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The present invention provides method and apparatus for treating tissue in a region at depth by applying optical radiation thereto of a wavelength able to reach the depth of the region and of a selected relatively low power for a duration sufficient for the radiation to effect the desired treatment while concurrently cooling tissue above the selected region to protect such tissue. Treatment may be enhanced by applying mechanical, acoustic or electrical stimulation to the region.
1. Apparatus for treating at least a selected region at depth of a patient while protecting tissue above the selected region, comprising:
an optical radiation source for delivering optical radiation at a power of between 0.2-50 W/cm2 to the patient's skin, said power varying at least in part as a function of the depth of said selected region, said optical radiation being applied to said selected region for at least approximately 2 seconds; and
a cooling mechanism for cooling tissue above said selected region to a temperature below that of said selected region.
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25. A method for treating at least a selected region at depth of a patient's body while protecting tissue above the selected region, comprising:
(a) selectively delivering optical radiation at a power between approximately 0.2 and 50 W/cm2 to the patient's body above said selected region, said power varying at least in part as a function of the depth of said selected region, said optical radiation being applied to said selected region for at least approximately 2 seconds; and
(b) concurrently cooling patient tissue above said selected region to a temperature below that of the selected region.
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47. Apparatus for treating at least a selected region at depth of a patient while protecting tissue above the selected region, comprising:
an optical radiation source for delivering radiation at a power of between 0.2-50 W/cm2 to the patient's skin for a duration between two seconds and two hours, both said power and said duration increasing with increased depth for said selected region; and
a cooling mechanism for cooling tissue above said selected region to a temperature below that of said selected region.
48. Apparatus for treating at least a selected region at depth of a patient while protecting tissue above the selected region, comprising:
an optical radiation source for delivering radiation of a wavelength between 600 nm and 1850 nm and at a power of between 0.2-50 W/cm2 to the patient's skin, the wavelength and the power both varying as a function of the depth of the selected region; and
a cooling mechanism for cooling tissue above said selected region to a temperature below that of said selected region.
49. Apparatus for treating at least a selected region at depth of a patient while protecting tissue above the selected region, comprising:
an optical radiation source for delivering radiation of a wavelength between about 600 nm and about 18500 nm, at a power of between 0.2-50 W/cm2 to the patient's skin for a duration between two seconds and two hours, the wavelength, duration and power all varying as a function of the depth of the selected region; and
a cooling mechanism for cooling tissue above said selected region to a temperature below that of said selected region.
50. A method for treating at least a selected region at depth of a patient's body while protecting tissue above the selected region, comprising:
(a) selectively delivering radiation at a power between approximately 0.2 and 50 W/cm2 to the patient's body above said selected region for a duration of two seconds to two hours, both said power and said duration varying with the depth of said selected region; and
(b) concurrently cooling patient tissue above said selected region to a temperature below that of the selected region.
51. A method for treating at least a selected region at depth of a patient's body while protecting tissue above the selected region, comprising:
(a) selectively delivering radiation of a wavelength between about 600 nm and about 1850 nm and at a power between approximately 0.2 and 50 W/cm2 to the patient's body above said selected region, both said power and wavelength varying as a function of the depth of said selected region; and
(b) concurrently cooling patient tissue above said selected region to a temperature below that of the selected region.
52. A method for treating at least a selected region at depth of a patient's body while protecting tissue above the selected region, comprising:
(a) selectively delivering radiation to the patient's body above said selected region to heat the region;
(b) concurrently cooling patient tissue above said selected region to a temperature below that of the selected region; and
(c) applying at least one of mechanical, acoustic and electrical stimulation to said region.
53. A method for treating at least a selected region at depth of a patient's body while protecting tissue above the selected region, comprising:
(a) selectively delivering radiation to the patient's body above said selected region to heat the region, said radiation being selected so as not to be scattered or absorbed by tissue above said selected region sufficiently to prevent sufficient radiation from reaching the selected region to effect a desired treatment; and
(b) concurrently cooling patient tissue above said selected region to a temperature below that of the selected region.
54. A method as claimed in
wherein said radiation at least includes at least one wavelength selectively absorbed by fat.
55. A method for hair management comprising:
(a) selectively delivering radiation to the patient's body above a region of subdermal fat containing a bulb for a hair to be removed to heat the region and thus the hair bulb, resulting in damage thereto; and
(b) concurrently cooling patient tissue above said region to a temperature below that of the region.
[0001] This invention claims the benefit of co-pending U.S. Provisional Patent Application Serial No. 60/389,871, filed Jun. 19, 2002, entitled "Method and Apparatus for Subdermal Heating," by G. Altshuler, et al., incorporated herein by reference in its entirety.
[0002] 1. Field of the Invention
[0003] This invention relates to methods and apparatus for the photothermal treatment of tissue and, more particularly, to methods and apparatus for photothermal treatment of at least a selected region of tissue located starting at a depth at about the boundary zone of dermal and subdermal tissue and extending therebelow.
[0004] 2. Description of the Related Art
[0005] The benefits of being able to raise and/or lower the temperature in a selected region of tissue for various therapeutic and cosmetic purposes has been known for some time. For instance, heated pads or plates or various forms of electromagnetic radiation, including microwave radiation, electricity,infrared radiation and ultrasound have previously been used for heating subdermal muscles, ligaments, bones and the like to, for example, increase blood flow, to otherwise promote the healing of various injuries and other damage, and for various therapeutic purposes, such as frostbite or hyperthermia treatment, treatment of poor blood circulation, physical therapy, stimulation of collagen, cellulite treatment, adrenergic stimulation, wound healing, psoriasis treatment, body reshaping, non-invasive wrinkle removal, etc. The heating of tissues has also been utilized as a potential treatment for removing cancers or other undesired growths, infections and the like. Heating may be applied over a small localized area, over a larger area, for example to the hands or feet, or over larger regions of tissue, including the entire body.
[0006] Since most of the techniques described above involve applying energy to tissue at depth through the patient's skin surface, peak temperature generally occurs at or near the patient's skin surface and decrease, sometimes significantly, with depth. Further, while microwaves or ultrasonic and other acoustic radiation have been used in the past for certain heating treatments at depth, as disclosed in, for example, U.S. Pat. No. 5,871,524 to Knowlton, U.S. Pat. No. 5,769,879 to Richards, et al., U.S. Pat. No. 5,507,790 to Weiss, or U.S. Pat. No. 5,143,063 to Feliner, since such radiation, particularly microwaves, are potentially mutagenic and can otherwise result in cell or systemic damage and, particularly for acoustic sources, are relatively expensive, and may not be practical for large-area treatment, these techniques have had limited use for the heating of tissues.
[0007] While optical and near infrared (NIR) radiation ( collectively referred to hereinafter as "optical radiation" is generally both less expensive and, being non-mutagenic, safer than microwaves radiation, the use of optical radiation has heretofore not been considered suitable for most applications involving heating of tissue at depth, the term "tissue at depth" as used herein meaning tissue at the border zone of the dermis and hypodermis, some of which tissue may be in the lower dermis, mostly at a depth deeper than 1 mm, and tissue below this border zone to a depth of up to about 50 mm The reason why this radiation has not been considered suitable is because such radiation is both highly scattered and highly absorbed in surface layers of tissue, precluding significant portions of such radiation from reaching the tissue regions at depth to cause heating thereof. In view of the energy losses due to scattering and absorption, substantial optical ( including NIR) energy must be applied in order for enough such energy to reach a region of tissues at depth to have a desired effect. However, such high energy can cause damage to the surface layers of tissue, making it difficult to achieve desired photothermal treatments in tissue regions at depth. For these reasons, optical radiation has heretofore had at most limited value for therapeutic and cosmetic treatments on tissue at depth.
[0008] Further, while heating of tissue at depth alone is useful for many treatments, there are treatments, for example to relieve pain and stiffness in muscles or joints, where heating in conjunction with massage or other mechanical stimulation, ultrasound or other acoustic stimulation or electrical stimulation of the tissue may also be useful.
[0009] Thus, a need exists for improved method and apparatus for photothermal treatment of tissue regions at depth, and in particular for treatment of subdermal regions of tissue, and for method and apparatus for combining heating with stimulation in such regions for various treatments.
[0010] The present invention generally relates to methods and apparatus for photothermal treatment, both therapeutic and cosmetic, of tissue located at depth in a patient's body, as this tern has previously been defined. Optical radiation utilized in practicing the invention is at a wavelength or wavelength band which is neither highly scattered in the patient's skin nor highly absorbed by water in tissue so that the maximum quantity of such radiation can reach the treatment region at depth. The wavelength utilized typically is between about 600 nm and about 1850 nm, more preferably between about 800 nm and about 1350 nm, and most preferably between about 1050 nm and about 1250 nm. Other potential ranges for certain depths of tissue are set forth in Table 1. The longer the wavelength, the lower the scattering; however, outside of the indicated bands, water absorption is so high that little radiation can reach tissue at depth. While the tissue to be treated may be a chromophore at the wavelength(s) utilized within the above bands, this is not a limitation on the invention, and absorption by water, and to a lesser extent fat or lipid, in the region is generally sufficient to achieve the desired heating. In some applications, absorption at certain wavelengths can be increased by delivering a suitable chromophore to the treatment region. The optical radiation source utilized may be a monochromatic source, such as a laser or light emitting diode (LED), or may be a wide spectrum source such as a halogen lamp or arc lamp. Where a wide spectrum source is used, filtering or shifting of wavelengths outside the above bands may be performed. The source may also be a pulsed source or a continuous wave (CW) source. Natural light sources such the sun can also be used to practice this invention. Where the source is a pulsed source, the source typically remains over a treatment region for the duration of each pulse, or a train of pulses may be applied. Where the source is a (CW) source, it is typically moved over the surface of the patients skin at a selected rate, the rate of movement determining the dwell time over a given treatment region.
[0011] The invention also requires that cooling be applied to the patient's skin surface concurrently with the application of optical radiation thereto. While the radiation reaches the tissue at depth to be treated quickly to begin the heating thereof, cooling propagates as a cold wave protecting tissue above the treatment region and moving the depth of maximum heating further into the skin. Ideally the cooling wave propagates to a depth just above the treatment region, but does not extend to the treatment region at least until sufficient energy has been delivered to the treatment region to effect the desired treatment Cooling may also be applied to the patient's skin prior to the application of radiation thereto to more effectively protect tissue above the treatment region and to more rapidly result in maximum heat being at or near the desired depth. This may also permit higher energy and shorter duration for the radiation source. The head used to apply the radiation may also be used to apply cooling.
[0012] Another feature of the invention is that the radiation is applied at low power for an extended time, the time varying with the depth of treatment and with the treatment being performed. For example, the time may vary from approximately 2 seconds to approximately 2 hours for depths of approximately 1 mm to 50 mm respectively. Depending on depth, the treatment being performed and other factors, the power density may vary from approximately 0.2 to 50 W/cm2, more preferably from approximately 0.5 to 20 W/cm2, and most preferably from 0.5 to 10 W/cm2 or 0.5 to 5 W/cm2.
[0013] Other advantages, novel features, and objects of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings, which are schematic and which are not intended to be drawn to scale. In the figures, each identical, or substantially similar component that is illustrated in various figures is represented by a single numeral or notation. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention.
[0014] Non-limiting embodiments of the present invention will be described by way of example with reference to the accompanying drawings in which:
[0015]FIG. 1 is a schematic diagram of one embodiment of the invention, as applied to a tissue sample;
[0016]FIG. 2 is a schematic diagram of another embodiment of the invention, showing an internal design configuration;
[0017]FIG. 3 is a schematic diagram of another embodiment of the invention, showing another internal design configuration;
[0018]FIG. 4 is a schematic diagram of another embodiment of the invention, showing another internal design configuration;
[0019]FIG. 5 is a schematic diagram of another embodiment of the invention, showing another; internal design configuration
[0020]FIG. 6 is a schematic diagram of another embodiment of the invention, showing another internal design configuration;
[0021]FIG. 7 is a schematic diagram illustrating a plurality of devices of the invention being used in conjunction with each other;
[0022]FIG. 8 is a schematic diagram of another embodiment of the invention, showing yet another internal design configuration;
[0023]FIG. 9 is a schematic diagram of another embodiment of the invention having a different configuration;
[0024]FIG. 10 is a schematic drawing of a model of tissue, used in certain calculations;
[0025]FIG. 11 is a plot of the temperature produced by an embodiment of the invention in a tissue sample versus tissue depth;
[0026]FIG. 12 is a plot of a temperature relaxation profile produced by an embodiment of the invention in a tissue; and
[0027]FIG. 13 is a plot of depth of heating vs. treatment time as determined using Equation 12.
[0028] Applications in which the invention may be useful include the treatment of varios diseases, particularly, cellulite and subcutaneous fat treatment, physical therapy, muscle and skeletal treatments, including relief of pain and stiffness for muscles and joints, and treatment of spinal cord problems, and treatment of cumulative trauma disorders (CTD's) such as carpel tunnel syndrome (CTS), tendonitis and bursitis, fibromyalgia, lymphedema and cancer therapy.
[0029] More specifically with respect to cancer therapy, hyperthermia resulting from utilizing the teachings of this invention may be utilized to treat various skin cancers including, but not limited to, basel cell carcinoma, squamous cell carcinoma, lymphoma and possibly treatment (palliative) of melanoma. Hyperthermia may also enhance the efficacy of radiation, for example x-ray, therapy, chemotherapy, therapy with immunmodulators such as ALDARA or PDT therapy. Such combination therapy may for example reduce required treatment time.
[0030] The tissue to be treated may be a collagen-rich tissue. Collagen-rich tissues that may be treated include superficial cortical bone, synovium joint capsules, tendon sheaths, menisci, myofascial interfaces, periosteum, fibrotic muscle, or major nerve trunks. The device may also be used for reshaping procedures such as non-invasive wrinkle removal through stimulation of collagen production in a subsurface region of tissue. Heating of the subsurface region of tissue to a temperature of between 37.5 and 45� C. may stimulate generation of new collagen and/or elastin. For example, expression of HSP70 ("Heat Shock Protein") may be stimulated when the tissue is heated to between 41 and 42� C. for between 20 and 30 minutes. Other proteins, cytokins and/or growth factors may also be stimulated or released in response to heating. Significant new collagen deposition, formation or rearrangement may be possible, which may improve skin appearance or texture, allowing wrinkles, fine lines, scars, stretch marks or other indicators to be removed. In general, there exists a relation between the temperature reached and the time of application that is necessary to stimulate new collagen deposition and prevent irreversible damage. Additionally, multiple treatments may be used in some treatment modalities.
[0031] Hypothermia resulting from utilizing the teachings of this invention may also be utilized for hair growth management, and for treatment of psoriasis, scars, rosacea and various conditions of toe and finger nails. For hair growth management, which includes temporary and permanent hair removal and control of hair growth, a dermal or subdermal temperature rise of a few degrees, for example to 42-45� C. can produce an anagen effluvium. This could be particularly useful for hair grow management on hairs containing little or no melanin, for example gray, white or blond hairs. The efficacy of such treatment may be enhanced by using wavelengths absorbed by melanin or by performing the treatment in conjunction with other hair removal techniques. Hypothermia may also be used to treat psoriasis, including psoriasis plaques and nail psoriasis. The teachings of this invention may thus be used to treat psoriasis, either alone or conjunction drug treatment, light treatment, for example with an excimer laser, flashlamp, uv or pulse dye laser, or other existing treatment. Scars, having different crosslinking and different denaturation thresholds then normal tissue, may be treated by hypothermia to, for example, reduce turnover, turnover being significantly enhanced for scar tissue. A special handpiece with an aperture adjustable to the shape of the scar may be desirable for treating scars. Hypothermia induced in accordance with the teachings of the invention may also be used to kill demodex mites resident in follicles which cause rosacea. Finally, hypothermia induced by this invention may be used to enhance or control growth rate of toe or finger nails or to otherwise treat conditions of these nails, for example nail fungus and dystrophic nails. The nail (matrix) is relatively accessible to light treatment. The nails can be cooled by emergence in a water bath and exposed to the light. The mechanism for enhanced nail growth may be enhanced metabolism, blood supply (vasodialation by heat and light) or biostimulation.
[0032] The application of thermal energy to tissue may also be used, for example, in physical therapy treatments, such as to enhance or accelerate wound healing or relieve pain. Beneficial effects may include a decrease in joint stiffness, an increase in joint extensibility of collagenous structures such as tendons and scar tissue, pain relief, blood-flow changes, or a decrease in muscle spasm and increase in muscle tone. As another example, large protein molecules may have high absorption coefficients, and the heating of protein-rich collagenous tissues may contribute to healing. A wide variety of conditions may be treated using this invention, for example, but not limited to, strained tendons, tenosynovitis, torn ligaments, tendonitis, bursitis, torn joint capsules, or torn muscles. As yet another example, other processes may be activated or deactivated within the tissue during heating. For example, heating of the tissue may be used to enhance or modify the activity of a pharmaceutical or another bioactive substance or to facilitate the delivery thereof through the skin. Mechanical or electrical stimulation, such as massage, may be used in conjunction with heating to achieve benefits greater then can be achieved by either alone. Pressure may also be applied to the skin surface above the treatment region to facilitate the treatment.
[0033] In another example, when tissue is heated to greater then the damage temperature of the tissue, irreversible changes to the tissue may occur, up to and including cell death, apoptosis or the like. The damage temperature is the temperature by which cells, collagen, or other tissue components may be irreversibly damaged. The damage temperature may be useful in certain therapeutic situations, for example, to damage unwanted cells or other structures, such as collagen, malignant or benign tumors, hair bulb, deep pigmented lesions or fat. Further, by heating tissue to a temperature above the body temperature (typically 37� C.), but below the damage temperature, it may be possible to change the dynamics of various biological processes, such as metabolism.
[0034] Where the tissue is a tumor, it may be desired to use heat in accordance with the teachings of this invention to kill the tumor, or at least a portion thereof, such as a necrotic center. Where the tissue is an artificially created tissue, such as a tissue-engineered scaffold, preferential heating of the center of the artificial tissue may be used, for example, to stimulate cell division within the tissue, to promote cell division or cell growth within the artificial tissue structure.
[0035] In certain embodiments, the present invention may be used for non-invasive or non-destructive reduction of localized fat deposits. For example, the invention may be used to heat fat or adipose cells past their damage temperature, causing cell damage and/or necrosis. Alternatively, the treated cells may undergo apoptosis, resulting in cell death. The dead cells may then be removed or resorbed into the body, for example, by the body's phagocytic or lymphatic systems. Fat reduction may also be achieved by heating fat or adipose cells to an elevated temperature, but below the damage temperature. For example, the fat cells may be heated to a temperature of between about 41� C. and about 45� C. Under these conditions, applying heat to subcutaneous fat may activate lipases or metabolize lipids contained within the adipose tissue found within the subcutaneous fat layer, or blood flow may increase to the heated area. Additionally, "lipolysis," or the process of breaking down fat in the body, may be regulated by enzymes sensitive to temperature, such as HSL ("hormone-sensitive lipase"). Thus, elevating the temperature of the adipose cells may increase the lipolysis rate, and thus contribute to a reduction in subdermal fat in the area being treated. This temperature can be below the temperature for vascular/lymph damage so damaged fatty cells and fatty acids can be easily removed from the treatment region. Additionally, application of the present invention may be used in combination with other fat-reduction techniques, such as medication, exercise, or adrenergic stimulation Heating of subcutaneous fat may also result in increased dermal thickness. Thus, fatty tissue may be replaced by fibrous and dermal tissue, this resulting in improved skin appearance. Thermal activation of lymph systems in subcutaneous fat can also be used to treat cellulite by removing proteins from extra cell spaces.
[0036] Stated another way, fat and/or cellulite reduction may be achieved utilizing the teachings of this invention by providing an elevated (but below damage threshold ˜43-48� C.) temperature in the targeted region at depth. The mild hyperthermia initiates biological response through one or several of the following pathways:
[0037] 1. Increase of activity of enzymes regulating the process of lipolysis, in particular, hormone sensitive lipase (HSL). As a result, decrease of fat stores in hypodermis.
[0038] 2. Stimulation of blood and lymph flow in the targeted area with multiple positive consequences, including (but not limited to) further decrease in the fat stores and accelerated regeneration of connective tissue.
[0039] 3. Induction of apoptosis in adipocytes, with subsequent removal of residual cell material by the body's scavenging system.
[0040] 4. Decrease of lipid's viscosity, resulting in increasing mobility of fat globules and permeability of adipocytes' membranes.
[0041] 5. Stimulation and or reorganization of the connective tissue surrounding subdermal fat depots with or without concurrent changes of the dermal collagen.
[0042] The net result is a shift of balance between fat and connective tissue in hypodermis toward the latter and improved appearance of skin.
[0043]FIG. 1 shows an apparatus 100 for one embodiment of the invention. For this apparatus, optical energy 30 from a suitable energy source 1 passes through optical (for example, focusing) device 2, filter 3, cooling mechanism 4 and contact plate 8, before reaching tissue 31. A suitable optical impedance matching lotion or other suitable substance would typically be applied between plate 8 and tissue 31 to provide enhanced optical and thermal contact. Tissue 31, as shown in FIG. 1, is divided into an upper region 5, which, for applications where radiation is applied to the skin surface, would be the epidermis and dermis, and a lower region 6 which would be a subdermal region in the previous example. Energy 30, possibly in conjunction with one or a combination of focusing from optical device 2, and wavelength selection from filter 3, and with cooling from mechanism 4, results in maximum heating occurring at a selected depth in tissue 31, which depth is, as previously indicated, at or near the junction of regions 5 and 6 or in lower region 6 for this invention. In some embodiments of the invention, certain of these components, such as, for example, filter 3 where a monochromatic source is utilized or optics 2, may not necessarily be present.
[0044] In some embodiments of the invention, energy source 1, optical device 2 and/or filter 3 may also require a cooling mechanism. This cooling mechanism may or may not be the same as or connected to cooling mechanism 4 that cools tissue 31 through contact plate 8, as indicated by arrows 32 in FIG. 1. For example, in the embodiment shown in FIG. 1, cooling mechanism 7, shown separately from cooling mechanism 4, is used to cool filter 3. Energy source 1 may be any suitable optical energy source able to produce optical energy 30 at a wavelength that produces heating within tissue 31 at the depth of a desired treatment region. The exact energy source, and the exact energy chosen, may be a function of the tissue 31 to be heated, the depth within the tissue at which treatment is desired and of the absorption of that energy in the desired area to be treated. For example, energy source 1 may be a radiant lamp, a halogen lamp, an incandescent lamp, a arc lamp, a fluorescent lamp, a light emitting diode, a laser (including diode and fiber lasers), the sun or other suitable optical energy source.
[0045] Energy source 1 may produce electromagnetic radiation, such as near infrared or visible light radiation over a broad spectrum, over a limited spectrum or at a single wavelength, such as would be produced by a light emitting diode or a laser. In certain cases, a narrow spectral source may be preferable, as the wavelength(s) produced by the energy source may be targeted towards a specific tissue type or may be adapted for reaching a selected depth. In other embodiments, a wide spectral source may be preferable, for example, in systems where the wavelength(s) to be applied to the tissue may change, for example, by applying different filters, depending on the application.
[0046] As previously indicated, in order to minimize both scattering and absorption of the applied optical radiation, the optical radiation produced by energy source 1 should be radiation with a wavelength which is minimally scattered and absorbed, the available wavelengths decreasing with increasing depth as generally indicated in Table 1.
[0047] Certain wavelengths may be preferentially absorbed by the tissue to be treated. As one example, if the tissue to be treated includes subcutaneous fat, certain wavelengths may be absorbed more effectively by the fat or adipose cells than by the surrounding tissues. For example, optical radiation having wavelengths around 925 nm, 1206 nm, 1730 nm and 2300 nm may be desirable (see for example copending application Ser. No. 09/277307, which is incorporated herein by reference, for suitable ranges); however, only the lower three of these ranges would typically provide sufficient penetration for use in practicing this invention. Using electromagnetic radiation of these wavelengths, the coefficient of absorption by this radiation in the lipids, and in particular the triglycerides located within the adipose tissue may be greater than that of the absorption coefficient of these wavelengths in water. Thus, these wavelengths when applied to a tissue sample, will preferentially be absorbed by the fat tissue, thus resulting in the preferential heating of this tissue. The selective heating of the fatty tissue can be enhanced by the lower heat capacity of fatty tissue vs. aqueous tissue. Also, the decreased blood perfusion of the subcutaneous fat vs. the dermis can be used to enhance selective heating of the fatty tissue. Compression sufficient to reduce blood flow within the target area can minimize unwanted heat convection, and therefore heat leakage, from the target area. The compression to the subdermal target area can be made selective by forming a skin fold and applying skin pressure sidewise. This results in compression of the subcutaneous fat and of skin outside the field of optical exposure. The skin on top of the skin fold, which skin is exposed to the optical radiation, is not compressed, and therefore the blood flow therein is not appreciably reduced so long as the length of the skin fold does not exceed a critical length. Blood flow within the part of the dermis exposed to optical radiation can help to remove unwanted excessive heat in this skin component.
[0048] Where optical device 2 is a focusing device, it may be any suitable device able to focus at least a portion of energy 30 arriving from energy source 1 at tissue 31, and in particular at a selected depth in tissue 31. For example, device 2 may include mirrors, prisms, reflectors, lenses such as Fresnel lenses, collimating lenses or focusing lenses, diffraction gratings, or other optical device.
[0049] Filter 3 may be any suitable filter able to select, or at least partially select, certain wavelengths or wavelength bands from energy source 1. In certain types of filters, a specific set of wavelengths may be blocked by the filter. It is also possible that undesired wavelengths in the energy from source 1 may be wavelength shifted in ways known in the art so as to enhance the energy available in the desired wavelength bands indicated above and in Table 1. Thus, filter 3 may include elements designed to absorb, reflect or alter certain wavelengths of electromagnetic radiation. For example, filter 3 may be used to remove certain types of wavelengths that are absorbed by surrounding tissues. For instance, dermis and epidermis tissues are primarily composed of water, as is much of the rest of the human body. By using a filter that selectively removes wavelengths that excite water molecules, the absorption of these wavelengths by the body may be greatly reduced, which may contribute to a reduction in the amount of heat generated by light absorption in these molecules. Thus, by passing radiation through a water-based filter, those frequencies of radiation which may excite water molecules will be absorbed in the water filter, and will not be transmitted into tissue 31. Thus, a water-based filter may be used to decrease the amount of radiation absorbed in tissue above the treatment region and converted into heat.
[0050] In other embodiments, filter 3 may be combined with other elements of the device, for example, cooling system 4 or cooling mechanism 7. Thus, water may both attenuate energy 30 arising from energy source 1, as well as cool the contact plate, and tissue in contact with the contact plate, or various other components of the device. More than one filter or filter type may also be present.
[0051]FIG. 1 shows a cooling mechanism 4 adjacent to the surface of tissue 31. Cooling mechanism 4 may be any suitable cooling mechanism able to reduce the temperature of tissue 31. Heat energy 32 may be drawn from tissue 31 across contact plate 8 into cooling mechanism 4. For example, cooling system 4 may be air or other suitable gas that is blown over contact plate 8, cooling water, or a cooling oil or other fluid. Mixtures of these substances, such as an oil and water mixture, may also be envisioned. Cooling mechanism 4 may have any suitable configuration, for example, a flat plate, a series of conducting pipes, a sheathing blanket, or a series of channels for the passage of air, or other gases, or liquid across plate 8. For example, in one embodiment, cooling system 4 may be a water-cooled contact plate. In another embodiment, cooling mechanism 4 may be a series of channels carrying a coolant fluid or a refrigerant fluid (for example, a cryogen), which channels are in contact with tissue 31 or with plate 8. In yet another embodiment, cooling system 4 may comprise a water or refrigerant fluid (for example R134A) spray, a cool air spray or air flow across the surface of tissue 31. In other embodiments, cooling may be accomplished through chemical reactions (for example, endothermic reactions), or through electronic cooling, such as Peltier cooling. In yet other embodiments, cooling mechanism 4 may have more than one type of coolant, or cooling mechanism 4 and/or contact plate 8 may be absent, for example, in embodiments where the tissue is cooled passively or directly, for example, through a cryogenic or other suitable spray. Sensors or other monitoring devices may also be embedded in cooling mechanism 4, for example, to monitor the temperature, or determine the degree of cooling required by tissue 31, and be manually or electronically controlled.
[0052] In certain cases, cooling mechanism 4 may be used to maintain the surface temperature of tissue 31 at its normal temperature, which may be, for example, 37 or 32� C., depending on the type of tissue being heated. In other embodiments, cooling mechanism 4 may be used to decrease the temperature of the surface of tissue 31 to a temperature below the normal temperature of that type of tissue. For example, cooling mechanism 4 may be able to decrease the surface temperature of tissue 31 to, for example, a range between 25� C. and −5� C.
[0053] In some embodiments of the invention, such as shown in FIG. 1, energy 30 from energy source 1 may pass through cooling mechanism 4. In these types of configurations, cooling mechanism 4 may be constructed out of materials able to transmit at least a portion of energy 30, for example, air, water or other gases or fluids, glass, or a clear plastic. In other embodiments, cooling mechanism 4 may be formed out of a series of discrete channels, and energy 30 may pass between these channels. In other embodiments of the invention, energy 30 may not be directed through cooling mechanism 4. For example, in the embodiment shown in FIG. 8, energy source 19 and cooling system 18 may be positioned on opposite sides of chamber 17.
[0054] Contact plate 8 may be made out of a suitable heat transfer material, and also, where the plate contacts tissue 31, of a material having a good optical match with the tissue. Sapphire is an example of a suitable material for plate 8. In some embodiments, contact plate 8 may have a high degree of thermal conductivity, for example, to allow cooling of the surface of the tissue by cooling mechanism 4. In other embodiments, contact plate 8 may be an integral part of cooling mechanism 4, or be absent. Contact plate 8 may be made out of a deformable or viscoelastic material in some embodiments of the invention, for example, a gel such as a hydrogel. In other embodiments, contact plate 8 may be made of a solid material, such as a glass, a crystal such as sapphire, or a plastic. In some embodiments of the invention, such as shown in FIG. 1, energy 30 from energy source 1 may pass through contact plate 8. In these configurations, contact plate 8 may be constructed out of materials able to transmit at least a portion of energy 30, for example glass, sapphire, or a clear plastic, or contact plate 8 may be constructed in such a way as to allow at least a portion of energy 30 to pass through contact plate 8, for example, via a series of holes within contact plate 8.
[0055] In certain embodiments of the invention, various components of system 100 may require cooling. For example, in the embodiment shown in FIG. 1, optical device 2 and filter 3 may be cooled by cooling mechanism 7. The design of cooling mechanism 7 may be a function of the components used in the construction of the apparatus. Cooling mechanism 7 and cooling mechanism 4, in FIG. 1, are illustrated as separate systems. However, in other embodiments, cooling mechanism 7 and cooling mechanism 4 may be part of the same system, or one or both may be absent. Cooling mechanism 7 may be any suitable cooling mechanism known in the art, such as air, water, or an oil. Mixtures of these substances, such as an oil and water mixture, may also be envisioned. Cooling of the components may be accomplished through convective or conductive cooling.
[0056] One or more of energy source 1, optical device 2, filter 3, cooling mechanism 4, or cooling mechanism 7 may be electronically controlled. For example, sensors embedded in cooling mechanism 4 or contact plate 8 may determine the amount of energy reaching tissue 31, and may direct energy source 1 to produce more or less energy or may direct cooling mechanism 4 to increase or decrease cooling, depending on the application. Other sensors and the like may be embedded in any of the components illustrated herein. The controls may be, for example, electronically preprogrammed, or manually operable.
[0057] The present invention is not limited to treating a specific region or area of tissue. For example, as illustrated in FIGS. 8 and 9, the invention may be constructed in such a way as to treat an entire person. For example, in FIG. 8, chamber 17 contains cooling mechanism 18 and energy source 19. Cooling mechanism 18 may be cooled in the same ways described above for cooling mechanisms 4 and 7. Energy source 19 may contain, for example, a series of lamps or other energy sources, optionally surrounded by filters 40. In this embodiment, filters 40 are built into the side of chamber 17. FIG. 9 shows another design, where chamber 17 has a cooling mechanism 18, but does not contain an energy source. Instead, energy 42 from the sun 41 or another energy source, such as an external lamp, is directed to chamber 17, for example, directly, by means of reflectors 20, or by means of a lens such as Fresnel lens 19. The patient may be cooled within the chamber by air flow or other suitable cooling mechanism 18.
[0058] In FIG. 2, another embodiment of the invention is shown. In this embodiment, a lamp 9, for example an incandescent lamp, is used as the energy source. Lamp 9 is surrounded by a specially coated reflector 10 to maximize light delivery efficiency to the treatment region of tissue 31. A fluid 13 may pass between contact plate 8 and filter 3. Contact plate 8, cooled by fluid 13, may cool the surface of the tissue to which it is applied. In FIG. 3, lamp 9 has been replaced by a monochromatic light emitting element 11 and lens 12, element 11 being, for example a laser diode, other suitable laser or a light emitting diode. As in the embodiment shown in FIG. 2, contact plate 8 and filter 3 are cooled by fluid 13 flowing therebetween; these two components may also be cooled by flow of cold liquid gas, for example R134A, from a pressurized can. Thus, this embodiment illustrates how a monocromatic element 11 may be used as the energy source.
[0059] A different type of cooling mechanism is illustrated in FIG. 4. In FIG. 4, energy arising from energy source 1 is reflected using reflector 10 through filter 3, a transparent isolating material 16, and contact plate 8. Two fluids are used to cool the filter and the contact plate. Upper fluid 14 flows between filter 3 and isolating material 16, while lower fluid 15 passes between isolating material 16 and contact plate 8. Fluids 14 and 15, in this embodiment, may not be the same fluid; however, in other embodiments, the two fluids may be the same fluid, or have a common reservoir. Contact plate 8, in this embodiment, may be made out of, for example, a transparent or a semi-transparent material, such as a glass, plastic or sapphire. Alternatively, contact plate 8 may be formed out of an opaque material, but have openings to allow energy to pass through contact plate 8. A similar embodiment of the invention is shown in FIG. 5, where the energy source 1 has been replaced by an element that produces discrete wavelengths, such as a light emitting diode or a laser diode 11. Optional lens 12 has also been added to the system as illustrated in FIG. 5.
[0060] In certain embodiments of the invention, contact plate 8 may be absent. For example, in the embodiment shown in FIG. 6, no contact plate is used, and fluid 13 (for example a liquid, gas such as air or a spray) passes or flows directly over the surface of tissue 31. Legs 42 connected to the device may be constructed in such a manner as to correctly position filter 3 over the surface of the tissue. Legs 42 may be any component able to maintain a proper distance between the surface of tissue 31 and device 100. In some embodiments of the invention, legs 42 may be constructed out of a flexible or a semi-solid substance that, for example, may conform to the surface of tissue 31, such as a gel. In other embodiments of the invention, legs 42 may be constructed out of a solid substance, such as rubber or plastic. Legs 42 may have any arrangement underneath the device that allows for the proper positioning of the device relative to the tissue. For example, legs 42 may be arranged in a triangular or a square pattern. In other embodiments of the invention, legs 42 may be a ring or a series of bars that surrounds the area being treated or legs 42 may be absent.
[0061] More than one device 100 of this invention may be used simultaneously. For example, in FIG. 7, a series of devices 100 have been arranged into a semicircular pattern. These devices may be linked together to treat large areas of a subject's body. Additionally, the devices may be interconnected in such a way as to provide flexibility, so that, for example, the apparatus may conform to the contours of the body. For example, the device may be worn as a belt, a leg wrap, an arm wrap, or wrapped around the torso. Devices 100 may also be mounted to a chair, bed or other suitable surface for the treatment of a patient's back, thighs and/or buttocks. Alternatively, devices 100 may be used to create an array of small island areas within a larger area (see for example copending application Ser. No. 10/033,302 which is incorporated herein by reference). This may, for example, be a safer alternative to large area heating, particularly for extended treatment regimens. By optimizing the spacing between treated areas, for example, through the addition of "masks" in filter 3 between energy source 1 and tissue 31 that block portions of the energy arising from energy source 1, and/or through the use of multiple separate devices 100 as is shown in FIG. 7, treatment of the subdermal tissue may be maximized, while causing a minimal amount of patient discomfort, and/or allowing faster recovery time.
[0062] Where optical source 1 is a continuous wave (CW) or other long duration source, device 100 for various of the embodiments may be slid or scanned over the surface of the patient's skin to overlie successive treatment regions, the dwell time, and thus the treatment duration, for each such region being a function of the rate at which the device is movedThe device may also include a cooling mechanism ahead of the portion of the device under source 1 to precool skin above the treatment region (see for example issued U.S. Pat. Nos. 6,273,884 and 6,511,475, which are incorporated herein by reference).
[0063] Any of the embodiments can include a contact sensor to assure good optical and thermal coupling, and systems operating in the sliding mode may also include one or more motion sensors to control radiation delivery, cooling and other functions dependent on scanning speed, to enhance system safety and for other reasons.
[0064] In addition to coupling the deep heating treatment of this invention with deep cooling to enhance treatment of fat, bone, muscle, etc., device 100 may also include a massager, vibrator or other mechanical stimulation device or a DC or other suitable electrical stimulation source. It has been found that such mechanical or electrical stimulation is more effective for hot tissue. Similarly, the effect of deep heating may be enhanced by massage or other stimulation because both heat and cold generally penetrates better in compressed skin and subdermal tissue. Thus, the combination of deep heating and mechanical or electrical stimulation may provide significantly better results then either one alone. Heating may also be enhanced by supplementing the optical heating with, for example electro-stimulation by AC/DC, or additional heating by RF, etc. Tensioning or pressure applied to the skin overlying the treatment region may also enhance treatment effect.
[0065] The teachings of this invention may also be utilized for hair removal treatments by targeting the hair bulb, which is generally located in the subcutaneous layer 6. The treatment would be done at low power sufficient to raise the temperature of the fat surrounding the hair bulb, and thus the hair bulb, to roughly 45� C. and should be performed for a relatively long time period, for example, 15 minutes. The hair bulb also contains high proliferation water cells which react strongly with the applied radiation to increase bulb temperature, leading to the destruction thereof.
[0066] The function and advantages of these and other embodiments of the present invention will be more fully understood from the following examples. These examples are intended to be only illustrative in nature and are not intended to limit the scope of the invention.
[0067] This example illustrates theoretical calculations corresponding to one embodiment of the invention as applied to human skin.
[0068] Initially, a model of the skin was prepared. This model included two layers of tissue possessing distinct optical and thermal properties: dermis and subcutaneous fat (FIG. 10). The presence of fine structures such as the basal layer and the vessel plexus was neglected. Monochromatic light was assumed to be incident normal to the surface. The input power density was designated as F0. Both the surface temperature (Ts) at depth z=0 and the bottom temperature (Th) at depth z=h were kept fixed at prescribed levels. Specifically, Th was set at 37� C. due to the temperature stabilization effect of blood and metabolic heat generation on muscle tissue. The objective of this example was to evaluate the steady-state temperature distribution within the skin and to find the characteristic depth zmax where the steady-state temperature reaches a maximum.
[0069] Starting with the problem of light transport within the tissue, scattering in both tissue layers predominated strongly over absorption, allowing the diffuse approximation to be applied. This approach was particularly valid within the wavelength range of 600 min to 1400 nm, which may also be referred to as the "therapeutic window". The one-dimensional light transport problem in the diffusion approximation for the two-layered tissue model of FIG. 10 can be solved assuming both the tissue irradiance and the light flux to be the continuous functions of coordinate z at the dermis and fat interface. The resulting expression for the tissue irradiance, ψ, obtained may be written in the following general form:
ψ1(z)=F 0�τcol �[V 1�exp(−κ1 �z)+V 2�exp(κ1 �z)−V3�exp(−μt 1 �z)], z≦hd d,
ψ2(z)=F 0�τcol [V 4�exp(−κ2�(z−h d))−V 5�exp(−μt 2�(z−h d))], z>h d (1)
[0070] where indices 1 and 2 stand for dermis and subcutaneous fat, respectively. κ={square root}{square root over (3�μa�μtr)} and μt=μa+μs, are the diffusion and extinction coefficients for light in the corresponding layers, and
[0071] is the attenuation coefficient of the collimated light at the surface.
[0072] Flux amplitudes V1 to V5 were determined by the boundary and interface conditions. In particular, if the coefficients of refraction of both layers are the same, the interface condition at z=hd is such that both the radiance and the total light flux should be continuous functions of depth. 20 Turning to the problem of heat conduction within the two-layered tissue model, the time dependent equation of heat conduction in the k-th layer was:
[0073] yielding the following steady-state equation:
[0074] where αk was the thermal diffusivity of the k-th layer (k=1,2). The heat source term Qk in these equations describes the generation of heat due to light absorption in the tissue. In the steady-state case, the source term is:
[0075] where μak, ρk and ck are the coefficient of absorption, density, and specific heat of the k-th layer, respectively.
[0076] Boundary conditions were assumed to be T(0)=Ts, T(h)=Th. The solution of Equation (3) was then found to be:
[0077] where parameters A and B have to be found from the interface conditions. For the case of perfect thermal contact:
[0078] where and k1 and k2 are the thermal conductivities of dermis and fat, respectively.
[0079] The analytic expression for the temperature, T(z), was then obtained by substituting Equation (3) into Equations (4) and (5).
[0080] A simpler expression for the temperature distribution was obtained for a homogenous medium with no layered structure. In this case, the radiance distribution took the following general form:
ψ(z)=F 0τcol[exp(−μ,z)+φd(z)], (7)
[0081] where the first term was the collimated radiance and the second one was the diffuse radiance given by:
φd(z)=V2�exp(−κ�z)−V 1�exp(−μ,z) (8)
[0082] The temperature distribution was:
[0083] Differentiating Equation (9) with respect to z yields the following implicit expression for the depth zmax, the localized tissue depth at which maximum temperature occurs:
[0084] Tmax=Th−Ts is maximum temperature rise in the tissue at the depth zmax.
[0085] Equation (10) was solved numerically. To get an approximate analytic expression, the inequality μ1>>κ was used, which is typically valid within the therapeutic window. Then, dropping the exponential terms with μt, and solving the simplified equation with respect to zmax yielded the following
[0086] Maximum temperature can be calculated from (9) as Tmax=T(zmax)
[0087] It can be seen from these results that an increase in F0 caused the temperature maximum to move upwards, provided the input flux is sufficiently small. At larger value of F0, the maximum ceased to move while proceeding to grow in amplitude. The treatment time should be long enough to remove heat from the layer 0<z<zmax. This time tmin was given by the formula:
[0088] where z1 is the depth into dermis and z2 is depth into subcutaneous fat, and z1+z2=z is depth of treatment. The numerator constant (6�60) varies within the given range depending on how close the desired temperature is to Tmax, being 6 for Tzmax=90% Tmax and 60 for Tzmax=99% Tmax. The treatment time must be longer than tmin. FIG. 11 shows a typical temperature distribution in the body. FIG. 13 and Table 2 show minimum treatment time as a function of depth of treatment z.
[0089] Equations (10), (11), and (12) describe a set of heating and cooling parameters that allow control of both the value and location of the internal temperature maximum. FIG. 11 shows a graph generated using these equations that shows that a broad spectral source, having a proper set of filters, combined with surface cooling, allows the temperature within the adipose layer of tissue to be elevated to a maximum, while maintaining acceptable temperatures surrounding tissue and in particular, in tissue above the treatment region through which the radiation passes.
[0090] Thus, this example illustrates theoretical calculations corresponding to one embodiment of the invention.
[0091] The following prophetic example illustrates treatment parameters for different body layers that may be used in one embodiment of the invention, as applied to human skin.
[0092] Based on the calculation illustrated in Example 1, treatment parameters for different layers of the body that may be used in one embodiment of the invention can be determined. These calculations are summarized in Table 1. The body layers model includes the reticular dermis, dermis subcutaneous fat junction, and subcutaneous fat layer.
[0093] Using a broad-spectrum lamp in this embodiment of the invention, the treatment parameters include a surface cooling mechanism able to maintain a surface cooling temperature of between 0� C. and 32� C.; a broad-spectrum lamp, where the color temperature of the lamp is between 300 K and 3000 K, with filtering of more than 50% of the light having wavelengths of less than 800 nm and greater that 1800 nm, preferably 900 to 1400 nm, and most preferably 1100 to 1250 nm. Depending on depth, the treatment being performed and other factors, the power may vary from approximately 0.2 to 50 W/cm2, and more preferably from approximately 0.5 to 20 W/cm2, with a treatment time of between 2 sec for a 1 mm depth and 7300 sec for a 50 mm depth When operating in sliding mode, treatment power and duration increase.
[0094] Thus, this prophetic example illustrates exemplary treatment parameters that may be used to heat different layers of the body, in one embodiment of the invention.
[0096] In this example, a device 100 of this invention substantially as shown in FIG. 2 was used to heat subcutaneous fat in the stomach region of a volunteer. Light from a halogen lamp 9 was filtered with a combination of a short cut or high pass filter 8 with an 800 nm cut-off and a 3 mm thick water layer 41. The temperature of water 41 was 12� C., while the temperature of a sapphire plate 8 and of the skin interface was 18� C. Power density was 4 W/cm2 and the treatment time was 300 sec. After heating the subcutaneous fat layer for 300 sec., the device was removed, and two thermocouples were immediately implanted 1 mm and 8 mm below the skin surface under the heated region to determine the final, steady-state temperatures and to monitor the temperature relaxation profiles in the dermis and fat layer respectively. Temperature data recorded by the two thermocouples are shown in FIG. 12. The initial temperatures of the subcutaneous fat layer at a depth of 8 mm was found to be approximately 45� C., while the temperature of the dermis, 1 mm below the surface of the skin, was found to be about 40� C. and the temperature at the epidermis was 24� C. Over the course of the next several minutes, the temperatures of the dermis and the subcutaneous fat layer decreased towards basal levels of 37� C. for the subcutaneous fat layer and approximately 32� C. for the dermis.
[0097] The same device 100 was used to perform the same test on a 25 mm bulk of pig skin and subcutaneous fat which was placed on a thermally stable plate with a temperature of 37� C. The power density for this test was 10 W/cm2 and cooling water having a temperature of 4� C. was used. After a treatment time of 300 sec., peak temperature of 53� C. was found at a depth 14 mm into the fat. The temperature at the epidermis at this time was 38� C. After about 6 weeks, this exposure setting induced reduction of subcutaneous fat without evidence for epidermal damage. A partial replacement of fatty tissue by connective collagen tissue was observed. A reduction of hair growth was also observed several weeks after this and similar exposure settings, even if a lower temperature rise was obtained and only a single treatment was performed. This clearly emphasized the possibility of using this method to manage unwanted hair growth. Highly proliferating cells like sebocytes within the sebaceous glands or hair matrix cells within the hair follicle are particularly sensitive to heating which can be used to achieve selective effects on these structures even by unselective heating of the depth were these structures are located. Hair matrix cells are also surrounded by fatty cells and the sebaceous glands are generating lipids. The decreased heat capacity for lipids provides additional selective effects. This can also be specifically useful for the treatment of non pigmented hairs that are usually not affected by standard light assisted methods for photoepilation based on selective photothermolysis. Hair growth management may include permanent or temporary hair removal or merely controlling/slowing hair growth rate.
[0098] These examples thus illustrates how a device of the invention may be used to heat a subdermal layer of tissue to a temperature significantly higher than normal body temperature and the temperature of surrounding tissue, including tissue between the skin surface and the treatment region.
[0099] While several embodiments of the invention have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and structures for performing the functions and/or obtaining the results and/or advantages described herein, and each of such variations or modifications is deemed to be within the scope of the present invention. More generally, those skilled in the art would readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that actual parameters, dimensions, materials, and configurations will depend upon specific applications for which the teachings of the present invention are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described. The present invention is directed to each individual feature, system, material and/or method described herein. In addition, any combination of two or more such features, systems, materials and/or methods, if such features, systems, materials and/or methods are not mutually inconsistent, is included within the scope of the present invention. In the claims, all transitional phrases or phrases of inclusion, such as "comprising," "carrying," "having," "containing," and the like are to be understood to be open-ended, i.e. to mean "including but not limited to." Only the transitional phrases or phrases of inclusion "consisting of" and "consisting essentially of" are to be interpreted as closed or semi-closed phrases, respectively.
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Author(s): Stone, Randall W.
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With the end of the Cold War, the International Monetary Fund emerged as the most powerful international institution in history. But how much influence can the IMF exert over fiercely contested issues in domestic politics that affect the lives of millions? In Lending Credibility, Randall Stone develops the first systematic approach to answering this question. Deploying an arsenal of methods from a range of social sciences rarely combined, he mounts a forceful challenge to conventional wisdom. Focusing on the former Soviet bloc, Stone finds that the IMF is neither as powerful as some critics fear, nor as weak as others believe, but that the answer hinges on the complex factor of how much credibility it can muster from country to country.
Stone begins by building a formal, game-theoretic model of lending credibility, which he then subjects to sophisticated quantitative testing on original data from twenty-six countries over the 1990s. Next come detailed, interview-based case studies on negotiations between the IMF and Russia, Ukraine, Poland, and Bulgaria. Stone asserts that the IMF has exerted startling influence over economic policy in smaller countries, such as Poland and Bulgaria. However, where U.S. foreign policy interests come more heavily into play, as in Russia, the IMF cannot credibly commit to enforcing the loans-for-policy contract. This erodes its ability to facilitate enduring market reforms. Stone's context is the postcommunist transition in Europe and Asia, but his findings carry implications for IMF activities the world over.
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POT Syndrome Center - Kennewick, WA
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Harbor Guest House
Gracious hospitality, awaits you in a charming Tudor guest house, nestled ON THE WATER, in the village of Fish Creek. Spectacular water views, and Fieldstone wood burning fireplaces, enhance the charm, of this special guest house. One and Two bedroom options, fully appointed kitchens, balconies or decks, cable T.V. , and A.C. Walking distance to restaurants,shops,beaches,and State Park. Boatslips avail. Open Year Round. Quiet season rates, Nov.- mid May. www.harborguesthouse.com
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Entertainment News Archive - February 05, 2006
By Dean Goodman LOS ANGELES (Reuters) - The new horror remake "When a Stranger Calls" connected with young thrill-seekers at the weekend box office in North America, but moviegoing generally took a back seat to Sunday's Super Bowl showdown.
Like nearly every house in New Orleans, Bethany Bultman's home has holes in its roof. Buckets to catch rainwater surround her desk, and she is hesitant to go out at night. Much of her neighborhood is still completely without power.
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Written By: Michael DeLaura
Contractors have been using prefabricated, EIFS Panels as an energy efficient and expedient construction process for over 40 years. Why does everyone love EIFS Panels? The panels, which can be structural or non structural, are manufactured off-site in a warehouse, offering increased quality control, highly engineered connections, no interruption during inclement weather, and improved productivity with little or no scaffolding required.
Another thing to love about prefabricated, EIFS panels is that they can contribute to LEED Points in several categories including:
- Energy & Atmosphere, Optimize energy performance
- Materials & Resources, Building product disclosure and optimization-sourcing of raw materials
- Materials & Resources, Construction and demolition waste management planning
- Indoor Environmental Quality, Low-emitting Materials, Thermal Comfort
- Innovation
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Let's Talk about the Construction
Construction of the panels begins offsite as the floors are being poured. Once the floors are completed, the panels are transported to the jobsite and installation occurs on site using a tower crane. The entire construction schedule is reduced by 30 to 40 percent as compared to an in place application. Additionally, the panels can be either structural or non-structural, depending on the type of construction and building height. A structural prefabricated EIFS Panel consists of many components including, a metal stud frame, exterior sheathing, air barrier, adhesive, insulation, basecoat, mesh, and finish.
A double silicone sealant joint installed between the panels ties them together, providing a watertight exterior cladding assembly. A 7/8" closed cell backer rod is installed in the ¾" expansion joint. The sealant joint has an hour-glass configuration with a width to depth ratio of 2:1.
A non-structural EIFS Panel consists of the same components without the metal stud frame and exterior sheathing.
The EPS insulation has a furring channel embedded in the foam with a sleeve on each end to allow for a mechanical attachment to the substrate. The panel is attached to the substrate with mechanical and adhesive attachment. There is no need to modify an existing structure for retrofits and remodels. A ship-lap design is used as one method for joining the panels. Sealant joints installed between the panels provides a watertight seal. Non-structural panels are ideally suited for existing low-rise buildings where disruption of the existing business is critical.
Don't Forget Specialty Finishes
Prefabricated, EIFS Panels can replicate brick, granite, limestone, metal panels, and precast finishes. Specialty finishes are easier to install and can require fewer specialty trades than traditional cladding materials. The finishes offer a cost-effective aesthetic option, increase energy efficiency, and moisture protection. A specialty finish offers an identical look to the natural cladding, but is less heavy, allowing the creation of a lighter building with the potential for a more economical structure.
A Case in Point – The Mayfair Renaissance
The Mayfair Renaissance is a 36-story tower built in downtown Atlanta constructed to match an existing precast tower on site. The structural panels, built off-site in a controlled environment in Lexington, Kentucky, increased quality control and no days lost to inclement weather. The lightweight, prefabricated panels reduced the amount of structural steel as compared to the precast. Prefabricated, EIFS Panels have been a popular method of construction in the hotel industry for the last 30 years, reducing construction time and allowing the owner to receive revenue more quickly when compared to a traditional, in place application. In addition, EIFS panel are more energy-efficient with a blanket of continuous insulation to reduce heating and cooling costs.
Panels and Design
The decision to use prefabricated panels should begin early in the design process. The design professional must determine whether the project is suited for EIFS Panels. In many cases, not all areas of the project will be panelized – there could be an in-place application on a portion of the project depending on tie-ins and connections. However, for many projects, prefabricated, EIFS panels can provide significant savings to both the construction process and its costs.
Michael DeLaura is a contributing writer for various publications. With more than 30 years of sales experience, he also is an Exterior Cladding Specialist at Sto Corp., a leading German manufacturer of construction materials with offices in the United States and worldwide. Michael can be reached at firstname.lastname@example.com.


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1969 plymouth factory big block 4 speed B5 blue roadrunner,above average driver condition,no fender tag & no build sheet.clean ga title ...this car is... More
Very original well maintained car that runs and drives perfectly. Other than an aluminum radiator for improved cooling, this car is all stock and... More
1932 Plymouth PB Sedan For Sale or Trade. Fresh barn-find. Just pulled out a barn in New Hampshire where the car has been stored since... More
Beep! Beep! .This 1969 Plymouth Road Runner is from Wisconsin. The cars exterior body and paint were restored only. One single repaint, Factory Yellow that... More
``RARE`` !!... 1949 Plymouth ``P17 Suburban`` 2 Dr. Station Wagon !! Just 44 K on it`s clock and well taken care of. High gloss... More
If you want a good time, this is the 63 Plymouth Sport Fury for you. You can put it in your garage and stare... More
1948 Plymouth Deluxe Drive and runs well... More
All vehicle trades considered, including classics and performance. Back in 1970 the GTX was Plymouth's top-of-the-line offering for luxury performance. As such, it is one... More
BeepBeep, this 1969 black on black Roadrunner is sure to out run any coyote! The My Hot Cars Team is excited to be able... More
1936 Plymouth Sedan 4 Door If you are interested in this vehicle or have any questions, please call Fred at 503-631-3576 3 speed, Older restoration, No rust, New glass and... More
1963 Max Wedge - 4 speed Belvedere. A real survivor kind of car. A Documented Govier Max Wedge engine and listed in the Davis... More
Part of private collection, absolutely gorgeous, black with gray interior. AACA senior winner in 2007 with multiple repeat preservation awards, the latest from the... More
Beautifully restored example of the classic P-10 Plymouth convertible coupe. Local car that had body off restoration done about 10 year ago but only... More
1963 Plymouth Valiant 2 Door For Sale or Trade. Billed as America's spacious compact car when this, this Valiant is a great combination of originality... More
Up for sale in our Houston showroom is the famous 1970 Plymouth Road Runner. Plymouth??s goal in 1968 was to offer Detroit??s biggest bang... More


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OverviewFounded in June 2009, Gaming Minds Studios GmbH is an internal development studio of Kalypso Media GmbH and located in Gütersloh, Germany.
The studio is led by Daniel Dumont (CEO) and Kay Struve (Technical Director), and consists of a team of fifteen developers formerly employed by Ascaron Entertainment.
There is no trivia on file. If you have any interesting trivia about this company, please add it.
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- Gaming Minds Studios GmbH (official website)
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Love you EG
By Mooka
from Toronto
The first time I enjoy putting shadow.. But I never encountered such beautful and an excellent quality colors! I can thank you enought Elizabeth.. lOVE YOU..
Bottom Line Yes, I would recommend this to a friend
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Just love the product.
By Barbara
Excellent choice of colours. Nice packaging. Will buy it again
( 5 of 5 customers found this review helpful)
By DBDB reviews............
from PRINCE ALBERT
i received this eye shadow in one of Elizabeth's sets.....- luv it...- have a funny story about it...- i use the light tone under my brow and in the corners for highlight...amazing...then i would use the lighter taupey tone (below the dark brown in the palette) on my lid AND then use the dark brown in the crease to create the deep tone AND then i would add a thin line along the brown using the brighter peach tone (that is in the top right corner)....- i tryed to copy the pros!!!...it looked amazing...that was my special occasion LOOK...- NOW BEING REALISTIC (I have to think of JOAN because she would have a funny expression or face!! to describe my ritual) my special occasion look was once in a blue moon...- i could not be bothered...so everyday i just used the highlight tone for under my brow and the taupe tone on my whole lid...done and out the door..it LOOKED AMAZING !! ... the colors gave my eyes such a nice fresh youthful look that i stopped using eyeliner...- problem was that i used the taupe up ..nothing left..i have never in my life emptied a eye shadow down to the metal!!- so one day in a rush i did the highlight but forgot i did not have any taupe left and no time to look for another eye shadow so i put the brighter peach on my entire lid!!! ...- WOW...i thought the taupe had taken 20 yrs. off my eyes this PEACH made me feel like i was in my 20's again....here all along i was thinking it was too bright to use as a main color...silly me..- i also have the palette in mauve/purple tones which i see now is out of stock...never tried it....lost it in one of my drawers..i definitely have to hunt it down !!!- since i got it in a set...would i pay the regular price? absolutely....i have been using this palette forever....LUV it !!!!- thank-you Elizabeth !!!!!!
( 3 of 3 customers found this review helpful)
By Sandra
from Kingston, Ontario
Love this eye shadow! Very soft and great color....I wear natural colors so this goes with everything. Highly recommend anything in Elizabeth's line :)


text:
Holiday Quiz Page 15
by AccountingWEB US on printer friendly
No, that's not correct. The 8 Steps to Implementing Change [1], which were presented to AccountingWEB members in a live workshop with consultants from Results Accountants' Systems, include communicating your vision of the change with others in the firm.
Proceed to Question 6 [2].
Proceed to Question 6 [2].


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Winter!: Prepare for holiday gaming!
Game Night!: This weekend! https://www.facebook.com/events/317792721696252/
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Answer this question....: Eyup or Nope?
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This is where it started for me. The Dragon Order guild cause such a war that the creators had to stop us.
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Very cool game. Still trying to make it through the single player portion.
I have a account but dont play. Still have it so I can hang with my son who loves the game.
played this for a short time but my first son was getting older and my play time had to go away.
Great Game. Best RTS I have played yet.
still the best pvp
of Warcraft Death Knight Players choose Blood Elf or Human as their Race.
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text: Candida viswanathii Sandhu et Randhawa (ATCC® 28269™) Strain Designations: CSF 40 / Product Format: freeze-dried General Information Characteristics Culture Method History Documentation Print Email Share Share this product Facebook Twitter Google+ Permits and Restrictions View Permits Deposited As Candida viswanathii Sandhu et Randhawa, anamorph Strain Designations CSF 40 Biosafety Level 1 Product Format freeze-dried Type Strain no Preceptrol® no Medium ATCC® Medium 200: YM agar or YM broth Growth Conditions Temperature: 25.0°C Name of Depositor HS Randhawa Chain of Custody ATCC <<--HS Randhawa<<--D.K. Sandhu Isolation cerebrospinal fluid, India Cross References Nucleotide (GenBank) : AX109698 Sequence 431 from Patent WO0123604. Nucleotide (GenBank) : AX109744 Sequence 477 from Patent WO0123604. Nucleotide (GenBank) : AX110838 Sequence 1571 from Patent WO0123604. Permits These permits may be required for shipping this product: Customers located in the state of Hawaii will need to contact the Hawaii Department of Agriculture to determine if an Import Permit is required. A copy of the permit or documentation that a permit is not required must be sent to ATCC in advance of shipment. Basic Documentation Product Sheet Certificate of Analysis SDS


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Alvaro Negredo is loving his strike-partnership with Manchester City teammate Sergio Aguero.
Negredo, who earned his ŌĆśBeastŌĆÖ nickname at former club Sevilla for his bustling, robust style, is proving the perfect foil for pin-up boy Aguero.
He said: ŌĆ£The partnership with Sergio has been very good from the first day. With both of us speaking Spanish, we understand each other well. HeŌĆÖs a great player, and with great players itŌĆÖs easy to get along.
ŌĆ£ItŌĆÖs an honour to become the first Spanish player to get a hat-trick for a non-Spanish team particularly here at City because people are treating me very well.
ŌĆ£I am delighted to get three so quickly and letŌĆÖs hope I can get a lot more ŌĆō that would be a good sign for everybody. The most important thing is that they help the team.ŌĆØ
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Mon-Fri: 7am-1am EST / Sat-Sun: 7am-11pm EST
ApplianceJenn-Air Range
Level of DifficultyEasy
Time to do repair30 - 60 mins
Age of Appliance5 - 10 years
Screw drivers
We replaced 3 of 4 igniters on the stove top according to the previously submitted recommendations. Easy to do butt after putting one of the modules back together, we found one igniter still didn't function. We discovered the solution was to run the connecting wire under the gas tubing. Apparently it was compressed when it was over the top of the tube and not under it.
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One problem, Ghandi says, was the design of the cooler's antenna. "You couldn't tell what was wrong by looking at it," he says, "but it wouldn't work in certain parts of Ethiopia." Finally, after switching to a different type of antenna and devising some tricks to make up for unexpected gaps in the system (such as the lack of a built-in timestamp on Ethiopian text messages), they were able to get a reliable device up and running.
That's par for the course for such projects, Gmez-Mrquez says. "You want, during the first trip, for a lot of things to go wrong," he says. "That's why you go over there." The key thing for this project was enlisting local users to try out a new system under real-world conditions. "We found amazing engineers" at the Addis Ababa Institute of Technology, he says, who "did an enormous amount of work" to help get the system working.
These local engineers, in fact, were delighted to have the chance to work on such a project, which they could see was something that could be built and maintained within the country. Young says one of them told her, looking at an expensive MRI machine in the local hospital, "Nobody I know will ever use this." By contrast, he said of the new cooler, "This is something I can actually see being used by people I know."
|Contact: Caroline McCall
Massachusetts Institute of Technology


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A fatal attraction?As Tony Blair's domestic popularity suffers, nervous Labour MPs are asking if it's time he distanced himself from Bush.
In focus p18
A new American dreamNow the most powerful nation, the US feels destiny has chosen it to remake the world, says William Pfaff.
In focus p19
Who knows that help is out there?
Parents need to be told about care, support and their children's rights when teenagers fall pregnant, says Maureen Freely.
I wasn't told my daughter was going to have a baby ... or that she was keeping it
Does a parent have a right to know? David Townsend recounts his reaction to his 14-year-old's pregnancy.


text:
Noted oncologist V. P. Gangadharan will take charge as special officer in an advisory role for a cancer centre in the district.
Speaking to The Hindu, Dr. Gangadharan said that he has in principle agreed to provide scientific and technical expertise for a cancer centre. This was conveyed to the Minister for Health V.S. Sivakumar after he considered the proposal regarding his contribution put forward by the Minister for setting up a state-of-the-art centre.
He said that his consultancy as oncologist would remain unhindered.
His name was announced in the Assembly on Monday when S. Sarma, MLA, raised the issue of Kochi being left out by being denied any funds for a cancer centre in the State budget presented on Friday.
Keywords: V. P. Gangadharan, Kochi Cancer centres


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Do you have an owners manual. that will suggest the correct motor oil. But I would suggest a good quality single weight like 30W specifically made for Diesel Engines (Though I have seen more and more marine diesel manufacturers say its ok to use Multiwieghts like a 10W-30)
Make sure its for Diesels (You can tell its made for Diesels because it will have a API Service category rating on it like "CF" or "CG-4" When you look at the can of oil (as opposed to "SJ" or another "S" rating which is for gasoline engines.)
Here is a little write up on the ratings http://api-ep.api.org/filelibrary/ACF1E1.pdf
Go to your local Marine store and they should be able to set you up. Like the above said "Rotella" is a good brand for marine diesels.
The MOST important thing to do is to change your oil and filter often. Thats the easiest way to help your engine last longer. Every 50-100 hours and at least once a year before you put her away for the winter or store her
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Kosher Food Trucks Park at AIPAC
Delegates report the food at this year's policy conference isn't half bad
"It's really good!" Danielle Galitzer, a 10th-grader from Rockville, Maryland, exclaimed over lunch today at the AIPAC conference. She had good reason to be pleasantly surprised: She was eating a plate of yellow-tinted shawarma from Park'n'Pita, a faux food truck stationed in the basement of the Washington convention center. One of her dining companions, David Fuller, noted that the plate wouldn't stand up to anything you could get in Jerusalem—"The pita is cold," he said, waving it damningly in the air—but never mind: It was kosher, and it was there, along with falafel, for as little as $9 a plate.
The food-truck phenomenon, which started with Korean barbecue tacos in L.A., is now so pervasive that AIPAC's caterer, Connecticut-based Centerplate, built Potemkin truck façades to decorate the food stations in the vast "AIPAC Village" at the Washington Convention Center. Along with Park'n'Pita, there's one labeled "Bento Blossom," serving teriyaki beef and ginger chicken, and another, "Barbecue to the Rescue," dispensing pulled beef brisket and chicken tenders. (There was, however, no redux of the short-lived Sixth & Rye truck rolled out by the Sixth & I Synagogue a couple of years ago.)
The food, prepared under the supervision of Washington's kosher authority, the Vaad Harabonim, was the same at less-kitschy stands upstairs, but people seemed to take the trucks at face value, standing and debating which one to go to as though they were out on the street. "You should get the barbecue," one man earnestly told a woman trying to choose where to go for lunch.
And why not? As I reported last month, there's a dearth of kosher food in downtown Washington, and it was nice to see people taking their options seriously. Also, people were hungry: Secret Service confiscated food items like apples and oranges from delegates this morning on their way in to see Vice President Joe Biden. "I have pretzels and cherry tomatoes in my bag," Danielle's mother, Sharon, confided. "I think they were taking food that could be used as projectiles."
Earlier: DC's Missing Kosher Food
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Show us your pictures on "THE GREAT PLAINS"
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Joined: Mar 2013
Location: Manhattan, KS
Oddometer: 7
New to the board, but have lurked long enough to check out this entire thread. Kudos to all of the contributing photographers on this thread. Great work. Keep 'em coming.
I've often said that as a KS native, I have an advantage over a lot of people in that I love my home because it's my home, and can travel and appreciate the relative beauty in most other places (implying that KS ain't much to begin with). In other words, I love KS but I get why others may not. Self-deprecating, if you will.
But I've since changed my tone, and this thread supports that change. If a person can't see and appreciate the beauty of the Great Plains/Flint Hills, then that's their problem, not the territory's problem.
I hope to contribute some pics soon. I like to dabble in photography, but by no means am I a pro. I'm even more of a novice on a motorcycle; my first-ever bike was delivered today. Can't wait to take the DSLR out on a ride, though....
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The Tigers had all five starters score in double figures for the first time in an SEC game in four years in Saturday's win against Georgia, and will look for more of the same in road games at South Carolina and LSU this week.
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