 illustrates filter 28 comprising six primary struts 32 each having first ends that emanate from a hub 30 . Hub 30 secures the first ends of primary struts 32 together in a compact bundle to define a central axis of the filter. Similar to the hub 10 in the first embodiment discussed above, the hub 30 in this embodiment has a minimal diameter for the size of wire used to form the struts.
The primary struts 32 in this embodiment are similar in structure to the primary struts 12 in the first embodiment above. For example, in the second embodiment, each primary strut 32 of the filter 28 includes first and second curved portions 33 and 35 , removal hook 36 , free ends 37 , an anchoring hook 38 , and a barb 39 which are respectively similar to the first and second curved portions 13 and 15 , removal hook 16 , free ends 17 , the anchoring hook 18 , and the barb 19 of the filter 28 in the first embodiment. Preferably, the primary struts 32 are shaped and dimensioned such that, when the filter 28 is deployed and expanded, the filter 28 has a diameter of about 35 mm and a length of about 5 cm. For example, when expanded, the filter 28 may have a diameter of between about 30 mm and 40 mm, and a length of between about 3 cm and 7 cm. The primary struts 32 have sufficient spring strength such that when the filter is deployed the anchoring hooks 38 will anchor into the vessel wall.
Preferably, the primary struts 32 are formed of the same material as the primary struts 12 mentioned above, e.g., stainless steel wire, MP35N, Nitinol, or any other suitable material. In this embodiment, the primary struts 32 are formed from wire having a round cross-section with a diameter of about 0.015 inches. As stated above, it is not necessary that the primary struts have a round cross-section.
In this embodiment, each primary strut 32 has one secondary strut 34 secured thereto by laser welding, brazing, crimping or any suitable process that will not damage the material or add to the thickness of the filter and thus the size of the delivery system. The secondary struts 34 may be made from the same type of material as the primary struts. Preferably, the secondary struts may have a smaller diameter, e.g., about 0.012 inches, than the primary struts. As in the first embodiment, each of the secondary struts 34 in this embodiment is formed of a single curve and is secured to one of the primary struts 32 on the first curved portion such that the secondary strut 34 becomes a continuation or extension of the first curved portion of the primary strut 32 . As shown, each of the secondary struts 34 flares away from one primary strut 32 and is in radial alignment therewith.
When opened, the free ends of the secondary struts 34 will expand outwardly to a diameter of about 35 mm to engage the vessel wall. For example, the secondary struts 34 may expand outwardly to a diameter of between about 30 mm and 40 mm. Similar to the secondary struts 14 in the first embodiment, the secondary struts 34 in this embodiment function to stabilize the position of the filter 28 about the center of the blood vessel in which it is deployed. As a result, the filter 28 has two layers or planes of struts longitudinally engaging the vessel wall of the filter. The length of the filter is preferably defined by the length of a single set of primary struts. Furthermore, the diameter of the hub 30 is defined by the size of a bundle containing the primary struts 32 . As in the first embodiment, the secondary struts in this embodiment, although maintaining the filter in a centered attitude relative to the vessel wall and formed as a part of a netting configuration of the filter, minimally add to the diameter of the hub or the overall length of the filter.
FIG. 10 illustrates the netting configuration of the filter 28 formed by the primary struts 32 and the hub 30 . As shown, the secondary struts 34 are positioned behind and in alignment with the primary struts 32 and, thus, avoid substantially affecting blood flow. The netting configuration functions to catch thrombi carried in the blood stream prior to reaching the heart and lungs to prevent the possibility of a pulmonary embolism. The netting configuration is sized to catch and stop thrombi that are of a size that are undesirable to be carried in the vasculature of a patient. As shown, the hub 30 houses a bundle of ends of the six primary struts 34 . Due to its compacted size, the hub minimally resists blood flow.
It is to be noted that the filter 28 may be deployed in the vena cava in the same manner previously discussed for filter 20 with reference to FIGS. 2 , 4 , and 5 . Additionally, the filter 28 may be removed from the vena cava with the removal procedure previously discussed for filter 20 with reference to FIG. 8 .
Although the embodiments of this device have been disclosed as being constructed from wire having a round cross section, it could also be cut from a tube of suitable material by laser cutting, electrical discharge machining or any other suitable process.
While the present invention has been described in terms of preferred embodiments, it will be understood, of course, that the invention is not limited thereto since modifications may be made to those skilled in the art, particularly in light of the foregoing teachings.
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A removable filter for capturing thrombi in a blood vessel. The filter comprises a plurality of primary struts having first ends connected to each other to define a central axis of the filter. Each primary strut has a curved member extending from the central axis and terminates at an anchoring hook to engage the blood vessel at a first axial plane. The filter further comprises a plurality of secondary struts connected to the curved members of the primary struts and extending therefrom to a free end at a second axial plane to centralize the filter in the blood vessel.
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CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application claims priority from U.S. Provisional Patent Application No. 60/673,686 filed Apr. 21, 2006.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
[0002] Not Applicable.
BACKGROUND OF THE INVENTION
[0003] 1. Field of the Invention
[0004] The invention relates to a Cardiac Resynchronization Therapy (CRT) implantable pacemaker that uses impedance cardiography to calculate cardiac output, and to a method for optimizing cardiac resynchronization therapy using the pacemaker.
[0005] 2. Description of the Related Art
[0006] Congestive heart failure and left ventricular dysfunction are the result of multiple and common disease processes, including coronary disease, hypertension, diabetes, cardiomyopathy to name but a few. It will be responsible for more deaths than all other causes combined by 2010, and accounts now for the lion's share of health care cost in the United States.
[0007] Current therapies available today include surgery, such as bypass or valve surgery, or more recently, ventricular remodeling surgery; medical therapy including medications known as ACE inhibitors, beta blockers, aldosterone antagonists, and so forth; and recently, the application of cardiac resynchronization therapy in selected patients. Cardiac resynchronization therapy, CRT, as it is known, is a pacemaker based technology in which leads are placed in both left and right ventricles in order to synchronize their contraction and thus optimize cardiac function. Cardiac resynchronization therapy systems have been developed by various medical device companies.
[0008] Approximately one fourth of patients receiving cardiac resynchronization therapy fail to respond favorably to this very expensive and labor intensive therapy, and in such patients, attempts are made to optimize the many adjustable parameters of the cardiac resynchronization therapy device. Optimization is conducted by confirming proper position of the leads, but primarily by Doppler analysis of blood flow characteristics during echocardiographic evaluation, a moderately expensive procedure which takes about 30 to 45 minutes to perform, and is occasionally technically inadequate for purpose of optimization.
[0009] Impedance cardiography is a technique by which there is made an indirect measurement of the cardiac output, or volume of blood pumped by the heart in the time of one minute, wherein the cardiac output is calculated from the measured intrathoracic impedance. To this point in time, impedance cardiography is performed much like an electrocardiogram, that is, with wires placed on the skin of the chest and extremities. A tiny current is introduced between two points (a current source and a current sensor) placed some distance from one another on the chest, the impedance of the current is analyzed and is translated into the cardiac output.
[0010] Impedance cardiography is an older science and has historically been slow to evolve due to the fact that the measurement of impedance is affected by many variables, typically resulting in spurious results and therefore unsupported assumptions. Proprietary algorithms have been developed to increase the accuracy of the calculation of cardiac output from impedance measurements, and it is felt that these algorithms have solved issues addressing accuracy of cardiac output calculation. In the future, concepts of impedance cardiography will be incorporated into upcoming models of pacemakers to allow for early detection of a falling intrathoracic impedance, which in and of itself is an indication of impending congestive heart failure. Significantly further benefit will accrue if the calculation of impedance can lead to an accurate calculation of cardiac output, which in turn will lead to more precise manipulation of medical and pacemaker therapies being applied to the management of congestive heart failure.
[0011] Therefore, there exists a need for a method to optimize cardiac resynchronization therapy using a pacemaker that uses impedance cardiography to calculate not only impedance, but cardiac output, accurately.
BRIEF SUMMARY OF THE INVENTION
[0012] The foregoing needs are met by the present invention which provides an implantable pacemaker device with an algorithm capable of calculating cardiac output, in turn allowing for simple, accurate and real-time optimization of cardiac resynchronization therapy without the need for echocardiography. The implantable device is capable of accurate measurement of impedance, which can be interrogated transdermally in a clinic or outpatient setting, much as current pacemakers are interrogated today, by the treating physician (the cardiologist or electrophysiologist). The ability to obtain this data and convert it to cardiac output simply, accurately and cost effectively, would be expected to revolutionize the management of congestive heart failure and possibly impact not only the cost of the disease, but its morbidity and mortality.
[0013] Such an implantable device allows not only for optimization of cardiac resynchronization therapy in patients who fail to respond to therapy, but would allow for optimization of medical therapy, such as dose adjustment of medications, adding or subtracting therapies as cardiac output is positively or negatively impacted; adjusting CPAP or biPAP settings in patients being treated for sleep apnea; monitoring cardiac function easily and inexpensively in patients receiving chemotherapy (much of which is cardiotoxic); risk assessment in any or all post myocardial infarction patients, and so forth.
[0014] It is therefore an advantage of the present invention to provide a method for optimizing cardiac resynchronization therapy using a pacemaker that uses impedance cardiography to calculate cardiac output.
[0015] These and other features, aspects, and advantages of the present invention will become better understood upon consideration of the following detailed description, drawing, and appended claims.
BRIEF DESCRIPTION OF THE DRAWING
[0016] FIG. 1 is a schematic of a cardiac pacing system used with the invention.
DETAILED DESCRIPTION
[0017] In FIG. 1 , there is shown a cardiac pacing system 10 suitable for use with the present invention. The cardiac pacing system 10 includes a pacemaker 15 having a circuit in electrical communication with a patient's heart 12 by way of three leads 20 , 24 and 30 suitable for delivering multi-chamber stimulation and shock therapy. The circuit of the pacemaker 15 is also in communication with an electrode 17 that is located on or near the pacemaker. The pacemaker 15 is implanted subcutaneously in the patient's body between the skin and upper ribs. The pacemaker 15 provides stimulating pulses from a pulse generator to the heart.
[0018] To sense right atrial cardiac signals and to provide right atrial chamber stimulation therapy, the pacemaker 15 is coupled to an implantable right atrial lead 20 having a right atrial tip electrode 22 , which typically is implanted in the patient's right atrial appendage. The right atrial lead 20 may also have a right atrial ring electrode 23 to allow bipolar stimulation or sensing in combination with the right atrial tip electrode 22 .
[0019] To sense left ventricular cardiac signals and to provide left-chamber stimulation therapy, the pacemaker 15 is coupled to a coronary sinus lead 24 designed for placement in the coronary sinus region via the coronary sinus ostium so as to place a distal electrode adjacent to the left ventricle. The coronary sinus lead 24 is designed to receive left ventricular cardiac signals and to deliver left ventricular stimulation therapy using a left ventricular tip electrode 26 .
[0020] The pacemaker 15 is also shown in electrical communication with the patient's heart 12 by way of an implantable right ventricular lead 30 having a right ventricular tip electrode 32 , a right ventricular ring electrode 34 , and a right ventricular coil electrode 36 . Typically, the right ventricular lead 30 is transvenously inserted into the heart 12 so as to place the right ventricular tip electrode 32 in the right ventricular apex so that the right ventricular coil electrode 36 will be positioned in the right ventricle. Accordingly, the right ventricular lead 30 is capable of receiving cardiac signals, and delivering stimulation in the form of pacing and shock therapy to the right ventricle.
[0021] During operation, the pacemaker 15 provides an alternating current signal between the pacemaker 15 and the left ventricular tip electrode 26 . The electrode 17 on or near the pacemaker 15 and a coronary sinus ring electrode 27 (or left ventricular tip electrode 26 , or right ventricular tip electrode 32 , or right ventricular ring electrode 34 , or right atrial tip electrode 22 ) provide signals representative of impedance changes between the pacemaker 15 and the heart to the circuit in the pacemaker 15 . The circuit in the pacemaker 15 includes a microprocessor having software or firmware for storing the impedance data.
[0022] The pacemaker 15 also provides pacing pulses to the atrial tip electrode 22 , the right ventricular tip electrode 32 and the left ventricular tip electrode 26 during operation. In order to maximize cardiac output, the pacing pulse interval between the atrial tip electrode 22 and the right ventricular tip electrode 32 must be optimized, and the pacing pulse interval between the right ventricular tip electrode 32 and the left ventricular tip electrode 26 must be optimized, along with other appropriate programmable parameters.
[0023] The circuit of the pacemaker 15 also includes a receiver capable of receiving interrogation signals (such as radio frequency signals) from an external computing device. The interrogation signals pass through the receiver to the control logic in the pacemaker microprocessor memory. The memory will produce information relating to interrogation signals and generate this data back through the control logic into a transmitter in the pacemaker so that the transmitter transmits this data to the external computing device. For example, the external computing device may send interrogation signals requesting the impedance values from the pacemaker 15 . The interrogation signals pass through the receiver in the pacemaker 15 to the control logic and impedance data is generated back through the transmitter to the external computing device where cardiac output is calculated from the impedance data. As is known, a measure of cardiac output can be obtained by extracting the first time derivative of cyclical impedance changes. Suitable software, including a proprietary algorithm for calculating cardiac output from impedance, is available from Vasamed, Minneapolis, Minn., USA. The cardiac output value may be displayed on the display of the external computing device. In a similar manner, the external computing device may send interrogation signals requesting the current pacing pulse interval between the atrial tip electrode 22 and the right ventricular tip electrode 32 , and the current pacing pulse interval between the right ventricular tip electrode 32 and the left ventricular tip electrode 26 . This pacing pulse interval data may then be displayed on the display of the external computing device (e.g., a laptop computer).
[0024] Having described the components of a cardiac pacing system 10 suitable for use with the present invention, various methods of the invention can be described.
[0025] In one version of the invention, there is provided a method for optimizing cardiac resynchronization therapy using the cardiac pacing system 10 . First, a timing interval between successive right atrial stimulation pulses, which are provided from the pacemaker pulse generator to the right atrial tip electrode 22 , and right ventricular stimulation pulses, which are provided from the pacemaker pulse generator to the right ventricular tip electrode 32 , is stored in a memory location in the pacemaker microprocessor. An alternating current signal is generated between the pacemaker 15 and the left ventricular tip electrode 26 . Impedance changes are sensed between the electrode 17 on or near the pacemaker 15 and the coronary sinus ring electrode 27 (or left ventricular tip electrode 26 , or right ventricular tip electrode 32 , or right ventricular ring electrode 34 , or right atrial tip electrode 22 ) to provide signals representative of impedance.
[0026] Then, impedance values are transmitted to a computing device external to the patient, thus allowing the calculation of cardiac output in the computing device and display of the calculated cardiac output values on a display of the computing device. The timing interval in the pacemaker microprocessor memory location can be adjusted by transmitting signals to the microprocessor from the computing device. Also, the cardiac output values as a function of time may be stored in the microprocessor or on the computing device for analysis.
[0027] In another version of the invention, there is provided a method for optimizing cardiac resynchronization therapy using the cardiac pacing system 10 . First, a timing interval between successive right ventrical stimulation pulses, which are provided from the pacemaker pulse generator to the right ventricular tip electrode 32 , and left ventricular stimulation pulses, which are provided from the pacemaker pulse generator to the left ventricular tip electrode 26 , is stored in the pacemaker microprocessor. An alternating current signal is generated between the pacemaker 15 and the left ventricular tip electrode 26 . Impedance changes are sensed between the electrode 17 on or near the pacemaker 15 and the coronary sinus ring electrode 27 (or left ventricular tip electrode 26 , or right ventricular tip electrode 32 , or right ventricular ring electrode 34 , or right atrial tip electrode 22 ) to provide signals representative of impedance.
[0028] Then, impedance values are transmitted to a computing device external to the patient, thus allowing the calculation of cardiac output in the computing device and display of the calculated cardiac output values on a display of the computing device. The timing interval in the pacemaker microprocessor memory location can be adjusted by transmitting signals to the microprocessor from the computing device. Also, the cardiac output values as a function of time may be stored in the microprocessor or on the computing device for analysis.
[0029] In yet another version of the invention, there is provided a method for adjusting dosage of a medication in a patient having a pacemaker located external to the patient's heart. In the method, an alternating current signal is generated between the pacemaker 15 and the left ventricular tip electrode 26 . Impedance changes are sensed between the electrode 17 on or near the pacemaker 15 and the coronary sinus ring electrode 27 (or left ventricular tip electrode 26 , or right ventricular tip electrode 32 , or right ventricular ring electrode 34 , or right atrial tip electrode 22 ) to provide signals representative of impedance. Then, impedance signals are transmitted from the microprocessor to an external computing device, and cardiac output values are calculated from impedance signals received in the external computing device. The cardiac output values as a function of time are stored in the microprocessor or in the external computing device and then reviewed by a physician. The dosage of the medication may then be adjusted based on the stored cardiac output values.
[0030] Thus, the present invention provides an implantable pacemaker that uses impedance cardiography to calculate cardiac output, and in so doing, a method for optimizing cardiac resynchronization therapy by interrogating the CRT device, itself, or of a multitude of other therapies.
[0031] Although the present invention has been described with reference to certain embodiments, one skilled in the art will appreciate that the present invention can be practiced by other than the described embodiments, which have been presented for purposes of illustration and not of limitation. Therefore, the scope of the appended claims should not be limited to the description of the embodiments contained herein.
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An implantable pacemaker that uses impedance cardiography to measure intrathoracic impedance and then transmit impedance data to an external PC based analyzer for accurate calculation of cardiac output, and a method for optimizing cardiac resynchronization therapy using the pacemaker are disclosed.
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FIELD OF THE INVENTION
[0001] The present invention relates to a handle for an angular brush having an holding tenon for the glue, to the relative brush and to the method for its construction.
[0002] Brushes consist of an elongated handle to which bristles are fixed. The bristles are firstly glued together at one end to form a pack. They are then fixed to the handle by means of a collar. The collar is fixed to the brush by two nails or clouts.
[0003] With prolonged use of the brush, these nails tend to cause cracks to open in the wood of the handle, they can rust and hence ruin the brush, to the extent of making it unserviceable.
[0004] Moreover, when they are inserted into the wood they tend to raise the collar, hence forming a slight projection on the collar which can be annoying if not dangerous to the user.
SUMMARY OF THE INVENTION
[0005] The object of the present invention is to provide a brush which is without the drawbacks of the known art, and is of simple construction.
[0006] This object is attained according to the invention by a handle for a brush of angular type, characterized in that said handle comprises, at one end of said handle, a tenon having a profile inclined to the central axis of said handle, said profile comprising at least one circular recess, said profile further comprising at least one lateral chamfer along a major side thereof.
[0007] Said object is also attained by a brush of angular type comprising a handle and bristles, characterized in that said handle comprises a tenon having a profile inclined to the central axis of said brush, said profile comprising incorporating means, said bristles being fixed to each other and also fixed to said handle by glue, said glue gripping said incorporating means and said bristles.
[0008] Said object is also attained by a method for constructing a brush of angular type including a handle having an end inclined to its central axis, a collar and bristles, comprising the steps of providing suitable recesses in said end of said handle; providing on said end of said handle at least one lateral chamfer along a major side thereof; inserting said bristles through a first opening in said collar; pouring glue into said collar through a second opening opposite said first opening; inserting said end of said handle into said collar through said second opening; said glue gripping said bristles and said recesses.
[0009] Further characteristics of the invention are described in the dependent claims.
[0010] In accordance with the present invention an angular brush can be constructed without the use any nail. The construction is simplified compared with traditional constructions. The brushes no longer present breakages or cracks in the wood.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The characteristics and advantages of the invention will be apparent from the ensuing detailed description of one embodiment thereof, illustrated by way of non-limiting example in the accompanying drawings, in which:
[0012] FIG. 1 is a front view of a brush;
[0013] FIG. 2 is a front view of a handle;
[0014] FIG. 3 is a side view of a handle;
[0015] FIG. 4 is a top view of a handle.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0016] With reference to the accompanying figures, the brush consists of a handle 10 , bristles 12 and a collar 16 .
[0017] At one end, namely in its wider end, the handle 10 has a tenon 11 having on its outer edge a profile 13 which is inclined by an angle α of about 70° to a central axis 15 of the brush, in the direction of the brush length.
[0018] This is therefore a so-called angular brush, i.e. presenting the end of the bristles 12 inclined by the predetermined angle α. The collar 16 is also of inclined type.
[0019] The profile 13 presents a chamfer 20 , preferably on both sides (the longer sides) to enable it to more easily penetrate into the glue subsequently used for gluing.
[0020] At the point at which it engages the handle 10 , the tenon 11 has a perimeter slightly less than that of the handle along a section taken at that point. In this manner an edge 17 is obtained at which to position the collar 16 .
[0021] The bristles 12 are grouped together to form a pack suitable for the brush dimensions, and are partially inserted into the collar 16 . A glue of the type normally used for this type of application is inserted through the other opening of the collar 16 , to fix the bristles 12 together. For this operation, the bristles 12 and the collar 16 are placed in an inclined position, equal to the inclination of the angle α of the brush, so that the glue settles on the head of the bristles in a horizontal position.
[0022] The tenon 11 is then inserted through that end through which the glue has been inserted, and becomes glued to the bristles 12 .
[0023] The operation can be carried out in a single step by inserting a quantity of glue adequate both for gluing the bristles and for gluing the handle. Alternatively, but requiring an additional working step, the glue for gluing the bristles 12 can be inserted as a first step, left to dry and then a new quantity of glue be inserted followed by insertion of the handle 10 .
[0024] Hence in both cases, between the bristles 12 and the profile 13 of the handle 10 a region 14 of previously determined dimensions is created, in which the sealing glue for the brush is present.
[0025] The recesses 18 , and in particular the undercuts obtained thereby, serve to cause the glue to adhere to and securely grip the handle 10 . The recesses 18 are provided as laterally as possible to reduce any stresses undergone by them.
[0026] The recesses 18 are of circular shape as they are made by simple drill bits. They can also have other shapes (for example of dovetail type with a aperture at their tip, or two or more oblique cuts) such as to form elements having an undercut in which the glue can grip, but in that case the construction may be more complex and require more than one working step.
[0027] Brushes of the known art, in which the collar is fixed to the handle by nails, require a metal insert to bind the bristles to the handle. The insert, having suitable holes or other gripping elements for the glue, is inserted into the glue used to glue the bristles, it extending along the interior of the collar and being fixed to the handle by the nails.
[0028] According to the present invention, this insert is no longer required, so further saving production costs.
[0029] By virtue of the edge 17 the collar 16 , which is contained within it and does not project from it, cannot annoy the user. Because of the particular inclination of the profile 13 , which equals that of the bristles 12 , the size of the region 14 can be dimensioned such as to reduce as much as possible the quantity of glue used while at the same time maintaining secure fixing, so reducing glue costs and the relative weight. The collar 16 preferably presents ribs which by gripping the materials in its interior prevent it from moving or sliding along the tenon 11 .
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Handle for angular brush characterized in that said handle comprises, at one end of said handle, a tenon having a profile inclined to the central axis of said handle, said profile comprising at least one circular recess, said profile further comprising at least one lateral chamfer along a major side thereof.
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CROSS REFERENCE TO RELATED APPLICATION
This application is a continuation in part of U.S. patent application Ser. No. 11/835,412 filed Aug. 7, 2007, now U.S. Pat. No. 7,819,087 which claims priority to Provisional Application No. 60/821,919, filed Aug. 9, 2006 the contents of each of which are incorporated herein by reference.
FIELD OF THE INVENTION
The present invention relates generally to animal training systems, and more particularly to a light accessory for electronic animal training systems. The invention has particular utility in connection with dog tracking systems, which may be used alone or in combination with a remote dog training system, and will be described in connection with such utility, although other utilities are contemplated.
BACKGROUND OF THE INVENTION
The invention relates to systems for animal training and tracking, and more particularly to an improvement and accessory for animal training systems to allow for visual tracking of an animal in low ambient light situations.
While a number of devices are known for remotely stimulating dogs and other animals for training purposes, it is difficult to track such animals if they are off-leash and moving far afield. In fact, dogs may be lost during training exercises or competitions should they wander too far from the owner or trainer. In this situation, not only may a prize animal be lost, but also so would the expensive training collar being worn by the animal. These problems are particularly acute in low lighting conditions.
Animal lighting apparatuses are known. For example, U.S. Pat. No. 4,173,201, issued to Chao et al. on Nov. 6, 1979, discloses an illuminated collar including small electric lamps powered by a dry cell battery and disposed along an elongated leather strap. A manually operated switch carried on the collar for operation of the lights. U.S. Pat. No. 3,935,443, issued to Allen P. Simmons on Jan. 27, 1976, discloses an illuminated collar, which includes a plurality of miniature filament lamps connected in parallel. A battery is disposed along the length of the collar which, when secured in its container, completes an electrical circuit to provide power to the lights. U.S. Pat. No. 5,523,927, issued to James A. Gokey on Jun. 4, 1996, discloses a collar for placement on an animal including a light emitting diode, a motion sensitive switch designed to respond to the motion of the animal, an on/off switch to selectively turn the battery power to the circuit, a battery and a timing circuit. U.S. Pat. No. 7,140,327, issued to Sondra Morehead on Nov. 28, 2006, discloses a collar with an illumination source in communication with a light emission inset through light transferring fibers. The illumination source may be manipulated with a control mechanism in communication with the illumination source through a radio frequency transceiver, or possibly an infrared link or other wireless technology. A person may activate the illumination source remotely without the necessity of capturing the animal prior to activating the illumination source.
While the above patents generally disclose an illuminated pet collar or harness, the references require the lighting on the collar to be switched on or off manually. The constant on position of the light source rapidly depletes the energy source for the lighting. Also, the above references do not disclose a light attachment that may be added to an existing wireless training system.
Thus, there is an unmet need for an improved remote training device that reliably provides a remote training device that (1) provides maximum selectability of the intensity of stimulus applied to the animal, (2) achieves very reliable, repeatable electrical contact of the electrodes with the animal's skin over the entire desired range of selectable stimulus intensity settings, and (3) allows for selective illumination of the animal in low lighting conditions to allow greater visibility to the owner.
The present invention provides improvements over the above prior art and other existing animal illumination systems.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the invention to provide a remote control animal training system that overcomes the aforesaid and other disadvantages of the prior art.
It is another object of the invention to provide a remote animal training system with a reliable way for a trainer to monitor whether an animal is moving or motionless when the animal is out of sight and/or to allow the trainer to better locate an animal in low lighting conditions.
It is another object of the invention to provide a remote animal training system that allows visual identification of an animal by a trainer or third party so that animals running off-leash with the device may avoid a vehicle-animal accident since the operator of the vehicle may see them.
Briefly described, and in accordance with one embodiment thereof, the invention provides a system and method for coupling a light accessory to a receiver that is responsive to a transmitter. A command to selectively illuminate a light accessory incorporated into the animal training system is transmitted to the receiver. The received information is demodulated in the receiver to produce a signal representative of the requested lighting status. A microprocessor in the receiver receives and operates on the signal to generate and transmit to the accessory via a low frequency communication channel an output of predetermined duration to light the light accessory.
In one embodiment, the light function is activated and controlled using a RFID function of a transmitter with an associated accessory. An RFID signal is transmitted by an antenna on a transmitter to an accessory receiving antenna and detected by a microcontroller. The received signal is demodulated to create instructions for the accessory device. The RFID signal transmitted to the accessory activates the light when the RFID transmitter is in close range with the accessory.
Accessory light devices may perform a variety of functions. For example, a Locate Feature may be encoded wherein the device will flash when the transmitter is set to accessory setting and a button is pressed. The Locate Mode may instruct the LED units of the device to continuously shine at its highest intensity. The light accessory may be coupled with an infrared (IR) LED for more effective use in the K9 protection functionalities.
In another embodiment, the LEDs may be customized to emit a specific color to allow for multiple dog usage. Further, the LED flash rate, or color, or both may be used for identifying a particular animal. The flash rate, color, or other element of the device may be coupled to, for example, a motion sensor, accelerometer, heart rate monitor, electronic compass or GPS system to indicate to a user whether the animal is in motion, being motionless (pointing), or treeing an animal. A secondary benefit is that the LED provides light to the tree where the dog is baying. In a particular embodiment, a pressure sensor is added to the neck of an animal such as a horse to monitor cribbing or foaling, and provide feedback information to the user. An electronic compass or GPS module may also be used in the accessory unit and coupled to the device such that the flash rate or color will indicate direction or orientation of an animal.
In addition to a light accessory, sound, vibration and other modules may be provided that draw power from an existing power supply and receive instructions via an RFID function of a transmitter. This allows a trainer or owner to add functionality onto an animal training product they have already purchased in an economical fashion.
Furthermore, modules for data collection applications, use in areas related to environments where a human cannot go such as search & rescue, crime scenes, etc. may be provided using the method and apparatus of the invention. In a particular embodiment, a module could hold medical supplies to aid with rescues.
In yet another embodiment of the invention, there is provided a remotely controlled animal training system having a transmitter including a control apparatus for selectively transmitting a signal to a collar mounted receiver, said transmitter and receiver each having a battery, said receiver further including a light source and a connection to couple the light source to the battery of the receiver;
a control to selectively power the light source and to enable various lighting patterns.
In still yet another embodiment of the invention, there is provided an accessory unit for a remotely controlled animal training system having a battery and a receiver, comprising:
a functional unit;
a connection to couple the functional unit to the battery of the animal training system and;
a control to selectively power and enable the functional unit.
The functional unit may comprise, for example, a sensor unit including but not limited to a temperature sensor, a moisture sensor and a biometric sensor, a GPS unit, and a compass.
BRIEF DESCRIPTION OF THE DRAWINGS
Many aspects of the invention can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present invention. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.
FIG. 1A is a perspective view of a receiver of an animal training system including a light accessory of the present disclosure;
FIG. 1B is an exploded view of the receiver of FIG. 1A ;
FIG. 2 is a block diagram of a remote animal training system, in accordance with an embodiment of the present disclosure;
FIG. 3 is a block diagram of the remote animal training system of FIG. 2 , in accordance with an embodiment of the present invention;
FIG. 4 is a circuit diagram of an element of the remote animal training system of FIG. 2 , in accordance with an embodiment of the present invention;
FIGS. 5 and 6 are block diagrams of accessory devices for the remote animal training system of FIG. 2 ;
FIG. 7 is a block diagram of a portion of the accessory device for the remote animal training system of FIG. 2 ;
FIG. 8 is an illustration of an emitter signal for the light module accessory device for the remote animal training system of FIG. 2 ;
FIG. 9 is an illustration of a portion of the emitter signal of FIG. 6 for the remote animal training system of FIG. 2 ;
FIG. 10 is an illustration of a portion of the emitter signal of FIG. 6 for the remote animal training system of FIG. 2 ;
FIG. 11 illustrates actual captured signal in accordance with an embodiment of the present disclosure; and
FIG. 12 is a schematic of a circuit to enact the present disclosure.
DETAILED DESCRIPTION
Referring to FIGS. 1A and 1B , in one embodiment, a light accessory 10 on an animal training system is activated by an accessory function in a receiver 12 of the animal training system. The light accessory or other accessory 10 is coupled to the existing battery 14 and is controlled by receiver 12 and shares power from the battery unit 14 of the animal training system. The receiver 12 and accessory 10 each have a collar strap tab 15 a , 15 b . Thus, if the collar strap tab of the receiver were to break or fail, the collar strap tab of the accessory will continue to secure the receiver and accessory to the animal, and vice versa. In a particular embodiment, the light accessory 10 comprises two or more high intensity light emitting diodes (LEDs) on board. LEDs are commercially available, such as, for example, Everlight Reference Part No. 99113UTC/1318507/TR8. The luminous intensity of the LEDs is preferably greater than about 800mCD. The housing for the light module accessory 10 is transparent and may include reflective material to maximize light visibility.
FIG. 2 is a block diagram of a remote animal training system 110 A, in accordance with a first exemplary embodiment of the present invention. The remote training system 110 A includes a remote transmitter 111 having several push-button switches 113 for setting a stimulus level code that selects one of for example, three to six desired electrode stimulus signal levels. The stimulus level selected is digitally encoded into an RF signal 108 . The RF signal 108 is transmitted by a remote antenna 114 on the remote transmitter 111 to a collar antenna 116 and detected by an RF receiver 115 . The receiver output 117 of the RF receiver 115 is demodulated by a demodulator 120 to produce a digital output 121 . The digital output 121 of the demodulator 120 represents the stimulus code/data selected by push-button switches 113 of remote transmitter 111 . The digital output data 121 is translated by a microprocessor 122 into one of six or more possible stimulus level selection signals 123 . The stimulus level selection signal 123 may be a pulse width signal having one or more pulses, each pulse having a substantially similar width. Intensity selector switch 112 provides a plurality of settings, e.g. six or more settings for selecting from one of several, e.g. six or more available intensity levels. Switches 113 allow the user to select between several functions/types of stimulus such as momentary or continuous stimulation, e.g., light, sound, electric stimulation (shock), or vibrations, and low, medium, or high stimulation by pressing one or more switches.
Referring to FIG. 3 , another embodiment, the remote animal training system 110 A includes a remote transmitter 111 having several push-button switches 113 for setting a stimulus level code that selects one of for example, three to six or more desired electrode stimulus signal levels. The stimulus level selected is digitally encoded into an RF signal 108 . A remote antenna 114 on the remote transmitter 111 transmits the RF signal 108 to a collar-mounted receiver unit 119 carried by the animal. The receiver unit 119 includes an RF receiver and an (LF) magnetic coupling transmitter 119 A ( FIG. 3 ) attached to a collar 119 B ( FIG. 3 ). An accessory magnetic coupling receiver device 151 (e.g., a beeper, light, or similar) also may be attached to the collar 119 B or integrated into the receiver unit 119 . The receiver unit 119 may receive signals from the remote transmitter 111 corresponding to electric stimulus levels and a light selection. At least two electrodes 133 and 134 of the transceiver unit 119 electrically contact the skin of the animal and apply thereto stimulus signals the intensity of which is in accordance with the RF signal 108 sent from the remote transmitter 111 .
A switch or a setting on an ISS knob 132 on the remote transmitter 111 may actuate the collar-mounted accessory device 151 . Upon actuation of the switch or knob 132 , the collar mounted accessory device 151 receives a signal from the LF transmitter in the RF receiver unit 119 A to produce an audible and/or visual signal, e.g., a strobe that enables the trainer to audibly/visually determine if the animal is moving or is motionless, e.g., “pointing” or for purposes of locating. The signal transmitted from remote transmitter 111 to the RF receiver/LF transmitter 119 A may be approximately 27 MHz (RE), for example, and the signal from the receiver/transmitter 119 A to the collar-mounted accessory device 151 may be approximately 125 KHz (LF) for example. Accessory device may be replaced with lighting accessory 10 as shown in FIG. 1 . The light accessory may perform a variety of functions. For example, a LOCATE FEATURE may be encoded wherein LED 186 (see FIG. 5 ) will flash when the transmitter is set to an accessory setting and a button is pressed. The Locate Mode may instruct the LED units of the device 186 ( FIG. 5 ) to continuously shine at its highest intensity.
In another embodiment, the LEDs 186 may be customized to emit a specific color to allow for multiple dog usage. Further, the LED flash rate, or color, or both may be used for identifying a particular animal. The flash rate, color, or other element of the device may be coupled to, for example, a motion sensor, accelerometer, heart rate monitor, electronic compass or GPS system (not shown) to indicate to a user whether the animal is in motion, motionless (pointing), or treeing an animal. In a particular embodiment, a pressure sensor is added to the neck of an animal such as a horse to monitor cribbing or foaling and provide feedback information to the user. An electronic compass or GPS module also may be used in the accessory unit and coupled to the device such that the flash rate or color will indicate direction or orientation of an animal.
The intensity selector switch 112 on the remote transmitter 111 , which may be a rotary switch, may be used to select “zero” level or any one of for example, six or more desired output levels of the pulses of stimulus voltage V o produced by the Flyback transformer 131 ( FIG. 2 ). The several push button switches 113 can be depressed individually or in combination to select the frequency and number of the pulses of stimulus voltage signal V o . The intensity selector switch 112 may be adapted to adjust the accessory module. For example, the intensity selector switch 112 may adjust the light intensity, flash rate, color, or other aspect of the light module, or the volume, frequency, or other aspect of a sound module etc.
FIG. 3 is a block diagram of the remote animal training system 110 A of FIG. 2 , in accordance with another embodiment of the present invention. The remote training system 110 A includes the remote transmitter 111 having several push-button switches 113 for setting a stimulus level code that selects one of the stimulus signal levels. The stimulus signal level selected is digitally encoded into an RF signal 108 . The RF signal 108 is transmitted by a remote antenna 114 on the remote transmitter 111 to a collar antenna 116 (referring back to expanded receiver 119 in FIG. 2 ) and detected by an RF receiver 115 . The collar antenna 116 and the RF receiver 115 are part of the collar-mounted receiver unit 119 carried by the animal.
The receiver output 117 of the RE receiver 115 is connected to the input of a filter and data slicer circuit 120 , which may be separate or part of a microprocessor 122 . An output signal of the filter and data slicer/comparator circuit 120 provides a digital output 121 , a serial digital encoded signal that becomes a data input to the microprocessor 122 . Filter and data slicer/comparator circuit 120 is a conventional circuit that filters and shapes the signals produced from the RF receiver 115 to generate the digital output 121 as an input to the microprocessor 122 .
The microprocessor 122 supplies a stimulus level select signal 123 that includes a pulse width modulated stream of output pulses. Each of the output pulses in the stimulus level selection signal 123 for any one stimulus level selection have a substantially similar width, although pulse widths may differ between different stimulus level selections. The stimulus level selection signal 123 , which includes pulse-widths of which correspond to the stimulus levels selected by the intensity selector switch 112 of the remote transmitter 111 .
The stimulus level selection signal 123 is applied through the resistor 104 to a control electrode of a switch transistor 130 connected to a primary winding 131 A of a Flyback transformer 131 and a diode 102 in series with a Zener or TVS diode 100 . The Zener or TVS diode 100 may have a response time of less than 8 microseconds. The peak-to-peak voltage produced between the pair of electrodes 133 and 134 connected to the secondary winding terminals of the Flyback transformer 131 corresponds to the pulse width of the drive pulses, and hence to the stimulus level selected by push-button switches 113 of the remote transmitter 111 .
When a Flyback signal is produced on the primary winding 131 A of the Flyback transformer 131 , the Zener or TVS diode 100 suppresses the voltage to the primary side. On the primary side, when a signal occurs at the collector of the switch transistor 130 , the diode 102 biases the primary winding 131 A of the Flyback transformer 131 thereby allowing the Flyback transformer 131 to be energized to the proper level for signal delivery to a load and preventing minimal, if any, current flow through the Zener diode 100 . When the transistor 130 is switched “OFF”, the Zener diode 100 charges, thereby delivering the “Flyback signal” across the transformer 131 at an acceptable voltage. The voltage suppression effectuated by the Zener diode 100 that occurs on the primary side corresponds to an open-circuit peak voltage suppression level.
FIG. 4 is a circuit diagram of an element of the remote animal training system 110 A of FIG. 2 , in accordance with the second exemplary embodiment of the present invention. The microprocessor 122 (shown in FIG. 4 ) provides a digital signal via conductor 148 to an encoded magnetic signal generator circuit 149 . Using a magnetic signal is beneficial in that it is easy to comply with FCC regulations, but those having ordinary skill in the art will recognize other types of signal generators may be relied upon for the same purpose described herein. For example, in addition to LF Comm. and other RF based methods, sound, light, etc. could also be used to generate a signal. The encoded magnetic signal generator circuit 149 includes an encoder transistor 149 A with a base connected to conductor 148 , an emitter connected to ground, and a collector connected to one terminal of an inductor 400 . The other terminal of the inductor 400 is connected to a voltage source+V. This inductor in relation with transistor 149 A produces a “boosted” LF signal. Capacitor 106 resonates at the LF frequency 125 KHz to produce the magnetic coupling signal. The inductor 149 B may have a value of, for example, 9 mH; and the capacitor 106 may have a value of, for example, 150 pF. The capacitor 106 tunes an emitter signal 150 emitted from the inductor 149 B. Using the exemplary values above, the equation:
f o =[2π√( LC )] −1
where f o denotes the resonance frequency, the frequency of the emitter signal 150 generated by the encoded magnetic signal generator circuit 149 is around 125 kHz. However, the inductor 149 B and the capacitor 106 values may be designed above 125 kHz to compensate for some other non-ideal effects in the encoded magnetic signal generator circuit 149 .
FIGS. 5 and 6 are block diagrams of an accessory device 151 for the remote animal training system 110 A of FIG. 2 . The accessory device 151 includes an accessory inductor 151 A receiving the emitter signal 150 from the encoded magnetic signal generator circuit 149 . The accessory inductor 151 A is connected to a low frequency communication receiver 151 B, which in one embodiment is incorporated into an accessory microprocessor 180 . Alternatively, the low frequency communication receiver 151 B may be separate from the accessory microprocessor 180 . The accessory microprocessor 180 may control a number of possible accessories, including a light generation circuit 184 of the low frequency communication receiver 151 B. Accessory microprocessor 180 is connected to the light generation circuit/driver 184 . The light generation circuit/driver 184 is connected to an LED or other light emitter 186 .
FIG. 7 is a block diagram of a portion of the accessory device 151 for the remote animal training system 110 A of FIG. 3 in accordance with one embodiment of the present disclosure.
FIG. 8 is an illustration of an emitter signal 150 for the accessory device 151 for the remote animal training system 110 A of FIG. 3 . The emitter signal 150 produced by the encoded magnetic signal generator circuit is a square wave. The emitter signal 150 is initially primed with a preamble signal 192 that contains an initial preamble 125 kHz square wave that lasts for 6 ms. When a signal of this time duration or greater is initially detected, the accessory device 151 prepares to receive more data from the corresponding transmission There is a 0.1 to 0.5 ms of gap time 194 right after the preamble signal 192 . After that, the encoded magnetic signal generator circuit 149 sends out the first sequence of data 196 with “0”s and “1”s for 16 ms duration followed by 44 ms of wait time 198 . The data sequence then repeats with another 6 ms preamble, followed by 0.1 ms of wait time and a second sequence of “0”s and “1”s. This second sequence of “0”s and “1”s is actually the sequence processed by the accessory device 151 . The second sequence of “0”s and “1”s is followed by 88 ms of wait time 198 before the sequence is repeated.
FIG. 9 is an example of one type of an LF communication signal, and illustrates a portion of the emitter signal 150 of FIG. 10 for the remote animal training system 110 A of FIG. 2 , in accordance with the second exemplary embodiment of the present invention. FIG. 9 is operative for explaining the sequence of data 196 shown in FIG. 8 . As shown in FIG. 9 , a “0” is represented by a 0.2 ms long flat line, followed by a 0.1 ms long 125 kHz square wave, and ended with a 0.2 ms long flat line. A “1” is represented by a 0.1 ms long flat line, followed by a 0.2 ms long 125 kHz of square wave, and ended by a 0.2 ms long flat line. Hence, each data bit, whether a “1” or a “0” is 0.5 ms long. There are a total of 32 bits (16 ms of 0.5 ms bits) in the data sequence 196 (4 bits for MSB, 4 bits for LSB, 4 bits for FUNCTION and 4 bits for CHKSUM). Thus, a 16 ms data sequence 196 is transmitted.
With respect to FIG, 9 , depending upon the sensitivity of the receiver and the environmental conditions relative to transmission of the emitter signal 150 , it may be worthwhile to provide fewer, longer bits within the 16 ms data sequence 196 to provide a more reliable system. For instance, using a system similar to that disclosed in FIG. 9 , a total of 8 bits, each up to 2.0 ms long, may be transmitted during the 16 ms data sequence 196 . Further, other patterns, e.g., ⅓-⅔ long modulations, may be available for providing a “1” or a “0” as detailed above.
FIG. 10 is an illustration of a portion of the emitter signal 150 of FIG. 2 and of the signal shown in FIG. 8 for the remote animal training system 110 A of FIG. 2 . FIG. 10 is one of many possible alternatives to the illustration of FIG. 9 and is operative for explaining the sequence of data 196 shown in FIG. 8 , As shown in FIG. 10 , a “0” is represented by a 0.6 ms long 125 kHz square wave and a 1.2 ms long flat line. A “1” is represented by a 1.2 ms long 125 kHz of square wave a 0.6 ms long flat line. Hence, each data bit, whether a “1” or a “0” is 1.8 ms long. There are a total of 8 bits (16 ms of 1.8 ms bits, with 1.6ms to spare) in the data sequence 196 . Thus, a 16 ms data sequence 196 capable of 256 different commands (2 8 ) is transmitted.
The emitter signal 150 represents a command the LF receiver (up to 256 commands are possible). Typically, no addressing is required because of the short range of the magnetic coupling. Commands would appear as addresses for accessory units that only are capable of activating only one response to a command. For example, an accessory unit that only produces an electrical stimulation of a specific intensity level (specific frequency and Vrms value) when it sees the specific command, will not respond to any other command, therefore, the command also appears as an address. There might be accessory units that respond to multiple commands but only when the specific (1 of the 3) 8-bit command is decoded. Other accessory units will respond to a specific command that will activate one of several hardware selected (switch) outputs of the unit. While accessory device 151 is on, it operates in a mode selected by internal DIP switches (not shown). In one selectable mode, if the accessory device 151 is a beeper, two different beeping patterns correspond to two different animals. In another selectable mode, light is emitted only when an ambient light detector within the accessory device 151 detects low levels of light surrounding the animal. The accessory unit also could comprise a strobe, vibration or electric stimulation device.
FIG. 11 illustrates actual captured signal in accordance with a second exemplary embodiment of the present invention.
An LF Comm Transmitter will automatically transmit a minimum of 4 packets of data with a button press from the remote transmitter. The data is modulated at 125 kHz. Detection of 2 valid packets will activate or deactivate the accessory unit. The decoding of packet data is performed by a microprocessor interfaced to the LF Comm receiver chip by 3 lines (UPLND_DATA, UPLND_WAKE, and UPLND_RST (reset)). Activation (or deactivation) requires a minimum of 2 falling edge signals (from VCC to Ground) on the UPLND_WAKE line into the microprocessor within 100 ms of each other. The LF Comm receiver will output a low on the UPLND_WAKE line when a preamble is detected (minimum 5.64 ms Preamble duration) through the receiver antenna input. FIG. 9 illustrates the activation of the accessory function.
As seen in the FIG. 11 , the UPLND_WAKE line is normally high until a preamble is detected. Once the first packet is detected, the microprocessor will reset the LF Comm receiver chip by pulsing the RESET line (Bottom Signal—CH3). If a second preamble signal is detected within 100 ms of the first, the UPLND_WAKE will again go low and the microprocessor will activate the accessory function (or deactivate). After the second preamble detection, data will be available at the UPLND_DATA (second signal from top—CH2) line for command decoding. If a second falling edge signal at the UPLND_WAKE line within 100 ms of the first, the accessory function will fail to activate (or deactivate) and the activation process will be reset and 2 more valid preamble signals will be expected to activate or deactivate the accessory function of the accessory unit.
While the above description relates to a light-emiting type of accessory device, it should generally be understood that this circuit is generally applicable to accessory devices that emit sound (substituting, e.g., the LED 186 out for a piezo-electric transducer 186 ) or the like. The improvements over the art described in any of the embodiments above may be added or excluded in several different combinations, and no description is intended to limit this disclosure to only the combinations described herein. Similarly, signal lengths, frequencies, and amplitudes are provided for exemplary purposes only and are not intended to limit the scope of the invention.
In another embodiment, the light module is activated by detecting a radio frequency (RF) transmission. In this embodiment, the user's animal training system 110 A ( FIG. 3 ) need not comprise an existing accessory channel to allow remote activation of the light module 10 ( FIG. 1 b ) accessory by an existing animal training system. The user would simply hold the transmitter antenna 114 ( FIG. 3 ) close (within a few inches to the module 10 — FIG. 1 b ) and the lights 186 ( FIG. 5 ) would illuminate. The light module 10 ( FIG. 1 b ) would detect the transmission of an RF signal 108 ( FIG. 3 ) and would activate the lighting circuit accordingly. In a particular embodiment, one LF Comm or RF transmission will cause the unit to flash twice every three seconds, another transmission will cause it to glow steady and a third transmission will cause the lights to go out.
If desired, the light accessory module 10 ( FIG. 1 b ) will have a separate main power on/off switch (not shown), and will be powered by the same battery as the receiver to which it is attached. Alternatively, the light accessory module will be turned on by the receiver main power switch, in which case the light accessory module 10 ( FIG. 1 ) will be designed to draw very low (>100uA) standby current, so that the LED's 186 ( FIG. 5 ) can be switched on remotely. The screws 16 ( FIG. 1 b ) that mount the light module to the receiver may be provided as a part of what the user receives when they purchase the device. The screws 16 ( FIG. 1 b ) are the same size and threading of the existing receiver battery screw, but are long enough to thread through the battery 14 ( FIG. 1 b ) and the module into the receiver 12 ( FIG. 1 b ) and provide sufficient torque to effect a seal.
FIG. 10 shows a typical circuit structure used for one embodiment of the invention. Signal 108 ( FIG. 2 ) is received at antenna 116 ( FIG. 2 ) and instructions processed to determine the behavior of LEDs 186 ( FIG. 5 ).
It should be emphasized that the above-described embodiments of the present invention, particularly, any “preferred” embodiments, are merely possible examples of implementations, merely set forth for a clear understanding of the principles of the invention. Many variations and modifications may be made to the above-described embodiments of the invention without departing substantially from the spirit and principles of the invention. For example, the accessory unit may be packaged as a stand-alone device with electronic circuits for activation/deactivation of the light, control of flash, rate, color, or both, and may also include a monitor sensor, accelerometer, heart rate monitor, electronic compass or GPS system as above described. Also, if desired, the LED(s) may be mounted directly to the circuit boards, and made visible through a transparent window in the device housing or the device housing may be formed from a transparent or translucent material. The accessory unit also comprises two or more devices such as a strobe and an electric stimulation device, which may be separately addressable. Also, two or more separately addressable accessory units may be worn on a single animal. Additionally, the accessory device may include other functionality such as GPS functionality. Still other modifications are contemplated. For example, one having skill in the art may recognize that communications between the transmitter and receiver may be accomplished through methods besides those listed above. All such modifications and variations are intended to be included herein within the scope of this disclosure and the present invention and protected by the following claims.
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A light accessory is provided for a remotely controlled animal training system, allowing visual tracking of an animal in low ambient light conditions. The light accessory may be a stand-alone accessory or be in conjunction with a wireless receiver. The light accessory may be controlled by an accessory channel that exists in the remotely controlled animal training system, or may be controlled by the presence of a generic proximate radio frequency transmission.
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RELATED APPLICATION
This application claims priority of U.S. Provisional Application No. 60/164,090, filed on Nov. 6, 1999, the disclosure of which is incorporated herein by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an apparatus and method of use for measuring the geometry of a foot in the position the foot will be in when inside of a shoe. More particularly, the present invention relates to an apparatus having a foam impression block specially formed into the shape the target foot wear will have. Moreover, the present invention relates to methods of using such an apparatus for measuring the plantar contour and instep of a foot in the position the foot will be in when inside of a shoe.
2. Description of the Related Art
A number of methods currently exist to measure the geometry of the plantar contour of a foot. The accurate measurement of the plantar contour is used in the manufacture of custom insoles. The prior art methods include plaster casting, optical scanning, contact sensor measurement, as well as foam impression measurement. These methods require the foot to be in a planar position. However, some shoes, such as high heels or other shoes with a slope, distort the plantar contour and instep due to the shifting of the user's body weight. Accordingly, the insoles made using these prior art methods do not account for such distortions. Moreover, these prior art methods are not well suited for home use.
The optical scanning methods and contact sensor measurement methods utilize expensive equipment. These methods provide an accurate and complete measurement of the foot. But, the size, expense and complexity of the equipment necessary for these methods makes them not suitable for use in all locations. Moreover, these methods do not permit accurate measurement of the geometry of the foot in the position it will be in when inside of a shoe.
Plaster casting methods require the measurement to be performed by a person other then the one being measured. This method provides an accurate and complete measurement of the foot but can be very messy and time consuming. Thus, plaster casting methods are not suitable for use in a person's home or by one's self. Moreover, these methods do not permit accurate measurement of the geometry of the foot in the position it will be in when inside of a shoe.
Foam impression measurement methods and apparatus utilize an easily deformable foam block. A person steps onto the block, thus crushing the foam in the locations of higher pressure. In this manner, the foam block deforms in the approximate shape of the persons' plantar contour. While this prior art method may be suitable for home use, it produces a sub-optimal characterization of the foot for a number of reasons. First, the foam block is uniform in thickness from heel to toe. This causes the toes to be forced upward as the foot is pressed into the foam because the toes of the foot have substantially less pressure on them than the region of the foot from the heel to the metatarsal heads. Forcing the toes upward can cause a number of problems including, hyper-extension of the plantar fascia, lowering of the correct arch height, and improper measurement of the forefoot and heel. Second, under full body weight, the foot expands allowing for a larger than normal foot impression. Additionally, the prior art does not provide for measurement of the instep. Moreover, the current foam materials and methods do not permit accurate measurement of the geometry of the foot in the position it will be in when inside of a shoe.
In the manufacture of custom insoles, the use of the plaster casting and foam impression methods also require the use of a scanning system. The scanning system may act directly on the negative impression within the foam or plaster. Scanning systems that act directly on negative impressions are known in the art. These laser scanning systems consist of a laser with a line generating optic. The laser projects a line at a know incident angle onto the negative impression. A camera is used to read the position of the laser line on the negative impression. Alternatively, the scanning system may act on a positive plaster model made from the negative impression within the plaster or foam. Scanning systems that act directly on the positive impressions are also known in the art. One such scanning system, provided by U.S. Pat. No. 4,876,758, specially constructed array of pin-like sensors. In either circumstance, the scanning system is used to digitize the measured contour. The digitized contour is provided to a computer controlled milling machine. The milling machine uses the digitized information to manufacturing a custom insole matching the digitized contour. Accordingly, the apparatus and methods of the present invention provide for cheaper and easier means to provide custom manufactured insoles to a customer.
Accordingly, it is an object of the present invention to provide foot measurement apparatus and methods, which overcome the limitations set forth above.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an apparatus for measuring a plantar contour. The apparatus has a foam impression block, and a carrier having a heel. The block has a toe thickness, a length and a heel thickness. The toe thickness is less than the heel thickness. The block is disposed upon the carrier such that the heel thickness and the heel are adjacent one another.
It is a further object of the present invention to provide an apparatus for measuring a plantar contour and an instep. The apparatus has a foam impression block and a carrier. The carrier has a heel and a plurality of straps. The block has a toe thickness, a length and a heel thickness wherein the toe thickness is less than the heel thickness. The block is disposed upon the carrier such that the heel thickness and the heel are adjacent one another. The plurality of straps are disposed upon the carrier and are adapted to wrap around the instep such that a plurality of sizing graduations disposed upon each of the straps are readable.
It is also an object of the present invention to provide a method for measuring the plantar contour of a foot. The method having the steps of: (1) placing the plantar contour over a foam impression block disposed upon a carrier having a heel wherein the block has a toe thickness, a length and a heel thickness, the toe thickness is less than the heel thickness, and the block is disposed upon the carrier such that the heel thickness and heel are adjacent one another; (2) aligning the toes with the toe thickness; and (3) urging the plantar contour into the block to deform the block.
It is a further object of the present invention to provide a method for measuring the plantar contour and instep of a foot. The method having the steps of: (1) placing the plantar contour over a foam impression block disposed upon a carrier having a heel and a plurality of straps, wherein the block has a toe thickness, a length and a heel thickness, the toe thickness is less than the heel thickness, the block is disposed upon the carrier such that the heel thickness and the heel are adjacent one another, and the plurality of straps are disposed upon the carrier are adapted to wrap around the foot; (2) aligning the toes of the foot with the toe thickness; (3) urging the plantar contour into the block to deform the block; (4) wrapping the straps around the instep such that a plurality of sizing graduations disposed upon each of the straps are readable; and (5) noting the sizing graduation indicated by each of the straps.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side perspective view of a first embodiment of the foam block of the present invention.
FIG. 2 is a rear perspective view of a second embodiment of the foam block of the present invention.
FIG. 3 is a front perspective view of a third embodiment of the foam block of the present invention.
FIG. 3 a is a side view of a foot being placed on an embodiment of the foam block of FIG. 1 .
FIG. 3 b is a side view of a foot being placed on an alternate embodiment of the container of FIG. 2 .
FIG. 3 c is a rear view of a foot being placed on the container of FIG. 3 b.
FIG. 4 is a side perspective view of a foot being placed on the foam block of FIG. 1 .
FIG. 5 is a side perspective view of the foot fully deforming the foam block of FIG. 1 .
FIG. 6 is a side perspective view of the foot being removed from the deformed foam block of FIG. 1 .
FIG. 7 is a rear perspective view of the deformed foam block of FIG. 1 after the foot has been removed.
FIG. 8 is a front perspective view of the deformed foam block of FIG. 2 showing an instep measurement embodiment.
FIG. 9 is a rear perspective view of the foam block of FIG. 2 showing a wedge correction embodiment.
FIG. 10 a is a side view of a first metatarsal support embodiment of the present invention.
FIG. 10 b is a side view of a second metatarsal support embodiment of the present invention.
FIG. 11 a is a rear view of a foot being placed into a dual density embodiment of the present invention.
FIG. 11 b is a side view of the dual density embodiment of FIG. 11 a.
FIG. 12 is a perspective view of the heel guide embodiment of the present invention.
FIG. 13 is a perspective view of the clear embodiment of the container of the present invention.
FIG. 14 is a top view of a scanning mark embodiment of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to the figures and more particularly to FIG. 1, a foam impression block is shown and is generally designated by the number 10 . Block 10 is made from pressure sensitive materials, which compress when a person's foot is pressed into the block. Preferably, block 10 comprises a foam casting material having low density, high flexural modulus and low shear strength. Accordingly, block 10 provides a material, which is easily deformed, with little or no memory, and retains the deformed shape indefinitely. Expanded phenolic materials such as those commonly used for insulation and ultra low density expanded polystyrene are suitable for block 10 . In the preferred embodiment, block 10 is expanded phenolic material.
Block 10 has a hardness or density from about 2 to about 25 pounds per square inch (hereinafter“psi”). Selection of the correct foam density depends on factors such as body weight, lifestyle or desired usage (e.g., sport, casual, or formal). For example, a density of about 2 psi is selected for casting a foot in block 10 while in the sitting position, a density of about 5 psi is selected for casting a foot in block 10 while in standing position, and a density of about 10 psi is selected for taking a dynamic casting of a foot in block 10 as described hereinbelow.
Shown in FIG. 1, block 10 has a toe thickness 14 , a heel 16 , a heel thickness 18 , and a length 19 . In one embodiment, toe thickness 14 and heel thickness are the same. In the preferred embodiment, toe thickness 14 , heel thickness 18 and length 19 provide the block with a wedge-like shape. In this embodiment, toe thickness 14 is less than heel thickness 18 , which minimizes any tendency for the toes of a person's foot to lift up while being pressed into block 10 . For instance in a first embodiment, heel thickness 18 is in a range from about 20 mm to about 35 mm and toe thickness 14 is in a range from about 10 mm to about 15 mm. In the preferred embodiment, heel thickness 18 is approximately 35 mm and toe thickness 14 is approximately 10 mm.
Block 10 is disposed upon the top of carrier 21 . Carrier 21 includes a heel 16 disposed on the bottom of the carrier. Heel 16 provides carrier 21 with a shape similar to a woman's shoe 5 . Block 10 is disposed upon carrier 21 such that heel thickness 18 and heel 16 are adjacent to one another.
Heel 16 improves the accuracy of the measurement of a person's foot using block 10 . Heel 16 and carrier 21 by more closely approximating the position and shape a foot assumes when wearing the desired shoe. An alternate embodiment of heel 16 , shown in FIG. 2, the slope of a man's shoe is approximated. In this embodiment, heel 16 and carrier 21 form an integral container 22 . In yet another embodiment of heel 16 , shown in FIG. 3, the slope of a sneaker or tennis shoe is approximated. In this embodiment, heel 16 and carrier 21 form integral container 22 . In yet another embodiment, block 10 is provided with heel 16 having an adjustable height. The height of heel 16 is adjustable from (1) a heel height less than the toe height, providing a negative slope to block 10 ; (2) a heel height equal to the toe height, providing no slope to block 10 ; (3) a heel height more than the toe height, providing a positive slope to block 10 . Preferably, container 22 is shaped so as to approximate the visual appearance of the exterior of a sole of a shoe. Moreover, the inside of container 22 is shaped having side-walls 22 - 1 at about a ninety degree angle with respect to its bottom surface 22 - 2 as shown in FIG. 11 a , or having side-walls 22 - 1 with a radius with respect to its bottom 22 - 2 as shown in FIG. 3 c.
In an alternate embodiment of FIGS. 3 b and 3 c , container 22 includes a vertical guide portion 34 . Portion 34 extends upwardly from container 22 above the level of block 10 . Accordingly, portion 34 aids the user to align the foot with regards to block 10 .
In an alternative embodiment, carrier 21 and/or container 22 act to provide flexure to block 10 . In this embodiment shown in FIG. 3 a , carrier 21 includes a biasing section 23 . Biasing section 23 is positioned between heel 16 and toe portion 17 . Preferably, biasing section 23 is positioned between heel 16 and foot pivot point portion 13 . Biasing section 16 elastically flexes or biases under the weight of the user shown as position 23 - 1 and returns to its original position after use shown as position 23 - 2 . Accordingly, biasing section 23 further improves the accuracy and support of the measurement of a person's foot in a weighted position using block 10 . In another alternate embodiment, the amount of flexure in biasing section 23 is adjustable. The amount of flexure in biasing section 23 is adjustable either along the length of the foot, along the width of the foot, or along a combination of the length and width.
It should be recognized that combinations of heel 16 , carrier 21 and/or biasing section 23 which more closely approximates the position of the foot wearing the shoe is included within the scope of the present invention.
By way of example, the use of block 10 to measure a person's plantar contour is described below with reference to the embodiment of block 10 shown in FIG. 1 . The user positions one foot over block 10 with their toes toward toe thickness 14 and their heel towards heel thickness 18 and moves their foot towards block 10 in the direction shown by arrow A, shown in FIG. 4 . Next, the user applies weight to that foot in the direction shown by arrow A until block 10 is fully deformed, shown in FIG. 5 . The user's foot, with weight applied thereon, will conform to the shape the foot has when wearing a shoe having a heel height substantially equal to the height of heel 16 . Thus, block 10 will deform in the shape the user's foot will assume when wearing the shoe. Next, the user removes that foot from deformed block 10 in the direction shown by arrow B, shown in FIG. 6. A fully deformed block 10 , having the shape of the person's foot will conform to when wearing the shoe, is shown in FIG. 7 .
In an alternative embodiment of the present invention, block 10 has been modified to provide for measurement of the instep or top surface of the foot. This information is often also required to properly fit footwear. A person with a“high instep” would require a shoe that is deeper and may prevent the person from properly fitting into snugger fitting footwear. Further, by knowing the instep of a subject foot and knowing the internal geometry of a particular shoe, it is possible to determine if the shoe will fit properly. This information is vital when manufacturing custom plantar contours. For instance, if it is known via measurement using the present invention that there will be 2 mm of extra space in the shoe, it is possible to tailor the characteristics of the plantar contours to take up this extra space.
A plurality of straps 80 are used to characterize the instep, as shown in FIG. 8 . Each strap 80 has a plurality of graduations 81 on its top surface indicating instep range. Each strap 80 is disposed upon carrier 21 or container 22 and is run over the top of the foot, and the instep range is read off of graduations 81 . As an additional feature, straps 80 secure block 10 to the person's foot such that the person can walk with the block secured to their foot. Thus, straps 80 enable dynamic casting of the foot. The shifting in body weight and the changing of foot size, which occur as a result of walking, will therefore be captured by block 10 . Dynamic casting of the foot requires block 10 to have a density of at least 3 psi.
It is oftentimes desirable to make adjustments to the position of the foot. For instance, it is often desirable to manipulate the angle that the plantar contour of the foot has with respect to the floor to correct for excessive pronation, supination or the like. In this instance block 10 , as shown in FIG. 9, is further provided with a support 30 . Support 30 is insertable between block 10 and support 21 to correct for pronation or supination of the foot or for difference in the length of the leg. Alternately, support 30 is insertable into a slot 31 defined within container 22 . In another embodiment, support 30 is formed within carrier 21 /container 22 . Support 30 further improves the accuracy of the measurement of a person's foot by more closely approximating the position and shape their foot will assume when wearing the desired shoe having a desired level of pronation or supination correction.
In alternate embodiments, support 30 is a metatarsal support under block 10 shown in FIG. 10 a or on block 10 as shown in FIG. 10 b . Support 30 , as a metatarsal support, further improves the accuracy of the measurement of a person's foot by more closely approximating the position and shape their foot will assume when wearing the desired shoe having a desired level of metatarsal support.
In yet another alternate embodiment shown in FIGS. 11 a and 11 b support 30 is provided by the selective use of various density foams within block 10 . In this instance, block 10 includes a region 10 - 1 having a first density and a region 10 - 2 having a second lower density. Region 10 - 1 , being of higher density, ensures that the heel of the user is properly centered within block 10 . Support 30 further improves the accuracy of the measurement of a person's foot by more closely approximating the position and shape their foot will assume when properly centered. For instance, in a preferred embodiment region 10 - 1 has a density of 5 psi and region 10 - 2 has density of 3 psi. In this embodiment, the higher density of region 10 - 1 ensures that the foot is properly centered within the lower density region 10 - 2 .
It should be recognized that support 30 which aids to adjust the foot within block 10 to more closely approximate the correct position of the foot wearing the shoe are included within the scope of the present invention.
It is desirable for container 22 to be used for more than one shoe size. In the embodiments where support 30 is secured within container 22 , the foot must be properly aligned over the support. Thus, a heel guide 44 shown in FIG. 12 is provided. Heel guide 44 enables container 22 to be used for more than one shoe size. Heel guide 44 is adapted to be removably coupled to container 22 in one or more positions such that the guide properly positions the foot of the user within the container. In a preferred embodiment, heel guide 22 includes studs 45 and container 22 includes recesses 46 . Studs 45 are adapted couple with recesses 46 to removably secure heel guide 44 to container 22 . Studs 45 are positioned on guide 22 and recesses 46 are positioned on container 22 so as to approximate the desired range of shoe sizes.
Shown in FIG. 3, a thin compliant medium 85 , such as, but not limited to, terry cloth, is placed on top surface block 10 . The foot is pressed into compliant medium 85 , which in turn compresses block 10 . Compliant medium 85 acts to prevent any of block 10 from adhering to the user's foot.
It is oftentimes desirable to mark specific points on the bottom of foot where problems, such as a metatarsal head, exists. In this instance, it is desirable for container 22 to be of optically clear material as shown in FIG. 13 . Optionally, only a portion of container 22 to be of optically clear material, such as bottom surface 22 - 2 . Preferably, clear container 22 includes a reference grid 60 disposed thereon. Optionally, reference grid 60 is a Harris mat, a pedo bar graph, a grid that relates to computer display software for corrections or the like. Clear container 22 therefor enables the user to remove block 10 from container 22 , to place their foot on reference grid 60 and precisely mark any existing problem spots.
As described above, the plantar contour measured by block 10 is often used in the manufacture of custom insoles. The process of converting the contour on block 10 into the custom insole often times requires using a scanner to digitize the contour directly from block 10 . In this instance, it is desirable for carrier 21 and/or container 22 to include one or more scanning reference marks 33 as seen in FIGS. 12 and 14. Mark 33 assists the optical scanner in the fast and accurate centering of the container and measured plantar contour.
Optionally, container 22 and/or carrier 21 includes mechanisms to secure block 10 therein. For example, in a first embodiment an adhesive is used to secure block 10 within container 22 . In alternate embodiments, indentations 70 (shown in FIG. 10 a ) or slots 71 (shown in FIG. 10 b ) are formed in container 22 . Indentations 70 and/or slots 71 allow removal of block 10 prior to deformation of the block. However, once deformed by the user, block 10 expands into indentations 70 and/or slots 71 to secure the block in container 22 .
It should be understood that the foregoing description is only illustrative of the invention. Various alternatives and modifications can be devised by those skilled in the art without departing from the invention. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variances that fall within the scope of the appended claims.
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An apparatus and method for measuring a plantar contour having a foam impression block and a carrier. The apparatus has a foam impression block including a front portion and a rear portion and a carrier including a height adjuster. The block is associated with the carrier such that the rear portion and the height adjuster are adjacent one another.
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FIELD OF INVENTION
[0001] Exemplary embodiments of this invention relate to care, strengthening and repair of keratin substrates and in particular of keratin fibers. Exemplary embodiments of the invention relate to compositions comprising at least one natural peptide synthesized from naturally derived amino-acids and of a molecular weight suitable for penetration into the hair shaft. The terminal amino-acids can be selected from those that are substantive to damaged sites on human hair, thus making the peptide able to bind and repair human hair. An additional advantage of exemplary embodiments of the present invention is providing a natural way to repair and reconstruct human hair with human hair identical peptides without using the traditional hydrolyzed human hair or hydrolyzed sheep wool protein.
BACKGROUND OF INVENTION
[0002] Keratins are fundamental compounds of the skin, the hair, the eyelashes and the nails. These water-insoluble fibrous proteins contribute towards their form, elasticity and strength. For years now, scientists have been utilizing hydrolyzed proteins to condition and strengthen the hair, and there are both patents and research publications covering the subject. However, hydrolyzed peptides that give the most advantage to hair strength come from human origin or sheep wool. The usage of human and animal products is limited by regulations, ethical and health concerns. Additionally, hydrolyzed wool and human hair proteins can break down into as many as 100-300 fragments. The actual composition, purity and molecular size of these fragments are hard to control and thus the efficacy of hydrolyzed hair is lowered.
[0003] Therefore, there is a need to synthesize and make available the specific peptides that are beneficial to hair strength, manageability and overall conditioning and can be substantive to hair using nature-made amino acids.
SUMMARY OF INVENTION
[0004] The solid phase peptide synthesis was used to create hair-identical peptides in a precise and controlled manner using natural amino acids as starting materials.
[0005] Development started from the review of the published literature on hair structure and selection of the specific Keratin proteins KRT35 and KRT85 that are expressed in the hair-forming matrix of the cortex and cuticles. KRT35 is tied to the basic inner structure of hair and KRT85 is tied to protein cross-linking to enhanced durability, stability, and strength.
[0006] Keratin KRT85 is a type II cuticular Hb5. The protein encoded by this gene is a member of the keratin gene family as a type II hair keratin, it is a basic protein which heterodimerizes with type I keratins to form hair and nails.
[0007] Keratin KRT35 is type I cuticular Ha5. The protein encoded by this gene is a member of the keratin gene family. This type I hair keratin is an acidic protein which heterodimerizes with type II keratins to form hair and nails.
[0008] The next decision was to identify how to lower the molecular weight of these keratins to make them suitable for penetration into the hair shaft. It was decided to terminate the peptides to make them more substantive to hair and the two amino acids that were selected as terminal were: cysteine and arginine.
[0009] Cysteine has the largest concentration of amino acid found in hair. Cysteine is an α amino acid with the formula HO 2 CCH(NH 2 )CH 2 SH. It is biosynthesized in humans. The side chain on cysteine is thiol, which is non-polar and thus cysteine is usually classified as a hydrophobic amino acid. The thiol is susceptible to oxidization to give the disulfide derivative cystine, which serves an important structural role in hair. It has been proven that cystine participate in disulfide crosslinks and thus have major role in the binding to hair proteins.
[0000]
[0010] Cystine, as shown above in its neutral form, is derived from two molecules of cysteine connected with a disulfide bond. Cysteine residues play a valuable role by crosslinking proteins which increase the rigidity and strength of hair.
[0011] Arginine is also one of the largest components of keratin and has been proven to help with the moisture retention of hair due to its high hydrophilicity. Arginine is a basic amino acid that has a guanidine group that gives it high affinity to hair protein. Arginine is shown below.
[0000]
[0012] Arginine has been shown to rapidly adsorb to hair on its own, and increase the cosmetic feeling of hair. Therefore, cysteine and arginine where chosen as terminal in the selected sequences.
[0013] The following peptides ending in cysteine and arginine were deemed beneficial:
1. CRSYR 2. CGVTR 3. CGSSRSVR 4. CAPCQPR 5. CGGLSYSTTPGR 6. RMIGR 7. RSGGVC 8. RAGSCGR 9. CVPCPGGR 10. RTNCSPR 11. CLPAASC 12. RSFSAC 13. CLPALC
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] Having thus described the invention in general terms, reference will now be made to the accompanying drawings, where:
[0028] FIG. 1 is a chart showing untreated hair fibers compared to hair fibers soaked in Rhodamine B pretagged peptides (0.1% aqueous) for 15 minutes with subsequent water rinse;
[0029] FIG. 2 is a chart showing a comparison of mean fluorescence intensity for untreated hair fibers and Rhodamine B pretagged peptides (0.1% aqueous) with 5, 15 and 60 minute and overnight treatments; and
[0030] FIG. 3 is a chart showing the cumulative effect of a peptide soak and subsequent washing.
DETAILED DESCRIPTION OF THE INVENTION
[0031] The invention thus relates to a composition comprising, preferably in a physiologically acceptable medium suitable for topical application to keratin substrates, at least one peptide or peptide fragment prepared from naturally derived amino acids with a molecular weight of 400-2500 Daltons and is capable of penetrating human hair.
[0032] The particular peptides that have been found to be useful in the present invention to repair and strengthen damaged human hair are fragments containing at least 3 consecutive amino acids of the selected sequences, preferably of at least 5 amino acids and even more preferentially 5 to 6 consecutive amino acids. The selected amino acids comprise at least one amino acid capable of forming covalent bonds (e.g.: cysteine), hydrogen bonds (e.g.: tyrosine), hydrophobic bonds (e.g.: glycine, valine, leucine) and saline bonds (e.g.: lysine, arginine, histidine, aspartate or glutamate) with other constituent proteins of the hair.
[0033] Accordingly, the present invention is directed to a hair dressing treatment comprising a mixture of hair identical peptides synthesized from the following amino-acids: (S) Serine, (Y) Tyrosine, (R) Arginine, (T) Threonine, (G) Glycine, (V) Valine, (F) Phenylalanine, (C) Cysteine, and (L) Leucine, in the selected sequence.
[0034] In addition, the composition covered in the present invention may contain hair conditioning ingredients and solvents that can enhance the penetration and deposition of the peptides onto and into the keratin fibers.
Experiments.
[0035] We used human blonde hair purchased from International Hair Importers (Glendale, New York) and bleached it three times with persulfate bleach and 40 volume developer. Substantivity of the peptides to hair was demonstrated via microfluorometry. The peptides were pre-tagged with Sulforhodamine B and applied to hair as a solution soak followed with the subsequent rinsing under running water for 30 seconds. The hair strands were dried and placed under the microscope. The intensity of the fluorometric reading is an indication of the presence and the relative amount of the peptide that is bound to the hair.
Experiment I. Evaluation of Peptide Deposition on Human Hair Via Microfluorometry Slide Preparation:
[0000]
1. Hair fibers were taken from a 3-times lab bleached tress.
2. The fiber was attached to a square of white tape.
3. Steps 1 and 2 were repeated twice until 3 hair fibers were adhered to the piece of white tape.
4. The hair fibers were then mounted to a glass microscope slide and the ends were secured with adhesive tape.
5. Each hair fiber was labeled consecutively on the white tape.
Microscope Settings:
[0000]
1. Texas Red Filter was used.
[0042] 2. 20× Objective was used.
3. Polarized filter was pulled out (no polarization). 4. Camera auto exposure was set to 100 ms.
I. Peptide Deposition
[0000]
1. The peptide deposition was confirmed by comparing 3-times bleached hair as a control to the hair that was soaked with Rhodamine B pretagged peptide solution for 15 minutes and rinsed with deionized water.
[0000]
TABLE 1
Untreated hair fibers vs. hair fibers soaked in Rhodamine B
pretagged peptides (0.1% aqueous) for 15 minutes
Sample Name
mean
standard dev
Untreated Hair Fibers (no dye)
25.07
6.02
0.1% Rhodamine B pretagged peptides
396.87
80.93
[0046] FIG. 1 shows untreated hair fiber vs. hair fibers soaked in Rhodamine B pretagged peptides (0.1% aqueous) for 15 minutes with subsequent water rinse.
[0047] Conclusions: The hair fibers soaked in Rhodamine B pretagged peptide solution show high fluorescence, therefore confirming the deposition.
Experiment II. Time-Dependent Penetration of Peptides to Hair.
[0000]
1. The four groups of 3 hair fibers were viewed under the microscope to take the initial readings (Untreated hair) and removed from the slides.
2. Each set of fibers was soaked in peptide solution (peptide was pre-tagged with
[0050] Rhodamine B) for 5 minutes, 15 minutes, 1 hour and overnight.
3. After soaking, each group was rinsed with deionized (DI) water for 30 seconds and dried. 4. The hair fibers were reattached to a glass microscope slide and the ends were secured with adhesive tape. 5. Readings for mean fluorescence intensity were taken using the Nikon microscope and NIS Elements software.
[0054] FIG. 2 shows the mean fluorescence intensity of untreated hair before 5 minute, 15 minute, 1 hour and overnight soak, and the mean fluorescence intensity of hair fibers treated with the peptide solution (peptide pre-tagged with Rhodamine B) with 5 minute, 15 minute, 1 hour and overnight treatments.
[0055] Conclusions: There is a definite deposition of peptide on hair even after a 5 minute soak.
[0056] The 5 minute and 15 minute soaks in Rhodamine B-peptide solution show similar levels of deposition and are not statistically different from each other. The 1 hour and overnight soaks show higher deposition and are not statistically different from each other either. The 1 hour (and overnight) show higher fluorescent intensity than the 5 and 15 minute soaks, indicating more deposition. It seems that there is enough of an increase in intensity at the 5 minute time point to show that there is uptake and attachment of the peptides.
Experiment III. Cumulative Effect:
[0000]
1. Untreated readings for mean fluorescence intensity were taken across the hair fibers using the Nikon microscope and NIS Elements software.
2. The hair fibers were detached from the slide and soaked in 0.1% (total active) Rhodamine B pretagged peptide solution for 5 minutes (in a 50 ml beaker with enough solution to cover the fibers) and rinsed in DI water for 30 seconds and dried.
3. The NIS Elements software was used to compute mean fluorescence intensity by taking 6 mean fluorescence intensity readings across each hair fiber (for a total of 18 readings per group) and averaged.
4. Fibers were then washed with 2 drops of 10% sodium lauryl ether sulfate (SLES) (while still on the slide, ends unsecured from the scotch tape), gently lathered for 60 seconds, rinsed for 30 seconds with DI water, and dried.
5. Mean fluorescence intensity readings were taken again.
6. Subsequent soaks, rinses and readings were conducted by repeating steps 2-5 two more times.
[0063] FIG. 3 is a chart showing mean fluorescence intensity of three successive treatment and 10% SLES wash cycles. FIG. 3 shows the cumulative effect of the peptide soak and subsequent washing.
[0064] Conclusions: The experiment shows that with daily use of peptide solution and subsequent washing of the hair, high level of peptide deposition can be easily achieved and maintained on hair. This effect gives reconstruction, repair, and enhancement in conditioning properties of hair.
[0065] The present invention has been described with respect to the preferred embodiment of the invention. It will be clear to those skilled in the art that modifications and/or variations of the disclosed methods and compositions may be made without departing from the scope of the invention set forth herein. The invention is defined by the claims that follow.
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A hair treatment composition containing at least one peptide identical to human hair, where preferably the peptide is synthesized from naturally-derived amino acids and can serve as a natural alternative to the commonly used human or animal derived (wool) keratin peptides.
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BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a topically applied oral bandage that can be adhered to and is protective of oral mucosa and to a storage stable gel composition providing such bandage.
2. The Prior Art
Aphthous ulcers or oral canker sores are the most common oral lesions afflicting humans. These lesions tend to recur in susceptible patients, often lasting for weeks and are characterized as necrotizing ulcerations of oral mucosal tissue located on soft, non-keratinized mucosa. The lesions are painful, affect nutritional intake, and disrupt oral hygiene. They lead commonly to secondary infections by opportunistic organisms.
Various products are in use for relief of discomfort identified with canker sores and associated lesions such as fever blisters and cold sores, these products forming a protective coating or film about the source of irritation so as to prevent exacerbation of the discomfort caused by normal eating and drinking practices and to allow the lesion to heal naturally. Typically, these products are in the form of ointments and solutions for topical application to the lesions. For the treatment of canker sores, for example, these products have variously employed ingredients such as astringents of which alum and tannic acid are examples, keratolytics such as salicylic acid and anesthetics such as benzocaine.
For example, U.S. Pat. No. 5,081,158 discloses a liquid composition which forms a medicated protective film in situ on oral mucosa, the composition consisting of a medicament dissolved in a solvent such as ethanol, hydroxypropyl cellulose and an agent such as salicylic acid or tannic acid which is disclosed as reacting by esterification with the hydroxypropyl cellulose to form the film. The patent discloses at column 2, lines 27-31, that the formation of the film is specific to hydroxypropyl cellulose and that closely related alkyl or hydroxyalkyl substituted cellulose compounds such as methyl cellulose or hydroxyethyl cellulose are not suitable substitutes for hydroxypropyl cellulose.
SUMMARY OF THE INVENTION
According to the present invention there is provided a method for rapid symptomatic relief of the discomfort associated with lesions of the oral mucosa which method comprises the topical application of a storage stable gel containing an anesthetic compound, an astringent such as tannic acid, a kerolytic compound such as salicylic acid contained in a volatile liquid vehicle such as ethanol and at least 8% by weight of an ethyl cellulose gelling agent, wherein the gel once applied to the oral mucosa, forms upon evaporation of the solvent, an adherent protective film bandage on the afflicted area. The gels of the present invention form an adherent, protective film on the oral mucosa without reliance on chemical reaction as is required with liquid compositions based on hydroxypropyl cellulose.
The oral film bandage formed on lesions in the oral mucosa using the topically applied gel of the present invention exhibits long-lasting adhesion to the oral mucosa, is resistant to removal by saliva flow in the mouth and protects the affected mucosa from worsening of the lesion due to irritation.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Ethyl cellulose is known to the art and more fully described in the "Encyclopedia of Polymer Science and Engineering", John Wiley, 2 nd ed. 1985, Vol. 3, p. 254, ff. Ethyl cellulose is soluble in ethanol at a degree of substitution (D. S.) in the range of 2.3 to 2.6.
The amount of ethyl cellulose present in the gel product used in the method of the present invention is from about 8 to about 12% by weight. Concentrations greater than 12% by weight may be used, but such higher concentrations did not materially add to the functionality and stability of the gel product. As will hereinafter be demonstrated, it is critical to the practice of the present invention that the concentration of ethyl cellulose incorporated in the gel formation be at least 8% by weight as such minimum concentration is necessary for satisfactory storage stability of the gel.
Ethyl alcohol is the preferred vehicle for the gel ingredients and preferred amounts range from about 50 to about 60% by weight. Other vehicle materials include purified water in amounts of about 5 to about 10% by and propylene glycol in amounts of about 2 to about 5% by weight.
Benzocaine or benzocaine hydrochloride in amounts of about 10 to about 20% by weight is the preferred anesthetic compound although lidocaine or lidocaine hydrochloride may be substituted for benzocaine or benzocaine hydrochloride. Tannic acid is the preferred astringent compound and is present in the gel formulation at a concentration of about 1 to about 5% by weight. Salicylic acid is the preferred keratolytic agent and is present in the gel formulation at a concentration of about 1 to about 5% by weight.
The gel formulation may also contain pharmaceutically inactive ingredients as for example, a sweetener such as sodium saccharin (0.1-1% by weight) and a flavorant (0.1-1% by weight) such as mint and menthol flavors.
The gel compositions of the present invention are easy to package in conventional containers and as will hereinafter be demonstrated have good stability upon long term storage at ambient and elevated temperatures. Containers known to the pharmaceutical and cosmetic arts as being suitable for the storage and convenient dispensing of gels for topical use may be used to package the gel of the present invention, tubes being preferred as the gel of the present invention is in extrudable form. In tubes, the gel composition of the present invention may be easily transported in an individual's pocket, purse or carrying bag and small quantities may be effectively dispensed for use with little waste and discomfort due to spillage. The gel composition of the present invention is also of pleasant appearance, odor and consistency, all of which promotes and enhances the patient's desire to use the gel composition as needed to relieve pain and discomfort of lesions in the oral mucosa.
The gels of the present invention may be prepared by any conventional process known in the pharmaceutical and cosmetic arts. In accordance with a preferred procedure, a sweetener is dissolved in water to prepare a first phase. A second phase is prepared by mixing antiseptic, flavorant, kerolytic and astringent compounds with alcohol. The first and second phases are then mixed together until a homogenous gel is obtained, all process steps being performed at ambient room temperature (20°-25° C.).
The following example provides a detailed illustration of a gel composition according to the present invention as well as a method of producing the same.
EXAMPLE
A gel formulation adapted for topical application to the oral mucosa to form an oral bandage film to protect lesions formed from further irritation was prepared having the following ingredients:
______________________________________Ingredients Weight %______________________________________Purified water 6.0Saccharin sodium 0.3Ethyl alcohol (95%) 57.2Benzocaine 15.0Propylene glycol 3.0Tannic acid, USP 7.0Salicylic acid USP 3.0Mint flavor 0.5Ethyl cellulose 8.0______________________________________
The following procedure was used to prepare the gel formulation:
Fifteen (15) kilograms (kg) of purified water was transferred at 23° C. into a 10 gallon capacity stainless steel kettle equipped with a high speed mixing device. Sodium saccharin USP (0.9 kg) was added to the water and agitation was continued for 15 minutes to assure that the saccharin was dissolved in the water.
Ethyl alcohol 95%, USP (171.6 kg) was transferred into a steam jacketed tank and the temperature maintained at 20°-25° C. Benzocaine (45.0 kg) was added to the ethyl alcohol and then agitated for 10 minutes to insure that the benzocaine was dissolved in the ethyl alcohol. The following ingredients were added to the ethanol solution in the order given and agitation continued for a sufficient time (5-10 minutes) to insure that each ingredient was completely dissolved before adding the next.
Propylene Glycol USP (9.0 kg)
Tannic Acid, USP (21.0 kg)
Salicylic Acid (9.0 kg)
Cool Frost Flavor (1.5 kg)
Ethyl cellulose (24.0 kg)
After complete dissolution of the ingredients added to the steam jacketed tank was achieved, the aqueous saccharin solution from the stainless steel kettle was then added to the ingredients in the steam jacketed tank and the ingredients agitated until complete dissolution was obtained. The resultant composition was a clear amber colored gel having an antiseptic medicinal color and an antiseptic mint taste, a pH of 3.4-3.9 and a specific gravity of 0.8812-0.9740.
For purpose of comparison when the procedure of the Example was repeated except hydroxypropyl methyl cellulose (5.0%) was substituted for ethyl cellulose, the hydroxypropyl methyl cellulose product did not form a homogeneous gel.
The gel composition of the Example was tested for storage stability using an accelerated aging test wherein plastic tubes filled with the gel were maintained at 105° F. for 4 weeks. The results are recorded in the Table below.
For purposes of further comparison, the procedure of the Example was repeated, except that lower concentrations of ethyl cellulose, i.e., 2.5% and 5.0% by weight were used to prepare the gel. The results of these comparative aging tests are also recorded in the Table below.
______________________________________Ethyl Cellulose Aging Period AppearanceConcentration in Gel (Wt. %) Weeks @ 105° F.) of Aged Gel______________________________________5.0 4 Very thin gel8.0 4 Thick gel______________________________________
It was determined that the gel composition of the Example when topically applied with a cotton swab to the inner lip of human subjects promptly formed a coherent film that was strongly adherent to the mucosa and had an opaque, continuous and occlusive appearance.
To determine the acceptability of the gel of the Example to consumers, sixty-four dentists and oral hygienists at a professional dental meeting were asked to compare the physical properties of the gel product prepared in accordance with the procedure disclosed in the Example against a comparative gel which had been prepared in accordance with the procedure of the Example, except 2.5% hydroxypropyl cellulose was used to prepare the gel instead of ethyl cellulose. The gel prepared in accordance with the Example was preferred by a predominate number of the test participants, that is, 47 of the 64 dental professionals who participated in the evaluation preferred the ethyl cellulose formulated gel product over the hydroxypropyl cellulose formulated gel.
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A method of administering an oral bandage to lesions in the oral mucosa is disclosed wherein there is prepared a storage stable topical gel formulation adapted to form an oral bandage adherent to the oral mucosa when applied thereto, the gel containing at least one anesthetic compound, a keratolytic compound, an astringent compound and an ethyl cellulose gelling agent in an amount of at least about 8% by weight and then applying the gel to the area of the oral mucosa experiencing irritation to form an adherent oral bandage.
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CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of International Application No. PCT/GB01/01775, filed Apr. 19, 2001, which was published in the English language on Oct. 25, 2001 as International Publication No. WO 01/78794 A3 and the disclosure of which is incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to air care products and, in particular, to products which are capable of diffusing perfume or deodorizing components into the surrounding air.
[0003] The use of various devices for the diffusion of volatile compounds, for example perfumes, deodorizing compositions, insect repellents, and the like, into the atmosphere has become increasingly popular in recent years. For example, air-freshening devices or deodorizers are currently used in practically all households to mask bad odors, or to impart fragrances to the ambient air. Various different types of devices are known for the diffusion of volatile compounds into the surroundings. For example, devices of the spray type, such as aerosol sprays, may be used to dispense a liquid composition into the ambient air. Other devices comprise housings enclosing the active ingredients in liquid form. Typically, the diffusion of the active ingredients takes place through membranes permeable to the vapors of said ingredient, or through a wick which is placed in a reservoir containing the ingredients.
[0004] Solid state devices are also known which comprise solid materials or carriers impregnated with an active ingredient. Such devices may be formed of various materials which are capable of absorbing the ingredient and subsequently releasing it in a more or less controlled manner. Examples of such known materials include gels, such as agar-agar or sodium stearate gels, synthetic polymer resins, or blocks of mineral material, e.g., plaster or silica.
[0005] Solid state devices have the advantage that they are easy to handle and can be easily shaped. Typically, the solid state devices are enclosed within a housing with one or more grills which communicate with the surrounding air.
[0006] The main disadvantage with solid state devices is that the release of active ingredients from the blocks is not constant with time and drops dramatically over the lifetime of the device. Furthermore, such devices are inefficient, in that the device may cease to diffuse the active ingredient into the surrounding atmosphere when the outside of the block is spent, even though considerable amounts of the active ingredient may still reside within the core of the block. The residual active ingredient, such as perfume, is thus totally lost.
[0007] International patent application Publication WO 96/05870 discloses a device for perfuming, deodorizing or sanitizing air or enclosed spaces which comprises an anhydrous gel element. Such a device is capable of diffusing volatile substances at a relatively constant rate throughout the entire lifetime of the device and, furthermore, is capable of releasing substantially all of the volatile substance into the air or enclosed space within its effective lifetime.
[0008] The devices of WO 96/05870, although practically very useful, are unattractive since they are in the form of substantially colorless gels. However, because of the manner in which the gels are formed, it is difficult to incorporate dyes or colorants into the gels. Many dyes will not disperse within the system and result in unattractive, non-homogenous products, in which the dye is not uniformly dispersed therethrough. Neither the colorless gels of WO 96/05870 nor the non-homogenous colored gels would be attractive to the purchaser of such devices, which generally will be on display in the room or space which they are intended to perfume or deodorize.
BRIEF SUMMARY OF THE INVENTION
[0009] A colored anhydrous gel element for perfuming or deodorizing air or enclosed spaces is provided. The gel element comprises a cross-linked functionalized liquid polymer selected from the group consisting of maleinized polybutadiene, maleinized polyisoprene, and a copolymer of ethylene and maleic anhydride, wherein the functionalized liquid polymer is cross-linked with a cross-linking agent comprising at least one complementary functional group in the presence of a non-aqueous perfume or deodorizing base and at least one metal-free solvent dye, wherein the metal-free solvent dye is soluble in the non-aqueous perfume or deodorizing base or is provided as a solution in a non-aqueous solvent which is compatible with the non-aqueous perfume or deodorizing base.
[0010] A process for preparing the colored gel element as described above is also provided, which comprises cross-linking the functionalized liquid polymer with the cross-linking agent in the presence of the non-aqueous perfume or deodorizing base and at least one metal-free solvent dye.
DETAILED DESCRIPTION OF THE INVENTION
[0011] It has been found that homogenous, colored anhydrous gels can be prepared from the components as disclosed in WO 96/05870 if a very careful selection is made of the dyes for incorporation therein.
[0012] By the term “functionalized liquid polymer” as used herein is meant a material which is liquid at room temperature and which has a viscosity of not more than about 5 Pas at 25° C., preferably about 0.25 to about 1.0 Pas.
[0013] The functionalized liquid polymer which is used in the present invention is preferably a maleinized polybutadiene having a number average molecular weight of about 5,000 to about 20,000 or a maleinized polyisoprene having a number average molecular weight of about 200,000 to about 500,000. Examples of these materials are given in European published patent application EP-A-0023084. These materials are commercially available from Revertex Limited as Lithene™. Among the different grades of Lithene™ which are available, particularly good results have been obtained using Lithene™ N4-9000 10MA, in which 9000 represents the molecular weight of the polybutadiene before maleinization and 10MA indicates the degree of maleinization (in this case, 10 parts of maleic anhydride per 100 parts of polybutadiene, i.e., about 9.1%). Lithene™ N4-B-10MA and Lithene™ N4-5000-10MA are also particularly useful.
[0014] Alternatively, the liquid polymer may comprise a copolymer of ethylene and maleic anhydride, for example.
[0015] Examples of cross-linking agents which may be used in forming the anhydrous gels are as follows:
[0016] alkylpropyldiamines having an ethoxylated or propoxylated higher aliphatic chain such as the products commercially available from Croda Chemicals Limited as Dicrodamet™;
[0017] ethoxylated or propoxylated primary fatty amines available as Crodamet™, for example Crodamet™ 02 (oleylamine having 2 ethylene oxide units per molecule);
[0018] polyoxyalkylenediamines such as those commercially available from Huntsman Corporation as Jeffamine™, in particular the D and ED series, for example Jeffamine™ D-400, Jeffamine™ EDR-148, and Jeffamine™ D-2000; and
[0019] polyoxyalkylenetriamines such as those commercially available from Huntsman Corporation as Jeffamine™, in particular the T series, for example Jeffamine™ T-403.
[0020] It is also possible to use as the cross-linking agent polybutadiene having a hydroxylic functionality known as HFPB (commercially available from Revertex Limited), which gellifies when admixed with maleinized polybutadiene. Sometimes, the use of specific catalysts allows a better control of the gel formation. Examples of such catalysts are tertiary amines (e.g., DAMA 1010, commercially available from Albermarle SA). Mixtures of Hycar CTBN 1300×21, which is an amine-terminated liquid polybutadiene/acrylonitrile copolymer commercially available from B. F. Goodrich, and maleinized polybutadiene are particularly advantageous.
[0021] The functionalized liquid polymer and the cross-linking agent are mixed in a molar ratio of about 3:1 to about 5:1, preferably about 1: 1, based on the molar ratio of the functional groups which are present.
[0022] The perfume base which is used in the device of the invention may comprise any of the current bases used in perfumery. These can be discrete chemicals, but more often are more or less complex mixtures of volatile liquid ingredients of natural or synthetic origin. The nature of these ingredients can be found in specialized books of perfumery, e.g., in S. Arctander, Perfume and Flavor Chemicals, Montclair N.J., USA (1969) or Perfumery, Wiley-Intersciences, New York, USA (1994).
[0023] The perfume base may be replaced by a deodorizing base, such as a base which comprises a deodorizing composition.
[0024] The characteristic feature of all the compositions of the present invention is that the liquid polymer, cross-linking agent, and dye which are used in the preparation of the gellified composition are all soluble in the perfume or deodorizing base. Optionally, one or more of the liquid polymer, cross-linking agent or dye may be dissolved in a solvent which is compatible with the perfume or deodorizing base, but generally this is not necessary since the components will dissolve in the active base.
[0025] The perfume or deodorizing base is non-aqueous and will generally constitute about 50 to about 95% by weight, preferably about 60 to about 90% by weight, more preferably about 70 to about 85% by weight of the gel element.
[0026] Optional additives which may be included in the gel composition include plasticizers, such as diethylphthalate.
[0027] Examples of suitable classes of dyes which may be used in the present invention are monoazo dyes, diazo dyes, anthraquinone dyes and methine dyes, provided that the dyes are metal-free solvent dyes. Specific examples of dyes which may be successfully used in the present invention are:
Chemical Characterization Trademark (Manufacturer) C.I. Solvent Red 27 Fat Red 5B-02 (Clariant) C.I. Solvent Red 111 Sandoplast Red PFS (Clariant) C.I. Solvent Yellow 14 Fat Orange R-01 (Clariant) C.I. Solvent Yellow 93 Sandoplast Yellow 3G (Clariant) C.I. Solvent Violet 13 Iragon Violet SV113 (Ciba) C.I. Solvent Violet 37 Sandoplast Violet FBLP (Clariant) C.I. Solvent Green 3 Iragon Green SGR3 (Ciba) C.I. Solvent Green 28 Sandoplast Green G (Clariant) C.I. Solvent Blue 104 Sandoplast Blue 2B (Clariant)
[0028] Dyes such as those listed above are generally available in powder form. Accordingly, in order to be useful in the present invention, the dye is generally soluble in the perfume or deodorizing base. However, it may be possible to use some dyes which are either not soluble in or insufficiently soluble in the base by using the dye as a concentrated solution in a non-aqueous solvent which is compatible with the base.
[0029] Generally, a relatively small amount of dye will be sufficient to color the anhydrous gel. For example, amounts of about 0.01 to about 1.0% by weight, typically about 0.05% by weight based on the gel element, may be used.
[0030] Many dyes cannot be used in the present invention. Examples of such dyes which are either not metal-free solvent dyes and/or are not soluble in the perfume or deodorizing base, are given below:
Chemical Characterization Trademark (Manufacturer) C.I. Solvent Orange 63 Hostalsol Red GG (Clariant) C.I. Solvent Red 179 Sandoplast Red 2GP (Clariant) C.I. Solvent Red 89 Savinyl Fire Red GLSP (Clariant) C.I. Solvent Red 91 Savinyl Red 3BLS P (Clariant) C.I. Solvent Red 127 Savinyl Pink 6BLS P (Clariant)
[0031] The anhydrous gel element of the present invention may be used as the active element of a solid state air freshening or deodorizing device, with the gel element being incorporated within a housing with one or more grills which communicate with the ambient air.
[0032] Alternatively, the gel element may be formed in situ within the recesses or grooves of a solid casing or housing. This type of device does not require the use of a grill to cover the gel element. The recesses or grooves of the solid casing or housing are filled with the mixture of functionalized liquid polymer, cross-linking agent, perfume or deodorizing base, and dye, and the cross-linking reaction to form the gel takes place in situ. The gel so-formed thus adheres to the sides and/or bottom of the recesses or grooves in order to provide an integral structure.
[0033] The present invention will be further described with reference to the following specific, non-limiting Examples.
EXAMPLE 1
[0034] To a vessel containing 63.975 g of a perfume base (Lavandair 150.120D, commercially available from Firmenich S A, Geneva, Switzerland) was added 0.025 g of dye (Iragon Violet SVI13; commercially available from Ciba Speciality Chemicals, Switzerland) with stirring. 17.0 g of Lithene™ N4-B-10MA was then added manually and mixed. In another vessel 16.0 g of the perfume base (Lavender 150.120D) and 3.0 g of Jeffamine™ D-400 were mixed and then added to the original vessel with stirring. After about 5 minutes at room temperature, a purple gel resulted, encapsulating the perfume base. Gel setting was complete in about 20 minutes.
EXAMPLE 2
[0035] To a vessel containing 63.91 g of perfume base (Solar Splash 150.555; commercially available from Firmenich S A, Geneva, Switzerland) was added 0.09 g of dye (Sanoplast Yellow 3G; commercially available from Clariant UK Ltd, United Kingdom) with stirring. 17.0 g of Lithene™ N4-B-10MA was then added manually and mixed. In another vessel 16.0 g of the perfume base (Solar Splash 150.555), 1.12 g of Jeffamine™ EDR-148 and 1.88 g of diethyl phthalate were mixed and then added to the original vessel with stirring. After about 5 minutes at room temperature, a yellow gel resulted, encapsulating the perfume base. Gel setting was complete in about 20 minutes.
EXAMPLE 3
[0036] To a vessel containing 63.97 g of a perfume base (Summer Fruits 150.535; commercially available from Firmenich SA, Geneva, Switzerland) was added 0.03 g of dye (Fat Red 5B02; commercially available from Clariant UK Ltd, United Kingdom) with stirring. 17.0 g of Lithene™ N4-B-10MA was then added manually and mixed. In another vessel 16.0 g of the perfume base (Summer Fruits 15.535), 2.40 g of Jeffamine™ D-400, 0.22 g of Jeffamine™ EDR0148 and 0.38 g of diethyl phthalate were mixed and then added to the original vessel with stirring. After about 5 minutes at room temperature, a deep red gel resulted, encapsulating the perfume base. Gel setting was complete in about 20 minutes.
EXAMPLE 4
[0037] To a vessel containing 63.98 g of a perfume base (Nile Blossom 438.910; commercially available from Firmenich S A, Geneva. Switzerland) was added 0.02 g of dye (Iragon Green; commercially available from Ciba Speciality Chemicals, Switzerland) with stirring. 17.0 g of Lithene™ N4-B-10MA was then added manually and mixed. In another vessel 16.0 g of the perfume base (Nile Blossom 438.910), 2.40 g of Jeffamine™ D-400, 0.22 g of Jeffamine™ EDR-148 and 0.38 g of diethyl phthalate were mixed and then added to the original vessel with stirring. After about 5 minutes at room temperature, a blue/green gel resulted, encapsulating the perfume base. Gel setting was complete in about 20 minutes.
EXAMPLE 5 (COMPARATIVE)
[0038] To a vessel containing 63.97 g of a perfume base (Summer Fruits 150.535; commercially available from Firmenich S A, Geneva, Switzerland) was added 0.03 g of dye (Savinyl Fire Red GLSP; commercially available from Clariant UK Ltd, United Kingdom) with stirring. 170 g of Lithene™ N4-B-10MA was then added manually and mixed. In another vessel 16.0 g of the perfume base Summer Fruits 150.535), 240 g of Jeffamine™ D-400, 0.22 g of Jeffamine™ EDR-148 and 0.38 g of diethyl phthalate were mixed and then added to the original vessel with stirring. After about 5 minutes at room temperature, a gel resulted, but the color was not homogeneously distributed throughout, resulting in an unattractive aspect. Gel setting was complete in about 20 minutes.
EXAMPLE 6
[0039] To a vessel containing 3.998 g of a perfume base (Lavandair 150.120D; commercially available from Firmenich S A, Geneva, Switzerland) was added 0.00156 g of dye (Iragon Violet SVI13; commercially available from Ciba Speciality Chemicals, Switzerland) with stirring. 1.0625 g of Lithene N4-B-10MA was then added manually and mixed. In another vessel 1.0 g of the perfume base (Lavandair 150.120D) and 0.1875 g of Jeffamine™ D-400 were mixed and then added to the original vessel with stirring. Once a homogeneous mix was attained, the mixture was added to a suitable decorative device containing grooves which the liquid mix could run through. After about 5 minutes at room temperature, a purple gel, in the shape of the device, resulted, encapsulating the perfume base. Gel setting was complete in about 20 minutes.
[0040] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
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A colored anhydrous gel element for perfuming or deodorizing air or enclosed spaces is provided. The element is formed by cross-linking a functionalized liquid polymer selected from maleinized polybutadiene, maleinized polyisoprene or a copolymer of ethylene and maleic anhydride with a cross-linking agent which contains at least one complementary functional group in the presence of a non-aqueous perfume or deodorizing base and a least one metal-free solvent dye which is soluble in the non-aqueous perfume or deodorizing base, or which is provided as a solution in a non-aqueous solvent which is compatible with the non-aqueous perfume or deodorizing base. The gel elements may be incorporated into devices which are used as air fresheners or deodorizers.
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[0001] This invention is related to balanced feed for breeding bovines and, especially feed for breeding bovine neonates and the necessary process for applying it to newborn animals in order to provide them with a feed specifically prepared for highly accelerating the optimum development of the rumen; thus allowing neonates to be weaned on the second or third week of life, and providing an excellent animal growth under optimum sanitary conditions.
[0002] An additional purpose of this invention comprises the optimization of available resources for breeding, due to the fact that providing bovine neonates with this kind of feed, the management of breeding animals is remarkably simplified and cost effective by reducing cost and labor expenses of milk and/or milk substitutes.
[0003] Therefore, the purpose of this invention is obtaining a feed scientifically prepared for highlighting and taking advantage of the natural physiological conditions of bovine neonates during their digestive evolution from monogastric and milk-fed animals—pre-ruminant phase—to polygastric animals which depend only on dry feed intakes—ruminant phase. Bovine neonates needed a 4-month period to completely achieve this transformation. Through the feed and system of the invention, this takes approximately 14 days.
[0004] In the prior art detailed below there are several works developed and related to the present invention, among which we can mention the following United States patents:
[0005] U.S. Pat. No. 6,156,333 refers to “Pre-ruminant Invigorating and Stimulating Feed and its Use” and contains a dry formula based on 50 to 75% of proteins: 10 to 50% of animal plasma, 2.5 to 10% of micronutrients selected among a large number of minerals such as Co, Cu, I, etc. and, organic elements such as niacin, d-pantothenic acid, riboflavin, etc., several vitamins in well-determined quantities, not less than 2.5% of electrolytes selected from the salt group of Na, Mg, K, Ca and their combinations, not less than 2% of alicine, 2% of fructooligosaccharides and approximately 1% of microbes selected from a group composed of coagulans, licheniformis, subtilis, bifidobacteria bifidum, lactobacillus, acidophilus, casei, dairy, streptococcus diacetylactis and their mixtures. Percentages above are stated in weight.
[0006] The above mentioned patent is an extension of U.S. Pat. No. 5,795,990 which comprises the same formula and preparation method. It consists on providing the required quantity of water for dissolution.
[0007] U.S. Pat. No. 5,372,811 is a feed supplement for animals which contains a co-spray of dried-protein plasma and amylase.
[0008] U.S. Pat. No. 4,919,935 is a “Feed” supplemented with a carrier containing bacillus subtilis C-3102, organism deposited in the Institute of Fermentative Research, Department of Industrial and Technological Sciences of Japan.
[0009] Taking into account the above mentioned patents, it is obvious not only that their formulas do not interfere with that of this invention, but also that they comprise a complex and expensive formulation.
[0010] On the other hand, several kinds of domestic animal feed can be found in the marketplace and their formulas have similar features. However, they are different to the one comprised in this invention, and especially they have a different application. The following Argentine patents are examples thereof:
[0011] U.S. Pat. No. 244,954 is referred to “Animal Balanced Feed” providing a great protein, vitamin and mineral contribution that can be easily digested. It is composed of hydrolyzed feathers, fish silage, a vegetable load of bran and vegetable meal.
[0012] U.S. Pat. No. 240,863, “Feeding Mineral Mixture for Ruminants” is used for ruminants at pasture. It includes macro and micro-elements. Its purpose is to obtain cattle productive profitability by optimizing forage intakes so as to gain weight with less quantities of forage. It comprises milled minerals added in certain quantities.
[0013] Basically, all formulas found in the prior art refer to formulas for feeding animals either at home or at farms, or for improving weight gain. Those stated for pre-ruminants are based on chemical organic or mineral elements or milk substitutes which are added to diets in order to accelerate their development. However, these products generally cause delays that slow down animals' growth since natural factors have not been considered, as stated below. These problems are solved with this invention.
[0014] Therefore, in order to take advantages from this invention, feed for breeding and a process for its use described below, the product is composed of 94 to 88% of dry matter, 20 to 30% of protein, 6 to 10% of fat, 3 to 6% of fiber, 5 to 7% of ashes, 1.2 to 1.4% of Ca and 0.8 to 1.2 of P. The product's digestibility reaches 93% providing metabolizable energy of 4,200 calories. The process for using this feed comprises a daily milk diet, its later interruption, the gradual introduction of this feed and baled fiber contribution. This combination will be defined in a consumption table described below.
[0015] For the purpose of providing a better understanding of this invention comprising feed for bovine neonates breeding and its use, so as to implement an easy feeding program, the following paragraphs include an accurate description of all the chemical and anatomic-biological features of calves growth from the womb to the ruminant phase upon which this invention is based. The invention also comprises a method in which several known factors intervene and result in the novelty disclosed herein by the inventors, stated as an example but not limiting the invention; its components can be selected among other equivalents following the principles of the invention.
[0016] Physiology and nutrition of nursing calves. Despite the fact that newborn calves are bound to become ruminants, with a four-compartment stomach that facilitates fiber digestion, they have not yet developed this ability, as it is known by those skilled in the art, and supported by accurate scientific researches carried out by the inventors. Therefore, the abomasum or true stomach that they have in this phase is the only stomach compartment with functional capacity. In order to fulfill that anatomic requirement, newborn calves have a structure made of rumen and reticulum tissues, called esophageal groove which, upon the nerve stimuli originated by sucking and the flow of liquids or chemicals (copper) through the esophagus, produce a partial contraction forming a tube that enables the flow of milk or milk substitutes during artificial breeding directly into the abomasum, allowing calves to digest and absorb nutrients contained in milk diets.
[0017] When milk gets into the abomasum two enzymes, called rennin and pepsin, are secreted and they curdle milk proteins (basically casein) resulting in a solid part (clot) which is retained at the abomasum, and a liquid part (whey) which still contains some proteins and all the lactose. Whey will pass to the duodenum at a rate of 300 to 400 ml/hr. for its later absorption.
[0018] Said clot contains milk fat that is partially digested by means of another enzyme called lipase. This enzyme is secreted by saliva and is included in milk diets while being swallowed. Digestion of fat in the pre-gastric phase is more efficient with milk fat than with other types of fat due to the different components of fatty acid chains. Coconut and palm oils are the most similar to milk.
[0019] The most effective enzyme that breaks down milk proteins is rennin, especially in the nearly neutral pH that exits at the abomasum immediately after milk diet intakes. The relation that exists between these two enzymes may vary among different calves.
[0020] As regards abomasum pH, while being nearly neutral before the intake, it becomes extremely acid (pH=2) after the secretion of hydrochloric acid.
[0021] Lactase is another enzyme secreted at the small intestine. It is in charge of the breakdown of lactose into beta-d-galactose and alpha-d-glucose molecules, which will be absorbed at the intestine via passive diffusion in order to be transported through the portal bloodstream to the liver taking part of glycolysis and glycogenic phenomena or both of them, according to the final destination of the carbohydrates (immediate use or energetic reserve).
[0022] The final digestion of fat and proteins in milk or milk substitutes occurs at the small intestine through the secretion of enzymes by the pancreas. Proteins are broken down into amino acids and fats into glycerol and fatty acids which will be actively or passively transported into the portal and lymphatic bloodstream as kilomicrons ending at the liver. There they will be converted into proteins and fats that will constitute kilograms of weight, or they will be used for other purposes through glycogenic processes or the formation of ketone groups.
[0023] Digestion at the small intestine will be carried out under alkaline conditions as a result of pancreatic secretion.
[0024] Therefore, it could be stated that calves maintain an acid and alkaline balance in their digestive system. Nutritional disorders or bacterial infections arising out of inadequate feeding programs and mismanagement, respectively, cause diarrhea attacks resulting not only in the dehydration of the animal but also in a loss of electrolytes, thus modifying said acid-base balance, worsening the situation and placing their lives at risk.
[0025] Rumen Development. As it was stated above, although ruminants have a four-compartment stomach (omasum, abomasum, reticulum and rumen), during their first weeks of life the abomasum is the only compartment anatomical and functionally developed (monogastric phase).
[0026] The other stomach compartments are developed by the increase of solid diets. The development and functional capacity of these compartments are directly related to the increase of dry feed intakes. This growth has two phases called pre-ruminant and ruminant.
[0027] In order to get an idea of the changes that occur in the development of these stomach compartments it could be mentioned, for instance, that the abomasum constitutes 60% of the newborn's stomach capacity and the rumen makes up only 25%. A four-month calf's abomasum makes up 20% of the stomach capacity and the rumen 60%. In mature animals, the abomasum constitutes 7% of the stomach and the rumen 80%.
[0028] The production of volatile fatty acids (VFA) from the fermentation of dry feed is responsible for rumen tissue development. Rumen development and dry feed intakes are correlated in a positive way, so that rumination starts approximately at the second week of life.
[0029] Acetic, propionic and butyric acids are essential VFAs that influence rumen development. Propionic and butyric acids are particularly important for the development of ruminal papillae, where end-products of the dry feed intake are absorbed. However, the presence of fiber helps rumen development by maintaining an optimum pH. It is known that the degree of acidity affects the type and efficiency of the papilla.
[0030] Digestion in the rumen is carried out through the fermentation of dry feed by million of bacteria and protozoa which appear naturally at birth. Ruminal bacteria and protozoa are first inoculated by the mother through liking after birth.
[0031] Size and functional development of the rumen must be balanced with the growth of other organs, hormones and enzymes that take part directly or indirectly in the digestion of dry feed and the absorption of the end-products produced.
[0032] In general, ruminants meet their glucose needs with the aid of gluconeogenesis. The main precursor is propionate. Glycogenic amino acids, especially alanine and glutamic acid, meet 25% of their needs. The rest is covered through glycerol or lactate which are used in special physical conditions.
[0033] Gluconeogenesis increases with glucose needs during pregnancy or lactation. Pancreas hormones, insulin and glucagon, control this process.
[0034] The quantity and type of rumen fermentation determine gluconeogenesis.
[0035] In the ruminant, glucose is converted into: energy, via citrate cycle.- Lactose synthesis. Fetus feed. Lipogenesis. Glycerol, citrate and amino acids synthesis.
[0036] Glucose is the fetus' principal source of energy in pregnancy and of lactose in lactation. During growth, glucose provides the basic carbon for the synthesis of non-essential amino acids. This is essential in protein synthesis and meat production. High levels of propionate in the ruminal liquid are related to a greater retention of N due to the nature of propionate, thus releasing gluconeogenesis proteins.
[0037] Carbohydrates metabolism during fetal and neonate phases: Metabolism can be divided into four phases:
[0038] 1) Fetal phase: the fetus receives glucose through the mother's bloodstream.
[0039] 2) Neonate phase (up to the 2 or 3 week): the rumen is functional and glucose is supplied by lactose.
[0040] 3) From the 3 to 12 week of life: the rumen starts to develop and less quantities of milk are supplied.
[0041] 4) Adult: the rumen is well developed with glucose supply through gluconeogenesis.
[0042] During the fetal phase, placenta converts glucose into fructose; therefore, blood has a high level of fructose and a low level of glucose.
[0043] Glucose concentration in the fetus' blood increases to 50% of the mother's. At the end of its gestation, fetus' liver synthesizes great quantities of glycogen that double the adult's concentration. This occurs due to the presence of enzymes that generate it from glucose and, eventually, fructose. Like adults, the fetus converts part of the glucose into fatty acids, preferentially acetate.
[0044] In the neonate phase, during the following two days after birth, the level of fructose in whey decreases from 60 mg to less than 5 mg/ml. Fructose is eliminated through urine since the necessary enzymes to metabolize it do not exist yet at the liver. Simultaneously, glucose levels increase from 50 to 100 mg/ml, even when the neonate is not fed. This implies glycogen synthesis which starts to flow rapidly and reaches levels of 10 mg within few hours after birth. The level in the cardiac muscle also decreases through a stimulus of the sympathetic nervous system, thus the release of adrenaline activates phosphorylase. Low level of glucose at birth may be attributed to a sympathetic stimulus.
[0045] Glucogen at the liver increases in the 3 rd week of life to levels similar to those in mature animals, 40 mg/gr. Something similar happens with the level of glucose in blood which is related to the simultaneous rumen development (McCandless and Dye; Attebery and Colvin). However, many works state that this is independent from rumen development, ration and VFA concentration and set forth that it is dependent on ontogenetic development (Steger, Lambert, et al.; Lupien, et al.).
[0046] Fetuses and neonates contain glucose both in plasma and in erythrocytes but, during the first weeks of life, erythrocyte levels decrease to the level in mature animals. One of the reasons for the decrease of glucose levels in blood is the lowest concentration of glucose in erythrocytes. This would result due to the replacement of fetal erythrocytes, rich in glucose, by adult erythrocytes which have less quantities of glucose.
[0047] Another factor contributing to the decrease of glucose levels is the reduction in milk intakes.
[0048] Within the following three months after birth, the development of the young ruminant to mature animals is related to the functional change in carbohydrates metabolism. Insulin secretion has no effects on one-day calves (Edwards, et al.). However, during the 2 and 4 weeks, the insulin level in plasma increases due to a glucose load. Later on, the capacity to secrete insulin decreases. Simultaneously, glucose level and its conversion rate decrease. This fact shows that, as the ruminant grows, the importance of glucose in the metabolism decreases (Comline and Edwards; Jarret, et al.). It is also shown by the decrease of glucose absorption capacity at the intestines in mature animals, while pre-ruminant calves can absorb it rapidly (Coombre and Smith).
[0049] The above stated shows that the enzymatic system is adaptable to feeding program changes, which passes from glucose conversion to gluconeogenesis requirements. Pentose-cycle enzyme activity, like those of glycolysis, is higher in neonates than in mature ruminants (Filsell, et al.; Howarth, et al.; Goetsch, et al.). Moreover, the activity of the enzymes that catalyses glycogen formation from glucose diminishes (Ballard and Oliver) while that of glucose-6-phosphatase and fructose-1-6-dyphosphatase, which participate in the conversion of propionate and pyruvate to glycogen, increases (Howard, et al.).
[0050] These enzymatic changes occur due to the proliferation of VFAs in the rumen, whose derivatives activate pyruvate-carboxylase stimulating the formation of glucose. At the third week of life, hepatic enzyme (citratoliase), in charge of synthesizing lipids from glucose, has nearly the same activity than that of mature animals, almost non-existent. Therefore, the enzymes which facilitate the synthesis of lipids from acetate of adipose tissue acquire greater importance.
[0051] Digestion of carbohydrates. Most of the carbohydrates are digested in the rumen but there is a variable ration that may be digested in post-ruminal areas. All soluble carbohydrates are incorporated as stored microbial polysaccharides. The optimum pH for the polysaccharides synthesis is 6 or less. Since pH diminishes after the ingesta, there is an influence in the production of polysaccharides in the rumen. Bacteria contribute more than protozoa in its formation and utilization. Protozoa contribute with the 10% of the total utilized. Although they make a better use of saccharose, they store 80% of absorbed sugar as starch and they are more important in the formation of polysaccharides. They are very sensitive to the acid environment where they are destroyed.
[0052] Bacteria that do not grow, synthesize more starch than those that grow. The growth is limited to the presence of available N. Starch ferments in the rumen more slowly than in monogastrics, it increases ten times the glucose level in the ruminal liquid what leads to a greater poiysaccharides synthesis. In its degradation, pH drops and the proportion of propionate increases. Protozoa have a very important function since they may absorb large amounts of starch quickly and thus prevent starch from the bacterial attack. Due to pH reduction, soluble starch rations cause the extinction of protozoa eliminating their beneficial effect.
[0053] The digestion of carbohydrates at the small intestine needs the enzymes provided by the organism. In the first weeks of life, calves that are mainly milk fed have a high lactase activity, low maltase and amylase activity and practically a non-existent saccharase activity. Therefore, lactose is easily digested, maltase and starch are not so easily digested and saccharose is indigestible. Enzymes supplied by the organism determine the digestion of carbohydrates in a young animal. In pancreas, the maltase activity remains constant and the amylase activity increases considerably due to the starch increase. This implies constant changes in animal diets.
[0054] Most starch coming from the rumen is broken down at the small intestine and is partially completed at the large intestine (caecum and colon) In tests done, 72% of the starch at the small intestine and 28% at the large intestine disappeared (Warson, Table 34). This reveals a limited capacity of digestion at the small intestine. It has been tested (Huber, et al.) that, both in calves and mature animals, the utilization of lactose is higher than the one of non-treated starch. Besides, it has been verified in experiences with calves (Huber, et al., Natrajan, et al.) that the starch fermented in the rumen is more digestible than forage gross content, motivated by the presence of microbial polysaccharides or by the rumen partial degradation. During two months, they have checked calves adaptation to bigger starch intakes due to higher digestibility. This brings as a result a higher sugar concentration in blood and a better development of pancreas tissue that is in charge of secreting amylase.
[0055] Mayer and Orskov provided information about the troublesome digestion of starch at the intestine. They tested that the starch infusions between 15-27 gr./kg of PV 0.75 the carbohydrates fractions that disappeared in the ileum were the following (sic): glucose with alpha bonds 58%, glucose 92% and oligosaccharides 69%. From this, it is inferred that the maltase digestion of oligosaccharides would restrict the digestion of starch at the intestine. The same authors have also tested that the intestinal tract presents glucose absorption limitations, and in sheep exceeding 400 gr/dose there appears glucose in feces.
[0056] The optimum pH values in the intestine for the amylase range from 6.2 to 6.9 and from 6.8 to 7 for the maltase. In rations with high amounts of non-degradable starches in rumen, their fermentation in the large intestine should be considered; in this case, the caecum is functionally comparable to the rumen. The problems that arise are that part of the generated VFAs are lost in the feces and that bacterial protein produced cannot be digested, consequently N is also lost.
[0057] Nutritional characteristics of milk and milk substitutes: Milk substitutes that contain powdered whole or skim milk form clots of smaller size, but in larger amounts. The problem that may arise with these products is that during the process of dehydration, high temperatures are needed producing some denaturalization of milk proteins and resulting in a poor clot formation milk. The same occurs with milk substitutes that contain whey proteins and add protein supplements that come from soybean and fish proteins or from any other source. These milk substitutes do not form clots. Since these substitutes may achieve good results in calf breeding, it is necessary to admit that these animals can adapt themselves to a milk diet that fails to clot.
[0058] However, it is useful to state that these animals depend mostly on the quality of the protein supplements used, and a better management will be required during their breeding.
[0059] The use of low-quality protein supplements in milk substitutes may produce lack of digestibility of protein fractions and even of starch at the abomasum and intestine causing diarrhea crisis as a result of the presence of protein fractions in the intestinal lumen causing coloidosmotic and osmotic pressures that may bring water to the intestinal lumen.
[0060] The presence of protein fractions that induce inflammatory processes of allergenic origin at the abomasum and small intestine causes assimilation crisis or electrolyte loss resulting from damages to the abdominal and intestinal mucosa. This will cause an increase in the water flow to the intestinal lumen in order to balance osmotic pressures generating an increase in the volume of liquid at the intestine, what will cause a diarrheic process. What is much more serious is the loss of functional tissue in the abdominal and intestinal mucosa that affects the breakdown of nutrients in the future.
[0061] Anyway, and as a consequence of the increased use of milk substitutes, with productive results different from those obtained by the use of milk but, undoubtedly, quite satisfactory, it could be stated the great capacity that calves have in order to adapt to important quantity and quality variations of nutritional components of their milk diets. What has been stated before clearly explains the higher rates of morbidity and mortality on the first two weeks of breeding milk substitute-fed calves in comparison to liquid milk-fed calves. These problems are generally reduced by the use of diverse combinations of antibiotics in the different milk substitutes formulas.
[0062] The quality and quantity variations of milk substitutes nutritional components refer to the quantity of dairy components in their formulas, the type of dairy components (whey, whey protein concentrates, whole or skim milk), the nutritious quality of non-dairy components (soybean isolated proteins, soybean protein concentrates, micronized soybeans, wheat proteins, fish proteins) and the failure to generate inflammatory processes of allergic type in the calf digestive tract or causing complexes that unable the digestion of some dietary digestive structures.
[0063] Types of calf breeding and its management. There are some systems that separate female or male calves from their mother in order to get a cost-effective result and not to alter milk routines and/or cow management after birth.
[0064] The most common breeding method used in most dairy production countries is to breed calves away from their mothers. These methods are the following:
[0065] a) Individual:
[0066] 1) in stalls,
[0067] 2) in pens.
[0068] b) Collective:
[0069] I) with a nurse cow, in groups.
[0070] II) with milk or milk substitutes, in groups.
[0071] Each method has advantages and disadvantages. The main advantage in individual methods is the possibility of breeding calves in an independent way. Therefore, it allows to control the progress in intakes as well as the isolation of sick animals. Economics is its main disadvantage, being the stalls the most convenient method. Besides, after using this method for a long time, another important disadvantage that can be added is the great physical effort and time that breeders invest in calves moving. The latter is even more evidenced in those farms where more than 100 calves are bred.
[0072] Collective breeding methods are practically not used now except for countries such as New Zealand and Uruguay because their main advantage is their low cost but it is impossible to control dry and/or liquid feed intakes, there is little sanitary control over calves and the spread of diseases is more possible.
[0073] Apart from the breeding method used, calf management and a suitable breeding environment are extremely important.
[0074] With regard to calf management, it is essential to understand that it is necessary to control some external factors that produce a great number of nervous reactions in calves. Therefore, it is necessary to control some factors such as the intake timing, order and temperature.
[0075] Considering the environment, since calves are born with an immature thermo-regulating system, they are not able to control internal temperature; therefore, it is very important to provide shelters in order to avoid calves' exposition to extremely low and high temperatures.
[0076] It is also necessary to say that calves are born with a non-developed immunomodulatory system. Therefore, antibodies should be administered via colostrum. The mother's antibodies are big-sized macromolecules that can only get through the small intestine within the first 18 hours after birth. After this, the intercellular spaces of the intestinal mucosa start to close and the passage of antibodies is impossible.
[0077] Feeding. It is composed by the following:
Milk Diet and Solid Diet
[0078] The milk diet is based on milk or milk substitutes (dairy substitutes for mother's milk, generally composed of powder feed to be dissolved in water). Two daily intakes are normally administered with an 8-hour interval.
[0079] In nurse cow systems or in some collective systems it is not possible to control the amount of milk diet consumed by the animal, so the intake of important amounts of dry feed is delayed, and, therefore, calf rumen development is delayed and weaning problems may arise.
[0080] It is essential to follow quite strict management rules: 1) a fixed feeding order and timing should be followed since reflexes affect the esophageal groove and this allows the feed to get into the abomasum for its digestion. 2) feed temperature must be of 38-40°, within this range dietary fatty acids are better soluble, therefore, animals can easily digest them; if not, cases of bad digestion and absorption of fatty acids may arise reducing the dietary energy significantly.
[0081] Milk feed is administered for 50-90 days. This varies according to the systems used.
[0082] The solid diet is composed of concentrates and fiber.
[0083] The use of liquid and solid diets in calf breeding is associated with getting a fast calf rumen development, including both a constant supply of milk feed and ad limitum dry feed, by increasing it gradually but constantly. The latter is directly related to rumen physical and functional development. It is important to state clearly that concentrates are administered for rumen histological and functional development while baled fibers are administered for rumen physical and functional development.
[0084] Since calf feeding is reduced to a constant milk diet from the fifteenth day after birth, calves weight gain rate is directly related to the nutritional quality of concentrates as well as to the intake capacity that calves may develop.
[0085] Calves reach daily intake rates of 1 kg. on the 30 th day after birth with a good concentrate. It is important to mention that the dry feed intake amount depends on another component that is the animal, in this case the intake rate is related to calves' metabolic size. Moreover, weight gains while breeding are always higher in calves weightier at birth, what is always related to a higher concentrate intake rate per animal.
[0086] Having been fed properly and taking into account each of the items mentioned before related to feeding, calves can only be weaned on average on the 60 th day after birth.
DESCRIPTION
[0087] Physiological Bases for Weaning Calves by the 14 th day After Birth With the Formulation of the Invention.
[0088] According to what has been said, newborn calves have an enzymatic activity related to an immature digestive capacity, very high lactase activity, low amylase and muitase activities and non-existent disaccharidase activity. Therefore, lactose is easily digested, amylase and starch are not so easily digested and saccharose is indigestible.
[0089] As a result, it is clear that enzymes supply in newborn calves determines the digestion of carbohydrates. At the pancreas, maltase activity remains constant and amylase activity increases considerably in comparison with the gradual increase of starch intakes by calves, becoming constant around the one hundredth day of life. It has also been proved that the enzymes activities are totally dependent on the ingesta, having a great adaptability to dietary changes.
[0090] Most rumen carbohydrates are absorbed at the small intestine, 72%; only a small amount is digested at the large intestine, 28%.
[0091] Natrajan, et al. and Huber, et al. verified that calves' adaptability to higher starch intakes was possible if starch digestibility was improved. This was evidenced by the presence of larger sugar rates in blood and a better pancreas development mainly due to a larger amylase secretion.
[0092] Meyes and Orskow tested three starch infusions, incompatible digestion of 92% for glucose, 58% for glucose with alpha bonds and 69% for oligosaccharides, and they also verified that maltase reduces the oligosaccharides' digestion, thus limiting the digestion of starch at the intestine.
[0093] According to this invention, the use of dry feed as the only feed for calves with a digestibility of over 92% from the 14 th day of breeding will completely allow interruption of milk supply or milk substitutes, in no way affecting further calves growth.
[0094] The use of this type of feeds provides a better ruminant digestive tract development and, after 30 days, its development is similar to the one of a 4-month calf.
[0095] Nowadays, histological, immunohistochemical and statistical research works are still being effected in order to establish accurately all the benefits that may arise from this technique, having already been detected in experimental trials but not yet systematized. The studies that are being carried out refer to the program whose results demand valuable farm and lab work. For the purposes of this paragraph, it is understood that those results may be included in this document when finished, not considering this as a non-valid data extension of this document.
[0096] The trial technical diagram uses 100 Holando-argentino calves that are fed half with the feed and procedure of this invention and the other half with a feed administered in a conventional way, aimed at using the Physical, Physiological, Chemical, Histological and Statistical monitoring system according to the principles of this invention.
[0097] The Physical Monitoring comprises the visual evaluation of calves' general status, diarrhea incidences, the measure of intakes progress, animals' weighing, the weight gain and conversion and the measure of stomach and ruminant papillae size.
[0098] The Physiological and Chemical Monitoring may allow to establish and compare the progress of the animal internal balance (homeostasis) what is tested by sexological analysis. The following will be tested: GOT-CPK-GTP- the alkaline and acid phosphates, enzymes that have a direct relation to the production of any type of cellular damage; insulin and glucagons, hormones generated by the pancreas that have a direct relation to carbohydrates; and pH measures of ruminal acidity.
[0099] The Histopathologic Monitoring will allow to measure tissue development and compare it with normal and abnormal histological evolutions as well as providing data for immunohistochemical studies.
[0100] All these studies require samples of the upper, medium and lower parts of the esophagus; front and back of the rumen; abomasum fundic glands; duodenum, plates of Peyer and jejunum of the small intestine; the ileocaecal valve of the large intestine; kidneys and left and right lobes of the liver; and pancreas. They will be performed by two stainings so as to see inflammatory responses.
[0101] The Statistical Monitoring, which will be a unique development in this country and there are not evidences of having been performed in the world, requires a detailed study of all the variables under the most strictly scientific rules.
[0102] In the ruminal microbiology, the stored samples, duly analyzed, of the 50 animals that were subjected to the study will facilitate future progress in the better development of ruminants.
[0103] Therefore, the objective of the compared researches is the following:
[0104] Test of Two Breeding Systems for 8 Weeks:
[0105] A) Traditional system with AF 80 feed and Calf Starter
[0106] B) Invented Feed
[0107] Test Diagram:
[0108] a) Newborn calves that have been with their mother between 3 and 5 days are separated.
[0109] b) When starting breeding, glutaraldehyde trial is done in order to test colostrum.
[0110] c) Earrings with an identification number are placed on them.
[0111] d) Calves weighing
[0112] e) In the Trial List entrance weight and immunitary state are registered.
[0113] f) Every seven days each calf's weight is written down on the list.
[0114] g) In case of diarrhea or any illness, write down on the list specifying earring number and treatment performed.
[0115] h) Calves should be fed at 8 a.m. and 4 p.m.
[0116] i) The order of feed intakes should be followed.
[0117] Feeding Guidelines are Scheduled in the Following Way:
[0118] For Conventionally Fed Animals:
[0119] a) Two daily intakes of AF80 substitute of 2 liters each.
[0120] b) Supply of Calf Starter from the entrance day, with the following expected daily intake:
[0121] 1. After 15 days . . . 0.500 kg
[0122] 2.After 30 days . . . 1,000 kg
[0123] 3. After 45 days . . . 1,500 kg
[0124] More than 1,500 kg calf/day should not be supplied
[0125] c) Bale supply after the 20th breeding day.
[0126] For Animals Treated with the Feed:
[0127] It will be diluted in a proportion of 9:1 at a temperature of 40° C. and it will be administered according to the following Table of Intake:
Breeding Milk diet Dry feed days Intake Procedure The Feed. Calf starter Bale 0-7 4 liters 2 + 2 200 gr./day No No 8-14 4 liters 2 + 2 400 gr./day No No 15-21 No No 800 gr./day No No 22-28 No No 1000 gr./day No Yes (at discretion) 29-35 No No 1200 gr./day No Yes (at discretion) 36-45 No No 1000 gr./day 500 gr./day Yes (at discretion) 45-56 No No No 1500 gr./day Yes (at discretion) Estimated 56 liters 30-35 15-20 15/20 Intake kg./day kg./day kg./day
[0128] Comparative trials with a necropsies diagram, serologic sampling and ruminal acidity are scheduled to be done every four days in animals fed with the Feed, and every 15 days in animals conventionally fed.
[0129] The product and the use of the invention are defined in the following paragraphs.
[0130] Centesimal Composition of the Invented Feed:
[0131] Dry matter 88/94% Protein 20/30% Fat 6/10% Fiber 3/6% Ash 5/7% Ca 1.2/1.4% P 0.8/1.2% Digestibility 93% Metabolizable energy 4,200 cal.
[0132] Use of feed for calves breeding. The implementation of this feed is very simple. The priority of this invention is the harmonic development of calves, taking into account that the daily feeding and evolution basis will depend on the early development of their polygastric digestive system, using the monogastric one as little as possible, without affecting for this reason gain weight rates.
[0133] The fundamental difference with traditional breeding systems is that after a 15-day lactation, calves will only be fed with dry feed.
Application scheme of the feeding method Breeding Milk days diet Feed Bale 6-7 4L. (2 + 2) 200-400 gr./calf/day NO 8-14 4L. (2 + 2) 400-800 gr./calf/day NO 15-21 NO 800-1200 gr./calf/day NO 21-28 NO 800-1300 gr./calf/day YES (at discretion) 28-35 NO 800-1500 gr./calf/day YES (cat discretion) 36-45 NO 1000-1600 gr./calf/day YES +500 gr (at discretion) 45-56 NO 1500 gr./calf/day CS YES (at discretion)
[0134] CS stands for calves starter, commercial balanced feed name.
[0135] Management of herd in individual breeding. The same standards used in traditional breeding systems can be applied for calves management, to wit:
[0136] 1) Calves must stand at the foot of their mother from birth to the next 48-72 hours, always bearing in mind that colostrum ingesta is fundamental in adequate amounts during the first 18 hours of life.
[0137] 2) After this, calves must enter the individual breeding system, in stalls or in pens.
[0138] 3) From the first individual breeding day, calves are fed with 4 liters of milk or milk substitutes, 2 intakes of two liters each. The invented feed will be administered according to the above table of intake, not exceeding the suggested intake amount.
[0139] 4) Milk or milk substitutes will be administered until the 14 th breeding day, as stated before.
[0140] 5) From the 15 th day, calves will always receive the Feed in the amounts stated in the table of intake.
[0141] 6) From the 22 nd breeding day, baled fiber will be administered taking into account not to affect the Feed intakes stated for this breeding stage.
[0142] 7) From the 28 th day, calves may abandon the stalls and be managed in groups. Special attention should be paid so that Feed intakes were as stated, if not, it is recommended to leave them in stalls until the 45 th day.
[0143] 8) From the 36 th day, calves will receive an extra calf starter ration of 500 gr., which should be mixed with the Feed.
[0144] 9) From the 45 th day on, the Feed supply is suspended, providing calves only with Calf Starter and bale.
[0145] 10) From the 56 th day, calves are bred following each farm schemes. The estimated intakes are as follows:
[0146] Milk/substitute: 56 liters —Feed: 30/35 kg. —C.S: 15/20 kg. —Bale: 15/20 kg.
[0147] Some recommendations for practical purposes:
[0148] a) Calves should be sheltered both in winter and in summer.
[0149] b) It is fundamental for adequate calves development to administered good colostrum.
[0150] c) Check always that the Feed intakes were the ones suggested for that stage.
[0151] d) It is possible that within the first 48 hours post weaning, calves consume 600 gr. of the Feed.
[0152] e) Feed amounts higher than indicated in the breeding table should never be administered.
[0153] f) Until the 35 th breeding day, calves should not take more than four liters of water per day.
[0154] Water should be fresh and of good quality.
[0155] Procedure:
[0156] The different components of this invention have been stated in order to explain its nature. Moreover, this description is complemented by the Feed formula in comparison with other diets conventionally used in Individual Breeding.
COMPARATIVE TABLE OF FEED FOR INDIVIDUAL CALVES BREEDING Milk Liquid Milk Substitute Balanced FEED Diet Formula per liter per liter Feed per kg. per kg. Dry matter 12% 12% 88% 92% Protein 2.8/3.4% 2.2/2.5% 18% 25% Fat 2.8/3.6% 1/2% 2% 6.6% Gross fiber 0.01% 0.03/0.09% 6% 4% Ashes 0.8% 0.9% 8% 6% Digestibility 100% 93% 72% 93% Metabolizabie 600-650 cal. 425-500 cal. 2,700 cal. 4,200 cal. energy
[0157] This comparative table evidences that the distinct feature of the Feed described in this document is its digestibility, which is similar to that of liquid diets, milk and milk substitutes, and highly superior to that of known balanced feed, thus allowing calves to be weaned on the fourteenth day of Individual Breeding.
[0158] The breeding method described in this document allows rumen development on the 30/35 days of life, similar to the one developed on 4/5-month calves. Therefore, the animal may be included in traditional productive systems (feedlot/farm) much earlier and in a more efficient way.
[0159] In this way, preferred exemplary embodiments of the invention have been described, to which those skilled in the art may introduce modifications and/or changes without departing from the spirit and scope of the invention which is only limited by the appended claims.
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The invention relates to a feed for neonates breeding producing a metabolic energy of 4200 calories and a process for using such feed.
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BACKGROUND OF THE INVENTION
[0001] This invention provides stable pharmaceutical compositions of the N-methyl-D-aspartic acid (NMDA) receptor antagonist, (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol, methods of preparing such pharmaceutical compositions and methods of treating stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases such as Alzheimer's disease, senile dementia of the Alzheimer's type, Huntington's disease, Parkinson's disease, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and an ischemic event arising from CNS surgery, open heart surgery or any procedure during which the function of the cardiovascular system is compromised, using the pharmaceutical compositions of this invention. (1S,2S)-1-(4-Hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol (hereafter referred to as the “Compound”) is a neuroprotecting agent that is useful for the treatment of stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases such as Alzheimer's disease, senile dementia of the Alzheimer's type, Huntington's disease, Parkinson's disease, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and an ischemic event arising from CNS surgery, open heart surgery or any procedure during which the function of the cardiovascular system is compromised. The Compound exhibits activity as an NMDA receptor antagonist. NMDA is an excitatory amino acid involved in excitatory neurotransmission in the central nervous system. NMDA antagonists are compounds that block the NMDA receptor by interacting with the receptor's binding site.
[0002] Antagonists of neurotransmission at NMDA receptors are useful therapeutic agents for the treatment of neurological disorders. U.S. Pat. No. 4,902,695 is directed to series of competitive NMDA antagonists useful for the treatment of neurological disorders, including epilepsy, stroke, anxiety, cerebral ischemia, muscular spasms, and neurodegenerative disorders such as Alzheimer's disease and Huntington's disease. U.S. Pat. No. 4,968,878 is directed to a second series of competitive NMDA receptor antagonists useful for the treatment of similar neurological disorders and neurodegenerative disorders. U.S. Pat. No. 5,192,751 discloses a method of treating urinary incontinence in a mammal, which comprises administering an effective amount of a competitive NMDA antagonist.
[0003] Commonly assigned U.S. Pat. No. 5,272,160 and commonly assigned U.S. Pat. No. 5,710,168 (the disclosures of which are hereby incorporated by reference) disclose the Compound and methods of using the Compound for treatment of diseases or conditions that are susceptible to treatment by blocking NMDA receptor sites, including stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and ischemic events.
[0004] Commonly assigned U.S. Pat. No. 6,008,233 (the disclosure of which is hereby incorporated by reference) discloses the methanesulfonate trihydrate of the Compound and uses thereof for treatment of the aforesaid diseases and conditions.
[0005] The Compound is preferably administered as an intravenous infusion lasting many hours. Such administration is intended to maintain a desired blood level of the compound for the duration of the therapy. Typically, therapy with the Compound is initiated in the hospital emergency room and continues for a desired time in the ICU or other critical care units.
[0006] Formulations and dosage presentations of the Compound should be designed for convenient and efficient administration and should be especially suited for the emergency setting. Degradation of the Compound in such formulations should be minimized.
SUMMARY OF THE INVENTION
[0007] This invention provides relatively stable formulations of the Compound in aqueous solutions made by reducing or removing the presence of trace metal ions in the solutions. Stability is further improved through the use of a pharmaceutically acceptable buffer. Additional stability is afforded by reducing the presence of oxygen in the formulations.
[0008] One aspect of the present invention is pharmaceutical compositions comprising a pharmaceutically effective amount of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof and water, wherein said compositions contain less than about 2 parts per million of free copper ion and less than about 2 parts per million of free iron ion.
[0009] Another aspect of the present invention is pharmaceutical compositions comprising (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof, water and a pharmaceutically acceptable chelating agent, preferably ethylenediaminetetraacetic acid, citric acid, succinic acid or tartric acid or a pharmaceutically acceptable salt thereof, at a concentration effective to chelate with trace metal ions present in said composition.
[0010] A further aspect of the present invention is pharmaceutical compositions comprising (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof in an aqueous solution, wherein the percent of the degradation product, 4-hydroxybenzaldehyde, is no more than about 0.15 percent of said composition following storage at 50° C. for 12 weeks, preferably no more than about 0.07 percent and most preferably no more than about 0.04 percent.
[0011] An additional aspect of this invention is pharmaceutical compositions comprising (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof in an aqueous solution, wherein the percent of the degradation product, 4-hydroxy-4-phenylpiperidine, is no more than about 0.2 percent of said composition following storage at 50° C. for 12 weeks, preferably no more than about 0.1 percent and most preferably no more than about 0.05 percent.
[0012] An additional aspect of this invention is methods of treating stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases such as Alzheimer's disease, senile dementia of the Alzheimer's type, Huntington's disease, Parkinson's disease, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and an ischemic event arising from CNS surgery, open heart surgery or any procedure during which the function of the cardiovascular system is compromised, in mammals, comprising administering to a mammal in need of such treatment a pharmaceutical composition of this invention.
[0013] In a preferred embodiment of the composition aspects of this invention, the compositions are substantially free of free copper ion and free iron ion.
[0014] In another preferred embodiment of the composition aspects of this invention, the compositions contains less than about 2 parts per million of any free trace metal ion, and more preferably is substantially free of any free trace metal ion.
[0015] Another preferred embodiment of the composition aspects of this invention provides that the compositions comprise a pharmaceutically acceptable buffer at a concentration effective to maintain the pH of the compositions at between about 3.8 to about 5.0 and more preferably at between about 4.0 to about 4.5. In a more preferred embodiment, the anion of the buffer is selected from acetate, citrate, tartrate, formate and lactate, most preferably lactate.
[0016] A further preferred embodiment of the composition aspects of this invention provides that the compositions are substantially free of oxygen.
[0017] In a preferred embodiment of the method of treatment aspects of this invention, the mammal is a human.
[0018] The term “chelating agent” as used herein means any compound that sequesters, forms a complex or otherwise interacts with trace metal ions such that the destabilizing effect of such metal ions to the Compound in aqueous solution is minimized. Exemplary chelating agents include ethylenediaminetetra-acedic acid (EDTA) and its salts, trans-1,2-diaminocyclohexanetetra-acedic acid (DCTA) and its salts, bis-(2-aminoethyl)ethyleneglycol-NNN′N′-tetraacetic acid (EGTA) and its salts, diethyllenetriamineepenta-acetic acid (DTPA) and its salts, tri-(2-aminoethyl)amine (tren), NNN′N′-tetra-(2-aminoethyl)ethylenediamine (penten), nitrilotriacedic acid (NTA) and its salts, 2,3-dimercapto-1-propanesulfonic acid (DMPS) and its salts, meso-2,3-dimercaptosuccinnic acid (DMSA) and its salts, hydroxyl acids such as citric, tartaric, lactic, succinic, etc. and their salts, and certain amino acids such as glycine, histidine, and glutamic acid and their salts.
[0019] The term “Degradant 1” as used herein refers to the degradation product of the Compound, 4-hydroxybenzaldehyde.
[0020] The term “Degradant 2” as used herein refers to the degradation product of the Compound, 4-hydroxy-4-phenylpiperidine.
[0021] The terms “free copper ion”, “free iron ion” and “free trace metal ion” as used herein means copper ions, iron ions or trace metal ions, respectively, that when present in an aqueous composition comprising the Compound are in a form or state as to enable them to cause, initiate, encourage or catalyze degradation of the Compound.
[0022] “Headspace” refers to the difference in volume between a closed container (e.g., a vial) and the volume of liquid contained in that container. The headspace can be quantified as a percent of the total volume of the closed container.
[0023] The expression “means to remove trace metal ions” as used herein means any means that may be used to remove trace metal ions from an aqueous solution. For example, such means can include the use of metal chelating resins or other chelating reagents that are known to those skilled in the art.
[0024] The term “non-reactive gas” as used herein means any gas that does not react or interact chemically with a pharmaceutical composition or any of its components. Such gas is preferably nitrogen, but may be argon, helium, or any other gas known by those skilled in the art for its non-reactive properties.
[0025] The expressions “percent of Degradant 1” and “percent of Degradant 2” means the percent of the applicable degradation product present in a pharmaceutical composition of the Compound in weight versus weight (w/w) terms. The percent is calculated from peak areas derived from HPLC analysis according to the formula:
Percent of Degradant=[( A SAMP ×D SAMP )/( R AVG ×C LAB )]×100
[0026] where:
[0027] A SAMP =impurity peak area
[0028] D SAMP =dilution factor, calculated as:
D
SAMP
=C
LAB
/C
SAMP
[0029] where:
[0030] C LAB =label concentration of the Compound in the formulation being tested (free base concentration)
[0031] C SAMP =concentration of the free base of the Compound in the sample tested (based upon dilution of the label concentration used to make the sample)
[0032] R AVG =is the average standard response factor (“R”) obtained from analysis of a standard solution, calculated as:
R=A STD /( C STD ×PF )
[0033] where:
[0034] A STD =peak area of the Compound in the standard solution
[0035] C STD =concentration of the Compound in the standard solution
[0036] PF=potency factor of the Compound in the standard solution, calculated as the molar weight of the free base of the compound divided by the molar weight of the actual compound in the standard solution.
[0037] The dilution factor, D SAMP , accounts for dilution that may be necessary so that the sample tested is within the validated concentration limits of the HPLC method.
[0038] The expression “pharmaceutically acceptable” as used herein refers to carriers, diluents, excipients, buffers and/or salts that are compatible with the other ingredients of the formulation and are not deleterious to the recipient thereof.
[0039] The term “substantially free” as used herein with respect to the presence of trace metal ions in pharmaceutical compositions comprising the Compound, means a quantity that is less than that which would have a substantial effect on degradation of the Compound in such compositions. Notwithstanding the foregoing, such an amount is less than about 2 ppm for any applicable trace metal ion. The term “substantially free” as used herein with respect to the presence of oxygen in or in contact with pharmaceutical compositions comprising the Compound, means a quantity of oxygen that is less than that which would have a substantial effect on degradation of the Compound in such compositions. For example, in compositions packaged in closed containers or vials having a headspace wherein such headspace is 25% or less of the volume of the container or vial, the term “substantially free” means that there is less than 10% oxygen in such headspace.
[0040] The term “trace metal ion” as used herein means any metal ion that, when present in an aqueous pharmaceutical composition comprising the Compound, causes, initiates, encourages or catalyzes degradation of the Compound, especially ions of transition metals and most especially iron and copper ions.
DETAILED DESCRIPTION OF THE INVENTION
[0041] The active ingredient in the present pharmaceutical compositions is (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol, which may be present as its free base or as a pharmaceutically acceptable salt, preferably the methanesulfonate (mesylate) salt. The preparation of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol is described in U.S. Pat. No. 5,272,160 and in U.S. Pat. No. 6,008,233. The preparation of the mesylate salt trihydrate is described in U.S. Pat. No. 6,008,233.
[0042] In a representative example, (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol is administered to a stroke or head trauma patient at the emergency site or in the hospital emergency room by intravenous infusion. Therapy would continue in the ICU or other critical care units. The amount of the compound to be administered would, in part, depend on the body weight of the patient.
[0043] A concentrated solution of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol that can readily be diluted according to the needs of the patient provides the required dosing flexibility. The concentrated solution would, if necessary, be diluted to the appropriate concentration for administration to the patient.
[0044] Formulations of the present pharmaceutical compositions may be in the form of concentrated solutions intended to be diluted in a suitable IV diluent prior to administration. The formulations may also be prepared as ready to use forms that are at concentrations that can be administered without further dilution. The preferred concentration of the compositions in concentrate form is 10 milligrams of the free base of the active compound, (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol, per 1 milliliter of solution (i.e., 10 mgA/mL). The preferred concentration of the ready to use forms is 1.25 mgA/mL.
[0045] The composition is administered full strength or is diluted as required. A preferred dosage concentration for administration to the patient is 0.1 mgA/mL to 10 mgA/mL. A more preferred dosage for administration is at a concentration of 0.5 mgA/mL to 2.0 mgA/mL. An even more preferred dosage concentration is 1.25 mgA/mL. The preferred IV diluent of the composition is normal saline solution (0.9% NaCl).
[0046] Two degradants produced by the chemical degradation of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol in aqueous solutions are the compounds 4-hydroxybenzaldehyde (hereafter “Degradant 1”) and 4-hydroxy-4-phenylpiperidine (hereafter “Degradant 2”). While not essential to the practice of this invention and not intending to be limited in any manner thereby, it is believed that such degradation is the result of oxidation of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol.
[0047] Trace metal ion contamination has been found to be a critical factor in the degradation of the Compound. Such effects are exemplified by spiking experiments of solutions containing the Compound with iron or copper ions. Table 1 shows the effect of iron and copper ions in unbuffered water for injection (WFI) solution on degradation product formation.
TABLE 1 Effect of Fe 2+ and Cu + spiking on degradation of the Compound. Numbers represent percent of Degradant 1 (w/w). Days at 70° C. WFI only Fe 2+ (20 ppm) Cu + (20 ppm) Day 0 0.002% 0.024% 0.085% Day 3 0.007% 0.061% 0.107% Day 7 0.009% 0.110% 0.128%
[0048] An effective means of improving the chemical stability of the Compound is achieved by removing trace metal ions from the aqueous formulation. One method of metal ion removal is by employing agents specifically designed for this purpose. Exemplary metal ion removing agents include chelating resins such as Chelex® (Chelex is a trademark of Bio-Rad Laboratories, Inc., Hercules, Calif.). However, other pharmaceutically acceptable chelating resins or reagents performing the same function would be acceptable so long as they do not detrimentally affect the Compound or other components of the formulation.
[0049] Treatment for removal of trace metal ions may be performed on individual components of the formulation prior to final formulation or such treatment may be performed on the formulation itself. For example, water that is to be used in the formulation may be treated to remove trace metals. Alternatively, concentrated buffer solutions may be treated prior to dilution with water and formulation with the active ingredient. In another alternative, the aqueous solution containing all components of the formulation except for the active pharmaceutical ingredient may be treated to remove metal ions. A still further alternative is to treat the complete formulation that contains all components, including the active ingredient.
[0050] An alternative to removal of trace metal ions is to incorporate certain compounds in the formulation that will form a chelate with the trace metal ions, thereby minimizing their degradation effect. Examples of such chelating agents include ethylenediaminetetraacetic acid (EDTA) disodium and citrate and tartrate buffers. The preferred concentration of EDTA disodium, citrate buffer and tartrate buffer is 10 mM each. Citrate and tartrate are believed to act as chelating agents for trace metal ions. In addition, succinate is believed to act as a chelating agent. Other chelating agents will be apparent to those skilled in the art in light of this disclosure.
[0051] Aqueous solutions of the Compound are susceptible to pH shift. The compound is believed to exhibit its best chemical stability between pH 4.0 and 4.5. When the Compound is formulated with only water, the pH of the formulation increases above 5. This pH shift results in conditions favorable to the oxidative degradation reaction, thus accelerating the degradation of the aqueous formulation. The increase in pH also decreases the solubility of the compound, thereby increasing the possibility of precipitation out of solution.
[0052] The pH shift may be minimized by using a suitable buffer. Those skilled in the art will appreciate that any pharmaceutically acceptable buffer that maintains the pH of the formulation within a certain range may be used. The pH range of such buffer is preferably between about 3.8 and about 5.0, and most preferably between 4.0 and 4.5. Suitable buffers include, but are not limited to, acetate, benzoate, citrate, formate, lactate and tartrate buffers, preferably lactate.
[0053] Table 2 exemplifies the use of various buffers to stabilize the pH of formulations containing 10 mgA/ml of the Compound.
TABLE 2 pH at 70° C. Initial Buffer lot (post-TS) 2 days 4 days 7 days 21 days 10 mM acetate 4.16 N/T 4.14 4.14 4.17 10 mM benzoate 4.21 N/T 4.16 4.20 N/A 10 mM citrate 4.16 4.16 N/T 4.17 4.11 10 mM formate 4.17 4.18 N/T 4.16 4.13 3 mM lactate 4.24 4.21 N/T 4.20 4.14 10 mM tartrate 4.15 4.17 N/T 4.17 4.07
[0054] In order to further improve stability of the active compound, it is preferable that the oxygen content in the formulation be reduced. This can be done by sparging the formulation solution with nitrogen, argon or other non-reactive gas and, when the compositions of the invention are packaged in vials or similar containers containing a headspace, using such inert gas for the headspace. When the compositions of the invention are packaged so that they contain a headspace, it is preferable that the oxygen content in the headspace be less than about 12% and most preferably less than about 8%. Oxygen may be removed by other methods, including the use of a vacuum to remove air and oxygen. Other methods of oxygen removal will be apparent to those skilled in the art.
[0055] A preferred presentation of the composition aspects of the invention comprises the Compound at a concentration of 10 mgA/mL. This concentration is near the maximum solubility of the Compound (about 12 mgA/mL at 5° C.). The preferred solution of the composition is 10 mM lactate buffer. However, those skilled in the art will appreciate that buffer solutions of other anions may be used, including, but not limited to, buffer solutions of the anions acetate, citrate, tartrate and formate.
[0056] A preferred packaging of the compositions is a 40 cc, Flint Type I molded glass vial with rubber stopper and aluminum shell. Alternative presentations can include other vial or container types, pre-filled syringes or pre-filled IV bags. Other packaging presentations will be apparent to those skilled in the art.
[0057] Vials are preferably sterilized by terminal sterilization methods employing an autoclave. Preferably, sterilization is for 8 minutes at 121° C. Sterilization may cause a slight shift of pH. In the lactate buffered formulation, pH shifted slightly down. In order to achieve a mid-point in the preferred pH range, the initial pH is preferably set to 4.5. The terminal sterilization cycle reduces the pH to about 4.2.
EXPERIMENTAL EXAMPLES
[0058] The present invention is illustrated by the following examples, but is not limited to the details thereof.
[0059] Percentages of Degradant 1 and Degradant 2 where measured using reverse-phase HPLC analysis on a Kromasil® C4 column, 5 μm, 25 cm length×4.6 mm ID (EKA Chemicals, Bohus Sweden). Column temperature was 30° C.±5° C. Mobile phase A: water/acetonitrile/trifluoracetic acid, 90/10/0.1 (v/v/v). Mobile phase B: water/acetonitrile/trifluoracetic acid, 40/60/0.1 (v/v/v). Gradient profile: linear. Detection: UV @ 215nm. Flow rate: 1.5 mL/min. Injection volume: 10 μL.
Example 1
[0060] Effect of Treatment with a Chelating Resin.
[0061] Solutions of sodium chloride of 0.3, 0.6 and 0.9% were treated with 5% w/w of Chelex® resin and stirred slowly for 1 hour. The pH of the solutions was adjusted to 4.6 while stirring with the Chelex resin. The mixture was then filtered. Control samples of sodium chloride solutions of 0.3, 0.6 and 0.9% were prepared which were not treated with the Chelex resin. Treated and untreated solutions were combined with (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol at a concentration of 1.25 mgA/ml and stored in sealed 5 cc Flint type I molded vials containing 4.0 ml solution fill and 2.0 ml air headspace at 70° C. for 7 days. The results of this experiment are represented in Table 3.
TABLE 3 Numbers represent percent of Degradant 1 (w/w). % NaCl Untreated Treated 0.3 0.034% 0.004% 0.6 0.038% 0.003% 0.9 0.033% 0.003%
Example 2
[0062] Effect of Formulating with a Chelating Agent.
[0063] The following solutions were made to a concentration of 10 mM each at pH 4.2:
[0064] 1. Unbuffered normal saline (0.9% NaCl);
[0065] 2. 10 mM Citrate buffer in normal saline (0.9% NaCl);
[0066] 3. 10 mM Tartrate buffer in normal saline (0.9% NaCl); and
[0067] 4. 10 mM EDTA disodium in normal saline (0.9% NaCl);
[0068] Solutions of each were combined with (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol to a concentration of 1.25mgA/ml and the pH was adjusted to 4.2. Each formulation was subjected to an 8 minute autoclave cycle at 121° C. and then stored at 70° C. The results of this experiment are represented in Table 4 below.
TABLE 4 Numbers represent percent of Degradant 1 w/w). 0.9% NaCl 10 mM 10 mM 10 mM Saline Tartrate Citrate EDTA Day 0 N/A 0.002% 0.000% 0.000% Day 3 N/A 0.003% 0.001% 0.000% Day 7 0.033% 0.006% 0.001% 0.002%
Example 3
[0069] 4-Hydroxybenzaldehyde (Degradant 1).
[0070] NMR analysis was performed at ambient temperature on a Bruker Avance DRX 500 MHz NMR spectrometer using a Bruker 5mm gradient broadband inverse probe (Bruker Instruments, Inc., Billerica, MA). Sample was dissolved in 99.9% deuterated dimethyl sulfoxide (DMSO).
13 C-NMR 1 H-NMR Carbon (PPM) H’s Attached Proton (PPM) δ Proton Multiplicity 115.84 1 6.92 doublet 128.43 0 132.10 1 7.74 Doublet 163.32 0 190.95 1 9.77 Singlet
Example 4
[0071] 4-Hydroxy-4-phenylpiperidine (Degradant 2).
[0072] NMR analysis was performed at ambient temperature on a Bruker Avance DRX 500 MHz NMR spectrometer using a Bruker 5 mm gradient broadband inverse probe. Sample was dissolved in 99.9% deuterated dimethyl sulfoxide (DMSO).
13 C-NMR 1 H-NMR Carbon (PPM) H’s Attached Proton (PPM) δ Proton Multiplicity 39.05 2 1.49 doublet 1.77 triplet 42.03 2 2.70 doublet 2.92 triplet 70.41 0 124.70 1 7.46 doublet 125.97 1 7.18 triplet 127.76 1 7.30 triplet 150.76 0
Example 5
[0073] Formulation of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol in Lactate Buffer.
Concen- Weight tration Component Grade Function (mg/vial) (mg/ml) (1S,2S)-1-(4- Pharm Active 586.01 14.577 hydroxyphenyl)-2-(4- ingredient (equal to hydroxy-4- 10 mgA/ml) phenylpiperidin-1- yl)-1-propanol mesylate trihydrate Lactic Acid USP Buffer 41.12 1.023 Sodium Hydroxide NF pH modifier Ca 13.87 Ca 0.345 Hydrochloric Acid NF pH modifier 0 0 Water for Injection USP Vehicle 39711.76 987.855
[0074] The pH of the initial formulation is set at pH 4.5 to accommodate the slight pH down-shifting upon terminal sterilization. The terminal sterilization cycle lowers the pH to about 4.2. Sodium hydroxide and hydrochloric acid are used as needed to adjust the solution to the desired pH.
Example 6
[0075] Accelerated Stability Study.
[0076] A 10 mgA/ml solution of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol in 10 mM lactate buffer was prepared. The pH of three separate portions was adjusted so that the initial post terminal sterilization pH was 3.9, 4.2 or 4.6. The formulation was packaged in vials containing varying concentrations of oxygen or in air. Terminal sterilization was by autoclave at 121° C. for 8 minutes. Samples were stored in 40 ml Flint type I vials with 40 ml fill and 10 ml headspace for 12 weeks at 30° C., 40° C. and 50° C.
[0077] The results of this experiment are presented in Table 5 and Table 6 below.
TABLE 5 Numbers represent percent of Degradant 1 (w/w). Head space, pH Initial Post T.S. 30° C. 40° C. 50° C. 4% O 2 , pH 4.2 0.002% 0.004% 0.003% 0.005% 0.009% 6% O 2 , pH 4.2 0.002% 0.004% 0.004% 0.005% 0.011% 10% O 2 , pH 4.2 0.004% 0.003% 0.004% 0.006% 0.015% Air, pH 4.6 0.003% 0.003% 0.008% 0.015% 0.033% Air, pH 4.2 0.003% 0.004% 0.004% 0.006% 0.032% Air, pH 3.9 0.003% 0.003% 0.009% 0.019% 0.040%
[0078] [0078] TABLE 6 Numbers represent percent of Degradant 2 (w/w). Head space, pH Initial Post T.S. 30° C. 40° C. 50° C. 4% O 2 , pH 4.2 0.003% 0.006% 0.008% 0.010% 0.017% 6% O 2 , pH 4.2 0.003% 0.006% 0.008% 0.010% 0.019% 10% O 2 , pH 4.2 0.002% 0.006% 0.009% 0.013% 0.024% Air, pH 4.6 0.002% 0.005% 0.012% 0.018% 0.043% Air, pH 4.2 0.001% 0.005% 0.008% 0.012% 0.042% Air, pH 3.9 0.001% 0.003% 0.013% 0.023% 0.051%
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This invention relates to stable pharmaceutical compositions of the NMDA receptor agonist, (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol], methods of preparing such pharmaceutical compositions and methods of treating stroke, spinal cord trauma, traumatic brain injury, multiinfarct dementia, CNS degenerative diseases such as Alzheimer's disease, senile dementia of the Alzheimer's type, Huntington's disease, Parkinson's disease, epilepsy, amyotrophic lateral sclerosis, pain, AIDS dementia, psychotic conditions, drug addictions, migraine, hypoglycemia, anxiolytic conditions, urinary incontinence and an ischemic event arising from CNS surgery, open heart surgery or any procedure during which the function of the cardiovascular system is compromised using the pharmaceutical compositions.
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FIELD OF THE INVENTION
[0001] The present invention relates to patient garments. More specifically, the present invention relates to garments for preserving an infant's body heat and facilitating access to a localized region of the body surface of a patient.
BACKGROUND OF THE INVENTION
[0002] Around the beginning of the twentieth century, most women gave birth at home. As modern hospitals gained popularity during the 1920s, women were encouraged to seek professional health care for themselves and their newborns in the supervised environments of these new hospitals. By 1936, approximately one-third of all live births occurred in hospitals, and by 1945, approximately eighty percent of women gave birth in hospitals. Although tremendous advances have been made in the field of medicine, hospital apparel—including infant garments—has changed little.
[0003] For years, the traditional infant garment has been a short shirt ending at the waistline. Typically, some type of undergarment, such as a diaper, has also used been used for additional protection against soiling. The short shirt is open in the front with two side panels crossing over one another for closing and fastening the shirt shut. Early shirts were shut in the back with ties. These ties were later replaced with snap fasteners. The short shirt allows a cloth diaper to be used, thereby decreasing the possibility of soiling the upper garment and reducing the frequency of laundering. Although rubber or plastic pants can also be used with short shirts, their use has typically been discouraged because they can contribute to improper air circulation and increased susceptibility to the development of rashes.
[0004] Another type of traditional undergarment for infants is the undershirt. Undershirts for newborns have front tabs that can be fastened to a cloth diaper with safety pins. This forms a full-length, warm, cloth garment that can be secured in place so as to not ride up on the infant. As disposable diapers were slowly introduced into nurseries in the late 1970s, however, the front tabs have been omitted since potentially hazardous safety pins were no longer necessary.
[0005] Currently, hospital garments for infants have the same waist-length undershirt with cross-over front panels that snap shut. Such garments typically require the use of a separate, disposable diaper. A drawback of these types of garments is that crossing the front panels over and snapping them shut can be confusing and cumbersome. Since the garment is separate from the diaper, another drawback of the infant garment commonly in use today is that the shirt may tend to ride up under the infant's armpits. This unnecessarily exposes portions of the surface of an infant's body and can contribute to a loss of body heat.
[0006] Since the body temperatures of infants should normally be maintained within a very narrow range, the effects of heat loss on infants can be especially dangerous. Excessive heat loss stemming from the use of existing infant garments can, for example, contribute to the onset of hypothermia. As a result, newborn care, policies, and techniques attempt to thermo-regulate the body of newborns by achieving a healthy and an efficient balance between heat loss and heat production. Because the garments worn by infants sometimes may not always effectively maintain a proper body temperature, however, it can become necessary to expend significant resources to create appropriate temperature-controlled neonatal environments.
[0007] Another drawback of current hospital garments is that they can impede patient care. Specifically, the garment itself can impede access to various locations on an infant's body which may require monitoring or treatment. Current standards of patient care, however, emphasize the responsibility of hospital personnel to easily assess patients and quickly identify real and potential problems.
[0008] Therefore, there is a need in the industry for hospital garments, especially garments for infants, that more effectively preserve body heat while providing improved access for the assessment and care of the patient wearing the garment.
SUMMARY OF THE INVENTION
[0009] The apparatuses and methods according to the various embodiments of the present invention provide thermo-regulating infant garments. The thermo-regulating infant garments generally present an opening that provides accessibility for assessing a physical condition or parameter or caring for a wound site. The wound site may be, for example, the site of a post-birth resection of the umbilical cord, an introduction of an intra-venous tube or a needle, a surgical incision, or other physical injury. The physical condition or parameter may be, for example, heart rate, respiration, or the functioning of the bowels.
[0010] When worn by a patient, the garment of the present invention helps retain the patient's body heat. A desired region of the patient's body surface can also be accessed and for assessing a physical condition and, if necessary, providing treatment. A slit in the garment allows such assessment and treatment without requiring the garment to be removed. In addition, a cuff sewn onto the distal end of a sleeve of the garment can be folded so as to selectively cover or uncover the open, distal end of the sleeve. Covering the open, distal end of the sleeve can thereby cover the hand-opening of the sleeve to reduce the risk of self-inflicted injury and further retain body heat.
[0011] The present invention is generally described in relation to embodiments of garments for neo-natal babies. Alternative embodiments could easily be adapted for use by adults, however, without departing from the spirit or scope of the present invention.
[0012] In an embodiment of the present invention, a thermo-regulating infant garment provides access to an umbilical region of a patient and includes (i) a torso cover having a front and a back and defining a head opening, two spaced-apart arm openings, and a bottom opening, (ii) a pair of rollable sleeves having a proximal end and a distal end, the proximal end being attached to the torso cover at the arm openings and the distal end defining a hand opening and forming a cuff, and (iii) a flap intermediate the front and the back of the torso cover and opposite the head opening. The flap is attachable to the torso cover to at least partially cover the bottom opening. The front of the torso cover has a bottom edge and defines a slit extending from the bottom edge. The cuff is reversibly foldable over the hand opening.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The embodiments of the present invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
[0014] FIG. 1 is a front view of an infant garment according to an embodiment of the present invention;
[0015] FIG. 2 is a front view of an infant garment according to an embodiment of the present invention having a sleeve folded over itself; and
[0016] FIG. 3 is a perspective view of an infant garment according to an embodiment of the present invention presented on the body of an infant.
[0017] While the present invention is amendable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the present invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention as defined by the appended claims.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0018] The garment of the present invention can be used in a variety of applications, including as hospital and non-hospital garments for children and adults. The garment is particularly advantageous for use as an infant garment, however. Accordingly, the present invention is described by way of example in connection with, but is not limited to, a neo-natal infant garment, as indicated generally at garment 100 in FIG. 1 . It should be understood that garment 100 of the present invention is not in any way limited to such use and can be applied to a variety of other garments, such as garments for toddlers and adults.
[0019] Referring to FIG. 1 , garment 100 according to an embodiment of the present invention includes torso cover 102 , sleeves 104 , and pelvic flap 106 . Torso cover 102 generally has front 110 , back 111 , patient-assessment opening 112 , head opening 114 , armpit regions 116 , and shoulder regions 118 . Torso cover 102 may also have a hood (not shown). Generally, overlapping portions of front 110 and back 111 of torso cover 102 define head opening 114 and shoulder regions 118 . Lower edge 120 of front 110 of garment 100 generally has fastening members 122 a . In an example embodiment, pelvic flap 106 of garment 100 is attachable to front 110 of torso cover 102 .
[0020] Patient-assessment opening 112 permits a portion of the body of a user wearing garment 100 to be accessed. Patient-assessment opening 112 facilitates such access without requiring garment 100 to be removed or pelvic flap 106 to be detached from front 110 of torso cover 102 . In an example embodiment, patient-assessment opening 112 is positioned on garment 100 so that the umbilical or lower abdominal region of a user wearing garment 100 can be accessed, as depicted in FIG. 3 . Patient-assessment opening can also be positioned on garment 100 so that a different region of the patient's body can be accessed. This allows a particular condition or parameter to be monitored or assessed while decreasing the disturbance normally caused by repositioning garment worn by a patient. In an alternative embodiment, patient-assessment opening 112 is positioned on garment 100 so that heart, lungs, or bowels of a patient can be monitored, such as, for example, with a stethoscope.
[0021] Patient-assessment opening 112 may be any number of types of openings that would permit an area of a patient's body, such as the umbilical or lower abdominal region, to be monitored. Generally, patient-assessment opening 112 defines slit 124 . In an example embodiment, slit 124 is in front 110 of garment 100 and runs from lower edge 120 toward head opening 114 . Slit 124 can be between approximately one inch and eight inches in length. In an example embodiment, slit 124 is approximately four-and-one-half inches in length. One skilled in the art will readily recognize that patient-assessment opening 112 may have a configuration other than slit 124 and/or be located in an area other than front 110 of garment 100 running from lower edge 120 toward head opening 114 without departing from the spirit of scope of the present invention.
[0022] Referring to FIG. 1 , slit 124 has slit edges 126 . In an example embodiment, slit edges 126 are not fastenable or overlapping. Patient-assessment opening 112 thereby remains open in an example embodiment, as depicted in FIG. 3 . In an alternative embodiment, slit edges 126 may have fastening members so that patient-assessment opening 112 may be closed.
[0023] Each sleeve 104 has proximal end 130 , distal end 131 , anterior side 132 , and posterior side 133 . Proximal end 130 is contoured so as to define a shape complementary to armpit regions 116 of torso cover 102 , as depicted in FIG. 1 . Distal end 131 has cuff 134 with cuff edge 135 . Distal end 131 also defines hand opening 136 . Hand opening 136 is generally large enough and positioned on sleeve 104 so as to be able to receive the hand of an individual wearing garment 100 . Generally, cuff 134 occupies only a portion of distal end 131 . For example, cuff 134 may be located on the anterior side 132 or posterior side 133 of sleeve 104 , but generally does not extend around the circumference of distal end 131 of sleeve 104 . The portion of sleeve 104 that has cuff 134 therefore generally has more layers of fabric material than the portion of sleeve 104 that does not have cuff 104 .
[0024] Cuff 134 can be folded over distal end 131 of sleeve 104 to cover or uncover hand opening 136 . Sleeve 104 having uncovered hand opening 136 a and sleeve 104 having covered hand opening 136 b are depicted in FIG. 3 . In an example embodiment, cuff 134 is positioned on anterior side 132 of sleeve 104 having uncovered hand opening 136 a and is positioned on the posterior side 133 of sleeve 104 having covered hand opening 136 b , as depicted in FIG. 3 . Accordingly, cuff edge 135 can be viewed on anterior side 132 of sleeve 104 having uncovered hand opening 136 a , but cannot be viewed on anterior side 132 of sleeve 104 having covered hand opening 136 b . In an alternative embodiment, cuff 134 is positioned on anterior side 132 of sleeve 104 having covered hand opening 136 b and is positioned on posterior side 133 of sleeve having uncovered hand opening 136 a , as depicted in FIG. 2 . Accordingly, cuff edge 135 can be viewed on anterior side 132 of sleeve 104 having covered hand opening 136 b , and can also be viewed on posterior side 133 of sleeve 104 having uncovered hand opening 136 b . By having cuff 134 that can be selectively folded and unfolded, sleeves 104 of garment 100 can be quickly and easily modified to cover the hands of an individual wearing garment 100 , such as, for example, an infant.
[0025] Pelvic flap 106 has bottom edge 140 and side edges 142 . Bottom edge 140 has fastening members 122 b . Generally, fastening members 122 b on bottom edge 140 of pelvic flap 106 function in concert with fastening members 122 a of lower edge 120 of front 110 of torso cover 102 . Fastening members 122 a,b can be any number of fastening members that facilitate the attachment of bottom edge 140 of pelvic flap 106 to lower edge 120 of torso cover 102 . In an example embodiment, fastening members 122 a,b are snaps. In alternative embodiments, fastening members 122 a,b are zippers, button-and-eye fasteners, or hook-and-loop fasteners.
[0026] Pelvic flap 106 of garment 100 can have any numbers of shapes and sizes. In an example embodiment, pelvic flap 106 is shaped so that, when attached to torso cover 102 , pelvic flap 106 and torso cover 102 form leg openings 148 , but otherwise substantially cover an individual below his or her umbilical region, as depicted in FIG. 3 . For example, side edges 142 may have a convex shape when pelvic flap 106 is not attached to torso cover 102 , as depicted in FIG. 1 . Referring to FIG. 3 , the legs of an individual wearing garment 100 can be extended through leg openings 148 when pelvic flap 106 is attached to torso cover 102 . In an alternative embodiment, bottom edge 140 and side edges 142 of pelvic flap 106 are shaped so to not form an opening when pelvic flap 106 is attached to torso cover 102 . In this alternative embodiment, pelvic flap 106 generally defines a pair of apertures (not shown) through which the legs of an individual wearing garment 100 can be extended.
[0027] Sleeves 104 and pelvic flap 106 may be attached to torso cover 102 in any number of ways. In an example embodiment, sleeves 106 are separate from torso cover 102 and pelvic flap 106 . In accordance with this embodiment, sleeves 104 are generally sewn onto torso cover 102 , as depicted in FIGS. 1-2 . In an alternative embodiment, sleeves 104 , pelvic flap 106 , and torso cover 102 constitute the same piece of fabric material. In accordance with this embodiment, a single shape can be cut out from a roll of fabric material such that the cut material forms garment 100 when folded over itself and sewn together. In another embodiment, sleeves 104 , pelvic flap 106 , and torso cover 102 are all formed from separate pieces of material.
[0028] Garment 100 may be made from any number of materials and in any number of ways. Referring to FIG. 1 , torso cover 102 and pelvic flap 106 generally form a single piece of material, while sleeves 104 form separate pieces of material. Sleeves 104 and torso cover 102 and pelvic flap 106 can be made from tubular or non-tubular fabric that is sewn together. In an example embodiment, sleeve material is sewn along seam 150 to form sleeve 104 having cuff 134 , while torso cover 102 and pelvic flap 106 are formed from tubular fabric. Generally, back 111 is cut higher than front 100 . An elongated back 111 can then be folded toward front 110 to create shoulder regions 118 .
[0029] In an alternative embodiment, torso cover material and lower portion material is sewn along seams (not shown) to form torso cover 102 and pelvic flap 106 . Torso cover 102 and pelvic flap 106 can also be sewn so as to have seam bindings 154 , 156 , as depicted in FIG. 1 . In an example embodiment, seam bindings 154 , 156 are formed by folding a separate piece or pieces of fabric material over the edges of garment 100 and sewing the separate piece or pieces. In an alternative embodiment, seam bindings 154 , 156 are formed by folding over and sewing the edges of fabric material, such as, for example, bottom edge 140 of pelvic flap 106 and lower edge 120 of front 110 of garment 100 .
[0030] In example embodiment, sleeves 104 are attached to armpit regions 116 of torso cover 102 along attachment seams 158 . Although FIGS. 1-3 depict garment 100 constructed from torso cover 102 , sleeves 104 , and pelvic flap 106 cut in a particular pattern, it will be apparent to one skilled in the art that any number of shapes can be cut from fabric material so as to form garment 100 . For example, in an alternative embodiment, torso cover 102 and pelvic flap 106 are separate, individual components.
[0031] Generally, all components of garment 100 are made from the same materials. In an example embodiment, garment 100 —other than fastening members—is made substantially from an elastic cotton knit. Seam bindings 154 , 156 and garment 100 can be made from the same or different material and can have the same or different weaves. In an example embodiment, seam bindings 154 , 156 are made from the same material as garment 100 , but have a tighter weave per square inch than garment 100 . In an alternative embodiment, garment 100 —other than fastening members—is made from a non-cotton material.
[0032] In operation, garment 100 can be worn by an individual to reduce the loss of body heat while providing an access point to the umbilical region of the individual. Specifically, an individual's arms can be inserted through sleeves 104 and the individual's head can be inserted through head opening 114 of torso cover 102 . Pelvic flap 106 is drawn between the legs of the individual from back 111 of torso cover 104 toward front 110 of torso cover 102 . To maintain pelvic flap 106 in place, fastening members 122 b on bottom edge 140 of pelvic flap 106 are secured to fastening members 122 a on lower edge 120 of front 110 of garment 100 .
[0033] With garment 100 secured around the individual, the area of the individual's body exposed by the patient-assessment opening 112 can be monitored and/or cared for. In an example embodiment, patient-assessment opening 112 allows the site at which the umbilical cord was resected from a neo-natal baby to be monitored and/or be cared for.
[0034] Garment 100 can also be used to cover the hands of an individual wearing garment 100 . Specifically, cuff 134 can be folded over hand opening 136 of sleeve 104 so as to cover hand opening 136 . Cuff 134 can also be folded back over hand opening 136 of sleeve so as to uncover hand opening 136 . In an example embodiment, hand opening 136 is covered by folding cuff 134 from anterior side 132 of sleeve 104 to posterior side 133 of sleeve 104 , while hand opening 136 is uncovered by folding cuff 134 from posterior side 133 of sleeve 104 to anterior side 132 of sleeve 104 . In an alternative embodiment, hand opening 136 is covered by folding cuff 134 from posterior side 133 of sleeve to anterior side 132 of sleeve 104 , while hand opening 136 is uncovered by folding cuff 134 from anterior side 132 of sleeve 104 to posterior side 133 of sleeve 104 .
[0035] The embodiments above are intended to be illustrative and not limiting. Additional embodiments are within the claims. In addition, although the present invention has been described with reference to particular embodiments, those skilled in the art will appreciate that changes can be made in form and detail without departing from the spirit and scope of the present invention. Any incorporation by reference of documents above is limited such that no subject matter is incorporated contrary to the explicit disclosure herein.
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An infant garment preserves body heat and facilitates access to a localized region of the body surface of a patient. The garment has a slit on the front that allows the region of the patient's body surface to be monitored and, if necessary, treated without requiring removal of the garment. The garment also has sleeves with cuffs that can be reversibly folded to cover or uncover the hand-openings in the distal ends of the sleeves.
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[0001] This is a continuation of U.S. application Ser. No. 09/369,058, filed Aug. 4, 1999, the entirety of which is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to a modular system for introducing therapeutic or diagnostic devices, such as a blood filter, occluder, atherectomy device, stents, angiographic catheters., and pressure monitors to a vessel or cardiac tissue. More particularly, the system delivers the devices independently or in combination through a single incision on the vessel or cardiac tissue via one or more removably attached access ports and lumens.
BACKGROUND OF THE INVENTION
[0003] During various cardiothoracic, pulmonary, and vascular surgeries, including coronary artery bypass grafting, heart valve repair or replacement, atrial or ventricular septal defect repair, angioplasty, atherectomy, aneurysm repair, and pulmonary thrombectomy, cannulation of a patient's vessel(s) are often required to provide vascular access for delivery of various diagnostic and therapeutic devices. In a conventional approach, separate incisions are needed for introduction of each medical device. For example, during coronary artery bypass grafting (CABG) surgeries, cardiopulmonary bypass is established by cannulation of the aorta to provide circulatory isolation of the heart and coronary blood vessels. Two incisions on the aorta may be required, i.e., one for insertion of the arterial cannula and another for insertion of a balloon occluder to provide coronary isolation from the peripheral vascular system. When cardiac arrest is desired, a third incision may be required on the aorta to introduce a catheter for delivering cardioplegic solution to the coronary arteries. Additional incisions may be required for insertion of other crevices, such as a blood filter, pressure monitor, or atherectomy device. Once the incisions are made on the aorta, the devices often remain in the aorta throughout the entire procedure despite only being used intermittently, e.g., the cardioplegia catheter.
[0004] Due to significant mortality and morbidity associated with conventional CABG surgeries from the use of cardiopulmonary bypass for circulatory support and the traditional method of access by median sternotomy, minimally invasive concepts recently have been adopted to make cardiothoracic procedures less invasive. Minimally invasive alternatives include the minimally invasive direct CABG procedure in which the operation is performed through minimal access incisions, eliminating cardiopulmonary bypass. The second alternative is to perform the procedure through minimal access incisions, and cardiopulmonary support is instituted through an extra thoracic approach, i.e., the port access approach. The third alternative is to perform the procedure on a beating heart which allows greater access for more extensive revascularization, i.e., the “off pump” sternotomy approach. In any of the minimally invasive alternatives, the space allowed for multiple instrumentation and device insertion is limited.
[0005] The disadvantages associated with the conventional or minimally invasive approach are that (1) by having multiple devices inserted in the aorta, the space available for the surgeon to perform procedures is limited, and (2) the aorta is traumatized as a result of multiple incisions, which may result in aortic dissection, aortic wall hematoma, and/or embolization of calcium plaque from the aortic wall. The greater the aortic trauma, the higher the perioperative morbidity a patient will endure.
[0006] New devices or systems are therefore needed which provide access to a patient's vessel and introduction of multiple diagnostic and therapeutic devices during cardiovascular procedures, thereby minimizing crowding caused by the multiple device insertions and trauma to the vessel wall.
SUMMARY OF THE INVENTION
[0007] The methods and systems of the present invention provide means of introducing a combination of multiple devices or instruments into a vessel through a single incision site, thereby reducing the number of incisions on the vessel and minimizing space crowding during vascular surgeries. More particularly, various devices and instruments can be inserted into the vessel through one or multiple lumens and access ports which are removably attached to a cannula in the modular access port systems, thereby minimizing the trauma of exchanging devices through the vessel wall. The methods and systems can be used in conventional or minimally invasive surgeries to provide any combination of the following functions: perfusion, drug delivery, fluid infusion, vessel occlusion, filtration, aspiration, blood sampling, venting, fluid diversion, venous return in cardiopulmonary bypass, atherectomy, fluid pumping, suturing, stapling, collagen or fibrin delivery, placement of pacing leads, use of angiographic catheters, angioplasty catheters, valvuloplasty catheters, electrode catheters, sizing tools, internal vessel segregating or isolating dams, endoscopic cameras, pressure monitors, shunts, stents, grafts, stent/grafts, vessel surfacing modalities, radioactive isotopes, graft delivery, and endoscopic devices. For example, devices traditionally introduced through the femoral artery (i.e., stents, atherectomy catheters, or angioplasty catheters) can also be introduced directly into the aorta, if deemed advantageous or beneficial to the patient.
[0008] In a first embodiment, the cannula has a lumen communicating between a proximal end and a distal end. The distal end is adapted for perfusion of blood, i.e. for use as an arterial cannula or venous return cannula in cardiopulmonary bypass. The proximal end is adapted for attachment to a bypass-oxygenator machine. A clip-on access port is removably attached to a distal region of the cannula. The access port has a lumen extending from a proximal end to a distal end. The proximal end of the port is adapted to receive medical devices. In certain embodiments, the access port can be attached to any standard arterial or venous cannula in any orientation. In other embodiments, the access port is attached to the cannula only in one orientation to ensure a desired relationship between the cannula and the access port.
[0009] In another embodiment, a second access port is removably mounted to the distal region of the cannula adjacent to the first access port, such that the ports are arranged at the vertices of a triangle. Having the triangular arrangement may be preferred in minimally invasive procedures where surgical space is limited. Alternatively, the second port is removably mounted to the first port, such that the ports and the cannula are arranged in a linear configuration. A hemostatic valve may be included in the lumen of either or both of the access ports. The distal ends of the cannula and/or the access ports may include a suture flange for securing the system onto the vessel.
[0010] In a first method to provide insertion of medical devices and cannulation of a vessel or cardiac tissue, the access port is attached adjacent the distal region of the cannula. The distal ends of the cannula and the access ports are inserted through an incision on the vascular or cardiac tissue. For example, to provide arterial cannulation for cardiopulmonary bypass, the cannula is inserted through an incision on the aorta. A medical device, such as a cardioplegia catheter, can be inserted through the proximal end of the access port and deployed in the aorta. When cardioplegia is no longer required, the catheter can be removed from the access port and another medical device, such as a pressure monitor can be inserted into the aorta through the port. In this way, the cannula system allows exchange of multiple devices through the access port without requiring additional incision.
[0011] In another method, when deployment of multiple medical devices into a vessel or cardiac tissue is necessary, a second access port can be attached to either the cannula or the first access port prior to inserting the cannula into the vascular tissue. For example, during arterial cannulation for cardiopulmonary bypass, a blood filter may be inserted through the first access port, and an occlusion catheter having a balloon occluder may be inserted through the second port into the aorta. The blood filter is expanded to entrap embolic materials, calcium, myocardial tissue debris, or atheroinatous plague, which arise as a result of introducing instrumentation or manipulating tissue during surgery. The balloon occluder is expanded to provide circulatory isolation of the coronary vessels from the peripheral vascular system. The proximal end of the cannula is attached to a bypass-oxygenator machine to deliver oxygenated blood to the aorta. After the cardiopulmonary bypass is established, a surgical procedure can be performed on the heart and/or aorta.
[0012] Alternatively, the blood filter and the occlusion catheter can be inserted sequentially through the access ports into the aorta. After completion of the surgical procedure, one or both devices can be removed from the access ports. In situations where continuation of the cardiopulmonary bypass is desired post-operatively due to a patient's low cardiac output state, the blood filter may be removed, leaving the occlusion catheter and the cannula in the aorta. In this manner, multiple therapies and procedures are employed in combination or independently of each other.
[0013] It will be understood that there are several advantages to using the clip-on access port(s) disclosed herein for delivering medical therapies. For example, the access port(s) (1) permit a combination of therapies to be employed through only one incision site, thereby minimizing trauma to the vessel wall, (2) allow multiple devices to be operated in combination or independently, (3) reduce the number of devices used concomitantly, thereby minimizing crowding in the surgical field, (4) can be employed in a variety of cardiac or vascular surgeries, (5) can be used in minimally invasive procedures, (6) can be easily mounted to a standard arterial or venous cannula and hereafter removed, and (7) can be mounted to a modified cannula, such that the port is attached to the cannula in only one orientation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] [0014]FIG. 1A depicts an oblique view of an embodiment of a clip-on access port according to the present invention.
[0015] [0015]FIG. 1B depicts a lateral view of the clip-on access port of FIG. 1A.
[0016] [0016]FIG. 1C depicts an embodiment of a cannula adapted for insertion into a vein or artery.
[0017] [0017]FIG. 1D depicts a spatial relationship between the access port of FIG. 1B and cannula of FIG. 1C.
[0018] [0018]FIG. 1E depicts the access port of FIG. 1B attached to the cannula of FIG. 1C.
[0019] [0019]FIG. 1F depicts a blood filter inserted through the access port of FIG. 1E.
[0020] [0020]FIG. 1G depicts a distal view of the blood filter of FIG. 1F.
[0021] [0021]FIG. 2A depicts an oblique view of another embodiment of the clip-on access port.
[0022] [0022]FIG. 2B depicts a lateral view of the access port of FIG. 2A.
[0023] [0023]FIG. 2C depicts another embodiment of the cannula having a mounting mechanism at its distal region.
[0024] [0024]FIG. 2D depicts the access port of FIG. 2B attached to the distal region of the cannula of FIG. 2C in a predetermined orientation.
[0025] [0025]FIG. 3A depicts an obturator adapted for insertion into the access port of FIG. 1A.
[0026] [0026]FIG. 3B depicts a lateral view of the obturator of FIG. 3A.
[0027] [0027]FIG. 3C depicts the access port of FIG. 3A having the obturator of FIG. 3B inserted through its lumen.
[0028] [0028]FIG. 4 depicts a cannula with a second port adjacent the distal end of the cannula and adjacent the first port, wherein the ports and the distal end of the cannula are arranged substantially in a line.
[0029] [0029]FIG. 4A depicts a cross-section of the cannula of FIG. 4 through section line A-A.
[0030] [0030]FIG. 5 depicts a cannula with a second port adjacent the distal end of the cannula and adjacent the first port, wherein the ports are arranged at the vertices of a triangle.
[0031] [0031]FIG. 5A depicts a cross-section of the cannula of FIG. 5 through section lines A-A.
DETAILED DESCRIPTION
[0032] In a first embodiment, a clip-on access port for deployment of medical devices, including a blood filter, a balloon occluder, a pressure monitor, an endoscope, a windsock filter, a flow director, an atherectomy catheter, an aspiration/suction catheter, a cardioplegia catheter, a coronary stent, a graft, and a perfusion catheter, in a vessel or cardiac tissue is provided as depicted in FIGS. 1A and 1B. The access port comprises proximal end 10 , distal end 15 , and lumen 20 . Proximal end 10 , which may include a hemostatic valve, is adapted to receive a medical device. Attachment mechanism 25 , shown as a plurality of opposed clips, is mounted on distal region 22 of the access port. The attachment mechanism is adapted to be removably attached to a distal region of a cannula. Flange 30 may be included adjacent the distal end of the access port. First and second aligning members 26 , which are mounted on distal region 22 , can engage a suture flange on the cannula. Flange 30 and aligning members 26 fit to ensure proper circumferential alignment and coupling between the access port and a cannula.
[0033] The access port described above can be removably attached to a standard arterial or venous cannula shown in FIG. 1C. The cannula has proximal end 35 , distal end 40 , and lumen 44 . Suture flange 45 may be slideably mounted on distal region 49 of the cannula for securing the cannula onto the vascular tissue. Lumen 44 is adapted to receive oxygenated or deoxygenated blood. Proximal end 35 is adapted for attachment to a bypass-oxygenator machine.
[0034] In use for cardiopulmonary bypass, for example, the access port is attached to distal region 49 of the cannula through attachment mechanism 25 in any preferred orientation as depicted in Figs. 1D and 1E. In certain embodiments, the alignment will be fixed by a complementary fit between the clip-on port and the cannula, as by the engagement of opposing flat surfaces (e.g., aligning members 26 of the access port engages suture flange 45 of the cannula, and flange 30 of the access port engages distal region 41 of the cannula). After the access port is secured onto the cannula, distal end 40 of the cannula is inserted through an incision on the aortic wall into the ascending aorta. Various medical devices can then be inserted through proximal end 10 and passed through distal port 15 of the access port to deploy in the aorta.
[0035] In FIGS. 1F and 1G, a blood filter device carrying filter 50 is inserted into proximal end 10 of the access port. The filter device includes plunger 55 , which upon activation deploys filter 50 through port 15 of the access port. Filter 50 is shown in an expanded state. The reader is referred to Barbut et al., U.S. Pat. No. 5,769,816, Maahs, U.S. Pat. No. 5,846,260, Tsugita et al., U.S. Pat. No. 5,911,734, and Barbut et al., U.S. Pat. No. 5,662,671 (all of which are expressly incorporated herein by reference in their entirety), for a detailed description of the design and construction of blood filter devices. During cardiopulmonary bypass, oxygenated blood will be delivered to the aorta from proximal end 35 , lumen 44 and distal port 40 of the cannula. Proximal end 35 is attached to a bypass-oxygenator machine 100 through connector 99 . Expanded filter 50 captures embolic material, such as calcium deposits, atheromatous plaque, myocardial tissue debris, and thrombi, generated during cardiac surgery. Alternatively device 55 can be any of a balloon occluder, pressure monitor, endoscope, atherectomy device, aspirator, drug delivery catheter, blood-sampling device, valvuloplasty catheter, electrode catheter, segregating or isolating dams, endoscopic camera, or stent, graft, shunt, and perfusion catheters.
[0036] In certain embodiments, a second access port can be attached to the first access port or the cannula to provide deployment of other medical devices. For example, a catheter with a balloon occluder can be inserted into the second access port to provide circulatory isolation of the coronary and peripheral arteries. The catheter can also deliver carioplegia solution to arrest the heart. Alternatively, multiple ports will be bonded to form a single clip-on unit. In this way, the cannula system allows delivery of multiple medical therapies to the aorta through one incision, thereby minimizing trauma to the aortic wall.
[0037] [0037]FIGS. 2A. and 2 B depict another embodiment of the access port, which comprises proximal end 10 , distal end 15 , and lumen 20 . Proximal end 10 , which includes hemostatic valve 90 , is adapted to receive a medical device. Attachment mechanism 25 , mounted on distal region 22 of the access port, is adapted to engage a distal region of the cannula in a specific orientation. Extension member 30 is mounted on distal end 15 of the access port to ensure proper attachment to a cannula. In an alternative embodiment, the access port may include a second port 80 adjacent the first port, including proximal opening 81 , lumen 82 , and distal port 83 .
[0038] Another embodiment of the cannula, which is modified to accommodate the attachment of the access port, is shown in FIG. 2C. The cannula has proximal end 35 , distal end 40 , and lumen 44 . Suture flange 45 may be slideably mounted on distal region 49 of the cannula for securing the cannula onto the vascular tissue. Lumen 44 is adapted to receive oxygenated or deoxygenated blood. Proximal end 35 is adapted for attachment to a bypass-oxygenator machine. Housing 60 , which provides a complementary fit for the attachment mechanism of the access port, is mounted on distal region 49 of the cannula.
[0039] In use, the access port is attached to distal region 49 of the cannula through engaging attachment mechanism 25 with housing 60 in a fixed orientation as depicted in FIGS. 2D. After the access port is secured onto the cannula, distal end 40 of the cannula is inserted through the vascular or cardiac tissue of interest. Sutures can be placed on suture flange 45 to secure the cannula onto the vascular tissue. Various medical devices can then be deployed by inserting through proximal end 10 and passing through distal port 15 of the access port. Having the access port attached to the cannula in one orientation may be preferred in situations where a specific direction of medical device deployment is required.
[0040] In certain embodiments, the access port includes an obturator adapted for insertion in proximal end 10 and lumen 20 of the access port as depicted in FIGS. 3A, 3B, and 3 C. The obturator has proximal end 61 , body 62 , and distal end 63 . Proximal end 61 includes releasable engaging mechanism 66 (snap cap), depicted as a latch in FIGS. 3A and 3B. Gripping members 70 are mounted proximal to the engaging mechanism 66 on opposite sides of the obturator. The engaging mechanism is operated by depressing the gripping members radially inward for insertion into the access port. Proximal end 61 also includes porous plug 75 , which allows passage of air or gas, but not fluid or blood. Body 62 of the obturator has longitudinal grooves 77 , which communicate with porous plug 75 and provide passage for air or gas.
[0041] In use, the obturator is inserted through proximal end 10 and lumen 20 of the access port as depicted in FIG. 3C. Distal end 63 of the obturator protrudes distal to port 15 . The access port is then clipped onto a cannula and inserted into a vascular structure of interest. When the access port is not in use, the obturator can remain inserted to prevent back flow of blood or fluid. Porous plug 75 allows venting of air or gas and not blood or fluid. When insertion of a medical device is desired, the obturator is removed by depressing gripping members 70 radially inward to release engaging members 66 from proximal end 10 of the access port, and withdrawing the obturator from the access port.
[0042] The length of the cannula will generally be between 10 and 60 centimeters, more preferably approximately 20 to 35 centimeters, more preferably approximately 30 centimeters. The inner diameter of the cannula will generally be between 0.5 and 1.5 centimeters, preferably approximately 1.0 centimeters. The length of the clip-on access port will generally be between 2.0 and 10.0 centimeters, preferably approximately 6.0 centimeters. The inner diameter of the lumen of the access port will generally be between 0.2 and 1.2 centimeters, preferably approximately 0.6 centimeters. The foregoing ranges are set forth solely for the purpose of illustrating typical device dimensions. The actual dimensions of a device constructed according to the principles of the present invention may obviously vary outside of the listed ranges without departing from those basic principles.
[0043] Thus, while the invention has been described in connection with what is presently considered to be the most practical embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.
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Modular systems comprising a cannula and at least one clip-on access port adjacent to a distal end of the cannula to provide insertion of one or more therapeutic or diagnostic devices into a vessel or cardiac tissue through a single incision site. The access port can be removably attached to a distal region of the cannula in a fixed orientation or in any desired orientation. The devices can be operated in combination or independently. The systems can be employed to provide multiple therapies, including blood perfusion, filtration, aspiration, vessel occlusion, atherectomy, and endoscopic devices. Methods of using the system for vessel cannulation are also disclosed herein.
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BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a disposable multipurpose catheter making it possible in particular to introduce into the human body, at the operating site, surgical mandrins or to inject liquid such as serum or methylene blue in order to perform various pre-operative and intra-operative tests.
2. Description of Background and Relevant Information
Multipurpose catheter is understood as meaning a catheter/trocar having the function of a tool for perforating the walls and the function of a catheter for introducing, into the operating site, either liquid products or a range of surgical mandrins or other instruments, or both simultaneously.
Catheters of this type are known which comprise a cylindrical body integral at one of its ends with a head which is equipped with two access routes or inlets, while the other end is provided with a balloon which can deform elastically under the effect of a pressure.
This type of catheter makes it possible to perform certain tests or operations but it cannot simultaneously receive surgical mandrins and injection of liquids or passage of a miniature endoscope on account of the fact that the channels formed in the cylindrical body are coaxial to each other and centred in relation to the main axes of the body.
A first channel, centred about the main axes of the body, permits the insertion of a miniature endoscope or the passage of a liquid or the insertion of a surgical mandrin. All of its elements being introduced separately and independently. The second channel coaxial to the first one is provided solely to elastically deform the balloon.
U.S. Pat. No. 5,437,637 likewise discloses a catheter which comprises a flexible cylindrical body having, in its inner part, several non-coaxial channels for the passage of stiffening elements, instruments and/or liquids. This catheter comprises, on its outer periphery, a balloon which can dilate under the effect of a pressure.
It will be noted that, because of its flexibility, this type of catheter cannot be used as a trocar for perforating walls. Moreover, the connection means permit introduction, into each non-coaxial channel, either of instruments or liquids, but they do not allow the surgeon to hold the catheter in order to be able to use it as a tool.
It is these disadvantages which the present invention is intended to eliminate in particular.
SUMMARY OF THE INVENTION
The invention provides for a multipurpose catheter intended to permit various interventions, comprising a cylindrical body of small diameter which has, at one of its ends, a connection mechanism which communicates with non-coaxial channels formed in the inner part of the cylindrical body in such a way that at least one of the channels supplies, to the end remote from that bearing the connection mechanism a balloon which is able to deform elastically under the effect of a pressure, characterized in that the connection mechanism includes a monobloc head made of rigid plastic material which is injection-molded to attach itself in a sealed manner around the cylindrical body, while the head includes independent inlets which communicate with the non-coaxial channels via bores, so that the channels permit introduction either of liquids or of a range of surgical mandrins and/or other instruments, or both simultaneously at the different operating sites.
The invention also provides for a multipurpose catheter characterized in that the head consists of a slightly bulged wall receiving the independent inlets joining opposite the wall via another wall of inwardly curved profile in such a way that the head has an ergonomic profile facilitating the gripping of the catheter.
The invention also provides for a multipurpose catheter characterized in that each wall has surfaces of different inclinations.
The invention also provides for a multipurpose catheter intended to permit various interventions, comprising a cylindrical body of small diameter which has, at one of its ends, connection mechanism which communicates with non-coaxial channels formed in the inner part of the cylindrical body in such a way that at least one of the channels supplies, to the end remote from that bearing the connection mechanism, a balloon which is able to deform elastically under the effect of a pressure, characterized in that the cylindrical body has, remote from the connection mechanism, an end with a conical profile.
The invention also provides for a multipurpose catheter characterized in that the conical profile of the end of the cylindrical body has its axis on the main channel.
The invention also provides for a multipurpose catheter characterized in that the main channel is eccentric in relation to the external diameter of the cylindrical body.
The invention also provides for a multipurpose catheter characterized in that the inclination of the conical profile of the end is intended to lie in the continuation of the instruments or mandrins when they have a conical end.
The invention also provides for a multipurpose catheter characterized in that the balloon is fixed on the cylindrical body in immediate proximity to the cone of the end and more particularly at the widest base of the cone, that is to say the one furthest from the end of the catheter.
The invention also provides for a multipurpose catheter intended to permit various interventions, comprising a cylindrical body of small diameter which has, at one of its ends, connection mechanism which communicates with non-coaxial channels formed in the inner part of the cylindrical body in such a way that at least one of the channels supplies, to the end remote from that bearing the connection mechanism, a balloon which is able to deform elastically under the effect of a pressure, characterized in that the connection mechanism includes a head made of rigid plastic material and equipped with three independent inlets which each communicate by way of a sealed mechanism in one of the channels of the cylindrical body, in order to permit introduction either of liquid products or of a range of surgical mandrins and/or other instruments, or both simultaneously at the different operating sites.
The invention also provides for a multipurpose catheter characterized in that the connection mechanism includes a head made of rigid plastic material and equipped with three independent inlets which each open into an internal bore via bores, the bores being provided to receive through a sealed mechanism the external profile of the cylindrical body such that the bores of each independent inlet communicate via holes passing through the cylindrical body and/or the sealed mechanism with the non-coaxial channels so that the channels permit introduction either of liquid products or of a range of surgical mandrins and/or other instruments, or both simultaneously at the different operating sites.
The invention also provides for a multipurpose catheter characterized in that the sealed means consist of a first ring which is arranged around the cylindrical body opposite the inlet in a shoulder of the bore, and a second ring which is placed around the said cylindrical body in the continuation of the first, in such a way as to cooperate with the bores of the head.
The invention also provide for multipurpose catheter characterized in that the sealed mechanism includes a ring which is arranged around the cylindrical body opposite the inlet in a shoulder of the bore, while the external diameter of the body is directly fixed in the bore of the head.
The invention also provides for a multipurpose catheter characterized in that the rings are bonded on the external profile of the cylindrical body and on the internal periphery of the bores in order to make the head integral with the body.
The invention also provides for a multipurpose catheter characterized in that the ring has a length which is defined in order to delimit, in the shoulder of the bore, a chamber which communicates with the bore of the inlet of the head via a space.
The invention also provides for a multipurpose catheter characterized in that the space is provided solely on the inlet side of the head, while the outer wall of the cylindrical body is in tight contact, on the one hand with the internal periphery of the bore and, on the other hand, opposite the space, with the internal periphery of the bore.
The invention also provides for a multipurpose catheter characterized in that the cylindrical body has two non-coaxial channels of different diameters which are offset in relation to each other and laterally in relation to the main axes of the body, in such a way that the first channel communicates with two inlets of the head, while the second channel cooperates with the third inlet for supplying the sealing mechanism.
The invention also provides for a multipurpose catheter characterized in that the cylindrical body has at least three non-coaxial channels of different diameters which are offset in relation to each other and laterally in relation to the main axes of the body, in such a way that the first channel of greater diameter communicates with the first inlet of the head, the second channel with the third inlet of the head for supplying the sealing mechanism, and the third channel with the second inlet for emerging from the body at the same level as the first channel.
The invention also provides for a multipurpose catheter characterized in that the cylindrical body has a hole to permit communication between the channel and the bore of the inlet.
The invention also provides for a multipurpose catheter characterized in that the cylindrical body has a hole permitting communication between the channel and the bore of the inlet.
The invention also provides for a multipurpose catheter characterized in that the cylindrical body has two channels which communicate via holes in the chamber connected to a space in order to open into the bore of the second inlet of the head in order to supply the sealed mechanism.
The invention also provides for a multipurpose catheter characterized in that the range of instruments includes of mandrins cooperating with the channels of the cylindrical body in order to perform various tests or operations.
The invention also provides for a multipurpose catheter characterized in that the surgical mandrins include a head integral with a rod whose free end varies in its geometric shape and its material.
The invention also provides for a multipurpose catheter characterized in that the mandrin has a free end designed with a hemispherical profile.
The invention also provides for a multipurpose catheter characterized in that the mandrin has a rod of curved profile whose free end is designed with a hemispherical profile.
The invention also provides for a multipurpose catheter characterized in that the cylindrical body is rigid.
The invention also provides for a multipurpose catheter characterized in that the cylindrical body is flexible.
The invention also provides for a multipurpose catheter characterized in that the cylindrical body is transparent.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention also provides for a multipurpose catheter comprising a cylindrical body including a first end, a second end, and at least three internal non-coaxial channels, a connection mechanism disposed adjacent the first end for communicating with the at least three non-coaxial channels, the connection mechanism comprising an ergonomic monobloc head which is sealingly attached to the first end of the cylindrical body, the ergonomic monobloc head comprising a bulged wall having at least three independent inlets for communicating with the at least three non-coaxial channels via bores, two walls which continue from the bulged wall, and a concave inwardly curved connecting wall, the connecting wall being disposed adjacent the first end of the cylindrical body and connecting the two walls, wherein the two walls comprise first opposite facing inclined surfaces and second opposite facing inclined surfaces having a different inclination, one of the at least three internal non-coaxial channels being adapted to provide communication between at least one of the at least three independent inlets and an elastically deformable balloon disposed adjacent the second end, and two of the at least three internal non-coaxial channels being adapted to allow the respective introduction of a liquid and a surgical mandrin, wherein the ergonomic monobloc head is adapted to be gripped by a user.
The catheter may be adapted for use in various medical interventions. Each of the at least three independent inlets may communicate with a corresponding internal non-coaxial channel via a corresponding bore. The catheter may be adapted to simultaneously deliver the liquid and the surgical mandrin via separate internal non-coaxial channels while the balloon is expanded via a different internal non-coaxial channel. The ergonomic head may comprise an injection moldable rigid plastic material. The first opposite facing inclined surfaces may comprise a shorter length than the second opposite facing surfaces and each of the first and second opposite facing inclined surfaces may be inclined inwardly and towards one another. The second end of the cylindrical body may comprise a conical profile. One of the at least three internal non-coaxial channels may comprise a large main channel, the large main channel comprising an axis which corresponds to an axis of the conical profile. The large main channel may be eccentrically disposed with respect to an external diameter of the cylindrical body.
The second end may comprise a cone shaped profile and the balloon may be fixedly disposed in an immediate proximity to the cone shaped profile. The balloon may be disposed in the immediate proximity to a widest diameter portion of the cone shaped profile. The bores of the connection mechanism may comprise separate internal bores, each of the bores providing separate sealed communication between the at least three independent inlets and the at least three internal non-coaxial channels. The first end of the cylindrical body may extend into the connection mechanism. The catheter may be adapted to introduce one of a range of surgical mandrins and a range of surgical instruments into a patient.
The connection mechanism may be connected to the first end of the cylindrical body via a sealing mechanism which comprises a first ring arranged around the cylindrical body. The first ring may be disposed in a bore of the connection mechanism wherein the bore has a shoulder. The connection mechanism may further comprise a second ring arranged around the cylindrical body, the second ring being disposed in another bore of the connection mechanism. The first and second rings may be bonded to each of the cylindrical body and the connection mechanism in order to make the ergonomic monobloc head integral with the cylindrical body. The sealing mechanism may be disposed adjacent the inwardly curved connecting wall. The connection mechanism may comprise a chamber disposed in the area of the first ring and the shoulder of the bore. The connection mechanism may comprise a space which communicates with the chamber and at least one of the at least three independent inlets.
Two of the at least three internal non-coaxial channels may comprise different diameters, and wherein each of the two internal non-coaxial channels are offset in relation to each other. Each of the two internal non-coaxial channels may be laterally offset relative to a main center axis of the cylindrical body and wherein one of the two internal non-coaxial channels communicates with two of the at least three independent inlets and wherein another channel of the two internal non-coaxial channels communicates with another of the at least three independent inlets and the balloon. The at least three internal non-coaxial channels may have different diameters which are offset in relation to each other and offset laterally in relation to a main center axis of the cylindrical body. The at least three internal non-coaxial channels may comprise a first channel, a second channel and a third channel and wherein the at least three independent inlets comprise a first inlet, a second inlet and a third inlet, wherein the first channel communicates with the first inlet, the second channel communicates with the third inlet and the balloon, and the third channel communicates with the second inlet.
The cylindrical body may comprise at least one bore which cooperates with at least one bore in the connection mechanism to permit communication between at least one channel of the at least three internal non-coaxial channels and at least one inlet of the at least three independent inlets. The cylindrical body may comprise a plurality of bores which cooperate with corresponding bores in the connection mechanism to permit communication between the at least three internal non-coaxial channels and the at least three independent inlets. The surgical mandrin may comprise a head which is integral with a rod, the rod having a free end. The free end may comprise a hemispherical profile. The rod may comprise a curved profile. The cylindrical body may comprise a rigid cylindrical body. The cylindrical body may comprise a flexible cylindrical body. The cylindrical body may comprise a transparent material.
The invention also provides for a multipurpose catheter comprising a small diameter cylindrical body including a handle end, a balloon end, and at least a first, a second, and a third internal non-coaxial channel, a connection mechanism disposed adjacent the handle end for communicating with the first, second and third internal non-coaxial channels, the connection mechanism comprising an ergonomic handle head which is sealingly attached to the handle end, the ergonomic handle head comprising a bulged wall having a first, a second and a third independent inlet, each of the first, second and third independent inlets communicating with a corresponding first, second, and third internal non-coaxial channel via first, second, and third bores, two walls which extend from the bulged wall, and a concave inwardly curved connecting wall, the connecting wall being disposed adjacent the handle end of the cylindrical body and connecting the two walls, wherein the two walls comprise first oppositely facing inclined surfaces and second oppositely facing inclined surfaces having a different inclination, the first internal non-coaxial channel communicating with the first independent inlet and an elastically deformable balloon disposed adjacent the balloon end, and the second and third internal non-coaxial channels being adapted to respectively allow introduction of a liquid and a surgical mandrin, wherein the ergonomic handle head comprises an ergonomic shape which is adapted to be gripped by a user.
The description which follows with reference to the attached drawings, given as nonlimiting examples, will permit a better understanding of the invention, of its characteristic features and of the advantages it is likely to afford:
FIG. 1 is a general view representing the multipurpose catheter according to the present invention.
FIG. 2 is a cross section illustrating a first variant of the catheter in which the inlets of the head open into channels of the cylindrical body.
FIGS. 3 and 4 are cross sections along III—III and IV—IV in FIG. 2, showing the position of the channels formed in the cylindrical body of the catheter according to the first variant.
FIG. 5 is a cross section representing a second variant of the multipurpose catheter according to the present invention.
FIGS. 6 and 7 are cross sections along VI—VI and VII—VII in FIG. 5, illustrating another configuration of the channels formed in the cylindrical body of the catheter.
FIG. 8 is a view showing a third variant of the multipurpose catheter, more particularly as regards the profile of the connection head.
FIGS. 9 and 10 are cross sections representing the connection head according to FIG. 8 and more particularly the position of the independent inlets which cooperate with the non-coaxial channels of the multipurpose catheter.
FIG. 11 is a cross section illustrating the profile of that end of the multipurpose catheter remote from the end with the connection head, and the position and the profile of the balloon.
FIG. 12 is a cross section similar to that in FIG. 11 showing another profile of the balloon.
FIGS. 13 a , 13 b and 14 a , 14 b are views showing mandrins provided to cooperate with the channels of the catheter in different operations.
FIG. 15 is a view illustrating an example of use of the multipurpose catheter according to the present invention.
FIG. 16 is a view similar to that of FIG. 15, but representing another example of use of the catheter according to the present invention.
FIG. 17 is a view showing the use of the multipurpose catheter as a trocar during laparoscopy.
FIG. 18 is a view representing another application concerning the use of the multipurpose catheter according to the invention.
DETAILED DESCRIPTION OF THE INVENTION
In FIG. 1, a catheter 1 is shown which utilizes a cylindrical body 2 of translucent plastic material which is substantially flexible or rigid and integral at one of its ends with a head 3 forming a connection mechanism and including three independent inlets 30 , 31 and 32 .
At the end remote from the one bearing the head 3 , the cylindrical body 2 has sealing mechanism 4 utilizing a balloon 40 which can deform elastically under the effect of a pressure.
Near the balloon 40 , the free end of the cylindrical body 2 , ends with a tapered profile 20 in a point (FIGS. 11, 12 ).
The connection head 3 is made of a rigid plastic material which may or may not be transparent and whose inner part is hollow in such a way that each inlet 30 , 31 and 32 opens into channels formed in the cylindrical body 2 .
The connection head 3 is monobloc and has a double Y-shape forked profile, that is to say the inlet 30 is on the same longitudinal axis as that of the cylindrical body 2 , while the other two inlets 31 and 32 are offset laterally so as to be arranged to each respective side of the inlet 30 .
The inlets 30 , 31 and 32 are each integral with a joining element 33 which permits sealed attachment, for example, of a valve 5 for introduction of liquids, a stopper 6 obstructing an inlet, and the positioning of a series of surgical mandrins 7 whose profiles vary depending on the intervention.
In FIGS. 2 to 4 , a first variant of the multipurpose catheter 1 is shown whose cylindrical body 2 has two channels 21 and 22 running along its length, and along longitudinal axes offset in relation to the main axes XX′ and YY′.
It will be noted that the diameter of the main channel 21 is greater than that provided for the channel 22 and that these channels are arranged on at least one main axis ZZ′ of the cylindrical body 2 (FIG. 4 ). The channels 21 and 22 are also offset in relation to one another. Furthermore, the channel 21 is eccentric in relation to the external diameter of the cylindrical body 2 .
The head 3 has an internal bore 34 which opens out into each inlet 30 , 31 and 32 via a bore 35 , 36 and 37 . The inlets 30 , 31 and 32 each comprise a chamber 38 into which opens, on the one hand, each bore 35 , 36 and 37 , and on the other hand, the joining elements 33 .
The joining elements 33 have an internal bore 39 which communicates with the chamber 38 of each inlet 30 , 31 and 32 of the head 3 .
The head 3 is attached to the cylindrical body 2 in a sealed manner by way of a first ring 24 which is arranged around the body and opposite the inlet 30 in a shoulder of the bore 34 which is provided with a diameter greater than this bore.
A second ring 23 is placed around the cylindrical body 2 in the continuation of the first one, in such a way as to cooperate with the bores 34 and 35 of the head 3 . The rings 23 and 24 are bonded on the external profile of the cylindrical body 2 and on the internal periphery of the bores 34 and 35 in order to Lake the connection head 3 integral with the body.
The two rings 23 and 24 are provided with different external diameters, while their internal diameter is identical in order to cooperate coaxially around the cylindrical body 2 .
The cylindrical body 2 passes through the chamber 38 of the inlet 30 to allow the channel of large diameter 21 to open into the bore 39 of the corresponding joining element 33 .
At the opposite end, the main channel 21 emerges from the cylindrical body 2 along the tapered profile 20 of pointed or conical shape.
It will be noted that the end 20 of the cylindrical body 2 has a conical profile which is arranged on the axis of the main channel 21 . The latter is eccentric in relation to the external diameter of the cylindrical body 2 , which gives this particular profile to the end 20 (FIGS. 11, 12 ).
Thus, the end 20 has a conical profile which has an inclination of about 30° [sic] degrees.
The conical profile of the end 20 is intended to be disposed in the continuation of the instruments or mandrins 7 whose end is also conical.
It will be noted that the balloon 40 is fixed on the cylindrical body 2 of the catheter in immediate proximity to the cone of the end 20 , and more particularly at the widest base of the cone, that is to say the one furthest from the end of the catheter (FIGS. 11, 12 ).
The ring 23 and the cylindrical body 2 have a first through-hole 25 allowing the bore 37 of the inlet 31 to communicate with the channel of large diameter 21 .
The inlet 31 cooperates with a leaktight stopper (not shown) which, by being clamped onto the threaded part of the inlet 31 , forms a leaktight seal with the mandrin or the instrument introduced into the channel 21 .
Thus, it will be noted that two inlets 30 and 31 open into the same channel 21 formed in the inner part of the cylindrical body 2 .
Likewise, the ring 23 and the cylindrical body 2 have another through-hole 26 situated opposite the first one 25 for allowing the bore 36 of the inlet 32 to communicate with the channel of smaller diameter 22 . The latter, arranged parallel to the channel 21 , is intended to open out in the area of the sealing mechanism 4 in order to inflate the balloon 40 .
It will be noted that the multipurpose catheter 1 described above is of the type with three inlets and two routes, that is to say two inlets open into the same channel.
In FIGS. 5 to 7 , a second variant of the multipurpose catheter 1 is shown whose cylindrical body 2 has, in addition to the channels 21 and 22 , another channel 27 arranged on axes which are offset laterally in relation to the main axes XX′and YY′ of the cylindrical body 2 , and offset in relation to those of the channels 21 and 22 .
In this variant there are two channels 22 which run, on either side of the channel 27 , between the latter and the channel 21 . It will be noted that the channels 22 are on one and the same axis which is parallel to the axis XX′ of the cylindrical body 2 , but arranged in a different vertical plane, as is shown in FIG. 7 .
It will be noted that the channels 21 and 27 are arranged on the same axis ZZ′ of the cylindrical body 2 (FIG. 7 ).
The cylindrical body 2 is integral with the head 3 described above and equipped with its three independent inlets 30 , 31 and 32 .
It will be noted that the inlets 30 , 31 , 32 are integral with the joining element 33 , in order to delimit the chamber 38 .
The cylindrical body 2 is integral with the head 3 by way of the ring 24 , as has been described above, while in this variant the external diameter of the body 2 is bonded directly into the bore 35 .
It will be noted that the ring 24 is shorter in length than that described above in order to delimit, in the shoulder of the bore 34 , a chamber 8 which the cylindrical body 2 passes through.
Removal of the ring 23 makes it possible to form a longitudinal channel 10 (FIGS. 5 and 6) in the bore 34 in such a way as to bring the chamber 8 into communication in order to supply the channels 22 for inflating the balloon 40 .
The longitudinal channel 10 is provided solely on the inlet side 32 , so that the outer wall of the cylindrical body 2 is in tight contact on the one hand on the internal periphery of the bore 35 and, on the other hand, opposite the longitudinal channel 10 , on the internal periphery of the bore 34 so that the bore 37 of the inlet 31 cannot communicate with the chamber 8 .
At the bore 37 of the inlet 31 , the cylindrical body 2 has a first through-hole 28 which permits communication between the bore 37 and the channel 27 .
In this variant, the channels 21 and 27 emerge at the side remote from the head 3 and more particularly at the tapered pointed end 20 .
It will be noted that the cylindrical body 2 has, in the area of the chamber, through-holes 29 which communicate with the channels 22 . Thus, the inlet 32 is connected via its bore 36 , the longitudinal channel 10 , the chamber 8 , holes 29 and channels 22 , with the balloon 40 which is arranged on the cylindrical body 2 at the opposite end from the head 3 , in order to deform it elastically under a pressure.
The catheter 1 described above and shown in FIGS. 5 to 7 has three inlets and three routes or channels compared to the preceding one which had only two routes or channels.
FIGS. 8 to 10 show a third variant of the multipurpose catheter 1 concerning the profile of the connection head 3 on the cylindrical body 2 .
The connection head 3 has a highly ergonomic profile allowing the surgeon to easily hold the catheter 1 between the fingers of one hand during various interventions.
The head 3 includes a slightly bulged wall 14 receiving the three independent inlets 30 , 31 , 32 . The wall 14 , is arranged perpendicular to the cylindrical body 2 and is continued on each of the said body by a wall 15 , 16 with inclined surfaces. Each wall 15 , 16 has, in proximity to the inlets 31 , 32 , an inclined surface 17 of short length which is oriented in the direction of the cylindrical body 2 . Each inclined surface 17 is continued by another inclined surface 18 of different inclination and oriented away from the cylindrical body 2 . Each inclined wall 18 of the walls 15 , 16 meets, at the area of the cylindrical body 2 and opposite the wall 14 , via a wall 19 curved inwards in the direction of the body.
Thus, the profile of the connection head 3 permits a better grip by the surgeon in order to precisely introduce the cylindrical body 2 into the different operating sites.
FIG. 9 shows the inner part of the connection head 3 whose inlets 30 , 31 , 32 cooperate with the non-coaxial channels 21 , 22 of the cylindrical body 2 , as has been described in FIGS. 2 to 4 .
Thus, the connection head 3 allows the inlet 30 to communicate with the channel 21 , called the main channel, while the inlet 32 cooperates with the channel 22 to supply the balloon 40 .
It will be noted that the inlet 31 also cooperates with the channel 21 of the cylindrical body 2 . It will be noted that the inlet 30 comprises an internal bore 35 which is axially offset in order to cooperate with the channel 21 , given that the latter is eccentric in relation to the external diameter of the cylindrical body 2 (FIG. 4 ).
In this embodiment of the connection head 3 , it will be noted that the chambers 38 have been omitted, so that each bore 35 , 36 , 37 of the inlets 30 , 31 , 32 opens directly into the non-coaxial channels of the body 2 and at the end of the head 3 .
In FIG. 10, the inner part of the connection head 3 has been illustrated, where the inlets 30 , 31 , 32 cooperate with the non-coaxial channels 21 , 22 , 27 of the cylindrical body 2 , as has been described for FIGS. 5 to 7 .
Thus, the connection head 3 allows the inlet 30 to communicate with the channel 21 , while the inlets 31 and 32 cooperate, respectively, with the channel 27 , called the operator channel, for the passage of instruments, and the channels 22 for supplying the balloon 40 .
It will be noted that the inlet 31 has an internal bore 37 whose inclination permits communication with the channel 27 via a hole made through the cylindrical body 2 .
By contrast, the inlet 32 has an internal bore 36 which is also inclined and turned a quarter of a turn about the axis of the cylindrical body 2 so as to come into communication via holes in the channels 22 . This position makes it possible to omit the chamber 8 and the longitudinal channel 10 , shown in FIG. 5 .
In the solutions described above and shown in Figures [sic] 9 and 10 , the connection head 3 is made of injection-molded plastic which attaches directly at the moment of molding around the cylindrical body 2 , thereby guaranteeing perfect sealing of the head 3 on the body 2 .
In FIG. 11, the end of the cylindrical body 2 is integral with a balloon 40 whose external profile depends on the distance between the points of attachment of the said balloon on the body 2 .
Thus, it will be noted that the zones of attachment of the balloon 40 are close together allowing the balloon, when inflated, to present a very rounded profile like a tire, around the cylindrical body 2 .
In FIG. 12, the zones of attachment of the balloon 40 are further apart than those shown previously, making it possible to define a volume of the balloon which is different when it is inflated.
The balloon 40 provided at the end of the cylindrical body 2 of the catheter 1 permits sealing by bearing against the wall of the operating site, as will be better seen below. Also, the balloon 40 provides a bearing and a sort of pivoting mechanism which facilitates the movements of the catheter 1 in the space of the operating site and prevents expulsion from the site.
FIGS. 13 a , 13 b and 14 a , 14 b show a series 7 a , 7 b , 7 c , 7 d of surgical instruments, or mandrins 7 , making it possible to carry out the examinations illustrated in FIGS. 15 and 11.
The mandrins 7 in each representation have a head 70 of plastic integral with a metal rod 71 of small diameter.
It will be noted that only the free end opposite the head 70 varies in its geometric shape and its material in order to permit different types [sic] of examination.
In FIG. 13 a , the mandrin 7 a has at the end of its rod 71 a free end 72 designed with a hemispherical profile.
In FIG. 13 b , the mandrin 7 b has a rod 70 presenting a curved profile, but whose free end 72 is designed with a hemispherical profile.
In FIG. 14 a , the mandrin 7 c has at the end of its rod 71 a free end 73 with a very tapered point or conical shape whose inclination is similar to that of the end 20 of the cylindrical body 2 so as to lie in its continuation (FIG. 11 ).
Finally, in FIG. 14 b , the last mandrin 7 d of the series has a free end 74 of conical profile, but the end is slightly rounded. In the same way as before, the conical profile of the end 74 lies in the continuation of the conical end 20 of the body 2 .
The multipurpose catheter 1 described above and its mandrins 7 a , 7 b , 7 c , 7 d are designed to perform a number of procedures coming under the term FERTILOSCOPY and having of several stages permitting:
evaluation of the state of the uterus,
evaluation of the permeability of the tubes,
evaluation of the ovarian and tube environment,
unparalleled visualization of the distal part of the fallopian tubes and the ovaries,
evaluation of the quality of the fallopian tubes by associated salpingoscopy.
FIG. 15 illustrates a first example of an examination using the multipurpose catheter 1 including a head 3 with three inlets and two channels 21 and 22 .
The catheter 1 is introduced into the uterus a of a patient P in order to perform, for example, a methylene blue test so as to verify permeability of the fallopian tubes b.
The head 3 , and more particularly the inlet 31 , is integral with a valve 5 connected to a syringe 9 filled with a liquid comprising methylene blue, while the inlet 30 is closed tight by the head 70 of a mandrin 7 .
The inlet 32 is connected via a nonreturn valve to a source of air or liquid under pressure 11 in order to inflate the balloon 40 inside the uterus a so as to obstruct the latter and seal it for introduction of the methylene blue.
The mandrins 7 a or 7 b are introduced via the inlet 30 which communicates with the same channel 21 as that of the inlet 31 used for introducing methylene blue so that the end 72 is accommodated in the operating site of the uterus a. The introduction of a mandrin 7 a or 7 b permits mobilization of the uterus a in order to facilitate its examination upon joint laparoscopy.
FIG. 16 shows another intervention using the multipurpose catheter 1 with three inlets and two channels for FERTILOSCO
This operation provides for making an incision in the vaginal pouch c under local anesthetic. This FERTILOSCOPY is performed using the multipurpose catheter 1 combined with a mandrin 7 such as 7 c which is introduced into the operator channel 27 of the cylindrical body 2 .
The FERTILOSCOPY provides for creating an artificial ascites with serum which is injected using the multipurpose catheter into the operating site in order to permit observation of the adnexa under the most physiological conditions possible.
It is also possible, using the catheter 1 with three inlets and three routes or channels, to perform a FERTILOSCOPY by introducing surgical mandrins into the channel 27 of the cylindrical body, and in particular a clamp stabilizing the infundibulum, a FERTILOSCOPE with which it is possible to perform independent salpingoscopy.
The same channel 27 can be used to perform biopsies, hydrosalpinx incision before deciding whether to operate.
FIG. 17 shows another application of the multipurpose catheter 1 as a trocar during laparoscopy for a salpingoscopy.
The multipurpose catheter 1 is introduced into the infundibulum of a fallopian tube b which is lifted by a clamp 12 . The balloon 40 is inflated by a source of air or liquid under pressure 11 which is connected to the inlet 32 via a nonreturn valve 5 . A miniature endoscope 13 is introduced via the inlet 30 so that its lens is accommodated inside the infundibulum to be auscultated. This miniature endoscope is placed after the withdrawal of a mandrin 7 c at end 73 making it possible to pierce the skin of the patient P.
A syringe 9 is arranged on the inlet 31 which includes another valve 5 in order to fill the infundibulum with serum, facilitating visual examination.
After withdrawing the miniature endoscope 13 , salpingotomy can be performed if necessary using the balloon 40 .
FIG. 18 illustrates still another application of the multipurpose catheter 1 for performing salpingoscopy. The catheter used has three inlets and three routes, so that when it has been introduced into the operating site, it is possible to move a clamp 41 through the operator channel 27 , while a miniature endoscope 13 is arranged in the eccentric channel 21 . The dimensions of the latter make it possible to inject a liquid around the miniature endoscope 13 during examination of the fallopian tube held by the clamp.
It will be noted that the diameters of the channels 21 and 27 are adapted to receive the rods 71 of the mandrins 7 a , 7 b , 7 c , 7 d or surgical instruments while permitting injection of a liquid in the same channel.
It will be noted that the multipurpose catheter 1 , when used as a trocar, replaces the liquid infiltration sheath which is obligatory when using miniature optical endoscopes 13 . In addition, the diameter of the channel 21 can receive any miniature endoscope 13 whose external diameter does not exceed 4 mm when the infiltration sheath is withdrawn.
Moreover, the cylindrical body 2 is made of a transparent plastic material permitting monitoring of the descent of the lens 13 inside the catheter 1 .
It will be noted that the multipurpose catheter according to the present invention replaces the sheaths necessary when using miniature endoscopes.
Finally, it will be noted that the multipurpose catheter 1 may be most commonly used in the field of gynecology for performing all the examinations performed to date.
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Multipurpose catheter including a small diameter cylindrical body including a first end, a second end, and at least three internal non-coaxial channels. A connection mechanism is disposed adjacent the first end for communicating with the non-coaxial channels. The connection mechanism comprises an ergonomic monobloc head which is sealingly attached to the first end of the cylindrical body. The monobloc head comprises a bulged wall having at least three independent inlets for communicating with the three non-coaxial channels via bores and two walls which continue from the bulged wall. An inwardly curved connecting wall is also included. The connecting wall is disposed adjacent the first end of the cylindrical body and connects the two walls. The two walls comprise first opposite facing inclined surfaces and second opposite facing inclined surfaces having a different inclination. One of the at least three channels is adapted to provide communication between at least one of the independent inlets and an elastically deformable balloon disposed adjacent the second end. Two of the at least three channels are adapted to allow the introduction of one of a liquid and a surgical mandrin. The ergonomic monobloc head is adapted to be gripped by a user.
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This application is a continuation of application Ser. No. 07/135,988, filed Dec. 21, 1987 (now abandoned).
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally relates to a foot positioning training aid for training and instructing individuals in the proper positioning of their feet when engaged in various activities in which the position and movement of the feet are critical to proper execution of desired functions. The invention has particular utility for training individuals engaged in athletic activities such as moving or positioning a bat to engage a thrown ball, positioning and swinging a golf club to strike a stationary golf ball, positioning a racquet for optimum engagement with an approaching ball or other projectile and other similar activities. The training aid includes a generally rectangular panel which can be supported on various supporting surfaces and is provided with a raised rear edge portion and raised side edge portions to position the feet but not form barriers to movement. The side edges of the training include progressive numerical indicia and VELCRO alongside of the indicia together with positionable indicators on the VELCRO to provide indicators for initial position of the feet and also indicators to indicate movement or secondary positions of the feet for optimum performance of certain functions. The disclosure in this application relates to training a batter in striking a ball with a bat by instructing the batter in various proper batting techniques.
INFORMATION DISCLOSURE STATEMENT
There have been provided many devices to assist in training individuals in hitting a baseball, softball or the like, properly striking a golf ball, swinging a tennis racquet and the like. While such devices have accomplished beneficial results to some extent, none of the previously known devices utilize the structural arrangement of this invention and none of the devices utilize the same technique as this invention. A separate information disclosure statement will be filed.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a foot positioning training aid for use in training individuals to properly position their feet when engaged in various activities and which includes a flat panel supported on a support surface and having an upper surface to be engaged by the feet of a person being trained together with position indicating arrangements associated with the panel to provide instructions to an individual as to optimum foot position and optimum foot movement when participating in certain activities.
Another object of the invention is to provide a training aid in accordance with the preceding object in which the panel is of rectangular configuration and the indicating arrangements include an upstanding edge element along one end edge and two side edges of the panel combined with numerical indicia and VELCRO strips adjustably and detachably receiving VELCRO indicators to indicate the position of the feet of an individual at a starting point and to indicate movement of one or both feet and a subsequent position of the feet during a particular activity.
A further object of the invention is to provide a training aid in accordance with the preceding objects which is especially useful in instructing individuals in proper foot positions when using a bat to bat a baseball, softball and the like with the training aid also being useful in training individuals in other sports, athletic endeavors or other endeavors in which foot position and foot movement are critical to optimum performance of such activities.
These together with other objects and advantages which will become subsequently apparent reside in the details of construction and operation as more fully hereinafter described and claimed, reference being had to the accompanying drawings forming a part hereof, wherein like numerals refer to like parts throughout.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the foot positioning training aid of the present invention when used in training an individual in batting a thrown ball.
FIG. 2 is a perspective view of the invention illustrating the manner in which it is initially positioned with respect to a home plate.
FIG. 3 is a perspective view illustrating the invention used when training an individual in bunting a baseball or the like.
FIG. 4 is a top plan view of the training aid.
FIG. 5 is a longitudinal, sectional view, on an enlarged scale, taken along section line 5--5 on FIG. 4.
FIG. 6 is a transverse, sectional view taken along section line 6--6 on FIG. 4.
FIG. 7 is a fragmental perspective view, on an enlarged scale, illustrating the specific structural details of a side edge portion of the training aid.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now specifically to the drawings, the foot positioning training aid of the present invention is generally designated by reference numeral 10 and in the embodiment disclosed, it is associated with a conventional home plate 12 used in baseball or softball and is used to train an individual batter 14 in various phases of using a baseball bat 16 to hit a baseball that is thrown over home plate 12 in a manner described in more detail hereinafter.
The training aid 10 includes a rectangular panel 18 constructed of rubber, plastic or other material which can be positioned on a supporting surface 20 such as the ground surface, the floor of a gymnasium or any other surface area which is generally flat. The panel 18 is provided with an upper surface 22 that may be in the form of artificial turf or the like or other material that is cleat proof so that the individual 14 wearing cleated baseball shoes may effectively stand on the panel 18. While dimensions may vary to some extent, the panel 18 is solid rubber and may have dimensions of 3/4" thickness, 24" width and 42" length with the device being somewhat flexible but still capable of being self supporting on the supporting surface 20.
Along one end edge of the panel 18, a raised end element 24 is attached which is generally an inverted channel shaped rubber member or it may be a solid rubber member 24 having inclined side walls 26 at approximately 45° to the surface of the panel 18 as illustrated in FIG. 5 which forms a positioning device for the rear foot 28 of an individual batter 14 when batting right handed is illustrated in FIG. 1.
Each side edge of the panel 18 is provided with a side edge raised element 30 of generally inverted channel shaped configuration with the upper surface thereof being generally transversely arcuate and provided with numerical indicia printed thereon, formed thereon or otherwise applied thereto as indicated by reference numeral 32 with the numerical indicia 32 increasing from number 1 adjacent the end element 24 to the number 40 at the opposite end edge of the panel with the indicia 32 including transverse division lines 34 spaced at 1" increments or at some other equal spacing.
As illustrated, the side edge raised elements 30 are spaced inwardly from the side edges of the panels approximately two inches with a VELCRO strip 36 being provided on the panel 18 outwardly of the raised side edge elements 30 as illustrated in FIGS. 4, 6 and 7 with the upper surface of the VELCRO strip 36 being spaced slightly below the upper surface of the raised side edge element 30 to provide some protection for the VELCRO strip 30 which can be secured to the panel 18 in any suitable manner such as by bonding or the like.
Releaseably and movably positioned on the VELCRO strip is a plurality of indicator strips 38, which are a rectangular configuration and which have matching VELCRO material on the undersurface thereof for detachable mounting and adjustable mounting on the VELCRO strips 36. The hook and loop pile formed respectively on the strip 36 and the shorter strips 38 represent conventional fastener materials which are well known and enable the indicator strips 38 to be positioned at desired positions along the length of either of the VELCRO strips 36. By providing VELCRO strips 36 along both edges of the panel 18, the training aid 10 can be used on either side of home plate 12 to enable left-handed and right-handed batters to use the device. The VELCRO strips 36 are approximately 2" in width and extend throughout the length of the side edge of the panel 18 as illustrated in FIG. 4 with the side edge raised elements 30 being approximately 2" wide and 2" high and 39" in length since these elements terminate at the forward edge of the end raised element 24 as illustrated in FIG. 5. All of these components may be constructed of rubber, plastic or similar material with the VELCRO strips 36 and 38 being of conventional construction and provided with a flexible backing with the loop and pile material thereon to enable the VELCRO strip 36 to be easily bonded to the panel 18 and to enable the strips 38 to be distinguishably colored. In the preferred embodiment, there are four strips 38 each of which may be 4" in length or any other desired length and have a width equal to or greater than the width of the VELCRO strips 36 with three of the indicator strips 38 being one color such as grey and the other indicator strip 38 being a different distinguishable color such as red to facilitate positioning of these strips and provide observable significance to them which can be readily recognized by the individual being trained.
The five components of the present invention are easily usable and are relatively inexpensive. The panel 18 is of non-skid rubber or plastic material covered with a cleat proof surface with the raised edge elements being of solid or hollow rubber or plastic material and the VELCRO strip 36 and indicator VELCRO strips 38 being commercially available items.
The side edge elements 30 and the numerical indicia 32 thereon provide reference to a starting point and/or placement of both feet 28 and 29 when a batter is in the set position so that the hitter or batter may place the indicator strips 38 at precisely the same point or position each time that he takes a batting stance. This also provides the batter or hitter with a reference point as to the location of his feet during the stride and during each phase of hitting. Thus, the hitter will always place his feet in the same position and stride precisely in the same manner each time he hits which is important in learning his strike zone and training his body in a neuromuscular manner to react to a ball being thrown across home plate with precise timing and accuracy each time.
FIG. 2 illustrates the placement of the training aid in reference to home plate 12 which also must be precisely set at the same place during each practice. The training aid is positioned by the hitter placing his bat 16 perpendicular to the outside edge of the plate 12 at a point 81/2 inches from the front edge where the plate begins it break to the back point. The training aid 10 is then placed on the ground next to the knob 17 on the handle of the bat 16 with this line defined by the bat 16 being oriented perpendicular to the side edge of the training aid 10 and the bat 16 can also be used to adjust the training aid with respect to the length of the bat which occurs when the hitter places his bat 16 so that the knob 17 rests against the inclined edge 26 of the end member 24 in parallel relation to the side edge member 30 as illustrated in FIG. 2. One grey indicator strip 38 is then placed where the handle hits element 24 and another indicator strip is placed to the inside edge of the barrel of the bat and the red indicator strip 38 is placed directly between the two grey indicator strips and is lined up perpendicular to the line formed by the bat 16 when it is positioned across home plate in the manner indicated in FIG. 2. Thus, the red indicator strip will serve as a guideline for the placement of the hitter's head when in the normal batter's stance as illustrated in FIG. 1 since it is most important that the head does not move during the attempt to hit the ball inasmuch as improper movement of the head either up, down, in or out or front-to-back is caused by improper control of the body weight shift during the swing. The red indicator strip 38 positioned as illustrated in FIG. 2 will aid the hitter in keeping the head positioned over the center of gravity during the swing. The third grey strip 38 is then placed 4" in advance of the second grey strip as illustrated in FIG. 2. Thus, the purpose of the four indicator strips include marking the precise place where the hitter 14 will place his rear foot when taking his place in the simulated batter's box formed by the training aid. The second grey indicator strip will mark the precise place where the hitter will place his striding foot 29 when taking his stance and the third grey strip will indicate the precise place where the hitter should stride with his striding foot 29 with each pitch. Thus, the training aid puts the hitter at exactly the same place each time he steps to home plate.
One key factor in hitting is the hitter avoiding a swing at a pitch outside of the strike zone. The present invention allows the hitter to learn his strike zone quickly and aid him in disciplining himself to swing only at strikes. Prior to entering the batter's box during a game, the hitter is allowed to take preliminary swings at the designated on-deck circle which enables the hitter to get his timing with respect to the pitcher with the hitter preparing himself mentally and physically to hit the ball. The present invention can be used as an on-deck circle during regulation games.
Hitting a baseball may be separated into five steps, namely, stance, ready, tracking (hip turn), trigger and follow through and the present invention aids to teach proper techniques and correct common faults in each phase of hitting. At the stance phase, the hitter's toes should be aligned with the raised side element 30 which eliminates open and closed stances and allows the hitter to hit both inside and outside pitches. In an open stance, the hitter sometimes has problems with an outside pitch because the body motion seems to make the plate move away. In a closed stance, the hitter sometimes has problems with an inside pitch because the body motion causes to the plate to seem to move away. The placement of the rear foot 28 is the key to hitting to all fields. If the toes are placed perpendicular to the plate, the hitter will hit through the middle of the diamond most of the time but if the toes are pointed towards the catcher, the ball will be hit to the opposite field most of the time and if the toes are pointed towards the pitcher, the ball will be pulled most of the time. The raised end element 24 will make the hitter aware of his rear foot placement each time he steps into the batter's box. The knees are bent and positioned on the inside of both feet with the end element 24 being used by the hitter to assure proper weight distribution on the ball of the rear foot. Also, the end element 24 forces the hitter to shift his weight forward during the swing so that the heel on the rear foot can clear the element 24 during hip rotation. Also, the feet should be spread comfortably with the toes of the lead foot pointed perpendicular to the pitcher some four to six inches short of the bat length. The hips and shoulders should be level with the ground and the bat should be held in the fingers of both hands with the knuckles of both hands lined up in order to unlock the wrists and elbow joints with the bat held from perpendicular to 45° with respect to the ground. The arms are cocked with the hands and wrists relaxed and held over the rear foot in a manner by which the hands will come through first. The wrists of both hands should not roll below a straight line when the arm is extended parallel to the ground. Also, the head should be upright with the chin over the front shoulder and above the body, the eyes should be level with both of them looking at the point of release of the pitch and the elbow joints should be very relaxed and pointing towards the ground. The training aid of this invention thus aids in proper stance of the hitter preparatory to swinging and during the swing of the bat.
In the ready position in which the hands are cocked back and the front foot stride occurs as the pitcher reaches his ready position, the hitter's lead shoulder and chin should make contact and the bat is also brought into contact with the rear shoulder which helps the hitter to be aware of the location of the body parts prior to the swing and to aid in body part timing with the swing. As the hitter cocks his shoulders back, he will begin his stride position with about 60% of his body weight shifted to his back foot. The weight should remain in this distribution until after the striding foot hits the ground. The hitter should stride directly to the pitcher and try to hit the ball through the middle. The training aid of this invention prevents an incorrect stride since the hitter cannot stride closed, opened or over stride. Also, the invention enables the hitter to discipline himself so that the striding foot remains closed with both knees pointing towards the plate until the important hip turn begins with the knees kept between the feet, the hands and back of the rear foot, the waist, shoulders and eyes kept level, the chin over the lead shoulder until after the stride is complete and hips begin to open then maintaining the lead arm so that it does not straighten or lock-out, which causes loss of speed and power with the forearm of the bottom hand being held parallel to the ground and parallel to the level shoulders with the bat barrel remaining up and above the hands. The stride remains the same whether the pitch is an inside pitch, outside pitch or over the plate with the hip turn and movement of the hands differing with each pitch.
The tracking phase is aided by this invention so that when the hip and legs are committed to the ball, they will initiate movement of the hands to the ball. The hip begins the move and must clear the way for the hands with the arms, hands, wrists and elbows not moving toward the ball during tracking. Also during tracking, the bat will remain in contact with the rear shoulder, the head and chin remains still and down, the hips begin to turn towards the ball and weight begins to be shifted forward to the front leg, the knees begin to turn with the back knee initiating the move, the back hip pops forward with the arms remaining cocked until the hips clear so that power is obtained from the weight shift thereby avoiding the biggest fault of movement of the arms or upper body during hip turns. The barrel of the bat must remain up during the beginning of the hip turn with the hip tracking and turning according to the location of the pitch since the hips will not turn as much on an outside pitch as they would on an inside pitch.
The trigger phase, which is a commitment of the hands and arms to the ball, is assisted by the present invention with both elbows down, bent, compact and close to the body until the hips clear with both hands being thrown toward the ball as the body weight completes its shift to the front leg with the lead arm extending to form a straight line with the bat. At contact with the ball, the barrel of the bat should be above the hands and the hands above the ball and the hands at the point of contact will be palm down for the lead hand and palm up for the trailing hand and the back arm should lock out just after contact. Both arms will then be extended to form a triangle after contact and for maximum force, the head and eyes should remain down and the chin looking over the rear shoulder after rotation, that is, the shoulder and lower body will rotate but the head remains still.
The follow-through position includes the rolling of the wrist after the triangle is formed with the knees being between both feet during the follow-through. The bat should end up at approximately the opposite position from where it started and the head should remain still during the entire swing, which can be checked during training by using the red indicator strip 38 to determine if the head of the hitter is in line with that strip after each swing. As soon as the ball is hit, the hitter becomes a runner and the training aid of this invention allows the hitter to practice his running to first base with maximum effort each time he hits a ball.
The invention also assists in training a hitter in bunting techniques for all major types of bunts in which common positions are used. The body must be aligned with the plate, which is accomplished by the feet of the bunter being positioned with respect to the side elements and the bat must be held at the top of the strike zone and must be balanced to prevent the ball from being popped up. The bat must be placed in fair territory, forwardly of home plate, to prevent the ball from going foul. The hitter should only attempt to bunt strikes and must run full speed to first base after execution of the bunt. The training aid of the present invention enables practice of bunting techniques including positioning of the batter, the bat and reacting to pitches in the strike zone and running to first base.
While the invention has been specifically described with respect to baseball, it also can be used with softball and may also be used with other athletic activities including golf, tennis, and other activities in which the initial position and subsequent movement of the feet are important and in which it is important to locate and position the feet precisely during each training session.
Among some of the advantages and benefits derived from the use of the training aid of the present invention includes teaching hitters to stride closed with the lead foot so that lower body power is stored until the hips turn, provide adjustment of components to allow for individual batting styles, elimination of obstacles that would distract or hinder a stride during batting practice, eliminate mechanical devices which could hang up or break and possibly cause injury, provide adjustment to match individual striding style and distance, enable a hitter to place the rear foot where desired in order to dictate where the ball will be hit, enable adjustment of the batter's box in relation to home plate for each hitter with the length of the bat determining this distance and permit the batter to repetitively reproduce precisely all aspects of hitting until a desired level of skill is attained.
In addition, the device allows a hitter to practice hitting a ball off a tee, practice in any outside or inside area, enable a hitter to align himself with home plate with his center of gravity in alignment with the plate, place his head in line with home plate, enable the hitter to concentrate totally on hitting the ball and which will serve both right-handed and left-handed hitters. Essentially, this device can be used in training all aspects of an individual developing proper techniques for optimum contact with a ball by a hand manipulated implement.
The foregoing is considered as illustrative only of the principles of the invention. Further since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and, accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.
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A foot positioning training aid for training and instructing individuals in the proper positioning of their feet when engaged in various activities in which the position and movement of the feet are critical to proper execution of desired functions. The training aid includes a generally rectangular panel which can be supported on various supporting surfaces and is provided with a raised rear edge portion and raised side edge portions to position the feet but not form barriers to movement. The side edges of the training include progress numerical indicia and VELCRO alongside of the indicia together with positionable indicators on the VELCRO to provide indicators for initial position of the feet and also indicators to indicate movement or secondary positions of the feet for optimum performance of certain functions.
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of prior application number Ser. No. 11/379,665 filed on Apr. 21, 2006.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable.
BACKGROUND
Lift chairs are now well known in the art. These lift chairs extend beyond chairs to all types of seating furniture, including sofas, chairs and sectionals. A lift chair is designed to assist a user both in sitting down in a chair and in getting up from a chair. A wide variety of lift chairs now exist in the marketplace. All of these lift chairs achieve the basic function of raising some portion of the chair to assist the user. Some chairs raise just the arms, while others raise the seat, back and arms together in one unit. People need and use lift chairs for a variety of reasons, most of which relate to the health and strength of the user.
While lift chairs currently exist, they suffer certain drawbacks. Most lift chairs utilize relatively complex lifting mechanisms. This complexity leads to increased weight, cost and repair concerns. A relatively simple lift chair mechanism is needed. Additionally, lift chair mechanisms offer limited, if any, flexibility to the manufacturers. If a lift mechanism is used, the chair manufacturer may not have the flexibility needed to configure the lift chair as desired. In some instances, it may be desirable to lift the seat and back together in one unit, maintaining the orientation of the back relative to the seat. In other instances, it may be desirable to position the back more vertically as the seat is lifted. A lift mechanism that offers manufacturers and users the flexibility to configure a lift chair for both instances is needed. Lift chairs also exist that offer a reclining back feature in addition to the lift feature. However, these mechanisms suffer from the complexity concern noted above. A lift mechanism offering a reclining back feature is needed that is simple in construction.
Thus, while lift chairs are known, there remains a need for a lift chair and lift chair mechanism that are of relatively simple construction, that offer flexibility in configuration and that can accommodate a reclining back feature, while not limiting the furniture styling.
BRIEF SUMMARY OF THE INVENTION
Accordingly, the present invention provides an article of seating furniture with a lift mechanism. The article of seating furniture can be a chair with a base and a seat that is pivotally connected to the base. A back is coupled to the seat and may be fixed with respect to the seat in one embodiment and rotatably coupled to the seat in another embodiment. An actuator is mounted to the base, preferably in the middle of the base and extending towards the rear of the chair. The actuator is pivotally coupled to the base on one end and is pivotally coupled to the seat on the other end. In use, the actuator is used to move the seat from a generally horizontal position of normal use, to a raised assisted position that allows the user to more easily exit the chair. In the embodiment where the back is rotatably mounted to the seat, a linkage bar can be added that extends from the front of the base to a lower portion of the bracket that mounts the back to the seat. The linkage bar functions to recline the back as the seat of the chair is raised from the seated position to the assisted position.
In yet another embodiment a second actuator can be mounted below the connection point of the first actuator to the seat. This second actuator is coupled on the other end to the back brackets. The second actuator can be used to selectively recline the back from an upright position to a reclined position.
In yet another embodiment, a four bar linkage is used to couple the seat to the base. In this embodiment, the seat is not directly pivotally coupled to the base at a single point. Instead, the four bar linkage is used to control the motion of the seat as the actuator of the seat is engaged. The four bar linkage raises the rear of the seat relative to the front of the seat, but also raises the front of the seat relative to the base of the chair.
As will be seen from the detailed description that follows, the lift mechanism utilizes fewer working parts than the previous embodiments contained in the prior art. Additional advantages, and novel features of the invention, will be set forth in part in a description which follows and will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
In the accompanying drawings which form a part of the specification and which are to be read in conjunction therewith, and in which like reference numerals are used to indicate like parts in the various views:
FIG. 1 is a side cross-sectional view of an article of seating furniture with certain parts removed for clarity;
FIG. 2 is a view similar to FIG. 1 , showing the seat in a raised position;
FIG. 3 is a partial, enlarged, cross-sectional view taken along the line 3 - 3 of FIG. 1 ;
FIG. 4 is a partial perspective cross-sectional view of the article of FIG. 1 ;
FIG. 5 is a side cross-sectional view of a different embodiment of an article of seating furniture with certain parts removed for clarity;
FIG. 6 is a view similar to FIG. 5 , showing the seat in a raised position;
FIG. 7 is a perspective view of the embodiment of FIG. 5 , again with parts removed for clarity;
FIG. 8 is a side cross-sectional view of a different embodiment of an article of seating furniture with certain parts removed for clarity;
FIG. 9 is a view similar to FIG. 8 , showing the back in a reclined position;
FIG. 10 is a view similar to FIG. 8 , showing the seat in a raised position;
FIG. 11 is a perspective view of the embodiment of FIG. 8 , again with parts removed for clarity;
FIG. 12 is a perspective view of a different embodiment of an article of seating furniture with certain parts removed for clarity;
FIG. 13 is a side elevation view of the embodiment of FIG. 12 ;
FIG. 14 is an enlarged view of the area indicated by circle 14 of FIG. 13 ;
FIG. 15 is a view similar to FIG. 13 , showing the back in a reclined position;
FIG. 16 is a view similar to FIG. 13 , showing the seat and back in an elevated position;
FIG. 17 is an enlarged view of the area indicated by circle 17 of FIG. 16 ;
FIG. 18 is a perspective view of a different embodiment of an article of seating furniture with certain parts removed for clarity;
FIG. 19 is a side elevation view of the embodiment of FIG. 18 ; and
FIG. 20 is a view similar to FIG. 19 , but showing the seat and back in an elevated position.
DETAILED DESCRIPTION
Referring to the drawings in greater detail and initially to FIG. 1 , a lift chair 10 is shown and designated generally by the numeral 10 . Chair 10 includes a base 12 , a number of legs 14 , a seat 16 and a back 18 . Chair 10 is shown with certain parts removed, such as the seat fabric, cushioning, etc, for the sake of clarity in the explanation that follows. It should be understood that chair 10 , in use, is a fully-finished chair. The base 12 typically sits on the legs 14 providing the appearance of an ordinary chair. Base 12 includes left and right side panels 20 and front and back panels 22 . Panels 20 and 22 form a frame for attachment of the seat, arms and other components of the finished chair. As best seen in FIG. 3 , front frame panel 22 can be a two-piece construction, as shown, but could also be a one-piece construction.
As best seen in FIGS. 1-4 , a lift frame bracket 24 is attached to the front panel 22 . Frame bracket 24 has a front section 26 and a side section 28 that transitions to a back section 30 . The front section 26 has a pair of mounting holes 32 (as seen in FIG. 4 ) that are used to couple the bracket 24 to the front panel 22 . For example, bolts or screws could be used to connect these two elements. Other mounting mechanisms could also be used. The side section 28 also has a number of holes. The upper-most hole 34 is used to couple the bracket 24 and the seat 16 , as is further described below. The lower-most holes 36 are used to couple an articulating link to the back 18 , as will be described below with reference to FIGS. 5-7 . The back section 30 also has a pair of mounting holes 38 that are used to couple bracket 24 to side panels 20 . Again, bolts, screws or other mounting mechanisms could be used to achieve this end.
Seat 16 is supported on chair 10 with a seat frame 40 . Seat frame 40 is preferably made from a sturdy material, such as square steel tubing. It should be understood that other materials with similar characteristics could be used as well. Seat frame 40 is shaped with a perimeter matching that of seat 16 . The front portion of seat frame 40 is pivotally coupled to base 12 . More specifically, the front portion of seat frame 40 is pivotally coupled to side section 28 of bracket 24 using the upper-most hole 34 . This can be achieved with a pin, rivet, or other attaching mechanism that couples the seat frame 40 to the bracket 24 in a manner that allows the seat frame to pivot with respect to the base 12 . As best seen in FIG. 4 , a seat suspension system is typically provided, such as through the use of sinuous wire springs 42 . The use of springs 42 is well known in the art, as are other suspension methods. The particular manner of support is not of particular importance, and any of the known methods are acceptable. In use, additional padding and covering material would be used, as is clearly understood by those in the art.
Returning to FIG. 1 , a back bracket 44 is mounted on seat frame 40 near the rear of chair 10 . One back bracket 44 is mounted to each side of frame 40 , such that a left and right back bracket are used. In the embodiment shown in FIGS. 1-4 , the bracket 44 is fixedly coupled to the frame 40 . To achieve this coupling, a pair of mounting holes 46 is located in a middle section of the bracket 44 . Holes 46 are both used in this embodiment to fix bracket 44 in place with respect to frame 40 . The upper section of bracket 44 is fixedly coupled to the seat back 18 . As best seen in FIG. 4 , back 18 is shown without the usual padding material, upholstery or other covering for the sake of clarity. The lower section of bracket 44 extends below and beside the frame 40 , and will be discussed in more detail with respect to FIGS. 5-7 below.
Returning now to the front of chair 10 , a mounting tube 48 is coupled to the front section of 26 of bracket 24 . The tube 48 can be attached to bracket 24 in any way that provides a long-lasting attachment. Tube 48 extends between brackets 24 and forms a mounting location for a u-shaped yoke 50 as best seen in FIG. 4 . Yoke 50 is attached to tube 48 such as by weldment, bolts, screws or the like. Yoke 50 has a pair of spaced apart legs 52 with a mounting hole 54 through each leg 52 . Mounting holes 54 are used to pivotally couple an actuator 56 to the yoke 50 . Actuator 56 can be a motorized actuator, as shown, or could be another device that operates to linearly extend a rod 58 or other element from a main body. Gas cylinders and electric actuators are some of the devices suitable for use. The actuator 56 should be capable of moving seat 16 when a person is seated within chair 10 . While not shown, it should be understood that actuator 56 has a corresponding control associated with the chair 10 such that a user of the chair can control the actuator 56 . For example, the control could be physically mounted to the chair 10 in a convenient location, such as on the arm, or could be a control wand arrangement. The end of actuator 56 opposite tube 48 is also coupled to a u-shaped mounting yoke, labeled as 60 , having a pair of mounting holes 62 . Yoke 60 provides a pivotal coupling between actuator 56 and a mounting bridge 64 . A pin or other element is placed through holes 62 and the extending rod from actuator 56 to achieve the pivotal coupling. Yoke 60 is fixedly attached to the mounting bridge 64 . The mounting bridge 64 is, in turn, coupled to the seat frame 40 , extending from one side to the other. As an example, bridge 64 can be welded to seat frame 40 , although other rigid mounting arrangements could be used as well.
In use, the chair 10 can be used as a normal chair, as shown in FIG. 1 . In this position, the chair functions as any other chair. The chair can be moved, by controlling the actuator, to the position shown in FIG. 2 . In this position, the user of the chair is assisted in exiting the chair. To achieve this position, the user uses the control associated with the actuator 56 . The actuator extends rod 58 to exert an upward force on seat 16 . The pivot mounting of actuator 56 at yokes 50 and 60 allows the actuator to pivot as needed. The seat 16 is allowed to pivot upwardly due to its coupling to bracket 24 at hole 34 . In this embodiment, the back is fixed relative to the seat, such that the back and seat orientation remain the same throughout the motion of the seat.
Another embodiment of chair 10 is shown in FIGS. 5-7 . Many of the components are the same as that described above with respect to FIGS. 1-4 , as evidenced by the same reference numerals. The embodiment shown in FIGS. 5-7 adds a linkage bar 66 . Bar 66 is coupled proximate the front of chair 10 . More specifically, bar 66 is pivotally coupled to bracket 24 using one of lower holes 36 . The location at which bar 66 is coupled to bracket 24 determines the motion of back 18 , as is further discussed below. A number of holes 36 are provided to allow the desired motion to be achieved. The opposite end of bar 66 is pivotally coupled to the lower end 68 of back bracket 44 using a hole 70 in the back bracket. As best seen in FIG. 7 , it is preferable that a linkage bar 66 be provided on each side of chair 10 .
The other change in the embodiment shown in FIGS. 5-7 , compared with that of FIGS. 1-4 , is that back bracket 44 is rotatably coupled to seat frame 40 . To achieve this coupling, only one hole 46 is used. As shown in FIGS. 5-7 , only the rear-most hole 46 is used.
The addition of bar 66 allows and forces the back 18 to recline, or pivot rearwardly, as the actuator rod 58 is extended. In use, the chair functions as a normal chair when the actuator is not extended, as shown in FIG. 5 . In this position, a user would notice no difference between the chair of FIG. 1 and the chair of FIG. 5 . If the user desires to exit the chair 10 and to have assistance, the user can use the control for the actuator 56 to extend the rod 58 . As the rod 58 extends, the seat 16 is forced upwardly, pivoting about the attachment point at hole 34 . As the seat frame pivots upwardly, bar 66 exerts a rotating force on back bracket 44 (counter-clockwise as viewed in FIG. 6 ). Back bracket 44 pivots about the attachment point at hole 46 . Because the back 18 is fixedly coupled to back bracket 44 , the back 18 is forced into a reclining motion, pivoting rearwardly away from seat 16 . This allows the back 18 to move away from the occupant as the seat 16 rises. Certain users may find this more comfortable, as the back will allow the user to maintain a different posture when exiting the chair.
The addition of bar 66 is a simple operation, and can be done by a manufacturer prior to sale or even in a post-sale, retrofit environment. The coupling of back bracket 44 to seat frame 40 is changed from a fixed coupling to a rotatable coupling, and the bar 66 is pivotally coupled to back bracket 44 and lift frame bracket 24 . In this way, the same basic components can be used to achieve two entirely different motions, based on the desire of the chair manufacturer and chair user.
Yet another embodiment of chair 10 is shown in FIGS. 8-11 . In this embodiment, many of the same components are used, as evidenced by the use of the same reference numerals for the same components described above. In the embodiment of FIGS. 8-11 , the connection between the actuator 56 and the back 18 is different. A different yoke 72 is attached to mounting bridge 64 . Yoke 72 has holes 74 that are used to pivotally couple the yoke 72 to the actuator 56 . However, yoke 72 also has a pair of depending legs 76 . Legs 76 extend downwardly from bridge 64 and extend toward the front of chair 10 . Each leg 76 has a hole 78 extending through it. A second actuator 80 is coupled between legs 76 , using holes 78 . Actuator 80 extends toward the rear of chair 10 . Actuator 80 can be a gas cylinder or other device that operates to retract and extend a rod 82 . While not shown, the actuator 80 also has a control associated therewith that allows the user to engage the actuator 80 when desired, as is more-fully described below. The rod 82 is attached to a coupling block 84 , which is in turn pivotally coupled to a yoke 86 . Yoke 86 is rigidly coupled between back brackets 88 as is more-fully described below. Bracket 88 differs from bracket 44 in the lower portion. Bracket 88 is fixedly coupled to back 18 and rotatably coupled to seat frame 40 , as in the embodiment shown in FIGS. 5-7 . Bracket 88 has a mounting leg 90 that extends inwardly from the side of chair 10 . Leg 90 is used to rigidly couple bracket 88 to a cross tube 92 . Cross tube 92 and legs 90 thus serve to connect the brackets 88 . Cross tube 92 serves as the mounting base for the yoke 86 , as best seen in FIG. 11 .
In use, the chair 10 can function as a normal chair, just as the embodiments shown in FIGS. 1 and 5 . In contrast to the chairs described above with respect to FIGS. 1-7 , the chair of FIGS. 8-11 allows the user to recline the back 18 with the user in a seated position, as shown in FIG. 9 . To recline the back, the user must engage the actuator 80 . Actuator 80 functions to retract rod 82 , which in turn exerts a forward motion on the lower end of bracket 88 . The bracket 88 pivots about the connection point to seat frame 40 , which in turn reclines the back 18 .
The chair 10 of FIGS. 8-11 also allows the user to move the chair to the assist position shown in FIG. 10 . To achieve this position, the user engages actuator 56 , as with the embodiments of FIGS. 1-7 . As shown in FIG. 10 , the user can engage only actuator 56 , in which case the back 18 of chair 10 will remain fixed relative to the seat 16 . The user could also first engage actuator 80 , in which case the back 18 will be reclined relative to seat 16 with the seat in the assisted position.
Yet another embodiment of chair 10 is shown in FIGS. 12-17 . Many of the components are the same as that described above with respect to FIGS. 8-11 , as evidenced by the same reference numerals. The embodiment shown in FIGS. 12-17 adds a linkage mechanism 100 to connect the base 12 to the seat 16 , the importance of which will be discussed in greater detail below.
Linkage 100 is coupled on one end to lift frame bracket 24 . More specifically, linkage 100 includes a first link 102 and a second link 104 , each having one end pivotally coupled to lift frame bracket 24 . Bracket 24 is slightly different in this embodiment and includes a pair of mounting holes 106 that allow the pivotal coupling of links 102 and 104 . As best seen in FIG. 14 , a third link 108 is pivotally connected to link 102 on the end opposite bracket 24 as indicated by number 110 . Link 108 is also pivotally coupled on the opposite end to seat frame 40 at pivot point 112 . A third pivotal connection exists between the two ends of link 108 to the second link 104 as indicated at pivot point 114 . Linkage 100 also has a fourth link 116 that is pivotally connected on one end to second link 104 , as indicated by pivot point 118 , and on the other end to seat frame 40 , as indicated by pivot point 120 . As further described below, linkage 100 serves as the connection between the base 12 and the seat frame 40 . Seat frame 40 is not pivotally connected to bracket 24 at its front end, as noted with respect to the embodiment of FIGS. 1-11 . As best seen in FIG. 12 , each side of chair 10 has a linkage 100 coupling the base 12 to the seat 16 .
The embodiment of FIGS. 12-17 is shown with a slightly different yoke 122 pivotally connecting the actuator 56 to the bridge 64 . Yoke 122 also serves to pivotally connect the yoke 122 to the second actuator 80 . As with the embodiment shown in FIGS. 8-11 , actuator 80 is pivotally connected on its opposite end to a yoke 86 , which is in turn coupled to the cross tube 92 . As best seen in FIG. 15 , the embodiment of FIGS. 12-17 allows the back of the chair to recline. The position of the back is held in place through actuator 80 . While not shown, it should be understood by those of skill in the art that actuator 80 is provided with a control mechanism that, when engaged, controls the actuator 80 to move the back of the chair.
In use, the actuator 56 can be used to lift the seat 16 and back 18 , as best seen in FIGS. 16 and 17 . Linkage 100 operates to lift and rotate the seat frame 40 as the rod 58 of actuator 56 extends. In contrast with the embodiments described with reference to FIGS. 1-11 , linkage 100 not only rotates the seat frame 40 , but also lifts the seat frame 40 , including the front end. This arrangement provides more of a vertical lift assist to the chair occupant as compared to the embodiments of FIGS. 1-11 .
Yet another embodiment of chair 10 is shown in FIGS. 18-20 . Many of the components are the same as that described above with respect to FIGS. 12-17 , as evidenced by the same reference numerals. The embodiment shown in FIGS. 18-20 is simplified as compared to that of FIGS. 12-17 . In the embodiment of FIGS. 18-20 , the second actuator 80 and cross tube 92 are removed. Additionally, the back brackets 88 are coupled to the frame 40 and are not allowed to rotate. As best seen in FIG. 19 , back brackets 88 can be secured with two bolts 124 extending through mounting holes 46 . Linkage 100 operates in this embodiment as described above with respect to FIGS. 12-17 , as can best be seen by comparing FIGS. 16 and 20 .
The present invention has been described in relation to particular embodiments, which are intended in all respects to be illustrative rather than restrictive. Alternative embodiments will become apparent to those skilled in the art to which the present invention pertains without departing from its scope.
It will be seen from the foregoing that this invention is one well adapted to attain the ends and objects set forth above, and to attain other advantages, which are obvious and inherent in the device. It will be understood that certain features and sub-combinations are of utility and may be employed without reference to other features and sub-combinations. This is contemplated by and within the scope of the claims. It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, all matter herein set forth or shown in the accompanying drawings is to be interpreted as illustrative and not limiting.
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An article of seating furniture is provided with a lift mechanism. The article can be a chair with a base and a seat that is pivotally connected to the base. A back is coupled to the seat and may be either fixed to the seat or rotatably coupled to the seat. An actuator is mounted to the base extending towards the rear of the chair. The actuator is pivotally coupled to the base on one end and is pivotally coupled to the seat on the other end. The actuator moves the seat between a generally horizontal position and a raised position. With the back rotatably mounted to the seat, a linkage bar can be added that extends from base front to a bracket that mounts the back to the seat. The linkage bar reclines the back as the seat is raised from horizontal position to the raised position.
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BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to the fields of medicine and organic chemical engineering. More particularly, the invention relates to the manufacture of healing promoting wound dressings. By way of further characterization, the invention pertains to a moisture control burn wound dressing used in instances where skin growth is necessary. More particularly, but without limitation thereto, the invention will be disclosed as it relates to a laminated article to serve as artificial skin during the treatment and healing of skin damaging burns.
2. Description of the Prior Art
A burn covering has two functions. First, it should prevent excessive loss of body fluids and proteins due to uncontrolled evaporative water loss from the burned area. This water loss can be of the order of ten times greater than the normal rate of evaporation through the skin. For a victim with severe burns over a large portion of his body, the total loss is substantial and can lead to shock and death during the immediate (0-5 days) postburn period. Second, it should promote the formation of a viable interface between the wound and covering.
A viable interface is defined as a living, growing fibrin network and is desirable for two reasons. One, neutrophils and macrophages readily enter the network and kill bacteria. This action helps not only to prevent burn wound sepsis--a major cause of limb loss or death--but also to remove exudate which is typically found in a wound. Two, once the fibrin network is developed, the damaged area will more readily accept an autograft--the ultimate goal of burn therapy. A viable interface is indicated by adherence of the covering to the wound. The covering must be flexible in order to conform to the contours of the body so adherence is complete.
Presently, human-donor and porcine skin are the most successful and widely used burn coverings. Both promote the formation of a viable interface and control the evaporative water loss from the burn area. Coverings composed of those skins must be removed or are rejected by the body every three to five days. New skins are then applied. Collagen film has also been tested as an artificial skin.
Laminates of synthetic, non-biodegradable materials are also available for burn treatment. Silastic film laminated with nylon velour has been applied to animals. For example, fabrics impregnated with latex and commercially available synthetic plastic compositions have been used. Metallic foils have also been used as backing material for these types of wound dressings. Although satisfactory for limited purposes and applications, the known burn dressings lack one or more optimum parameters for burn treatment applications where skin growth is an important factor.
It is also known in the art to spray the burned portion of the patient with a solution of poly-ε-caprolactone in a solvent which evaporates to leave a covering layer. Such a treatment, although practical for emergency treatment of flash burn victims, lacks the advantages of compress type treatment in promoting the growth of new skin.
SUMMARY OF THE INVENTION
The invention relates to a dressing useful in treatment of burns using a plasticized poly-ε-caprolactone vapor control and support layer bonded to a porous layer of the same material formed from a foam, a flocked fabric, or a velvet. The porous layer configures to promote new skin growth.
Accordingly, it is an object of the invention to provide a lamination useful in treatment of wounds.
Another object of the invention is the provision of a laminate which is biodegradable.
A further object of the invention is the provision of a wound dressing which promotes the growth of skin over a wound.
These and other objects of the invention will become clear in considering the following description, claims, and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a sectional view of a form of the invention employing a velvet contact layer;
FIG. 2 is a sectional view of the invention employing a foam contact layer; and
FIG. 3 is a sectional view of the invention employing a fabric contact layer.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIG. 1, the wound dressing of the invention is indicated generally at 11. A layer of plasticized poly-ε-caprolactone 12 provides a body conforming support for the laminate and is configured as a sheet to control moisture transmission therethrough. Layer 12 is from 0.001 to 0.01 inches in thickness and the poly-ε-caprolactone has a molecular weight between 2,000 and 300,000. The material thus formed has the advantage of permitting sufficient moisture flow to prevent the collection of excess amounts of body fluid thereunder and yet prevent dehydration of the wound area. A layer 14 is bonded to layer 12 at a junction 13. This bonding is accomplished by taking the film 12 and moistening it with a suitable solvent and pressing the layer 14 thereagainst. The softening provided by the solvent interacts with both layers 14 and 12 to permit a welding or joining along the contacting surface.
The layer 14 which contacts the wound area where it is desirable to promote the growth of skin is, in the illustrated arrangement, made of a plush or velvet material having a woven backing 15 and a contained fibrous nap 16. Both the woven back 15 and the plush 16 are made of the same poly-ε-caprolactone as is backing sheet 12. This dressing has proven to be more comfortable for patients than the silastic-nylon velours of the prior art and have not exhibited failure of the bonding lamination as was common with other known arrangements.
Both the plush and backing sheets may be plasticized by using triacetin or triethylcitrate, or mixtures thereof. These plasticizers prevent hardening of the two layers and permit easy applications and body conforming contact of the laminate. These plasticizing materials are the triacetic acid ester of glycerol and the triester of ethyl alcohol and citric acid, respectively. The hydrolysis products of these esters are ingredients which are found in living organisms and are considered to be bio-compatible. Additionally, these particular plasticizers make the laminate more conformable without lowering the watering permability of the structure beyond the desired range.
The cut plush nap 16 of the arrangement shown in FIG. 1 is particularly easy to remove from the wound without tearing newly formed tissue in comparison to the velours and plushes used heretofor.
For certain burn applications and various parts of the body where the growth of skin is different, other configurations of the invention may be substituted for the embodiment illustrated in FIG. 1.
Referring to FIG. 2, an alternate form of the invention is illustrated wherein a foam layer 18 is substituted for the velvet plush layer 14 and bonded to layer 12. The same bonding technique used for the species of FIG. 1 may be employed in this arrangement.
Likewise, in some instances, a knit or woven fabric made of poly-ε-caprolactone may be employed. In this instance a layer of such fabric indicated at 21 is bonded to the backing 12 to produce the illustrated laminate shown at 19.
In production a polished surface such as stainless steel is used to receive a layer of poly-ε-caprolactone in solvent solution thereon and it is allowed to form a solid film of the desired thickness by allowing the solvent to evaporate. A suitable solvent such as acetone is spread over this layer and the layer 14 or the sponge 18 or the fabric 21 is then impressed on the backing film 12 and held in contact therewith to promote the bonding therebetween. This bond has proven to be adequate in test applications and no instances of layer separation has been noted.
The foregoing description taken together with the appended claims constitutes a disclosure such as to enable a person skilled in the biochemical arts and having the benefits of the teachings contained therein to make and use the invention. Further, the structure herein described meets the aforegoing objects of the invention, and generally constitutes a meritorious advance in the art.
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A wound dressing for burn patients comprises a two layer compress made of ly-e-caprolactone material. One layer is configured for optimum wound contact while the other is configured for moisture control.
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CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application contains subject matter of my provisional application Serial No. 60/286,750 filed Apr. 26, 2001, entitled Attachable Surgical Accessory Instrument.
BACKGROUND OF THE INVENTION
[0002] 1. Field of Invention
[0003] The invention relates to surgical devices and more specifically to clasping and other similar instruments with elongated handles for use in attachment to rigid and supporting adjunct instrumentation. Such attachment allows for fewer hands and affords, a clamping or holding when required in connection with a surgical procedure.
[0004] 2. Related Art
[0005] During the development of the vaginal speculum of the type which is the subject of my U.S. Pat. No. 5,868,668 and my present pending application Ser. No. ______ it was realized that tenaculums and other instruments that are inserted into the opening enlarged by the speculum require means to positively affix them to the speculum. There are numerous surgical procedures that require two or more instruments to be used. For example grasping, retracting, sewing, etc. tissues during surgical procedures. Examining vaginal and other cavities may require two or more long handled instruments to be used in conjunction with the desired speculums, which have in their structures a frame that can be used for attachment of the elongated handles of the instruments. This lessens the necessity of additional assistants during procedures. During a surgical procedure, the surgeon often requires sources of lighting, a suctioning catheter with handle irrigation tubes with attachments. Accordingly, it is highly desirable that these multiple instruments be attached to a readily accessible device so that these instruments can be available for use at a moment's notice. In addition the use of multiple instruments that can be readily available and selectively configured for a specific use will allow the surgeon convenience and less cost in doing the surgery. Such a device will also provide the surgeon more freedom and comfort so that instrument will not require additional personnel to assist or even allow instruments that might fall from the area of surgery. This device will also help the surgeon by keeping the instruments available for immediate use while minimizing any obstruction of view and manipulation of the surgical site. Such a device will also have locking capabilities and may be made for permanent use and/or disposable handling for simplicity of use.
BRIEF DESCRIPTION OF THE DRAWING
[0006] [0006]FIG. 1 depicts a series of four views of the invention, a surgical instrument attachment device with FIG. 1 a being a side perspective view, FIG. 1 b being a top view, FIG. 1 c being a side view of the side shown in FIG. 1 a and FIG. 1 d is a bottom view;
[0007] [0007]FIG. 2 shows a series of four perspective views taken by rotating the within attachment device above a longitudinally with FIG. 2 a showing the left side and top, FIG. 2 b showing the lower surface of the top and both sides, FIG. 2 c showing the left side and top, and FIG. 2 d showing the top and right side;
[0008] [0008]FIG. 3 shows a pair of perspective views with instruments. FIG. 3 a depicts a right bottom view and FIG. 3 b shows a similar attachment device but is a generally reverse or mirror image to that of FIG. 3 a;
[0009] [0009]FIG. 4 is a pair of perspective views with FIG. 4 a showing a top and right side with length adjusting (projecting) provision and FIG. 4 b showing a similar attachment device but is a generally reverse or mirror image to that of FIG. 4 a.
[0010] [0010]FIG. 5 is a front perspective view of the within attachment device.
[0011] [0011]FIG. 6 is a rear perspective view of the within attachment device; and
[0012] [0012]FIG. 7 shows the within attachment device in use and attached to a speculum type of medical instrument.
[0013] The applications of the within invention are many. For example, a common surgical procedure requires tension to be maintained on tissues being surgitized, such as, a dilation and curettage (D&C) of the uterus procedure when the cervix portion of the uterus is held under tension. To accomplish this with the present invention, the cervix is grasped and clamped by the prongs of the tenaculum and pulled forward. To maintain the clamping and tension, the within attachment device is secured to the tenaculum and are locked together into the aperture of the yoke portion of the vaginal instrument maintaining the clamped position while executing the D&C procedure.
[0014] Neurosurgeons while performing spinal surgery may require tenaculums to hold layers of tissues with grasping, clamping and maintaining tension for retraction and keeping exposure of the operative site available. Thoracic surgeons while doing lung and cardiovascular surgeries will find similar advantages. General surgeons, vascular surgeons, urologists and gynecologists (includes obstetrical procedures) will find benefits when utilizing the within attachment device while performing procedures in the abdominal cavity, such as, for example, appendectomies, nephrectomies, colectomies, cesarean section (delivering babies surgically), aneurysmectomies, etc. Orthopedic surgeons could use the within attachment device with spinal procedures hip surgeries which both require grasping, clamping and tension actions when performing surgery in deep structured areas.
[0015] While the present invention is susceptible of various additional modifications and alternative constructions, illustrative embodiments are shown in the drawings and will herein be described in detail. It should be understood however, that it is not to be intended to limit the invention to the particular forms disclosed, but, on the contrary, the intention is to cover all modifications, equivalents, and alternative construction falling within the spirit and scope of the invention as expressed in the appended claims.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0016] Referring now to FIG. 1, a surgical attachment device, 10 L, carrying out the principles of the instant invention are illustrated in four views. This surgical attachment device 10 L, has in FIG. 1 a , a proportionately positioned series of hook projections, 21 , 22 , 23 , 24 and 25 on the top front side of the body of the attachment device, which serves to attach the device, 10 L, to compatible surgical instruments as shown in FIG. 7. In other applications for these hooks to properly function, it has been found that the hooks must have variable heights that will allow attachment to the cooperating member and ensure proper alignment, clearance and solid locking. The apertures 12 and 13 in FIG. 1 b allows the construction of the stabilizing rails 14 , 15 , 16 and 17 within the housing of device 10 L, so as to permit only non rotational movements as it rests on the handles of other instruments. The flanged portion 26 , and the lip edge, 28 of the attachment device, 10 L allows it to engage and lock onto the ringed handle portion 31 of tenaculums and other similar devices as shown in FIG. 7. The bottom view of FIG. 1 d shows the edge of the housings' inner side wall, 11 . The outer housing wall's edge, 18 , is shown in FIG. 1 c and FIG. 1 d.
[0017] In FIG. 2, a series of four perspective views illustrates the rotation of the left handle side attachment device as shown in FIG. 3 b . In FIG. 2 a the outer wall 18 also shows the flanging of the rear portion wall 28 that braces against the finger rings of the tenaculum or other instrumentation as seen in FIG. 7. FIG. 2 b reveals the cut out 27 , the inner rear of device 10 L that locks onto the left ring handle of the tenaculum 31 while the right ring handle 32 would serve the right device, 10 R. In FIG. 2 c the flanged edge 28 of the rear portion for engaging the ringed handle is more clearly depicted. In the outer wall of device 10 L, a cut out 29 is provided to allow this side of the device clearance from the outer wall, 33 . In FIG. 2 d the cut out 19 at the front inner side of device 10 L keeps the handles closing freely without obstruction. The cut out 20 in sidewall 11 allows the attachment device 10 L to engage the inner ring handle 31 without obstruction to the closing of the ratchet or saw-toothed portions 34 and 35 of the tenaculum to lock the right and left handles.
[0018] [0018]FIG. 3 shows the right and left or mirror image 10 R of the device, 10 L. FIG. 3 b shows the inner side 36 of the top portion of device 10 L and the inner portion of the top, 30 in the FIG. 3 a of right attachment device 10 R. The attachment device 10 R, a right mirror image of device 10 L shows respective inner wall 50 , an outer wall 48 and a flanged portion 49 .
[0019] [0019]FIG. 4 a , is a left-sided device, but in two sections 39 and 41 of a device resembling 10 L when integrated and locked into position. This occurs when screw 42 , is rotated clockwise into any of the plural mating apertures, 44 . This allows a variance of length in the bodies depending on the length of the handle portions of tenaculums or other like instruments that are used. When elements 39 and 41 or mirror images 38 and 40 are connected, they will acquire the construction of attachment device, 10 L and 10 R respectively.
[0020] In FIG. 5 the attachment device 10 L is shown in a front view with its respective constructions 11 , 18 , 21 , 28 , 36 appropriate to this device as previously discussed.
[0021] In FIG. 6 the rear view of attachment device 10 L and the respective components, 11 , 18 , 25 , 28 and 36 are shown.
[0022] In FIG. 7 the within attachment device 10 R is shown in an operative position resting on the right handle of a tenaculum 46 and positioned against the finger ring portion 32 . The hook projection 22 R is advanced into the aperture 47 of the right side of the yoke, ( 37 on left side of yoke respectively), for locking purposes. The tenaculum 46 is of the type shown in my U.S. Pat. No. 5,868,668 although any surgical instrument provided with apertures that cooperate with the within attachment device could be utilized.
[0023] The within attachment devices 10 R constructions 38 , 40 and 10 L constructions 39 , 41 , (when locked together) may be constructed of rigid material such as plastic, e.g. polycarbonate; polypropylene; metal or a combination thereof. The hooks 21 thru 25 may be of varying sizes and arrangements so as to accommodate other applications as required in surgical procedures. It is pointed out that while the within embodiment of the present invention is described as utilizing hooks that cooperate with apertures to secure the attachment device to a surgical instrument, it would be well within the spirit and scope of the present invention to utilize equivalent attachment means. The applicability of the within attachment devices to surgical instruments that apply tension or locking affords an excellent service for the surgeon and a cost-effective result for the procedure as described earlier.
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A surgical assisting instrument and device having an elongated rectangular u-shaped body with fasteners extending outward therefrom. These fasteners can be of any number and mounted on the top or sides of the body. The body is affixed vertically on the long handle of a tenaculum or other similar elongated handles of surgical clasping instruments. This permits such surgical clasping devices to be anchored or braced onto a fixed surgical device to provide the surgeon with auxiliary clasping and holding assistance.
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CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority from U.S. patent application Ser. No. 08/813,363 filed Mar. 7, 1997, entitled “Fishing Surveillance Device”, which claims priority from U.S. Provisional Patent Application Ser. No. 60/013,125, filed Mar. 11, 1996.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to fishing and, more particularly, to an apparatus for viewing fish during fishing and a method for using the apparatus.
[0004] 2. Description of the Prior Art
[0005] In recent years, fishermen have taken advantage of technological advances to improve their performance. These advances include, for example, satellite services that provide up-to-the-minute ocean currents and water temperatures to better locate fish. Utilizing this information, modified radar systems are utilized to detect exact locations on the water and modified sonar is utilized to detect the exact location of fish in the water. Fishing poles are made out of space age materials for strength and sensitivity and computer designed lures imitate the exact motions of the prey they are modeled after.
[0006] In spite of these advances, fishermen still lack specific real time information regarding the fishing environment and the actions of any fish that are present. More specifically, there is no provision for detecting the presence and/or desirability of fish, the attractiveness of bait or lure to the fish, whether the rig is configured properly, whether the fish are striking the bait or merely taking investigatory nibbles, the proper time of applying a hooking yank, whether the fish is hooked and how aggressively the fish should be reeled in.
[0007] Heretofore, prior art solutions have been utilized to locate fish. However, these prior art devices do not enable a fisherman to obtain accurate information about the foregoing real time variables.
[0008] It is, therefore, an object of the present invention to provide a submersible camera that is utilized with a fishing line to detect the presence and desirability of fish, the attractiveness of bait or lure to the fish, whether the rig is configured properly, whether the fish is striking the bait or lure or merely taking investigatory nibbles, the proper time to apply a hooking yank, whether the fish is hooked and how aggressively the fish should be reeled in. It is an object of the present invention to provide a submersible camera that is easily attachable to a fishing line and is easy and entertaining to use. It is an object of the present invention to provide a fishing apparatus that enables a visual record of a fishing catch to be recorded. Still other objects will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description.
SUMMARY OF THE INVENTION
[0009] Accordingly, I have invented an underwater surveillance apparatus comprising a watertight housing having a transparent part and a video tube received in the watertight housing. The video tube has a light receiving end positioned to view through the transparent part of the watertight housing. A video cable extends from the video tube to a video monitor disposed above the surface of the water. The watertight housing is configured such that the transparent part of the watertight housing is urged in a direction downstream when the watertight housing is submerged in a body of fluid moving relative to the watertight housing.
[0010] An optical lens can be attached to the light receiving end of the video tube and the transparent part of the watertight housing can be disposed at an end thereof.
[0011] A positioning means can be used for positioning the watertight housing in the body of fluid moving relative to the watertight housing. Preferably, the positioning means includes one or more fins attached to the watertight housing for orienting the watertight housing in a body of fluid moving relative to the watertight housing.
[0012] I have also invented a submersible camera for use in viewing fish in a body of water. The camera includes a watertight housing having a transparent end and a video tube received in the watertight housing. The video tube has a light receiving end positioned to view through the transparent end of the watertight housing. A video cable extends from the video tube to a video monitor disposed above a surface of the water. The camera is configured such that, in response to relative movement between the water of the body of water and the watertight housing, the light receiving end of the video tube orients to view in a direction downstream of the watertight housing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] [0013]FIG. 1 is a side sectional view of a submersible camera;
[0014] [0014]FIGS. 2 a - 2 c are side sectional views of the submersible camera of FIG. 1 attached to a video cable and an adjustment cable for adjusting the angle of the submersible camera;
[0015] [0015]FIG. 3 is an illustration of the submersible camera of FIG. 1 attached to a fishing line and suspended in a body of water behind a moving boat; and
[0016] [0016]FIG. 4 is an illustration of the submersible camera of FIG. 1 attached to a fishing line and suspended in a body of moving water behind a stationary boat.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] A submersible camera 2 is connected to a video monitor 4 via a video cable 6 . A video recorder 8 is optionally attached to the video monitor 4 for recording visual images displayed thereon. A microphone (not shown) is optionally attached to video recorder 8 to record narration of a human operator.
[0018] The submersible camera 2 includes a torpedo-shaped housing 9 having a support eyelet 10 attached adjacent one end thereof for attaching the housing 9 to the video cable 6 . A fin 12 is attached to the end of the housing 9 opposite the support eyelet 10 . The fin 12 extends radially outward from the housing 9 . Attached to an edge of the fin 12 positioned away from the housing 9 is a swivel eyelet 14 .
[0019] The side of the fin 12 adjacent the end of the housing 9 includes a slot 15 adapted to receive a light source 16 therein. The light source 16 is a submersible lightbulb or a lightbulb contained in a transparent housing (not shown).
[0020] A video tube or camera 18 is positioned inside the housing 9 with the longitudinal axis of the video tube 18 parallel with the longitudinal axis of the housing 9 . Housing 9 is adapted to be watertight so that fluid, and in particular water, does not enter the housing 9 and come into contact with the video tube 18 . The video tube 18 contains processing electronics (not shown) to convert video images received thereby to electronic signals. The electronic signals from the video tube 18 are transmitted to the video monitor 4 via the video cable 6 . The video cable 6 is also utilized to provide power to the video tube 18 from a power supply 19 positioned remote from the housing 9 . Alternatively, a power supply 19 ′ is positioned in the housing 9 to provide power to the video tube 18 . The power supply 19 or 19 ′ can also provide power to the light source 16 and other gauges or devices carried by housing 9 .
[0021] The end of the video tube 18 adjacent the fin 12 has a lens assembly 20 positioned thereon. The lens assembly 20 may include a fixed or replaceable lens for focusing the light received thereby onto a receiving array and/or an adjustable iris for controlling the amount of light received by the receiving array. The lens, adjustable iris and receiving array are omitted from FIG. 1 for simplicity. The end of the housing adjacent the lens assembly 20 is transparent so that light can pass therethrough from outside the housing 9 for receipt by the lens assembly 20 .
[0022] With reference to FIGS. 2 a - 2 c , an adjustment cable 22 is attached between a position on the video cable 6 between the support eyelet 10 and the video monitor 4 and the swivel eyelet 14 . The length of the adjustment cable 22 and the attachment of the adjustment cable 22 to the video cable 6 may be fixed. Alternatively, the adjustment cable 22 can be extended between the swivel eyelet 14 and an adjustment position above the surface of the water via a cable eyelet 24 attached to the video cable 6 between the support eyelet 10 and the video monitor 4 . In this embodiment, the angle of the camera 2 to view the bait receiving end of the fishing line 30 (shown in FIGS. 3 and 4) can be adjusted by adjusting the length of the adjustment cable 22 between the cable eyelet 24 and the swivel eyelet 14 .
[0023] With reference to FIG. 3, the submersible camera 2 is suspended in a body of water via the video cable 6 attached to a downrigger 28 which is attached to a boat B. Also suspended in the water is a fishing line 30 having a lure or bait 31 received at a bait receiving end thereof. Attached between swivel eyelet 14 and the fishing line 30 is a release clip 34 . The release clip 34 releasably secures the submersible camera 2 to the fishing line 30 so that the submersible camera 2 can observe the bait receiving end of the fishing line 30 when the camera 2 and the bait receiving end of the fishing line 30 are submerged. The release clip 34 enables the submersible camera 2 and fishing line 30 to be separated. More specifically, the release clip 34 separates the fishing line 30 from the submersible camera 2 in response to the application of a hooking yank to the fishing line 30 . In this manner, once a fish is hooked to the bait receiving end of the fishing line 30 , the submersible camera 2 can be disengaged from the fishing line 30 to avoid potential damage to the submersible camera 2 or entanglement with the video cable 6 by the fish F trying to free itself from the fishing line 30 .
[0024] By observing the video monitor 4 , the fisherman can determine the appropriate moment to apply a hooking yank. Moreover, by observing the bait 31 , the fisherman can assess the desirability of the lure or live bait 31 to the fish F. As shown in FIG. 3, the housing 9 of the submersible camera 2 may include additional fins 12 ′ which enable the angle of the camera 2 to be controlled. These extra fins 12 ′ may be fixed in position on the housing 9 or may be adjustable on the housing 9 to enable the angle of the housing 9 to be adjusted to suit a desired fishing environment, trolling speed or water current speed.
[0025] With reference to FIG. 4, boat B is held stationary on the surface of the water via anchor A. The submersible camera 2 is suspended in the body of water via the video cable 6 attached to the downrigger 28 . A sinker S attached to support eyelet 10 is utilized to help maintain the position of the submersible camera 2 in the body of water. The fishing line 30 is also suspended in the body of water. The fishing line 30 has a lure or bait 31 attached to a bait receiving end thereof and is connected to a fishing pole 32 at an end opposite the bait receiving end. In this embodiment, the adjustment cable 22 is connected between the swivel eyelet 14 and a position on the boat B via cable eyelet 24 . The release clip 34 is releasably attached between the submersible camera 2 and the fishing line 30 . A release line 40 is attached between the release clip 34 and a position above the surface of the water and, preferably, on the boat B. Applying tension of a sufficient extent to the release line 40 causes the release clip 34 to release the fishing line 30 from the submersible camera 2 . In the absence of tension of sufficient extent on the release line 40 , the submersible camera 2 and the fishing line 30 remain connected via the release clip 34 . In this manner, when a fish F is hooked on the bait receiving end of the fishing line 30 , the struggle of the fish F against the fishing line 30 can be observed and/or recorded as desired.
[0026] In use, the fishing line 30 is releasably connected to the submersible camera 2 . The camera 2 and the fishing line 30 are submerged so that the submerged camera 2 orients under the influence of water current C to view the bait receiving end of fishing line 30 and, more specifically, the lure or bait 31 attached to the bait receiving end of the fishing line 30 . The submersible camera 2 transmits visual pictures of the bait receiving end of the fishing line 30 to the video monitor 4 for observation by a fisherman. At an appropriate time, a hooking yank is applied to the fishing line 30 to hook a fish thereon and the fishing line 30 is released from the submersible camera 2 . The fishing line 30 is released from the submersible camera 2 by the application of the hooking yank to the fishing line 30 or by a fish F striking the lure or live bait 31 received on the bait receiving end of the fishing line 30 . Alternatively, the fishing line 30 is released from the submersible camera 2 by applying tension to a release line 40 connected to the release clip 34 attached between the submersible camera 2 and the fishing line 30 . Visual images displayed on the video monitor 4 can be recorded by a video recorder 8 . Moreover, the angle of the submersible camera 2 relative to the bait receiving end of the fishing line 30 can be adjusted via the adjustment cable 22 .
[0027] As can be seen from the foregoing, the present invention provides a visual indication of the presence and desirability of fish F, the attractiveness of the lure or bait 31 to the fish F, whether the fish F is striking the lure or bait 31 or merely taking investigatory nibbles, the proper time to apply the hooking yank, whether the fish F is hooked, and how aggressively the fish F should be reeled in.
[0028] The above invention has been described with reference to the preferred embodiments. Obvious modifications, combinations and alterations will occur to others upon reading and understanding the preceding detailed description. For example, the housing 9 can be permanently attached to the fishing line 30 . Moreover, the present invention can be utilized to fish from freestanding structures such as a pier or bridge. Moreover, if an undesirable fish F approaches the lure or bait 31 , the fisherman can move the lure or bait 31 in an undesirable manner to scare the undesirable fish F away. It is intended that the invention be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
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An underwater surveillance apparatus includes a watertight housing having a transparent part and a video tube received in the watertight housing. The video tube has a light receiving end positioned to view through the transparent part of the watertight housing. A video cable extends from the video tube to a video monitor disposed above a surface of the body of water. The watertight housing is configured such that the transparent part of the watertight housing is urged in a direction downstream when the watertight housing is submerged in a body of fluid moving relative to the watertight housing.
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BACKGROUND OF THE INVENTION
(1) Field of the Invention
This invention relates to agricultural irrigation and more particularly to applying water to the land from a pipe which moves, as it waters, laterally of its length.
(2) Description of the Prior Art
In commercial practice today agricultural fields are often watered by sprinkling from a moving pipe. Most of these irrigation systems are center pivot type. The water is sprinkled from the pipes which constantly move as they irrigate.
Certain irrigation devices have discharged water through socks or soakers. For example, SCHEUTMAAT, U.S. Pat. No. 2,174,600.
LANNINGER, German Pat. No. 348102, discloses irrigation system having a discharge close to the ground.
SUMMARY OF THE INVENTION
New and Different Function
I have discovered that water can be applied to land much more efficiently by running the water through a sock or short flexible hose directly into the furrow to be watered. There is less evaporation than if the water is sprinkled on the ground. There is also less power required because the only pressure required on the water is for even distribution from the pipe. The water is evenly distributed especially if the land to be irrigated is furrowed and diked. Therefore I achieve a better distribution of water, less evaporation and at less power than by the previous methods of irrigation.
Thus it may be seen that the total function of my invention far exceeds the sum of the functions of the individual elements such as pipes, hoses, valves, etc.
Objects of this Invention
An object of this invention is to irrigate cultivated agricultural land.
Further objects are to achieve the above with a device that is sturdy, compact, durable, lightweight, simple, safe, efficient, versatile, ecologically compatible, energy conserving, and reliable, yet inexpensive and easy to manufacture, install, adjust, operate and maintain.
Other objects are to achieve the above with a method that is versatile, ecologically compatible, energy conserving, rapid, efficient, and inexpensive, and does not require skilled people to install, adjust, operate and maintain.
The specific nature of the invention, as well as other objects, uses, and advantages thereof, will clearly appear from the following description and from the accompanying drawing, the different views of which are not scale drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a portion of a center pivot system embodying this invention.
FIG. 2 is a perspective view of a portion of a lateral system embodying this invention.
FIG. 3 is a sectional view taken on line 3--3 of FIG. 1 showing a side sectional view of the equipment with the diked furrows being watered.
FIG. 4 is a top plan view of the system taken on line 4--4 of FIG. 2 showing the system.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to FIG. 1 there may be seen a standard center pivot system such as ZIMMATIC manufactured by Lindsay Manufacturing Company, Lindsay, Nebr., a subsidiary of Dekalb Agresearch, Inc. Such a system includes an elongated pipe 10 carrying water. The pipe is supported above the ground by a plurality of vehicles 2, each vehicle having wheel 14. The vehicles 12 will support the pipe 10 a set distance above the land to be watered. There is a move means such as an electric or water motor 16 attached to the vehicles for moving the pipe with the water therein over the land. Supply means such as the center pivot 18 is attached to the pipe for supplying water to the pipe as it moves.
Those having ordinary skill in the art will recognize that the system as described at this point is well known and commercially available on the market.
The system also has a plurality of outlets 20 for discharging the water from the pipe 10. According to my invention an inverted U pipe 22 is attached to the outlet 20 and a drop pipe 24 is attached to the U pipe. The drop pipe terminates at point 26 above the level of the land 28 to be irrigated. There is connected a drop pipe extension 30 which extends at a angle of 135° to the drop pipe 24 and which extends at a 45° angle to the land 28.
Short flexible drop hose 32 is attached to the drop pipe extension 30. It may be seen that the drop pipe extension 30 terminates at a point 34 also above the level of the land 28 to be irrigated. However the length of the drop hose 32 is such that not only it reaches the land to be irrigated and the bottom 36 of the furrow in the land but also it has a portion 38 which drags along the bottom of the furrow. It may be seen in FIG. 1 for the drop hose 32 to drag along the furrow that it is necessary for the land to be plowed in a circle. That is to say the furrows each have circular configuration having the center pivot 18 as their center. The system is well adapted for irrigating fields having a growing crop 40 growing on top of the beds 42 between the furrows with bottoms 36.
To prevent the water from evaporating or running at a distance from where it is placed, dikes 44 are formed along within the furrows. Equipment for forming the dikes is well known. Normally the dikes will be placed at a spacing of about 2 or 3 times the furrow spacing. That is to say that if the furrows are spaced 40 inches apart that the dikes would be spaced about 80 inches or 120 inches apart. This spacing may vary. However I have found it desirable that the spacing for the dikes be no more than 6 times the furrow spacing. That is to say if the furrows are 40 inches apart, the dikes should be no more than 20 feet apart.
This system is particularly adapted for supplemental irrigation for crops grown in semi-arid land. In areas where there is sufficient rainfall to support a minimum crop, this system is good to provide additional water so that a superior crop may be grown. Normally in such areas the crops are planted in a spaced pattern, Normally there are two rows of planted crop and one or two rows skipped. In such instances the land is watered only in the furrow between the two planted rows. That is to say that the drop pipes 24 would be spaced only in every third furrow if the crop were planted two in and one out (two rows planted, one row skipped) or they would be spaced only in every fourth furrow if it were planted two in, two out.
FIGS. 2 and 4 show a embodiment of this invention attached to a lateral move system with straight rows. That is to say that FIG. 2 shows a system having an elongated pipe 110 supported by a plurality of vehicles 112 each having wheels 114. Only one vehicle has been shown in FIG. 2, but those with skill in the art will understand that there would be a plurality of vehicles. Also the vehicles as shown in FIG. 2 would have a move means 116 attached to the vehicle for moving pipe 110 over the land to be irrigated. Supply means in the form of a supply hose 118 having one end attached to the supply pipe 119 and the other with the elongated elevated pipe 110 supplies water to the elevated elongated pipe 110 as it moves.
Again, those familiar with the system will understand that the embodiment as shown in FIG. 2 as described to this point, is old and commercially available on the market from, for example, Zimmatic by Lindsay Manufacturing Company, supra. To this standard system drop pipes 124 are attached to outlet nipples 120 depending from the elevated elongated pipe 110. On bottom of each of the drop pipes is connected the flexible drop hose 132.
As with the previous embodiment the drop pipe 124 will terminate at a point 134 above the land 28 to be watered and the drop hose will have a portion 138 which drags in the bottom 136 of the furrows between beds 142 having growing plants 140 thereon. As previously indicated there will be additional beds 141 not having a plant growing thereon in a two in, one out planted pattern. There will be drop pipes and drop hoses only between the two rows or beds 142 having plants 140 growing thereon. The furrows of FIG. 4 also show the dikes 144 therein. These dikes will not necessarily be exactly spaced, as are the furrows. However the spacing between the dikes will be less than six times the row spacing and more generally about two or three times the furrow spacing.
As may be seen in both instances the elongated pipe is at right angles to the rows and furrows to be irrigated. Of course in the embodiment shown in FIG. 1, the elongated pipe revolves around the center pivot, but it is also at right angles to the row and it moves laterally or along the row. This is certainly true of the embodiment shown in FIG. 2. That is to say that the elongated elevated pipe is at right angles to the row, that the movement is laterally of the pipe along the row. Water is discharged from the open terminal end of the drag hose 32 and 132.
As an aid to correlating the terms of the claims to the exemplary drawing, the following catalog of elements is provided:
______________________________________10 110 elongated pipe12 112 vehicles14 114 wheel16 116 move means18 118 supply means-- 119 supply pipe20 120 outlets22 -- u pipe24 124 drop pipe26 -- terminal point28 -- land30 -- external pipe32 132 drop hose34 134 terminal point36 136 b. furrow38 138 drag port40 140 crop-- 141 added bed42 142 bed44 144 dike______________________________________
The embodiments shown and describe above are only exemplary. I do not claim to have invented all the parts, elements or steps described. Various modifications can be made in the proportions, material, arrangement, and operation, and still be within the scope of my invention. The limits of the invention and the bounds of the patent protection are measured by and defined in the following claims. The restrictive description of the specific examples above do not point out what an infringement of this patent would be, but are to enable the reader to make and use the invention.
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A furrowed irrigated field is diked and water is applied to the furrows. The water is prevented from running down the furrows by the dikes and therefore stays in the approximate location where applied. The water is applied to the furrows from an elevated pipe at right angles to the furrows. The pipe moves along the furrows. At each furrow to be irrigated, a drop pipe extends downward, terminating a short distance above the ground. A sock or flexible drop hose is attached to the end of the drop pipe. The hose drags along the ground so that there is a minimum of erosion to the soil or evaporation of the applied water.
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This application is a continuation of application Ser. No. 09/627,398 now U.S. Pat. No. 6,333,006 filed on Jul. 27, 2000, which is a continuation of application Ser. No. 08/142,049 now U.S. Pat. No. 6,123,900, filed Oct. 28, 1993.
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention pertains to methods of optimizing the sterilization process for chemical compositions and to allow extended shelf life for sterilized chemical compositions on-site for operational use. In particular, the subject invention concept is directed to a method of sterilizing chemical compositions utilizing irradiation techniques which allow for the chemical composition being sterilized to be maintained within containers for extended periods of time with the assurance that the contents are maintained in a sterilized state. Still further, this invention concept is directed to an improved sterilization method for chemical compositions in general and particularly for isopropyl alcohol used in decontamination procedures. More particularly, this invention is directed to a method where chemical compositions within containers are hermetically sealed to provide a relatively contaminant free outer surface subsequent to a gamma irradiation process for sterilization of the contents of the container being sealed. Still further, this invention directs itself to a method wherein a hermetically sealed container is further hermetically sealed with a second sealing layer which in itself is formed around and encases the first sealing layer and container. More in particular, this invention directs itself to a method of optimizing the sterilization procedure for a chemical composition by providing a third sealing layer around one or a plurality of double sealed containers prior to a gamma ray irradiation process. Still further, this invention provides for a series of processing steps whereby a carton containing sterilized containers may be shipped to a relatively contaminated area and removed to a relatively contamination free area while still maintaining a double hermetic seal around the sterilized containers.
2. Prior Art
Sterilization procedures for chemical compositions are well known in the art. However, increasing statutory demands call for extended, complicated and time-consuming sterilization procedures which require detailed cataloguing and analysis associated with the assurance that a sterilized composition is being maintained in a sterilized state over a period of time so that such can be assured of being sterilized when operationally used.
In some prior art techniques, a single covering layer is used for sealing irradiated chemical compositions. However, such sterilized chemical compositions lose their sterilization ratings over an extended period of time due to the fact that even when on the shelf of a clean room, such are impinged with various microorganisms and contamination particulates. Thus, shelf lives had to be catalogued with the result that there was extended periods of time used in documenting as well as analyzing sterilization procedures in maintaining the sterilization requirements. Still further, in other prior art systems, the contents of a container were irradiated however, no sealing layers were added which even further decreased the sterilization maintenance of the contained chemical compositions.
SUMMARY OF THE INVENTION
This invention is directed to a method of sterilization which includes the step of providing a chemical composition to be sterilized. The chemical composition is then charged into a container and the container is encased within a first sealing layer forming a single layer sealed container enclosure. The single layer sealed container enclosure is then encased within a second sealing layer forming a second layer sealed container enclosure. Both the first and second sealing layers provide for hermetic sealing and the entire second layer sealed container enclosure is inserted into a carton which is lined with a third sealing layer. The third sealing layer is then closed and the entire carton is irradiated at a predetermined radiation level for sterilizing the chemical composition contained within the original container.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a block diagram showing the method steps for the method of sterilization as herein described;
FIG. 2 is a cross-sectional view of a first sealing layer being placed over a chemical container;
FIG. 3 is a cross-sectional view of a second sealing layer encasing the first sealing layer and forming a second layer sealed container enclosure;
FIG. 4 is a cross-sectional view of a carton having a third sealing layer lining for insertion of the second layer sealed container enclosure; and,
FIG. 5 is a perspective view of a closed carton member being irradiated in a plurality of planes.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to FIGS. 1-5, there is shown a method of sterilization for maintaining chemical compositions in a sterilized state over an extended period of time. The subject invention concept is directed to both the combined sterilization process for chemical compositions in combination with the maintenance of the sterilization state for the chemical compositions over a long period of time in order that the user may safely use the sterilized compositions at their discretion with the assurance that the chemical composition remains in a sterilized state. Thus, the problems associated with sterilization are two-fold in nature where the initial problem of sterilization is only one portion of the maintenance of the sterilization concept of the subject method. In general, chemical compositions are sterilized and then shipped in cartons such as cardboard containers with a plastic lining to protect the sterilized compositions maintained in their own containers within the cardboard cartons. The cardboard cartons are generally shipped by normal shipping procedures such as trucks, rail cars, or air transportation. The cartons are brought to the site where the sterilized containers are to be used and in general, procedures have been worked out where the containers and their plastic enclosure are brought internal to the work place while the container which may by then have various contaminating microbes or other particulates are left external to the workplace. The workplace then may store the chemical composition containers in a clean room or other type of room which in itself is designated as a room relatively free of contaminants but such clean rooms also have microbes and various other contaminating particulates in the atmosphere. Thus, a shelf life must be designated for such sterilized chemical composition containers even when used in a clean room type of atmosphere.
In order to solve the problem of shelf life, the subject invention concept's method provides for a series of steps which allow the sterilized chemical compositions within their own containers to be maintained over extended periods of time without a shelf life dependent on the sterilized state being designated nor being important to the maintenance of the chemical composition sterilization.
The use of the subject invention concept method for sterilization of chemical compositions has great use in the pharmaceutical industry. The pharmaceutical industry uses a large amount of alcohol for decontamination since it does kill various organisms. Thus, the pharmaceutical industry demands sterile alcohol and in particular the chemical compositions as herein described and detailed direct themselves to alcohol compositions and particularly to isopropyl alcohol used extensively in the pharmaceutical industry.
Referring now to FIG. 1 which provides a block diagram associated with the overall method of sterilization as herein described, the chemical composition is obtained from a vender and assayed in block 10 wherein it is determined that a proper formulation of the chemical composition has been received. In the case of isopropyl alcohol many different types of composition formulations may be required under varying statutory laws associated with sterilization in different environments. In general, if an alcohol such as isopropyl alcohol is used it may be assayed or measured to provide predetermined compositions or formulations, two of the standards being 70% isopropyl alcohol with 30% water or 91% isopropyl alcohol and 9% water by volume.
The analyzed and measured chemical composition is then passed to a filter mechanism represented by block 20 in FIG. 1 . The filter shown in block 12 may be a standard mechanical filter such as a cartridge filter having a predetermined filtering range such as a 0.22 micron filter to allow removal of particulate matter greater than the filter size. In effect, filter 12 removes residual particulates that may be in the chemical composition and at the size range of 0.22 microns even removes bacteria that may be in the chemical composition liquid. Thus, certain bacteria and spores as well as other particulate contaminants are removed during this phase of the overall method of sterilization.
The chemical composition is brought from the mechanical filter 12 to block 14 which is a test for particulate or microscopic matter. Testing is done in accordance with Test Number 788 dictated in the USP XXII Journal for determination of particulate matter contained within various chemical compositions. The test procedure is well known and used as a standard in the chemical industry where the composition is mixed in a container and the chemical composition has a vacuum applied thereto to allow passage into and through a filter. A section of the filter assembly is removed from the container while maintaining the vacuum and the filter is then placed in a Petri slide. The filter is dried with the cover of the Petri slide slightly open and particles on the filter are counted. Such testing is well known in the art and determines whether particulate matter of predetermined sizes has been removed from the chemical composition.
Once the particulate material testing in block 14 has been completed, the chemical composition is then brought to a secondary concentration test block 16 where the concentration of the chemical composition is once again analyzed to make sure that the proper chemical composition formulation has teen maintained. Secondary concentration test block 16 may be a standard well known concentration test as was provided in block 10 . Once the chemical composition has passed through secondary concentration test block system 16 , the chemical composition is then ready for packaging and has been assured of a proper formulation composition as well as an assurance to the fact that predetermined particulate sizes have been removed from the overall chemical composition.
Thus, in the flow blocks associated with FIG. 1, after passage through the initial concentration or assaying test block 10 , mechanical filter 12 , testing for microscopic material 14 and insertion into the secondary concentration test block 16 , there has been provided a chemical composition of predetermined concentration which is to be sterilized in accordance with the invention concept steps of the subject method.
After the secondary concentration testing as shown in block 16 is completed, container 20 shown in FIGS. 2 and 3 is filled with the chemical composition as provided in block 18 of FIG. 1 . Chemical composition container 20 may be a standard aerosol can or alternatively may be a container with a cap closure. When using isopropyl alcohol as the chemical composition, such is generally inserted under pressure with an inert element such as nitrogen or another chemical formulation acting as the propellant into an aerosol can type chemical composition container 20 . Once the chemical composition is inserted into chemical composition container 20 as shown in block 18 , a nozzle may be mounted at one end with differing nozzle pattern generating systems being used dependent upon what is necessary for a particular decontamination operation. Such type of closure whether it be a nozzle arrangement system or a cap closure is not important to the inventive concept as herein described with the exception that such provide egress of the chemical composition appropriate for a particular decontamination operation. Once the filling composition container 20 has been filled, the operational phase moves to block diagram 22 of FIG. 1 where container 20 is encased within first sealing layer 24 forming a single layer sealed container enclosure 26 .
First layer 24 seen in FIGS. 2 and 3, may be formed of a plastic composition of the closed cell type and in particular may be formed of a polyethylene composition. Once chemical composition container 20 has been encased by first layer 24 , first layer 24 may be heat sealed to form a substantially hermetic seal for chemical composition container 20 as shown in FIG. 2 . At this stage of the process steps, single layer sealed enclosure 26 has been created and is moved to block 28 of FIG. 1 where second sealing layer 30 encases single layer sealed enclosure 26 to form second layer sealed container enclosure 32 . Second sealing layer 30 may also be formed of a plastic composition of the closed cell type and in particular may also be a polyethylene composition similar to first layer 24 . Second sealing layer 30 may then be also heat sealed to provide a hermetically sealed second layer sealed container enclosure 32 as shown in FIG. 3 .
Once second sealing layer 30 has been applied and heat sealed to establish second layer sealed container enclosure 32 ., the enclosure 32 is then inserted into plastic lined carton 36 as shown in FIG. 4 and depicted in flow block 34 of FIG. 1 . Carton 36 may be a cardboard type container adaptable for transportation and associated shipping to the operations site. Additionally, there is provided third sealing layer 38 as shown in FIG. 4, which is a lining for carton 36 . Third sealing layer 38 may once again be formed of a plastic type composition of the closed cell type which may also be a polyethylene bag-like element. Third sealing layer 38 lines the internal walls of carton 36 in order to provide an insert for one or a plurality of second layer sealed container enclosures 32 therein. Third sealing layer 38 may then be closed through tying or some like closure mechanism at an upper section 40 and in this manner the entire second layer sealed container enclosure 32 is then contained therein. Finally, carton 36 may be closed in the standard manner of flap closures for container members.
Once the second layer sealed container enclosure has been inserted into lined carton 36 as shown in block 34 of FIG. 1, carton 36 is then brought to block 42 for carton irradiation processes. The carton irradiation step as depicted in block 42 of FIG. 1 may be a gamma irradiation system where the decay of each atom of cobalt 60 generates a pair of photons of gamma radiation having predetermined energies as well as a beta particle. The beta particle is captured within a housing of the cobalt 60 and the photons of gamma radiation provide for the sterilization radiation process. In general, cartons 36 are brought into the irradiation plant where the cobalt 60 is transported in shielded flasks. Following transfer from the flasks to the irradiation plant, doubly encapsulated cobalt 60 in stainless steel tubes are incorporated into a three-dimensional array which form the energy source for processing carton 36 as depicted in FIG. 5 where the directional arrows 44 show impingement of the gamma radiation in a three-dimensional array direction concept. Cartons 36 are generally passed through the irradiation plant on conveyor systems either using roller beds or suspended carrier systems where the gamma radiation dose absorbed by the chemical composition within the closed cartons 36 is directly proportional to the activity level of the source and the duration of exposure.
Gamma radiation is generally used for sterilization of chemical compositions in that the gamma radiation has a high penetration capability. This high penetration capability enables relatively dense products or compositions to be processed easily. Dosages are generally defined in Grays with one Gray representing the absorption of one Joule of energy per kilogram of material. Sterilizing doses generally are in the 25-35 kilogray range and as the products undergo the irradiation process, obviously the face of carton 36 facing the source of radiation will receive a higher dosage than the side away from the source.
To insure appropriate dose levels between 20-40 kilograys, carton 36 is measured with dosimeters which measure the amount of irradiation impinging on the closed carton 36 . In this manner, the contents of container 20 is assured of appropriate irradiation levels being applied thereto.
The closed cartons 36 are then prepared for shipping as provided in block 44 of FIG. 1 and are transported for operational use downstream.
In this manner, when received at the operational site, closed cartons 36 may be then opened and third sealing layer 38 contained therein may be removed on the loading dock prior to entry into a clean room. The chemical containers 20 are maintained within third sealing layer 38 in a closed manner until removed and then brought to a clean room type operating site with the opened container 36 being left on the loading dock.
Once transported into the clean room or other operational site, third sealing layer 38 may be removed and the chemical containers 20 forming second layer sealed container enclosures 32 may be placed on a shelf for future use. It must be remembered that at this point, there is both a first layer 24 and a second sealing layer 30 encompassing chemical container 20 . When placing the second layer sealed container enclosures 32 on the shelves for use in the clean rooms, generally sterilized gloves are used however, these in themselves as well as the atmosphere of clean rooms have various particulates such as microbes or bacteria which dictate a shelf life for chemical containers 20 if only a single first layer 24 were formed around the chemical containers 20 . However, with the first and second layers 24 and 30 , the now somewhat less than sterilized second layer sealed container enclosure 32 may be kept on the shelf for an indefinite period of time prior to use of the contents of chemical container 20 .
Once the contents of chemical container 20 are to be used, second sealing layer 30 may be stripped from second layer sealed container enclosure 32 leaving first layer 24 surrounding and encasing chemical container 20 in a sterilized manner. Use then can be made of the contents of chemical containers 20 with the assurance that such has been maintained in a sterilized state.
Thus, there has been shown a method of sterilization for chemical compositions in general and in particular isopropyl alcohol compositions where the chemical composition to be sterilized is provided prior to block 10 . In overall concept the chemical composition is secondarily tested for its appropriate concentration in block 16 with an additional test for particulate or microscopic material being made in block 14 . A container 20 is then charged with the chemical composition as provided in block 18 and container 20 is encased within first sealing layer 24 forming a single layer sealed container enclosure 26 as provided in block 22 .
After the first sealing layer 24 is applied, the single layer sealed container enclosure 26 is then encased within second sealing layer 30 forming a second layer sealed container enclosure 32 as provided in flow block 28 . The encasement is provided for hermetically sealing initially the chemical container 20 with the first layer 24 and then the single layer sealed enclosure 26 with the second sealing layer 30 as shown in FIGS. 2 and 3.
The second layer sealed container enclosure 32 is then inserted into an open carton member 36 which is lined with a third sealing layer 38 as shown in flow block 34 and depicted in FIG. 4 . The carton member is then closed as depicted in FIG. 5 and irradiated at a predetermined radiation level for some predetermined time interval for sterilizing the chemical composition contained within container 20 .
Although this invention has been described in connection with specific forms and embodiments thereof, it will be appreciated that various modifications other than those discussed above may be resorted to without departing from the spirit or scope of the invention. For example, equivalent elements may be substituted for those specifically shown and described, certain features may be used independently of other features, and in certain cases, particular locations of elements may be reversed or interposed, all without departing from the spirit or scope of the invention as defined in the appended claims.
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A sterilized chemical composition is stored in a sterile environment for a prolonged period of time, hermetically sealed in successive enclosures and a shipping enclosure. The third sealing layer is removed prior to entering a storage area. The second layer is removed prior to taking the container to the sterile environment. The storage area may also be sterile. The innermost container may be an aerosol container and the composition a disinfectant liquid such as alcohol. The entire shipping enclosure and contects is preferably sterilized with gamma radiation.
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BACKGROUND OF THE INVENTION
[0001] The invention relates to a capsule for releasing agents contained therein at defined points in a body, particularly useful for the examination of the digestive tract.
[0002] It is a generally known fact that a significant part of all drugs is taken in the form of tablets or capsules containing agents that can be absorbed in the digestive tract. With the exception of the stomach, for which the application of medicaments is well managed, the precise location of the absorption could not be adjusted until now. An inherent disadvantage resides in the fact that the passage speed through the intestine and the pH value in the intestine varies considerably for different persons and even for a particular individual depending upon his/her condition. Therefore, even especially prepared capsules used for medicaments, e.g. time controlled, enzyme controlled, pH value controlled or pressure controlled capsules, imply the risk that the agent may pass the target area without being absorbed in a sufficiently large quantity. But, conversely, if intentional overdoses are used, there will be the risk of unintended side effects.
[0003] In the past, a number of methods, arrangements and capsules have become known that were focused on the determination of the specific position of a medicament capsule in the intestine and, if the target position was reached, were implemented to release the agent via remote control; see Andrä, W. et al., A novel method for real-time magnetic marker monitoring in the gastrointestinal tract, Physics in Medicine and Biology 45: 3081-3093 (2000); Hemmati, A., The Site of Iron Absorption in the Gastrointestinal Tract, German Med. Mth., Vol. XIII: 569-573 (1968); DE 29 28 477 A1; Grönig, R., Computer-controlled drug release from small-sized dosage forms, Journal of Controlled Release 48: 185-193 (1997); U.S. Pat. No. 510,801 A; DE 19745 890 A1; U.S. Pat. No. 4,239,040 A; U.S. Pat. No. 5,279,607 A. Most of the capsules described in the aforementioned publications have at least one of the following disadvantages. First, they contain a hard cover. Thus, there is the risk that such capsules may get stuck on stenoses in the intestine and possibly have to be removed by operative surgery. According to the publication by Rösch, T et al., in Derzeitige klinische Indikationen der Kapsel-Endoskoopie (Current clinic indications of capsule endoskopy) in the German journal Zeitschrift für Gastroenterologie (Journal for gastroenterology) 40: 971-978 (2002), this danger can even exist if stenoses have not been registered during a previous x-ray examination. Additionally, the capsules mentioned include hard parts, such as metal springs, batteries and electronic components or circuits that can have a toxic effect if they contact the intestinal wall.
[0004] These two aforementioned disadvantages can be avoided by means of the intestine therapy capsule manufactured according to DE 197 45 890 A1 and, in the same way, by an already suggested capsule with a rotating ball, if suitable substances are used. But these solutions suggest a disadvantage that is due to the mechanism of release. The release is achieved by heating up a partial volume of the capsule (hereinafter referred to as heating element) in an alternate magnetic field by magnetic losses or by friction losses to such a degree that an organic substance melts or the opening of the capsule is activated in another way. Here, the intestine content or the intestinal wall, or the liquid agent is positioned in the direct vicinity of the heating element. The thermal conductivity of this environment is so high that the increased heating of the heating element causes the dissipation of an increased amount of heat into the environment that therefore does not contribute to the temperature rise of the heating element.
[0005] The maximally achievable rise in temperature is determined by the fact that the total power that is input by the alternating field is dissipated into the environment. According to the theory of thermal conduction, the maximally achievable rise in temperature is proportional to the input power and approximately reversely proportional to the thermal conductivity of the environment. The thermal conductivity of the environment for the capsules described is 0.2 W/(m-K) or higher. The thermal resistance between the heating element and the environment is on the order of 1 to 10 K/W. The selected input power of the alternate magnetic field must be sufficiently high to reach the desired maximum temperature despite the heat dissipation. The input power of the alternate magnetic field must not be as high as may be desired because, otherwise, an excessive heating of the patient can be caused by eddy current losses in the body tissue [Brezovich, I. A., Low frequency hyperthermia: capacitive And ferromagnetic thermoseed methods, Medical Physics Monographs 16: 82-111 (1988)].
[0006] It is therefore the object of the present invention to avoid the described disadvantages in an capsule design in accordance with the invention directed to preventing the capsule from getting stuck on stenoses while endowing the same with thermally acceptable characteristics and favorable properties from the point of view of energy.
SUMMARY OF THE INVENTION
[0007] The object of the present invention is achieved by a capsule for releasing at least one agent contained therein at defined positions in a body, which comprises capsule parts enclosing the capsule including at least one insulating capsule part, a material of which has a greater thermal resistance than an other of said capsule parts. At least one heating element at least partially surrounded by said at least one insulating capsule part is provided, wherein the capsule is openable by heating the at least one heating element under an effect of at least one alternating magnetic field. The capsule is dissolvable when entering in contact with a solving liquid. The thermal resistance of the capsule part(s) surrounding the heating elements(s) should be higher than the thermal resistance of the other capsule parts or of common capsules used for medicaments, at least by one order. The invention makes it possible that, on the one hand, all parts of the capsule consist of substances that disintegrate or dissolve when entering in contact with a liquid medium and, on the other hand, the capsule part designated as the heating element is surrounded by a cover that has a considerably greater thermal resistance than 10 K/W. The power required to reach the release temperature is reduced by adding a thermal insulation envelope. The heating generated under the influence of the alternate magnetic fields in at least one part of the capsule leads to a remote-controlled evaporation of an easily evaporating liquid disponed threrin. This liquid presses the agent (or several agents) out of the interior of the capsule, or it causes the capsule wall, which is comprised of parts, to burst. An advantageous embodiment of this invention contains a capsule part at least partially surrounding the heating element, which is closed against the agent by a wall, variable with respect to its position and/or its expansion.
[0008] In a preferred embodiment, at least one heating element that contains a magnetic powder, e.g. Fe 3 O 4 (magnetite), is surrounded by a thermally insulating envelope. Said envelope can be double-walled, in which the walls consist essentially of water-soluble material, such as hard gelatin or sugar, and which are separated by a gas layer, e.g. air. As the whole capsule may only have a specific size to avoid difficulties when swallowing it, the thickness of this envelope is also reduced. Therefore, this thickness must be considered when comparing the thermal conductivity without and with this envelope. Ideally, the thermal resistance of the envelope is about 500 K/W, in relation to a normal medicament capsule of the same size of which the thermal resistance is about 10 K/W. Instead of the double-walled envelope it is also possible to use a porous envelope of water-soluble material with enclosed gas pockets. The thermal conductivity of such porous materials and the conductivity of air differ only slightly.
[0009] The present invention will now be described in more detail by way of the following schematic examples.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a longitudinal section through capsule in accordance with an embodiment of the invention with a bag that can be bloated;
[0011] FIG. 2 is a longitudinal section through an inventive capsule with a stamp;
[0012] FIG. 3 is a longitudinal section through an inventive capsule with a movable dividing wall; and
[0013] FIG. 4 is a longitudinal section through an inventive capsule with two heating elements and two dividing walls that can change their position.
DETAILED DESCRIPTION OF THE INVENTION
[0014] FIG. 1 depicts a capsule 10 , which comprises two parts 11 , 12 with a common geometric axis X-X that are hermetically connected with each other, nested, and for example made of hard gelatin. The open end of the bigger part 11 slides over the smaller part 12 and, in a two-dimensional bent area, the bigger part 11 being provided with a small opening 112 that is closed by a membrane 13 against the spontaneous escape of the agent 14 contained in the capsule 10 . Normally, the agent does not contain water. Alternative to use of a membrane 13 closure, the opening 112 can be made sufficiently small or have a valve design such that the spontaneous escape of the agent 14 is not possible under normal pressure conditions. The capsule part 12 is double-walled and provided with air or another suitable insulation material between the walls for purposes of heat insulation 15 . Capsule part 12 contains a thin-wall bag 17 made of latex or polyethylene and filled with a heating element 16 . The folded structure 171 of this bag 17 allows the enlargement of the volume of the heating element 16 by at least 1 cm 3 or to double the volume. In the example, the heating element 16 is made of a composition of about 40 Vol. % Fe 3 O 4 , the losses of which are about 1 J/kg in a magnetic reversal cycle, and of about 60 Vol-% ethyl alcohol that has a boiling point at 78° C. and evaporates at this temperature and its expansion generates a pressure in the capsule 10 that opens the opening 112 so that the agent 14 escapes to the outside. It is also possible to use another easily evaporating and biocompatible liquid instead of ethanol. The rise in temperature is caused by an alternate magnetic field, which is generated by an electric coil 18 in a commonly known manner, in combination with the Fe 3 O 4 components in the bag 17 .
[0015] A thin layer (eg., film or foil) 19 of polyethylene, shellac or another suitable substance covering the whole capsule 10 protects the capsule 10 against decomposition in a water containing and/or enzyme containing environment, that is given, for example, in the intestinal tract. The opening 112 can also be arranged at another point of the capsule part 11 . Instead of the double-walled part 12 , it is also possible to use a component that contains gas pockets and is made of water-soluble material. Finally, the capsule 10 is neither bound to the embodiment shown in FIG. 1 nor to the two-part design described with respect thereto. The position of the coil 18 is schematically illustrated, and is located outside the body during the application.
[0016] FIG. 2 also depicts a capsule 10 , the parts 11 and 12 of which are held together by a foil (film) 19 that surrounds the entirety of capsule 10 , and which should not be between the nested parts, i.e., in the area 20 . In this area, a biocompatible lubricant, e.g. paraffin, can optionally be added between the two capsule parts 11 , 12 . The heat-insulating part 12 includes bag 17 therein with heating element 16 that is located in the direct vicinity to the bent area 121 of part 12 and supports itself against the bent area 121 during the expansion of the heating element 16 . Additionally, the part 12 is provided with guide surfaces 122 for the supporting and sealing elements 211 of a stamp 21 that can move towards the axial direction marked by an arrow 212 . If the heating element 16 is heated in the manner described with reference to FIG. 1 , the liquid in the heating element expands and presses the stamp 21 with the part 11 towards the direction indicated by the arrow 212 . The foil 19 is torn in the area 20 and the agent 14 is discharged to the outside, for example into the intestinal tract. The penetrating water or other liquid decomposes the parts 11 and 12 from the inside. Like the supporting elements 211 , the stamp 21 should be made of a water-soluble material.
[0017] FIG. 3 again depicts a two-part capsule 10 with a part 12 that is filled with an insulation material 15 and which is slid axially into the part 11 that is provided with an opening 112 . Here, the part 12 is fixed by a foil 19 . Part 12 contains (preferentially without the bag 17 of FIG. 2 ) an element 16 that acts like a heating element if an alternate magnetic field is applied from the outside. A movable diving wall 213 separates said element 16 from the agent 14 which takes up most of the part of the capsule interior. When heating the element 16 , element 16 expands, for example, to double the volume and presses onto the agent 14 in such a way that a membrane 13 that closes the opening 112 in the capsule part 11 is caused to burst. The agent 14 can escape via the opening 112 and the solvent, for all capsule parts including the dividing wall 213 , can flow in. Furthermore, the disclosure relative to FIGS. 1 and 2 applies analogously to FIG. 3 .
[0018] In is noted that the dividing wall 213 that is movable in the capsule part 12 is not bound to the configuration shown in FIG. 3 .
[0019] FIG. 4 also includes a two-part capsule with the two adjoining parts 11 and 12 that are provided with insulation materials 151 , 152 , and which therefore exhibit a greater thermal resistance than the other parts of the capsule. Each of the parts 11 and 12 contain elements 161 and 162 each that functions like a heating element if an alternate magnetic field is applied from the outside and which is separated from the agent 141 and 142 by a movable and/or expandable dividing wall 213 and 214 . If the corresponding elements are heated, they expand to double the volume for example and press the agents, possibly one after the other, to the outside through the openings 1121 , 1122 that can be closed for example by a plug (a valve) 131 , 132 . The heating elements 161 and 162 can be comprised of different materials or different compositions of easily evaporating liquids and magnetic oxide powders so that the evaporation takes place at different temperatures or for different power values of the alternate magnetic field. Furthermore, the agents 141 and 142 in the capsule parts 11 , 12 can be different. These agents 141 , 142 can also be prepared in such a way that the desired effect is only produced after their mixture. Within the capsule 10 , the unintended mixture of the two agents 141 and 142 can be avoided by a fixed dividing wall 215 .
[0020] The described invention demonstrates advantage in comparison to the state of the art. Due to the much greater thermal resistance of the insulation of part 12 , the power of the alternate magnetic field supplied to the capsule 10 can be considerably less for the same intended maximum temperature, e.g. 78° C., than for the capsules without an insulation cover. Although the volume of the heating element becomes smaller due to the insulation, the required supplied power for the same maximum temperature is ideally less than 1% of the power that must be supplied for the capsule without thermal insulation. Another advantage is offered by the expandable bag 17 or a flexible and/or movable wall that closes the heating element 16 against the agent 14 . Such approach avoids the use of pistons and similar elements made of hard material. When heating the magnetic powder above the temperature of ebullition of the liquid contained in the heating element, said liquid will evaporate and the agent will be discharged after a short period of time. Thus, the point of time and the location of the agent application are much better defined in this invention than in the methods and arrangements known heretofore. It is even possible to apply the agent subsequently in several portions if the supplied alternate field power is measured out appropriately. The construction of the capsule 10 has the effect that after the discharge of the agent 14 , the water-containing intestinal liquid, for example, enters into the capsule 10 and decomposes the capsule parts 11 , 12 or the hard gelatin stamp 21 from the inside. The other parts of the capsule (magnetic powder, polyethylene foil) can be easily ducted so that the remainder of the capsule do not get stuck on stenoses.
[0021] The individual features or any combination thereof described in the invention and the figures are inclusive of, but not limiting of, the invention, which is defined by the claims.
LIST OF REFERENCE NUMERALS
[0022] 10 capsule
[0023] 11 , 12 (capsule) parts
[0024] 13 membrane
[0025] 14 , 141 , 142 agents
[0026] 15 , 151 , 152 air, insulation material
[0027] 16 , 161 , 162 heating elements
[0028] 17 bag
[0029] 18 coil
[0030] 19 layer, foil
[0031] 20 area
[0032] 21 stamp
[0033] 111 , 121 bent zones
[0034] 112 , 1121 , 1122 openings
[0035] 122 guide surfaces
[0036] 131 , 132 valves, plugs
[0037] 171 folded structure
[0038] 211 sealing and supporting elements
[0039] 212 arrow
[0040] 213 , 214 flexible and/or movable dividing walls
[0041] 215 fixed dividing wall
[0042] X-X axis
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A capsule is capable of releasing at least one agent that is contained therein by heating at least one heating element under the effect of at least one alternating magnetic field at a defined point in a body, said capsule dissolving when entering in contact with a dissolving liquid. The capsule avoids getting stuck on stenoses while being thermally acceptable and favorable from the point of view of energy. In the capsule, the heating element is at least partially surrounded with a capsule part, material of which is provided with greater thermal resistance than the walls of common capsules used for medicaments.
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CROSS-REFERENCE TO RELATED APPLICATIONS
This is a continuation-in-part of U.S. application Ser. No. 08/883,853 filed Jun. 27, 1997, entitled "Air Seeder Blockage Monitoring System", which application was a continuation-in-part of U.S. application Ser. No. 08/855,625 filed May 14, 1997, entitled "Method and Circuit for Determining if Seed Sensor is Operably Connected to Seed Monitor System".
BACKGROUND OF THE INVENTION
Prior art seed blockage monitoring systems typically employ a seed flow detector comprising a pin which extends into the seed flow path. The end of the pin is fixed to one face of a ceramic piezoelectric transducer. Seeds flowing in a seed path impact the pin, causing the piezoelectric transducer to undergo a strain. The signals generated by the piezoelectric transducer are detected and interpreted as signals generated by seeds flowing in the seed flow path. Examples of this type of monitoring system are U.S. Pat. No. 5,177,470 to Repas, and U.S. Pat. No. 4,441,101 to Robar. One problem with this type of sensor is that the intrusion of the pin into the seed flow path can itself be the cause of seed flow blockage.
Another type of piezoelectric sensor is disclosed in U.S. Pat. No. 4,238,790. In this patent, a metal plate 16 (FIG. 2) located within a conduit is struck by seeds as they pass down the conduit. The impact of the seeds on the plate strains a piezoelectric crystal to which the plate is affixed, which in turn generates signals indicative of seed flow. A problem associated with this type of sensor is that the striking of the hard metal plate may damage the seeds. Further, because the momentum of the seed must affect the entire mass of the rigid plate before imparting a strain in the piezoelectric crystal, the sensor sensitivity is low.
In U.S. Pat. No. 4,491,241 to Knepler et al., piezoelectric sensors 10, 12 (of undisclosed design) emit an electrical signal when struck by a seed. The electrical signal is input to a one-shot circuit 36 (FIG. 2), which functions as a one-bit memory to store the seed pulse for a period determined by a capacitor 42. A respective sensor circuit 14, 16 (FIG. 1) is coupled intermediate each of the sensors 10, 12 and a common signal line 18. The sensor circuits 14, 16 are coupled in series circuit, with the first sensor circuit 14 connected to an enable line 20 and the last sensor being connected to a termination circuit 17. The common signal line 18 and the enable line 20 are each coupled at one end to a monitoring and control circuit 22. This circuit includes a clock signal generator and a counter. The monitoring and control circuit 22 also drives an alarm indicator 24 (FIG. 11A) and a visual display 26 (FIG. 1) and indicates to the operator when a particular sensor has failed to detect seeds.
In operation, the sensor circuits are enabled sequentially by a signal applied to flip flop 30 (FIG. 2) on enable line 20 from the monitoring and control circuit 22. Flip-flops 30 and 32 operate jointly to enable the gate 34 to pass sensor data from one-shot circuit 36 to common signal line 18 and, as well, to generate an enabling signal to the next sensor circuit in the series connection after the initial interrogation of the gate 34. If, at the time the one-shot circuit 36 is interrogated, the output therefrom indicates that seeds are being dispensed, a logic 1 signal is placed on the common signal line 18. If no seeds are being dispensed, a signal level intermediate a logic 1 and a logic 0 is placed on the common signal line 18. The monitoring and control circuit discerns the intermediate level signal and displays that a seed dispensing fault has occurred at a particular sensor location indicated on a counter 98 (FIG. 3A).
Upon the last sensor in the series connection being interrogated, the termination circuit 17 receives the enable signal, which has been passed along from one sensor circuit to the next in bucket brigade fashion as each is interrogated. The termination circuit, in response to receiving the enable signal, places a logic 0 on the common signal line 18. The logic 0 on the common signal line 18 causes the monitoring and control circuit 22 to reset the counter 98. Should a failure occur in the termination circuit 17 or related components, the counter will continue to count upwardly, thus triggering a failure signal and an alarm.
One disadvantage with the system disclosed in Knepler et al is that, once the one-shot has detected a seed being dispensed, another seed can not be detected until the one-shot has reset itself As the period of each one-shot is determined by the value of the capacitor 42, this period can not readily be adjusted.
In the embodiment illustrated in FIG. 6 of Knepler et al, a microprocessor is employed to scan the circuits 14,16, etc. at a preferred rate of 10 kHz(see column 1 1, line 31). This overcomes a delay in scanning encountered when using the prior embodiment. In that embodiment, when a failure signal is detected, scanning is suspended from one-half to one second while a display of the number of the failed unit is activated (see column 10, line 23).
Although use of a microprocessor allows more rapid scanning of the sensor circuits 14,16, etc., the fundamental limitations of the circuitry, as discussed above, still exist. Thus, even in this embodiment the one-shot retains the seed strike information for approximately 34 ms (see column 16, line 41). Therefore, increasing rate of the interrogation beyond about 30 times per second (the inverse of 34 ms) accomplish nothing, since there is no new information to be obtained until the one-shots have reset themselves.
Another disadvantage of the circuitry in Knepler et al is that a termination circuit 17 is required to make the system operable; should the termination circuit 17 fail, the entire system becomes inoperable.
A final disadvantage of all the prior art seed blockage monitoring systems known to applicant is that the piezoelectric elements are ceramic elements. The ceramic element undergoes a strain when a hard, inflexible surface or pin that is attached to the ceramic element is struck by a seed. This has the disadvantages of the seed possibly being damaged by striking the hard surface or pin, and the sensing not being as sensitive as it could otherwise be. Since the entire mass of the rigid pin or plate must be affected before causing a strain (i.e., output signal) in the piezoelectric element, the sensitivity is reduced. For this reason, the prior art systems are not well adapted to detecting very small seeds.
Also, the prior art seed blockage monitoring systems are subject to error resulting from induced noise, as may result from static charge buildup/discharge on the seed planter equipment or from other induced voltages resulting from electromagnetic fields.
Finally, the prior art seed blockage monitoring systems are not easily adapted to different seed monitoring configurations. For instance, it may be desired to operate with only one sensor connected per header (one example of what will be called herein as a "partial-run" configuration) in order to monitor for a primary seed tube blockage, thereby reducing the overall cost of the seed blockage monitoring system to a minimum. Or, it may be desired to operate with each secondary seed tube having its own sensor (herein termed a "full-run" configuration) so as to be able to monitor blockage of all the primary and secondary seed tubes. Prior art seed blockage monitoring systems are not well-suited to operating in both a "partial-run" and a "fill-run" seeding operation.
BRIEF SUMMARY OF THE INVENTION
A first object of the present invention is to provide a piezoelectric sensor element that is relatively soft and pliable rather than rigid, so that seeds are not damaged when they impact onto the sensor and so that the sensor is more sensitive, thus enabling smaller seeds to be detected by requiring less momentum transfer in order to detect a seed.
A second object of the invention is to minimize the intrusion into the seed flow path by the sensor. This is accomplished in part by the design of the sensor, which makes it more sensitive, and in part by the manner in which the sensor is mounted in the seed flow path. The decrease of the intrusion of the sensor into the seed flow path has two advantages. It reduces the possibility that seeds will be damaged as they strike the sensor, and almost eliminates the possibility that a sensor element will cause a seed flow blockage.
A third object of the invention is to increase the rate that information may be obtained from the piezoelectric sensors, thereby enabling a particle blockage monitor to also provide information as to the actual number of particles flowing in various monitored particle flow paths as well as information as to the relative rates of particle flow.
A fourth object of the invention is to eliminate the need to employ a termination circuit 17 as employed in U.S. Pat. No. 4,491,241.
A fifth object of the invention is to provide circuitry wherein the memory period of an impact event (hereinafter termed "seed event", in view of the immediate applicability of the invention to determining seed blockage) can be readily adjusted.
A sixth object of the invention is to provide circuitry wherein data from multiple sensor memory units can be simultaneously read and reset, thereby enabling higher data rates to be achieved than in the prior art.
A seventh object of the invention is to decrease the possibility that discharges from static build-up, or from other electromagnetic fields, may affect the operation or accuracy of a blockage monitor, especially a seed blockage monitor.
The present invention will be more fully understood from the detailed description and accompanying drawings, which are given by way of illustration only, and thus, are not limitative of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of a tractor towing an air seeding system including a blockage monitoring system according to an embodiment of the present invention;
FIG. 2 is a cut-away side view of the blockage monitoring system of the present invention in association with the air seeding system of FIG. 1;
FIG. 3 shows a top view of a "full-run" air seeder blockage monitoring system;
FIG. 4 shows a top view of a "partial-run" air seeder blockage monitoring system;
FIG. 5 is a perspective view of a fully assembled blockage sensor unit;
FIG. 6 shows an exploded view of the blockage sensor unit of FIG. 5;
FIG. 7A is a view of the top of a flexible piezoelectric sensor element used in the invention;
FIG. 7B is an exploded side view of the same sensor element as shown in FIG. 7A;
FIGS. 8A-8C show top, side cross-sectional and perspective views, respectively, of a blockage sensor unit cover;
FIGS. 9A-9C illustrate the blockage sensor unit, with FIG. 9A being a top view and FIGS. 9B and 9C being respective side views of two different embodiments that do not differ in top view but differ in their side views;
FIG. 10 is an exploded view of a slave unit enclosure;
FIG. 11 is a schematic diagram illustrating the circuitry in the various slave units and the connections between the blockage monitoring unit and the various slave units;
FIG. 12 is a schematic diagram illustrating the circuitry contained in a blockage monitor unit or slave unit to interface to a piezoelectric sensor;
FIG. 13 is a diagram of one example of framing and input bits that may be used when employing 16 bit, parallel input, serial output, shift registers in accordance with the invention as illustrated in FIG. 11; and,
FIG. 14 is a display of the hit data and status of the sensors associated with a particular header.
DETAILED DESCRIPTION
FIG. 1 shows a side view of a tractor 20 intended to represent various types of farm tractors that perform various tasks in a high volume agricultural environment as may be present on a farm. In the depiction of FIG. 1, the tractor 20 is towing an air seeding system 22, including a tool bar 24 and an air cart 26, by a tow bar 28. The air seeding system 22 can be any known air seeding system, such as the 735 Air Seeder and 737 Air Hoe Drill, both available from the John Deere Company.
The tool bar 24 creates multiple parallel furrows in the soil of a field area to be planted, dispenses a controlled quantity of seeds into the furrows, and then covers the furrows in a manner that allows the seeds to germinate and then become plants. Known air seeding systems such as the air seeding system 22 can simultaneously plant up to ninety-six rows of seeds. The configuration of the tool bar 24 and the air cart 26 can be reversed in that the tractor 20 can tow the air cart 26 and the air cart 26 can tow the tool bar 24.
FIG. 2 shows a cut-away, side view of a portion of the air seeding system 22. The air cart 26 (FIG. 1) includes a hopper 30 that holds a quantity of a particulate matter to be dispensed by the air seeding system 22. The hopper 30 can hold any particulate matter for the purposes described herein, such as various grains, seeds, fertilizers, and herbicides. For the purposes of this discussion, the air seeding system 22 will be described as dispensing seeds 32 of any suitable type. The flow of seeds 32 from the hopper 30 is controlled by a rotary metering system 34. The controlled flow of seeds 32 from the metering system 34 distributes the seeds 32 into a primary manifold 36 through a suitable conduit 38. A plurality of primary seed tubes 40, one of which is shown in FIG. 2, are connected to the primary manifold 36 to receive the flow of seeds 32 from the hopper 30. For the embodiment of the air seeding system that seeds ninety-six rows, there would be eight primary seed tubes 40.
A fan 42 is connected to the primary manifold 36 by a hose 44. The fan 42 provides air pressure to the primary manifold 36 so as to cause the seeds 32 to move through the primary manifold 36 into the primary seed tubes 40 under air pressure. Each primary seed tube 40 is connected to a separate secondary manifold, commonly referred to as a header 46. A plurality of secondary seed tubes 48 are connected to each of the headers 46. In the embodiment being discussed herein, there are twelve secondary seed tubes 48 connected to each header 46. Each secondary seed tube 48 is connected to an opener 50. The opener 50 can be a blade device that creates furrows in the soil being planted from the motion of the tool bar 24 such that the seeds 32 are dispensed from the opener 50 at the appropriate depth into the soil. Ground closers 52, depicted in FIG. 1, then close the furrows to cover the seeds 32 with soil. A blockage monitor unit 54, is attached to the tool bar 24 in close proximity to one of the headers 46. A blockage sensor unit 56 is attached to the secondary seed tube 48.
One preferred embodiment of the air seeder blockage monitoring system, referred to as a "full-run" air seeder blockage monitoring system, is depicted in FIG. 3. A "full-run" air seeder blockage monitoring system is defined as one in which every connected secondary seed tube 48 in the system is fitted with an individual blockage sensor unit 56, such that blockage can be detected if it occurs in any of the primary seed tubes 40 or in any of the secondary seed tubes 48 which are connected to the system.
FIG. 3 shows a top view diagram of the "full-run" air seeder blockage monitoring system. For clarity, the diagram has been simplified such that elements of the system which can be plural in nature may appear in singular or in a limited representation of their true number. The seeds 32 are carried by a plurality of primary seed tubes 40 to a number of headers 46, located on the tool bar 24. The headers 46 distribute the seeds 32 through a plurality of secondary seed tubes 48 (e.g., twelve secondary seed tubes per header). Blockage sensor units 56 are inserted in the secondary seed tubes 48.
The processing hardware for the "full-run" air seeder blockage monitoring system is located within the blockage monitor unit 54. The blockage monitor unit 54 is housed in a rugged enclosure (e.g., John Deere wedge box) and contains a microprocessor 60 (not shown in FIG. 3) or other signal processing means by which to analyze sensor data. The blockage monitor unit 54 is linked to a display area by a common data bus 58, such as CAN or SAE J1850B. Two serial interface links 62 and 62A are used to send signals and receive data from auxiliary data collection units, referred to as slave units 64. The serial interface links 62 and 62A are four wire interconnects that link a plurality of slave units 64 with the blockage monitor unit 54 in a serial manner (referred to hereinafter as a daisy chain configuration).
Each header 46 in the "full-run" air seeder blockage monitoring system (other than the header monitored by the blockage monitor unit 54) may be equipped with one slave unit 64, such that all of the blockage sensor units 56 associated with the secondary seed tubes 48 for a particular header 46 are interfaced to the associated slave unit 64 by suitable sensor wire cable harnessing 66 (e.g., 22 AWG stranded, twisted pair with PVC insulation). Or, as illustrated in FIGS. 3 and 4, one or more blockage sensor units 56 may be connected directly to the blockage monitor unit 54. In this case, the blockage sensor units 56 connected to the blockage monitor unit 54 are interfaced through the sensor interface circuit 162 (FIG. 12) to digital inputs of the microprocessor 60. In an alternative embodiment, the analog sensor signals of the directly-connected sensor units 56 are input to analog inputs of the microprocessor 60. The main harnessing that provides power to monitor unit 54 also contains sensor wire cable harnessing 66, allowing it to connect directly to a plurality of blockage sensor units 56 associated with the secondary seed tubes 48 of one of the headers 46.
Each slave unit 64 is housed in a special enclosure (FIG. 10) which includes within the enclosure circuitry (FIG. 12) which filters, amplifies, and converts analog signals received from the blockage sensor units 56 into a digital format. The digital format signals from various blockage sensor units 56 are then serially transmitted to the blockage monitor unit 54 (FIG. 11) by using a serial shift register having parallel data input ports or by other equivalent structure for the purpose intended, such as by using a microprocessor.
An alternate, cost-reduced embodiment of the air seeder blockage monitoring system, referred to as a "partial run" air seeder blockage monitoring system, is depicted in FIG. 4. A "partial run" air seeder blockage monitoring system is defined as one which has been mainly designed to detect blockage of the primary seed tubes 40.
FIG. 4 shows a top view diagram of one example of a "partial-run" air seeder blockage monitoring system. For clarity, the diagram has been simplified, such that elements of the system which can be plural in nature may appear in singular or in a limited representation of their true number. The seeds 32 (FIG. 2) are carried by a plurality of primary seed tubes 40 to a number of headers 46, located on the tool bar 24. The headers 46 distribute the seeds 32 through a plurality of secondary seed tubes 48 (e.g., twelve secondary seed tubes per header). Blockage sensor units 56 are inserted in a representative sample set of the secondary seed tubes 48 associated with each header 46 (e.g., one blockage sensor unit per header).
The processing hardware and software for the "partial-run" air seeder blockage monitoring system is located within the blockage monitor unit 54. The blockage monitor unit 54 is housed in a rugged enclosure (e.g., John Deere wedge box) and contains a microprocessor 60 (not shown in FIG. 4) or other signal processing means by which to analyze sensor data. The blockage monitor unit 54 is linked to a display area by a common data bus 58, such as CAN or SAE J1850B. Two serial interface links 62 and 62A are used to send signals and receive data from auxiliary data collection units, referred to as slave units 64. The serial interface links 62 and 62A are four-wire interconnects that link a plurality of slave units 64 with the blockage monitor unit 54 in a daisy chain configuration.
Each header 46 in the "full-run" air seeder blockage monitoring system (other than the header monitored by the blockage monitor unit 54) may be equipped with one slave unit 64, such that all of the blockage sensor units 56 associated with the secondary seed tubes 48 for a particular header 46 are interfaced to the associated slave unit 64 by suitable sensor wire cable harnessing 66 (e.g., 22 AWG stranded, twisted pair with PVC insulation). Or, as illustrated in FIGS. 3 and 4, one or more blockage sensor units 56 may be connected directly to the blockage monitor unit 54. In this case, the blockage sensor units 56 connected to the blockage monitor unit 54 are interfaced through the sensor interface circuit 162 (FIG. 12) to digital inputs of the microprocessor 60. In an alternative embodiment, the analog sensor signals of the directly-connected sensor units 56 are input to analog inputs of the microprocessor 60. The main harnessing that provides power to monitor unit 54 also contains sensor wire cable harnessing 66, allowing it to connect directly to a plurality of blockage sensor units 56 associated with the secondary seed tubes 48 of one of the headers 46.
For "partial-run" systems, it should be noted that other configurations of electronic control box arrangements are feasible. For example: all sensors 56 could plug into the blockage monitor unit 54, thus obviating the need for any slaves; or, more than two sensors could be plugged into the blockage monitor unit 54 and each slave unit 64.
FIG. 5 shows an isometric view of the fully assembled particle blockage sensor unit 56 and FIG. 6 shows an exploded view of the particle blockage sensor unit 56. In this embodiment of the particle blockage sensor unit 56, seeds 32 pass through a secondary seed tube 48 and enter the blockage sensor unit 56. Some of the seeds 32 impinge on a flexible piezoelectric sensor element 68, such as piezoelectric film. When a seed 32 impinges on the flexible piezoelectric sensor element 68, the piezoelectric effect generates a voltage, which is transmitted either to one of the slave units 64 and then to the blockage monitor unit 54, or to the blockage monitor unit 54 directly, and is interpreted as a "seed event".
The flexible piezoelectric sensor element 68 (FIG. 7A) is commercially available from AMP Incorporated. As shown in the exploded, side view of FIG. 7B, MYLAR sheeting 70, 70A sandwiches silk-screened, silver ink layers 71B and silk-screened piezoelectric material 71C, with layers 71A being adhesive layers. A second piece of MYLAR sheeting 70A may be bonded in place over the top of the piezoelectric material to act as a flexible protective covering. Two solder-type connectors 72 and 72A are crimped into place at the base of the flexible piezoelectric sensor element 68 and connected to suitable sensor wire cable harnessing 66 (e.g., 22 AWG stranded, twisted pair with PVC insulation) equipped with a connector body 73 (such as connectors commercially available from Packard Delphi) having female terminals. Alignment holes 74 and 74A insure that the flexible piezoelectric sensor element 60 is aligned correctly when it is installed into a blockage sensor cover 76 (shown in detail in FIGS. 8A-8C).
The blockage sensor cover 76 can be made of an injection molded thermoplastic material such as a polycarbonate/ABS blend. The flexible piezoelectric sensor element 68 (FIG. 7A) is designed such that the alignment holes 74 and 74A fit directly over alignment pins 78 and 78A (shown in cross-section in FIG. 8B) in the blockage sensor cover 76. This allows the sensing area of the flexible piezoelectric sensor element 68 to be aligned directly upon the angled portion of the blockage sensor cover 76, referred to as an angle of intrusion α. The illustrated angle α is an angle of approximately, but not limited to, thirteen degrees. (This angle, illustrated in FIG. 9B, may alternatively be measured from the intrusion surface normal to a direction that is normal to the flow axis of seeds in blockage sensor unit 56. A thirteen degree angle of intrusion reduces the cross-sectional area of the secondary seed tube 48 by no more than seven percent, yet allows seeds 32 to effectively impact the flexible piezoelectric sensor element 68 while not being slowed significantly in their travel along the seed tube.
Referring to FIG. 8A, an air gap 82 is designed into the blockage sensor cover 76 directly behind the sensing area of the flexible piezoelectric sensor element 68. This air gap 82 effectively increases the sensitivity of the flexible piezoelectric sensor element 68 (by allowing strain in the flexible piezoelectric sensor element to occur freely) so that even small seeds, such as canola, can create a piezoelectric- effect output from the sensor.
A directional arrow 84 appears in the isometric view of the blockage sensor cover 76 in FIG. 8C. This directional arrow 84 has been added to the design as an aid in correctly placing the blockage sensor unit 56 into the secondary seed tube 48 at the time of installation. The directional arrow 84 is to point following the direction of seed flow from the header 46, through the secondary seed tube 48, to the opener 50. The inner surface edge 87 of the blockage sensor cover 76 has been prepared in such a manner that it can be fitted directly onto a blockage sensor tube 86 (FIG. 9) and welded ultrasonically into place. The blockage sensor cover 76 is designed to include a means of tension relief 88 for the sensor wire cable harnessing 66, which is set in place during the ultrasonic welding operation.
FIGS. 9A-9C illustrate the blockage sensor unit. FIG. 9A shows a top view of two alternate embodiments of the blockage sensor tube 86 that have an identical top view. FIGS. 9B and 9C are side views that illustrate the differences between the two alternate embodiments. The blockage sensor tube 86 can be made of an injection molded thermoplastic such as a polycarbonate/ABS blend. The blockage sensor cover 76 (FIG. 8) is designed such that the pins 78 and 78A fit into corresponding impressions 90 and 90A in the blockage sensor tube 86. In the first embodiment,as illustrated in FIG. 9B, the flexible piezoelectric element is generally planar in shape. The angle of intrusion α of the intrusion surface 80 upon which the flexible piezoelectric sensor element 68 is fastened matches the angled slope 92, which is inclined at the angle a to a central axis of the secondary seed tube. The sensor area cutout 94 exposes the sensing area of the flexible piezoelectric sensor element 68 to the seeds 32 (FIG. 2) flowing through the secondary seed tube 48. Thus, a small portion of the seeds flowing in the seed flow path strike the flexible piezoelectric sensor.
Because it is believed that a velocity gradient of particles within the tube exists wherein, for example, seeds nearer the center of the tube have a higher velocity as a result of increased air velocity propelling them near the center of the tube, it may be desirable to form the flexible sensor surface into an arcuate shape, wherein the angle of intrusion decreases towards the sensor end nearest the center of the tube. Such as design is illustrated in FIG. 9C. This would appear to have an advantage in that a more constant amount of momentum is transferred to the sensor, resulting in a more uniform sensitivity of detection across the sensor surface as well as reduced risk that the presence of the sensor intruding into the tube will itself contribute to a blockage. The arcuate shape removes a more nearly constant amount of forward momentum from a seed, irrespective of a velocity gradient within the seed tube.
A combination of factors lead to advantageous results when using the present sensor arranged in the manner illustrated. First, because the impact object is a flexible MYLAR sheet as opposed to an inflexible plate or pin, as in the prior art, the amount of strain induced in the piezoelectric detector for a given seed impact is higher than in the prior art. This results in the piezoelectric sensor being more sensitive, and allows very small seeds, such as canola, to be monitored with the present monitoring system. Second, the higher sensitivity detector also allows the intrusion angle of the sensor into the flow path to be reduced. This results in only a slight change of momentum for most seeds that strike the flexible MYLAR surface of the sensor, and virtually eliminates any seeds from being damaged. By minimizing the change in momentum needed to detect seed flow, the forward momentum of all the seeds in the seed path is maintained to a greater extent than with prior art systems. Thus seed blockages, caused by the seed blockage sensor being in the path of the seeds, are minimized.
The outer surface edge 96 of the blockage sensor tube 86 (i.e., that which is complementary to the inner surface edge 87 of the blockage sensor cover 76) has been prepared in such a manner that the blockage sensor cover 76 (FIGS. 8A-8C) can be directly welded into place ultrasonically. Both ends of the blockage sensor tube 86 have an increased internal and external diameter in comparison to its center portion. The increase in diameters of the ends conform to the thickness of the secondary seed tube 48, forming acceptors 98 and 98A (FIG. 9A). Ends of the secondary seed tubes 48 are inserted into acceptors 98 and 98A. The portions of the secondary seed tubes 48 and the attached blockage sensor tube 86 that constrain the seeds have identical internal diameters so that a smooth flow path boundary is achieved. Acceptor 98 contains two fastener holes 100, 100A and acceptor 98A contains two fastener holes 100B, 100C. Metal spring clips 102 and 102A (FIG. 5 and FIG. 6), fit into these holes so as to secure the connection of the blockage sensor tube 86 to the secondary seed tube 48.
FIG. 10 shows an exploded view of the preferred embodiment of the slave unit enclosure 104. The slave unit enclosure top 106 can be made of an injection molded thermoplastic such as a polycarbonate/ABS blend. The slave unit enclosure 104 is uniquely designed to house the circuitry and to provide multiple connector ports 108 for the sensor wire cable harnessing 66 (FIG. 6). Two serial interface ports 110 and 110A are designed for serially linking the slave units 64 and for communicating with the blockage monitor unit 54. Three mounting holes 112, 112A, and 112B are provided.
The slave unit enclosure bottom 114 can be made of an injection molded thermoplastic such as a polycarbonate/ABS blend. Four screw holes 116 are provided for screws to fasten the slave unit enclosure bottom 114 to the slave unit enclosure top 106. A partial block insert 118 can be made of an open cell urethane with a protective film or of a closed cell urethane. The partial block insert 118 is used to close extraneous connector ports 108 when the circuitry has been depopulated for use in the "partial-run" air seeder blockage monitoring system. Or alternatively, the holes can be plugged by molded plastic using an insert into the molding tool.
FIG. 11 is a schematic diagram illustrating the circuit connections between the blockage monitor unit 54 and various slave units 64. For clarity, FIG. 11 has been simplified, such that only one serial interface link is represented. It is to be understood that other serial interface links may be utilized in the same manner. Each of the serial interface links 62 and 62A (illustrated in FIG. 3)are clocked separately by the microprocessor 60. Although a plurality of slave units 64 are understood to exist, only two slave units 64 are represented in the schematic diagram of FIG. 11, each functioning in the same manner. It is also to be understood that the microprocessor 60 of the blockage monitor unit 54 directly monitors a plurality of blockage sensor units 56 (not shown)through the sensor interface circuit 162 from one header 46.
In FIG. 11, the blockage monitor unit 54 contains the microprocessor 60, (e.g., Siemens C167 series) and associated circuitry. A driver line 120 of a serial interface link is shown exiting the microprocessor. The driver line 120 carries the clock signal 122 to each of the slave units 64. The blockage monitor unit 54 communicates with all of the slave units 64 connected to the driver line 120 via pulses of the clock signal 122. Each slave unit 64 receives the pulses of clock signal 122 in a respective shift register 132 and responds by serially transmitting any stored digital signals in the form of bits back to the blockage monitor unit 54 via the receiver line 126.
Within the driver line 120, the clock signal 122 is used to perform a number of different signaling functions: signaling when the slave unit 64 should capture data, when it should clear stored data, and when it should perform sensor detection (see timing diagram at the top of FIG. 11). When the clock signal 122 is driven high, a latch/load signal 128 is created in the latched state by a positive peak detector 130. The high level of the latch/load signal 128 is then detected and held while the clock signal 122 is switching and slightly longer. This latches the bits in the serial shift register 132 so that they aren't cleared during the clock signal 122 shifting. The serial shift register 132 of a given slave unit 64 has a plurality of sensor data input lines 133, which receive the digital signal output 148 (see FIG. 12) as bits from the sensor interface circuit 162.
As shown in FIG. 11, there is provided a shift register 132 for each respective slave unit 64, and the shift registers are connected in series. A clock signal 122 is fed to each shift register so as to shift the data in each shift register. In the preferred embodiment, the data from each register that is shifted (in a serial fashion) into the blockage monitor unit 54 consists of up to 12 data input lines 133. A total of 16 bits are shifted to the blockage monitor unit 54 by each slave unit 64, of which 12 data bits are from sensors and the other 4 are framing bits to maintain data integrity. When the latch/load signal 128 drops to its low level again, it enables the load function so that new data can enter the serial shift register 132. Therefore, the rising (see FIG. 13) edge of the clock signal 122 enables the transition from the open state to the latched state. Also, at the rising edge of the clock signal 122 an active low one shot 134 generates the clear signal 136 that clears the latched comparator 144 to allow new seed events to be captured. When the clock signal 122 is driven high and held for an extended period of time, the negative peak detector 158 is allowed to time out and drive the sensor detect signal 156 high. This signal is used in the sensor interface circuit 162 to determine which sensors are attached to the slave.
FIG. 12 is a schematic diagram illustrating the circuitry within a blockage monitor unit 54 or slave unit 64 to interface to a piezoelectric sensor. The flexible piezoelectric sensor element 68 generates an analog signal at the occurrence of a seed event. In a preferred embodiment, a bandpass filter 138 and an amplifier 140 are provided, however, these two items can be omitted or their order interchanged. In the preferred embodiment, the analog signal from a sensor first passes through a bandpass filter 138 and than an amplifier 140. Then it is compared to a reference voltage 142. If the analog signal exceeds the level of the reference voltage 142, it will change the state of the output comparator 144 to the open state which is then pulled high by resistor 149. A diode feedback 146 latches the output comparator 144 such that, as soon as the digit signal output 148 trips high, it stays high. The clear signal 136 travels through diode 154 and forces the positive input of the output comparator 144 low in order to enable it again. The clear signal 136 returns high such that, as soon as new seed events are received, the comparator 144 (which serves as a latch) i.e., a unit bit memory element) is enabled to capture these events.
The sensor detect signal 156 is used to determine whether a piezoelectric sensor is connected to the sensor interface circuit 162. Sensor detect signal 156 is generated and travels through an impedance, such as a capacitor 160, and into a sensor element interface line 163. If the flexible piezoelectric sensor element 68 is present, it reduces the peak amplitude of the signal input to the comparator 144 sufficiently that it doesn't trip the comparator 144. If the flexible piezoelectric sensor element 68 is not present, then the sensor detect signal 156 will generate a peak voltage at the input to the comparator sufficient to trip and latch the comparator 144 into a high state.
The microprocessor in the blockage monitor unit 54 monitors and tabulates the serial inputs received from the various shift registers 132 (which each serve as a multiple bit memory element) of the slave units 64 as well as any inputs received directly from the sensor interface circuitry 162 in the blockage monitor unit 54 so as to obtain the total number of seed events within a given time period for each sensor element 68.
FIG. 13 illustrates an example of the framing bits and input bits of a 16 bit, parallel input, serial output, shift register which may be employed as the shift registers in FIG. 11. (Of course, other shift registers, such as ones having 8 or 32 bit parallel inputs, etc., could be used depending on design choice and cost considerations.) In the preferred embodiment, logic 1 framing bits are placed in bit positions 0 and 15 by inputting a logical low signal to these parallel inputs of the shift register. Also, logic 0 framing bits are placed in bit positions 1 and 14 by inputting a logical low signal to these parallel inputs of the shift register. This allows the microprocessor 60 to positively determine the presence of the data from a slave unit 64. Also, by absence of the framing bits, the absence or failure of a slave unit can be inferred. Of course, these framing bits could also incorporate parity or other check bits to implement error detection or correction. Thus, a 16 bit shift register allows 12 data bits to be placed simultaneously into the register in bit positions 2-13. These data bits can then be clocked into the microprocessor of blockage monitor unit 54 by serial clock pulses 122 at a high rate.
As shown in FIG. 14, a display is provided which shows hit data and the status of the sensors associated with a particular header. Along the left column is shown the sensors (R1-R12) attached to, in the case illustrated, Header 1. In the second column are listed the hit data, corresponding to the number of particles detected by each sensor. In the third column, is listed the particle flow status (e.g. "blocked", "not blocked") of a particle flow path associated with a respective sensor R1-R12, as well as the status of the sensor (e.g. "not present", "disabled", "failed" or "ignored").
One advantage of the present invention over the prior art is that the rate at which data can be obtained from the piezoelectric sensors is much higher. A high rate of monitoring for seed events in a blockage monitoring system provides additional useful information to the operator besides the occurrence of seed blockages. For example, data as to the relative seed flow rates of the various flow paths can be displayed.
In addition, from empirical data (obtained by correlating the number of detected seed events for a given seed type versus the number of seeds that actually flowed through the tube in the same period of time), the seed flow rate can be readily obtained by means of a look-up table, with the inputs being seed type and number of detected seed events per given period of time. Or, as an alternative, if one assumes that the seeds passing through the seed tubes are uniformly distributed, the number of seeds passing through a seed tube can be determined by merely multiplying the detected number of seed events and the inverse of the per cent intrusion of the flexible piezoelectric sensor into the seed tube cross-sectional area.
The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.
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A particle blockage monitoring system employs a flexible piezoelectric particle sensor element in a portion of a particle flow path so that a number of particles traveling in the particle flow path strike the flexible particle sensor element while preventing damage to the particles and maintaining the forward momentum of all the particles in the particle flow path. In order to provide flexibility in monitoring particles of different types and to increase the information rate, the use of a one-shot multivibrator to temporarily store a particle detection signal as in the prior art is avoided. Also, serial sampling of the particle sensor data is avoided to increase the information rate. Instead, a comparator that includes a diode in a feedback loop so as to function as a latch is used in conjunction with a serial shift register that has parallel data input lines. This enables a microprocessor to monitor the output from a multiple-bit memory element which stores a digital representation of the outputs of plural sensor elements at a higher rate than attainable in the prior art. As a result of the increased rate at which information can be obtained from the particle sensor elements, the microprocessor can not only provide particle flow blockage status data but can also provide particle flow rates for the monitored particle flow paths.
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FIELD OF THE INVENTION AND BACKGROUND
[0001] This invention relates in general to respiratory care and therapy, and, in particular, to the controlled delivery of heated and/or humidified respiratory gases to a user being so cared for or treated. More particularly, this invention relates to controlling the temperature of the gas or gases used for such care or treatment at the point of the delivery of such gas or gases to the user.
[0002] In the administration of heated and/or humidified gas or gases to a user or patient, especially those considered as requiring neonatal care, such as premature infants and some pediatric patients, it is desirable to closely control and monitor the temperature at which the gas or gases are delivered. Such gases may be oxygen, heliox, nitrogen, or combinations thereof, as well as other gases known to those healthcare providers or clinicians providing such services. For convenience of illustration the term “gas” will be used hereinafter, but it is to be understood that such term includes a single gas as well as a combination of gases used in respiratory care and therapy by a user or patient. Also, for purposes of convenience, the term user or patient will be referred to hereinafter as “patient”.
[0003] Respiratory gas delivered to, for example, neonate patients is preferably delivered at a low flow rate, between about 1 and about 15 liters per minute. When heated gas flows through a delivery conduit at such low flow rates, the temperature of the gas will decrease in transit to the patient delivery point, resulting in a lower temperature gas being applied to the patient and condensate being formed in the gas delivery conduit. The lower temperature gas can cause irritation of the nares and other discomforts to the patient, as well as reducing the core temperature of the patient. In addition, the accumulation of condensate can result in the gas propelling a bolus of condensate into the patient's respiratory system causing coughing or choking. Accordingly, it is highly desirable that the temperature of the respiratory gas being delivered to the patient be controlled at the very point where the gas is being delivered to the patient, to insure that the desired gas temperature is being applied to the patient with the desired humidification level. Such controlled delivery will increase the patient's comfort level, and reduce the amount of condensate heretofore occurring in available heated-gas delivery systems.
SUMMARY
[0004] The above and other needs are met by a low flow heated/humidified respiratory gas delivery system, especially useful for low flow rates as preferred in the treatment of neonate and other such patients, wherein the respiratory gas is heated and humidified as desired for delivery to the patient and the temperature is monitored at the point of delivery to the patient. In this manner, the gas temperature can be controlled so that the temperature of the gas being applied to the patient is accurately maintained, and the formation of condensate in the delivery conduit is minimized to reduce accumulation. Patients are believed to be much more tolerable of such a treatment, and less likely to be disengaged therefrom. Fewer adverse reactions, such as abrasions, are believed to be incurred, and the patient can still be fed or can eat without necessitating the removal or disconnecting of the gas delivery system.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] Further advantages of the invention are apparent by reference to the detailed description when considered in conjunction with the drawing figures, which are not to scale so as to more clearly show the details, wherein like reference numbers indicate like elements throughout the several views, and wherein:
[0006] FIG. 1 is an illustration of the delivery system wherein a delivery tube or conduit is coupled with a suitable heater to deliver heated/humidified gas to a patient through a nose cannula;
[0007] FIG. 2 is an enlarged partial sectional view of a portion of the delivery tube or conduit through which heated/humidified gas is delivered to the nose cannula to illustrate the manner in which the respiratory gas is heated;
[0008] FIG. 3 is an exploded illustration of a portion of the delivery tube or conduit through which heated/humidified gas is delivered to the nose cannula for application to the patient;
[0009] FIG. 4 is an exploded illustration of another portion of the delivery tube or conduit through which the temperature of the heated/humidified gas is monitored at the point of delivery to the patient;
[0010] FIG. 5 is an enlarged illustration of a portion of the delivery tube or conduit illustrated in FIGS. 3 and 4 in an embodiment in which the nose cannula is formed with a partition which separates the input of respiratory gas to the patient from the sensing of the gas temperature for controlling the operation of the heater to better illustrate the monitoring of the temperature of the gas as it is being applied to the patient, and the path of the air flow; and
[0011] FIG. 6 is an enlarged illustration of a portion of the delivery tube or conduit illustrated in FIGS. 3 and 4 in an embodiment in which the nose cannula is formed without a partition which separates the input of respiratory gas to the patient from the sensing of the gas temperature for controlling the operation of the heater to better illustrate the monitoring of the temperature of the gas as it is being applied to the patient, and the path of the air flow.
DETAILED DESCRIPTION
[0012] Referring now to FIG. 1 , there is illustrated a respiratory gas delivery system 100 wherein a source of suitable respiratory gas (not shown) is coupled to a connector 8 and passes through a conduit 9 for connection to a humidification chamber which may be, for example, a reusable or a single-patient-use humidification or nebulizing chamber 10 through an inlet coupling 11 . As is known to those skilled in the art, the respiratory gas may nebulize a liquid, or a liquid with medicant, contained in the chamber 10 , or the respiratory gas may be bubbled through the liquid if desired, and the heated gas passed from the chamber 10 with, or without, a vapor mist as prescribed by a healthcare provider or clinician. The temperature of the respiratory gas passing from the chamber 10 is heated by means of a heater 15 , such as the heater disclosed in U.S. Pat. No. 6,988,497 assigned to Smiths Medical ASD, Inc. of Rockland, Mass.
[0013] The heated gas is passed out from the chamber 10 through an outlet connector 12 and passes through a standard flexible delivery tube or conduit 20 , for delivery to a patient through a nose cannula 50 . As illustrated in FIG. 2 , the delivery tube or conduit 20 may be of the type disclosed in Anthony V. Beran, et al, U.S. Pat. No. 6,167,883, “MEDICAL AIR-HOSE INTERNAL FLOW HEATER” assigned to the assignee of the present invention and the disclosure of which is incorporated herein by reference. As illustrated therein, a flexible ribbon 34 spans the width of a first portion 20 a of the flexible tube 20 , and carries therein a heating element 42 , preferably an electrically conductive wire or plurality of wires connected to a power supply in order to heat the flow of gas traveling within this portion of the delivery tube 20 a . While there is illustrated a heater wire 42 carried within the tube 20 by a flexible ribbon 34 , the wire 42 may be positioned within the tube 20 without being supported by a flexible ribbon such as, for example, by being coiled along the interior of the tube 20 .
[0014] As better illustrated in FIG. 4 , the distal portion 42 a of the heating element 42 terminates at the entrance into the nose cannula 50 , at the point at which the heated gas is applied or administered essentially directly to the patient. In this manner, the respiratory gas is heated all the way through the first portion 20 a of the flexible tube 20 so that the slow rate of flow of the respiratory gas will not cool the gas below the desired temperature, but is applied directly to the patient at the clinician prescribed temperature level. Maintaining the respiratory gas heated to the prescribed temperature level at the point of delivery to the patient, will thereby minimize the occurrence of condensate formation.
[0015] The temperature of the respiratory gas being delivered to the nose cannula 50 through the flexible tube 20 , is controlled by a sensor 60 , preferably a thermister, which is carried within a second portion 20 b of the flexible tube 20 extending from an input 13 from the heater 15 to a position within the nose cannula 50 directly adjacent to the point at which the respiratory gas is applied or administered, 56 , essentially directly to the patient, as best illustrated in FIGS. 5 and 6 . The positioning of the sensor in this position, in the nose cannula, will give direct feedback to the clinician of the temperature of the respiratory gas entering the patient's nose. The output from the sensor 60 may, if desired, be coupled to a digital display 65 to provide the clinician with an accurate visual display of the temperature of the respiratory gas as actually being administered to the patient.
[0016] Because the air flow is constantly flowing from the outlet 12 of the chamber 10 to the patient's nose cannula 50 , only inspiratory air is delivered to the patient through the first portion 20 a of the flexible tube 20 . Accordingly, re-breathing of exhaled air by the patient is substantially minimized or eliminated entirely.
[0017] As best illustrated in the embodiment of FIG. 5 , the nose cannula 50 may be formed with a partition 55 which separates the input of the respiratory gas to the patient from the sensing of the gas temperature for controlling the operation of the heater 15 . The positioning of the sensor 60 in this manner, in the nose cannula 50 in thermal contact with the respiratory gas at the point of administration of the gas to the patient, 56 , results in substantially reducing or eliminating the effect that ambient room temperature and humidity might have on control of the gas temperature and moisture content. It is to be understood, however, that the nose cannula 50 may be constructed without the partition 55 separating the input of the respiratory gas to the patient from the sensing of the gas temperature. In such an embodiment the sensor 60 , however, is still to be positioned in substantially direct thermal contact with the respiratory gas at the point of administration, 56 , of the gas to the patient.
[0018] As best shown in the embodiment of FIG. 6 , the nose cannula 50 is constructed without the partition 55 , and the sensor 60 is still positioned directly adjacent to the point of administration, 56 , of the gas to the patient.
[0019] The foregoing description of a preferred embodiment for this invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiment described has been chosen and described in an effort to provide the best illustrations of the principles of the invention and its practical application, and to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited for the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.
[0020] Also, this application was prepared without reference to any particular dictionary. Accordingly, the definition of the terms used herein conforms to the meaning intended by the inventors acting as their own lexicographer in accordance with the teaching of the application, rather than any dictionary meaning which is contrary to or different from the inventors' meaning regardless of the authoritativeness of such dictionary.
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A low flow heated/humidified respiratory gas delivery system, especially useful for low flow rates as preferred in the treatment of neonate and other such patients, wherein the respiratory gas is heated and humidified as desired for delivery to the patient and the temperature is monitored at the point of delivery to the patient.
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BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The invention relates generally to an apparatus for controlling an electrical device using a bio-signal that is extracted from movement of a face, and method thereof, and more particularly, to an apparatus for controlling an electrical device using a bio-signal capable of controlling an electrical device only by simply moving a face portion, and method thereof.
[0003] 2. Description of the Prior Art
[0004] In case of a computer, a user interface has been changed from a command-keyboard mode to an icon-mouse mode. Researches and developments for utilizing voice recognition as the user interface have recently been made. Further, there has been an attempt to research a human-friendly interface using a face expression, a gesture, and a bio-signal such as the brain wave(electroencephalogram), the electroocculogram, and the electromyogram.
[0005] In case of the brain waves, the brain waves are used in learning or mediation by applying a bio-feedback mode to an alpha wave generated at a relaxed state. Further, there has been developed to control an electrical device using the electroocculogram and blinking which are generated when the pupil of the eye is moved.
[0006] A prior art in which the machine is controlled by using the bio-signal measured at the face portion mainly discloses a technology by which the one's eyes are traced through the electroocculogram. The technology has usually employed a method of determining a mental decision (i.e., select a specific icon) by staying one's eyes at the specific icon or blinking one's eyes for a given period of time. However, as the method of tracking one's eyes based on the electroocculogram must correct variations in the location and angle of the face, it is required that the method employ a sensor such as an acceleration sensor or use a camera to perceive variations in the location and angle of the face. In addition, in case of the eye's blinking or staying of one's eyes used to determine a mental decision, additional bio-signals such as brain waves or evoked potentials, or variations in the pupil size were additionally used in order to discriminate between natal and intentional blinking or staying one's eyes. However, the above prior arts have disadvantages that they require a user to hold inconvenient bio-signal detector (for example, a helmet-type device), to prevent a movement of the face during tracking user's eyes, or to fix eye gaze or to blink carefully for the purpose of estimating a mental decision.
[0007] These kinds of the prior arts include U.S. Pat. No. 5,649,061 issued to C. C. Smyth (1997), entitled “Device & Method for Estimating a Mental Decision). The patent is to confirm a mental decision of a user by using eye tracking and the evoked potential. Thus, there is a characteristic that the machine can be manipulated only using a user' eyes. However, this method has a disadvantage that it requires a user to hold an inconvenient bio-signal detection unit in order to measure various kinds of bio-signals for estimating a mental decision.
[0008] Another prior art includes Korean Patent No. 179250 (issue date: Dec. 26, 1998) issued to LG Co., Ltd., entitled “Input Device Using Motion of an Eyelid”. This prior art uses motion of the eyelid to turn on/off an electrical device. The above patent has an advantage that it can turn on/off consumer electronic devices such as TV, computers, electrical lights, and the like. However, the prior art has a disadvantage that it requires a user to blink intentionally and carefully in order to make a decision and thus makes the user inconvenient.
[0009] Still another prior art includes Korean Patent Application No. 1999-0010547 (application date: Mar. 26, 1999) Dail Information Communication Co. entitled “Remote Control Apparatus in an Electrical Device using Motion of the Eyes”. This prior art has electrodes attached on the glasses to track one's eyes through the electroocculogram generated by the motion of the eyes. Thus, a handicapped person can make a selection corresponding to a movement of the mouse and a click by simply moving his/her eyes. However, this patent has also a disadvantage that requires a user to blink and move his/her eyes intentionally and carefully in order to make decision and thus makes the user inconvenient.
SUMMARY OF THE INVENTION
[0010] The present invention is contrived to solve the above problems and an object of the present invention is to provide an apparatus for controlling an electrical device using a bio-signal and method thereof. The invention is capable of controlling equipments more reliably and controlling electrical devices only using a non-expensive and simple apparatus even when the physiological state of a user is varied, in such a way that the apparatus for controlling the electrical device is controlled using the bio-signal extracted from simple motion of a face portion (motion of the head and mouth).
[0011] In order to accomplish the above object, an apparatus for controlling an electrical device using a bio-signal detected when a user moves his/her face according to the present invention, is characterized in that it comprises a bio-signal detection means for detecting the bio-signal generated when the user shuts his/her mouth (for example, clench teeth with the mouth shut) and when the user moves his/her head left and right; and a means for controlling the electrical device for analyzing the bio-signal detected in the bio-signal detection means to control the electrical device depending on a command from the user.
[0012] Preferably, an apparatus for controlling an electrical device using a bio-signal detected when a user moves his/her face, is characterized in that it comprises a bio-signal detection unit for detecting the bio-signal generated when the user shuts his/her mouth and when the user moves his/her head left and right; a bio-signal amplification unit for amplifying the amount of the bio-signal detected in the bio-signal detection unit; an A/D converter for converting the amplified bio-signal into a digital mode; a control unit for analyzing the bio-signal of the digital mode to determine a corresponding command of the user and then generating a determined command of the user; and a transmission unit for transmitting the command throughout infrared signal from the control unit to the electrical device
[0013] More preferably, a method of controlling an electrical device using a bio-signal extracted through movement of a user's face, is characterized in that it comprises the steps of a first step of detecting the bio-signal when the user moves his/her mouth and when the user moves his/her the head; a second step of amplifying the amount of the detected bio-signal and then converting the amplified bio-signal into the bio-signal of a digital mode; a third step of analyzing the converted bio-signal to determine a corresponding command of the user and then generating a determined command; and a fourth step of transmitting the generated command to the electrical device throughout infrared signal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The aforementioned aspects and other features of the present invention will be explained in the following description, taken in conjunction with the accompanying drawings, wherein:
[0015] [0015]FIG. 1 illustrates an operation flow of an apparatus for controlling an electrical device using a bio-signal according to one embodiment of the present invention;
[0016] [0016]FIG. 2 is a flowchart illustrates a process of activating a control mode in a control unit used in an apparatus for controlling an electrical device according to the present invention;
[0017] [0017]FIG. 3 is a flowchart illustrating a process of determining an intention of left/right movement and an intention of selection according to the present invention;
[0018] [0018]FIG. 4 a to FIG. 4 c illustrate a method of extracting features from a bio-signal for activating a control mode according to the present invention;
[0019] [0019]FIG. 5 a and FIG. 5 b illustrate a method of extracting features from a bio-signal for estimating an intention of left and right movement between command items according to the present invention; and
[0020] [0020]FIG. 6 a and FIG. 6 b are drawings for explaining “International 10-20 System of Electrode Placement” used in the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0021] The present invention will be described in detail by way of a preferred embodiment with reference to accompanying drawings.
[0022] [0022]FIG. 1 illustrates an operation flow of an apparatus for controlling an electrical device using a bio-signal according to one embodiment of the present invention.
[0023] As shown in FIG. 1, the apparatus for controlling the electrical device includes a bio-signal detection unit 110 , a bio-signal amplification unit 120 , an A/D converter 130 , a control unit 140 and a transmission unit 150 .
[0024] The bio-signal detection unit 110 detects the bio-signal of a user using two electrodes attached on the forehead of the user. The displacement of the electrodes attached on the forehead follows Fp1 and Fp2 under “International 10-20 System of Electrode Placement”. However, a ground electrode may be positioned between the two electrodes for ground. At this time, as the shape where the ground is positioned does not significantly affects the present invention, the bio-signal detection unit 110 having only two electrodes can be included.
[0025] The bio-signal amplification unit 120 amplifies the bio-signal extracted from the bio-signal detection unit 110 . At this time, the bio-signal amplification unit 120 does not filter 60 Hz alternating current that is usually performed to measure the bio-signal.
[0026] The A/D converter 130 converts the amplified bio-signal of an analog mode into the bio-signal of a digital mode.
[0027] The control unit 140 receives the bio signals of the digital mode from the A/D converter 130 . Thereafter, The control unit 140 determines an activation/inactivation state of a control mode in a corresponding electrical device, left and right movement, and selection between command items using the bio-signal of the digital mode and then generates a command.
[0028] The transmission unit 150 receives a corresponding command from the control unit 140 and then transmits the command to a corresponding electrical device throughout infrared signal.
[0029] “International 10-20 System of Electrode Placement” used in the present invention is used to explain the location of the electrodes attached on the surface of the head. The method is most widely used, by which the location of the electrodes attached on the surface of the head using characters in which English characters and numbers are combined as shown in FIGS. 6 a and 6 b is confirmed. At this time, the used characters includes “F”—frontal lobe, “T”—temporal lobe, “C”—middle cranial lobe, “P”—parietal lobe, “O”—occipital lobe, and the like (Note: there is no middle cranial lobe in the cerebral cortex. “C” is only used as confirmation). Even numbers (2, 4, 6, 8) indicate right-side cerebral hemisphere. Odd numbers (1, 3, 5, 7) indicate the locations of the electrodes attached to the right-side cerebral hemisphere.
[0030] An operation of the apparatus for controlling the control device as constructed above will be described below.
[0031] The bio-signal detection unit 110 detects the bio-signal using the two electrodes attached on the forehead of the user. The bio-signal detection unit 110 then transmits the signal to the bio-signal amplification unit 120 . Next, the bio-signal amplification unit 120 amplifies the signal and then transmits the amplified signal to the A/D converter 130 . Then, the A/D converter 130 converts the bio-signal of an analog mode into the bio-signal of a digital mode and then transmits the bio-signal of the digital mode to the control unit 140 . Next, the control unit 140 determines an activation/inactivation state of a control mode in the electrical device, left and right movement, and selection between command items using the received bio-signal of the digital mode and then generates a command. Thereafter, the transmission unit 150 receives the generated command and then transmits the command to a corresponding electrical device throughout infrared signal.
[0032] [0032]FIG. 2 is a flowchart illustrates a process of activating the control mode in a corresponding electrical device, using the control unit used in the present invention.
[0033] First, the control unit receives a corresponding bio-signal of a digital mode from the A/D converter (S 210 ) and then filter the bio-signal except for electromyogram by using a high-frequency band pass filter of 60˜100 Hz (S 220 ). Features are then extracted from the signal through the high-frequency band pass filter (S 230 ) to determine whether a user want to activate the control mode (S 240 ).
[0034] At this time, in the apparatus for controlling the control device according to the present invention, if the user shuts his/her mouth twice sequentially (in detail, firmly clenching teeth with the mouth shut), it means that the control mode of the corresponding electrical device is changed to an active (ON) mode.
[0035] Thereafter, it is analyzed that the user changed the corresponding electrical device to the active mode. As a result of the analysis, if it is a command to change the device to the active mode, a corresponding ‘active’ command is transmitted to the transmission unit (S 260 ). On the contrary, if it is not the ‘active’ command of the user, the bio-signal is sequentially received and the above procedure is thus repeated.
[0036] [0036]FIG. 3 is a flowchart illustrating a process of determining an intention of left/right movement and an intention of selection between command items through movement of a user's face (firmly shutting mouth and head movement) when the control mode of a corresponding electrical device is activated.
[0037] In the apparatus for controlling the control device according to the present invention, it is determined that left (right) movement is made between command items if the user moves his/her head left (right) and a corresponding command item is selected if the user shuts his/her mouth once.
[0038] If the bio-signal is received from the A/D converter (S 310 ), the control unit filters the bio-signal except for electromyogram using high-frequency bandpass filter (S 311 ). Then, the control unit extracts features from the filtered bio-signal (S 312 ) to determine whether the user has an intention to select a command among the command items (S 313 ). Next, it is determined that the user has an intention to select the command item (S 314 ). As a result of the determination, if so, the control unit issues a selection command (S 315 ). On the contrary, if not, the control unit sequentially receives the bio-signal and thus repeats the above procedure.
[0039] On the other hand, the bio-signal inputted from the A/D converter is passed through the low-frequency band pass filer of 0.1˜5 Hz (S 321 ). Next, corresponding features are extracted from the filtered bio-signal (S 322 ). Then, it is determined that the extracted features indicate an intension of left and right movement (S 323 ). Thereafter, it is determined that the movement is made (S 324 ). As a result of the determination, if a corresponding user has an intention to move left and right between command items, the movement command is generated (S 325 ). On the contrary, if not, the bio-signal is sequentially received and the above procedure is thus repeated.
[0040] [0040]FIG. 4 a to FIG. 4 c illustrate a method of extracting features used in the apparatus for controlling the control device according to the present invention.
[0041] [0041]FIG. 4 a is a bio-signal diagram inputted from the A/D converter. As shown, the electrodes around the forehead measure electromyogram in every two sequential wave-packets generated when the user sequentially shuts the mouth twice.
[0042] [0042]FIG. 4 b is a signal shape after the high-frequency bandpass filtering. FIG. 4 c illustrates an average value of corresponding signal values within a moving time-window for the signal in FIG. 4 b. As shown in FIG. 4 c, it is determined that the user sequentially shuts the mouth, by examining the presence of two wave-packets at a proper reference value (value indicated by dot line in the drawing), the interval between the two wave-packets, and the presence of other wave-packets on the front and rear of the two wave-packets.
[0043] At this time, the time and strength with which the user shuts the mouth may be different. Thus, an initialization step of setting the reference value and the length of the wave-packet suitable for the user may be added. This method can be applied to a method of extracting other features which can be easily used by those having ordinary skill in the art.
[0044] [0044]FIG. 5 a and FIG. 5 b illustrate a method of extracting features necessary in a signal processing process for left and right movement between corresponding command items used in the present invention.
[0045] [0045]FIG. 5 a illustrates the bio-signal measured when the user moves his/her head right and left with his/her eyes fixed to the center of the screen (monitor, TV, etc.). FIG. 5 b illustrates a resulting signal after the bio-signal in FIG. 5 a is passed through the low-frequency bandpass filter. At this time, right and left movement can be determined by the increase and decrease of the average value of the resulting signal for a given period of time.
[0046] Further, at this time, the moving speed and angle of the head may be different, depending on users when using the apparatus for controlling the control device. Thus, an initialization step for obtaining a proper time period suitable for the user and the average value of increase and decrease for a corresponding signal can be added.
[0047] Also, in the present invention, it is determined that the user has an intention to move left (right) only when the user moves his/her head left (right) from the center in order to prevent confusion of the user and malfunction of the control device.
[0048] Finally, a case that the user views TV using the apparatus for controlling the electrical device according to the present invention will be below described.
[0049] First, the user shuts his/her mouth twice in order to activate (ON) the control mode of the apparatus for controlling the electrical device.
[0050] In a non-active state (OFF), TV is never affected even though the user shuts his/her mouth or shakes his/her head left and right (for example, conversation or eating, etc.)
[0051] If the control mode of a corresponding electrical device is activated, a stripe with ‘left’ on the left side at the bottom of the screen, a channel currently viewed at the center of the screen, and ‘right’ at the right side of the screen, is displayed. Every time when the user moves his/her head left (right) once, the channel is moved to a lower channel or a higher channel. Also, in case of controlling the color of the screen, the user moves his/her head in order to move a current color to a desired color and then shuts his/her mouth in order to specify the color. As such, if the user finishes selecting the color, he/she shuts his/her mouth twice in order to switch the active mode to the non-active mode.
[0052] As described above, according to the present invention, a bio-signal depending on a simple movement of the user's face (firm-set mouth and head movement) is employed. Therefore, the present invention has an outstanding advantage that it can control electrical devices through left and right movement and selection between desired command items even by a handicapped person. Further, a simple apparatus for processing the bio-signal is used. Therefore, the present invention has an effect that it can obtain a high performance with a low cost.
[0053] The present invention has been described with reference to a particular embodiment in connection with a particular application. Those having ordinary skill in the art and access to the teachings of the present invention will recognize additional modifications and applications within the scope thereof.
[0054] It is therefore intended by the appended claims to cover any and all such applications, modifications, and embodiments within the scope of the present invention.
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The present invention relates to an apparatus for controlling an electrical device using a bio-signal measured when a user moves his/her face, and method thereof. The apparatus according to the present invention comprises a bio-signal detection unit for detecting the bio-signal generated when the user firmly shuts his/her mouth and when the user moves his/her head; a bio-signal amplification unit for amplifying the amount of the bio-signal detected in the bio-signal detection unit; an A/D converter for converting the amplified bio-signal into the bio-signal of a digital mode; a control unit for analyzing the bio-signal of the digital mode to determine a corresponding command of the user and then generating a determined command of the user; and a transmission unit for transmitting the determined command to the electrical device via infrared rays. Therefore, the present invention can be used to input various commands more realistically in a virtual reality since the hands and a foot can be used for another work.
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BACKGROUND OF THE INVENTION
[0001] 1. Field of Invention
[0002] The present invention relates generally to vascular occlusions of the respiratory system, and more particularly to non-invasive devices and methods for the diagnosis of a pulmonary embolism and related disorders.
[0003] 2. Description of Prior Art
[0004] A pulmonary embolism occurs when an embolus become lodged in lung arteries, thus blocking blood flow to lung tissue. An embolus is usually a blood clot, known as a thrombus, but may also comprise fat, amniotic fluid, bone marrow, tumor fragments, or even air bubbles that block a blood vessel. Unless treated promptly, a pulmonary embolism can be fatal. In the United States alone, around 600,000 cases occur annually, 10 percent of which result in death.
[0005] The detection of a pulmonary embolism is extremely difficult because signs and symptoms can easily be attributed to other conditions and symptoms may vary depending on the severity of the occurrence. Frequently, a pulmonary embolism is confused with a heart attack, pneumonia, hyperventilation, congestive heart failure or a panic attack. In other cases, there may be no symptoms at all.
[0006] Often, a physician must first eliminate the possibility of other lung diseases before determining that the symptoms, if any, are caused by a pulmonary embolism. Traditional diagnostic methods of testing involve blood tests, chest X-rays, and electrocardiograms. These methods are typically more effective in ruling out other possible reasons than for actually diagnosing a pulmonary embolism. For example, a chest x-ray may reveal subtle changes in the blood vessel patterns after an embolism and signs of pulmonary infarction. However, chest x-rays often show normal lungs even when an embolism is present, and even when the x-rays show abnormalities they rarely confirm a pulmonary embolism. Similarly, an electrocardiogram may show abnormalities, but it is only useful in establishing the possibility of a pulmonary embolism.
[0007] As a pulmonary embolism alters the ability of the lungs to oxygenate the blood and to remove carbon dioxide from the blood, one method of diagnosing the condition involves taking a specimen of arterial blood and measuring the partial pressure of oxygen and carbon dioxide in the arterial blood (i.e., an arterial blood gas analysis). Although a pulmonary embolism usually causes abnormalities in these measurements, there is no individual finding or combination of findings from the arterial blood gas analysis that allows either a reliable way to exclude or specific way of diagnosing pulmonary embolism. In particular, at least 15-20% of patients with a documented pulmonary embolism have normal oxygen and carbon dioxide contents of the arterial blood. Accordingly, the arterial blood analysis cannot reliably include or exclude the diagnosis of a pulmonary embolism.
[0008] The blood D-dimer assay is another diagnostic method that has become available for commercial use. The D-dimer protein fragment is formed when fibrin is cleaved by plasmin and therefore produced naturally whenever clots form in the body. As a result, the D-dimer assay is extremely sensitive for the presence of a pulmonary embolism but is very nonspecific. In other words, if the D-dimer assay is normal, the clinician has a reasonably high degree of certainty that no pulmonary embolism is present. However, many studies have shown a D-dimer assay is only normal in less than ⅓ of patients and thus produces a high degree of false positives. As a result, the D-dimer assay does not obviate formal pulmonary vascular imaging in most patients with symptoms of a pulmonary embolism.
[0009] In an attempt to increase the accuracy of diagnostic, physicians have recently turned to methods which can produce an image of a potentially afflicted lung. One such method is a nuclear perfusion study which involves the injection of a small amount of radioactive particles into a vein. The radioactive particles then travel to the lungs where they highlight the perfusion of blood in the lung based upon whether they can penetrate a given area of the lung. While normal results can indicate that a patient lacks a pulmonary embolism, an abnormal scan does not necessarily mean that a pulmonary embolism is present. Nuclear perfusion is often performed in conjunction with a lung ventilation scan to optimize results.
[0010] During a lung ventilation scan, the patient inhales a gaseous radioactive material. The radioactive material becomes distributed throughout the lung's small air sacs, known as alveoli, and can be imaged. By comparing this scan to the blood supply depicted in the perfusion scan, a physician may be able to determine whether the person has a pulmonary embolism based upon areas that show normal ventilation but lack sufficient perfusion. Nevertheless, a perfusion scan does not always provide clear evidence that a pulmonary embolism is the cause of the problem as it often yields indeterminate results in as many as 70% of patients.
[0011] Pulmonary angiograms are popular means of diagnosing a pulmonary embolism, but the procedure poses some risks and is more uncomfortable than other tests. During a pulmonary angiogram, a catheter is threaded into the pulmonary artery so that iodine dye can be injected into the bloodstream. The dye flows into the regions of the lung and is imaged using x-ray technology, which would indicate a pulmonary embolism as a blockage of flow in an artery. Pulmonary angiograms are more useful in diagnosing a pulmonary embolism than some of the other traditional methods, but often present health risks and can be expensive. Although frequently recommended by experts, few physicians and patients are willing to undergo such an invasive procedure.
[0012] Spiral volumetric computed tomography is another diagnostic tool that has recently been proposed as a less invasive test which can deliver more accurate results. The procedure's reported sensitivity has varied widely, however, and it may only be useful for diagnosing an embolism in central pulmonary arteries as it is relatively insensitive to clots in more remote regions of the lungs.
[0013] These pulmonary vascular imaging tests have several disadvantages in common. Nearly all require ionizing radiation and invasiveness of, at a minimum, an intravenous catheter. The imaging tests also typically involve costs of more than $1,000 for the patient, take more than two hours to perform, and require special expertise such as a trained technician to perform the tests and acquire the images and a board-certified radiologist to interpret the images. Notably, none are completely safe for patients who are pregnant. As a result of these shortcomings, the imaging procedures are not available in many outpatient clinic settings and in many portions of third world countries.
3. OBJECTS AND ADVANTAGES
[0014] It is a principal object and advantage of the present invention to provide physicians with an instrument for non-invasively diagnosing pulmonary vascular occlusions.
[0015] It is an additional object and advantage of the present invention to provide an instrument that accurately diagnoses pulmonary vascular occlusions.
[0016] It is a further object and advantage of the present invention to provide an instrument for measuring and interpreting pulmonary test data.
[0017] Other objects and advantages of the present invention will in part be obvious, and in part appear hereinafter.
SUMMARY OF THE INVENTION
[0018] In accordance with the foregoing objects and advantages, the present invention provides a device and method for non-invasively diagnosing a pulmonary embolism. The device of the present invention comprises a breathing tube having sensors for measuring the flow of air into and out of a patient's lungs while a data processing unit simultaneously determines the oxygen and carbon dioxide concentrations. The device further includes a display screen for visually graphing the resulting calculations and providing a visual means for determining the likelihood that a pulmonary embolism is present based upon a change in measured gas concentrations.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] [0019]FIG. 1 is an illustration of a respiratory system during inhalation.
[0020] [0020]FIG. 2 is an illustration of a respiratory system during exhalation.
[0021] [0021]FIG. 3 is an illustration of a respiratory system afflicted with a pulmonary vascular occlusion during exhalation.
[0022] [0022]FIG. 4 is a schematic representation of the system of the present invention.
[0023] [0023]FIG. 5 is a perspective view of an attachment to the invention.
[0024] [0024]FIG. 6 is an illustration of a display screen readout.
DETAILED DESCRIPTION
[0025] Referring now to the drawing in which like reference numerals refer to like parts throughout, there is seen in FIG. 1 a representation of lungs 10 free from any pulmonary occlusions. In healthy lungs 10 , blood flows freely from the pulmonary arteries 12 into the capillaries 14 surrounding the individual alveoli 16 of the lungs 10 . When inhaled air 18 is drawn into the lungs 10 and alveoli 16 , oxygen is transferred from the inhaled air 18 to the blood stream and carbon dioxide is transferred out. Inhaled air 18 typically contains an oxygen partial pressure of approximately one hundred (100) torr and a carbon dioxide partial pressure of zero (0) torr.
[0026] Once the inhaled air 18 reaches the alveoli 16 , the oxygen content decreases while the carbon dioxide content increases until an equilibrium with blood gas levels in the pulmonary arteries 12 is reached. The inhaled air 18 is then, as seen in FIG. 2, expired as exhaled air 20 . Exhaled air 20 from properly functioning lungs typically contains a partial pressure of oxygen of about eighty (80) torr and a partial pressure of carbon dioxide of about forty (40) torr.
[0027] [0027]FIG. 3 depicts the functioning of a respiratory system afflicted with a pulmonary embolism 22 which, as an example, occludes blood flow to an afflicted lung 24 . As a result, there is a reduction in the number of alveoli 16 that participate in gas exchange. This volume of space available in the alveoli 16 that is lost from participation is commonly referred to as alveolar deadspace. Due to the deadspace and loss of total alveolar volume available for gas exchange, afflicted lung 24 does not exchange gases as readily as the healthy lung 10 . Accordingly, exhaled air 26 contains a higher partial pressure of oxygen and lower partial pressure of carbon dioxide than air exhaled from a healthy lung. In the example depicted in FIG. 3 , exhaled air 26 exiting the respiratory system contains a partial pressure of oxygen of about eighty-five (85) torr and a partial pressure of carbon dioxide of about twenty (20) torr. Thus, the ratio of carbon dioxide to oxygen in exhaled air 26 from afflicted lung 24 (i.e., 20:85) is smaller than the ratio in exhaled air 20 from healthy lung 10 (i.e., 40:80) as seen in FIG. 2.
[0028] As seen in FIG. 4, a system 28 for measuring and diagnosing pulmonary disorders comprises a measuring unit 30 in combination with a data processing unit 50 and a display screen 60 . Measuring unit 30 determines the overall flow of air inhaled into and exhaled out of the lungs while simultaneously determining the partial pressure of oxygen and carbon dioxide. Data processing unit 50 computes the concentrations of carbon dioxide, oxygen, and nitrogen from the partial pressures and determines the ratio of carbon dioxide to oxygen from the raw data obtained by measuring unit 30 . The ratio of carbon dioxide to oxygen is then plotted against expired volume on display screen 60 . By comparing the carbon dioxide ratios to average readings, the likelihood that a given patient has a pulmonary embolism can be determined.
[0029] Measuring unit 30 comprises a patient mouthpiece 32 connected in fluid communication to a breathing tube 34 having an open end 42 through which air can be inhaled or exhaled. Measuring unit 30 further comprises three sensors; a pneumotach 36 , a capnometer 38 , and an oxygen monitor 40 . The three sensors are situated in series and in-line with breathing tube 34 for simultaneously measuring the flow, carbon dioxide, and oxygen levels of inhaled and exhaled air. Infrared and paramagnetic type sensors are preferred respectively. Sensors using spectrometric techniques may also work for both oxygen and carbon dioxide measurements providing they can supply data with rapid enough response time for breath-to-breath, real-time plotting. The mainstream technique for measuring the inhaled or exhaled air is preferred, but the sidestream technique may also be effective.
[0030] As seen in FIG. 5, a T-piece adaptor 70 may optionally be provided at open end 42 of breathing tube 34 for use with patients that are oxygen dependant. T-piece adapter 70 contains an inlet valve 72 and an outlet valve 74 which properly direct the passage of inhaled and exhaled air through the breathing tube 34 . By connecting an oxygen dependant patient's supply to the intake valve 72 , inhaled air can first be passed through the three sensors 36 , 38 , 40 to establish baseline readings of the oxygen and carbon dioxide concentrations for comparison to exhaled air, since an oxygen dependent patient receives air that has different concentrations than present in ambient air.
[0031] Data processing unit 50 comprises a commercially available computer processor programmed with software for the interpretation of the data obtained from measuring unit 30 and background comparison data. Software can be specifically developed to perform the necessary calculations to determine the partial pressures and carbon dioxide to oxygen ratios or software can optionally be purchased commercially and, if necessary, modified to run the appropriate algorithms. After additional research, the background comparison data can be updated based on data obtained from use of the invention to further refine expected normal values.
[0032] Display screen 60 comprises a cathode ray tube or other visual display for displaying computerized data. Screen 60 can optionally display graphs representing predetermined reference or background data for test populations against which the current readings can be plotted for a visual comparison. In addition to displaying the carbon dioxide to oxygen ratios as a function of time calculated by data processing unit 50 , screen 60 may optionally display a plot of the expired oxygen and carbon dioxide partial pressures. Using this display, a physician may estimate the efficiency of alveolar ventilation in patients with acute respiratory distress syndromes to assist in deciding the mechanical ventilation settings.
[0033] In addition to the three primary sensors 36 , 38 , 40 , data processing unit 50 may optionally be connected to a pulse oximeter 44 that measures arterial oxygen saturation of hemoglobin in the arterial blood. From this data, and the additional measurement of pH and hemoglobin concentration in a peripheral venous blood sample, the cardiac output of the patient can be calculated according to the Fick equation. In order to perform the Fick equation, the average total oxygen consumed, the arterial oxygen content and venous oxygen content must be determined. The average total oxygen consumed can be determined from the oxygen tension and flow curves over a predetermined time period. For the purposes of determining cardiac output, a one minute time period is sufficient. The arterial oxygen content can be estimated by multiplying the arterial oxygen saturation (measured by pulse oximeter 44 ) by the hemoglobin concentration (determined from the venous blood sample). The venous oxygen content can be calculated by determining the nadir (mean lowest) oxygen tension measured during expiration over the predetermined time period. From the nadir oxygen tension, venous oxygen saturation can be estimated according to published oxygen binding curves for the measured pH. The venous oxygen content is then calculated by multiplying the venous oxygen saturation by the venous hemoglobin (measured from the venous blood sample). Once these calculations have been made, the cardiac output is determined by dividing the total oxygen consumed by the difference between the arterial oxygen content and the venous oxygen content. The algorithm for the Fick calculation can be programmed into the data processing unit software and the results displayed on screen 60 . The cardiac output measurement is useful for assisting the physician in determining the success or failure of treatment designed to relieve pulmonary vascular obstructions, or to treat circulatory shock.
[0034] Device 28 is used by having a patient breathe (inhale and exhale a predetermined number of times in succession) through mouthpiece 32 of the measuring unit 30 . As the patient inhales and exhales the pneumotach flow sensor 36 , capnometer 38 , and oxygen monitor 40 perform their respective readings, which are then electrically transmitted via wires or cabling to data processing unit 50 . The programmable software loaded into data processing unit 50 convert the measurements into volume and concentration readings, calculate the carbon dioxide to oxygen ratio, and display this ratio on screen 60 in the form of a graph against the volume of air expired. Readings may be optimized by requiring the patient to hold in inhaled air for several heartbeats before exhaling through the mouthpiece 32 of the measuring unit 30 . It is generally accepted that patients without a pulmonary embolism will normally have a carbon dioxide to oxygen ratio of 0.30 or greater while patients with a pulmonary embolism will have a carbon dioxide to oxygen ratio of 0.25 or less.
[0035] Device 28 may also be used for the detection of whole-body oxygen consumption and determination of the adequacy of oxygen delivery during resuscitation from shock. During conditions of systemic inflammation the body will extract oxygen at higher levels than normal, resulting in an increase in the carbon dioxide to oxygen ratio in exhaled air. By using T-piece 70 in the manner explained above, the concentration of the oxygen provided to the patient and the concentration of the oxygen exhaled can be determined. As illustrated in FIG. 6, when the level of oxygen delivery (i.e., the amount provided minus the amount exhaled) observed at two inspired oxygen concentrations reaches normal levels a physician has visual conformation that the resuscitation performed is adequate. One method of determining the adequacy of resuscitation is to determine oxygen delivery at both relatively low fixed concentrations of oxygen and at relatively high fixed concentration. Relatively low concentrations include from about twenty-one to thirty percent (21-30%) oxygen and relatively high oxygen concentrations involve about forty-five to fifty percent (45-50%) oxygen. The difference between oxygen delivery at relatively low concentrations verses relatively high concentrations can be compared against a nomogram for healthy patients of similar age, body mass, body mass index, and gender and used to assess the adequacy of fluid and vasopressor resuscitation.
[0036] Data processing unit 50 can additionally be programmed to display on screen 60 any of the individual measurements taken by sensors 36 , 38 , 40 , and 44 , or combinations thereof for diagnostic purposes. For example, a plot of the expired carbon dioxide and oxygen concentration over time could be used to estimate the efficiency of alveolar ventilation in patients with acute respiratory distress syndrome. Additionally, the plotted data from sensors 36 , 38 , 40 , and 44 could be used to assist in deciding how to properly adjust mechanical ventilators setting, such as the degree of positive end-expiratory pressure, minute ventilation, and peak inspiratory pressure settings, to optimize patient care. For example, data from sensors 36 , 37 , 40 , and 44 , can be plotted individually in patients who are being mechanically ventilated. By simultaneously plotting the partial pressures of oxygen and carbon dioxide as a function of volume of each breath, the amount of carbon dioxide released and percentage of oxygen extracted can be determined. If the barometric pressure is known or inputted into data processing unit 50 , the efficiency of alveolar ventilation during each tidal volume breath can be calculated. This information can then be used to adjust mechanical ventilation to optimize alveolar efficiency or breathing alveolar ventilation efficiency.
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The invention involves a device and method for ascertaining the functioning of the respiratory system and determining whether a pulmonary embolism is present. The device comprises an apparatus containing sensors for measuring the oxygen and carbon dioxide concentrations as well as the volume of air inhaled and exhaled by a patient. From this data, a processor computes the ratio of carbon dioxide to oxygen for the volume of expired air and displays the results on a screen. By comparing the results to predetermined normal values, an accurate determination can be made regarding the presence of a pulmonary embolism.
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CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application Ser. No. 14/537,900 filed on Nov. 10, 2014 by Gerald William Pirkl, titled “SLIDING SHELF CONTAINMENT SYSTEM” (which will issue as U.S. Pat. No. 9,277,819 on Mar. 8, 2016), which is incorporated herein by reference in its entirety, and which claims priority benefit of U.S. Provisional Patent Application No. 61/908,188 filed Nov. 25, 2013 by Gerald W. Pirkl, titled “SLIDING SHELF CONTAINMENT SYSTEM,” and of U.S. Provisional Patent Application No. 61/965,331 filed Jan. 29, 2014 by Gerald William Pirkl, titled “SLIDING SHELF CONTAINMENT SYSTEM.”
FIELD OF THE INVENTION
[0002] The present invention relates to shelves, and in particular to systems and methods for containing objects placed on a sliding shelf.
BACKGROUND OF THE INVENTION
[0003] There are no specifications that relate to dimensional qualities of slide out shelves. Typical sliding shelves are custom built for their needed application. When we think of slide out shelves, kitchen food storage, pots and pans, cleaning products, laundry supplies, garage storage, and other storage applications come to mind. Custom built slide out shelves for these applications are usually constructed from a wood or laminate, or combination thereof. Typical shelves sides are random heights, but the majority of products that I have researched, have what the industry refers to as the height of the width of a credit card. This translates to two and a quarter inches (5.7 cm)—plus or minus. There are custom built installations that have taller sides, and depending on the total height between the floor of the sliding shelf, in question, and the bottom of the shelf above it, may not need this invention. My research shows that the vast majority of owners of typical slide out shelves have a problem with objects falling off the shelves when in operation.
[0004] A Patent Search has been conducted by an independent patent attorney, studying items that relate to ‘Sliding Shelf and Barrier.’ The closest U.S. Pat. No. is 6,039,422. Other sliding shelf patents reviewed are: U.S. Pat. Nos. 7,942,486; 7,806,277; 6,364,136; 5,230,554; 5,037,163; and 4,901,972. His written opinion claims that he did not find any patented products that fit the description of my invention.
[0005] Two Provisional Patents 61/908,188 and 61/965,331, have been submitted for two different versions of this invention. I have included both of them in this one Non-Provisional Submittal.
BRIEF SUMMARY OF THE INVENTION
[0006] The advantages of this invention are to eliminate or greatly reduce materials falling over the edge or sides of slide out shelves.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0007] FIG. 1A is a top oblique view of a sliding shelf, shown with a rail containment system 101 according to one embodiment of the present invention.
[0008] FIG. 1B is an enlargement oblique view of the top left rear corner of the containment shelf of rail containment system 101 .
[0009] FIG. 1C is a front enlargement view of a rail standard of rail-containment system 101 .
[0010] FIG. 1D is a side enlargement view of the rail standard of FIG. 1C .
[0011] FIG. 2A is a top oblique view of a sliding shelf, with a rigid-panel containment system 201 according to one embodiment of the present invention.
[0012] FIG. 2B is an enlargement oblique view of the top right rear corner of containment system 201 , as viewed along line 2 B of FIG. 2A .
[0013] FIG. 2C is a top cross-section view of containment system 201 , as viewed along line 2 C of FIG. 2A .
[0014] FIG. 2D is a front cross-section view of containment system 201 , as viewed along line 2 D of FIG. 2A .
DETAILED DESCRIPTION OF THE INVENTION
[0015] FIGS. 1A, 1B, 1C and 1D relate to the first embodiment corresponding to Provisional Application 61/908,188.
1. The sliding shelf, front, back, sides, and bottom, are existing elements of a conventional sliding shelf unit. 2. Sliding shelves are built in random lengths and widths, and this invention will accommodate units from 12.0 inches to 22.5 inches (30.5 cm to 57.2 cm) in length and 12.0 inches to 30.0 inches (30.5 cm to 76.2 cm) in width. Standard two rail system can accommodate an 8-inch (20.3-cm) sliding-shelf space. A three rail system can accommodate up to an 11-inch (27.9-cm) space. 3. Element 115 (also referred to herein as a containment member)—telescoping rail of metal or rigid material, to accommodate shelf varying widths and lengths. 4. Drawings for this embodiment are: FIG. 1A , FIG. 1B , FIG. 1C , and FIG. 1D .
[0020] FIG. 1A is a top oblique view of a sliding shelf and a rail containment system 101 .
1. Existing sliding shelf, elements 103 front, 105 bottom, 107 side, and 109 back. 2. Element 111 (also referred to herein as a containment-member support)—rail standard—is attached to the shelf sides and back, every four to six inches, with screws, and holds the rails in place. 3. Element 113 —self tapping, #8, ½ inch lath screws, attach rail standards 111 to sides and back of sliding shelf. 4. Element 115 —telescoping rail of metal or rigid material, to accommodate shelf varying widths and lengths. 5. Element 117 —rail end cap of rubberized or plastic material, to close off the ends of the rails, and eliminate sharp edges.
[0026] FIG. 1B is an enlargement oblique view of the top left rear corner of the containment shelf and rail containment system 101 .
1. Existing sliding shelf, elements 103 front, 105 bottom, 107 side, and 109 back. 2. Element 111 —rail standard—is attached to the shelf sides and back, every four to six inches (10 to 15 cm), with screws, and holds the rails in place. 3. Element 113 —self tapping, #8, ½ inch lath screws, attach rail standards 111 to sides and back of sliding shelf. 4. Element 115 —telescoping rail of metal or rigid material, to accommodate shelf varying widths and lengths. 5. Element 117 —rail end cap of rubberized or plastic material, to close off the ends of the rails, and eliminate sharp edges.
[0032] FIG. 1C is a front enlargement view of a rail standard in rail containment system 101 .
[0033] FIG. 1D is a side enlargement view of the rail standard of FIG. 1C .
1. Existing sliding shelf, elements 105 bottom, 107 side, and 109 back. 2. Element 111 —rail standard is a metal or rigid material, approximately ⅛ inch in thickness, by ⅞ inch in width, by 8.0 inches in height (taller standards may hold up to three rails; for example, a first containment member, a second containment member, and a third containment member). 3. Element 113 —self tapping, #8, ½ inch lath screws, attach rail standards 111 (for example, a first containment-member support, a second containment-member support, and a third containment-member support) to sides and back of sliding shelf. 4. Element 115 —telescoping rail of metal or rigid material, to accommodate shelf varying widths and lengths. The outside diameter of these rails may be up to ½ inch in diameter. 5. Element 119 —rail cradle is a metal stamping, or molded protrusion from the rail standard 111 material, made to hold the telescoping rails. The rails can have a thin plasticized material wrapped around the rails at the location of the cradles to provide flexibility when snapping the rail into the cradle. A thicker plasticized material will be wrapped around the inner telescoping rail, to accommodate a snug fitting into the standard size cradle.
[0039] FIG. 2A , FIG. 2B , FIG. 2C , and FIG. 2D relate to the second embodiment corresponding to Provisional Application 61/965,331.
[0040] In FIG. 2A , FIG. 2B , FIG. 2C , and FIG. 2D :
1. The sliding shelf, front, back, sides, and bottom, are existing elements of a conventional sliding shelf unit. 2. Sliding shelves are built in random lengths and widths, and this invention will accommodate units from 12.0 inches to 22.5 inches in length and 12.0 inches to 30.0 inches in width. Standard system can accommodate an 8 inch high sliding shelf space. An 11.0 inch containment panel can accommodate up to a 12 inch high space. 3. Element 135 —containment panel can have elongated screw hole channels to allow panel sliding movement, to accommodate shelf varying widths and lengths. 4. Drawings for this embodiment are: FIG. 2A , FIG. 2B , FIG. 2C , and FIG. 2D .
[0045] FIG. 2A is a top oblique view of a sliding shelf and a rigid panel containment system 201 .
1. Existing sliding shelf, elements 103 front, 105 bottom, 107 side, and 109 back. 2. Element 135 —is a rigid material, approximately ⅛ inch in thickness that may be opaque or transparent. This material is attached to the shelf sides and back, every four to six inches (10 to 15 cm), with screws 113 , and holds the material in place. Elongated screw hole channels allow for panel sliding movement, to accommodate shelf varying widths and lengths. 3. Element 113 —self tapping, #8, ½ inch lath screws, attach containment panels 135 to sides and back of sliding shelf. 4. Element 131 —edge cap is a rigid plasticized material forming a U channel that has an approximate inside dimension of ¼ inch in width by ½ inch legs. This cap clips together the containment panels 135 and filler strips 133 to reinforce the containment panel 135 edges, while at the same time, eliminating sharp edges. Material can accommodate cutting to various lengths with a razor knife or similar. 5. Element 133 —filler strip is an approximate ¾ inch strip of containment panel 135 material, used under the edge cap 131 , at places where overlapping panels do not occur. This strip provides a second thickness to accommodate the snap-on edge cap 131 . The filler strip 133 has an etched grove every ½ inch of its length, to accommodate selecting the approximate length by utilizing snap breaking joints. The filler strip 133 is held in place with a mastic type material of rubberized or plastic material. Filler strip 133 material is also used in 2.0 inch lengths to provide double wall thickness at screw locations, where only a single inside (closest to the center of the shelf) containment panel 135 exists.
[0051] FIG. 2B is an enlargement oblique view of the top right rear corner of the containment shelf and containment system 201 , as viewed along line 2 B of FIG. 2A .
1. Existing sliding shelf, elements 103 front, 105 bottom, 107 side, and 109 back. 2. Element 135 —is a rigid material, approximately ⅛ inch in thickness that may be opaque or transparent. This material is attached to the shelf sides and back, every four to six inches, with screws, and holds the material in place. Elongated screw hole channels allow for panel sliding movement, to accommodate shelf varying widths and lengths. 3. Element 113 —self tapping, #8, ½ inch lath screws, attach containment panels 135 to sides and back of sliding shelf. 4. Element 131 —edge cap is a rigid plasticized material forming a U channel that has an approximate inside dimension of ¼ inch in width by ½ inch legs. This cap clips together the containment panels 135 and filler strips 133 to reinforce the containment panel 135 edges, while at the same time, eliminating sharp edges. Material can accommodate cutting to various lengths with a razor knife or similar. 5. Element 133 —filler strip is an approximate ¾ inch wide strip of containment panel 135 material, used under the edge cap 131 , at places where overlapping panels do not occur. This strip provides a second thickness to accommodate the snap-on edge cap 131 . The filler strip 133 has an etched groove every ½ inch of its length, to accommodate selecting the approximate length by utilizing snap breaking joints. The filler strip 133 is held in place with a mastic type material of rubberized or plastic material. Filler strip 133 material is also used in 2.0 inch lengths to provide double wall thickness at screw locations, where only a single inside (closest to the center of the shelf) containment panel 135 exists.
[0057] FIG. 2C is a top cross-section view of containment system 201 , as viewed along line 2 C of FIG. 2A .
1. Existing sliding shelf, elements 103 front, 105 bottom, 107 side, and 109 back. 2. Element 135 —is a rigid material, approximately ⅛ inch in thickness that may be opaque or transparent. This material is attached to the shelf sides and back, every four to six inches, with screws, and holds the material in place. Elongated screw hole channels allow for panel sliding movement, to accommodate shelf varying widths and lengths. 3. Element 113 —self tapping, #8, ½ inch lath screws, attach containment panels 135 to sides and back of sliding shelf. 4. Element 133 —filler strip is an approximate ¾ inch wide strip of containment panel 135 material, used at places where overlapping panels do not occur. The filler strip 133 has an etched grove every ½ inch of its length, to accommodate selecting the approximate length by utilizing snap breaking joints. Filler strip 133 material is used in 2.0 inch lengths to provide double wall thickness at screw locations, where only a single inside (closest to the center of the shelf) containment panel 135 exists.
[0062] FIG. 2D is a front cross-section view of containment system 201 , as viewed along line 2 D of FIG. 2A .
1. Existing sliding shelf, elements 103 front, 105 bottom, 107 side, and 109 back. 2. Element 135 —is rigid material, approximately ⅛ inch in thickness that may be opaque or transparent. This material is attached to the shelf sides and back, every four to six inches, with screws, and holds the material in place. Elongated screw hole channels allow for panel sliding movement, to accommodate shelf varying widths and lengths. 3. Element 113 —self tapping, #8, ½ inch lath screws, attach containment panels 135 to sides and back of sliding shelf. 4. Element 131 —edge cap is a rigid plasticized material forming a U channel that has an approximate inside dimension of ¼ inch in width by ½ inch legs. This cap clips together the containment panels 135 and filler strips 133 to reinforce the containment panel 135 edges, while at the same time, eliminating sharp edges. Material can accommodate cutting to various lengths with a razor knife or similar. 5. Element 133 —filler strip is an approximate ¾ inch wide strip of containment panel 135 material, used under the edge cap 131 , at places where overlapping panels do not occur. This strip provides a second thickness to accommodate the snap-on edge cap 131 . The filler strip 133 has an etched grove every ½ inch of its length, to accommodate selecting the approximate length by utilizing snap breaking joints. The filler strip 133 is held in place with a mastic type material of rubberized or plastic material. Filler strip 133 material is also used in 2.0 inch lengths to provide double wall thickness at screw locations, where only a single inside (closest to the center of the shelf) containment panel 135 exists.
[0068] General
[0069] Sliding shelves are typically manufactured in random sizes to fit in existing cabinetry space shelf width and length measurements. Typically, the side and back heights of these sliding shelves is 2¼ inches—plus or minus. Custom manufacturers can offer increased wall heights during the initial manufacturing process. This product is produced to retro-fit existing sliding shelves that have not been manufactured with extended walls. Typical wall heights contribute to materials tipping and falling off the shelves. This invention is to solve these tipping and falling item problems. Back to dimensions—the third dimension is to measure the height of the cabinetry space to determine the height and type of products that can be placed on these shelves. If the major problem is to solve the tipping and falling condition, then the first embodiment corresponding to Provisional Application 61/908,188—the telescoping rail system solves the problem. If the shelf is to contain horizontally stacked items, and the sliding of these items causes problems—then the second embodiment corresponding to Provisional Application 61/965,331—the containment panel system works better. This application also solves the item tipping and falling problem. Both product applications have a standard height of 8 inches from shelf bottom to top of containment. Higher containment levels can be produced for both products, to bring the rail system up to 11 inches and the panel system up to 12 inches.
[0070] Materials for the first embodiment corresponding to Provisional Application 61/908,188—telescoping rail system 101 .
a. telescoping rail 115 —stainless steel, steel, other metals, fiberglass, rigid plastic and other high tensile materials. b. rail standard 111 —stainless steel, coated steel, other metals, rigid plastic and other high tensile materials. c. rail end cap 117 —stretchable vinyl material with ½ inch inside length and diameter to fit over the ends of the rail. d. screws 113 —zinc coated, 8-gauge, ½ inch length phil mod truss, lath screws.
[0075] Materials for the second embodiment corresponding to Provisional Application 61/965,331—containment panel system 201 .
a. containment panel 135 —0.125 inch thick polycarbonate, 0.125 inch thick acrylic sheet, materials in clear or colored, 8 inch high×12 inch long and 8 inch high×10 inch long typical panels, 12 inch high panels available. All panels are predrilled, and elongated screw hole channels allow for panel sliding movement, to accommodate shelf varying widths and lengths. b. edge cap 131 —c-line Slide 'N Grip Plastic Binding Bars, 11×¼ inches, cut and shaped for vertical and horizontal ells sections. c. filler strip 133 —same material as the containment panel, ¾×12 inch pieces with scoring every ½ inch to allow for break-off lengths. Filler strips at screw location, for maintaining double thickness, are ¾×2 inch dimensions with predrilled screw holes. d. screws 113 —zinc coated, 8-gauge, ½ inch length phil mod truss, lath screws.
[0080] Assembly for the first embodiment corresponding to Provisional Application 61/908,188—telescoping rail system 101 .
a. measure the inside of the existing sliding shelf. Shelf rail standards 111 , to be installed four to six inches center to center. Shorter length and width shelves will have sides and or back lengths that may have three rail standards 111 as close as four inches center to center. Using a pencil, mark rail standard 111 locations, beginning 2 ¼ inches from each inside corner, to the center of the first rail standard. Divide the remaining distance by 6, and increase to the next whole number. Divide the remaining length by this whole number, to get the spacing for the rail segment. Example for a 30 inch back width shelf—30 minus 4½ (2¼ inches from each corner), equals 25½ inches, divided by 6 is 4¼. Increase to next whole number is 5. Twenty-five and one half inches divided by 5 is a 5.1 inch spacing for this back section. Measure the shelf sides and repeat the same process to obtain spacings. Mark all spacings for rail standards 111 on the shelf bottom, immediately adjacent to the shelf sides and back sections. b. Install rail standards 111 at all spacing marks. Hold a rail standard 111 in place, lining up the space marking with the center of the rail standard 111 , and mark the bottom drill hole. Drill at the bottom hole and install the rail standard (with the rail cradle protrusion to the outside of the shelf) with a screw. Snug up the screw to hold the rail standard 111 in place. Plumb the rail standard 111 to vertical using any 90 degree angle item (like a deck of cards, credit card, note pad, small square, etc.). Mark, drill, and install screw in upper rail standard hole. Check for vertical 90 degrees, and tighten both screws. Complete this process for the remaining rail standard 111 installations. c. Lay out rails next to all three shelf walls. For side sections, partially insert a smaller diameter rail into a large one. Install rail end caps on each end (smaller end cap onto smaller rail, and larger cap onto larger rail end). Lay the side sections into the rail cradles 119 , of the shelf standards 111 , with the larger diameter rail toward the front of the shelf. Assemble the shelf back wall rails (three rail sections will have a small diameter rail on each end). Two rail sections will be the same as the side wall sections. Install rail end caps 117 as necessary, and lay the back rails into the back rail standard 111 rail cradles 119 (two section rails can have the small diameter at either end of the back section). d. Extend the telescoping rails to be flush with the back side of the pull out shelf front. Extend corner telescoping rails to meet at the corners. Pencil-mark each rail at the center of the rail cradle 119 . e. Remove one side rail assembly. Two thicknesses of cradle tape are supplied. Use the thin tape and wrap one revolution over each pencil marking on the large diameter rails. Do the same for the small diameter rails—using the thick tape. Reinstall the side rail assembly, by pressing it down to the bottom of each receiving cradle. Repeat the same process for the other side and back of the shelf.
[0086] Assembly for the second embodiment corresponding to Provisional Application 61/965,331 containment panel system.
a. measure the inside of the existing sliding shelf. Twelve inch deep shelves require only one side 8 inch×12 inch containment panel 135 . Twelve and a half to 22½ inch depth requires two containment panels 135 . Twelve inch wide shelves require only one 8 inch×12 inch containment panel. Twelve and a half to 20.0 inch require 2 containment panels 135 (1-8×12 and 1-8×10 inch). Twenty to 22 inch widths require-2 containment panels 135 (2-8×12 inch). Twenty-two to 30 inch widths require 3 containment panels 135 (2-8×12 and 1-8×10 inch). b. Measure the inside depth of sliding drawer. If the side dimension is 14½ inches or more, install 8×12 side panel at the right rear corner, using the 8 inch side as the panel height. Drill and install the upper screw hole 2¼ inches from the corner. Hold up the second panel (panel closest to the middle of the slide out shelf), against and touching the back of the pull out shelf front 103 . Pencil mark proposed screw holes, in the double thickness portion, 2 inches from the overlap, and evenly along the side panel every 4 to 6 inches. Attach glue side of 2 inch long filler strips 133 to the outside (closest to the pull out shelf side 107 ) of the panel at screw locations where the inside panel is single thickness. Drill and install one screw at a location close to the midpoint of where the panels overlap. This will hold both panels in place while you drill and install the remaining screws at marked points, using the predrilled panel holes as a guide. Repeat the same installation on the opposite pull out shelf side 107 . c. For side depths of less than 14½ inches and more than 12½ inches—temporarily install corner side panel using the top screw hole 2 inches from the corner. Hold up the second 8×12 inch panel and pencil mark screw holes and attach filler strips 133 , as described in 4.b. (above). Remove screw holding the first panel. Hold up both panels and drill and install a screw at a marked hole near the midpoint of the double thickness area. This will hold both panels in place until all screws are installed. Repeat the same installation on the opposite pull out shelf side 107 . d. For back panel installation where the back dimension is less than 14½ inches and more than 12½ inches—start the right rear corner, hold the first panel against the pull out shelf back 109 , with the end touching the installed side panel and repeat the steps contained in 4.c. above. e. For back panel installation where the dimension is less than 22 inches and more than 14½ inches—start the first 8×12 panel against the pull out shelf back 109 right rear corner. Drill and install the upper screw hole 2¼ inches from the corner. Hold up the second 8×12 panel (panel closest to the middle of the slide out shelf), against and touching the left rear corner. Pencil mark proposed screw holes at the mid point of the double thickness portion, and evenly along the back panel every 4 to 6 inches. Attach glue side of 2 inch long filler strips to the outside (closest to the pull out shelf back 109 ) of the inside panel at screw locations where the inside panel is single thickness. Drill and install one screw at a location close to the midpoint of the panel. This will hold both panels in place while you drill and install the remaining screws at marked points, using the predrilled panel holes as a guide. f. For back panel installation where the dimension is less than 30 inches or more than 24 inches—install an 8×12 panel against the pull out shelf back 109 in each corner. Drill and install the upper screw hole 2¼ inches from each corner. Center the third 8×10 panel in the gap between the first two panels. Pencil mark all screw hole locations and install filler strips as necessary in the gap between the first two panels. Attach glue side of 2 inch long filler strips to the outside (closest to the pull out shelf back 109 ) of the panel. Drill and install one screw at a marked location close to the midpoint of the panel. This will hold all panels in place while you drill and install the remaining screws at marked points, using the predrilled panel holes as a guide. g. Before you install the top and front edge cap 131 , additional filler strips must be installed to provide a gripping surface for the edge cap 131 . All areas along the edge cap 131 , must receive filler strips to make the edge a double thickness. Starting on the side panel at the right rear corner of the sliding shelf—this single section will receive a filler strip 133 , on the side closest to the sliding shelf center. Hold the break-off strip against the single panel and mark the length with a pencil. If this mark falls in between break-off points, go to the next shortest break-off point on the strip and (using two pliers) break the strip at that location. That will allow the strip to fit into the gap. Install the glue side to the inside of the corner side panel. Moving toward the front of the sliding shelf, repeat the measurement, break off, and glue attachment for the strip on the outside of the second panel. Then repeat the measurement, break-off, and glue attachment for the vertical front strip. Move to the other side and repeat the same procedure. Now move to the back right corner of the shelf, and repeat the measurement, break-off, and glue and attach the strip on the inside of the first panel attached to the back of the shelf. Then repeat the measurement, break-off, and glue attachment for the entire horizontal strip. As you move toward the shelf left back corner, alternate sides (when there are two or three back panels) when applying filler strips 133 . h. When all filler strips are installed, there should be a continuous double thickness of containment panels 135 and filler strips 133 , all along the top of the containment panels 135 , and from the top of the front two containment panels 135 , down to the top of the pull out shelf front. i. Begin installing edge caps 131 . Use the ell edge cap 131 consisting of the vertical and horizontal angle—to be applied to the front two corners of the containment panels. Measure the distance from the top of the front two containment panels 135 , down to the top of the pull out shelf front. Using a razor knife, carefully cut the ell edge cap 131 , to the measurement. Install edge cap 131 , starting at the top of the pull out shelf front. Spread the bottom corner legs of the edge cap, and insert it over the containment panel 135 , and filler strip 133 , at the bottom of the vertical section. Gently apply pressure on the back of the edge cap 131 , as you move up the edge cap. When the edge cap is fully seated on the vertical portion of the panel, gently apply pressure on the back of the edge cap 131 , as you move horizontally toward the rear corner of the shelf. When this edge cap is fully seated, install the horizontal ell edge cap 131 on the back corners, using the same procedure. There will be gaps between the ell edge caps 131 on the tops of the panels on the sides and back of the shelf. Measure the gap distance, and (using a razor knife) carefully cut and install a section of straight edge cap 131 , to the measurement. Two straight sections of edge cap 131 may be required on the back panels of wide shelves. Apply pressure to all edge cap 131 sections to complete the installation.
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Mechanisms and methods to install upper restrictive barriers onto existing pull-out shelves to prevent or decrease the likelihood of the shelf contents from falling over the back or sides of the shelf.
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RELATED APPLICATIONS
[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62/074,609, filed Nov. 3, 2014, which is expressly incorporated in its entirety.
BACKGROUND
[0002] 1. Technical Field
[0003] The invention relates to the field of medical devices, and more particularly medical devices or delivery systems for and methods of controllably deploying stents and reconstraining partially deployed stents.
[0004] In some applications, the invention relates to systems for delivering a self-expandable intraluminal graft (“stents”) for use within a body passageway or duct which are particularly useful for repairing blood vessels narrowed or occluded by disease.
[0005] 2. Related Devices and Methods
[0006] Transluminal prostheses have been widely used in the medical arts for implantation in blood vessels, biliary ducts, or other similar lumens of the living body. These prostheses are commonly known as stents and are used to maintain, open, or dilate tubular structures. An example of a commonly used stent is given in U.S. Pat. No. 4,733,665 filed by Palmaz on Nov. 7, 1985, which is hereby incorporated in its entirety herein by reference. Such stents are often referred to as balloon expandable stents. Typically the stent is made from a solid tube of stainless steel. Thereafter, a series of cuts are made in the wall of the stent. The stent has a first smaller diameter which permits the stent to be delivered through the human vasculature by being crimped onto a balloon catheter. The stent also has a second, expanded diameter, upon the application, by the balloon catheter, from the interior of the tubular shaped member of a radially, outwardly extending force.
[0007] However, such stents are often impractical for use in some vessels such as the carotid artery or the superficial femoral artery. The carotid artery is easily accessible from the exterior of the human body, and is often visible by looking at one's neck. A patient having a balloon expandable stent made from stainless steel, or the like, placed in his or her carotid artery might be susceptible to severe injury through day-to-day activity. A sufficient force placed on the patient's neck, such as by falling, could cause the stent to collapse resulting in injury to the patient. In order to prevent this and to address other shortcomings of balloon expandable stents, self-expanding stents were developed. Self-expanding stents act like springs and will recover to their expanded or implanted configuration after being crushed.
[0008] One type of self-expanding stent is disclosed in U.S. Pat. No. 4,665,771, which stent has a radially and axially flexible, elastic tubular body with a predetermined diameter that is variable under axial movement of ends of the body relative to each other and which is composed of a plurality of individually rigid but flexible and elastic thread elements defining a radially self-expanding helix. This type of stent is known in the art as a “braided stent” and is so designated herein.
[0009] Other types of self-expanding stents use alloys such as Nitinol (Ni—Ti alloy) which have shape memory and/or superelastic characteristics in medical devices that are designed to be inserted into a patient's body. The shape memory characteristics allow the devices to be deformed to facilitate their insertion into a body lumen or cavity and then be heated within the body so that the device returns to its “memorized” shape. Superelastic characteristics on the other hand generally allow the metal to be deformed and restrained in the deformed condition to facilitate the insertion of the medical device containing the metal into a patient's body, with such deformation causing the phase transformation. Once within the body lumen the restraint on the superelastic member can be removed, thereby reducing the stress therein so that the superelastic member can return to its original un-deformed shape by the transformation back to the original phase, or close to it (as the implanted shape is designed to have some deformation to provide a force to prop open the vessel in which it is implanted).
[0010] Alloys having shape memory/superelastic characteristics generally have at least two phases. These phases are a martensitic phase, which has a relatively low tensile strength and which is stable at relatively low temperatures, and an austenitic phase, which has a relatively high tensile strength and which is stable at temperatures higher than the martensitic phase.
[0011] When stress is applied to a specimen of a metal such as Nitinol exhibiting superelastic characteristics at a temperature above which the austenite is stable (i.e. the temperature at which the transformation of martensitic phase to the austenite phase is complete), the specimen deforms elastically until it reaches a particular stress level where the alloy then undergoes a stress-induced phase transformation from the austenitic phase to the martensite phase. As the phase transformation proceeds, the alloy undergoes significant increases in strain but with little or no corresponding increases in stress. The strain increases while the stress remains essentially constant until the transformation of the austenite phase to the martensite phase is complete. Thereafter, further increase in stress is necessary to cause further deformation. The martensitic metal first deforms elastically upon the application of additional stress and then plastically with permanent residual deformation.
[0012] If the load on the specimen is removed before any permanent deformation has occurred, the martensitic specimen will elastically recover and transform back to the austenite phase. The reduction in stress first causes a decrease in strain. As stress reduction reaches the level at which the martensitic phase transforms back into the austenite phase, the stress level in the specimen will remain essentially constant (but substantially less than the constant stress level at which the austenite transforms to the martensite) until the transformation back to the austenite phase is complete, i.e. there is significant recovery in strain with only negligible corresponding stress reduction. After the transformation back to austenite is complete, further stress reduction results in elastic strain reduction. This ability to incur significant strain at relatively constant stress upon the application of a load and to recover from the deformation upon the removal of the load is commonly referred to as superelasticity or pseudoelasticity. It is this property of the material which makes it useful in manufacturing tube cut self-expanding stents. The prior art makes reference to the use of metal alloys having superelastic characteristics in medical devices which are intended to be inserted or otherwise used within a patient's body. See for example, U.S. Pat. No. 4,665,905 (Jervis) and U.S. Pat. No. 4,925,445 (Sakamoto et al.).
[0013] A now conventional delivery system for a self-expanding stent is a so-called “pin and pull” system. The following is an example of a “pin and pull” system. The delivery system includes an outer sheath, which is an elongated tubular member having a distal end and a proximal end and a lumen therethrough. A typical outer sheath is made from an outer polymeric layer, an inner polymeric layer, and a braided reinforcing layer between the inner and outer layers. The reinforcing layer is more rigid than the inner and outer layers. It is this outer sheath which is “pulled” in the “pin & pull” system. The “pin & pull” system further includes an inner shaft located coaxially within the outer sheath. The shaft has a distal end, extending distal of the distal end of the sheath, and a proximal end, extending proximal of the proximal end of the sheath. It is this shaft which is “pinned” in the “pin & pull” system. A “pin & pull” system further has a structure to limit the proximal motion of the self-expanding stent relative to the shaft. This “stent stopping” structure is located proximal to the distal end of the sheath. Lastly, a “pin & pull” system includes a self-expanding stent located within the sheath. The stent in its reduced diameter state for delivery makes frictional contact with the inner diameter of the outer sheath, more specifically, with the inner diameter of the inner layer of the outer sheath. The stent is located between the stop structure and the distal end of the sheath, with a portion of the shaft disposed coaxially within a lumen of the stent. The stent makes contact with the stop structure during deployment as the sheath is withdrawn and moves the stent with it (due to the frictional contact between the stent and the inner diameter of the sheath). The proximal motion of the proximal end of the stent is stopped as it comes into contact with the stop structure and the stop structure provides a counteracting force on the stent, equal and opposite to the frictional force from the sheath on the stent.
[0014] To deploy a stent from a “pin & pull” system, the system is navigated to the treatment location. Then the inner shaft, which extends proximal of the proximal end of the outer sheath is held fixed against the patient with one hand of the operator (medical professional). This action fixes the location of the inner shaft along a longitudinal axis of the patient's lumen being stented. This action is the “pin” step in the “pin & pull” system. The physician takes his or her other hand and pulls the outer sheath proximally (drawing some of it out of the patient toward the “pinning” hand) to unconstrain, expose, and deploy the stent. This action is the “pull” step in the “pin & pull” system.
[0015] An early example of another “pin & pull” system is the Gianturco stent delivery system as described in U.S. Pat. No. 4,580,568 issued Apr. 8, 1986. In this prior art delivery system, the outer sheath is a tube of a single material, which does not have a reinforcing structure within it. A cylindrical flat end pusher, having a diameter almost equal to the inside diameter of the sheath is inserted into the sheath behind the stent. The pusher or inner shaft is then used to push the stent from the proximal end of the sheath to the distal end of the sheath. Deployment of the stent is accomplished by holding the inner shaft fixed with respect to the patient's body and pulling back on the sheath to expose the stent, which expands upon removal of the radially restraining force, as illustrated in FIGS. 4 & 5 of U.S. Pat. No. 4,580,568, which are incorporated herein by reference.
[0016] Another early self-expanding stent on the market was the Wallstent. It was braided and changed both length, which shortened, and diameter, which increased, when it was deployed, and the change to its length was appreciable. U.S. Pat. No. 4,655,771 to Wallsten, herein after “Wallsten”, describes a couple of delivery systems for a braided stent, called a “tubular body” in the patent. One of the delivery systems is illustrated in FIG. 11 of Wallsten, which is described as follows, “[i]In FIG. 11 there is shown another embodiment of the assembly for use in expanding the tubular body. This assembly constitutes a flexible instrument intended to introduce the tubular body in contracted state into for example a blood vessel and then to expand the body when located therein. The parts of the instrument consist of an outer flexible tube 61 and a concentric also flexible inner tube 62. At one end of the outer tube an operational member 63 is arranged. Another operational member 64 is attached to the free end of inner tube 62. In this manner the inner tube 62 is axially displaceable in relation to the outer tube 61. At the other end of inner tube 62 a piston 65 is attached which when moving runs along the inner wall of outer tube 61. When the instrument is to be used the tubular expansible body 69 in contracted state is first placed inside tube 61, the inner tube 62 with the piston 65 being located in the rear part 66 of outer tube 61. The starting position of piston 65 is shown by dashed lines at 67 in FIG. 11. In this manner part of tube 61 is filled with the contracted tubular body 69 in the starting position. During implantation the flexible tubular part of the device is inserted to the location of a blood vessel intended for implantation. Member 64 is then moved in the direction of arrow 68, the contracted body 69 being pushed out through end 70 of tube 61, the part of the tubular body 69 leaving tube end 70 expanding until in its expanded position 71 it is brought to engagement with the interior of vascular wall 72. The tubular body 69, 71 is for sake of simplicity shown in FIG. 11 as two sinus-shaped lines. To the extent that the expanded body 21 comes into engagement with vascular wall 72 tube end 70 is moved by moving member 63 in the direction of arrow 73. The contracted body 69 is moved by the piston 65 pushing against one end of the body. Thus, the implantation takes place by simultaneous oppositely directed movements of members 64 and 63, the displacement of member 64 being larger than that of member 63.” Like the delivery system for the Gianturco stent, its sheath was not reinforced, but was a single material tube, and its inner shaft did not extend through the stent, but terminated at the proximal end of the stent constrained at the distal end of the outer sheath. The inner shaft was coaxial with the outer sheath, and had an outer diameter that was larger than the inner diameter of the reduced diameter “constrained” or crimped stent.
[0017] Many conventional self-expanding stents are designed to limit the stent foreshortening to an amount that is not appreciable (e.g., less than 10%). Stent foreshortening is a measure of change in length of the stent from the crimped or radially compressed state as when the stent is loaded on or in a delivery catheter to the expanded state. Percent foreshortening is typically defined as the change in stent length between the delivery catheter loaded condition (crimped) and the nominal deployed diameter (i.e., the labeled diameter which the stent is intended to have when deployed, i.e., a “10 mm stent” has a nominal deployed diameter of 10 mm.) divided by the length of the stent in the delivery catheter loaded condition (crimped), multiplied by 100. Stents that foreshorten an appreciable amount (e.g., equal to or more than [insert a value here]) can be more difficult to deploy where intended axially when being deployed in a body lumen or cavity, such as a vessel, artery, vein, or duct. The distal end of the stent has a tendency to move in a proximal direction as the stent is being deployed in the body lumen or cavity. And, in conditions where the distal end is stationary with respect to the vessel wall, the proximal end of the stent will move distally as a function of the foreshortening upon expansion. Thus foreshortening may lead to a stent being placed in an incorrect or suboptimal location. Delivery systems that can compensate for stent foreshortening would have many advantages over delivery systems that do not.
[0018] When a self-expanding stent is deployed in the vessel in an unintended location, an additional stent may be required to cover the full length of the diseased portion of the vessel, and some stent overlap may occur. Obviously, the ability to reposition a stent to correctly deploy it in the intended location is preferred. Often, repositioning a stent requires that the stent first be reconstrained within the outer tubular member of the delivery system (often referred to as a “sheath”). To reconstrain a stent, the outer tubular member is pushed distally to slide over the stent and radially compress it back to its crimped diameter. To resist the axial force of the sheath on the stent due to friction, the proximal end of the stent which is still in the sheath is typically restrained from distal motion relative to the sheath and inner member. A number of delivery system designs provide features to restrain the proximal end of the stent from distal motion, see, e.g., U.S. patent application Ser. No. 12/573,527, Attorney docket number FSS5004USNP, filed Oct. 5, 2009, and Ser. No. 13/494,567, Attorney docket number FSS5004USCIP, filed Jun. 12, 2012, and European Patent Publication No. 0696442 A2, and U.S. Patent Publication No. 2007/0233224 A1.
SUMMARY OF THE INVENTION
[0019] One aspect of the invention is a method of reconstraining a partially deployed self-expanding stent that uses a mechanism to move the inner shaft and the outer tubular member in opposite directions at rates that are proportional to each other in accordance to the foreshortening ratio of the stent being reconstrained.
[0020] Another aspect of the invention is a number of hand or motor actuated mechanisms that may be actuated to perform the above method.
[0021] One invention described and claimed herein is a method of reconstraining a foreshortening self-expanding stent with a known foreshortening ratio between the crimped diameter in an intraluminal catheter based delivery system and the nominal deployed diameter in the body lumen, wherein the proximal end of the stent is in releasable fixed relation about a location along the length of an inner member of a stent delivery system, the method comprising translating proximally the outer member with respect to the stent at a first rate, thereby exposing at least a portion of the stent, at the same time that the outer member is translating proximally, translating distally the inner member, thereby translating distally the proximal end of the stent at a rate equal to the known foreshortening ratio multiplied by the first rate at which the outer member is translating proximally, after exposing at least a length of the stent, but before translating proximally the distal end of the outer member past the proximal end of the stent, deciding to reconstrain the partially deployed stent, subsequently translating distally the outer member with respect to the stent at a second rate, thereby reconstraining the length of the stent exposed in the previous translating proximally step, and at the same time that the outer member is translating distally, translating proximally the inner member at a rate equal to the known foreshortening ratio multiplied by the second rate at which the outer member is translating distally.
[0022] Another invention described and claimed herein is a medical device delivery system comprising a first lead screw having a right-handed thread and a central longitudinal axis, a second lead screw having a left-handed thread and a central longitudinal axis, a first follower operationally coupled to the right-handed thread to translate without rotating, a second follower operationally coupled to the left-handed thread to translate without rotating, wherein when the first and second lead screws rotate, the first follower translates parallel to the central longitudinal axis of the first lead screw in a first linear direction and the second follower translates parallel to the central longitudinal axis of the second lead screw in a linear direction opposite the first linear direction.
[0023] Yet another invention described and claimed herein is a medical device delivery system comprising a first lead screw having a right-handed thread and a central longitudinal axis, a second lead screw having a left-handed thread and a central longitudinal axis, a first follower operationally coupled to the right-handed thread to translate without rotating, a second follower operationally coupled to the left-handed thread to translate without rotating, wherein the central longitudinal axis of the first and second lead screws are on a common line and are coupled together to rotate about the common line in the same rotational direction and at the same time, such that when the first and second lead screws rotate, the first follower translates parallel to the common line in a first linear direction and the second follower translates parallel to the common line in a linear direction opposite the first linear direction.
[0024] These and other features, benefits, and advantages of the present invention will be made apparent with reference to the following detailed description, appended claims, and accompanying figures, wherein like reference numerals refer to structures that are either the same structures, or perform the same functions as other structures, across the several views.
BRIEF DESCRIPTION OF THE FIGURES
[0025] The figures are merely exemplary and are not meant to limit the present invention.
[0026] FIG. 1 illustrates a stent delivery system;
[0027] FIG. 2A illustrates a self-expanding stent in a constrained diameter and length;
[0028] FIG. 2B illustrates a self-expanding stent in a nominal deployment diameter and length;
[0029] FIG. 3 illustrates an assembly of two lead screws and two followers;
[0030] FIG. 4 illustrates the assembly of FIG. 3 connected to two elongated members;
[0031] FIG. 5 illustrates a side view of a handle of a medical device delivery system including an embodiment of one aspect of the present invention;
[0032] FIG. 6 illustrates a front view of the handle of FIG. 5 ;
[0033] FIG. 7 illustrates a front view of another embodiment of one aspect of the present invention;
[0034] FIG. 8 illustrates a front view of yet another embodiment of one aspect of the present invention;
[0035] FIG. 9 illustrates a partial side view of the embodiment of FIG. 8 ;
[0036] FIG. 10 illustrates a front view of fourth embodiment of one aspect of the present invention;
[0037] FIG. 11 illustrates a partial side view of the embodiment of FIG. 10 ;
[0038] FIG. 12 illustrates a front view of an embodiment of a follower;
[0039] FIG. 13 illustrates a front view of an embodiment of a follower with bearings;
[0040] FIG. 14 illustrates a side view of yet another alternative embodiment of the mechanism, in which the first and second lead screws can have their central longitudinal axes parallel to one another; and
[0041] FIG. 15 illustrates a front view of the embodiment of FIG. 14 .
DETAILED DESCRIPTION
[0042] As used herein, “foreshortening ratio” is defined as the result of dividing the value of the length of the nominal diameter stent subtracted from the length of the crimped diameter stent by the length of the crimped diameter stent.
[0043] In FIG. 1 , a stent delivery system 10 includes a self-expanding stent 12 at the distal end 14 of the lumen 16 of a flexible tubular member 18 , which surrounds a smaller diameter flexible tubular member 20 . Each of the tubular members is connected to a hard plastic structure ( 21 , 24 ), which serves, among other functions, as the piece with which to manipulate the tubular member. At the proximal end, the smaller diameter flexible tubular member 20 is connected to a stiffer tubular member 22 , which may be a hypotube, and the grip or handle 24 is connected to the proximal end of the hypotube 22 . Stiffer tubular member 22 and flexible tubular member 20 may have a lumen for tracking over a guidewire 25 . Structure 26 mounted on flexible tubular member 20 functions to keep stent 12 is releasable fixed relation to a longitudinal point on the length of tubular member 20 . Finally, stent delivery system may include a distal tip that is distal to the distal end of flexible tubular member 18 and acts as a dilator when entering the body, a blood vessel in particular.
[0044] The stents that are delivered to the treatment location may be self-expanding. FIG. 2A is a schematic representation of a fully connected, helical geometry self-expanding stent 29 in a state of crimped diameter and length. This is the state of the stent when completely constrained in the lumen of the outer tubular member of the stent delivery system. FIG. 2B is a schematic representation of the same stent 29 in the nominal deployed state, which has a larger diameter and a shorter length. The difference between the crimped length and the nominal deployed length is considered significant if it is greater than 10%. When deployed, if the distal end of the stent contacts the vessel wall when it expands, the distal end is then stationary with respect to the vessel. In these conditions, the proximal end of the stent must move distally from that time on to permit the stent to expand as it deploys.
[0045] Reconstraining includes pushing the outer tubular member distally to slide over the expanded stent until the tubular member constrains the entire length of the stent and the stent is no longer in contact with the vessel wall, and can be repositioned without risk of stretching the vessel which may lead to injury. Just as the proximal stent stop applied counteracting distal forces to the proximal end of the stent to counteract the proximal friction forces along the outer diameter of the stent in contact with the proximally translating outer tubular member, and allowed the tubular member to be withdrawn to expose the stent, a structure is needed to apply proximally acting forces to the stent to counteract the distally acting friction forces of the distally translating tubular member on the outer diameter of the stent. If insufficient counteracting force is provided, when the tubular member is advanced distally, since the distal end of the stent is in contact with the vessel wall, which resists distal motion, one possible outcome is that the tubular member does not slide over the stent, such that the portion of the stent that is exposed and unconstrained begins to evert around the advancing distal end of the tubular member as the constrained portion of the stent at a smaller diameter is advanced toward a relatively stationary expanded diameter distal end of the stent. Systems are known in the art for providing structures to provide such a counteracting proximal force, and examples are U.S. patent application Ser. No. 12/573,527, Attorney docket number FSS5004USNP, filed Oct. 5, 2009, (a rotatable band which interfaces with the inner diameter of the crimped stent, protruding through it and holding that part of the stent in place, when against a stop on the inner shaft) and Ser. No. 13/494,567, Attorney docket number FSS5004USCIP, filed Jun. 12, 2012, (a rotatable stent lock with has axially extending protrusions that interface with the proximal end of the stent at the same radial location as the crimped stent, when against a stop on the inner shaft) and European Patent Publication No. 0696442 A2 (four radially projecting members fixes to the inner shaft which mechanically interfere with axial motion of the crimped stent (proximal or distal)), and U.S. Patent Publication No. 2007/0233224 A1 (rotatable, but axially fixed (to the inner shaft) bumpers that stick to the inner diameter of the crimped stent). However, when a stent has an appreciable (relative to the length of the section of the vessel being treated) increase in length upon constraining (or, i.e., crimping), proximal motion of the structure that provides these counteracting forces may provide optimal conditions for reconstraining a stent.
[0046] FIG. 3 illustrates a side view of a mechanism 30 that can provide constant ratio relative motion by either advancing the inner tubular member while retracting the outer tubular member (for exposing and deploying a stent) or by alternatively retracting the inner tubular member while advancing the outer tubular member (for reconstraining a partially deployed stent). Thus when the proximal end of the stent is fixed longitudinally with respect to the longitudinal axis of the inner tubular member, the proximal end of the stent is translated the expected distance to account for the expected foreshortening distally upon deployment or forelengthening proximally into the outer tubular member during reconstraining. Turning to mechanism 30 , it includes a first lead screw 32 with a helical thread 34 over length L 1 . In the illustrated mechanism, helical thread 34 is right handed and has a predetermined pitch. Mechanism 30 includes a second lead screw 36 with a helical thread 38 over length L 2 . In the illustrated mechanism, helical thread 38 is left handed and has a predetermined pitch. First and second lead screws both have central longitudinal axes which are axially aligned along a common line 40 . In the illustrated mechanism 30 , first and second lead screws are fixedly connected to a smaller diameter shaft 42 , used for mounting the assembly of lead screws to a frame (not shown). Mechanism 30 includes a first follower 50 , illustrated in FIG. 3 as a square. First follower 50 interfaces with lead screw 32 and when constrained from rotating, translates parallel to common line 40 , when lead screw 32 rotates. Mechanism 30 includes a second follower 52 , illustrated in FIG. 3 as a square. Second follower 52 interfaces with lead screw 36 and when constrained from rotating, translates parallel to common line 40 , when lead screw 36 rotates. Initial positions of followers 50 and 52 are depicted in solid lines and final positions are depicted in broken lines. Arrows illustrate the translation parallel to common line 40 between the initial and final positions. The ratio of the pitches of the helical threads is, in the depicted embodiment, equal to the ratio of L 1 to L 2 . In FIG. 3 , it can be seen that followers 50 and 52 move in opposite directions, and at different rates given the same rotational input of their respective lead screw.
[0047] Mechanism 30 can be operated to translate at the same time two members in opposite directions at different rates with a single rotational input. In FIG. 4 , mechanism 30 is illustrated connected to two elongated tubular members. The first elongated tubular member 60 is operatively connected to follower 50 at its distal end 62 . As illustrated elongated tubular member 60 is hollow and has a lumen 64 . A second elongated tubular member 70 is operatively connected with follower 52 at its proximal end 72 . Elongated tubular member 70 has a smaller outer diameter than the inner diameter of elongated tubular member 60 , and as illustrated, a length less than the total length of 70 is inside the lumen 64 and co-axial with elongated tubular member 60 . When shaft 42 is rotated, follower 50 will translate proximally and elongated member 60 will translate an equal amount at the same time due to the operative connection between them. When shaft 42 is rotated, follower 52 will translate distally and elongated member 70 will translate an equal amount at the same time due to the operative connection between them.
[0048] FIG. 5 illustrates the assembly of mechanism 30 and elongated members 60 and 70 in half of a housing 90 . Housing 90 substantially encloses mechanism 30 , in addition to enclosing the proximal portions of elongated members 60 and 70 . Housing 90 defines opening 92 at its distal tip for the elongated members 60 and 70 to translate through. Housing 90 defines an opening 94 for a portion of a follower that may be used as an input 114 to the system by manipulation by a user. In some embodiments, opening 94 is a straight slot. Housing 90 defines an opening 96 to accommodate a rotatable input 110 operatively connected to shaft 42 . Shaft 42 is mounted in bearings 100 to housing 90 . In some embodiments, not depicted, housing 90 defines additional openings. In some embodiments of the present invention, housing 90 functions as a handle to a medical device delivery system. In some embodiments of the present invention, housing 90 is sized to be grasped by a human hand. Such sizing does not necessarily impact the length of housing 90 , just the circumference of a transverse cross section to common line 40 (like shown in FIG. 6 ). As housing 90 substantially encloses mechanism 30 , mechanism 30 is accordingly sized to housing 90 .
[0049] Input 110 as illustrated in FIG. 5 is a short cylinder with a knurled or otherwise grippable surface, for example, using facets 112 about the generally cylindrical circumference. It is envisioned that an operator of mechanism 30 may use a thumb or finger to apply tangential force to input 110 to rotate it about common line 40 . Input 110 is operatively connected to the two lead screws, such that rotation of input 110 results in rotation (in the same direction) of lead screws 32 and 36 , and translation of followers 50 and 52 , and translation of elongated members 60 and 70 . The larger the diameter of input 110 , the greater the mechanical advantage to operate the mechanism.
[0050] In the illustrated embodiment of FIGS. 5 & 6 , mechanism 30 is configured such that follower 50 can be used as an input to the system. To accommodate such manipulation of follower 50 in embodiments with a housing, follower 50 is configured to project through opening 94 to present a tab or other suitable structure for a user to manipulate by translation within opening 94 . Such structure is alternatively referred to herein as an input 114 . If a user translates input 114 , lead screw 50 rotates, resulting in lead screw 52 rotating in the same direction as lead screw 50 , follower 52 translating in an opposite direction from the input translation, and input 110 rotating in the same direction as lead screw 50 . Of course, due to the operative connections of elongated tubular members to the respective followers, translating input 114 will also translate the elongated members in opposite directions.
[0051] Gripping the outer elongated tubular member outside of the housing and translating it along its longitudinal axis is, in some embodiments, an acceptable input to the mechanism as well, resulting in the translation of the follower to which it is operatively connected to translate in the same direction, rotating the first lead screw, and producing the rest of the motions the mechanism is configured to produce as described above.
[0052] Thus, in some embodiments of a device incorporating such a mechanism 30 , a user may achieve the desired exposure of a constrained stent or reconstraint of a partially deployed stent by rotating input 110 , translating input 114 , or translating outer tubular member 60 external to the housing 90 and patient in the desired direction to accomplish the desired exposure or reconstraint.
[0053] FIG. 6 illustrates a front view of the complete housing in phantom lines, and the input 110 , shaft 42 , follower 50 , input 114 , follower 52 and elongated tubular members 60 and 70 to show other aspects of mechanism 30 . In the illustrated embodiment, a follower interfaces with its respective lead screw over an internal angle alpha, α, of less than 180 degrees, and more closely approximating 90 degrees. As long as the follower interfaces sufficiently with the threads of the lead screw, such an angle measurement over which the two parts are in contact is not necessary. Alternatively, followers 50 and 52 could be annular rings, like a nut, about and co-axial with the lead screw and its longitudinal axis, here the common line 40 . The follower must be prevented from rotating, so that elongated tubular members can translate in a straight line through housing 90 and out opening 92 . Another aspect illustrated in FIG. 6 is the portion of input 110 which extends through opening 96 in housing 90 . Here the knurled or faceted ring-like surface of input 110 may be manipulated by a user's thumb or finger for one handed operation (i.e., hold the handle and rotate input 110 with the thumb of the same hand, or by one or more digits on the hand not holding the handle for two handed operation via input 110 . FIG. 6 also illustrates input 114 extending through opening 94 to provide a structure that can be manipulated by the user to translate (in and out of the page in the view of FIG. 6 ) to actuate mechanism 30 and provide opposite and scaled translation between the two tubular members of the device.
[0054] Another embodiment of a rotatable input (with respect to the housing 90 ) is illustrated in FIG. 7 , which is another front view, to most easily show difference between this embodiment and the last. Here input 110 is an internal gear 120 with a larger diameter than the short cylinder illustrated in FIGS. 5 and 6 . The internal gear 120 has teeth 122 that engage mating teeth 124 of a spur gear 126 located within the internal opening of the internal gear 120 . Spur gear 126 is axially aligned with common line 40 and is operatively connected to lead screw 50 (and the rest of mechanism 30 ). Thus a greater mechanical advantage is obtained using the illustrated embodiment, and all other things being the same about mechanism 30 , fewer rotations of input 110 are needed to fully expose or reconstrain a stent with a delivery system including this embodiment.
[0055] Yet another embodiment of rotatable input 110 is illustrated in a front view in FIG. 8 and a partial side view in FIG. 9 . This input to the mechanism rotates about an axis 130 that is perpendicular to the common line 40 , and relies on a face gear 132 , that is, one with teeth 134 projecting along the axis 130 of the gear off of one “face” of the gear 132 , rather than projecting radially inward (as in an internal ring gear) or radially outward (as in an external ring gear). Here again, housing 90 is drawn in phantom lines to more clearly see arrangement of new components. Face gear 132 engages with a spur gear 136 , the same as or similar to the one illustrated in FIG. 7 , but the user interface is different. Instead of rotating the input 110 across the handle, a user rotates the input 110 in-line with the longitudinal axis of the handle. As illustrated, the rotatable input 110 would be on one lateral side or the other with respect to the longitudinal midplane 140 of the handle.
[0056] Yet another embodiment of rotatable input 110 is illustrated in a front view in FIG. 10 and a partial side view in FIG. 11 to illustrate differences between this embodiment and the others. This embodiment builds on the last embodiment by incorporating an “in-line” rotatable input 110 on the handle, but additionally, it centers the input 110 along the longitudinal midplane 140 of the handle. This requires an additional rotatable structure, here the combination of a knurled short cylinder 144 fixedly connected to a spur gear 146 . The face gear of the last embodiment additionally must have external teeth 148 with which to engage the spur gear 136 , thus being a combination face and external gear 150 . The housing 90 and gears can be sized to optimize the desired ease of handling and gear ratio between the input and the gears in the chain (here 146 , 150 , and 136 ) that operate mechanism 30 and result in opposite movement of the two tubular members operatively connected to the followers.
[0057] A follower that is also going to function as a translatable input to the mechanism can have different forms than depicted in FIGS. 5-11 . FIG. 12 illustrates a front view of a follower 156 that provides a projection ( 158 , 160 ) laterally on either side of a vertical midplane 140 of the handle. Housing 90 is accordingly adjusted moving opening 94 from the “bottom” of the handle to a side and also defining an additional opening 162 for the lateral projection on the opposite side of the follower. That way, translating the lateral projection of the follower on either side of the handle can be used to actuate mechanism 30 and provide translation in opposite directions of the two elongated tubular members operatively connected to the two followers.
[0058] And an additional design option for operation requiring less actuating force is illustrated in FIG. 13 , which illustrates the incorporation of bearings into a mechanism utilizing followers similar to that illustrated in FIG. 12 . In this embodiment, followers 50 and 52 define an additional through-hole 164 which is a bearing surface against a bearing rod 166 , which runs parallel to common line 40 . Additionally, a round bearing 170 , the inner race of which surrounds a vertical post 172 extending down from the follower 50 , counteracts the moment exerted on the follower 50 from the rotation of the lead screw 32 . The lower bearing 170 rotates against one of two vertical walls 174 , 176 provided in housing 90 to prevent rotation of follower 50 .
[0059] In order to reduce system friction, it may be desirable to exchange the “threads” of lead screw and follower with more of a cam-follower setup. In this embodiment, follower 50 contains a bearing in contact with it and the leadscrew, which now longer is strictly a lead screw (as there are not interfacing grooves, i.e., mating threads, in follower 50 ). Instead structure 50 is actually a helical cam for that bearing to follow.
[0060] Reducing system friction to negligible amounts increases efficiency and allows backdriving so that translation of translatable input 114 can rotate lead screw 32 . The cam/bearing method is one way to achieve this. Also a ball nut could be used or simply very low friction materials, lubricants, etc.
[0061] FIGS. 14 and 15 illustrate an alternative embodiment of the mechanism, in which the first lead screw 32 and second lead screw 36 have parallel central longitudinal axes ( 184 , 186 ), rather than axially aligned ones. The elongated members 60 , 70 attached to the first and second followers 50 , 52 have a common central longitudinal axis 182 parallel to each of the respective central longitudinal axis of the first and second lead screw. In such an embodiment, a single rotatable input 110 may be an internal ring gear 120 engaging with two spur gears 126 , 180 , one for each of the two parallel lead screws, similar to the embodiment depicted in FIG. 7 . In this embodiment, the axis of rotation 190 for the rotatable input is parallel to the central longitudinal axes of the first and second lead screws. The axis of rotation 190 of the rotatable input may be axially aligned with the common central longitudinal axis of the first and second elongated members, or it may be parallel to it, as depicted in FIG. 15 . The teeth of internal gear 120 and spur gears 126 , 180 are not shown, and instead the pitch circles of such gears are illustrated for ease.
[0062] Aspects of the present invention have been described herein with reference to certain exemplary or preferred embodiments. These embodiments are offered as merely illustrative, not limiting, of the scope of the present invention. Certain alterations or modifications which are possible include the substitution of selected features from one embodiment to another, the combination of selected features from more than one embodiment, and the elimination of certain features of described embodiments. Other alterations or modifications may be apparent to those skilled in the art in light of instant disclosure without departing from the spirit or scope of the present invention, which is defined solely with reference to the following appended claims.
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A medical device delivery system including a mechanism to concurrently move an inner member and an outer member in opposite directions and at pre-set speed ratio can be operated, for example, to reconstrain a foreshortening self-expanding stent with a known foreshortening ratio between the crimped diameter in an intraluminal catheter based delivery system and the nominal deployed diameter in the body lumen. The mechanism can include two oppositely handed lead screws that concurrently turn and two followers, each follower operatively connected to one of the two shafts (e.g., the inner and outer member).
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CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional Application No. 61/895,663 filed on Oct. 25, 2013. The above identified patent application is herein incorporated by reference in its entirety to provide continuity of disclosure.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a toilet training aid for children. More specifically, the present invention pertains to an improved toilet training doll that encourages children who are being toilet trained. The doll is adapted to recognize the sound of clapping or a toilet flush and provides an audible encouragement. The doll comprises a hook that can be used to mount the doll to a support structure. In this way, the doll can be conveniently used in a bathroom during toilet training.
[0004] Most parents anticipate toilet training as a milestone in their child's development. Toilet training, however, is a long and a difficult process that can become frustrating and overwhelming for both the child and the parents. Thus, toilet training requires the child and parents to devote time, patience, and enforce positive encouragement.
[0005] Additionally, toilet training requires parents to provide the child with proper equipment to facilitate use of the toilet. For instance, a potty chair or an adaptor seat that attaches to a regular toilet seat can help children feel more comfortable on the toilet. Other devices comprise training aids that provide entertainment while the child is toilet training. Conventional training aids such as these, however, are not interactive and static. Additionally, toilet training gears are initially unfamiliar and generally do not appeal to children. Therefore, children are not motivated to use conventional training aids. Thus, an interactive training aid that appeals to children who are being toilet trained is desired.
[0006] The present invention relates to a toilet training aid for children. The present training aid is in a form of a doll, wherein the doll may resemble a princess or a pirate, depending upon embodiment. The doll comprises imbedded electrical components therein. In an exemplary embodiment, the electrical components include a microphone, a speaker, a memory, and a sound recognition processing module. The sound recognition processing module is adapted to detect the sound of clapping or flushing of a toilet through the microphone. When a clapping sound or a flushing sound is detected, the sound recognition processing module actuates the speaker to play a pre-recorded message that is stored in the memory. The pre-recorded message is preferably of a positive encouragement. It is contemplated that the pre-recorded message associated with the princess embodiment can be articulated by a female voice, and the pre-recorded message associated with the pirate embodiment can be articulated by a male voice. The doll further comprises a hook that can be used to mount the doll to the toilet tank or to a doll stand. Thus, the doll can be securely placed near the toilet while a child is toilet training.
[0007] The primary advantage of the present invention is not only its capability to provide an instant audible feedback upon successful use of the toilet, but also its outward appearance that appeals to children. Thus, the present invention motivates children to use the toilet. The present invention can be utilized until the child successfully completes toilet training, or as needed to continue monitoring the performance of the child's toilet training and to foster a good habit.
[0008] 2. Description of the Prior Art
[0009] Devices have been disclosed in the prior art that claim toilet training aids in form of dolls. These include devices that have been patented and published in patent application publications. These devices generally disclose dolls that ingest a liquid and simulates urination. These devices, however, do not provide an audible feedback upon detecting sound of clapping and water flushing. The foregoing is a list of devices deemed most relevant to the present disclosure, which are herein described for the purposes of highlighting and differentiating the unique aspects of the present invention, and further highlighting the drawbacks existing in the prior art.
[0010] Specifically, U.S. Published Patent Application Number 2004/0175688 to Smith discloses a toilet training doll comprising a doll with an interior volume adapted to hold a water bottle therein. When the water bottle is inserted in the doll, the valve of the water bottle is in fluid connection with an output port. Thus, when the doll is squeezed, the water from the water bottle can exit through the output port. Similarly, U.S. Pat. No. 5,509,808 to Bell and U.S. Pat. No. 5,890,907 to Minasian disclose toy toilet training systems that comprise a doll that receives a fluid through a mouth opening and that can discharge the fluid from an outlet to simulate urination. The toy toilet training systems further comprises a toy toilet to receive the discharged fluid. The foregoing devices, however, differ from the present invention in that the present invention is provides an audible feed back to the child when the child uses the toilet. The foregoing devices do not disclose electrical components necessary to perform this function.
[0011] U.S. Pat. No. 6,417,773 to Vlahos discloses a sound-actuated system for encouraging good personal hygiene in toilet facilities. The system comprises a microphone and a speaker that are in communication with a microcontroller. The microphone detects sound of running water to generate an audible output, which comprises a pre-recorded message that encourages the child. While the system of Vlahos discloses a sound-actuated system, Vlahos does not disclose dolls having such sound-actuated system imbedded therein. The present invention discloses dolls having an audio input means, an audio output means, and a sound detecting means. The present invention is advantageous in that the dolls appeal to children who are being toilet trained. Thus, the present invention provides an effective means to toilet train young children.
[0012] Finally, U.S. Pat. No. 5,363,516 to Butts discloses a toilet training aide comprising a receptacle for receiving urine therein. The bottom wall of the receptacle comprises thermally actuated latent image element whereby urine received within the receptacle actuates the element, causing the latent image to appear and be seen by the child. In this way, the device of Butts encourages the child to use the toilet. Unlike the present invention, however, the Butts does not disclose a doll that can play a pre-recorded sound.
[0013] The devices disclosed in the prior art have several known drawbacks. None of the devices in the prior art disclose a doll that is adapted to detect a clapping sound or a water flushing sound, whereby the doll can play a pre-recorded sound upon detecting such types of sounds. The present invention overcomes these limitations by disclosing a doll with imbedded electrical components, including a microphone, a speaker, a memory, and a sound recognition processing module for detecting sounds of clapping and water flushing. Additionally, the present doll resembles a princess or a pirate, depending upon embodiment. In this way, the present invention appeals to young children who are learning to use the toilet.
[0014] It is therefore submitted that the present invention is substantially divergent in design elements from the prior art, and consequently it is clear that there is a need in the art for an improvement to toilet training aids. In this regard, the instant invention substantially fulfills these needs.
SUMMARY OF THE INVENTION
[0015] In view of the foregoing disadvantages inherent in the known types of toilet training aids now present in the prior art, the present invention provides a new and improved toilet training doll for children wherein the same can be utilized for rewarding children for successfully completing toilet training.
[0016] It is therefore an object of the invention to provide a new and improved toilet training doll for children that has all of the advantages of the prior art and none of the disadvantages.
[0017] Another object of the present invention is to provide a new and improved toilet training doll for children having a microphone, a speaker, a memory containing pre-recorded message, and a sound recognition processing module for detecting a clapping sound and a flushing sound.
[0018] Yet another object of the present invention is to provide a new and improved toilet training doll for children that provides an audible form of encouragement.
[0019] Yet another object of the present invention is to provide a new and improved toilet training doll for children wherein the doll resembles a princess.
[0020] Still yet another object of the present invention is to provide a new and improved toilet training doll for children wherein the doll resembles a pirate.
[0021] Still yet another object of the present invention is to provide a new and improved toilet training doll for children wherein the device may be readily fabricated from materials that permit relative economy and are commensurate with durability.
[0022] Other objects, features, and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTIONS OF THE DRAWINGS
[0023] Although the characteristic features of this invention will be particularly pointed out in the claims, the invention itself and manner in which it may be made and used may be better understood after a review of the following description, taken in connection with the accompanying drawings wherein the numeral annotations are provided throughout.
[0024] FIG. 1 shows a front perspective view of a first embodiment of the present invention.
[0025] FIG. 2 shows a rear perspective view of a first embodiment of the present invention.
[0026] FIG. 3 shows a front perspective view of a second embodiment of the present invention.
[0027] FIG. 4 shows a rear perspective view of a second embodiment of the present invention.
[0028] FIG. 5 shows a schematic diagram of the internal components of an exemplary embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0029] References are made herein to the attached drawings. Like reference numerals are used throughout the drawings to depict like or similar elements of the toilet training doll for children. For the purposes of presenting a brief and clear description of the present invention, the preferred embodiment will be discussed as used to reward children for successfully completing toilet training. The figures are intended for representative purposes only and should not be considered to be limiting in any respect.
[0030] Referring now to FIGS. 1 and 2 , there are shown front and rear perspective views of the first embodiment of the present invention. The present invention comprises a doll 21 . In a first exemplary embodiment, the doll 21 resembles a princess. The doll 21 has a doll torso 35 having a pair of arms 36 and a head 37 rotatably attached thereto. The head 37 comprises a quantity of artificial hair 38 that fall down to the shoulders 39 of the torso 35 , and a face 40 printed thereon with durable ink. The face 40 comprises eyebrows, eyes, lips, and cheeks. It is contemplated that in some embodiments, the face 40 may comprise a layer of protective coating on the exterior there of so that the eyebrows, eyes, lips, and cheeks are prevented from degradation.
[0031] The arms 36 are rotatably attached to the doll torso 35 so that the arms 36 can rotate. While not seen in FIG. 1 , it is contemplated that the doll torso 35 further includes a pair of legs. The legs may be rotatably attached to the doll torso 35 so that the legs can move, thereby allowing the doll to walk. In some embodiments, the legs may bend at the knees so that the doll 21 can be manipulated into a seated position. The doll torso 35 is preferably composed of a molded plastic or other suitable material.
[0032] The doll 21 further comprises clothing, such as a floor length dress 41 supported upon the doll torso 35 as illustrated in FIGS. 1 and 2 . Additionally, the doll 21 may comprise a tiara 42 supported on the head 37 , a necklace 43 worn around the neck, a bracelet 44 worn around the wrist, and dress shoes. The doll 21 can be mounted to an edge of a toilet tank or to a doll stand via a clip 25 that is disposed on the back of the doll 21 . The clip 25 is substantially J-shaped when viewed from the side. The clip 25 may be composed of metal, plastic, or other suitable material. The clip 25 is preferably permanently affixed to the back of the doll 21 via fasteners, such as a screw, or via strong adhesives so that the clip 25 does not become misplaced or lost.
[0033] The torso 35 of the doll 21 comprises a defined interior volume with internal electrical components therein. The electrical components are powered via batteries. As such, the doll 21 comprises a battery compartment 22 that is accessible via a door 23 that is attached to the back of the doll 21 via hinges 24 . In the illustrated embodiment, the door 23 is a made to look like a part of the dress 41 so that it is camouflaged when it is closed and does not detract from the appearance of the doll 21 . Additionally, the door 23 is accessible to the user from the exterior of the dress 41 so that the user does not have to disrobe the doll 21 to access the battery compartment 22 .
[0034] Referring now to FIGS. 3 and 4 , there are shown views of the second embodiment of the present invention. The second embodiment of the present invention comprises a male pirate doll 31 . Similar to the previous embodiment, the doll 31 comprises a doll torso 45 with rotatably attached arms 46 , legs 47 , and a head 48 . In this way, the arms 46 , the legs 47 , and the head 48 can turn or rotate so that the doll 31 can be manipulated into various poses or stances. The head 48 comprises a printed face 49 , including eyebrows, eyes, lips, and facial hair. The doll 31 further comprises a pirate outfit, which includes a long sleeved shirt 50 , a vest 51 , a pair of pants 52 , a sash 53 , and a belt 54 . The doll 31 may further comprise pirate accessories such as boots 55 , a head scarf 56 , a pirate hat 57 , and an eye patch 58 . The doll 31 further includes a clip 32 that is disposed at the back near the sash 53 and the belt 54 , as shown in FIG. 4 .
[0035] The doll torso 45 of the illustrated embodiment comprises a hollow interior for holding internal components therein. The internal components are connected to a power source, such as batteries. The batteries are stored in the battery compartment that is disposed on the back of the torso 45 , wherein the battery compartment is accessible via a door that may be secured thereto via a hinge or a snap fit. In the illustrated embodiment, the door to the battery compartment is concealed under the long sleeved shirt 50 that is worn over the torso 45 .
[0036] Referring now to FIG. 5 , there is shown a schematic diagram of the internal components of an exemplary embodiment of the present invention. The internal components described herein are disposed in the hollow interior of the torso portion of the doll 21 . The internal components comprise a microphone 26 , a sound recognition processing module 27 , a memory 33 , and a speaker 30 . It is contemplated that the internal components of the present invention are internally powered via a power source such as batteries.
[0037] The microphone 26 is adapted to receive audio input, and relay the received audio to the sound recognition processing module 27 . The sound recognition processing module 27 comprises a clap detection module 28 and a flush detection module 29 . The clap detection module 28 is adapted to detect the sound of hands clapping, while the flush detection module 29 can detect the sound of running water or toilet flushing. If the clap detection module 28 detects a clapping sound or the flush detection module 29 detects a sound of toilet flushing, the sound recognition processing module 27 actuates the speaker 30 to play a pre-recorded message or audio 34 that is stored in the memory 33 .
[0038] The pre-recorded message or audio 34 is preferably of a positive encouragement, such as a cheer, a compliment, or other types of verbal feedback. The pre-recorded message or audio 34 may comprise recordings of different messages or audio 34 . Additionally, the pre-recorded message or audio 34 can be selected and played randomly so that the child hears a different message each time after successfully using the toilet.
[0039] The pre-recorded message or audio 34 may be customized to correlate to the personality of the dolls. For instance, the first embodiment, as illustrated in FIG. 1 , may be adapted to play messages that incorporate princess-like sayings. The second embodiment as illustrated in FIG. 3 may be adapted to play messages that incorporate pirate phrases and terms. It is contemplated that the pre-recorded message associated with the first embodiment can be articulated by a female voice, and the pre-recorded message associated with the second embodiment can be articulated by a male voice. Furthermore, the female voice may be whimsical and good-natured to emulate a personality of a fictional princess. Conversely, the male voice may comprise an accent to emulate a personality of a fictional pirate. In this way, the voice or the audible output of the doll is correlated with its outward appearance.
[0040] It is therefore submitted that the instant invention has been shown and described in what is considered to be the most practical and preferred embodiments. It is recognized, however, that departures may be made within the scope of the invention and that obvious modifications will occur to a person skilled in the art. With respect to the above descriptions then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function, and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specifications are intended to be encompassed by the present invention.
[0041] Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.
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Disclosed is a toilet training aid for children. The device comprises a doll having a microphone, a sound recognition processing module, a memory, and a speaker imbedded therein. The sound recognition processing module is adapted to detect a clapping sound or a flushing sound. When either of the clapping sound or the flushing sound is detected through the microphone, a pre-recorded message recording is played through the speaker. The pre-recorded message recording verbally encourages the child and rewards the child for a successful completion of a toilet training experience. In one embodiment, the doll may resemble a princess, and in another embodiment, the doll may resemble a pirate. The doll further includes a clip that may be used to mount the doll onto a toilet tank or on a doll stand.
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BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to the field of nasal dilators and air filtration and, more particularly, to an interal nasal dilator incorporating filtration having two semi-spherically topped substantially cylindrical reticulated foam depth filters with an integral interconnecting resilient member and arculate band set for insertion into the user's nostrils for nasal dilation and air filtration.
2. Description of the Related Art
Millions of people suffer from nasal obstructions or physiological conditions that make nasal breathing difficult, uncomfortable, or impossible. Examples of such conditions include narrowing of the nasal valve, allergic reactions, enlarged adenoid tissue and swollen nasal mucosa. The nasal valve, named by P.S. Mink in 1903 is the narrowest area in the nasal cavity, the adjacent area being larger both upstream and downstream. The nasal valve is located at the junction of the upper lateral and lower lateral cartilages about one third of the way from the tip of the nose.
The mucus membranes in the nasal valve area are extremely vascular. Any inflammation in this area causes swelling of the vascular tissue, narrowing down the nasal valve space and causing difficulty breathing. Decongestants can often help to reduce the swelling and make it easier to breathe. However, they can have a deleterious effect after several days of use and may cause an increase in swelling.
The airflow resistance provided by the nasal airways during breathing is essential for good pulmonary function. The nose is responsible for most of this resistance and consequently within the nasal air passageways, the nasal valve functions as a sort of flow limiting device. However, if the nasal valve area is reduced due to mucusal swelling or because the outer wall tissue of the nasal passage draws in during inhalation, breathing through the nose becomes difficult creating a tendency to mouth breathe.
Breathing through the mouth bypasses the natural air handling system of the body thereby negating all the built-in physiological benefits. Some reasons nasal breathing is superior include: (1) air is held in the lungs longer thus facilitating the interchange of oxygen and carbon dioxide, (2) air passing through the nasal mucosa carries the stimuli to the reflex nerves that control breathing, (3) the nostrils and cilia filter the air, (4) the sense of smell is enhanced, (5) the air is warmed, moisturized or dehumidified, (6) the tendency to snore, a precursor of sleep apnea, is reduced and (7) common cold germs and bacteria are more easily intercepted and discarded.
The advantage of breathing through the nose clearly offers significant physiological benefits. This is especially so for athletes and others who participate in strenuous physical activities such as sports. They process a far greater volume of air than more sedentary people and consequently are sensitive to restrictions in the air pathways such as the nasal valve. Clearly, any approach that mitigates a reduced nasal passageway and filters the air at the same time offers significant health benefits to the millions of people who suffer from nasal obstructions or physiological conditions that make nasal breathing difficult, uncomfortable, or impossible.
One such approach is a surgical technique using alar batten grafts as described by Becker et al, Journal of Long-Term Effects of Medical implants, 13(3)259-269(2003). Another surgical technique is a revision rhinoplasty, internal valve stenosis as described by Becker et al. However, surgical intervention is expensive, time consuming and may not entirely ameliorate the problem.
For those seeking a non-surgical or non-pharmaceutical option, there is generally known prior art that teaches the use of nasal dilators. As defined by the Food and Drug administration, “a nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow.” A nasal dilator, therefore, decreases airway resistance and increases nasal airflow.
There are two kinds of nasal dilators, external and internal. The external dilator, which is not a feature of the present invention, is constructed from one or more layers of material upon which a truss member is attached, with a skin adhesive applied to adhere to the outside of the nose. The external nasal dilator acts with a pulling action against the truss member to pull on the external nose tissue to open the nasal passageways. The adhesive must have enough strength to hold the dilator to the nose but not too much so that it is difficult or painful to remove. The internal nasal dilator has historically been made of metal or plastic and is placed inside the nostrils. It opens the nasal passages by pushing the nostrils open by pressing on the interior nasal side walls.
As a second alternative to a surgical approach to treat nasal obstruction, many others have proposed the use of internal nasal dilators. Unfortunately, most have overlooked the advantages of coincident filtration.
Examples of US internal nasal dilator patents include:
Year
Number
Issued
Inventor
Title
6,328,754
2001
Marten et al
Nasal dilator
6,270,512
2001
Jean Rittmann
Internal nasal dilator
6,238,411
2001
Robert Thorner
Internal nasal dilator
6,106,541
2000
Charles Hurbis
Surgically implanted dilator
5,922,006
1999
Joe Sugarman
Nasal appliance
5,895,409
1999
Mehdizadeh
Nasal dilator
5,816,241
1998
Cook
Coiled nasal dilator
5,479,944
1996
Bjorn Petruson
Nasal devices
5,350,396
1994
Isaac Eliachar
Nasal splint
4,759,365
1988
Leo Askinazy
Spring coil wire device
4,414,977
1983
Rezakhany
Nasal dilator
4,201,217
1980
Robert Slater
Nostril expander
3,710,799
1973
Carlos Caballero
Nose dilator
3,460,533
1965
C. Riu Pla
Nasal expander-inhaler
2,515,756
1950
C. Bove
Nasal appliance
1,709,740
1929
J. R. Rogers
Nasal distender
1,672,591
1928
W. A. Wells
Nostril dilation
1,597,331
1926
H. Thurston et al
Nostril expander
1,481,581
1924
H. R. Woodward
Nostril expander
1,255,578
1918
C. Boxley
Nasal appliance
1,135,675
1915
G. E. Dixon
Nostril dilating device
1,077,574
1913
H. R. Woodward
Nostril expander
1,014,758
1912
A. C. Knowlson
Nostril expanding device
1,014,076
1912
F. M. McConnell
Nasal expander
851,048
1907
H. R. Woodward
Nostril expander
513,458
1894
W. A. Dayton
Nasal expander
Examples of US internal nasal dilator patent application publications include:
Year
Number
Pub.
Inventor
Title
2004/0059368
2004
Paz Maryanka
Nasal Cavity Dilator
2004/0147954
2004
Charles Wood
Internal nasal dilator
2003/0144684
2003
Ronald Ogle
Adjustable nasal dilator filter
Examples of foreign internal nasal dilator patents include:
Year
Number
Issued
Inventor
Title
Country
DE19736717
1998
M. F. B. Velasquez
Nostril
Germany
expander
CH689199
1998
Berthod Remy
Nasal
Switzerland
passage
expander
A review of the prior art teaches that solutions were being sought for nasal breathing impediments for two centuries. Generally the devices proposed in the patents are suitable for their intended purposes but suffer from the significant disadvantage of no coincident filtration. For example, both U.S. Pat. No. 6,270,512 issued to Rittman and U.S. Pat. No. 6,238,411 issued to Thorner do not incorporate any filtration, as does the present invention. The depth filter of the present invention incorporates reticulated foam that captures and holds contaminates by providing a tortuous path for the air flow to follow as it passes through the filter media. A foam depth filter has the greatest particle retention efficiency and airflow while still maintaining the lowest pressure drop of all the common filter materials. Also, both Rittman and Thorner teach the use of a hard spring like material that fits within the nostril—0.020″ gauge steel wire (Rittman) and phos-bronze spring material (Thorner). Unlike the present invention that utilizes soft gentle foam to hold the dilator in place, the use of metal spring material can be uncomfortable to insert in the nostrils and difficult to adjust for various nose shapes and sizes.
Two internal nasal dilator patent application publications U.S. 2003/0144684, Ogle and U.S. 2004/0147954, Wood, teach air filtration in addition to internal nasal dilation. Ogle teaches of two 0.050 inch diameter nylon loops joined by a retaining tube. Upon careful insertion in the nostrils the nylon loops apply an outward force to the inside of the nasal tissue walls causing dilation. Ogle also teaches that the loops will cause a static electrical charge as air moves over the nylon loops and that this charge will capture particulate. Unlike the present invention, which utilizes a highly efficient depth filter, it is unlikely that the 0.050″ thick nylon loops situated in the mucosa of the inside of the nose will generate a meaningful static charge of sufficient amount to facilitate particulate capture. In addition, the loop diameter is so small that the loops may cause discomfort or erode the inside of the nose.
Wood teaches of two tapered housings that are intended to be inserted in the nostrils. The tapered housings are constructed of a resilient material configured as an open framework of tubular mesh in the manner of nasal filter prior art. Wood teaches that various filtering media can be placed within the tubular framework to filter air prior to introduction into the lungs. Unlike the present invention, which incorporates a resilient member to provide the dilation force, the tapered shape must be inserted further into the nose to achieve greater dilation. Depending upon the angle of the housing taper, the device could be very uncomfortable to insert and wear. The tapered shape is extremely stiff in the axial direction, possibly causing great discomfort during insertion. Also, there are small, difficult-to-handle pieces, the housings are not conformable to the inside of the nose and it is difficult for the housings to seal in different size nostrils thereby facilitating blowby, the passage of air between the tapered housing and the inside of the nose. Wood also teaches that the housings may be reusable possibly leading to contamination, which may be present in the nose including rhinoviruses, adenoviruses, and bacteria. Also, Wood teaches that air filtration media configured in a hollow conical shape may accomplish air filtration but presents no data to indicate that filtering or even breathing through the filter is possible. As determined by laboratory simulation, discussed later, the present invention utilizes a highly efficient depth filter rated at a retention efficiency of 97% for particulate 7 microns and larger at a flow rate of approximately 1 cubic feet per minute and a filter pressure drop of less than one inch of water.
It is therefore desirable to provide for nasal dilation and at the same time utilize a unitary foam depth filter to clean the air drawn into the lungs.
It is further desirable that an internal nasal dilator filter provide a method for dilating the nose and filtering the air inhaled through the nose by providing a reticulated foam filter shaped to be soft and gentle to the interior of the nose while effectively preventing airborne contaminates such as allergens, animal dander, house dust, mites and grass pollens from entering the respiratory system.
As opposed to a filter media with a separate piece inserted in a tapered housing, it is desirable that the filter consists of a single filter material molded into a shape that can be easily and safely inserted into and removed from the interior of the nose and nostrils. A unitary design provides the maximum surface area and volume for maximum airflow and filter efficacy.
Another desirable feature of a new internal nasal dilator filter is that when fully seated within the nostrils its appearance will be aesthetically pleasing.
It is further desirable to provide an internal nasal dilator filter that will remain in place during eating, drinking, talking and heavy exertion but may be expelled in the event of an explosive sneeze.
Additionally it is desirable to provide an internal nasal dilator filter that is easily manufactured, and intended to be disposable thereby minimizing the opportunity to reinsert a unit contaminated with viruses, bacteria and allergens.
It is also desirable to provide a simple, low cost, portable, internal nasal dilator filter that can be economically used by all members of society.
It is also desirable to utilize the natural ability of foam to expand, fill and form to the nostril area thereby sealing the internal nasal dilator filter within the nostrils, eliminating filter blow-by and providing maximum filtering area. Also it is desirable that the foam can easily be compressed both axially and radially, Further, it is desirable to utilize the inherent ability of the resilient member and foam to apply gentle pressure to expand the outer nasal wall tissues from the septum structures thereby providing nasal dilation, increased air flow and subsequent filtering efficacy.
Still further, it is desirable to provide an internal nasal dilator filter of the depth filter type which will capture and hold contaminates by providing a tortuous path for the air flow to follow as it passes through the filter media.
SUMMARY OF THE INVENTION
The present invention provides a combination of internal nasal dilation and nasal filtration operating synchronously. Given this particular combination, the increase in airflow resistance due to the foam filter is offset by the increased airflow caused by the dilation thereby providing an increase in clean air to the lungs.
Air filtration is achieved by retaining particulate in a nasal foam depth filter as air is inhaled through the nose. The filter retention efficiency is 97% for particulate 7 microns and larger at a flow of approximately 1 cubic feet per minute (I CFM) and a filter pressure drop of less than one inch of water (1″ H 2 O).
Internal nasal dilation is provided by the effect of a resilient member adhesively affixed to the nasal foam depth filter and which when bent from a planar surface applies equal outward biasing forces to the inside of the nose so that breathing is facilitated. The soft, gentle foam of the depth filter distributes the biasing force and protects the inside of the nose from irritation. The present invention thus provides an improved internal nasal dilator filter which functions to provide increased air flow through dilation while improving the quality of breathing air by removing particulate during respiration.
The present invention is a combination of internal nasal dilation and internal nasal filtration functioning synergistically to overcome nasal airflow resistance and to provide a greater quantity of filtered air to the lungs by utilizing a highly efficient depth filter to clean the air. The present invention consists of two semi-cylinders of reticulated foam filter media with a spherical shape on the distal (interior nose) end and a flat surface on the proximal end joined to each other at the proximal end with a thin flexible band. The thin flexible band is integrally molded with the semi-cylinders and is made from the same material and at the same time as the semi-cylinders.
Overlaying the thin flexible band and adhesively attached to it and both semi-cylinders is a resilient member in its normal planar orientation. Internal dilation is provided by the effect of the resilient member which when bent from a planar surface applies outward biasing forces to the inside of the nose so that breathing is facilitated. The soft, gentle foam of the filter distributes the biasing forces and protects the inside of the nose from irritation.
The resilient member and adhesively attached foam is intended to be formed into a graceful “U” shape with the resilient member to the inside of the “U.” The distal, spherical shaped end of each semi-cylinder is intended to be inserted in the nostril and located just inside and within the nasal vestibule. The spherical ends guide the internal nasal dilator filter into position and prevent damage to delicate nasal membranes. The proximal end is tucked in within the nasal vestibule just behind where the ala of the nostril narrows. The resilient member and thin flexible band prevent over-insertion of the semi-cylinders and serve as a handle to remove the internal nasal dilator filter from the nose.
The energy expended and applied to the resilient member to form the “U” shape is exactly opposite to the first and second biasing force, or restoring force developed by the resilient member. So that when placed in both nostrils the internal nasal dilator filter constantly exerts an outwardly restoring force (orthogonally against the nasal tissues) of a magnitude sufficient to return the resilient member to an unbent, planar state. Therefore, various embodiments of the present invention provide a desired amount of dilation force as determined by the physical characteristics of the resilient member with differing characteristics leading to differing degrees of dilation.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other features and advantages of the present invention will be better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein:
FIG. 1 is a bottom, front, left side perspective view of the internal nasal dilator filter of the present invention;
FIG. 2 is a top, plan view of the internal nasal dilator filter of FIG. 1 ;
FIG. 3 is a front elevation view of the internal nasal dilator filter of FIG. 1 , the rear view being a mirror image thereof;
FIG. 4 is a right side elevation view of the internal nasal dilator filter of FIG. 3 , the left side elevation being a mirror image thereof;
FIG. 5 is a front view of the internal nasal dilator filter of the present invention formed into a “U” shape prior to insertion in the nostrils;
FIG. 6 is a front view of the internal nasal dilator filter of the present invention inserted in the nostrils;
FIG. 7 is an elevation, section view of the internal nasal dilator filter of the present invention inserted in the nostrils;
FIG. 8 is a plan and end view of the resilient member of the internal nasal dilator filter of the present invention; and,
FIG. 9 illustrates a laboratory simulator used to measure the retention efficiency of the filter portion of the internal nasal dilator filter of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
Referring to the drawings, FIG. 1 shows the assembly of the internal nasal dilator filter invention. The filter portion incorporates two semi-cylindrical shapes 12 of the same nominal diameter, which have at each distal end a spherical shape 14 to match and blend with the nominal semi-cylindrical diameter and at each other proximal end a base 16 with a flat surface whose plane is perpendicular to the cylinder axis. A thin, strong, flexible band 18 made of the same material as the semi-cylinders joins the semi-cylindrical shapes. The entire filter portion is made from the same material, reticulated foam of the polyurethane or silicone chemical family and of the polyether or polyester category. For the embodiments shown, the semi-cylindrical shapes and connecting flexible band are integrally molded, Referring again to FIG. 1 , extending longitudinally along the thin, strong, flexible band 18 and further extending along a loft line of the circumferential surface of a portion of both of the semi-cylindrical shapes is a plastic, flexible resilient member 20 , which for the embodiment shown is adhesively attached. FIG. 1 shows an embodiment of the present invention in the “relaxed” state. In use, the resilient member is bent into a “U” shape causing the semi-cylindrical shapes to be substantially parallel with the attachment loft lines of the circumferential surfaces to which the resilient member is attached adjacent one another on the legs of the U. The resilient member 20 applies a first and second biasing force, orthogonal to the lateral nostril walls, when bent in the shape of a “U”, as will be shown in greater detail subsequently.
The manufacturing process for the filter portion of the present invention consists of first producing the foam by a chemical reaction process and then removing the cell walls within the foam by a thermal or chemical process thereby producing reticulated foam. The reticulated foam consists of a three dimensional matrix with voids and intricacies within a skeletal structure.
The reticulation process removes the cell walls, leaving only a structure of skeletal strands and voids. This makes the reticulated foam exceptionally porous and permeable but with many particulate catching strands and great contaminate holding capacity within the void spaces.
The reticulated foam manufacturing process is well understood by those skilled in the field and results in a foam with consistent properties including density, tensile strength, tear strength, elongation, compression set and pore size (ppi—pores per inch).
The pores per inch specification relates directly to the efficaciousness of the filter, with a higher number relating directly to greater filtering ability and a greater breathing resistance. Current embodiments of the present invention are molded using reticulated foam of from 40 to 130 ppi so that the user may choose the best filtering characteristic based on individual need.
The reticulated foam is manufactured in large sections approximately six feet by four feet by one foot thick and then supplied to a foam fabricator skilled in the field. For current embodiments, the fabricator slits the foam to the appropriate thickness of about 0.65 inch with a 48 inch by 72 inch sheet, saws the sheet to the handling blocks of about 12 inches and then die-cuts the blocks to produce individual precurser blocks of 1 inch by 2 inches by 0.65 inch which are then further die-cut to shape approximating the semi-cylinders and connecting band suitable as a preform for the molding process. The preform is then placed in a mold and, utilizing heat and pressure, the net shape of the product incorporating the present invention is produced (including a felting step to compress the connecting band). When the product comes from the mold, the molded preform is bent to place a loft line on each of the semi-cylinders in substantially planar relation with the flexible band and the self adhesive resilient member 20 is centered, overlaid and adhered to the thin, flexible band 18 and semi-cylinders producing a product that is ready for use.
Referring to FIGS. 2 and 3 , there is a slight tapering of the semi-cylindrical shape from the proximal end or base 16 to the beginning of the spherical shape 14 providing a frustoconical section. This taper and the rounding at the vertex of the distal end of the spherical shape 14 allows for an easier insertion into the nose by guiding and gently expanding and forming the nostrils during insertion. The foam employed in the embodiments of the invention is easily compressed in an axial and radial direction, whereby insertion discomfort is minimized.
Referring to FIGS. 2 and 3 , the thin flexible band 18 is integrally molded to the proximal end 16 of the semi-cylindrical shapes and coincident with the centerline that joins the centers of the faces at the base 16 of the proximal ends of both semi-cylindrical shapes 12 . The thin flexible band 18 has one surface in the same plane as the flat surface of the base 16 of the semi-cylindrical shapes and the other surface in a parallel plane a small distance away from the proximal end plane.
Referring to FIGS. 1 , 2 , 4 and 6 , the thin flexible band 18 and resilient member 20 are substantially thinner and narrower than the semi-cylindrical shapes thereby allowing great conformability to the exterior of the end of the nasal septum 22 . This conformity allows the base 16 of the proximal end of the semi-cylindrical shapes to be placed within the nasal vestibule just behind the narrowing of the nostril, the ala 24 . The foam of the filter is so soft and gentle that when formed into the “U” shape and inserted in the nostrils, the resilient member sinks into and is cradled by the foam.
The internal nasal dilator filter is gently restrained within the nostrils so that it will not be dislodged by normal activities such as talking and eating and yet still release under the pressures of an explosive sneeze.
Again referring to FIGS. 1 and 2 , the semi-cylindrical shape has a slightly flattened surface 32 on all four sides to better match the ovoid shape of the nostrils. The slightly flattened sides of the cylinders are spaced circumferentially around the frustoconical semi-cylinder and smoothly blended with the spherical shape 14 to assure a gentle yet retained fit within the nostrils.
FIG. 5 shows the internal nasal dilator filter 10 with the resilient member 20 formed from its normal, at rest planar shape, into a smooth “U” shape, as it would be inserted into the nostrils. The “U” shape applies first and second biasing forces at ninety degrees to the long axis of the “U”. This force is applied to both the right and left of the interior nose tissue expanding and dilating the nasal air passageways. The force is cushioned by the projected width of the foam filter so there will be no irritation to the sensitive tissues of the inside of the nose.
Referring to FIG. 6 , the internal nasal dilator filter 10 is shown inserted into the nostrils. When the device is inserted the filter foam is compressed as it passes into the vestibule area and expands to seal the nostril area. Due to the narrow shape of the resilient member with respect to the semi-cylinders, the first and second biasing forces are distributed over the rounded shape of the semi-cylinders. This then distributes the stress over a larger area and reduces the possibility of nose irritation.
Referring to FIG. 7 , when installed in the nose, the internal nasal dilator filter dilates the air passages in the nostrils 24 of the nose 26 to achieve a result similar to adhesive dilators that are affixed to the exterior of the nose. The foam expansion to seal the nostrils presents a larger filter surface area and, as a consequence, lower face velocity across the filter resulting in greater filter efficiency.
Again referring to FIG. 7 , the proximal ends 16 of both semi-cylindrical shapes 12 expand the nostril to conform to the shape of the filter, secure the internal nasal dilator filter to the nostril and assure that all the inhaled air passes through the reticulated air filter. The adaptability, softness and gentle expansion ability of the foam easily conforms to the resilient member and nostril to make a leak proof seal around the nostrils. The gentle expansion ability of the foam makes a nominal size suitable for many people. It is understood that the size of the may be varied in alternative embodiments to accommodate noses of other shapes and sizes.
Referring to FIG. 8 , the resilient member 20 is indicated as a single piece for ease of visualization. In various alternative embodiments, more than one resilient member is employed and the size of the resilient member is varied in area, thickness, length, and shape. For this exemplary embodiment typical dimensions are length 1.75″ by 0.010″ thickness by 0.13″ wide. The material of construction of the resilient member is varied in alternative embodiments but provides that the first and second biasing forces are developed orthogonally when the resilient member is bent into the “U” shape. Some materials found to be acceptable include polycarbonate (PC), polypropylene (PP), polyvinyl chloride (PVC) and acrylonyitrile butyl styrene (ABS).
The adhesive for the present embodiment is of the transfer adhesive type of high tack and strong adhesion to both the resilient member and the polyurethane filter foam.
Although several manufacturers are capable of producing an acceptable adhesive, the following 3M Medical Specialties, St Paul Minn. adhesives have been found to perform well— 1509 , 1512 , 1522 and 1524 . These adhesives are hypoallergenic, conformable and have faceside adhesive strength in the 25 to 53 oz./in. range.
Referring to FIG. 9 the laboratory simulator is used to measure the particle retention ability or efficiency of the filter portion of the internal nasal dilator filter.
The test apparatus consists of an ambient, unfiltered air input and a filtered air input connected to a laser particle counter. The filtered air input is a tee fitting designed to accept both the right and left nostril filters of an internal nasal dilator filter whereas the ambient air input is unfiltered. Both filtered and unfiltered air inputs are connected by tubing to the laser particle counter.
The laser particle counter, model C 1-500 as manufactured by Climet Corporation, Redlands Calif., is of the manifold design so either the filtered or unfiltered input can be automatically selected during the test period. In addition, the laser particle counter measures 12 different particle size ranges at the same time while maintaining a flow rate of one cubic foot per minute (1 CFM).
A test sequence consists of automatically counting the particles in all 12 ranges in the ambient, unfiltered flow and then counting the particles in the same ranges in the filtered flow. The entire counting cycle is automatically repeated 8 times and the average particle count determined for each of the 12 ranges for both the filtered and unfiltered airflows. The retention efficiency is determined from the following formula:
Removal Efficiency (%)=(1−filtered count/unfiltered count)*100
The filter was tested in the laboratory simulator described with respect to FIG. 9 at a one cubic foot per minute (I CFM) air flow. Table 1 presents the removal efficiency percentages at each of 12 ranges for the filter portion of an internal nasal dilator filter.
It is important to specify the flow rate as a test parameter so the particle counts are taken at a normal breathing condition. If the flow rate is too low it could indicate that the pressure drop across the filter is excessive and breathing through the filter would be difficult or impossible.
Normal, at rest, breathing is approximately 12-15 times a minute at a volume of 25-30 cubic inches or 0.25 cubic feet a minute. A flow rate of 1 cubic feet per minute therefore represents a safety factor of 4 to allow for an increase in breathing rate and amount inhaled during moderate work or exercise.
TABLE 1
Particle Size Range (microns)
Removal Efficiency (%)
0.3–0.4
6
0.4–0.55
6
0.55–0.7
6
0.7–1.0
7
1.0–1.3
10
1.3–1.6
19
1.6–2.2
33
2.2–3.0
54
3.0–4.0
71
4.0–5.5
89
5.5–7.0
93
7.0–10.0
97
Having now described the invention in detail as required by the patent statutes, those skilled in the art will recognize modifications and substitutions to the specific embodiments disclosed herein. Such modifications are within the scope and intent of the present invention as defined in the following claims.
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A device combining internal nasal filtration and internal nasal dilation operating synchronously provides air filtration by retaining particulate in a single piece foam nasal filter during inhalation through the nose. Internal nasal dilation is provided by the effect of a resilient member adhesively affixed to the nasal foam filter and which when bent from a planar surface applies outward biasing forces to each nostril so that breathing is facilitated. The soft, gentle foam of the nasal filter distributes the biasing forces over a large area and protects the inside of the nose from irritation. An improved internal nasal dilator filter functions to provide increased air flow through dilation while removing various sizes of particulate through filtration.
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BRIEF DESCRIPTION OF THE DRAWINGS
[0001] For a more complete understanding of the present invention, including its features and advantages, reference is now made to the detailed description of the invention taken in conjunction with the accompanying drawing in which:
[0002] FIG. 1 is a diagram utilized to explain an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0003] While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts that may be embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention.
[0004] Pregnenolone is a natural hormone that is sometimes referred to as the body's “master hormone” since it is the precursor for all other steroid hormones. It is converted directly into dehydroepiandrosterone (DHEA) and/or progesterone. DHEA converts to testosterone and estrogens; progesterone converts to estrogens, cortisol and aldosterone. It is this succession of conversions that makes human life possible. Without pregnenolone, there can be no human steroid hormone production.
[0005] Back in the 1940's, when researchers started experimenting with the use of pregnenolone, they realized that it could be helpful for people under stress and it could increase energy in those who were fatigued. However, about the same time, cortisol was discovered.
[0006] Cortisol stole the limelight. When cortisol was given to individuals with rheumatoid arthritis, they experienced outstanding short-term improvements. Photographs of these remarkable recoveries were circulated and the medical community was impressed. Scientists then basically put pregnenolone aside to focus on cortisol. The structure of cortisol was altered to make similar molecules such as dexamethasone and prednisone, much more powerful steroids. Dexamethasone and other similar corticosteroids could be patented, and thus a pharmaceutical company could make a lot of money. Pregnenolone has stayed in relative obscurity since the 1940's, with only rare mentions in the medical literature. However, there have been few studies published on pregnenolone in recent years, and only a couple of the studies involve human subjects.
[0007] Some people find pregnenolone improves energy, vision, memory, clarity of thinking, wellbeing, and often sexual enjoyment or libido. Pregnenolone may be considered a good brain enhancer in those who are deficient. Studies in rodents show pregnenolone to be one of the most effective and powerful memory boosters. In addition, pregnenolone may increase levels of acetylcholine in the hippocampus and other memory regions in the brain. Some women report lessening of hot flashes or premenstrual symptoms.
[0008] Pregnenolone production has also been found to decrease as humans get older. Like many health-promoting hormones, levels of pregnenolone drop with age. Although the data is not as abundant or definitive for pregnenolone as it is for DHEA, Dr. Eugene Roberts, a pioneer in hormone research, believes that the age-related drop in pregnenolone is as dramatic as the drop in DHEA. At 75, our bodies typically make 60% less pregnenolone than at age 35. This is a point of great concern, considering pregnenolone's numerous protective, health-promoting properties Pregnenolone replacement therapy normally consists of patients taking oral supplements but the therapy is still evolving.
[0009] An embodiment of the present invention utilizes pellets of pregnenolone that are injected into the subcutaneous fat (fat beneath the skin) of a patient at various areas. FIG. 1 illustrates an example patient 100 . In this embodiment, the pregnenolone pellets are injected into the subcutaneous fat in the hands 104 of the patient 100 . Moreover, the pellets can also be injected into the thighs 110 of the patient. This embodiment contemplates an injection every 10-12 weeks in each of those areas. In addition, the pellets used are 25 and 50 milligram. First, the 25 milligram pellets are used, then the blood pressure of the patient should be checked before use of the 50 milligram pellets. If the blood pressure rises, use of the 50 milligram pellets should be avoided. Applications of this type have shown to positively effect the energy level of patients as well lowering the stress levels of the patients.
[0010] Another embodiment includes equal parts of pregnenolone and DHEA combined into a cream and is applied directly on the skin. Application directly on the skin helps replenish the pregnenolone and DHEA normally produced within the skin. Consequently, direct skin application has been found to improve the overall health of a patient. In addition, positive effects have been found if the cream is applied to thin vascular skin such as between the inner arm and the side of the arm or flank.
[0011] In this embodiment, the pregnenolone/DHEA cream is applied topically to skin on the face 102 , hands 104 and the chest 106 of the patient 100 . This embodiment contemplates two applications per day in each of those areas. Applications of this type have shown to positively effect the mood and well-being of patients. In addition, these types of applications have also shown to decrease pro-inflammatory cytokine secretion production stimulated by ACTH and stress. Such, the applications have been shown to improve the muscle to fat ratio of patients.
[0012] The pregnenolone/DHEA cream can also be applied to the nipples and clitoris of a female patient and the head of a male's penis. This application has been shown to improve libido and sexual response of the patients. One reason that this type of application helps is because the combined pregnenolone/DHEA cream has been shown to have a strong affinity for the Sex Hormone Binding Globulin (SHBG).
[0013] These types of applications have a strong affinity for serum albumin and positively effect cognition, depression and mobility. In addition, the applications affect global self-rated health for men and especially women. Moreover, the applications lower blood pressure and improve cardiovascular health in men. Further, the applications are antagonistic to cortisol and thus decrease abdominal fat. The applications also improve the skin and joints and increase hair growth.
[0014] Although this invention has been described with reference to an illustrative embodiment, this description is not intended to limit the scope of the invention. Various modifications and combinations of the illustrative embodiments as well as other embodiments of the invention will be apparent to persons skilled in the art upon reference to the description. It is therefore intended that the appended claims accomplish any such modifications or embodiments.
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A method is described herein for improving the overall health of a patient by providing subcutaneous pellets containing pregnenolone to at least one part of the body of the patient. In another embodiment, pregnenolone is mixed with DHEA into a cream and the resulting pregnenolone/DHEA cream is applied to at least one part of a body.
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TECHNICAL FIELD
This invention relates to a device used to clean barbeque grills.
BACKGROUND OF THE INVENTION
Barbeque grills routinely accumulate charred debris from cooked foods that adhere stubbornly to the grill bars and the intervening grooves. And these are difficult to dislodge and remove. Also, attempting to clean the surfaces with conventional metal brushes lead to the charred debris dropping into the housing of the grill as well as to the floor.
The current invention is designed to overcome the above problems. The cleaner according to this invention is operated only in one direction; thus the debris is likely to fly in only one direction (backwards). Further, the provision of the bristles on a wheel assures that the direction of flight of the debris will be upward, as well as backward. The prong that engages the grill bar at the front end of the cleaner is for efficiently scraping the grill bar surfaces. A further refinement in the invention is the provision of a bag at the top to capture the debris.
The combination of the above components assures efficient cleaning as well as removal of the debris without littering around the grill.
SUMMARY OF THE INVENTION
A grill cleaning device has a handle, a scraper and a rotatable bristled cleaning wheel assembly. The handle has a handle end portion and a cleaning end portion. The scraper projects from the cleaning end portion. The rotatable bristled cleaning wheel assembly has a rotatable axle held in the cleaning end portion. The bristled cleaning wheel is affixed to the axle. The bristled wheel has substantially radially extending cleaning bristles on each of the lateral ends of the cleaning wheel and two sets of opposing laterally extending bristles. Each set of lateral bristles projects inwardly from a wheel rim toward a lateral center of the wheel assembly. The bristles are wire preferably made from stainless steel or another non-corrosive metal. The ends of the laterally extending bristles are spaced from the center of the wheel a distance equal to or slightly less than a grill rod. The radially extending bristles extend from a hub end on each side of the wheel to a distance to contact either support rods of a grill underlying the grill rods or at least below the grill rods.
The grill cleaning device further has a cavity adjacent and behind the cleaning wheel in the cleaning end portion. The cavity holds a debris-holding container. The debris-holding container has an open intake for catching dislodged debris. The debris-holding container can be a folded bag assembly adapted to be stowed inside the cavity and upon unfolding becomes the debris-holding container. The folded bag includes an upper forward pull tab to raise or unfold the bag. The folded bag has a rotatable rear mounted support to hold the bag fixed open during use. The structure further has an external wheel affixed to the rear bag support, the wheel rotatable and pivots the support to move the bag into or out of a folded condition. The bag is fixed to the scraper at a lower forward tab. The upper pull tab has a snap to fit onto a projecting pin on the scraper which also holds the lower tab. The bag can be made of a woven fabric or can be made of a thermoplastic. The bag is preferably detachable for cleaning and can be disposable.
The cleaning wheel assembly rotates counterclockwise upon a rearward pull of the handle. The counterclockwise rotation of the cleaning wheel causes dislodged debris to be directed on either lateral side of the scraper rearwardly and upwardly into the debris-holding container, some portion of the loose debris may fall into the bottom of the grill, most however is captured in the debris-holding container.
The handle portion has a threaded hole and the cleaning end portion has a threaded shaft for securing the two portions. The handle portion further comprises an outer grip sleeve, the grip sleeve fits over the handle.
The grill cleaning device can be manufactured with the debris cleaning end portion being a molded plastic structure, more preferably, a metal structure of aluminum or stainless steel. The scraper is made of steel or another metal. The handle end portion can be wood, plastic or more preferably, a metal structure of aluminum or stainless steel. The handle grip sleeve can be a thin membrane of plastic or elastomeric material.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be described by way of example and with reference to the accompanying drawings in which:
FIG. 1 is a perspective view of the grill cleaning device made according to the present invention.
FIG. 2 is a second perspective view looking upwardly at the grill cleaning device from FIG. 1 showing the folded debris-collecting container fully extended and the cleaning wheel assembly and scraper at the cleaning end portion.
FIG. 3 is a third perspective view of the grill cleaning device with the debris-collecting container shown folded in a retracted position.
FIG. 4 is a fourth perspective view similar to FIG. 3 , but with the debris-collecting device fully extended and open.
FIG. 5 is a cross sectional view of the grill cleaning device taken along the longitudinal length of the device.
FIG. 6 is an end cross sectional view taken along the dashed or broken line 6 - 6 from FIG. 5 , the dashed lines of FIG. 6 show an exemplary grill.
FIG. 7 is an end cross sectional view of the folded debris container taken along dashed or broken line 7 - 7 taken from FIG. 5 .
FIG. 8 is a longitudinal cross sectional view similar to FIG. 5 , but with the debris-collecting container fully extended and open.
FIG. 9 is an exploded view of the grill cleaning device made according to the present invention.
FIG. 10 is an exploded view of the bristled cleaning wheel assembly.
FIG. 11 is a view of the grill cleaning device in use.
DETAILED DESCRIPTION OF THE INVENTION
With reference to FIG. 1 , a grill cleaning device 10 is shown. The device 10 has a handle 12 , a scraper 40 and a rotatable bristled cleaning wheel assembly 20 . The device 10 has a handle end portion 12 and a cleaning end portion 14 . The scraper 40 projects from the end of the cleaning end portion 14 . The rotatable cleaning wheel assembly 20 has a rotatable axle held in the cleaning end portion 14 . As illustrated, the device 10 further has a folded debris container 30 . The folded container 30 as illustrated can be a fabric or plastic member that is shown in a collapsed and folded state. An upper forward end tab 36 is shown that is snapped to the scraper assembly 40 using a snap-in fastener 37 .
With reference to FIGS. 2 , 3 and 4 , various perspective views of the assembly are shown. In FIG. 2 , the device 10 is shown with the debris-holding container 30 in a released, fully extended position such that the debris container 30 can receive debris from the wire wheel assembly 20 during the cleaning procedure. With reference to FIG. 3 , another perspective view is shown of the device 10 . In this view the folded debris container 30 is shown secured at the fastener 37 in its folded and retracted condition. In FIG. 4 , the debris container 30 is shown in the same view as FIG. 3 only with the container 30 being in the fully extended and upward position. In this position, the support 32 helps maintain the folded bag in this upright and fully opened position.
With reference to FIG. 5 , a cross sectional view of the device 10 is shown. The handle end portion 12 is shown threadingly engaged onto a shaft 15 of the end cleaning portion 14 . To accomplish this fastening of the two portions, a threaded opening 16 is provided in the handle portion 12 . The handle portion 12 is further shown with an elastomeric sleeve or covering 12 A that surrounds the handle 12 . This elastomeric or plastic sleeve 12 A is provided to give the user a gripping surface upon which to hold the device 10 . As further illustrated, in the cleaning end portion 14 the support 32 is shown horizontal in the stowed position. In dashed lines, this support 32 is rotated vertically in a vertical position when the container 30 is moved to the fully upright and open extended position. The wheel assembly 20 underlies the scraper 40 as illustrated and is held to the end portion 14 via an axle 24 .
With further reference to FIGS. 6 and 10 , the rotatable bristled wheel assembly 20 is illustrated. In FIG. 6 , a cross sectional view of the device 10 cut along line 6 - 6 from FIG. 5 shows the wheel assembly 20 in its mounted condition held securely in the end portion 14 . As shown, with reference to FIGS. 5 and 9 , the axle 24 extends across the wheel assembly 20 into openings 55 on each side of the end portion 14 . This axle 24 is retained by retaining washers 25 that are snapped over the ends of the axle 24 pinning the axle in the end portion 14 as illustrated in FIG. 6 . Inward of the retaining washers 25 and the sides of the end portion 14 are shown radially extending wire wheels 21 . These wire wheels 21 are formed from wire bristles extending radially outwardly. These wire wheels 21 have a center hub 27 . The center hub 27 has a square or rectangular end on each laterally inward side of the wheel 21 . The square hub 27 is adapted to fit into the rims 28 and lock into a square opening 29 on the rim 28 itself, as shown in FIG. 10 . Projecting from the rim 28 are laterally extending wire bristles 23 . These laterally extending wire bristles 23 are directed facing the opposite laterally extending wire bristles 23 on the opposite rim 28 . These rims 28 are fitted into a center hub 26 and are rotatably fixed to the hub 26 in such a fashion that as the wheel assembly 20 rotates, the center hub 26 and both of these rims 28 with laterally extending wire bristles 23 will rotate in a counterclockwise direction as the handle assembly 12 is pulled toward the user. This is best illustrated in FIG. 11 showing the hand 3 of an operator pulling the device 10 backwards along the rods 2 wherein the debris 5 on the rod 2 is then flipped off the rod 2 with the lateral extending wire bristles 23 rotating in such a fashion that the debris 5 is either thrown generally rearwardly and upwardly into the debris-holding container 30 as illustrated through the opening 33 . This debris 5 projects on each side of the scraper 40 . The scraper 40 provides a means to pull any remaining surface debris 5 along the top surface of the rod 2 . The lateral bristles 23 loosen and deflect a large portion of the debris 5 as the wheel assembly 20 rotates. To facilitate rotation, the center hub 26 can be pushed against the rods 2 upon which the hub 26 is riding. This provides additional rolling assistance for the wheel assembly 20 as it is being turned and pulled over the rods 2 cleaning them. The radially extending bristles 21 extend from a hub 27 end on each side of the wheel assembly 20 to a distance to contact either support rods 4 of a grill underlying the grill rods 2 or at least below the grill rods 2 , as shown in FIG. 6 .
With reference to FIG. 7 , the debris container 30 is shown in a folded and retracted position inside a cavity 31 in the end portion 14 . A knob 50 is shown attached to the support 32 of the device 10 such that the wheel 50 can be rotated to move the support 32 from a horizontal stowed position to a vertical position as the bag 30 is being extended into its fully opened position.
With reference to FIG. 8 , this is best shown in the fully open position wherein the container 30 is extended from the cavity 31 in the end portion 14 . With further reference to FIG. 8 , the container 30 is held by snaps 39 , 38 and 37 and snaps 60 , 62 . To remove the container 30 , one simply pulls the snaps open releasing the container 30 . The container 30 can be cleaned or washed or discarded and replaced at the user's option.
With reference to FIG. 9 , an exploded view of the entire device 10 is shown. In this view, the scraper 40 is more clearly shown having a projected end 41 with a scraper surface 42 that extends back to a flanged end 44 . This flanged end 44 has openings to hold snaps or rivets 60 , 62 which can securely hold the scraper 40 into position. Preferably these snaps or rivets 60 , 62 are solidly riveted to the end portion 14 through the openings 57 shown in FIG. 9 . Additionally, the support 32 , formed as two portions held together by fastener 52 , extends through openings 54 on each side of the end portion 14 . The axle 24 of the wheel assembly 20 extends through the openings 55 in this end portion 14 as shown in FIG. 5 . As further shown, the handle 12 is shown in a preferred embodiment with the opening 16 being threaded. The handle 12 being a solid structure having a flexible sleeve 12 A covering it.
It is important that the wire bristles on both the radially extending wheel 21 and laterally extending wires 23 on the rims 28 of the wire wheel assembly 20 be made of a tough durable material, preferably a stainless steel or aluminum material of high stiffness. This will ensure that the wheels 20 when rotating about the rods 2 of the grill cleaning it can provide enough rigidity to break free the debris 5 from the rods 2 of the grill allowing the debris 5 to be removed easily. The cleaning end portion 14 and the handle portion 12 can be made of a lightweight aluminum or stainless steel or other metal material or alternatively can be made of heavy duty fabric material if so desired or the handle alternatively could be made of wood. It is believed that preferably lightweight aluminum assembly provides the most advantageous construction as it provides both corrosion resistance and strength.
The present invention provides a mechanical grill cleaning device 10 that requires no vacuum assist in collecting debris or battery operated rotation of the wheel assembly 20 , although such additions could be used without departing from the inventive concept. It is believed preferable that the entire cleaning can be manually accomplished with the device 10 . One of the main objectives is to keep the surroundings of the grill from being splattered by the charred dislodged debris 5 . It is further important that the debris 5 mainly is captured in the debris container 30 with some residual debris 5 being dropped into the bottom of the grill, but otherwise not allowing the dislodged debris 5 from spraying over the patio deck as is a common problem with conventional grill cleaning.
Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described, which will be within the full intended scope of the invention as defined by the following appended claims.
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A grill cleaning device has a handle, a scraper and a rotatable bristled cleaning wheel assembly. The handle has a handle end portion and a cleaning end portion. The scraper projects from the cleaning end portion. The rotatable bristled cleaning wheel assembly has a rotatable axle held in the cleaning end portion. The bristled cleaning wheel assembly is affixed to the axle. The bristled wheel assembly has substantially radially extending cleaning bristle wheels on each of the lateral ends of the cleaning wheel assembly and two sets of opposing laterally extending bristles. Each set of lateral bristles projects inwardly from a wheel rim toward a lateral center of the wheel assembly. The bristles are made from sturdy non-rusting metal. The ends of the laterally extending bristles are spaced from the center of the wheel assembly a distance equal to or slightly less than a grill rod.
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CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the priority benefit of provisional application 61/305,238, “Rolling Closure with Pivoted, Side-by-Side Panels, for a Shower Stall Doorway”, filed Feb. 17, 2010, inventor Mark E. Lambert.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This disclosure relates generally to portal closures and more particularly to a closure for a shower stall.
[0004] 2. Description of the Related Art
[0005] Shower stall closures are generally doors of the conventional kind, that is, having hinges on one side of the door and a latch on the opposing side. The latch is often a magnetic latch, or a spring loaded conventional door latch. The prior art teaches such shower doors in: Lehman U.S. Pat. No. 1,944,440, Backman U.S. Pat. No. 2,627,327, Whitney U.S. Pat. No. 4,598,433, Doan U.S. Pat. No. 244,535, Lax U.S. Pat. No. 3,803,764, Lyons U.S. Pat. No. 5,123,129, Kiefer US2005/0166366, and especially Risk et al U.S. Pat. No. 3,335,784. Such shower doors have certain disadvantages. First of all, shower doors of the conventional type must be made of a structural type of glass that is resistant to being broken and such glass is relatively heavy. Therefore, the framing of a shower stall must be robust in order to support such a heavy door and the framing must be secured to wall panels in an equally robust manner. Such construction is heavy itself, relatively expensive, and generally more time consuming to install. Another disadvantage of such heavy shower doors is that they are difficult to operate, especially by children, older folks and the infirm and senile. An obvious disadvantage of using large glass doors is that they present a significant danger upon being broken.
BRIEF SUMMARY OF THE INVENTION
[0006] The presently described invention provides a welcome solution to conventional construction providing light-weight shower door closures that are easy to operate, inexpensive to manufacture and install, durable, and, of course, prevent water from spraying out of the shower room or stall.
[0007] In one embodiment, the invention may be a rolling closure type shower door intended to be mounted in a shower stall doorway. The door may comprise multiple (often four or more) pivoted, side-by-side panels. The panels fit underneath a top a structural channel held rigidly in position by a frame with an opening of the channel facing upwardly. The door consists of a plurality of these vertical panels arranged in side-by-side positions, where each of the panels pivotally engaged by a hanger and the hangers engaged with the upper channel, thus holding the panels in an upright attitude. Further, there are a plurality of rods engaged with the hangers and with the panels so that the panels are able to mutually pivot between an open and a closed position. Thus the panels are able to either close-off the shower stall doorway in a closed position, and are alternately able to open the doorway as a pass through in an open position.
[0008] Alternatively or additionally, the invention may be a segmented door for a shower stall, built within a fixed structural frame with a horizontal upper and lower channel. The door is constructed using a plurality (often four or more) of vertically disposed, side by side arranged, moveable panels that are hung from the upper channel by a plurality of moveable and pivoting wheeled hangers engaged with this upper channel. These moveable panels are connected to each other by a plurality of pivotally joined horizontal rods, which enables the moveable panels to move as a group. Often one of the moveable panels is joined to the upper and lower channel by clamp-on hinges, so that this panel is only able to move by pivoting. The moveable panels are able to move between an open door configuration and a closed door configuration, and can be designed with slight overlap so as to prevent shower spray from going beyond the panels.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a perspective view of a first embodiment of the present invention as seen from above, and from inside a shower stall with individual panels of the invention being shown in their partially open attitude providing access to the shower stall, and showing means for moving all four panels shown laterally.
[0010] FIG. 2 is an enlarged view of the upper portion of FIG. 1 but showing the right most panel clamped in place, and showing the individual panels in their closed attitude and particularly showing details of hinging and hanging means thereof.
[0011] FIG. 3 is a top partial perspective view of the invention particularly illustrating a channel used as a track for receiving the hanging means and in controlling rolling movement of the panels during pivotal action between the closed and open attitudes.
[0012] FIG. 4 is an exploded partial perspective view of a lower portion of the invention as seen from below, and particularly illustrating a lower channel and rolling, pivoting and guiding means of the invention as it is normally engaged with the lower channel.
[0013] FIG. 5 is a partial perspective view of the lower portion of the invention as seen from one side and particularly illustrating the rolling means engaged with the lower channel.
DETAILED DESCRIPTION OF THE INVENTION
[0014] The above described drawing figures illustrate the apparatus and its method of use in at least one of its preferred, best mode embodiments, which is further defined in detail in the following description. It should be understood that what is illustrated is set forth only for the purposes of example and should not be taken as a limitation in the scope of the present device or apparatus and its method of use.
[0015] The present invention, a segmented closure for a shower stall entranceway 5 , is described now, in detail. As shown in FIG. 1 , the present invention is an entranceway closure which is mounted, and operated, within a fixed structural frame 7 . The moving portion of the invention is made-up of a plurality of individual, vertically disposed panels 10 disposed in a side-by-side arrangement. The panels 10 are hung from a horizontally disposed upper channel 20 which is held by, and extends between spaced-apart, vertically disposed, left 30 and right 40 struts. Struts 30 and 40 are appropriately secured to fixed building structures such as walls (not shown). A horizontally disposed lower channel 50 is secured between struts 30 and 40 as well, and is, importantly, oriented in parallel with upper channel 20 . Lower channel 50 is preferably supported by a structural base surface (not shown). The struts 30 and 40 define the width W of the structural frame 7 , said frame comprising elements 20 , 30 , 40 , and 50 . Clearly, as shown in FIG. 1 , a fixed panel 60 may be mounted within structural frame 7 , thereby taking up a portion W′ of its total width W, and leaving entranceway 5 as an open passway to be selectively covered and uncovered by the segmented closure, which, as previously described, is the moving portion of the present invention.
[0016] As shown in FIG. 1 , the panels 10 are individually referred to as “ 10 - 1 ” for the first panel (adjacent to fixed panel 60 ), “ 10 - 2 ” for the next panel to its left, and so on. Four panels 10 are shown in the figures, but the number of panels 10 may be any number depending on the width of the doorway opening that is to be covered, and, of course, on the width of the individual panels 10 and the dimension of their overlap as best illustrated in FIG. 2 . It is noted that in FIG. 1 , all four panels 10 are mounted by wheels 110 so that they are able, as a group, to be moved to the left or right on channel 20 . Notice too, that the four panels 10 might be moved behind panel 60 to fully unobstruct entranceway 5 . As shown in FIG. 2 , panels 10 are arranged in mutually parallel side-by side positions with a slight overlap, and are interconnected by elongated rods; a longer rod 70 and a shorter rod 80 as will be presently described. Noting again that the illustration of FIG. 2 is as viewed from inside the shower stall, we see that each panel 10 overlaps the immediately adjacent panel 10 to its left. In this arrangement, shower spray would preferably originate from the right side of FIG. 2 so that spray would not pass through the closure even if it were not absolutely fully tightly closed. Should the spray originate from the left side of FIG. 2 , the panels 10 could be assembled so that each panel 10 would overlap a panel 10 to its right. All of the hardware of this invention is adapted to enable the moving portion (the closure) to open to the right, as in the present illustrations, or to open to the left, that is, it is fully reversible.
[0017] Now referring again to FIG. 2 , we can understand that in this embodiment, panel 10 - 1 is joined by clamp-on hinges 90 to both the upper channel 20 (shown) and the lower channel 30 (so that panel 10 - 1 is laterally immobile, yet is able to pivot between the closed position, as shown in FIG. 2 , and the open position, as shown in FIG. 1 . Clamp on hinges 90 may be positioned selectively so that the panel 10 - 1 may be positioned at a desired location on channel 20 . A rod 80 (the shorter rod) is pivotally joined at its distal end 82 to the edge 12 of panel 10 - 1 at a medial position 14 of the edge 12 . This same rod 80 is pivotally joined at its proximal end 84 to a vertical hanger 100 and to the distal end of panel 10 - 2 as more clearly shown in FIG. 1 . The means (hardware) for enabling pivotal motion between the parts of this invention, as herein called-for, may be of any type that is known to those of skill in the art, so that these means are not specifically described herein.
[0018] Still referring to FIG. 2 , rod 70 (the longer rod) is pivotally joined at its distal end 72 to the edge 12 of panel 10 - 1 at a proximal position 13 on the edge 12 . This same rod 70 is also pivotally joined at its medial point 73 to the edge 12 of panel 10 - 2 at its medial position 14 on the edge 12 . Finally, this same rod 70 is also pivotally joined at its proximal end 74 to a vertical hanger 100 and to a distal end of panel 10 - 3 . It is noted that rods 70 in this invention are pivotally joined at three points, a distal point 72 , a medial point 73 and a proximal point 74 . It is here noted that, as shown in the figures, points to the right of elements shown in the figures are referred to as “distal” and points to the left of elements shown in the figures are referred to as “proximal,” with points located between these two are referred to as “medial.” A further rod 70 has a relationship with panels 10 - 2 , 10 - 3 and 10 - 4 that is identical to the relationship previously described for above described rod 70 with panels 10 - 1 , 10 - 2 , and 10 - 3 . Finally, a further rod 80 is pivotally joined at its distal end 82 to the edge 12 of panel 10 - 3 at the proximal position 13 on the edge 12 , and is also pivotally joined at its proximal end 84 to panel 10 - 4 at its medial position 14 .
[0019] In summary, then, we see that the first panel 10 (leftmost or rightmost) in this second embodiment, is always hinged to the channels 20 , 50 using clamp-on hinges 90 and is hung from channel 20 in the manner described above for panel 10 - 1 using a hanger 100 . Also, we see that the last panel 10 (rightmost or leftmost) is always mounted as described above for panel 10 - 4 using a short rod 80 and a hanger 100 . Finally, we see that each of the remaining intermediate panels 10 that are mounted between the first panel 10 and the last panel 10 are mounted as described above for panels 10 - 2 and 10 - 3 using rods 70 and hangers 100 . As shown in the figures, the top of each of the panels 10 are sandwiched within channel stock edgings 15 . Assuming that the panels 10 are made of glass, as is preferable, such edgings 15 are necessary for pivotally mounting rods 70 and 80 and hangers 100 . However, when the panels 10 are made of a material, such as plastic, wood or metal, where such materials are better able to receive pivotal hardware structural engagements, the edgings 15 may not be necessary. In either case, when we refer above to the distal, medial and proximal ends of the “edge 12 ,” we are referring to either the bare upper or lower edge surfaces of the panel 10 itself, or alternately, to the up-facing ( FIG. 2 ), or down-facing ( FIG. 4 ) edge surface of the edgings 15 .
[0020] FIG. 3 shows upper channel 20 and its relationship with hangers 100 . Hangers 100 are L-shaped bars with wheels 110 mounted at their upper distal ends for rotating about the wheels 110 horizontal rotational axes. The wheels 110 are received by channel 20 and roll therein to afford the pivotal motion of the panels 10 as they fold between the closed and open attitudes, and when in the open attitude, panels 10 are able to be rolled into close adjacency with each other so as to take up relatively little space in the passageway 5 or to one side of it.
[0021] As shown in FIG. 4 , the lower ends of panels 10 are joined by rods 70 and 80 in an identical arrangement as described above for the upper ends of panels 10 . However, as shown, instead of joining the rods 70 and 80 to hangers 100 , spacers 120 are substituted and wheels 110 are rotationally mounted to the lower terminal ends of spacers 120 . As shown in FIG. 5 , the spacers 120 and their attached wheels 110 are positioned within channel 50 in order to control the bottom of the panels 10 so that they move in a straight lateral direction. Common hardware, such as nuts and threaded studs 130 are used to fasten channels 15 to panels 10 and to mount the rods 70 and 80 to the channels 15 . Other hardware is used to fasten the other parts of this invention together as would be within the normal skill of an individual versed in the art.
[0022] In some embodiments, in order to create a still firmer seal between adjacent panels when in the shut position, it may be advantageous to cover the vertical edges of the panels (often from top to bottom or at least a substantial amount, i.e. greater than 75%, of the length from top to bottom) with strips of a deformable material such as rubber or plastic (such as polyvinyl). This helps close any remaining openings between the panels, thus reducing the amount of water spray from the shower heads that can penetrate past the shower doorway.
[0023] The enablements described in detail above are considered novel over the prior art of record and are considered critical to the operation of at least one aspect of the apparatus and its method of use and to the achievement of the above described uses. The words used in this specification to describe the instant embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification: structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use must be understood as being generic to all possible meanings supported by the specification and by the word or words describing the element.
[0024] The definitions of the words or drawing elements described herein are meant to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for anyone of the elements described and its various embodiments or that a single element may be substituted for two or more elements in a claim.
[0025] Changes from the described subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalents within the scope intended and its various embodiments. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements. This disclosure is thus meant to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted, and also what incorporates the essential ideas.
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A segmented door for a shower stall, built within a fixed structural frame with a horizontal upper and lower channel. The door is constructed using a plurality (often four or more) of vertically disposed, side by side arranged, moveable panels that are hung from the upper channel by a plurality of moveable and pivoting wheeled hangers engaged with this upper channel. These moveable panels are connected to each other by a plurality of pivotally joined horizontal rods, which enables the moveable panels to move as a group. Often one of the moveable panels is joined to the upper and lower channel by clamp-on hinges, so that this panel is only able to move by pivoting. The moveable panels are able to move between an open door configuration and a closed door configuration, and can be designed with slight overlap so as to prevent shower spray from going beyond the panels.
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CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority of German application No. 10 2008 035 549.6 filed Jul. 30, 2008, which is incorporated by reference herein in its entirety.
FIELD OF THE INVENTION
[0002] The invention relates to a method for the production of angiography recordings. The aim of angiography is to map the vascular system for diagnostic purposes. The generation of angiographic images of the vascular system generally requires two recordings of the tissue under examination: one recording without a contrast medium, a so-called mask recording, and a second recording with a contrast medium in the vessels of the region to be recorded, a so-called contrast recording.
BACKGROUND OF THE INVENTION
[0003] The recordings can be produced with the aid of various recording methods:
Magnetic resonance tomography (MR angiography), Computed tomography (CT angiography), 3D angiography with C-arm angiography devices and/or X-ray projection (DSA, digital subtraction angiography).
[0008] The first three methods are cross-sectional or volume imaging methods, and the fourth method is a 2D projection method.
[0009] In addition to the imaging of vessels during angiography, the visualization of contrast medium accumulation in tissue, for example in order to measure cerebral blood volume (CBV), has an increasing role to play.
[0010] Since the contrast medium spreads out dynamically within the tissue and the vascular system, the point in time at which the second recording, the contrast recording, is made is of central importance.
[0011] Owing to the relatively small amounts of contrast medium in the tissue, an observation by a human analyzer is more difficult and the operating experience on the basis of which the timing of the contrast recordings could be set is still limited.
[0012] The second recording of an angiography, the contrast image, is usually triggered manually by the operator of the device, for example a radiologist, as described for example in U.S. Pat. No. 4,483,342, or after a delay that can be varied according to the injection, as described in U.S. Pat. No. 4,581,635. The delay is in turn set by the operator on the basis of empirical values.
[0013] DE 32 15 552 C1 describes a method for 2D projection images in which the optimal mask image, which lies shortly before the rise of the contrast medium by one pixel along the time-contrast medium curve, and the optimal contrast image, the image with the maximum contrast medium density, are determined automatically. The points in time of the two sought images are found on the time-contrast medium density curve with threshold methods.
[0014] U.S. Pat. No. 4,581,635 A describes in general terms x-ray angiography systems and digital subtraction angiography. This does not include the triggering of recordings by automatic tracking of bolus arrival at a target location, which forms the main part of our invention.
[0015] U.S. Pat. No. 5,459,769A describes a method of determining the optimal start time for the recording, but this method differs from our invention as follows:
1. Bolus arrival is monitored manually. We have described a fully automatic method. 2. Bolus arrival is determined with a time-contrast curve by means of a user-defined region of interest (ROI), whereas our method takes the whole image into consideration, thus making automatic calculation possible. 3. As the recording is linked to (many) user interactions, the method in D2 cannot be considered to be a triggering, which is the main idea of our invention.
SUMMARY OF THE INVENTION
[0019] The object on which the invention is based is to embody a method of the type described in the introduction such that an optimal triggering of the second recording for angiography or blood volume measurement can take place automatically.
[0020] This object is achieved according to the invention by means of a method having the following steps:
S1 Recording of a mask image with a first modality, S2 Starting an injection of contrast medium, S3 Recording of a control image with a second modality, S4 Image-based determination of the spreading of the contrast medium and analysis for the control of subsequent recordings, S5 Determining whether a recording criterion has been achieved and, if applicable, repeating steps S3 to S5, S6 Recording of a contrast image with the first modality, S7 Processing mask image and contrast image, and S8 Analyzing processing step S7.
[0029] An optimal selection of recording parameters and recording methods is made possible by the automatic triggering of the second recording of an angiography or blood volume measurement on the basis of the analysis of continuously recorded control images.
[0030] According to the invention a subtraction and/or an analysis can be performed in processing step S7, the analysis in accordance with processing step S7 possibly being a blood volume measurement.
[0031] It has proven advantageous for the control images to be produced with different recording parameters, for example a lower dose, than the mask image.
[0032] Advantageously the first modality can be a modality from the following group:
Magnetic resonance tomography (MR angiography), Computed tomography (CT angiography), 3D angiography (C-arm angiography) and/or X-ray projection (digital subtraction angiography (DSA)).
[0037] It is particularly advantageous if the recordings of the control images are produced using x-ray fluoroscopy.
[0038] According to the invention the analysis of processing step S7 in accordance with step S8 can be a visualization of a subtraction image.
[0039] The analysis according to step S8 of the processing of mask image and contrast image according to step S7 can advantageously be an automatic analysis of a subtraction image.
[0040] It has proven advantageous for the total amount of contrast medium in the volume being observed to be determined as the recording criterion according to step S5 for the degree of spreading of the contrast medium.
[0041] In the case of 3D imaging methods it has proven expedient for the amount of contrast medium in the volume being observed to be determined as the recording criterion according to step S5 by summation of the grayscale values across all volume elements.
[0042] In the case of projection methods, as a recording criterion according to step S5 for the degree of spreading of the contrast medium it is advantageous for the intensities of I f and I m of the mask and contrast-control image to be subtracted from each other and summated across all pixels X in accordance with the following formula:
[0000]
F
(
t
)
=
∑
x
=
0
N
(
ln
I
f
(
x
,
t
)
-
ln
I
m
(
x
,
t
)
)
[0043] According to the invention the exceeding of a specified threshold by the volume of contrast medium can constitute the recording criterion according to step S5 for the contrast image.
[0044] Alternatively the criterion that the volume of contrast medium increases no further can be selected as the recording criterion according to step S5 for the contrast image.
[0045] The recording parameters and/or the recording method can be determined advantageously as a function of the analysis according to step S4 for controlling subsequent recordings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] The invention is described below in more detail with reference to exemplary embodiments shown in the drawing, in which:
[0047] FIG. 1 shows a known x-ray C-arm system with an industrial robot as a support apparatus.
[0048] FIG. 2 shows from an axial viewing direction a view of the orbit of a detector and a radiation source according to FIG. 1 about an object to be examined,
[0049] FIG. 3 shows the flow of the method according to the invention,
[0050] FIG. 4 shows the trend in the volume of contrast medium as functions F(t) over time t, and
[0051] FIGS. 5 to 7 show different possible combinations of different recording technologies.
DETAILED DESCRIPTION OF THE INVENTION
[0052] FIG. 1 shows an x-ray diagnostic device for generating C-arm CT recordings, said device having a C-arm 2 mounted rotatably on a stand in the form of an industrial robot 1 , with said C-arm having an x-ray radiation source, for example an x-ray emitter 3 , and an x-ray image detector 4 arranged at its ends.
[0053] The x-ray image detector 4 can be a rectangular or square, flat semiconductor detector that is preferably made of amorphous silicon (a-Si).
[0054] A patient 6 to be examined is positioned on a patient positioning couch 5 in the path of the radiation beam of the x-ray emitter 3 for the recording of a heart for example. A system control unit 7 with an imaging system 8 is connected to the x-ray diagnostic device, said imaging system 8 receiving and processing the image signals of the x-ray image detector 4 . The x-ray images can then be viewed on a monitor 9 .
[0055] By means of the industrial robot 1 known for example from DE 10 2005 012 700 A1, which preferably has six axes of rotation and thus six degrees of freedom, the C-arm 2 can be displaced spatially as required, being rotated for example about a center of rotation between the x-ray emitter 3 and (including) the x-ray detector 4 . The x-ray system 1 to 4 according to the invention is rotatable in particular about centers of rotation and axes of rotation at the plane of the x-ray image detector 4 , preferably about the center of the x-ray image detector 4 and about axes of rotation intersecting the center of the x-ray image detector 4 .
[0056] If 3D data sets are to be produced in accordance with the so-called DynaCT method known for example from the pamphlet “AXIOM Artis FD Systems/DynaCT—A Breakthrough in Interventional 3D Imaging” by Patrick Kurp, a “Reprint from Medical Solutions, January 2005, pages 46-51”, order number A91100-M1400-D105-1-7600, print reference CC 66105 SD 12043, the rotatably mounted C-arm 2 with x-ray emitter 3 and x-ray image detector 4 is rotated such that, as shown schematically in FIG. 2 by the aerial view of the axis of rotation, the x-ray emitter 3 (represented here figuratively by its beam focus) and the x-ray image detector 4 move in an orbit 10 about an object 11 to be examined. In order to produce a 3D data set the orbit 10 can be full or partial.
[0057] In accordance with the DynaCT method the C-arm 2 with x-ray emitter 3 and x-ray image detector 4 preferably moves about an angular range of at least 180°, for example 180° plus fan angle, and records projection images in rapid succession from various projections. The reconstruction can be performed using just one section of this recorded data.
[0058] The object 11 to be examined can be for example an animal body or a human body or indeed a phantom body.
[0059] The x-ray emitter 3 emits a beam of radiation 12 originating from a beam focus of its x-ray radiation source, said beam striking the x-ray image detector 4 .
[0060] The x-ray emitter 3 and the x-ray image detector 4 each move about the object 5 such that the x-ray emitter 3 and the x-ray image detector 4 are positioned at opposite sides of the object 11 .
[0061] In normal radiography or fluoroscopy by means of an x-ray diagnostic device of this type the medical 2D data of the x-ray image detector 4 may be buffered in the imaging system and subsequently displayed on the monitor 9 .
[0062] FIG. 3 illustrates the steps involved in producing an angiography recording. In the first step S1 a mask image is recorded. These recordings can have been produced with the aid of the following recording methods, for example:
Magnetic resonance tomography (MR angiography), Computed tomography (CT angiography), 3D angiography (C-arm angiography) and/or X-ray projection (digital subtraction angiography (DSA)).
[0067] The injection of contrast medium commences in the second step S2. Next a control image is recorded in the third step S3 by means of x-ray radiation. In the fourth step S4 an image-based determination of the spreading of the contrast medium is performed in this control image. In the subsequent fifth step S5 it is determined whether the recording criterion has been achieved. If this is not the case, a recording of a control image is performed in addition to that recorded in step S3, until the recording criterion is achieved. If this is the case a contrast image is recorded in the sixth step S6, which image is fed in the seventh step S7 to a subtraction function in which the mask image produced in the first step is subtracted from the contrast image. In the eighth step S8 a visualization is finally output on a display or an automatic analysis of the subtraction image is performed.
[0068] The recording criterion mentioned in FIG. 3 can be for example that the volume of contrast medium, the trend of which is shown in FIG. 4 as functions F(t) over time t, exceeds a specified threshold. This can be for example the threshold S that has been achieved at the time t 1 . However the recording criterion can also be fulfilled if the volume of contrast medium does not increase any further, as is the case at time t 2 .
[0069] By means of the method according to the invention the contrast recordings of an angiography, based on the image-based analysis of control images, can be triggered automatically.
[0070] A method of this type has the following advantages:
Patient-specific variances in the spreading of the contrast medium are taken into consideration and consequently the number of erroneous recordings is reduced, Manual test injections can be avoided in particular in the case of venous injections, since a more precise and more rapid determination of the spreading of the contrast medium can be achieved than is the case by human observers, and Newer sensitive recording methods are made possible as a result, for example the measurement of cerebral blood volume (CBV).
[0074] The method according to the invention is conceivable in the widest possible range of combinations of recording technologies, such as those specified schematically by way of examples in the following three combinations.
[0075] FIG. 5 represents a first example of a recording technology. The mask image is produced by means of C-arm CT. The control image is monitored using fluoroscopy. The contrast image is in turn recorded by means of C-arm CT and the result is a recording in 3D angiography.
[0076] FIG. 6 shows a second example of a recording technology. A C-arm CT recording is again used as the mask image. The control is again performed by means of fluoroscopy. The contrast image is also a C-arm CT recording. However no subtraction image is produced from these images, but instead the spreading of the contrast medium is determined and a measurement of the cerebral blood volume (CBV) is performed.
[0077] FIG. 7 illustrates an example of a further recording technology. In this case an x-ray projection is used as the mask image. The control images are again produced by means of fluoroscopy. An x-ray projection is used as a contrast image, the result of which is a normal angiography recording.
[0078] The method according to the invention serves for automatically triggering the second recording of an angiography or blood volume measurement on the basis of the analysis of continuously recorded control images. Here the control images can be generated using different recording parameters (for example a lower dose) or a completely different recording method (for example x-ray fluoroscopy to record a control image for 3D angiography) than the angiography recordings themselves. The aim here is to generate the control images using a method that enables the spreading of the contrast medium to be determined within the best possible time interval and with minimal exposure for the patient (e.g. in terms of x-ray dose), and consequently to identify the ideal time for the angiography recording, which is then performed using a method that provides the best possible answers to the clinical questions.
[0079] The sequence of steps according to the invention for producing the angiography recording is as follows:
Recording of a mask image, Starting the injection of contrast medium, Image-based determination of the spreading of the contrast medium, Recording of a contrast image, Subtraction of the mask image and contrast image, and Visualization or automatic analysis.
[0086] The total amount of contrast medium in the volume being observed can be determined as a criterion for the degree of spreading of the contrast medium.
[0087] In the case of 3D imaging methods the amount of contrast medium in the volume being observed can be determined by summation across all volume elements, if it is assumed that the grayscale values of a voxel have a linear relationship with the concentration of contrast medium.
[0088] On the other hand, in the case of projection methods the intensities of I f and I m in the mask image and contrast image are subtracted from each other and summated across all pixels X:
[0000]
F
(
t
)
=
∑
x
=
0
N
(
ln
I
f
(
x
,
t
)
-
ln
I
m
(
x
,
t
)
)
[0089] The sum F then corresponds to the amount of contrast medium except for an unknown multiplicative constant. Depending on the type of imaging the constant can be determined analytically, by simulation or by calibration measurements.
[0090] The recording criterion for the contrast image can be for example that the volume of contrast medium exceeds a specified threshold (see figure, time t 1 ) or that the volume of contrast medium increases no further (see figure, time t 2 ).
[0091] In the method according to the invention a control of subsequent recordings (in terms of parameters and recording methods) takes place as a function of the analysis. The online analysis of an “x-ray image being observed” is used to control the timing of the actual “recordings”. Not only different recording parameters but also entirely different recording methods can be used here. Provision is made in particular for the combination of 2D and 3D methods, examples of which are given in the following table.
[0000]
Online observation -
Recording -
control image
mask image and contrast image
2D x-ray examination -
3D rotation scan -
fluoroscopy
C-arm CT
MR angiography
MR angiography
CT fluoro
CT spiral scan
2D ultrasound
3D rotation scan
2D ultrasound
MR angiography
2D ultrasound
CT spiral scan
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The invention relates to a method for the production of angiography recordings. First, a mask image is recorded with a first modality. A contrast medium is injected after the first recording. A control image is recorded with a second modality after the injection of the contrast medium. A spreading of the contrast medium is determined based on the images and the control of subsequent recordings is analyzed. A recording criterion is checked to determine whether the recording criterion has been achieved. If it has not been achieved, the control image is repeatedly recorded for repeatedly determining the spreading of the contrast medium. If it has been achieved, a contrast image is recorded with the first modality and the mask image and the contrast image are processed and analyzed.
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BACKGROUND OF THE INVENTION
[0001] 1. Technical Field
[0002] The present invention generally relates to an airflow diverter. More specifically, the present invention relates to an aquarium airflow diverter.
[0003] 2. Description of Related Art
[0004] Air stones are employed frequently for aerating the water of an aquarium to provide oxygen for fish and other marine life that may be present in the aquarium. The air stone is constructed of a body of porous material through which air can propagate. In a typical installation in an aquarium the air stone is connected via a flexible air tubing to an air pump located outside of the aquarium. The pump pumps air via the tubing into the air stone. The air stone then disperses the air to form a stream of bubbles that migrate upwardly through the water. The air stone can also be placed within the lift tube of an aquarium undergravel filter to allow an entrained stream of bubbles to draw water through the lift tube and, thereby, circulate water through the filter.
[0005] The construction of the air stone permits its use in situations, other than that of the fore-going aquarium, in which it is desired to disperse a gas within a fluid. However, for purposes of demonstrating the use of the invention, it is presumed that the air stone is to be employed for aeration of water in an aquarium.
[0006] A problem arises in the construction of air stones in that air forced into the stone tends to propagate through a portion of the porous material of the stone located generally in the vicinity of the air inlet to the stone, while the remaining portion of the body of porous material is essentially inactive in the process of dispersing the air. As a result, there is a significant diminution in the esthetic appearance to the paths of bubbles emanating from the air stone because the bubbles emanate only from the upper portion of the stone rather than emanating uniformly from the entire exterior surface of the stone. In addition, there is usually a mineral build up at the end of the air inlet into the stone that starts to clog after a while. Also, since the path of air is only through the upper part of the stone, the underutilization of the lower portion of the air stone results in a more rapid clogging and wearing of the upper portion of the air stone resulting in a more frequent need for replacing the air stone.
[0007] It would therefore be useful to develop a device for altering the flow of air from an air stone. It would also be useful to develop a device that improves the appearance of the air stone, thus making the air stone more attractive.
SUMMARY OF THE INVENTION
[0008] According to the present invention, there is provided a method of altering airflow of an aquarium air supply by placing a bottle over the air supply and altering the airflow. Also provided is a decorative attachment assembly for use in an aquarium. The assembly including a bottle having at least a first hole and a second hole, wherein the first hole is capable of accepting an aerating device, and the second hole is of a size sufficient to allow air to flow from the aerating device into the aquarium.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Other advantages of the present invention are readily appreciated, as the invention becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:
[0010] [0010]FIG. 1 shows the bottle of the present invention; and
[0011] [0011]FIG. 2 shows a side view of the bottle of the present invention positioned at an angle within the aquarium.
DETAILED DESCRIPTION OF THE INVENTION
[0012] Generally the present invention provides a method and device for altering the airflow in an aquarium. The present invention also provides a device for covering an air stone. The device is preferably an attractive bottle 10 that disguises the presence of the air stone while directing the flow of air from the air stone in a desired direction.
[0013] It is well known to those of skill in the art that aerating devices are used in aquariums. One problem with such aerating devices is that they do not evenly distribute the flow of air bubbles and are unattractive to view in the aquarium. Since many individuals who have aquariums in their homes include in the aquariums other display pieces for making the aquarium more attractive, it is more desirable to have a product that is capable of at least partially blocking the view of the aerating device and any filters associated therewith. The present invention accomplishes this by covering the aerating device with a bottle 10 or other container capable of having a first hole 12 and a second hole or spout 14 spaced therefrom. The aerating device is placed within the bottle 10 and the air is allowed to escape from the top of the bottle 10 .
[0014] The airflow altering device is preferably a bottle 10 . The bottle 10 is placed within the aquarium and the aerating device is placed within the bottle 10 . The bottle 10 is then partially buried in the gravel found on the bottom of the aquarium. This can be at any angle desired by the individual placing the bottle 10 . Thus the bottle 10 can appear to be part of buried treasure or can be standing upright within the aquarium.
[0015] The bottle 10 can be any type of bottle. The bottle 10 can be made from glass, plastic, or of any other material that can withstand the rigors of a water environment. Examples of such bottles can be liquor bottles, wine bottles, decorative bottles, or artistic bottles available to individuals. The bottle 10 of the present invention can be of any color that glass can be formed, it can be clear, opaque, or completely tinted thus preventing light to shine through. Therefore, any bottle can be utilized. All that is required is that the bottle 10 be able to withstand having a hole made in the bottle 10 that enables the insertion of an aerating device into the bottle 10 .
[0016] The bottle 10 of the present invention includes at least two holes. The first hole 12 is a hole into which an aerating device is placed. The first hole 12 is typically located at the base of the bottle 10 . Alternatively, the first hole 12 can be located anywhere on the bottle 10 that will be in close proximity to the bottom of the aquarium in which the bottle 10 is placed. In other words, the bottle is modified so that there are two holes in the bottle while not altering the general appearance of the bottle. The bottle 10 is not required to have an actual base, therefore if one does not wish to drill a hole, they can remove the bottom of the bottle 10 and the aerating device can be placed into the bottle 10 from the lack of base. The second hole 14 is at the end of the bottle 10 that is facing upward. It is through the second hole or spout 14 that the air bubbles are allowed to escape, thus aerating the aquarium.
[0017] The aerating device can be any aerating device known to those of skill in the art. Such a device can be as simple as a hose pumping air into the aquarium to an air stone or more complicated system. The air stone that can be used in conjugation with the present invention can be any aerating device that is known to those of skill in the art. The aerating device is typically continually connecting to an aerating processor through an airline tubing. The aerating processor maintains a constant flow of air to the aerating device thus maintaining the proper aeration of the water present in the aquarium. An example of such an aerating device can be used in an aquarium as disclosed below.
[0018] An aerating device can be used in aquarium tank constructed of transparent glass walls and holding water for support of marine life. A layer of gravel is typically disposed on a bottom wall of the tank. An air stone rests upon the gravel, and is connected by a connector to an air inlet conduit constructed as flexible plastic tubing. An air pump located outside of the tank is connected to the tubing for pumping air into the air stone. The air stone is fabricated of a porous material that is held together by cement, such as a one part acrylic adhesive material. The air stone is permeable to air. The density of the air stone can be varied. However, generally, the greater the density the more air pressure will be needed. Air delivered by the pump through the tubing permeates through the pores of the material of the air stone to be dispersed and to emit bubbles along the outer surface of the air stone. The bubbles migrate upwards through the water to aerate the water and to introduce a movement to the water by virtue of entrainment of the bubbles within the water.
[0019] An under gravel aquarium filter is installed in the bottom of the aquarium tank. The filter comprises a perforated plate having depending leg portions along the outer edges of the plate for supporting the plate parallel to and spaced apart from the bottom wall to form therewith a chamber. A layer of gravel is disposed along the top surface of the perforated plate. An airlift tube submerged within the water is oriented vertically, and passes through the layer of gravel to be seated within an aperture of the plate. The aperture allows the tube to communicate with the chamber. The air stone with the air-supply tubing are disposed within the lift tube with the air stone being located adjacent the bottom of the lift tube.
[0020] In operation of the filter, bubbles emanate from the air stone, become entrained in a column of water within the lift tube, and introduce an upward flow of water within the lift tube as the bubbles migrate upwards through the lift tube. As the water flows upward through the lift tube, water from the chamber enters the bottom of the lift tube, and other water from the central region of the tank moves downward through the layer of gravel and through perforations of the plate into the chamber. Thus, there is circulation of water about the tank, with circulated water passing through the filter to produce clear water within the chamber. The gravel and the perforated plate serve to filter debris and pollutants from the aquarium water while the air stone aerates the water to provide oxygen for marine life which may be placed in the aquarium tank.
[0021] The bubbles emanate from the upper portion of the air stone in the vicinity of the air output of the stem. This occurs because the propagation path of air through the porous material as shown by the arrows is relatively short in the vicinity of the stem, and relatively long in a direction downward from the stem towards the bottom of air stone. Resistance to passage of air through the porous material of the stone increases with propagation distance. Thus, all or nearly all of the bubbles appear in the upper portion of the stone while virtually no bubbles appear at the lower portion of the stone.
[0022] The extent from which the bubbles leave from the exterior surface of the air stone depends upon a combination of factors including the density of the air stone and the amount of air pressure supplied. For a denser air stone, and with sufficient air supply, bubbles can be forced to leave from a lower portion of the air stone. However, this requires considerable additional pressure that is often not available in aquarium systems. This is especially a problem where large air stones are utilized. Frequently, such large air stones are desirable in order to keep the air tubing down and prevent it from bobbing upward. However, with such large air stones being very dense, the amount of air pressure required to drive the air out of the lower portions of the air stone becomes impractical to achieve with regular air pumps and, would tend to damage the air pump if driven so hard. Accordingly, typically with standard air stones the bubbles only leave from the upper part of the air stone.
[0023] This presents a poor aesthetic appearance to the air stone. Additionally, since only the upper portion is being utilized, it tends to clog and once it clogs, it retards the flow of air. It also presents a non-uniform utilization of the material of the air stone since the bottom half is hardly used. This becomes a further problem since at the exit of the stem, there tends to be a mineral build-up as a result of the content of the water and this further clogs the flow of air so that after a while the standard air stone becomes a poor supply of air to the aquarium tank.
[0024] In the construction of the air stone, the stone comprises a cylindrical sidewall that encloses and defines the chamber, and a lower end wall, which closes off the lower end of the chamber. Preferably, the thickness of the lower end wall is equal to the thickness of the sidewall so as to provide for equality of propagation paths for air propagating from the chamber through the porous material of the stone. This enables the air to exit in dispersed fashion as the bubbles from an outer surface of the stone.
[0025] In inserting the stem into the port of the chamber, the stem is coated with a barrier layer, typically adhesive material and secured within the chamber. The adhesive material can be of the same type of cement that is used to retain the air stone material together which can be a one part acrylic material without the use of any catalyzers. The entire length of the stem is coated and then inserted into the chamber. However, as will be described hereinafter, the extent of the coating can vary dependent upon the density of the air stone material.
[0026] As a result of the barrier layer, the flow of air it receives a greater resistance to flow in the upper half of the air stone material. As a result, the air leaving from the stem enters into the plenum formed within the chamber and disperses through the walls of the air stone in the lower half of the air stone. Because the sidewalls and bottom wall thickness of the air stone material surrounding the plenum is substantially equal, air will leave equally from the sidewalls below the stem and the bottom wall.
[0027] The invention has been described in an illustrative manner, and it is to be understood that the terminology that has been used is intended to be in the nature of words of description rather than of limitation.
[0028] Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is, therefore, to be understood that within the scope of the appended claims, the invention can be practiced otherwise than as specifically described.
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A method of altering airflow of an aquarium air supply by placing a bottle over the air supply thus, altering the airflow. The method can be accomplished using a decorative attachment assembly that covers an air stone in an aquarium. The assembly includes a bottle having at least a first hole and a second hole, wherein the first hole is capable of accepting an aerating device, and the second hole is sized to allow air to flow from the aerating device into the aquarium.
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FIELD OF THE INVENTION
This invention relates to a water purification system which incorporates a double pass reverse osmosis membrane assembly for filtering pretreated water and to a method of operating such a system.
BACKGROUND OF THE INVENTION
A typical prior art water purification system is illustrated in FIG. 1 . Feed water is pretreated at 20 and fed to a first storage tank 22 prior to heating in a heat exchanger 24 to a specified membrane operating temperature, typically 25° C. Pre-treatment equipment, which is based on the potable source water quality, typically comprises a multimedia filter to remove particulates, a softener to remove mineral scale, a carbon filter to remove chlorine/chloramines or a chemical injection system using a bisulphite type chemical, possibly a UV station for bacteria kill, and prefilters (1-10 μm) to remove particulates prior to the water entering the reverse osmosis system. After some chemical additions 26 , the water is fed to a reverse osmosis membrane assembly 28 and the purified water is treated with ultraviolet light in a first UV station 30 , deionized at deionization station 32 , treated in a second UV station 34 , and passed through a first sterilizing filter 36 before being fed to a second storage tank 38 . Water is drawn from the second storage tank 38 at various points of use generally indicated by reference numeral 40 after appropriate treatment including a third UV station 42 , a second sterilizing filter 44 and a second heat exchanger 46 to maintain ambient temperatures. Water from the second storage tank 38 is also recirculated through an ozonation system 48 with a pump 50 to reduce bacterial growth. An alternative microbial control design may include a heat exchanger for periodic heat sanitization.
It will be seen from FIG. 1 that excess reject water from the reverse osmosis membrane assembly 28 is drawn through pump 52 to be recirculated to the reverse osmosis membrane assembly 28 while the balance of the reject water is sent to drain. Operation of the system is controlled with a central programmed logic controller (PLC) indicated at 54 .
The system is quite complicated in that it has many technologies to monitor and control. The majority of these types of systems are custom built due to the variability of source water and the intricacies of different production demands. With the current approach in the industry, a human operator cannot control and monitor all of the variables to a satisfactory level. This necessitates an expensive PLC control system. The PLC system is also custom designed due to the above considerations. The complexity of this system dictates long lead times for delivery of the equipment. Once the equipment is placed at location, a long process is employed to adjust all of the technologies in order to maintain the desired water quality. Regular cleaning and sanitization must be performed on the equipment to ensure microbial integrity. Due to the variety and complexity of equipment employed, the maintenance is high. If one piece of equipment fails, the water production process ceases. Depending on the location of the failure, it may dictate sanitization of the equipment or system prior to placing it back into service. This represents lost production time. The complexity of the equipment dictates a thorough investigation and testing prior to releasing the system for production. High-energy input is required to temper the water (increase to 20-25° C.) to feed the system and meet reverse osmosis membrane specifications. In addition, high energy consumption and labour are required to maintain the system within specifications. The percent of water recovery or yield is low, being typically 60 to 75 percent of the system's demand.
Microorganisms, specifically bacteria, form biofilm, which is an extra-cellular organic polymer (polysaccharide in nature). Biofilm can also incorporate divalent metal ions that can form a lattice structure consisting of both organic and inorganic mass. This structure protects the organisms from sanitization and cleaning chemicals. Once this formation develops within a system it is very difficult to remove.
The storage tank is a grower of microorganisms unless an ozonation system is applied. This option is capital intensive and has associated operating and maintenance expenses. In addition ozone is a hazardous substance requiring appropriate safety precautions. Ozone is an added substance to the purified water in order to control the microbial integrity. In systems not employing ozone, the microbes will settle onto the tank surface, due to little movement of water (no velocity), and produce biofilm. Free-floating (planktonic) organisms will reproduce and contaminate the distribution system. Biofilm will protect the organisms from chemical sanitization and allow them to reproduce. Chemical sanitization will be reduced in effectiveness. Systems employing heat sanitization are capital and energy intensive and do not remove biofilm.
The typical prior art water purification system is not designed to prevent the growth of microbes. The approach has been to allow the microbial population to increase to a certain range in numbers, then to clean and/or sanitize the system, thus reducing the microbial population. Microbiological procedures require an incubation period of approximately two days or longer prior to enumeration. The delay in results can have the system out of specification for microbial numbers prior to cleaning and sanitizing. Alternatively, a high frequency scheduled cleaning and/or sanitization regimen is implemented to reduce the possibility of the microbial numbers exceeding specification. This approach is labour and energy intensive and prevents the use of the system while the procedures are being conducted. The design of the prior art does not inherently reduce or prevent the growth of microorganisms during the water purification process.
Various attempts to regulate the conductivity of high purity product water have been described in the prior art. A major problem identified in a double pass reverse osmosis system is the difficulty in rejecting gases such a carbon dioxide. Carbon dioxide present in the feed water will pass through the first pass membranes and the second pass membranes forming carbonic acid and the corresponding equilibrium equation products which result in increased conductivity of the product water. This phenomenon is viewed negatively by the prior art since the increase in conductivity is perceived as decreasing the quality.
The following equations express the carbonic acid formation and equilibrium:
Carbonic acid formation
Carbonic acid equilibrium
It is noted that the formulas were not reproduced in the form in which they were filed. The arrows are missing. If necessary, they may be replaced by equal signs.
Methods attempted for removing carbon dioxide are described in several US patents some of which are discussed below. In U.S. Pat. No. 4,574,049 and U.S. Pat. No. 5,997,745 an alkaline agent is added between the first and second pass to convert the carbon dioxide gas to carbonate which is rejected by the second pass membranes. Addition of an alkaline is used prior to the first pass in conjunction with an acid to the second pass with or without a gas liquid separation module in U.S. Pat. No. 5,766,479. Gas removal by hydrophobic gas permeable membrane contactors is described in patents U.S. Pat. No. 5,156,739 and U.S. Pat. No. 5,670,053. Removal by a forced draft decarbonator and a vacuum degasifier is explained in U.S. Pat. No. 5,338,456 and U.S. Pat. No. 5,250,183. Removal by a forced/induced draft decarbonator before or after a two pass reverse osmosis system is disclosed in U.S. Pat. No. 5,925,255. One solution described in U.S. Pat. No. 6,258,278 is to first treat feed water with a strong base anion resin and subsequently removing carbon dioxide in order to maintain a high pH of 6 to 9.5. U.S. Pat. No. 6,080,316 and U.S. Pat. No. 6,126,834 describe the use of caustic injections to adjust the pH of the infeed water that is controlled by a PLC based on resistivity measurements of the product water. These patents plus others describe a removal process for CO 2 or methods of preventing the CO 2 from ending up in the product water. These patents view the increase in conductivity due to the presence of CO 2 in the product water negatively.
Prior art water purification systems are typically designed to produce the purified water at a defined rate. It is usually based on the maximum required water volume demand during a period of time (hour, shift, day or number of dialysis machines, etc.). To this rate a storage tank can be sized to provide this maximum rate with a minimum buffer volume of approximately 20 percent. The systems cannot vary their production rate by more than a few percentages of the original designed rate.
The object of the invention is to provide a better means of producing water that will meet the specifications of Purified Water and Water for Injection as defined by the United States Pharmacopeia Convention Inc. (as defined but not limited to the current edition XXV) and water for dialysis as defined by the American Association for Advancement of Medical Instrumentation (AAMI).
The invention provides a means of purifying water that supplies the purified water to the point or points of use to allow the water to be drawn immediately on demand. The water that is not used immediately is recycled and repurified to ensure continuous quality.
Another object of the invention is to provide purified water directly to the point or points of use without the requirement for a storage and distribution system. The means of providing the water directly to the point of use is an integral part of the purification process.
The invention's objective is to provide purified water having very low microbial counts. Still another object of the invention is to provide a means of purifying water, which is not conducive to growth of microorganisms within the purification process.
In addition, the object of the invention is to provide a means of removing microorganisms that may grow within the purification process.
The object of the invention is also to provide variable production rates to meet variable demand requirements. In addition this saves energy and water.
It is another object of the invention to provide a means to self-clean the purification system of mineral scale and microorganisms.
Still another object of the invention is to allow the system to self-purge itself of purified water that does not meet the conductivity or temperature parameters.
The objects of this invention include providing a water purification system, which can be operated to produce high purity water at a reduced capital cost investment and with lower operating costs.
SUMMARY OF THE INVENTION
Sanitation and cleaning of the system is done by controlling the pH so that it is normally acidic in contrast to prior art systems and this is done naturally without any acid additions by maintaining a high carbon dioxide concentration in solution, the carbon dioxide being concentrated into the permeate from a reverse osmosis membrane assembly used to purify the water. To increase pH to neutral values for end uses, or reduce the conductivity of the purified water by that contributed by the CO 2 , a base may be added or carbon dioxide may be allowed to escape from solution.
BRIEF DESCRIPTION OF THE DRAWINGS
In order to better understand the invention, illustrative embodiments of a water purification system are described below with reference to the accompanying drawings, in which:
FIG. 1 is a schematic flow diagram showing a typical prior art water purification system including a single pass reverse osmosis membrane assembly and a distribution system including a storage tank;
FIG. 2 is a schematic flow diagram showing a water purification system according to the invention and including a double pass reverse osmosis membrane assembly with points of use and operating at a cold temperature;
FIG. 3 is a schematic flow diagram showing a water purification system according to the invention and including a double pass reverse osmosis membrane assembly with points of use and operating at a hot temperature, or to be operated cold and to be periodically hot water sanitized;
FIG. 4 is a schematic flow diagram showing a water purification system according to the invention and including a double pass reverse osmosis membrane assembly with points of use and operating at a cold temperature and having a serpentine loop return after the purification system for continuous circulation in the loop;
FIG. 5 is a schematic flow diagram showing a water purification system according to the invention and including a double pass reverse osmosis membrane assembly with points of use and operating at a hot temperature and having a serpentine loop return for recirculated excess permeate not used at points of use;
FIG. 6 is a schematic flow diagram showing a water purification system according to the invention and including a double pass reverse osmosis membrane assembly with points of use and operating at both hot and cold temperatures;
FIG. 7 is a schematic flow diagram showing a water purification system according to the invention which is similar to the system drawn in FIG. 2 but which includes small degasification modules for sampling a fraction of product water;
FIG. 8 is a schematic flow diagram showing a water purification system according to the invention which is similar to the system drawn in FIG. 2 but which includes a large degasification module for removing CO 2 from all of the product water;
FIG. 9 is a schematic flow diagram showing a water purification system according to the invention which is similar to the system drawn in FIG. 2 but which includes a large degasification module for removing CO 2 from all of the product water in association with an eductor for returning CO 2 into the system upstream from a first reverse osmosis membrane assembly;
FIG. 10 is a graph showing the reduction in pH over time of the water circulating onto first pass reverse osmosis membranes when the system is operated in idle or circulation mode;
FIG. 11 is a graph showing the reduction in conductivity over time of the water circulating onto first pass reverse osmosis membranes when the system is operated in idle or circulation mode; and
FIG. 12 is a graph showing the reduction in alkalinity over time of the water circulating onto first pass reverse osmosis membranes when the system is operated in idle or circulation mode.
DESCRIPTION OF THE INVENTION
In its simplest embodiment, a water purification system in accordance with the invention and indicated generally by reference numeral 60 in FIG. 2 , has purified water (permeate) drawn directly from the purification process at points of use generally indicated by reference numeral 62 without any previous storage in a tank or locations where water will stagnate and be susceptible to bacterial growth.
The feed water is fed to appropriate pretreatment at 64 and optionally has its pH adjusted to a basic condition through the addition of sodium hydroxide (NaOH) at 66 whereafter it is passed through a first ultraviolet radiation treatment station 68 prior to being pumped with a variable speed pump 70 to a first reverse osmosis membrane assembly 72 .
The permeate from the first reverse osmosis membrane assembly 72 is fed to a second reverse osmosis membrane assembly 74 and its permeate is passed through a second ultraviolet radiation treatment station 76 before being drawn at various points of use 62 , as required. Excess permeate water not used at the points of use 62 , and a major portion of the reject water from both the first reverse osmosis membrane assembly 72 , and all of the reject water from the second reverse osmosis membrane assembly 74 is recycled through the first reverse osmosis membrane assembly 72 after passing through the first ultraviolet radiation treatment station 68 . The ultraviolet radiation treatment sterilizer station 68 is used to reduce the incoming microbial load from the pretreated source water and circulation water prior to entry into the first pass reverse osmosis membrane assembly 72 while the second ultraviolet radiation treatment sterilizer station 76 is used to kill organisms that will eventually grow on the downstream side of the membrane of the second reverse osmosis membrane assembly 74 .
The invention is characterized by the absence of a storage tank, which would otherwise provide fertile ground for microbial growth and contamination of permeate. This is rendered possible by appropriate design selection of the supply capacity to maintain an approximate minimum velocity of 3 ft/sec. (1 meter/sec.) and usually 5 to 7 ft/sec (2 meters/sec.) and by operating the system to keep the permeate in circulation. A minimum velocity to maintain a continuous turbulent flow condition within the piping is known to be approximately 3 ft/sec (1 meter/sec). Conveniently, maintaining a minimum turbulent velocity will reduce the growth of microorganisms and prevent the formation of biofilm on the walls of the point of use piping.
System production rate is designed based on the expected draw off demand and the appropriate serpentine pipe size with the corresponding velocity. Assuming an average pipe velocity of 6 ft/sec., systems can be built with common pipe sizes as follows:
1/8″ pipe (3.0 mm)
0.2 US gpm (0.85 Lpm)
{fraction (3/16)}″ pipe (4.8 mm)
0.5 US gpm (2.1 Lpm)
¼″ pipe (6.2 mm)
0.9 US gpm (3.8 Lpm)
⅜″ pipe (9.6 mm)
2.0 US gpm (8.5 Lpm)
½″ pipe (12.5 mm)
3.6 US gpm (15.0 Lpm)
¾″ pipe (19.0 mm)
8.0 US gpm (34.0 Lpm)
1.0″ pipe (25.4 mm)
14.5 US gpm 60.0 Lpm)
1.25″ pipe (32.0 mm)
23.0 US gpm (95.0 Lpm)
1.5″ pipe (36.0 mm)
32.0 US gpm (135.0 Lpm)
2.0″ pipe (51.0 mm)
60.0 US gpm (240 Lpm)
2.5″ pipe (64.0 mm)
90.0 US gpm (380 Lpm)
3.0″ pipe (76.0 mm)
130 US gpm (550 Lpm)
3.5″ pipe (90.0 mm)
180 US gpm (750 Lpm)
4.0″ pipe (100 mm)
230 US gpm (950 Lpm)
Etc.
The required maximum demand at the points of use 62 would first be found. As an example, 30 US gpm. (120 Lpm) are required at the point of use on a continuous basis. In order to maintain an approximate minimum velocity of around 3 ft./sec. (1 meter/sec.) on the loop return, a system would have to produce 2 times the continuous amount required at the point of use. This would dictate a 2″ (51 mm) distribution loop and an average production rate of around 60 US gpm. (240 Lpm).
The invention is typically designed with a surface area of the first pass having 1.5 to a maximum of 3 times the surface area of the second pass membranes, but most usually 2 times. Ideally the first pass membrane flux (flow rate per unit surface area per unit time) is in a range of 10 to 20 gallons per square foot per day (406 to 812 litres per square meter per day). The water feed flow to the first pass membranes is typically a minimum of 3 times the average production rate from the second pass reverse osmosis assembly 74 to provide high cross flow that will reduce fouling of the membranes.
EXAMPLE
A phenomenon was discovered that produced two effects. The system is generally run in two different modes of operation. The “production mode” is defined when water is being drawn from the system. The “circulation or idle mode” of operation occurs when no water is being drawn off at the points of use. All water, except for reject water, is recirculated and repurified. A system of the same design as shown in FIG. 2 was operated for 30 minutes in production mode (water drawn from the system) under different product recovery levels (80%, 90% 95%) and then placed on idle or circulation mode having the same recovery levels. Osmonics Inc. manufactured the polyamide membranes, model designation AK8040, used in the system.
The tap water feed was first softened and then dechlorinated, using a bisulfite injection system, prior to a 5.0-micron cartridge filter system. The feed water had a pH of 7.2, a conductivity of 340 μS/cm. and alkalinity of 119 ppm. (as CaCO 3 ).
After a 30 minute production stabilization period, the circulating water fed to the first pass membranes was sampled for pH, conductivity and alkalinity, as a function of time for each product recovery level. FIGS. 10 , 11 and 12 show the effect of circulation mode over time for the reduction in pH, conductivity and alkalinity respectively.
The conductivity of the circulation water, which consisted of the new water entering the system, the majority of the water recycled from the reject of the first pass, all of the reject water from the second pass, and all of the product water, dropped to less than one half of the conductivity of the incoming feed water. In addition a second effect was observed that produced a corresponding reduction in pH (see FIG. 10 ) with the reduction in conductivity. The pH dropped to below 6.5 when the recirculating water's conductivity dropped below one half of the feed water conductivity. The rate of the effect to demonstrate itself was in proportion to the total dissolved solids in the recirculated water. The significant reduction in all three parameters from the production mode values to well below the tap feed water values demonstrates the self-cleaning ability of the invention when operated in circulation mode.
The second pass reverse osmosis product water in all three operating conditions, that is, at product recovery levels of 95%, 90% and 80% consistently had a pH of below 5.5.
The invention is further characterized by, the reverse osmosis membranes having the well known property of producing a permeate with dissolved carbon dioxide content. The water purification system 60 is operated to produce an acidic permeate during normal production and times when no water is drawn from the points of use at 62 (idle mode), the acidity in the permeate, and in the system, being increased in part by allowing the pH to decrease as a result of pressurizing the water to maintain carbon dioxide in solution.
An acidic condition is desirable to remove the inorganic fouling fraction from membrane surfaces and to reduce scaling. Minerals such as calcium and magnesium carbonates which are dissolved and maintained in solution are sent to drain. In addition, the high level of acid within the system will permeate the membranes and be distributed through the system sanitizing the whole reverse osmosis system and point of use piping. Microorganisms have an optimum pH range in which they grow. This range is ideally between pH 6.5 to 7.5. As the pH drifts above or below these values, the alkalinity or acidity becomes toxic to the organisms. Organisms that are commonly found in source water (i.e. Pseudomonades) will not grow in acid conditions. In fact, acid conditions at and below pH 5.5 will kill acid sensitive organisms. The area of most concern in the reverse osmosis system is the product spacer screens of the second pass. Reverse osmosis membrane manufacturers do not make claims for sterility of the permeate water. They do state that there will be >99% rejection of microorganisms. The first pass in theory will remove >2 logs and the second pass will reject approximately 2 logs. The problem that has been observed is that the organisms eventually culture and those, which pass the first stage, infect the second stage. The organisms that grow on the second stage will eventually pass into the permeate of the second stage. Due to the inherent design construction of reverse osmosis membranes, the organisms start to culture in the second pass permeate side of the membranes. This is the major area of infection that directly contributes to the contamination of the product water. The organisms then slough off into the water and infect the downstream piping. In this invention, the high acidic conditions after the second pass, approximately pH 5.5 or below, effectively prevent the growth of or kill the organisms that have cultured in the second pass permeate spacers.
The invention thus allows for self-sanitization without peripheral stations for additional, sterilizing filters, and ozonation systems typical of the prior art. The invention can maintain an undesirable state to prevent microorganisms from growing and to clean mineral deposits when the system is not called upon to produce water for a process. The ability of this invention to produce low pH product water, particularly on the permeate side of the second pass, will kill acid sensitive organisms and prevent growth of microorganisms. The invention operated under these conditions is the most desirable.
The ability to reduce the conductivity and pH of the water in circulation mode will allow for operation of the invention without the use of a water softener in the pretreatment. A softener would not be required in pretreatment for removal of water hardness under conditions where the feed water is low to moderately hard and the system is not called upon to produce water for a process on a continuous bases. The circulation or idle mode will clean the membrane of material collected during the production mode.
The current state of the membrane art has developed two different types of membranes: cellulose acetate (CA) and thin film composite (TFC) which are commonly employed in water purification. Each membrane has its strengths and weaknesses. The CA membrane is not susceptible to chlorine but is susceptible to basic conditions (high pH). The TFC membranes are not susceptible to high pH but are susceptible to chlorine. TFC membranes require chlorine removal—usually carbon or bisulphate injection. Carbon grows bacteria that will contaminate the system. If carbon is used, a provision is made to sanitize it with heat (hot water or steam increasing the cost of equipment and operating costs). Both membranes will tolerate low pH. A system using CA membranes would not require any form of pre-treatment (no chlorine removal, no softening/acid/anti-scale injection) other than a mechanical cartridge type filter for particulate removal. A system using TFC type membranes would not require softening/acid injection/anti-scale but would require a provision for particulate and halogen removal. The TFC system could incorporate a chlorine destruct ultraviolet system to destroy chlorine (i.e. as produced by Aquafine or Trojan). The ultraviolet system would be placed just prior to the pump. The acidified water would assist in preventing mineral scale build-up on the quartz sleeves forming part of the ultraviolet system and which would affect the overall intensity of the ultraviolet radiation into the water. The ultraviolet radiation would also inactivate microorganisms that would be introduced in the feed water and potentially any that would be derived from the distribution system.
Heat exchangers to temper the feed water are not required for operation of this device. It is well known in the art of membrane water purification that as the temperature decreases the water viscosity increases and visa versa. The water viscosity directly affects the production rate of the reverse osmosis membranes. This can be as-high as a decrease in production capacity of >2% for every degree C. below 25° C. (25° C. is the membrane manufacturers standard flux rating temperature). At 5° C. the decrease in production rate can exceed 40% at the same specified pressure. In decreasing water temperatures, to maintain the same production rate, a corresponding increase in pressure is required. Water purification systems incorporating the invention do not use heat exchangers to temper water for the following reasons:
a. The membrane surface area in the design is increased to account for the production loss due to temperature.
b. It is desirable from a microbiological point of view to maintain a low temperature within the reverse osmosis and point of use and return piping to decrease the rate of growth of microorganisms.
c. A significant amount of energy can be saved by not tempering the water to 25° C.
The selection of reverse osmosis membranes and the process design of this invention preclude the need to temper the feed water. Membrane manufacturers modelling programs (i.e. Osmonics and Dow) will determine the best membrane selection for the ionic quality of the product water as it relates to the temperature of the feed water. A combination of membrane surface area and types can be employed to obtain the desired ionic quality and production rate. Heating energy represents a significant contribution to operating costs on prior art systems and can be as high as 50% during the winter months in northern climates.
Cooling exchangers are not normally employed in the design of this device. The water rejected from the first pass membranes and the water drawn at points of use acts as a heat sink for the system. Typically an increase of approximately a couple of degrees Celsius is observed between the infeed temperature and the product water returning from the use points. The heat build up within the system is based on the percent recovery, the draw off volume with cycle rate, and the membranes' maximum allowable operating temperature. Storage based systems build up heat from the pump and frictional losses within the distribution system. These systems employ cooling exchangers to maintain the temperature usually between 20-25° C., which is an ideal temperature for microbial growth. Under conditions of high recovery rates where source waters are inherently warm (tropical climates) a cooling exchanger could be employed with this invention. The location of the exchanger would be on the infeed, or in the circulation system within the device (prior to the pump and membranes), thus insuring lower capital cost since sanitary design is not necessary as with storage based systems.
It will be appreciated that high temperature product water or water that does not meet the conductivity specification will be automatically sent to drain. A normal reject rate is established in the system usually between 2 and 50% of the product production rate or 50-98% recovery. The water rejected to drain and product water drawn off act as heat sinks to dump the heat from the system that is built up due to pump horsepower and friction. A conductivity/temperature sensor 14 , 18 measures product water quality on either the purified water supply line to the points of use 62 (product line) or on the return piping back to the reverse osmosis membrane assembly 72 . If water exceeds either or both limits, an automatic valve forming part of a reject assembly 73 on the reject line opens to dump additional water to drain. This acts to purge the system of water which in not within specification. After the quality has been re-established, the automatic valve 73 closes to return the system to normal operating conditions.
A variable frequency drive (VFD) is associated with the motor controlling pump 70 and used for hydraulic control within the system. A flow meter with sensor 12 , 16 on the product water line and/or point of use return line will monitor product flow rate. The sensor or sensors ( 12 , 16 ) will transmit a signal to the variable frequency drive to increase or decrease the speed of the pump motor 70 . The VFD will allow for operation of a water purification system according to the invention from a minimum of 3 feet per second (1 meter per second) to a maximum recommended velocity of 9 feet per second (2.7 meters per second). It will be understood that the system is designed for continuous operation so that water is never left stagnant. Exceeding 10 feet per second (3.0 meters per second) can produce water hammer within the system. This equates to a production rate as low as 50% of the average designed rate to a maximum of 150% of the average designed rate. The VFD is employed for different operating conditions and reasons:
a) During draw down the loop return flow sensor 16 will detect a decrease in flow. This will speed up the revolutions per minute (RPM) of the pump 70 to increase the applied pressure on the reverse osmosis membrane assemblies 72 , 74 , which in turn will produce more water to compensate for the draw down volume. This also maintains the minimum requirement of 3 feet per second (1 meter per second) velocity in the return line.
b) In northern climates, water sources can vary in temperature depending upon the season particularly if the source water is from a surface source (lake, river or reservoir). The VFD will automatically control the production rate based on product flow, irrespective of temperature and water viscosity. Temperature variation will not affect production rate.
c) Temporary adjustments can be made for increased or decreased water demand. Production rates can be modulated within defined parameters. A manual setting of the VFD can set the production rate from as low as 50% of the pumps RPM range to 100% of its range, which would produce a production, range of from 50% to 150% of the designed average production rate.
d) Maintaining the velocity in the point of use piping of ideally 3 feet per second (1 meter per second) but not to exceed 6 feet per second (2 meters per second) during idling times, when no water is drawn from the system, will reduce water consumption and power requirements to save energy. It also reduces the possibility of microbes from settling onto the piping wall that will eventually form biofilm and contaminate the system.
e) In the case of a power failure, the VSD will soft start the system. When power is restored, the pump 70 will initiate a slow ramp up to bring the system up to operating specifications increasing the RPM to operational speed. This prevents hydraulic shocks, which reduces ware and tear on the system and associated point of use equipment. The system will be self-regulating to return itself to producing the desired water quality and quantity.
f) Used during clean in place (CIP) of the system. The frequency drive would be set at around 50 percent of the motor's maximum frequency, in addition the back pressure regulating valves would be opened on the recirculation lines. This produces a good velocity of flow within the system at low pressures. During CIP, it is desirable to maintain a high velocity across the membranes at low pressures to lift the deposited material off the membrane surface. The cleaning chemicals can be dosed into the system with appropriate chemical neutralization on the first pass reject.
Energy efficiency can be realized with the use of submersible pumps. The water being pumped cools the motor. This heat energy is picked up by the water from the pump motor and friction through the distribution system and assists in reducing water viscosity, which increases production rate at a specified pressure. This in turn saves energy costs on pump horsepower.
Sanitary design considerations are used throughout. At least one pump 70 is used to apply pressure to the first pass. The residual pressure from the first pass is used to feed the second pass. This is a more sanitary design than a pump for the first pass and a second pump for the second pass. In addition, the pump 70 is located on the contaminated side of the purification process, which is upstream of the first set of membranes. If a pump 70 has to be replaced, sanitization of the process and point of use 62 piping would not be required as in the typical prior art. In addition a spare pump could be added to the system, swing elbows from the existing pump could be rotated over to the second pump very quickly to reduce down time.
The invention can be operated to regulate itself to maintain product water quality and quantity with only 2 sensors, a combination conductivity/temperature sensor ( 14 , 18 ) and a flow sensor ( 12 , 16 ). No other controls are required to allow the system to self regulate. The flow sensor ( 12 , 16 ) will provide the feedback for the VFD to maintain the velocity and production rate. The conductivity/temperature sensor ( 14 , 18 ) will regulate the automatic valve located on the reject assembly 73 to send high temperature or conductivity water to drain which will clear the system quickly and maintain the hydraulic balance.
The system can be operated with very simple controls. A programmed logic controller (PLC) or proprietary control systems are not required for operation.
The invention is adaptable to various source water qualities up to approximately 2,000 mg/L of total dissolved solids (TDS) based on the existing membrane art. Adjustments can be made to the percent recovery on the system to ensure the final product water quality (from 50% to 98%). In addition, choices can be made of different membranes having different rejection characteristic to assist in the final water quality. As membrane technology advances, higher rejection membranes can be employed to use this device on even higher TDS source water. In cases where the source water exceeds recommended operating guidelines, as specified by the membrane manufacturers, appropriate pre-treatment, as designed by those skilled in the art of water purification, can be employed.
Typical two pass reverse osmosis systems in the prior art are usually designed to run with a 50-60% overall recovery. The typical recovery for this design is 80 to 98% during the production mode. The percent recovery would be dependant on source water temperature and total dissolved solids level.
Where system recovery, in the production mode, is below 90%, it can be increased to 90-98% when operated in circulation or idle mode by using an additional automated valve on the reject assembly 73 . The automated valve would close once the idle mode has been initiated to decrease the amount of water sent as reject water.
Conveniently, the acidified water circulating over the first pass membranes 72 during circulation or idle mode also assists in the reduction of chlorine and chloramines.
Prior art systems have employed a process called direct feed that does not use a storage tank. Essentially this consists of a distribution pipe from the outlet of the purification process that feeds purified water to the points of use. Some systems employ a return line from the points of use back to the inlet of the purification process. This allows circulation of the water when not called upon by the points of use. Typically, in this type of design, the demand rate at the point of use is determined. The systems production rate is designed to meet this demand with an additional 10-20 percent. This invention employs a different concept from the prior art. The design of this invention is to provide purified water where required (point of use) but as a direct draw off point within the high purity side of the inventions purification process. Water obtained is a direct draw of freshly purified water from the invention. Unlike the prior art, the piping to the use point and return to the membrane assembly is an integral part of the purification process. The production rate of the invention is typically twice that of the draw off demand. The hydraulic conditions are different from the prior art in order to maintain the velocities within the purification process. In addition, the low total dissolved solids, water and carbon dioxide balance is required in the volume of water that is returned to the membrane assembly on a continuous basis.
The natural state of the system is to run it without pH adjustment to derive the benefits of the CO 2 in the production and circulation mode. The conductivity of the product water will be elevated due to the dissolved CO 2 gas, which forms carbonic acid and in turn contributes to conductivity. In applications where a specified conductivity is to be maintained for the reason of determining the maximum allowable total dissolved solids content without the interference of the conductivity contributed by CO 2 , the CO 2 gas can be removed on a low volume product sample stream. A sample stream of the product water from either the outlet of the second pass membranes before the loop, or water returning back from the loop, or both places, can be passed through a small degas membrane module 59 (e.g. Liqui-Cel by Celgard or similar) prior to a conductivity sensor 14 , 18 as shown in the water purification system 61 of FIG. 7 . The conductivity sensor 14 , 18 would then register only the conductivity contributed by the total dissolved solids (i.e. USP Stage 1 online conductivity analysis).
Where a requirement exists to produce water of a reduced conductivity, sodium hydroxide or other suitable alkali can be added to the feed water at 66 to convert the CO 2 to carbonate, which will be rejected by the membranes, producing lower conductivity product water. Suitable systems for pH adjustment under variable flow conditions are commercially available such as those manufactured by Prominent Fluid Controls. In this case, a softener would be required in the pretreatment to prevent a more rapid scaling of the membranes under alkaline conditions. Under these conditions, a timing mechanism or a manual turning off of the NaOH injection pump 66 will produce a low pH in the system and distribution loop to achieve self cleaning and sanitizing, during off hours of production. This state can also be achieved between draw off requirements during normal production. The normal state will be to maintain a low pH. When water is required, a switch by the points of use will activate the NaOH pump 66 to bring the pH to within the desired range (approximately 8.3 on the first pass membranes) in order to provide water of a lower conductivity. After draw down, the NaOH pump 66 is once again turned off to maintain an acid cleaning and sanitizing state.
Alternatively, the CO 2 gas can be removed from the water, by incorporating a carbon dioxide degassing module such as a membrane contactor (e.g. Liqui-Cel by Celgard or similar) to increase the pH back to a specified and desired value and also to reduce conductivity at the points of use, as required. A membrane contactor 55 , placed on the permeate side of the second pass, prior to the ultraviolet radiation treatment, will remove the CO 2 gas as shown in the water purification system 71 of FIG. 8 . The removal of the gas will reduce the conductivity and increase the pH back to the specified and desired value. The degas module can be connected to a sweep gas source or a vacuum can be drawn on the module to remove the CO 2 from the product water. Another alternative is to allow the gas to escape from the purified water after drawing it from the system. Once the pressure has been released, the CO 2 will naturally evolve from the water decreasing the conductivity and increasing the pH.
Another alternative system 81 shown in FIG. 9 is to use an eductor 8 connected to a membrane contactor, which is located after the second pass and prior to the ultraviolet system. An eductor 8 , placed on a water line from the discharge of the pump 70 and connected to the inlet of the pump, and having the vacuum line of the eductor connected to the membrane contactor 55 removes CO 2 gas from the product water and introduces it to the feed water. This will reduce the alkalinity in the feed water, reducing scaling of the membranes and reducing pH within the system prior to the contactor to prevent microbial growth
Where the points of use require hot water or the membrane selected for use in the reverse osmosis membrane assemblies 72 , 74 are operated at higher temperatures (70-80° C.), continuously or periodically to kill bacteria, the ultraviolet radiation systems 68 and 76 may be replaced by heat exchangers identified by reference numerals 78 , 80 respectively in the embodiment of a water purification system 82 shown in FIG. 3 . The remaining components are otherwise similar to those in the water purification system 60 of FIG. 2 and are identified by like numerals. The second optional heat exchanger 80 is disposed to control the temperature of the permeate before reaching the points of use indicated at 62 to increase or maintain high water temperatures, for example, in water for injection purposes, to cool the water for other end uses, or to sanitize the loop and associated equipment attached to the point of use loop. In such systems, it will be appreciated that operating costs will be higher because of the energy costs associated with heating water. Therefore, the aforementioned operating cost advantages described with reference to FIG. 2 will be reduced.
Both systems 60 and 82 of FIGS. 2 and 3 may be modified to create systems 86 , 88 as shown in FIGS. 4 and 5 in which a serpentine loop return is added in which permeate is drawn through pump 84 disposed to bypass both the first and second reverse osmosis membrane assemblies 72 , 74 . Placing the systems 86 , 88 on standby, where pump 70 is operated for a few minutes every hour, to flush the systems, will reduce overall water requirements to conserve water while maintaining a minimum velocity of water in the point of use piping that inhibits the formation of biofilm and prevents water stagnation.
A hybrid system 90 of systems 60 and 82 is illustrated in FIG. 6 where the first reverse osmosis membrane assembly 72 is operated at a cold temperature and is associated with an upstream ultraviolet radiation station 68 and the second reverse osmosis membrane assembly 74 is operated at an elevated temperature and is associated with an upstream heat exchanger 92 and pump 94 disposed between the first reverse osmosis membrane assembly 72 and the second reverse osmosis membrane assembly 74 . A second optional heat exchanger 80 is disposed to control the temperature of the permeate before reaching the points of use indicated at 62 .
It will be seen that the permeate from the second reverse osmosis membrane assembly 74 is drawn by the pump 94 to return through the heat exchanger 92 into the second reverse osmosis membrane assembly 74 while the reject water from the second pass reverse osmosis membrane assembly 74 is divided into two fractions supplying both the first and second pass reverse osmosis membrane assemblies 72 , 74 .
The permeate from the first pass reverse osmosis membrane assembly 72 also has a fraction which is recycled through the ultraviolet radiation station 68 and its reject water is divided into two fractions, one of which goes to drain while the other is recycled through the ultraviolet radiation station 68 .
In use, it will be appreciated that a water purification system built in accordance with the invention provides enormous cost benefits. The capital costs are significantly lower, providing savings in the order of 30 to 50% over prior art systems which include a water storage tank. Operating costs are also reduced by 20 to 50%, the savings being attributable to lower energy consumption and reduced labour for cleaning and sanitizing. Most advantageously, a system built in accordance with the invention produces water of high microbiological purity without the infrastructure associated with hot water sanitization and ozone sanitization.
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A process is provided to produce water that will meet the specifications of the United States Pharmacopeia Inc. For Purified Water and Water for Injection, and water for dialysis as circumscribed by the American Association for Advancement of Medical Instrumentation (AAMI). The system has no storage tanks where stagnant water will be fouled by biofilm colonizing the tank surface. Water is circulated throughout the purification system and drawn as required, on demand. The water is purified and used immediately or recycled and repurified to ensure quality. Sanitation of the purification system, maintaining microbiological purity and cleaning is done by controlling the pH so that it is normally acidic by maintaining a high carbon dioxide concentration in solution, the carbon dioxide being allowed to pass into the permeate from a reverse osmosis membrane assembly used to purify the water.
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CROSS REFERENCE TO RELATED APPLICATION
The present application claims the benefit of U.S. Provisional Patent Application No. 60/700,128, filed Jul. 18, 2005, which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
The present invention relates in general to athletic equipment and in particular to protective athletic bands that can be worn about various areas of the human body.
BACKGROUND OF THE INVENTION
Many commercially available athletic bands are dedicated to perspiration absorption. A typical example is an elastic terry cloth band commonly known as a “sweatband” that is may be worn around the user's head or wrist. While well suited to absorbing the wearer's perspiration, sweatbands offer little meaningful protection from impacts arising from speeding balls (or other moving sporting equipment), or contact with other players and playing surfaces.
Other athletic gear are primarily protective in nature and are designed to absorb impacts. These devices are typically much more bulky and complex in construction than conventional sweatbands and are not adapted to provide effective perspiration absorption. An example of such protective gear may be found in U.S. Pat. No. 6,625,820.
Some athletic bands are constructed as a layer of impact-absorbing material wholly or partially contained within a layer of cloth. Examples of such bands may be found in U.S. Pat. Nos. 4,910,804; 5,946,734; 6,000,062; 6,266,826 and 6,675,395, as well as in Published U.S. Patent Application No. 2002/0189004. Of these, however, only U.S. Pat. No. 5,946,734 addresses the advantage of providing “breathable” impact-absorbing cellular material for the wearer's comfort. However, in the sole embodiment thereof which mentions this feature, the “breathable” open-cell foam is a bulky ⅝ to 1 inch in thickness which renders the band thick and bulky in appearance.
An advantage exists, therefore, a thin athletic band which is economical to manufacture yet provides considerable impact protection coupled with effective perspiration removal.
SUMMARY OF THE INVENTION
The present invention is a protective athletic band including a layer of breathable, moisture wicking material and a layer of perforated, impact-absorbent elastomeric material of less than about 3 mm in thickness. The band may be continuous or a strip having first and second detachably connectable ends. The resultant product is a thin athletic band which is economical to manufacture yet provides considerable impact protection coupled with effective perspiration removal.
Other details, objects and advantages of the present invention will become apparent as the following description of the presently preferred embodiments and presently preferred methods of practicing the invention proceeds.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will become more readily apparent from the following description of preferred embodiments thereof shown, by way of example only, in the accompanying drawings wherein:
FIG. 1 is a perspective, partially disassembled view of a protective athletic band according to the present invention.
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 reveals a preferred construction of a protective athletic band according the present invention. The athletic band, identified generally by reference numeral 10 , comprises a layer of breathable, moisture wicking material 12 and a layer of impact-absorbent material 14 . Although athletic band 10 is preferably constructed as an endless loop it may also be formed as a strip having first and second ends that are detachably connectable to one another such as by buttons, snaps, hook and loop type fasteners, or the like (not shown).
Moisture wicking layer 12 may be any suitable porous natural, synthetic or blended fabric such as, for example, elastic terry cloth or the like of the type commonly used in conventional sweatbands. According to a preferred embodiment, the moisture wicking layer preferably encloses or envelops the layer 14 of impact-absorbent material.
The impact-absorbent layer 14 is desirably a very thin, elastic, and breathable material. Layer 14 is preferably less than bout 3 mm in thickness so as to provide the band 10 with a very thin profile comparable to conventional sweatbands. According to the invention, layer 14 is a noncellular elastomeric material such as natural or artificial rubber, neoprene, Calprene®, or the like, provided with a plurality of perforations 16 . A suitable material is a perforated, approximately 1.5 mm thick layer of noncellular Calprene® H-6170. The inventor has observed that such material effectively passes moisture from the wearer while at the same time providing more than a 50% reduction in impact force sensed by a wearer as compared to conventional fabric sweatband material alone. It will be appreciated that greater thicknesses, up to about 3 mm, will produce even greater impact absorption without noticeably compromising the thin profile of athletic band 10 .
Layers 12 and 14 may be joined by any suitable means or method. In preferred embodiment, they are sewn together by conventional sewing equipment. The resultant band is thin and breathable and may be worn about any area of a user's body that is, depending on a particular sport, frequently subject to athletic impact such as the head, wrist, elbow and knee.
Although the invention has been described in detail for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that variations can be made therein by those skilled in the art without departing from the spirit and scope of the invention as claimed herein.
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A thin athletic band which is economical to manufacture yet provides considerable impact protection coupled with effective perspiration removal.
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BACKGROUND
The present invention relates to apparatus for setting up and playing a children's game, and, more particularly, to a maze game that can readily be set up indoors or outdoors and which is comprised of light, easy to assemble construction components.
The use of a maze or labyrinth as a basis for a children's game is well known and there have been many differing types of apparatus to establish the basic maze for the enjoyment of the children. Basically, the maze is set up so that the children can proceed down a particular path and are not readily visible to other children in the same maze such that each child wends a unique path and chances an encounter with another child. With a typical maze set up, there are certainly many games that can thus be played and with certain of the maze setups, the children themselves can improvise and make up their own games for amusement.
One of the more simple games enjoyed by children with a maze arrangement is to chase each other through the maze in an effort, simultaneously, to catch and evade each other as they progress through the intricate passageways therethrough.
Despite the seemingly availability of the construction materials for a maze, there are no such games or kits that can conveniently be provided to a parent and which can be easily set up, stored and moved with a minimum of difficulty. Thus, while someone could probably individually purchase various equipment and materials to construct a maze, there is no convenient source of the assemblage of materials available in a form that can be used by the parent to readily set up the maze expeditiously and that is adaptable to be used indoors or outdoors.
For example, in U.S. Pat. No. 4,154,440 of Rusk, there is a maze apparatus where the maze is comprised of posts that are driven into the ground and which are interconnected by panels that are made out of a rigid material such as wood. Thus, the maze of the Rusk patent is a permanent structure, intended only for outdoor use and is not of the type that can be used by children where it is advantageous to be able to quickly set up the apparatus for the game and, just as quickly and easily, disassemble the maze apparatus when the game had ended.
In U.S. Pat. No. 5,364,311 of Chou, the is a collapsible maze that is stated to be intended for use by both children and adults. However, in this patent, there are various support members that are specially designed so as to fit into preformed holes in the ground surface and there are a plurality of collapsible wall board panels that comprise a pair of wall sections joined together with an interlocking projection and, again, would not be easy to set up and take down and requires some permanent structure requirements. Too, if the Chou maze is used indoors, it is necessary to provide the holes in the surface on which the apparatus is located and thus not suitable for use in a household. As with the prior Rusk patent, the apparatus is of a more permanent nature and requires considerable structure to establish the maze or labyrinth, and that permanence is due, in part, to the use of wall board or wooden panels that are considerably heavy, rigid and certainly difficult for the parent to quickly set up at the behest of a child that is, no doubt, ready to play the game immediately Thus, it would be advantageous in view of both Rusk and Chou to have a maze apparatus that could be lightweight so as to be easily moved to a location by a parent, set up at that location, be it indoor or outdoors, and then removed after the game has terminated.
A further maze apparatus is shown in U.S. Pat. No. 5,046,720 of Bolly and, again, there is a maze that would be extremely cumbersome and difficult for the normal parent to assembly and to disassembly. In the Bolly construction the maze is constructed of a flexible material of a fairly heavy material such as cloth-backed vinyl and thus the material used in this patent is at least lighter and more portable than in the Chou and Rust construction, however, the Bolly apparatus is assembled and supported by reliance upon some suspension from a ceiling and thus is adapted to exclusively be used indoors as that access to a ceiling is required to support the maze. Thus, while the Bolly side panels are at least lighter, the structure still does not go far enough to allow a parent to set up the apparatus quickly and be easily transportable by that parent and used in locations either outdoors or indoors with equal facility.
Therefore, as can be seen, the prior art simply does not provide a maze game apparatus that is light, comprised of readily transportable components by a parent, and which is adaptable to be as easily set up indoors as well as outdoors. Thus, it would be advantageous to have such a maze and particularly one that could be made of easily washable materials, adjustable for varying conditions and have standard component for inexpensive manufacture as well as to allow the overall apparatus to be stored by the user without having cumbersome parts.
SUMMARY OF THE INVENTION
Now, in accordance with the present invention, there is provided a new and improved apparatus for the establishing of a maze game for play by children. With the present apparatus, all of the materials and components are light weight and can easily be transported from location to location by a parent or parents so that the game can be set up at any variety of locations and can even be taken to a public park or recreational area along with the children to create the maze at that location.
The present apparatus is capable of being used indoors or outdoors such that the children can play outside with the game or inside during the colder months or during inclement weather. In either case, the present invention provides an apparatus that can readily adapt to the particular location or conditions.
In the present invention, the components are, as indicated, light weight to make the overall apparatus portable however such components are sufficiently strong so as to be assembled and remain in place during the playing of the game. The maze apparatus comprises a plurality of vertically disposed poles. The poles may be a hard, impact resistant plastic material or of a light metal, such as aluminum, it only being important that the material be light, easily transported and yet be sufficiently strong to provide support for the overall apparatus. At the upper portion of each of the vertical poles, there are sets of holes provided and each set may be comprised of two or more holes in the poles. In the preferred embodiment, there are four holes in each set located about ninety degrees apart, that is, equally spaced around the peripheral surface of the poles. There may be two or more sets of such holes in the upper portion of the vertical poles.
The vertical poles are established and maintained in the vertical orientation by the lower ends of the vertical poles establishing a supporting contact with the particular ground or floor on which the maze is to be erected. In particular, if the maze is intended to be constructed outdoors, the lower ends of the vertical poles are pointed and can simply be driven into the ground to establish the vertical orientation. If, on the other hand, the maze is intended to be set up and used indoors, the lower ends of the vertical poles can be comprised of generally flat, planar, weighted bottoms so as to enable the vertical poles to stand independently on a flat floor and be orientated vertically.
In the preferred embodiment the vertical poles are supported in the alternative locations by means of a lower adapter section that is affixed to the lower end of a vertical pole. Thus, there can be differing lower adapter sections to be affixed to the vertical poles and one of such lower adapter sections can be formed with a pointed end to be used in the outdoor environment while another lower adapter section can be formed with a relatively large flat, planar bottom surface so as to allow the vertical post to stand on a floor or carpet within a home without damaging that floor or carpet. Accordingly, the parent, in the preferred embodiment, can have the option of setting up the present maze apparatus in either location with the use of the same basic components.
With the present invention, there are also a plurality of horizontal poles and which have their ends interfitted into the one of the selected sets of holes in the vertical poles such that each horizontal pole interconnects a pair of vertical poles and the horizontal poles are supported by being force fitted into the holes formed in the upper portion of the vertical poles. In the preferment embodiment, the horizontal poles are comprised of the same light weight material as the vertical poles and are only somewhat smaller in cross sectional area.
As is now obvious, with the differing sets of holes in the vertical poles, the horizontal poles can be interfitted to a desired set of holes at the vertical height off of the floor or ground to fit the height of the children and thus the parent can simply select the particular set of holes that is most applicable to the children playing the game. Again, as preferred, the various sets of holes at the varying heights can be color coded, that is, the sets of holes at each height can have the same color to enable the user to easily select and use a particular set of holes at the desired height from the ground by merely using a consistent color of holes to set up the apparatus and to install the horizontal poles.
The maze apparatus is completed by the use of a flexible, light fabric panels that are suspended from the horizontal poles and which hang down at least substantially the entire height of the vertical poles. It is preferred that the panels be comprised of a light fabric so that the visibility of the children to see into any adjoining path is curtailed and yet the overall apparatus is sufficiently light that it can be readily moved at will by the parent. Preferably, the fabric can be similar to or actual bedroom sheets that are also readily available to anyone for use in the game. It is certainly preferred that the fabric be readily washable, and fire retardant for indoor use and one such material is a fire retardant nylon webbed sheeting.
Accordingly, with the use of a fabric, the overall apparatus can be light and easy to transport to any location. In the preferred embodiment, the fabric panels are affixed to the horizontal poles by a quick and sure means including the use of tabs or loops that are affixed to the upper edges of the fabric and can be looped around the horizontal poles and reattached to the fabric and can be the use of hooks and loops arrangement currently available under the trademark Velcro. In a preferred embodiment, the may be sets of Velcro at the ends of the fabric vertically separated as the panels are looped over the horizontal poles. By the use of different sets of Velcro fasteners, at a plurality of spaced vertical locations along the fabric panels, the user can easily change the vertical height of the panels to account for different terrain or for different selected holes in the vertical poles by merely further looping the fabric panel over the horizontal poles and selecting a different set of Velcro fasteners.
Thus, the maze of the present invention is simple to set up and take down, is lightweight so as to be readily portable, and also has the adaptability to be used with children of differing heights for the carrying out of a game indoors or outdoors.
These and other improvements and features of the present invention will become better understood from the detailed description of the preferred embodiment set forth below taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a maze apparatus constructed in accordance with the present invention and set up for use by children,
FIG. 2 is an enlarged perspective view of a typical upper connection of a vertical pole used with the present invention,
FIG. 3 is an enlarged perspective view of a typical junction of horizontal poles, used with the present invention,
FIG. 4 is an enlarged perspective view of a typical interior vertical pole connection of the present invention;
FIGS. 5A and 5B are side cross-sectional views of a lower adapter section for use, respectively, to set up the present apparatus on the outside ground and in the interior of a building.
DETAILED DESCRIPTION OF THE INVENTION
Turning not to FIG. 1, there is shown a perspective view of a maze apparatus set up for the playing of a game by children. As can be seen, there are a plurality of vertically oriented poles 10 and which are used to establish and set up the overall maze game. For purposes of the present description, the vertical poles 10 will be referred to as outside vertical poles 12 and inside vertical poles 14 , however, as will later be explained, the outside and inside vertical poles 12 , 14 may be identical. The vertical poles 10 , in general, are disposed a predetermined distance from each other and are affixed to the ground or to a floor in a manner that will later become clear.
It is clear, however, from FIG. 1, that there may be any number of vertical poles 10 to set up the maze depending, of course, upon the complexity of the desired maze and/or the amount of room available at the particular location.
As can also be seen in FIG. 1, there are a plurality of horizontally oriented members or horizontal poles 16 that interconnect the vertical poles 10 generally at the upper portion of the vertical poles 10 to make up the overall maze apparatus. As will be seen, again, the actual number of horizontal poles 16 is up to the user and is dependent upon the availability of space and the desired complexity of the game. As will also become apparent, although there is shown a particular configuration in FIG. 1 as an example, by the use of the present invention and the interconnecting of the horizontal poles 16 and the vertical poles 10 , there can be any number of configurations that can be set up by the parent to vary the game for the participants and to increase or decrease the complexity of the maze.
Thus, there are a plurality of panels 18 that are affixed to the horizontal poles 16 and extend downwardly at least substantially the entire height of the vertically oriented vertical poles 10 . Preferably, the panels 18 are comprised of a light weight fabric so that the overall apparatus can be light and easily carried to the particular site to be used for the game, and any non-transparent fabric can be used that is relatively strong, preferably a common household bed sheet or like fabric can be employed.
Thus, not only are the vertical poles 10 and the horizontal poles 16 adaptable and can be constructed by the user to any particular configuration, but once the overall frame of the horizontal poles 16 and vertical poles 10 are erected, the panels 18 can be moved or positioned to suit the user and once a game has been played, the panel 18 can simply be removed easily from the horizontal poles 16 and affixed to a different horizontal pole to vary the next game. Accordingly, with the present construction, not only can the parent vary the game easily, but the children themselves can use their imagination and change the game as it suits them without requiring any extensive breaking down of the basic maze structure and a rebuilding process.
Turning now to FIG. 2, there is shown an enlarged perspective view of an outside vertical pole 12 and having interfitted thereto a horizontal pole 16 and showing a further exploded view of a horizontal pole 16 to be interfitted to the outside vertical pole 12 . As can be seen, the outside vertical pole 12 has a plurality of sets of holes 20 , 22 , 24 that are formed therein. In FIG. 2, only one hole of each of the sets if visible however it is obvious that there is at least another hole for locating the other horizontal pole interfitted to the outside vertical pole 12 . Accordingly, in the construction of the maze apparatus, the outside vertical pole 12 is initially affixed in its vertical orientation and the construction is furthered by interfitting horizontal poles 16 into one of the sets of holes 20 , 22 , 24 . By the use of different sets of holes 20 , 22 , 24 , the user can choose the proper height of the maze apparatus depending upon the height of the children intending to play the game. The interfit of the horizontal poles 16 into one of the sets of the holes 20 , 22 , 24 , can be by means of a force fit so that the interconnecting and removal of the horizontal poles 16 with respect to any of the vertical pOoles 10 is easy to facilitate.
In the preferred embodiment, each set of holes is color coded to enable the user to set up the apparatus easily and accurately by simply using the holes of a certain color and thus inserting the horizontal poles consistently into that set of color coded holes.
In addition, with respect to FIG. 2, it can be seen that the fabric panel 18 is affixed to the horizontal pole 18 by means of a loop 26 that encircles the horizontal pole 16 to be affixed to suspend the fabric panel 18 . Various means can be used to carry out that affixation of the top of the panel 18 to the horizontal pole 16 that is easy to attach and detach, however, in the preferred embodiment, there is a conventional hook and loop affixing device available under the trademark Velcro to carry out the affixing of the panels 18 to the horizontal poles 16 .
In the preferred embodiment there may be a plurality of sets of Velcro fasteners spaced horizontally along the panels 18 when installed to a horizontal pole. The use of the horizontally spaced fasteners allows the user to fasten the panel 18 at, for example, spaced locations every foot across the horizontal disposition of the of the panels 18 , that is, with the preferred width of about four feet across the horizontal, there may be four sets of Velcro fasteners.
There can also be a plurality of sets of vertically disposed Velcro fasteners when the panels are installed overlooping a horizontal pole 16 to enable the user to easily change the vertical drop of each panel by simply selecting a different set of vertically disposed fasteners. Thus, if the particular panel 18 is too long, the user can simply fold the upper end of that panel further over the horizontal pole to the next set of vertical Velcro fasteners and attach the panel in that raised position. Thus, with varying vertically located fasteners, the panels 16 can be easily adjusted as to the vertical height to adapt the panels to the particular vertical space between any horizontal pole and the surface on which the apparatus is set up, i.e. the ground or the floor of a building.
Turning now to FIG. 3, there is shown an enlarged perspective view of a tee connector 30 that is used to connect various horizontal poles 16 together and, again, with the tee connector 30 , the horizontal poles 16 can be affixed to the tee connector 30 by means of an interference fit so as to make the connection easily and to allow the overall maze apparatus to be readily taken down after the game has been completed. Again, as can be seen, the panel 18 can be preferable affixed to the horizontal pole 16 by the user of a loop 26 having a connector of Velcro material.
Turning now to FIG. 4, there is shown a enlarged perspective view of a inside vertical pole 14 and showing one set of holes 20 formed in that inside vertical pole 14 . The affixation of the horizontal pole 16 is shown in an exploded view and the horizontal poles 16 are interfitted by means of a force fit into the set of holes 20 . As can be seen in the view, the set of holes 20 comprise four holes, spaced around the periphery of the upper portion of the inside vertical pole 14 , or about ninety degrees apart so that a horizontal pole 16 can be interfitted from all four directions.
The use of four holes per set is intended for an inside vertical pole 14 as opposed to an outside vertical pole 12 of FIG. 2, however, for uniformity, the inside and outside vertical poles 12 , 14 can be made identically with both having four circular holes for each set of holes for simplicity of manufacture and for more versatility in setting up and establishing the particular maze game. As noted in FIG. 4, there is only one set of holes 20 shown; it being understood that the inside vertical pole 14 would have the same plurality of sets of holes as described with respect to FIG. 2 so that the user can choose the particular vertical height from the ground or floor for the panels 18 to match the height of the children playing the game. Again, as noted, each set of holes is preferable color coded.
Turning finally to FIGS. 5A and 5B, there is shown, side cross sectional views of a lower pointed adapter section 32 in FIG. 5A that is used to enable the vertical poles 10 to be driven into the ground by the user in the event the maze apparatus is being set up outdoors and, in FIG. 5B, a lower flat adapter section 34 having a flat, planar bottom 36 for use when the maze apparatus 10 is used indoors and the vertical poles 10 are to be located on a hard floor or carpeted floor within a building. As can be seen the lower, flat planar bottom 36 is kept low to the ground to prevent children from inadvertently tripping during their use of the maze apparatus.
Thus, with either of the adapters, the maze game can be easily set up in either location and converted readily to be set up inside the house of other building or, alternatively, the maze apparatus can be set up so as to be used outdoors. In either installation, the lower end of the vertical pole 10 can be interfitted into an opening 38 in that particular adapter and the interchanged easily by the user as desired.
While the preferred embodiments have been described and illustrated, various modifications and substitutions may be made without departing from the scope and spirit of this invention. It is to be understood, therefore that the present invention has been described by way of illustration and not limitation.
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An apparatus is disclosed comprising a light weight maze game that can be used indoors or outdoors and which has light weight vertical poles and horizontal poles that interconnect together to make up the frame of the maze apparatus. The panels are made of a light weight fabric and are readily attached and detached from the horizontal poles such the panels hang downwardly from the horizontal poles to establish the various isolated pathways through the maze. By the construction, the maze apparatus can be set up easily and quickly by a user and the vertical height of the panels can be selected by the user for differing heights of the children.
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BACKGROUND OF THE INVENTION
This invention relates to tree stands.
More particularly, the invention relates climbing tree stands.
PRIOR ART
Two part tree stands are known in the prior art.
The prior art shows tree stands having seats with various degrees of adjustability utilizing pins mounted on sliding arms, see Untz U.S. Pat. Nos. 4,417,645; 4,452,338; Williams, U.S. Pat. Nos. 4,890,694; 4,802,552 and other patents sited therein. The need for spikes for climbing has been both cited as a necessary safety feature and as a potential danger to trees and spikes are therefore well known as a part of the prior art and a problem associated with the prior art. A major question comes where the user finds himself in need of additional traction and the spikes have not been utilized due to attempts at tree conservation.
The use of solid part tree wrapping bands are also known with or without gripping members. The adjustment of these members is typically a very serious problem. One method of addressing this problem has been to mount pins utilizing biasing springs as in U.S. Pat. No. 4,890,694 FIG. 12 item 136, and FIG. 9 item 82. These adjustments are necessary in order to provide for varying diameters of trees and to allow adjustment after the different portions are in place. These fail to completely release the tree wrapping arms and therefore tend to interfere with full adjustability.
The use of foot straps is also known in the art. These foot straps serve the purpose of easing climbing by allowing the user to pull the bottom portion up during the climbing process. One of the problems with existing foot straps lies in the difficulty of using or disengaging the foot straps as the user moves around or climbs. Existing foot straps are too loose or too tight. This can be particularly dangerous where a foot slips out of the strap while climbing.
Also known in the art are gun rests. Those available in the prior art are particularly noisy and not easily adjusted for quick use. Some prior art applies to gun rests those do not address this problem in tree stands.
Typically, in a situation where a hunter is using a stand, the hunter may move to a site before the sun comes up and wait for hours so as not to disturb the environment. A gun rest serves the purpose of supporting the gun in a position close to that desired for shooting. The present invention incorporates a gun rest. Because a change in the hunter's sitting position or the target area, the hunter, already in a precarious position, may find that he must quietly adjust the gun rest or lose the benefit of the gun rest.
GENERAL DISCUSSION OF THE INVENTION
The present invention provides for a shooting rest bar which is easily adjusted. The bar is constructed using steel arms. The bar passes through a nylon tension adjuster further described as a threaded sleeve which is provided with spacing and a cap with cooperating treads which can be tightened onto the sleeve. The steel arms move through the threaded sleeves and caps when the sleeves and caps are loosened from each other allowing for adjustment. Nylon is used for maintaining silence. When the threaded sleeves are tightened to the caps, the spacing, typically in the form of slits, is reduced so that the movement of the arms through the sleeves is restricted. This allows for quick and quiet control of the height and position of the shooting rest bar.
Retractable climbing studs are put in place in the props which fit against the tree. This allows for the retraction or extension of the climbing studs during the climbing stage or waiting stage of the hunt using the climbing hunting stand.
Foot straps are provided with an elastic band extending behind where the ankles fit within the straps. These straps are continuous along the ankles and serve to hold the hunters feet within the straps. A single intervening eye hook separates the elastic band into sections behind each foot. On either side of the hook or eyehole bolt the elastic band is equipped with a pull tab. This pull tab allows for the elastic band to be stretched behind one ankle merely by pulling on the pull tab.
The invention also utilizes free swinging wing-nut and bolt type attachments for fixing the position of a sturdy bar type climbing part described herein as the swing arm. The wing-nuts are detachable from one or more bolts which are fixed into the swing arm. The wing-nuts are fixed in approximate location by a flexible leader by way of a pivoting member attached to the wing nuts.
A further element of the present stand is a pocket below the seat and gun rest which serves, along with the positioning of the other elements set forth above, to have all of the adjustments easily accessible to the user of the tree stand.
It is, therefore, an object of this invention to provide an improved tree stand.
It is a further object to provide a tree stand having an improved gun rest.
It is a further object of the invention to provide a tree stand having retractable climbing studs.
It is a further object of the invention to provide for an improved foot anchoring mechanism in the form of an elastic band having pull straps.
It is a further object of the invention to provide a tree stand which is easily utilized and has all of the adjustable parts easily accessed by the user.
These and other objects and improvements of the invention described herein will become better seen from the drawings attached hereto and from the following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
For a further understanding of the nature and objects of the present invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings in which like parts are given like reference numerals and wherein:
FIG. 1 is a plan view of the invention in place on a tree.
FIG. 2 is a detail view of the retractable stubs shown in FIG. 1.
FIG. 3 is a side view of the folded tree stand showing the interaction of the two main parts.
FIG. 4 is a cross sectional view of the hand climber forming a portion of the tree stand.
FIG. 5 is a plan view of the hand climber.
FIG. 6 is a detail view of the tension adjuster for the gun rest.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
As can best be seen by reference to FIG. 1, the tree stand comprises two major sections. The first of these sections is the upper portion referred to as the hand climber 1. The lower section is referred to as the foot climber 2.
The hand climber 1 comprises a hand climber swing arm 3 and a hand climber primary arm 5. The hand climber primary arm extends forward to accept safety strap hooks 47 for safety strap 46. The hand climber primary arm 5 defines one or more arm holes 30 which receive bolt 35 which is set into one of the holes 29 in the swing arm. Wing nut 34 is used to secure bolt 35. The bolt 35 may be welded in place on the swing arm 3 or the swing arm 3 may have threaded holes 29 to receive the bolt 35 which is then fixed in place by the cooperating threads 54 of wing nut 34. The threads 54 are located within the wing nut 34 opposite pivot 33.
Wing nut 34 is attached by way of pivot 33 to leader 31. Leader 31 is attached to the hand climber primary arm 5 at 32 so that the wing nut 34 can be disengaged without losing the wing nut 34. Hand climber swing arm 3 also has swing arm holes 29 which can be threaded or have bolts 35 welded in place. The bolt 35 in swing arm 3 may be aligned with the main arm holes 30 so that the swing arm 3 and primary arms may be joined. The plurality of hole 30 allows for the width of the opening defined by the joining of the swing arm 3 and primary arm 5 to be varied for trees of various widths.
The primary arm 5 and main arm 6 are equipped with a prop brace 28 on which a climbing prop 24 is located. This climbing prop 24 can be fitted with a retractable stud 25 as discussed in more detail below and as shown on FIG. 2.
FIG. 2 shows the prop 24 and retractable stud 25 as used on the base 49. Studs 25 are threaded and cooperate with threads in bolt 26 which lies over a hole drilled through the prop 24. Prop 24 is mounted to base 49 by way of the forward most portion of the base 49 which comprises a prop brace 28. The rear of each stud 25 is equipped with a stud adjustment 27 for turning the stud 25. In this way the stud 25 may be extended or retracted. The tip of the stud 25 is shown in contact with a tree 50 in this embodiment. The studs 25 may be used for climbing and retracted when the stand is in place or may be extended when in place and not used for climbing to avoid injury to the tree 50. Studs 25 may be similarly place on the prop 24 of the hand climber 1.
The foot climber 2 comprises a foot climber base 49 from which a foot climber main arm 6 extends. This main arm 6 is also equipped with one or more main arm holes 30. There is a foot climber swing arm 4 which has one or more swing arm holes 29 to receive a bolt 35a on either side. The foot climber main arm 6 and foot climber swing arm 4 cooperate like the hand climber swing arm 3 and hand climber primary arm 5. The foot climber main arm 6 is attached to a leader 31 which is in turn attached to a pivot 33 which is, in turn, attached to a wing nut 34 for securing the main arm 6 to the swing arm 4 in a manner identical to that used on the hand climber 1. The foot climber 2 has one or more holes 29a on either side of the foot climber swing arm 4 for mounting bolt 35a. The foot climber 2 has holes 30a to receive bolt 35a on either of two main arms 6.
The foot climber 2 is attachable to the feet of the user at the base 49 by way of adjustable foot straps 36. The foot straps 36 are adjustable for a tighter or looser fit by having buckles 51 which receive either end of the straps 36. These foot straps 36 are attached to the base 49. The users foot is also held in place by an elastic band 37 running generally behind the straps 36. Elastic band 37 is held in place by a band holder 48 which is a metal strip running along the width of the base 49. The elastic band 37 runs through an eye hole bolt 38 which is behind and between the foot straps 36 and is mounted onto the base 49.
The eye hole bolt 38 separates the elastic band 37 into a section behind the left foot and a section behind the right foot. Each of these sections has a pull tab 39 attached so that the user may pull back the elastic band 37 to insert or release a foot easily.
The main arm 6 serves as a mounting for a seat 22. Seat 22 is held on seat pivots 44 which hold the seat to a plurality of seat arms 40 which are mounted on seat arm pivots 41. In this way the seat 22 may be folded down onto the base 49 for transporting. When the seat 22 is lifted it is held in place by seat belt 53. The seat 22 defines a pocket 23 which may be shut by way of a zipper 23(a). This seat 22 is positioned directly below the gun rest pad 9 for easy access.
The stand defined in this specification provides for a gun rest comprising two gun rest arms 7 attached by gun rest pivots 8 to the foot climber main arm 6. A tension adjuster 21 is held by way of gun rest support arm upper pivot 43 to the gun rest support arm 42 which is in turn attached to foot climber main arm 6 by way of lower pivot 52. This arrangement provides that the gun rest arms 7 must move through the tension adjustment 21 to rise or fall. When the tension adjustment 21 prevents the movement of the arms 7, the invention is held fixed in place.
As can best be seen by reference to FIG. 6, gun rest arm 11 passes through the tension adjuster 21. The position of the gun rest pad 9 is thereby controlled. The tension adjuster 21 consists of a sleeve 19 having a rear opening 12 and a forward opening 15. The sleeve 19 has exterior threads 13 which correspond to and cooperate with interior threads 16 on the cap 20 which is the second part of the tension adjuster 21. The forward opening lies at the end of a slanted portion of the sleeve. Two slits 15 are defined by the forward portion of the sleeve so that the forward portion 15 may be compressed to put tension on the gun rest arm 11. This tension is applied when the forward portion of the sleeve is screwed into the cap 20 which slants downward to cause this effect. In the preferred embodiment, the cap 20 can be turned while the sleeve 19 is held in place by pivot 43 shown on figure 1 so that it may be easily reached by the user who is sitting with his back to the tree 50 and his front to the gun rest bar 9.
FIG. 3 shows that when the seat 22 and gun support 9 are fully folded the base 49 and foot climber main arm 6 form an angle of more than 90 degrees. The pocket between the two main arms 6 can receive the hand climber 1. The hand climber primary arm 5 is bent at a similar angle to that formed by the base 49 and main arm 6. The hand climber 1 is more narrow than the distance between the main arms 6 so that the hand climber 1 may be packed within the foot climber 2 for transporting.
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An improved tree stand incorporating two part design having improved carrying capability, adjustable shooting rest bar designed for quiet adjustment, retractable climbing and mounting studs, improved foot straps and improved adjusting means for climbing tree wrapping arm comprising wingnuts with pivoted attachments to a leader attached to fixed bolts in the tree wrapping arms.
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This is a division, of U.S. patent application Ser. No. 08/561,896 filed Nov. 22, 1995, now U.S. Pat. No. 5,573,112.
FIELD OF THE INVENTION
The present invention relates to the field of sporting goods and equipment. More specifically, the present invention relates to embodiments of a golf bag and method of making which subdivides the central containment area of the golf bag into individual compartments which extend the full length of the golf bag, and which provides for a series of inner portions which may fit into a common outer portion.
BACKGROUND OF THE INVENTION
Conventional golf bags have a central containment volume in the form of an elongate cylindrical space. Typically the top or entrance of the golf bag may be reinforced with structures tending to divide only the entrance of the contained volume. While a subdivision of only the entrance of the golf bag helps to protect the club heads to a degree, the club shafts within the bag are free to bump and scratch each other. Further, the extent of the subdivision of the space at the entrance of the golf bag is typically limited to three or six openings. This number does not provide even separation of the clubs, which must be stored at least two clubs per opening. The opening subdivision structure also tends to have thick dividing members which restrict the entrance opening into the golf bag. Consequently a larger number of small subdivided spaces equates to a lesser overall opening space into the golf bag.
Many prior golf bags have attempted division of the bag space. For example, U.S. Pat. No. 5,392,907 to Blanchard et al, and entitled "Golf Club Separating Insert," discloses a series of hexagonal tubes forming a honeycomb pattern and encased in a golf bag. U.S. Pat. No. 4,172,484 to Luther T. Henning, and entitled "Golf Bag" discloses a further variation on the honeycomb pattern resulting in a hexagonal shaped golf bag.
U.S. Pat. No. 5,255,781 to Dulyea, Sr., entitled "Club organizer for Golf Bags", discloses a rigid continuous star shaped insert having a pinched configuration, and which uses connector inserts to hold the pinched configuration. U.S. Pat. No. 5,279,414 to Brasher, entitled "Golf Club Bag with Club Compartments", discloses a square golf bag having a center tube held in place by a series of angled compartments sized to carry the golf clubs with the handles in the up position. U.S. Pat. No. 5,226,533 to Antonious entitled "Golf Club Holder Insert for a Golf Bag" discloses a central finned tube inserted into a golf bag and wherein the central tube is higher than the rim of the golf bag.
These structures all disclose a rigid, heavy solution to the problem of sub-dividing the space within a golf bag. The method for joining the dividers only adds to the weight
A pair of golf bags constructed earlier this century disclosed full length dividers. Great Britain patent No. GB-02-1911 disclosed a first embodiment having a transverse cross section divided into pie shaped chambers. A second embodiment disclosed a length of serpentine arranged material which formed a series of outwardly directed cup shaped (when view ed from the transverse direction) spaces used to support golf clubs individually. Bindings of leather close the bottoms of the formed pockets, and a central rod is used to hold the bag together.
In U.S. Pat. No. 1,798,638 to J. O. Stone and entitled "Golf Club Holder" a series of strips of material are sewn together with alternating width location seems such that when one set of opposite corners are pulled apart and secured to the inside of the golf bag, a 9×9 matrix is formed. A simpler model illustrating a seven unit matrix is also shown.
The problem with these designs include their weight, and in the case of Stone, the necessity to vertically anchor the expanded matrix along the length of the golf bag. Further, where the bottom of a series of individual spaces is closed or pinched, there may be a tendency to either wear the end of the golf club handle or to readily wear out the bottom and adjacent side edges of the individual chamber.
One bag which has been on the market has enabled a subdivision of the spaces of a golf bag from the entrance to the bottom. This bag has been originally commercially available by Cal Malibu, Inc. and sold under the trademark name CROSPETE®. The pattern involves looping side pockets, with the central space defined by the outer portion of the side pockets and also subdivided by an "X" divider. The upper two or three inches of the divided space is stiffened, giving way to soft material extending toward the bottom of the golf bag. Each space formed within the CROSPETE® bag is individual, extending all the way to the bottom of the bag. The CROSPETE® bag has 10 small storage spaces about the inner periphery of the bag in combination with four central storage spaces created by the "X" shaped divider which divides the remaining space. The advantages of providing individual spaces include the preservation of the golf clubs. The even dispersion of the spaces within the golf bag prevents the clubs from bunching at one side of the bag or the other. For golfers who carry their bags, the prevention of bunching can assist the golfer in carrying the bag.
Consequently it is important to prevent bunching of the clubs, and to stabilize them within the golf bag. It is preferable that they be stabilized about the periphery of the golf bag, but a given diameter golf bag has a limited peripheral space in which to store the clubs. What is needed is a bag which will enable separate storage spaces for clubs and will enable the distribution of the clubs in a pattern about the periphery of the bag space. The needed design should provide for some give and take between the individual storage spaces and should protect the grip ends as well as possible. The needed design should also allow for better control of the individual compartments, and avoid some of the irregular space which arises due to the "looping" of the material about the inner periphery of the golf bag. The area available for club storage should be subdivided to equalize areas available for club storage, yet not occupy the available area at the upper end of the bag.
Even more importantly, the design should accommodate the slamming of the golf club down into the bag with no appreciable wear of the dividers or the golf club grip end, and without a loud sound. The removal of the clubs should be accompanied by no binding or entangling of the golf club whatsoever.
The distribution should provide a compromise between the limited interior perimeter of a golf bag and the advantages of peripheral distribution of the clubs within the golf bag. The needed golf bag should be easy to construct. The construction of the needed golf bag should be amenable to a process which consistently produces a uniform high quality product.
SUMMARY OF THE INVENTION
The golf bag of the present invention is formed of an outer portion including a plurality of closable compartments as is typical in golf bags for the storage of golfing accessories. However, an inner portion is provided having a golf club storage configuration which helps circumferentially distribute the load from the weight of the clubs about the internal periphery of the golf bag. The storage area has various shapes which are incorporated to lend stability to the golf bag, protect the clubs, and make the golf bag easier to use and carry. The golf clubs may be carried in storage spaces formed about the periphery of the inner portion.
The inner portion is made up of material sewn along the axial length of the inner portion and supported by a more rigid tubular exterior. The rigid tubular exterior is sewn to the soft cloth interior at one end to enhance the support and separation of the soft cloth interior, by providing a pulled anchoring of the soft cloth interior and its associated divider set. In one embodiment, the lower edge of the soft cloth interior is recessed one inch above the base of the rigid tubular exterior to provide adequate clearance for a central bumper pad carried in the base of the outer portion. In another embodiment, a plastic shield is provided which is sewn to the softer material and which may be provided with a rubber pad on the interior.
Several embodiments, and their variants, are shown which operate to distribute the clubs spacing. By keeping the bulk of the clubs (or accessories) in a position where they cannot move around significantly and cannot shift across the middle axis of the bag, the fully loaded golf bag will be less apt to shift balance and will be more enabled to maintain a stable balance.
A first embodiment is formed by joining each of four lengths of material having a "V" cross section, from one point on an inner portion, to a square core, and then to another point on the inner portion. A second set of lengths of material join the midpoint of the "V" to the outer periphery of the inner portion. A second embodiment is had by subdividing the core in half.
In a third embodiment, the storage area has the shape of a six pointed star and provides six separate storage spaces between the six pointed star and an outer covering of the inner portion and six separate storage spaces in the tips of the six pointed star, and a storage space at the middle of the star. A fourth embodiment is formed by providing a divider which subdivides the core in half.
The fifth embodiment is achieved by using a hexagonal core and attaching angled sections to the core to form a six pointed star shape. A sixth embodiment is formed by subdividing the core of the third embodiment into halves.
A seventh embodiment is centered about a centrally located right angled cross divider and having individual curved sections of material added to the angular space between the right angled sections of the cross divider. These added sections have sufficient material and are sewn along a sufficient amount of the cross divider to form a relatively smaller diameter curve about midway to the center point of the cross divider. In an eighth embodiment, two additional individual compartment portions are added to each angular space between the right angled sections of the cross divider.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention, its configuration, construction, and operation will be best further described in the following detailed description, taken in conjunction with the accompanying drawings in which:
FIG. 1 is a perspective exploded view of a first embodiment of the golf bag of the present invention and illustrated with the inner portion above the main golf bag outer portion;
FIG. 2 is a downward view into an assembled golf bag which was shown in FIG. 1;
FIG. 3 is a typical length of material which is incorporated into the golf bag of the present invention and is shown being fitted at its upper end with a fold of reinforcing material;
FIG. 4 illustrates a perspective end view of the segments which are joined together to form the divider system shown in FIGS. 1 and 2;
FIG. 5 illustrates the formation of the soft collar where a flexible plastic strip is sewn with a padded material and folded inwardly to form a collar;
FIG. 6 illustrates the soft outer cylindrical layer being sewn to the structure shown in FIG. 4 along with the collar of FIG. 5 and including reinforcement sewing at each place where the divider structure contacts the collar;
FIG. 7 illustrates the surrounding of the soft cylindrical layer with a plastic cylindrical member having an elongate seam, as well as the addition of a reinforcing ring underneath the collar, and how the base of the plastic cylindrical member is sewn to the lower edge of the soft cylindrical layer;
FIG. 8 is an alternative method of construction using a lower plastic insert and attachment structure;
FIG. 9 is a schematic view of the lengths of material and their seams which are joined to make the embodiment of FIGS. 1, 2, and 4;
FIG. 10 is a view similar to FIG. 4, but with the addition to an additional length of material to form a central divider;
FIG. 11 illustrates a second embodiment formed by adding the additional length of material as shown in FIG. 10;
FIG. 12 illustrates a fifth embodiment of the golf bag of the present invention in the shape of a six pointed star within a circle;
FIG. 13 illustrates a perspective end view of the end segments which are joined together to form the divider system shown in FIG. 12;
FIG. 14 is a schematic view of the lengths of material and their seams which are joined to make the embodiment of FIGS. 12 and 13;
FIG. 15 illustrates a fourth embodiment formed by adding an additional length of material to subdivide the central space;
FIG. 16 illustrates a perspective end view of the end segments which are joined together to form the divider system shown in FIG. 15;
FIG. 17 illustrates a seventh embodiment of the golf bag of the present invention in the shape of a right angled cross providing space for curved outwardly disposed pockets;
FIG. 18 illustrates a perspective end view of the end segments in a position to be joined together to form the divider system shown in FIG. 17;
FIG. 19 is a schematic view of the lengths of material and their seams which are joined to make the embodiment of FIGS. 17 and 18;
FIG. 20 is a view similar to that of FIGS. 17-19, but with the addition of two additional lengths of material to form an additional peripheral divider;
FIG. 21 illustrates a perspective end view of the end segments in a position to be joined together to form the divider system shown in FIG. 20; and
FIG. 22 is a schematic view of the lengths of material and their seams which are joined to make the embodiment of FIGS. 20 and 21.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The description and operation of the invention will be best described with reference to FIG. 1. FIG. 1 is an exploded view of the golf bag 21 of the present invention which generally includes an outer portion 23 and an inner portion 25. The golf bag housing or outer portion 23 is a shell which may be formed in a conventional manner. The outer portion 23 has various compartments 27, as well as a carrying strap 29. The compartments 27 are typically closable as by zippers, snaps, and the like. The compartments 27 are typically used to carry extra towels, golf balls and tees. The outer portion 23 also may have a base 31 which may have structures to protect the bag 21 when it is placed on the ground.
The inner portion 25 includes an outer relatively rigid covering portion 33 which includes a vertical length of stitching 35 to form the covering portion 33 into a cylinder. Stitching 35 is shown in dashed line format, as is all stitching the drawings whether identified by number or not. Dashed lines indicate stitching, especially in the schematic drawings of FIGS. 9, 14, 19 and 22. The upper part of the inner portion 25 includes a thickened rim 37 and an upper shape which is suitable to interfit with the golf bag outer portion 23. The inner portion 25 is configured to fit within the outer portion 23 and may be held therein by a combination of glue or a strap from the outer portion 23 which secures the inner portion 25.
Also shown in FIG. 1 is a rubber pad 39 which is inserted into the outer portion 23 before the inner portion 25 is introduced. The rubber pad 39 protects the ends of the grips of the golf clubs and is arranged to cushion and keep quiet the golf clubs as they are placed in the golf bag.
Referring to FIG. 2, a view taken along line 2--2 of FIG. 1 illustrates the overall configuration of the first embodiment of the golf bag 21. The inner portion 25 of the first embodiment has a central rectangular area and a series of lengths of materials forming dividers which extend virtually the full length of the inner portion 25. As will be shown, some clearance can be left to accommodate a foam or rubber pad which may be mounted in the base of the outer portion 23 of the golf bag 21. Limiting the extent to which the inner dividers which form divider set 40, extend in the downward direction, will cause an accommodation for the raised height rubber pad 39.
The dividers of FIG. 2 have a pattern which was based upon the sewn construction thereof. The central rectangle was made of one length of material 41. Each set of further dividers are made from a single length of material 43 which extends from a connection to the outer periphery, to a connection with the rectangular length of material 41, to a connection to the outer periphery. In addition, the center of each length of material 43 is also connected to the outer periphery of the divider structure by a single length of material 45. Note that some of the connection points have a series of end segments extending from the joints at angles which represent sharp deviations to the adjacent material. These end segments are used to assist in the sewing of the lengths of material 41, 43, and 45 to each other and to the periphery of the inner portion 25.
Since cloth material does not form a good bond based upon point contact, the end segments help to better hold the materials in a sewn fashion. Although not explicitly shown in FIG. 2, a thin length of material surrounds and is immediately connected to the lengths of material 41, 43, and 45 formed into the divider pattern shown in FIG. 2. The details of the construction will be shown beginning with FIG. 3.
FIG. 3 illustrates a length of material 43. Length of material 43 is shown, although either of the lengths of material 41 and 45 could be shown as an equivalent for purposes of the reinforcement material illustrated. The lengths of material 41, 43, and 45 differ only in their width.
A small piece of reinforcing material 47 is stitched to the top end of the length of material 43 using a pair of stitches 49. The reinforcing material 47 may be felt or corduroy. The purpose of the reinforcing material 47 is twofold. First, it provides some stiffening and reinforcing influence on the top of the divider group. Secondly, it can provide a finishing layer which will give an improved appearance.
Referring to FIG. 4, an exploded perspective view of the end portions of the divider formed by the lengths of material 41, 43, and 45 is shown. Ideally, the lengths of material 43 and 45 will be sewn with one edge of the rectangular material 41 at a time. As the fourth set of the lengths of material 43 and 45 are joined to the rectangular length of material 41, the rectangular length of material 41 may be simultaneously closed.
Referring to FIG. 5, the formation of a collar 51 is shown. The collar 51 is made up of three layers of material. These materials have an area of expanse, although the term length will be used for simplicity. As can be seen in the Figures, the area of expanse must be sufficient to cover the inside and outside of the golf bag 21 structures with which the material is associated. A well-finished, rubber backed material 53 is sewn and arranged to be folded over the line of joinder of the three materials to form a soft, attractive rim. A second length of material 55 is made of relatively thin, relatively rigid material, such as polyvinyl chloride. This material will support being sewn to the divider structures previously shown in FIGS. 1-4.
Between the rubber backed material 53 and the inner second length of material 55 is a length of ring accommodating material 57.
As can be seen, rubber backed material 53 is oriented such that the rubberized side faces and is joined to ring accommodating material 57. This enables the rubber backed material 53 to be brought upward and around the seam where it is joined to materials 55 and 57 and down along side the inside of material 55 to expose the finished surface and to hide the rubber backing completely.
The length of ring accommodating material 57 has a gentle groove along its length which will accommodate a welded ring between the ring accommodating material 57 and the second length of material 55.
It is preferable for a thin length of covering material 61 to be incorporated into the divider structure at the same time in which the collar 51 is formed, and also while the divider assembly is formed. The upper edge of the thin length of covering material 61 is preferably captured between the second length of material 55 on the outside and the rubber backed material 53 as it extends downward along the inner surface of the collar 51. This sewing step could be facilitated by using a form or other structure to hold the layers together during sewing.
A pair of stitching 62 surrounds the second length of material 55 and may extend through a part of the thin length of covering material 61.
In some cases only a limited extent of the upper edge of the thin length of covering material 61 need be captured between the second length of material 55 and the rubber backed material 53, to facilitate this sewing procedure. Optionally, the reinforcing material 47 may be used along the upper length of the thin length of covering material 61 where further reinforcement and rigidity is needed. However, the reinforcing material 47 would preferably be somewhat thinner in order to prevent undue packing of the upper end of the divider set 40.
The thin length of covering material 61 may preferably be made slightly longer than the lengths of material 41, 43, and 45. At the upper end, this would enable more of it to be trapped in the layers forming the collar 51.
At the lower end of the divider set 40, this enables the end of the lengths of material 41, 43, and 45 to be recessed with respect to the thin length of covering material 61. This accomplishes several important functions. First, it enables the further sewing of the one inch length of covering material 61 which extends beyond the end of the lengths of material 41, 43, and 45 forming the divider structure. Second it provides a clearance for the rubber pad 39 which may be attached to the bottom of the outer portion 23. Third, the clearance will exceed the height of the rubber pad 39 and will thus provide some further clearance between the materials 41, 43, and 45 and the rubber pad 39 so that the ends of the golf club grips will not continually rub the bottom edge of the materials 41, 43 and 45 with their edges. This will contribute to a longer life for the divider while not subjecting the grips to rubbing by the divider material.
Referring to FIG. 6, the length of material 61 is joined together by an elongate stitch 63, while the collar 51 is joined by a short joining stitch 65. Also shown is the ring 67 being brought into place to be moved over the length of material 61 and outside of the second length of material 55, but inside the softer length of ring accommodating material 57 of the collar 51. The ring 67 is typically about one fourth of an inch in diameter and may have welded ends rather than to be formed of a single length of material. The ring 67 rests against the second length of material 55 and within the groove in the softer length of ring accommodating material 57. The groove enables the ring 67 to be retained in place, especially once the inner portion 25 is brought to rest within the outer portion 23, to create clamping forces on the upper part of the inner portion 25.
Once the structure shown in FIG. 6 is formed, it has no rigid covering portion 33 as was shown in FIG. 1. The rigid covering portion 33 should preferably be made of a relatively thin layer of polyvinyl chloride. A length of such material is readily made into a cylinder by the use of an elongate stitch 35. The bulk of the lengths of material 41, 43, and 45 which form the divider structure beneath the collar 51 are then slipped into the covering portion 33.
Ideally the diameter of the covering portion 33 will somewhat match the diameter of the second length of material 55 so that neither one will "jam" into the other. The covering portion 33 is attached to the thin length of covering material 61 adjacent the bottom edge of the material 61. Thus, the covering portion 33 will be able to rotate about one fourth of an inch or less against the second length of material 55.
Also shown in FIG. 7, is a perspective view of the bottom of the inner portion 25 showing how the bottom of the divider set 40 is attached to the rigid covering portion 33. A single bottom stitch 68 surrounds the bottom periphery of the inner portion 25 joining the thin length of covering material 61 to the rigid covering portion 33. In this manner, the rigid covering portion 33 tends to anchor the thin length of covering material 61, which in turn stabilizes the lengths of material 41, 43, and 45, to stabilize the spacing and orientation of divider set 40.
The resulting structure leaves the only connection that the collar 51 will have with the rigid covering portion 33 to be through the thin length of covering material 61. The fact that the rigid covering portion 33 abuts the lower edge of the collar 51 will be sufficient to keep the structure of the divider set 40 in tact. Preferably, the vertical stitching 35 does not join the rigid covering portion 33 with the materials 41, 43, and 45 making up the divider structure.
FIG. 8 illustrates an alternative embodiment for the exterior of any of the inner portions 25 shown with respect to the present invention. In this embodiment, the rigid covering portion 33 is not added and the exterior of the divider set 40 will be formed by thin length of covering material 61. This view also fully illustrates vertical stitching 69 which joins the thin length of covering material 61 to the lengths of material 43 and 45. As can be seen, this connection will enable the inner materials 41, 43 and 45 to be held in their proper shape once the thin length of covering material 61 is pulled down and into place by the rigid covering portion 33 shown in FIG. 7.
However, for FIG. 8, a planar length of material 71 is joined to the thin length of covering material 61. The method of joining is by a circular stitch 73 which engages the lower edge of the thin length of covering material 61 as it is flared out parallel to the planar length of material 71.
The tension or downward anchoring necessary to keep the divider set 40 in an oriented position may be had through a patch of velcrostick material 75 which may be either one of an area of hook-like and felt like material to engage the other of hook-like or felt-like material which would be in place at the bottom of the outer portion 23. Both pieces of material 75 would preferably be fitted with adhesive, although it may be sewn to the planar length of material 71. As golf clubs are continued to be loaded into the completed golf bag 21, the material 71 will become even more attached and even further stabilize the divider set 40.
FIG. 9 illustrates a schematic overview of how the lengths of material 41, 43, and 45 are cut, sewn, partially or fully folded and joined. The dashed lines between each set illustrate the starting points for the vertical joinder of the relative two lengths of material. FIG. 9 is a guide as to how the material is cut and the relationships between the individual lengths of material 41, 43, and 45.
Referring to FIG. 10, a view similar to that shown in FIG. 4 is illustrated, but being partially completed. Also, there is the addition of an extra length of material which will form a center divider 79. Center divider 79 sub-divides the central space within the rectangular length of material 41 into two triangularly shaped spaces to form the second embodiment or divider set 81. Thus, without the center divider 79, the resulting golf bag 21 will have 13 individual compartments, while with the center divider 79 the golf bag will have 14 individual compartments. Note that for both the 13 and 14 compartment versions how evenly spaced and proportioned are the individual compartments.
Referring to FIG. 12, a third embodiment divider set 83 is made in the shape of a six pointed star shape structure, including its outer circle which is now known to be formed of the finished side of rubber backed material 53. The divider set 83, is made up of an inner hexagonal portion 85, and a series of outer angled portions 87, surrounding the inner hexagonal portion 85.
Each outer angled portion 87 extends from a point at the circular periphery of the divider set 83 to its midpoint where it is attached to an outside corner of the inner hexagonal portion 85 and then to another point at the circular periphery of the divider set 83. Both of the points of attachment for each outer angled portion 87 are shared with the other angled portions 87 such that each point of attachment provides attachment to two angled portions 87. The angled portions 87 again have some additional material to facilitate rugged sewn attachment.
FIG. 13 illustrates a perspective end view of the end segments which are joined together to form the divider system which was shown in FIG. 12. Again, the inner hexagonal portion 85 and outer angled portions 87 will carry reinforcing material 47 at the top edge as was shown in FIG. 3. The thin length of covering material 61 used in the first two embodiments will be joined to the embodiment of FIG. 13 in an identical pattern, although it is not shown in FIG. 13. Since both the inner hexagonal portion 85 and the outer angled portions 87 will preferably be made of soft thin material, the material may initially assume a rather limp overall shape.
As an alternative to all embodiments, both the inner hexagonal portion 85 and outer angled portions 87 can be made by using semi-rigid materials and the like. Of course, where very thin materials will be used, the star shape at the top of the divider set 73 may give way to a more loose internal organization. However, as will be shown, where an outer layer such as thin length of covering material 61 is joined to the rigid covering portion 33 in a manner identical to that for the first and second embodiments, the six pointed star shape will be sufficiently maintained along the depth of the divider.
FIG. 14 illustrates a schematic overview of how the inner hexagonal portion 85 and outer angled portion 87 are joined together with the thin length of covering material 61 to form the embodiment of FIGS. 12 and 13.
FIG. 15 illustrates a fourth embodiment formed by adding an additional length of material, or center divider 89 to form divider set 91. Without the center divider 89, the resulting divider set 83 defines 13 individual compartments. With the center divider 89, the divider set 91 defines 14 individual compartments.
FIG. 16 illustrates the formation of divider set 91, and including the presence of the center divider 89. The thin length of covering material 61 used in the first two embodiments will be joined to the embodiment of FIG. 16 in an identical pattern. Although the pattern shown is represented by the shapes of the center divider 89, inner hexagonal portion 85 and outer angled portions 87, in their final form which are shown in exploded view apart from each other, the sewing operation will involve sequentially forming one joint or connection at a time.
Typically the connections relating to the center divider 89 will be formed such that one connection will be first formed with a corner of the inner hexagonal portion 85 to its associated outer angled portion 87, and the connection to the collar 51 and or thin length of covering material 61 will be made after the corners of the inner hexagonal portion 85 are all attached to their outer angled portions 87. The center divider 89 will preferably be added during the connection of the first outer angled portion 87 and then during the connection of the fourth outer angled portion 87. In this manner the center divider 89 is added as the inner hexagonal portion 85 is formed. An equivalent method would be to form the center divider 89 as the second and fifth corners are attached to the center divider 89. Another equivalent method would involve the formation of the center divider 89 as the third and sixth corners of the inner hexagonal portion 85 is formed.
Again shown in FIG. 16 is the presence of reinforcing material 47. It is also still possible to attach the thin length of covering material 61 while the inner hexagonal portion 85, center divider 89 and the outer angled portions 87 are being attached.
FIG. 17 illustrates a seventh embodiment of the golf bag of the present invention in the shape of a right angled cross providing space for curved outwardly disposed pockets. This divider set 95 includes a first main divider 97 and a second main divider 99. A number of individual compartment portions 101 are distributed between the ends of the first and second main dividers 97 and 99. Two of the individual compartment portions are numbered 100 and 102 to show a starting point and a finishing point. Since an equal number of individual compartment portions 101, 100 and 102 are distributed between the ends of the first and second main dividers 97 and 99, right angles are formed at the center of the divider set 95.
As can be seen in FIG. 18, the first and second main dividers 97 and 99 are joined at their respective midlines to each form a right angle with itself and also a right angle with respect to the space between the first and second main dividers 97 and 99, respectively. The individual compartment portions 101, 100, and 102 are not merely left to assume a freeform shape, but are joined to each other and to a main divider 97 or 99. The joinder of the individual compartment portions 101, 100, and 102, as well as the specification of the width of the individual compartment portion widths that will be used for a given diameter of the divider set 95, will determine the relative distribution of the area available for storage.
Each compartment portion 101, 100, 102 is circumferentially outwardly disposed and defines an outer compartment space 103 in its outwardly disposed area, and defines an inner compartment space 105 between directly adjacent compartment portions 101, 100, and 102 and one or both of the first and second main dividers 97 and 99. Thus, adjacent compartment spaces 103 and inner compartment spaces 105 have areas of approximately similar magnitude.
Further, the adjacent compartment portions 101, 100, and 102 to be joined need only be joined with sets of stitching 107 which are shown as controlling the shape and curvature of the resulting compartment space 105 and the space within the outer compartment spaces 103. At the junctions of the individual compartment portions 101, 100, and 102 are small end portions 108, similar to the end portions shown in earlier Figures, which helps to secure the divider set 95 to the collar 51, as was shown for the first embodiment.
Referring to FIG. 18, a perspective end view of the end segments during formation to manufacture divider set 95 are shown. They are in a position to be joined together to form the divider system 95 shown in FIG. 17. The reinforcing material 47 has been eliminated from FIG. 20 for clarity of illustration. Normally, all embodiments of the inner portion 25 will be expected to have such portions of reinforcing material 47 at the ends unless the material of construction is otherwise thick or durable enough to withstand an accidental poke from the end of a golf club.
Alternately, the top portions of the material 41, 43, 45, 85, 87, and 89 can be folded over on itself and sewn with stitches 49 to provide a reinforcing thickness. An insert can be incorporated where desired, to further stiffen the upper edges for any of the embodiments of the invention.
The process for constructing the inner portion 25 of FIGS. 17 and 18 may be best accomplished by first joining the first and second main dividers 97 and 99 at their center points. Next, pairs of individual compartment portions 101, 100, and 102 may be sewn together, remembering to leave small end portions 108 to enable the individual compartment portions 101, 100, and 102 to be better secured to the inside of the collar 51. Next, pairs of the formed sets of compartment portions 101, 100, and 102 are joined to both sides of one of the projections of one of the first and second main dividers 97 and 99.
The first operation of joining pairs of individual compartment portions 101, 100, and 102 involve four steps. The second operation of joining pairs to the first and second main dividers 97 and 99 also involves four steps. Both steps involve sewing the applicable materials all the way along their length.
After these steps have been accomplished, all that is left is to join the resulting structure to the collar 51 while adding on the thin length of covering material 61.
FIG. 19 is a schematic view of the lengths of material and their seams which are joined to make the embodiment of FIGS. 17 and 18. This embodiment involves the use of several pieces, but the fact that the individual compartment portions 101, 100, and 102 are exactly alike saves time and improves the accuracy and quality of the product formed.
FIG. 20 is a view similar to that of FIGS. 17-19, but with the addition of two additional lengths of material to form a pair of additional compartment portions 109. Since the additional compartment portions 109 cause the resulting total number of compartment portions 101, 100, and 102 and 109 to be unevenly divided about the periphery of the resulting divider set 111 of the eighth embodiment, the first and second main dividers 97 and 99 will not meet at right angles.
Where divider set 95 contained 12 individual compartments, including outer compartment spaces 103 and inner compartment spaces 105, the divider set 109 contains 14 such individual compartments. Since divider set 109 will probably exist within the same overall outside diameter as the divider set 95, the compartments are proportionately smaller. A set of four inner compartment spaces 105 includes two which are larger and two which are smaller. A set of ten outer compartment portions 101, and 109 are presumably of equal size thus causing the uneven division of space between the pairs of inner compartment spaces 111. Alternatively, the angles of the first and second main dividers 97 and 99 could remain at the right angled relationship of FIG. 18 while the sizes of the individual outer compartment spaces formed by portions 101 and 109 could be enabled to vary.
FIG. 21 illustrates a perspective end view of the first and second main dividers and the adjacent compartment portions 101 and 109 in a position to be joined together to form the divider system shown in FIG. 20. Again, the reinforcing material 47 is not shown, only for illustrative convenience and clarity. It is understood that the widths of the adjacent compartment portions 101 and 109 may be altered to change the overall function of the configuration shown in FIG. 20. The widths of the compartment portions 101 and 109 and the location of the stitching 107 could be adjusted to give any configurational mix to the divider set 101.
FIG. 22 is a schematic view of the individual lengths of material, including individual compartment portions 101, 100, and 102, 109 and first and second main dividers 97 and 99 used to form divider set 111.
As can be seen, each of the divider sets 40, 71, 73, 81, 95 and 111 can fit into a common outer portion 23. Thus, the divider sets 40, 71, 73, 81, 95 and 109 can be used with outer portions 23 of various configurations, colors and types to enable further customization of the golf bag 21 without having to commit to a complete golf bag 21 configuration.
While the present invention has been described in terms of a golf bag, and in terms of several embodiments of an interior portions to be inserted into an outer portion of a golf bag, as well as the method of construction of the inner portions, one skilled in the art will realize that the structure and techniques of the present invention can be applied to many appliances. The present invention may be applied in any situation where compartments are to be created which are to circumferentially balance the load resulting from placement of objects in the compartments.
Although the invention has been derived with reference to particular illustrative embodiments thereof, many changes and modifications of the invention may become apparent to those skilled in the art without departing from the spirit and scope of the invention. Therefore, included within the patent warranted hereon are all such changes and modifications as may reasonably and properly be included within the scope of this contribution to the art.
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A golf bag of the present invention is of two-tube construction and has an outer tubular portion including a plurality of closable compartments. An inner tubular portion is provided having several embodiments of a golf club storage configuration which helps circumferentially distribute the load from the weight of the clubs about the internal periphery of the golf bag. The two-tube construction makes for a lighter, stronger, golf bag. The inner portion is made up of material sewn along the axial length of the inner portion and supported by a more rigid tubular exterior. The rigid tubular exterior is sewn to the soft cloth interior at one end to enhance the support and separation of the soft cloth interior, by providing a pulled anchoring of the soft cloth interior and its associated divider set. In one embodiment, the lower edge of the soft cloth interior is recessed one inch above the base of the rigid tubular exterior to provide adequate clearance for a central bumper pad carried in the base of the outer portion. In another embodiment, a plastic shield is provided which is sewn to the softer material and which may be provided with a rubber pad on the interior.
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This is a continuation of application Ser. No. 08/473,525, which was filed on Jun. 7, 1995, now abandoned, which is a divisional of Ser. No. 08/447,351, filed May 23, 1995, now U.S. Pat. No. 5,782,760.
BACKGROUND OF THE INVENTION
This invention generally relates to a system for detecting electrical activity or signals within a patient's heart and particularly for determining the source of signals causing arrhythmia from within a blood vessel of the patient's heart.
Prior methods for treating a patient's arrhythmia include the use of antiarrhythmic drugs such as sodium and calcium channel blockers or drugs which reduce the Beta-adrenergic activity. Other prior methods include surgically sectioning the origin of the signals causing the arrhythmia or the conducting pathway for such signals. More frequently, however, to terminate the arrhythmia the heart tissue which causes the arrhythmia is destroyed by heat, e.g. applying a laser beam or high frequency electrical energy, e.g. RF or microwave, to a desired location on the patient's endocardium
In the latter instance, the location of the tissue site causing or involved with the arrhythmia must be accurately known in order to be able to contact the desired location with a tissue destroying device. A major problem of ablating the site of the origin of the signals or a conductive pathway is to accurately determine the location of the site so that an excessive amount of good tissue is not damaged or destroyed along with the arrhythmogenic site, while at the same time ensuring that the arrhythmia does not return. For example, the average arrhythmogenic site consists of an area of about 1.4 cm 2 of endocardial tissue, whereas a re-entrant site might be much larger. RF ablation techniques produce lesions about 0.5 cm 2 in area, so several lesions may be necessary to completely ablate an area of interest. If the arrhythmogenic or re-entrant site is not accurately mapped, much good tissue surrounding the site will be unnecessarily damaged or destroyed.
A variety of prior methods have been used to detect electrical activity within a patient's heart to facilitate the mapping of electrical activity causing the arrhythmia. A number of these prior methods are disclosed in U.S. Patents which use elongated intravascular signal sensing devices with one or more electrodes on a distal portion of the device which are advanced through the patient's vasculature until the distal portions of the sensing devices are disposed within one or more of the patient's heart chambers with one or more electrodes in contact with the endocardial lining. While this procedure is widely used, it does not always allow the site of arrhythmogenic signals to be accurately determined.
In copending application Ser. No. 08/188,619, filed Jan. 27, 1994, now U.S. Pat. No. 5,509,411, reference is made to intravascular devices which are advanced through a patient's coronary arteries or cardiac veins to desired locations in the patient's epicardium where electrical activity is detected by means of electrodes on the distal ends of the devices to locate arrhythmogenic sites or conductive pathways causing or involved with arrhythmia. In copending application Ser. No. 08/207,918, filed Mar. 8, 1994, now abandoned, an intravascular device is described which uses RF energy to occlude a blood vessel in order to destroy tissue distal to the catheter by creating ischemic conditions therein.
What has been needed is a method and system for accurately detecting the source of signals which cause the arrhythmia and to create an lesion which effectively terminates the arrhythmia without detrimentally effecting tissue not involved with the arrhythmia.
SUMMARY OF THE INVENTION
This invention is directed to an elongated intravascular device for creating a lesion in tissue adjacent a patient's blood vessel from within a patient's blood vessel. The device preferably has means for detecting electrical activity in adjacent tissue from within the blood vessel to facilitate accurate placement of the device within the blood vessel to ensure creating an effective lesion. The device is particularly suitable for creating a lesion in a patient's heart which terminates the electrical activity causing an arrhythmia.
The intravascular device of the invention comprises an elongated shaft with proximal and distal ends, a port in the distal end and a guidewire lumen extending through at least the distal section of the shaft to the guidewire port in the distal section. The distal section of the shaft is configured so as to be advanceable through the desired blood vessel or other desired body lumen, such as the patient's coronary arteries or cardiac veins. The device may also be used in blood vessels or other body lumens in other parts of the patient's body.
In accordance with the invention, distal shaft section is provided with at least one emitting electrode which is electrically connected by means of a conductor which extends through the shaft to a high frequency electrical energy source exterior to the patient. The emitting electrode on the distal shaft section preferably forms the distal tip of the elongated shaft and has an inner lumen extending to the port in the distal end which is a continuation of the lumen extending within the shaft. This allows the intravascular device to be advanced over a guidewire to the desired location within a body lumen where the ablation is to occur.
To form an effective lesion in the tissue adjacent to the body lumen without causing unnecessary tissue damage, the temperature of the emitting electrode should be controlled during emission between about 70° C. and 100° C. and preferably about 75° C.-85° C.
To effectively cool the electrode, it is preferably provided with one or more fluid directing passageways which extend radially or longitudinally to facilitate passage of cooling fluid when the emitting electrode is in operation. Alternatively, the emitting electrode may be provided with a sheath on the exterior thereof which directs cooling fluid along the outer surface to control surface temperatures. The emitting electrode may be provided with a proximal tubular extension which is secured by a suitable adhesive within the inner lumen extending within the shaft.
In one presently preferred embodiment, a plurality of sensing electrodes are also provided on the distal shaft section proximal to the emitting electrode so that electrical activity can be detected in tissue adjacent to the body lumen to ensure accurate placement of the emitting electrode within the body lumen and effective lesion formation. The sensing electrodes may be electrically configured for monopolar or multipolar operative modes. Up to 15 or more sensing electrodes may be provided along the distal shaft section. The sensing electrodes may have constant or variable electrode spacings and they may be arranged in a first array of sensing electrodes with a compact spacing and a second array of sensing electrodes with a much greater spacing than that in the first array. In this latter embodiment, the second array of sensing electrodes may be used to detect the general location of electrical activity, such as an arrhythmogenic site or pathway, and then the first array may be utilized to more accurately pinpoint the area of interest based upon the general location detected by the first array of sensing electrode means. The interelectrode spacing in the second array of electrodes should be between about 0.25 and about 2 mm, preferably between about 0.5 and about 1.5 mm, and the interelectrode spacing between the electrodes in the first array may be about 1 to about 10 mm. When a bipolar or multipolar mode of sensing is to be used, the spacing between a pair of bipolar electrodes may be much less than the spacing between pairs of bipolar electrodes.
The shaft of the intravascular device is preferably formed of a plurality of individually insulated electrical conductors braided or wound into an elongated tubular member with the inner lumen extending therein. However, not all of the braided strands which make up the tubular member need be electrical conductors. Some may be high strength fibers such as nylon, Kevlar® and the like. The insulation on individual electrical conductors is exposed adjacent to each of the electrodes to facilitate an electrical connection with the electrode and the electrode may be secured to the exposed conductor by means of a suitable solder or brazing material. The sensing electrodes may be secured by their inner periphery to the underlying tubular member formed of electrical conductors by a suitable adhesive to further ensure maintenance of electrical contact between the electrodes and the exposed conductors.
The sensing electrodes may be circular bands about 0.25 to about 1 mm in width (the longitudinal dimension when on the device) and are preferably made from conducting material such as gold which is biocompatible with the body fluids.
A plastic jacket, preferably a lubricous polymer such as a thermoplastic fluoropolymer, Pebax or a polyethylene may be provided on the exterior of the shaft with a slight overlap of the jacket over the edges of the individual electrodes to prevent exposure of a sharp metallic edge which can cause damage when the elongated device is advanced through blood vessels. The entire exterior of an electrode need not be exposed. For example, the plastic jacket may be disposed about the distal shaft section on which the electrodes are mounted and holes may be made in the jacket to expose small portions of the underlying electrodes. The proximal ends of the electrical conductors connected to the electrodes are electrically connected to one or more multi-pin connectors on the proximal end of the shaft which may be configured to be connected to a receiving member in electrical communication with a video unit which can display representations of the electrical activity sensed.
When using the intravascular device of the invention, a guiding catheter is first introduced into the patient's vasculature and advanced therein until the distal tip of the guiding catheter is seated within the ostium of the coronary sinus or the ostium of a coronary artery. A guidewire is then advanced through the guiding catheter out the distal end thereof and then directed to a desired venous or arterial branch. The intravascular device of the invention is advanced over the guidewire to the desired location where the lesion is to be formed. The sensing electrodes on the distal section of the intravascular device are used to detect the electrical activity causing or involved with the arrhythmia. Once located, the position of the intravascular device can be adjusted to the extent necessary to place the emitting electrode on the distal tip of the device within the vessel as close as possible to the tissue causing or involved with the arrhythmia so, when the lesion is formed by emitting high frequency electrical energy, the tissue in question is within the lesion.
With the device of the invention, the arrhythmogenic site is accurately detected and the lesion formed is large enough to encompass the site with little damage to tissue not involved with the arrhythmia so as to effectively and permanently terminate the arrhythmia. These and other advantages of the invention will become more apparent from the following detailed description of the invention and the accompanying exemplary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an elevational view of an intravascular device having features of the invention wherein an emitting electrode is provided on the distal end of the device for the delivery of high frequency electrical energy.
FIG. 2 is a transverse cross-sectional view of a distal portion of the intravascular device shown in FIG. 1 taken along the lines 2--2.
FIG. 3 is a longitudinal cross-sectional view of a distal portion of an alternative embodiment of the invention wherein a plurality of radially extending passageways are provided in the emitting electrode to allow for the passage of cooling fluid.
FIG. 4 is a transverse cross-sectional view of the embodiment shown in FIG. 3 taken along the lines 4--4.
FIG. 5 is a longitudinal cross-sectional view of a distal portion of another alternative embodiment of the invention wherein a plurality of longitudinally extending passageways are provided in the emitting electrode to allow for the passage of cooling fluid.
FIG. 6 is a transverse cross-sectional view of the embodiment shown in FIG. 5 taken along the lines 6--6.
FIG. 7 is an elevational view, partially in section, of another alternative embodiment of the invention wherein a portion of the emitting electrode is provided with an insulating sheath.
FIG. 8 is a transverse cross-sectional view of the catheter shown in FIG. 7 taken along the lines 8--8.
FIG. 9 is an elevational view, partially in section, of another alternative embodiment of the invention wherein a sheath is positioned on the exterior of the proximal end of the emitting electrode to direct cooling fluid onto the outside of the electrode.
FIG. 10 is a transverse cross-sectional view of the catheter shown in FIG. 9 taken along the lines 10--10.
FIG. 11 is an elevational view, partially in section, of another alternative embodiment of the invention wherein an expandable balloon is provided on one side of the distal section of the device so when it is inflated, the emitting electrode will be urged against the interior of the body lumen.
FIG. 12 is a transverse cross-sectional view of the catheter shown in FIG. 11 taken along the lines 12--12.
FIG. 13 is a longitudinal cross-sectional view of another alternative embodiment of the invention wherein the distal section of the device is provided with an emitting electrode formed of a coiled wire.
FIG. 14 is a transverse cross-sectional view of the catheter shown in FIG. 13 taken along the lines 14--14.
FIG. 15 is a longitudinal cross-sectional view of an embodiment similar to that shown in FIGS. 13 and 14 but with separate guidewire and fluid lumens.
FIG. 16 is a transverse cross-section of the catheter shown in FIG. 15 taken along the lines 16--16.
FIG. 17 is a longitudinal cross-sectional view of the distal section of another embodiment of the invention.
FIG. 18 is a transverse cross-sectional view of the embodiment shown in FIG. 17 taken along the lines 18--18.
DETAILED DESCRIPTION OF THE INVENTION
Reference is made to FIGS. 1-2 which schematically illustrate an embodiment of the invention wherein the elongated intravascular device 10 includes shaft 11 with a distal section 12 and a proximal section 13 and an inner lumen 14 extending within the shaft. The shaft 11 has a braided tubular member 15 formed of a plurality of electrical conductors 16. All the strands forming the tubular member 15 need not be conductors 16, some may be formed of polymer materials such as nylon or Kevlar®. The distal section 12 of the shaft 11 is provided with an emitting electrode 17 at the distal tip and a plurality of sensing electrodes 18 located proximal to the emitting electrode.
The emitting electrode 17 has a proximal tubular extension 19 which extends within the inner lumen 14 and is secured by suitable adhesive to the interior surface of the braided tubular member 15. One or more individual insulated electrical conductors 16 are electrically connected by solder 20 to the emitting electrode 17. Individual insulated electrical conductors 16 are also electrically connected to the sensing electrodes 18 by solder (not shown). The conductors 16 extend to the proximal end of the shaft 11 where they are bundled and formed into cable 21 leading to multiple pin electrical connector 22 where each electrical conductor is connected to a separate pin (not shown). The proximal extremity of the conductor or conductors electrically connected to the emitting electrode 17 are electrically connected through the pins to a source of high frequency electrical energy (RF or microwave) and the proximal extremities of the conductors electrically connected to sensing electrodes 18 are connected through the pins to a display system (not shown) where representations are presented on the signal received by the sensing electrodes.
Preferably a safety wire 23 extends within the wall of the shaft 11 and is secured by its distal end to the emitting electrode 17 to prevent its loss within the patient. The distal extremity 24 of the safety wire 23 is coiled within the shaft wall proximal to the emitting electrode 17 and is bonded by suitable adhesive 25 to the proximal extension 19. The proximal end of the safety wire may be secured to the a band (not shown) in the shaft 11 spaced proximal to the emitting electrode 17.
A conventional adapter 27, which is secured to the proximal end of the shaft 11, has a central arm 28 for entry of a guidewire into the inner lumen 14 and a side arm 29 also in fluid communication with the inner lumen 14 for delivery of flushing or cooling fluid to the emitting electrode 17 on the distal section of the shaft. An O-ring may be provided in the proximal hub of the central arm 28 to prevent the escape of fluid.
The embodiment shown in FIGS. 3 an 4 is essentially the same as the embodiment shown in FIGS. 1 and 2 (and is similarly numbered) except that a plurality of radially extending passageways 30 extend between the inner lumen 14 and the exterior of the electrode 17. The guidewire 31, having a core 32 and a coil 33 on the distal extremity of the core, is slidably disposed within the inner lumen 14 and the coil on the distal end of the guidewire extends beyond the passageways 30 and to a significant extent occludes the inner lumen 14 and reduces considerably the passage of fluid through the port 34 in the distal tip of the emitting electrode 17. Fluid flowing through the inner lumen 14 will then be forced to flow through the radial passages 30 thereby cooling the emitting electrode 17.
Another embodiment is shown in FIGS. 5 and 6 where the emitting electrode 17 has longitudinally disposed passageways 35 for directing cooling fluid from the inner lumen 14 through the electrode and out the ports 36 in the distal tip of the electrode. A tubular sheath 37 formed of a high strength polymer material, such as polyimide, extends between the body of adhesive 25 securing the coiled distal extremity of the safety wire 24 to the tubular extension 19 of the emitting electrode 17 to the proximal end of the electrode to direct fluid which passes from the inner lumen 14 through the ports 38 in the tubular extension 19 to the passageways 35 as indicated by the arrows shown in FIG. 5. The intravascular device shown is otherwise essentially the same as the prior devices and is similarly numbered. A guidewire 31 may be used to occlude inner lumen 14 as in the prior embodiment to ensure an adequate flow of cooling fluid through passageways 35 to maintain the temperature of the emitting electrode 17 at a desired level.
FIGS. 7 and 8 illustrate yet another embodiment of the invention wherein an arcuate insulating sheath 40 is secured about an exterior portion of the emitting electrode 17 to ensure a more focused emission of high frequency electrical energy from a smaller exposed portion of the electrode toward the tissue to be treated to control the size of the lesion formed. This device is for the most part the same as the previously discussed embodiments, except for insulation sheath 40, and is therefore similarly numbered.
Another embodiment is depicted in FIGS. 9 and 10 wherein a fluid control sheath 41 which is secured by its proximal extremity to the adhesive 25 and extends over the exterior of the emitting electrode 17. The inner diameter of the distal end of the sheath 41 is slightly larger than the outer diameter of the electrode 17 to provide an annular gap 42 therebetween which directs cooling fluid along the exterior surface of the electrode as indicated by the arrows. The cooling fluid passes from the inner lumen 14 through the ports 38 in the tubular extension 19 and through the annular gap 42. In this embodiment a guidewire 31 is disposed within the inner lumen 14 with the coil 33 at least partially occluding the distal portion of the inner lumen so that an adequate flow of cooling fluid passes along the exterior of the electrode 17 to ensure sufficient cooling thereof.
In larger blood vessels, it frequently is difficult to maintain contact between the emitting electrode 17 and the blood vessel wall. To overcome this problem, it is desireable to provide an expandable positioning member, such as an inflatable balloon 43, which when inflated ensures contact between a desired portion of the blood vessel wall 44 and the emitting electrode 17 as shown in FIGS. 11 and 12. An inflation lumen 45 extends through the shaft 11 from its proximal end to a location within the interior of the balloon 43. To accommodate for the extra lumen a three arm adapter (not shown) is secured to the proximal end of the shaft. While only one sensing electrode 18 is shown in the drawings, a plurality of sensing electrodes may be provided proximal to the balloon 43. The maximum transverse dimension of the balloon 43 as measured from the opposite side of the shaft 11 may range from about 0.5 to about 5 mm, preferably about 1.5 to about 4 mm.
FIGS. 13 and 14 represent another embodiment where the emitting electrode 50 is a helical coil on the distal end of the shaft 11. The proximal end of the coil 51 is secured by solder 52 to the distal end of the shaft 11 shown in FIG. 13 to facilitate an electrical connection with the conductors 16 in the shaft 11 and the distal end of the coil is secured by adhesive to the enlarged distal end 53 of the lining 54. Perfusion holes 55 are provided in lining 54 to allow fluid passing through inner lumen 14 to contact and thus cool the coil 51.
In the embodiment shown in FIGS. 15 and 16 the inner lumen 14 is disposed within the inner tubular member 60 which extends to the distal tip 61. Annular lumen 62 extends between the interior surface of braided tubular member 15 and the exterior surface of inner tubular member 60. Electrode coil 63 is secured by its proximal end to the shaft 11 by solder 64 and is electrically connected to a conductor of the braided tubular member 15. The distal end of the coil 63 is secured to the distal tip 61 by a suitable adhesive or by fusing the distal tip about the distal end of the coil. In this embodiment the delivery of cooling fluid through the annular lumen 62 is independent of a guidewire (not shown) in lumen 14.
FIGS. 17 and 18 illustrate the distal portion of yet another embodiment of the invention where an emitting coil electrode 70 is secured to the distal tip of shaft 11 by means of adhesive or solder. A safety wire 71, which extends through the shaft 11 as in the previous embodiments, is soldered to the distal tip of the emitting coil electrode 70. Sensing electrodes 18 are provided on shaft 11 proximal to the emitting electrode coil 70 as in the previous embodiments. The details of shaft 11 are the same as shown in the prior embodiments.
The overall length of the intravascular devices of the invention may range from about 80 to about 300 cm, typically about 120 to about 175 cm for delivery through the femoral artery or vein and about 80 to about 120 cm for delivery through the brachiocephalic artery or internal jugular vein. Because the intravascular device is to be advanced over a guidewire, the guidewire must be longer than the catheter by about 20 to about 60 cm. The outer diameter of the shaft of the intravascular device should be less than about 0.065 inch (1.65 mm) and preferably about 0.035-0.06 inch (0.89-1.5 mm). The inner lumen 14 has an inner diameter of about 0.01 to about 0.04 inch (0.25-1 mm) to facilitate the reception and advancement of a guidewire therethrough, which is typically about 0.010 to about 0.018 inch (0.25-0.46 mm) in outer diameter. The diameter of the inner lumen through the emitting electrode may be much smaller than the diameter of the inner lumen in the more proximal portions of the shaft 11. The distal section 12 of the shaft is about 3 to about 20 cm in length. An intermediate section having an intermediate stiffness may be provided between the proximal section 13 and the distal section 12 with a length of about 5 to about 40 cm in length, typically about 20 cm in length. The radial passageways 30 are typically about 0.02 inch (0.5 mm) in diameter and the longitudinal passageways 35 are typically about 0.01 inch (0.25 mm). The emitting electrode is generally longer than about 2 mm. For solid electrodes the length is generally less than about 10 mm, but for an emitting electrode in the form of helical coil the length may be about 2 to about 30 mm, preferably about 2 to about 20 mm.
To the extent not previously described, the materials of construction of the intravascular device of the invention may be formed of conventional materials. The electrical conductors 16 may be electrical grade copper wire about 0.003 inch (0.08 mm) in diameter which are provided with a thin insulated jacket or coating of polyimide or other suitable insulator. The outer jacket may be a thermoplastic polyurethane such as PBAX which is available from Eif Atochem Polymers of Philadelphia, Pa. The jacket of the proximal section is preferably Pebax 1147, the jacket of the intermediate section is Pebax 6333 and the jacket of the distal section is Pebax 4033. The sensing and emitting electrodes are preferably formed of an alloy of platinum and iridium, e.g. 90% Pt and 10% Ir (wt. %) or of Gold (100%). The safety wire 23 may be a stainless steel wire about 0.003 inch (0.08 mm) in diameter with a polyimide coating. The preferred solder used to join the electrical conductors to the various electrodes is 95% Sn-5% Ag or 80% Au-20% Sn.
One presently preferred method of using the elongated intravascular device includes first advancing a guiding catheter through the patient's vascular system until the distal tip of the guiding catheter is seated within the coronary sinus ostium or the ostium of one of the coronary arteries. The guiding catheter is torqued by its proximal extremity which extends out of the patient to guide the distal tip into the selected ostium. Once the distal end of the guiding catheter is seated, the intravascular device of the invention with a guidewire slidably disposed within the inner lumen thereof are advanced through the guiding catheter and out the distal end thereof. The guidewire is first advanced into the target vein or artery and the intravascular device of the invention is advanced over the guidewire into the target blood vessel. The sensing electrodes 18 on the intravascular device of the invention are used to detect electrical activity which allows the physician or operator to determine the location of the arrhythmogenic focus. When the focus is located, the intravascular device is moved within the blood vessel, as required, to position the emitting electrode 17 as close as possible to the focus. High frequency electrical energy, preferably in the RF range, is directed through the electrical conductors 16 connected to the emitting electrode 17 to form the desired lesion which encompasses the arrhythmogenic focus. Energy levels of about 5 Watts to about 100 Watts, preferably about 30 Watts to about 70 Watts are suitable to terminate most arrhythmias. Typical lesions formed are about 3 mm to about 20 mm in diameter and about 3 mm to about 20 mm in length. In some instances, where the site of the arrhythmic activity is detected by other means, an intravascular device may be utilized which does not have sensing electrodes. For example, the guidewire utilized to advance the intravascular device of the invention into the desired blood vessel may be provided with sensing electrodes for detecting the electrical activity of interest. A suitable device is described in copending application Ser. No. 08/188,619, filed Jan. 27, 1994, which is incorporated herein by reference.
While there are several means described herein to cool the emitting electrode, a wide variety of means can be used to control the temperature of the emitting electrode. For example, the electrical energy to the emitting electrode can be controlled so as to maintain the temperature thereof. A thermistor or other temperature sensing device can be employed to monitor the electrode temperature and the temperature sensed is used to control in a conventional feedback arrangement the electrical power delivery.
Although individual features of one embodiment of the invention may be described herein and shown in one or more of the drawings and not in others, those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment of the invention. Various modifications and improvements may be made to the invention without departing from the scope thereof.
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An over-the-wire electrophysiology catheter which has an emitting electrode on the distal tip electrically connected to a source of high frequency electrical energy. The intravascular device is configured to be advanced through a patient's cardiac veins or coronary arteries and preferably is also provided with sensing electrodes for detecting electrical activity of the patient's heart from within a blood vessel of the heart. The device forms large lesions in tissue adjacent to the blood vessel in which the device is located without significantly damaging the blood vessel to effectively terminate signals causing arrhythmia.
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RELATED APPLICATION
The present application claims priority to, and the benefits of, U.S. Provisional Application Ser. Nos. 60/765,144, filed Feb. 4, 2006, and 60/842,074, filed on Sep. 1, 2006, the entire disclosures of which are hereby incorporated by reference.
FIELD OF THE INVENTION
This invention relates generally to safety helmets and, in particular, to helmet straps and their adjustment.
BACKGROUND OF THE INVENTION
Helmets for head protection are worn in a variety of environments and for various purposes. Helmets are often secured to a wearer's head by a flexible chin strap. The chin strap may include multiple segments of flexible strap material that are secured at either side of the helmet and pass below the chin, where the segments are releasably joined. In some helmets the strap segments on either side of the helmet are attached to the helmet at two positions, in front of and behind the wearer's ear. When joined, the two strap segments form a single strap that may be adjusted in length. Many of the available approaches to connecting the strap segments are cumbersome and lack security. In some cases, for example, the wearer must pass one end of the strap through a buckle or a pair of “D-rings” with a return loop, making it difficult to quickly remove the helmet in an emergency. In other cases, a quick release “snap” lacks security due to the possibility of accidental release. Two-finger release mechanisms, while more secure, typically attach to the ends of the strap segments and thus require intervening length in line with the straps. This makes it difficult to place the fastener near the chin, which can be important to the stability of the helmet.
Simplifying the strap arrangements may reduce the awkwardness of disengagement, but often at the price of reduced helmet stability. For example, single-strap systems may allow play in the helmet when worn. Indeed, even multiple-strap systems can allow helmet movement if the straps are not aligned so as to maintain consistent lines of tension.
SUMMARY OF THE INVENTION
The present invention provides practical and reliable solutions to the foregoing problems. In various embodiments, the invention provides a secure retention system for protective helmets that facilitates easy adjustment. In particular, the stability of a protective helmet is improved when the straps that connect to the helmet on each side have substantially straight, continuous lines of tension extending through the buckle that joins them. Accordingly, in preferred embodiments, two V-shaped strap segments are drawn into an “X” configuration that channels the tension in the straps along continuous lines, rather than allowing the tension to dissipate in an intervening length of strap.
For example, a releasable two-part buckle in accordance with the invention may comprise a male component attached at one end to a flexible strap segment and having at least two fingers extending from the other end of the component, which can snap-engage a female component. The engagement can be released by simultaneously pressing the two fingers. In a preferred embodiment, the female component has a pass-through area along its underside, parallel to the direction of introduction of the male component, through which a second flexible strap segment may be passed. Flush abutment between flat surfaces of the male and female components without significant intervening linear space helps maintain tension between the strap components.
In one embodiment, a system of flexible straps comprises a chin-holding component having one strap segment passing below the chin and another strap segment passing between the chin and the lower lip; retention components on left and right sides of the helmet having one strap segment connecting to the front portion of the helmet and another strap segment connecting to a rear portion of the helmet; and a connecting device of the present invention joining the chin-holding component to the retention component on one side of the wearer's head such that the strap segments intersect substantially in the shape of the letter “X”.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:
FIG. 1 is a plan view of the male and female components of a buckle in accordance with the present invention.
FIG. 2A is an upper plan view of the buckle of FIG. 1 in the connected position.
FIG. 2B is a lower plan view of the buckle of FIG. 2A .
FIG. 3 is an exploded view of the buckle of the present invention showing the flexible straps to which the male and female components are to be connected.
FIG. 4 shows another embodiment of the present invention in plan view.
FIG. 5 shows the two embodiments of the female component of the buckle taken from FIG. 1 and FIG. 4 to illustrate the critical geometry of the present invention.
FIG. 6 is a side view of a protective helmet with straps connected at the chin using a buckle constructed according to the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
With reference to FIG. 1 , a buckle in accordance with the present invention comprises a male component 51 and a female component 54 coupling together flexible straps comprising, with respect to male component 51 , strap segments 57 a , 57 b , and with respect to female component 54 , strap segments 60 a , 60 b . Male and female components 51 , 54 are preferably molded from a strong, flexible, resilient plastic material such as Nylon or Delrin. The fingers 63 a , 63 b and guide member 66 are received within a receptacle area 69 of the female component 54 using normal manual pressure. During this coupling movement, fingers 63 a and 63 b deflect laterally toward guide member 66 until engaging features 72 a , 72 b have cleared surfaces 75 a , 75 b of the female component 54 . At this point, the flexibility of the fingers 63 a , 63 b cause them to return outwardly to their uncompressed position, so that surfaces 75 a , 75 b resist return movement of engaging features 72 a , 72 b , thereby preventing separation of the male component 51 from the female component 54 . The female component 54 has openings 78 a , 78 b that afford access to fingers 63 a , 63 b following insertion of the male component 51 into the female component 54 .
With reference to FIGS. 2 and 3 , fingers 63 a , 63 b are sufficiently exposed through the openings in the female component 54 to permit the wearer to pinch the fingers and flex them inwardly, thereby freeing the engaging features 72 a , 72 b from surfaces 75 a , 75 b and allowing the male component 51 to be withdrawn from the female component 54 . A flexible intermediate strap 81 passes through a slot 79 in male component 51 , and a flexible intermediate strap 87 is secured to female component 54 through a pass-through area 84 .
In the preferred embodiment, intermediate strap 81 is sewn or otherwise permanently affixed to the flexible strap components 57 a , 57 b . As illustrated, the components 57 a , 57 b are part of the same single length of strap, which is folded to form a V-shaped configuration. Alternatively, however, components 57 a , 57 b can be separate strap segments that are joined to form the same configuration. In either case, the apex 88 of the V is substantially aligned (i.e., flush) with the abutment face 90 of male component 51 , which, when the male and female components are locked, makes contact with a complementary abutment surface 93 of the female component 54 . As a result, the edges of the V-shaped straps at their apices are substantially in contact along the entire apex 88 edge length.
Similarly, the pass-through area 84 in the female component accepts intermediate strap 87 , which is sewn or otherwise affixed to strap segments 60 a , 60 b and positioned so that the apex 89 of the V is substantially flush with the abutment surface 93 . The pass-through area 84 is oriented parallel to the direction of introduction of the male component 54 , and locates the tensioning region of the strap segments 60 a , 60 b adjacent the front surface 93 of the female component 54 , very close to the point where the female component joins the male component.
It is also possible to utilize the invention with single linear strap segments rather than V-shaped segments. In this case, the male component 51 may be connected to one of the single straps directly through the slot 79 (see FIG. 2 ) instead of employing the intermediate strap 81 , and the female component 54 may be connected directly to the other single strap using the pass-through area 84 , thereby obviating the need for the intermediate strap 87 . Another alternative is to use one free, single strap and one V-shaped strap, in which case it is advantageous for the male component 51 to be connected to the single strap directly through the slot 79 and the female component 54 to be connected to the V-shaped strap via intermediate strap 87 .
FIG. 4 illustrates another embodiment 54 ′ of the female component. The component 54 ′ has many of the same features as the female component 54 shown in previous figures, including receptacle area 69 , surfaces 75 a , 75 b , and openings 78 a , 78 b which cooperate with features of the male component 51 as described previously. Straps 60 a , 60 b are attached to the component 54 ′ via mounts such as the slots 95 a , 95 b . This embodiment is particularly well suited to applications where two straps are joined at the female side with one or two straps on the male side.
FIG. 5 shows how both female components 54 and 54 ′ share the critical geometry that allows tension to pass through the buckle without being dissipated by intervening linear space. The dotted lines A-A′ and B-B′ follow the tension in the flexible straps 60 a , 60 b respectively. The slots 95 a , 95 b are angled toward each other so that the lines of tension A-A′ and B-B′ intersect each other at or very near the front surface 93 of the female component. As can be seen in FIG. 5 , both embodiments 54 and 54 ′ of the female component provide this geometry. When the male and female components are engaged, these lines of tension are substantially continuous—that is, the lines A-A′ and B-B′ shown in FIG. 5 are substantially congruent with complementary lines from the V-shaped strap of the male component. This is because when the male and female portions of the buckle are locked, the V-shaped straps come together to form the letter “X,” so that tension in the opposed straps are aligned. This has been found to substantially improve helmet stability.
FIG. 6 shows a system of helmet straps employing the buckle of the present invention to secure a protective helmet 96 . A chin-holding component comprises the strap segment 57 a , which passes between the chin and the lower lip, and the strap segment 57 b , which passes below the chin and is joined to the male component 51 of the buckle. The retention strap segment 60 a is connected to the side of helmet toward the front, and the strap segment 60 b is connected to the side of the helmet toward the rear. These are joined, as described above, to the female component 54 of the buckle. When the male component 51 is inserted into the female component 54 , the strap segments 57 a , 57 b and 60 a , 60 b abut to form the letter “X” because the buckle does not occupy significant space between them. The result is improved stability of the helmet 96 with respect to the wearer's head.
Having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. The described embodiments are to be considered in all respects as only illustrative and not restrictive.
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A mounting buckle for a safety helmet includes at least one mating member configured for attachment to a V-shaped strap having an apex, the apex of the strap being substantially flush with the abutment surface. This configuration channels the tension in the straps along continuous lines, rather than allowing the tension to dissipate in an intervening length of strap.
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CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application Ser. No. 12/507,684, filed Jul. 22, 2009, which claims the benefit of U.S. provisional patent application No. 61/082,653, filed Jul. 22, 2008 (now expired).
TECHNICAL FIELD
[0002] Embodiments of the subject matter described herein relate generally to video game technology. More particularly, embodiments of the subject matter relate to massively multiplayer online video game technology.
BACKGROUND
[0003] Massively multiplayer online (“MMO”) games enjoy tremendous popularity, with some games numbering players in the hundreds of thousands or even millions. Such games' players typically control one or more player characters, and these player characters interact with other player characters as well as with non-player characters, i.e., characters controlled by the system, and further interact with the game environment itself.
[0004] A central design goal for an MMO is to bring the world and characters of the game environment to life. Giving the game environment believable characters and features requires that the experience be engaging, deep, and immersive.
[0005] Typical cut scenes or narrative voice overs (VO) are used to enliven characters in a game. However, players have certain expectations of properties with well-known or iconic characters, e.g., licensed superheroes, and in a game setting, the game environment should make each iconic character feel rounded and real. The environment should connect players with such characters personally and socially, creating an illusion that the characters have lives and ambitions beyond any one interaction a player may have with them.
[0006] In other words, part of the immersion experience for a player is to have realistic and/or engaging responses from non-player characters and the environment. In prior systems, such responses have had little or no reliance on a player character's prior actions or on game (or world) events. To the extent they did, they were based on prior quests completed, or other such generic game variables.
BRIEF SUMMARY
[0007] Implementations of the system and method enhance the realism of a simulation such as an MIO by enhancing the relationship of non-player characters to player characters, using, e.g., personal contact, social communication, and shared history. Personal contact means that the player character acts alongside the non-player character, in many cases fighting with or against the player character. Quests, tasks, or the like, are arranged such that the non-player character purposely encounters the player character. Social communication is described in more detail below and pertains to acts and speech which communicate information from the non-player character to a player character. For personal contact and social communication, a given non-player character may have a range of responses, based on, e.g.: variety (to avoid repetition), relationship with the player character, and framing (to give context to what the player character is doing). Another category, shared history, provides a way for a player character to learn more about a non-player character. For example, the player character may find a newsreel with footage about the origin of the non-player character. The level of depth for which information about a non-player character may be available may depend on the category of non-player character, e.g., primary, secondary, global, or generic.
[0008] In the social communication aspect, the system and method provide ways to make a non-player character act and communicate in a more realistic fashion, in particular, by using historical events such as prior interactions to make the non-player character's acts and communications more relevant to player characters (and thus players). In particular, the response of a non-player character to a player character action may be via one or more of various actions: a verbal response, an emotive response such as a frown, grin, or smile, or a physical response such as running away, attacking, a clap on the back, or the like. The non-player character's responses, whether actions or communications, are based on more than just standard game variables. The responses are based on the experiences of the player character, including milestones, actions, communications, as well as on in-game or world events, or in-game interpretations of world events. In essence, non-player characters are made to act and communicate as if their personalities were persistent and dynamic. This may be particularly important in the MIO environment because of its persistent nature. Non-player characters are made to appear to react to player character actions over time. They appear to form an opinion of a player character over time and this opinion can be made to affect and modify the player's experience.
[0009] To accomplish the above, data is tracked pertaining to the interaction(s) of a subject player character with other player characters and non-player characters. Non-player character responses may be based not only on interactions with the subject player character, but also on the subject player character's interactions with other player characters and non-player characters, as well as the player character's interactions with the environment, e.g., tasks attempted and subsequent results. Tracked data may also pertain to events that are relevant with or to a subject player character. In any case, tracked data may be stored on a game server.
[0010] In one aspect, the invention is directed toward a computer-readable medium, comprising instructions for causing a processor in an electronic device to perform a method of generating responses of a non-player character in a simulation. The method includes steps of: receiving a first signal from a client computing device, the first signal indicating that a player character has initiated a communication with a non-player character; calculating a response to the first signal, where the calculating includes calculating a response based on one or more acts performed by the player character prior to the receiving; and transmitting a second signal, corresponding to the response, to the client computing device, the response in part causing a video renderer or sound renderer in the client computing device to render an indication of the response on a video or audio device, respectively, or both.
[0011] Implementations of the invention may include one or more of the following. The calculating a response based on one or more acts performed by the player character prior to the receiving may include calculating a response based on one or more quests or tasks accomplished or attempted by the player character, one or more prior communications or interactions between the player character and the non-player character, or one or more prior communications or interactions between the player character and other player characters or non-player characters. The calculating a response may further include choosing one of a plurality of responses at random, or calculating a response based on one or more in-game events.
[0012] In another aspect, the invention is directed toward a computer-readable medium, comprising instructions for causing a processor in an electronic device to perform a method of enabling interactions of player characters with non-player characters in a simulation. The method includes steps of receiving a first signal, the first signal indicating that a player character is within a predetermined distance from a personal contact spawning point; and upon the receiving, transmitting a second signal to the client computing device, the second signal indicative of a contact between the player character and a non-player character. The second signal causes one or more of the following: a rendering of a communication of the non-player character addressing the player character, the rendering performed by a video renderer or a sound renderer, the rendering indicating the initiated contact on a video or an audio device, respectively, or both; a locating and rendering of the non-player character in a vicinity of the player character, the rendering performed by a video renderer or a sound renderer on a video or an audio device, respectively, or both; or an arranging and rendering of the non-player character in a situation with the player character such that the non-player character is working with or against the player character to accomplish a common task, objective, or goal, the rendering performed by a video renderer or a sound renderer on a video or an audio device, respectively, or both.
[0013] Implementations of the invention may include one or more of the following. The rendering a communication may be based on one or more acts performed by the player character prior to the receiving, including one or more quests or tasks accomplished or attempted by the player character, one or more prior communications or interactions between the player character and the non-player character, or one or more prior communications or interactions between the player character and other player characters or non-player characters. The rendering a communication may include a step of choosing one of several potential communications at random, or may be based on one or more in-game events.
[0014] In yet another aspect, the invention is directed toward a computer-readable medium, comprising instructions for causing a processor in an electronic device to perform a method of providing information about a non-player character to a player character in a simulation. The method includes: receiving a first signal, the first signal indicating that a player character is within a predetermined distance from a shared history spawning point; upon receipt of the first signal, transmitting a second signal to the client computing device, the second signal causing the client computing device to display an activatable element corresponding to information about a non-player character; and upon receipt of a third signal corresponding to an activation of the displayed element, transmitting a fourth signal to the client computing device, the fourth signal causing the client computing device to play back a media file corresponding to the information about the non-player character.
[0015] Implementations of the invention may include one or more of the following. The causing the client computing device to play back a media file may include choosing a media file to play, wherein the choosing includes choosing a media file based on one or more quests or tasks accomplished or attempted by the player character, one or more prior communications or interactions between the player character and the non-player character, or one or more prior communications or interactions between the player character and other player characters or non-player characters. The choosing a media file to play may further include choosing one of a plurality of media files at random. The causing the client computing device to play back a media file may include causing the client computing device to play back a cinematic sequence or a cut scene. The causing the client computing device to play back a media file may include choosing a media file to play, and the choosing may be based on an in-game event.
[0016] In a further aspect, the invention is directed toward a computer-readable medium comprising a system for enhancing responses of a non-player character in a multiplayer game. The medium including the following modules: a database module for storing data about a plurality of player characters, a plurality of non-player characters, and a plurality of features in a game environment; and a response calculating module for calculating responses of non-player characters to player character interactions, where the response calculating module is configured to calculate a response based on one or more acts performed by the player character, or to alternatively calculate a response based on one or more in-game events.
[0017] Implementations of the invention may include one or more of the following. The calculating module may be configured to calculate a response based on one or more quests or tasks accomplished or attempted by the player character, one or more prior communications or interactions between the player character and the non-player character, or one or more prior communications or interactions between the player character and other player characters or non-player characters.
[0018] In another aspect, the invention is directed toward a computer-readable medium comprising a system for enabling interactions of player characters with non-player characters in a multiplayer game. The medium includes the following modules: a database module for storing data about a plurality of player characters, a plurality of non-player characters, and a plurality of features in a game environment; and a response calculating module for calculating responses to player character interactions, where the response calculating module is configured to, upon receipt of a first signal indicating that a player character is within a predetermined distance from a personal contact spawning point, transmit a second signal to the client computing device, where the second signal causes one or more of the following: a rendering of a communication of the non-player character addressing the player character, the rendering performed by a video renderer or a sound renderer, the rendering indicating the initiated contact on a video or an audio device, respectively, or both; a locating and rendering of the non-player character in a vicinity of the player character, the rendering performed by a video renderer or a sound renderer on a video or an audio device, respectively, or both; or an arranging and rendering of the non-player character in a situation with the player character such that the non-player character is working with or against the player character to accomplish a common task, objective, or goal, the rendering performed by a video renderer or a sound renderer on a video or an audio device, respectively, or both.
[0019] Implementations of the invention may include one or more of the following. The communication may be based on one or more acts performed by the player character prior to the receiving, which may include one or more quests or tasks accomplished or attempted by the player character, one or more prior communications or interactions between the player character and the non-player character, or one or more prior communications or interactions between the player character and other player characters or non-player characters.
[0020] In another aspect, the invention is directed toward a computer-readable medium, comprising a system for providing information about a non-player character to a player character in a multiplayer game. The medium includes the following modules: a database module for storing data about a plurality of player characters, a plurality of non-player characters, and a plurality of features in a game environment; and a response calculating module for calculating responses to player character interactions. The response calculating module is configured to, upon receipt of a first signal indicating that a player character is within a predetermined distance from a shared history spawning point, transmit a second signal to the client computing device, where the second signal causes a client computing device to display an activatable element corresponding to information about a non-player character. The response calculating module is configured to, upon receipt of a third signal corresponding to an activation of the displayed element, transmit a fourth signal to the client computing device, the fourth signal causing the client computing device to play back a media file corresponding to the information about the non-player character.
[0021] Implementations of the invention may include that the media file is selected based on an occurrence of an in-game event, and may be a cinematic.
[0022] Advantages of the invention may include one or more of the following non-limiting examples. Non-player character responses are made so as to be more realistic by choosing or developing the responses, for a given player character, based on tracking data reflecting that player character's interactions with the non-player character, with other non-player characters and player characters, on characteristics of the player character or an associated player or user, on in-game events, on real-world events, or the like. Non-player characters may be made more realistic by having the same act alongside or against player characters in scenarios, as well as by revealing non-player character backstories by having player characters find, watch, listen to, or otherwise consume clues about the same. Other advantages will be apparent from the following description, including the figures and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 illustrates an exemplary environment of the simulation, e.g., a multiplayer game, and further illustrates how proximity to certain locations (or characters) may be employed to enhance the level of a player's immersion by providing scenarios and responses that are relevant to that player.
[0024] FIG. 2 illustrates a logical diagram of a system that may be employed to implement a simulation such as a multiplayer game, including a client-server architecture.
[0025] FIG. 3 is a flowchart of a method for implementing one embodiment of the invention, in particular employing social communication.
[0026] FIG. 4 is a flowchart of a method for implementing another embodiment of the invention, in particular employing personal contact.
[0027] FIG. 5 is a flowchart of a method for implementing yet another embodiment of the invention, in particular employing shared history.
DETAILED DESCRIPTION
[0028] Referring to FIG. 1 , an exemplary environment of the simulation, e.g., a multiplayer game, is illustrated. The environment may vary widely, and may be, e.g., a fantasy simulation, a science fiction simulation, a space simulation, a real world simulation, a city simulation, an apocalyptic simulation, a superhero simulation, and so on. The exemplary simulation of FIG. 1 shows a number of characters 32 , 33 , 34 , and 36 , and the same are shown traversing various streets 30 and 31 within a game environment 20 . In FIG. 1 , the characters 32 , 33 , and 34 are intended to portray player characters, controlled by players. The same interact with other players' player characters as well as with computer-controlled characters, termed non-player characters. The character 36 is intended to portray a non-player character, controlled by the simulation or game engine. That is, a non-player character is controlled by the simulation, either at the server level or by the client software, and the same acts in a way dictated by the software instructions and data set for that non-player character. A player may interact with the non-player character 36 by clicking on or otherwise activating icon 38 , this icon associated with the non-player character 36 . In some implementations, the player may also click directly on the non-player character.
[0029] A number of city features are also shown, such as a bank 22 , a city hall 24 , a convenience store 26 , and a private home 28 . The features will vary according to the applicable game environment. An icon 42 is also indicated adjacent the private home 28 . The user may click on such an icon 42 to, e.g., direct their focus to the private home 28 to perform any number of associated tasks, e.g., to rescue an occupant, prevent a crime, or the like. Each structure may have such an activatable element, according to the degree of interaction intended between player characters and the given structure.
[0030] A number of radii and circles, both full and partial, are illustrated, indicating how proximity to certain locations (or characters) may be employed to enhance the level of a player's immersion by providing scenarios and responses that are relevant to that player. For example, the center of the intersection of streets 30 and 31 serves as the locus of a circular zone of radius R player character or R personaContact . Similarly, the private home 28 serves as the locus of a circular zone of radius R SH or R SharedHistory . And in the same way, the bank 22 serves as the locus of a circular zone of radius R 1 .
[0031] Proximity to certain locations is just one way to initiate interactions that provide enhanced scenarios and responses. Other ways may include providing an activatable object that tells a player character about a non-player character, initiating an interaction where a non-player character plays alongside a player character, having a non-player character respond in a way that takes account of a player character's prior actions and exploits, or the like. Non-player characters within the game react to players, and their associated player characters, with a range of emotional responses cued by real-world events, player milestones, and player actions. They act as if their personalities are persistent and dynamic based on their personal history with a player character. This is not necessarily only a factional response, e.g., based on the player's reputation with a particular group for which the non-player character has a response set. Rather, it may be a deep series of verbal reactions, stories, and attitudes that convey the relationship status between the player and the character.
[0032] These and other aspects are discussed below in connection with FIGS. 3-5 .
[0033] FIG. 2 illustrates a logical diagram of a system 30 that may be employed to implement a simulation such as a multiplayer game. The system 30 includes an MMO or simulation client computing device 49 and an MMO or simulation server 45 which communicate by way of a network 48 . The client computing device 49 includes one or more processors 44 which communicates with the network 48 via a network card 46 or via a network-enabled processor (not shown). The client computing device 49 has client software running which enables communication with the network 48 and server 45 .
[0034] The client computing device 49 includes at least one input device 62 , which may include a keyboard, mouse, game controller, haptic controller, touchscreen, or other devices which may provide an input to a computer. The client 49 further includes a computer-readable medium 52 , such as a hard drive, flash memory, solid state drive, or the like, which stores instructions 54 for the processor 44 , including calculating module 56 . The computer-readable medium 52 may also store media files 58 , including graphics files, cinematics files, and media files for cut scenes. These media files may also be streamed when needed from the server 45 . In some implementations, certain media files may be downloaded to the client, especially those that are often used, and others may be kept at the server for later streaming, to avoid cluttering the client system. Certain media files are may also be cached at the client system, such as those pertaining to the immediate game locale of the player character.
[0035] The system 30 also includes a sound renderer 64 , such as a sound card, by which signals pertaining to game sounds may be put in a form suitable for playing on a sound device 68 , e.g., computer speakers. Moreover, the system 30 also includes a video renderer 66 , such as one or more GPUs or video cards, or both, by which signals pertaining to game video may be put in a form suitable for playing on a video device 72 , e.g., a computer display.
[0036] The simulation server 45 controls the game, and may be a game server having a processor 47 and running a game engine 61 and other components, including a physics engine 59 , user interface, input/output components, a database 57 , and the like. Certain of these components or modules may be implemented on a computer-readable medium 51 , which includes instruction 53 for carrying out these and other processes, including module 55 for calculating responses of non-player characters to player character actions. The computer-readable medium 51 may also include media files, including cinematics and cut scenes, for downloading or streaming to client computing devices 49 .
[0037] FIGS. 3-5 are flowcharts that illustrate certain ways to increase player immersion, primarily by enhancing the relationship of non-player characters to player characters. In particular, ways to enhance the relationship of non-player characters to player characters may include social communication, personal contact, and shared history.
[0038] The first way, an implementation of which is shown in FIG. 3 , is via social communication, which pertains to acts and speech which communicate information from the non-player character to a player character. In this aspect, the system and method provide ways to make a non-player character act and communicate in a more realistic fashion, in particular, by using historical events such as prior interactions, to make the non-player character's acts and communications more relevant to player characters (and thus players). In particular, the response of a non-player character to a player character action may be via one or more of various actions: a verbal response, an emotive response such as a frown, grin, or smile, or a physical response such as running away, attacking, a clap on the back, or the like. By way of the implementations of the system and method, the non-player character's responses, whether actions or communications, are based on more than just standard game variables. The responses are based on the player character, including milestones, actions, communications, as well as on in-game or world events, or in-game interpretations of world events. The responses may also be based on the player associated with the player character, including birthdays, anniversaries, and the like.
[0039] In the exemplary method 40 of FIG. 3 , a first step is to receive a first signal from a client computing device, the first signal indicating that a player character has initiated a communication with a non-player character (step 74 ). For example, and referring back to FIG. 1 , a player character may click on an activatable element or icon 38 associated with the non-player character 36 . Step 74 may include a step of receiving the first signal via the client computing device receiving a signal from an input device, e.g., from a game controller, keyboard, mouse, touchscreen, haptic controller, or via any other input device (step 82 ). The player may activate the element, icon, or non-player character for any number of reasons, including a request to converse, transact business such as to buy or sell items or trade skills, attack, subdue, protect, observe, rescue, transport to or away from a target location, and others.
[0040] This activating step, while sometimes employed, is not required in many implementations. That is, a non-player character may provide a response to a player with no activation step—the non-player character may provide the response, e.g., if the player character is within a certain proximity of the non-player character or a predetermined landmark. For example, as indicated in FIG. 1 , the player character 32 is shown within a radius R 1 from the bank 22 , and this proximity may be employed as a response trigger for a nearby non-player character. In the case where a response is triggered if a player character comes within a certain proximity or radius of a non-player character, then this radius may move if the non-player character moves.
[0041] Another way for a non-player character to interact with a player character is by way of a communication screen, or “communicator”. This is a pop-up display in the player's user interface that simulates a video phone call from the non-player character to the player character. Other aspects of such a response are described below in connection with ally personalization.
[0042] An optional step is to provide some indication to the player that they have activated, “clicked on”, or otherwise initiated a communication with the non-player character. This step may be accomplished by, e.g., highlighting or otherwise distinguishing the non-player character.
[0043] A second step is to calculate a response to the first signal, and transmitting a second signal back to the client computing device (step 78 ). The second signal, or another signal based thereon, is transmitted to a renderer and a rendering step is performed; this step may be accomplished, for example, by transmitting a second or corresponding signal to a GPU or video card or sound card (step 84 ) to render an indication of the response. The indication may be, e.g., an audio playback of words spoken by the non-player character, a textual indication of words so spoken, both, or the like.
[0044] The step 78 of calculating a response to the communication may be accomplished in a number of ways. For example, a response may be calculated based on prior acts of the player character (step 86 ). In other words, responses may be based on quests or tasks performed by the player character, prior communications between the player character and the non-player character, or prior communications between the player character and other characters, e.g., player characters or non-player characters, or combinations of these (step 92 ). Responses may also be given a degree of randomness (step 94 ). For example, a number of potential responses may be calculated using step 92 , and a random choice may then be made between the potential responses. The random choice ensures some degree of variety, variability and believability in the non-player character's response.
[0045] Another way to calculate a response is based on in-game events (step 88 ). For example, an in-game event may give rise to all player characters being offered certain quests or tasks related to the event. A calculated response may incorporate a mention of the in-game event or a mention of the related quests or tasks. As is known, in-game events may often be related to real life events or holidays.
[0046] In one implementation, responses may depend on player histories in the following way. Player activities across all play sessions are logged and metrics created. This metrics constitutes metadata which is then employed to drive the non-player character's state in relation to the player character. By playing the game and interacting with the non-player character, the player may skew this base state into a variety of alternate conditions. Thus there is an overall range of reactionary states in which a non-player character can be, and the player's behavior determines where on this spectrum the non-player character's responses fall.
[0047] Generally, not all non-player characters will be provided with a rich backstory. In some cases, only iconic characters are provided with such, or other characters which the developer desires to have a deeper level of communication with a player character. The amount and kind of characterization may depend primarily on the status of the player's relationship with the non-player character.
[0048] Non-player character responses for social communication may be categorized in the following non-limiting way. A first is “ally personalization” responses, e.g., voice-overs. These are responses that a non-player character sends directly to the player based on actions the player has taken, and may range from congratulations for quests successfully accomplished to admonishments for failure. Such responses may also include personal events in a player's life, such as birthdays or other important dates. Other types of ally personalization, often provided via text or voice-over, include: requests, where a non-player character requests that a player character undertake an action, and there may be variants of these requests depending on relationship or location; affirmation anchors, where a non-player character affirms actions a player character has taken; admonishment anchors, where a non-player character admonishes a player character for taking certain actions; temporal responses, where a non-player character responds to a player character in such a way as to make the player feel that the non-player character is aware of temporal events and their connection to the player, and may include past events such as anniversaries of accomplishments the non-player character and player character shared, present events such as the time of day or season, future events such as prompts or holidays established in-game or out-of-game, or personal events such as a birthday, the anniversary of the date the player began playing the game, accomplishments, or the like (assuming the same is in-character and appropriate for the non-player character to acknowledge).
[0049] Another type of response is “enemy personalization” responses, e.g., voice-overs. These are responses that a non-player character targets at a player character with a negative connotation, such as mocking or the like. These responses may also include memorable anniversaries, such as the non-player character reminding a player character of a previous battle or the like. Other types of enemy personalization, often provided via text or voice-over, include: challenge responses, where an enemy non-player character desires to challenge the player character to a face-to-face confrontation or to trick them into an action, and there may be variants of this based on relationship or location; curse or critical responses, which are negative versions of affirmations, where a non-player character curses or otherwise criticizes actions a player character has taken; temporal responses, which are similar to those described above in connection with ally personalization, but where the non-player character responds to a player character in a negative way.
[0050] Yet another type of response is related to in-game events, e.g., a non-player character's response reacting to events in-game. Such responses may include commands to players, e.g., missions, commentary, or opinions. Such responses may also include responses about group accomplishments.
[0051] Yet another type of response is a framing response, which may include the responses that a non-player character will employ to frame any content they are concerned about but not directly involved with. For example, a superhero may use a voice-over to let a player character know of an event at a given location, and that the superhero wants the player character to investigate. Such responses may be generally based on the content the character is involved in, and may be further divided into scenario type and location.
[0052] Another way to enhance the relationship of non-player characters to player characters, an implementation of which is shown in FIG. 4 , is via personal contact. Personal contact, also termed “action characterization,” means that the player character acts alongside the non-player character, in many cases fighting with or against him or her. In this implementation, quests, tasks, or the like, are arranged such that the non-player character purposely encounters the player character.
[0053] Referring to a method 50 depicted in the flowchart of FIG. 4 , a first step may include receiving a first signal indicating that a player character is within a predetermined distance from a personal contact spawning point (step 96 ). For example, in the implementation of FIG. 1 , player characters 33 and 34 are within a distance R player character from a personal contact spawning point, but player character 32 is not. This first step may include a step of receiving the first signal from the game engine (step 102 ), as the game engine may be the best source of data about where characters are in relation to each other and in relation to events of interest. Besides proximity to predefined locations, other triggers may be employed, including character mentions of keywords, proximity to certain non-player characters, and the like.
[0054] A second step is to initiate contact between a non-player character and the player character (step 98 ). The second step may be accomplished in a number of ways; in each way, generally, a second signal is transmitted to the client computing device (step 99 ). For example, a communication may be made from the non-player character to the player character, and the communication may then be rendered on the client computing device by a video or audio renderer (step 104 ). The communication may be a response that is calculated based on prior acts of the player character (step 112 ), such as quests or tasks performed by the player character, prior communications between the player character and the non-player character, or prior communications between the player character and other characters, e.g., player characters or non-player characters, or combinations of these. Responses may have a degree of randomness (step 114 ), for the same reasons and by the same techniques as indicated above in connection with steps 92 and 94 .
[0055] Another type of contact that may be initiated is to locate the non-player character in the vicinity of the player character (step 106 ). For example, the system may situate an iconic non-player character in the same vicinity as the player character, and the player character may then take the opportunity to play alongside, or against, the non-player character. In this case, the second signal causes the rendering of the non-player character in the vicinity of the player character.
[0056] In another example, the system may arrange a non-player character in a situation with the subject player character such that there is a common goal the two must accomplish, or alternatively work against each other to accomplish (step 108 ). In this case, the second signal causes the rendering of the non-player character in the vicinity of the player character and the notification of the player of the goal or goals the non-player character and player character are striving toward.
[0057] Generally, only non-player characters that are or will be part of actual gameplay scenarios may have this type of personal contact. The depth and scope of the personal contact may depend on the number of times the content calls for the non-player character to interact directly with players.
[0058] Non-player character responses for personal contact may be categorized in the following non-limiting way. Non-player characters may be provided with ally scenario responses, e.g., ally scenario voice-overs, for situations where the player character being addressed is an ally. Ally scenario responses may include: greetings, used at the beginning of a scenario, and which may include variants based on location or relationship to a player character, as well as variants based on the urgency of the scenario; objective responses, which are used to direct the player to accomplish specific tasks in an encounter, and which may include attacking, securing, protecting, transporting, destroying, or collecting a target; affirmation responses, which may be used to have the non-player character affirm the player character for successes, and different degrees of affirmation may be provided based on a player's qualitative or quantitative completion of an objective; admonishment responses, which are used to admonish the player character for mistakes, and as with affirmations different degrees of admonition may be provided; call-out responses, which are used by the non-player character as quick commands, such as “look out”, “over there”, or “stay back”; and culmination responses, employed at the completion of a scenario, and which may include variants based on location or relationship to a player character, as well as variants based on the scenario.
[0059] Similarly, non-player characters may be provided with enemy scenario responses, e.g., enemy scenario voice-overs, for situations where the player character being addressed is an enemy. Enemy scenario responses may include: interaction responses, which are generic responses employed to establish a non-player character or player character within the scenario; curse responses, which are employed when a player character is successful at a task, and there may be variants of this depending on the player character's degree of success; criticism responses, which are employed when a player character fails at a task, and there may be variants of this depending on the player character's degree of failure; call out responses, which are used by the non-player character as quick commands to his or her minions; and culmination responses, employed at the completion of a scenario, and which may include variants based on location or relationship to a player character, as well as variants based on the scenario.
[0060] Other potential personal contact responses include social responses, which again may be voice-overs or the like, and which may be the generic responses used by a non-player character in social settings. Social responses may include: greetings, used to greet player characters, and which may include variants based on location or relationship to a player character; affirmation anchor responses, which may have scenario and relationship variants and which may be used to have the non-player character affirm the player character for actions they have taken, which may be particularly relevant when a player character encounters an iconic non-player character after just playing through a scenario with them; admonishment anchor responses, which are used to admonish the player character for actions they have taken, which may have scenario and relationship variants; and redirection responses, which are employed to redirect a player to another general area or character, thus reinforcing the content line the player character is already on, emphasizing its importance.
[0061] Another potential personal contact response includes key moments responses, which again may be voice-overs or the like, and constitute specific responses non-player characters will use in corresponding specific scenarios.
[0062] As above, these responses may be in the form of voice-overs, visual effects, or a combination of the same.
[0063] For both personal contact and social communication, a given non-player character may have a range of responses, based on, e.g.: variety (to avoid repetition), relationship with the player character, and framing (to give context to what the player character is doing). For variety, i.e., in order to prevent too much repetition in phrases, each personal contact element may have, e.g., three variations, while social communication may vary as needed. Generally, shared history elements need not vary. To accommodate and account for differences in relationship with the non-player character, there may be provided a number of tiers of relationship: trusted, liked, neutral, disliked, or hated. Both personal contact and social communication may vary based on the tier. For framing, i.e., in order to frame the content users are playing, there may be location and scenario variants that allow the non-player character to give context to what the user is doing without specifically stating the same.
[0064] Yet another way to enhance the relationship of non-player characters to player characters, an implementation of which is shown in FIG. 5 , is via shared history, which provides a way for a player character to learn more about a non-player character. In this way, the player character may become aware of information about a non-player character's past history or exploits, and in this way receive an impression of the non-player character beyond just what they hear from the non-player character. For example, the player character may find a newsreel with footage about the origin of the non-player character. Other examples may include family videos, audio recordings, press clippings, personal diaries, photographs, writings or artworks, or the like. These items may be collected in the player character's inventory, and replayed whenever the user desires.
[0065] Referring to a method 60 depicted by the flowchart of FIG. 5 , a first step may include receiving a first signal indicating that a player character is within a predetermined distance from a shared history spawning point (step 116 ). This first step may include a step of receiving the first signal from the game engine (step 124 ), and/or the game database, as noted above in connection with FIG. 4 .
[0066] A second step is to choose a media file to play (step 128 ). This step may also occur after a user clicks on an activatable element as described below in connection with step 118 . The choice of media file may be by default or may be based on prior acts of the player character (step 134 ), as well as by other criteria. If prior acts are employed, the choice of media file may be based on quests or tasks performed by the player character, prior communications between the player character and the non-player character, or prior communications between the player character and other characters, e.g., player characters or non-player characters, or combinations of these. Also in this aspect, the choice of media file may have a degree of randomness (step 136 ), similar to steps 92 and 94 above. The choice of media file may also generally depend on whether the player has previously seen the media file, or whether the player has seen other shared history files which give a given media file context, e.g., “prerequisite” media files.
[0067] A next step is to transmit a second signal to the client computing device, the second signal in part causing the rendering of an activatable element pertaining to the non-player character (step 118 ). A part of this step may be accomplished, for example, by transmitting the second signal to a GPU or video card (step 126 ). This step provides an indication to the player that an opportunity for a shared history or background characterization has been offered.
[0068] As an example, in FIG. 1 , a shared history spawning point is illustrated as the private home 28 , and player characters within a proximity R SH may be enabled to see the activatable element 42 , such as an icon. For example, the player character 34 may see the element 42 , but not the player characters 32 and 33 .
[0069] By activating or clicking on the activatable element, the next step is initiated, that of rendering and playing back a media file corresponding to the non-player character (step 122 ).
[0070] In one implementation, the step 122 may include a step of playing back a cinematic sequence or cut scene (step 132 ). “Playing back” steps, such as step 132 , may include steps of sending the file to a renderer and performing a rendering step. Following playback, if appropriate, an item giving rise to the media file, e.g., a newsreel, may be placed in the player character's inventory and played back again at a subsequent time. Of course, not all shared history need be passive, e.g., watching media files. The same may involve dialogue with a non-player character or any other type of interaction in which history may be shared.
[0071] Whether social communication, personal contact, or shared history, the level of depth for which information about a non-player character is available may depend on the category of non-player character: primary, secondary, global, or generic. Primary characters, e.g., iconic non-player characters, may be provided with significant levels of all characterization types. Secondary characters serve a supporting role, and may be provided with more of one type of characterization than another, e.g., personal contact. Their social communication and shared history may be more limited, and may serve to support the primary characters. Global characters are similar to secondary ones, but have somewhat greater depth. These characters may be useful as information and content sources for player characters. Global characters may have some shared history and personal contact, but their focus may be social communication. Generic characters are ones that support the reality of a given scenario, and include firemen, policemen, thugs, and ordinary citizens. Such characters may have minimal personal contact, virtually no shared history, and their social communication may often be limited to specific scenarios. For example, a fireman may call for heroes to help fight a fire.
[0072] What have been described are systems and methods for managing the actions or responses of a digital entity in a simulation to reflect its interaction with a player character over time.
[0073] One implementation of the system and method includes one or more programmable processors and corresponding computer system components to store and execute computer instructions, such as to provide the server and client systems to operate the game environment and to monitor and control the data and interaction of non-player character's and player characters in the game environment. The modules, components, or portions thereof, may also be stored on one or more other servers, i.e., there is no requirement that all components be located on a common server, and in some cases certain components will be located on client computing devices.
[0074] Data may be tracked in various ways. In one implementation, the server stores data for a non-player character reflecting the past interactions with each player character and of events that are defined as relevant to the non-player character. For example, the system could store information about the state of the relationship between the two characters based on their last conversation and whether the player character helped the non-player character or not. Similarly, the system could store data reflecting significant events in the real world, such as the election of a president or the player's birthday, or in the game world, such as the player character's success or failure in a prominent mission or their joining a new organization. As part of maintaining the player character's data, various data about the player character will also be available to manage the non-player character reactions. For example, data such as the player's occupation, rank in an organization, age, and address could be used to form the non-player character's reaction. In this way, the non-player character will treat the player character more like a real person and, in turn, feel more like a real person to the player through its responses and reactions. Additional variations may be used depending on the nature of the game or system.
EXAMPLES
[0075] In one implementation, a server computer system in conjunction with one or more client computer systems provide an MMO that has a superhero theme where players create and use player characters which may be heroes or villains. The same may interact with superheroes or iconic villains. The following non-limiting examples are set in this milieu.
Example 1
Personal Contact
[0076] The player character, playing as a hero, may enter a dilapidated warehouse and find himself surrounded by enemies. He may go on the offensive, attempting to attack the group. An iconic non-player character superhero may then appear, defeating the group and calling the player character to follow the superhero deeper into the building.
Example 2
Social Communication
[0077] The player may be controlling a player character that is a minor villain. The player character may have pulled a few minor capers in the city. The player character's communicator may suddenly receive a communication from an iconic non-player character superhero, telling the player character that she has gone too far, and that the superhero will soon bring her to justice.
Example 3
Shared History
[0078] A hero or villain may find a newsreel depicting an important moment in the history of an iconic superhero. For example, in a grainy black-and-white picture it portrays a crime scene in an ally, with two victims lying prone and detectives taking photographs of the scene. The camera may pan to the superhero as a youth, watching the scene with emotion and being taken away to a new life.
[0079] It will be apparent to one of ordinary skill in the art, given this teaching, that variations in the above description will be encompassed by the scope of the claims. For example, the development system could be applied to other types of games, e.g., fantasy and science fiction games, or offline games. The event tracking could also apply to events that are defined in the game but do not directly involve the non-player character, e.g., a natural disaster that occurred in another location and causes the non-player character to have a new goal or request. In another example, a non-player character may use data reflecting indirect relationships as well, e.g., if the player character has done something beneficial for a friend of the non-player character, the non-player character may react favorably towards or mention the favor to the player character. Accordingly the scope of the invention is to be limited only by the claims appended hereto, and equivalents thereof.
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Apparatus and methods are provided to implement a technique for managing the response of a digital entity in a simulation to reflect its interaction with one or more players over time, such as managing a non-player character's responses to player characters in an online computer game. In the system, a computer system tracks the interaction of the digital entity with other entities and the occurrence or status of internal and external events to control how the digital entity reacts to current events and interactions.
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CROSS-REFERENCE TO RELATED APPLICATION
[0001] This is a perfection of Provisional Application No. 62/045,142, filed on Sep. 3, 2014, the disclosure of which is fully incorporated by reference herein.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to an apparatus for quickly and easily manipulating flowers into evenly distributed patterns to create a flower bouquet of a specific size and shape. This apparatus joins a plurality of flower stems into a tube to form the bouquet handle resulting in a three-dimensional bouquet where each flower is situated in a fixed position and at a proper height. The invention achieves a well-balanced, aesthetically pleasing flower bouquet with repeatable end use assembly.
[0004] The apparatus allows for changes to be made to a bouquet after initial assembly/formation so that new and/or replacement flowers can be inserted and then later removed. The apparatus can be used to create a flower bouquet with any type of material; fresh flowers and greenery, artificial flowers, or other products like jeweled brooches that are increasingly popular in flower bouquets. With predefined insertion points, this apparatus minimizes floral waste. And with its preferred dome, it makes bouquet assembly easy and quick. Furthermore, this device provides for the consistent assembly of bouquets, i.e., allowing for substantially the same bouquet to be constructed at two or more locations, thereby promoting greater arrangement duplication/consistency.
[0005] The apparatus of this invention is hemispherical, preferably dome-shaped, or of another similar three-dimensional configuration, any one of which has an enhanced outer edge for rigidity containing: a specified number of flexible apertures and specifically sized slits for flower insertion, a flexible tube handle to cover the flower stems, an optional flexible fluted tube handle collar placed above the flexible tube handle to aid in covering stems coming into the tube at an angle, and a stretchable fabric-like wrapper for the tube handle. Any dome shape and size can be manufactured and used to create the desired bouquet. The outer rim of that dome can be further enhanced with a plurality of smaller, simplified apertures into which may be inserted additional complimentary greenery if needed, or as desired.
[0006] 2. Description of Relevant Art
[0007] Flower bouquet holders utilizing a foam head or a foam enclosed in a cage, with an integrated handle have been used extensively in the past. The use of these holders, however, requires some floral design experience and knowledge of the correct placement of flowers and greenery into that foam head for achieving a well-balanced, three-dimensional bouquet.
[0008] Various bouquet holders are known as shown and described in: Smithers U.S. Pat. No. 2,765,585, Hrivi U.S. Pat. No. 4,204,365, Hasty U.S. Pat. No. 5,070,644. Graham et al U.S. Pat. No. 5,454,189, Ghiotti U.S. Pat. No. 6,862,841 and Miller U.S. Pat. No. 7,310,910. Some disadvantages with the foregoing devices include: (1) the floral design experience needed to assure that flowers get placed in the correct positions for achieving a well balanced bouquet; (2) the foam area available is quite limited. So, after a flower is inserted into the foam, valuable space is taken up thus further limiting the amount of space remaining for additional flower stems; (3) if a designer removes a flower from the foam and inserts another flower therein, it is difficult to re-use the empty hole and assure that his/her replacement flower stem will remain secure in that foam base; (4) the foam head, with repeated insertions and occasional stem removals, begins to break down or disintegrate, thereby leading to flowers falling out from the arrangement prematurely. That, in turn, requires securing such flowers back in the assembled bouquet with wire or other fastening devices. Finally, (5) the aforementioned plastic handles are sometimes difficult to hold, especially for extended periods of time, and have been known to bend with heavier flower arrangements.
[0009] Although not for specific use as a hand-carried bride's bouquet, Matteucci U.S. Pat. No. 5,758,452 and the Fresh Flower Bouquet System of Foster Published U.S. patent application Ser. No. 11/217,416 (2006) utilize a vase or vessel grid-like cap, wherein flowers are inserted into grid holes. There are also problems with any flat grid system. They are two-dimensional, and require a more experienced, or professional, floral designer to arrange the flowers three-dimensionally therein. As such, they are not conducive towards assembling into a hand-held flower bouquet, let alone repeatable duplicative bouquets.
[0010] For traditional hand-tied bouquet methods that do not utilize a foam-type bouquet holder, the assembly of a flower bouquet is not straightforward and rather time-consuming. With or without a foam head device or grid, the assembly of any flower bouquet requires knowledge of: (1) floral design methodology in the selection of product, (2) the correct placement of flowers to achieve the desired result, and (3) the correct use of floral industry tools and supplies (such as picks, tapes, wires and the like) for properly securing a flower arrangement.
[0011] Use of these fastening products to create a hand-held flower bouquet is a time-consuming process because it must first be decided where to place the next flower. Each flower must then be fastened to the bouquet . . . one flower at a time.
SUMMARY OF THE INVENTION
[0012] The present invention is an apparatus that quickly and easily creates a three-dimensional bouquet that is proportionally correct and well balanced with each flower duly secured into a fixed position and at the correct height.
[0013] Brides may request a bouquet of any size or shape. The device of this invention would likely be manufactured for accommodating at least three sizes. But for purposes of this disclosure, no specific dimensions are given as the bouquet size could vary, depending on latest trends, customer preference, different shapes that may come into style.
[0014] The apparatus, generally 10 includes a main holder 12 that is available in several configurations (round, tear-drop or other geometrical shape) and in varying sizes: 8-12″ for a typically round wedding bouquet or 6″ for a nosegay. Sometimes, the overall size of a flower arrangement may vary with the bride's desires, strength (i.e., ability to carry a heavier bouquet) and/or body shape (i.e., smaller arrangements for shorter or more petite framed brides). Still other potential shapes include a cascade, crescent, Hogarth (or S-curve), diagonal, heart, triangular (or pyramidal), oval or horizontal-shape with flowers flowing down from the arm or hand-held arrangement. The larger of these shapes, especially the oval and/or horizontal varieties, are suitable for use as table centerpieces. Each holder will contain a plurality of apertures (or slits) 20 for accepting flower stems F, usually one stem per aperture.
[0015] The apparatus includes a tube 60 and optional tube collar 30 for “housing” a plurality of flower stems F. The tube 60 and tube collar 30 are made of flexible plastic sheet rolled into the shapes shown. Slits 40 in the upper half of tube collar 30 permit its further expansion to provide additional coverage of stems F as they converge at a joining point.
[0016] The tube 60 and tube collar 30 may be manufactured from plastic or any other malleable material such as aluminum. Ideally, both may be bent (or hand-molded) to provide a more comfortable grip for the eventual bouquet carrier/holder. Tube 60 and tube collar 30 may also be manufactured in any color and/or texture (embossed). The tube 60 may be fully or partially encrusted with glued-on crystals, pearls, jewels or other ornamentation, thereby eliminating the need for a ribbon or other wrapper 80 thereover.
[0017] The present vertical split 70 in tube 60 and vertical splits 40 in tube collar 30 may be pulled open, and using the expansion resistance present, hold the multiple flower stems F in place. Tube collar 30 and tube 60 may also be easily slipped onto (or over) these flower stems F from the bottom of the assembled arrangement and then pulled up to the highest joining point of the flower stems F, provided the overall diameter of the joined stems F does not exceed the diameter of tube 60 .
[0018] A stretchable fabric-like sleeve (wrapper) 80 is shown having the same diameter as tube 60 and may completely cover it.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Further features, objectives and advantages for these inventions will become clearer when referring to the following detailed description made with reference to the accompanying photographs in which:
[0020] FIG. 1 is a side plan view of one embodiment of bouquet holder apparatus according to this invention broken down into its primary components, i.e., a main holder (its dome-shape being representative), a tube collar, a tube wrapper and one representative stemmed flower for inserting into one of the apertures in the main holder;
[0021] FIG. 2 is a top perspective view of just the main holder (dome) from FIG. 1 with its plurality of primary apertures 20 ;
[0022] FIG. 3 is a top plan view of the main holder (dome) from FIG. 1 ;
[0023] FIG. 4 is a side plan view taken along lines IV-IV of FIG. 3 ;
[0024] FIG. 5 is a top perspective view of a first alternate embodiment of domed main holder with its plurality of primary apertures 120 and smaller secondary apertures 126 ;
[0025] FIG. 6 is a top plan view of the alternate main holder (dome) from FIG. 5 ;
[0026] FIG. 7 is a side plan view taken along lines VII-VII of FIG. 6 ;
[0027] FIG. 8A is a top view of a first embodiment of aperture/slit 24 according to this invention;
[0028] FIG. 8B is a top view of a second embodiment of aperture/slit 123 , 124 ;
[0029] FIG. 8C is a top view of a third embodiment of aperture/slit 224 ;
[0030] FIG. 8D is a top view of a fourth embodiment of aperture/slit 324 , with optional slits 325 ;
[0031] FIG. 8E is a top view of a fifth embodiment of a gapped aperture/slit 426 ;
[0032] FIG. 8F is a top view of a sixth embodiment of a five-standing aperture/slit 524 ;
[0033] FIG. 9 is a front perspective view of an optional tube collar 30 with slits 40 for allowing extra room for the expansion of flower stems between flower head and tube collar 30 . It includes a vertical slit 50 that lets this tube collar expand for the wrapping of stems therein. It also shows a tube 60 as the flower bouquet handle, said tube having a vertical slit 70 that permits expansion for wrapping around gathered stems;
[0034] FIG. 10 is a side view of the optional stretchable tube wrapper 80 ;
[0035] FIG. 11 is a side view of a completed flower bouquet using the apparatus of this invention;
[0036] FIG. 12A is a top plan view of a first alternative configuration for a cascade-shaped arrangement;
[0037] FIG. 12B is a top plan view of a second alternative configuration for a crescent-shaped arrangement;
[0038] FIG. 12C is a top plan view of a third alternative configuration for a Hogarth (or S-) curve shaped arrangement;
[0039] FIG. 12D is a top plan view of a fourth alternative configuration for a diagonal-shaped arrangement;
[0040] FIG. 12E is a top plan view of a fifth alternative configuration for a heart-shaped arrangement;
[0041] FIG. 12F is a top plan view of a sixth alternative configuration for a triangular-shaped arrangement;
[0042] FIG. 12G is a top plan view of a seventh alternative configuration for an oval-shaped arrangement; and
[0043] FIG. 12H is a top plan view of a seventh alternative configuration for a horizontal-shaped arrangement.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0044] When referring to the alternate embodiments of main holders (dome-shaped or otherwise), apertures/slits, etc. herein, it is to be understood that common components will be commonly numbered though in the next hundred series.
[0045] While shown in a round, hemispherical or dome shape, it is to be understood that still other configurations/shapes may be practiced according to this invention. For instance, for a table centerpiece, there may be an elongated bread loaf-shaped, centerpiece flower holder. For still other bride-desired arrangements, pre-shaped apparatus may include a main holder that is; cascade-shaped, like element 212 in FIG. 12A ; crescent-shaped like holder 312 in FIG. 12B ; Hogarth or S-curve shaped like holder 412 in FIG. 12C ; diagonal shaped like holder 512 in FIG. 12D ; heart-shaped like holder 612 in FIG. 12E ; triangular (or pyramidal)-shaped like holder 712 in FIG. 12F ; oval-shaped like holder 812 in FIG. 12G ; and/or horizontal-shaped like holder 912 in FIG. 12H . All such alternate configurations include one or more of the various inventive aspects described below.
[0046] Referring to FIGS. 1 through 4 , main holder (dome) 12 of apparatus 10 is configured to have a hemispherical cross-sectional shape, from the top 14 of that dome to its base or lower perimeter/edge 16 . Each dome 12 will include a plurality of apertures (or slits) 20 , usually inside of a surrounding circular perimeter 22 with a crosscut 24 across the diameter of perimeter 22 in two or more locations of each aperture/slit 20 . These apertures/slits 20 are situated a predefined distance from one another, each aperture/slit being capable of holding the stem of a flower F pushed therein. In the case of this preferred dome configuration, there is also an uppermost, central aperture 18 .
[0047] These apertures/slits 20 should have sufficient flexibility for pulling through materials with one or more leaves attached (intact). The larger leaves might need to be removed, but smaller materials/greens may be pulled through such apertures. This applies to both artificial and fresh flower arrangements.
[0048] Main holder 12 is preferably constructed of plastic as that term is used in a generic sense. It could be a polyvinyl chloride PVC, a sufficiently rigid PTFE blend or other composite-like construction. A rigid synthetic plastic is preferred for its construction, with flexible slits/holes or apertures 20 . Alternately, main holder 12 may be made from a polycarbonate shell using rubber-like silicone about its apertures 20 . To a lesser preferred degree, main holder 12 could be constructed of a non-plastic material such as aluminum provided it is rigid enough to withstand the force of repeatedly pushing or pulling flower stems F (live or artificial or both) through its apertures 20 without collapsing.
[0049] During assembly, the heads to the respective flowers F shall come to rest on an uppermost surface of main holder 12 . As such, this dome prevents the bunch of flower heads from being placed too high or too low in relation to the one another.
[0050] The stems of flowers F that are inserted shall protrude loosely below main holder (dome) 12 while the remaining flowers F get inserted into other apertures/slits within this main holder 12 . A first flower F is inserted into the centermost aperture 18 , with other flowers F added sequentially, working from the inner circle to the outer rim of the dome all the way down to its lowermost perimeter 16 . Except for this centermost first flower F, the user may elect to slightly bend or curve the stem from its flower head to approximately 5″ down. This will help hold all other (subsequent) flower stems in the center of the arrangement.
[0051] Excess greenery from the bottom two thirds of each flower stem F may be removed prior to insertion into its aperture 20 . Determination of any additional greenery to be removed from the flowers may be made after final assembly, as greenery in the upper third of the stem (just below the main holder 12 ) will usually provide adequate coverage of bare stems. The purpose of removing the lowest leaves from the respective flowers avoids having these leaves take up unnecessary space within tube 60 .
[0052] The thickness of the combined stems may be greater than the diameter desired for the bouquet handle. One solution is to first insert all of the flower stems into their apertures 20 before cutting any number of stems to a depth below the top rim of tube collar 30 . Then using any floral adhesive, the arranger should secure the cut and loose stem to the tube collar and/or adjacent stems if needed.
[0053] Additionally, the area below main holder 12 may be enhanced with a decorative base of tulle, lace, or other fabric that will be secured in place when the tube collar 30 is pushed up to the joining point for all the flower stems. This addition of decorative product (inserted between the tube collar 30 and underside of main holder 12 ) helps fill in any gaps and assists in camouflaging those sections of flower stems extending below the main holder 12 . Slits 40 in the upper half of tube collar 30 may expand to provide additional coverage of any stem extensions from the dome to the common joining point.
[0054] Vertical split 50 in tube collar 30 may be used to force (or split open) the tube collar 30 . Using the expansion resistance present, it can then wrap and hold the flower stems in place. Alternately, tube collar 30 may be slipped up and over the flower stems F from the bottom of the arrangement. There, it can be pulled/raised to the highest possible joining point of the combined stems provided the overall diameter of these joined stems does not exceed the maximum diameter of tube collar 30 bottom.
[0055] Tube 60 can cover the remaining flower stems while further serving as the bouquet handle. A vertical split 70 in tube 60 may be used to force (or split) it open sufficiently for wrapping and holding the flower stems in place using the expansion resistance present. Alternately, tube 60 may be slipped over these stems from the bottom of the arrangement and pulled up to the highest possible point before slipping into the bottom of tube collar 30 , if utilized, or pushed to the topmost convergence point of the stems, provided the overall diameter of the joined stems does not exceed the maximum diameter of tube 60 .
[0056] Towards completion of the arrangement, the user will determine if it's necessary to turn the flower heads or fluff the petals to cover any gaps (empty spaces). To incorporate fillers or other secondary or tertiary material, the user may make use of the same apertures as used for the main flower, or incorporate material into a plurality of smaller, secondary apertures shown as element 126 in FIGS. 5 through 7 , for example. Furthermore, the apertures/slits, themselves, may assume the standard size and shape (across the full diameter of a circular surround 22 , 122 , 222 , 322 , 422 , 522 , 622 and 722 as shown in the accompanying drawings). Or, as shown in the alternate slit shapes of FIGS. 8B through 8F , these same slits may include: a larger central aperture 123 with cut lines 124 extending outwardly therefrom ( FIG. 8B ); between three to eight cut lines alone ( FIG. 8C depicting a trio of such for representative purposes), none of which extend from circular perimeter to circular perimeter; a plurality of main cut lines 324 , with optional additional cuts shown in dotted lines 325 in FIG. 8D ; a purposefully gapped set of cut cross-sectional lines, spaced apart as per element 426 in FIG. 8E ; and/or a set of cut lines ALONE, element 524 in FIG. 8F , without any “formal” circular perimeter surround. The intent behind any such aperture/slit configuration is to maximize how far the aperture can be spread “open” for the passage of thicker stemmed flowers (live or artificial) therethrough without detrimentally impacting the chance for subsequent removal of flowers and possible reuse of the main holder in another, second flower arrangement. These various aperture/slit configurations should accommodate various flower stem “sizes” without ripping the underlying “holes” too excessively.
[0057] A standard dimension for a hand-tied bouquet handle is usually about two hand-lengths (or an average of about 7.5 to 8 inches long). Ideally, tube 60 may be manufactured with one or two break away sections that can be easily removed using perforations built into tube 60 . They can provide for an immediate adjustment to the overall height/length of tube 60 as desired.
[0058] When using fresh flowers, stems may be purposefully left protruding from the bottom of tube 60 to enable suspension of the assembled bouquet in a water container for maintaining freshness of the arrangement until needed. In some instances, the final bouquet design may leave these protruding stems. But more often, such stems are cut to a blunt and even edge before being encased in a wrapping.
[0059] When using artificial flowers, their lower stems may also be left protruding from the bottom of tube 60 for a more “natural” appearance. Otherwise, for both artificial and fresh flowers, excess stem lengths may be trimmed away with wire cutters for artificial flowers and with scissors or a florist's knife for fresh (or live) flower arrangements. A stretchable fabric-like sleeve (wrapper) 80 having about the same diameter as tube 60 may then be used to cover the handle. Manufactured from any number of materials, this wrapper could be provided in any number of colors or styles.
[0060] Prior to wrapping tube 60 with stretchable tube sleeve 80 or any other wrapping material, it is important for the arranger/assembler to secure the bottom of stems to tube 60 using OASIS brand Floral Adhesive, acceptable for use on both fresh and artificial materials. After allowing the glue to dry for 24-36 hours, the stretchable sleeve 80 or other wrapping is attached there over.
[0061] Other tube 60 wrappers might include ribbon, raffia, tulle, lace and fabric trim. Additionally, tube 60 may be covered with glued-on crystals, pearls, jewels or other material that will match the colors of the event (i.e., wedding colors).
[0062] To a less preferred extent, it may be desired (in some instances) to add another piece to the device, namely a snap-in bottom shield (not shown) for beneath the main holder. Like a concave-shaped, salad bowl cover, it would be rigid while also connecting to/about the tube.
[0063] It may also be prudent to assist less-experienced arrangers by adding some type of color coding system about the various aperture surrounds (also not shown). In that instance, larger holes may be coded in green surrounds, medium-sized holes in blue and the smallest holes for accessorizing greenery in red surrounded holes.
[0064] Having described the presently preferred embodiments, it is to be understood that the invention may be otherwise embodied within the scope of the appended claims below.
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A reusable flower bouquet arranging apparatus is presented for creating a hand-held bouquet with a hand tied appearance as would be used for a wedding bouquet or nosegay. Made from plastic with a plurality of spaced apart apertures, it can be used to make arrangements having an overall shape that is domed, cascading, crescent-shaped, heart-shaped, oval or several other configurations.
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This application is a continuation of application Ser. No. 08/452,172 filed May 26, 1995 now abandoned.
BACKGROUND OF THE INVENTION
Poor material handling practices of arsenic containing compounds and some on-site disposal has resulted in contamination of soil and groundwater at various sites. Not only is the source of the arsenic in soil due to various industrial waste processes but also from the use of lead arsenic in pesticides which was used in this country from approximately the turn of the century to the 1950's. Arsenic in herbicide manufacturing also generates much arsenic waste and also contributed to much of the contamination.
The arsenic compounds contaminating sites around the U.S. include a number of both arsenate and arsenite salts. However, these contaminated sites also contain other heavy metals, volatile and semivolatile organic compounds, and organic pesticides, notably the organochlorine pesticides.
Arsenic is exceedingly toxic to mammals. Arsenic forms poisonous compounds which, if absorbed by mammals, such as humans, causes various types of cancer, exfoliation and pigmentation of skin, herpes, polyneuritis, hematopoiesis, and degeneration of both the liver and kidneys. Acute symptoms range from irritation of the GI tract which can progress into shock and death.
Remediation of these sites is now necessary given the new Environmental Protection Agency (EPA) laws due to this extreme toxicity. The EPA has developed criteria for classifying wastes or soils as hazardous due to leaching of heavy metals, such as arsenic, in the leaching from contaminated soil. The EPA standard for arsenic leachability and non-waste water matrices is 5 mg per liter (ppm) arsenic in the leachate as measured by the Toxicity Characteristic Leaching Procedure (TCLP) leachate. Ideally, a means to solidify or chemically stabilize the arsenic and other contaminants in the contaminated soil is preferred. Preferably, the method chosen would be suitable for in-situ treatment, and would result in a volume increase of less than 10 percent in the treated soil.
Arsenic exhibits relatively complex behavior due in part to its ability to assume a range of oxidation states (-III, O, III, V) and to form organic as well as inorganic compounds. Arsenic was usually disposed predominantly in the trivalent (III) and pentravalent (V) oxidation states, as arsenite and arsenate compounds. Arsenate forms relatively insoluble compounds with calcium, iron, aluminum and copper, and is strongly adsorbed into iron and aluminum oxides and hydroxides. Arsenite compounds are generally more soluble than arsenate compounds, making arsenite more mobile and having a greater leaching ability and contamination potential. In addition, arsenite is more toxic. It is also adsorbed onto iron and aluminum oxides and hydroxides, although to a lesser degree than arsenate. This is due in part to the markedly different pH-dependence of arsenite and arsenate adsorption. The maximum adsorption for arsenate occurs at pH 4-5, whereas that for arsenite occurs at pH 9. Due to the anionic nature of arsenate and arsenite ions (above pH 9) and the negative charge developed on oxide and hydroxide surfaces under alkaline conditions, adsorption decreases dramatically at higher pH due to electrostatic repulsions.
In the past, in order to eliminate or reduce arsenic contamination, cement stabilization was used. The problem with using cement for arsenic treatment is that it has little or no effect on arsenic stabilization and does not consistently render the soil nonhazardous for arsenic leaching. Cement and cement kiln dust do not stabilize arsenic against leaching by binding it in a cement matrix as once thought. In addition, cement causes an increase in pH wherein the arsenic becomes more soluble. In addition, cement solidifies the soil causing an increase in volume and therefore an increase in cost in disposing the contaminated material. Further, cement treated contaminated soil is difficult to work with due to the change in physical properties resulting from the treatment. For arsenic contaminated soils, cement alone is not effective at doses of even 25 and 50 percent. Tests indicate that cement or cement kiln dust in combination with various salts were not effective at reducing the leachability of arsenic to the desired levels. The samples treated with cement in combination with various salts show the same degree of leachability as those samples to which only pH control additives were applied.
As previously stated, the cement treatments also lead to an increase in volume. The increase in volume for the cement-treated samples is determined by measuring the weight of soil and final volume of the cement treated samples.
The 25 percent cement treatment resulted in a 54 percent increase in volume for the laboratory sample, while the 50 percent treatment resulted in an 82 percent volume increase.
One stabilization approach that can be used is the addition of ferric iron salts as demonstrated by McGaham U.S. Pat. No. 5,252,003 ('033 patent) in which ferric salt in combination with magnesium oxide is used to stabilize arsenate contaminated wastes or soils. However, one problem not addressed by the '033 patent is that the ferric iron may be reduced to ferrous iron in land disposal environments. Ferrous iron is not effective at stabilizing arsenic. The ferrous arsenate salts are much more soluble than the ferric salts. Arsenic may be released into ground water from the treated waste if such a reduction occurs.
Organic binders were also used to stabilize arsenic-contaminated material. Organic binders are also not preferred due to the fact that they also increase volume similar to that of cement and, therefore, increase the cost of eliminating the contaminated material.
SUMMARY OF THE INVENTION
This invention is a method for treatment of solid or semi-solid materials such as soils and sludges containing arsenic compounds in order to stabilize the contaminated material against leaching of arsenic. Specifically, this treatment utilizes aluminum compounds and an alkaline buffer in order to immobilize the arsenic via precipitation and adsorption. Preferably, this invention can be performed as an in situ treatment of arsenic contaminated soil utilizing aluminum sulfate and magnesium oxide.
The aforementioned problems of the prior art, that being the reduction of ferric compounds which result in release of arsenic back into the soil, are avoided using the present invention due to the fact that aluminum doesn't undergo oxidation-reduction reactions. Therefore, aluminum sulfate and a pH buffer combination results in a more effective and long term stable treatment of arsenic contaminated soil than the prior art ferric sulfate-magnesium oxide. In particular, the aluminum sulfate is best suited for applications under anoxic conditions (conditions which are void of oxygen). Conversely, ferric sulfate is better suited under oxic conditions (oxygenated). However, in soil, anoxic conditions are common. Therefore, if the iron treated soil becomes anoxic, the treatment process simply reverses, thereby releasing the arsenic back into the soil or environment. The ability to obtain effective treatment under anoxic conditions is extremely important regarding municipal landfills. In municipal landfills, the conditions are always anoxic and therefore, this invention has superior qualities over the prior art in municipal applications.
This invention is also especially effective against arsenate. However, if arsenite is found in a contaminated matter, it may be oxidized to form arsenate prior to treatment. An example of how to oxidize the soil is via hydrogen peroxide.
An example of a chemical reaction within the scope of this invention can be shown as follows:
Al.sub.2 (SO.sub.4).sub.3 +Na.sub.3 HAsO.sub.4 →2AlAsO.sub.4 +3Na.sub.2 SO.sub.4
The resulting arsenic stabilization is two-fold, utilizing both adsorption as well as precipitation. The aluminum arsenate product precipitates and therefore stabilizes the arsenic. The "alum" or aluminum sulfate also forms aluminum hydroxide which coprecipitates or adsorbs the arsenic, resulting in additional arsenic stabilization. Therefore, it is a combination of the AlAsO 4 plus arsenic adsorbing on the surface of aluminum hydroxide and getting trapped in a resulting matrix.
It is an object of the present invention to provide a method for treatment of materials such as soils or sludges containing arsenic compounds.
Further, an object of this invention is to render soil or waste that is hazardous for arsenic non-hazardous under TCLP tests.
Another object of the invention is to stabilize the material such as soil or sludges against leaching of arsenic in the natural environment.
Another object of the invention is to provide a convenient and inexpensive treatment. This is achieved primarily because the chemicals and equipment required to utilize the method of this invention are commercially available and relatively inexpensive and therefore make utilizing the method of this invention more convenient.
A further object of the invention is to result in minimal increase in the volume of the treated contaminated soil.
Still another object of this invention is to provide a method for treatment acceptable under the Synthetic Precipitation Leaching Procedure (SPLP) Test as well as the Multiple Extraction Procedure (MEP).
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The form of arsenic contemplated within the scope of this invention can be organic or inorganic arsenicals. Examples of inorganic arsenicals may include, but is not limited to, arsenic acid and arsenic oxides. The organic arsenicals may include methane arsenicals such as mono-methyl sodium arsenate, Na(CH 3 )AsO 2 OH, cacadylic acid, dichlorophenylarsine and diethylarsine.
The contaminated soil or sludge to be treated will vary in consistency and composition. Also, the level of soil or sludge moisture may vary greatly. Sludge may consist of sedimentated or filtered waste product consisting of a thick viscous mass. Whether the treatment is for contaminated soil or contaminated sludge, the process of using this method is basically the same. The aluminum sulfate and the alkaline buffer is simply added to the soil (or sludge) and thoroughly mixed. It is especially beneficial if the soil has enough moisture to dissolve and subsequently form the products of the reaction, aluminum hydroxide and aluminum arsenate.
The preferred embodiment of this invention is the use of aluminum sulfate. However, other aluminum compounds may be utilized including aluminum chloride or any soluble aluminum salt or sodium aluminate.
The alkaline buffer used in this invention could be either magnesium oxide, magnesium hydroxide or a reactive form of calcium carbonate or calcium magnesium carbonate or any other suitable buffer that has the ability to buffer between pH 5 and 10. Since aluminum sulfate is an acid, the alkaline base is necessary to neutralize the acid and it is essential that this alkaline base therefore keep the pH in the appropriate range for forming the aluminum arsenate.
Soil Samples
All three soil samples tested were TCLP toxic for arsenic. The three soil samples (Sample Borings 1, 2 and 3 or "SB-1", "SB-2" and "SB-3") were supplied to the RMT Applied Chemistry Laboratory by S. S. Papadopulos and Associates. The samples were homogenized, and then subsamples were taken for the initial testing. Both TCLP (SW-846 Method 1311) and compositional analysis were performed on all three samples. On the basis of the results of the compositional and TCLP testing, the majority of the subsequent testing was on sample SB-1, since this sample had high compositional arsenic (24,000 mg/kg) and leached fairly high concentrations of arsenic in the TCLP test (150 mg/L). SB-2 had lower compositional arsenic, and so less work was done on that sample. SB-3 was used as a confirmation sample for the treatment process, since in terms of compositional arsenic, Sb-3 was similar to SB-1.
EXAMPLE 1
The testing performed on the samples was designed to determine what was in the samples and the leaching potential for those materials. The primary element of concern as arsenic. Leaching was evaluated in several ways. The Toxicity Characteristic Leaching Procedure TCLP test, Method 1311 in SW-846!, 55 Fed. Reg. 126, pgs. 26,986-998 (1990) is used by the USEPA for classifying wastes as hazardous. The test is designed to simulate the leaching potential of an actively degrading municipal landfill. As such, the TCLP test may not provide a realistic evaluation of the leaching potential of a waste disposed in an area other than a municipal landfill. An alternative test that can be used to ml leaching under less severe environments than a municipal landfill is the Synthetic Precipitation Leaching Procedure (SPLP, Method 1312, SW-846), which uses a simulated acid rain leaching solution. The leaching solution for the SPLP test is much less buffered than either of the two solutions used in the TCLP test; thus, it provides a less aggressive leaching medium. To model long-term leaching from a waste, the USEPA uses a serial elution leaching test, the Multiple Extraction Procedure (MEP). The original MEP was designed using the EP Toxicity test followed by nine elutions with a simulated acid rain. Since the time that the MEP was originally designed, the EPA has replaced the EP Toxicity test with the TCLP test, and has redesigned the simulated acid rain step to use the SPLP test. The MEP test procedure has not officially been updated, however.
Analytical laboratory procedures were done according to the USEPA protocols outlined in SW-846. However, a few analytical laboratory procedures were done using other protocol, most notably moisture content, which was done using ASTM Method D-2216-80. MEP tests were run using a standard TCLP test for the first elution, followed by nine successive elutions using the SPLP leaching solution.
For the treatability screening tests, a modified TCLP procedure was used to facilitate testing a large number of samples. The screening test uses one-tenth of the amounts of solid and liquid used in the standard test. The leaching solution used is chosen on the basis of knowledge of the waste and additives. If there is a question about which solution to use, either the TCLP pretest is run on the sample or both solutions are used. The samples are tumbled for 18 hours (±2 hours) on the standard TCLP tumbler, and are then filtered through a 0.45 μm filter. The filtrate is then analyzed directly without the normal digestion step. Arsenic was analyzed on graphite furnace AA.
The screening TCLP test uses one tenth of the prescribed sample weight and reagent volume, and a screening metals analysis in the laboratory, with no digestion or matrix spikes. The results are for screening purposes only. The procedure does not fulfill the requirements of the standard TCLP test.
Some screening SPLP tests were also conducted. The screening SPLP is similar to the screening TCLP test except that the SPLP leaching solution is used.
A number of treatment test additives can be used. For pH control, CaO (also contributes calcium ion) and MgO were added.
Aluminum addition was in the form of aluminum sulfate (alum) and CaO or MgO. Another additive may be copper sulfate.
With the exception of the solidified samples, the treatment additives were introduced into the bottle used for the screening TCLP test. The samples were mixed, but no extra water was added until the TCLP test solution was run. Normally, the screening TCLP test was run within a few minutes of mixing the treatment additive with the soil.
The solidified samples were prepared by mixing the soil with the additives. Water was added to form a cement-like slurry. The samples were cured for seven days. The samples were then pulverized to pass through the sieve used in the TCLP test. The screening TCLP test was performed on the pulverized material.
All additive weights are based on the wet weight of soil and the dry weight of additive, since the TCLP test is run on a wet weight basis. The weight of additive used is based on the weight of soil, not on the weight of the mixture (i.e., a 10 percent dose is the equivalent of 10 g additive per 100 g soil wet!).
Soil Characterization Prior To Stabilization
The results of the soil characterization are given in Tables 1 and 2. SB-1 and SB-3 contained 24,000 to 23,000 mg/kg of arsenic, respectively. Sample SB-2 had a lower arsenic concentration at 6,600 mg/kg (see Table 1).
TABLE 1______________________________________TREATABILITY STUDY SOILS COMPOSITIONAL METALS SB-1 SB-2 SB-3Parameter (mg/kg) (mg/kg) (mg/kg)______________________________________Arsenic 24,000 6,600 23,000______________________________________
All three samples leached arsenic above the hazardous waste criterion in the TCLP test. SB-1 leached 150 mg/L, SB-2 leached 240 mg/L, and SB-3 leached 550 mg/L in the TCLP tests (see Table 2).
TABLE 2______________________________________TREATABILITY STUDY SOILS TCLP METALS TCLP Criteria* SB-1 SB-2 SB-3Parameter (mg/L) (mg/L) (mg/L) (mg/L)______________________________________Arsenic 5.0 150 240 550______________________________________ *40 CRF 261.24 NS No Standard
The other metals were all below their respective hazardous waste criteria. Sample SB-3 contained higher levels of volatile compounds and organochlorine pesticides than did the other two soils.
In summary, all three soils were hazardous for arsenic.
Soil Characterization After Stabilization
In order to determine whether the arsenic in the soil samples was in the arsenate or arsenite form, several samples were oxidized with hydrogen peroxide, and then treated. If the arsenic were in the arsenate form initially, then the peroxide treatment should have little influence on the treatment test results. If a significant portion of the arsenic were in a reduced form (e.g., arsenite), then the peroxide oxidation should improve the treatment testing results. The results for both the unoxidized and oxidized samples are very similar, indicating that the arsenic is primarily in the arsenate form in the soil.
pH Control
Calcium oxide and magnesium oxide were added to samples SB-1 and SB-2 to determine the influence of pH on the leaching behavior of arsenic. Arsenic concentrations for both soils decrease as the pH increases; however, arsenic concentrations do not drop below 5 mg/L in the screening test until a lime dose of 20 percent is used and the pH is raised to 12.5. Under the conditions of the test, the solubility was not reduced sufficiently by the formation of relatively insoluble compounds (e.g., calcium arsenate) to render the soil nonhazardous.
Aluminum Addition
Aluminum can adsorb or precipitate arsenic, in a manner similar to ferric iron salts. The removal mechanism for arsenic is most likely adsorption onto aluminum hydroxide particles with coprecipitation of aluminum hydroxide and aluminum arsenate also occurring. Arsenic adsorption onto aluminum hydroxide decreases under very alkaline conditions due to electrostatic repulsion. Therefore, aluminum treatment is therefore most effective under mildly acidic to mildly basic conditions, namely pH from approximately 5 to 10. Several dosages of aluminum were tested on both soils SB-1 (see Table 3) and SB-2 (see Table 4). The results indicate that aluminum can reduce arsenic to around the 3 to 5 mg/L range. In order to confirm that the soil did not contain arsenite, the soil was oxidized with hydrogen peroxide prior to aluminum treatment. Treatment effectiveness was not improved by oxidizing the soil with peroxide, again indicating that there was no arsenite in the soil.
TABLE 3______________________________________SCREENING TEST RESULTS - ALUMINUM TREATMENT - SB-1SAMPLE pH.sub.1 Arsenic (mg/L)Soil SB-1______________________________________Untreated 5.0 150+ 2.5% Al.sub.2 (SO.sub.4).sub.3 4.91 5.6+ 5% Al.sub.2 (SO.sub.4).sub.3 4.79 3.2+ 2.5% MgO & 2.5% Al.sub.2 (SO.sub.4).sub.3 4.70 14+ 2.5% MgO & 5% Al.sub.2 (SO.sub.4).sub.3 4.58 8.7+ 5% MgO & 5% Al.sub.2 (SO.sub.4).sub.3 5.75 33+ 7.5% MgO & 5% Al.sub.2 (SO.sub.4).sub.3 8.57 4.8+ 7.5% MgO & 7.5% Al.sub.2 (SO.sub.4).sub.3 8.37 2.5+ 5% MgO & 10% Al.sub.2 (SO.sub.4).sub.3 5.03 3.8+ 7.5% MgO & 10% Al.sub.2 (SO.sub.4).sub.3 7.29 3.2+ 10% MgO & 10% Al.sub.2 (SO.sub.4).sub.3 8.40 4.9AFTER PEROXIDE TREATMENT+ 7.5% MgO & 5% Al.sub.2 (SO.sub.4).sub.3 8.57 6.5+ 7.5% MgO & 7.5% Al.sub.2 (SO.sub.4).sub.3 8.37 3.9______________________________________ pH.sub.1 = Final pH in screening test.
TABLE 4______________________________________SCREENING TEST RESULTS - ALUMINUM TREATMENT - SB-2SAMPLE pH.sub.1 Arsenic (mg/L)Soil SB-2______________________________________Untreated+ 2.5% Al.sub.2 (SO.sub.4).sub.3 4.94 14+ 5% Al.sub.2 (SO.sub.4).sub.3 4.77 8.3+ 2.5% MgO & 2.5% Al.sub.2 (SO.sub.4).sub.3 4.59 17+ 2.5% MgO & 5% Al.sub.2 (SO.sub.4).sub.3 4.58 9.0+ 5% MgO & 5% Al.sub.2 (SO.sub.4).sub.3 6.80 4.4______________________________________ pH.sub.1 = Final pH in screening test.
Other Stabilizing Agents
Copper sulfate may be incorporated as a treatment additive. Copper arsenate is highly insoluble (less soluble than ferric arsenate), and the copper sulfate may effectively reduce arsenic leaching.
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A method of treating arsenic-contaminated matter using an aluminum compound in conjunction with an alkaline buffer, thereby stabilizing the arsenic contained in the contaminated matter and decreasing leaching ability. Preferably, the aluminum compound is a soluble aluminum salt such as aluminum sulfate and the alkaline buffer is magnesium oxide.
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CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of and claims priority to U.S. application Ser. No. 13/477,335, filed on May 22, 2012, which application is a continuation application of and claims priority to U.S. application Ser. No. 12/721,874, filed on Mar. 11, 2010, now issued U.S. Pat. No. 8,204,589, which application is a continuation application of and claims priority to U.S. application Ser. No. 10/841,367, filed on May 7, 2004, now U.S. Pat. No. 7,706,878. These applications are hereby incorporated by reference.
TECHNICAL FIELD
[0002] This invention relates to devices for assisting caregivers in delivering therapy to a patient (e.g., automatic external defibrillators).
BACKGROUND
[0003] Resuscitation treatments for patients suffering from cardiac arrest generally include clearing and opening the patient's airway, providing rescue breathing for the patient, and applying chest compressions to provide blood flow to the victim's heart, brain and other vital organs. If the patient has a shockable heart rhythm, resuscitation also may include defibrillation therapy. The term basic life support (BLS) involves all the following elements: initial assessment; airway maintenance; expired air ventilation (rescue breathing); and chest compression. When all these elements are combined, the term cardiopulmonary resuscitation (CPR) is used.
[0004] There are many different kinds of abnormal heart rhythms, some of which can be treated by defibrillation therapy (“shockable rhythms”) and some which cannot (non-shockable rhythms”). For example, most ECG rhythms that produce significant cardiac output are considered non-shockable (examples include normal sinus rhythms, certain bradycardias, and sinus tachycardias). There are also several abnormal ECG rhythms that do not result in significant cardiac output but are still considered non-shockable, since defibrillation treatment is usually ineffective under these conditions. Examples of these non-shockable rhythms include asystole, electromechanical disassociation, and other pulseless electrical activity. Although a patient cannot remain alive with these non-viable, non-shockable rhythms, applying shocks will not help convert the rhythm. The primary examples of shockable rhythms, for which the caregiver should perform defibrillation, include ventricular fibrillation, ventricular tachycardia, and ventricular flutter.
[0005] After using a defibrillator to apply one or more shocks to a patient who has a shockable ECG rhythm, the patient may nevertheless remain unconscious, in a shockable or non-shockable, perfusing or non-perfusing rhythm. If a non-perfusing rhythm is present, the caregiver may then resort to performing CPR for a period of time in order to provide continuing blood flow and oxygen to the patient's heart, brain and other vital organs. If a shockable rhythm continues to exist or develops during the delivery of CPR, further defibrillation attempts may be undertaken following this period of cardiopulmonary resuscitation. As long as the patient remains unconscious and without effective circulation, the caregiver can alternate between use of the defibrillator (for analyzing the electrical rhythm and possibly applying a shock) and performing cardio-pulmonary resuscitation (CPR). CPR generally involves a repeating pattern of five or fifteen chest compressions followed by a pause during which two rescue breaths are given.
[0006] Defibrillation can be performed using an AED. The American Heart Association, European Resuscitation Council, and other similar agencies provide protocols for the treatment of victims of cardiac arrest that include the use of AEDs. These protocols define a sequence of steps to be followed in accessing the victim's condition and determining the appropriate treatments to be delivered during resuscitation. Caregivers who may be required to use an AED are trained to follow these protocols.
[0007] Most automatic external defibrillators are actually semi-automatic external defibrillators (SAEDs), which require the caregiver to press a start or analyze button, after which the defibrillator analyzes the patient's ECG rhythm and advises the caregiver to provide a shock to the patient if the electrical rhythm is shockable. The caregiver is then responsible for pressing a control button to deliver the shock. Following shock delivery, the SAED may reanalyze the patient's ECG rhythm, automatically or manually, and advise additional shocks or instruct the caregiver to check the patient for signs of circulation (indicating that the defibrillation treatment was successful or that the rhythm is non-shockable) and to begin CPR if circulation has not been restored by the defibrillation attempts. Fully automatic external defibrillators, on the other hand, do not wait for user intervention before applying defibrillation shocks. As used below, automatic external defibrillators (AED) include semi-automatic external defibrillators (SAED).
[0008] Both types of defibrillators typically provide an auditory “stand clear” warning before beginning ECG analysis and/or the application of each shock. The caregiver is then expected to stand clear of the patient (i.e., stop any physical contact with the patient) and may be required to press a button to deliver the shock. The controls for automatic external defibrillators are typically located on a resuscitation device housing.
[0009] AEDs are typically used by trained medical or paramedic caregivers, such as physicians, nurses, emergency medical technicians, fire department personnel, and police officers. The ready availability of on-site AEDs and caregivers trained to operate them is important because a patient's chances of survival from cardiac arrest decrease by approximately 10% for each minute of delay between occurrence of the arrest and the delivery of defibrillation therapy.
[0010] Trained lay caregivers are a new group of AED operators. For example, spouses of heart attack victims may become trained as lay caregivers. Lay caregivers rarely have opportunities to defibrillate or deliver CPR, and thus they can be easily intimidated by an AED during a medical emergency. Consequently, such lay providers may be reluctant to purchase or use AEDs when needed, or might tend to wait for an ambulance to arrive rather than use an available AED, out of concern that the lay provider might do something wrong.
[0011] Some trained medical providers, e.g., specialists such as obstetricians, dermatologists, and family care practitioners, also rarely have the opportunity to perform CPR and/or defibrillate, and thus may be uneasy about doing so. Concerns about competence are exacerbated if training is infrequent, leading the caregiver to worry that he or she may not be able to remember all of the recommended resuscitation protocol steps and/or their correct sequence.
[0012] Similarly, both medical and lay caregivers may be hesitant to provide CPR and rescue breathing, or may be unsure when these steps should be performed, particularly if their training is infrequent and they rarely have the opportunity to use it.
[0013] It is well known to those skilled in the art, and has been shown in a number of studies, that CPR is a complex task with both poor initial learning as well as poor skill retention, with trainees often losing 80% of their initial skills within 6-9 months. It has thus been the object of a variety of prior art to attempt to improve on this disadvantageous condition. Aids in the performance of chest compressions are described in U.S. Pat. Nos. 4,019,501, 4,077,400, 4,095,590, 5,496,257, 6,125,299, and 6,306,107, 6,390,996. U.S. Pat. Nos. 4,588,383, 5,662,690 5,913,685, 4,863,385 describe CPR prompting systems. AEDs have always included voice prompts as well as graphical instructions on flip charts or placards since the earliest commercial versions in 1974 to provide both correct timing and sequence for the complex series of actions required of the rescuer (caregiver) as well as placement of the defibrillation electrodes. U.S. patent application Ser. No. 09/952,834 and U.S. Pat. Nos. 6,334,070 and 6,356,785 describe defibrillators with an increased level of prompting including visual prompts either in the form of graphical instructions presented on a CRT or on printed labels with backlighting or emissive indicia such as light emitting diodes. AEDs since the 1970s have used the impedance measured between the defibrillation electrodes to determine the state of the AED as well as appropriate messages to deliver to the rescuer (e.g. “Attach Electrodes” if the initial prompts on the unit have been delivered and the impedance remains greater than some specified threshold) or to determine if there is excessive patient motion (as in U.S. Pat. No. 4,610,254.) U.S. Pat. No. 5,700,281 describes a device which uses the impedance of the electrodes to determine the state of the AED for delivering messages such as “Attach Electrodes”. Enhanced prompting disclosed in these patents provides some benefit to the rescuer in improved adherence to the complex protocol required of them to successfully revive a cardiac arrest patient, but the enhanced prompting is usually not sufficient in real world situations. U.S. Pat. Nos. 5,662,690 and 6,356,785 (and the commercially available OnSite defibrillator) attempts to improve prompting by providing a rescuer-accessible “Help” key that initiates more detailed prompting in cases in which the rescuer or test subject is confused. But testing has shown that with the heightened level of anxiety that accompanies a real cardiac arrest, rescuers rarely remember to press such a Help key. Even notifying the rescuer at the beginning of the protocol to press the Help key does not help a the confused rescuer press the Help key. Furthermore, even if the Help key is pressed, it is necessary to have the rescuer work through a series of user interface interactions via a touchscreen, softkeys or other input means, for the help software to determine at which step the rescuer is in need of additional instructions. Putting the user through these interactions with the help software detracts from the rescuer's ability to provide aid to the patient, and thus delays delivery of therapy.
[0014] AEDs have also been solely focused on defibrillation, which, while it provides the best treatment for ventricular fibrillation and certain tachycardias, is of no therapeutic benefit for the 60% of the cardiac arrest patients presenting in pulseless electrical activity (PEA) or asystole. As AEDs are becoming more prevalent in the home, there are also a host of other health problems that occur such as first aid as well as incidents related to chronic conditions such as asthma, diabetes or cardiac-related conditions for which the AED is of no benefit.
SUMMARY
[0015] In a first aspect, the invention features a device for assisting a caregiver in delivering therapy to a patient, the device comprising a user interface configured to deliver prompts to a caregiver to assist the caregiver in delivering therapy to a patient; at least one sensor configured to detect the caregiver's progress in delivering the therapy, wherein the sensor is other than an electrode in an electrical contact with the body; a memory in which a plurality of different prompts are stored; a processor configured to determine which of the different prompts should be selected for delivery based on the progress detected by the sensor.
[0016] Preferred implementations of this aspect of the invention may incorporate one or more of the following: There may be a plurality of sensors configured to detect the caregiver's progress in delivering the therapy, wherein each of the plurality of sensor is other than an electrode connected to the body. The processor may be configured to vary the time at which prompts are delivered based on the progress detected by the sensor. One or more additional sensors may be configured to detect the caregiver's progress in delivering the therapy, wherein the one or more additional sensors comprise an electrode in electrical contact with the body. The at least one sensor may comprise a photoelectric sensor on the electrode for assisting in detection of whether the electrode has been applied to clothing. The therapy may comprise a series of steps in a protocol, and at least two sensors may be configured to detect whether at least two of the steps in the protocol have been successfully completed. The processor may select a series of more detailed prompts for delivery to a user when progress is slower than a predetermined pace. The processor may be configured to slow down the rate at which prompts are delivered when progress is slower than a predetermined pace. The processor may be configured to choose from among at least three rates at which prompts are delivered, and the choice is based at least in part on the progress detected by the sensor. The progress detected by the sensors may comprise whether a step in the protocol has been initiated and whether the step has been completed. The user interface may deliver at least some of the prompts as oral instructions to be heard by the caregiver. The user interface may deliver at least some of the prompts as visual instructions to be seen by the caregiver. The user interface may comprise an electronic display. The electronic display may provide a series of images. The user interface may comprise a series of printed pages. The device may further comprise one or more detectors configured to detect which page of the series of pages is being viewed by the caregiver. The detectors may comprise magnetic sensors that detect the presence of magnetic members supported by the pages. The processor may be configured to provide prompts with a first level of detail when progress is occurring at or faster than a predetermined rate, and with a second level of detail more specific than the first level of detail when progress is occurring at or slower than the predetermined rate. The sensor may be configured to detect whether the caregiver has made a predetermined error in delivering the therapy, and the processor may be configured to deliver one or more prompts designed to assist the user in correcting the predetermined error. The progress detected by the sensors may comprise whether a step in the protocol has been initiated and whether the step has been completed, and the processor may be configured to pause in delivery of prompts if a step has been initiated but not completed, and no predetermined error associated with the step has been detected. The device may be configured to assist a caregiver in delivering therapy for one or more cardiac malfunctions. The device may be configured to assist a caregiver in delivering therapy for one or more cardiac malfunctions. The device may be configured to assist a caregiver in delivering chest compressions. The device may be configured to assist a caregiver in delivering CPR. The device may be configured to assist a caregiver in delivering an electrical stimulus to the heart. The electrical stimulus may include defibrillation. The electrical stimulus may include pacing.
[0017] The device may comprise a defibrillator; and electrodes constructed to acquire data, indicative of the heart rhythm of the patient and indicative of whether the electrodes are properly placed on the patient and to deliver a defibrillating shock if appropriate. The device may further comprise on a portion of a housing for the device, a series of graphics configured to prompt a caregiver to perform a sequence of steps appropriate for treating a victim of suspected cardiac arrest The graphics may include a picture configured to prompt the caregiver to check the patient for responsiveness. The graphics may include a picture configured to prompt the caregiver to call for emergency assistance. The graphics may include a picture configured to prompt the caregiver to open the patient's airway. The graphics may include a picture configured to prompt the caregiver on how to open the patient's airway. The graphics may include a picture configured to prompt the caregiver to check the patient for signs of circulation. The graphics may include a picture configured to prompt the caregiver to attach the electrodes to the patient. The graphics may include a picture configured to prompt the caregiver on where the electrodes should be attached. The graphics may include a picture configured to prompt the caregiver to stand clear of the patient. The graphics may include a picture configured to prompt the caregiver to press a treatment button to cause the device to administer a defibrillating shock. The graphics may include a picture configured to prompt the caregiver to perform CPR. The graphics may include one or more pictures illustrating procedures for chest compressions and rescue breathing. The pictures may include a heart symbol indicating the location of the treatment button. The device may include a treatment button configured to be pressed by the caregiver to cause the defibrillator to administer a defibrillating shock. The device may further include a light source associated with each of the graphics in the series. The device may comprise electronics configured to sequentially illuminate the light sources. The graphics may include one or more pictures selected from the group consisting of: a picture configured to prompt the caregiver to check the patient for responsiveness; a picture configured to prompt the caregiver to call for emergency assistance; a picture configured to prompt the caregiver to open the patient's airway; a picture configured to prompt the caregiver to check the patient for signs of circulation; a picture configured to prompt the caregiver to attach the electrodes to the patient; a picture configured to prompt the caregiver to stand clear of the patient; and a picture configured to prompt the caregiver to perform CPR. The graphics may include a picture configured to prompt the caregiver to press a treatment button to cause the defibrillator to administer a defibrillating shock. The graphics may include one or more pictures selected from the group consisting of: a picture configured to prompt the caregiver to check the patient for responsiveness; a picture configured to prompt the caregiver to call for emergency assistance; a picture configured to prompt the caregiver to open the patient's airway; a picture configured to prompt the caregiver to check the patient for signs of circulation; a picture configured to prompt the caregiver to attach the electrodes to the patient; a picture configured to prompt the caregiver to stand clear of the patient; and a picture configured to prompt the caregiver to perform CPR. The light sources may comprise LEDs. The audio prompts may be associated with the series of graphics and are given sequentially to guide the caregiver through the sequence of steps. The device may further comprise electronics configured to sequentially illuminate the light sources, wherein the audio prompts are associated with the series of graphics and with the sequential illumination of the light sources, to guide the caregiver through the sequence of steps. The device may further comprise electronics configured to measure the time elapsed from the time at which the caregiver turned the power on to activate the defibrillator, and at least some of the audio prompts are timed to occur based on the elapsed time. At least some of the graphics may be provided on a cover portion of the defibrillator device housing. At least some of the graphics may be provided on the outside of the cover portion of the device. The graphics on the cover portion may include a picture indicating that the cover should be removed from the device. The cover portion may include a space provided for local emergency information. The cover portion may include a window behind which a card bearing local emergency information can be placed. At least some of the graphics may be provided in the form of backlit, translucent images. At least some of the graphics may be provided in the form of a decal. The device may further comprise buttons, associated with at least some of the graphics, which, when pressed, cause more detailed audio prompts related to the associated graphic to be output by the device. The graphics may include one or more pictures indicating that the caregiver should place a passive airway support under the shoulders of the patient. The graphics may include a picture configured to prompt the caregiver to check to see if the patient is breathing. The prompts and graphical interface may illustrate the entire sequence of resuscitation activities that are recommended by the American Heart Association. The prompts may include instructions for performing first aid. The device may comprise a cover to the device whose removal the processor is capable of detecting; and a series of bound pages on the face of the device under the cover with one or more sensors for determining to which page the bound pages have been turned. The device may further comprise a portion of the device used specifically for storage of items commonly used in the course of providing aid such as bandaids, bandages, splints, antiseptic. The storage area may be partitioned into individual wells in which each of the items is stored and a detections means may be provided for determining which, if any, of the items has been removed by the user. Photoelectric sensors may be provided in each of the wells. The prompts and graphical interface may illustrate the Red Cross First Aid treatment protocols.
[0018] The device may include a cover whose removal the processor is capable of detecting; a defibrillator for delivering defibrillation shocks; electrodes configured to be attached to a patient, to acquire data indicative of the patient's heart rhythm and to deliver a defibrillating shock if appropriate; a storage area for said electrodes; and at least one sensor for determining if the electrodes have been removed from the storage area by the user. The storage area may be a compartment that is part of the housing of the device. The storage area may be a package removable from the housing of the device. The cover may be shaped for use as a neck rest for maintaining the patient's airway in the necessary open condition during CPR. A detection means may be provided for determining if the patient's head is correctly located on the cover while it is being used as a neck rest. The detection means may be provided by a pressure sensor. The detection means may be provided by a photoelectric sensor.
[0019] The device may further comprise a decision making system provided by a distributed network may comprise a remotely located human expert, an electronic processor in the device, and an electronic communication link between the human and electronic processor. The information transmitted over the communication link may be both voice and digital data. The data may be bi-directional. The digital data may contain information about the device's location and the status of the device. The device may be capable of being remotely controlled by the human expert. The electronic processor may revert to providing internally generated responsive feedback prompts if the communication link is lost to the remotely located human expert. The device may further comprise a decision-making system comprising circuitry and an electronic processor located in the device. The device may further comprise a decision making system provided by a distributed network comprising a remotely located electronic processing system, a local electronic processing system in the device and an electronic communication link between the remote and local electronic processing system. The device may further comprise a processing system that measures and records the times required for a user to complete a sequence of steps and/or sub-steps in a protocol, and, based on the measured times adjusting the rate of the prompting delivered by the processor and user interface. The adjusting may be based on a comparison of the measured times with a set of stored values. The device may comprise decision-making circuitry for evaluating the difference between the measured times and the set of stored values. The device may further comprise elements for correctly identifying a set of voice commands delivered by the user and performing a set of actions in response to those user voice commands.
[0020] In a second aspect, the invention features an automatic external defibrillator for assisting a caregiver in delivering resuscitation therapy to a patient, the defibrillator comprising a memory in which a plurality of different prompts are stored; a processor configured to determine which of the different prompts should be selected for delivery; a user interface configured to deliver the selected prompts to a caregiver to assist the caregiver in delivering therapy to a patient, wherein the user interface comprises a series of printed pages and one or more detectors configured to detect which page of the series of pages is being viewed by the caregiver.
[0021] Preferred implementations of this aspect of the invention may incorporate one or more of the following. Detectors may comprise magnetic sensors that detect the presence of magnetic members supported by the pages.
[0022] Among the many advantages of the invention (some of which may be achieved only in some of its various aspects and implementations) are that the invention provides a more comprehensive and effective system for prompting users in the delivery of care for first aid, chronic health problems as well as cardiac arrest.
[0023] The invention can provide the further benefit that a device can intelligently vary the amount of detail to provide in prompts to the caregiver. In currently available devices, the prompting has been optimized for the average user, and this is both frustrating and obstructive for the expert user; the more detailed prompting is not needed by the expert user and actually delays delivery of treatment. The invention can eliminate the need for this compromise, by intelligently delivering prompts needed by the particular user.
[0024] Other features and advantages of the invention will be apparent from the description and drawings, and from the claims.
DESCRIPTION OF DRAWINGS
[0025] FIG. 1 is a perspective view of an AED with its cover on.
[0026] FIG. 2 is a perspective view of the AED of FIG. 1 with the cover removed.
[0027] FIG. 3 is a block diagram of the AED.
[0028] FIG. 4 is a plan view of the graphical interface decal used on the cover of the AED of FIG. 1 .
[0029] FIG. 5 is a plan view of the graphical interface decal used on the device housing of the AED of FIG. 1 , as shown in FIG. 2 .
[0030] FIG. 6 a - 6 e are flow charts indicating audio prompts provided during use of the AED of FIG. 1 and steps to be performed by the caregiver in response to the graphical and audio prompts.
[0031] FIGS. 7 a and 7 b list the audio prompts used in the flowcharts shown in FIGS. 6 a - 6 e.
[0032] FIG. 8 is an exploded perspective view of the cover and housing.
[0033] FIG. 9 is a side plan view of the cover indicating angle ‘A’.
[0034] FIGS. 10 a and 10 b are side views of a patient with and without the cover placed beneath the shoulders, to show the effect on the patient's airway of placing the cover beneath the shoulders.
[0035] FIG. 11 is a plan view of a decal providing graphical instructions on the cover for placing the cover under a patient's shoulders.
[0036] FIG. 12 shows an integrated electrode pad.
[0037] FIG. 13 is another view of an electrode pad.
[0038] FIG. 14 is an isometric view of an electrode well along one side of the housing.
[0039] FIG. 15 is a schematic of the electronics contained in the integrated electrode pad of FIG. 12 .
[0040] FIG. 16 is an isometric view of a first-aid kit implementation.
DETAILED DESCRIPTION
[0041] There are a great many possible implementations of the invention, too many to describe herein. Some possible implementations that are presently preferred are described below. It cannot be emphasized too strongly, however, that these are descriptions of implementations of the invention, and not descriptions of the invention, which is not limited to the detailed implementations described in this section but is described in broader terms in the claims.
[0042] The terms “caregiver”, “rescuer” and “user” are used interchangeably and refer to the operator of the device providing care to the patient.
[0043] Referring to FIGS. 1 and 2 , an automated external defibrillator (AED) 10 includes a removable cover 12 and a device housing 14 . The defibrillator 10 is shown with cover 12 removed in FIG. 2 . An electrode assembly 16 (or a pair of separate electrodes) is connected to the device housing 14 by a cable 18 . Electrode assembly 16 is stored under cover 12 when the defibrillator is not in use.
[0044] Referring to FIG. 3 , the AED includes circuitry and software 20 for processing , a user interface 21 including such elements as a graphical 22 or text display 23 or an audio output such as a speaker 24 , and circuitry and/or software 25 for detecting a caregiver's progress in delivering therapy—e.g., detecting whether one or more of a series of steps in a protocol has been completed successfully In some preferred implementations, the detecting also includes the ability to determine both whether a particular step has been initiated by a user and additionally whether that particular step has been successfully completed by a user. Based on usability studies in either simulated or actual use, common user errors are determined and specific detection means are provided for determining if the most prevalent errors have occurred.
[0045] If it is determined that the current step in the protocol has not been completed, then the processor will pause the currently-scheduled sequence of instructions. If, for instance, it has been determined that a particular step has been initiated but not completed, but none of the common errors has occurred subsequent to initiation of the particular step, then the processor may simply provide a pause while waiting for the user to complete the step. If, after waiting for a predetermined period of time based on prior usability tests, there has been no detection of the step completion, the processor may initiate a more detailed set of prompts, typically at a slower sequence rate, describing the individual sub-steps that comprise a particular step. If one of the common errors is detected while waiting for completion of the step, the processor may initiate a sequence of instructions to correct the user's faulty performance.
[0046] Device housing 14 includes a power button 15 and a status indicator 17 . Status indicator 17 indicates to the caregiver whether the defibrillator is ready to use.
[0047] The cover 12 includes a cover decal 30 ( FIG. 1 ) including a logo 31 and a series of graphics 32 , 34 and 36 . Logo 31 may provide information concerning the manufacturer of the device and that the device is a defibrillator (e.g., “ZOLL AED”, as shown in FIG. 1 , indicating that the device is a Semi-Automatic External Defibrillator available from Zoll Medical). Graphics 32 , 34 and 36 lead the caregiver through the initial stages of a cardiac resuscitation sequence as outlined in the AHA's AED treatment algorithm for Emergency Cardiac Care pending arrival of emergency medical personnel . (See “Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Supplement to Circulation,” Volume 102, Number 8, Aug. 22, 2000, pp. I-67.) Thus, graphic 32 , showing the caregiver and patient, indicates that the caregiver should first check the patient for responsiveness, e.g., by shaking the patient gently and asking if the patient is okay. Next, graphic 34 , showing a telephone and an emergency vehicle, indicates that the caregiver should call for emergency assistance prior to administering resuscitation. Finally, graphic 36 indicates that after these steps have been performed the caregiver should remove the cover 12 of the defibrillator, remove the electrode assembly 16 stored under the lid, and turn the power on by depressing button 15 . The graphics are arranged in clockwise order, with the first step in the upper left, since this is the order most caregivers would intuitively follow. However, in this case the order in which the caregiver performs the steps is not critical, and thus for simplicity no other indication of the order of steps is provided.
[0048] The device housing includes a device housing decal 40 , shown in FIG. 2 . The graphics are configured to lead the caregiver through the entire resuscitation sequence, as will be explained below with reference to FIGS. 6 a - 6 e . Decal 40 also includes a center graphic 50 , which includes representations of a hand and a heart. Center graphic 50 overlies a treatment button which, when depressed, causes the defibrillator to deliver a defibrillating shock to the electrode assembly 16 .
[0049] Each of the graphics on device housing decal 40 is accompanied by a light source that can be temporarily illuminated to indicate that the illuminated step should be performed at that particular time. These light sources guide the caregiver, step-by-step, through the resuscitation sequence, indicating which graphic should be viewed at each point in time during resuscitation.
[0050] The light source for each of the graphics 42 - 50 is preferably an adjacent LED (LEDs 56 , FIG. 2 ). The heart 54 may be translucent and backlit by a light source in the device housing (not shown). Alternatively, the heart may include an adjacent LED (not shown) and/or the hand 52 may include an LED 57 as shown. Programmable electronics within the device housing 14 are used to determine when each of the light sources should be illuminated.
[0051] In some preferred implementations, a liquid crystal display 51 is used to provide the more detailed graphical prompts when a user is unable to complete the rescue sequence on their own. In these implementations, the purpose of the printed graphics is to provide a more general indication of the current step in the overall sequence, e.g. airway graphics 44 provides an indication that the rescuer should be performing the “Open Airway. Check for Breathing.” sub-sequence, but may not provide a detailed enough description for someone who has forgotten the correct actions to perform. In an alternative embodiment, the graphical instructions may be provided by a larger version of the liquid crystal display (LCD) 51 whereby the LED-lit printed instructions are eliminated or removed and most or all of the graphical instructions are provided by the LCD 30 . In this case, the LCD 51 will automatically show the more detailed instructions when it determines that the user is unable to properly perform the action.
[0052] The programmable electronics may also provide audio prompts, timed to coincide with the illumination of the light sources and display of images on the liquid crystal display 51 , as will also be discussed below with reference to FIGS. 6 a and 6 e .
[0053] The cover 12 is constructed to be positioned under a patient's neck and shoulders, as shown in FIGS. 10 a and 10 b , to support the patient's shoulders and neck in a way that helps to maintain his airway in an open position, i.e., maintaining the patient in the head tuck-chin lift position. The cover is preferably formed of a relatively rigid plastic with sufficient wall thickness to provide firm support during resuscitation. Suitable plastics include, for example, ABS, polypropylene, and ABS/polypropylene blends.
[0054] Prior to administering treatment for cardiac arrest, the caregiver should make sure that the patient's airway is clear and unobstructed, to assure passage of air into the lungs. To prevent obstruction of the airway by the patient's tongue and epiglottis (e.g., as shown in FIG. 10 a ), it is desirable that the patient be put in a position in which the neck is supported in an elevated position with the head tilted back and down. Positioning the patient in this manner is referred to in the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care as the “head tilt-chin lift maneuver.” The head tilt-chin lift position provides a relatively straight, open airway to the lungs through the mouth and trachea. However, it may be difficult to maintain the patient in this position during emergency treatment.
[0055] The cover 12 has an upper surface 24 that is inclined at an angle A ( FIG. 9 a ) of from about 10 to 25 degrees, e.g., 15 to 20 degrees, so as to lift the patient's shoulders and thereby cause the patient's head to tilt back. The upper surface 24 is smoothly curved to facilitate positioning of the patient. A curved surface, e.g., having a radius of curvature of from about 20 to 30 inches, generally provides better positioning than a flat surface. At its highest point, the cover 12 has a height H ( FIG. 9 ) of from about 7.5 to 10 cm. To accommodate the width of most patients' shoulders, the cover 12 preferably has a width of at least 6 inches, e.g., from about 6 to 10 inches. If the cover 12 is not wide enough, the patient's neck and shoulders may move around during chest compressions, reducing the effectiveness of the device. The edge of the cover may also include a lip 11 ( FIG. 9 ) or gasket (not shown) to prevent water from entering the housing when the cover is in place. The positions shown in FIGS. 10 a and 10 b (a patient in the head lift-chin tilt position and a patient with a closed airway) are also shown in the AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Aug. 22, 2000, p. 1-32, FIGS. 7 and 8 .
[0056] The cover 12 is provided with one or more sensors for determining if the patient's shoulders have been properly positioned on the cover 12 . Referring to FIG. 8 , two photoelectric sensors 156 , 157 are used to determine if the cover has been placed underneath the patient's back. The sensors 156 , 157 are located along the acute edge of the cover 12 , with one facing inward and one facing outward with the cable 155 providing both power to the sensors 156 , 157 as well as detection of the sensor output. If the cover 12 is upside down, the inner sensor 156 will measure a higher light level than the outer sensor 157 ; if the cover has been placed with the acute edge facing toward the top of the patient's head, then the outer sensor 157 will measure higher than the inner sensor 156 and will also exceed a pre-specified level. In the case of a properly positioned cover, both inner 156 and outer sensor 157 outputs will be below a pre-specified level. In another embodiment, the detections means is provided by a pressure sensor 158 located underneath the cover decal. Referring to FIG. 6 c , if the processing means 20 detects that the cover is upside down, it will cause an audible prompt to be delivered to the user that is more detailed than the original prompt. The processing means 20 will also slow down the rate of speech of the audio prompts. If the cover is still upside down after a predetermined period of time, the processing means 20 will deliver an even more detailed message on how to properly place the cover. If, after three attempts to get the user to properly position the cover 12 , the processing means 20 will deliver the next audio prompt without further waiting for proper placement of the cover 12 .
[0057] In the preferred embodiment, the defibrillator includes communication capability such as cell phone, global positioning system (GPS) or simpler wireless phone capability. Preferably, both cell phone and GPS are included in the device. The cell phone is preconfigured to automatically dial the Emergency Response Center (ERC) in the community in which it is located such as “911” in much of the United States. The cell phone service is chosen which is able to provide voice, data, as well as GPS capability. Thus in response to a command by the device to “Call 911 by Pressing the Phone button”, the device automatically dials 911 and the built-in speaker 360 and microphone 159 on the device function to provide speakerphone capability. If a connection is successfully made to the emergency response center, the device transmits its exact location based on its GPS capability and also can transmit to the response center the status of the defibrillator. In more advanced modes, the emergency response center can remotely control the operation of the defibrillator via the bi-directional data capability. When a connection is made to the ERC and emergency response personnel (ERP), the automatic voice prompting of the defibrillator can be remotely de-activated by the ERP so as not to distract the rescuer from the instructions given by the ERP. While coaching the rescuer via the speakerphone capability in the defibrillator, the ERP can utilize the responsive feedback prompting functionality of the device to provide more accurate coaching of the rescuer. It is well known, however, that cell phone and other wireless communication methods are not especially reliable even under the best circumstances, and are often completely unavailable in industrial facilities, basements, etc., thus it is important to provide a means of automatically reverting to the mode wherein the device provides all responsive feedback prompts to the user when the processor detects that the communication link has been lost. Additional prompts will also be provided to the user to assuage any concern they might have that the connection to the human expert has been lost (e.g. “Communication has been temporarily lost to 911 personnel. Don't worry. This AED is able to perform all steps and help you through this procedure.”). When a communication link has been lost, the device will preferably automatically begin recording all device and patient status as well as all audio received by the built-in microphone. If the communication link is subsequently reacquired, the device will preferably automatically transmit the complete event, including patient, device and audio data, acquired during the time communication was not available, providing ERP valuable data to help in their medical decision-making The ERP may remotely control the defibrillator via a bi-directional communication link that transmits both voice and data.
[0058] In another embodiment, a remote computer located at the ERC, that is more capable than the processor in the device may provide the remote decision-making capability. The remote computer would run artificial intelligence software utilizing such techniques, e.g., as fuzzy logic, neural nets and intelligent agents to provide prompting to the user.
[0059] FIG. 6 a illustrates, in flow chart form, the default graphical and audio prompts provided by the device for a caregiver performing resuscitation. The prompts shown in the figure do not include responsive feedback prompts by the device that provide more detailed instructions depending on whetherparticular sequences have been successfully completed by the caregiver. The text in boxes indicates steps performed by the caregiver. The text in caption balloons, with ear symbols, indicates audio prompts generated by the defibrillator. FIGS. 6 b - 6 e provide flowcharts of more detailed responsive feedback prompts (the content of which are shown in FIGS. 7 a , 7 b ) that may be provided to supplement the steps of calling for help, open airway/check for breathing, and defibrillation electrode application.
[0060] Thus, when a person collapses and a caregiver suspects that the person is in cardiac arrest 100 ( FIG. 6 a ), the caregiver first gets the defibrillator and turns the power on 102 . If the unit passes its internal self tests, and is ready for use, this will be indicated by indicator 17 , as discussed above. Next, the defibrillator prompts the caregiver with an introductory audio message, e.g., “Stay calm. Listen carefully” (audio prompt 104 ).
[0061] Shortly thereafter, the defibrillator will prompt the caregiver with an audio message indicating that the caregiver should check the patient for responsiveness (audio prompt 106 ). Simultaneously, the LED adjacent graphic 42 will light up, directing the caregiver to look at this graphic. Graphic 42 will indicate to the caregiver that she should shout “are you OK?” and shake the person (step 108 ) in order to determine whether the patient is unconscious or not.
[0062] After a suitable period of time has elapsed (e.g., 2 seconds), if the caregiver has not turned the defibrillator power off (as would occur if the patient were responsive), the defibrillator will give an audio prompt indicating that the caregiver should call for help (audio prompt 110 ). Simultaneously, the LED adjacent graphic 42 will turn off and the LED adjacent graphic 43 will light up, directing the caregiver's attention to graphic 43 . Graphic 43 will remind the caregiver to call emergency personnel (step 112 ), if the caregiver has not already done so.
[0063] After a suitable interval has been allowed for the caregiver to perform step 112 (e.g., 2 seconds since audio prompt 110 ) the defibrillator will give an audio prompt indicating that the caregiver should open the patient's airway and check whether the patient is breathing (audio prompt 114 ). The LED adjacent graphic 43 will turn off, and the LED adjacent graphic 44 will light up, directing the caregiver's attention to graphic 44 , which shows the proper procedure for opening a patient's airway. This will lead the caregiver to lift the patient's chin and tilt the patient's head back (step 116 ). The caregiver may also position an airway support device under the patient's neck and shoulders, if desired, as discussed below with reference to FIGS. 10 a , 10 b . The caregiver will then check to determine whether the patient is breathing.
[0064] After a suitable interval (e.g., 15 seconds since audio prompt 114 ), the defibrillator will give an audio prompt indicating that the caregiver should check for signs of circulation (audio prompt 118 ), the LED adjacent graphic 44 will turn off, and the LED adjacent graphic 45 will light up. Graphic 45 will indicate to the caregiver that the patient should be checked for a pulse or other signs of circulation as recommended by the AHA for lay rescuers (step 120 ).
[0065] After a suitable interval (e.g., 5 to 7 seconds since audio prompt 118 ), the defibrillator will give an audio prompt indicating that the caregiver should attach electrode assembly 16 to the patient (audio prompt 122 ), the LED adjacent graphic 45 will turn off, and the LED adjacent graphic 46 will light up. Graphic 46 will indicate to the caregiver how the electrode assembly 16 should be positioned on the patient's chest (step 124 ).
[0066] At this point, the LED adjacent graphic 47 will light up, and the defibrillator will give an audio prompt indicating that the patient's heart rhythm is being analyzed by the defibrillator and the caregiver should stand clear (audio prompt 126 ). While this LED is lit, the defibrillator will acquire ECG data from the electrode assembly, and analyze the data to determine whether the patient's heart rhythm is shockable. This analysis is conventionally performed by AEDs.
[0067] If the defibrillator determines that the patient's heart rhythm is not shockable, the defibrillator will give an audio prompt such as “No shock advised” (audio prompt 128 ). The LEDs next to graphics 48 and 49 will then light up, and the defibrillator will give an audio prompt indicating that the caregiver should again open the patient's airway, check for breathing and a pulse, and, if no pulse is detected by the caregiver, then commence giving CPR (audio prompt 130 , step 132 ). Graphics 48 and 49 will remind the caregiver of the appropriate steps to perform when giving CPR.
[0068] Alternatively, if the defibrillator determines that the patient's heart rhythm is shockable, the defibrillator will give an audio prompt such as “Shock advised. Stand clear of patient. Press treatment button” (audio prompt 134 ). At the same time, the heart and/or hand will light up, indicating to the caregiver the location of the treatment button. At this point, the caregiver will stand clear (and warn others, if present, to stand clear) and will press the heart, depressing the treatment button and administering a defibrillating shock (or a series of shocks, as determined by the defibrillator electronics) to the patient (step 136 ).
[0069] After step 136 has been performed, the defibrillator will automatically reanalyze the patient's heart rhythm, during which audio prompt 126 will again be given and graphic 47 will again be illuminated. The analyze and shock sequence described above will be repeated up to three times if a shockable rhythm is repeatedly detected or until the defibrillator is turned off or the electrodes are removed. After the third shock has been delivered, the device will illuminate LEDs 48 and 49 and issue the audio prompts 130 / 132 . The device will keep LEDs 48 and 49 illuminated for a period of approximately one minute indicating that if CPR is performed, it should be continued for the entire minute. “Continue CPR” audio prompts may be repeated every 15-20 seconds during this period to instruct the user to continue performing chest compressions and rescue breathing.
[0070] After approximately one minute has elapsed, the device will extinguish LEDs 48 and 49 and illuminate LED 47 . Audio prompt 126 (stand clear, analyzing rhythm) will also be issued and a new sequence of up to three ECG analyses/shocks will begin.
[0071] If the caregiver detects circulation during step 132 , the caregiver may turn off the defibrillator and/or remove the electrodes. Alternatively, the caregiver may not perform further CPR, but nonetheless allow the device to reanalyze the ECG after each one minute CPR period in order to provide repeated periodic monitoring to ensure the patient continues to have a non-shockable rhythm.
[0072] Thus, in the continuing presence of a shockable rhythm, the sequence of three ECG analyses and three shocks, followed by one minute of CPR, will continue indefinitely. If, instead, a non-shockable rhythm is or becomes present, the sequence will be analyze/no shock advised, one minute of CPR, analyze/no shock advised, one minute of CPR, etc. When a shock is effective in converting the patient's heart rhythm to a heart rhythm that does not require further defibrillating treatment, the sequence will be: analyze/shock advised, shock (saves patient), analyze/no shock advised, one minute CPR period (if pulse is detected then caregiver will not do CPR during this period), analyze/no shock advised, one minute CPR period, etc., continuing until the caregiver turns the defibrillator (e.g., if the caregiver detects a pulse) or the electrodes are removed.
[0073] If electrode contact is lost at any time (as determined by the impedance data received from the electrode assembly), this will result in an appropriate audio prompt, such as “check electrodes” and illumination of the LED adjacent graphic 46 . The electrodes 208 may be stored in a well 222 ( FIG. 14 ) that is structurally integrated with the housing 14 or may be a separate pouch 16 .
[0074] It has also been discovered that a not-insignificant portion of caregivers are unable to open the packaging for the electrodes; therefore, a sensor may be provided to determine if the electrode package has been opened. If detection of the electrode package 16 opening has not occurred within a predetermined period of time, the unit will provide more detailed instructions to assist the user in opening the packaging 16 .
[0075] Referring to FIGS. 12 and 13 , in preferred implementations, a means is provided of detecting and differentiating successful completion of multiple steps of electrode application: (1) taking the electrodes 208 out of the storage area 222 or pouch 16 ; (2) peeling the left pad 212 from the liner 216 ; (3) peeling the right pad 214 from the liner 216 ; (4) applying the left pad 212 to the patient 218 ; and (5) applying the right pad 214 to the patient 218 . Referring to FIGS. 12 and 13 , a package photosensor 210 is provided on the outer face of the electrode backing 220 . Detection that the electrode 208 is sealed in the storage area is determined by the photosensor output being below a threshold. A photoemitter/photosensor (PEPS) 223 combination is embedded into each electrode facing towards the liners 216 . The liner 216 is constructed so that a highly reflective aluminized Mylar, self-adhesive disk 224 is applied to the liner 216 in the location directly beneath the PEPS 223 . The reflective disk 224 is coated with a silicone release material on the side in contact with the electrode 208 so that it remains in place when the electrode 208 is removed from the liner. In such a configuration, the processor is fully capable of differentiating substantially the exact step in the protocol related to electrode application. When the package photosensor 210 detects light above a certain threshold, it is known that the electrodes have been removed from the storage area 222 or pouch 16 . The high reflectance area 224 beneath each PEPS 223 provides a signal that is both a high intensity as well as being synchronous with the emitter drive with low background level; thus it is possible to distinguish with a high degree of accuracy which, if either, of the electrodes 212 , 214 is still applied to the liner 216 . When an electrode 212 , 214 is removed from the liner 216 the background level of the signal increases due to ambient light while the synchronous portion decreases because there is little if any of the photoemitter light reflected back into the photosensor; this condition describes when an electrode 212 , 214 is removed from the liner 216 . When it has been determined that an electrode 212 , 214 has been removed from the liner 216 , the processor means 20 proceeds to the next state—looking for application of that electrode to the patient. Application of the electrode 212 , 214 to the patient will result in a decrease in the background level of the signal output and some synchronous output level intermediate to the synchronous level measured when the electrode 212 , 214 was still on the liner 216 . If it has been determined that both electrodes 212 , 214 are applied to the patient 218 but there is an impedance measured between the electrodes that is significantly outside the normal physiological range then it is very possible that the user has applied the electrodes to the patient without removing the patient's shirt. Surprisingly, this is not uncommon in real situations with users; a patient's shirt will have been only partially removed when electrodes are applied resulting in insufficient electrical contact with the patient's skin. FIG. 6 d shows the flowchart for prompting related to retrieval and application of electrodes. As in the case with responding to a user's interactions.
[0076] Many other implementations are within the scope of the following claims.
[0077] For example, the graphics on the center decal can be accompanied by any desired light source. For instance, if desired, all of the graphics can be translucent, and can be backlit. Alternatively, the graphics can be provided in the form of LED images, rather than on a decal.
[0078] While the electrodes have been illustrated in the form of an integral electrode assembly, separate electrodes may be used.
[0079] In some implementations, generally all of the graphically illustrated steps are shown at the same time, e.g., as illustrated by the decal described above. This arrangement allows the caregiver to see the steps that will be performed next and thus anticipate the next step and begin it early if possible. However, alternatively, the graphics can be displayed one at a time, e.g., by using a screen that displays one graphic at a time or backlit graphics that are unreadable when not back lit. This arrangement may in some cases avoid overwhelming novice or lay rescuers, because it does not present the caregiver with too much information all at the same time.
[0080] If desired, each graphic could have an associated button that, when pressed, causes more detailed audio prompts related to that graphic to be output by the defibrillator.
[0081] The cover 12 of the AED may include a decal on its underside, e.g., decal 200 shown in FIG. 11 . Decal 200 illustrates the use of the cover as a passive airway support device, to keep the patient's airway open during resuscitation. Graphic 202 prompts the caregiver to roll the patient over and place cover 12 under the patient's shoulders, and graphic 204 illustrates the proper positioning of the cover 12 under the patient to ensure an open airway.
[0082] While such a graphic is not included in the decal shown in FIG. 5 , the decal 40 may include a graphic that would prompt the user to check to see if the patient is breathing. Such a graphic may include, e.g., a picture of the caregiver with his ear next to the patient's mouth. The graphic may also include lines indicating flow of air from the patient's mouth.
[0083] “Illuminated”, “light up”, and similar terms are used herein to refer to both a steady light and a light of varying intensity (e.g., blinking) A blinking light may be used, if desired, to more clearly draw the user's attention to the associated graphic.
[0084] Referring to FIG. 16 , in other implementations, a home first aid device may be provided for providing instructions and therapy, as needed, for a variety of medical situations. In some implementations, the device would include: (a) a cover to the device whose removal the processor is capable of detecting; (b) a series of bound pages 230 on the face of the device under the cover 12 with a detection means providing for determining to which page the bound pages have been turned; (c) a processor ; (d) a speaker 232 providing audio output. The home first aid device may also include a portion of the device used specifically for storage of items commonly used in the course of providing aid such as bandaids, bandages, splints, antiseptic, etc. The storage area preferably takes the form of a partitioned tray 234 . Alternatively, the storage area may take the form of multiple pockets, pouches, straps, or slots. The storage area is partitioned into individual wells in which each of the items is stored. Photoelectric sensors 236 , 237 may be provided in each of the wells, thereby providing a means of determining which, if any, of the items has been removed by the user. Detecting which page the bound pages are turned to may be provided by embedding small high magnetic intensity samarium cobalt magnets 240 in locations specific to each page. In some implementations, the magnets 240 are located along the bound edge of the pages, outside the printed area of the pages. Magnetic sensors 241 are located in the device housing 14 that correspond to the locations where the magnets 240 located in the specific pages make contact when the specific page is turned. The magnetic sensor 241 may be a semiconductor device employing the Hall effect principle, but may also be a reed switch or other magnetically activated switch. By providing a means of detecting user actions automatically such as the detection of which page the user has turned to or which first aid item has been removed from the storage container, the device is able to interact and respond to the rescuer in an invisible manner, improving both speed as well as compliance to instructions. In such a manner, interactivity is preserved while at the same time providing a printed graphical interface to the user.
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A device for assisting a caregiver in delivering therapy to a patient, the device comprising a user interface configured to deliver prompts to a caregiver to assist the caregiver in delivering therapy to a patient; at least one sensor configured to detect the caregiver's progress in delivering the therapy, wherein the sensor is other than an electrode in an electrical contact with the body; a memory in which a plurality of different prompts are stored; a processor configured to determine which of the different prompts should be selected for delivery based on the progress detected by the sensor.
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CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of U.S. application Ser. No. 08/245,971 filed on May 19, 1994, now U.S. Pat. No. 5,522,593. The application hereinabove is incorporated herein and is a part thereof.
BACKGROUND OF THE INVENTION
(a) Field of the Invention
The present invention relates to a golf club head, especially relates to so-called an iron golf club head, a putter golf club head or a pitching golf club head.
(b) Description of Prior Art
For example, U.S. Pat. Ser. No. 4,874,171 discloses in its FIG. 5 a golf club head provided with sythetic resin containing reinforcing fiber (the specific gravity ranging from 2 to 4) on metallic sole at the back of face. The prior head has the upper end of the synthetic resin member connected to the upper end of face, while the lower end thereof connected to the back end of sole having protrusion thereon. Further, the back surface of the synthetic resin member is formed with arc-shaped convex curved surface.
It is well acknowledged that you can enlarge a sweat area in a golf club head by elongating the depth of the CG of the head (i.e.,elongating the distance between the face and the center of gravity.) and having the weight distribution of face biased toward periphery of the head. Particularly, such weight distribution is effective in preventing the unsteadiness of the head in striking balls, since an ordinary head is unstable unless balls are struck at the center of face.
According to the prior head shown in FIG. 5 of U.S. Pat. No. 4,874,171, although the center of gravity can be postioned backward by providing the protrusion in the center of sole, the head is too partially weighted at sole side, therefore, there is no consideration for enlarging sweet area by dispersing the weight distribution on face.
In addition, when a player addresses a ball prior to striking the same, he is generally required to carefully choose the positional relationship between the face and the ball. According to U.S. Pat. No. 4,874,171, however, as the back surface of the synthetic resin member is formed with arc-shaped convex curved surface, such convex curved surface will be an obstacle to addressing a ball.
SUMMARY OF THE INVENTION
To eliminate the above-mentioned problems, it is, therefore, an object of the present invention to provide a golf club head which has a larger sweet area.
It is another object of the present invention to provide a golf club head of which the balance weight will not disturve a player's concentration in addressing balls.
According to a major feature of the present invention, a golf club head comprises: a head body having a face at its front and a concave portion at its back, said concave portion being defined by a rear surface of the head body and a peripheral portion of the back; a balance weight made of material denser than that of said head body which, is secured into said concave poriton, the back of said head body being located on the same plane relative to a back of said weight, wherein said peripheral portion is thickened such that a depth of said concave portion is greater at its lower side than at its upper side, while a height thereof is greater at its inside than at its outside.
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects, features and advantages of the invention will be apparent to those skilled in the art from the following description of the preferred embodiments of the invention, wherein reference is made to the accopmpanying drawings, of which:
FIG. 1 is a section showing a first embodiment of the invention.
FIG. 2 is a perspective view showing a first embodiment of the invention.
FIG. 3 is a rear view showing a first embodiment of the present invention.
FIG. 4 is a section showing a second embodiment of the invention.
FIG. 5 is a section showing a third embodiment of the invention.
FIG. 6a is a section showing a fourth embodiment of the invention.
FIG. 6b is an enlarged view of a section showing a fourth embodiment of the invention.
FIG. 7 is a perspective view showing a fourth embodiment of the invention.
FIG. 8 is a rear view showing a fourth embodiment of the invention.
FIG. 9 is a section showing a fifth embodiment of the invention.
FIG. 10 is a section showing a sixth embodiment of the invention.
FIG. 11 is a perspective view showing a sixth embodiment of the inveniton.
FIG. 12 is an exploded perspective view showing a sixth embodiment of the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Hereinafter is described a first embodiment of the present invention with reference to FIGS. 1 to 3.
Referring to FIG. 1, reference numeral 1 designates a head body made of titanium, aluminium or the alloy thereof, having face 2 inclined at a preset angle at its front side, neck 4 at one side for connecting shaft 3 thereto. The back of the head body 1 is formed with concave portion 5 having entire periphery of thickened portion 1A, thus forming sole 1B at its bottom side.
The depth A of a lower portion of the concave portion 5 is formed greater than the depth B of the upper portion thereof, while the height D of the inside or front portion greater than the height C of the outside or back portion thereof.
The weight 6 to be provided in the concave portion 5 is formed of comparatively denser materials, such as iron, copper, beryllium copper alloy or lead, which is pressed into the concave portion 5 by means of a pressing device or the like, thus securing the same to the head body 1. In such pressing-in and securing operation, the back surface of the head body 1 is formed on the same plane relative to back surface 6A of weight 6, as shown in a dotted line of FIG. 1. In the boundary portion between back surface 1A and 6A is provided a small groove 7 having V-shaped section as an ornament, which is colored red or the like (not shown).
With the structure thus made, as weight 6 denser than head body 1 is provided in the back thereof, the CG thereof can be positioned backward, thus elongating the depth Le of the CG to enlarge sweet area. Further, the concave portion 5 has such a dovetail structure that the lower depth A is formed greater than the upper depth B, while the comparatively inside height D greater than the comparatively outside height C, thereby ensuring the securing of the head body 1 to the weight 6, and thus further elongating the depth Le of the CG since the center of gravity (not shown) of weight 6 itself is lowered and positioned backward. Furthermore, as the back surface of the head body 1 is provided evenly with respect to the back surface 6A of the weight 6, there will be no obstacles to the view in the back portion of a club head, so that a player can enhance his concentration in addressing balls.
In addition, since the back surface of the head body 1 is formed annular such that the entire periphery thereof is thickened as illustrated by the thickened portion 1A, titanium, aluminium or the alloy thereof can be disposed in the back periphery of the face 2, thus realizing well-dispersed weight distribution. Consequently, if a player strikes a ball slightly off the center of the face 2, he can still be free from unsteadiness of the head when striking a ball due to the excellent dispersion of weight distribution.
In FIGS. 4 and 5 showing second and third embodiments of the invention respectively, the same portions as those described in a first embodment will be designated as common reference numerals, and their repeated detailed description will be omitted.
In a second embodiment, there is provided convex portion 12 protruding backward from approximately the center of bottom surface 11 of concave portion 5 formed in head body 1. The cross-width defined by side surface 13 of the convex portion 12 generally increases toward the back, i.e., formed reverse-tapered, so that weight 6 can be also secured by this dovetail-shaped convex portion 12. Similarly to a first embodiment, back surface 1A of the head body 1 is formed on the same plane relative to back surface 6A of the weight 6. Accordingly, in this embodiment, the weight 6 can allow the depth of CG to be greater, and there will be no obstacles to the player's view in the back portion of a club head, so that he can enhance his concentration in addressing balls as well.
In FIG. 5 showing a third embodiment of the invention, the same structure as that shown in a first embodiment is applied to a putter golf club head. That is, there is provided concave portion 5 in a head body 1, into which is pressed weight 6 denser than head body 1. Similarly, each structure shown in each foregoing embodiment can be applied to not only an iron golf club head but a putter golf club head.
Incidentally, in the preceding embodiments, any suitable combination of material for head body 1 and weight 6 may be provided.
Referring to FIGS. 6 to 8 showing a fourth embodiment of the invention, reference numeral 21 designates head body made of stainless steel, copper, beryllium copper alloy or lead, having face 22 inclined at a preset angle at its front side, hosel 24 at one side for connecting shaft 23 thereto. The back of the head body 21 is formed with concave portion 25 having entire periphery of thickened portion 21A, thus forming sole 11B at its bottom side.
The depth E of a lower portion of the concave portion 25 is formed greater than the depth F of the upper portion thereof, while the height H of the inside portion greater than the height G of the outside portion thereof. There is provided protrusion 27 integral with bottom portion 26 of the concave portion 25, said protrusion 27 having reverse-trapezoid section, having wider dimension at its back side, while narrower dimension at its bottom 26 side. Balance weight 30 provided in the concave portion 25 is made of material having the less specific gravity than that of head body 21, such as titanium, aluminium or the alloy thereof, which is formed in advance slightly greater than the concave portion 25, having another concave portion 31 slightly smaller than the opposite protrusion 27.
After the balance weight 30 is pressed into the concave portion 25 by a suitable pressing device, the back surface of the head body 21 is disposed on approximately the same plane relative to back surface 30A of the balance weight 30, as illustrated in FIG. 6. More specifically, there is provided continuous concave curvature defined by the back of the head body 21 and the back surface 30A of the balance weight 30.
As to a combination of materials, since the greater difference in the specific gravity between the head body 21 and the balance weight 30 is desirable, the head body 21 may be preferably made of beryllium copper alloy., while balance weight 30 made of titanium alloy.
Referring to an enlarged section in FIG. 6, there is provided groove 32 formed by endmilling or the like, thus making clear boundary line adding the beauty, which, without such goove 32, might become unclear when securing the weight 32, as shown in a dotted line thereof. The groove 32 is arc-shaped, having a height I in section and a depth J, being colored blue, red or the like.
With the structure thus made, as the back surface of the head body 21 is located on approximately the same plane relative to the back surface 30A of the balance weight 30, a player can enhance his concentration in addressing a ball as being free from an obstacle to the view at that time. Particularly, as there is provided continuous concave curvature defined by the back of the head body 21 and the back surface 30A of the balance weight 30, he can visually confirm back end 11B' of sole 11B when addressing a ball.
Further, the back of the head body 21 is formed annular such that the entire periphery thereof is thickened as designated as thickened portion 21A, whereby denser metallic material such as stainless steel, copper, beryllium copper alloy or lead can be disposed in the periphery of the back of the head body 21. Accordingly, the head body 21 is partially weighted at the periphery of the back of face 22, thereby ensuring the accurate striking if a ball is struck slightly off the center of face 22.
In a preferred form of the invention, as the head body 21 is formed of beryllium copper alloy, while the balance weight 30 formed of titanium alloy, the difference in the specific gravity between the two members can be greater, so that excellent positioning of the CG of the head can be realized. Additionally, such position of the CG can be further fine adjusted so as to be best suited for a discrete player by adjusting the width I and depth J of the groove 32. In addition, as the groove 32 is arc-shaped in section, sand or soil is hard to choke it up, thus keeping it clean. The endmilling of the groove 32 is also advantageous in respect of accuracy and easiness in such milling.
In FIG. 9 showing a fifth embodiment of the invention, there is not provided the groove 32 of a fourth embodiment, and the back surface of the head body 21 is located on the same plane relative to the back surface 30A of the balance weight 30.
As to a combination of materials for head body 21 and balance weight 30, any suitable combination may be selected in a fourth and fifth embodiment as well as the preceding embodiments.
In FIGS. 10 to 12 showing a sixth embodiment of the invention, reference numeral 43 designates head body, which is made of stainless steel (the specific gravity 7.8), having hosel 42 for connecting shaft 41 thereto, and is formed with sole 44, heel 45 and top 46. Sole 44, heel 45 and top 46 define a face equivalent portion which has a striking face 47. Striking face 47 corresponding to face of the head body 43 is provided with through-hole 49 extending up to back face 48 of the head body 43, into which is securely inserted face member 50. The through-hole 49 is formed with stepped portions such as the first and second dovetail grooves 51 and 52. The first groove 51 has outside width K less than inside width L (K<L), while the second groove 52 has inside width M less than the inside width L (M<L). The head body 43 is formed thicker at sole 44 side than at top 46 side (i.e., N>P).
The face member 50 is made of material of the specific gravity less than that of head body 43, such as pure titanium (the specific gravity: 4.5) or titanium alloy. The front surface of the face member 50 is formed with face 50A, while the back surface thereof is formed with protrusion 50B, which reversely corresponds in shape to the through-hole 49 having dovetail grooves 51 and 52, yet formed slightly greater than the same, so that the protrusion 50B is pressed from the striking face 47 side into the through-hole 49 to be secured thereto until the back surface 53 thereof arrives through stepped portion 56 at nearly the same plane relative to the back surface 48 of the head body 43. In a preferred form of the invention, the back surface 53 is curved slightly concavely.
Reference numeral 54 is an ornament ring made of synthetic resin, which is firmly fitted into the stepped portion 56 between the back surfaces 48 and 53. The ring 54 has a circular section and is approximately pentagonal seen from the front, which is colored with suitable color other than that of the head body 43, for example, purple or the like. Reference numeral 55 designates grooves called score lines formed on face 50A.
In a preferred form of the invention, the back surface 53 of the protrusion 50B may be positioned on the same or approximately the same plane relative to the back surface 48 of the head body 43, and the thickness X of face member 50 may be at least 70% of the depth Q of the through-hole 49, more preferably 80% or above, most preferably 90% or above thereof.
Now the action and effect of a golf club head having the above-described structure will be explained.
The center of gravity CG of the head body 43 is displaced toward back and sole 44 side, owing to the greater thickness of the thickness N relative to the thickness P (N>P). Thus, the distance Le between the center of gravity CG and the face 50A can be elongated to enlarge sweet area. Further, as the head body 43 made of stainless steel having the through-hole 49 is denser than the face member 50 made of pure titanium or titanium alloy, the weight distribution of the head can be effectively dispersed toward the periphery of the head, thus further enlarging sweet area.
Furthermore, as the back surface 53 of face member 50 is formed so thick that it arrives at nearly the same plane relative to the back surface 48, the face member 50 is less subjected to elastic deformation when striking a ball, thus ensuring the enhancement of a sense of stability when striking a ball.
Additionally, as the head body 43 is made of stainless steel, while the face member made of pure titanium or titanium alloy, the difference in the specific gravity between the two members can be greater such that a ratio of the specific gravity is 1 to 0.58, thereby enlarging the depth of the CG and obtaining still dispersed weight distribution.
In addition, in this embodiment, there is provided the stepped portion 56 between the back surfaces 48 and 53, in which is securely fitted the ornament ring 54, whereby the joint line can be covered therewith to enchance the beauty. The ring 54 has the circular section free of abrupt corners, so that it will not be an obstacle to a player's concentration when addresing a ball. As the head body 43 is connected to the face member 50 by dovetail joint, the connection strength can be enhanced.
Alternatively, the head body may be made of beryllium copper alloy, while the face member made of aluminium alloy in a sixth embodiment.
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A golf club head having a larger sweet area for easier visual confirmation by a player when adressing a ball. Head body 1 is provided with denser weight at its back, thus displacing CG toward a back side of the head body 1 to enlarge a depth Le of CG and sweet area. The back of the head body 1 is located on the same plane relative to the back 6A of the weight 6, thus eliminating an obstacle to view when a player addresses a ball to enhance the concentration of the player. The back of the head body 1 is annularly formed with thickened portion 1B so that the entire periphery of the back is suitably weighted with titanium, aluminium or the alloy thereof. Owing to such dispersed weight distribution, a player can be free from a sense of unstability and accuratetly strike a ball if the ball is struck a little off the center of face 2.
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FIELD OF THE INVENTION
This invention relates generally to cabinets and similar structures and particularly to the intersecting portions thereof.
BACKGROUND OF THE INVENTION
Perhaps one of the familiar structures in modern dwellings is that generally referred to as cabinets or the like. For example, in a typical kitchen environment, a substantial amount of storage is provided by a plurality of floor supported storage cabinets usually topped by a countertop or work surface. Often a plurality of additional cabinets are supported above the countertop work surface in a configuration generally conforming to the arrangement of floor supported cabinets. While the structures of such cabinets is subject to substantial design variation and aesthetic considerations, generally all utilize a partially recessed support base at the junction between the lower cabinets and the supporting floor. As a general convenience element, this recessed base portion permits the user to stand close to the countertop work surface while engaging in various kitchen tasks and allows the user's feet to be comfortably positioned upon the floor extending beneath the cabinets. It has been found through the years that this recessed base portion greatly enhances the comfort and avoids the difficulty associated with standing close to the cabinets and countertops which would otherwise arise without the use of such recessed portions.
While the recessed base structure of the typical kitchen cabinet or the like enhances user comfort, it often makes cleaning the floor surface difficult. This problem is particularly acute for those areas or portions of the cabinet arrangement which form corners at the cabinet junctions. In the most common of kitchen arrangements, at least one and sometimes several right angle intersections of cabinet portions are provided to maximize space. The resulting corner junction of the cabinets and floor portion in the corner vicinity along the baseboards forms a difficult to reach and often hard to clean area.
A similar problem may arise in other cabinet structures such as those found in office work stations or other commercial environments which utilize floor supported storage cabinets or the like. In addition, in certain environments, other cabinet intersections with supporting surfaces such as countertops or worktops may provide similar difficult to clean corner portions.
In many commercial applications, as well as some kitchen environments, the problem is addressed by generally avoiding sharp angled corner cabinet intersections by using corner angled cabinet elements. For example, U.S. Pat. No. 5,028,098 issued to Fedder, et al. sets forth a MODULAR COUNTER WORK STATION FOR TELLERS in which a generally U-shaped work station is formed by a plurality of floor supported cabinet elements. A countertop having a similar U-shape is supported upon the cabinets. The corner portions of the cabinets and countertop include angled facets which define sufficient area to support the teller apparatus for the work station.
While some flexibility may be utilized to avoid sharp angled or right angled corner intersections in work environments such as kitchen cabinet structures or the like, there remains a continuing need in the art for providing an easier to clean structure for such areas without sacrificing the efficiency of such cabinet arrangements.
SUMMARY OF THE INVENTION
Accordingly, it is a general object to provide an improved cabinet structure for use in environments such as kitchen cabinets or office work stations. It is a more particular object of the present invention to provide a corner element which facilitates the cleaning activity associated with the corner junctions of kitchen cabinets, office work stations or the like.
In accordance with the present invention, there is provided for use in combination with a cabinet structure having convergingly angled base portions, a corner element comprises: a body having convergingly angled side portions corresponding to the angled base portions and a concave curved surface extending between the angled side portions forming intersecting edge portions therebetween, the body being positionable with the side portions contacting the base portions such that the curved surface extends between the base portions.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 sets forth a perspective view of a typical kitchen cabinet corner area having the present invention corner element utilized therein;
FIG. 2 sets forth a perspective view of the present invention corner element;
FIG. 3 sets forth a top plan view of the present invention corner element in a typical corner installation; and
FIG. 4 sets forth a rear perspective view of the present invention corner element.
DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 1 sets forth a perspective view of a corner portion of a typical kitchen cabinet environment within which the present invention corner element has been utilized. A cabinet section 11 constructed in accordance with conventional fabrication techniques defines a front face 12 to which a plurality of access doors such as doors 13 and 14 have been secured. Front face 12 defines a lower edge 15 beneath which a recessed base portion 16 extends downwardly to support cabinet section 11 upon a floor 20. A similar cabinet section 30 also constructed in accordance with the conventional fabrication techniques defines a front face 31 which supports a plurality of access doors such as doors 32 and 33. Front face 31 defines a lower edge 34 beneath which a recessed base support 35 extends downwardly to support cabinet section 30 upon floor 20. Cabinet sections 11 and 30 intersect forming a corner portion 40. Similarly, recessed base portions 16 and 35 intersect to form a recessed base corner 41 (better seen in FIG. 3).
In accordance with the present invention, a corner element generally referenced by numeral 50 is received within the corner thus formed between recessed bases 16 and 35. Corner element 50 defines a concave generally cylindrical curved surface 51. In its preferred form, corner element 50 extends above floor 20 to a heighth generally corresponding to the heighth of recessed bases 16 and 35. A conventional broom 43 is shown utilized in FIG. 1 in a typical cleaning operation in which dirt and debris is being swept from the surface of floor 20. Also shown in FIG. 1, is an accumulated debris portion 42 within the corner intersection area of cabinet sections 11, 30 and floor 20. In accordance with an important aspect of the present invention, the utilization of corner element 50 and curved surface 51 thereof within the intersecting corner of recessed base portions 16 and 35 prevents accumulated debris 42 from extending into base corner 41 (seen in FIG. 3). Thus, in accordance with an important aspect of the present invention, the movement of broom 43 in a curved sweeping motion in the direction of arrow 44 causes accumulated debris 42 to be easily swept from the corner area of floor 20 and thus avoids the difficult cleaning problem otherwise posed by base corner portion 41. As can be seen by examination of FIG. 1, the provision of curved surface 51 greatly facilitates the ease with which the otherwise hard to reach corner portion of floor 20 is cleaned. As can also be observed in FIG. 1, the use of corner element 50 does not interfere with the above-mentioned advantages in kitchen cabinet utility and comfort provided by recessed base portions 16 and 35. It should also be noted that corner element 50 may be added to cabinet sections 11 and 30 at any convenient point in the structure assembly and may, if desired, be secured in a removable fashion to provide additional flexibility of use and adaptation.
FIG. 2 sets forth a enlarged view of corner element 50 showing recessed base portions 16 and 35 in dashed line representation for purposes of reference. As described above, corner element 50 defines a concave preferably cylindrical curved surface 51. Corner element 50 further defines a pair of side surfaces 52 and 53 together with an angled facet 56. The angular relationship between side surfaces 52 and 53 is selected in correspondence with the angular relationship between recessed base portions 16 and 35 in the corner within which corner element 50 is to be utilized. Thus, in a common corner configuration, recessed base portions 16 and 35 intersect at approximately ninety degrees to form a right angle base corner 41. In such case, corner element 50 is correspondingly configured such that side portions 52 and 53 are mutually perpendicular. In accordance with an important aspect of the present invention, angled facet 56 extends between sides 52 and 53 of corner element 50 to provide substantial clearance between corner element 50 and corner 41 of recessed bases 16 and 35. This increased clearance substantially enhances the ease with which corner element 50 may be placed and permits the accommodation of less than perfect corner structures at corner portion 41.
In accordance with the present invention, curved surface 51 extends upwardly from floor 20 forming a curved intersection 57 which, as described above, greatly facilitates cleaning operations such as the above-described sweeping process. To further enhance the cleaning ease provided by corner element 50, sides 52 and 53 intersect curved surface 51 at the outer portions of corner element 50 to form substantially small thin edge portions 54 and 55 respectively. In its preferred form, corner element 50 is fabricated such that edges 54 and 55 are as small as practical to avoid the accumulation of debris at the intersections of edges 54 and 55 with bases 16 and 35 respectively and floor surface 20.
It will be apparent to those skilled in the art that corner element 50 may be fabricated utilizing a variety of materials such as wood or composite wood and resin material. It will be further apparent that corner element 50 may be fabricated of a molded plastic material or the like. It will also be apparent to those skilled in the art that the attachment of corner element 50 to recessed bases 16 and 35 may be easily accomplished using conventional adhesive deposits upon side portions 52 and 53 to permanently secure corner element 50. It is also recognized that in certain applications it may be desirable to secure corner element 50 in a removable attachment such as that provided by conventional fasteners or the like where such removable attachment is preferred. In certain environments, corner element 50 may also be utilized in the manner shown in FIG. 2 with the additional capability to support a conventional molded plastic base overlay such as that commonly used in office environments. In such case, the molded plastic base overlay may be adhesively secured directly to curved surface 51 and extend continuously from recessed base 16 across curved surface 51 to recessed base portion 35. In most installations, however, corner element 50 remains exposed as shown in FIG. 2 in which case curved surface 51 is preferably covered with a coordinated finish generally matching that of recessed base portions 16 and 35.
FIG. 3 sets forth a top section view of the corner installation of corner element 50 in the manner shown in FIG. 1. Thus, as described above, recessed base portions 16 and 35 of cabinet sections 11 and 30 respectively intersect to form a base corner 41. As is also described above, corner element 50 constructed in accordance with the present invention defines a curved generally cylindrical surface 51 and a pair of side surfaces 52 and 53. Angled facet 56 extends between the rear portions of side surfaces 52 and 53 and provides a clearance space 45 between base corner 41 and corner element 50. Curved surface 51 intersects side surfaces 52 and 53 at a pair of narrow preferably thin edge portions 54 and 55 respectively. For purposes of illustration, edge portions 15 and 34 of cabinet sections 11 and 30 respectively are shown in dashed line representation to illustrate the recessed position of base portions 16 and 35.
As described above, during the cleaning process, an accumulated debris quantity 42 is often found or encountered at the corner portion formed by floor 20 and recessed base portions 16 and 35. In accordance with the present invention, corner element 50 and curved surface 51 thereof cooperate to prevent this accumulated debris from accumulating at base corner 41. Thus, with debris 42 maintained by curved surface 51 at the portion of floor 20 shown, the movement of broom 43 in a typical sweeping motion such as that shown by arrow 44 easily permits broom 43 to wisk the accumulated debris from the corner area of floor 20. But for corner element 50, this debris accumulation would occur in the remote angled portion of base corner 41 making cleaning difficult and time consuming.
As mentioned above, FIG. 1 as well as FIG. 3 depicts the most typical intersection corner found in kitchen cabinets or the like in which base portions 16 and 35 form a right angle intersection. As is also mentioned above, the angular relationship between sides 52 and 53 is correspondingly configured to provide a similar right angled relationship. This facilitates the installation and attachment of corner element 50. It will be apparent to those skilled in the art, however, that the angular relationship between sides 52 and 53 is correspondingly configured to match the angular relationship between base portions 16 and 35 in the event the intersections thereof form a different angle. Thus, in the event base portion 16 and 35 intersect at an acute angle, for example, corner element 50 is preferably fabricated such that sides 52 and 53 define a corresponding acute angle. A similar situation, of course, arises in the event an oblique angle intersection is defined by base portions 16 and 35.
FIG. 4 sets forth a rear perspective view of corner element 50. Thus, as described above, corner element 50 defines a concave preferably cylindrical curved surface 51 and a pair of generally planar side portions 52 and 53. An angled facet 56 extends between side portions 52 and 53. The intersection of curved surface 51 with side portions 52 and 53 forms edge portions 54 and 55 respectively.
What has been shown is a convenient, easy to install, low cost corner element which may be utilized in virtually any configuration of cabinet corner environments to greatly facilitate the cleaning process of the floor portions in such corner floor areas. The corner element shown may be fabricated using a variety of materials such as wood, composite wood and resin material, or molded plastic. The corner element shown may be inexpensively fabricated and may be fabricated to suit a variety of cabinet intersection angles.
While particular embodiments of the invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the invention in its broader aspects. Therefore, the aim in the appended claims is to cover all such changes and modifications as fall within the true spirit and scope of the invention.
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A corner element for use in combination with cabinet corner structures such as those found in kitchen cabinets or the like includes a pair of side portions having an angular relationship therebetween which corresponds to the angle of cabinet intersection. An obliquely angled facet extends between the side portions. A generally cylindrical concave curved surface extends between the remaining end portions of the side surfaces to complete the corner element. In its preferred use, the corner element is secured to the cabinet base portions at the corner area to interpose the curved surface between the base portions and preclude dirt or debris from accumulating within the corner intersection of the cabinet bases.
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FIELD OF THE INVENTION
[0001] The invention relates generally to a chess game, more specifically to a novel chess game, in particular to a method and device for playing a chess game between two pairs of players.
BACKGROUND OF THE INVENTION
[0002] In a traditional method of playing chess between two players the players alternatively move chess pieces on a game board (playing field) comprising 64 equal squares of alternating light and dark colors. Chess clocks are used to limit the time for thinking over the moves in chess competitions, each of the chess clocks having a timing unit connected to two displays and a control unit. At the start of the game each player has the same number of chess pieces and pawns, one player having light-color (white) pieces and the other player having dark-color (black) pieces. Each set of chess pieces includes: one king, one queen, two rooks, two bishops, two knights and eight pawns. White starts the game; the right to play with white pieces is generally decided by a game of chance. A player must move one piece at a time, with the exception of castling. Omission of moves is prohibited. This combination of chess game features has been retained almost in all variants of improved chess games, because they are substantially aimed at structural embodiments or insignificant modification of chess game rules. Consider three examples of improved chess game variants. A first variant disclosed in U.S. Pat. No. 6,203,016 BA (Cl.7 A63F 3/02, 1999) is a method of playing chess intended to add more interest to the game process owing to insignificant modification in the above rules. The second variant disclosed in U.S. Pat. No. 6,382,626 BA (Cl.7 A63F 3/02, 2000) is a device and method for playing chess, wherein central pawns differ from the other pawns not only in size, but also in a way of moving across the chess board. In a third variant disclosed in U.S. Pat. No. 6,702,287 (Cl.7 A63F 3/02, 1999) a device and method for playing chess use a game board having 110 black and white squares. Similarly to the traditional chess game, at the start of the game the players have equal number of pieces and pawns, one player having light-color pieces, and the other one having dark-color pieces. A feature of this device is that each of the chess sets includes seventeen additional pieces which are not obligatory chess pieces.
[0003] The aforementioned devices and methods of playing chess between two players suffer from low audience appeal associated with the lack of team contest. This is explained by the fact that the current chess game process is mathematically formalized to a great extent, i.e. it is practically devoid of “mystery”. To put it differently, the current chess game is reduced to a contest between two players who only repeat, in the best case, computer-predicted chess moves at critical moments of the game. That is why a team game in which a single chess game is played between two teams, each consisting of a plurality of players, is of main interest for chess fans. Rather many attempts to overcome this problem have been made for the moment. By way of example, in U.S. Pat. No. 5,586,762 (Cl.6 A63 F 3/02, 1994) four sets of chess pieces are used for a chess game played between several teams at a time, each of said sets being provided with marks distinguishing pieces of one group from pieces of the other groups; and a square game board comprises a central matrix of sixty-four squares and four side regions, each including sixteen squares. Players alternatively move a piece according to the standard rules of chess, attempting to advance pawns to the edge rows of the squares in the central matrix. U.S. Pat. No. 6,260,848 BA (Cl.7 A63F 3/02, 2000) describes a device for playing chess between four players, comprising a game board of 144 squares of two alternating colors. In some prior art devices adapted for playing a game between more than two players, several game boards are used. For example, WO 38805 A1 (Cl.7 A63F 3/02, 1999) discloses a device for playing chess which differs from the traditional game in that three or four players play on three or four game boards at the same time. However, the aforementioned and other known methods of playing a chess game between two teams suffer from low entertaining appeal. This is primarily explained by the fact that players members of the same team can cooperate and this excludes the basic feature of pair game—the need of taking an independent decision by each player in the pair at a respective time in the game. Other deficiencies of traditional systems will be discussed in the following description. In light of the aforementioned, the object of the invention is to overcome the shortcomings mentioned above.
SUMMARY OF THE INVENTION
[0004] The object of the present invention is to provide a method of playing a chess game which can be played by at least two pairs of players, and a device for carrying out the method.
[0005] The object is attained in a device for playing a chess game comprising: at least two playing fields which are divided into squares of two alternating colors; two sets of chess pieces, each set consisting of two groups of chess pieces; and two chess clocks, each chess clock including a timing unit connected to two displays and to a control unit; said device for playing a chess game further comprises means for exchanging data related to positions of chess pieces on the playing fields, and each chess clock comprises a device for locking the control unit, wherein all timing units of the chess clocks are linked together.
[0006] The above device can be used to implement a method of playing a chess game including alternatively moving, by players, members of a first or second team, a chess piece on a playing field during a time limit allotted to each player, said method further comprising: using in said set of chess means respective locking devices, e.g. a device for locking the switching of a chess clock by a player; setting a time limit for the first and second team, and setting the turn of moves of a chess piece by players by locking access to a predetermined chess means at a respective time.
[0007] A distinctive feature of the present invention is a chess computer included as at least one player in a first or second team. Other features and advantages of the invention will become apparent from the following detailed description, as well as from claims 1 to 16 .
BRIEF DESCRIPTION OF DRAWINGS
[0008] The invention will be further explained with reference being made to the attached drawings wherein:
[0009] FIG. 1 is a general plan view of a chess table;
[0010] FIG. 2 is a schematic diagram of a device for playing a chess game between two pairs of players in a first embodiment;
[0011] FIG. 3 is a schematic diagram of a piece position sensor;
[0012] FIG. 4 is a first embodiment of circuitry of two chess clocks;
[0013] FIG. 5 is a second embodiment of circuitry of two chess clocks;
[0014] FIG. 6 is a circuit showing how chess clocks are connected to a piece position sensor;
[0015] FIG. 7 is a schematic diagram of a device for playing a chess game between two pairs of players in a second embodiment;
[0016] FIG. 8 is a schematic diagram of a device for playing a chess game between two pairs of players in a third embodiment;
[0017] FIG. 9 is a schematic diagram of a device for playing a chess game between two teams, each team including a chess computer as a player;
[0018] FIG. 10 is a schematic diagram of a device for playing a chess game between two pairs of players, wherein one of the players in each team is a chess computer;
[0019] FIG. 11 is a general view of portable devices for playing chess between two pairs of players;
[0020] FIG. 12 is a flow diagram illustrating an algorithm of playing a chess game.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] In further description of the preferred embodiments of the invention, the underlined terms will be replaced with abbreviations shown in brackets. FIG. 1 shows a chess table (CT) 1 on which chess clocks (CC) 2 having two displays: a display (DIS) 3 and DIS 4 are arranged; a count down process at DIS 3 is started by pressing a button 5 , and a count down process at DIS 4 is started by pressing a button 6 . At the count down start at DIS 3 , DIS 4 registers the time accumulated during the game, and vice versa, at the count down start at DIS 4 , DIS 3 registers the time accumulated during the game. Depicted on the chess table 1 is a playing field (PF) 7 , a square field divided into squares of two alternating colors. Light-color squares are referred to as white fields, and dark-color squares are referred to as black fields. The set of chess pieces includes two groups of chess pieces. A first group 8 includes light-color (white) pieces, and a second group 9 includes dark-color (black) pieces. Each group of chess pieces includes: a king 10 , a queen 11 , two rooks 12 , two bishops 13 , two knights 14 and eight pawns 15 . In addition to PF 7 , two fields 16 and 17 can be depicted on the CT 1 , comprising conventional signs used to designate each field, e.g. when recording separate game moves. According to the rules of algebraic chess notation, the field 16 comprises letters of Latin alphabet (from “a” to “h”), and the field 17 comprises ciphers (from “1” to “8”). In addition, each chess piece has its letter notion: King K, Queen Q, rook R, bishop B, knight N; notation p for pawns is used only to record positions, and omitted in records of the game. To indicate white and black fields, light-emitting diodes 18 are provided on the surface of the CT 1 in parallel with the fields 16 and 17 . FIG. 2 shows a general view of a device for playing a chess game between two pairs of players at two CTs 1 . A first player (FP A ) 19 and a second player (SP A ) 20 are members of a first team (team A); a first player (FP B ) 21 and a second player (SP B ) 22 are members of a second team (team B); communication between players in each team is prohibited. A feature of the device is that the CCs 2 located on two CTs 1 communicate through various communication means described below. To transmit information about a move that was made, each player can use data exchange means (DEM) adapted to exchange data, between players 19 , 20 , about positions of chess pieces 10 , 11 , 12 , 13 , 14 , 15 on the playing fields 7 . In the present case, one of the DEMs comprises two linked digital displays (DDIS) to show the position of a chess piece, in particular, a first DDIS 1 23 and second DDIS 2 24 . DDIS 1 23 and DDIS 2 24 communicate via a link 25 . Another DEM, comprising a third DDIS 3 26 and a forth DDIS 4 27 communicating via a link 28 , serves to exchange chess moves between FP B 21 and SP B 22 . Piece position information may be entered in a respective DDIS either automatically or by a player entering a respective algebraic chess notation with the aid of an input device. It should be noted that a variety of electronic devices that can be used as DEM are commercially available. They include, in particular, a mobile telephone (MT) and pocket personal computer (PPC). PPC can be also referred to as a personal digital assistant, palm personal computer, portable computer. Consider a peculiarity of using the latter in the DEM. An input device in the PPC relies either on its keys or on the screen with a special sensitive layer and a protective film applied thereon. A player may enter piece position information by writing a chess notation on the screen. A dedicated software installed in the PPC recognizes the handwritten letters and digits and then sends them to another PPC via link 25 or 28 . A plastic stylus is used to write text data and operate on the PPC screen by touching the screen surface (which is pressure sensitive). If both PPCs have an IR-port, Bluetooth or Wi-Fi module, links (channels) 25 , 28 between them can be wireless. DEM can be also a pen with a miniature TV camera connected to a means for recognition letters or digits written on paper. If no means of such kind is available, a digital pen, PC Notes Taker, can be used to enter graphic information or hand-written text in a computer. The main feature of this embodiment is that a player writes with the digital pen on a plain paper, and the exact copy of the record appears immediately on the screen of an appropriate PPC 23 , 24 , 26 , 27 . This result is provided by the fact that the pen sends an IR signal to a receiver integrated in a base unit. The base unit is a detachable device comprising an IR receiver, which is attached to the piece of paper. DEM can be also one or more display boards 29 connected to the PF 7 and comprising a piece position sensor_(PPS). If two PFs 7 are used, a link 30 should be provided between them. FIG. 3 shows an embodiment of PPS 31 circuitry. The PPS 31 includes a microcomputer (MC) 32 and a comparator module (CM) 33 comprising sixty four voltage comparators. The microcomputer 32 operates on digital data encoded as zeroes and ones at the output of the CM 33 . Analog part of the PPS 31 comprises sixty four pairs of conductive plates 34 , 35 overlying each of the white and black fields of the PF 7 . Plates 35 are connected to output of a generator 36 , while each of the plates 34 is connected to a respective input of the voltage comparator included in the CM 33 . Furthermore, light-emitting diodes 18 and a wireless adapter (WLA 1 ) 37 that replaces the wire link 30 by a wireless one are connected to output of the MC 32 . The wireless adapter includes a transceiver coupled to an output of the MC 32 via a digital modulator and to an input of the MC 32 via a clocking unit. The latter is used to recover digital data present at the output of the MC 32 at the instant of transmission thereof to another PF(s) 7 . It should be noted that the transceiver may be a standard Bluetooth 1.1. device, such as D-Link DBT-900AP. The generator 36 of the microcomputer 32 and CM 33 are supplied from own power supply (PS). For normal functioning of the PPS 31 , the lower part 38 of chess pieces must be conductive. PPS 31 operates in the following manner. Initially, the MC 32 stores original positions of chess pieces. After each move of a piece discrete signals appear at output of a respective comparator, and MC 32 determines from them a new position of the piece on the PF 7 . All the moves of chess pieces on a PF 7 are accompanied by generation in the MC 32 of signals which are transmitted via WLA 1 37 to another PFs 7 . After each change in a chess piece position on the PF 7 two light-emitting diodes (LED) 18 light, one of the LEDs being in the vicinity of the field 16 , and the other one in the vicinity of the field 17 . The LEDs light on several PFs 7 at once, the mode of LED activation being specified by the MC 32 software. Generation of a discrete signal at the comparator's output is caused by a change in the variable voltage at its input after a piece move. Each move of a chess piece alters the capacitance between plates 34 , 35 , hence the value of the variable voltage part output from the generator 36 to the input of a respective comparator changes as well. Response voltage of comparators in the CM 33 is chosen such that in case of appearance of a chess piece, a discrete signal corresponding to logical one appears at the respective comparator output. The capacitance C N between plates 34 , 35 changes when a chess piece is present owing to the additional parallel connection to C N of two series-connected capacities C F 1 and C F 2 , where C F 1 is the capacity whose plates are plate 34 and the lower part 38 , and C F 2 is the capacity whose plates are plate 35 and the lower part 38 . FIG. 4 shows two circuits of CCs 2 for generating all electric signals required for operation of the CCs 2 . Each circuit includes: a timing unit (TU) 39 coupled to a displaying module 40 comprising two displays: DIS 3 and DIS 4 , and to a control unit (CU) 41 . The latter comprises (initially) open contacts 42 , 43 coupled to buttons 5 , 6 . Operation parameters of CC 2 , e.g. time limit T C , are set by closing contacts 44 . The TU 39 includes two counters for accumulating the game time, the counters being connected to a common pulse generator whose frequency is set by a quartz resonator 45 . It should be noted that the timing unit 39 can be a timing microprocessor (TMP), such as SMC 6280 available from Seiko Epson. In this case the TU 39 operation algorithm is stored in the TMP memory in its manufacture. In addition to the aforementioned components, CC 2 comprises a locking device (LD) 46 for locking the control unit 41 . The locking device 46 comprises a trigger 47 and two logical coincidence circuits (LCC) 48 , 49 , the upper input of the LCC 48 on the circuit being a control input of the LD 46 . It is seen from the drawing that in this embodiment of the CC 2 , TUs 39 are linked together via the LD 46 . The circuit further comprises LED 50 and LED 51 . The former is to indicate activation of DIS 3 , and the latter is to indicate activation of DIS 4 . CC 2 is supplied from a battery 52 . FIG. 5 shows a second embodiment of CC 2 . In this embodiment LD 46 is implemented in the TU 39 software and includes an input/output device (I/O) connected via a bus 53 to a wireless adapter (WLA 2 ) 54 whose parameters are matched with that of WLA 2 54 of the other CC 2 . Thus, I/Os of TUs 39 , such as TMP, are linked together via wireless link 55 . The CC further includes additional LEDs 56 , 57 to indicate activation of the LD 46 . FIG. 6 shows an embodiment of a chess clock wherein WLA 2 54 is matched with WLA 1 37 included in one or more PPS 31 . Such connection enables locking an appropriate button 5 , 6 of the CC 2 when a player in one team erroneously repeats a move on his PF 7 . This event can be indicated by one of LEDs 56 , 57 . Another possible function of LEDs 56 , 57 is to indicate locking activation mode, in which mode the depression of e.g. the button 5 when LED 57 is activated will not result in switching the CC 2 . FIG. 7 shows a device for playing a chess game between two pairs of players, wherein playing fields and chess clocks are implemented in the following service computers (SC): SC 1 58 , SC 2 59 , SC 3 60 , SC 4 61 . Each of the SCs comprises: a virtual playing field (VPF) generation unit 62 , a virtual chess piece (VCP) set generation unit and a virtual chess clock (VCC) generation unit 63 . These units generate, on a display of each SC, a set of chess means in the form of a VPF 62 with VCPs and VCCs 63 located thereon. It should be noted that one of the SCs or PPS 31 may comprise a LD for locking a piece move on the PF 7 or VPF 62 , such as a DEM locking unit for locking DEM related to positions of chess pieces on the PF 7 or VPF 62 . To exchange data, SCs 58 , 59 , 60 , 61 are linked together through a network channel, such as Ethernet or local wireless network. In the former case, SCs 58 , 59 , 60 , 61 can be linked together using adapters, T-connectors and a hub 64 . It should be noted that the local network can be a computer network concentrated in a single building, the residence of the World Chess Federation (FIDE). If SCs 58 , 59 , 60 , 61 are linked by the Internet 65 ( FIG. 8 ), they can be generally located at any point on the Earth. In conclusion it may be said that if every SC includes means for locking a piece move on the VPF 62 , the control inputs thereof are also linked via a hub 64 or the Internet 65 . FIG. 9 shows a device for playing a chess game between two teams, each team including three players, wherein one the players in each team is a chess game computer (CGC). Therefore, a first team (team A) includes a first player (FP A ) 19 , a second player (SP A ) 20 and a third player (TP A ) such as a first chess game computer (CGC 1 ) 66 , and a second team (team B) includes a first player (FP B ) 21 , a second player (SP B ) 22 and a third player (TP B ) such as a second chess game computer (CGC 2 ) 67 . To exchange data between SC 1 58 , SC 2 59 , SC 3 60 , SC 4 61 , internal wireless adapters such as D-Link DW L-G520 are used, operating at frequencies in the range from 2.4 GHz to 2.483 GHz and having an external antenna 68 . Chess game computers CGC 1 66 and CGC 2 77 are, in turn, connected to an external wireless adapter 69 such as Eline ELW-9610SXg-Wireless LAN Broadband Router 9610SX-g54M having an external antenna 70 . FIG. 10 shows a device for playing a chess game between two teams, each including two players, wherein one of the players in each team is own personal CGC connected to MC 32 included in PPS 31 . The latter comprises in particular a PF 7 . Therefore, team A includes a first player FP A 19 and second player, CGC 1 66 , and the team B includes a first player FP B 21 and second player, CGC 2 67 . FIG. 11 shows two portable devices (PD) 71 for playing a chess game, that are linked via a wireless link 72 including removable external antennas 73 . The portable devices 71 are designed for playing chess between at least two pairs of players. In addition to the removable external dipole antenna 73 , the portable device 71 also comprises an internal antenna. Portable devices 71 for playing chess are designed for amateur chess players and for secondary schools as an effective chess game tutorial and means for improving intelligence level of students. The device comprises a PPS, an electronic CC 2 having DIS 3 and DIS 4 , and LEDs 50 , 51 , 56 , 57 . A basic feature distinguishing the device from that shown in FIG. 1 is that PPS 31 , CC 2 , PF 7 , MC 32 and WLA 1 37 are all integrated in a single housing. Another distinctive feature of PD 71 is an additional row of LEDs 18 replacing the field 16 . PD 71 further comprises internal wireless adapters operating under the conventional Bluetooth or Wi-Fi standard. Both standards generate electromagnetic radiant flux at a frequency within the range from 2.4 to 2.48 GHz. The term “Wi-Fi” refers to a variety of wireless local network standards. The internal wireless adapters and link 72 enable communication between means included in the PD 71 , such as PPS 31 and CC 2 . In an embodiment of PD 71 , the integrated MC 32 can perform the functions of not only PPS, but also of TU 39 . In this case all of the aforementioned locking devices can be implemented in the MC 32 software. Here, the turn of moves of chess pieces 8 , 9 by players is specified by a special service routine stored in memory of MC 32 and matched with a service routine of another PD 71 . A device for playing a chess game operates in accordance with an algorithm shown in FIG. 12 . The algorithm can be practiced using a dedicated and standard software stored in read-only memories of the following means: 2 , 23 , 24 , 26 , 27 , 32 , 39 , 58 , 59 , 60 , 61 , 66 , 67 , 71 . The device for playing chess starts its operation after step 74 of generating a turn N(N=1, 2, . . . ) of plies to be made by players. The term “ply” (or half a move) refers to N-th move made by one party only. To simplify the following description the following notations will be used: N W is a ply made by white pieces, and NB is a ply made by black pieces. A ply turn routine can be also stored in read-only memories of the following means: 2 , 23 , 24 , 26 , 27 , 32 , 39 , 58 , 59 , 60 , 61 , 66 , 67 , 71 . Saying it differently, the turn of moving pieces by players is specified by storing a service routine in a memory of a respective chess means. The turn of plies N w , N b is determined beforehand in accordance with the rules set for given chess game. Consider possible variants of the turn of plies in a chess game between two teams, each team including two players, i.e. a team A (white pieces) includes players FP A 19 and SP A 20 , and a second team B (black pieces) includes FP B 21 and SP B 22 . From here on, the turn of N-th ply for given player will be indicated in brackets, i.e. record SP A (2N w ) means that a player SP A with white pieces must make all even plies N w : N w =2, 4, . . . N w E , where N w E is the last ply with white pieces in the game. It should be noted that the turn of moves can be generally specified using not only a deterministic law, but a random law either. The latter may include such factors as player's rating “r”; number k (k=2, 3, . . . ) of players in a team; total running time t spent by a player during the game, etc. In the latter case, the record may be: SP A (N w =F(t,k,r)), where F(t,k,r) is the probability that the right to ply will be given to the player SP A having rating “r”. It is evident that the choice of the function type may influence the strategy of cooperation between the players in the same team. For example, if probability F(t,k,r) increases with reduction in t value, to obtain preference in the pair game a player with a higher rating must play faster than his partner in the team. The invention will be further described with reference to a device for playing a chess game between two teams, a first team including players FP A 19 and SP A 20 , and a second team including players FP B 21 and SP B 22 . The turn of plies will be as follows: FP A (2N w −1), SP A (2N w ), FP B (2N b −1), SP B (2N b ). With a device having the structure shown in FIG. 2 , after a time limit T 0 has been set by closing contacts 44 on both CCs 2 and with the CCs running (step 75 ), count down starts simultaneously at two CCs 2 (step 76 ). The count down at CCs 2 can be synchronized by various methods, e.g. using a single master oscillator that provides pulses to the other CCs 2 via a wireless link 55 . In another embodiment master oscillators included in MC 32 can be symphonized via this link. At both CCs 2 the count down of accumulated time T after activation (step 76 ) terminates at DIS 3 after duplicating on both PFs 7 the chess move and pressing button 6 at both CCs 2 . At the instant of count down completion, DIS 3 registers value (T 0 −t*), where t* is the time spent for one move, then count down starts at DIS 4 . It terminates after pressing buttons 5 (not obligatory at the same time). Thus, after specifying the above turn of moving chess pieces 10 , 11 , 12 , 13 , 14 , 15 by players FP A , SP A , FP B , SP B , the device will function in the following manner. Assume that the game is played on two PDs 71 , wherein FP A , FP B play at a first PD (PD 1 ), and SP A , SP B play at a second PD (PD 2 ). Assume further that the player FP A 19 gets the right to 9-th ply during the game; at this instant his DIS 3 reads: 17 min 42 sec, LED 57 at PD 2 and LEDs 56 , 57 at PD 2 are activated, i.e. light. Lighting of the LEDs means that button 5 at PD 1 and buttons 5 , 6 at PD 2 are locked, i.e. depression of the buttons will not result in switching the CC. Then according to the specified turn the player FP A makes 8-th ply with white knight (N w =9) “9.Nc3-e2” and presses the button 6 of the CC 2 (“Yes” at step 78 ); at the instant of this depression DISs 3 of both CCs 2 read: 14 min 36 sec. After transmission of the ninth ply via link 72 and respective activations of LED 18 at PD 2 the player SP A repeats the ply “9. Nc3-e2” at his PD 2 and then presses button 6 of his CC 2 (“Yes” at step 79 ). Only after this event both CCs 2 switch simultaneously (step 81 ) i.e. the right to ply N b =9 passes to the player FP B (step 81 ). Note that immediately after repeating the 9-th ply by the player SP A LED 56 at PD 2 goes out, and after pressing the button 6 it lights again. As mentioned above, in case of incorrect repetition of the ply, LED 56 will remain activated, and both CCs 2 will remain in the original count down state at DIS 3 despite the depression of the button 6 at PD 2 by SP A . Due to a delay τ (τ>0) in the repetition of 9-th ply by the player SP A , at the instant of his depression of the button 6 DISs 3 of both CCs 2 read: 14 min 35 sec (τ=1 sec), i.e. emphasize again that count down of time t* of one ply for team A is not over until the player SP A repeatedly presses the button 6 . Then, according to the specified turn the player FP B gets the right to make 9-th ply with a black piece; at this instant DIS 4 reads: 18 min 14 sec; LED 57 is disabled (the other LED 57 and two LEDs 56 are activated). After making the ply with a black pawn “9 . . . e7-e5”, the player FP B shortly presses the button 5 of the CC 2 (“Yes” at step 78 ); at this instant DISs 4 of both CCs 2 read: 17 min 7 sec, i.e. the FP 2 spent 1 min 7 sec for thinking over the move. After transmitting the 9-th ply via link 72 , the SP B repeats the ply “9 . . . e7-e5” on his PD 2 and then presses the button 5 of his CC 2 . Only then both CCs 2 switch simultaneously (step 79 ), i.e. the right to make 10-th ply (N w =10) after disabling the LED 57 at PD 2 passes to the player SP A (step 81 ). Due to a delay in repetition of 9-th ply by the player SP B at the instant of his short-time depression of the button 5 DISs 4 of both CCs 2 read: 17 min 5 sec (τ=2 sec). The aforementioned steps are then repeated in respect of 10-th ply “10.c2-c3” with the only difference that the ply is made by the player SP A , and the player FP A repeats the ply. The same steps are also repeated in respect of 10-th ply with a black piece (N w =10) “10 . . . Kb8-c6”, i.e. the player SP B makes the ply and player FP B repeats the ply. After expiration of the time limit T 0 (T 0 =0) at one of the time limit displays (“Yes” at step 77 ), the game terminates (step 82 ). Note that the functions of LEDs 56 , 57 can be performed by LEDs 50 , 51 , e.g. by intermittently lighting to indicate the locking mode. Now consider some structural features of technical means used to implement steps 78 , 79 and step 81 . Step 81 is implemented on the basis of a device for locking the switching of the CC 2 included therein. In the simplest case this device is used to lock the CC switching when the switching has been made by a single player only. The locking device can be implemented either in software ( FIG. 5-FIG . 11 ) or hardware. FIG. 4 shows a CC comprising a hardware LD 46 . Its operation will be described on the example of the above algorithm of playing a chess game between two pairs of players. Assume that TU 39 generates signals of count down of accumulated time T at DIS 3 or DIS 4 only when logical one is present at input A 1 or A 2 of the TU 39 , and logical zero is simultaneously present at the other input A 2 or A 1 , respectively; the CCs retain the running time T count down mode at DIS 3 or DIS 4 in case of conversion of logical one to logical zero. The order of CC activation is determined by internal program in the TU 39 . Assume that in the original state before 9-th ply output Q of the trigger 47 in both clocks has a voltage corresponding to logical one (log.“1”), i.e. log.“1” and log.“0” are applied to inputs A 1 and A 2 (LED 50 and DIS 3 are activated). Then, after a short-time depression by the player FP 1 on the button 6 of the CC (“Yes” at step 78 ) contacts 43 at his CC close, this resulting in log.“0” appearing at output Q of the trigger 47 . It is evident from the schematic diagram that only after pressing the button 6 of the second CC 2 DIS 4 will be activated and DIS 3 will be disabled on both CCs. Actually, in this case log.“1” appears at input A 2 of the TU 39 of both CCs (at this instant log.“0” is present at two inputs A 1 ), which is the necessary condition for switching the VCC 63 . Using the circuits shown in FIGS. 7 to 11 , the VCC 63 will be automatically switched immediately after a chess move, e.g. using a mouse pointing device. In this case the turn of moving, by players FP 1 19 , SP, 20 and FP 2 21 , SP 2 22 , chess pieces on respective SC 1 58 , SC 1 59 , SC 1 60 , SC 1 61 is specified by locking a respective input device, such as a keyboard or a mouse pointing device. With the circuits shown in FIGS. 7 to 11 , delay τ in switching the VCC 63 will be generally determined by the time of propagation of a respective signal between service computers and chess game computers SC 1 58 , SC 1 59 , SC 1 60 , SC 1 61 , CGC 1 66 and CGC 2 67 , and the time of processing the signal. In conclusion it may be said that various embodiments of portable device 71 for playing chess are possible. In one of the variants buttons 5 , 6 for switching the CC 2 can be omitted, the switching being performed automatically, but only if steps 78 , 79 (making i-th ply by a player of team A or B in accordance with the specified turn (step 78 ) and its repetition (step 79 ) by a second player of team A (B) at the other portable device 71 ) have been executed. As this takes place, microcomputers of portable devices 71 functioning as e.g. PPS 31 , TU 39 , control unit 41 and devices for locking them must be in the mode of active communication via wireless link 72 .
INDUSTRIAL APPLICABILITY
[0022] The invention can be used for organization of a world championship under the aegis of FIDE in pair category. High competition among computer companies for participation in this kind of chess games is explained by the fact that a variant of the game can be conducted not only between the pairs including two human players, but also between the pairs, each including a human player and a computer. In the latter case the human player may preliminary “train” his “partner”. Methods and means of such “training” may be used in manufacture of common computers. The invention can be used as a tutorial instead of the ordinary chess recommended by UNESCO to be used in schools worldwide. The invention can be also used in organization of mass production of portable devices for playing chess between at least two pairs of players.
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The invention relates to chess game playing method, in particular to a novel type of a chess game between two pairs of players. The inventive chess game playing device comprises at least two playing fields ( 7) which are divided into squares of two alternating colours, two sets of chess pieces, each of which consists of two groups ( 8, 9) of chess pieces ( 10 - 15) and two chess-clocks ( 2) each of which is provided with a timer ( 39) connected to two displays ( 3, 4) and to a control unit ( 41) which is used for switching said displays ( 3, 4). The chess game playing device also comprises means for exchanging data related to the location of the chess pieces ( 10 - 15) on the playing fields ( 7), each chess-clock ( 2) comprises a device for locking the control unit ( 41), wherein all timers ( 39) are interconnected.
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CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application is a divisional of application Ser. No. 11/033,605 filed Jan. 11, 2005, the disclosure of which is incorporated fully herein by reference.
SUMMARY OF THE INVENTION
[0002] Birding, that is the recreational activity of observing birds, is an increasingly popular pastime around the world. An important component of birding is the identification of the species of an observed bird. At least as important to the birder is the identification of the genus or family, of an observed bird, especially if the species is unknown. Of special importance to serious birders is aiding their accomplishment of learning to identify observed birds in the field.
[0003] To date, birders have had only field guides and recordings as personal aids for identifying and learning to identify birds. However, in no case do these aids actually determine an identification, they only provide comparative references and the judgment of whether a match is made or not is left entirely to the birder. Further, in no case is any feedback given on the quality or reliability of the match they have just made, Additionally, in the case of learning bird songs and calls, there is currently no practical way to precisely indicate to the learner which aspects of a particular bird's song are most relevant to the identification. In consequence, making progress in learning identification is slow at best.
[0004] More recently, there have been electronic versions of field guides created (sometimes including audio recordings) that speed the process of searching for a particular comparative reference. However, even with these more sophisticated approaches, the ultimate judgment about a match is left entirely to the birder and no feedback on the quality of their match is provided, or even possible.
[0005] For other birders, such as people who set out bird feeders in their backyard, the joy of knowing what birds have visited their yard is foremost and learning the skill of identifying the birds is not as important. For these birders, field guides and recordings, electronic or not, have another significant liability. This liability is that the birder must be actively engaged in birding at the time a bird shows up in their yard in order to make the identification. Every backyard birder will surely identify with the experience of noticing an interesting bird, perhaps by hearing its unusual song, and running to get a field guide only to discover that the bird has left by the time they get back to make the identification.
[0006] The current invention teaches how to overcome all the deficiencies noted above with an apparatus that automatically identifies birds by way of their vocalizations (calls and songs) and employs a novel method for doing so. Previous methods for attempting to identify birds by their vocalizations such as neural network, hidden Markov model, dynamic time warping, and other techniques, attempt to match an incoming bird vocalization against a library of exemplars using an overall similarity standard to determine a match. These techniques have not achieved notable success in resolving any of the deficiencies noted above.
[0007] The current invention takes a different approach. Instead of an overall similarity standard, the current invention, as described in detail below, employs a hierarchical method that largely parallels the neuro-physiological hierarchy of bird vocalizations. When this method is embodied in a very portable computing device, such as a personal digital assistant augmented with appropriate software and audio capture capability, this method allows the device to determine that a bird is singing, even if nothing else about the bird can be determined. Further, it allows the family of a bird to be determined, even if the species cannot be determined. Finally, it allows the species to be determined. Additionally, it provides for the time-based annotation of the bird song so that that the relative importance of each part of the song for the purpose of identification can be relayed to the birder to aid in their learning.
[0008] The current invention teaches how to embody such functionality in a hand-held computational device together with a microphone, an audio capture card or other means, a user application that runs on the device, and a library of vocalization characteristics that, because it resides on the audio capture card, is accessible to the application but generally inaccessible to the user. This last characteristic allows for new libraries of characteristics to be sold as hardware additions, lessening the problem of unauthorized distribution.
[0009] The intended use of this invention is two-fold. When a birder carrying the device hears a bird of interest while observing birds in the field, they point the microphone of the device toward the calling bird and activate the identification function of the device. The device processes the sound and presents the results of the analysis to the birder. The possible results include that no bird was detected; that a bird was detected but the family could not be determined; that a bird was detected and the family was identified (and was so and so), but the species could not be determined; that a bird was detected, the family was determined (and was so and so) and the species was determined to be so and so.
[0010] Alternatively, the device can be used in backyard mode in which all incoming sounds are analyzed and when a bird is detected the device automatically proceeds with the identification process and records the results for the birder to review immediately or at a later time.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] These and other aspects of the invention will be better understood by reference to the drawings herein.
[0012] FIG. 1A is a pictorial elevation view of an embodiment of the invention.
[0013] FIG. 1B is a side view of the embodiment of FIG. 1 .
[0014] FIG. 1C is a pictorial elevation view of an alternate embodiment of the invention.
[0015] FIG. 1D is a side view of another alternate embodiment of the invention.
[0016] FIGS. 2A and 2B are elevation and side views of another alternate embodiment of the invention.
[0017] FIG. 3 is a block diagram of a preferred embodiment of the invention.
[0018] FIG. 4 is a diagram comparing the hierarchy of the components of the invention with physiological/neurological hierarchy of bird vocalization.
[0019] FIG. 5 is a waveform diagram and graph of a segment of a particular species of bird.
[0020] FIG. 6 is a functional block diagram of the software employed in the computational device according to the present invention.
[0021] FIG. 7 is an additional block diagram of a subset of the software used in the present invention.
[0022] FIG. 8 is a diagram of dataflow through the components of the present invention.
[0023] FIG. 9 is an illustration of a display provided by the computational device for a specific species of bird.
DETAILED DESCRIPTION OF THE INVENTION
[0024] FIG. 1A is a front view of the embodiment of the current invention in which the system is to be used inside a residence or other building to keep track of birds that come near the window. For example, if a birder has a bird feeder or other attractive feature outside their kitchen window, they may use this system to identify birds that come into their yard.
[0025] In this embodiment, holding cradle 130 is attached to the interior side of windowpane 120 of window 110 by suction cups 150 or other attachment mechanism. The purpose of the cradle 130 is to hold the handheld computational device 160 on the window so that it can be operated while looking out the window and yet be easily removed for maintenance including battery charging or using wired means of communication with other devices to, for example, exchange recorded bird identifications. Accordingly, there is a connector 170 that provides for a connection between the handheld computational device 160 including an audio capture means (not illustrated in this figure) and a contact microphone 190 through a microphone cable 180 . The contact microphone 190 employs the entire windowpane 120 as a diaphragm, as is well known in the art, enhancing the sensitivity of the bird detection system. The connector 170 allows for the handheld computational device to be physically removed from the window location without also displacing the contact microphone.
[0026] FIG. 1B illustrates a side view of the embodiment of the current invention in which the system is to be used inside a residence or other building to keep track of birds that come near the window. In particular, it illustrates the manner in which the contact microphone 190 is attached to the interior surface of the windowpane 120 and requires that the connector 170 be removed in order to remove the handheld computational device 160 from the cradle 130 .
[0027] FIG. 1C illustrates an alternate embodiment of the current invention in which instead of being a contact microphone attached to the interior side of windowpane 120 of window 110 , the sound receiver is an open air microphone 195 attached to a remote location such as a bird feeder 185 or the external side of windowpane 120 through an extended cable 180 .
[0028] FIG. 1D illustrates another view of the embodiment of the current invention in which instead of employing a contact microphone attached to the interior side of windowpane, the sound receiver is instead an open air microphone 195 attached to a remote location such as a bird feeder 185 or the external side of windowpane 120 through an extended cable 180 . In this embodiment the cable 180 is of the flattened type that can pass between the windowpane and the frame without damage.
[0029] FIG. 2 illustrates the embodiment of the current invention that provides for use of the invention in field conditions such as walking through a forest. It includes a hand-holdable cradle 230 that is used to secure both the handheld computational device 160 and a directional open-air microphone 290 . The cradle includes attachment means 235 to hold the microphone in place and a connector 170 that allows the microphone cable 280 to be removed from the handheld computational device 160 including an audio capture means (not illustrated in this figure) to make it possible to remove the handheld device so that it may be used in other contexts such as charging its battery or connecting to other devices.
[0030] FIG. 3 illustrates the system block diagram of the preferred embodiment of the current invention. It shows a microphone subsystem 303 comprising microphone 390 with a cable terminating in a connector 170 . The audio capture subsystem 302 is contained in a compact flash or secure digital input/output or other suitable case that allows it to be plugged into the extension slot of hand-held computational device 301 . The audio capture subsystem 302 comprises a connector 385 that mates with microphone connector 170 , an analog to digital converter 380 , a random access memory buffer 380 wherein the result of the signal digitization are temporarily stored, non-volatile storage 375 such as flash memory in which is stored the data necessary for the family and species characterizations. These are connected to a card interface that includes control logic and power, data, and control signal connections in the usual way. Access to the non-volatile storage, and hence the data contained therein, should be through a proprietary control sequence rather than standard bus logic so users cannot readily copy the contents and distribute it to others.
[0031] The audio capture subsystem mates with a hand-held computational device 301 comprising an extension card interface 360 , a system data bus 340 , non-volatile storage 355 accessible to the user, a central processing unit 310 , system random access memory 350 , a user display 345 , communication port 315 , key input 335 , (optional) touch screen input 330 , and a power supply 320 .
[0032] FIG. 4 illustrates the parallelism between the neuro-physiological hierarchy of bird vocalization and the hierarchy of detection means employed in the current invention. The lowest levels of the hierarchy correspond to aspects of bird vocalizations that change slowly even on evolutionary time scales. These map to the bird detection means, 410 . One such aspect, and the one employed in the preferred embodiment, is the fact that birds have dual, substantially identical but independent, vibrating membranes in their syrinx. The corresponding audio characteristic of such a feature is used to establish that a bird was vocalizing at a particular time and providing fiduciary points for the next level of the hierarchy of analysis.
[0033] The next levels of the hierarchy correspond to aspects of bird vocalizations that change more rapidly on evolutionary time scales but are largely independent of the neural activity of the bird. These map to the family detection means, 420 . One such aspect, and the one employed in the preferred embodiment, is the set of dynamical modes achievable by a bird's vocal tract. Just as a duck call (or, for that matter, a flute) has only a limited number of dynamical modes no matter how you play it, so too do bird vocal tracts, as evidenced by experiments in which the syrinx is excised as played independently of the bird. The corresponding audio characteristics of the dynamical modes are used to index potential bird families vocalizing at various time regions and to focus analysis at the next level on familialy coherent regions of the vocalization.
[0034] The next levels of the hierarchy correspond to aspects of bird vocalizations that are neurologically controlled, but at lower levels of the neurological control hierarchy. These stereotypical aspects evolve over many generations. These map to the species detection means 430 . One such aspect, and one employed in the preferred embodiment, is the patterned sequence of shifts between dynamical modes. The corresponding audio characteristics, combined with the results of the other levels of analysis, allow for the rapid and sure identification of the family and species of a particular bird vocalization.
[0035] The next levels of the hierarchy correspond to aspects of bird vocalizations that are neurologically controlled and can change over the course of a bird's life
[0036] FIG. 5 illustrates in schematic form the signal annotation process of the current invention. In this figure is shown a graph 610 of a segment of recorded vocalization of a screech owl. Highlighted in the graph are four regions 601 , 602 , 603 , and 604 whose significance will be explained below. The illustration element 620 represents a region of memory containing the digitized signal as time-ordered samples.
[0037] The illustration element 630 represents the region of memory logically parallel to that represented in 620 but which contains the results of the bird detection means according to the current invention. Although one skilled in the art will realize that there are many ways to encode this information (for example, recording the start and stop times of positive results) for the purposes of illustration we will assume that the signal is represented by a copy of the original signal with the audio sample values replaced by detection result values. In this case, the highlighted signal region 601 is one in which the bird is apparently switching from vocalizing with one side of its syrinx to the other side. Hence in this region both sides of the syrinx will be in operation and the bird detection means will give a positive result as shown by the shaded is-bird region of 630 .
[0038] The illustration element 640 represents a region of memory logically parallel to those represented in 620 and 630 but which contains the results of the family identification means according to the current invention. For purposes of illustration as above, we will assume here that the family signal is represented by a copy of the original signal with the audio sample replaced by family or dynamical mode index values. In the preferred implementation, the family identification means is preferentially applied to the region of the digitized signal around which the bird detection means has returned a positive result. In this way, the possibility of inappropriately applying the means to non-bird sounds is lessened. The bird detection signal thus provides time anchoring for the family, and eventually species, determinations. In this illustration there are three regions of the signal (highlighted in 602 , 603 , and 604 ) surrounding the positive bird identification region in which the family identification means has returned meaningful values. In region 602 , the family identification means has found a dynamical mode, A, which is highly characteristic of the owl family. In regions 603 and 604 , it has found a mode, B, which while not as characteristic, is consistent with the owl family.
[0039] The illustration element 650 represents a region of memory logically parallel to those represented in 620 , 630 , and 640 but which contains the results of the species identification means according to the current invention. For purposes of illustration as above, we will assume here that the species signal is represented by a copy of the original signal with the audio sample replaced by species values. In the preferred implementation, the species identification means examines broader characteristics of the signal in a region including and surrounding regions consistent with a single family to determine the identity of the species in question. In the illustrated case it has determined that the entire region corresponds to a vocalization of a screech owl.
[0040] FIG. 6 illustrates functional blocks of the software application to be employed on the handheld device in the current invention for field use. Upon user initiation of the application, represented by block 710 in FIG. 6 , the application moves to process block 720 in which the user is presented with the current status of the time, date, and location and the user is enabled to confirm the current settings or revise them.
[0041] For the location data, the user may be presented with a scrollable map with the last known position marked and allowed to select, graphically, a new location. Alternatively, the user may enter geographic coordinates (or import them from a GPS or other positioning system), or select from a list of known places. The date, time, and location information is used in the system in two ways. First, it is used to annotate any recorded bird events so that the time, date, and location will be available along with other information about the event. Second, it is used to prioritize the list of candidate bird families and species to be considered as candidates in an identification attempt. To prioritize the list of candidates, a probability function for each family and species, constructed in the usual way from report densities and stored with the software, is evaluated on the time, date, and location data. The value of that probability serves as the ranking index of the family and species. This ranking is used to sequence the process of identification with the more probable candidates being examined first, although no candidates are ruled out on the basis of the time, date, and location data.
[0042] The application then proceeds to choose block 730 in which the user can select among modes of operation. In particular, the user may choose to enter a mode in which they can manage the list of identifications they have accumulated, exchange data with another device, and so on. This is represented by process block 760 and is described in more detail in another figure. Alternatively, the user may review and revise their location, time and date (process block 720 ,) enter field identification mode (process block 770 ) or exit the application (exit block 740 .)
[0043] Actual bird identification is enabled when the user enters field identification mode (process block 770 .) When this mode is entered, the application activates the audio digitization means (see FIG. 3 ) including an analog to digital converter and associated buffer. In field identification mode, the audio digitization means is then continuously recording (and, eventually, discarding) incoming sound and must therefore be draining power from the system, which can pose a problem for field use if unmanaged. It is thus important that the recording means be deactivated when exiting field identification mode either to choose another mode (process block 730 ) or to exit the application (exit block 740 .)
[0044] After entering field identification mode, the application proceeds to process block 772 in which it waits for the user to indicate that they are hearing, or just have heard, a bird they wish to have identified, that they wish to change mode, or that they wish to exit the application. In case they wish to identify a bird, the application proceeds to process block 774 in which the currently recorded (that is, already digitized and present in the buffer 370 of FIG. 3 ) signal is transferred out of the continuous recording buffer and into system memory where it can be examined without interfering with the operation of the recording means. It also queues up the process of transferring later blocks of recorded sound to system memory as they are required by the identification process and become available from the recording means. The application then proceeds to the decision block 776 . In this block, the application calls on the bird detection means to examine the currently recorded sound to establish whether or not a bird's vocal production is apparent in the recording.
[0045] In the preferred embodiment of this invention, this detection means looks in the signal for a pair of an harmonically related spectra that are shaped by the same resonant cavity. If no bird is detected, the application proceeds to process block 784 in which the recording in system ram can be saved or discarded (in this case discarded), any pending transfer queues are cancelled, and the user is informed of the result (negative in this case.) The purpose of aborting the search as early as possible under these conditions is three-fold. First, it gives immediate feedback to the user that the current conditions are unlikely to yield valuable results and thus train them more quickly to choose favorable over unfavorable conditions as best they can. Second, it allows the user to attempt another identification as soon as possible, without waiting for the (possibly lengthy and likely unsuccessful) repeated attempts at comparing with less and less likely family and species candidates. Third, in the case where bird characteristics are not present anywhere in the sample, the search for a family and species, if successful, is more likely to return spurious results than would be desirable.
[0046] If, on the contrary, a bird's vocal production is apparent in the recording, the application proceeds to decision block 778 . In this block, the application calls on the family identification means to examine the currently recorded sound near the time points at which the bird detection means has indicated that a bird's vocal production is apparent. This use of the bird detection means helps insure that the family identification means does not waste resources in trying to determine the bird family corresponding to a sound that was not produced by a bird. In the preferred embodiment, the family identification means employs a dynamical synchronization method to suggest to which family, if any, among the families whose representation is available to the application, this bird belongs. The dynamical synchronization method, most widely used in the field of communications through chaotic systems, couples the output signal of an unknown dynamical system to one or more models of dynamical systems and determines by the degree of synchronization of each model to the signal which model best represents the unknown system. For example, in the communication method known as chaos-shift keying, at any given time the message transmitter selects the output of one of two predetermined chaotic dynamical systems to be transmitted. The receiver couples the incoming signal to two model dynamical systems and determines which synchronizes to the incoming signal. In the current application to bird families, there will be one or more dynamical models for each family corresponding to the modes of oscillation that family employs.
[0047] In the case that the family is not successfully identified, the application proceeds to process block 782 in which the failure is reported to the user along with such additional information as may be desirable to the user. This information would include, for example, which families were considered and the degree of evidence discovered for each. The application then proceeds to process block 784 in which the user chooses whether to save the recorded sound in more permanent data storage for later analysis or, instead, to discard it.
[0048] In the case in which the family has been successfully identified, the application proceeds to process block 780 in which the species identification means is employed on the part of the recording around that in which the family was identified. This successive scoping aids in the identification process by focusing attention on the most relevant, and coherent, parts of the recording thus lessening the problems due to overlapping songs from other birds, or other interfering background noise. The candidate species to consider are determined by the family identified and prioritized for consideration by their likelihood of occurrence correlated to the time, date, and location. In the preferred embodiment, the species is identified by matching larger-scale characteristics of the sound against those characteristics of the candidate species. These characteristics include the time-base of the sound (characteristic frequency and duration of a phoneme or indecomposable unit) and which dynamical mode switches occur in what order. Whatever the results of these comparisons, the application then continues to process block 782 in which the results of the process are reported to the user. The application then continues to process block 784 described above and then back to block 772 to await another event.
[0049] FIG. 7 illustrates additional detail of functional blocks of the software application to be employed on the handheld device in the current invention for field use. In particular, it illustrates the functional blocks associated with mode in which the user can review and manage the collection of captured identification results they have saved and exchange data with another, suitably arranged, computing device such as a laptop or desktop computer or remote server. In process block 760 , the user chooses whether they would like to exchange data, review their list, or choose another mode. In the final case, the application continues to process block 730 , previously described. In the first case, the application continues to process block 810 in which the well-known desktop or remote server synchronization process is undertaken. In this specific case, the recordings and related information the user has accumulated on their handheld device through the use of this invention but not yet archived is transmitted in the usual way to the desktop or other device and archived there. Similarly, data for use with the family and species identification means, or updates to the application, which is present on the desktop or other device but not presently installed on the handheld are transmitted to the handheld and incorporated into the system. Once the user's data has been transmitted for archive, this fact is noted with the data so that the user can more easily decide which items they can delete on the handheld without losing them completely.
[0050] In the case that the user indicates that they would like to review their list, the application proceeds to process block 815 in which a scrolling or otherwise paginated list of items with short identifying information is presented to the user. In addition to scrolling or paging through the list, the user can either leave this mode, in which case the application proceeds to process block 760 , or select an item from the list represented here by process block 820 . Once an item has been selected, the user can either discard an item (process block 825 ) and return to review list process block 720 , or view details of that item (process block 830 .) In process block 830 all the saved information about the identification attempt is presented to the user including the time and date, the location, the bird family (if successfully identified,) the bird species (if successfully identified,) the recorded sound (if the user chose to save it,) and whether this item has been archived. From here the user can choose ( 835 ) to add or delete a photo or other image file to this item (so that if they also took a photo of this bird when they identified it, they can add this to their record of the event). Similarly, they can choose ( 840 ) to add or edit a text annotation to this item (so if they made other observations of interest such as the surrounding in which the event occurred, they can record this as well). If in addition, the user's device is appropriately configured to allow for playback of sound recordings and if the user chose to save the recorded data, they may choose ( 845 ) to play back the recorded sound. If, in addition, the user has other sound recording installed on their device in the usual way they can choose ( 850 ) to play one or more of those for comparison.
[0051] In an extension of this invention, the application here described can be integrated with a more typical electronic field guide containing descriptions, identification marks, photos or drawings, and sample sound recordings. In particular, the species or family information can be used as in index into the electronic field guide so that all the addition information available from the field guide can be viewed here as well.
[0052] FIG. 8 illustrates the dataflow aspects of the current invention when deployed for unattended operation, for example for use inside a residence as illustrated in FIGS. 1A-1D . This embodiment does not require the user to indicate to the system that the user is hearing, or has just heard, the song of a bird of interest. It must, therefore, make the determination of the presence of a bird of interest on an ongoing basis. Accordingly, all the processes shown in FIG. 8 operate concurrently to form a processing pipeline, as illustrated.
[0053] Those skilled in the art will recognize that such effective concurrency is often achieved through multiple threads of programmatic control that time-share a single central processing unit rather than employing multiple processing units actually operating in parallel.
[0054] In operation, sound, including bird-produced sound, enters microphone 910 and is converted to a continuous electrical sound signal that passes to analog-digital converter (ADC) 915 . Here, the signal is converted, in the usual way, to a digitized signal by sampling the signal periodically and recording each sample as a digital quantity in successive locations in a RAM buffer 920 . In the preferred embodiment, the ADC is a separate processor that operates independently of the central processing unit and takes samples approximately 44,000 times per second, and records each sample as a 16 bit quantity. In the preferred embodiment, the RAM buffer 920 is separate from system RAM, is directly addressable by the ADC 915 , is capable of storing approximately 6 seconds of recorded audio, and is operated as a circular buffer. That is, after the ADC 915 records a sample at the last available 16-bit block in the buffer, it continues recording at the first available location, overwriting the sample already in that location.
[0055] The purpose of the buffer is to allow ADC 915 to continue to record sound uninterrupted even while the central processing unit is occupied with one or another of the other processes described here.
[0056] From the buffer 920 , the digitized signal flows to the bird detector process 925 . In the preferred embodiment, the bird detector process 925 is carried out by the central processing unit and employs the bird detection means. In the bird detector process, the digitized signal is transferred out of the buffer 920 and analyzed with a sliding window methodology. That is to say, the incoming signal is treated as a sequence of overlapping blocks (windows into the signal data,) each approximately one half second in duration. The bird detection means is applied to a block and the result is recorded, keyed to that block. The next block to be analyzed is formed by adding one or more subsequent later samples to the block and removing the same number of earlier samples from the block. Both the digitized signal and the results of the bird detection process keyed to the signal are stored by the bird detector process into a known region of system RAM 930 for additional processing.
[0057] In the preferred embodiment, the bird detector process discards, before saving into system RAM 930 any parts of the digitized signal that are not within approximately 3 seconds of a window in which a bird was detected. This approach solves the problem that, in typical unattended conditions, there may be hours that go by without any bird vocalizations and without this mechanism, system RAM would fill up with useless data. With the current invention, after any number of hours of operation without bird vocalizations, at most 3 seconds of data would be accumulated into system RAM.
[0058] From the region of system RAM 930 in which the bird detector process stored the relevant parts of the digitized signal along with the results of the bird detection analysis, the data flow to the family detector process 935 . In this process, family identification data are generated from the family identification means applied to the digitized signal and bird detection data. The resulting family index data are keyed to the digitized signal and both are written to a known region of system RAM 940 to enable further processing. In the preferred embodiment, the family detector process 935 is carried out by the central processing unit and employs the family identification means. In this embodiment, the family detector process locates family-associated dynamical modes in the signal surrounding the time windows in which a bird vocalization has been detected. It does so by determining which of the dynamical models available to the application will synchronize with the time regions of the signal. The time sequence of these synchronizing models constitutes the family index of the signal over time.
[0059] From the region of RAM 940 in which the family detector process stored the relevant parts of the digitized signal along with the result of the family identification analysis, the data flow to the species detector process 945 . In this process, species identification data are generated from the species identification means applied to the digitized signal and family index data. The resulting species identification data are keyed to the digitized signal and both are written to a known region of system RAM 950 .
[0060] FIG. 9 illustrates the salient features of the bird song replay aspect of the software application in accordance with the current invention. An important element of the utility of the current invention is to assist birders in their ability to learn bird songs themselves. Because both the family index data and the species identification data are stored with, and keyed to, the digitized recorded signal, an abstract of this information can be displayed to the user in synchrony with the audio replay of the song itself. This allows the user to learn for themselves which elements of the bird's vocalization were most important for the identification of the family and species and therefore, to learn which elements to listen for to improve their capacity to identify birds for themselves. Although there have long been bird illustrations in field guides that include arrows or other methods to highlight visual characteristics most relevant to the identification of a species, prior to this invention there was no effective method to emphasize the elements of a bird's vocalization that are relevant to the identification, and certainly no method that enabled those elements to be emphasized in a just-made recording in the field.
[0061] FIG. 9 represents a possible screen shot of the display 1210 of the personal computational device on which the software application is running and the user has selected a recording for replay. The recording information 1215 is shown typically including the time, date, and location of the recording, and the family and species determination (if any) that was made in accordance with the current invention. Also shown are typical replay controls including a volume control 1225 and a play bar 1220 that allows the user to start, stop, rewind, and select a time in the recording. In addition to these typical elements, there are indicators 1230 and 1235 of the relevance of the time block of the recording immediately surrounding the current time point of the playback to the identification of the family and the species, respectively. Thus, at any time around which a dynamical mode characteristic of the family has been identified, the family relevance bar will be high. If this is not the case, the bar will be low. At any point near a mode transition characteristic of the species or in a time region in which the song is undergoing a smoother parameter change (an upward sweep of frequency, for example) that is characteristic of the species, the species relevance bar will be high and otherwise it will be low. In an alternate implementation in accordance with the current invention, the two types of information can be merged (say, summed) into a single display of relevance. In a further elaboration, this same relevance signal can be used to alter the volume control during the replay so that those parts of the song most relevant to identification are played at a higher volume level, while those less relevant are played at a lower volume level.
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An apparatus for detecting and identifying birds based upon electronic analysis of their bird calls and songs and method for doing so by utilizing a step-by-step hierarchical method of breaking down bird vocalizations according to order, family, and species of the specific bird. Several embodiments of the apparatus are disclosed particularly a hand held computational device, microphone, audio capture card, user application software and a collection of prerecorded audio data.
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Latin name: Malus domestica.
Varietal denomination: ‘CN 121’.
BACKGROUND OF THE NEW VARIETY
The present invention relates to a new, novel, and distinct variety of apple tree, ‘ Malus domestica ,’ and which has been denominated varietally as ‘CN 121’.
ORIGIN
The present variety of apple tree resulted from an ongoing program of fruit breeding which was implemented by the inventor and a licensee. In this regard, seed from an open pollinated ‘Honeycrisp’ apple tree (U.S. Plant Pat. No. 7,197) were collected during the 1994 growing season. These seeds were germinated and the seedlings produced were subsequently grown to a stage of development where they were planted at an orchard which is located at Worthington, Minn. One seedling designated ‘CN 121’ was selected, in 2004, as having desirable characteristics. Subsequently, budwood was removed from this promising seedling and were then budded onto M26 rootstock (unpatented) in 2007. This M26 rootstock was then growing in the orchard of a licensee which is located near Ephrata, Wash. Subsequently, periodic evaluations of the trees and the fruit produced from this first asexually reproduced seedlings were compared to the fruit and other tree characteristics of the chance seedling ‘CN 121’ in 2009 and 2010, respectively. The subsequent evaluations of these first asexually produced trees have demonstrated that those asexually reproduced trees run true to the original chance seedling. All characteristics of the original tree, and its fruit, were established, and appear to be transmitted through the succeeding asexual propagations.
SUMMARY OF THE VARIETY
‘CN 121’ is a new and distinct variety of apple tree which is quite distinguishable from the closest known variety, that being, the ‘Honeycrisp’ apple tree (U.S. Plant Pat. No. 7,197) from which it was derived as a chance seedling. In this regard, the fruit produced by the ‘CN 121’ apple tree develops an intense fruit skin color and pattern, whereas the fruit produced by the ‘Honeycrisp’ apple tree exhibits a striped pattern. In addition to the foregoing, the fruit produced by the new variety of apple tree ripens ten days later than the ‘Honeycrisp’ apple trees when grown at the same geographical location, and under the same cultural conditions. Moreover, internal indices of the new variety show that the fruit produced by this new apple tree has a greater fruit pressure; higher sugar content; higher pH; and lower titratable acid content as compared to the fruit produced by the ‘Honeycrisp’ apple tree (U.S. Plant Pat. No. 7,197).
BRIEF DESCRIPTION OF THE DRAWINGS
This new variety of apple tree is illustrated by the accompanying photographic drawings.
FIG. 1 is a picture of the original dormant ‘CN 121’ mother tree as currently seen in the orchard where it is growing.
FIG. 2 is a picture of a second generation ‘CN 121’ apple tree shown at full bloom.
FIG. 3 shows the fruit produced by a mature, second generation, ‘CN 121’ apple tree.
FIG. 4 depicts the fruit produced by a second generation ‘CN 121’ apple tree as compared to the fruit produced by a ‘Honeycrisp’ apple tree (U.S. Plant Pat. No. 7,197).
The colors in these photographs are as nearly true as is reasonably possible in a color representation of this type. Due to chemical development, processing, and printing, the leaves and fruit depicted in these photographs may, or may not, be accurate when compared to the actual specimen. For this reason, future color references should be made to the color plates (Royal Horticultural Society) and descriptions provided, hereinafter.
NOT A COMMERCIAL WARRANTY
The following detailed description has been prepared to solely comply with the provisions of 35 U.S.C. §112, and does not constitute a commercial warranty (either expressed or implied), that the present variety will, in the future, display the botanical, pomological or other characteristics as set forth, hereinafter. Therefore, this disclosure may not be relied upon to support any future legal claims including, but not limited to, breach of warranty of merchantability, or fitness for any particular purpose, or non-infringement which is directed, in whole or in part to the present variety.
DETAILED DESCRIPTION
Referring more specifically to the pomological details of this new and distinct variety of apple tree, the following has been observed during the sixth fruiting season under the ecological conditions prevailing at the orchards of a licensee which are located near Ephrata, Wash. All major color code designations are by reference to The R.H.S. Colour Chart (Fourth Edition) provided by The Royal Horticultural Society of Great Britain. Common color names are also occasionally used.
TREE
Size .—Generally considered average as compared to other common apple cultivars. The current trees were pruned to a height of about 7.5 feet, and had a crown diameter of about 4.5 feet.
Vigor .—Considered moderate for the species.
Tree form .—Considered upright to upright spreading.
Hardiness .—Considered hardy with respect to U.S.D.A. Zone 6[a].
Productivity .—Considered average for the species.
Trunk .—Size — About 2.6 cm in diameter when measured at a height of about 20 cm above the graft union.
Bark texture .—Rough.
Bark color .—Gray/orange (RHS gray/orange group 165B).
Lenticels .—Generally — Present, and in moderate number. About 18 lenticels will be found in a four square centimeter area.
Lenticels .—Shape — Elongated.
Lenticels .—Width — About 0.3 mm to about 0.5 mm.
Lenticels .—Length — about 1.5 to 2.7 mm.
Lenticels .—Color — Orange/white (RHS 159B).
First year branches.— Diameter — When measured at the mid-point of growth the diameter is about 3.4 mm to about 4.4 mm.
Color .—Gray/orange (RHS Group N199C).
Lenticels .—Numbers — Considered numerous.
Lenticels .—Shape — Round, and about 0.2 mm in diameter.
Lenticels .—Color — White (RHS 155D).
Branch pubescence .—Generally — Considered present, and light in abundance.
Branch pubescence .—Color — Gray/orange (RHS Group 166A).
Internodes .—Size — About 3.1 cm to about 4.1 cm in width.
Dormant fruiting buds .—Shape — Considered conical.
Dormant fruiting buds .—Length — About 7.4 mm.
Dormant fruiting buds .—Basal Diameter — About 3.5 mm.
Dormant fruiting buds .—Color — Gray/orange (RHS 199C).
Two year old fruiting branches .—Size — Generally — About 5.8 mm to about 9.0 mm in diameter when measured at approximately the mid-point of the growth. Branch Color — Gray/brown (RHS Group 199A). Spur Development — Generally — Considered light. Spur Length — About 1 cm to about 2.9 cm in length. Spur Shape — Considered moderately acute.
Lenticels .—Numbers — Numerous, and averaging about 15 lenticels per square centimeter of surface area.
Lenticels .—Shape — Considered generally oval.
Lenticels .—Length — About 0.9 mm.
Lenticels .—Width — About 0.4 mm.
Lenticels .—Color — White (RHS Group 155D).
Scaffold branches .—Size — About 1 cm to about 1.3 cm in diameter when measured at a distance of about 10 cm from the trunk.
Scaffold branches .—Crotch Angle — As currently trained in the orchard, the crotch angle is about 45 degrees from the vertical. However, this characteristic should not be considered distinctive of the present variety.
Scaffold branches .—Color — Gray/brown (RHS N199C).
Scaffold branches .—Lenticels — Numerous lenticels are present. On average, about 8 lenticels appear per square centimeter of surface area.
Scaffold branch lenticels .—Shape — Elongated and small.
Scaffold branch lenticels .—Size — About 0.7 mm in width and in length.
Scaffold branch lenticels .—Color — Orange/white (RHS Group 159C).
LEAVES
Leaf shape .—Generally — Considered broadly acute and generally upwardly folded.
Leaf texture .—Dorsal Surface — Considered leathery and slightly undulating.
Leaf texture .—Lower Surface — Considered glabrous.
Surface sheen .—The dorsal surface has a high sheen. The ventral surface has a somewhat dull appearance.
Pubescence .—Generally — The pubescence appears on the ventral surface only, and covers substantially the entire surface.
Pubescence .—Texture — Considered fine.
Pubescence .—Color — White (RHS 155C).
Leaves .—Length — Variable from about 77 mm to about 100 mm.
Leaves .—Width — About 48 mm to about 62.8 mm.
Leaves .—Marginal Form — Considered mostly serrate, although occasionally bi-serrate portions will be seen.
Leaf tip shape .—Generally — Considered acuminate.
Leaves .—Base Shape — Considered rounded.
Leaves .—Stipules — Generally absent. On occasion one will be found on a petiole. Stipules — Length — About 7.1 mm. Stipules — Width — About 1.1 mm. Stipules — Color — The dorsal and ventral surfaces both have a yellow-green color (RHS 147B).
Leaf pubescence.— Generally — The Pubescence is generally present on the ventral surfaces, but it is considered fine in texture. The leaf pubescence only covers about 50% of the ventral leaf surface.
Leaf pubescence.— Color — White (RHS 155C).
Leaf blade color.— Dorsal Surface — Yellow/green (RHS 147A).
Leaf blade color.— Ventral Surface — Yellow/green (RHS 147C).
Leaf midvein.— Shape — Considered prominent, and having a fine pubescence on its ventral surface.
Leaf mid-vein.— Width — When measured at midblade it is about 1.1 mm in width.
Mid-vein color.— Dorsal Surface — Gray/yellow (RHS 160C).
Mid-vein pubescence.— Color — White (RHS 155C).
Petiole.— Length — About 20.2 to 35.4 mm.
Petiole.— Diameter. When measured at the mid-point, it is about 1.3 to 1.7 mm.
Petiole.— Color — Yellow/Green (RHS 147D). Further highlights of gray/red (RHS 181A) are seen at the basal end thereof.
Petiole.— Pubescence — Generally it is considered abundant, and having a fine texture over the entire length and circumference of the petiole.
Pubescence color.— White (RHS 155C).
FLOWERS
Date of full bloom.— In 2010, the date of full bloom was April 27.
Number of blossoms per bud.— Generally 5 to 6 blossoms will be found per bud.
Flower size.— Generally — Considered medium to medium large.
Flower diameter.— At full expansion it is about 43 to about 51 mm.
Flower petals.— Width — About 20 to about 23 mm.
Flower petals.— Length — About 14 to about 19 mm.
Flower petals.— Color — White (RHS 155B). Further, the flower petals may have highlights of gray/purple (RHS 186D).
Petal vein color.— Gray/purple (RHS 186B).
Flower stamen.— Numbers — About 18 to 20 stamens will be found.
Filament.— Length — About 5.2 to 11.8 mm.
Filament color.— Yellow (RHS Group 2D).
Anthers.— Shape — Kidney shaped.
Anthers.— Width — About 1.6 mm.
Anthers.— Length — About 1.7 mm.
Anthers.— Color — At full maturity the anthers gray/yellow (RHS 160C).
Pistil.— Length — About 14.3 to about 16.1 mm.
Styles.— Numbers — Typically 5, and they are usually fused at the middle.
Styles.— Color — They are usually white, and pubescent below the union.
Styles.— Length — About 6.9 to about 8.7 mm.
Styles.— Color — Yellow/green (RHS 144C).
Stigma.— Shape — Club-like.
Stigma.— Color — Gray/yellow (RHS 162A).
Sepals.— Numbers — Typically 5 per blossom are found.
Sepals.— Form — Usually the sepals are curled back towards the peduncle.
Sepals.— Shape — Considered deltoid.
Sepal tip.— Shape — Acuminate.
Sepal base.— Shape — Truncate.
Sepals.— Length — About 8.4 mm.
Sepals.— Width — About 3.8 mm.
Sepal pubescence.— Generally speaking this is present on both the dorsal and ventral surfaces.
Sepal color.— Green (RHS 146C). Further the tips of the sepals are typically highlighted with a gray/orange color (RHS 165A).
Peduncle.— Length — About 16 to about 20 mm.
Peduncle.— Color — Yellow/green (RHS 144A). Occasionally a yellow/green color (RHS 152A) appears along the mid-ribs of the peduncle.
FRUIT
Maturity when described.— Ripe for harvesting and shipment about Sep. 19, 2010. This harvesting date was 10 days later than the apple tree ‘Honeycrisp’ which was growing at the same geographical location and under similar cultural conditions.
Fruit form.— Considered mostly conical, and occasionally round, with about 50% of the fruit appearing lopsided. The equatorial cross-sectional shape is irregular.
Fruit size.— Considered medium to medium large under normal crop loads.
Equatorial fruit diameter.— About 83.6 mm.
Axial diameter.— About 74.5 mm.
Fruit stem.— Length — Considered medium, about 22.1 mm.
Fruit stem.— Diameter — About 2.4 mm.
Stem cavity.— Average Width — About 34.3 mm.
Stem cavity.— Average Depth — About 19.3 mm.
Stem cavity.— Shape — Acute.
Stem cavity.— Form — No lipping is apparent.
Basin cavity.— Average width — About 28.7 mm.
Basin cavity.— Average depth — About 10.3 mm.
Basin cavity sides.— Shape — Rounded.
Eye.— Generally considered erect.
Sepal.— Color — White (RHS 155C) and appearing downy in appearance.
Fruit skin.— Surface — Considered glabrous and a light bloom is present.
Fruit skin.— Appearance — Considered washed out, especially on the side of the fruit which is not directly exposed to sunlight.
Fruit color.— Generally — The overall color is more intense on exposed sides.
Skin color.— Overcolor — Red (RHS 46A).
Skin color.— Undercolor — Yellow/green (RHS 150C).
Fruit skin thickness.— Generally — Medium.
Fruit skin texture.— Considered tough.
Fruit skin lenticels.— Generally — Scattered, small, and considered indistinct and more numerous towards the Calyx end of the fruit.
Lenticels.— Numbers — About 3 per cm square are found when measured at the stem end, and 10 per cm square when this is measured at the Calyx end.
Lenticels.— Surface Texture — Smooth. The skin appears areolar in appearance.
Lenticels.— Surface Color — White (RHS N155D).
Lenticels.— Size — About 0.2 to about 0.4 mm in diameter but otherwise considered round.
Fruit core.— Position — Considered distant.
Fruit core.— Line position — Basal clasping.
Fruit core.— Diameter — About 32.7 mm.
Fruit core.— Length — About 26.9 mm.
Fruit core.— Shape — Considered flat and conical.
Fruit cell.— Numbers — 5.
Fruit cell.— Form — Considered tufted, and narrow lines circumvent the cell walls.
Tuft.— Color — The tufting is white (RHS 155C).
Fruit cell.— Shape — Considered elliptical.
Fruit cell.— Length — About 17.1 mm.; Fruit Cell — Width — about 9.3 mm.
Fruit cell.— Depth — About 7 mm.
Tube.— Shape — Cone-like.
Stamen position.— Generally considered medium.
Axis.— The cells are axially disposed and considered open.
Seeds.— Numbers — 1-2 seeds are found, mostly 2.
Seed shape.— Generally — Considered mostly acute, and some approaching acuminate in shape.
Seed length.— About 8.3 to 8.9 mm.
Seed width.— About 4 mm to about 5.3 mm.
Seed color.— Brown (RHS Group 200B).
Fruit flesh.— Generally — Considered firm, crisp, melting, sweet, sub-acid and juicy.
Flesh texture.— Considered medium coarse grained.
Flesh color.— White (RHS 155A).
Flesh aroma.— Apple-like, and mild in intensity.
Fruit pressure.— The new variety of apple tree produces fruit having a fruit pressure of about 17.5 pounds. This is higher than the fruit pressure produced by the fruit of the ‘Honeycrisp’ apple tree. When that tree is grown under the same ecological conditions its fruit has a pressure of about 13.76 pounds.
Brix.— The new variety of apple tree, at commercial maturity, produces fruit having a brix of about 14.6. This brix is higher than that produced by the fruit of the ‘Honeycrisp’ apple tree (U.S. Plant Pat. No. 7,197) which, when grown under the same ecological conditions, has a brix of about 13.8.
pH.— At commercial maturity, the fruit of the present variety of apple tree has a pH of about 3.43. This pH is lower than that produced by the fruit of the ‘Honeycrisp’ apple tree (U.S. Plant Pat. No. 7,197) which, at full commercial maturity, and grown under the same ecological conditions, has a pH of about 3.35.
Fruit keeping quality.— Considered excellent. The fruit of the present variety has been kept up to five months in cold storage with no deleterious effects noted.
Pollination.— The present variety may be pollinated by any diploid apple tree that blooms at approximately the same season.
Fruit use.— Considered a fresh desert apple.
Disease and insects resistance.— The present variety is considered to be susceptible to all insects and diseases found in the region of central Washington.
Although the new variety of apple tree which is described herein possesses the aforementioned characteristics when grown under the ecological conditions prevailing near Ephrata, Wash., in the central part of Washington State, it should be understood that variations of the usual magnitude and characteristics incident to changes in growing conditions, fertilization, pruning, pest control, frost and climatic variables and other horticultural management practices are to be expected.
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A new and distinct variety of apple tree ' Malus domestica ' which is denominated varietally as 'CN 121' and which produces an attractively colored apple which his mature for harvesting and shipment approximately September 19 under the ecological conditions prevailing near Ephrata, Wash., in the central portion of Washington State.
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BACKGROUND INFORMATION
1. Field
Embodiments of the disclosure relate generally to the field of operator mental state monitoring and more particularly provides a system and method for monitoring alertness of an operator such as a pilot for lowered alertness and high stress states with alertness recovery stimulation, normal display functionality and reduced display clutter based on thresholds for accommodation of the mental state of an operator,
2. Background
Operators of modern vehicles and machinery, particularly pilots of aircraft, are provided with significant information by instruments and systems displays in the vehicle or machine being operated. Often the amount of data presented on system displays can be very complex. Operators, particularly pilots, also may be required to remain in control of the vehicle for significant periods of time. Additionally, increasingly high stress levels may be induced by traffic congestion, bad or, severe weather, aircraft damage or other emergencies, or combat situations. The mental state or condition of the operator affects how well the operator can assimilate information presented by the instruments and systems displays.
It is therefore desirable to provide a system and method for monitoring alertness of an operator such as a pilot for lowered alertness and high stress states with control system adjustment for accommodation of the mental state.
SUMMARY
Embodiments described herein provide a system for display management based on operator stress level which employs a biosensor detecting stress level of an operator. A biomonitoring system receives input from the biosensor and provides an output responsive to a threshold of stress. An operational display control receives the output from the biomonitoring system and using software modules modifies an information display based on the stress threshold.
In an exemplary embodiment. An aircraft cockpit display management system responsive to pilot stress level incorporates a biomonitoring sensor package including sensors selected from the set of a neuro-headset to read the brainwaves, sensors to read to heart rate, temperature, perspiration level, respiration and eye movement sensing. A biomonitoring system receiving input from the biomonitoring sensor package provides an output responsive to a threshold of stress. An operational display control receives the output from the biomonitoring system and using software modules modifies an information display for decluttering based on a predetermined elevated stress threshold.
In one operational scenario, the exemplary embodiment provides a method for display management based on operator stress level which initializes an operational display control with base values for display complexity and then monitors output of a biosensor. A current stress value is calculated based on the biosensor output to determine if a lower initial threshold has been exceeded indicating reduced attentiveness. If so, a display management system is notified that a first lower threshold has been exceeded and activates additional tasks to raise the operator's alertness level. A determination is made if normal stress levels have returned and, if so, to normal operational display complexity is restored,
The features, functions, and advantages that have been discussed can be achieved independently in various embodiments of the present invention or may be combined in yet other embodiments farther details of which can be seen with reference to the following description and drawings,
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic block diagram of the bio-monitoring system sensors and control;
FIG. 2A is a simulated view of a cockpit display system for normal conditions;
FIG. 2B is a simulated view of the cockpit display system after adjustment for a first threshold based on mental state;
FIG. 2C is a simulated view of the cockpit display system after adjustment for a second threshold based on mental state; and,
FIG. 3 is a flow chart of a calibration method to establish database values for reduced alertness thresholds; and
FIGS. 4A and 4B are a flow chart of operation of the system
DETAILED DESCRIPTION
The embodiments described herein relate to an aircraft system with a pilot. However, the described system and method are equally applicable to operators of heavy machinery, ships, military vehicles or other devices both mobile and stationary and the term operator is used as a general descriptor herein. The example embodiment provides a biomonitoring sensor package 10 attached to the operator incorporating sensors as shown in FIG. 1 including a neura-headset 12 to read the brainwaves, cuff mounted sensors 14 to read to heart rate and other biosignals such as temperature or perspiration level, and a visual sensing device such as :video camera 16 for monitoring eye movement. The video camera may be mounted to a headset 18 or helmet as shown in FIG. 1 or to a remote support on the instrument panel or cockpit structure. The biomonitoring sensor package 10 provides signals to a biomonitor system 20 through either wired or wireless communications interfaces (designated. B and C) and constantly monitors the mental state of the operator by reading the signals and comparing them to one or more predefined thresholds. As will be described in greater detail subsequently, more than one threshold may be present to grade the system reaction to operator mental state or behavior.
If a threshold is reached or is approached, a message is sent by the biomonitoring system 20 to an operational display control 22 , integrated into the computer system for the aircraft flight control system 24 , which includes the displays in the cockpit 28 and controls such elements as the Electronic Flight Bag (EFB) 30 , Primary Flight Display (PM) 32 and/or Multifunction Display (MFD) 36 (sometimes referred to as a Navigational Display (ND) when employed for that function) shown in FIG. 2A . Examples of normal cockpit display details on the EFB, PFD and MFD/ND displays in the cockpit are represented in FIG. 2A . The EFB will typically display navigational information such as course maps 40 , destination airport information or Notices to Airmen (NOTAMS) 42 and vertical flight path information 44 . The PFD 36 will display vertical position indication/turn and bank information 46 , airspeed, 48 , altitude 50 and horizontal direction indication 52 . The MFD 32 typically displays aircraft system information 54 and flight path information 56
The operational display control 22 in the FCS 24 is computer controlled and incorporates software modules providing different modes responsive to signaling from the biomonitor system 20 . One mode is “biosignal threshold reached”. If this mode is activated, the operational display control 22 will automatically declutter the screen displays dramatically and focus only on the information the operator needs right now to fly the aircraft (e.g. turn off NOTAM depiction on the EFB 30 ). Levels of display decluttering are shown in FIGS. 2B and 2C which will be described in greater detail subsequently. In a combined cockpit computer system, some displays are switched off automatically to control the operator's attention and draw it to the system(s) that need his intention most at that particular moment. The biomonitoring system 20 will continue reading the biosignals of the operator. The operational display control 22 would then revert into “normal” mode when biosignals return to “normal” within the threshold limits. Alternatively, an override or reset switch associated with the operational display control 22 may be employed to restore complete normal functionality to the displays.
The monitoring devices including the sensors of the biomonitoring sensor package 10 and the associated biomonitor system 20 is a personal device and therefore is configured to the person wearing it. Calibration of the combined biomonitoring sensor package and biomonitor system may be undertaken for specifically “tuning” defined threshold levels for individuals. The biomonitoring sensor package 10 and associated biomonitor system 20 would also be able to detect any emotional stress (e.g. problems the operator has at home or other personal issues) and may automatically change the depiction,/ arrangement of displays and application presented by the operational display control 24 as soon as it is switched on. There could be a color adjustment of the EFB application, of course the color adjustment would not affect any critical elements but, for example, the main background color or the frame of the application or buttons could change color to bring the operator into a less emotional mood (e.g. blue color or grey color could have a calming/neutralizing effect). It would therefore be independent of “emergency-only” situations
The neuro-headset 12 of biomonitoring sensor package 10 monitors electroencephalogram (EEG) signals of the operator. The brain waves need to be captured as close to the skull as possible. The operator is typically wearing a headset 18 or helmet while flying the aircraft. A sensor is attached to the headset that can then directly read the brain waves from the operator's skull. The EEG is the depiction of the electrical activity occurring at the surface of the brain and is a primary method used to detect wake conditions and stress state of the operator. Normal EEG waveforms, like many kinds of waveforms, are defined and described by their frequency, amplitude, and location. For example, rising alpha (8-11 Hz) and theta (4-7 Hz) EEG activities indicate loss of attentiveness or alertness and thus the potential for lapses in attention and behavior. The main indicator of stress is beta brain waves above 18 Hz. With that level the operator feels slightly stressed due to having to perform several tasks at the same time. When the brainwave level increases above 30 Hz the brainwaves will interfere with the ability to think clearly and effectively which becomes a threat to the operators and aircrafts safety. The operator feels confused and will not be able to focus on one task. This would be the indicator for a very high stress level like maybe in an emergency situation (in case of multiple engine failures etc.) The biomonitor system 20 employs Alpha and Theta waves to define the condition of the operator (e.g. sleepy, stressed).
The biomonitor system 20 verifies the detected state/ condition of the operator with a combination of two or more measurement methods. The heart rate, body temperature or muscle active measurement requires additional sensors or electrodes attached to the skin of the operator. This can be resolved by sewing the sensor into the operator's uniform (e.g. at a position at the sleeves of a shirt close to the wrist) where it contacts the skin. The secondary source of bio data measurements for the example embodiment is provided by the cuff mounted sensor 14 for heart rate variability, body temperature or muscle activity. This enables a second reading of measurement that can be matched to the brain wave reading,
As an additional measurement eye movement is employed. The slower the eye movement the more likely the operator has a reduced alertness. This can result in less attention on the task and can be measured in blink duration and blink frequency. Video camera 16 is installed in the cockpit to be able to record the eye movement of the operator as well as blink duration and frequency. Software modules in the biomonitor system 20 are then used to automatically evaluate and interpret the measurement and then match it to the brain wave reading. Alternative measurable inputs such as respiration rate may also or alternatively be employed.
From the combination of two sensor inputs (primary: Brain wave reading via headset, secondary: heart rate reading via sensor in operators uniform) bio-monitoring data can be extracted. This data is compared to an average value of this operator in a neutral state (awake, not stressed or tired). Comparing the measurements to the average value the software modules in the biomonitor system 20 can detect any deviation from a predetermined buffer area around the average. In case of an abnormal comparison result several actions are possible depending on the direction of the reading (towards reduced alertness, towards highly stressed).
In case of reduced alertness detection the reaction of the cockpit system can also vary depending on the “severity” of alertness reduction. If the biomonitor system 20 detects that the operator reaches an initial reduced alertnesse threshold, additional distraction/more tasks to be fulfilled are provided by the operational display control 22 . If the biomonitor system 20 detects that the operator reaches a second reduced alertness threshold an output signal (represented as D in FIG. 1 ) may activate a vibration module 26 in the seat of the operator in order to increase alertness of the operator. Alternatively, aural or visual indicators can be presented by the operational display control 22 .
In case of an increased stress detection by the biomonitor system 20 the operational display control can automatically start to declutter various screens on the front panel to reduce information and distraction. In case of emergency or other stressful situations the operational display control can automatically display a priority list of tasks. Instead of blinking and voice commands of various systems (in case of a multi system failure) the system will detect the stress level of the operator and then adapt the warning messages and methods. It can, for example, focus the operator's attention on the task with a predetermined highest priority,
On a data driven charting EFB 30 , all unimportant data for the current situation can be decluttered/reduced when a high work load/stress level is detected, e.g. radio frequencies, all shown waypoints reduced to next waypoint, airspace depictions reduced to important airspaces in vicinity such as nearest airport for landing.
On MFD 32 an appropriate checklist can be shown, for example if there are several warnings in the cockpit an optimized checklist is provided to the operator for the next tasks to help him to work on the tasks in a prioritized order. Dependant on the number of stress level thresholds, an appropriate depiction for each level is chosen for each display for each phase of flight. The decluttering differs for the various phases of flight. For the different warnings in the aircraft, the aircraft manufacturer determines in which order the response checklists are depicted.
FIG. 2B shows an example of a first level of “decluttering” in response to exceeding the initial upper threshold for stress. In the EFB 30 the operational display control enlarges the most important elements (like text information that can be easily missed such as Minimum Operating Altitude (MOA) display 60 ) and positions them more prominent in the primary field of view. The number of displayed map elements is reduced, for example only displaying route 62 and associated waypoints 64 , no additional text, with only main functions like “zoom in” 66 , “zoom out” 68 , “center on A/C” 70 available for selection.
On the PFD no changes are made and the PFD creates a “fall back” solution; one system should always look the same and contain the most basic instruments/panels.
With respect to the MFD/ND, the display is decluttered for example only depicting immediately required information (e.g. current route 72 ). If an emergency or failure is detected in the system, a checklist 74 can be displayed. The operator is forced to elect check off boxes 76 (to assure that required checks are performed).
FIG. 2C demonstrates the additional decluttering created upon exceeding the secondary threshold. In stress level 2 , the EFB 30 may be switched off by the biomonitoring system, dependant on the flight phase. An indicator 78 is provided to show that the system was switched off on purpose, not due to power loss. A function to return to the last displayed screen, “one click” functions to access information for “nearest airport”, “go around procedure chart”, etc. may be alternatively provided. In case of a system failure the operator needs to focus on controlling the aircraft and on checklists.
As with stress level 1 previously described, the PFD 36 remains unchanged.
The MFD 32 can be used to depict a checklist 80 comparable to that provided for stress level I but with enhanced sizing or color features, the example includes a miniature depiction of the current flight plan 82 (including current position and the next waypoint 84 only) as well as the checklist. Checklist items for Captain and First Officer may be separated. Here in shown as “clear” items for CPT, “shaded” items to be checked by the FO, text/font size is enlarged the better readability with the “OK” buttons 86 to confirm check of the item.
The EFB and/or MFD may alternatively each be used to display a checklist (e.g. having one checklist for the pilot and one for the FO displayed),
FIGS. 3 , 4 A and 4 B depict a method employing the embodiments described or implementing an interactive display control system based on operator stress level. Calibration of the overall system is accomplished as shown in FIG. 3 . The sensors in the biosensor monitoring package are attached to the operator, step 302 , for the embodiment disclosed by donning a flight suit or uniform shirt with the cuff mounted sensor and headset with the EEG sensor. A controlled environment is established with the operator in a well rested state in a simulator of the cockpit or similar device, step 304 . The biomonitor system then monitors EEG, step 306 , heart rate and body temperature, step 308 , from the biosensor monitoring package and after an equalization period a normal stat is recorded for EEG, step 310 and heart rate/body temperature, step 312 . Stress is then induced on the operator by simulated emergencies in the simulator or other stress inducer, step 314 and the resulting EEG is measured, step 316 , and heart rate/body temperature is measured, step 318 . This may be repeated a number of times for data confirmation and/or at varying stress levels to obtain extended data points. One or more threshold levels are then established from the data, step 320 . A sleep state is then induced in the operator (this may occur in a separate environment at a selected time for normal sleep), step 322 . The resulting EEG is measured, step 324 , and heartrate/body temperature is measured, step 326 . Data may be recorded over a period of time for wakefulness to sleep transition values. One or more threshold levels are then established from the data for reduced alertness, step 328 .
FIGS. 4A and 4B demonstrate the method for operational implementation of the system based on the calibration data. Upon entry into the cockpit by the operator, the biomonitoring sensor package 10 is connected to the biomonitor system 20 and the operational display control 22 is initialized with base values for display complexity, step 400 . The biomonitor system 20 then monitors EEG from the headset sensor 12 and secondary sensors from the cuff sensor 14 , steps 402 a and 402 b . The biomonitor system then calculates a current stress value based on the sensor inputs, step 404 . A determination is made if a lower initial threshold has been exceeded indicating operator reduced attentiveness, step 406 . If not, the monitoring system tests for higher stress level thresholds as will be described in greater detail subsequently. If the lower initial threshold has been exceeded, the system determines if the operator has, in fact, passed a sleep threshold, step 408 . If not, the operational display control 22 is notified that the drowsiness threshold has been exceeded and additional tasks are activated, step 410 , to raise the operator's alertness level. Repeated biosensor system monitoring is employed to determine if normal stress levels have returned, step 412 . If not, the additional tasks presentations by the operational display control 22 are continued and or varied in a predetermined manner. If normal conditions have returned, the biomonitor system 20 indicates a normal stress level and the operational display control 22 is reset to normal operational display complexity 414 .
If in step 408 a determination was made that the sleep threshold had been reached, the biomonitor system 20 activates the vibrator 26 and/or other aural or physical stimulus to wake up the operator, step 416 . If wakefulness is achieved, step 418 , the system returns to step 412 to determine if normal stress levels are present or whether additional tasks to further stimulate the operator are required.
If the biomonitor system determined in step 406 that no drowsiness was present then testing for elevated stress levels is made and a determination if an initial upper threshold for stress has been exceeded, step 420 . If not, monitoring continues with a return to node B. If the initial threshold has been exceeded, a determination is made if a second upper threshold level has been exceeded, step 422 , if not, a determination is made if an emergency state exists which is causing the increased stress level, step 424 . If not, the biomonitor system instructs the operational display control system 22 and a first declutter level is established, step 426 . If an emergency state exists in step 424 the operational display control 22 provide a predetermined display of prioritized tasks to address the emergency, step 428 and then the first declutter level on the displays is established, step 426 . The system then monitors the sensor levels and if normal stress levels return, step 430 , the system returns through node C for reseting the normal display levels.
If the second upper threshold level has been exceeded in step 422 , a determination is made if an emergency state exists which is causing the increased stress level, step 432 . If not, the biomonitor system instructs the operational display control system 22 and a second declutter level is established, step 434 . If an emergency state exists in step 432 the operational display control 22 provides a predetermined display of prioritized tasks to address the emergency, step 436 , which is further edited consistent with the second level threshold of increased stress and then the second declutter level on the displays is established. Monitoring of sensor levels then continues to determine if the stress level has dropped below the second upper threshold, step 440 . If so, the system returns to step 420 for the initial upper threshold level determination with the associated first declutter levels and task lists, if required, and, if stress levels return to normal, a reset of the system for normal operation.
Having now described various embodiments of the invention in detail as required by the patent statutes, those skilled in the art will recognize modifications and substitutions to the specific embodiments disclosed, herein. Such modifications are within the scope and intent of the present invention as defined in the following claims.
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A system for display management based on operator stress level employs a biosensor detecting stress level of an operator. A biomonitoring system receives input from the biosensor and provides an output responsive to a threshold of stress. An operational display control receives the output from the biomonitoring system and modifies an information display based on the stress threshold.
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a divisional of U.S. patent application Ser. No. 09/716,783, filed Nov. 20, 2000, now U.S. Pat. No. 6,429,217, which is a divisional of U.S. patent application Ser. No. 09/139,442, filed Aug. 25, 1998, now U.S. Pat. No. 6,479,523, which claims priority to U.S. Provisional Application Ser. No. 60/072,284, filed Jan. 23, 1998 and U.S. Provisional Application No. 60/056,994, filed Aug. 26, 1997.
BACKGROUND OF THE INVENTION
Minimally invasive direct coronary artery bypass (MIDCAB) surgery, both via sternotomy and alternative incisions, is a substantially revolutionary development in surgery for allowing bypass surgery to be conducted on a beating heart. However, beating heart surgery shows an undesirably higher rate of early graft failure than conventional coronary artery bypass procedures using cardiopulmonary bypass and cardioplegia. The technical difficulty of sewing the coronary artery anastomosis on a beating heart is likely an important factor in this difference in outcome between the two techniques. Controlled intermittent asystole (CIA) during brief intervals required for placing anastomotic sutures is suitable for improving the precision of coronary anastomoses performed on a beating heart and reducing graft failure while increasing ease of operation.
Cardiopulmonary bypass (CPB) and chemical arrest using cardioplegia solutions have traditionally provided surgeons with optimal operative conditions: hemodynamic control and cardiac quiescence. This optimal field has contributed to technical success in increasingly complex cardiac surgical operations. However, there has been recent interest in performing coronary artery bypass surgery without either complete cardiopulmonary bypass or cardioplegia. The quality of the distal anastomosis is a primary concern among cardiac surgeons who observe and perform coronary artery bypass graft (CABG) procedures unaided by cardioplegic arrest and cardiopulmonary bypass. Coronary artery bypass graft failure rates reported with minimally invasive direct coronary artery bypass range from 3.8 to 8.9%, while traditional CABG on CPB has a reported anastomotic failure rate of 0.12%. This may reflect a difference in anastomotic precision between MIDCAB and CPB-aided CABG. Although the benefits of avoiding extracorporeal circulation and global cardioplegia in beating heart procedures are important, they do not outweigh the performance of an optimal coronary anastomosis.
The key difference in the anastomotic results between conventional CABG and beating heart CABG is related to achieving elective asystole during construction of the distal anastomosis. Cardiac motion can be minimized during MIDCAB procedures via pharmacologic bradycardia (adenosine, β blockade) and mechanical stabilization using various devices. Although these techniques do improve operative conditions, they only approximate the advantages of elective asystole achieved with CPB and cardioplegia.
Applicants show that a state of controlled intermittent asystole (CIA) is produced off CPB, which provides a major advantage otherwise gained by cardioplegic arrest on CPB. In particular, CIA is achieved using unilateral (or bilateral) vagus nerve stimulation coupled with pharmacologic suppression of electromechanical escape activity.
Applicants demonstrate that elective, controlled intermittent asystole is produced by vagus nerve stimulation after treatment with an acetylcholinesterase inhibitor, a β-adrenergic receptor blocker, or a calcium channel blocker, or combinations thereof.
BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 Duration of asystole achieved during 60 second vagal stimulation. Lines connect the periods of asystole observed in the non-drug treated and drug treated states in each experimental animal. Drug administration lengthened significantly the period of asystole.
FIG. 2 . Representative left ventricular and aortic pressure tracings during 60 second vagal stimulation in the non-drug treated (A) and drug treated states (B). Dark and open arrows mark the initiation and termination of the vagal impulse, respectively. Before drug treatment, a short pause followed by escape and bradycardia was observed during the 60 second impulse. After drug treatment, prolonged asystole occurred during the 60 second impulse with return of mechanical function after termination. lvp—left ventricular pressure; aop—aortic pressure.
FIG. 3 . Representative left ventricular and aortic pressure tracings during sequential 15 second vagal stimulations in the non-drug treated (A) and drug treated states (B). Dark and open arrows mark the initiation and termination of the vagal impulses, respectively. Before drug treatment, each 15 second stimulation produced a short pause followed by bradycardia, while after drug treatment, asystole lasted the duration of each 15 second stimulation. lvp—left ventricular pressure; aop—aortic pressure.
Abbreviations and Definitions
CABG
Coronary artery bypass graft
CIA
Controlled intermittent asystole
CPB
Cardiopulmonary bypass
MIDCAB
Minimally invasive direct coronary artery
bypass; intended to include any CABG
without the use of global cardioplegia;
synonymous with beating heart surgery,
irrespective of incision
DETAILED DESCRIPTION OF THE INVENTION
Increased acetylcholine activity by acetylcholinesterase inhibition and prevention of electromechanical escape activity by β-adrenergic receptor and calcium channel blockade during vagal stimulation produces a marked potentiation of vagal-induced asystole and a means of achieving CIA. CIA achieved by pharmacologic potentiation of vagal-induced asystole is a suitable technique to facilitate MIDCAB operations. In particular, anastomoses and other complex suturing is facilitated during such controlled asystolic events, a readily appreciated advantage in surgery involving minimally invasive direct coronary artery bypass operations on a beating heart. CIA might have particular advantages in partially or totally endoscopic CABG, and possibly in percutaneous or surgical transmyocardial laser revascularization.
The present invention provides a pharmaceutical composition, comprising an acetylcholinesterase inhibitor, a β-adrenergic receptor blocker, and a calcium channel blocker, said composition useful for performing beating heart surgery. The invention also provides that the composition is useful for controlled intermittent asystole in minimally invasive direct coronary artery bypass surgery. The invention further provides that the compositions can be administered in combination with vagus nerve stimulation. Vagus nerve stimulation can be achieved by direct or indirect electrical stimulation.
In preferred independent embodiments, the acetylcholinesterase inhibitor can be pyridostygmine bromide, the β-adrenergic receptor blocker can be propranolol hydrochloride, and the calcium channel blocker can be verapamil bromide.
The invention also provides a pharmaceutical composition, comprising an acetylcholinesterase inhibitor and a β-adrenergic receptor blocker, said composition useful for performing beating heart surgery. In preferred embodiments, the acetylcholinesterase inhibitor can be pyridostygmine bromide, and the β-adrenergic receptor blocker can be propranolol hydrochloride. The invention also provides that the composition is useful for controlled intermittent asystole in minimally invasive direct coronary artery bypass surgery. The invention further provides that the compositions can be administered in combination with vagus nerve stimulation. Vagus nerve stimulation can be achieved by direct or indirect electrical stimulation.
The invention also provides a pharmaceutical composition, comprising an acetylcholinesterase inhibitor and a calcium channel blocker, said composition useful for performing beating heart surgery. In preferred embodiments, the acetylcholinesterase inhibitor can be pyridostygmine bromide, and the calcium channel blocker can be verapamil bromide. The invention also provides that the composition is useful for controlled intermittent asystole in minimally invasive direct coronary artery bypass surgery. The invention further provides that the compositions can be administered in combination with vagus nerve stimulation. Vagus nerve stimulation can be achieved by direct or indirect electrical stimulation.
The principal challenge of beating heart CABG surgery has been to recreate the advantageous operative conditions of a quiescent operative field provided during conventional CABG with CPB and cardioplegic arrest. A variety of pharmacologic manipulations and mechanical stabilizing techniques assist in performing CABG off pump. These interventions to date minimize, but do not eliminate, cardiac motion. The concept that a state of controlled intermittent asystole improves the conditions for construction of distal coronary artery bypass anastomosis in non-CPB assisted cases was demonstrated by applicant. CIA is defined as operator-initiated and controlled intervals of mechanical cardiac standstill. These intervals may be timed to coincide with placement of sutures in the anastomosis, after which normal cardiac rhythm and hemodynamics are restored while preparations are made for the next successive stitch. Experiments reported by the applicant indicate that the minor bradycardia known to be produced by vagus nerve stimulation is dramatically augmented to function as an electromechanical “on-off switch” by pharmalogical inhibition of acetylcholinesterase and blockade of β-adrenergic receptors and calcium channels. Controlled intermittent asystole may prove equally useful for CPB-assisted cardiac surgery without global cardioplegia.
The chronotropic effects of vagal nerve stimulation have been well described and typically produce an initial pause followed by a “vagal escape” beat and sustained bradycardia during continuous optimal stimulation of the vagus nerve. Cardiac responses to a 60 second vagal stimulation without adjunctive therapy achieved an average pause of 1.6 seconds terminated by vagal escape beats with a 19% reduction in heart rate. Vagus nerve stimulation alone did not produce a controlled period of asystole desired for CIA. In contrast, a triple pharmacologic regimen of e.g, pyridostigmine, propranolol and verapamil inhibited vagal escape, and allowed sustained periods of asystole lasting up to 60 seconds and sequential asystoles of 15 seconds each. Sequential asystoles had no significant hemodynamic consequences.
It is apparent that suppression of the electromechanical escape during vagal stimulation is necessary to produce a sufficient interval of asystole to allow a single stitch to be reliably placed during construction of a distal CABG anastomosis. The negative chronotropic effects of vagal stimulation are produced by acetylcholine release. Acetylcholine activity may be enhanced by inhibition of acetylcholinesterase activity by agents such as pyridostigmine. Additionally, it is known that calcium channel blockade by e.g. verapamil potentiates the negative chronotropic effect of vagus nerve stimulation. Another component in electromechanical escape may be related to increased catecholamine activity in the sympathetic nervous system, triggered by hypotension. Catecholamines increase the rate of diastolic depolarization and decrease the threshold potential. β-adrenergic receptor blockade via e.g. propranolol reduces the effects of catecholamine activity and facilitates suppression of electromechanical escape.
Administration of this combination therapy produced a significant reduction in heart rate and maximum developed ventricular pressure along with an increase in left ventricular end-diastolic pressure, but did not alter mean arterial pressure. There was no apparent fatigue of this pharmacologic effect after sequential stimulations. The animals used for pilot experiments appeared to tolerate this pharmacologic regimen without other adverse hemodynamic side effects, such as acidosis.
The short-term hemodynamic effects of a single prolonged stimulation were found to be substantially insignificant. Likewise the metabolic consequences as detected by pH and changes in base deficit were insignificant.
The pharmacologic regimen used in this investigation sustained the period of vagal-induced asystole for about sixty seconds. This interval would allow more than sufficient time for construction of a distal CABG anastomosis. Animals followed for two hours after administration of drugs displayed responses to vagal stimulation similar to those in the non-drug treated state, confirming reversibility of the drug effects.
An untoward effect of the pharmacologic regimen which requires consideration before clinical application is vagal-induced secretions. All animals displayed significant salivation after initiation of vagal stimulation. However, there were no problems with oxygenation and ventilation due to tracheobronchial secretions in these experiments. Vagal-induced oropharyngeal and tracheobronchial secretions are pertinent in the clinical setting. Additionally, the effects on recurrent laryngeal nerve function require consideration.
Evidence suggests that the long-term effects of this regimen on the vagus nerve are not harmful. Chronic vagus nerve stimulation has been utilized as therapy for intractable seizure disorders without apparent nerve injury or impaired function. Applicants have shown that vagal-mediated chronotropic control at two hours after completion of the experimental protocol was similar to the non-drug treated state.
In summary, controlled intermittent asystole can be achieved by potentiation of vagal-induced asystole via a pharmacologic combination of e.g, propranolol and verapamil for suppression of electromechanical escape and e.g, pyridostigmine for acetylcholinesterase inhibition. Asystole can be reproducibly achieved for prolonged intervals and for shorter multiple sequential intervals using this technique.
Nerve Stimulation
To achieve consistent asystole, applicants have found that nerve stimulation of the right vagus nerve before or after treatment with the pharmacological combinations of the present invention is preferred.
Electrical stimulation is carried out on the right vagus nerve, preferably at a site on the neck. Other suitable locations for vagus nerve stimulation include, but are not limited to, unipolar or bipolar electrical stimulation of the right or left vagus, or both, stimulation of the vagus in the chest after sternotomy, stimulation with a percutaneous catheter or electrode probe in the internal jugular vein, esophagus, or trachea, or combination of these. The nerve stimulator is typically a Grass wire with a single point of contact, but other suitable stimulators include a pair of pacing wires or electrodes placed about 1 cm apart to allow bipolar prodromic stimulation. A single continuous impulse is applied of between about 5 seconds to about 90 seconds, preferably between about 5 seconds and about 15 seconds, to allow a single stitch during surgery. Impulse parameters can readily be varied, e.g, a frequency range of between about 1 Hz and about 500 Hz, preferably between about 20 Hz to about 80 Hz, more preferably about 40 Hz, with an amplitude between about 1 to about 40 volts.
Pharmacologic Potentiation
The acetylcholinesterase inhibitor is also known as a cholinesterase inhibitor. Suitable acetylcholinesterase inhibitors include, but are not limited to tacrine hydrochloride, pyridostigmine bromide, neostigmine methylsulfate, and edrophonium chloride. One preferred acetylcholinesterase inhibitor is pyridostigmine bromide. Acetylcholinesterase inhibitors are administered in a dosage range between about 0.01 mg/kg and about 100 mg/kg, preferably between about 0.1 mg/kg and about 2.0 mg/kg, more preferably about 0.5 mg/kg.
The beta-adrenergic receptor blocker is also known as a beta-adrenergic blocking agent. Suitable beta-adrenergic receptor blockers include, but are not limited to, sotalol HCl, timolol maleate, esmolol hydrochloride, carteolol hydrochloride, propranolol hydrochloride, betaxolol hydrochloride, penbutolol sulfate, metoprolol tartrate, acetbutolol hydrochloride, the combination of atenolol and chlorthalidone, metoprolol succinate, pindolol, and bisoprolol fumarate. One preferred beta-adrenergic receptor blocker is propranolol hydrochloride. Beta-adrenergic receptor blockers are administered in a dosage range between about 0.01 mg/kg and about 100 mg/kg, preferably between about 0.1 mg/kg and about 2.0 mg/kg, more preferably about 80 μg/kg.
Suitable calcium channel blockers include, but are not limited to, nifedipine, nicardipine hydrochloride, diltiazem HCl, isradipine, verapamil hydrochloride, nimodinpine, amlodipine besylate, felodipine, bepridil hydrochloride, and nisoldipine. One prefererred calcium channel blocker is verapamil hydrochloride. Calcium channel blockers are administered in a dosage range of between about 0.001 mg/kg to about 1 mg/kg, preferably between about 0.01 mg/kg and about 0.2 mg/kg, more preferably about 50 μg/kg.
It will be understood that other dosage combinations may be effective. The appropriate dosage is determined by the age, weight, sex, health status of the patient, and may vary with a variety of other factors according to conventional clinical practice.
EXAMPLE 1
Experimental Preparation
The sheep in the examples of the present invention received humane care in compliance with “Principles of Laboratory Animal Care” formulated by the National Society for Medical Research and the “Guide for Care and Use of Laboratory Animals” prepared by the National Academy of Sciences and published by the National Institutes of Health (NIH Publication No. 80-23, revised 1985). The experimental protocol was approved by the Institutional Animal Care and Use Committee of Emory University.
Seven sheep weighing 44 to 45 kg were premedicated with xylazine (0.1 mg/kg) and atropine (0.2 mg/kg) 30 minutes prior to induction of anesthesia with intravenous thiopental (2.2 mg/kg) and lidocaine (2.2 mg/kg). The animals were endotracheally intubated and placed on a volume ventilator with isoflurane for maintenance of anesthesia. Limb leads and precordial lead were placed for electrocardiographic monitoring. The right femoral artery was cannulated for arterial pressure and arterial blood gas monitoring. Tidal volume was adjusted to 10 cc/kg and a rate of 12 breaths per minute, with adjustments made to maintain pH at 7.35-7.45, pO2 greater than 100 mm Hg, and pCO2 between 35-45 mm Hg.
A right cervical incision was performed, the vagus nerve was carefully isolated, and a nerve stimulation probe (Harvard Apparatus, South Natick, Mass.) was placed on the nerve. A median sternotomy was made to expose the heart. A high-fidelity solid-state micromanometer (Millar Inc, Houston, Tex.) was secured in the ascending aorta for aortic blood pressure monitoring. An additional micromanometer was introduced into the left ventricle through the apex for left ventricular pressure monitoring.
EXAMPLE 2
Experimental Protocol
Each animal underwent vagal stimulation before and after drug administration. The pharmacologic regimen consisted of pyridostigmine (0.5 mg/kg) for acetylcholinesterase inhibition, propranolol (80 μg/kg) for β-adrenergic receptor blockade, and verapamil (50 μg/kg) for calcium channel blockade. Vagal stimulation was performed with a nerve stimulator (Grass Instrument Co, Quincy, Mass.) in the monopolar mode at a frequency of 40 Hz, an impulse duration of 0.4 msec, and an amplitude of 2-6 volts. Vagal stimulations were delivered in two regiments: 1) continuous 60 second impulse and 2) sequential 15 second impulses. The continuous 60 second stimulation was designed to determine the longevity of vagal-induced asystole and the physiologic effects of prolonged vagal-induced hypotension. Sequential 15 second vagal stimulations were performed to simulate the suturing intervals required for graft anastomoses and to determine whether cardiac fatigue, electromechanical escape, and physiologic effects occurred under these practical conditions.
EXAMPLE 3
Data Acquisition and Analysis
Electrocardiographic and hemodynamic data were gathered via an analog-to-digital conversion board (Data Translation, Inc, Marlboro, Mass.) and processed, stored, and analyzed via a microprocessor personal 486 computer (Compaq Computer Corp, Houston, Tex.) using interactive proprietary software (Spectrum™, Triton Technology, San Diego, Calif.). The system was configured to collect 4 channels of physiologic data at a frequency of 50 Hz (sufficient for slow-wave waveforms and mean pressure data) over a 200 second period that encompassed the 60 second stimulation or the sequential 15 second train of stimulations. The software allowed subsequent videographic display and analysis of the hemodynamic data.
EXAMPLE 4
Results
Before drug administration, vagal stimulation for 60 seconds produced a brief pause in electromechanical activity (1.6±0.9 seconds) followed by vagal escape and resumption of sinus rhythm with a reduction in heart rate by 19.4±11.9% compared to pre-stimulation heart rate. Similarly, sequential 15 second vagal stimulation performed to stimulate the suturing intervals required for CABG anastomoses produced a short pause (1.1±0.4 seconds) followed by vagal escape and sinus rhythm with a reduction in heart rate of 37±6%.
Administration of the pharmacologic regimen (propranolol, verapamil, pyridostigmine) reduced the heart rate and increased the left ventricular end diastolic pressure, but did not affect the mean arterial pressure or maximum dP/dt as shown in Table 1.
TABLE 1
Hemodynamics before and after drug treatment
Before drugs
After drugs
p value
(mean ± SEM)
(mean ± SEM)
(paired t test)
Heart rate (bpm)
114 ± 4
87 ± 4
0.002
MAP (mm Hg)
84 ± 5
84 ± 5
NS
dP/dt max
3286 ± 232
2847 ± 140
NS
(mm Hg/sec)
LVEDP (mm HG)
3.9 ± 0.5
7.3 ± 0.9
0.005
bpm - beats per minute; dP/dt max - maximum developed left ventricular pressure; LVEDP - left ventricular end diastolic pressure; MAP - mean aortic pressure; NS - not significant; SEM - standard error of the mean; sec - seconds.
After drug administration, 60 second vagal stimulation produced asystole averaging 52±5.6 seconds. The individual responses of the animals before and after drug administration are shown in FIG. 1 . Six animals achieved controlled asystole. Five of these six achieved controlled asystole for greater than 50 seconds. The effects of 60 second vagal stimulation before and after drug treatment in responsive animals are contrasted by representative left ventricular and aortic pressure tracings are shown for a representative experiment in FIG. 2 . Before drug regimen treated, vagal stimulation produced no appreciable change in cardiac rhythm or hemodynamics. In contrast, the triple drug regimen facilitated a consistent asystole and circulatory arrest until the stimulus was withdrawn, after which hemodynamics were rapidly restored to pre-stimulation values. The prolonged asystole and circulatory arrest produced no significant differences in the hemodynamic parameters measured before and after drug-aided 60 second vagal stimulation (Table 2).
TABLE 2
Hemodynamics pre- and post-asystole produced
by 60 second stimulation after drug treatment
Pre-asystole
Post-asystole
p value
(mean ± SEM)
(mean ± SEM)
(paired t test)
Heart rate bpm)
91 ± 8
87 ± 7
NS
MAP (mm Hg)
86 ± 6
92 ± 6
NS
dP/dt max
3032 ± 182
3223 ± 212
NS
(mm Hg/sec)
LVEDP (mmHg)
5.8 ± 1.0
6.0 ± 0.8
NS
bpm - beats per minute; dP/dt max - maximum developed left ventricular pressure; LVEDP - left ventricular end diastolic pressure; MAP - mean aortic pressure; NS - not significant; SEM - standard error of the mean; sec - seconds.
Likewise there was no difference in the parameters measured by arterial blood gases at one and five minutes after the 60 second stimulation compared to pre-stimulation values (Table 3).
TABLE 3
Arterial blood gas data pre-, 1 minute post-, and 5
minutes post-systole produced by 60 second stimulation after drug
treatment
Post-asystole
Pre-asystole
1 minute
5 minutes
(mean ±
(mean ±
(mean ±
p p value
SEM)
SEM)
SEM)
(ANOVA)
pH
7.42 ± 0.03
7.40 ± 0.03
7.42 ± 0.03
NS
PCO 2
41 ± 4
42 ± 4
40 ± 4
NS
(mm Hg)
PO 2
377 ± 87
380 ± 75
390 ± 83
NS
(mm Hg)
HCO 3
26 ± 1
26 ± 1
26 ± 1
NS
(mEq/L)
Base excess
1.2 ± 0.7
1.0 ± 0.4
1.3 ± 0.5
NS
(mEq/L)
ANOVA - one-way analysis of variance with repeated measures; NS - not significant; SEM - standard error of the mean.
Five to six sequential 15 second vagal stimulations in the drug treated state produced consistent and stable asystole (FIG. 3 ). Three of the six animals had a single escape beat during one of the 15 second stimulations. The other three displayed complete asystole during each of the 15 second stimulations. A sustained cardiac rhythm began an average of 5.3±1.8 seconds after termination of each 15 second impulse during which interval a single beat was often observed immediately after withdrawal of stimulation.
While the foregoing specification teaches the principles of the present invention, with examples provided for the purpose of illustration, it will be understood that the practice of the invention encompasses all of the usual variations, adaptations, and modifications, as come within the scope of the following claims and its equivalents.
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A method for indirectly stimulating a vagus nerve of a patient includes the steps of positioning one or more electrodes in the vicinity of the vagus nerve and then actuating the electrode(s) to create an electrical field for stimulating the vagus nerve. Disclosed embodiments include positioning one or more electrodes in the esophagus, trachea, or jugular vein, on the neck of the patient, and combinations thereof.
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BACKGROUND OF THE INVENTION
This invention relates to a device for testing the performance of respiratory protective devices, e.g. self-contained breathing apparatus. More particularly, this invention relates to a device for automatically performing tests on the critical functions of self-contained breathing apparatus without disassembly, with no special tools and without specially trained personnel.
Supplied air respirators are often worn by workers when exposed to highly toxic or oxygen deficient atmospheres. A self-contained breathing apparatus (SCBA) is a type of supplied air respirator. The most widely used type of SCBA supplies breathing air from a compressed air cylinder to the user.
A typical SCBA consists of the air cylinder, a first stage regulator which lowers the air pressure to approximately 120 psi, a chest mounted pressure gauge which enables the user to check his remaining air supply, a demand valve which supplies air in response to the user's inhalation, a face mask, and a warning device which alerts the user that only a fraction of his air supply is remaining.
There are many types of respiratory protective devices which utilize an airline running between a source of quality breathing air to the user.
In about 1970, a significant improvement was made in respiratory protective devices, with the introduction of positive pressure. The demand regulator was modified to continuously maintain a slight positive pressure (about 1 inch water column) in the facepiece. The idea was that all leakage would be outward from the facepiece, preventing inward leakage of contaminants.
For many years the performance of respiratory protective devices has been controlled by the U.S. Bureau of Mines, and more recently, by the National Institute for Occupational Safety and Health (NIOSH). For any respiratory protective devices to be used or sold in the United States, certain design and performance criteria must be met. These criteria include breathing resistance, and in addition for SCBA, pressure gauge accuracy, remaining service life indicator accuracy and service duration.
In order to perform the most critical of these tests, breathing resistance, an instrumented breathing machine is used. This machine consists of a test head connected to a piston assembly which functions as an artificial lung. As the piston moves in and out, exhalation and inhalation are simulated. The rate of piston movement is governed by a test curve which simulates human breathing. A pressure transducer is connected to the test head and data is recorded for all cylinder pressures.
There have been other ways to test the performance of SCBA in the field. The most common method is the use of a "regulator tester". This device measures the maximum flow which a regulator can deliver in the constant flow condition. While this and other similar tests can indicate a gross malfunction, it is not truly indicative of the performance required in actual use. Moreover, no testing devices are presently available for testing all vital functions of SCBA in a manner similar to actual use and which will give accurate and dependable results.
SUMMARY OF THE INVENTION
The above-described and other problems and deficiencies of the prior art are overcome or alleviated by the device for testing self-contained breathing apparatus of the present invention. In accordance with the present invention, automated test equipment is provided that performs quantitive tests and operational checks on respiratory protective devices including self-contained breathing apparatus. The present invention is intended to be used by SCBA end-users to assure that their SCBA equipment in the field meets and continues to meet accepted performance standards. The present invention includes a breathing-machine mode which can test any respiratory protective device.
The testing device of the present invention is comprised of a bench-top instrument cabinet containing electronic, electro-mechanical, and pneumatic components, a test head with the likeness of human form attached on top of the instrument cabinet, a detachable computer keyboard, and a pneumatic manifold and hose assembly. With the present invention, a layman operator can determine the readiness of the SCBA equipment for service. The present invention can also be used as a diagnostic tool during maintenance procedures.
The testing device of the present invention can test the breathing resistance on any type of respiratory protective device such as airline respirators, air purification masks and devices, and escape hoods.
In addition, the testing device of the present invention can test all vital functions of SCBA in a manner similar to actual use. At the conclusion of the tests, a hardcopy of the results are printed for permanent record keeping.
Significantly, at least the following tests can be performed at all tank pressures while consuming only a fraction of tank air capacity:
1. MASK LEAK CHECK--The presence of leaks in the facemask can be determined.
2. STATIC MASK PRESSURE--The steady-state pressure in the facepiece can be measured and displayed.
3. HI PRESSURE LEAK CHECK--Leaks in the air delivery system can be detected.
4. PRESSURE GAGE ACCURACY CHECK--Accuracy of the tank and chest-mounted pressure gauges can be determined.
5. REMAINING SERVICE LIFE INDICATOR ACCURACY--Low pressure warning system can be checked.
6. BREATHING RESISTANCE--Pressure in the facepiece can be measured at operating conditions simulating various workrates. Conformance to accepted standards is determined.
The above-discussed and other features and advantages of the present invention will be appreciated and understood by those skilled in the art from the following detailed description and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Referring now to the drawings, wherein like elements are numbered alike in the several Figures:
FIG. 1 is a perspective view of a SCBA testing device in accordance with the present invention;
FIG. 2 is a perspective view of the testing device of FIG. 1 showing the interior components thereof;
FIG. 3 is a perspective view of self-contained breathing apparatus attached to the test head of the SCBA testing device of FIG. 1;
FIG. 4 is a cross-sectional elevation view of a manifold used in conjunction with the SCBA testing device of FIG. 1;
FIG. 5 is a diagrammatic view of the SCBA testing device of FIG. 1 showing the interface between the electronics and the pneumatic/electro-mechanical components;
FIG. 6 is a schematic view of the electronic components of the SCBA testing device of FIG. 1;
FIG. 7 is a perspective view of a detachable keyboard for use with the device of FIG. 1;
FIGS. 8-19 are flow charts of the computer program utilized in conjunction with the present invention;
FIGS. 20A-C are printed records of test results obtained from the present invention; and
FIG. 21 is a printed record of other test results obtained from the testing device of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring first to FIGS. 1 and 2, a self-contained breathing apparatus (SCBA) testing device in accordance with the present invention is shown generally at 10. Testing device 10 comprises four major components including a test head, breathing simulator (bellows mechanism), pressure-reducing manifold and electronics.
Still referring to FIGS. 1 and 2, a human form test head 12 is attached to the top of a cabinet or enclosure 14. It will be appreciated that during all phases of testing the performance of the SCBA, the facemask (see FIG. 3) of the SCBA is attached to test head 12. Head 12 has a breathing passageway 16 leading from the base of the neck 18 to an opening in the mouth 20. SCBA facemask pressure is measured by means of a static pressure port 22 located in the left eye of head 12. A tube 24 is connected to pressure port 22 and brings the facemask pneumatic signal to a differential pressure transducer 26 in the electronics enclosure 14.
A breathing simulator means provides air movement to the SCBA to simulate worker respiration. The breathing simulator means preferably comprises a bellows assembly including a bellows 28 (preferably having an effective inner diameter of 9 inches) which is associated with DC servo bellows drive 30 and linkage 32 therebetween. As shown in FIG. 1, the top of bellows 28 is sealed to the base 34 of test head 12 with the opposing end (bottom) of bellows 28 being capped by a circular baseplate (not shown). Bellows drive 30 is preferably a 20 RPM 100 ounce-inch DC gear motor which is connected to the baseplate of the bellows by a bell crank 32 which acts to move bellows 28 in a reciprocating motion. A DC power supply 36 is provided within cabinet 14 for supplying power to gear motor (bellows drive) 30.
Turning now to a joint consideration of FIGS. 1-4, and particularly FIG. 3, a well-known self-contained breathing apparatus is shown attached to test head 12 of SCBA testing device 10. The SCBA comprises an air cylinder 38 with associated valve 40, a first stage regulator 42 which lowers the air pressure in the tank to approximately 120 psi, a pressure gauge 44 which enables the user to check the remaining air supply, a demand valve 46 which supplies air in response to the user's inhalation, a face mask 48 and a low air warning device 50 which alerts the user that only a fraction of the air supply remains. Also, a pair of hoses 52 and 54 transfer the air supply between first stage regulator 42 and pressure gauge 44 and low air warning device 50, respectively. Another hose or conduit 56 is provided between a manual bypass 57 attached to valve 46 and the housing 59 for pressure gauge 44 and low air warning device 50.
It will be appreciated that the foregoing description of the SCBA components depicted in FIG. 3 is well known to those skilled in the art. It will also be appreciated that there is a need for a quick, efficient, reliable and accurate means of testing an SCBA such as is shown in FIG. 3 prior to it being used in the typically dangerous environments where it must be worn. Important tests which should be conducted on SCBA equipment to insure its reliability include (1) the presence of leaks in the facemask; (2) leaks in the air delivery system (i.e., various hoses 52, 54 and 56); (3) accuracy of the tank and chest mounted pressure gauges; (4) a check of the low pressure warning device 50; and (5) ensuring that the pressure in the facemask conforms to accepted standards. All of these various tests can be performed by the SCBA testing device of the present invention. In order to effect some of the tests however, a pressure-reducing manifold assembly 58 must be connected between valve 40 of tank 38 and first stage regulator 42 (normally regulator 42 is directly connected to valve 40).
The manifold assembly 58 comprises a manifold 60 (see FIG. 4) having a hose 62 extending therefrom and attached to a high pressure manifold transducer 64 located within enclosure 14 (see FIG. 2). As shown in FIG. 4, manifold 60 includes a cylindrical housing having an opening 66 therethrough with a female pneumatic fitting 68 to accept the fitting on valve 40 of tank 38, a critical-flow orifice 70 associated with opening 66, a pressure transducer fitting 72 (having hose 62 attached thereto) received in bore 65 downstream of orifice 70, and a male pneumatic fitting 74 which accepts a female fitting on regulator 42. The various male and female connectors 68 and 74 are standard commercially available fittings. Hose 62 connects manifold 60 to manifold pressure tranducer 64 in enclosure 14. Preferably, transducer 64 includes a quick-disconnect fitting to facilitate tool-free setup.
As will be discussed in more detail with regard to the operation of the present invention, manifold assembly 58 is important as it allows testing of SCBA to be conducted at selectable simulated tank pressures. The relative diameters of the opening 66 and critical orifice 70 are important in obtaining this result. Preferred diameters of opening 66 are 0.440 inch while orifice 70 are 0.005 inch for 2250 psi SCBA; 0.003 inch for 4500 psi SCBA. An important feature of this invention is that the total volume of hose 62 and opening 66 is about 0.09 liters for low pressure (2250 psi SCBA) and about 0.045 liters for high pressure (4500 PSI).
Referring simultaneously now to FIGS. 1, 2, 4 and 5, the electronic components of the testing device of the present invention will now be discussed. The electronics include a computer circuit board 76 which is preferably 8 bit and comprises a microprocessor 78 (6809E), Random access memory 80 (16,384 bytes), video display generator IC 82, keyboard scanning peripheral interface adapter 84 and power supply circuits 86.
The computer main board 76 is interconnected to several other electronic components. Video display generator 82 is connected to a computer video monitor 88 comprising a monochrome screen having a 9 inch diagonal measurement. The monitor is provided to present menus and to display acquired data to the user. The computer 76 and monitor 88 are capable of displaying 256 dots horizontally and 192 dots vertically. As shown in FIG. 1, two monitor adjustment knobs 90 are provided to control the image on the screen.
Also connected to computer main board 76 is a 16 key operator's keypad 92. This keypad includes the numbers 0 through 9, "Alarm", "Enter", "Yes", "No", "Right Arrow", "Left Arrow", "Paper" and "Help" buttons thereon.
The computer interface board 94 interfaces the computer main board 76 with various other components as is clearly shown in FIGS. 5 and 6. Interface board 94 includes the data, address and control bus buffer circuitry. Specifically, interface board 4 comprises 131,072 Bytes Erasable Prog Read Only Mem 96, 2048 Bytes Elec. Erasable Prog. Read Only Mem 98, 12 bit 35 Microsecond A/D Converter 100, 4 Channel Analog Signal Multiplexer 102, Sample-Hold Amplifier 104, 40 Column Impact Printer Drive Circuitry 100, 3 Channel 16 Bit Re-Loadable Counter/Timer I.C. 102, Four Quadrant Power MosFet PWM Servo Amplifier 104 and Servo Amplifier Over-Current Detector and Interrupt Latch 106.
A computer interface power supply 108 (+15 volts @ 0.4 Amp; -15 volts @ 0.4 Amp; and +5 volts @ 2.0 Amp) supplies power to computer interface board 94. As mentioned, a servo motor power supply 36 (+15 volts @ 6 Amps) supplies power to the servo motor 30.
A printer mechanism 112 is provided in enclosure 14 for printing out a ticket (printed record) with the testing results (see ticket 113A-C and 115 in FIGS. 20 and 21 respectively). Printer 112 is preferably a 40 column dot matrix printer.
As will be discussed in more detail hereinafter, the electronics of the present invention further comprises several sensing means including a previously described pressure transducer 64 (5000 PSIG). Transducer 64 has 0-5000 psi input range; 1 to 6 volts DC output and 1% static error band. As shown in FIGS. 5 and 6, transducer 64 measures the pressure from critical orifice outlet 65 of manifold 60. A second previously described pressure transducer 26 (also located in enclosure 14) measures the pressure in the face mask of the SCBA. Low pressure transducer 26 is a ±/-5 inch water column pressure transducer which has a -5 to +5 inches water input range; 1 to 6 volts output and 1% static error band. A position sensor 116 provides information on the location of servo motor 30 and hence breathing bellows 28. Position sensor 116 is a servo position feedback potentiometer with 10K ohms nominal impedance; 350 deg. nominal electrical travel and 1% linearity.
Finally, a detachable data entry keyboard 118 with connecting cable 120 (see FIG. 7) can be connected to the present invention via a front panel connector. Detachable keyboard 118 is used during initial set-up of the device to enter SCBA information and user information.
Software for the present invention is contained in the 128K bytes of EPROM and is written in PASCAL and 6809 Assembly language. High level tasks such as operator interface are implemented in PASCAL and run in the background while timing--critical tasks such as motor control and pressure data acquisition are performed by assembler routines in the foreground under interrupt control. Some software programs are all located together in either memory storage bank 96 or 98 of FIG. 6. Other programs are located separately in either memory storage bank 96 or 98 of FIG. 6. A PASCAL program selects the active memory bank. Software flow charts for the attached computer programs are set forth in FIGS. 8-19. FIGS. 8-11 are flow charts for the initial program sequences including main program (FIG. 8), hardware initialization and auto calibration (FIG. 9), date setting (FIG. 10), and main procedure (menu) selection (FIG. 11). The description of the flow charts in FIGS. 8-11 are clear from the drawing. The flow charts of FIGS. 12-19 will be discussed hereinafter with reference to the description of the testing procedures.
The operation of the testing device of the present invention will now be discussed with particular reference to FIGS. 3-5. Initially, the operation of pressure-reducing manifold 60 will be described.
Manifold 60 is interconnected between the SCBA air cylinder 38 and the SCBA first stage regulator 42 to allow testing to be conducted at selectable simulated cylinder pressures. The operation of manifold 60 is based on the fact that when the velocity of a compressible gas reaches the speed of sound in a restriction, the flow will not be increased by lowering the downstream pressure. Therefore, for a fixed orifice diameter and constant upstream pressure (cylinder 38 pressure), the flow will be constant regardless of the downstream pressure (manifold 60 pressure). To achieve a desired simulated cylinder pressure to conduct testing, the computer commands the bellows to breath at a rate greater than the choked flowrate until the desired pressure is reached. When the breathing rate is returned to the choked flowrate the pressure will be maintained about that point. Breathing rates faster or slower than the choked flowrate will cause the average pressure in the reservoir to fall or climb proportional to the difference. A different size orifice is included with manifolds for 4500 psi and 2250 psi cylinders and each is sized to provide a choked flowrate equivalent to the nominal NIOSH SCBA minimum performance rate of 40 liters per minute.
Turning now to a discussion of the electronics, upon power-up, the microprocessor beings execution of the application software contained in EPROM on interface board 94. The keyboard circuitry, the video display generator and memory decoding circuits on the main board are initialized. The timer/counter, printer circuitry, and the A/D circuitry is initialized on the interface board. The main PASCAL program is then begun and the operator is queried for desired operating modes.
Bellows 28 motion is effected by direct digital position control of DC gear motor 30. The computer senses the voltage of the motor feedback potentiometer 116 and calculates the position of the bellows. A lookup table containing command points of the desired shape breathing curve is accessed and an error is calculated. From the error, a corrective pulse-width is looked up in an error-to-pulse-width table. This process of detecting the actual position and correcting for errors is performed 288 times for each respiration cycle of the machine. Channel 1 of the counter/timer is hard-wired to the non-maskable interrupt. The non-maskable interrupt calls the motor control routine. Channel 1 controls the frequency of the interrupt, the interrupt controls the execution of the control routine. The speed of the bellows can therefore be controlled by adjusting the frequency of channel 1 of the counter/timer. Channel 3 of the counter/timer is programmed as a square wave oscillator with a frequency of 10 kilohertz. The output of channel 3 gates the input of channel 2 which is programmed as a monostable multivibrator (commonly called a one-shot). It is here that the pulse-width-modulated signal originates and can be adjusted on-the-fly periodically by the computer. The PWM frequency is set by channel 3 and is fixed at 10 kilohertz but the pulse width is set by channel 2 and is adjustable. The pulse-width is adjustable from 0 to 100 percent with one percent resolution. The PWM signal is input to a four-quadrant power mosfet H-bridge servo amplifier that controls the direction and speed of the motor.
Pressure data is acquired during the gear motor control routine and the update rate is software selectable up to 320 samples per second.
Test results are recorded on 40 column dot matrix printer mechanism 112. Printer motor current is switched by a power darlington that is enabled by a bit from the peripheral interface adapter on the interface board. Tachometer signals are signal conditioned by a zero crossing detector and are detected by another bit from the PIA. The Another bit from the PIA senses the closure of the carriage return reed switch. The four pin solenoids are actuated by four power darlingtons which are enabled by yet four other bits from the PIA. The microprocessor controls all timing and data calculations.
DATA STORAGE
Information about authorized users and SCBA can be stored in the test system of the present invention (see PASCAL procedure). Users' name, identification number, and company or affiliation may be entered on detachable keyboard 118 and stored permanently in the non-volatile (contents retained with power removed) memory of the device. The make, model, and pressure rating (2250 or 4500 psi) of SCBA normally to be tested by the users on the present invention may be entered permanently into the memory. The data may be changed at any time by attaching the data entry keyboard. The present invention is normally operated without the data entry keyboard attached. Data input to the computer is from the 18 key keypad 92 on the system front panel. A user identification number entered by the operator is checked against authorized users stored in memory. The operator inputs his name and company as well as the date and then selects SCBA type from a menu that is created from SCBA type entries in memory. For example, in FIG. 21, printout 115 shows the SCBA equipment being tested is SURVIVAIR, MARK II HP, Serial No. 77. The equipment is being tested by Jack Burt of BIOSYSTEMS on Apr. 15, 1987.
TEST DESCRIPTIONS
The following is a description of the tests that the present invention is capable of performing on respirator protective devices and SCBA. For all tests, it is assumed that the cylinder of air is nominally full and that the breathing gear is properly attached to the test head. For all tests except Breathing Machine Mode, it is assumed that pressure-reducing manifold 60 is interconnected between the breathing gear and the air cylinder.
A. BREATHING MACHINE MODE
The present invention is capable of testing the breathing resistance of any type of respiratory protective device which includes a respiratory inlet cover (e.g., face mask). Pressure in the respiratory inlet cover is measured while the breathing machine simulates the respiration of a man engaged in light, moderate, or heavy work. The pressure-reducing manifold is not interconnected between the SCBA and the cylinder for this testing procedure. The user selects the workrate and length of time the test is to run. For the following discussion, refer to the software flowchart "POSICHEK BREATHING MACHINE MODE" (FIG. 12).
The test begins with the user opening the cylinder valve and entering in desired workrate and desired test duration. Available work rates are light (24 respirations/minute, 40 liter-minute volume), moderate (28 resp/min volume, 70 liter-minute volume) and heavy (32.2 resp/min, 100 liter-minute volume). The test duration is selectable from 6 seconds to 6 hours.
The lung is positioned at the beginning of the inhalation stroke and a delay of one second is allowed for system transients to decay. The machine is then commanded to breathe at the selected rate while respiratory inlet cover pressure is acquired and plotted on the graphics screen. Respiratory inlet cover (e.g., mask) pressure (inches water) is plotted on the y-axis while time in the appropriate units is plotted on the x-axis. The test is terminated when the selected time has expired.
No determination is made by the present invention as to the acceptability of the data, however, the accepted limits of 3.5 and 0 inches water column are noted on the graph by dotted lines. It is left up to the user to ascertain the acceptability of the acquired data.
Following the conclusion of the test, the graph may be printed on the 40-column printer. Examples of the test results for standard work rates, hard word rates and maximum work rates are shown at 113A, 113B and 113C in FIGS. 20A-C, respectively.
B. SCBA TESTS
A software flowchart for the several tests which can be performed by the present invention is presented in FIG. 13. Also, reference should be made to FIG. 21 for a print out obtained from printer mechanism 112 showing the test results for the several testing procedures.
1. MASK LEAK
The presence of leaks in the facepiece can be determined. For the following discussion, reference should be made to the 10 software flowchart "POSICHEK MASKCHEK" (FIG. 14).
With the cylinder valve 40 closed, the lung is commanded to inhale, causing a vacuum to develop in the facepiece. When a pressure equal to 5 inches water column below atmospheric pressure is reached, the lung is halted and the pressure (vacuum) decay is measured. If the pressure is 0.1 inches water column or more below atmospheric pressure at the end of 5 seconds, the facepiece is considered to be free of significant leaks.
2. STATIC MASK PRESSURE
The steady-state (positive) pressure in the facepiece can be measured and displayed. For the following discussion, refer to the software flowchart "POSICHEK STATIC MASK PRESSURE CHECK" (FIG. 15).
The SCBA is exercised for 2 respirations at 24 respirations per minute and a 40 minute-liter volume. After a delay of 2 seconds to allow system transients to decay, the facepiece pressure is acquired. A static mask pressure greater than 0 and less than 1.5 inches water column is considered acceptable.
3. HI PRESSURE LEAK CHECK
Leaks in the air delivery system can be detected. For the following discussion, refer to the software flowchart "POSICHEK HIGH PRESSURE LEAK CHECK" (FIG. 16).
The cylinder valve 40 is opened and the breathing gear and pressure-reducing manifold 60 are allowed to charge up to the cylinder pressure. The operator is then prompted to close the cylinder valve 40 and the manifold pressure is acquired. Following a delay of 5 seconds, the manifold pressure is again acquired. If the pressure in the system decayed less than 200 psi in the 5 seconds, then the high pressure leaks are considered to be negligible.
4. BREATHING RESISTANCE
Pressure in the facepiece is measured while the breathing machine simulates the respiration of a man engaged in light, moderate and heavy work rates as discussed in the description of the Breathing Machine Mode. Testing is performed at simulated cylinder pressures of nominally full to 20 percent of nominally full. For the following discussion, refer to the software flowchart "POSICHEK BREATHING RESISTANCE CHECK" (FIG. 17).
The test begins by charging the breathing gear and pressure-reducing manifold to the cylinder pressure. The lung is moved to the beginning of the inhalation stroke and a delay of one second is allowed for the system transients to decay. The machine is commanded to breath while mask data is acquired and plotted on the screen. The x-axis of the graph contains manifold pressure (psi) while the y-axis contains mask pressure (inches water). Since the machine is flowing through the critical orifice 70 in the manifold 60, the pressure in the manifold slowly drops. The machine continues to breathe and data is acquired and plotted until the manifold pressure drops to 20 percent of a nominally full cylinder.
The performance of the SCBA is considered acceptable if the mask pressure remains positive but less than 3.5 inches water column with respect to atmospheric pressure.
At the conclusion of the test, the graph may be printed on the 40 column printer as shown in FIG. 21.
5. PRESSURE GAGE ACCURACY
Accuracy of the chest-mounted pressure gauge is determined by comparing the gauge indication with pressure transducer 64. For the following discussion, refer to the software flowchart "POSICHEK PRESSURE GAUGE CHECK" (FIG. 18).
The test beings with the charging of pressure reducing manifold 60 to the cylinder pressure. The operator is prompted to close the cylinder valve 40 and the breathing machine is commanded to "breathe down" the pressure in the manifold to a random pressure between 3/8 and 3/4 of a nominally full cylinder. The operator is prompted to enter the indication of the chest-mounted pressure gauge into keyboard 92. The gauge is considered to be of adequate accuracy if agreement with transducer 64 is within 5 percent of a nominally full cylinder.
6. REMAINING SERVICE-LIFE INDICATOR
The cylinder pressure at which the remaining service life indicator becomes active is verified to be within 20 and 25 percent of the pressure of a nominally full cylinder. For the following discussion, refer to the software flowchart "POSICHEK ALARM CHECK" (FIG. 19).
The test begins by charging the pressure reducing manifold 60 to the cylinder pressure. The cylinder valve 40 is closed and the breathing machine is commanded to breathe at the nominal workrate. The operator depresses the "ALARM" button on the keyboard 97 when the remaining service life indicator is heard. At the instant that the "ALARM" button is pressed, the manifold pressure is acquired by the system. The condition of the remaining service life indicator is considered acceptable if the acquired pressure is within 20 to 25 percent of a nominally full cylinder.
While preferred embodiments have been shown and described, various modifications and substitutions may be made thereto without departing from the spirit and scope of the invention. Accordingly, it is to be understood that the present invention has been described by way of illustrations and not limitation.
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Automated test equipment is provided that performs quantitive tests and operational checks on respiratory protective devices including self-contained breathing apparatus (SCBA). The testing device is comprised of a bench-top instrument cabinet containing electronic, electro-mechanical, and pneumatic components, a test head with the likeness of human form attached on top of the instrument cabinet, a detachable computer keyboard, and a pneumatic manifold and hose assembly. With the present invention, a layman operator can determine the readiness of the SCBA equipment for service. The present invention can also be used as a diagnostic tool during maintenance procedures.
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CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of co-pending provisional application No. 61/056,000 filed May 25, 2008.
FIELD OF INVENTION
[0002] This invention relates to pattern analysis. This invention relates particularly to methods and devices for detecting and analyzing energy fields emitted by organisms.
BACKGROUND
[0003] All live organisms emit energy fields, referred to herein as vital fields, which are characterized by the organic processes that produce or modify them. There is a significant amount of skepticism surrounding vital fields because no known scientific instruments can detect them. The inability to detect, measure, and describe the energy in a vital field is a problem that inhibits human understanding of biological interactions with the environment.
[0004] A wave in an energy field is considered to comprise four components—electric, magnetic, gravitational and temporal. The electric, magnetic, and gravitational components are orthogonal to each other. In an electromagnetic wave, the gravitational and temporal components have a static value, and the electric and magnetic components vary inversely. In this context, a static temporal component equates to time moving forward at a constant rate. In contrast, a vital wave is theorized to contain static electric and magnetic components and dynamic temporal and gravitational components. Such a wave is essentially a longitudinal or compression wave in the space-time fabric. Because vital waves do not have a dynamic magnetic component, they do not induce a current in a conductor. Most known devices rely on such induction and is therefore unable to reliably detect the presence of vital waves or measure or describe them scientifically.
[0005] Kirlian photography, discovered in the early 20th century, can be considered one of the earliest means of analyzing vital fields. Kirlian photography works by driving a photographic plate at high voltage, with a biological specimen resting on the plate. The resulting image left on the film is consistent with the corona discharge pattern of the specimen. Live specimens tend to show a shimmering coronal effect, whereas dead specimens and inanimate objects exhibit a more uniform pattern. The difference is attributed to the live specimen having at least one vital field. It should be noted, however, that Kirlian photography as an indication of vital fields has been met with skepticism, with the results explained away as errors in the experimental process.
[0006] Most vital field detection devices to date have been either a variation of Kirlian high-voltage equipment or low voltage electric field sensors. One device, used to detect pathogens in an organism, places the organism in an electrical field and detects an aura signature of pathogens energized by the field. Another device uses a passive detector that characterizes pulses of charge transfer called charge density pulses through conductive plates placed near the palms of the hands. The decay envelope of the detected pulse train may provide information useful for analysis of the body's chakra regions. However, the data is extracted from a pulse train that does not achieve a steady state, and so the data that can be obtained is limited. Further, the data describing the electric component of present waves would not completely describe the temporogravitational wave because its electric component is static.
[0007] Some detectors, such as electrocardiographs and electroencephalographs, analyze alternating current waveforms detected by electrodes placed on the skin of the test subject. One known device uses contacts on the palms and fingers to detect the physiological signals of the human body supposedly associated with auras. Other detectors introduce an electric current into the electrodes, such as with a galvanic skin response and others, which measure the organism's interaction with the introduced current through physical contact between the organism and the detector. Still other devices use capacitance to measure the interaction, but must be placed extremely close to the organism to be effective. Contact and capacitance based devices suffer significant problems with artifacts caused by the proximity.
[0008] One device capable of detecting the static magnetic component of a wave is the Superconducting Quantum Interference device, or “SQUID.” SQUIDS are highly sensitive, extremely expensive magnetometers. However, SQUIDS only detect the presence of strong waves. A typical vital field generated by an organism has weak vital waves that SQUIDS cannot detect. Further, SQUIDS do not detect the spectral information needed analyze a vital field.
[0009] A detection device that is inexpensive, reliable, and capable of detecting vital fields is needed. Therefore, it is an object of the present invention to reliably detect and analyze vital fields. It is a further object that the vital fields be detected with a device that is relatively inexpensive compared to known devices. It is another object of the invention that the device and method of detection reduces unwanted artifacts by not contacting the organism.
SUMMARY OF THE INVENTION
[0010] The present device is placed in a vital field such that the vital waves in the vital field are conducted into a detector having an avalanche diode and an avalanche initiator. The avalanche diode is preferably an avalanche photodiode (“APD”). The APD is reverse biased and the bias voltage is supplied by a voltage source. The avalanche initiator impacts the avalanche diode with sufficient energy to generate seed electrons for the electron avalanche process. The energy provided by the avalanche initiator to the avalanche diode may be continuous or pulsed. The avalanche initiator is preferably an optical energy source, and most preferably a silicon vertical cavity surface emitting laser (“VCSEL”), but may be a high-electronvolt generator if the avalanche diode is not a photodiode. Preferably, the vital waves are conducted into the active region of the APD through a focusing horn to concentrate the energy.
[0011] Control circuitry provides a first control signal at a first sampling frequency to the detector. The first control signal is chosen to undersample the vital waves from the vital field, which have very high frequency. The first control signal modulates the gain of the avalanche diode. The avalanche initiator provides sufficient energy to the avalanche diode to create free electrons that start the avalanche process. During the period of increased gain, the vital waves from the vital field cause a detectable interference with the electric field in the active region of the avalanche diode, producing a first mixed signal including a first beat frequency that is the difference between the frequency of the vital waves and a high harmonic of the first sampling frequency.
[0012] The first mixed signal is conducted to signal processing circuitry, which filters the signal and applies Fourier transforms. Extraction of the beat frequency from the first mixed signal indicates that the vital waves are present. Then, the control circuitry is adjusted to produce a second control signal and the detection process repeats, producing a second mixed signal with a second beat frequency. The signal processing circuitry uses the first and second beat frequencies to determine the frequency of the vital waves from the vital field. The results of the signal processing are then displayed on a screen. Both the control circuitry and the signal processing circuitry include components that work to limit noise and other artifacts generated during the detection process.
[0013] Through continued use of the device, a reference database is developed to associate vital fields with the organisms, organs, organic material, metaphysical changes, or conditions presumed to generate the vital fields.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a schematic diagram of the present device.
[0015] FIG. 2 is a circuit diagram of the preferred embodiment of the present device.
[0016] FIG. 3 is a circuit diagram of an alternate embodiment of the present device.
DETAILED DESCRIPTION OF THE INVENTION
[0017] FIG. 1 illustrates the present invention, which is a device 10 for detecting and analyzing vital fields. The device 10 is placed in the path of vital waves 19 that are present in the vital field to be detected. The detection process is initiated through a user interface 14 , such as by pressing a button or a designated part of a touch screen that indicates to control circuitry 11 that the process should begin. The control circuitry 11 then generates, as described in detail below, a first control signal having a first sampling frequency, and sends the first control signal to a detector 12 . The control circuitry 11 may also send the first control signal to signal processing circuitry 13 for use in a frequency converter as described below.
[0018] To achieve the desirably high sensitivity of the device 10 , the detector 12 may be substantially enclosed by electromagnetic shielding 15 . The shielding 15 protects the internal components of the detector 12 from unwanted interference by light and other electromagnetic waves. The shielding 15 may be a Faraday cage or other shielding structure. If light-sensitive components are not used, the shielding 15 may be a mesh of conducting material, but preferably the shielding 15 fully encloses the detector's 12 internal components, except that a small opening may be left in the shielding to allow the vital waves 19 to pass into the detector 12 . In the preferred embodiment, this opening is covered by an opaque dielectric material (not shown) that blocks light but allows the vital waves 19 to pass. The dielectric material may be any electrical insulator, including insulating tape such as vinyl, plastic, or polyester tape. Preferably, the dielectric material is black polyester tape.
[0019] The internal components of the detector 12 include an avalanche diode 16 and an avalanche initiator 17 that cooperate to control the parameters of an electron avalanche. The electron avalanche amplifies the signal passing through the avalanche diode 16 by a multiplication factor, known as the gain, which is inversely proportional to the difference between the avalanche diode's 16 breakdown voltage and the voltage applied to the avalanche diode 16 . The vital waves 19 entering the device are detectable at a high gain. The device 10 is therefore configured to drive the gain as high as possible. The gain is limited by the intrinsic resistance of the avalanche diode 16 but preferably the peak gain is at least 20,000 and most preferably about 50,000. The avalanche diode 16 may be any avalanche diode that can achieve this gain range and that has device geometry that allows the vital waves 19 to propagate substantially parallel to the electron avalanche, including a standard avalanche diode, a modified Zener diode, or an APD. The diode may use any suitable semiconducting material, including silicon, germanium, and InGaAs, and may be doped to increase the gain range. The diode may alternatively propagate the signal through an air avalanche, but a semiconducting material is preferable because it will have a much lower impedance than air. Preferably, the avalanche diode 16 is a doped silicon APD. The avalanche diode 16 is reverse biased and a constant voltage is applied to the cathode of the avalanche diode 16 to keep the avalanche diode 16 biased in its linear region. Then, the avalanche diode 16 is modulated to its peak gain as described below.
[0020] The avalanche initiator 17 emits energy that impacts the semiconducting material of the avalanche diode 16 , causing impact ionization and creating seed electrons for the electron avalanche. The appropriate avalanche initiator 17 will depend on the type of avalanche diode 16 used. In the preferred embodiment, the avalanche initiator 17 is an optoelectronic device with low residual intensity noise and sufficient energy to cause impact ionization in the preferred APD. Suitable devices include lasers such as a VCSEL or fiber laser, and light-emitting diodes such as a resonant cavity light-emitting diode (“RCLED”). The avalanche initiator 17 is most preferably a silicon VCSEL. Alternatively, the electron avalanche may be initiated by voltage alone, such as in a standard avalanche diode, and the avalanche initiator 17 may be a generator functioning as a device electrode and capable of applying enough electronvolts to the avalanche diode 16 to prompt impact ionization. Such an avalanche diode 16 may be doped to allow electron avalanche initiation by voltage alone.
[0021] The first control signal is directed to the avalanche diode 16 , where it causes the application of a low voltage to the cathode as described below. This low voltage brings the total voltage at the cathode up to within, preferably, several millivolts of the breakdown voltage of the avalanche diode 16 . The applied voltage significantly raises the operating gain of the avalanche diode 16 as it approaches the breakdown voltage of the avalanche diode 16 . The period of high operating gain is referred to as the high gain period. The low voltage is preferably modulated such that it varies from 0 to between 5 and 10 volts on a sine wave having the first sampling frequency. In the preferred embodiment, the high gain period lasts for between 20 and 50 picoseconds, during which the operating gain is increased from a factor of around 70 to a peak factor of more than 25,000. In the alternate embodiment described below, where a logic level pulse of low voltage is applied to the avalanche diode 16 , the high gain period lasts for as much as 10 nanoseconds, and typically between five and 10 nanoseconds.
[0022] In the preferred embodiment, described in detail below and in FIG. 2 , the avalanche initiator 17 constantly emits energy, most of which impacts the avalanche diode 16 . The amount of energy provided to the avalanche diode 16 is adjustable in order to generate approximately a desired number of seed electrons for the electron avalanche. Preferably, a low average number of seed electrons are generated, and most preferably the impact ionization produces an average of five seed electrons during the high-gain period of the avalanche diode 16 .
[0023] In an alternate embodiment, described in detail below and in FIG. 3 , the first control signal is synchronized to provide a current pulse to the avalanche initiator 17 during the high-gain period of the avalanche diode 16 . The current pulse causes the avalanche initiator 17 to pulse at the first sampling frequency. Each pulse of the avalanche initiator 17 causes an electron avalanche to propagate through the active region of the avalanche diode 16 .
[0024] In either described embodiment, the avalanche propagates so quickly, typically within about 100 picoseconds, that the first sampling frequency is retained in the resulting amplified signal that is emitted from the anode of the avalanche diode 16 . The resulting signal is called the first mixed signal, as described below.
[0025] The vital waves 19 pass into the detector 12 and are incident on the avalanche diode 16 . Preferably, a focusing horn 18 is used to concentrate the vital waves 19 into the active region of the avalanche diode 16 where the electron avalanche process takes place. The focusing horn 18 is made of a conductive material, preferably metal, that will reflect the vital waves 19 due to their static electric component. Suitable metals include brass, copper, and aluminum, but most preferably the focusing horn 18 is brass. The focusing horn 18 is soldered to the shielding 15 to prevent light leaks, and the dielectric material is used to cover the end of the focusing horn 18 inside the detector 12 .
[0026] An electron avalanche requires the presence of a strong electric field in the active region of the avalanche diode 16 . This field is static, assuming no interference and a constant applied voltage, and it has a known strength that is dependent on the intrinsic breakdown voltage of the avalanche diode 16 used. However, the incident vital waves 19 also have a static electric component, which interferes with the electric field in the active region and may advance or retard the avalanche process. In the case where the vital waves 19 have extremely high frequencies, of at least 30 gigahertz and further into the terahertz range, undersampling may be used to determine the frequency. The signal propagated through the avalanche diode 16 has sufficient harmonic content that heterodyning occurs between the vital waves 19 and a high harmonic of the first sampling frequency. As a result, the first mixed signal, carried out of the avalanche diode 16 by the amplified current, contains a first beat frequency that is the difference between the frequency of the vital waves 19 and a high harmonic of the first sampling frequency.
[0027] The first mixed signal is then processed by signal processing circuitry 13 . As described below, the first mixed signal undergoes filtration, optional frequency conversion, and Fourier transformation to extract the desired frequency data. During or after this processing, the control circuitry generates a second control signal having a second sampling frequency and sends it to the detector 12 , resulting in a second mixed signal having a second beat frequency. The second mixed signal is also processed by signal processing circuitry 13 . The second beat frequency is subtracted from the first beat frequency to obtain the beat frequency shift.
[0028] The harmonic with which the vital waves 19 were heterodyned is determined by dividing the sampling frequency shift by the beat frequency shift. The harmonic number of the first sampling frequency then allows calculation of the observed frequency imparted by the vital waves 19 . The detection process may be repeated with additional sampling frequencies to reduce uncertainties if multiple vital wave 19 frequencies are present.
[0029] The spectral data of the detection process may be formatted and displayed on a screen in the user interface 14 . Further, the spectral data may be compared to records in a reference database to determine if it matches information gathered on known vital fields. In this manner, if it has been determined that certain data previously gathered by the device 10 correlates to, for example, the presence of a blood disease or its precursors, the results of the detection process may be compared to the previously collected data to determine if the scanned person has the same disease or its precursors. Reference databases may be generated for specific plants and animals, and may be used to detect vital fields associated with bodily states and conditions, the presence or absence of diseases, and aspects of other body energies such as chakra or qi.
[0030] Referring to FIG. 2 , the preferred embodiment of the device 10 utilizes a silicon APD 21 . These devices are capable of a very high operating gain, which corresponds to desirably high sensitivity in detecting the weak vital waves in a vital field. However, APDs are also susceptible to significant noise due to their sensitivity. Therefore, the preferred embodiment of the present device endeavors to minimize noise in the circuit using components that filter unwanted signals and maintain low impedance on sensitive elements.
[0031] When the detection process is initiated, a master clock oscillator 28 supplies the master clock frequency to a signal source 55 , which produces the first control signal at the first sampling frequency. The master clock oscillator 28 is preferably a voltage controlled crystal oscillator, allowing the frequency to be controlled by a digital-to-analog converter 29 . Alternatively, the master clock oscillator 28 may be a frequency synthesizer. The signal source 55 is a frequency synthesizer. The signal source 55 sends the first control signal into the detector 12 .
[0032] Within the detector 12 , a pulse buffer 25 provides a low impedance drive for the APD 21 bias modulation. The pulse buffer 25 is a transistor amplifier, either discrete or part of an integrated circuit, and is preferably a GaAs monolithic microwave integrated circuit (“MMIC”). Alternatively, a MMIC using a different semiconducting material, or a CMOS inverter, may be used. A pulse inductor 53 performs impedance matching to maximize power transfer to the APD 21 . The pulse capacitor 22 and high-stop capacitor 23 present low impedance on the cathode of the APD 21 . The pulse capacitor 22 also couples a periodic low voltage onto the APD 21 bias. In a typical embodiment, the low voltage modulates in a sine wave having the first sampling frequency and a maximum amplitude of between five and 10 volts, which will sum with a constant high voltage bias to raise the applied voltage to just below the breakdown voltage of the APD 21 . During this modulation, the avalanche gain will peak at over 25,000 for about 35 picoseconds. The voltage source 35 supplies the high voltage bias to the APD 21 . The voltage level is controlled by an external computer processor. The voltage is adjusted to give a fixed current through the bias resistor 36 . The bias resistor 36 also forms a low pass noise filter with the pulse capacitor 22 . The pulse capacitor 22 coupling, low pass filtration, and low impedance together reduce noise contributed by the APD 21 dark current or light leakage in the vicinity of the APD 21 . Modulation of the APD 21 gain also eliminates any potential problems with sensitivity reduction due to the APD 21 gain-bandwidth product, because ejected electrons are more quickly replenished in the active region during periods of low gain. Noise from the dark current, caused by impurities in the APD 21 , is further reduced by keeping the active region of the APD 21 very small.
[0033] The VCSEL 30 has low noise but may be susceptible to temperature or manufacture variation that affects the consistency of emitted light. Therefore, an automatic level control circuit (“ALC”) 51 provides an adjustable current to the VCSEL 30 . The current from the ALC 51 causes the VCSEL 30 to emit a substantially constant amount of light, most of which impacts the APD 21 . Some of the light hits a monitor diode 52 , preferably a PIN diode, that detects the amount of light being emitted and signals the ALC 51 to adjust the current if the amount is outside the range needed to generate the desired average number of seed electrons by impact ionization of the semiconducting material in the APD 21 . In an alternate embodiment using an RCLED as the avalanche initiator 17 , an ALC 51 and monitor diode 52 may not be needed due to the RCLED being much less sensitive to temperature than a VCSEL.
[0034] The fewer the number of seed electrons, the higher the possible avalanche gain and hence, the sensitivity. However, with a sufficiently small number of seed electrons, the quantized nature of electron charge introduces quantization noise which limits the sensitivity. Preferably, at least five seed electrons are generated by an optical pulse, and most preferably exactly five. The signal is multiplied exponentially due to the nature of the electron avalanche process, and this effect is magnified by modulating the high-gain period of the APD 21 . Modulation at the first sample frequency creates harmonics that are beyond the harmonic content of the first control signal.
[0035] Because the APD 21 is biased in the linear region, the avalanche gain is limited by the intrinsic impedance of the APD 21 , including any parasitic reactance associated with the APD 21 . The APD 21 must see a short circuit at high frequencies, particularly between 2 and 3 gigahertz, to minimize this intrinsic impedance and also to eliminate frequencies that are contributed to the mixed signal by the APD 21 geometry. The short circuit is provided by a short-circuit lowpass filter 33 , which has a cutoff frequency of half the first sampling frequency. The short-circuit lowpass filter 33 therefore suppresses the first sampling frequency, preventing overload of the signal processing circuitry. In the preferred embodiment, the short-circuit lowpass filter 33 is a lumped element filter. The baseband DC amplifier 34 and baseband AC amplifier 54 both present a suitable terminating impedance for the short-circuit lowpass filter 33 and set the baseband noise floor after the APD 21 . The baseband DC amplifier 34 is DC coupled and is used if the first mixed signal has a low enough frequency to be passed through an analog-to-digital converter (“ADC”) 47 . The baseband AC amplifier 54 is AC coupled and filters out the DC portion of the first mixed signal if a frequency conversion is needed.
[0036] The first mixed signal, now a baseband signal, may be routed through a frequency converter 50 . This is not a necessary step, but it can provide a more practical realization by allowing a sampling frequency that is much higher than the ADC 47 sampling rate. Because most signals of interest are undersampled, doubling the sampling frequency will produce about a 3 decibel improvement in signal to noise ratio. Within the frequency converter 50 , the first intermediate frequency mixer 40 provides frequency conversion to a first intermediate frequency (“IF”) by mixing the first mixed signal with a signal generated by the first local oscillator 43 . The first local oscillator 43 is preferably a frequency synthesizer that is in phase lock with the master clock oscillator 28 . Preferably, the IF is 916.36 megahertz to allow the use of an inexpensive inline surface acoustic wave (“SAW”) filter for the first IF filter 41 . The first IF filter 41 then provides image rejection in the down-converted signal to improve the performance of a second IF mixer 56 . The second IF mixer 56 converts the first mixed signal to a frequency of 10.7 megahertz to allow the use of a ceramic filter as a second IF filter 57 , which provides high quality noise filtering of the signal. The sampling mixer 42 mixes the IF with a signal from a second local oscillator 44 to convert the first mixed signal down to a suitable range for the ADC 47 sampling rate. The second local oscillator 44 is preferably a frequency divider that takes the master clock signal as an input. The switch 38 is used to bypass the frequency converter 50 . Anti-alias lowpass filter 39 provides anti-aliasing filtering of the baseband first mixed signal when the frequency converter 50 is bypassed.
[0037] With a master clock of 44 megahertz, the second local oscillator 44 signal is 11 megahertz, the first sample frequency is 905.66 megahertz, and the baseband first mixed signal ranges from 0 to 452.83 megahertz. These frequencies are chosen to allow the use of low cost ceramic and SAW filters. Additionally, a sampling frequency at or near 1 gigahertz allows the use of smaller Fourier transforms during signal processing. The smaller transforms account for both random variation in detected frequencies and frequency drift in the signal source 55 . The frequency converter 50 loss is corrected by a converter amplifier 45 . Any out of band noise from the converter amplifier 45 is removed by a converter lowpass filter 46 .
[0038] The baseband signal is digitized by ADC 47 . A Fourier transform computer 48 computes a large fast Fourier transform (“FFT”) to detect the desired signals, such as the first beat frequency, within the baseband signal. After the detection process is run a second time to acquire a second beat frequency, the computer 48 calculates the input frequency. The FFT results are processed and displayed on the screen 49 .
[0039] Referring to FIG. 3 , an alternate embodiment of the device 10 utilizes a silicon APD 21 and a silicon VCSEL 30 . When the detection process is initiated, the master clock oscillator 28 supplies the master clock frequency to a clock frequency divider 27 , which produces the first sampling frequency. The clock frequency divider 27 supplies the first sampling frequency to an asynchronous state machine (“ASM”) 26 that generates a narrow pulse on one edge of the incoming waveform. The ASM 26 is preferably a gate and inverter, generating a first control signal having the first sampling frequency and a pulse length of several nanoseconds. The first control signal is sent into the detector 12 .
[0040] Within the detector 12 , the pulse buffer 25 provides a low impedance drive for the APD 21 bias pulsing. A pulse resistor 24 forms a low pass filter with high-stop capacitor 23 to limit the rate of APD 21 bias change. The pulse capacitor 22 and high-stop capacitor 23 present low impedance on the cathode of the APD 21 . The pulse capacitor 22 also couples a periodic low voltage onto the APD 21 bias. In a typical embodiment, the logic level pulse has a maximum voltage of about 2V, which will raise the biased voltage to just below the breakdown voltage of the APD 21 and raise the avalanche gain from 70 to about 20,000 for several nanoseconds. The voltage source 35 supplies the high voltage bias to the APD 21 . The voltage level is controlled by an external computer processor. The voltage is adjusted to give a fixed current through the bias resistor 36 . The bias resistor 36 also forms a low pass noise filter with the pulse capacitor 22 .
[0041] The time delay circuit 32 produces a time delay to align an optical pulse with the APD 21 high gain period. The time delay circuit 32 is a logic device or a resistor-capacitor circuit chosen to cause the desired delay while retaining the incoming signal frequency. A pulse generator 31 , preferably a regenerative switch, provides a current pulse to the VCSEL 30 on the rising edge of the first control signal. Alternatively, the pulse generator 31 may be a step recovery diode. The pulse generator 31 produces a pulse that is sufficient to cause the VCSEL 30 to emit a very short pulse of light. The duration of the light pulse is made as short as possible while emitting sufficient energy to generate approximately the preferred number of seed electrons in the APD 21 , as described below. For a VCSEL with 3 gigahertz bandwidth, the pulse is preferably in the range of 50-100 picoseconds. The pulse may be even shorter if a fiber laser is used.
[0042] The short circuit of high APD 21 frequencies is provided by short-circuit lowpass filter 33 , which has a cutoff frequency of half the first sampling frequency. In the present embodiment, short-circuit lowpass filter 33 is a lumped element filter. The baseband amplifier 34 presents a suitable terminating impedance for the short-circuit lowpass filter 33 , and sets the baseband noise floor after the APD 21 .
[0043] The first mixed signal, now a baseband signal, may be routed through a frequency converter 50 . Within the frequency converter 50 , intermediate frequency mixer 40 provides frequency conversion to the IF by mixing the first mixed signal with a signal generated by the first local oscillator 43 . In the present embodiment, the first local oscillator 43 is a direct digital frequency synthesizer that tunes from 11.0 to 17.8 megahertz. Preferably, the IF is 10.7 megahertz to allow the use of inexpensive ceramic filters for the first IF filter 41 . In the present embodiment, the first IF filter 41 is a ceramic filter that provides high quality noise filtering of the down-converted signal. The sampling mixer 42 mixes the IF with a signal from a second local oscillator 44 to convert the first mixed signal down to a suitable range for the ADC 47 sampling rate. The second local oscillator 44 is preferably a frequency divider that takes the master clock signal as an input. Switches 37 and 38 are used to bypass the frequency converter 50 at low frequencies if desired. Anti-alias lowpass filter 39 provides anti-aliasing filtering of the baseband first mixed signal when the frequency converter 50 is bypassed.
[0044] With a master clock of 44 megahertz, the second local oscillator 44 signal is 11 megahertz, the first sample frequency is 14.66 megahertz, and the baseband first mixed signal ranges from 0 to 7.33 megahertz. These frequencies are chosen to allow the use of low cost ceramic filters, and the use of low cost CMOS analog switches for frequency mixing. The frequency converter 50 loss is corrected by a converter amplifier 45 . Any out of band noise from the converter amplifier 45 is removed by a converter lowpass filter 46 .
[0045] The baseband signal is digitized by ADC 47 . A Fourier transform computer 48 computes a large fast Fourier transform (“FFT”) to detect the desired signals, such as the first beat frequency, within the baseband signal. After the detection process is run a second time to acquire a second beat frequency, the computer 48 calculates the input frequency. The FFT results are processed and displayed on the screen 49 .
[0046] While there has been illustrated and described what is at present considered to be the preferred embodiment of the present invention, it will be understood by those skilled in the art that various changes and modifications may be made and equivalents may be substituted for elements thereof without departing from the true scope of the invention. Therefore, it is intended that this invention not be limited to the particular embodiment disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.
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A device and method of detecting and analyzing a vital field places an avalanche diode in the path of vital waves in the vital field. The vital waves interfere with the electron avalanche process in the avalanche diode. Control circuitry and an avalanche initiator cause electron avalanches at a known sampling frequency. The interference from the vital waves produces a beat frequency that is output from the avalanche diode. By adjusting the sampling rate by a known amount, a second beat frequency is produced and the beat frequency shift is used to determine the input frequency of the vital waves. The vital waves are very weak and produce frequencies into the terahertz range, so that the input frequency is undersampled by the device. Further, high sensitivity is required and a circuit design is implemented to maximize sensitivity while minimizing noise and other interference that is common to avalanche diode operation.
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TECHNICAL FIELD
[0001] The present invention relates to a powdered medicine dispensing apparatus and a powdered medicine dispensation packaging apparatus using the same. More particularly, it relates to a powdered medicine dispensing apparatus and a powdered medicine dispensation packaging apparatus using the same that may significantly reduce the production cost of equipment to enable a more precise uniform dispensing of the powdered medicine while relying on half-manual work by a worker, allow many distribution operations to be performed easily and speedily, and dispense responsively according to an amount that is dispensed and an amount that is packaged, and a powdered medicine dispensation packaging apparatus using the same.
BACKGROUND OF ART
[0002] In general, medicines are classified into tablet form, capsule form, powdered medicine, liquid medicine and the like.
[0003] These medicines are prescribed by a physician to be taken routinely 1 to 3 times a day depending on the needs of each patient.
[0004] However, of the medicines mentioned above, most tablets, capsules, and liquid medicine may be dispensed easily according to one uniform dose, but due to the characteristic of powdered medicine, a precise machine must be used or a worker must use a specific sized spoon and the like for every single one.
[0005] However, powdered medicine dispensing apparatuses of the prior arts are not precise, and require much time for many distribution operations or the costs are very high, and have a disadvantage that a different machine must be used according to formulation (Patent document 1: Korean granted patent No. 10-0699689, Patent document 2: Korean patent application publication No. 10-2008-0017333).
[0006] Furthermore, in a case of dispensation by hand, the work must be done in a constantly tense state along with skills by hand, causing not only severe stress for workers, but also there is a problem of the dispensation not being done precisely.
DISCLOSURE OF THE INVENTION
Technical Problem
[0007] The present invention has been designed to improve the aforesaid characteristics of the prior arts, and its object is to provide a powdered medicine dispensing apparatus and a powdered medicine dispensation packaging apparatus using the same that may significantly reduce the production cost of equipment to enable a more precise uniform dispensing of the powdered medicine while relying on half-manual work by a worker, allow many distribution operations to be performed easily and speedily, and dispense responsively according to an amount that is dispensed and an amount that is packaged, and a powdered medicine dispensation packaging apparatus using the same.
Technical Solution
[0008] In order to accomplish the above present object, the present invention is configured as follows.
[0009] A powdered medicine dispensation packaging apparatus according to the present invention comprises, a partition means having a frame with a space of predetermined size, that divides the frame horizontally and vertically to form unit cells for powdered medicine to be uniformly distributed; a driving means connected to a vertically partitioning member whereby a vertical spacing of a member is adjusted; a dispensing means arranged under the partition means dispensing divided powdered medicine to split inject into a medicine wrapping paper; and a holding unit supporting the medicine wrapping paper.
[0010] On the other hand, a powdered medicine dispensation packaging apparatus according to the present invention is configured to comprise a partition means having a frame with a space of predetermined size, that divides the frame horizontally and vertically to form unit cells for powdered medicine to be uniformly distributed; a driving means connected to a vertically partitioning member whereby a vertical spacing of a member is adjusted; a dispensing means arranged under the partition means that dispenses divided powdered medicine; a plurality of individual slots whereby the divided powdered medicine dispensed from a powdered medicine dispensing apparatus is moved individually; an upper guide plate supporting the individual slots horizontally; a first horizontal driving unit that moves the individual slots horizontally as it moves horizontally along the upper guide plate; a first vertical driving unit provided at one side of the first horizontal driving unit, that moves the individual slots vertically; a second horizontal driving unit located at a lower part of the first horizontal driving unit, that moves the individual slots which were transferred by the first vertical driving unit, horizontally; an auxiliary slot unit provided under the second horizontal driving unit, which simultaneously opens an upper part of a medicine wrapping paper moving horizontally and injects powdered medicine stored in the individual slots into medicine wrapping paper; a lower guide plate arranged between the second horizontal driving unit and auxiliary slot unit to guide movement of individual slots; and a second vertical driving unit that moves individual slots which moved the lower guide plate, towards the upper guide plate of an upper part.
[0011] And the partition means is configured to have a frame, a plurality of horizontal partition members that divide the frame horizontally, a plurality of vertical partition members that are perpendicular to the horizontal partition members and divide the frame vertically, and a sliding plate arranged at a lower part of the frame, which folds as unit cells partitioned by the horizontal partition members and vertical partition members open and close downwardly and slides.
[0012] Further, a guide groove is formed at a lower part of the partition means whereby the dispensing means is slidably attached and detached.
[0013] And the dispensing means allow a dispensing slot corresponding with horizontal unit cells to be arranged and each vertical unit cell to be slidably attached and detached into a respective divided segment.
[0014] Further, the vertical partition member is configured to have a vertical plate with slots formed to be spaced in correspondence with the horizontal partition member, a perpendicular plate extending perpendicularly at both ends of the vertical plate, an extending plate extending horizontally in a direction opposing each other at the perpendicular plate, and a flat plate extending orthogonally to the extending plate to be connected with the driving means.
[0015] And an upper end of the vertical plate is formed to have an inclined surface in a thickness direction.
[0016] Further, the driving means is configured to have a driving rotary shaft arranged horizontally in a vertical direction to the partition means, that is operated by a handle, a driven rotary shaft arranged at a position facing the driving rotary shaft, a plurality of rotating bodies each coupled to the driving rotary shaft and driven rotary shaft, and a moving member connecting to each of the plurality rotating bodies.
[0017] And the rotary body is arranged in a number corresponding to the vertical partition member of the partition means.
[0018] Further, the rotating bodies increase in diameter towards an outer direction from the shaft.
[0019] And the diameters of the rotating bodies are in proportion to a distance moved horizontally by the vertical partition member connected to each rotating body.
[0020] Further, the powdered medicine dispensing apparatus is configured to further include a horizontal separating plate and a vertical separating plate whereby, out of the unit cells partitioned by the vertical partition members and horizontal partition members, only the unit cells where powdered medicine is injected and partitioned are distinguished and partitioned.
[0021] And the vertical separating plate differs in length according to the position of the horizontal separating plate which is positioned at the horizontal partition means.
[0022] Further, the dispensing means is configured to have a plurality of slots partitioned by the partition means, that enables divided powdered medicine to be dispensed towards the individual slot arranged below, a fixing unit fixing the slot on a belt, a roller and shaft for step-moving the slot vertically, a cover arranged at a lower part of the slot to open and close the lower part as it rotates by a hinge, and a hanging bar extended towards a side of the cover, which is pressed by a pressing bar according to a movement of the slot to open the cover.
[0023] And the individual slot is configured to have a slot storing powdered medicine divided and dropped from the dispensing means, a cover blocking a lower part of the slot, an opening means operating the cover to open and close the lower part of the slot, and a side fixing unit enabling the slot to be guided horizontally by the first horizontal driving unit.
[0024] Further, the opening means is configured to have a hinge rotatably connecting the cover to the slot, a link with a side coupled to the hinge side and a link shaft formed on the other side, a perpendicular bar rotatably connected to the link shaft, a pressing unit installed at an end part of the perpendicular shaft, and a guiding unit guiding the perpendicular bar in a state of being supported on the slot.
[0025] And the first and second horizontal driving units are configured to have a pressing unit pressing the individual slot horizontally, a belt with the pressing unit fixed, and a roller operating the belt.
[0026] Further, the first and second vertical driving units are configured to have a roller coupled to a shaft, a belt rotating by the roller, and a guiding unit coupled to the outer side of the belt, which seats the horizontally transferred individual slot.
[0027] And the auxiliary slot unit is configured to have a plurality of perpendicular shafts, an upper fixing bar installed at an upper part of the perpendicular shaft, a first spring positioned between a lower fixing bar installed at a position spaced with a predetermined spacing at the upper fixing bar, a guide bar installed at a perpendicular bar so that the guide bar is supported at an upper end of the first spring, and a pair of powdered medicine guiders rotatably installed on the guide bar, expand operating by the individual slot to guide powdered medicine to medicine wrapping paper.
[0028] Further, a second spring which is elastically supported in a direction opposite to each other on the powdered medicine guiders in connection with the guide bar is further provided.
[0029] And the second spring is formed to be less elastic than the first spring.
[0030] Further, a split sealing machine which is arranged in a proceeding direction of medicine wrapping paper supplied in a roll form to enable the medicine wrapping paper to be divided vertically is further provided in the powdered medicine dispensing apparatus.
[0031] And a powdered medicine dispensing apparatus, according to the present invention comprises a multilayered partition means having a frame with a space of predetermined size, that divides the frame horizontally and vertically to form unit cells for powdered medicine to be uniformly distributed; a first driving means connected to a vertically partitioning member of the multilayered partition means whereby a vertical spacing of a member is adjusted; and a second driving means which moves each of the multilayered partition means individually.
[0032] And the first driving means is arranged at a lower part of the frame and individually connected to a vertically partition member, whereby each is operated individually.
[0033] Further, a diameter of a rotating body is formed so that each of the first driving means operates proportionally to a distance moved by a vertical partition member.
[0034] And the multilayered partition means is configured to have a frame stacked with a plurality thereof and arranged to be slidable with each other, a plurality of horizontal partition members that divide the frame horizontally, a plurality of vertical partition members that divide in a vertical direction perpendicular to the horizontal partition members, and a bottom plate for controlling a bottom surface of a frame arranged at the lowermost part of the frame.
[0035] Further, the vertical partition member is configured to have a lower guide groove formed to have an inclined upper part and stepped lower part, and a first to third member formed to have a plurality of guide grooves in which the horizontal partition member is inserted into and slides along a length direction.
[0036] And an upper protrusion is formed closely contacting the lower guide groove at an inclined surface of the second and third members so that the vertical partition member may be guided as it moves in a length direction by closely contacting the lower guide groove.
[0037] On the other hand, as a powdered medicine dispensation packaging apparatus for packaging using a powdered medicine dispensing apparatus, it comprises a dispensing means arranged under a partition means to load powdered medicine partitioned into unit cells as it falls, a third driving means for lifting the dispensing means, an auxiliary slot unit provided under the dispensing means to open the upper part of the medicine wrapping paper by a falling force of the vertically moved distribution means and simultaneously inject powdered medicine stored in the dispensing means into medicine wrapping paper, and a plurality of split sealing machines for individually separating and packaging medicine wrapping paper in a state in which powdered medicine is injected.
Advantageous Effects
[0038] According to the present invention, there are effects of significantly reducing the production cost of equipment to enable a more precise uniform dispensing of the powdered medicine while relying on half-manual work by a worker, allowing many distribution operations to be performed easily and speedily, and dispensing responsively according to an amount that is dispensed and an amount that is packaged.
[0039] Further, according to the present invention, through a semi-automatic method, split injected powdered medicine is easily packaged.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] FIG. 1 is a plan view showing a powdered medicine dispensation packaging apparatus according to a first embodiment of the present invention.
[0041] FIG. 2 is a side view showing a powdered medicine dispensation packaging apparatus according to a first embodiment of the present invention.
[0042] FIG. 3 is a perspective view showing the vertical partition member shown in FIG. 1 .
[0043] FIG. 4 is a perspective view showing a dispensing means according to the present invention.
[0044] FIG. 5 is a perspective view showing a horizontal separating means according to the present invention.
[0045] FIG. 6 is a perspective view showing a vertical separating means according to the present invention.
[0046] FIGS. 7 to 10 are operational state views showing the operation of a powdered medicine dispensation packaging apparatus according to a first embodiment of the present invention.
[0047] FIG. 11 is a front view showing a powdered medicine dispensation packaging apparatus according to a second embodiment of the present invention.
[0048] FIG. 12 is a plan view showing a powdered medicine dispensation packaging apparatus according to a second embodiment of the present invention.
[0049] FIG. 13 is a schematic diagram showing a dispensing means shown in FIG. 11 .
[0050] FIG. 14 is a schematic diagram showing an individual slot shown in FIG. 12 .
[0051] FIG. 15 is a perspective view showing a powdered medicine guider of an auxiliary slot unit shown in FIG. 12 .
[0052] FIGS. 16 to 20 are operational state views showing the operation of a powdered medicine dispensation packaging apparatus according to a second embodiment.
[0053] FIG. 21 is a view showing a partition means of a powdered medicine dispensation packaging apparatus according to a third embodiment.
[0054] FIG. 22 is a view showing a vertical partition member shown in FIG. 21 .
[0055] FIG. 23 is a view showing a first driving means shown in FIG. 21 .
[0056] FIG. 24 is a schematic view showing a dispensing means and auxiliary slot unit according to a third embodiment of the present invention.
[0057] FIG. 25 is a view showing a dispensing means shown in FIG. 24 .
[0058] FIG. 26 is a view showing an auxiliary slot unit shown in FIG. 24 .
[0059] FIGS. 27 to 30 are operational state views of a powdered medicine dispensation packaging apparatus according to a third embodiment of the present invention.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0060] Hereinafter, preferred embodiments of the present invention will be described in more detail with reference to the accompanying drawings. The embodiments of the present invention can be modified in various forms, and the scope of the present invention should not be construed as limited to the embodiments set forth below. The present embodiments are provided to describe the present invention in more detail to those skilled in the art to which the present invention pertains. Accordingly, the shape of each element shown in the figures may be exaggerated in order to emphasize a more clear description.
[0061] The terms first, second, etc. may be used to describe various components, but the components should not be limited by the terms. The terms are used only to distinguish one component from another.
[0062] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limited the present invention. Singular forms include plural referents unless the context clearly indicates otherwise. In this application, the terms “comprises” or “having”, etc. are for specifying the presence of a feature, number, step, operation, component, or a combination thereof presented in the specification, and it should be understood that it does not pre-exclude the possibility of the presence or addition of one or more of other features, numbers, steps, operations, components or a combination thereof.
[0063] As shown in FIGS. 1 and 2 , a powdered medicine dispensation packaging apparatus 100 according to a first embodiment of the present invention comprises a partition means 110 , driving means 120 , dispensing means 130 , and a holding unit 140 .
[0064] The partition means 110 is provided with a frame 111 having a predetermined size and is configured to divide the frame 111 horizontally and vertically to form unit cells 114 for powdered medicine to be uniformly distributed in the unit cells 114 .
[0065] For this, a frame 111 in a rectangular form having a predetermined height and an open upper and lower part, a horizontal partition member 112 arranged evenly spaced in a horizontal direction in the frame 111 to divide the space inside the frame horizontally, a vertical partition member 113 arranged in a vertical direction of the frame 114 in plurality to divide vertically, and a sliding plate 115 arranged at a lower part of the frame 114 to open and close the lower part is comprised.
[0066] Further, a guide groove 116 guiding the sliding plate 115 and a guide groove 117 guiding the dispensing means 130 are formed respectively at the lower part of the frame 111 .
[0067] In addition, the vertical partition member 113 is connected to a driving means 120 thereby partitioning unit cells 114 , and horizontal spacing thereof is adjusted to allow powdered medicine that is injected in a unit cell to be uniformly distributed inside the unit cell.
[0068] Further, the vertical partition member 113 , as shown in FIG. 3 a , is configured to have a vertical plate 113 a , having slots 113 b formed to be spaced in correspondence with the horizontal partition member and an inclined surface 113 c at an upper surface inclined in a thickness direction, a perpendicular plate 113 e extending perpendicularly at both ends of the vertical plate 113 a , having an elastic member 113 d formed which pressurizes the vertical plate 113 a towards a sliding plate 116 , an extending plate 113 f extending horizontally in a direction opposite to each other from the upper end of the perpendicular plate 113 e , and a flat plate 113 g extending orthogonally from an end part of the extending plate 113 f to be connected with a moving member.
[0069] Here, the inclined surface 113 c is formed to prevent the vertical plate from being weakened by a slot 113 b extending to an upper end while preventing powdered medicine that is injected from being piled at the upper end of the vertical partition member.
[0070] Further, the sliding plate 115 is provided with a hinge 115 a so that the sliding plate may be folded at regular intervals as shown in FIG. 3 b.
[0071] The driving means 120 is a component that is connected to the vertical partition member which divides the horizontal direction, to adjust the horizontal spacing of the member.
[0072] As a specific configuration of the driving means 120 , it is configured to have a driving rotary shaft 122 arranged on one side of the frame 111 , that is operated by a handle 121 , a driven rotary shaft 123 arranged on the other side of the frame 111 , that is linkage driven by a rotation force of the driving rotary shaft, a plurality of rotating bodies 124 having different diameters in a shaft direction, coupled to the driving rotary shaft 122 and driven rotary shaft 123 , respectively, and a moving member 125 connecting the rotating bodies 124 to make them mutually linkage driven.
[0073] At the exterior circumference of the moving member 125 , the vertical partition member 113 is arranged in a number corresponding to the moving member, allowing each of the connected vertical partition members to operate with a different moving distance by the rotation of the rotating body.
[0074] Further, each of the rotating bodies 124 have diameters proportional to the moving distance of each of the vertical partition members 113 inside the frame, so as much as the diameter gradually expands from the rotating body of N 1 to the rotating body of N 5 , the moving distance of the vertical partition members connected to N 1 to N 5 respectively by a moving means each change from L 1 to L 5 , so that the horizontal expansion spacing of the unit cells are made uniform.
[0075] For example, each rotating body 124 gradually increases in diameter from N 1 to N 5 , and the moving distance of the vertical partition member 113 which is sequentially connected to N 1 to N 5 of the rotating body from the left side to the right side in reference to the drawings, are moved in proportion to the diameter of the rotating bodies. The moving distance moves as much as L 1 by the rotation of N 1 , as much as L 2 by the rotation of N 2 , and in this way of moving in distance, the moving distance increases from L 1 to L 5 , so the diameter of the rotating bodies are to be correspondent thereto.
[0076] Accordingly, the unit cells 114 partitioned by the vertical partition member and the horizontal partition member are extended according to the movement interval, and a uniform space may be ensured.
[0077] The driving means 120 is described in the form of a belt in the drawing, but it may be operated by a gear method, and if it is configured to move the vertical partition member horizontally evenly spaced, then any of the sort may be included.
[0078] The dispensing unit 130 , as shown in FIG. 4 is configured to have a dispensing slot 132 arranged in plurality, which has a predetermined size and a funnel shape that decreases in size from the upper part towards the lower part, and a sliding plate 131 to be slid and inserted along a guide groove 117 arranged at both ends of the dispensing slot 132 and formed on the frame 111 .
[0079] The dispensing means 130 is arranged in a number corresponding to the spacing of the unit cells that divide the frame horizontally, and the unit cells that are divided vertically, are assembled in a block shape as to be adjusted according to the amount of powdered medicine to be dispensed and packaged.
[0080] That is, the dispensing means 130 is detachable in a cartridge manner according to the quantity of the unit cells in which powdered medicine is vertically divided.
[0081] The holding unit 140 is arranged at a lower part of the partition means 110 and is not shown in the drawings as a means to support a medicine bag located under the dispensing means 130 , but may be guided from the partition means and coupled as a slidingly detachable structure.
[0082] On the other hand, as shown in FIG. 5 and FIG. 6 , a horizontal separating plate 150 and a vertical separating plate 160 are further provided.
[0083] The horizontal separating plate 150 is configured to have a horizontal plate 151 having a length corresponding with a horizontal spacing of the frame 111 , a handle 152 arranged at both ends of the horizontal plate 151 , and a gap blocker 154 arranged in a length direction at a lower part of the horizontal plate 151 , and the gap blocker 154 may be in form of a sol or use urethane, silicone, etc. that has excellent elasticity.
[0084] That is, the horizontal separating plate 150 is arranged having a corresponding length with the horizontal partition member at the upper part of the horizontal partition member.
[0085] The vertical separating plate 160 is configured to have slots 162 corresponding to the number of horizontal partition members, and a vertical plate 161 having a groove 163 formed in a length direction to be fixed to the vertical partition member in a clip form.
[0086] Further, the vertical separating plate 160 includes a plurality thereof that is formed with different vertical length according to the location the horizontal separating plate 150 is partitioned.
[0087] For example, the horizontal separating plate 150 and the vertical separating plate 160 are configured to separate the partitioned unit cells 114 according to the number of powdered medicine being divided to separate them from unit cells not being used.
[0088] Here, the number of vertical partition members is illustrated as 5, and the number of horizontal partition members is illustrated as 11, but it is noted that the number of vertical partition members and horizontal partition members may be increasingly formed according to the number of packages of powdered medicine, and it is also noted that the rotating bodies of the driving means is correspondingly increased.
[0089] Hereinafter, the operation state of the first embodiment of the present invention will be described with reference to the accompanying drawings.
[0090] First, a dispensing means 130 which is blocked in the form of a cartridge to match the quantity of medicine to be packaged, is slidingly inserted into the lower part of the partition means and then, as shown in FIG. 2 , a necessary amount of medicine wrapping paper (MB) is arranged on the holding unit 140 to enable the opening of each medicine wrapping paper to be inserted in the dispensing slot of the dispensing means 130 .
[0091] Then, as illustrated in FIG. 7 , the unit cell 114 is separated by using the horizontal separating plate 150 and vertical separating plate 160 as needed and powdered medicine (PW) is injected in the separated unit cell 114 . At this time, the horizontal separating plate 150 is located on an upper part of the horizontal partition member 112 , and the vertical separating plate 160 is closely arranged on a side of the vertical partition member arranged at the very right side out of the vertical partition members 113 in reference to the drawing, and an end part of a side of the vertical separating plate is closely arranged to a side of the horizontal separating plate.
[0092] Further, medicine that is mixed according to a prescription that is pulverized in a large number and arranged is used as the powdered medicine.
[0093] If the amount of powdered medicine to be injected is large, horizontal separating plate is moved towards another horizontal partition member to partition the horizontal separator plate, and a vertical separating plate corresponding thereto is arranged on the vertical partition member side. That is, the vertical separating plate is prepared individually in plurality to have a length corresponding to the spacing of the divided horizontal partition member.
[0094] In this state, if the powdered medicine (PW) is injected into the separated unit cells 114 , the injected powdered medicine is piled up to have a higher height than the one partitioned by the horizontal partition member and vertical partition member, so this must be adjusted so that powdered medicine is uniformly distributed to the unit cells.
[0095] For this, as shown in FIG. 8 , the handle 121 is operated so that as the driving rotary shaft 122 and the driven rotary shaft 123 are rotated the connected moving means 125 is moved in the rotating direction.
[0096] At this time, a vertical partition member 113 is connected to the moving means 125 so the vertical partition member moves as much as the moving distance of the moving means.
[0097] Further, each of the vertical partition members is moved in different distances by rotating bodies having different diameters, so the partitioned unit cells are expanded with uniform spacing, and powdered medicine (PW) as shown in FIG. 9 for the expanded unit cells 114 ′ is horizontally aligned with the upper end of the unit cell 114 ′
[0098] According to another method, when the total volume of the powdered medicine is known, the spacing of the vertical partition members at which the powdered medicine becomes aligned horizontally with the upper end of each unit cell may be calculated by a simple calculation, and the vertical partition member is moved at the same interval and then the powdered medicine is injected, and the upper part of the partition member is evened out. At this time, it is possible to install a scale along the vertical direction to accurately identify the spacing between the vertical partition members.
[0099] Then, as shown in FIG. 10 , if the moving means 125 is moved by rotating the rotating body to inject a uniformly divided powdered medicine to the medicine wrapping paper, each of the connected vertical partition members 113 are vertically aligned with the unit dispensing slots 132 arranged underneath.
[0100] In this state, when the sliding plate 115 disposed at the lower part of the partition means is slid out along the guide groove 116 , the powdered medicine placed in the unit cell is naturally introduced towards the medicine wrapping paper (MB) arranged respectively along the dispensing slot 132 . At this time, the sliding plate 115 is arranged with a hinge 115 a at regular intervals in a sliding direction so that the sliding plate is lowered downward when the sliding plate is slid off, thereby minimizing the space occupied by the sliding plate.
[0101] When the powdered medicine is injected into the medicine wrapping paper, uniformly distributed powdered medicine is stored in each medicine wrapping paper when the powdered medicine is separated from the dispensing slot.
[0102] At this time, when the holding unit 140 is enabled to slide off from the partition means, it is possible to easily perform a packaging operation by separating a medicine wrapping paper in a state inserted into the dispensing slot at once.
[0103] As shown in FIGS. 11 and 12 , the powdered medicine dispensation packaging apparatus 200 according to a second embodiment of the present invention comprises a partition means 110 , driving means 120 , a dispensing means 210 , an individual slot 220 , an upper guide plate 230 , a first horizontal driving unit 240 , a first vertical driving unit 250 , an auxiliary slot unit 260 , a lower guide plate 270 , a second horizontal driving unit 280 and a second vertical driving unit 290 .
[0104] The partition means 110 and the driving means 120 use the structure used in the first embodiment, and thus the detailed description thereof will be omitted.
[0105] As shown in FIG. 13 , the dispensing unit 210 is provided under a partition means 110 and a driving means 120 , and as a component to sequentially store the powdered medicine divided into unit cells by the partition means and driving means, is arranged to have a width and area corresponding to the lower area of the partition means and driving means so a roller 215 is driven by a shaft 214 connected to a motor (not shown), and a plurality of slots 211 are coupled to a fixing unit 212 on a belt 213 wound on the roller 215 . The slot 211 is preferably arranged in a number corresponding to the horizontal direction of the unit cells partitioned by the partitioning means.
[0106] Further, a pressing bar 216 a capable of opening the lower part of each slot 211 under the dispensing means 210 is arranged inclining in the slot direction while being orthogonal to a horizontal bar 216 b , wherein the slot 211 is configured to have a cover 211 a pressurized by the pressing bar 216 a to open or close the lower part of the slot, a hinge 211 b that turns the cover 211 a , and a hanging bar 21 c at the pressing bar, which is caught by the pressing bar according to a movement of the slot thereby opening the cover.
[0107] The individual slots 220 are located under the dispensing means 210 , and a quantity corresponding to the number of slots of the dispensing means is arranged to be pressed and moved individually by the first horizontal driving unit and is separately moved towards the first vertical driving unit.
[0108] Further, the separate slot has an open upper part and a lower part that is opened and closed by the cover 222 , and as shown in FIG. 14 , is configured to have a slot 221 having a gradually narrowing width gradually from the upper part to the lower part, an opening means 223 connected to the cover 222 and performing an operation for opening and closing the cover 222 from the slot, and a side fixing unit 224 arranged in a position opposite to the slot 221 side.
[0109] And the opening means 223 is configured to have a hinge 223 a rotatably connecting the cover 222 and the slot 221 , a link 223 b with a side fixed to the hinge 223 a , provided with a link shaft 223 c on its end in a state where it is extended to a certain length, a perpendicular bar 223 d rotatably connected to the link shaft 223 c and extended to a certain length, a pressing unit 223 e extending orthogonally at an end part of the perpendicular bar 223 d , which is pressurized by the auxiliary slot unit described below, and a guiding unit 223 f having a guiding groove 223 g to guide the perpendicular bar 223 d when moving vertically. The guiding unit 223 f is connected to a side of the slot 221 .
[0110] The upper guide plate 230 is arranged on the lower part of the individual slots 220 to guide the individual slots 220 and has a cutting hole 231 , 232 cut on both ends to a size big enough to allow the individual slots 220 to pass through.
[0111] The first horizontal driving unit 240 is configured to horizontally move the individual slots 230 , wherein a roller 242 installed to a shaft 244 with a spacing corresponding to the moving distance of the individual slots is arranged, and a belt 243 is wound on the roller 242 and operated, and a pressing unit 241 is provided on the belt 243 that pressurizes and pushes the individual slot horizontally.
[0112] That is, the first horizontal driving unit 240 is configured to horizontally move the pressing unit 241 , and move the individual slots in a state where they are seated on the upper guide plate from the side of the second vertical driving unit to the side of the first vertical driving unit, wherein the individual slots are pushed stepwise so the individual slots may be discharged one by one towards the cutting hole 231 of the upper guide plate, by the first vertical driving unit.
[0113] The first vertical driving unit 250 is configured to have a roller 252 connected to a shaft 251 which is spaced apart evenly, a rotating belt 253 wound on the roller 252 , and a guiding unit 254 which is fixed to the belt 253 , and a coupling groove 255 in which a side fixing unit of the individual slot is inserted and seated is formed on the guide plate 254 .
[0114] That is, the first vertical driving unit is configured to grab the individual slots which move by the first horizontal driving unit to move to the auxiliary slot unit underneath.
[0115] The auxiliary slot 260 is arranged at a lower side of the first vertical driving unit 250 as shown in FIG. 15 , to guide the powdered medicine stored in the individual slots 220 moved by the first vertical driving unit 250 to a medicine wrapping paper, wherein it is configured to have a pair of perpendicular shafts 261 which are arranged at both sides of the medicine wrapping paper (MB) moving the lower part in the horizontal direction, an upper fixing bar 262 fixed to the upper end of the perpendicular shaft 261 , and a lower fixing bar 263 arranged at a position spaced apart with a certain spacing from the upper fixing bar 262 , a first spring 264 arranged between the upper fixing bar and the lower fixing bar, a guide bar 265 inserted into a perpendicular shaft to be supported by the first spring 264 , and a powdered medicine guider 266 rotatably coupled to the guide bar 265 .
[0116] Here, the powdered medicine guider 266 is arranged to have a curved shape as a pair, and a second spring 267 is further included between the powdered medicine guider and guide bar so that the pair of powdered medicine guiders 266 are pressed in a direction opposite to each other.
[0117] It is preferable that the second spring 267 has a relatively strong elasticity relative to the first spring 264 . This is to allow the powdered medicine guider to be opened by pressurizing the individual slot after the first spring is first compressed and constantly compressed by the pressing force when the powdered medicine guider is pressurized by the individual slots entering the upper part.
[0118] The lower guide plate 270 is a means to guide the individual slots when moving horizontally to move back to the upper guide plate after the individual slots drop the powdered medicine into the medicine wrapping paper, wherein a cutting hole 271 cut so that the individual slot may move towards the auxiliary slot unit with a length corresponding to the upper guide plate is formed on one side.
[0119] The second horizontal driving unit 280 and the second vertical driving unit 290 are arranged in a position corresponding to the first horizontal driving unit 240 and the first vertical driving unit 250 , respectively, and the description thereof is omitted.
[0120] According to the second embodiment of the present invention, a split sealing machine 300 which is neighboring the auxiliary slot unit 260 while being arranged on the side of the proceeding direction of the medicine wrapping paper (MB) to allow the cartridge to be divided vertically, is further arranged to enable the powdered medicine injected in medicine wrapping paper to be packaged in divided areas.
[0121] Further, the medicine wrapping paper is guided by the guide roller 310 in the form of a roll, and passes between the auxiliary slots, and stores a powdered medicine that is dropped from the auxiliary slot.
[0122] Here, the dispensing means, the first horizontal driving unit, and the second horizontal driving unit, the first vertical driving unit and the second vertical driving unit are respectively operated by a motor (not shown) connected to a shaft, and the motor is not shown, but is controlled by a control unit for controlling each operation.
[0123] Hereinafter, the operation state of the second embodiment of the present invention will be described with reference to the accompanying drawings.
[0124] First, as in the first embodiment of the present invention, a partition means 110 and a driving means 120 is used for dividing the powdered medicine into unit cells, and then as shown in FIG. 16 , the lower part of divided powdered medicine is opened stepwise to allow the divided powdered medicine to be moved to a slot 211 of a dispensing means 210 . At this time, in the present embodiment, the distribution means is moved vertically from the lower part of the partition means and driving means so that the powdered medicine is separated, but on the other hand, an entire partition means and driving means may move stepwise and the medicine may be dropped by the dispensing unit.
[0125] The powdered medicine injected to the dispensing means is made to be present in a slot closed by a cover 211 a , and a hanging bar 211 c arranged in the cover according to the movement of the slot is caught by a pressing bar 216 a and is turned by a hinge 211 b to be slowly opened to allow the powdered medicine to be dropped towards the individual slots 220 arranged underneath to store the powdered medicine inside each individual slot. Then, as shown in FIG. 17 , the first horizontal driving unit 240 is operated to push the individual slots 220 to the first vertical driving unit 250 , thereby enabling the individual slots 220 ′ of the front end of the unit individual slots to be connected to the guiding unit 254 of the first vertical driving unit 250 .
[0126] That is, the dispensing means is able to inject the powdered medicine from the dispensing means in a stepwise manner as it is moved towards the powdered medicine of the state stored in the unit cells, and are opened by a pressing bar arranged on the lower part of the individual slots to allow the powdered medicine to be dropped into individual slots.
[0127] In this state, the first vertical driving unit 250 is operated to move the individual slots 220 ′ of the grabbed state to a lower side and move to the auxiliary slot unit 260 to allow the individual slots 220 ′ to be located on the powdered medicine guider 266 side of the auxiliary slot unit 260 .
[0128] Next, as shown in FIG. 18 , when the individual slot is lowered by operating the first vertical driving unit 250 , the pressing unit 223 e of the opening means 223 coupled to the individual slots 220 ′ pushes the guide bar 265 and the pressurized guide bar compresses the first spring 264 and is lowered so the lower end of the powdered medicine guider 266 is inserted between the medicine wrapping paper (MB), making the gap in between the medicine wrapping paper to be spaced apart from each other.
[0129] Thereafter, as shown in FIG. 19 , by the individual slots that descend when the compressive force generated by the continuous compression of the first spring 264 is stronger than the spring force of the second spring, powdered medicine guider 266 is opened apart oppositely from each other and the medicine wrapping paper becomes even more spaced apart while a cover 222 of the lower part of the individual slots is opened by an operation of a link and a perpendicular shaft of an opening means of a pressed state, so that the powdered medicine that used to be stored is dropped and stored in a medicine wrapping paper.
[0130] After dropping the powdered medicine from the individual slots, as shown in FIG. 20 , the medicine wrapping paper is horizontally moved, while simultaneously the stored powdered medicine is partitioned by using the split fusion machine 300 .
[0131] Further, the individual slots 220 ′ to which the dropping of powdered medicine is finished, operates the first vertical driving unit 250 in an upper direction to pass through the cutting hole 271 of the lower guide plate 270 while simultaneously operating a second horizontal driving unit 280 to move while being guided by the lower guide plate 270 towards the second vertical driving unit 290 , and then by the second vertical driving unit 290 passing through the cutting hole 232 of the upper guide plate 230 of the upper part and may be positioned in the first horizontal driving unit.
[0132] Then, the first horizontal driving unit operates a movement that moves the individual slots horizontally again to move the individual slots to be located under the distribution unit.
[0133] This operation is repeatedly performed and the powdered medicine, which is divided by the partition means, can be injected into a continuous process.
[0134] As described above, the present invention may be able to correspond to an appropriate amount required by the patient as well as allow quick uniform separation of the powdered medicine to be divided, thereby obtaining high efficiency at low cost in a hospital dealing with a large amount of powdered medicine.
[0135] As shown in FIGS. 21 and 24 , the powder dispensing packaging apparatus 300 according to a third embodiment of the present invention comprises a partition means 310 , a first driving means 320 , a second driving means 330 , a dispensing means 340 , a third driving means 350 , an auxiliary slot unit 360 , and a split sealing machine 370 .
[0136] The partition means 310 comprises a frame 311 which is formed in a predetermined space by four closed surfaces and is stacked in plurality layers, as shown in FIGS. 21 to 23 , a horizontal partition member 312 which divides the horizontal direction inside the frame 311 into even intervals, a plurality of vertical partition members 313 arranged in a direction perpendicular to the horizontal partition member 312 , and a bottom plate 311 a which controls the bottom surface of the frame arranged at the lowermost side of the frame.
[0137] The horizontal partition member 312 and the vertical partition member 313 are arranged to form a unit cell 314 partitioned in a frame so that a predetermined amount of powdered medicine is stored in the unit cells 314 .
[0138] The horizontal partition members 312 are provided individually on each of a plurality of frames 3111 , 3112 , 3113 stacked in plurality layers, to be able to move together with each frame as it is operated individually, and as shown in FIG. 23 , a guide groove 3113 a is formed on a lower surface of a frame 3113 arranged on the lowermost layer out of each frame stacked in plurality layers so that each unit cell is expanded so when vertically moving, a holding protrusion 323 may pass in a state where powdered medicine is uniformly distributed.
[0139] The vertical partition member 313 is configured to have a first to third members 3131 , 3132 , 3133 , and the first member 3131 comprises a guide groove 3131 a formed to be evenly spaced along a length direction in the form of a plate having a certain length, an inclined surface 3131 b formed on the upper surface thereof, and a lower guide groove 3131 c formed on the lower surface thereof, and the second member 3132 comprises a guide groove 3132 a formed to be evenly spaced along a length direction in the form of a plate having a certain length, an inclined surface 3132 b formed on the upper surface thereof, a lower guide groove 3132 c formed on the lower surface thereof, and an upper protrusion 3132 d formed on a side of the inclined surface 3132 b formed in plurality, and the third member comprises a guide groove 3133 a formed to be evenly spaced along a length direction in the form of a plate having a certain length, an inclined surface 3133 b formed on the upper surface thereof, a hanging groove 3133 c formed on the lower surface thereof, and an upper protrusion 3133 d formed on a side of the inclined surface 3133 d in plurality.
[0140] Further, the first through third members 3131 , 3132 , 3133 are provided, stacked on each of the multilayered frames 311 , and the first member slides along the upper surface of the second member if the frame 3111 of the uppermost layer moves when the multilayered frame is individually operated by the second driving member, and the second member slides along the upper surface of the third member and the frame 3113 of the lowermost layer moves and is separated from the bottom plate when the frame 3112 of a middle layer moves.
[0141] The first driving means 120 , as shown in FIG. 23 is configured to have a rotating body 321 arranged at the lowermost frame 3113 of the frame 311 and connected via a shaft to operate, an endless track 322 which surrounds the rotating body 321 and moves by the rotation of the rotating body, and a hanging protrusion 323 which is arranged on one side of the upper surface of the endless track 322 to be inserted into the lower guide groove 3133 c formed on the third member 3133 of the lowermost layer out of the vertical partition member 313 .
[0142] Further, the first driving means 320 moves the third member as an endless track 322 operates between the grooves 311 b formed on the bottom plate 311 a to change the sizes of the unit cells dividing the frame.
[0143] Here the first driving means 320 is arranged in a number corresponding to a plurality of vertical partition members 313 forming unit cells as it moves horizontally to individually operate each vertical partition member, and a diameter of the rotating body is formed to allow each of the vertical partition members to operate in proportion to the distance moved.
[0144] That is, the first driving means 320 performs an operation for individually moving a plurality of vertical partition members to a predetermined length in a horizontal direction.
[0145] For example, when the first driving means 320 are individually connected to the vertical partition members, the first driving means referred to as M 1 to M 6 respectively, and the vertical partition members referred to as L 1 to L 6 , respectively, they are connected in a manner in which M 1 and L 1 are connected, and M 2 and L 2 are connected, and the moving distance of L 2 is moved farther than L 1 , and thus the rotating body may have a corresponding diameter thereto. In such a way, the diameter of the rotating body is differed from each other so as to perform the operation of M 1 to M 6 to correspond to a moving distance of L 1 to L 6 , and apart from this, a measurement means (not shown) capable of measuring the number of rotations of the rotary body is provided whereby the moving distances of the vertical partition members may be adjusted by varying the number of rotations of a motor in a rotating body with a same diameter.
[0146] The second driving means 330 is configured to have a rotating body 331 arranged at both sides of the frame horizontally, an endless track 332 which surrounds the rotating body and operates by the rotating body, and a bracket (not shown) for individually connecting the endless track 332 to the respective frames 3111 , 3112 , 3113 .
[0147] That is, the second driving means 330 is arranged in a number corresponding to each frame that is stacked and performs an operation of moving the frame in a vertical direction.
[0148] Here, the first driving means 320 is described in the form of a belt in the drawing, but it may be operated by a gear method, and if it is configured to move the vertical partition member horizontally evenly spaced, then any of the sort may be included, and it is described to be operated by the handle but it is also possible to be connected to a motor and such to be operated.
[0149] The dispensing means 340 is located under the partition means 310 as shown in FIGS. 24 and 25 , and a plurality thereof is arranged to have spacing which corresponds with the spacing of the unit cells partitioned by a the vertical partition members. A storage slot 341 having an open upper part and a lower part which is opened and closed by a cover 346 a , formed to decrease gradually more towards the bottom part, to store powdered medicine that is partitioned from the unit cells, and an opening means 346 which is connected to the cover 346 a and performs an operation for opening and closing the cover 346 a from the storage slot 341 is configured.
[0150] The opening means 346 is configured to have a hinge 346 b for rotatably connecting the cover 346 a and the storage slot 341 , a link 346 c which a side thereof is fixed to the hinge 346 b and has a link shaft 346 d in a state extended to a certain length on an end, a perpendicular bar 346 e which is rotatably connected to the link shaft 346 d and has a certain length extended in a vertical direction, a pressing plate 346 g which extends orthogonally at the end of the perpendicular bar 346 e and is pressed by an auxiliary slot unit which will be described below, and a guide unit 346 f having a guide groove 346 h formed to guide the perpendicular bar 346 e when moving in a vertical direction. The guide unit 346 f is connected to a side of the storage slot 341 .
[0151] The third driving unit 350 is arranged in a vertical direction and configured to have a plurality of rotating bodies 351 arranged respectively on both lateral sides of the dispensing means 340 , an endless track 352 which surrounds each rotating body 351 and operates to be connected vertically, and a bracket 353 for connecting the endless track 352 and the dispensing means 340 .
[0152] The auxiliary slot unit 360 is arranged under the dispensing means 340 to be operated by the dispensing means 340 moving downward, as shown in FIG. 24 , a pair of perpendicular shafts 361 which are arranged at both sides of the medicine wrapping paper (MB) moving the lower part in a horizontal direction, an upper fixing bar 362 fixed on the upper end of the perpendicular bar 361 and a lower fixing bar 363 arranged at a position spaced apart with a certain spacing from the upper fixing bar 362 , a first spring 364 arranged between the upper fixing bar and the lower fixing bar, a guide bar 365 inserted into a perpendicular shaft to be supported by the first spring 364 , and a powdered medicine guider 366 rotatably coupled to the guide bar 365 .
[0153] Here, the powdered medicine guider 366 is arranged to have a curved shape as a pair in group in a number corresponding to the dispensing means 340 and storage slot 341 , and a second spring 367 is further included between the powdered medicine guider and guide bar so that the pair of powdered medicine guiders 366 are pressed in a direction opposite to each other.
[0154] It is preferable that the second spring 367 has a relatively strong elasticity relative to the first spring 164 . This is to allow the powdered medicine guider to be opened by pressurizing the individual slot after the first spring is first compressed and constantly compressed by the pressing force when the powdered medicine guider is pressurized by the individual slots entering the upper part.
[0155] The split sealing machine 370 is arranged between a plurality of powdered medicine guiders 366 arranged evenly spaced in the proceeding direction of the medicine wrapping paper and configured to moves towards the medicine wrapping paper to seal the medicine wrapping paper using heat or high frequency waves when powdered medicine is injected in the medicine wrapping paper, wherein a general sealer for sealing medicine wrapping paper and the like is used.
[0156] Hereinafter, the operation state of the third embodiment of the present invention will be described with reference to the accompanying drawings.
[0157] According to the present invention, the horizontal sections of the unit cells 314 are described as three in number.
[0158] The powdered medicine filled in the unit cells, must change the volume of the unit cells according to a dose since the powdered medicine corresponding to a single dose is accommodated in one unit cell, and the volume of the unit cells must be changed through the movement of the vertical partition member and the capacity of the powdered medicine being filled in each unit cell must be uniform. For this, as shown in FIG. 27 , a predetermined amount of powdered medicine (PW) is injected and filled in a separated space by the unit cells 314 partitioned to be evenly spaced inside a frame 311 by horizontal partition members 312 and vertical partition members 313 .
[0159] In the multilayered frame, the lowermost frame and the intermediate frame are in a state completely filled with the powdered medicine, but at the uppermost frame it is in a piled up state and since the volume spacing of the unit cells don't meet the capacity of one dosage, the uniform distributions of the powdered medicine has not been performed on all of the unit cells.
[0160] In this state, to uniformly distribute in respect to each unit cell of the powdered medicine, as shown in FIG. 28 , the first driving means 320 is operated to move the vertical partition member 313 in a horizontal direction to a certain extent.
[0161] At this time, the first driving means 320 are divided into M 1 to M 6 and are individually connected to each of the vertical partition members distinguished as L 1 to L 6 , so that the moving distance of L 1 to L 6 is different depending on the operation of M 1 to M 6 .
[0162] That is, in order to uniformly distribute the powdered medicine in the unit cells, L 1 and L 2 , L 3 and L 4 , L 5 and 16 are in close contact respectively, and M 1 to M 6 are operated respectively, so that L 3 and L 4 is moved twice as much as the distance L 1 and L 2 moved, and L 5 and L 6 are moved four times as much in distance. At this time, the operation of the first driving means is operated by a control signal of a control unit (not shown).
[0163] Shown here is, the frame when seen from a plan view, so the frames stacked at a lower part are simultaneously operated by the connection of the first member to third member of the vertical partition member so the operation of the vertical partition member in the entire frame can be described as the operation of the uppermost frame.
[0164] When a generally uniform powdered medicine is distributed in the unit cells by the horizontal expansion of the vertical partition members, as shown in FIG. 29 , the spacing of unit cells 314 ′ in a state where it is expanded to match the spacing of the dispensing means arranged underneath is maintained as the spacing of the unit cells filled with the powdered medicine is adjusted.
[0165] That is, the spacing between the first ({circle around ( 1 )}) to third ({circle around ( 3 )}) unit cells filled with powdered medicine distributed between L 1 and L 2 , L 2 and L 3 , L 4 and L 5 respectively, is maintained as L 2 to L 6 are generally moved in a horizontal direction, to form a space between L 1 and L 2 , L 3 and L 4 , and L 5 and L 6 respectively, so that through this spacing, the space in between the storage slots of the dispensing means arranged at a lower part is adjusted to match, and also by maintaining the spacing in between the first ({circle around ( 1 )}) to third ({circle around ( 3 )}), when the frame is moved vertically the powdered medicine is prevented from falling over to a frame of the middle layer from a frame of the uppermost layer while powdered medicine may be dropped to the dispensing means.
[0166] Also, as shown in FIG. 29 , after expanding the vertical partition member, a frame of the uppermost layer is moved vertically, so that the powdered medicine in the frame is dropped while simultaneously the height of the powdered medicine placed on the middle layer is uniformly weighed using the frame, and the vertical partition member of L 1 to L 6 is returned as shown in FIG. 28 after dropping the powdered medicine of the uppermost layer and the middle layer, so the vertical partition member is expanded to its maximum at a state where L 2 is attached to L 1 , L 4 to L 3 , and L 6 to L 5 , and then moving the uppermost layer vertically to drop, wherein this method is used to sequentially drop the powdered medicine of each layer to have it stacked on the dispensing means. At this time, through a guide groove 3113 a formed at a lower part of the horizontal partition member of the lowermost layer, it is possible to move without being interrupted by a hanging protrusion.
[0167] According to another method, when the total volume of the powdered medicine is known, the spacing of the vertical partition members at which the powdered medicine becomes aligned horizontally with the upper end of each unit cell may be calculated by a simple calculation, and the vertical partition member is moved at the same interval and then the powdered medicine is injected, and the upper part of the partition member is evened out. At this time, it is possible to install a scale along the vertical direction to accurately identify the spacing between the vertical partition members.
[0168] Next, as shown in FIGS. 30 and 31 , a powdered medicine which is partitioned by a partition means 310 drops to a dispensing means arranged under the partition means, and a second driving means 330 connected to the uppermost frame 3111 is operated first to allow the powdered medicine to drop into the unit cells 314 ′ divided by the horizontal partition member 312 and the vertical partition member.
[0169] That is, the second driving means 330 moves the frames 3111 , 3112 , 3113 of the partition means in the vertical direction and the powdered medicine filled in the unit cells is dropped stepwise to the distribution means, wherein the powdered medicine in the frame located at a lower part thereof is weighed to be compared to be equal with the height of the frame, thereby preventing the powdered medicine in the unit cell from being lost in the process of moving the frame to the storage slot side by the guide plate 341 a which is extended with an incline to one side of the storage slot 341 .
[0170] On the other hand, in the operation of the present invention only the process of dropping from the first unit cell of the uppermost frame 3111 will be described as follows. This is because the dropping process of powdered medicine is the same to that of other frames.
[0171] When the uppermost frame 3111 is moved in a vertical direction by the operation of the second driving means, a powdered medicine (PW) is dropped inside the storage slot 341 by way of a guide plate 341 a of a storage slot 341 located on a lower part.
[0172] The dropped powdered medicine is placed in the storage slot 341 , and is lowered by operation of the third driving means 350 as shown in FIG. 32 .
[0173] As shown in FIG. 33 , it is located on the upper side of the auxiliary slot unit 360 arranged under the dispensing means 340 , and when the storage slot 341 is lowered, the pressing unit 346 g of the opening means 346 coupled to the storage slot 341 ′ presses the guide bar 365 and the pressurized guide bar compresses and lowers the first spring 364 and the lower end of the powdered medicine guider 366 is inserted between the medicine wrapping paper (MB), making the gap in between the medicine wrapping paper to be spaced apart from each other.
[0174] In this state, as shown in FIG. 34 , the powdered medicine guider 366 cancels out the spring force of the second spring due to the storage slot which is lowered when the compressive force generated by the continuous compression of the first spring 364 is stronger than the spring force of the second spring, and the powdered medicine guider 366 is opened apart oppositely from each other and the medicine wrapping paper becomes more spaced apart while a cover 364 a of the lower part of the storage slots 341 ′ is opened by an operation of a link 346 c and a perpendicular shaft of an opening means in a pressed state, so that the powdered medicine (PW) that used to be stored is dropped and stored in a medicine wrapping paper (MB).
[0175] A plurality of split sealing machines 370 arranged in evenly spaced manner as shown in FIG. 32 operate oppositely facing the medicine wrapping paper in a direction towards it to seal it to make the medicine wrapping paper separated from each other.
[0176] Here, each shaft is connected to a motor (not shown) to operate, and the motor is not shown but is controlled by a control unit for controlling each operation.
[0177] This operation is repeatedly performed and the powdered medicine divided by the partition means may be injected in a continuous process.
[0178] In this way, it is possible not only to respond to an appropriate amount in compliance with the amount required by a patient, but also to rapidly divide the powdered medicine uniformly, and thereby it is possible to obtain a large effect with less expense in a hospital handling a large amount of powdered medicine.
[0179] Although the present invention has been described with reference to the preferred embodiments, it is intended to aid in the understanding of the technical content of the present invention, and the technical scope of the invention is not intended to be limited thereto.
[0180] That is, it would be obvious to those skilled in the art that various changes and modifications can be made to the invention without departing from the technical gist of the present invention, and such changes and modifications are within the technical scope of the present invention in view of the interpretation of the claims.
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The present invention relates to a powdered medicine dispensing apparatus, and a powdered medicine dispensation packaging apparatus using the same. According to the present invention, the production cost of the apparatus is significantly reduced, and thereby more precise uniform dispensing of the powered medicine can be facilitated while relying on half-manual operation by a worker, many distribution operations can be performed easily and speedily, and dispensing can be made responsive according to the amount that is dispensed and the amount that is packaged.
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CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 61/138,668, filed on Dec. 18, 2008, and incorporated herein by reference.
BACKGROUND
[0002] This invention relates to a portable stand, in particular to a portable music stand that allows for greater flexibility in use and portability.
SUMMARY
[0003] One aspect provides a portable stand. The portable stand includes a shelf having a back plate with a front surface and a rear surface, wherein the back plate includes at least two attachment locations and at least one securing locations, a bottom flange forming an angle with the back plate, extending toward the front surface at a first angle from the plate, and a mounting element. The portable stand includes a shelf extension including two elongated flanges formed at an angle equal to the first angle configured to selectively couple to the shelf, and an arm pivotably attachable to the shelf extension.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
[0005] FIG. 1 illustrates a perspective view of a portable stand as an erected assembly according to one embodiment.
[0006] FIG. 2 illustrates a front view of a shelf according to one embodiment.
[0007] FIG. 3 illustrates a perspective view of the shelf according to one embodiment.
[0008] FIG. 4 illustrates a back view of the shelf according to one embodiment.
[0009] FIGS. 5A and 5B illustrate side views of a shelf extension according to one embodiment.
[0010] FIGS. 6A and 6B illustrate perspective views of the shelf extension according to one embodiment.
[0011] FIG. 7 illustrates an end view of the shelf extension according to one embodiment.
[0012] FIG. 8 illustrates a front view of an arm according to one embodiment.
[0013] FIG. 9 illustrates a side view of the arm according to one embodiment.
[0014] FIG. 10 illustrates a cross-sectional view of the arm according to FIG. 9 .
[0015] FIG. 11 illustrates a perspective view of the portable stand as assembled for carrying according to one embodiment.
DETAILED DESCRIPTION
[0016] In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
[0017] It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise.
[0018] A portable stand is provided that is configured to have improved ease of transport and use. Embodiments described below provide a portable stand that is configured to be disassembled from an erected assembly and reassembled into a compact carrying assembly. The portable stand is desirably lightweight and compact for ease of transporting. The portable stand is desirably adjustable and provides a sturdy platform when erected. The portable stand provides ease of assembly and disassembly as well as ease of adjustability in positioning when assembled.
[0019] FIG. 1 illustrates a portable stand 100 as an erected assembly, according to one embodiment. In one embodiment, portable stand 100 includes shelf 10 , shelf extension 12 , arm 14 , and tripod 16 . In one embodiment, shelf extension 12 couples with back plate 18 and flange 20 of shelf 10 . In one embodiment, shelf extension 12 is coupled to either side 22 of shelf 10 with brackets 24 . In one embodiment, arm 14 is connected to shelf extension 12 at connection point 26 . Arm 14 is pivotable to any desired angle with respect to shelf extension 12 at connection point 26 . In one embodiment, for example, arm 14 is oriented parallel to the side 22 of shelf 10 . In another embodiment, arm 14 is angled toward shelf 10 . In one embodiment, an extension 12 may be coupled to each side 22 of shelf 10 . When assembled to shelf 10 , shelf extension 12 and arm 14 enable portable stand 100 to accommodate full size sheet music. In one embodiment, shelf 10 , shelf extension 12 , arm 14 , and tripod 16 are made of a rigid material such as rigid plastic, metal, a combination of plastic and metal, or any other suitable material. In one embodiment, shelf 10 , shelf extension 14 and arm 16 are a powder-coated metal.
[0020] In one embodiment, portable stand 100 provides a stable platform for displaying sheet music or other material. Portable stand 100 may be erected with or without shelf extension 12 and arm 14 . Shelf 10 is adjustable such that back plate 12 is oriented horizontally, vertically or at some other angle. In another embodiment, portable stand 100 may be used as a portable workstation for a laptop or other devices by pivoting shelf 10 with respect to tripod 16 , thereby providing a relatively horizontal workstation. Further, shelf 10 is rotatable on a vertical axis with respect to tripod 16 . In one embodiment, tripod 16 engages with shelf 10 at a first end 28 . Support legs 30 at the opposing second end 32 are extendable outward from vertical post 34 . In one embodiment, tripod 16 includes three support legs 30 , however four support legs, for example, are also acceptable. In one embodiment, the height of vertical post 34 is adjustable through extension and retraction of sections 36 . In one embodiment, sections 36 are adjustable with one hand of a user while portable stand 100 is erected.
[0021] FIGS. 2-4 illustrate shelf 10 of portable stand 100 . As seen in the front view of shelf 10 provided in FIG. 2 , shelf 10 includes back plate 18 and flange 20 . In one embodiment, back plate 18 is rectangularly shaped and includes top edge 19 , bottom edge 17 , and two side edges 22 . In one embodiment, the exposed outer corner edges 23 of shelf 10 are rounded. As seen in the perspective of shelf 10 illustrated in FIG. 3 , bottom plate or flange 20 is connected to back plate 18 at bottom edge 17 . In one embodiment, shelf 10 is an L-shaped configuration wherein bottom plate 20 extends from front surface 44 of back plate 18 at a first angle 48 . In one embodiment, first angle 48 is approximately 90 degrees.
[0022] In one embodiment, holes 40 and 42 are provided through back plate 18 , extending from front face 44 to back face 46 . In one embodiment, two attachment holes 40 are located near top edge 19 . In another embodiment, attachment holes 40 are located along side edges 22 , between top edge 19 and bottom edge 17 . In one embodiment, holes 40 provide for attaching a carrying strap, shoulder strap, or other transporting mechanism (illustrated in FIG. 11 ). In one embodiment, securing holes 42 are provided near bottom edge 17 of back plate 18 . In one embodiment, securing holes 42 are used for securing other elements of portable stand 100 , discussed below, to shelf 10 during transport or storage.
[0023] As illustrated in FIG. 4 , a mounting element 50 is provided on back surface 46 . In one embodiment, mounting element 50 is suitable for mating with first end 28 of tripod 16 . In one embodiment, mounting element 50 includes nuts, bolts, pivot legs, brackets or other means to facilitate assembly with tripod 16 when the portable stand 100 is assembled for use. Mounting element 50 provides a pivotable connection to tripod 16 . Mounting element 50 is configured to be suitable for attachment to the vertical post of any standard tripod. Any standard mounting configuration is acceptable.
[0024] FIGS. 5A and 5B illustrate side views of shelf extension 12 according to one embodiment. In one embodiment, each of the two elongated flanges 50 include a connection point 26 and bracket 24 , respectively. In one embodiment, brackets 24 include sliding portion 60 , stop 62 , and fixed portion 64 . Fixed portion 64 is fixedly coupled to flange 50 . In one embodiment, stop 62 extends away from flange 50 and joins fixed portion 64 to sliding portion 60 in a z-shaped configuration. In one embodiment, connection point 26 is included on elongated flange 50 . In one embodiment, connection point 26 is a hole positioned on the opposite end of elongated flange 50 with respect to brackets 24 .
[0025] FIGS. 6A and 6B illustrate perspective views of shelf extension 12 . Shelf extension 12 includes two elongated flanges 50 that are connected along elongated side 52 at an angle 54 equal to first angle 48 on shelf 10 . In one embodiment, the corners 56 of elongated flanges 50 which are not connected along elongated side 52 are rounded or smoothed for safety in handling. FIG. 7 is an end view of shelf extension 12 . In one embodiment, the width of brackets 34 extends to be approximately equal to the width of elongated flanges 50 .
[0026] FIGS. 8-10 illustrate embodiments of arm 14 . In one embodiment, arm 14 is an elongated plate including first end 70 and opposite second end 72 . In one embodiment, first end 70 is flat and includes connection 76 . In one embodiment, connection 76 is a hole which corresponds to, and is capable of connecting to at least one of connection point 26 of shelf extension 12 . In one embodiment, beveled portion 74 extends from first end 70 and is slightly angled between horizontal planes of the first end 70 and second end 72 . In one embodiment, extending from beveled portion 74 , toward second end 72 , sides 78 are bent slightly inward along center line or ridge 80 .
[0027] FIG. 11 illustrates portable stand 200 configured for transport or storage according to one embodiment. In one embodiment, portable stand 200 includes shoulder strap 92 and flexible connectors 90 . As discussed above, holes 40 are included in back plate 18 for attachment of a carrying strap as well as holes 42 for attachment of flexible connectors 90 which secure the shelf extension 12 , arm 14 , tripod 16 or other elements to the shelf 12 during transport or storage. In one embodiment, the portable stand 200 may be easily transported with or without the additional use of a carrying bag.
[0028] In one embodiment, flexible connectors 90 secure tripod 16 to back plate 18 by connecting to holes 42 . In another embodiment, flexible connectors 90 are removably secured with one end at holes 42 and an opposing end removably secured at side edge 22 . In one embodiment, flexible connectors 90 are extendable straps of elastic material with hooks at both ends, although other suitable attachment devices may be used. In one embodiment, holes 42 are positioned such that when tripod 16 is secured to back plate 18 , tripod 16 is positioned on top of bottom plate 20 . In one embodiment, tripod 16 is a collapsible stand and is secured to back plate 12 in its collapsed state. In one embodiment, legs 30 are collapsed or retracted parallel to telescoping rod 34 . In another embodiment, additional items may be secured by flexible connectors 90 to back plate 18 . In one embodiment, tripod 16 in a collapsed state, shelf extension 12 and arm 14 are each approximately the length of bottom edge 17 .
[0029] Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.
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A portable stand includes a shelf having a back plate with a front surface and a rear surface, wherein the back plate includes at least two attachment locations and at least one securing locations, a bottom flange forming an angle with the back plate, extending toward the front surface at a first angle from the plate, and a mounting element. The portable stand includes a shelf extension including two elongated flanges formed at an angle equal to the first angle configured to selectively couple to the shelf, and an arm pivotably attachable to the shelf extension.
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CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10/046,767 filed Jan. 17, 2002.
FIELD OF THE INVENTION
[0002] This invention relates generally to an Oro-Pharyngeal Airway, and more specifically to an airway that can be combined with a carbon dioxide monitor, that is used for a sedated or unconscious patient, such as when a patient is under or recovering from anesthesia, for detecting the carbon dioxide in the breath exhaled from the patient.
BACKGROUND OF THE INVENTION
[0003] During surgical procedures, particularly when the patient is under or recovering from general anesthesia, it is highly desirable to monitor the carbon dioxide of the breath exhaled by the patient. The amount of carbon dioxide in the exhaled breath, particularly at the end of the respiratory cycle, known as ETCO 2 , indicates the health of the patient, and can be used to forecast changing conditions of the patient.
[0004] The American Society of Anesthesiologists implemented a new standard mandating the use of carbon dioxide (CO 2 ) monitoring during all general anesthesia, whether in or out of the operating room, for both intubated and non-intubated patients. This new standard of care necessitates recognition, support, and compliance by key personnel involved in the management and delivery of anesthesia and procedural sedation. As the use of procedural sedation expands beyond the operating room, implementation of the standard becomes relevant to a broad spectrum of settings including hospitals and ambulatory care facilities as well as office-based practices for medical, surgical, dental, and oral surgery offices. Capnography, the monitoring of carbon dioxide in the patient's expelled breath, significantly reduces patient's safety risks by giving the earliest detection of hypoventilation.
[0005] Some authorities indicate that capnography should now be considered an essential component of patient monitoring in all situations in which drugs are given that impact levels of consciousness, responsiveness, and airway protective reflexes.
[0006] Qualitative clinical signs such as chest excursion, observation of the reservoir breathing bag, and auscultation of breath sounds are useful. Continual monitoring for the presence of expired carbon dioxide is to be performed unless invalidated by the nature of the patient procedure or equipment.
[0007] In addition, monitoring of other aspects of the patient's breath can also be beneficial, such as the detection of certain drugs, alcohol, DNA, antibodies (including tumor), blood sugar, billirubin, acetone, and other elements in organic and inorganic compounds that might be present in the body.
[0008] Preferably, the sample of the patient's breath should be collected next to the opening of the larynx at the end of the respiratory cycle so that the tested sample will have minimal dilution from the ambient air, therefore be a truer sample for analysis.
[0009] Respiration devices and alarm systems for such devices are known in the art. Alarms are provided for alerting an operator when a patient is not breathing or the patient's breathing is failing outside of a normal breathing pattern. Such respiratory devices that are provided with alarms are disclosed in U.S. Pat. Nos. 3,798,629; 3,802,417; 3,961,627; 4,287,886; 4,366,821; 4,368,740; 4,413,632; 4,417,589; and in my prior U.S. Pat. No. 4,651,746. However, it is desirable to monitor the breath exhaled by the patient at the larynx to provide the evaluation of breath undiluted by ambient air or other conditions of the throat and mouth.
[0010] Another desired situation for monitoring exhaled breath is that the intubation device that reaches the larynx should have the ability to perform several functions, such as insufflation of medication directly to the larynx area of the throat, aspiration of mucus from the throat, monitoring of the breath expelled from the larynx area of the throat, and maintaining a continuously open airway for continuous breathing by the patient, all without removal of the oro-pharyngeal airway from the throat. This is particularly important for infants and children of small size because the small change in condition can be traumatic for the smaller body. Early detection of the change in breath condition of the smaller patient might be critical.
[0011] It is to these problems and objectives that this invention is directed.
SUMMARY OF THE INVENTION
[0012] Briefly described, the present invention concerns a method and apparatus for monitoring the carbon dioxide of a patient's breath, particularly the portion of the breath exhaled at the end of the respiratory cycle from the vicinity of the larynx of the patient's throat during the time when the patient is unconscious, as when the patient is recovering from general anesthesia or when the patient is otherwise incapable of communicating with the surgeon or other medical staff. The monitoring of the patient can be accomplished with a multi-function airway placed in the patient's throat that permits other procedures to be performed without removing the airway.
[0013] In the preferred embodiment, an oro-pharyngeal airway is provided for insertion into the patient's throat. The airway includes an elongated body that is curved to fit the shape of the throat and having a proximal end for placement at the mouth of the patient and a distal end that extends through the throat to the vicinity of the larynx. The elongated body is provided in different sizes and is shaped to be compatible with the size and shape of the patient's throat, by providing airways of different lengths and breadths. The proximal end of the body of the airway is sized and shaped for engagement by the person's mouth, having a radially extending protrusion configured to block the movement of the proximal end into the patient's mouth, thereby stabilizing the proximal end at the mouth of the patient, accessible to the physician.
[0014] The elongated body of the airway defines an open-ended passage extending through the length of the body and being open at the proximal and distal ends of the elongated body. A front conduit segment or nipple extends beyond the radially extending member, with its opening that is approximately coextensive with the open-ended passage. A second conduit segment is positioned between the nipple and the radially extending protrusion so that it will be located outside the patient's mount. The second conduit segment extends approximately radially from the elongated body with its passage formed in a T-shaped intersection with the passages of the nipple and the elongated body. The T-shaped intersection of the passages is of larger breadth and volume than the open ended passage of the elongated body of the airway. The T-shaped intersection forms a plenum outside of the patient's mouth for the accumulation of the exhaled breath of the patient. This larger plenum chamber can accumulate the breath at the end of the respiratory cycle at the proximal end of the airway and progressively feed the end tidal to the monitor at the rate induced by the monitor for a more even measurement of the carbon dioxide or other gas to be detected and measured. The placement of the plenum at the nipple end of the airway allows the airway to include the plenum without increasing the external breadth of the airway that extends into the throat, thereby keeping the external breadth of the elongated body of the airway as small as practical.
[0015] External protrusions extend from the elongated body of the airway and are shaped to engage the facing surfaces of the throat of the patient and form breathing passages that straddle the elongated body and extend along and externally of the elongated body. This provides the patient with a pair of air passages formed along the throat regardless of the manipulation of the open-ended passage extending through the length of the elongated body of the airway.
[0016] When in use, the nipple typically will be connected to a suction device that can intermittently aspirate the throat of the patient through the open ended passage, clearing mucus from the throat and maintaining the air passages that straddle the airway open for breathing. Also, a supply of oxygen can be connected to the same nipple for the purpose of supplying oxygen to the lungs of the patient. Other devices such as an insufflation device can be used to move airborne medication through the open-ended passage to the larynx and lungs. In the meantime, the radially extending conduit that intersects the air passage of the airway can remain closed by the use of a plug or by the attendant's finger covering the opening thereof for controlling the effectiveness of the aspiration or insufflation of the throat, or can be connected to a monitoring device that monitors the content of the exhaled breath of the patient, particularly the breath at the end of the respiratory cycle. The monitor can be a carbon dioxide monitor.
[0017] The monitoring device usually will include an open-ended flexible tube having a first end connected to the radially extending conduit of the airway and its other end connected to the monitoring device. This provides an uncontaminated source of the patient's breath taken at the larynx without dilution or contamination from other sources along the throat and mouth and ambient air about the mouth of the patient.
[0018] A monitor suitable for this use is a capnographic monitor. When the monitor detects an increase or decrease in the carbon dioxide of the patient's breath, this becomes a forecast as to the health of the patient. A noticeable increase in the detection of carbon dioxide indicates, for example, hypoventilation by the patient, whereas a noticeable decrease in the detection of carbon dioxide indicates, for example, recovery from hypoventilation by the patient. This information can be used to decide what drugs are to be used to stabilize the patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] [0019]FIG. 1 is a side view of the airway, showing the airway positioned in the throat of a patient, with the patient shown in dash lines, and with the monitor, oxygen supply and pump shown schematically connected to the airway.
[0020] [0020]FIG. 2 is a perspective illustration of the airway.
[0021] [0021]FIG. 3 is a side elevational view of the airway, partially in cross section to show the plenum at the proximal end of the airway.
[0022] [0022]FIG. 4 is a cross-sectional view of the elongated body portion of the airway, taken along line 4 of FIG. 3.
DETAILED DESCRIPTION
[0023] Referring now in more detail to the drawings in which like numerals indicate like parts throughout the several views, FIG. 1 shows a patient 10 that is intubated with the airway 12 , with the airway extending to the larynx of the patient. The airway, shown better in FIGS. 2 - 4 , includes an elongated body 14 formed of a suitable substantially rigid material, such as a relatively light-weight thermoplastic that can be gas assisted injection molded into the detailed shape. The gas assisted injection method is in any conventionally known method. This is important to the invention to provide the smooth and precisely formed small exterior of the airway that can pass along the throat of the patient, particularly the small patient, while providing a thin wall for forming ample breadth of passage through the interior. While the shapes and sizes of the exterior surfaces of the device are important since they contact the patient, the shapes and sizes of the internal surfaces of the elongated body 14 are not necessarily critical to the operation and function of the invention. Therefore, gas assisted injection molding is a suitable and most desirable form of manufacture of the device.
[0024] The elongated body 14 includes a proximal straight section 16 and a distal arcuate section 18 . A pair of opposed, spaced, longitudinally extending parallel ribbon-like flange elements 20 and 22 are formed on opposite surfaces of conduit 24 . An internal, open-ended passage 26 (FIG. 4) extends throughout the length of the elongated body 14 . The passage 26 terminates in open end 28 , with side ports 30 opening to the side of the conduit 24 at its distal end.
[0025] The flanges 20 and 22 protrude laterally of the conduit 24 , and are sized and shaped to engage the facing surfaces of the throat of the patient, so that the throat surfaces and the flanges, together with the external surface of the conduit 24 , form air passages 28 about the elongated body, so that the patient has open air passages to the outside along the entire length of the elongated body 14 .
[0026] The proximal end 16 of the elongated body 14 terminates in radial protrusions 30 that are formed by a pair of radially extending flanges. This forms a rest for the airway, to rest against the lips of the patient when the patient is intubated with the airway, as shown in FIG. 1.
[0027] A nipple or converging conduit section 32 is mounted to the proximal straight section 16 of the elongated body 14 , with its passage 33 coextensive with the passage 26 of the elongated body 14 . The nipple 32 is formed in a diverging shape so as to be compatible with a friction fit with interior surface of the end of a flexible conduit (not shown) wedged onto the exterior surface of the nipple, when connecting other devices to the airway. In the alternative, the internal passage of the conduit section 32 can be formed in a converging configuration for the wedging of a smaller end portion of a flexible conduit into the passage. Moreover, other connector configurations can be utilized for screwing, clamping, or other conventional means of connecting the flexible conduit to the conduit section 32 of the airway.
[0028] A T-shaped connection is formed by radially extending conduit section 34 , and its open-ended passage 36 communicates with the passage 26 of the elongated body 14 and passage 33 of nipple 32 . Like the converging conduit section 32 , the radially extending conduit section 34 can be of various shapes to expedite the connection of the end portion of an open-ended flexible tube.
[0029] It will be noted that the radially extending conduit section 34 is positioned on the distal side of the radial protrusion 30 , so that the mouth of the patient will not interfere with access to the conduit section 34 .
[0030] As illustrated in FIG. 1, a monitor, such as a carbon dioxide monitor 40 , is connectable to the radially extending conduit section 34 of the airway 12 , while other devices, such as an oxygen supply 42 and/or a spray pump 44 , are connectable individually or together to the converging conduit section 32 of the airway. The dash lines 46 extending from monitor 40 represent flexible open-ended plastic tubing of conventional design. Similar flexible tubing 47 , 48 connects the suction pump 44 and oxygen supply 42 to the nipple 32 .
[0031] [0031]FIG. 3 illustrates the T-shaped intersection of the passage 36 of the radial conduit section 34 with the passages 26 and 33 of the nipple 32 , and elongated body 14 . The dimensions of the T-shaped intersection are of greater breadth than the passages 26 and 33 , forming a plenum generally designated at 50 that is at least twice as large, preferably four times as large as the breadths of the nipple passage 33 and the open ended passage 26 . The plenum is located at the proximal end of the airway, at a position beyond the radial protrusion 30 and beyond where the mouth of the patient is to be placed. This avoids the placement of the plenum in the elongated body of the airway where the size of the airway is to be kept as small as practical. The plenum 50 functions to accumulate a large volume of the exhaled breath from the larynx of the patient, preferably at the end of the respiratory cycle of the patient, forming a larger supply of exhaled breath with high content of carbon dioxide that can be delivered to the monitor at the rate induced by the monitor.
[0032] As stated above, the airway can be manufactured in different sizes for use with patients of different sizes. A different color is applied to each different size airway to designate the size of the airway. The color in the disclosed embodiment is carried by a collar 52 that surrounds the base of the nipple, but the color identifier can be applied in different ways, such as the material of the airway being formed in colors that correspond to the size of the airway.
Operation
[0033] The apparatus can be used in several ways, such as utilizing the suction pump 44 to withdraw mucus from the throat of the patient deep within the throat adjacent the larynx, using the oxygen supply 42 to supply the patient with oxygen, and utilizing the monitor 40 to analyze the breath of the patient, particularly the carbon dioxide content of the breath for the purpose of predicting the physical condition of the patient. Conventional valves (not shown) are used to open and close communication between the airway and the oxygen supply, the suction pump and the monitor so these devices can be use one at a time.
[0034] It will be noted that the distal end portion 18 of the elongated body 14 is placed deep within the throat, adjacent the larynx, so that its passage 26 opens through the open end 28 and the lateral air opening 29 . This allows the suction pump 44 to withdraw the mucus from adjacent the larynx, and also allows the monitor 40 to monitor the condition of the breath at the larynx, before the breath passes through the outer portion of the throat, through the mouth into the atmosphere, thereby avoiding contamination of the breath with additional outside air or other conditions of the throat and mouth. Thus, a more pure sample of the content of the patient's exhaled breath can be obtained with this invention. In addition, the monitoring of the patient's exhaled breath can be continued without requiring further intubation of the patient, without interrupting the other intermittent functions of the airway, and without significant discomfort or injury to the patient.
[0035] In operation of the oro-pharyngeal airway 12 , the device is inserted into the patient's mouth until the curved distal section 18 extends through the back of the patient's throat, adjacent the pharynx. In the meantime, the radial protrusion 30 , in the form of oppositely extending flanges, comes to rest against the exterior of the patient's mouth, avoiding inadvertent movement of the proximal end further into the mouth of the patient. The flanges 20 and 22 engage the facing surfaces of the patient's throat, forming the air passages or channels 28 . Since the flanges 20 and 22 extend along the entire length of the airway, the air passages formed on opposite sides of the elongated body will not be interrupted by any of the functions that are carried on internally of the airway. The patient is then able to breathe through the channels 28 that extend along the exterior of the conduit 24 of the elongated body 14 .
[0036] In addition to the ability of the patient to breathe exteriorly of the elongated body 14 , the patient can also breathe through the internal passage 26 of the airway, as long as the passage is open and not being used for other purposes.
[0037] When it is necessary to perform a throat evacuation to remove fluid, mucus, blood, etc. from the throat, a flexible tubular conduit represented by the dash lines 50 of FIG. 1, is frictionally engaged over the converging conduit section 32 of the airway. The suction pump apparatus 44 is connected to the distal end of the flexible tube and is operated to create a mild suction within the passage 26 of the airway 12 , withdrawing such fluids from the patient's throat. This can be performed without removing the suction airway 12 from the patient's mouth.
[0038] Alternatively, insuflation of the patient's lungs can be accomplished by connecting the tube to a insuflation device, such as an oxygen supply apparatus 42 in order to inject a stream of oxygen through the passage 26 of the airway, through the distal end 28 , down the patient's throat, to the patient's lungs.
[0039] During either the suction or oxygen supply operations, the patient is still able to breathe through the side air channels or passages 28 formed between the airway and the facing surfaces of the throat.
[0040] The radially extending conduit section 34 can be used as a valve by the attending physician, either covered or opened, to control the strength of the suction of the suction pump 44 , by applying the attendant's fingertip to the passage 36 of the radially extending conduit section 34 .
[0041] More importantly, the carbon dioxide content of the patient's exhaled breath can be monitored by the application of a flexible tube to the radially extending conduit section 34 , and extending the other end of the tube to a monitor 40 . This causes the exhaled breath of the patient to be moved directly to the monitor 40 without contaminating the sample of breath with ambient air adjacent the patient's mouth or other contaminants derived from the throat and/or mouth of the patient.
[0042] Although preferred embodiments of the invention have been disclosed in detail herein, it will be obvious to those skilled in the art that variations and modifications of the disclosed embodiments can be made without departing from the spirit and scope of the invention as set forth in the following claims.
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An oro-pharyngeal airway includes external air passages ( 28) formed between it and the facing surfaces of the patient's throat for continuous breathing by the patient. The open-ended passage ( 26) of conduit ( 24) transmits exhaled breath of the patient directly from the distal end of the airway at the larynx into the plenum ( 50) at the proximal end of the airway, and the breath is extracted radially from the plenum though the conduit section ( 34) and is analyzed by monitor ( 40). Alternatively, oxygen can be provided from source ( 42) through the converging conduit section ( 32) of the elongated body, and mucus, etc. Can be aspirated from the larynx area of the throat by suction pump ( 44). These functions can take place without the need for additional intubation of the patient.
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This application is a continuation of U.S. patent application Ser. No. 10/182,213, which is a national stage application under 35 U.S.C. 371 of PCT/GB00/04873, filed Dec. 18, 2000, and claims priority benefit of GB Patent Application 0002382.0, filed Feb. 3, 2000.
Almost all hospitals in the western world are provided with sterilizing equipment to ensure the sterility of instruments and devices which may come into contact with humans. The risks and dangers of conducting operative procedures on living creatures including animals and humans with non-sterile equipment and in non-sterile surroundings is well documented. In an environment in which patients expect to be treated successfully and in a sterile manner, the requirement for effective sterilization is an essential one, and devices have been developed to test the efficacy of sterilizers and sterilization.
Although the following description relates exclusively to the use of sterilizer test devices in hospitals, the device of the present invention has much wider application, and specifically can be used in bench top sterilizers such as might be provided in community healthcare and animal care clinics for the sterilization of utensils, dressings, medical textiles and the like.
Modern sterilizers, many of which are in the form of high pressure autoclaves, subject their contents to high temperature steam for a predetermined period of time. The three fundamental parameters of the sterilization process are accordingly time, temperature, and the presence of steam. Effective sterilization can only be achieved if there is steam contact with all parts of the load to be sterilized for the correct period of time. Air trapped and entrained within the load will prevent this necessary steam penetration. The thermodynamic irregularities of air/water vapour mixtures, and the necessarily hostile environment developed inside cabinet autoclaves makes the monitoring of sterilization process difficult, and therefore a simple visual indicator test was developed.
In the 1960s, the Bowie Dick test assessed whether the air removal stage of the sterilization process was sufficient to ensure rapid and even steam penetration to all parts of the load. The test involved placing within the sterilizer a stack of towels approximately 11 inches high and having a cross-sectional area roughly approximating to the size of an A4 sheet of paper. Within the stack at approximately half height thereof, there was placed a sheet of paper on one surface of which was applied a pattern of a chemical indicator ink which was extremely sensitive to and changed colour in the presence of high temperature steam. The test was performed by simply placing the stack towels within the sterilizer, and initiating a standard cycle of the sterilizer which would be carried out on, for example a tray of surgical instruments, hospital bed linen and the like, for a certain period of time, for example 3-4 minutes. On removal of the stack of towels, the indicator sheet was inspected for a uniform colour change of the indicator over the entire surface of the sheet, and if this was the case then the sterilizer air removal stage was considered to be functioning effectively.
It is well known that heat alone can provide effective sterilization, however the rapid inactivation of microorganisms is significantly faster in the presence of moist heat (steam). For example, effective sterilization can be achieved by subjecting material to dry heat at 160° C. for 1 hour, whereas the same level of sterilization can be achieved by introducing steam at 130° for 3 minutes.
In the Bowie Dick test, the towels were used as what is now termed a “porous load”. Such loads are deemed one of the most difficult to assess the penetration characteristics of the steam or to provide some resistance to the steam as it progresses towards the indicator sheet. The rationale behind this test is that if the steam can penetrate the porous load to adequately change the colour of the indicator sheet, then any medical device, textile or the like having a lower resistance to steam penetration will be effectively sterilized.
A current modification of the original Bowie & Dick test is the use of a disposable or reusable barrier surrounding a chemical indicator sheet. This is calibrated to perform in a similar manner to the original Bowie & Dick towel pack with a chemical indicator inserted. After the pack has been subjected to a conventional sterilization, the indicator sheet is removed and inspected for a uniform colour change over the entire surface area of the sheet, which is indicative of the effective operation of the sterilizer air removal stage.
A disadvantage with this method of testing is that the product once used must be discarded. When it is considered that millions of tests are conducted annually in hospitals and other sterile environments around the world, the cost saving to be made by a reusable device may be considerable.
One alternative currently available to the disposable test pack described above is a device which comprises a coiled narrow lumen approximately 2-3 metres in length and having a diameter of approximately 2 mm, open at one end and connected at its alternate end to a small accessible capsule into which a chemical indicator can be placed. In use, the coiled lumen is placed inside the sterilizer whereafter the sterilization procedure is initiated during which the steam gradually progresses along the interior of the lumen until reaching the capsule into which the lumen passes. The efficacy of steam penetration can be assessed based on the chemical indicator result. Thereafter, the device may be reused, using a new indicator in the capsule.
The length and narrow entrance of the lumen open end render the lumen arguably not analogous to a porous load for reasons of mass, directional sensitivity, and physical shape etc.
Hence there are a number of serious disadvantages associated with the lumen device. Firstly, the history of use of the device cannot easily be established and although the chemical indicator may be replaced before each use of the device, there is no guarantee that the device was not previously mistreated or was not fully prepared for the next use by the previous user. It is to be borne in mind that in a busy hospital, the device may simply left proximate the sterilizer for use by any of the numerous staff who have cause to use same.
Secondly, there is a risk that the openable capsule is not securely closed. This would allow the steam an easier path to the open end of the indicator tube within the capsule, and thus the device could give the false indication that the sterilizer was functioning satisfactorily.
Thirdly, steam has a propensity to condense on the external, and more importantly the internal walls of the lumen. If sufficient steam condenses of the internal wall of the lumen along the path to the capsule, there may be a plug of condensate which could prevent the steam from reaching the open ended indicator tube within the capsule.
Fourthly, the problem of condensation is also apparent when the lumen is removed after the test has been completed, and in some cases there can be a fine mist of water vapour or a fluid bubble retained within the lumen. When a subsequent test is conducted, the lumen is heated in the sterilizer and by means of conduction, this water vapour could also heat and be urged towards the chemical indicator within the capsule. The device could in this circumstance also provide false results.
Finally, it is contended by many of those in the art that the single narrow opening through which the steam passes before travelling the length of said lumen is too directionally sensitive, that is it does not provide a fair average of the steam penetration characteristics within the sterilization chamber.
Examples of directionally sensitive sterilization test devices are shown in consecutive published patent applications PCT/DE94/00687, PCT/DE94/00688, PCT/DE94/00689, all to Van Dijk Medezintechnik GmbH. All these documents disclose essentially cylindrical hollow test devices, one end of which is closed off from the atmosphere by means of a plug or stopper proximate to which a chemical indicator means is positioned in an inner chamber of the device, the alternate open end of the devices having different inserts provided therein to provide a penetrable barrier through which steam must pass to interact with the chemical indicator within the device.
In particular, PCT/DE94/00687 discloses the use of a threaded plug which is screwed into the open end of the device but which has threads of marginally lesser diameter than those provided internally of the device such that a helical channel is defined between the threads of the plug and those of the device. This device is effectively similar to the lumen device disclosed above, with the exception that a fixed helical path leads from the exterior of the device to the chemical indicator, as opposed to the spiral path along which the steam can travel within the lumen.
PCT/DE94/00688 discloses the use of an array of capillaries provided between the inner chamber of the device in which the indicator is located and the alternate open end of the device from which the steam within a sterilizer can penetrate, and PCT/DE94/00689 discloses the use of a porous material plug through which the steam can penetrate towards the indicator located in the inner chamber of the device. Neither of these latter two patent applications is specifically directed towards the use of a so-called “tortuous path” such as is provided by the helical path disclosed in PCT/DE94/00687 or the spiral path along which the steam travels in the lumen of the abovementioned current devices, whereas PCT/DE94/00687 does not consider the use of a so-called “porous load”.
Additionally, all the devices disclosed in the abovementioned patent applications are directionally sensitive in that steam can only begin to penetrate either the tortuous path or the porous load (or equivalent load) from one particular side, and furthermore only on one particular surface of the device. It is to be mentioned that the conditions within autoclave units in general are extreme and non-uniform, and it is possible that the directional sensitivity, which term is used to describe the generally linear path along which the steam or other sterilant travels before coming into contact with the indicator, of such devices can result in the device producing false results.
It is an object of the present invention to provide a sterilizer test device which at least mitigates if not eradicates the disadvantages of the prior art devices, and which is furthermore reusable and combines the advantageous qualities of the devices mentioned.
SUMMARY OF THE INVENTION
According to the present invention there is provided a sterilizer test device comprising a pair of bodies releasably and sealably connected together defining an internal primary chamber within the device to which access is gained by disconnecting said bodies, at least one of said bodies being essentially comprised of a porous element which allows penetration of steam therethrough and into said primary chamber, indicator means being provided between said bodies at some location within the primary chamber, said indicator means having a characteristic which changes while in the presence of steam and temperature after a predetermined time, characterised in that said porous element has one or more external surfaces through which steam can penetrate in a plurality of different directions.
Preferably intermediate tortuous path means is additionally provided internally of the device and sealingly divides the primary chamber into two secondary chambers, a first secondary chamber being defined between the tortuous path means and an inner surface of said at least one body through which steam having permeated said body emerges, and a second secondary chamber being defined to the alternate side of said tortuous path means from the first secondary chamber and having the indicator means disposed therein, said steam being constrained to flow into and around said tortuous path means before emerging into the second secondary chamber and thence coming into contact with the indicator means.
Preferably the said at least one body is provided with a substantially arcuate outer surface. In one embodiment, the said at least one body is preferably cylindrical.
Most preferably, the outer surface of the porous body is substantially continuous around at least one axis of the device.
It is most preferable that the two bodies connected together to form the device have a predetermined degree of porosity, and furthermore it is preferable that each of said two bodies is substantially hemispherical.
It is yet further preferable that at least one of the bodies is provided internally with a cavernous recess to increase the effective volume of the primary chamber.
It is further preferable that the porous bodies are manufactured from a sintered polypropylene material, which has the advantage that its porosity can be varied according to requirements of a particular device, and also that it can be formed in any desired shape. In an alternative embodiment, the porous bodies are manufactured from a spun bonded polymer material, but the manufacturing process for such materials is limited in that only articles having certain geometric shapes (such as a cylinder) can be produced because of the manner in which the polymeric material is spun.
It is yet further preferable that apertured diaphragm means is provided internally of the primary chamber substantially across the base of one of the said bodies thus defining a tertiary chamber with the surfaces of the cavernous recess in which steam having permeated the porous element from a plurality of different directions can collect before passing through said aperture into either the remainder of the primary chamber or the first secondary chamber.
It is also to be mentioned that such an apertured diaphragm could be used to sealingly divide either the first or second secondary chamber and thus define first and second tertiary chambers from said secondary chambers, and that two apertured diaphragms could be used to divide both the first and second secondary chambers as desired.
The division of the internal primary chamber into secondary and tertiary chambers has been shown experimentally to improve the overall performance of the sterilizer text device as a whole. Not wishing to be bound by theory, it is believed that this enhancement of performance is achieved because of the facility for steam to collect in the volume of the secondary and tertiary chambers in use which removes the effects on performance of the traditionally cyclical and intermittent operation of modern sterilizers, i.e. the alternate drawing of a vacuum and the introduction of steam into the sterilizer during use to substantially eliminate air.
In a further aspect of the invention there is provided a tortuous path means for use in a sterilizer test device of the type described above, said means comprising at least two substantially planar components having an outer surface and an inner surface separated by their thickness, said components being releasably connected together to bring their respective inner surfaces proximate one another, one or other or both of said components being provided with patterned grooved means on their inner surfaces following a labyrinthine, spiral or other tortuous path on said surface, one of said components being provided with an entry port leading from an outer surface of said component through the thickness thereof and opening at a particular location in said grooved means, characterised in that an intermediate member is sandwiched between the two components to sealingly close said grooved means and define a tortuous channel to at least one side of said intermediate member.
Preferably an exit port is also provided to allow fluid to escape from a particular location in the grooved means, or alternatively there is provided a recess in said inner surface of one of said components in which indication means as described above can be deposited.
Preferably the intermediate member is compressible to ensure sealing formation of said channel.
Preferably grooved means are provided on the inner surfaces of both components and the sandwiching of the intermediate member forms channels with each of said grooved means on either side of said member.
In a most preferred embodiment the components are hingedly connected over at a portion of their respective edges.
It is also preferable that the entry port of one component opens into the grooved means on the inner surface thereof proximate one end of said grooved means, and also that the exit port provided on the alternate component opens into the said grooved means in that component proximate one end thereof.
Most preferably, the intermediate member is secured to the hinged connection of the two components which ensures the correct positioning of said intermediate member when the said two components are releasably connected together.
It is yet further preferable that the intermediate member is provided with an aperture therein which links respective tortuous channels defined by said intermediate member on either side thereof.
In a yet further preferable embodiment, a chamber is defined internally of said tortuous path means in which steam can collect prior to being urged along said tortuous path.
It will be immediately understood by those skilled in the art that the provision of separable components having grooves brought together during the connection of the components to define respective channels with the intermediate compressible member allows for easy cleaning and airing of the grooved means. Hence, the device according to the invention can be both readily aired and cleaned while nevertheless being re-usable.
When the tortuous path means are used in connection with the sterilizer test device described above, the steam first permeates the porous bodies which substantially constitute the device and then is constrained to flow into a chamber of the device and thence through the tortuous path means before emerging therefrom into a further cavity in which is disposed the indicator means. The particular indicator means used is not important, and the device can be calibrated for use with a variety of different indicator types, such as chemical, biochemical, biological. It is also foreseen by the applicant that electronic sensing and detection apparatus may be used in place of the indicator means to provide accurate data logs on the characteristics of the atmosphere extant in the device in any of the chambers defined therein as a function of the time after the commencement of any particular sterilization sequence.
The fundamental advantages of the present invention are firstly that the use of cylindrical or hemi-spherical porous bodies to form the device allows steam to permeate into said bodies from any direction as substantially the entire surface of these bodies are porous, and secondly that the tortuous path means can be easily, simply, and quickly opened up to allow for airing and drying of the tortuous path. Thereafter both the test device and the tortuous path means can be reused. Obviously a quadrangular porous body having two or more of its external surfaces exposed to the steam to allow for penetration thereof would function in a similar manner.
BRIEF DESCRIPTION OF THE DRAWINGS
A specific embodiment of the invention is now given by way of example with reference to the accompanying Figures wherein:
FIG. 1 shows an exploded perspective view of a cylindrical test device in accordance with the invention,
FIG. 1A shows a perspective view of an apertured diaphragm which may be used in conjunction with the invention, and
FIG. 2 shows an exploded perspective view of a spherical test device in accordance with a different embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
Referring firstly to FIG. 1 there is shown a sterilizer test device indicated generally at 2 comprising an annular base 4 which on which the device stands when within a sterilizer, a cylindrical porous body 6 having a cavernous bore 8 provided therein of a depth less than that of the body 6 and chosen as required by the particular application. Above the body 6 , a number of different components are provided to allow the device to function correctly. The first of these is an annular cap 10 having formations 12 , 14 , 16 , 18 which permit the rotating locking connection of other components above said cap.
It will be seen from the diagram that the cap 10 is provided both with a collar 20 which is chamfered around its outer surface shown at 22 and is marginally greater in diameter than the body 6 over which it is disposed. An annular inner surface 24 is provided at approximately the median of the depth of the cap, and above and around the periphery of said surface 24 there is provided an annular skirt 26 which defines a circular recess with the said surface 24 . An aperture 28 allows steam which has permeated through the porous body 6 to pass from the upper surface 30 thereof and from within the cavity 8 through the cap 10 .
The apertured diaphragm 25 may be sealingly disposed either on the inner surface of the body 6 over the cavernous bore 8 or in the aperture 28 so that a tertiary chamber is defined by said diaphragm and said cavernous bore internally of the body, as this has experimentally shown to improve the performance of the device, that is to more accurately determine if a particular sterilizer under test is efficacious.
In accordance with the invention there is provided a tortuous path device consisting of three components 32 , 34 , 36 which are hingedly connected together around their circumferences at hinge means 38 , 40 , 42 respectively. Specifically, the hinge means 38 is a protrusion, 40 is an aperture of marginally greater size than said protrusion and through which said protrusion is fed before locating in a recess 42 in the component 36 in which it is pinned by means of rod 44 .
With specific regard to said components 32 , 34 , 36 , the first and third components 32 , 36 are substantially planar and provided with spiral grooves 46 in one surface (only shown in respect of component 32 ). The second component 34 is an intermediate component ideally of a compressible material which is sandwiched between components 32 , 36 on releasably connecting same together and ideally sealingly forms spiral channels with the said grooves provided in the surfaces of the first and third components on either side thereof.
The first and third components 32 , 36 are provided with apertures (one of which is shown at 48 in the component 36 ) at their centres which form entry and exit ports to the spiral channels formed between said components. The intermediate component 34 is additionally provided with an aperture 50 which allows fluid communication between the channel formed in the component 32 on one side of component 34 and channel formed in component 36 . Thus the fluid enters the spiral channel formed in the first component through the aperture in said component 32 at its centre, and is subsequently constrained to spiral outwardly from said centre until reaching the aperture 50 (which is ideally located at the end of the spiral groove 46 ). The fluid can then move through the aperture 50 and into the second spiral channel and wherein it is constrained to spiral inwardly towards the aperture 48 from which it ultimately emerges.
The entire arrangement of the tortuous path device ( 32 , 34 , 36 ) is received in the upper recess defined in the cap 10 by the surface 24 and its peripherally surrounding skirt 26 and optionally locked therein behind suitable flanges provided on the skirt 26 . As the device 2 is assembled, the pre-assembled tortuous device ( 32 , 34 , 36 ) may be simply dropped into said recess and rotated by means of thumb indentations (not shown) provided on the upper surface of component 38 .
Once secured in place, an indicator (not shown or described in this application as being considered beyond the scope hereof) is positioned above the aperture 48 , and a lid 52 having depending skirt 54 is secured to the device by interengagement of formations (not shown) provided on the inner surface of said skirt 54 with the formations 12 , 14 , 16 , 18 provided on the cap 10 . The device is then placed in a sterilizer which is then activated, and after a conventional sterilization operation is complete the device is removed and opened for inspection of the indicator.
It is to be mentioned that the device may be inverted, the base 4 dispensed with, and the lid 52 may be suitably designed to function as a base having an inner surface in which an indicator may be disposed. In terms of the wording of the claims appended hereto, the primary chamber internally of the device is defined by the cavernous bore 8 and the inner surface of said lid 52 through the aperture 28 . This chamber is sealingly divided by the interposing of the tortuous path means ( 32 , 34 , 36 ) on either side of which are defined first (on the side of the cavernous bore 8 ) and secondary (on the side of the lid 52 inner surface) chambers. The first secondary chamber may again be divided by the interposing of the apertured diaphragm 25 as previously mentioned so that a tertiary chamber is defined within the body 6 by said cavernous bore 8 and said diaphragm.
It is also to be mentioned that the device described with reference to FIG. 1 can be used as a sterilizer test device without the tortuous path means described above. An indicator may simply be placed on the annular surface 24 or within the lid 52 to which steam can gain access after having first permeated the porous body 6 .
Additionally the configuration of the device 2 is adapted to be further modified so that the porous body can be removed leaving only the base 4 , cap 10 , tortuous path means ( 32 , 34 , 36 ) and lid 52 .
However, use of the complete device having both porous body and tortuous path means is preferred.
Referring now to FIG. 2 there is shown a modified configuration of sterilizer test device 100 . The device comprises of a tortuous path device ( 32 , 34 , 36 ) as hereinbefore described disposed internally of the device, and two hemispherical porous bodies 102 , 104 . Body 104 is provided internally with a cavity 106 in which steam may collect, and the portions of both bodies 102 proximate their diametral planes are received in the hingedly connectable skirt members 108 , 110 having hinge formations shown at 112 , 114 .
As with the embodiment shown in FIG. 1 , a suitably sized apertured diaphragm may be used to define a chamber with said cavity 106 as previously discussed.
The skirt member 108 is provided with a plurality of slots 116 , 118 through which steam emerging from the planar surface 120 of body 102 can pass. When assembled together, the configuration is such that steam permeating through the body 102 passes to the outside of the tortuous path device and towards and into the cavity 106 without coming into contact with the indicator (not shown) which is disposed between the outer surface of the component 32 and the rear surface 122 of the cap 108 . The disposition of said indicator, possibly within a recess defined in said rear surface 122 , and the clamping arrangement of the two caps on the tortuous path device ( 32 , 34 , 36 ) thereover ensures that steam cannot adversely affect the indicator such that the device would give rise to false results.
In a similar manner to the operation of the device shown in FIG. 1 , the device 100 can be easily and quickly opened and the tortuous path device released from over the indicator which can then be inspected to ensure that a sterilizer is functioning correctly. Additionally, the tortuous path device can be removed quickly, and opened for drying and cleaning.
It is to be mentioned that the various arrows provided on the diagrams are indicative of the possible flow of steam from outside the devices and the particular flow paths possible inside said device. It is most important to note that both the devices disclosed herein are both reusable and “directionless” in that steam drawn towards the devices when inside an operative sterilizer can permeate through the porous body as soon as it comes into contact therewith. This is in sharp distinction to the currently available devices which are either not re-usable or which although being of similar size and shape to the devices described herein, generally provide only a few discrete ports through which access to a porous medium is contained. Such devices are heavily directional, and therefore disadvantaged in comparison to the present invention.
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A re-usable sterilizer test device is disclosed which is comprised of at least two parts which are releasably connected together. An indicator device which changes color in the presence of steam after a certain time period is deposited within the two parts. One or both of the bodies is manufactured from a material having a predetermined degree of porosity as regards steam and is generally cylindrical or spherical so that the outer surface of said one or both bodies forms a significant and substantial portion of the external surface of the assembled device. Steam penetrates the porous body and passes into a cavity inside the body from where the steam can move internally of the device through suitable passageways and into a chamber where the indicator is located.
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CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application is a non-provisional patent application that claims priority to Provisional Patent Application No. 60/588,678 filed on Jul. 16, 2004, entitled, “Bed Side Rail Method and Apparatus,” which is incorporated herein by reference thereto.
BACKGROUND
[0002] In general, bedside support devices am provided to assistance to patients or other individuals in need of a certain amount of support when getting out of bed or repositioning themselves. Many of the prior art devices have a static portions that are rigidly attached to the central lateral portion of a bed or adjacent structure which often times places a patient in peril in the event she is wedged between the static rigid portions and the lateral region of the bed. It is therefore in objective to provide a bedside rail support that is adapted to allow a handle region which repositions laterally and provides sufficient vertical support to the patient so she can reposition herself to a sitting position and stand with a certain amount of assistance from the bedside support device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] FIG. 1 shows an isometric view of the bedside support device.
[0004] FIG. 2 shows a side view of the bedside support device.
[0005] FIG. 3 shows an isometric view of the securing mechanism.
[0006] FIG. 4 shows a view of a patient grasping the handle region of the bedside support device.
[0007] FIG. 5 shows a patient positioning herself in a sitting orientation and applied a vertically downward force upon the handle region of the bedside support device to aid in raising herself from the bed.
[0008] FIG. 6 shows the patient in a standing position where the bedside support device provides mobile assistance to the patient.
[0009] FIG. 7 shows the handle region of the bedside support device in an extended lateral position.
DETAILED DESCRIPTION
[0010] The bedside support device 20 as shown in FIG. 1 is shown in one form. The general environment for the bedside support device 20 is shown in FIG. 5 where the device 20 is mounted to a bed indicated at 10 . The bed comprises a bed frame 11 . The bed frame comprises a corner region 12 and a lateral region 13 . An axis system 14 is defined as shown in FIG. 4 . The longitudinal axis 15 extends in a longitudinal direction and generally indicates the same. The lateral axis 16 indicates a lateral direction and the vertical axis 17 indicates a vertical direction. Of course the axis system 14 is for general reference purposes and indicates general directions that are not categorically perfectly orthogonal to one another.
[0011] With the foregoing in mind, there will first be description of the mechanical components of one form of the bedside support device 20 with reference to FIGS. 1-3 followed by a description of a the of operation of the bedside support device 20 .
[0012] As shown in FIG. 1 , the bedside support device 20 comprises a mounting region 22 and a support bar 24 . The mounting region 22 has a pivot attachment member 26 that is fixedly attached to a base frame 28 . In one form, the base frame 28 comprises a first member 30 and a second member 32 . The first and second members 30 and 32 are fixedly attached at the juncture 34 . In one form, these items are permanently attached to one another in an orthogonal relationship and are adapted to be fitted to a corner region 13 of the bad frame as shown in FIG. 3 . In one form, the mounting region 22 is made from a suitable metal in a configuration such as channel iron or the like to be adapted to handle the transmitted loads from the support bar 24 .
[0013] The pivot attachment member 26 in one form is a tubular sleeve 40 having an internal bushing or bearing to provide rotation substantially about a vertical axis. The internal bushing or bearing provides an internal cavity adapted to receive the lower portion of the base region 60 of the support bar 24 . As shown in FIG. 3 , the base region 60 extends through the lower region of the pivot attachment member 26 . In one form, the pivot attachment member 28 has a securing mechanism 46 having a spring-loaded pin device adapted to be received by channels such as channel 443 as shown in FIG. 3 . There can be numerous channels 48 in the base region 60 of the support bar 24 . As shown in FIG. 3 , an interior channel behind the pivot attachment member 26 is present where the security mechanism 26 has an internal pin extending therein. As shown in FIG. 3 , the channel 48 has a first engagement surface 50 and a second engagement surface 52 . These engagement surfaces are adapted to be received by the outer cylindrical surface of the pin of the security mechanism 46 in order to limit the rotational range of the support bar 24 . By providing a plurality of slots 48 the height of the support bar 24 can be effectively adjusted. As described further herein, the support bar 24 is adapted to freely rotate away from the lateral region of the bed so the occupant of the bed is not inadvertently pinched if he or she accidentally undergoes a traumatic fall or rolls off the bed.
[0014] As shown in FIG. 2 , the support bar 24 comprises a base region 60 and a handle region 62 . The handle region 52 comprises a substantially horizontally extending grasping area 63 . The base region 60 as described above is adapted to cooperate with the pivot attachment member 26 of the mounting region 22 to provide a one degree of freedom motion of rotation substantially about a vertical axis. Of course other forms of repositioning can be obtained such as the use of a linkage system instead of a peer rotational system. However, a pivot rotation about a substantially vertical axis is one way of allowing repositioning of the handle region 62 with respect to the bed frame.
[0015] Essentially, the base region 60 and handle region 62 are fixedly connected at a joinder portion 64 . In a preferred form of manufacture, the regions 60 and 62 are of a single piece of metal that is that substantially at a ninety-degree angle from one another, however other angle relationships can be employed. Further, the lower portion of the base region as mentioned above is adapted to extend through the open chamber region of the pivot attachment member 26 to provide a limited rotational movement therein.
[0016] In one farm, the resistance of the rotation about a vertical axis can be provided to dampen the rotational movement of the handle region 62 . This can be accomplished by having a sleeve that is constricted to provide circumferential friction about the base region 22 . This could be advantageous where it is desired to have a handle region 62 that repositions with a certain degree of resistance to provide some stability but will reposition in the event the patient falls off the bed and requires a safety limitation to fall freely without being pinched or strangled by any fixed open perilous gaps.
[0017] Now referring to FIG. 4 , a patient 70 is shown lying in the bed 10 . As shown in this figure, the patient grasps the handle region 62 and places a lateral and vertically downward force thereto. This load is transmitted to the base region 60 and through the pivot attachment member 26 . This load is transmitted to the mounting region 22 . The mounting region 22 in one form is fixedly attached to the corner region 12 of the bed 10 . This mounting region should be positioned at a corner region that has the lowest probability of a patient falling. In other words, the mounting region 22 would not be positioned in the central lateral portion of the bed because of the hazard of having a rigid structure attached to the bed frame which presents a perilous choking and suffocating hazard to a patient in need of assistance.
[0018] Now referring to FIG. 5 , the patient 70 was able to pull herself to a sitting position alongside the lateral region 13 of the bed 10 from this position as shown in FIG. 5 , the patient 70 desires to stand and move away from the bed 10 . Therefore, the patient will put a vertical load downwardly as indicated by the force vector 72 upon the handle region 62 of the bedside support device 20 . The patient 70 can further flex her upper torso and have a laterally inward force to position her center of gravity near the handle region 62 . Once the user stands up as Shawn in FIG. 6 , the handle region 62 freely repositions to a lateral direction and in one form pivots in a lateral and longitudinally forward position as shown in this figure. The patient can continue to put a downward force upon the handle region 62 to assist her. This is particularly advantageous when the patient is getting up after a period of not being on her feet and she requires the blood to get flawing to her legs for proper bipedal motion. In the event that her foot is asleep or she suffers any other temporary or permanent ailment, the patient 70 can back up where the handle region 62 freely allows this reverse motion and she can sit back down on the bed safely as shown in FIG. 5 .
[0019] If the patient feels that she can travel away from the bed, she can reposition the handle region 62 to a fully extended lateral position as shown in FIG. 7 whereby at this stage the patient 70 has the confidence to walk without any assisting device. Alternatively, a mobile bipedal motion assisting device such as a walker could be positioned at the distal lateral location from the bed 10 and the user could grasp this device to transfer herself to a desired location.
[0020] Of course various modifications and alterations can be performed without departed from the spirit scope of the invention.
[0021] From the foregoing, it will be appreciated that specific embodiments of the invention have been described herein for purposes of illustration, but that various modifications may be made without deviating from the spirit and scope of the invention. Accordingly, the invention is not limited except as by the appended claims.
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A bedside support device is disclosed. In one embodiment, the bedside support device is attachable to a bed assembly and comprises a mounting member attachable to the bed assembly, and a support bar attached to the mounting member. The support bar having a base portion rotatably mounted to the mounting member and is free swinging relative to the mounting member between first and second positions. The support bar has a handle portion attached to the base portion and is moveable in a plane relative to the bed assembly as the base portion moves between the first and second positions.
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BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a game that involves directing an object at a moving target and particularly to a game in which a moving object is guided along a predetermined path that is alternately blocked and opened by a moving barrier.
2. Description of the Prior Art
Representative examples of games in which rolling balls or other moving game pieces are directed at moving targets, pockets or entryways are provided in U.S. Pat. No. 1,481,786 issued Jan. 29, 1924 to G. T. Barber, U.S. Pat. No. 1,538,449 issued May 19, 1925 to F. Schulz, and U.S. Pat. Nos. 1,567,251 and 1,656,272 issued Dec. 29, 1925 and Jan. 17, 1928, respectively, to J. Ekstein.
The U.S. Pat. No. 1,481,786 to Barber shows a game having upwardly inclined parallel alleys that are substantially tangent to the upper surface of a drum rotating about a horizontal axis. The alleys are interrupted by an arcuate portion of the drum, which has a number of spaced holes at axially spaced locations aligned with the center of each alley. The object of the game is to roll a ball up one of the inclined alleys so that it arrives at the top coincidentally with a corresponding hole in the drum. If its velocity is not too great, the ball will then drop through the hole into the drum and return to the player via a discharge chute and return alley. If the player misses one of the holes in the drum or the velocity is too great, the ball continues in its path over the top of the drum to the end of the alley, where it drops into a vertical chute connecting with the return alley.
In the game apparatus of Schulz U.S. Pat. No. 1,538,449 a ball is rolled down an inclined board having side rails that converge to a discharge passageway. A horizontal disk is mounted for rotation about a vertical axis, the edge of the disk being adjacent to the discharge passageway. The disk has spaced openings cut out of its edge, and the object of the game is to drop the ball through one of these openings when the opening is aligned with the discharge passageway from the board. The ball will then drop through a vertical chute and strike a trigger to actuate a mechanism for delivering a prize to the player. If the ball passes through the discharge passageway when a disk opening is not so aligned or at too great a velocity, the ball will pass radially across the disk into a central well.
In the earlier Ekstein U.S. Pat. No. 1,567,251, a motor-driven vertical shaft carries a spider that supports radial channels for rotation past the end of a chute. The object of the game is to roll a ball down the chute so that it arrives at the end coincidentally with one of the radial channels. If the player is successful, the ball will enter the radial channel and be deposited in a center cup; otherwise the ball will strike a baffle and be deflected into a return chute leading to a receptacle for returned balls. In an alternative embodiment, the successful shot passes from the radial channel into a vertical tube leading downward from the inner end of the channel and thence through an arcuate slot in a support base for the rotating structure to another chute leading to the receptacle for returned balls.
The second Ekstein U.S. Pat. No. 1,656,272 discloses improvements to the earlier game apparatus. These improvements include substitution of closed pockets for the radial channels and provision for oscillatory vertical motion of the outer ends of the pocket structures superimposed on their horizontal rotation. In an alternative embodiment, a vertical disk is mounted for rotation on a horizontal shaft, with the plane of the disk parallel to the direction of a discharge chute. A number of angularly spaced pockets are mounted on the disk for successive alignment with the end of the chute as the disk rotates.
In the foregoing prior art games the moving ball changes either speed or direction as the result of a successful encounter with a moving entryway or pocket. In some of them, such as the Schulz and Barber games, successful interception requires not only proper timing but also that ball velocity be below some maximum value. In none of them is the size of the entry or pocket adjustable to adapt the game to players having varying degrees of skill.
SUMMARY OF THE INVENTION
The apparatus of the present invention provides a rotating go-no go barrier for a game or toy in which a rolling ball or other moving game piece is directed in a predetermined linear path by an elongated guideway. Although adaptable to many game situations, the present invention is intended primarily to increase the educational and game value of the modular space toy disclosed in my prior U.S. Pat. No. 3,686,789, issued on Aug. 29, 1972, by adding launch or encounter window simulation to the interplanetary space travel game described in that patent.
Accordingly, it is an object of the present invention to provide a game apparatus in which a moving barrier alternately blocks and unblocks a guideway for a moving game piece.
It is another object of the invention to provide a game apparatus having a rotating barrier with an opening of selectively adjustable size for alternately preventing and permitting passage of a moving game piece along a predetermined path, the relative duration of the passage preventing and permitting periods being determined by the selected size of the opening.
Another object of the invention is to provide a pivoting target mounted in an opening of a rotating transverse barrier positioned across a guideway such that passage through the opening of a game piece moving along the guideway will cause the target to pivot from a first predetermined position to a second predetermined position.
It is still another object of the invention to provide a motor drive train for a rotating barrier to produce a constantly varying speed of rotation.
These and other objects are accomplished by a game apparatus that includes an upright stand; a guideway attached to the stand for guiding a moving game piece along a predetermined path; a movable barrier in the form of a disk having a portion cut out from its circumference; means for mounting the disk on the stand directly above the guideway for rotation about the center of the disk in a plane transverse to the direction of the predetermined path such that passage of a moving game piece along the predetermined path is prevented by the disk except when the cut out portion is aligned with the guideway.
The disk preferably is equipped with a movable shutter for selectively varying the circumferential extent of the cut out portion to vary correspondingly the relative times that the guideway is blocked and unblocked during each revolution of the disk.
The disk also preferably includes a target plaque pivotally mounted in a cut out portion of the circumference for rotation from a first position in which one face of the target plaque is presented to a game player to a second position in which the reverse face of the target plaque is presented to the player.
To prevent a game piece that did not pass the barrier from bouncing back and obstructing the guideway, the game apparatus preferably also includes a one-way barrier in front of the disk that may comprise simply a step down in the guideway, with the riser of the step serving as a barrier to trap the game piece between the riser and the face of the disk. Protrusions, such as radial flanges extending from the face of the disk, then sweep the trapped piece laterally from the guideway to clear the path for the next game piece.
Means for rotating the disk may include a handcrank or preferably an electric motor driving through gear trains to provide either constant speed rotation or, optionally, continuously variable rotation speeds.
These and other features and objects of the invention will be apparent from the following description of preferred embodiments in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a rear perspective view of a rotating disk toy according to the invention as adapted to simulate an encounter window in combination with a modular space toy.
FIG. 2 is a front view of the rotating disk toy of FIG. 1.
FIG. 3 is a section view of the rotating disk toy of FIG. 2 taken along line 3--3.
FIG. 4 is an enlarged perspective view of a guideway attachment support for the rotating disk toy of FIG. 2.
FIG. 5 is a partial front perspective view of the rotating disk toy of FIG. 2 illustrating the manner of mounting a sector plate shutter on the disk.
FIG. 6 is a perspective view of an alternate drive train for the motor drive shown in FIG. 3.
FIG. 7 is a radial section view of a pivoting target plaque mounted in a cut out portion of the rotating disk of FIG. 2.
FIG. 8 is a partial front view of the rotating disk of FIG. 7 showing the target plaque in a first predetermined position.
FIG. 9 is a partial front view similar to FIG. 8 but showing the target plaque in a second predetermined position.
FIG. 10 is a partial section view showing an alternate mounting arrangement for the sector plate shutter of FIG. 5.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Reference has been made earlier to the particular applicability of the rotating barrier game apparatus of the present invention to simulate a launch or encounter window for interplanetary spaceship travel in conjunction with the modular space toy described in my prior U.S. Pat. No. 3,686,789. An arrangement for demonstrating such a simulation is illustrated by FIG. 1, in which conical bowls 1 and 2 and interconnecting guideway 3 are components of my prior modular space toy. The rotating disk toy of the present invention is designated generally by reference numeral 4.
In the game arrangement of FIG. 1, bowl 1 simulates a launching system for a spaceship, represented by moving ball 5. The flat bottom of bowl 1 represents a planet, such as Earth, and the ball is set to rotating counterclockwise around the inside of the bowl until it reaches "escape" velocity and enters tangential passageway 6 at the top of the bowl. From passageway 6, the ball enters interconnecting guideway 3 and travels toward the second bowl 2, representing Mars as shown in the diagram.
In order for a spaceship from Earth to enter landing orbit around Mars, it must lead the target because of the relative movement between Mars and Earth from the time of launch to the time of encounter. Rotating disk toy 4 provides the simulation for this maneuver.
Toy 4 includes an upright stand having a base 7 supporting a vertical panel 8. Panel 8 faces bowl 1 and has a cut out opening 10 for guideway 3 to pass through the panel. Above the guideway is a movable barrier such as flat circular disk 9 mounted on the panel for rotation about an axis through the center of the disk, the axis being located above the guideway by a distance such that the edge of the disk clears the guideway but prevents passage of ball 5 through the opening in the panel.
Disk 9 has a notch 11 extending for a predetermined circumferential extent in the edge of the disk. Notch 11 simulates the "encounter window" or "entry corridor" for the planet Mars in the illustrated embodiment of the game. As shown in FIG. 1, notch 11 must coincide with panel opening 10 to permit passage of ball 5 into "orbit" around Mars, as defined by the walls of bowl 2, with Mars at the base of the bowl. Assuming clockwise rotation of disk 9, as shown by the arrow, it is clear that the position of notch 11 must be at some point ahead of opening 10 at the time that the ball is "launched" from bowl 1. In the diagram, for example, notch 11 is approximately at the 2 o'clock position at the time of launch. The notch then rotates to the 6 o'clock position in the time that it takes ball 5 to travel along guideway 3 to the rotating disk. Thus, the combination of the rotating disk apparatus with the modular space toy of my prior U.S. Pat. No. 3,686,789 contributes substantially to increased educational value as well as enjoyment of the interplanetary space travel game.
The details and additional features of the preferred embodiment of the rotating disk apparatus are shown more clearly in FIGS. 2 through 5. As shown in these figures, disk 9 is attached to a shaft 12 that is journalled for rotation in panel 8. The forward end of shaft 12 is threaded for a nut 13, and the rear end of the shaft carries a drive gear 14. An electric motor 15 turns the disk through a pinion 16, a ring gear 17, a secondary shaft 18, and a second pinion 19 that engages the drive gear 14. Motor 15 is powered by batteries 20 installed on the rear of base 7 and connected to the motor through wires 21, 22 and a switch 23 that is located at any convenient position.
As an alternative to the electric motor drive, the disk can be driven by a simple handcrank 24 attached to an extension 25 of shaft 12 (see FIG. 3). To protect the fingers of children, the drive mechanism is surrounded by a cover 26.
Referring to FIG. 4, there is shown a preferred arrangement for attaching the guideway to either side of the panel. This arrangement comprises a guideway bracket 27, preferably made of molded plastic. The bracket is in the form of a horizontal guideway portion 28 with a dependent transverse flange 29 for attachment to panel 8 by means of screws 30. A longitudinal triangular gusset 31 provides a rigid connection between the bottom of guideway 28 and flange 29 and also supports a horizontal tongue 32 extending forward for frictional engagement with a mating groove formed by angle members 33 and 34 molded in the underside of a plastic channel member 35 that defines the travel path for ball 5 from bowl 1. A similar tongue 36 extends from the rear of guideway bracket 27 for frictional engagement with mating channel member 37 that continues the ball pathway to bowl 2.
An important feature of guideway bracket 27 is the provision of a one-way barrier to prevent bounce back of ball 5 into channel section 35 in the event that the ball fails to successfully pass through the notch in the rotating disk. This one-way barrier consists of a transverse riser 38 extending above the floor of guideway 28 at the forward end, with tongue 32 leading into the top of the riser. Thus, if the player miscalculates the necessary lead required in launching ball 5, the ball will enter guideway 28 when the notch of disk 9 is not aligned with the guideway. The ball will then strike the face of the disk and will reflect backward and downward into contact with riser 38, as indicated by the arrows.
In order to remove a ball trapped by barrier riser 38 from the guideway, rotary disk 9 carries at least one protrusion, in the form of a short radial flange 39, extending from its face adjacent to the edge of the disk. A portion of the left hand wall 40 of guideway 28 is removed so that as the radial disk rotates in the clockwise direction, flange 39 swings down and knocks the ball off the guideway so that it will not interfere with the next simulated spaceship to be launched.
Referring next to FIG. 5, a feature of the preferred disk embodiment is shown as a movable shutter in the form of a sector plate 41 having a radius equal to the radius of the disk. The shutter plate is pivotally mounted on shaft 12 in overlapping relation against the disk, with nut 13 holding the shutter in frictional engagement with the disk. Rotation of the shutter with respect to the disk against the frictional force permits adjustment of the effective circumferential extent of notch 11 by preselected increments, as measured by graduations 42.
Adjustment of sector plate 41 to uncover the complete extent of notch 11 (which is shown as approximately 90° in the illustrated embodiment) adapts the game for use by even very young children and simulates travel to a planet having a very wide entry corridor. On the other hand, adjusting the shutter to a narrow opening for the notch provides a challenge to even an adult player. In this way, the game can be adapted to be played by a number of persons of widely varying age and skills.
The drive train illustrated in FIG. 3 provides a constant angular velocity of the disk, preferably about 10-16 rpm. FIG. 6 illustrates an alternative embodiment in which a pair of meshing off-center gears 43 and 44 replace gears 16 and 17 in FIG. 3. As is well known, a pair of such off-center gears will provide a continuously varying output speed to shaft 18 from a constant input speed as delivered by the motor. Such continuously varying rotation speed more closely simulates the velocity of planets in an elliptical orbit and increases the challenge to the player's skill in properly choosing the ball release time.
Referring next to FIGS. 7-9, disk 9 can optionally be fitted with a target plaque 45 pivotally mounted in a notch 46 in the edge of the disk on axles 47 nad 48. The axis of axles 47, 48 intersects the sides of notch 46 at approximately their midpoints to permit the target plaque to flip from a first position in which one face of the plaque is exposed (FIG. 8) to a second position in which the reverse face is exposed (FIG. 9).
The target plaque is held in the first position by an offset lip 49 which abuts the inner edge of the notch and carries a piece of iron 50 for mating contact with a magnet 51 embedded in the disk. When the outer edge of the target is struck by a ball 5 with sufficient impact to disengage the piece of iron from the magnet, the target will flip to the second position shown by broken lines in FIG. 7. The target is held in the second position by a similar magnetic catch until it is reset by the player.
The exposed face of the target plaque in the first position may carry an illustration of an "enemy" space ship, as shown in FIG. 8, to increase the excitement of the game. When a hit is scored, the target plaque flips to reveal the enemy spaceship in flames (FIG. 9).
The optional target embodiment may be used in place of or, preferably, in addition to the notch and shutter combination. In the latter case the target notch can be spaced circumferentially from the "encounter window" notch.
FIG. 10 shows an alternative arrangement for permitting selective positive adjustment of the sector plate shutter 41 without loosening and retightening nut 13. In this arrangement, the back of the sector plate has a protrusion 52 that can selectively engage any one of a plurality of mating angularly spaced indentations 53 in the face of disk 9. A coil spring 54 positioned between the nut and the face of the sector plate allows the edge of the plate to be lifted so that protrusion 52 is clear of indentation 53, and the shutter can be rotated to another selected angular position without disturbing the nut on the shaft.
Although the preferred embodiments of the rotating disk toy of the present invention have been illustrated and described, it will be apparent that many variations in constructional details can be employed without departing from the scope of the invention.
Furthermore, although the present invention has been demonstrated as being particularly suitable for use in an interplanetary space travel game in conjunction with the modular space toy of my U.S. Pat. No. 3,686,789, it will also be apparent that is has broad application in any type of game in which a gamepiece is projected or propelled along a guideway in a predetermined path.
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A game for simulating launching and landing of spacecraft. An elongated channel attached to an upright stand defines a predetermined path for a moving game piece. A notched rotating disk mounted on the stand transversely above the channel prevents passage of the game piece except when the notch coincides with the channel. The effective circumferential extent of the notch can be selectively varied by a movable shutter for simulating approach corridors of varying widths. Alternatively, a target plaque pivotally mounted in the notch rotates from a first to a second position if struck by a simulated missile. Game pieces that fail to pass the rotating disk are prevented from bouncing back into the approach channel by a one-way barrier and are then removed from the channel by flanges protruding from the face of the disk. The disk may be rotated with constant angular velocity or with continuously varying velocity by means of off-center gears.
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BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to baby chairs which are suspendable from a table edge, and which can be removed and folded when not in use.
2. Prior Art
Portable baby chairs which can be attached to the edge of an ordinary table are well known. A variety of designs have been proposed for such chairs, and features which have proved advantageous include a cantilever arrangement for holding the chair to the table, a rigid seat bottom and back for greater chair strength, and foldability when the chair is not in use. Chairs embodying these features are described in U.S. Pat. No. 2,707,987 to Gibson, U.S. Pat. No. 3,052,500 to Hyde, U.S. Pat. No. 3,059,965 to Fornetti, U.S. Pat. No. 3,133,760 to Robinson, and U.S. Pat. No. Des. 200,850 to Palmer. Although the cantilever design allows the chairs to be conveniently hooked onto and unhooked from a table edge, it suffers from depending on a child's weight to create the friction needed to hold the chair stable against the table. If the child does not sit still, the chair can work its way back until one or both arm rests slip from the table, endangering the child. Thus, there is a need for a portable baby chair which can be better secured to a table top.
SUMMARY OF THE INVENTION
It is therefore the primary object of this invention to provide a portable baby chair which can be more reliably secured to a table top than could previously known cantilever style chairs. Another object is to provide a strong and stable chair which is convenient to use. This invention achieves these objects by providing a baby chair with a spring biased locking bar on each of the chair's under-table supports. The locking bars are pivoted at their lower ends to the supports. As the unfolded chair is slipped around the edge of a table top with the arm rests above and the supports below, the table top edge causes the bars to rotate backward against the spring force. The top ends of the bars, urged by their springs against the undersurface of the table, follow the pivoted bottom ends of the bars as the supports are swung under the table. Thus, the bars do not hinder hanging the chair from a table. However, once the chair is in place, pushing the chair away from the table causes the tops of the locking bars to dig in to the undersurface of the table and to hold the chair stationary. The locking bars are covered by gripping material for a better hold. When desired, the chair is easily removed from the table by grasping each of the bars and pulling it down from the table undersurface.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the chair;
FIG. 2 is a side elevation of the chair showing how it is slipped around a table edge;
FIG. 3 is a side elevation detail of one of the locking bars;
FIG. 4 is a rear elevation of the chair; and
FIG. 5 is a perspective view showing the chair folded for storage.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIGS. 1 and 2, the baby chair 10 may be suspended from the edge of an ordinary table 100. Chair 10 comprises a rigid seat bottom 12 and a rigid seat back 14, both made of suitable material such as plywood and foam padding covered with wipe-clean plastic. A safety harness 16 made, for example, of nylon webbing with a buckle 17 insures that a child does not slip out of the chair, which is normally suspended several feet above a floor on the edge of table 100. Aside from seat bottom 12, back 14, harness 16, table grips 25, 27, 45, 47, 55, and 57, and pivot spacers 19, the rest of the chair is made of metal. A pair of under-table supports 20 and 22 extend from respective rear corners, along the sides, and past the front corners, of seat bottom 12, and turn upward to end in vertical table-abutting sections 24 and 26. Seat bottom 12 is fixedly attached to and supported by supports 20 and 22. Making supports 20 and 22 from a continuous piece of tubular metal including section 21 (FIG. 4) around the back increases the chair's strength and, in particular, helps keep it from twisting or tilting sideways.
A pair of plates 30 and 32 are fixed by rivets, for example, to seat back 14, and each extends forward in a vertical plane parallel to the sides of the chair. A U-shaped seat back reinforcement 15 (FIGS. 2 and 4) may be provided to strengthen the chair, in which case plates 30 and 32 are preferably attached to seat back 14 by way of rivets 18 through reinforcement 15.
A pair of arm rests 40 and 42 rotate relative to plates 30 and 32 by way of plate pivots 41 and 43 respectively. Arm rests 40 and 42 extend forwardly parallel to the side edges and past the front edge 13 of seat bottom 12 to end in table tangent sections 44 and 46. The arm rests 40 and 42 may also be connected in a continuous piece including section 48 as shown in FIG. 4.
Supports 20 and 22 are suspended from arm rests 40 and 42, respectively, by a back pair of vertical links 60 and 62 and by a front pair of vertical links 70 and 72, respectively. The links are connected to the arm rests by pivots 41, 43, 76 and 77, and to the supports by pivots 61, 63, 71 and 73. The pivot connections allow the chair to be folded for storage as in FIG. 5 with the arm rest 40, support 20, and links 60 and 70 (and of course the corresponding members on the hidden side) forming a parallelogram, and to be unfolded for use as in FIG. 1 with the named members more rectangularly disposed.
Diagonal links 64 and 65 help to reinforce chair 10 from being deformed by a child's weight, but otherwise do not constrain the chair's folding action. Rather, diagonal links 64 and 65 couple the tilt of seat back 14 to the shape of the parallelogram structure defined by front links 70, 72, rear links 60, 62, arms rests 40, 42 and under table supports 20, 22. Thus, as seat back 14 is moved towards or away from seat 60, 62, 70, 72 and supports 20, 22 to pivot corresponding amounts. See FIGS. 2 and 5. Diagonal link 64 is connected to plate 30 and to link 70 by pivots 34 and 74 respectively, and likewise diagonal link 65 is connected to plate 32 and to link 72 by pivots 35 and 75 respectively.
As shown in FIG. 2, chair 10 is unfolded for use and slipped around the edge of a table 100. Any ordinary table less than 2" thick can be used without modification, although there must be adequate clearance for the child's legs between the seat front edge 13 and the lower corner and any panel (not shown) on table edge 102. A glass topped or otherwise fragile table may not be strong enough, and a pedestal table might tip over. The chair is suspended by cantilever action when a child's weight pulls the arm rest tangent sections 44 and 46 down on points near the edge 102 of table top 101, and the table-abutting sections 24 and 26 of the support bars bear upward on the underside 99 of the table at points further from table edge 102 than the points reached by arm rest sections 44 and 46.
Locking bars 54 and 56 are attached to supports 20 and 22 by pivots 50 and 52 respectively. Bars 54 and 56 pivot within the limits imposed by bar angles 58 and 59. Biasing springs 51 and 53 urge the bars towards the table abutting ends 24 and 26 of the supports. When the seat is being installed on a table top 100, table edge 102 pushes locking bars 54 and 56 against springs 51 and 53. Obtuse angle theta (FIG. 3) allows the bars to slide by the under surface 99 of the table. However, once the chair is in place, springs 51 and 53 maintain the locking bars against the table, and pushing or pulling chair 10 away from table 100 causes the locking bars 54 and 56 to dig in to the table underside 99 at acute angle phi.
To help keep chair 10 stationary relative to table 100, while protecting table surfaces from being scratched, non-abrasive frictional coverings such as plastic cups 25 and 27, 45 and 47, and 55 and 57 are provided respectively for the ends of table abutting sections 24 and 26, arm rest tangent sections 44 and 46, and locking bars 54 and 56.
When a chair 100 is in use, the child's weight keeps the chair unfolded to the limit imposed by arm rest stops 31 and 33, which are part of, and at right angles to the rest of, plates 30 and 32 respectively. A safety pin 36, shown locked in FIG. 1 and unlocked in FIG. 5, insures that the chair is locked open. Safety pin 36 has a pull knob from which a shaft extends through a hole in arm rest 40 and into a hole 37 in plate 30. A spring (not shown) inside the arm rest holds the pin in plate hole 37 until the shaft is retracted by pulling the knob.
Details have been disclosed to illustrate the invention in a preferred embodiment of which adaptions and modifications within the spirit and scope of the invention will occur to those skilled in the art. The scope of the invention is limited only by the following claims.
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A portable baby chair 10 suspendable from the edge of an ordinary table 100 and which has spring biased pivoted locking bars 54, 56 on the chair's under table supports 20, 22 to engage the underside 99 of the table top and prevent the chair from slipping.
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FIELD OF THE INVENTION
The present invention generally pertains to embolic balloons and delivery systems. In particular, the present invention relates to embolic balloons delivered by intravascular microcatheters to vascular defects.
BACKGROUND OF THE INVENTION
In treating vascular defects such as aneurysms and fistulas, which commonly occur in the neurovasculature, a microcatheter is navigated through the patient's vasculature until a distal end of the microcatheter is adjacent the defect. An embolic material is then delivered through the microcatheter and into the vascular defect, to thereby fill and seal-off the defect. However, because vascular defects like aneurysms and fistulas often have irregularly shaped and asymmetrical volumes, it is difficult to accurately and completely fill the defect with embolic coils, balloons or other embolic devices, which are typically symmetrically shaped. Although liquid embolic materials tend to fill irregularly shaped and asymmetrical volumes more precisely and completely, liquid embolic materials are often difficult to deliver through a microcatheter and are often difficult to contain within the defect. Accordingly, there is a substantial need for an embolic material and delivery system that is capable of filling an asymmetrical and irregularly shaped vascular defect, that is easy to deliver with a microcatheter, and that is easy to contain within the defect.
There is also an ongoing need for improved embolic balloons and associated delivery systems. In particular, there is a need for detachable embolic balloons that may be easily delivered and maintained in the vascular defect so as to not protrude into the native vascular lumen.
SUMMARY OF THE INVENTION
To address this substantial unmet need, the present invention provides, in an exemplary non-limiting embodiment, a solid embolic material that is capable of filling irregularly shaped and asymmetrical vascular defects in a controlled and predictable manner, without the difficulties associated with delivery of embolic material through a microcatheter and containment of embolic material in a defect. The solid embolic material of the present invention may be inflated with a liquid (e.g., liquid embolic material) to further engage the internal walls of the defect and to more completely fill the irregularly shaped volume of the defect.
The present invention also provides, in another exemplary non-limiting embodiment, a detachable embolic balloon and associated delivery system. The detachable embolic balloon in this embodiment may be filled with a curable liquid wherein the curing process may be aided by thermal means. The detachable embolic balloon may optionally incorporate a check valve for maintaining the liquid in the balloon prior to curing and/or a multi-leaflet covering to prevent the balloon from expanding into the native or parent vascular lumen.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a microcatheter, a syringe containing a solid embolic material therein for placement into a distal end of the microcatheter, and a syringe containing a fluid for injection into a proximal end of the catheter;
FIGS. 2A and 2B illustrate alternative methods of containing the solid embolic material, and loading the solid embolic material into the distal end of the microcatheter;
FIGS. 3A-3C schematically illustrate the delivery of the solid embolic material into an aneurysm having an irregular shape;
FIGS. 4A-4D schematically illustrate a first embodiment of a detachable embolic balloon and delivery system; and
FIGS. 5A-5D schematically illustrate a second embodiment of a detachable embolic balloon and delivery system.
DETAILED DESCRIPTION
The following description should be read with reference to the drawings wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings illustrate embodiments by way of example, not limitation.
Refer now to FIG. 1 which illustrates a microcatheter 10 , a syringe 40 , and a syringe 70 . Syringe 40 contains a solid embolic material 50 which may be disposed or injected into the catheter 10 as indicated by arrow 60 . Syringe 70 contains a fluid 80 (e.g., radiopaque saline solution or liquid embolic agent) for injection into the catheter 10 as indicated by arrow 90 .
Microcatheter 10 may be used to deliver the solid embolic material 50 to a vascular defect such as an aneurysm or fistula having an internal wall defining an internal volume therein. The solid embolic material 50 is particularly suitable for filling internal volumes that are irregular in shape and eccentric relative to the neck or opening to the native vascular lumen.
Intravascular catheter 10 is sized (length and diameter) and designed (pushability and trackability) to navigate a patient's vascular system to access vascular defects in the neurovasculature, coronary vasculature and/or peripheral vasculature. Intravascular catheter 10 may include one or more lumens and may be designed to accommodate a guide wire (not shown) and/or to incorporate a distally disposed inflatable balloon (not shown). Although a single lumen intravascular microcatheter 10 is illustrated, those skilled in the art will recognize that a wide variety of intravascular catheters may be used to deliver solid embolic material 50 to a vascular defect.
The basic design and construction of microcatheter 10 is conventional in the art, and is provided by way of example, not limitation. Intravascular microcatheter 10 includes an elongate shaft 12 having proximal end 14 and a distal end 16 . A hub assembly 18 is connected to the proximal end 14 of the elongate shaft 12 . A lumen (not visible) extends through the hub assembly 18 and through the length of the shaft 12 to a distal-facing opening (not visible) in the distal end 16 of the shaft 12 . Hub assembly 18 facilitates connection to ancillary devices such as syringe 70 for the injection or infusion of fluids 80 such as contrast media (e.g., radiopaque dye and saline solution) and liquid embolic agents (e.g., cyanoacrylate) into the lumen and out the opening at the distal end 16 . The distal end 16 may be rendered radiopaque by utilizing radiopaque loading in the polymers of the distal end 16 of the shaft 12 or by utilizing a radiopaque marker band 20 disposed thereon. Rendering the distal end 16 radiopaque allows the tip to be precisely navigated utilizing x-ray radiographic techniques.
Solid embolic material 50 defines an initially solid volume when disposed in syringe 40 and when disposed in the lumen at the distal end 16 of the shaft 12 . Sufficient solid embolic material is disposed in the lumen of the catheter 10 to fill the internal volume or lining of the targeted vascular defect. Solid embolic material 50 is readily stretchable, viscid and self-sealing such that the material is able to expand upon injection of a fluid into the solid volume thereof. Upon injection of a fluid into the solid volume, the solid embolic material 50 expands to create an internal volume which self-seals and retains the fluid therein. Upon expansion, the solid embolic material 50 is not elastically biased to its original state, but rather tends to assume and hold its expanded state with little or no pressure maintained in the volume created therein. To this end, the solid embolic material 50 is much like bubble-gum in its behavior, albeit for substantially different applications requiring substantially different compositions and designs.
The fluid 80 used to inflate the solid embolic material 50 may comprise a radiopaque liquid or a liquid embolic material (e.g., cyanoacrylate), for example. The solid embolic material 50 facilitates containment of the liquid embolic material in the vascular defect, and the liquid embolic material may be selected to solidify after injection into the solid embolic material 50 , in order to assist in sealing the inflated internal volume of the solid embolic material 50 . To facilitate injection of fluid 80 into the solid embolic material, a pressurized fluid source such as a syringe 70 may be connected to the hub assembly 18 of the catheter 10 . Such a device 70 may also be used to pressurize the lumen in the catheter 10 to urge the solid embolic material 50 out of the distal end 16 of the catheter 10 and into the vascular defect.
The solid embolic material 50 preferably has relatively high cohesivity and simultaneously is in a state capable of plastic deformation at low pressures. In addition, the solid embolic material 50 preferably has little or no elastic restoring force that will cause the material 50 to contract after pressure is released subsequent to inflation within the defect 100 . Further, in order to facilitate delivery in a compact size and subsequent inflation to a relatively large size, the solid embolic material 50 will preferably withstand 1000% elongation or more, for example, during inflation. Polymer based materials are probably the best candidates for this application. However there are a number of material classes that might be used, and within each class, there are a large number of possible formulations that may have suitable properties. Accordingly, although specific examples are given, the examples are illustrative only.
In one embodiment, for example, the solid embolic material 50 may comprise a medium to high molecular weight polymer in a semi-swollen or highly plasticized state. An example of such a polymer comprises poly(vinyl acetate) dissolved in ethanol/ethyl lactate. Another example of such a polymer comprises alkyl methacrylate (the alkyl side-chain being greater than C4) dissolved in a plasticizer (e.g., fatty acid ester, di-alkyl citrate, or triglyceride). Many other combinations of polymers with molecular weights greater than 100 KDa and blended with solvents and/or plasticizers may be applicable in this embodiment as well. The types and concentrations of the polymer/solvent mixture may be selected to optimize the desired characteristics. As an alternative, one of the components of the polymer solution/mixture may melt at a temperature slightly above body temperature and act as a plasticizer for the other component. In this alternative embodiment, a localized heat source may be used to heat the first component to a temperature above body temperature (37C).
Other embodiments of polymers suitable for the solid embolic material 50 include polymers that can be transformed to a low modulus state in-situ by small localized temperature changes. Examples of such polymers include non-cross linked polymers having semi-crystalline and amorphous phases (or possessing discrete liquid-crystalline phases) which have first or second order thermal transitions slightly above maximum body temperature (42C), such as long hydrocarbon side-chain acrylic copolymers. Such a polymer may utilize localized heating preferably during inflation and may incorporate tissue adhesive properties when heated.
Other examples of polymers that can be transformed to a low modulus state in situ by small localized environment (e.g. temperature) changes include high molecular weight linear polymers, copolymers or blends in a swollen gel or dissolved state which have a sharp decrease in solubility/swelling within the incorporated solvent in response to changes in temperature, ionic strength, or pH, such as poly(n-isopropyl acrylamide) copolymer/blend hyrogels. Such polymers may utilize localized cooling during inflation which causes the polymer to change from a solid or dense gel at body temperature to a swollen or loose hydrogel material capable of deformation at lower temperatures.
If a mixture of a polymer and a solvent is used, it may be important to ensure that the polymer remains mixed with the solvent until the time of use, in order for the solid embolic material 50 to retain its desired characteristics. For example, the polymer and solvent may be kept in separate containers and manually mixed just prior to use, using a syringe 40 to inject the mixture into the distal end 16 of the catheter 10 as shown in FIG. 1 .
Alternatively, a container 110 may contain a pre-mix of the polymer/solvent which may then be directly injected into the distal end 16 of the catheter 10 as shown in FIG. 2A . In this particular embodiment, the container 110 may be rolled, squeezed or shaken to ensure a homogenous mix, opened by removal of a cap (not shown), placed over the distal end 16 of the catheter 10 , and manually squeezed (as indicated by arrows 112 ) to inject the mixture therein (as indicated by arrow 114 ).
As a further alternative, a short tubular container 120 containing a premix of the polymer/solvent may be attached to the distal end 16 of the catheter 10 as shown in FIG. 2B . In this particular embodiment, the container 120 has a sealed distal end 122 that may be cut to provide an opening, and a proximal end 124 sealed by cover 126 . The proximal end 124 is sized to snuggly fit over and attach to the distal end 16 of the catheter 10 . The container 120 may be rolled, squeezed or shaken to ensure a homogenous mix, opened by removal of the cover 126 (as indicated by arrow 125 ), attached to the distal end 16 of the catheter 10 by sliding the proximal end 124 thereon (as indicated by arrow 127 ), and the distal end 122 cut (as indicated by arrow and dashed line 129 ) to provide a distal opening.
With reference to FIGS. 3A-3C , the solid embolic material 50 may be used to treat a vascular defect 100 such as an aneurysm or fistula. The vascular defect 100 includes an internal wall 102 defining an internal volume 104 . Although described herein with reference to the treatment of a vascular defect 100 , the solid embolic material 50 may also be used to occlude vessels for therapeutic purposes.
After preparing the catheter 10 with the solid embolic material 50 disposed in the distal end 16 thereof as described above, the catheter 10 may be navigated through a patient's vascular system until the distal end 16 is disposed adjacent the opening 106 to the vascular defect 100 as seen in FIG. 3A .
The solid embolic material 50 may then be urged from the lumen at the distal end 16 of the catheter 10 and into the vascular defect 100 as seen in FIG. 3B . This may be accomplished by applying fluid pressure in the catheter lumen proximal of the solid embolic material 50 using syringe 70 connected to the hub assembly 18 .
The solid embolic material 50 may then be further urged into the vascular defect until the solid embolic material substantially conforms to the internal wall 102 and substantially fills the internal volume 104 as seen in FIG. 3C , despite the irregular shape of the wall 102 and volume 104 . This may be accomplished by applying more fluid pressure in the catheter lumen proximal of the solid embolic material 50 using syringe 70 connected to the hub assembly 18 , to cause the fluid 80 to be injected into the solid embolic material 50 and to inflate the same. The solid embolic material 50 may be inflated to varying degrees to conform to vascular defects 100 of varying size and shape.
After the defect 100 is substantially filled as confirmed by x-ray fluoroscopy, the solid embolic material 50 in the defect 100 may be detached from the distal end 16 of the catheter 10 (and any solid embolic material 50 remaining in the distal end 16 ) by rotating the catheter 10 and/or by pulling the catheter 10 proximally.
Refer now to FIGS. 4A-4D which schematically illustrate a distal portion of a detachable embolic balloon catheter 200 . With specific reference to FIG. 4A , catheter 200 includes an elongate shaft 212 having a proximal end (not visible) and a distal end. Catheter 200 also includes a detachable balloon 214 having a proximal end thereof releasably connected to the distal end of the shaft 212 . The detachable balloon 214 may comprise, for example, any of the materials discussed previously with reference to solid embolic material 50 .
The shaft 212 may include a guide wire lumen lateral attachment 216 which defines a guide wire lumen (not visible) extending therethrough to slidably accommodate conventional guide wire 400 . The side attachment 216 may comprise, for example, a short tube connected to the shaft 212 by adhesive, thermal bond, and/or a heat shrink sleeve. The shaft 212 may also include a radiopaque marker band 218 connected to its distal end. Radiopaque marker band 218 may comprise, for example, a band of dense metal such as platinum, gold, iridium, or an alloy thereof.
With reference to FIG. 4B , the elongate shaft may comprise an outer tubular layer 222 surrounding an inner tubular layer 224 which extends distally beyond the outer layer 222 . A reinforcement layer (not shown) such as a metallic or polymeric coil or braid may be disposed between the inner layer 224 and the outer layer 22 to enhance navigational performance of the shaft 212 . The marker band 218 may be disposed on the inner layer 224 distal of the outer layer 22 such that the outside diameter of the marker band 218 is flush with or does not exceed the outside diameter of the outer layer 222 .
The proximal end of the balloon may include a radiopaque marker coil 226 molded into the wall of the proximal end of the balloon 214 or connected thereto by other means (e.g., adhesive, thermal bonding, etc.) The radiopaque marker 226 may comprise, for example, a wound wire coil of a dense metal such as platinum, gold, iridium, or an alloy thereof. Together with radiopaque marker band 218 , radiopaque marker coil 226 facilitates radiographic visualization during deployment of the detachable balloon 214 .
The inner tubular layer 224 defines a lumen 211 which extends through the full length of the shaft 212 and is in fluid communication with the interior 213 of the balloon 214 via optional check valve 228 . Check valve 228 may comprise a duck-bill type or flapper type valve that permits fluid flow in only the distal direction. As will be described in more detail hereinafter, check valve 228 helps retain the inflation liquid in the interior 213 of the balloon 214 to allow the inflation liquid to cure or to otherwise permit detachment of the balloon 214 from the distal end of the shaft 212 after filling the balloon 214 with a liquid. Detachment of the balloon 214 from the distal end of the shaft 212 may be accomplished with an electrolytic detachment system or with a break-away bond as described in more detail below.
Because, the balloon 214 may comprise a material that is highly compliant and flexible at low inflation pressures to permit low pressure expansion (e.g., less than 2 ATM), the connection between the distal end of the shaft 212 and the proximal end of the balloon 214 does not necessarily need to withstand high inflation pressures (e.g., greater than 15 ATM). Thus, the connection between the distal end of the shaft 212 and the proximal end of the balloon 214 may be made detachable by a weak chemical and/or mechanical bond, for example, that may be broken upon the application of torsional and/or longitudinal forces. For example, after the balloon 214 has been deployed, twisting and pulling the proximal end of the shaft 212 may be utilized as a means to break the bond and detach the balloon 214 from the shaft 212 . A relatively weak bond may be provided, for example, by utilizing a relatively lubricious polymer (e.g., PTFE or HDPE without surface activation) for the inner tubular layer 224 and a conventional biocompatible adhesive such as cyanoacrylate to bond the inner tube 224 to the proximal end of the balloon 214 .
As mentioned above, the interior 213 of the balloon 214 may be inflated or otherwise filled with a curable liquid such as acrylic monomers, urethane prepolymers, epoxy resins, cyanoacrylates, silicones, or similar material. The polymerization or curing process of such materials or a thermal transition of such materials may be accelerated or induced by heat. Accordingly, a heating device 230 may be introduced through the lumen 211 of the shaft 212 and into the interior 213 of the balloon 214 to supply thermal energy to the curable liquid disposed in the interior 213 of the balloon 214 as shown in FIG. 4C . The heating device 230 may also be used to heat the balloon 214 if the balloon 214 is formed of a thermally responsive material. The heating device 230 may comprise, for example, a hollow guide wire type shaft 234 having a distally disposed heating element 232 . By way of example, not limitation, the heating element 232 may comprise an electrical resistive heating coil powered via leads (not shown) extending through the shaft 234 to a power source (not shown).
Alternatively, the polymerization or curing process may be induced or accelerated by contact with an initiating chemical component or catalyst which may be present within the balloon 214 as a coating on the inside surface of the balloon 214 or as a blend contained in the balloon material. Alternatively, the initiating chemical component or catalyst may be delivered into the balloon 214 via a separate lumen in the shaft 212 or via a separate tube (e.g. hypotube) advanced through the shaft 212 .
In use, the catheter 200 is navigated through the patient's vascular system utilizing radiographic visualization or other visualization techniques until the balloon 214 is disposed adjacent the vascular defect. The balloon 214 is then advanced or otherwise urged into the vascular defect. The interior 213 of the balloon 214 is then inflated with a curable liquid via lumen 211 of the shaft 212 . As the balloon 214 is being inflated, the check valve 228 permits the liquid to enter the interior 213 of the balloon 214 but prevents substantial egress of the liquid thereout. The balloon 214 may then be inflated until the perimeter of the balloon 214 substantially conforms to the contours of the defect. After inflation of the balloon 214 , the liquid in the balloon is allowed to cure, with or without the use of a catalyst or an accelerator. If desired, after or during inflation of the balloon 214 , a heating device 230 may be advanced into the interior 213 of the balloon 214 and activated to initiate and/or accelerate the solidification process of the curable liquid, or to heat the balloon material. Once the inflation liquid has cured or otherwise substantially solidified, the catheter shaft 212 may be released from the balloon 214 by an externally activated detachment mechanism or by twisting and pulling, for example, thus leaving the detachable balloon 214 and associated components 226 / 228 in the vascular defect.
Refer now to FIGS. 5A-5D which schematically illustrate a distal portion of a detachable embolic balloon catheter 210 , which is substantially the same in design and function as catheter 200 except as described herein and illustrated in the drawings. As seen in FIGS. 5A and 5B , a plurality of leaflets 242 (e.g., 2, 3, 4, or more) are uniformly disposed about the balloon 214 and extend along the balloon 214 to a distal apex thereof. The proximal ends of the leaflets 242 may be hinged and are attached to the proximal end of the balloon 214 . The distal ends of the leaflets 242 collectively meet adjacent the distal apex of the balloon 214 . The leaflets 242 may be formed of a flexible polymeric or metallic material which is generally more rigid than the material of the balloon 214 . The leaflets 242 may have a rectangular cross-section with a convex exterior surface, a concave interior surface, and a distal inward taper to conform to the profile of the balloon 214 .
After the balloon 214 has been disposed in the vascular defect as described previously, and as the balloon 214 is being inflated, the leaflets 242 separate and expand about hinge points at their respective proximal ends as shown in FIG. 5C . Upon further expansion, the leaflets 242 and the balloon 214 conform to the inside surface of the defect as shown in FIG. 5D . Because the leaflets 242 are relatively more rigid than the balloon 214 , and because the leaflets 242 extend across the opening to the vascular defect, the leaflets 242 prevent the balloon 214 from expanding into the native vascular lumen to thereby confine the balloon 214 within the interior of the vascular defect. The use of catheter 210 is otherwise the same as catheter 200 described previously.
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, arrangement of parts and order of steps without departing from the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
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A solid embolic material that is capable of filling irregularly shaped and asymmetrical vascular defects in a controlled and predictable manner, without the difficulties associated with delivery of the embolic material through a microcatheter and containment of the embolic material in a defect. A detachable embolic balloon with optional check valve for maintaining liquid in the balloon prior to curing and optional multi-leaflet covering to prevent the balloon from expanding into the native vascular lumen.
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CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of Korean Patent Application No. 10-2010-0008138, filed with the Korean Intellectual Property Office on Jan. 28, 2010, the disclosure of which is incorporated herein by reference in its entirety.
BACKGROUND
[0002] 1. Technical Field
[0003] The present invention relates to a scintillator of a scintillation detector that detects high energy particles and a method of binding a scintillator in medical diagnostic imaging equipment, more specifically to a scintillator that emits light by detecting high energy particles generated by an object examined by a common medical diagnostic imaging equipment and a scintillation detector and medical diagnostic imaging equipment using such a scintillator.
[0004] 2. Background Art
[0005] Medical diagnostic imaging equipment commonly includes computed tomography (CT), magnetic resonance imaging (MRI) and the like. Such imaging technologies are increasingly used for a more accurate examination by spotting a region having growing tissues to identify a thrombus, a scar, dead cancer tissue and the like from living tissues. In the medical device industry, which has recently attracted more attention, the market size of the medical diagnostic imaging equipment has reached nearly 50% of the entire medical device markets.
[0006] As every kind of diagnostic imaging equipment has been accomplishing faster diagnosing time, real-time diagnosis and multi-dimensional imaging (e.g., 3D imaging and 4D imaging), various diagnostic methods have been developed for application in the medical diagnostic imaging equipment. However, not only does it take a great length of time to perform diagnosis using the medical diagnostic imaging equipment (e.g., 12 hours for full-body CT, 24 hours for full-body MRI, and 1 hour for full-body PET), but the examination cost is too high for the general public to afford, restraining a wide use of the medical diagnostic imaging equipment.
[0007] A cause of the above problems is the scintillator, which is an essential element that emits light by being in contact with high energy particles during an examination, and of which a crystal scintillator is commonly used. The crystal scintillator, which is expensive and processing of which is difficult and costly, is a main cause of raising the price of medical diagnostic imaging equipment and increasing the examination time due to its difficulty of constituting in a wide area.
SUMMARY
[0008] To overcome the limitations of structural improvement for enhancement of detection efficiency due to processing difficulty and high material costs caused by using the conventional scintillator, the present invention provides a plastic scintillator and a scintillation detector and medical diagnostic equipment using the plastic scintillator that can shorten the examination time and lower the manufacturing cost dramatically by utilizing a scintillator having a same effect and using a more economical material.
[0009] To achieve the above object, the present invention can use a plastic scintillator to maximally reduce a gap between scintillators by allowing the scintillators to have various cross-sectional shapes, constitute the scintillator by including optical fiber, which is an effective detecting material, to enhance detectability, and dramatically increase an area where the scintillator is constituted when utilized in a medical diagnostic imaging equipment.
[0010] With the present invention, the cost of raw material becomes remarkably lower than the conventional scintillator, and it becomes much easier for processing, thereby allowing for more efficient configuration and processing for detection of a high energy particle. Ultimately, the detection area of the medical diagnostic imaging equipment can be dramatically larger to reduce the detection time, allowing for increased convenience for users and supply at lower costs.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 shows conventional medical diagnostic imaging equipment.
[0012] FIG. 2 is a perspective view illustrating an embodiment of the present invention.
[0013] FIG. 3 is a perspective view illustrating some embodiments of the present invention.
[0014] FIG. 4 is a cross-sectional view illustrating an embodiment of the present invention.
[0015] FIG. 5 is an exploded view illustrating an embodiment of the present invention.
[0016] FIG. 6 is a perspective view illustrating some embodiments of the present invention.
[0017] FIG. 7 shows a configuration of an embodiment of the present invention.
[0018] FIG. 8 is a cross-sectional view illustrating an embodiment of the present invention.
DETAILED DESCRIPTION
[0019] Hereinafter, some embodiments of the present invention will be described in detail with reference to the accompanying drawings.
[0020] Several kinds of medical diagnostic imaging equipment have been developed, for example, positron emission tomography (PET), single photon emission computed tomography (SPECT), computed tomography (CT), magnetic resonance imaging (MRI) and the like. These kids of medical diagnostic imaging equipment detects a high energy particle generated at a particular region with a scintillator (a crystal exhibiting scintillation when struck by a particle), amplifies the high energy particle through a photomultiplier, converts the high energy particle into, and images a photocurrent detection signal to display the particular region where a problem occurs. As described above in the background art, most of these kinds of medical diagnostic imaging equipment are very expensive and thus are hardly utilized in a popular fashion. One of the causes of this shortcoming is the costly scintillator.
[0021] In the conventional medical diagnostic imaging equipment, a photomultiplier 100 has a scintillator (S) inserted therein. As illustrated in FIG. 1 , a plurality of the scintillators (S) are inserted into the photomultiplier 100 to form a scintillation detector 200 , which is arranged on a main body of the medical diagnostic imaging equipment to surround a cross-section of an examined object.
[0022] Used for the scintillator arranged in the scintillation detector is a crystal, but a highly pure crystal (BGO and various kinds of crystal) requires a long time of growth and is difficult to manufacture, making it costly to process and utilize the crystal for the scintillator of a medical diagnostic imaging equipment.
[0023] In the present invention, the conventional crystal (such as BGO) is not utilized as the scintillator of the medical diagnostic imaging equipment, but as illustrated in FIG. 2 , a plastic scintillator 10 and optical fiber 20 constituted therein are provided to have the same effectiveness as the conventional crystal but with a significant economical effect.
[0024] By using the plastic scintillator 10 for the scintillator constituted in the scintillation detector, the performance and detecting effect of the scintillator in accordance with the present invention is unchanged from the conventional crystal scintillator, but is so easy to process that it can be fabricated in various shapes at incomparably low costs.
[0025] It is so difficult and costly to process the conventional crystal scintillator that the scintillator is formed in the shape of a hexahedral cylinder, in which a cross-section on a side of detecting the high energy particle is close to a square, and bound with the photomultiplier. However, as illustrated in FIG. 3 , with the plastic scintillator in accordance with an embodiment of the present invention, it is possible to form a cross-section on a side of detecting the high energy particle in the shapes of various polygons, such as a triangle, a rectangle, a pentagon, a hexagon, a heptagon, an octagon, etc.
[0026] In the present invention, the effectiveness of detection can be enhanced by minimizing a gap among the scintillators, as the scintillation detector 200 is constituted with the photomultiplier 100 in which the plastic scintillator 10 in the shape of a hexagon is used. That is, as illustrated in FIG. 4 , in the case that the scintillation detector 200 of medical diagnostic imaging equipment is constituted with the plastic scintillator 10 having a hexagonal cross-section, which is commonly referred to as a honeycomb structure, gaps that can occur among the scintillators 10 are relatively smaller than those of other cross-sectional shapes, making it possible to detect the high energy particles more efficiently.
[0027] As illustrated in FIGS. 2 , 5 , 6 and 7 , it is possible to process and constitute this kind of plastic scintillator 10 in a highly efficient form and thus to form a hollow section h. Although it is possible to bind the plastic scintillator 10 as is with the photomultiplier 100 , an integrated plastic scintillator 10 ′ can be constituted by forming a hollow section h inside a central part thereof and inserting the optical fiber 20 into the hollow section h in order to collect the light emitted from the plastic scintillator and transfer the light to the photomultiplier. 100 . In such a configuration, it is possible to allow the optical fiber 20 to penetrate through the plastic scintillator 10 or allow the optical fiber 20 to penetrate the scintillator 10 where the scintillator 10 makes contact with the photomultiplier 100 and penetrate the scintillator 10 or be formed not to be exposed to an outside on the side of detecting the high energy particle. Moreover, it is possible to form a plurality of hollow sections h and insert a plurality of optical fiber 20 accordingly, or use a fiber optic core selectively or clad an external part of the core (not shown).
[0028] In constituting the scintillation detector 200 applied with the plastic scintillator 10 in which the optical fiber 20 is formed, one side of the optical fiber 20 can be directly connected with the photomultiplier 100 in order to enhance the effect of detection. It shall be appreciated that, in the case of a plastic scintillator 10 that does not include optical fiber 20 , its cross-section can be bound to the photomultiplier 100 in a conventional way.
[0029] As illustrated in FIG. 8 , the light can be better collected by forming a reflecting film on an external surface of the plastic scintillator 10 , in which case the reflecting film 30 can have a lower refractive index than a conventional plastic scintillator 10 .
[0030] Although there can be various methods of forming a plastic scintillator, in an embodiment of the present invention, fluorescent additives, which can be classified into a primary fluorescent additive and a secondary fluorescent additive, can be used for the plastic scintillator 10 . Used as the primary fluorescent additive can be p-terphenyl (PT) or 2,5-dephenyloxazole (PPO). Used as the secondary fluorescent additive, i.e., a wavelength transfer agent, can be POPOP or 4-bis(2-Methylstyryl)benzene (bis-MSB).
[0031] Used as the fluorescent additive for the optical fiber can be K27, BBQ(7H-benzimidazo[2,1-a]benz[de]isoquinoline-7-one) of National Diagnostics, or Lumogen of BASF. Accordingly, the fluorescent additive in the color of red, orange, yellow, green, blue, purple or pink can be added according to the usage of detection to use an entire wavelength between 200 nm and 900 nm, thereby allowing for use in the conventional photomultiplier tube (PMT), silicon photomultiplier (SIPM) or multi pixel photon counter (MPPC).
[0032] Used for a material to clad the optical fiber can be poly methyl metha acrylate (PMMA), of which the refractive index is 1.59 and the density is 1.19, in the case that PS is used as a core of the optical fiber for primary cladding of the optical fiber. In addition, any material (e.g., PTFE or PEFE) having the refractive index that is smaller than that of PMMA can be used for secondary cladding over the primary cladding, or the secondary cladding can be optionally omitted.
[0033] In the case that PMMA is used for the core of the optical fiber, it is preferable that PTFE or PEFE, of which the refractive index is smaller than that of PMMA, is used for the cladding. That is, it is preferable that aluminum or titanium dioxide (TiO 2 ) is used for the reflecting film located outside a scintillating cell,
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The present invention relates to a scintillation detector, which is largely divided into a scintillator and a photomultiplier, as a constituent element of a medical diagnostic imaging equipment, a scintillator, and a medical diagnostic imaging equipment using the same, and more specifically, to a plastic scintillator, and a scintillation detector and a medical diagnostic imaging equipment using the same wherein a plastic scintillator is provided as a scintillator constituting a scintillation detector of a medical diagnostic imaging equipment instead of a known crystal scintillator, thereby allowing easy processing of a scintillator, improving detection due to various configurations and remarkably reducing processing costs.
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RELATED APPLICATION
Variable Support Shoe, Ser. No. 310,836,filed Feb. 14, 1989.Related copending application Ser. No. 310,836 filed Feb. 14, 1989,shows the use of an air pump and air bladder arrangements, integral with an athletic shoe, to provide increased support to the foot and ankle in an athletic shoe during activity, and decreased pressure and support during periods of inactivity.
FIELD OF THE INVENTION
The present invention relates to an orthopaedic device, and specifically to an ankle brace for stabilizing an ankle before and after injury. In particular, the ankle brace of the present invention stabilizes the ankle against inversion and eversion and anterior subluxation while allowing normal dorsiflexion and plantarflexion movement.
BACKGROUND OF THE INVENTION
It has previously been proposed to provide an ankle brace or orthopaedic apparatus, including air inflatable bladders as shown in Glenn W. Johnson, Jr.'s U.S. Pat. Nos. 4,280,489,granted July 28, 1981,and No. 4,628,945,granted Dec. 16, 1986in which the apparatus is intended to be worn within a separate shoe and is inflatable with an external source of air pressure or is preinflated. In addition, various arrangements have been proposed for ventilating shoes by circulating air through the shoes. Typical patents showing this type of arrangement include M. Dunker, U.S. Pat. No. 2,552,711;D. W. Oltrogge, U.S. Pat. No. 2,560,591;A. C. Crawford, U.S. Pat. No. 2,676,422;C. N. Eaton, U.S. Pat. No. 3,029,530;E. Karras, U.S. Pat. No. 3,331,146;and James Faiella, U.S. Pat. No. 4,414,760.These patents disclose the use of an air pumping arrangement actuated by foot pressure for circulating air through a shoe, but do not include any orthopaedic support functions. Reference is also made to German publication designated OffenlegungSschrift No.2321817,published Nov. 15, 1973.That publication shows a ski boot with a rigid sole and a pump mounted in the sole. The pump can be latched to an inactive state when the inflatable pads are pressurized.
After injury to an ankle, such as a fracture or severe ankle sprain, it may be necessary to completely immobilize the ankle through the use of a molded plaster or resin cast. However, once the injury has been stabilized, recovery may be hastened by removing the molded plaster or resin cast and using a removable functional walking brace so that the ankle can be exercised during healing. Also, if the injury is not severe enough to require complete immobilization, it may only be necessary to use a functional walking brace to stabilize the ankle against inversion (the foot rolling inward), eversion (the foot rolling outward) or anterior subluxation (partial dislocation) while still permitting the normal dorsiflexion and plantarflexion forward and rearward motion of the lower leg relative to the foot) movement of the ankle. However, less pressure and support is required when resting. Furthermore, it is undesirable to have the feet or ankles subject to substantial pressure while resting as this may inhibit circulation during rest periods.
It is therefore desirable to have an ankle brace which provides greater support and pressure to the ankle during walking and the like and less pressure upon the ankle and foot during periods of rest.
SUMMARY OF THE INVENTION
The present invention is a new and improved ankle brace which provides varying amounts of pressure and support to the foot and ankle. The brace has two side supports with inflatable bladders attached to the supports. The brace also includes a pump which is activated by walking or running and supplies air to the inflatable bladders. Also included are means for securing the side supports to firmly encase the ankle. The means for securing the side supports could be an arrangement of straps and D-rings, straps and velcro type fasteners or other appropriate systems.
The air bladders may have a high pressure release valving arrangement, and also be provided with bleed arrangements so that the bladders may not be inflated above a predetermined pressure and so that the air pressure in the bladders will gradually leak out over a period of time.
One-way valves may be provided, both at the inlet to the pump and at the outlet therefrom, leading to the air bladders. With the pump located under the user's foot, pressure will be drawn in whenever the foot is raised, and air will be pumped out to the air bladders whenever the foot engages the ground and the pump chamber is compressed. The bladders may have a bleed valve arrangement as mentioned above which may be either in the form of a specific physical valve, or this function may be provided through a series of small holes extending through the surface of the bladders.
The pump may be in the form of a relatively flat chamber underlying the heel of the user, and is normally resiliently biased so that the air chamber is expanded. Then, when the person's foot is applied downward onto the chamber, it is compressed and the air is forced into the support bladders. Subsequently, when the foot is raised, the pump chamber expands under the resilient force, and air is sucked into the pump chamber. This process is repeated until the support bladders reach their full rated pressure. At this pressure level, the release valve may prevent further build-up of pressure within the bladders, thus controlling the level of pressure against the ankle and foot and the resultant support.
The valves may be implemented by separate valves which may be purchased independently and installed in the interconnecting tubing, or they may be implemented by integral plastic parts in the form of flaps or resiliently mounted plugs which close and open to control the air flow in a manner similar to the separate or independent valves.
At the outlet from the pump, a single one-way valve may be provided or, alternatively, separate one-way valves may extend to each of the support bladders.
The advantage of the system of the present invention is that full support to the ankle and foot is provided when the user is active but, when the user is resting, the bladder arrangements permit a reduction of pressure in the bladders. Heavy support pressure is not applied during resting periods, and circulation is not impaired. Some level of support may be maintained by the use of a compressible filler dispensed within the bladders or outside the bladders. This system prevents undesired eversion, inversion and anterior subluxation caused by activity while allowing for reduced pressure during rest periods.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of the ankle brace as it would appear while being worn with the shoe cut away for clarity.
FIG. 2 is a cross-sectional view taken along plane indicated at II--II in FIG. 1.
FIG. 3 is a partially cut-away view of the ankle brace as it would appear while being worn.
FIG. 4 is an overhead view of the pump with two inlet valves.
FIG. 5 is an overhead view of the pump.
FIG. 6 is a partially exploded view of the present invention.
FIG. 7 shows a cross sectional view of a flap type valve taken along plan 7--7 in FIG. 4.
FIG. 8 is a cross sectional view of a flap type valve taken along the plane VIII--VIII shown in FIG. 7.
DETAILED DESCRIPTION
With reference to FIGS. 1 and 6, the ankle brace of the present invention includes a pair of side supports 10 and 12 preferably made of vacuum molded plastic, having sufficient thickness and other properties so that they are relatively stiff or rigid; and they are shaped so as to fit about the lower leg and ankle and are at least eight inches in length. Inflatable bladders 20 and 21 (shown in FIGS. 2 and 3) are mounted on the side supports 10 and 12 on the side of the side support which faces in toward the leg. The inflatable bladders 20 and 21 can be attached to the side supports 10 and 12 by double-sided adhesive or any other suitable means. The inflatable bladders can be formed from two sheets of plastic heat-sealed along their edges to form an inflatable bag.
The side supports may be securely attached around the leg and ankle using the two securing straps 31 and 32 as shown in the cross-sectional view of FIG. 2 and the cut-away view of FIG. 3. These straps also include velcro portions on their outside surfaces as shown by velcro material 33 and with velcro material 34 at the end portion of the straps. The velcro 34 is attached to the side support 10. As shown in FIGS. 1 and 2, the straps may be tightly drawn around the leg and secured using the velcro material so that the ankle brace securely and firmly supports the ankle.
Interconnecting the two side supports 10 and 12 toward their bottoms is the bottom strap 40. Attached to the bottom strap 40 is a pad member 55, made of a flexible cushioning type material such as polyurethane foam. The bottom strap 40 may include a surface 49 of velcro material with the bottom strap being adjustable through the use of double openings 41 and 42 in the side supports. The ends of the bottom strap 40 may be fixed in position with the use of additional velcro material 44 located on the outside of the side support members as shown in FIG. 3 on side support member 10.
FIG. 1 shows the pump 50 located under the pad member 55 and connected to the bottom strap 40. As shown in FIG. 1, the pump 50 would be located under the wearer's heel. Referring now to FIG. 5, the pump 50 has an inlet valve 70, and an outlet valve 65. The pump also includes a variable volume air chamber 80 having upper and lower flexible sidewalls, and a biasing material 95 which may be a resilient flexible porous pad, and which normally biases the chamber 80 to its expanded volume configuration. When a wearer steps down on the pump 50, the outlet valve 65 opens, and the inlet valve 70 is closed. When the foot is raised, the resilient pad expands the chamber 80, drawing air in through the inlet valve 70, while the outlet valve 65 is closed. Inlet valve 70 and outlet valve 65 may be ball and spring-type valves, but it is to be understood that any appropriate type of one-way valve could be employed.
Extending upward from the outlet valve 65 are two small diameter tubes 61' and 62', each of which is connected to one of the inflatable bladders 20. Alternatively, separate one-way valves 66 and 67, shown in FIG. 4, could be placed in each of the small diameter tubes instead of using one outlet valve 65. It should be noted that the resilient pad 95 used to bias the variable volume air chamber 80 could be replaced with a metal spring, or other suitable resilient material which would bias the chamber to its expanded volume configuration when the user raises his foot and releases pressure from the pump.
FIGS. 4 and 5 show two alternative placements of the inlet valves of the pump 50. FIG. 4 shows the inlet valve 70 replaced with dual inlet valves 71 and 72 placed to either side of the front of the pump. FIG. 5 shows the inlet valve 70 placed toward the wearer's instep in the front of the pump. Also shown in FIG. 4 are the two small diameter tubes 61 and 62 as they could be arranged if each contained an outlet valve 66 and 67 similar to outlet valve 65.
The two inlet valves 71 and 72 of FIG. 4 could alternatively be of a fairly flat flap-type valve. Such a valve is pictured in FIGS. 7 and 8. In such a valve, air drawn in as indicated by the arrow forces the two sealing flaps 13 and 14, which are normally biased together, apart which allows the air to flow through the valve. Air forced in the direction opposite to that indicated by the arrow, toward the flaps, forces flaps 13 and 14 together and they create a substantially airtight seal. This flap-type valve could be made of flexible plastic or rubber and may be more comfortable than a rigid valve when used under the wearer's foot. FIGS. 1 and 6 show the release valve 98, which is an over pressure release and a bleed valve for the inflatable bladder 20. More specifically, a slight amount of air is permitted to bleed from the valve 98 continuously over prolonged periods of time. Further, the relief valve 98 changes state to release air from the inflatable bladder when pressure supplied by the pump becomes excessive, so the maximum pressure level is not exceeded within the inflatable bladders when the wearer of the ankle brace is active.
As an alternative to the bleed function which may be included in relief valve 98, the bladders 20 may be provided with a number of very small holes 96 shown in FIG. 6. The holes 96, which may be in the nature of pinholes, may provide the bleed function which may otherwise be accomplished through the relief valve 98. Also, the position of the relief valve 98 is not necessarily limited to the position shown.
An alternative embodiment of the present invention further includes a closed cell foam pad disposed within the inflatable bladder 20. This is shown in FIG. 6 as 99. The pad can be used to provide a minimum level of support and padding. Alternatively, the pad may be attached to the outside of inflatable bladders 20 and 21 on the side towards the wearer's leg as indicated by 22 and 23 in FIG. 2. The pad may also be open cell foam and may be placed between the bladders and the side supports (not shown).
In conclusion, it is to be understood that the foregoing detailed description relates to a presently preferred embodiment of the present invention. Various changes and modifications may be made without departing from the spirit and scope of the present invention. Thus, by way of example and not of limitation, the various valve structures which have been shown as separate elements may be implemented by constructions formed from the materials out of which the pump and/or bladders are made. Thus, plastic flaps may form one-way valve constructions as shown in FIGS. 7 and 8 and the pressure release valve may be formed of a plastic, rubber or other material which is resiliently biased closed, and forced open when a predetermined level of pressure is reached. Also, the release valve 98 may be preset to a maximum pressure at which it will release air from the inflatable bladder or it may be adjustable. It is further noted that a pump or bellows may be located under the arch or forefoot, instead of or in addition to that located under the heel, as shown in the drawings. Accordingly, the present invention is not limited to the constructions precisely as shown in the drawings or described in the detailed description.
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An ankle brace having two relatively rigid side supports with inflatable bladders attached to them. The side supports are connected at their bottom by a flexible strap upon which is mounted an air pump. The air pump is activated by walking and running and inflates the air bladders mounted on the side supports. The side supports are held firmly in place about the lower leg and ankle by straps. A relief valve and/or pin holes in the bladders prevent excessive pressure in the bladders and provide reduced support when the user is not active.
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BACKGROUND OF THE INVENTION
Field of the Invention
This invention relates to medical imaging systems. More particularly, this invention relates to operator interfaces in medical imaging systems.
Description of the Related Art
Cardiac arrhythmias, such as atrial fibrillation, occur when regions of cardiac tissue abnormally conduct electric signals to adjacent tissue, thereby disrupting the normal cardiac cycle and causing asynchronous rhythm.
Electrical activity in the heart is typically measured by advancing a multiple-electrode catheter to measure electrical activity at multiple points in the heart chamber simultaneously. A graphical user interface integrated with modern imaging systems for monitoring cardiac catheterization presents an abundance of dynamically changing information from the multiple electrodes to the operator, and facilitates efficient processing of the information by the operator.
Receiving atrial electrogram signals from intracardiac catheters is complicated by undesirable far field signal component mixed with near field electrical signals. In this environment near field signals indicate local activation, i.e., propagation of a signal through local regions being sensed by the electrodes. Detection of local activation is widely employed as an electrophysiological indicator of the local state of the heart. The far field electrical signals contain no useful information about local heart activation and only disturb the measurements.
Commonly assigned U.S. Patent Application Publication No. 2014/0005664 by Govari et al., which is herein incorporated by reference, discloses distinguishing a local component in an intracardiac electrode signal, due to the tissue with which the electrode is in contact from a remote-field contribution to the signal, and explains that a therapeutic procedure applied to the tissue can be controlled responsively to the distinguished local component.
SUMMARY OF THE INVENTION
Modern imaging systems adapted to cardiac electrophysiology produce dynamic functional electroanatomic maps of the heart, such as a time-varying map of local activation times (LAT), also known as a 4-dimensional LAT map. However, an operator who is attempting to annotate atrial activation onset times using a multi-electrode catheter and is presented with conventional maps of this sort may experience difficulty distinguishing near-field atrial activity from far-field ventricular activity.
According to disclosed embodiments of the invention, an indication of ventricular depolarization is visualized on a 4-dimensional LAT map as an icon, which is presented using the same time-window and color scale as the dynamic map, but is time-referenced to ventricular activity, e.g., an R-wave or QRS complex rather than to a local activation time of a point or region of the heart.
There is provided according to embodiments of the invention a method for guiding a medical procedure, which is carried out by inserting into a heart of a living subject a probe having sensing electrodes disposed on a distal portion thereof, placing the sensing electrodes in galvanic contact with respective locations in an atrium of the heart, thereafter acquiring electrograms from the sensing electrodes while concurrently detecting ventricular depolarization events, generating from the electrograms a time-varying electroanatomic map showing electrical propagation in the heart, and displaying the electroanatomic map in a series of visual images, the images including an icon that visually indicates the ventricular depolarization events.
The icon may be spaced apart from the electroanatomic map on the images. Alternatively, the icon may be positioned on the electroanatomic map at a center of mass of a ventricle of the heart.
An aspect of the method includes indicating local activation times for the respective locations on the electroanatomic map.
A further aspect of the method includes detecting on the electroanatomic map an indication of atrial depolarization in at least one of the respective locations, making a determination from a visual state of the icon that an instance of ventricular depolarization has occurred concurrently with the indication of atrial depolarization, and reporting responsively to the determination that the indication of atrial depolarization is a suspect false annotation event.
There is further provided according to embodiments of the invention an apparatus, including a processor connectable to an electrocardiographic sensor of ventricular activity and to a cardiac catheter having at least one sensing electrode disposed on a distal portion thereof. The apparatus includes a display linked to the processor, a memory accessible to the processor having programs and data objects stored therein. The programs include a graphical interface program. When the at least one sensing electrode is in galvanic contact with respective locations in an atrium of a heart, execution of the programs cause the processor to acquire electrograms from the at least one sensing electrode and concurrently detect ventricular depolarization events in the heart via the electrocardiographic sensor. The processor is further caused to generate from the electrograms a time-varying electroanatomic map showing electrical propagation in the heart, and to invoke the graphical interface program to present the electroanatomic map on the display as a series of visual images. The images include an icon that visually indicates the ventricular depolarization events.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
For a better understanding of the present invention, reference is made to the detailed description of the invention, by way of example, which is to be read in conjunction with the following drawings, wherein like elements are given like reference numerals, and wherein:
FIG. 1 is a pictorial illustration of a system for performing medical procedures in accordance with an embodiment of the invention;
FIG. 2 is a screen display generated by the system shown in FIG. 1 in accordance with an embodiment of the invention;
FIG. 3 is a screen display generated by the system shown in FIG. 1 in accordance with an embodiment of the invention;
FIG. 4 is a screen display generated by the system shown in FIG. 1 in accordance with an embodiment of the invention;
FIG. 5 is a screen display generated by the system shown in FIG. 1 in accordance with an embodiment of the invention; and
FIG. 6 is a flow-chart of a method of indicating ventricular electrical activity during atrial mapping in accordance with an embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
In the following description, numerous specific details are set forth in order to provide a thorough understanding of the various principles of the present invention. It will be apparent to one skilled in the art, however, that not all these details are necessarily needed for practicing the present invention. In this instance, well-known circuits, control logic, and the details of computer program instructions for conventional algorithms and processes have not been shown in detail in order not to obscure the general concepts unnecessarily.
Aspects of the present invention may be embodied in software programming code, which is typically maintained in permanent storage, such as a computer readable medium. In a client/server environment, such software programming code may be stored on a client or a server. The software programming code may be embodied on any of a variety of known non-transitory media for use with a data processing system, such as a USB memory, hard drive, electronic media or CD-ROM. The code may be distributed on such media, or may be distributed to users from the memory or storage of one computer system over a network of some type to storage devices on other computer systems for use by users of such other systems.
DEFINITIONS
“Annotations” refer to points on an electrogram that are considered to denote events of interest. In this disclosure the events are typically onset of the propagation of an electrical wave (local activation time) as sensed by an electrode.
Overview
Turning now to the drawings, reference is initially made to FIG. 1 , which is a pictorial illustration of a system 10 for performing diagnostic and therapeutic procedures on a heart 12 of a living subject, which is constructed and operative in accordance with a disclosed embodiment of the invention. The system comprises a catheter 14 , which is percutaneously inserted by an operator 16 through the patient's vascular system into a chamber or vascular structure of the heart 12 . The operator 16 , who is typically a physician, brings the catheter's distal tip 18 into contact with the heart wall at an ablation target site. Functional electroanatomic maps, e.g., electrical activation maps may then be prepared, according to the methods disclosed in U.S. Pat. Nos. 6,226,542, and 6,301,496, and in commonly assigned U.S. Pat. No. 6,892,091, whose disclosures are herein incorporated by reference. One commercial product embodying elements of the system 10 is the CARTO® 3 System, available from Biosense Webster, Inc., 3333 Diamond Canyon Road, Diamond Bar, Calif. 91765. This system may be modified by those skilled in the art to embody the principles of the invention described herein.
Areas determined to be abnormal, for example by evaluation of the electrical activation maps, can be ablated by application of thermal energy, e.g., by passage of radiofrequency electrical current through wires in the catheter to one or more electrodes at the distal tip 18 , which apply the radiofrequency energy to the myocardium. The energy is absorbed in the tissue, heating it to a point (typically about 60° C.) at which it permanently loses its electrical excitability. When successful, this procedure creates non-conducting lesions in the cardiac tissue, which disrupt the abnormal electrical pathway causing the arrhythmia. The principles of the invention can be applied to different heart chambers to treat many different cardiac arrhythmias.
The catheter 14 typically comprises a handle 20 , having suitable controls on the handle to enable the operator 16 to steer, position and orient the distal end of the catheter as desired for the ablation. To aid the operator 16 , the distal portion of the catheter 14 contains position sensors (not shown) that provide signals to a position processor 22 , located in a console 24 .
Ablation energy and electrical signals can be conveyed to and from the heart 12 through one or more electrodes 32 located at or near the distal tip 18 via cable 34 to the console 24 . Pacing signals and other control signals may be conveyed from the console 24 through the cable 34 and the electrodes 32 to the heart 12 . One or more sensing electrodes 33 , also connected to the console 24 , are disposed near the ablation electrode 32 and have connections to the cable 34 .
Wire connections 35 link the console 24 with body surface electrodes 30 and other components of a positioning sub-system. The electrodes 32 and the body surface electrodes 30 may be used to measure tissue impedance at the ablation site as taught in U.S. Pat. No. 7,536,218, issued to Govari et al., which is herein incorporated by reference. A temperature sensor such as thermocouples 31 , may be mounted on or near the ablation electrode 32 and optionally or near the sensing electrodes 33 .
The console 24 typically contains one or more ablation power generators 25 . The catheter 14 may be adapted to conduct ablative energy to the heart using any known ablation technique, e.g., radiofrequency energy, ultrasound energy, and laser-produced light energy. Such methods are disclosed in commonly assigned U.S. Pat. Nos. 6,814,733, 6,997,924, and 7,156,816, which are herein incorporated by reference.
The positioning processor 22 is an element of a positioning subsystem in the system 10 that measures, inter alia, location and orientation coordinates of the catheter 14 .
In one embodiment, the positioning subsystem comprises a magnetic position tracking arrangement that determines the position and orientation of the catheter 14 by generating magnetic fields in a predefined working volume and sensing these fields at the catheter, using field generating coils 28 . The positioning subsystem may employ impedance measurement, as taught, for example in U.S. Pat. No. 7,756,576, which is hereby incorporated by reference, and in the above-noted U.S. Pat. No. 7,536,218.
As noted above, the catheter 14 is coupled to the console 24 , which enables the operator 16 to observe and regulate the functions of the catheter 14 . Console 24 includes a processor, preferably a computer with appropriate signal processing circuits. The processor is coupled to execute a graphical user interface program that is operative to produce the visual displays described below by driving a monitor 29 . The signal processing circuits typically receive, amplify, filter and digitize signals from the catheter 14 , including signals generated by the above-noted sensors and a plurality of location sensing electrodes (not shown) located distally in the catheter 14 . The digitized signals are received and used by the console 24 and the positioning system to compute the position and orientation of the catheter 14 , and to analyze the electrical signals from the electrodes.
Typically, the system 10 includes other elements, which are not shown in the figures for the sake of simplicity. For example, the system 10 may include an electrocardiogram (ECG) monitor, coupled to receive signals from one or more body surface electrodes, to provide an ECG synchronization signal and signal ventricular depolarization events to the console 24 . As mentioned above, the system 10 typically also includes a reference position sensor, either on an externally-applied reference patch attached to the exterior of the subject's body, or on an internally-placed catheter, which is inserted into the heart 12 maintained in a fixed position relative to the heart 12 . Conventional pumps and lines for circulating liquids through the catheter 14 for cooling the ablation site are provided.
With modern imaging systems used for monitoring cardiac catheterization, an increasing abundance of dynamically changing information is presented to the operator, to the extent that efficient processing of the information by the operator is impaired. Modern navigation and ablation catheters typically have multiple sensors, sensing electrodes, and ablation electrodes, which can be active in many combinations. Each of these has its own time-varying status, which is important for the operator to evaluate concurrently with extensive electroanatomic information regarding cardiac function.
User Interface
Reference is now made to FIG. 2 , which is a typical screen display of an electroanatomic map of the left atrium, which is generated by the graphical user interface program on monitor 29 by the system 10 ( FIG. 1 ), in accordance with an embodiment of the invention. Right pane 37 shows electrograms obtained from multiple electrodes catheter. Left pane 39 presents a snapshot of a 4-dimensional LAT map 41 that was obtained at a time corresponding to vertical line 43 in the right pane 37 . A spherical icon 45 activates upon detection of an R-wave or QRS complex in one of the tracings or in another ECG lead (not shown). In the snapshot of the left pane 39 , the icon 45 is not activated, suggesting that signals being received from atrial regions 47 , 49 at the time of the snapshot are not far-field signals from the ventricle. While the icon 45 is spherical, both its shape and its location with respect to the map 41 are exemplary and not limiting. Other shapes and locations of the icon 45 are possible, so long as the relative states of activation of the icon and the atria are readily presented to the operator.
In one embodiment the icon 45 is spaced apart from the map 41 . Alternatively, the icon 45 may be placed approximately the center of mass of the ventricles. In any case, visual indicia, e.g., coloring of the icon 45 , are referenced to detections of ventricular depolarization, such as an R wave or QRS complex. The color scale for the icon 45 and the map 41 should be the same, in order to facilitate its interpretation by the operator. A different color scale would be less intuitive, and even confusing to the operator. It would likely create a distorted impression of the information displayed on the map.
Reference is now made to FIG. 3 , which is a screen display similar to FIG. 2 , in accordance with an embodiment of the invention. Atrial depolarization is detected in atrial region 51 . The icon 45 is active, indicating that ventricular depolarization has occurred. However the activation time is not consistent with the activation times of the atrial region 51 . It may be concluded with confidence that the signals received at the time of the snapshot from the atrial region 51 are not affected by far-field signals from the ventricle.
Reference is now made to FIG. 4 , which is another screen display similar to FIG. 2 showing the posterior wall of the atria, in accordance with an embodiment of the invention. The snapshot of the 4-dimensional LAT map is obtained at a time corresponding to vertical line 53 . At this time activity is noted on tracing 55 and a concurrent deflection indicative of ventricular depolarization is seen on tracing 57 . The icon 45 is active, consistent with the occurrence of ventricular depolarization. An atrial region 59 is monitored by a lead from which the tracing 55 was obtained. The region 59 shows apparent activation in the region of the sino-atrial (SA) node; however, because it is concurrent with the activation of the icon 45 , the region 59 cannot be reliably interpreted on this snapshot, as the lead may have detected far-field ventricular activity While the operator could reference the tracing 57 , evaluate the ordered atrial activations on the right pane, and deduce that the activation of region 59 as well as activations of neighboring regions are inconsistent with physiologic SA node activation, the illuminated state (or other visual appearance) of the icon 45 relieves the operator from the burden of this sort of analysis.
Reference is now made to FIG. 5 , which is a screen display similar to FIG. 2 , in accordance with an embodiment of the invention. A large region 61 shows apparent activation, but is coincident with ventricular depolarization, as shown by the illuminated state of the icon 45 . The map 41 indicates locations 63 of mapping electrodes of the cardiac catheter (not shown).
While snapshots are necessarily shown in the above-described figures, in practice the operator views a 4-dimensional LAT map, and becomes immediately aware of ventricular depolarization when activation of the icon 45 occurs. This avoids the inconvenience of reference to and interpretation of the extensive data shown on the right pane 37 . In particular, the information provided by the icon 45 relates presumptive atrial annotations to ventricular depolarization. When a presumptive annotation is represented at an atrial location on the map 41 the operator can immediately determine if ventricular depolarization is present at the same time. If so, the event is suspect as being a false annotation because it may be corrupted by far-field signals from the ventricle.
Operation
Reference is now made to FIG. 6 , which is a flow-chart of a method of indicating ventricular electrical activity during atrial mapping in accordance with an embodiment of the invention. The process steps are shown in a particular linear sequence in FIG. 6 for clarity of presentation. However, it will be evident that many of them can be performed in parallel, asynchronously, or in different orders. Those skilled in the art will also appreciate that a process could alternatively be represented as a number of interrelated states or events, e.g., in a state diagram. Moreover, not all illustrated process steps may be required to implement the method.
At initial step 65 the heart is catheterized conventionally using any suitable multi-electrode catheter. Catheters such as the PentaRay® NAV or Navistar® Thermocool® catheters, available from Biosense Webster, are suitable for initial step 65 . The electrodes of the catheter is placed in galvanic contact with respective locations in one of the atria.
Next, at step 67 recording of cardiac electrical activity occurs and an activation map of the heart is generated. Step 67 comprises step 69 where atrial activity is recorded. Step 69 is usually performed concurrently with the multiple electrodes of the catheter, each having a respective location in the atrium, as indicated in FIG. 5 . At the same time ventricular activity is recorded in step 71 , for example by using body surface electrodes. QRS complexes or R waves indicative of ventricular depolarization are input to the processor 22 ( FIG. 1 ), which activates of an icon on a graphical user interface, e.g., the icon 45 shown in the preceding figures. The time relationships of ventricular depolarization shown on the graphical display as the same visual scheme as that of the atrial electrodes, except that the visual scheme is linked to ventricular depolarization rather than to depolarization of the atria.
At step 73 atrial depolarization is detected in one or more of the locations of the catheter electrodes.
Control now proceeds to decision step 75 , where it is determined if concurrent ventricular depolarization was present concurrently with the atrial depolarization by reference to the above-mentioned icon. If the determination at decision step 75 is affirmative, then control proceeds to step 77 . The state of the icon constitutes the operator that the detection of atrial depolarization may not be reliable. The icon thus alerts the operator to the possibility that the detection of atrial depolarization may be a false is a suspect atrial activation, i.e., a false annotation event, and that far-field ventricular activity may be responsible.
If the determination at decision step 75 is negative, then control proceeds to step 79 . The detection of atrial depolarization is considered to be valid, and a local activation time of the location in which the atrial depolarization was detected is noted. There is no concern for VFF detection.
After performing step 77 or step 79 control returns to step 67 to iterate the procedure.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
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Cardiac catheterization is carried out using a probe having sensing electrodes disposed on a distal portion thereof, placing the sensing electrodes in galvanic contact with respective locations in an atrium of the heart, thereafter acquiring electrograms from the sensing electrodes while concurrently detecting ventricular depolarization events, generating from the electrograms a time-varying electroanatomic map showing electrical propagation in the heart, and displaying the electroanatomic map in a series of visual images, the images including an icon that visually indicates the ventricular depolarization events.
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REFERENCE TO RELATED APPLICATIONS
This application claims priority under 35 USC 119(e) from U.S. Patent application No. 60/288,415 filed May 4, 2001, 60/326,987 filed Oct. 5, 2001, 60/331,066 filed Nov. 7, 2001, 60/333,494 filed Nov. 28, 2001 and 60/374,801 filed Apr. 24, 2002.
FIELD OF THE INVENTION
The present invention relates to improved methods for manufacturing oil seed protein isolate, particularly a canola protein isolate.
BACKGROUND TO THE INVENTION
In U.S. Pat. Nos. 5,844,086 and 6,005,076 (“Murray II”), assigned to the assignee hereof and the disclosures of which are incorporated herein by reference, there is described a process for the isolation of protein isolates from oil seed meal having a significant fat content, including canola oil seed meal having such content. The steps involved in this process include solubilizing proteinaceous material from oil seed meal, which also solubilizes fat in the meal, and removing fat from the resulting aqueous protein solution. The aqueous protein solution may be separated from the residual oil seed meal before or after the fat removal step. The defatted protein solution then is concentrated to increase the protein concentration while maintaining the ionic strength substantially constant, after which the concentrated protein solution may be subjected to a Per fat removal step. The concentrated protein solution then is diluted to cause the formation of a cloud-like mass of highly associated protein molecules as discrete protein droplets in micellar form. The protein micelles are allowed to settle to form an aggregated, coalesced, dense, amorphous, sticky gluten-like protein isolate mass, termed “protein micellar mass” or PMM, which is separated from the residual aqueous phase and dried.
The protein isolate has a protein content (as determined by Kjeldahl N×6.25) of at least about 90 wt %, is substantially undenatured (as determined by differential scanning calorimetry) and has a low residual fat content. The term “protein content” as used herein refers to the quantity of protein in the protein isolate expressed on a dry weight basis. The yield of protein isolate obtained using this procedure, in terms of the proportion of protein extracted from the oil seed meal which is recovered as dried protein isolate was generally less than 40 wt %, typically around 20 wt %.
The procedure described in the aforementioned Murray II patent was developed as a modification to and improvement on the procedure for forming a protein isolate from a variety of protein source materials, including oil seeds, as described in U.S. Pat. No. 4,208,323 (Murray IB). The oil seed meals available in 1980, when U.S. Pat. No. 4,208,323 issued, did not have the fat contamination levels of the canola oil seed meals available at the time of the Murray II patents, and, as a consequence, the procedure of U.S. Pat. No. 4,208,323 cannot produce from such oil seed meals processed according to the Murray II process, proteinaceous materials which have more than 90 wt % protein content. There is no description of any specific experiments in U.S. Pat. No. 4,208,303 carried out using rapeseed (canola) meal as the starting material.
U.S. Pat. No. 4,208,323 itself was designed to be an improvement on the process described in U.S. Pat. Nos. 4,169,090 and 4,285,862 (Murray IA) by the introduction of a concentration step prior to dilution to form the PMM. The Murray IA patents describe one experiment involving rapeseed but provides no indication of the purity of the product. The concentration step described in the Murray IB patent served to improve the yield of protein isolate from around 20% for the Murray IA process.
SUMMARY OF INVENTION
It has now been found that it is possible to improve these prior art protein isolate processes as they apply to oil seeds, particularly canola, to obtain improved yields of dried protein isolate, in terms of the proportion of protein extracted from the oil seeds, of at least about 40 wt % and often much higher, at least about 80 wt %, and protein isolates of higher purity, at least about 100 wt % at a Kjeldahl nitrogen conversion rate of N×6.25.
It has Dryer been found that a significant proportion of the canola protein extracted from the meal in the process of Murray IA and IB and Murray II, as applied to canola meal, is lost as a result of discarding the supernatant from the PMM-formation step. A further improvement on the prior procedure is provided herein, which improves the overall yield of protein, wherein protein present in the supernatant is recovered generally by a process of concentration to remove impurities and drying the concentrate. The product obtained from the supernatant generally has a protein content (N×6.25) of greater than 100% and is a novel canola protein isolate product. Such novel product provides a flier aspect of the invention.
As a further improvement on the prior procedure, the concentrated supernatant may be mixed with the PMM and the mixture dried. Alternatively, a portion of the concentrated supernatant may be mixed with at least a portion of the PMM and the resulting mixture dried. The latter products are novel canola protein isolate products and constitute a further aspect of the invention.
In accordance with one aspect of the present invention, there is provided a process of preparing a protein isolate, which comprises (a) extracting an oil seed meal at a temperature of at least about 5° and preferably up to about 35° C. to cause solubilization of protein in said oil seed meal and to form an aqueous protein solution having a protein content of about 5 to about 25 g/L and a pH of about 5 to about 6.8, (b) separating the aqueous protein solution from residual oil seed meal, (c) increasing the protein concentration of said aqueous protein solution to at least about 200 g/L while maintaining the ionic strength substantially constant by using a selective membrane technique to provide a concentrated protein solution, (d) diluting said concentrated protein solution into chilled water having a temperature of below about 15° C. to cause the formation of protein micelles; (e) settling the protein micelles to form an amorphous, sticky, gelatinous gluten-like protein micellar mass, and (f) recovering the protein micellar mass from supernatant having a protein content of at least about 100 wt % as determined by Kjeldahl nitrogen×6.25 on a dry weight basis. The recovered protein micellar mass may be dried. The protein isolate is substantially undenatured (as determined by differential scanning calorimetry).
The protein isolate product in the form of protein micellar mass is described herein as “gluten-like”. This description is intended to indicate the appearance and feel of the isolate are similar to those of vital wheat gluten and is not intended to indicate chemical identity to gluten.
In one embodiment of this process, supernatant from the settling step is concentrated and the resulting concentrated supernatant is dried to provide a protein isolate having a protein content of at least about 90 wt % (N×6.25) on a dry weight basis. Such protein isolate is a novel product and is provided in accordance with further aspect of the invention.
In another embodiment of this process, supernatant from the settling step is concentrated, the resulting concentrated supernatant is mixed with the protein micellar mass prior to drying the same, and the resulting mixture is dried to provide a protein isolate having a protein content of at least about 90 wt % (N×6.25) on a dry weight basis. Such protein isolate is a novel product and is provided in accordance with another aspect of the invention.
In a further embodiment of the invention, supernatant from the resulting step is concentrated and a portion only of the resulting concentrated supernatant is mixed with at least a portion of the protein micellar mass prior to drying the same to provide other novel protein isolates according to the invention having a protein content of at least about 90 wt % (N×6.25) on a dry weight basis.
A key step in the process of the present invention and the ability to obtain higher yields of protein isolate at purities of at least 100 wt % than previously attained is concentration of the protein solution to a protein content of at least about 200 g/L, a much higher value than in the prior procedures described above. Another key step is the step of warming the concentrated protein solution, as necessary, prior to dilution into chilled water at a dilution rate of less than 1:15, when protein micellar mass only is recovered. This specific combination of parameters is not described in the prior art nor are the beneficial results of high protein yield and high purity protein isolate described therein. An additional step in improving protein yield, particularly in the case of canola meal, is the recovery of additional quantities of protein from the supernatant from the PMM formation and settling step.
In accordance with another aspect of the invention, there is provided a process for preparing a canola protein isolate of reduced pigmentation, which comprises (a) extracting canola oil seed meal at a temperature of at least 5° C. to cause solubilization of protein in said canola oil seed meal and to form an aqueous protein solution having a protein content of about 5 to about 25 g/L and a pH of about 5 to about 6.8; (b) separating the aqueous protein solution from residual canola oil seed meal; (c) subjecting the aqueous protein solution to a pigment removal step; (d) increasing the protein concentration of said aqueous protein solution to at least about 200 g/L while maintaining the ionic strength substantially constant by using a selective membrane technique to provide a concentrated protein solution; (e) diluting said concentrated protein solution into chilled water having a temperature below about 15° C. to cause the formation of protein micelles; (f) settling the protein micelles to form an amorphous, sticky, gelatinous, gluten-like micellar mass; and (g) recovering the protein micellar mass from supernatant having a protein content of at least about 90 wt % as determined by Kjeldahl nitrogen×6.25 on a dry weight basis.
The protein isolate produced according to the process herein may be used in conventional applications of protein isolates, such as, protein fortification of processed foods, emulsification of oils, body formers in baked goods and foaming agents in products which entrap gases. In addition, the protein isolate may be formed into protein fibers, useful in meat analogs, may be used as an egg white substitute or extender in food products where egg white is used as a binder. The canola protein isolate may be used as nutritional supplements. Other uses of the canola protein isolate are in pets foods, animal feed and in industrial and cosmetic applications and in personal care products.
BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 is a schematic flow sheet of a procedure for producing an oil seed protein isolate as well as other products in accordance with one embodiment of the invention.
GENERAL DESCRIPTION OF INVENTION
The initial step of the process of this invention involves solubilizing proteinaceous material from oil seed meal, particularly canola meal, although the process may be applied to other oil seed meals, such as soybean, traditional rapeseed, traditional flax, linola, sunflower and mustard oil seed meals. The invention is more particularly described herein with respect to canola seed meal.
The proteinaceous material recovered from canola seed meal may be the protein naturally occurring in canola seed or other oil seed or the proteinaceous material may be a protein modified by genetic manipulation but possessing characteristic hydrophobic and polar properties of the natural protein. The canola meal may be any canola meal resulting from the removal of canola oil from canola oil seed with varying levels of non-denatured protein, resulting, for example, from hot hexane extraction or cold oil extrusion methods. The removal of canola oil from canola oil seed usually is effected as a separate operation from the protein isolate recovery procedure of the present invention.
Protein solubilization is effected most efficiently by using a food grade salt solution since the presence of the salt enhances the removal of soluble protein from the oil seed meal. The food grade salt usually is sodium chloride, although other salts, such as, potassium chloride, may be used. The food grade salt solution has an ionic strength of at least about 0.10, preferably at least about 0.15, to enable solubilization of significant quantities of protein to be effected. As the ionic strength of the salt solution increases, the degree of solubilization of protein in the oil seed meal initially increases until a maximum value is achieved. Any subsequent increase in ionic strength does not increase the total protein solubilized. The ionic strength of the food grade salt solution which causes maximum protein solubilization varies depending on the salt concerned and the oil seed meal chosen.
In view of the greater degree of dilution required for protein precipitation with increasing ionic strengths, it is usually preferred to utilize an ionic strength value less than about 0.8, and more preferably a value of about 0.15 to about 0.6.
The salt solubilization of the protein is effected at a temperature of at least about 5° C., preferably up to about 35° C., preferably accompanied by agitation to decrease the solubilization time, which is usually about 10 to about 60 minutes. It is preferred to effect the solubilization to extract substantially the maximum amount of protein from the oil seed meal, so as to provide an overall high product yield.
The lower temperature limit of about 5° C. is chosen since solubilization is impractically slow below this temperature while the preferred upper temperature limit of about 35° C. is chosen since the process becomes uneconomic at higher temperature levels in a batch mode.
The aqueous food grade salt solution and the oil seed meal have a natural pH of about 5 to about 6.8 to enable the protein isolate to be formed by the micellar route, as described in more detail below. The optimum pH value for maximum yield of protein isolate varies depending on the oil seed meal chosen.
At and close to the limits of the pH range, protein isolate formation occurs only partly through the micelle route and in lower yields than attainable elsewhere in the pH range. For these reasons, pH values of about 5.3 to about 6.2 are preferred.
The pH of the food grade salt solution may be adjusted to any desired value within the range of about 3 to about 6.8 for use in the extraction step by the use of any convenient food grade acid, usually hydrochloric acid, or food grade alkali, usually sodium hydroxide, as required.
The concentration of oil seed meal in the food grade salt solution during the solubilization step may vary widely. Typical concentration values are about 5 to about 15% w/v.
The protein extraction step with the aqueous salt solution has the additional effect of solubilizing fats which may be present in the canola meal, which then results in the fats being present in the aqueous phase.
The protein solution resulting from the extraction step generally has a protein concentration of about 5 to about 30 g/L, preferably about 10 to about 25 g/L.
The aqueous phase resulting from the extraction step then may be separated from the residual canola meal, in any convenient manner, such as by employing vacuum filtration, followed by centrifugation and/or filtration to remove residual meal. The separated residual meal may be dried for disposal.
The colour of the final canola protein isolate can be improved in terms of light colour and less intense yellow by the mixing of powdered activated carbon or other pigment adsorbing agent with the separated aqueous protein solution and subsequently removing the adsorbent, conveniently by filtration, to provide a protein solution. Diafiltration of the separated aqueous protein solution also may be used for pigment removal.
Such pigment removal step may be carried out under any convenient conditions, generally at the ambient temperature of the separated aqueous protein solution, employing any suitable pigment adsorbing agent. For powdered activated carbon, an amount of about 0.025% to about 5% w/v, preferably about 0.05% to about 2% w/v, is employed.
Where the canola seed meal contains significant quantities of fat, as described in the Murray II patents, then the defatting steps described therein may be effected on the separated aqueous protein solution and on the concentrated aqueous protein solution. When the colour improvement step is carried out, such step may be effected after the first defatting step.
As an alternative to extracting the oil seed meal with an aqueous food grade salt solution, such extraction may be made using water alone, although the utilization of water alone tends to extract less protein from the oil seed meal than the aqueous food grade salt solution. Where such alternative is employed, then the food grade salt, in the concentrations discussed above, may be added to the protein solution after separation from the residual oil seed meal in order to maintain the protein in solution during the concentration step described below. When a colour removal step and/or a first fat removal step is carried out, the food grade salt generally is added after completion of such operations.
Another alternative procedure is to extract the oil seed meal with the food grade salt solution at a relatively high pH value about 6.8, generally up to about 9.8. The pH of the food grade salt solution, may be adjusted in pH to the alkaline value by the use of any convenient food-grade alkali, such as aqueous sodium hydroxide solution Where such alternative is employed, the aqueous phase resulting from the oil seed meal extraction step then is separated from the residual canola meal, in any convenient manner, such as by employing vacuum filtration, followed by centrifugation and/or filtration to remove residual meal. The separated residual meal may be dried for disposal.
The aqueous protein solution resulting from the high pH extraction step then is pH adjusted to the range of about 5 to about 6.8, preferably about 5.3 to about 6.2, as discussed above, prior to further processing as discussed below. Such pH adjustment may be effected using any convenient food grade acid, such as hydrochloric acid.
The aqueous protein solution then is concentrated to increase the protein concentration thereof while maintaining the ionic strength thereof substantially constant. Such concentration is effected to provide a concentrated protein solution having a protein concentration of at least about 200 g/L, preferably at least about 250 g/L.
The concentration step may be effected by any convenient selective membrane technique, such as ultrafiltration or diafiltration, using membranes, such as hollow-fibre membranes or spiral-wound membranes, with a suitable molecular weight cut-off, such as about 3000 to about 50,000 daltons, having regard to differing membrane materials and configurations.
The concentration step may be effected at any convenient temperature, generally about 20° C. to about 60° C., and for the period of time to effect the desired degree of concentration. The temperature and other conditions used to some degree depend upon the membrane equipment used to effect the concentration and the desired protein concentration of the solution.
The concentrating of the protein solution to a concentration above about 200 g/L in this step, significantly beyond levels previously contemplated and attained when employing the Murray I and Murray II processes, not only increases the process yield to levels above about 40 wt % in terms of the proportion of extracted protein which is recovered as dried protein isolate, preferably above about 80 wt %, but also decreases the salt concentration of the final protein isolate after drying. The ability to control the salt concentration of the isolate is important in applications of the isolate where variations in salt concentrations affect the functional and sensory properties in a specific food application.
As is well known, ultrafiltration and similar selective membrane techniques permit low molecular weight species to pass therethrough while preventing higher molecular weight species from so doing. The low molecular weight species include not only the ionic species of the food grade salt but also low molecular weight materials extracted from the source material, such as, carbohydrates, peptides, pigments and anti-nutritional factors, as well as any low molecular weight forms of the protein. The molecular weight cut-off of the membrane is usually chosen to ensure retention of a significant proportion of the protein in the solution, while permitting contaminants to pass through having regard to the different membrane materials and configurations.
Depending on the temperature employed in the concentration step, the concentrated protein solution may be warmed to a temperature of at least about 20° C., and up to about 60° C., preferably about 25° C. to about 40° C., to decrease the viscosity of the concentrated protein solution to facilitate performance of the subsequent dilution step and micelle formation. The concentrated protein solution should not be heated beyond a temperature above which the temperature of &e concentrated protein solution does not permit micelle formation on dilution by chilled water. The concentrated protein solution may be subject to a firer defatting operation, if required, as described in Murray II.
The concentrated protein solution resulting from the concentration step and optional defatting step then is diluted to effect micelle formation by adding the concentrated protein solution into a body of water having the volume required to achieve the degree of dilution desired. Depending on the proportion of canola protein desired to be obtained by the micelle route and the proportion from the supernatant, the degree of dilution of the concentrated protein solution may be varied. With higher dilution levels, in general, a greater proportion of the canola protein remains in the aqueous phase.
When it is desired to provide the greatest proportion of the protein by the nicelle route, the concentrated protein solution is diluted by about 15 fold or less, preferably about 10 fold or less.
The body of water into which the concentrated protein solution is fed has a temperature of less than about 15° C., generally about 3° C. to about 15° C., preferably less than about 10° C., since improved yields of protein isolate in the form of protein micellar mass are attained with these colder temperatures at the dilution factors used.
The dilution of the concentrated protein solution and consequential decrease in ionic strength causes the formation of a cloud-like mass of highly associated protein molecules in the form of discrete protein droplets in micellar form. The protein micelles are allowed to settle to form an aggregated, coalesced, dense, amorphous sticky gluten-like protein micellar mass. The settling may be assisted, such as by centrifugation. Such induced settling decreases the liquid content of the protein micellar mass, thereby decreasing the moisture content generally from about 70% by weight to about 95% by weight to a value of generally about 50% by weight to about 80% by weight of the total micellar mass. Decreasing the moisture content of the micellar mass in this way also decreases the occluded salt content of the micellar mass, and hence the salt content of dried isolate.
The combination of process parameters of concentrating of the protein solution to a protein content of at least about 200 g/L and the use of a dilution factor less than about 15, result in higher yields, often significantly higher yields, in terms of recovery of protein in the form of protein micellar mass from the original meal extract, and much purer isolates in terms of protein content than achieved using any of the prior art procedures (Murray IA, IB and II) referred to above.
The settled isolate, in the form of an amorphous, aggregated, sticky, gelatinous, gluten-like protein mass, termed “protein micellar mass”, or PMM, is separated from the residual aqueous phase or supernatant, such as by decantation of the residual aqueous phase from the settled mass or by centrifugation The PMM may be used in the wet form or may be dried, by any convenient technique, such as spray drying, freeze drying or vacuum drum drying, to a dry form. The dry PMM has a high protein content, in excess of about 100 wt % protein (calculated as Kjeldahl N×6.25), and is substantially undenatured (as determined by differential scanning calorimetry). The dry PMM isolated from fatty oil seed meal also has a low residual fat content, when the procedure of Murray I is employed, which may be below about 1 wt %.
In accordance with one aspect of the invention, particularly as it is applied to canola protein, it has now been found that the supernatant from the PMM formation and settling step contains significant amounts of canola protein, not precipitated in the dilution step. It has not previously been proposed, in the Murray IA, IB and II patents, to attempt to recover additional protein from the supernatant and no observation is made in this prior art as to any potential protein content of the supernatant. In accordance with this aspect of the invention, steps are taken to recover the canola protein from the supernatant.
In such procedure, the supernatant from the dilution step, following removal of the PMM, may be concentrated to increase the protein concentration thereof. Such concentration is effected using any convenient selective membrane technique, such as ultrafiltration, using membranes with a suitable molecular weight cut-off permitting low molecular weight species, including the food grade salt and other non-proteinaceous low molecular weight materials extracted from the source material, to pass through the membrane, while retaining canola protein in the solution. Ultrafiltration membranes having a molecular weight cut-off of about 3000 to 10,000 daltons having regard to differing membranes and configurations, may be used. Concentration of the supernatant in this way also reduces the volume of liquid required to be dried to recover the protein, and hence the energy required for drying. The supernatant generally is concentrated to a protein content of about 100 to 400 g/L, preferably about 200 to about 300 g/L, prior to drying.
The concentrated supernatant may be dried by any convenient technique, such as spray drying, freeze drying or vacuum drum drying, to a dry form to provide a further canola protein isolate. Such further canola protein isolate has a high protein content, usually in excess of about 90 wt % protein (calculated as Kjeldahl N×6.25) and is substantially undenatured (as determined by differential scanning calorimetry). If desired, the wet PMM may be combined with the concentrated supernatant prior to drying the combined protein streams by any convenient technique to provide a combined canola protein isolate. The combined canola protein isolate has a high protein content, in excess of about 90 wt % (calculated as Kjeldahl N×6.25) and is substantially undenatured (as determined by differential scanning calorimetry).
In another alternative procedure, a portion only of the concentrated supernatant may be mixed with at least part of the PMM and the resulting mixture dried. The remainder of the concentrated supernatant may be dried as any of the remainder of the PMM. Further, dried PMM and dried supernatant also may be dry mixed in any desired relative proportions.
By operating in this manner, a number of canola protein isolates may be recovered, in the form of dried PMM, dried supernatant and dried mixtures of various proportions by weight of PMM and supernatant, generally from about 5:95 to about 95:5 by weight, which may be desirable for attaining differing functional and nutritional properties.
As an alternative to dilution of the concentrated protein solution into chilled water and processing of the resulting precipitate and supernatant as described above, protein may be recovered from the concentrated protein solution by dialyzing the concentrated protein solution to reduce the salt content thereof. The reduction of the salt content of the concentrated protein solution results in the formation of protein micelles in the dialysis tubing. Following dialysis, the protein micelles may be permitted to settle, collected and dried, as discussed above. The supernatant from the protein micelle settling step may be processed, as discussed above, to recover further protein therefrom. Alternatively, the contents of the dialysis tubing may be directly dried. The latter alternative procedure is useful where small laboratory scale quantities of protein are desired.
DESCRIPTION OF PREFERRED EMBODIMENT
Referring to FIG. 1 , there is illustrated schematically a flow sheet of one embodiment to the invention. Canola oil seed meal and aqueous extraction medium are fed by line 10 to an extraction vessel 12 wherein the oil seed meal is extracted and an aqueous protein solution is formed. The slurry of aqueous protein solution and residual oil seed meal is passed by line 14 to a vacuum filter belt 16 for separation of the residual oil seed meal which is removed by line 18 . The aqueous protein solution then is passed by line 20 to a clarification operation 22 wherein the aqueous protein solution is centrifuged and filtered to remove fines, which are recovered by line 24 .
The clarified aqueous protein solution is pumped by line 26 through ultrafiltration membrane 28 to produce a concentrated protein solution as the retentate in line 30 with the permeate being recovered by line 32 . The concentrated protein solution is passed into a precipitation vessel 34 containing cold water fed by line 36 . Protein micellar mass formed in the precipitation vessel 34 is removed by line 38 and passed through a spray dryer 40 to provide dry canola protein isolate 42 .
Supernatant from the precipitation vessel 34 is removed by line 44 and pumped through ultrafiltration membranes 46 to produce a concentrated protein solution as the retentate in line 48 with the permeate being removed by line 50 . The concentrated protein solution is passed through a spray dryer 52 to provide further dry canola protein isolate 54 .
As an alternative, the concentrated protein solution in line 48 may be passed by line 56 to mix with the protein micellar mass before the mixture then is dried in spray dryer 40 .
EXAMPLES
Example 1
This Example illustrates the process of the invention.
‘a’ kg of commercial canola meal was added to ‘b’ L of 0.15 M NaCl solution at ambient temperature and agitated for 30 minutes to provide an aqueous protein solution having a protein content of ‘c’ g/L. The residual canola meal was removed and washed on a vacuum filter belt. The resulting protein solution was clarified by centrifugation to produce ‘d’ L of a clarified protein solution having a protein content of ‘e’ S/L.
The protein extract solution or a ‘f’ L aliquot of the protein extract solution was reduced in volume to ‘g’ L by concentration on an ultrafiltration system using ‘h’ dalton molecular weight cut-off membranes. The resulting concentrated protein solution had a protein content of ‘i’ g/L.
The concentrated solution at ‘j’ ° C. was diluted ‘k’ into 4° C. water. A white cloud of protein micelles formed immediately and was allowed to settle. The upper diluting water was removed and the precipitated, viscous, sticky mass (PMM) was recovered from the bottom of the vessel in a yield of ‘l’ wt % of the extracted protein and dried. The dried protein was found to have a protein content of ‘m’ wt % (N×6.25) d.b. The product was given designation ‘n’. The parameters ‘a’ to ‘n’ are outlined in the following Table I:
TABLE I
n
a
b
c
d
e
f
g
h
i
j
k
l
m
CPIA06-13
300
2500
13.0
1160
10.5
(1)
13
30000
303
(2)
1:10
(2)
106.5
BW-AH12-G16-01
225
1500
19.6
(2)
17.5
600
30
3000
245
30
1:15
(2)
104.1
BW-AL016-K15-
1200
8000
14.9
(2)
10.4
400
40
10000
257
30
1:15
46
106.9
01(3)
CPI-A06-33
300
2000
10.8
1800
8.7
(1)
55
30000
217
(2)
1:10
(2)
104.3
A11-04
300
2000
23.2
1772
21.7
1000
52
30000
240
34
1:15
(2)
107.2
Notes:
(1) All the protein extract solution was concentrated
(2) Not determined
(3) The concentrated retentate was diafiltered with 6 volumes of 0.15 M NaCl while holding the volume at 40 L prior to dilution.
Example 2
The process of Example 1 was repeated with the conditions of the procedure being varied. A number of parameters were studied.
(a) Extraction parameters:
The extraction parameters were varied to ascertain their effect on the concentration of protein solution obtained. The results are tabulated in the following Table II:
TABLE II
Extraction
Extraction
Extraction
Concentration of
pH of extraction
Protein
concentration
Temperature
Time
NaCl Solution
solution
concentration
5% w/v
13° C.
30 min
0.15 M
6.4
5.3 g/L
15% w/v
13° C.
30 min
0.15 M
6.2
12.7 g/L
15% w/v
8° C.
30 min
0.15 M
—
6.6 g/L
15% w/v
34° C.
30 min
0.15 M
—
14.6 g/L
15% w/v
22° C.
10 min
0.15 M
5.9
10.5 g/L
15% w/v
13° C.
60 min
0.15 M
5.9
10.6 g/L
10% w/v
15° C.
30 min
0.15 M
—
9.7 g/L
10% w/v
13° C.
70 min
0.15 M
—
9.3 g/L
10% w/v
13° C.
30 min
0.15 M
5.3
9.8 g/L
10% w/v
13° C.
30 min
0.15 M
6.2
10.6 g/L
(b) Dilution parameters:
The dilution parameters were varied to ascertain their effect on yield of PMM from the dilution step. The results are tabulated in the following Table III:
TABLE III
Protein
Dilution Water
Concentration
Temperature
Dilution Ratio
PMM Recovery
206 g/L
4° C.
1:10
51.7%
258 g/L
4° C.
1:10
61.8%
283 g/L
4° C.
1:10
42.6%
230 g/L
15° C.
1:10
4.5%
249 g/L
4° C.
1:5
40.4%
249 g/L
4° C.
1:3
30.7%
Example 3
This Example illustrates the effect of dilution water temperature on the yield of product protein isolate.
1200 kg of commercial canola meal was added to 8000 L of 0.15 M NaCl solution at ambient temperature and agitated 30 minutes to provide an aqueous protein solution having a protein content of 17.4 g/L. The residual canola meal was removed and washed on a vacuum filter belt. The resulting protein solution was clarified by centrifugation to produce 7464 L of a clarified protein solution having a protein content of 14.8 g/L
The protein extract solution was reduced in volume by concentration on an ultrafiltration system utilizing 3,000 dalton membranes. The resulting concentrated protein solution had a protein content of 230 g/L.
A 50 ml aliquot of the concentrated solution was warmed to 30° C. then diluted 1:10 into 15° C. tap water. A slight white cloud of very small micelles formed and was allowed to settle. The upper diluting water was removed leaving a very small amount of precipitate. The precipitate only represented 4.5 wt % of the protein in the 50 ml aliquot of the concentrated solution instead of a typical 50 wt % recovery achieved when diluted into 4° C. tap water. The 50 ml aliquot was taken from the batch with the designation BW-AH012-H14-01A. The data from this Example are also presented in Table m above with respect to the dilution ratio.
Example 4
This Example shows the effect of temperature of concentrated solution on dilution yield.
1200 kg of commercial canola oil seed meal was added to 8000 L of 0.15 M NaCl solution at ambient temperature and agitated for 30 minutes at 13° C. to provide an aqueous protein solution having a protein content of ‘a’ g/L. The residual canola meal was removed and washed on a vacuum filter belt. The resulting protein solution was clarified by centrifugation to produce a clarified solution having a protein content of ‘b’ g/L.
The clarified protein solution or a ‘c’ aliquot of the protein extract solution was reduced in volume to ‘d’ L on a ultrafiltration system using a ‘e’ dalton molecular weight cut-off membrane. The resulting concentrated protein solution had a protein content of ‘f’ g/L. The lots were given designation ‘g’.
The parameter ‘a’ to ‘g’ are given in the following Table IV:
TABLE IV
g
BW-AL011-J16-01A
BW-AL017-D11-02A
a
24.4
26.3
b
20.3
18.0
c
(1)
2000
d
152
e
3000
5000
f
287
285.9
Note:
(1) All the protein extract solution was concentrated.
50 ml retentate aliquots of lot BW-AL011-J16-01A were warmed to 30° C. and 60° C. before being diluted 1:10 into 4° C. water. In each case, a white cloud of protein micelles formed immediately and was allowed to settle. The upper diluting water was removed and the precipitated, viscous, sticky mass (PMM) was dried. The PMM was recovered from each experiment and the yield of the dilution step was calculated. In the case of the retentate temperature being 30° C., the protein recovery was 57.1 wt %, while for 60° C., the yield was 23.7 wt %.
5 ml retentate aliquots of lot BW-AL017-D11-02A were warmed to various temperatures between 30° C. and 60° C. and then diluted at dilution ratio of 1:10 or 1:15 into 4° C. water. In each case, a white cloud of protein micelles formed immediately and was allowed to settle. The upper diluting water was removed and the precipitated, viscous, sticky mass (PMM) was dried. The PMM was recovered from each experiment and the yield of the dilution step was calculated. The results obtained appear in the following Table V:
TABLE V
Retentate Temperature
Dilution Ratio
PMM Yield
30° C.
1:10
49%
40° C.
1:10
49
50° C.
1:10
47
60° C.
1:10
35
30° C.
1:15
51
40° C.
1:15
51
50° C.
1:15
39
60° C.
1:15
39
As may be seen from this Table, higher yields are obtained at moderately elevated temperatures while higher elevated temperatures tend to reduce yields.
Example 5
This Example illustrates the preparation of further canola protein isolates using various combinations of parameters and additionally including treatment with powdered activated carbon.
‘a’ kg of commercial canola meal was added to ‘b’ L of 0.15 M NaCl solution at ambient temperature and agitated ‘e’ minutes to provide an aqueous protein solution having a protein content of ‘d’ g/L. The residual canola meal was removed and washed on a vacuum filter belt. The resulting protein solution was clarified by centrifugation to produce a clarified protein solution having a protein content of ‘e’ g/L.
‘f’ wt % powdered Activated Carbon (PAC) was added to the clarified solution. The suspension was mixed for 15 minutes, following which the PAC was removed by filtration, resulting in ‘g’ L of a ‘h’ g/L extract.
A ‘i’ L aliquot of the protein extract solution from the PAC treatment step was reduced in volume to ‘j’ L on an ultrafiltration system using a 30,000 dalton molecular weight cut-off membrane. The resulting concentrated protein solution had a protein content of ‘k’ g/L.
The concentrated solution at ‘l’ ° C. was diluted 1: ‘m’ into 4° C. tap water. A white cloud formed immediately and was allowed to settle. The upper diluting water was removed and the precipitated, viscous, sticky mass was dried. The dried protein which was formed had a protein content of ‘n’ wt % protein (N×6.25 d.b.). The overall protein recovery i.e. the average of dried protein isolate expressed as a percentage of the protein solubilized in the extraction step, was ‘o’ wt %. The product was given designation CPI ‘p’.
The specific parameters “a” to “p” for these different samples of protein product are set forth in the following Table VI:
TABLE VI
p
a
b
c
d
e
f
g
h
i
j
k
l
m
n
o
A07-15
150
1000
30
14.0
13.1
2
700
8.9
460
21
246
30
10
103.5
44
A07-22
150
1000
120
13.0
12.3
4
800
8.2
800
9
490
20
5
106.9
(1)
A08-02
300
2000
300
14.0
14.5
0.06
1300
13.8
480
6
421
25
5
105.8
(1)
A10-13
300
2000
45
28.6
24.9
1
2150
22.7
1000
80
176
20
10
109.2
(1)
Note:
(1) not determined.
The effect of the addition of powdered activated carbon on colour of canola protein isolate is shown in Example 7 below.
Example 6
This Example illustrates an embodiment of the invention, wherein water was used in the extraction stage and salt was subsequently added.
150 kg of commercial canola meal was added to 1000 L of water at 13° C., agitated for 30 minutes resulting in a protein solution with a concentration of 4.5 g/L. The residual canola meal was removed and washed on a vacuum filter belt. The aqueous protein solution was clarified by centrifugation producing 1100 L of a 3.8 g/L extract.
Powdered activated carbon (PAC) was precoated on filter pads before the clarified solution was filtered producing 1000 L of a 3.2 g/L extract.
Sodium chloride was added to the latter protein solution to a concentration of 0.15M. The volume of the protein solution was reduced to 10 L on an ultrafiltration system using 30,000 dalton membranes. The concentrated solution had a protein content of 292 g/L. An aliquot of the concentrated protein solution was warmed to 30° C. prior to dilution 1:3 into 4° C. water.
A white cloud formed immediately and was allowed to settle. The upper diluting water was removed and the precipitated, viscous, sticky mass (PMM) was dried. The dried canola protein isolate, given identification CPI A07-18, had a protein content of 96 wt % protein (N×6.25). The recovery of protein was 59 wt % of the protein originally extracted.
Example 7
This Example provides a comparison of the colour of certain canola protein isolates produced herein in comparison to spray dried egg white, conventional soy protein isolate and products produced according to Murray H.
Samples of protein isolate were evaluated for lightness (L) and chromaticity (a and b) using a Minolta colourimeter. In the L a b colour space, the value moves from 0 to 100, with 100 being white and 0 being black The chromaticity coordinates, a and b, both have maximum values of +60 and −60, +a being the red direction, −a being the green direction, +b being the yellow direction and −b being the blue direction.
The following Table VII sets forth the results obtained:
TABLE VII
Sample
L
a
b
Comments
Egg White
90.34
−2.73
21.43
Soy Protein
85.10
−0.906
14.67
The a and b values are not as close
Isolate
to egg white as PAC treated CPI
CPI A07-15
82.77
−2.13
22.98
NaCl extraction with high (2%)
(Example 5)
PAC
CPI A07-18
82.80
−2.69
25.19
Water extraction with PAC
(Example 6)
CPI A06-33
75.60
0.404
26.51
NaCl extraction without PAC
(Example 1)
CPI A08-02
80.04
−2.87
23.37
NaCl extraction with low (0.06%)
(Example 5)
PAC
Murray II
65.81
0.962
18.27
Relatively dark product
The results set forth in Table VII show the beneficial effect on colour, namely more white, less yellow, by the use of powdered activated carbon.
Example 8
This Example illustrates the preparation of flier canola protein isolate including protein recovered from supernatant.
‘a’ kg of commercial canola meal was added to ‘b’ L of 0.15 M NaCl solution at ambient temperature and agitated for 30 minutes to provide an aqueous protein solution having a protein content of ‘c’ g/L. The residual canola meal was removed and washed on a vacuum filter belt. The resulting protein solution was clarified by centrifugation to produce a clarified protein solution having a protein content of ‘d’ g/L followed by the addition of 1 wt % Powdered Activated Carbon (PAC).
The suspension was mixed for 15 minutes, following which the PAC was removed by filtration, resulting in ‘e’ L of a ‘f’ g/L extract.
A ‘g’ L aliquot of the protein extract solution from the PAC treatment step was reduced in volume to ‘h’ L on an ultrafiltration system using 30,000 dalton molecular weight cut-off membranes. The resulting concentrated protein solution had a protein content of ‘i’ g/L.
The concentrated solution at ‘j’ ° C. was diluted 1: ‘k’ into 4° C. water. A white cloud formed immediately and was allowed to settle. The upper diluting water was removed and was reduced in volume by ultrafiltration using 3000 dalton molecular weight cut-off membranes by a volume reduction factor of ‘l’. The concentrate was added to the precipitated, viscous, sticky mass and the mixture was dried. The dried protein mixture which was formed had a protein content of ‘m’ wt % of protein (N×6.25). The product was given designation CPI ‘n’.
The specific parameters ‘a’ to ‘n’ for two different samples of protein product are set forth in the following Table VIII:
TABLE VIII
n
a
b
c
d
e
f
g
h
i
j
k
l
m
A10-04
300
2000
28.4
27.6
1330
16.3
200
18
186
28
10
11
100.3
A10-05
300
2000
27.7
21.9
1320
21.9
300
20
267
27
15
21
102.3
Example 9
This Example further illustrates the preparation of further canola protein isolate including protein recovered from supernatant without PAC treatment
‘a’ kg of canola meal was added to ‘b’ L of 0.15 M NaCl solution at a temperature of 20° C. and agitated for 30 minutes to provide an aqueous protein solution having a protein content of ‘c’ g/L. The resulting canola meal was removed and washed on a vacuum filter belt. The resulting protein solution was clarified by centrifugation and filtration to produce a clarified protein solution having a protein content of ‘d’ g/L.
The protein extract solution or a ‘e’ L aliquot of the protein extract solution was reduced in volume on n ultrafiltration system using membranes having a molecular weight cut-off of ‘f’ daltons. The resulting concentrated protein solution had a protein content of ‘g’ g/L.
The concentrated solution at ‘h’ ° C. was diluted ‘i’ into ‘j’ ° C. water. A white cloud immediately formed and was allowed to settle. The upper diluting water was removed and concentrated by ultrafiltration using 3000 dalton molecular weight cut-off membranes to provide a concentrated supernatant having a protein content of ‘k’ g/L. The concentrate was added to the precipitated, viscous, sticky mass and the mixture dried.
The dried protein mixture was found to have a protein content of ‘l’ wt % (N×6.25). The yield of canola protein isolate from the protein solution extract was ‘m’ wt %. The product was given designation ‘n’.
The specific parameters ‘a” to ‘n’ for two different samples of protein product are set forth in the following Table IX:
TABLE IX
n
BW-AL11-I21-01A
A11-01
a
1200
300
b
8000
2000
c
24.5
23.7
d
17.8
20.7
e
(1)
400
f
3000
30,000
g
284.7
200.2
h
31
32
i
1:10
1:15
j
8
4
k
279.0
104.7
l
100.2
102.8
m
68.1
(2)
Note:
(1) All the protein extract solution was concentrated
(2) not determined
Example 10
This Example illustrates extraction of the canola protein meal at a relatively high pH and recovery of protein from supernatant.
150 kg of commercial canola meal was added to 2000 L of 0.15 M NaCl having a pH adjusted to 9.5 by the addition of sodium hydroxide at ambient temperature, agitated for 30 minutes to provide an aqueous protein solution having a protein content of 13.2 g/L. The residual canola meal was clarified by centrifugation and filtration to produce 1210 L of a clarified protein solution having a protein content of 12.1 g/L.
The pH of the clarified protein solution was adjusted to 6.2 by the addition of hydrochloric acid. A 900 L aliquot of the protein extract solution was reduced in volume to 50 L by concentration on an ultrafiltration system using 3000 dalton molecular weight cut-off membranes. The resulting concentrated protein solution had a protein content of 276.2 g/L.
The concentrated solution at 30° C. was diluted 1:15 into 4° C. water. A white cloud formed immediately and was allowed to settle. The upper diluting water was removed and 390 L of this supernatant were concentrated by 24 L by ultrafiltration using 3000 dalton molecular weight cut-off membranes to provide a concentrated supernatant having a protein content of 149.0 g/L. The concentrate was added to the precipitated, viscous, sticky mass and the mixture dried.
The dried protein mixture was found to have a protein content of 103.3 wt % (N×6.25). The yield of canola protein isolate from the protein solution extract was 48.3 wt %. The product was given designation BW-AL017-D08-02A.
Example 11
This Example illustrates the preparation of canola protein isolate by processing of supernatant.
‘a’ kg of commercial canola meal was added to ‘b’ L of 0.15 M NaCl solution at ambient temperature and agitated for 30 minutes to provide an aqueous protein solution having a protein content of ‘c’ g/L. The residual canola meal was removed and washed on a vacuum filter belt. The resulting protein solution was clarified by centrifugation to produce a clarified protein solution having a protein content of ‘d’ g/L.
The clarified protein solution was reduced in volume on an ultrafiltration system using 3,000 dalton molecular weight cut-off membranes. The resulting concentrated solution had a protein content of ‘e’ g/L.
The concentrated solution at ‘f’ ° C. was diluted ‘g’ into 4° C. water. A white cloud formed immediately and was allowed to settle. The upper diluting water was removed and the precipitated, viscous, sticky mass (PMM) was recovered from the bottom of the vessel and dried. The dried protein was found to have protein content of ‘k’ wt % (N×6.25) d.b.
The removed upper diluting water was reduced in volume by ultrafiltration using 3,000 dalton molecular weight cut-off membranes to a protein concentration of ‘i’ g/L. The concentrate then was dried. The dried protein which was formed had a protein content of ‘j’ wt % (N×6.25). The product was given designation ‘l’.
The specific parameters ‘a’ to ‘l’ for two different samples of protein product are set forth in the following Table X:
TABLE X
l
AL016-J24
AL011-J16-01A
a
1200
1200
b
8000
8000
c
22.7
24.4
d
16.9
20.3
e
281
287
f
37
28
g
1:10
1:10
h
(2)
101.9
i
(3)
265
j
103.9
101.5
k
(2)
101.6
Note:
(1) All the protein extract solution was concentrated
(2) Not determined
(3) The supernatant was concentrated by a volume reduction factor of 16.
Example 12
This Example illustrates application of the process of the invention to cold pressed canola meal and the recovery of additional protein from the supernatant.
50 kg of canola meal was pressed and 13 L of oil recovered. 30 kg of the resulting crushed meal was added to 300 L of 0.15M NaCl solution at 20° C. and the mixture was agitated for 40 minutes, followed by a thirty minute settling period, 200 L of aqueous protein solution were obtained having a protein content of 19.5 mg/ml.
The aqueous protein solution was chilled to 4° C. and refrigerated at that temperature for 16 hours, to permit fat present in the meal and extracted in the extraction step, to separate, according to the procedure of Murray II. The resulting fat layer was removed from the surface of the aqueous protein solution. The remaining aqueous protein solution was filtered through a filter press having a 20 μm filter pad to remove remaining particles of hull and cell wall material as well as residual particles of fat. 200 L of filtrate with a protein content of 14.6 mg/ml were obtained.
The aqueous protein solution was reduced in volume to 10.5 L by concentration on an ultrafiltration system using 10,000 dalton molecular weight cut. off membranes. The resulting concentrated protein solution had a protein content of 200 g/L, which represented a yield of 67 wt % of the protein originally extracted from the canola meal. The resulting 10.5 L solution was again chilled to 4° C. and refrigerated at this temperature for 16 hours. The solution was then centrifuged at 10,000×g for five minutes and the separated fat removed from the concentrated protein solution.
The protein solution was warmed to 30° C. and was added to water at 4° C. at a dilution ratio of 1:9. Following overnight settling, 85 L of supernatant was decanted leaving approximately 9 L of precipitated, viscous, sticky mass (PMM). The PMM was further concentrated by centrifugation at 10,000×g for 5 minutes and an aliquot of the centrifuged PMM was freeze dried to determine its protein content The freeze dried PMM was found to have a protein content of 105.5 wt % (N×6.25).
The supernatant from the PMM formation step was concentrated to 11 L by concentration on a ultrafiltration system using 10,000 dalton molecular weight cut-off membranes. This latter concentrated solution had a protein concentration of 89.7 mg/ml. An aliquot of this concentrated solution was freeze dried to determine the protein content. The freeze-dried protein was found to have a protein content of 101.7 wt % (N×6.25).
The overall yield of protein as PMM and recovered from the supernatant from the protein extracted from the canola meal was 50 wt %.
Example 13
This Example illustrates application of the process of the invention to high erucic acid rapeseed.
35 kg of commercial high erucic acid rapeseed meal was added to 350 L of 0.3 M NaCl solution (10% w/v) at 15° C. and agitated for one hour to provide an aqueous protein solution having a protein content of 7.71 g/L. A second run under the same conditions produced an aqueous protein solution having a protein content of 7.36 g/L. The extract solutions were decanted and clarified by filtration though 20 n filter pads to remove residual meal and to provide a total filtrate volume of 550 L.
The filtrate then was concentrated to 9 L using a hollow fibre ultrafiltration system having 10,000 dalton molecular cut-off membranes The resultant concentrated protein solution had a protein content of 232 g/L.
The concentrated protein solution, at a temperature of 30° C., was then diluted 1:9 into 4° C. water. A white cloud immediately formed and was allowed to settle for 16 hours at 4° C. 80 L of supernatant was decanted and was reduced in volume by diafiltration concentration to a volume of 7 L of concentrated supernatant having a protein content of 47.7 g/L.
The settled viscous sticky mass (PMM) was collected and freeze dried. A one liter portion of the concentrated supernatant was freeze dried. 1393 g of freeze dried PMM was obtained from the process having a protein content of 106 wt % (N×6.25). 1 L of freeze dried concentrated supernatant yielded 67 g, so that the 7 L of concentrated supernatant contained 469 g of dried protein, for an overall protein yield from the protein extracted from the oil seed meal of 47 wt %. The freeze-dried concentrated supernatant had a protein content of 83 wt % (N×6.25) so that a mixture of PMM and protein from concentrated supernatant has a protein content of 102 wt % (N×6.25) on a dry weight basis.
Example 14
This Example illustrates application of the invention to mustard seed.
75 g of commercial mustard seed meal was added to 750 ml of 0.15 M NaCl solution (15% w/w) at 20° C. and agitated for 30 minutes. The extraction slurry was centrifuged at 10,000×g for 10 minutes to separate the spent meal from the extracted protein. The resulting 500 ml of protein solution having a protein content of 18.05 mg/ml was then filtered through Whatman #4 filters in order to further clarify the solution.
The clarified solution was concentrated to 27 ml on a Millipore mini-ultrafiltration stirred cell system using 10,000 molecular weight cut-off membranes. The resulting concentrated protein solution had a protein concentration of218 g/L.
22.2 ml of the total 27 ml of concentrated protein solution, at a temperature of 30° C., was then diluted 1:9 into 4° C. tap water. A white cloud immediately formed and was allowed to settle for 16 hours at 4° C. 200 ml of supernatant was decanted.
The settled viscous, sticky mass (PMM) was collected and centrifuged at 10,000×g for 5 minutes to reduce the moisture content of the pellet, which then was freeze dried. 4.48 g of freeze-dried pellet was obtained, representing a yield of protein in the freeze-dried pellet from the protein in the protein extracted from the oil seed meal was 50 wt % (if the entire 27 ml of retentate had been diluted, the final yield is extrapolated to be approximately 60 wt %). The freeze-dried PMM obtained from the process had a protein content of 103 wt % (N×6.25).
Example 15
This Example illustrates application of the process of the invention to non-GMO canola.
450 g of non-GMO canola meal was added to 3 L of 0.15 M NaCl solution (15% w/w) at 20° C. and agitated for 30 minutes to provide an aqueous protein solution having a protein content of 8.08 g/L. The mixture was allowed to stand for 30 minutes to permit residual meal and protein solution to separate. The protein solution was decanted, centrifuged for 10 minutes at 10,000×g and filtered through Whatman #4 filter paper to further clarify the solution.
The filtrate then was concentrated to a volume of 17 ml using a hollow fibre ultrafiltration system having 10,000 dalton molecular cut-off membranes. The resultant concentrated protein solution has a protein content of 205 g/L.
A 14 ml sample of the retentate, at a temperature of 30° C., was then diluted 1:9 into 4° C. tap water. A white cloud immediately formed and was allowed to settle. The supernatant was decanted and the settled viscous sticky mass (PMM) was collected and freeze-dried. 2.3 g of freeze-dried PMM was obtained from the process having a protein content of 103 wt % (N×6.25).
The overall yield of protein with respect to the protein extract from the oil seed meal was 41 wt %. If the entire 17 ml of retentate had been diluted approximately 2.66 g of dried protein would have been recovered for a yield of 46 wt %.
Example 16
This Example illustrates recovery of canola protein isolate by a dialysis procedure.
‘a’ kg of commercial canola meal was added to ‘b’ L of 0.15 M NaCl solution at ambient temperature and agitated for 30 minutes to provide an aqueous protein solution having a protein content of ‘c’ g/L. The residual canola meal was removed and washed on a vacuum filter belt. The resulting protein solution was clarified by centrifugation to produce ‘d’ L of a clarified protein solution having a protein content of ‘e’ g/L.
A ‘f’ aliquot of the protein extract solution was reduced in volume to ‘g’ L by concentration on an ultrafiltration system using ‘h’ dalton molecular weight cut-off membranes. The resulting concentrated solution had a protein content of ‘i’ g/L. The retentate was given designation ‘j’. The parameters ‘a’ to ‘j’ are outlined in the following Table A:
TABLE XI
j
BW-AL017-D17-02A
BW-AL017-D22-02A
a
150
150
b
1004
1003
c
25.1
27.1
d
1080
1132
e
18.0
16.5
f
710
1092
g
22.5
31.5
h
5000
5000
i
291.6
362.5
3.5 L of retentate from BW-AL017-D17-02A was dialyzed in 120 L of 4° C. water. The water was changed daily for several days and running water was used for the last two days. The conductivity of the retentate dropped from 6.89 millisiemens (ms) to 0.32 ms. As the conductivity dropped, micelles began to form in the retentate. At the completion of the dialysis, a large amount of PMM was present at the bottom of each dialysis tube. The PMM was recovered and dried. The canola protein isolate had a protein content of 103.0 wt % d.b.
The procedure was repeated with the retentate BW-AL017-D22-02A except that the dialysis was carried out in 60° C. water. As the conductivity decreased, the solution became cloudy but very little micelle formation occurred. Once the dialyzed solution was cooled to 10° C., micelle formation occurred. The resulting PMM, when dried, had a protein content of 106 wt % of d.b.
SUMMARY OF DISCLOSURE
In summary of this disclosure, the present invention provides a novel procedure for isolating protein from oil seeds in improved yields and protein content than has previously been achieved. Modifications are possible within Me scope of this invention.
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Oil seed protein isolates, particularly canola protein isolate, are produced at a high purity level of at least about 100 wt % (Nx6.25) by a process wherein oil seed protein is extracted from oil seed meal, the resulting aqueous protein solution is concentrated to a protein content of at least about 200 g/L and the concentrated protein solution is added to chilled water having a temperature below about 15deg C. To form protein micelles, which are settled to provide a protein micellar mass (PMM). The protein micellar mass is separated from supernatant and may be dried. The supernatant may be processed to recover additional oil seed protein isolate by concentrating the supernatant and then drying the concentrated supernatant, to produce a protein isolate having a protein content of at least about 90 wt %. The concentrated supernatant may be mixed in varying proportions with at least part of the PMM and the mixture dried to produce a protein isolate having a protein content of at least about 90 wt %.
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REFERENCE TO PARENT APPLICATION
[0001] This application is a Continuation-In-Par of “Photomultiplier Tube Identifier”, U.S. Ser. No. 09/127,987, filed on Aug. 3, 1998, which is incorporated herein by reference.
FIELD OF INVENTION
[0002] The present invention relates to scintillation cameras. In particular, the invention relates to a method and apparatus for improving the quality of images produced during positron emission tomography.
BACKGROUND OF THE INVENTION
[0003] In the human body, increased metabolic activity is associated with an increase in emitted radiation. In the field of nuclear medicine, increased metabolic activity within a patient is detected using a radiation detector such as a scintillation camera.
[0004] Scintillation cameras are well known in the art, and are used for medical diagnostics. A patient ingests, inhales or is injected with a small quantity of a radioactive isotope. The radioactive isotope emits gamma rays that are detected by a scintillation medium in the scintillation camera The scintillation medium is commonly a sodium iodide crystal, BGO or other. The scintillation medium emits a small flash or scintillation of light, in response to stimulating radiation, such as from a patient. The intensity of the scintillation of light is proportional to the energy of the stimulating photon, such as a gamma photon. Note that the relationship between the intensity of the scintillation of light and the gamma ray is not linear.
[0005] A conventional scintillation camera such as a gamma camera includes a detector which converts into electrical signals gamma lays emitted from a patient after radioisotope has been administered to the patient The detector includes a scintillator and photomuliplier tubes. The gamma rays are directed to the scintillator which absorbs the radiation and produces, in response, a very small flash of light. An array of photodetectors, which are placed in optical communication with the scintillation crystal, converts these flashes into electrical signals which are subsequently processed. The processing enables the camera to produce an image of the distribution of the radioisotope within the patient.
[0006] Scintillation cameras are used to take four basic types of pictures: spot views, whole body views, partial whole body views, SPECT views, and whole body SPECT views.
[0007] A spot view is an image of a part of a patient. The area of the spot view is less than or equal to the size of the field of view of the gamma camera. In order to be able to achieve a full range of spot views, a gamma camera must be positionable at any location relative to a patient.
[0008] One type of whole body view is a series of spot views fitted together such that the whole body of the patient may be viewed at one time. Another type of whole body view is a continuous scan of the whole body of the patient. A partial whole body view is simply a whole body view that covers only part of the body of the patient. In order to be able to achieve a whole body view, a gamma camera must be positionable at any location relative to a patient in an automated sequence of views.
[0009] The acronym “SPECT” stands for single photon emission computerized tomography. A SPECT view is a series of slice-like images of the patient. The slice-like images are often, but not necessarily, transversely oriented with respect to the patient. Each slice-like image is made up of multiple views taken at different angles around the patent, the data from the various views being combined to form the slice-like image. In order to be able to achieve a SPECT view, a scintillation camera must be rotatable around a patient, with the direction of the detector head of the scintillation camera pointing in a series of known and precise directions such that reprojection of the data can be accurately undertaken.
[0010] A whole body SPECT view is a series of parallel slice-like transverse images of a patient. Typically, a whole body SPECT view consists of sixty four spaced apart SPECT views. A whole body SPECT view results from the simultaneous generation of whole body and SPECT image data. In order to be able to achieve a whole body SPECT view, a scintillation camera must be rotatable around a patient, with the direction of the detector head of the scintillation camera pointing in a series of known and precise directions such that reprojection of the data can be accurately undertaken.
[0011] Therefore, in order that the radiation detector be capable of achieving the above four basic views, the support structure for the radiation detector must be capable of positioning the radiation detector in any position relative to the patient. Furthermore, the support structure must be capable of moving the radiation detector relative to the patient in a controlled manner along any path.
[0012] In order to operate a scintillation camera as described above, the patient should be supported horizontally on a patient support or stretcher.
[0013] A certain design of gantry or support structure for a scintillation camera includes a frame upon which a vertically oriented annular support rotates. Extending out from the rotating support is an elongate support. The elongate generally comprises a pair of arms. The pair of arms generally extends through a corresponding pair of apertures in the rotating support. One end of the pair of arms supports the detector head on one side of the annular support. The other end of the pair of arms supports a counter balance weight. Thus, the elongate support is counterbalanced with a counterweight on the opposite side of the detector head.
[0014] With such a design of support structure for a scintillation camera, a patient must lie on a horizontally oriented patient support. The patient support must be cantilevered so that the detector head can pass underneath the patient. If the detector head must pass underneath only one end of the patient, such as the patient's head, the cantilevered portion of the patient support is not long enough to cause serious difficulties in the design of the cantilevered patient support. However, if The camera must be able to pass under the entire length of the patient, the entire patient must be supported by the cantilevered portion of the patient support. As the cantilevered portion of the patient support must be thin so as not to interfere with the generation of images by the scintillation camera, serious design difficulties are encountered.
[0015] Among the advantages associated with such as design of support structure is that a patient may be partially pass through the orifice defined by the annular support so that the pair of arms need not be as long, However, the patient support must be able to support the patient in this position relative to the annular support, must be accurately positionable relative to the annular support, and must not interfere either with the rotation of the annular support or with the cables which will inevitably extend from the detector head to a nearby computer or other user control.
[0016] The photomultiplier tubes in a scintillation camera generate electric signals. The signals are processed, and images are created corresponding to the radiation emitted by the patient.
[0017] From time to time, images are generated that contain one or more artifacts or flaws. Artifacts are often caused by one or more malfunctioning photomultiplier tubes. A malfunctioning photomultiplier tube may be generating incorrect signals, may be generating no signal at all, or the processing of the signals from a particular photomultiplier tube may not be proper.
[0018] To determine the cause of the artifact and then correct the artifact it is important to identify all malfunctioning photomultiplier tubes. However, inspecting and testing photomultiplier tubes is difficult, time consuming and expensive.
[0019] From time to time, images of poor quality are also generated. Of particular concern are the images produced by Position Emission Tomography. Position Emission Tomography (PET) is a practice common in the art wherein two detectors are placed with their fields of view at 180° to one another. After the patient ingests the isotope, positrons are emitted from areas where is isotope has gathered in the body. The positrons that are released from the body in opposite directions collide with electrons in the body and effectively form two gamma rays. The gamma rays are detected by the detectors and as mentioned above are used to generate images. However, in PET, only gamma rays originating from a collision between a positron and an electron that are detected at 180° (referred to as coincidence) from one another are considered true events. Preferably only true events are used to generate images.
[0020] Unfortunately what sometime occurs is that the gamma ray will ricochet off a second electron in the body before being emitted and the angle is changed. The two gamma rays will not be detected at 180° from one another, resulting in a “random” event. Random events are really just noise signals that when used to generate an image, cause poor quality imagery. It is known in the art that an increase in area (of field of view) results in an increase in the probability of random events. Since conventional P cameras use relatively large detectors with large fields of view and they commonly use the total data values for the entire detector head, the chance of using random events to generate an image is high. As well, since data from a large field of view must be processed, the time frame window during which data is analysed is large resulting in yet a higher probability of detecting random events.
[0021] In Constant Fraction Discrimination (CFDs) cameras, the probability of random events is also relatively high, resulting in poorer quality images. FIG. 1 illustrates the data obtained from a Constant Fraction Discriminator. Constant Fraction Discriminators use a constant fraction (or percentage) of the input pulse to precisely determine the timing of an event. Inaccuracies occur when two events are detected in such a short time frame such as to create overlap. In the data when two or more events overlay, it is impossible to separate them to obtain before an event in order to separate the data. As seen in FIG. 1, the data from areas A, B and C can be separated in order to analyse the individual events 1 and 2 .
SUMMARY OF THE INVENTION
[0022] An object of the invention is to provide a method and apparatus for improving a PET image quality. This is achieved by analysing individual photomultiplier tubes for true events and by providing time stamps to photomultiplier tube signals. Analysing data from individual photomultiplier tubes as opposed to entire detector field of views results in smaller areas and smaller amounts of data to be processed. This then permits smaller time frame windows to be used The use of time stamps also permits data before and after a particular event to be kept as record.
[0023] The invention relates to an apparatus for improving the quality of images produced by a scintillation camera during positron emission tomography wherein both true events and random events occur, comprising: a photomultiplier tube for generating a photomultiplier tube signal; means for generating a code signal identifying the photomultiplier tube; a clock for generating a clock signal providing a time stamp for the photomultiplier tube; a bus buffer for transmitting an encoded signal comprising the photomultiplier tube signal followed by the code signal and the time stamp; a data analyser for determining whether the encoded signal represents a true event; a position computing device for calculating the position of a true event; an image computer for generating an image of the events from a plurality of encoded signals and the positions of their corresponding events; and a display for displaying the image.
[0024] The invention also relates to a method for improving the image produced by a scintillation camera comprising an array of photomultiplier tubes, comprising the steps of: generating a photomultiplier tube signal after an event; generating a code signal identifying the photomultiplier tube; generating a clock signal providing a time stamp for the photomultiplier tube; generating an encoded signal comprising the photomultiplier tube signal followed by the code signal and the time stamp; determining whether the event is a true event; calculating the position of the event; generating an image from a plurality of encoded signals; and displaying the image.
[0025] One embodiment relates to an apparatus for improving The image produced a scintillation camera comprising an array of photomultiplier tubes, comprising: means for generating a photomultiplier tube signal after an event; means for generating a code signal identifying the photomultiplier tube; means for generating a clock signal providing a time stamp for the photomultiplier tube; means for generating an encoded signal comprising the photomultiplier tube signal followed by the code signal and the time stamp; means for determining whether Me event is a true event; means for calculating the position of the event; means for generating an image from a plurality of encoded signals; and means for displaying the image.
[0026] Other advantages, objects and features of the present invention will be readily apparent to those skilled in the art from a review of the following detailed description of preferred embodiments in conjunction with the accompanying drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The embodiments of the invention will now be described with reference to the accompanying drawings, in which:
[0028] [0028]FIG. 1 illustrates the data obtained with a CFD;
[0029] [0029]FIG. 2 illustrates the basics of PET;
[0030] [0030]FIG. 3 is a drawing of an embodiment of the photomultiplier tube identifier of the present invention;
[0031] [0031]FIG. 4 is a drawing of the bus buffer of the embodiment of FIG. 3; and
[0032] [0032]FIG. 5 is a flowchart illustrating the operation of the data analyser.
[0033] Similar references are used in different figures to denote similar components.
DETAILED DESCRIPTION OF THE INVENTION
[0034] [0034]FIG. 2 illustrates the basics of PET, Briefly, when a collision occurs in the body, two gamma rays are emitted and detected by the detector (known as events). If it is determined that the events are true events (as detailed below), they are used in image generation. However, if one gamma ray, for example gamma ray 2 , ricochets to create event 3 rather than true event 2 , it causes a random or scattered event and is preferably not used in image generation.
[0035] [0035]FIGS. 3 and 4 illustrate an array of photomultiplier tubes 405 in a scintillation camera. A photomultiplier tube identifier 410 is an apparatus for identifying a photomultiplier tube in the array of photomultiplier tubes 405 .
[0036] The photomultiplier tube identifier 410 includes amplifier/integrators 415 , analog to digital converters (ADCs) 420 , bus buffers 425 , pull-up resistors 430 , a bus 435 , a position computing device 440 , an image computer 445 , a user display 450 and a clock 426 .
[0037] Output signals from individual photomultiplier tubes in the array of photomultiplier tubes 405 are amplified and integrated by the amplifier/integrators 415 . The output signals from the amplifier/integrators 415 are then digitized in the analog to digital converters 420 . The output signal from a digital to analog converter 420 corresponds to the strength of the signal from an individual photomultiplier tube in the array of photomultiplier tubes 405 .
[0038] The bus buffers 425 receive output signals from the digital to analog converters 420 . Some of the gates of the bus buffers 425 are also connected to the pull up resistors 430 . The gates of the bus buffer are set by the pull up resistors 430 to a logic high or logic low which correspond to the identities of the individual photomultiplier tubes from which signals have been obtained. To each output signal from the digital to analog converters 420 , the bus buffers 425 add a code below the least significant bits identifying the photomultiplier tube from which the signal was obtained. Thus, the output signals from the bus buffers 425 corresponds to the strength of the signals received from the array of photomultiplier tubes 405 plus a code identifying the photomultiplier tube from which the signals were obtained.
[0039] In addition, the clock 426 provides clock signals providing a continuously running clock or stream of time stamps to each photomultiplier tube identifier. The clock signals provide the time stamp for each photomultiplier tube output signal at a predetermined clock increment. The stream of time stamps maintain records of when events have taken place.
[0040] In a preferred embodiment, the clock increments in cycles from 0 to 256. That is, each cycle produces 256 time stamps, but any suitable number could be used depending upon the accuracy required.
[0041] In a preferred embodiment, time stamps are generated every two nanoseconds, but another suitable length of time can be chosen.
[0042] [0042]FIG. 4 illustrates a bit bus buffer 425 . Output signals 455 from a digital to analog converter 420 , in this case twelve most significant bits of signal data, are received by the bus buffer 425 . The twelve bit output signals 455 correspond to the specific photomultiplier tube providing the output signal. Logic values 460 from pull up resistors 430 , in this case 6 bits of data, provide a bard wired code corresponding to the identity of the specific photomultiplier tube. In this case, as the pull up resistors provide six bits of data, the signals from sixty four different photomultiplier tubes 405 may be encoded. As well, approximately ten bits of clock signals 461 , are also written into the bus buffer and encoded. While ten bits of time stamp data is preferable, any number of bits could be used.
[0043] Upon receipt of the enable command at 475 , the data (the data signal values, the photomultiplier tube identifier and time stamps) from the bus buffer is read onto the bus 435 . The signal values 465 , that is, the first twelve bits of data correspond to the output signal received from the digital to analog converter 415 . The code values 470 , that is, the next four bits of data, provide the code identifying the specific photomultiplier tube 405 providing the information. The time stamp values 428 provides the time data from the clock signals 461 . The signals 460 in FIG. 4 provide a code of 010011, ground being represented by 0 and VCC being represented by 1. If more codes are required, a larger bus buffer can be used, such as a twenty or thirty two bit bus buffer.
[0044] The first twelve bits of each encoded signal 480 are the signals values 465 , and six bits of each encoded signal 480 are the code values 470 while the remaining bits are the time stamp values 428 . The encoded signals 480 are received by a processing unit. Since the code values 470 are in the low part of the encoded signal 480 or data word used by the position computing device 440 , the change in value created by adding the code values 470 to the signal values 470 is negligible. Therefore, the code values 470 do not need to be removed before the encoded signal 480 is used by the position computing device 440 . For example, the encoded signal may represent the value 1,001,325,238. The final two digits, that is, eight and three, may be the code identifying the thy eighth photomultiplier tube in the array. The 0.038 value and the time stamp data could be removed from the encoded signal 480 prior to processing by the position computing device 440 and reattached to the signal 480 afterwards. However, such a calculation would not be beneficial as the 0.038 a negligible value compared with the value 1,001,325,238. If an artifact appears on the generated image, and the artifact can be traced to the data value 1,001,325,238, then photomultiplier tube number thirty eight can be repaired or replaced. Similarly, if an artifact appears on the generated image, and fewer data values traceable to photomultiplier tube number thirty eight than are statistically expected, then photomultiplier tube number thirty eight may need repairing or replacing.
[0045] Encoded signals 480 , including the tie stamp, are read onto the bus buffer 425 . This data for each multiplier tube is then fed across the bus 435 and may be stored in a temporary memory 428 . The data coming from a particular photomultiplier tube can be analysed by a data analyser 441 , If there is an event, the data before that event, and after the event is recorded. In the case of CFOs, this allows overlapping event signals to be separated into individual true event signals. In other words, if data from two events have overlapped, the data values for one event can be subtracted or removed from the data values for the second event. This is known in the art as deconvalving the events.
[0046] Similarly, the signals for all the photomultiplier tube outputs can be analysed for photomultiplier tubes that are at 180 degrees to one another. From this data, it can be determined whether an event is within a certain time window, and whether those photomultiplier tubes are in coincidence. This is accomplished by analysing the data for two photomultiplier tubes at 180 degrees within a very small time window, for example, two nanoseconds. The true events data is then transferred To a main memory 442 and then to processing and image generation. The other data (random data) is effectively useless and may be purged. In this way, the position computing device 440 can transmit information to the image computer 445 and then the display 450 quickly and inexpensively while retaining intact information identifying the specific photomultiplier tubes corresponding the specific data. Referring to FIG. 5, therefore, first individual tube values are analysed to determine whether an events are in coincidence and then to determine the location of the event.
[0047] Prior art systems typically operate in the following manner: when events occur, the location of the events are determined, and then whether the events are in coincidence is determined using the total data values from the entire detector heads.
[0048] As mentioned above, quality of PET imagery is affected by two factors: the probability of random events and the size of the time window.
[0049] Since the probability of random events increases as the field of view area increases, it is desirable to have less area to improve the PET images. Therefore, individual photomultiplier tubes are placed in coincidence which reduces the area, and the probability of random events is minimized. The data from individual photomultiplier tubes is used to determine coincidence as opposed to the data from the entire detector head. Note that it may be possible to have photomultiplier tubes that are skewed because it is where the events occur in the crystal that determine whether they are in coincidence.
[0050] Another way to improve PET images is to have smaller time windows during which data is analysed such that the time to pick up random events is reduced. Encoding a time stamp to each photomultiplier tube at predetermined times produces a stream of time stamps for each tube. Then each stream can be analysed to determined which tubes are in coincidence, Tubes in coincidence will have the same time stamp, or match a time stamp within a predetermined time window. By analysing individual photomultiplier tube data, smaller amounts of data are processed allowing a smaller time window to be used.
[0051] Numerous modifications, variations and adaptations may be made to the particular embodiments of the invention described above without departing from the scope of the invention, which is defined in the claims.
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A method and apparatus for improving the image quality of positron emission tomography is disclosed. This is achieved by analysing individual photomultiplier tubes for true events. The apparatus includes a photomultiplier tube for generating a photomultiplier tube signal. A series of pull up resistors generates a code signal identifying the photomultiplier tube. A clock generates a time stamp to the photomultiplier tube signal. A bus buffer generates an encoded signal. A position computing device calculates the position of the photomultiplier tube. An image computer generates an image from a plurality of encoded signals. A display displays the image. Analysing data from individual photomultiplier tubes results in smaller areas and smaller amounts of data to be processed. This then permits smaller time franm windows to be used. The use of time stamps also permits data before and after an event to be recorded.
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