Innovative disposable thoracostomy and cricothyrotomy trocar systems and new and improved methods for emergency management of upper airway obstructions and chest injuries are disclosed.

The invention relates to emergency airway devices and emergency thoracostomy devices; more particularly, it relates to trocar devices and method and apparatus for a establishing and maintaining an emergency opening to a body cavity.
Cricothyrotomy
A cricothyrotomy is an emergency procedure performed on a choking person to admit air into the lungs via an opening made in the cricothyroid membrane. The cricothyroid membrane lies between the cricoid and thyroid cartilages of the voice box and is easily located by palpation of the larynx and trachea. Only the thin skin of the throat covers the membrane; no large blood vessels, glands, or other critical structures are normally encountered if this site is used. Though this area is not well-suited to long-term, auxiliary airway maintenance, it offers the safest and most direct access in times of emergency. Presently available devices and methods for performing an emergency cricothyrotomy, however, have serious drawbacks for inexperienced personnel and are of limited effectiveness.
A tracheotomy is a surgical procedure used to admit air into the lungs when the normal breathing passage is obstructed or otherwise ceases to function properly. Briefly stated, a tracheotomy usually involves an incision through the skin of the neck below the level of the voice box and careful manipulation of the thyroid gland and several large blood vessels to expose the trachea. A small circular opening is made in the trachea and an endotracheal tube is inserted to maintain the opening and provide an airway. A tracheotomy is the procedure of choice when an auxiliary airway is to be maintained for an extended period. It is a delicate operation requiring the skill and knowledge of a surgeon and the facilities of a hospital emergency room. Unfortunately, the services of a surgeon and hospital facilities are usually not immediately available to someone who is choking. Unless the patient is given means to breathe, he will die in approximately three minutes. There are well-established non-surgical techniques for removing a supralaryngeal airway obstruction which should be utilized, whenever possible, before any surgical technique is applied. However, these non-surgical methods have a limited range of applicability and are sometimes ineffective. Therefore, there is a need for a device which will enable a person with limited training to provide an emergency airway at any location where a choking emergency occurs.
The inventor earlier created a class of emergency retractable trocar devices to address some of the above concerns, and they are described in U.S. Pat. No. 4,291,690 issued Sep. 29, 1981. However, at the time of the earlier invention, some of the requirements for a practicable, minimally traumatic and fully controllable cricothyrotomy airway were not addressed or dealt with.
Firstly, it is now appreciated that placement of a large trocar (7-8 mm O.D.) through the skin into the trachea is extremely difficult if an adequate surgical incision and sharp dissection of the underlying tissue layers is not accomplished prior to insertion. Extensive testing of many cutting tip and blade designs demonstrates that any blade that is no wider than the inside diameter of the cannula mounted on the trocar shaft and that is merely pushed straight in without any substantial lateral motion will not make an incision that is wide enough to allow a short, straight cannula to be pushed into the upper tracheal airway without excessive force and without extreme danger of over penetration and subsequent crushing trauma to underlying tissues, no matter what the shape or length of the blade. Trauma to the larynx during cricothyrotomy is the primary cause of subglottic stenosis, the most common but preventable complication.
In addition, uncontrolled lateral motion of a blade during incision into the cricothyroid ligament space can cut the recurrent laryngeal nerve resulting in vocal cord paralysis, another major complication of poorly done cricothyrotomy. If a scalpel is used to make a stab incision into the airway, it must be subsequently removed and some type of retractor or tissue separator inserted to enable placement of an airway. When the blade is taken out, the various tissue layers are free to slip relative to one and the path of insertion into the airway can be lost. Re-establishment of the path of insertion can be traumatic and time consuming if not impossible without re-incision.
Secondly, a fixed blade on the end of a trocar can lacerate or penetrate the posterior tracheal wall and esophagus during insertion. This is a potentially fatal complication.
Thirdly, full control of the airway and the ability to forcefully ventilate the patient requires placement of an adequately sized cuffed tracheotomy tube.
What is needed is an improved trocar device to address these additional requirements and any other concerns that arise in such emergency situations.
Thoracostomy
Trauma is the third leading cause of death in the United States and the leading cause of death in young people. Blunt and penetrating chest injuries account for a large number of trauma related deaths. A tension pneumothorax is one of the leading causes of death from chest trauma. A tension pneumothorax occurs when a patient suffers chest injuries resulting in a tear of the lung. Air escapes and builds up under tension outside of the lung in the pleural space. The air under tension changes the dynamics of the circulatory system by impeding blood return to the heart, resulting in severe shock and death if not immediately corrected. This can occur during positive pressure ventilation, when diseased lungs rupture more frequently, following direct chest trauma secondary to fractured ribs. A tension pneumothorax often develops rapidly after the lung injury and therefore the treatment of the tension pneumothorax is an important part of most emergency training protocols.
When a patient develops a tension pneumothorax there is an emergent need to decompress the thorax. When a tension pneumothorax is suspected, a procedure known as needle thoracostomy is typically performed to release the tension. A needle thoracostomy utilizes a large needle or an IV catheter with a one-way flutter valve. The needle is thrust blindly through the anterior chest to decompress the pneumothorax emergently. This procedure, sometimes referred to as xe2x80x9cplacing a flutter valvexe2x80x9d, is routinely taught to physicians, nurses and paramedics during formal training, including the Advanced Trauma Life Support (ATLS) and Advanced Cardiac Life Support Courses (ACLS), courses given to most practitioners dealing with critically ill patients.
Although generally helpful, there are several drawbacks to the current needle thoracostomy procedure. The needle or IV catheter can easily lacerate the lung and produce further lung injury or hemothorax (bleeding into the chest). In fact, a chest tube must always be placed after a needle thoracostomy to treat the presumed needle injury from the procedure, even if the diagnosis of pneumothorax was incorrect! Most injuries to the lung produce some degree of hemothorax anyway, and that increases the chance that blood will clog the typically small caliber needle that is currently used. Today, most health care providers simply use an IV catheter or make-shift needles with balloons, finger cots, or slit finger tips of latex gloves on the end to decompress a tension pneumothorax.
In a typical scenario, a trauma patient with an injured lung develops profound shock after endotracheal intubation. This results because the air introduced under positive pressure escapes through the injured lung and a tension pneumothorax ensues. The paramedics would listen for decreased breath sounds, and if absent, would perform a needle thoracostomy by placing a needle or IV catheter through the side with the decreased breath sounds.
Another common scenario is the patient in extremis who fails to respond to resuscitation. As called for in the ATLS and ACLS protocols, needle thoracostomies are often performed to xe2x80x9crule outxe2x80x9d a tension pneumothorax. While this can be successful when a tension pneumothorax is actually present, many patients are not completely decompressed because either the needle does not stay in position, the needle is too small in caliber to adequately decompress the thorax, or the needle has become clogged with blood and cannot continue to function.
In other situations, patients arrive at hospital with a clogged xe2x80x9cflutter valvexe2x80x9d, or it has become ineffective because of the variable thickness of the chest wall, or it has fallen out or become displaced in transport. When this happens, a tension pneumothorax redevelops, suggesting at least that the current technology is inadequate.
A review of the medical literature reveals several reports of attempts to develop a device in the 1970""s. The McSwain Dart is reported as a device that utilized a larger catheter and a tapered steel needle to decompress tension pneumothoracies. Despite an initial series of reports of the benefits by Dr. McSwain (see McSwain, JACEP 1977; 6(7):325-5; McSwain, Med. Instrum. 1982; 16(5);249-50; and Wayne, Ann. Surg., 1980; 191(6):760-2), the device does not appear to have caught on and does not appear to be currently in use. Independent critical review of the product criticized it as being dangerous because of the large steel needle""s propensity to lacerate the lung.
The issue of the needles becoming dislodged deserves further discussion. Patients with tension pneumothoracies often have multiple injuries and are very ill. There is a lot going on in an attempt to resuscitate them, sometimes including cardiopulmonary resuscitation (CPR). An unsecured needle or IV catheter can easily fall out and be unnoticed in this situation. Furthermore, long transport times are common as patients are often transferred great distances to regional trauma centers for specialized care. If the needle is dislodged or becomes clogged with blood, air begins to build up in the chest under tension. Frequently, upon arrival at an emergency room and when a large bore chest tube is placed, a large gush of air is encountered, indicating that there was a large volume of air not released by the needle thoracostomy.
This background taken together suggests that, while needle thoracostomy may be immediately life saving, it often works only briefly and it involves multiple risks. The pathophysiology of a tension pneumothorax can reoccur and the patient can again deteriorate. While it is ideal to quickly place a large bore chest tube after a needle thoracostomy, this is not practical during long ambulance or airlift transports or when the patient is in the immediate care of health care providers who do not routinely place chest tubes.
In any event, the literature suggests that there are far more indications for chest tube insertion, such as in pneumothoracies, hemothoracies, pleural effusions and empyemas, than there are for emergent needle thoracostomy. As previously mentioned, placement of a chest tube is always recommended after a needle thoracostomy anyway because of potential hemothorax.
Non-retractable trocar chest tube insertion systems are also known. These are also generally considered dangerous and, although purchased by many hospitals, not often used by physicians. They involve the use of a hollow sharp metal trocar with a chest tube inside. After the skin is incised, the trocar is advanced through the lateral chest wall until the pleura is penetrated and the chest tube is advanced forward while the trocar is withdrawn. The danger lies in having a sharp pointed, non-retractable trocar in the chest where it can injure the lung or heart. Because this technique is considered dangerous, most surgeons employ the standard hemostat technique of chest tube insertion. This involves incising the lateral chest wall, dissecting a subcutaneous tunnel above the rib with the finger and instruments, and punching through into the pleural space. A tube is then grasped with a hemostat and inserted through this tunnel. Sutures are then used to close the large wound around the tube.
A novel retractable trocar thoracostomy system is needed to replace the current needle thoracostomy technique that is used in emergency situations for patients who have tension pneumothorax, and to replace current chest tube insertion devices and procedures, as described above. A retractable trocar should be quicker, easier and less traumatic than currently used techniques, provided, among other criteria, that the cutting mechanism used to enter the chest is designed not to injure deep structures.
Devices and methods disclosed herein solve both the cricothyrotomy and the thoracostomy problems discussed above by, among other things, incorporating a twin-bladed, retractable incision mechanism, mounted within the end of a trocar. That is, not only is the trocar retractable, but the two part blades themselves are retractable within each trocar. Such devices make a precise incision greater than the width of the included cannula that is delivered with the trocar, and preferably about twice as wide as the I.D. of the cannula.
A surgical cutting tool is disclosed. It has a xe2x80x9ccam actionxe2x80x9d (the term defined further herein) retractable blade assembly with two blades, each with a blade edge and an angled blade point. Preferably, the blade assembly has two substantially identical blades each having an edge face with a single bevel cutting edge disposed at an angle to a longitudinal axis of the blade, each edge ending in a blade point at a distal end of the blade, each blade further having a pivot pin hole in a proximal region of the blade with a hole center lying on the blade axis. Also each blade has a cam slot distal to the pin hole with an distal cam slot center lying substantially on the blade axis and a proximal cam slot center lying substantially on a line between the pin hole center and the blade point. The two blades are pivotally mounted edge face to edge face upon the pivot pin engaged within both pin holes. The tool also has a cam pin, the cam pin relatively stationarily engaged (see below) within both cam slots, so that movement of the pivot pin in a distal direction urges the two blades to rotate their two blade points closer to each other in an extended configuration, and movement of the pivot pin in a proximal direction urges the two blades to rotate their two blade points further from each other in a closed or retracted configuration.
In the extended configuration, the two blades have overlapping blade points to form an extended blade profile, and the profile preferably has a relatively less sharp, xe2x80x9csafe zonexe2x80x9d (discussed further below) at its tip. The tool also has a spring and a pushrod engaging the blades to extend the blade assembly against spring resistance into a locked position when fully extended; the pushrod may advantageously be a wire, or other longitudinally flexible, but compression and stretch resistant, push-pull type linkage such as wire wound cable.
A improved cannula for surgical procedures is also provided. It is a self retaining cannula with a collapsible retention lattice at a distal end. In one aspect, the lattice is further comprised of struts, and the struts are formed in a partial frusto-conical (truncated cone shape) configuration at the distal end of the cannula. In another aspect, prior to assembly, the lattice structure is formed substantially flat, and the cannula is segmented, with cannula segments depending radially from the flat formed lattice. Alternatively, the cannula and lattice structure, after assembly, has four contiguous rectilinear zones defined by an intersecting pair of substantially perpendicular lines, a central portion of each of which is open or latticed.
A retractable trocar device is provided for placing and maintaining a percutaneous tube into a body cavity such as an airway or a chest cavity. The device has a cam action retractable blade assembly with two blades, each with its own blade edge and angled blade point. The blade assembly has two substantially identical blades each having an edge face with a single bevel cutting edge disposed at an angle to a longitudinal axis of the blade, each edge ending in a blade point at a distal end of the blade, the two blades pivotally mounted edge face to edge face upon a pivot pin, with the blade points overlapped in an extended configuration. The blade assembly of the trocar device desirably also has a xe2x80x9csafe zonexe2x80x9d at a tip of the extended configuration, as discussed above.
The trocar device has a handle enclosing at least a portion of a spring and a pushrod, with pushrod under spring tension or compression in an extended configuration, the pushrod engaging the blades to extend the blade assembly against spring resistance into a locked position when fully extended. There is also provided a releasable lock mechanism for the pushrod. Some embodiments of the trocar device have an additional tapered zone proximal to a distal end of a trocar shaft within which slides the pushrod. The trocar device has either a self retaining tubular cannula engaged for delivery upon a trocar shaft, or a self retaining expandable cannula folded and engaged upon a trocar shaft. There is also provided an optional self deploying, removable, one way exit valve foldably engaged upon a hub end of the cannula.
The cannula may alternatively be a multi-segmental flexible piece, the segments joined in the center by a geometrically regular network of filaments, the filaments shaped and conjoined in such a way as to enable the segments to be folded and interengaged into a substantially tubular shape with the filaments thereby forming an outwardly collapsible structure having at least two break lines. With this in mind, other geometrical arrangements will occur to those skilled in the art.
The inventor developed an earlier retractable trocar device that is described in U.S. Pat. No. 4,291,690 issued Sep. 29, 1981, and by this reference the text and drawings of this patent are herewith incorporated as if fully set forth herein.
The incision mechanism for an embodiment of the invention directed particularly toward cricothyrotomy has two identical single beveled blades that are pivotally mounted for cam action expansion with their cutting edge sides face to face and overlapped at their respective points when fully extended. They form a single pointed delta or xe2x80x9cVxe2x80x9d shaped edge when extended, with (looking edge on) one half beveled on the left and the other half beveled on the right, so that there is a double thickness, double beveled point in the center generally having a blade sharpness angle that is twice that of either single blade. The preferred profile of this delta cutting edge is about 100xc2x0 because it is desirable to make as gentle a surgical incision and insertion as possible to avoid crushing trauma to the larynx, without using so sharp and long a point that there is any danger of penetration of the tracheal wall at full insertion. The size and generally cylindrical shape of the tracheal lumen also make it further desirable that the lateral-most points of such a cutting edge come to rest (at furthest insertion) at the widest point of the lumen, so to avoid lacerating the tracheal wall during incision. It has been found that a delta point of about 100xc2x0 optimizes and addresses these concerns most favorably by presenting a relatively pointed and sharp edge for ease of incision, while maintaining a relatively short point length with lateral point spread no wider than a typical tracheal lumen.
In this embodiment, the trocar system or set is pushed straight into the cricothyroid ligament space at a right angle to the surface of the skin. Flutes extend through the length of the trocar and as soon as the airway is entered, a hissing sound can be heard indicating full penetration into the airway. At this point the index finger is moved to conveniently compress a trigger mechanism that releases a spring activated retractor which closes the blade mechanism and pulls it back into the trocar, thus producing a relatively blunt end. The tapered conical end of the trocar, upon which is preferably mounted a short 7.2 mm I.D. self-retaining, expandable airway cannula, centers the trocar within the cricothyroid ligament space and gently dilates the incision as the trocar is easily, controllably inserted.
In order to prevent over penetration during initial insertion if excessive force is used or the patient lurches suddenly, two penetration control bars extend down from the sides of the handle. The bars come to rest against the surface of the throat and effectively stop the advance of the blade. They are pulled back automatically into the handle as the spring-activated retractor pulls back the blades to allow complete insertion of the trocar.
It is desirable that the blade mechanism be closed prior to withdrawing the shaft from within the cannula. When this is not done, the outwardly extended blades can potentially jam and damage the cannula. In order to eliminate this possibility, a safety switch has been designed in that automatically sets off the spring-activated retractor if the operator tries to pull the shaft from the cannula but forgets to retract the blades first.
After the blades and penetration control bars have been retracted, the trocar is inserted fully, seating the hub of the airway cannula against the throat. At this point the trocar shaft is pulled out as tabs on the hub of the cannula are held against the throat. This action causes the end of the cannula, which is snapped into four retentive grooves on the end of the trocar shaft, to flare outwardly as the shaft is withdrawn, thus anchoring the preferably self retaining airway. The light finger spring action of the expanded plastic struts prevents expulsion of the tube as the patient forcefully exhales.
In order to fulfill the requirement that an adequately sized cuffed tracheotomy tube can be placed, the cannula is made so that its preferably thin walled quadrisegmental tube will dilate as the cuffed tube is pushed easily through it into the trachea.
The preferred tracheal cannula is preferably made of polypropylene. It is preferably molded in a relatively flat plane with the ends of the quadrisections joined in the center to a network of interconnecting struts or filaments that is stretched and folded up to form a basket weave-like pattern as the sections come together, overlapping like the petals of tulip, to form the percutaneous tube. The extracorporeal portion of the cannula comes together to form the manipulative tabs on the hub, leaving the cannula segments to form a long tapered, funnel-like throat whose inner surfaces wedge outwardly as the cuffed tube is pushed in. A short cylindrical xe2x80x9ckeeperxe2x80x9d, which fits over the assembled sections of the funnel to hold the cannula together, is preferably provided and shaped as a standard 15 mm resuscitator coupling. If placement of a cuffed tube is indicated, the keeper is removed to allow insertion and expansion of the cannula.
This device, described above for use in performing cricothyrotomy, may, with scale and relative dimensions modified, also be used for performing a thoracostomy.
A thoracostomy system is also disclosed that utilizes a large bore retractable trocar instead of a needle to decompress the thorax, with the trocar placed anteriorly, similar in location to current needle thoracostomies. This emergent decompressive thoracostomy trocar preferably includes a one-way valve so air could exit, but not enter the chest. In one embodiment there is provided a thin, flat elastic membranous sleeve preferably attached to the inside of the extracorporeal hub of the cannula, and which is inserted into the cannula during assembly of the device by insertion of the shaft into the cannula, thereafter to turn inside out with withdrawal of the shaft to make a one-way flutter valve. Where deemed medically appropriate, this system can also be attached to an air drainage system for definitive care of an isolated pneumothorax.
Preferably, a safe-ended incision mechanism is provided that is retracted upon entering the chest, thus avoiding the potential for internal injury during deployment. The incision mechanism for this embodiment of the invention directed particularly toward thoracostomy also has two identical single beveled blades that are pivotally mounted for cam action expansion with their cutting edge sides face to face and overlapped at their respective points when fully extended. They also form a delta or xe2x80x9cVxe2x80x9d shaped edge when extended, with (looking edge on) one halfbeveled on the left and the other half beveled on the right, so that there is a double thickness, double beveled point in the center generally having ablade sharpness angle that is twice that of either single blade.
The preferred profile of this alternate cutting edge is about a 135xc2x0 delta shape with a small zone, preferably about 1 mm, at the double thickness, double beveled center of the delta edge. The edge of this small zone is preferably perpendicular to the long axis of the trocar shaft. This slower cutting, less pointed zone is generally the result of an additional grinding step on each blade point that takes off a tiny portion of each sharp blade tip, while leaving the newly ground tip at the same blade sharpness angle as the rest of the blade, but in a new plane slightly skewed with respect to the plane of the cutting edge, and are the preferred safe-ended mechanism referred to above. The shallower delta shape and this safe zone serve to limit the depth and danger of initial penetration, particularly with respect to the danger of damage to underlying internal organs. The rib cage is strong enough to sustain the forces necessary to incise the dense, relatively noncompliant intercostal tissues fixed between the ribs, and to dilate a chest tube channel with this relatively wider, less pointed, slower cutting edge. These intercostal tissues provide sufficient resistance to allow the necessary cleavage forces to be achieved and maintained during sharp dissection.
On the other hand, the highly compliant, soft, rubbery tissues of the underlying internal organs do not provide sufficient resistance (as does the rib cage) to the widely spread axial pressure of the plunging trocar to enable it to penetrate. Preferably, the thick tapered body of the trocar shaft starts only 5 mm behind the leading edge of the extended blade, further adding to the resistance to penetration of soft organs. In addition, this style point prevents accidental engagement and distortion of the blade tip by the superior border of the rib (in case it is bumped) during insertion.
Flattening the V shaped incising edge to about 135xc2x0 spreads the force of insertion over a wider area and increases the amount of pressure that is needed to start penetration. Since the apex of the blade point is thus closer to the plane of the lateral blade ends, the blade point has to penetrate only about 5 mm to make a complete incision into the chest cavity. In this short distance, the soft underlying internal organs cannot produce enough resistance to the slower cutting delta edge to be punctured or cut. Significantly, the expanded or extended blade mechanism is closed and spring retracted into the trocar shaft at this point by the simple push of a button on the handle of the insertion tool and, as is also true of the cricothyrotomy device disclosed above, the trocar has a relatively blunt end throughout the rest of the insertion sequence.
The trocar is then fully inserted and then the trocar shaft is removed to leave in place an included 13 to 14 mm I.D. plastic delivery cannula. The cannula can then manually be directed to the portion of the chest where the chest tube needs to be inserted. The chest tube is then inserted through the cannula, and the cannula is removed (such as by the Seldinger Technique). The chest tube can then be hooked up to closed system drainage, if further deemed necessary. In situations when pleural adhesions are expected however, the hemostat technique can still be used if ultrasound equipment is not available to identify the exact location of the intrathoracic bolus of air or blood.
There are several advantages to the system presented herein. 1) Retractable trocars in general have shown themselves to be relatively safe in laparoscopic surgery and are therefore likely to be safer than the known system of plunging a large, nonretractable needle blindly into the chest. 2) There are no needles involved; this should appeal in emergency situations where high risk accidental skinbreak exposures often occur. 3) The caliber of the related cannula is much larger than any needle, and therefore less prone to clogging with blood. 4) A novel self retaining cannula is preferably employed, successfully addressing the problem of needle displacement. 5) The one-way valve does not allow air to enter from outside the chest, which is advantageous in the non-intubated patient or when the diagnosis of a tension pneumothorax is after all incorrect.
In the disclosed system the smallest possible surgical lesion is produced in the process of applying any of the devices disclosed, resulting in less post-operative pain and faster healing; the chest tube can be placed with the fewest possible steps in the shortest possible time; and the incision produced will be just large enough to allow relatively easy placement through the incised tissue of a preferred 13-14 mm I.D. delivery cannula that is sized to facilitate installation of a 36 size French chest tube.
In addition, the relatively minimal size of the incision and the dilation of the incision channel by a preferably tapered trocar shaft retains natural tissue resiliency and causes the tissue to close tightly and directly appose the chest tube after the delivery cannula is withdrawn. This allows a negative intra-thoracic pressure to be reliably maintained without the need for sutures on either side of the chest tube to close gaps around it. An optional one way exit valve can be included as a removable attachment for the delivery cannula which makes it useful for reducing compression pneumothoracies and eliminates the need to perform a secondary thoracostomy after the standard needle puncture technique. If the location of the chest access needs to be changed, the trocar can be easily reassembled and reapplied.
Installation of the preferred self-retaining delivery cannula in a single stroke prevents the path of insertion into the chest cavity from being lost during the procedure. The end of the thin-walled cannula collapses and flares out as the blunted trocar shaft is pulled from within it. This anchors the cannula lightly within the chest cavity. A conventional chest tube can then be placed through it with no further manipulation of the tissues, whereas the conventional technique requires multiple penetrations and extensive tissue manipulation to insert the tube.
The differences between the very restrictive anatomy of the laryngeal hard structures and the vacuous depths of the chest cavity will allow a thoracostomy trocar to be inserted further during deployment, provided that the end can be made safe after initial penetration. Thus one alternate embodiment adds a tapered extension of the trocar shaft just behind a relatively smaller set of blades, the tapered extension progressively dilating the smaller resulting incision and thus causing the tissues to fit more tightly around the cannula and result in a smaller scar. This version has a preferred 13 mm shaft which tapers slowly down to 9 mm and has two 9 mm blades (rather than the preferred 13 mm blades of the other version). A self-retaining 13 mm I.D. delivery cannula is provided to fit it on either version, depending on how the collapsing struts on the end are unfolded after it is made.
There is a potentially large market for this system, as it could be used by paramedics, emergency physicians, trauma surgeons, ICU doctors and anesthesiologists, all of whom encounter patients with pneumothoracies. Furthermore, a device such as this would improve the comfort and safety of critically ill patients during air transport because the attendant changes in altitude are known to worsen the physiologic effects of pneumothoracies by changing the air pressure differential in the thorax. The product of the invention can even be stocked on the xe2x80x9ccodexe2x80x9d carts or with other emergency equipment and therefore be immediately available. Code carts, used for emergency resuscitations in hospitals, are found in every patient care area, emergency room and operating rooms in every hospital as well as in many clinics. This product could easily be included with emergency equipment carried by paramedics and flight crews that care for injured patients prior to arrival to a hospital.
It will be appreciated that placement of a large ( greater than 10 mm O.D.) trocar through the skin into a body cavity (trachea, thorax, abdomen) is extremely difficult, if not impossible, if an adequate surgical incision and sharp dissection of the underlying tissue layers is not accomplished prior to insertion. Extensive testing of many cutting tip and blade designs demonstrates that any blade that is no wider than the inside diameter of the cannula mounted on the trocar shaft and that is merely pushed straight in without any substantial lateral motion will not make an incision that is wide enough to allow a short, straight cannula to be pushed through the body wall without excessive force and without extreme danger of over penetration and mutilation of underlying tissues, no matter what the shape or length of the blade. In addition, any uncontrolled lateral motion of a pointed blade during incision into the body cavity can lacerate organs which may be immediately underlying. The retractable cutting mechanism disclosed herein, that preferably makes an incision about twice as wide as the trocar shaft itself, enables easy and reliable insertion of the trocar.
As discussed above, the skin and body wall are well designed to resist puncture and penetration into body cavities. Only with adequate sharp surgical incision of the skin and underlying tissues can insertion of a large bore (10 mm+) percutaneous tube be easily, safely and reliably accomplished. Gentle, progressive dilation of the incision is desirable for installation of the tube. The disclosed design accomplishes incision, dilation and installation in one motion, one step, with one instrument, with anchoring and gentle retention of the preferred inserter sleeve/breathing tube/one-way valve combination accomplished as the shaft is withdrawn from within the cannula.
The tapered dilator segment of the trocar shaft is self-centering and insures axial force application during insertion, to prevent unwanted lateral motion and to prevent inadvertent deep organ penetration. A preferably built in tapered wound dilator, provided in varying sizes, transfers dilating forces from the tip of the trocar shaft to the sides of the cannula struts, due at least in part to preferred inletting of the collapsible cannula struts onto the trocar shaft. The resulting configuration locks the cannula onto the shaft and enables out folding of the self-retaining mechanism during withdrawal of the shaft.
For other applications, the retractable twin-bladed incision mechanism can be made in a large or miniature scale and can also be used to deliver tubes that are not expandable or are not self-retaining. The preferred spring loaded rod linkage which extends and retracts the blades can be made to any desired length and can be both flexible and activated remotely, as through a surgical endoscope or catheter. Therefore, without departing from the scope of the invention, the device could be modified by those skilled in the art for endoscopic microsurgical insertion of tubes or shunts which require a precise, controlled puncture into a body cavity.

Method and apparatus for placing and maintaining a percutaneous tube into a body cavity


A hair and scalp treatment composition containing (1) an anti-dandruff agent such as salicylic acid, (2) a polyethylenimine, and (3) an amphoteric surfactant. The composition provides superior effects for repairing damaged hair, protecting hair against chemical and mechanical damage. In addition, the composition also provides scalp treatment for against dandruff, seborrheic dermatitis and psoriasis. The composition could be incorporated into either aqueous or anhydrous solvent systems.

This invention is directed to the field of hair and scalp treatments.
The following is intended to provide a background of the inventive composition and method of this patent; however, this discussion is not intended to suggest that the information set forth is prior art.
In today""s hair care market, there continues to be a long-felt need for hair care products effective to facilitate the prevention of hair damage and also to repair damaged hair. There are many different products in the market and most of them target specific problems. Since most people have an accelerated life pace, they are looking for multi-functional products that can simplify their daily routine.
Pre-shampooing hair treatment or conditioning formulas are different from regular conditioners or conditioning rinses. In general they have stronger conditioning ingredients that are substantive to hair and will be left on the hair after shampooing. Upon rinsing the treated hair, the conditioning ingredients will be deposited on hair evenly to give hair softness and/or smoothness of feel, luster, body as well as manageability. For example, polyethylenimine (PEI) has been used in pre-shampooing condition treatments for this purpose. In comparison, regular conditioners or conditioning rinses generally do not leave a deposit on the hair for an appreciable length of time after rinsing, because of the small molecular weight of the conditioning ingredients.
Water-soluble cationic surfactants and PEI are cationic conditioning ingredients. Water-soluble cationic surfactants are widely used in after shampooing conditioners or conditioning rinses. In contrast, PEI has not been a widely used ingredient in after shampooing conditioners or conditioning rinses. If PEI is used in after shampooing conditioners or conditioning rinses, two problems are usually encountered: (1) over build-up of cationic polymer and (2) the hair has an unpleasant after-feel. When PEI is used in a pre-shampoo conditioning treatment, shampooing will remove the PEI polymer and cationic surfactants that have less affinity for the hair so there is less build-up. The leftover PEI polymer is evenly distributed on the hair and therefore leaves the hair soft and smooth with increased luster and manageability. Since PEI is a cross-linking polymer with a very high cationic charge density, it will coat the hair shaft very well, which will help repair split-ends as well as other chemical and mechanical damage to the hair. In addition, the cationic polymer can form stronger hydrogen bonds with hair and water in order to help balance the moisture content of hair.
PEI however is incompatible with many anionic surfactants in shampoo formulations in the normal pH range of shampoo, namely, 2 to 9. Indeed, mixing PEI with sodium lauryl sulfate forms a precipitate in the pH range of 2 to 9.
There are a number of chemicals useful as anti-dandruff agents. For example, zinc pyrithione and salicylic acid have been approved by the Federal Drug Administration for use as an anti-dandruff, anti-seborrheic dermatitis, and anti-psoriasis, ingredient in shampoos and skin care products for over the counter applications. There are various shampoos and body wash products in the market containing salicylic acid that target scalp and skin problems.
It is apparent that if one could use an anti-dandruff agent such as salicylic acid in the regular formula of conditioning rinses or leave-in conditioners as a scalp treatment ingredient, these products would have dual functions: (1) scalp treatment and (2) hair conditioning. Unfortunately, an agent such as salicylic acid is incompatible with cationic ingredients in conditioning rinses or in leave-in conditioners. Therefore, the most popular treatment compositions combine salicylic acid and anionic surfactants in cleansing formulations or use salicylic acid in emulsions.
Thus there exists a long felt, but unsolved need, for a composition for both hair and scalp treatment.
The present invention solves the foregoing need. The inventive composition utilizes, preferably, polyethylenimine (PEI) and an anti-dandruff agent in one formula so as to have both hair and scalp treatment functions. In general, the anti-dandruff agents are those that are incompatible with cationic ingredients in conditioning rinses or in leave-in conditioners. Preferably, the anti-dandruff agents are selected from the group consisting of salicylic acid, zinc pyrithione and mixtures thereof. The combination of PEI and the anti-dandruff agent can be incorporated into both the aqueous phase and the anhydrous phase.
In general, the inventive composition is composed of two major ingredients: polyethylenimine and/or its derivatives and mixtures thereof (individually and collectively xe2x80x9cPEIxe2x80x9d) and the foregoing anti-dandruff agents, preferably salicylic acid. Preferably, the composition includes: polyethylenimine in the amount of about 0.01% to about 8.0% and the anti-dandruff agent in the amount of about 0.01% to about 7.0% by total weight of the composition.
PEI are molecules with the units [(CH2CH2NH)n] of ethylenimine ranging from preferably 7 to 14,000 units with a corresponding molecular weight in the range of 300 to 602,000. Polyethylenimine has a three-dimensional cross-linking structure and is able to xe2x80x9cwrapxe2x80x9d or xe2x80x9ccoatxe2x80x9d hair to form an even film. To activate the conditioning function of polyethylenimine, neutralization is needed and the following three neutralizers are preferred: lactic acid, glycolic acid and benzoic acid. The amount of these acids depends upon the amount of polyethylenimine and the molecular weight of these three acids.
Preferably, the anti-dandruff agent is in the amount of about 0.01% to about 8.0% by total weight of the composition. In the composition of the present invention, this agent is neutralized to the pH range for regular cosmetic products with organic amines before mixing it with neutralized PEI. The amount of organic amines depends upon the amount of the agent and also the molecular weight of the organic amines.
Amphoteric surfactants (for example, alkyl betaines, alkylamido betaines, acylamphoglycinate and acylamphoproplonates) can also be used in the inventive composition. The amount of amphoteric surfactants preferably ranges from about 0.01% to about 12.0% of the total weight of the composition. Other ingredients can include preservatives, fragrance, de-ionized water and/or other organic solvents.
The effective preferable pH range of the inventive composition is in the range of about 2 to about 9 for aqueous based formulas. To exert the self-heating xe2x80x9chot oilxe2x80x9d function, lower molecular weight glycols and/or polyethylene glycols are used as solvents to replace deionized water. Examples of these glycols include propylene glycol, glycerin, polyethylene glycol 4-12, polypropylene glycol 7-15 and tripropylene glycol methyl ether. The ratio of PEI and anti-dandruff agents as well as all neutralization ingredients are kept the same as in the aqueous formula.
Other objects, features and advantages of the present invention will become apparent to those skilled in the art from the following detailed description. It is to be understood, however, that the detailed description and specific examples, while indicating preferred embodiments of the present invention, are given by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit thereof, and the invention includes all such modifications.
The inventive treatment composition contains a highly cationic polyethylenimine (PEI), a very effective hair conditioning ingredient, generally in the amount of about 0.01% to about 8.0%, preferably in the amount of about 0.10% to about 6.0%, and more preferably in the amount of about 0.5% to about 5.0%, by total weight of the composition, and an anti-dandruff agent, generally in the amount of about 0.01% to about 7.0%, preferably in the amount of about 0.10% to about 5.0%, and more preferably in the amount of about 0.5% to about 4.0%, by total weight of the composition. If zinc pyrithione is used as the anti-dandruff agent, the most preferable range is 0.1% to 3.0% of the total weight of the composition. The composition can also include amphoteric surfactants generally in the amount of about 0.01% to about 12.0%, preferably in the amount of about 0.10% to about 9.0%, and more preferably in the amount of about 0.5% to about 6.0%, by total weight of the composition. To help activate polyethylenimine, an acid, preferably lactic acid, glycolic acid and/or benzoic acid, are employed in the amount of about 0.2% to about 6.5% by total weight of composition depending on the molecular weight of the acid.
Water-soluble organic amines can be used to neutralize the anti-dandruff agent in the range of about 0.01% to about 10.0%, preferably about 0.10% to about 6.5%, and more preferably about 0.05% to about 5.0%, of the total weight of the composition depending on the molecular weight of the amines. Other ingredients that can be used in the composition are fragrance, preservatives and solvents (water or organic solvents). Exemplar preservatives include methylparaben, propylparaben, and DMDM hydantoin and exemplar organic solvents include propylene glycol, glycerin, polyethylene glycol 4-12, polypropylene glycol 7-15, and tripropylene glycol methyl ether.
The inventive pre-shampooing hair treatment provides the hair with improved physical and cosmetic conditioning properties for instant thickness, softness, gloss and manageability, including excellent wet and dry combing and body. In addition, it also provides scalp-conditioning benefits to fight against dandruff, seborrheic dermatitis and psoriasis. It is a helpful product for people who have dandruff, seborrheic dermatitis and psoriasis, among other scalp problems. They do not have to use anti-dandruff, anti-seborrheic dermatitis and psoriasis products daily and separately. Thus the composition of the present invention will help decrease the itchiness of the scalp.
The polyethylenimines used in the hair treatment composition should be both water soluble or soluble after neutralization and/or organic solvent soluble (lower molecular weight glycols and/or polyethylene glycols). The suitable polyethylenimines include, but are not limited to, molecules in the classes known as polyethylenimine, hydroxyethyl polyethylenimine, graft copolymers of polyethylenimine and silicone polymers.
The performance of the inventive composition is in part directly related to the molecular weight or structure of the polyethylenimines. In terms of conditioning properties, in general, the larger or longer chain the polyethylenimine molecule is, the better performance one obtains. However, if the molecule is too large, it may be difficult to remove it from the hair by shampooing. The suitable sizes of molecular weight are generally in the range of 300 to 602,000, preferably in the range of 645 to 107,500, and more preferably in the range of 1300 to 75,250. A range of 300 to 602,000 corresponds to the units of ethylenimine, which range from 7 to 14,000 {(CH2CH2NH)n, n=7-14,000)}. The more preferable range of from 30 to 1,750 units corresponds to a molecular weight range of 1300 to 75,250.
In general the pH should range from 2.0 to 9.0, preferably from 2.5 to 8.0, and the most effective performance pH range of polyethylenimines is between 3.0-7.0. Therefore, an acid is used to neutralize the PEI component of the composition of the present invention. Lactic acid, benzoic acid and/or glycolic acid have been preferably chosen to neutralize polyethylenimine to decrease the pH to 2-9. Other acceptable acids include acetic acid and propionic acid. Acetic acid and propionic acid can be used as neutralizers, but the odor of both ingredients are difficult to mask. Most inorganic monoacids can be used to play the same function. However, in general, inorganic multiple-acids and organic multiple acids (e.g. citric acid) are not suitable for neutralization function and they would have an incompatibility problem with polyethylenimines. Inorganic monoacids that are satisfactory include hydrochloride acid, hydrobromide acid and nitric acid.
The polyethylenimine and/or its derivatives used in the inventive composition include, but not limited to, Hydroxyethyl PEI-1000, Hydroxyethyl PEI-1500, Polyethylenimine7, Polyethylenimine 10, Polyethylenimine 15, Polyethylenimine 30, Polyethylenimine 35, Polyethylenimine 45, Polyethylenimine 250, Polyethylenimine 275, Polyethylenimine 700, Polyethylenimine 1000, Polyethylenimine 1400, Polyethylenimine 1500, Polyethylenimine 1750, Polyethylenimine 2500, Polyethylenimine 14000, and various Polyethylenimine-silicone graft copolymers.
The benefits of using polyethylenimine and its derivatives in hair conditioning originate from the three-dimensional cross-linking structures of polyethylenimine and/or its derivatives. After neutralized to pH at 2-9, polyethylenimines become highly positive charged polyethylenimonium. Neutralized polyethylenimonium generally readily deposits on hair since natural hair usually carries some anionic charge. These cross-linking molecules can tightly xe2x80x9ccoatxe2x80x9d the hair surface. Shampooing only removes the loosely deposited part and leaves the xe2x80x9cleft overxe2x80x9d part evenly spread on the hair. It gives hair softness, smoothness, gloss, moisture and manageability.
In order to link scalp treatment together with hair treatment in the same product, an anti-dandruff agent such as salicylic acid has been incorporated into the composition. Salicylic acid has been approved by Federal Drug Administration as an anti-dandruff, anti-seborrheic dermatitis and anti-psoriasis ingredient in over the counter products.
The inventive composition starts with two separated phases: one bears neutralized polyethylenimonium and the other contains neutralized anti-dandruff agent such as salicylic acid at about the same pH. By using amphoteric surfactants in either one of two water phases, physical and chemical stable composition have been obtained.
In general, it is important to control the ratio of the anti-dandruff agent to the PEI because of the potential incompatibility between these two ingredients. In general, the ratio of the salicylic acid to the PEI should range from about 1.0:0.05 to about 1.0:50, preferably from about 1.0:0.07 to about 1.0:35, and more preferably from about 1.0:0.1 to about 1.0:20. By employing these ratios, the resulting composition is stable after customary thermal and physical tests. Those tests include three cycle freeze and thaw, and elevated temperature at 40xc2x0 C. and room temperature stability. By stable, it is meant that the composition solution did not materially change and there is not any significant phase separation as well as significant precipitation.
Suitable organic amines include, but not limited to, primary amines (RNH2), secondary amines (R2NH) and tertiary amines (R3N). Within this class of amines, the most effective molecular weight range is from 100 to 2,000, although the preferable range is from 100 to 1500 and more preferably from 100 to 1000. The R groups include but are not limited to Alkyl, Aryl, Alkylamidopropyl, Polyethylene (and/or polypropylene), Glycol Alkyl, Hydrogenated Tallow, and Polyethylene Glycol Hydrogenated Tallow. Alkyl groups could be linear or branched and Aryl groups could be Aryl derivatives.
Examples of organic amines include, but not limited to, Babassuamidopropyl Dimethylamine, Behenamidopropyl Dimethylamine, Diethanolamine, Almondamidopropyl Dimethylamine, Cocamidopropyl Dimethylamine, Aminopropyl Laurylglutamine, Cocamine, Cocoyl Polyglyceryl-4 Hydroxypropyl Dihydroxyethylamine, Dibehenyl Methylamine, Dicocamine, Diethyl Ethanolamine, Diethylhexylamine, Dihydrogenated Tallow Methylamine, Dilinoleamidopropyl Dimethylamine, Dimethicone Copolyolamine, Hydrogenated Ditallowamine, Dimethicone Copolyol Bishydroxyethylamine, Dimethyl Behenamine, Dimethyl Hydrogenated Tallowamine, Avocadamidopropyl Dimethylamine, Dimethyl Myristamine, Dimethyl, Paimitamine, Dimethyl Soyamine, Dimethyl Stearamine, Dimethyl Tallowamine, Dipalmitamine, Disoyamine, Ditallowamidoethyl Hydroxypropylamine, Laurylamine Dipropylenediamine, Linoleamidopropyl Dimethylamine, Hydrogenated Tallowamine, Isostearamidopropyl Dimethylamine, Lauramidopropyl Dimethylamine, Lauraminopropylamine, Oleamine, Olivamidopropyl Dimethylamine, Minkamidopropyl Dimethylamine, Myristamidopropyl Dimethylamine, Oleamidopropyl Dimethylamine, Palmitamidopropyl Diethylamine, Palmitamine, Palmitoyl Methoxytryptamine, PEG-105 Behenyl Propylenediamine, PEG-3 Cocamine, PEG-15 Cocopolyamine, Palmitamidopropyl Dimethylamine, PEG-5 Hydrogenated Tallow Amine, PEG-5 Isodecyloxypropylamine, PEG-6 Oleamine, PEG-12 Palmitamine, PEG-2 Soyamine, PEG-5 Stearamine, PEG-7 Tallow Amine, PEG-3 Tallow Aminopropylamine, PEG-15 Tallow Polyamine, Piroctone Olamine, Poloxamine 304, PPG-2 Cocamine, PPG-2 Hydrogenated Tallowamine, PPG-2 Tallowamine, PPG-3 Tallow Aminopropylamine, Ricinoleamidopropyl Dimethylamine, Sesamidopropyl Dimethylamine, Stearamidoethyl Diethanolamine, Stearamine, Tallamidopropyl Dimethylamine, Soyamine, Soyaminopropylamine, Tallow Amine, Tallowaminopropylamine, Trilaurylamine, Wheat Germamidopropyl Dimethylamine.
Inorganic bases or smaller molecular weight organic bases do not work as well as larger molecular weight bases. Some of them may cause an incompatibility problem between polyethylenimine and salicylic acid. The amount of base used in the composition is dependent on the molecular weight of the base and also the hydrolytic reaction of the corresponding salt. The larger the molecular weight is, the more amount of amine is needed.
Suitable amphoteric surfactants include, but are not limited to, alkyl or alkylamido betaines; and acylamphoglycinates or acylamphoproplonates. The examples of alkyl or alkylamido betaines include, but not limited to, Behenamidopropyl Betaine, Almondamidopropyl Betaine, Canolamidopropyl Betaine, Apricotamidopropyl Betaine, Avocadamidopropyl Betaine, Babassuamidopropyl Betaine, Behenyl Betaine, Capryl/Capramidopropyl Betaine, Coco-Betaine, Cetyl Betaine, Cocamidoethyl Betaine, Decyl Betaine, Cocamidopropyl Betaine, Cocamidopropyl Betaine NI]EA Chloride, Coco/Oleamidopropyl Betaine, Dimethicone Propyl PG-Betaine, Hydrogenated Tallow Betaine, Isostearamidopropyl Betaine, Lauramidopropyl Betaine, Lauryl Betaine, Methacryloyl Ethyl Betaine/Acrylates Copolymer, Milkamidopropyl Betaine, Minkamidopropyl Betaine, Myristamidopropyl Betaine, Myristyl Betaine, Oleamidopropyl Betaine, Oleyl Betaine, Olivamidopropyl Betaine, Palmamidopropyl Betaine, Palmitamidopropyl Betaine, Palm Kernelamidopropyl Betaine, Polytetrafluoroethylene Acetoxypropyl Betaine, Ricinoleamidopropyl Betaine, Sesamidopropyl Betaine, Soyamidopropyl Betaine, Stearamidopropyl Betaine, Stearyl Betaine, Tallowamidopropyl Betaine, Tallow Betaine, Tallow Dihydroxyethyl Betaine, Undecylenamidopropyl Betaine, Wheat Germamidopropyl Betaine.
Examples of acylamphoglycinates and acylamphopropionates include, but not limited to, Caproamphoglycinate, Capryloamphoglycinate, Cocoamphoglycinate, Isostearoamphoglycinate, Lauroamphoglycinate, Myristoamphoglycinate, Oleoamphoglycinate, Stearoamphoglycinate, Tallowamphoglycinate, Undecylenoamphoglycinate, Cocobetainamido Amphopropionate, Cocoamphocarboxyglycinates, Cocoamphopropionate and Cocoamphocarboxypropionate.
In order to control the rheology of the composition, common rheology modifiers can be used to modify the viscosity and rheology. Either non-ionic or anionic polymers as well as cationic polymers are suitable for this purpose. The suitable non-ionic or anionic polymers include, but are not limited to, Carboxymethyl Hydroxyethylcellulose, Cetyl Hydroxyethylcellulose, Ditallow Dimonium Cellulose Sulfate, Ethylcellulose, Cellulose, Cellulose Acetate, Cellulose Acetate Butyrate, Cellulose Acetate Propionate, Cellulose Acetate Proplonate Carboxylate, Cellulose Gum, Hydroxybutyl Methylcellulose, Hydroxyethylcellulose, Methyl Hydroxyethylcellulose, Microcrystalline Cellulose, Hydroxyethyl Ethylcellulose, Hydroxypropylcellulose, Hydroxypropyl Methylcellulose, Hydroxypropyl Methylcellulose Acetate/Succinate, Methylcellulose, Methyl EthylcelluloseNitrocellulose, Nonoxynyl Hydroxyethylcellulose, Cellulose Ester, Acetobutyrate Cellulose, Acetylbutyrylcellulose, Acetylproplonylcellulose, Carboxymethyl Cellulose, Acetate Butanoate Cellulose, 2-Hydroxyethyl Ether Cellulose, 2Hydroxyethyl Ether, Polymer with N,N-Dimethyl-N-2-Propenyl-2-Cellulose, Cellulose, Hexadecyl Hydroxyethyl Cellulose, Hydroxyethylcellulose, Dimethyldiallylammonium Chloride Copolymer, Hydroxyethylcellulose Ethylether, Hydroxypropyl Methylcellulose 2208, Hydroxypropyl Methylcellulose 2906, Hydroxypropyl Methylcellulose 2910, 2Hydroxyethyl 2-(2-Hydroxy-3-(Trimethylammonio)Propoxy)Ethyl 2-Hydroxy-3(Trimethylammonio)Propyl Ether, 2-Hydroxyethyl 2-Hydroxy-3-(Trimethylammonio)Propyl Ether Cellulose, 2-Hydroxyethyl 23-Hydroxy-3-(Trimethylammonio)Propyl Ether Cellulose, 2-hydroxyethyl Methyl Ether Cellulose, 2-Hydroxypropyl Ether, Acetate Propanoate Cellulose, Butyrate Acetate Cellulose, Carboxymethyl Ether Cellulose, Carboxymethyl Ether, Sodium Carboxymethyl-2-Hydroxyethyl Ether Cellulose, Cellulose Ethyl Hydroxyethyl Ether, Ethyl Methyl Ether Cellulose, Hexadecyl 2-Hydroxyethyl Ether Cellulose, Hydroxybutyl Methyl Ether Cellulose, Hydroxyethylate, 2-Hydroxypropyl Methyl Ether Cellulose, 2-Hydroxypropyl Methyl Ether, Acetate Hydrogen Butanedloate Cellulose, 2-[2-Hydroxy-3-(Trimethylammonio)Propoxy]Ethyl Ether Cellulose, 2-[2-Hydroxy-3(Trimethylammonio)Propoxy]Ethyl Ether Cellulose, 2-[2-Hydroxy-3Trimethylammonio)propoxy]Ethyl ether Cellulose, Methyl Ether Cellulose, Ethyl Hydroxyethyl Cellulose, Ethyl Methyl Cellulose, H. E. Cellulose, Methyl Hydroxypropyl Cellulose, Carboxymethyl Hydroxypropyl Guar, Cyamopsis Tetragonotoba (Guar) Gum, Hydroxypropyl Guar, Ilex Paraguariensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, Hydroxypropyl Guar, Ilex Paraguariensis, Ilex Paraguariensis Leaf Extract, Cyamopsis Tetragonoloba (Guar) Gum, Extract of Guarana, Extract of Ilex Paraguariensis, Guarana Extract, Guar (Cyamopsis Tetragonoloba) Gum, Carboxymethyl 2-Hydroxypropyl Ether Guar Gum, 2-Hydroxypropyl Ether Guar Gum, 2-Hydroxy-3-(Trimethylammonio)Propyl Ether Guar Gum, Sodium Carboxymethyl Cellulose, Calcium Cellulose Glycolate, Sodium Cellulose Sulfate, Sodium Carboxymethyl Hydroxyethylcellulose, Calcium Carboxymethyl Cellulose.
Suitable cationic polymers include, but are not limited to, Nitrocellulose Quaternary Ammonium Compounds, Coco Alkyl (2,3-Dihydroxypropyl)Dimethyl, O-[2-Hydroxy-3(trimethylammonio)propyl] Guar Gum Chloride, Guar Hydroxypropyltrimonium Chloride, Hydroxypropyltrimonium Chloride, 2-hydroxypropyl 2-hydroxy-3-(trimethylammonio)propyl ether Guar Gum Chloride, Polyquaternium-2, Polyquaternium-4, Polyquaternium-6, Polyquaternium-7, Polyquaternium-10, Polyquaternium-11, Polyquaternium-22, Quaternium-76 Hydrolyzed Collagen, Quaternium-79 Hydrolyzed Collagen, Quaternium-79 Hydrolyzed Keratin, Quaternium-79 Hydrolyzed Milk Protein, Quaternium-79 Hydrolyzed Silk, Quaternium-79 Hydrolyzed Soy Protein, Quaternium-79 Hydrolyzed Wheat Protein, PG-Hydroxyethylcellulose Cocodimonium Chloride, PGHydroxyethyicellulose Lauryldimonium Chloride, PG-Hydroxyethylcellulose Stearyl dimonium Chloride, O-[2-Hydroxy-3-(trimethylammonio)propyl] Hydroxyethylcellulose Chloride. By changing the different polymers, compositions of variable viscosity and rheology can be prepared.
Other common cosmetic ingredients can include preservatives, color, and fragrance. However, they do not play functional roles for conditioning of hair and scalp.
The treatment composition has been designed to repair damaged hair, especially from split-ends and also to treat daily problems of the scalp. The composition is designed to be preferably used twice a week and will facilitate the elimination of split-ends and transform damaged hair into healthy hair. For normal hair, it helps protect hair from damage and balances the moisture of the hair leaving the hair healthier looking. At the same time, it also helps prevent itchiness of the scalp and helps prevent dandruff from forming.
The invention is further illustrated by the following exemplar formulations, which are intended as illustrations only and not as a limitation to the scope of the invention. The thermal and physical stabilities (compatibility of PEI and anti-dandruff agent) have been tested at both ambient temperature and 40xc2x0 C. for three (3) months.

Composition and method for hair and scalp treatment


An optical measurement device is presented. The device is attachable to the patient""s body and adapted for performing non-invasive measurements of blood-related signals. The device comprises a measurement unit for applying optical measurements to a first region on the patient""s extreme organ, and an occlusion assembly for applying over-systolic pressure to a second region on the patient""s body located upstream of the first location with respect to a normal blood flow direction. A substantially flexible, heating element is provided within the measurement unit, and is accommodated so as to engage at least a part of the first region for heating it to a desired temperature.

The present invention is in the field of non-invasive measurements of physiological parameters of patients, and relates to a device for measuring blood-related signals.
Numerous techniques have been developed for the non-invasive measurement of blood-related signals, being aimed at determining various blood-related parameters such as blood oxygen saturation and the concentration of substances contained in the blood, e.g., glucose. These techniques typically utilize a measurement device or probe, which is designed to be attached to a patient""s body (typically his finger), and includes an optical assembly for irradiating the finger with light and detecting its light response.
Most of the known devices are based on spectrometric techniques. According to these techniques, a tissue is irradiated with light of different wavelengths, and a photodetector detects light returned from the tissue. Analysis of the detected returned signal allows the determination of the required biological variable. The accuracy of the method depends on various conditions, some of which are associated with the detected signal and others with the irradiated tissue. This technique gives poor results due to a low signal-to-noise ratio, artifacts and the fact that the returned pulsatile signal might be very low.
Recently developed techniques propose various solutions directed towards overcoming the above drawbacks. U.S. Pat. No. 5,131,391 discloses a pulse oxymeter aimed at overcoming a problem associated with constriction of blood vessels that might occur during stress or invasive procedures such as surgery. To this end, the pulse oxymeter, in addition to a photodetector, has a warming device.
U.S. Pat. No. 5,638,818 discloses a measurement device having an improved optical probe designed so as to reduce noise in the course of measuring signals in a compressible tissue. The probe includes a base having an aperture for the finger to be inserted therein, which aperture leads to a chamber where a photodetector is placed in a manner to have no contact with the finger. A light source is affixed to the finger above the chamber. This design enables to maintain the optical path of transmitted light. A scattering medium is interposed between the light source and the finger so as to improve the signal-to-noise ratio. In a later patent of the same author (U.S. Pat. No. 5,782,757) a disposable optical probe and a reusable probe in the form of a padded clip-on bracket are disclosed. The probes are designed so as to fit comfortably onto a patient""s fingertip.
WO 9843096 discloses a measurement device, where measurements are applied to a part of the body whose thickness is modulated harmonically by at least two pressure modulating frequencies. This part of the body is irradiated with at least two different wavelengths, where at least one of them lies in a range of optical absorption of the blood components to be determined.
JP 10033512 discloses a measurement device having a slot for a patient""s finger to be inserted thereto. The walls of the slot are coated by an insulating material. A light source and a detector are accommodated at opposite sides of the slot so as to be at opposite sides of the finger.
DE 19629342 discloses a measurement device in the form of a holder for holding a patient""s finger at its one side in a manner to apply a slight pressure thereto. The device analyzes light reflected from the finger.
The above devices deal with natural pulsatile signals. What is actually measured by these devices is an enhanced optical pulsatile signal. It is known that a regular optical pulsatile signal is typically 2-3% of the total transmission. The above devices are capable of obtaining the enhanced pulsatile signal that reach 8-10% of the total light transmission intensity. This enhancement of the natural pulsatile signal is a boundary of all conventional techniques of the kind specified
A different technique is disclosed in a co-pending application PCT/IL 99/00331 assigned to the assignee of the present application, where the measured signals are not pulsatile. According to this technique, a state of blood cessation is created in a medium under measurement. This enables to significantly enhance the measured light response of the medium, as compared to that of the previously described techniques dealing with the pulsatile signals.
There is accordingly a need in the art to facilitate non-invasive measurement of significantly enhanced blood-related non-pulsatile signals, by providing a novel optical measurement device.
It is a major feature of the present invention to provide such a device that can be easily attached to the patient""s organ and enable to create the blood cessation state within a measurement region.
The present invention takes advantage of the fact that measurements taken during the state of blood cessation allows for a significant increase of the blood-related signals, as compared to those taken during the state of normal blood flow. This concept is disclosed in a co-pending application PCT/IL 99/00331, assigned to the assignee of the present application. To create a state of blood cessation within a patient""s organ, over-systolic pressure should be applied thereto. Measurements are taken at a location downstream of that where the over-systolic pressure was applied with respect to the direction of normal blood flow.
The main idea of the present invention is based on the fact that heating and optionally pressuring, effects significantly enhance the blood-related signals to be measured. The measurement device according to the invention includes a measurement unit and occlusion assembly, which are spaced-apart from each other along the patient""s organ, and the measurement unit comprises a substantially flexible heating element. This element, on the one hand, enables to heat an area under measurements to a desired temperature, and, on the other hand, is capable of providing pressurization and comfortable fixation of the organ, and prevents its displacement relative to an illumination-detection assembly during measurement.
There is thus provided according to one aspect of the invention, an optical measurement device for attaching to the patient""s body to perform non-invasive measurement of blood-related signals, the device comprising:
a measurement unit for attaching to the patient""s extreme organ, the measurement unit comprising an illumination-detection assembly for illuminating a first region within said organ, detecting light response of the illuminated region and generating data representative thereof, wherein the measurement unit comprises a substantially flexible heating element engaging at least a part of said first region for heating it to a desired temperature;
an occlusion assembly for applying substantially over-systolic pressure to a second region on the patient""s body located upstream of said first region with respect to a normal blood flow direction; and
a control unit, which is coupled to the measurement unit for selectively actuating the measurements, analyzing data indicative of the detected light response and determining at least one desired parameter of the patient""s blood, and is coupled to the occlusion assembly for selectively operating this assembly.
The occlusion assembly includes a cuff associated with a pneumatic drive for applying the over-systolic pressure. The cuff is either a ring mountable onto the patient""s organ, or a band with Velcro-like fasteners.
The measurement unit may be in the form of a clip supporting the illumination-detection assembly and having the substantially flexible heating element attached to its inner surface. Alternatively, the measurement unit may comprise only this substantially flexible heating element that supports the illumination-detection assembly. To this end, the element is in the form of a cuff-like cushion to be wrapped around the organ within the region under measurements. This cuff-like cushion is associated with a pneumatic drive, constituting together a pressurizing assembly for supplying desired, substantially under-systolic (e.g., 10-50 mmHg) pressure. His pressurizing assembly is aimed at, on the one hand, adjusting the cuff-like cushion to a specific patient, and, on tie other hand, providing slightly pressurization of the patient""s organ within the measurement area, thereby enhancing the measured signals.
Preferably, the desired temperature for heating the region under measurements is approximately 37xc2x0-38xc2x0. Heating can be either continuously or by applying short thermal pulses (e.g., electrical or light energy) to accelerate heating of the measurement region to the desired temperature.
The substantially flexible heating element may be in the form of a film made of a thermoconductive material, or of a non-conductive flexible material with a heater implemented therein. Alternatively, the substantially flexible heating element may be a two- or three-layer structure. If the two-layer structure is used, the first layer, which is in contact with the patient""s organ, is made of an insulating, material, and the second layer is made of an electrically conductive (i.e., heating) material. If the three-layer structure is used, the first layer, which is in contact with the patient""s organ, is made of an insulating material, the intermediate layer is made of a heating material, and the third layer is made of a dielectric material.
The illumination-detection assembly may be of any known kind. The assembly may be designed for detecting either light transmitted through the illuminated region or light scattered (reflected) therefrom.
Preferably, the patient""s organ under measurements is his finger.
According to another aspect of the present invention, there is provided a finger holder to be used in a measurement device performing non-invasive measurement of blood-related signals, the finger holder comprising:
a measurement unit for attaching to the patient""s extreme organ, the measurement unit comprising an illumination-detection assembly for illuminating a first region within said organ, detecting light response of the illuminated region and generating data representative thereof, wherein the measurement unit comprises a substantially flexible heating element engaging at least a part of said first region for heating it to a desired temperature;
an occlusion assembly for applying substantially over-systolic pressure to a second region on the patient""s body located upstream of said first region with respect to a normal blood flow direction; and
a control unit, which is coupled to the measurement unit for selectively actuating the measurements, analyzing data indicative of the detected light response and determining at least one desired parameter of the patient""s blood, and is coupled to the occlusion assembly for selective operating this assembly

Optical device for non-invasive measurement of blood-related signals and a finger holder therefor


Providing an abrasive belt with a pattern of holes through the abrasive-containing layer greatly increases the flexibility of the belt and reducing the need for flexing to generate a pattern of potentially destructive cracks in the abrasive surface.

An abrasive belt typically comprises a backing material which may be pretreated to close up any porosity in the structure with a polymerizable resin having a filler dispersed therein; a resin-based maker coat upon which are deposited abrasive grains before the resin is cured; and a resin-based size coat that helps anchor the abrasive grain to the substrate. Optionally a resin-based supersize coat may overlay the size coat. Thus a typical abrasive belt may have from 2 to about 4 resinous layers deposited thereon and cured in place. Since particularly the maker and size coats need to hold the abrasive grains very tightly if they are to do an effective job during grinding, the resins used in these coats at least tend to be very hard and inflexible. The most typical resin used for all the coats is a phenolic resin since this has high temperature resistance, is cheap and has all the necessary hardness properties.
A consequence of these multiple layers of hard inflexible resin is that the belts themselves become very stiff and inflexible and since belts must necessarily pass around pulleys when in action, this raises a problem. Traditionally to alleviate this problem the belt is flexed around a mandrel to induce a plurality of cracks in the cured resin binders which allow the belts to pass around pulleys. This is an effective route but it does cause the initiation of uncontrolled cracks in the surface that can propagate with disastrous results.
An alternative solution is to use resin binders with a degree of flexibility but this is always a matter of compromise since such resins do not hold the grits as tightly while under the pressures encountered during grinding.
A further alternative is to provide that the abrasive bearing portions of the backing are separated by portions of backing with little or no binder or abrasive. This approach has been attempted several times, for example in U.S. Pat. Nos. 2,001,191; 2,907,196; 5,014,468; 5,304,223; Japanese 2-83872 and Japanese 4-159084.
The purpose of this invention is to propose a further solution to this problem with the added advantages that it requires minimum disruption to existing processes and can be simply added to conventional production. It requires no flexing or cracking of the abrasive layers such that no crack pattern is developed. It is also adaptable to use with binders made from the conventional thermosetting resins that have proved the workhorse of the coated abrasives production for many years.
The present invention provides a coated abrasive belt in which a pattern of holes is created in at least the abrasive-bearing portions of the belt in locations and in numbers sufficient to provide improved flexibility to the belt.
The term xe2x80x9cholexe2x80x9d is used to convey the concept of a portion of the surface from which the abrasive bearing component is removed and which is surrounded by unmodified surface.
Since the source of the stiffness of an abrasive belt is primarily the abrasive containing layers, (including the maker, size and optional supersize coats), it is only necessary that the holes penetrate though this abrasive containing layer. In practice however it is simpler and therefore often preferred that the holes penetrate the fall thickness of the belt. This in itself confers a secondary benefit in that the belt can ran cooler because of the access of air to the grinding surface through the holes.
However while the hole often passes through the full thickness of the belt, it can also pass through just the portion of the belt represented by material deposited on the belt backing. The shape of the hole in vertical cross-section is frequently a right cylinder. Often however a stepped hole with the narrowest diameter passing through or at least adjacent the backing give a suitable combination of flexibility and retained structural strength in the backing material.
The holes in horizontal cross-section are most conveniently round but nothing in the nature of the invention dictates a round shape, and therefore square, oval or polygonal shapes can be used. Most frequently the holes are identical in size and shape though this is not essential. The pattern of the holes is conveniently in lines across the width of the belt with adjacent lines staggered such that, in the longitudinal direction, a line through the center of a hole in one line of holes will intersect a hole in, for example every second or every third, line of holes across the width of the belt. This ensures that, in the direction or travel of the belt, an equal surface area of abrasive is encountered at all points across the width of the belt except for a-region at the edges where holes may be omitted to preserve the integrity and strength of the belt in that region.
The size of the holes used represents a balance between a number of factors including (on the negative side), the grinding surface sacrificed and the weakening of the integrity of the belt; and (on the positive side), the increased flexibility, the cooler running and the decreased susceptibility of the belt to uncontrolled crack propagation. If the holes are too small they can become blinded by swarf such that the cooling effect is reduced. It is therefore preferred to have larger and fewer holes rather than smaller and more holes. For example a hole""s greatest dimension in the belt width direction in preferred belts can suitably be from 3 to 8% such as from 4 to 6% of the width of the belt. However if flexibility is the primary requirement and cooling is of secondary performance, small holes may be the preferred alternative.
In general it is preferred that, for a line drawn through the centers of the holes in a line of holes and from edge to edge of the belt has a length wherein 50% or less, such as from 25 to 50%, of the length intersects a hole. More preferably this maximum hole intersect length figure is 40% or less, such as about 35%, of the length of the line. This preferably applies to lines drawn across the belt width and therefore perpendicular to the direction of movement of the belt and also to lines drawn diagonally, at an angle less than 90xc2x0 to the width dimension.
In a preferred belt according to the invention the hole spacing is preferably closest in the width dimension of the belt and here the line drawn across the width and through holes with centers located along that line will intersect holes along 40 to 50% of its length, whereas a line at 45xc2x0 to the width line would intersect holes over a maximum of about 35% of its length. Clearly the maximum intersection occurs when the lines passes through the centers of all holes along that line. The minimum hole intersect length would be zero when the line passes between holes or tangentially to all holes.
Belts having such lines of holes are found to be more flexible than unflexed belts with exactly the same backing and amounts of the same abrasive, maker, size and supersize formulations applied to the backing and cured. By this is meant that less energy is needed to bend a straight strip of the product such that the ends of the strip come into but-end contact with one another.
The holes can be generated by any convenient means including the use of hole punches and, where the hole does not need to penetrate the backing, a de-burring tool which can be adapted to remove a layer of the desired thickness. Non-contact means can also be used such as for example a water-jet device, a laser beam and the like. It is also possible to provide that the backing is pre-treated to prevent adhesion of the maker coat to the backing such that the portion of the abrasive-containing layer deposited on such spots can be readily removed. It is also possible to prevent cure of the binder in the areas where removal is required such that removal is facilitated. There is therefore no essential process by which the hole must be created.

Saint-Gobain Abrasives Technology Company


A tube packing extension assembly is provided, wherein a conventional cap fitting with plug fitting is replaced with a tube packing extension enclosure that incorporates an extended, linearly elongated outer tube sheath for circumscribing in a concentric manner any tube end that extends outward from the outer conduit sidewall. This outer tube sheath is formed as attached to a tube fitting connection nut, and provides an extension, of selectable size, that extends outward from the conduit sidewall, yet fully encloses and protects the end of the sensing tube. A tube packing extension cap can thereby be removably affixed to the outer end of the tube packing extension enclosure outward by a sufficient length should any brushing or purging of the tubes be required.

There have been no previously filed related applications, nor any copending applications anywhere in the world.
This invention relates to insertion type fluid flow sensing elements for measuring air or gas flowrates, and more specifically to an improved tube packing extension assembly for use therewith. It is particularly useful in providing flow element tube access ports for use in conjunction with flow measuring devices in air and gas flow applications in large ducts or pipes, and at high temperatures.
The instrumentation and process control industry has recognized the use of the Pitot tube as a reliable device for measuring the volumetric flow of both liquids and gasses for many years. The Pitot tube operates based upon the principal that when a fixed probe is inserted into piping or duct work containing a moving fluid, the total pressure sensed by the probe is the sum of the static pressure exerted by the fluid, whether in motion or at rest, and the dynamic pressure equivalent to the kinetic energy of the fluid in motion. Conventional Pitot tube arrangements provide measurement of both the static and total pressure of the flowing fluid, the difference between which is the dynamic pressure. This differential pressure, i.e. the dynamic pressure, is directly related to and can be used to calculate the linear flow rate within the piping or duct work. The volumetric flow rate of the fluid is determined by multiplying the linear flow rate by the cross-sectional area of the conduit.
The Pitot tube is particularly useful in measuring gas flows in piping or duct work with a large cross-sectional area because they cause negligible pressure loss within the conduit. For use in conjunction with such traversing Pitot tubes, exterior instrument taps, connected to averaging headers, sensing heads, or the like, are provided for connection of each sensing tube to a differential pressure instrument for indicating flow rate and/or transmitting a flow rate signal. Such instrument taps typically penetrate the duct housing and are affixed to the housing utilizing a ferrule encircling the tube and compressed against a fitting by a nut. Similarly, the opposite end of the sensing tube can be affixed at a manifold or opposing duct housing penetration utilizing compression tube fittings. Such manner of generally affixing tubes penetrating a shell or connecting to other fittings is rather well known throughout the chemical process industries, but can result in material stress and fatigue related leakage or failure if various materials, such as differing grades of steel or stainless steel are utilized, causing differing expansion rates result upon heating or cooling. This is due to the fact that the use of conventional ferrules xe2x80x9clockxe2x80x9d onto the tubing, thereby preventing the movement necessarily resulting from thermal differential expansion
However, one particular improvement, disclosed in U.S. Pat. No. 5,736,651, issued in the name of Bowers, incorporated herein by reference in its entirety, provides a particular improvement wherein a high-temperature tubing connection for a shell penetration incorporates a high temperature packing that replaces the conventional ferrule. A ribbon packing or packing ring made of any pliable material resistant to high temperatures can be utilized for this packing. Particularly disclosed is the use of a GRAPHOIL ((trademark)) packing material, as manufactured by U-CAR ((trademark)), or similar and equivalent material as being successful in permanently xe2x80x9csealingxe2x80x9d the tube between the nut and the fitting, thereby assuring a high pressure seal such that the housing retains its integrity and remains leak-free even under conditions of extreme temperature or extreme temperature gradient cycling. Such a high temperature packing remains pliable to seal around the tubes, while still permitting lateral motion of the traverse tubes which is encountered when thermal differential expansion occurs. Such an improvement needs to be utilized at least at one end of the sensing tube in order to prevent the stress damaged mentioned above.
While many solutions to the problems associated with high temperature flow measurement are incorporated into the Bowers"" invention of U.S. Pat. No. 5,736,651, that disclosure does not address or anticipate the specific problems solved by the present invention. As such, the present invention is sufficiently novel and non-obvious so as to distinguish it from the prior art, including the present inventor""s own prior art. As the commercial success of such high temperature tube packings result in a greater number of industrial applications, other opportunities for improvement in Pitot tube connections have become apparent for use generally within the utility and industrial markets that otherwise have been unapparent. The present invention is one such improvement.
As a result of a general need for providing tube clean out ports in such high temperature Pitot tube applications, the present invention provides a tube packing extension assembly for use in such applications.
According to the preferred embodiment of the present invention, a tube packing extension assembly for use in high temperature gas flow sensing elements and the like is provided. A sensing tube penetrating a duct or conduit housing incorporates a high temperature packing that replaces a traditional ferrule. The high temperature packing is formed of a ribbon packing or packing ring made of any pliable material resistant to high temperatures. However, in its preferred embodiment, a GRAPHOIL ((trademark)) packing material, as manufactured by U-CAR ((trademark)), or similar and equivalent material has been found to be successful in permanently xe2x80x9csealingxe2x80x9d the tube between the nut and the fitting, thereby assuring a high pressure seal such that the housing retains its integrity and remains leak-free even under conditions of extreme temperature or extreme temperature gradient cycling. Such a high temperature packing remains pliable to seal around the sensing tubes, while still permitting lateral motion of traverse tubes which is encountered when thermal differential expansion occurs. Traditionally furnished with such a tube termination is a tube access port assembly having an annular cap fitting terminating the end of the tube and housing a plug fitting for plugging the port thereby created. Such access ports are useful for inspection or cleaning of the array tube interiors should debris accumulate in heavy particulate-laden applications.
In the present invention, the cap fitting with plug fitting is replaced with a tube packing extension enclosure that incorporates an extended, linearly elongated outer tube sheath for circumscribing in a concentric manner any tube end that extends outward from the outer conduit sidewall. This outer tube sheath is formed as attached to a tube fitting connection nut, and provides an extension, of selectable size, that extends outward from the conduit sidewall, yet fully encloses and protects the end of the sensing tube. A tube packing extension cap can thereby be removably affixed to the outer end of the tube packing extension enclosure outward by a sufficient length should any brushing or purging of the tubes be required.

Tube packing extension assembly for use in high temperature gas flow sensing elements and the like