WO2017127768A1

WO2017127768A1 - Sterile temperature controlling wound dressing device, system and method

Info

Publication number: WO2017127768A1
Application number: PCT/US2017/014469
Authority: WO
Inventors: Brian Doherty; David Abramson; Steven PENTELNIK; Faiz CHOWDHURY
Original assignee: Imanano, Inc.
Priority date: 2016-01-21
Filing date: 2017-01-21
Publication date: 2017-07-27

Abstract

In accordance with one embodiment of the present invention, the invention comprises a temperature controlling bandage containing a Phase Change Material (PCM) that maintains a nearly constant predetermined temperature while absorbing heat during phase transition. The predetermined temperature is maintained which the PCM absorbs heat from the body of the patient, thus maintain the patient's body temperature at a nearly constant predetermined temperature for as long as the PCM material is transitioning phase. The temperature controlling bandage, which in an embodiment forms an enclosed volume, may be comprised of a pouch which contains the PCM. The PCM may further comprise graphene particles in suspension. The temperature controlling bandage may be applied to a post-operative site of a person's body for absorbing heat from the post-operative site and thereby cooling the post-operative site to promote healing. The phase transition may be selected to be between 38° Fahrenheit and 70° Fahrenheit.

Description

STERILE TEMPERATURE CONTROLLING WOUND DRESSING

DEVICE, SYSTEM AND METHOD

INTERNATIONAL APPLICATION FOR PATENT UNDER THE PATENT

COOPERATION TREATY

CROSS REFERENCE TO RELATED APPLICATIONS AND INCORPORATION BY

REFERENCE

[001] This application claims the benefit of U.S. provisional application for patent serial number 62/281,683 filed in the United States Patent and Trademark Office (USPTO) on January 21, 2016, titled STERILE TEMPERATURE CONTROLLING WOUND DRESSING DEVICE, SYSTEM AND METHOD, which is hereby incorporated by reference in its entirety.

[002] U.S. patent no. 4,768,523 titled HYDROGEL ADHESIVE, which issued from the USPTO on September 9, 1988, is also hereby incorporated by reference in its entirety. U.S. patent publication number US20140298627, published from the USPTO on October 9, 2014 is also hereby incorporated by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR

DEVELOPMENT

[003] Not applicable.

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT

DISK

[004] Not applicable.

BACKGROUND OF THE INVENTION 1. Field of the Invention

[005] The field of the invention relates generally to devices, systems and methods for providing a temperature controlling bandage or wound dressing for providing thermal management to the skin of a person for medical use, including but not limited to post surgery recovery from joint surgery such as labrum repair and other shoulder and knee surgery. The invention also relates generally to the field of devices for providing thermal management of post-operative or other sites on an animal such as may be used in veterinary medicine. The invention relates generally to the field of thermal management of any object or system, as its use is not limited to human or non-human animal use. In an exemplary embodiment, the device, system and method of the invention may be utilized to provide a sterile cooling device for application to any wound site such as, by way of non-limiting example, a postsurgical site on the body of a person, and to provide cooling to the post-surgery site at a desired predetermined temperature. More specifically, the field of the invention is postsurgical cooling of a wound site using phase change materials. Thus the field of the invention is generally directed to thermoregulation of a body or other object using phase change materials and methods.

2. Background Art

[006] It is well established that post-operative cooling of body joints such as knees, shoulders, elbows and the like, and other surgical sites, promotes faster healing than if no cooling is used. Post-operative cryotherapy can reduce pain and may also increase the range of movement after knee or other joint surgery.

[007] Systems that are currently used for post-operative cooling include chiller units such as the Ossure Cold Rush Cold Therapy Unit, which are electrically drive pumps that circulate chilled water drawn from a reservoir containing a combination of ice and water, and pumps the water through a pad that is placed against the skin of a patient. These systems comprise reservoirs, electric motors, electronic controls, and a system of tubes moving fluid water. They are expensive, prone to leaking, are not portable while in use, draw on electric power, are large and bulky, and prevent a patient from being ambulatory while the unit is cooling the post-operative site. Once purchased they are not typically returnable.

[008] Other systems exist that are mobile, but are subject to widely fluctuating temperatures, and are thus undesirable. Flexible bladders exist that are intended to be filled with ice and water and then strapped onto an extremity such as a knee. These bladders are prone to leaking, are bulky, and can spread infection. Still further they do not provide constant temperature to a desired site. Instead, they deliver a temperature that has been shown to be too low, i.e. 32°F or lower, for proper healing of the extremity or body part. These temperatures are low enough that such devices may only be used intermittently because skin damage can occur with the constant application of low temperature.

[009] Furthermore, none of these prior systems are sterile and able to be applied directly to a post-operative wound.

[0010] What is needed in the art, therefore, is a device, system and method for providing sterile post-operative cooling that is not prone to fluid leakage, is not only portable but allows the use to be ambulatory while the cooling system is in use, is able to provide a controlled predetermined temperature to the post-operative site, and does not run the risk of damaging a patient's skin due to extended low temperature application.

BRIEF SUMMARY OF THE INVENTION

[0011] The present invention comprises an apparatus and method that have one or more of the following features and/or steps, which alone or in any combination may comprise patentable subject matter.

[0012] The present invention overcomes the shortcomings of the prior art in that it eliminates the use of chilled fluids for cooling, is portable, eliminates need for electromechanical components such as pumps and pump control systems, is able to provide a controlled predetermined temperature to the post-operative site, does not run the risk of damaging a patient's skin due to extended low temperature application and does not require electric power.

[0013] In accordance with one embodiment of the present invention, the invention comprises a pouch forming an enclosed volume and containing a Phase Change Material (PCM) that is selected to maintain a nearly constant predetermined temperature T while absorbing or yielding up heat while the PCM undergoes phase transition. The predetermined phase transition temperature T is maintained enabling the PCM to absorb heat when in thermal communication with a warmer object thus cooling the object, or supply heat when in thermal communication with a cooler object. The object may be any object that is desired both thermally managed, but in an exemplary intended use, the object is a portion of a body of a patient that is desired to be thermally managed, such as the application of cooling temperature to a post-operative site after joint or other surgery.

[0014] The pouch may be fabricated from plastics such as polyethylene, polyurethane, or any other pliable material and may further comprise adhesive on an exterior surface of the pouch, which adhesive may be pressure-sensitive adhesive, for attachment of the temperature controlling bandage of the invention to an object to be thermally managed, such as, for example, a post-operative site. In one exemplary use, the pouch containing the PCM may be releasably attached to the skin of a patient recovering post-operatively from a surgery such as shoulder, ankle, knee or other surgery to provide a cooling temperature to the post-operative area. The areas of adhesive may be covered with a protective layer which may be comprised of a material such as paper or a thin sheet of plastic. The protective layer may be peeled from the adhesive, exposing the adhesive and allowing the bandage to be releasably attached to an object such as the skin of a patient by pressing the area of the pouch having the adhesive against the skin of the patient.

[0015] In an embodiment of the temperature controlling bandagetemperature controlling bandage of the invention intended for use in cooling a post-operative site of a patient, the phase change material may be selected to transition phase at a predetermined temperature between 38° Fahrenheit and 70° Fahrenheit. In a still further preferred embodiment, the phase change material of the invention may be selected to transition phase at 49° Fahrenheit. In a still further preferred embodiment, the phase change material of the invention may be selected to transition phase at 59° Fahrenheit. In still a further embodiment, the phase change material may be selected to transition phase at a predetermined temperature between 40° Fahrenheit and 70° Fahrenheit. In still a further embodiment, the phase change material may be selected to transition phase at a predetermined temperature between 80° Fahrenheit and 110° Fahrenheit. The PCM may be selected such that any desired phase transition temperature may be achieved.

[0016] In an embodiment, the invention may further comprise sterile packaging fully enclosing the pouch. The sterile packaging may be any packaging known in the art that is adapted to completely enclose, for example, a bandage, and may be fabricated from plastic, paper or other materials such that the temperature controlling bandage is completely enclosed and is maintained as sterile during shipping and storage. When use of the temperature controlling bandage of this embodiment of the invention is intended, the sterile packaging is removed and discarded, the adhesive coverings are removed, the sterile temperature controlling bandage is placed upon the skin of a person over the site where thermal management is desired, and the areas of the pouch comprising adhesive are pressed firmly against the patient's skin such that the pouch of the temperature controlling bandage of the invention is in thermal communication with the skin of the patient at the desired location, which is typically the post-operative site. In this manner, when the PCM contained within the enclosed volume of the pouch undergoes phase transition, it either absorbs body heat or supplies heat to the post-operative site, depending on whether the post-operative site is at a higher or lower temperature than the PCM phase transition temperature T.

[0017] The sterile temperature controlling bandage of the invention has numerous applications and thus the claims and scope of the invention are not be construed as limited to only post-operation applications, wounds or even applications to the body of a person. The sterile temperature controlling bandage of the invention may be applied to any object such as the skin of a human, the exterior surface of a non-human animal, inanimate objects, or any other object for providing thermal management of such an object.

[0018] While the description herein references the use of the temperature controlling bandage to be packaged in a sterile package and to thermally manage wound sites such postoperative wound sites, the invention may be used in numerous non-sterile applications such as, for example, thermally managing electronic gear or any other object or device. Thus, as used herein, the object to be thermally managed may be any object, and the temperature controlling bandage may, or may not be, sterile.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The accompanying drawings, which are incorporated into and form a part of the specification, illustrate one or more embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for the purpose of illustrating the preferred embodiments of the invention and are not to be construed as limiting the invention. In the drawings: [0020] FIG. 1A depicts a cross section view of a sterile temperature controlling bandage of an exemplary embodiment of the invention comprising a pouch at least partially filled with PCM, depicting the phase change material captured within the pouch enclosed volume, and depicting an embodiment of the sterile packaging surrounding the pouch.

[0021] FIG. IB depicts a perspective view of an exemplary embodiment of a reusable package of the invention that is sealed on three sides, with one side having a removably closed attachment so that a temperature controlling bandage may be housed with the reusable package, removed when desired, and placed back into the reusable package in the direction of arrow G.

[0022] FIG. 2 depicts a bottom view of an embodiment of the sterile temperature controlling bandage of the invention, showing an exemplary placement of the adhesive and absorbent material, which may be spunbond or other similar material, on a bottom surface of the pouch.

[0023] FIG. 3A depicts a cross section view of a sterile temperature controlling bandage of an exemplary embodiment of the invention that is adapted to be removably attached to a surface of an object which is desired to be thermally managed by adhesive or chemical bonding, depicting the phase change material captured within the pouch enclosed volume, and depicting heat transfer H from the surface of an object which is desired to be thermally managed which may be, for example, the skin of a human, the exterior surface of a non-human animal, inanimate objects, or any other object to be thermally managed by the PCM contained within the enclosed volume formed by the pouch.

[0024] FIG. 3B depicts a cross section view of a sterile temperature controlling bandage of an exemplary embodiment of the invention that is adapted to be removably attached to a surface of an object which is desired to be thermally managed by a hydrogel which may comprise an adhesive, depicting the phase change material captured within the pouch enclosed volume, and depicting heat transfer H from the surface of an object which is desired to be thermally managed which may be, for example, skin of a human, the exterior surface of a non-human animal, inanimate objects, or any other object to be thermally managed to the PCM contained within the enclosed volume formed by the pouch.

[0025] FIG. 4 depicts a flow diagram of an exemplary method of the invention for thermally managing an object, which may be a post-operative site of a patient having previously undergone joint surgery, including the steps of determining a desired temperature to apply to the object; determining the thermal resistance between the PCM and the surface of an object to be thermally managed to which a temperature controlling bandage is to be applied; selecting PCM material for use in the temperature controlling bandage for maintaining a constant pouch temperature while the PCM material is transitioning state; providing a pouch comprising the selected PCM enclosed within the pouch; charging the PCM material to a desired temperature; and placing the temperature controlling bandage comprising the pouch against a surface of the object to be thermally managed while the PCM is transitioning phase.

[0026] In the figures, like item callout numbers refer to like elements.

DETAILED DESCRIPTION OF THE INVENTION

[0027] The following documentation provides a detailed description of the invention.

[0028] Although a detailed description as provided in the attachments contains many specifics for the purposes of illustration, anyone of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the following preferred embodiments of the invention are set forth without any loss of generality to, and without imposing limitations upon, the claimed invention. Thus the scope of the invention should be determined by the appended claims and their legal equivalents, and not merely by the preferred examples or embodiments given.

[0029] As used herein, "phase change material", or PCM, means a substance or mixture of substances with a heat of fusion which, when melting and solidifying at a phase transition, or phase change, temperature T enables the substance to absorb or release amounts of heat energy. Heat is absorbed or released when the substance changes state as from from solid to liquid, and vice versa, at the phase transition, or phase change, temperature T. T is a function of the physical properties of the phase change material. Phase change materials may comprise eutectic materials, salt hydrates, or organic materials. Eutectic materials tend to be solutions of salts in water that have a phase change temperature below 0°C (32°F). Salt hydrates are specific salts that are able to incorporate water of crystallization during their freezing process and tend to change phase above 0°C (32°F). Organic materials used as PCMs tend to be polymers with long chain molecules composed primarily of carbon and hydrogen. They tend to exhibit high orders of crystallinity when freezing and mostly change phase above 0°C (32°F). Examples of materials used as positive temperature organic PCMs include waxes, oils, fatty acids and polyglycols. The definition of "phase change material" or "PCM" further includes compositions comprised of more than one such substance, i.e., mixtures of phase change materials. Non-limiting examples of substances which are phase change materials are shown in Table 1.

[0030] Any embodiment of the invention may, but does not necessarily, comprise PCM containing graphene particles in suspension in the PCM. While the amount of graphene in suspension may be any percentage of graphene to PCM by volume, a preferred range of graphene is five percent (5%) to twenty percent (20 %) graphene to PCM by volume. A preferred volume of graphene suspension in the PCM is ten percent (10%) graphene to PCM by volume. The suspension of graphene enabled the PCM to transfer thermal energy more efficiently than when the graphene is not present in suspension in the PCM.

1 -Cyclohexylooctadecane

2-Heptadecanone

3 -Heptadecanone

4-Heptadacanone

9-Heptadecanone

Acetamide

Acetic acid

Acrylic acid

Actanilide

Alpha napthol

Aluminium

Azobenzene

Bee wax

Bees wax

Benzamide

Benzoic acid

Benzylamine

Bromcamphor

Camphene

Camphenilone Capric acid

Caprilic acid

Caprylone

Catechol

Cetyl acid

Chloroacetic acid

Copper

Cyanamide

Pinto toluent (2,4)

Diphenyl amine

Docasyl bromide

Durene

Eladic acid

Formic acid

Glautaric acid

Glycerin

Glycolic acid

Glyolic acid

Gold

Heptadecanone

Heptaudecanoic acid

Hydrocinnamic acid

Hypophosphoric acid

Iron

KNQ3

KNO3(10%)/NaNO3

KNQ3/KBr(4.7%)/KCl(7.3%) KNQ3/KC1(4,5%)

KOI I

Laurie acid

Lead

Lithium

Methly brombenzoate

Methyl behenate

Methyl eicosanate

Methyl fumarate

Methyl palmitate

Μη(Ν0₃)₂· 6H,Q+MnCl,- 4H₂0(4 w/w)

Paraffin 29-Carbons

Paraffin 30-Carbons

Paraffin 31 -Carbons

Paraffin 32-Carbons

Paraffin 33-Carbons

Paraffin 34-Carbons

Pentadecanoic acid

Phenol

Phenylacetic acid

Polyethylene glycol 600

Quinone

Silver

S mmlfate (Na₂SQ₄- 10H₂O)

Stearic acid

Stibene

Succinic anhydride

Thiosinamine

Thymol

Titanium

TME(63%w/w)+H₂0(37%w/w)

Trimyristin

Tristearin

Water

Zinc

a-Chloroacetic acid

a-Nepthylamine

β-Chloroacetic acid

TABLE 1.

EXEMPLARY PHASE CHANGE MATERIALS

[0031] As used herein, "plastic" includes within its meaning a material consisting of any of a wide range of synthetic or semi-synthetic organics that are malleable and can be molded into solid objects of diverse shapes. Plastics are typically organic polymers of high molecular mass, but they often contain other substances. They are usually synthetic, most commonly derived from petrochemicals, but many are partially natural. Examples of plastics include but are not limited to polyester (PES); polyethylene terephthalate (PET); polyethylene (PE); high-density polyethylene (HDPE); polyvinyl chloride (PVC); polyvinylidene chloride (PVDC) (Saran); low-density polyethylene (LDPE); polypropylene (PP); polystyrene (PS); high impact polystyrene (HIPS); polyamides (PA) (Nylons); acrylonitrile butadiene styrene (ABS); polyethylene/Acrylonitrile Butadiene Styrene (PE/ABS); polycarbonate (PC); polycarbonate/Acrylonitrile Butadiene Styrene (PC/ ABS); polyurethanes (PU); maleimide/Bismaleimide; melamine formaldehyde (MF); plastarch material; phenolics (PF) or (phenol formaldehydes); polyepoxide (Epoxy); polyetheretherketone (PEEK); polyetherimide (PEI) (Ultem); polyimide; polylactic acid (PLA); polymethyl methacrylate (PMMA) (Acrylic); polytetrafluoroethylene (PTFE); urea- formaldehyde (UF); furan; silicone; and polysulfone, or any combination of these materials. Also included with the meaning of "plastic" is any material defined as "plastic" as would be known by one of ordinary skill in the art.

[0032] As used herein, "spunbond" or "spunlaid" includes within its meaning a non- woven fabric material fabricated from polypropylene, polyester or similar materials and may further comprise coatings or infusions of anti-bacterial chemicals. Spunbond materials are generally produced bya a manufacturing technique in which molten polymers are directly converted into endless filaments, laid on a conveyor belt and eventually formed into nonwoven roll goods. Spunbond fabric is typically waterproof or water-resistant, environmentally- friendly, breathable, anti-bacterial (when coated or infused with antibacterial chemicals) and tear-resistant. Specific variants of spunbond that are included in the definition of "spunbond" are SMS and SMMS. SMS is the abbreviation of "Spunbond + Meltblown + Spunbond Nonwovens" that is a combined nonwoven fabric which two layers of spunbond material have been combined with one layer meltblown nonwoven between the spunbond layers, producing a layered product called SMS nonwoven fabric (spun-melt-spun. If two layers of meltblown nonwoven material are disposed between the outer spunbond layers the material is termed SMMS nonwoven fabric (spun-melt-melt-spun). Likewise when three of meltblown nonwoven fabric are disposed between the outer spunbond layers the material is termed SMMMS nonwoven fabric (spun-melt-melt-melt-spun). Also included with the meaning of "spunbond" or "spunlaid" is any material defined as "spunbond" or "spunlaid" as would be known by one of ordinary skill in the art. [0033] As used herein, "thermally managed" means to apply heat to, or to remove heat from, an object in order to achieve a desired change in temperature of the object, or to achieve a desired temperature of the object.

[0034] As used herein, "hydrogel" includes within its meaning any of the following: 1) a colloid in which the particles are in the external or dispersion phase and water in the internal or dispersed phase; 2) any gel in which water is the dispersion medium; or 3) any water insoluble, crosslinked, three-dimensional networks of polymer chains in which water fills the voids between polymer chains. The hydrogel used in an embodiment of the invention may be sterile. The hydrogel used in an embodiment of the invention may be a physical hydrogel in which the polymer chains are held together by electrostatic forces, hydrogen bonds, hydrophobic interactions or chain entanglements. Alternatively, the hydrogel used in an embodiment of the invention may be a chemical hydrogel in which the polymer chains of are connected by permanent covalent bonds. The hydrogels used in the invention may also comprise an adhesive, or act as an adhesive, for removable or permanent attachment to surface. Also included with the meaning of "hydrogel" is any material defined as a "hydrogel" as would be known by one of ordinary skill in the art.

[0035] As used herein, "phase change" and "phase transition" have the same meaning.

[0036] Referring now to FIG. 1A, a cross section view of a sterile temperature controlling bandage 001 of an exemplary embodiment of the invention is depicted, showing a phase change material 100 captured within a pouch 105 forming an enclosed volume, and depicting an embodiment of a sterile package 400. Phase change material 100 is disposed in a pouch formed, for example, by a first layer 101 and a second layer 102, wherein first layer 101 and second layer 102 are shaped as desired, overlaid on one another, and attached together to form a pouch having an enclosed volume by any means known in the art such as, for example, chemical bonding, heat sealing, ultrasonic welding, or the like. Pouch 105 thus formed is further defined as having an enclosed volume which contains PCM 100. PCM 100 may fill or partially fill the enclosed volume of pouch 105. The PCM 100 may be any PCM but is preferably selected by the method of the invention, taught herein. Pouch 105, which may be formed by any number and shape of elements, such as a plurality of separate sheets of material attached together forming an enclosed volume that is sealed and contains PCM 100, may be fabricated from any material that is capable of attaching and sealing to form an enclosed volume capable of containing a PCM, but is typically fabricated from a plastic material such as a plastic sheet material. Thus, in the exemplary embodiment of the pouch 105 depicted in the figures of the drawings, which is but one of many embodiments of the pouch, first layer 101 and second layer 102 may be rectangular sheets overlaid and attached together around their periphery at area C, which may extend continuously around the periphery of a sterile temperature controlling bandage 001 forming an enclosed volume capable of containing PCM 100 without allowing PCM 100 to escape the enclosed volume. Thus first layer 101 and said second layer 102 are sealingly attached along their periphery forming the enclosed volume of said pouch 105. The method of attachment of first layer 101 to second layer 102 may be any method known in the art such, for example, chemical bonding, heat sealing, ultrasonic welding, or the like. The width D of the peripheral seal area C may be any dimension but is preferably between .05 and .75 inches. However, the pouch of the invention 105 may be fabricated by any means known in the art that results in a sealed enclosed volume containing PCM. In the case in which pliable enclosure 102 is fabricated from plastic material, seams C may be formed by fabricating the enclosure from separate pieces or sheets of plastic in which the seams are closed and sealed by any means known in the art such as chemical bonding, heat sealing, ultrasonic welding, or the like, forming pouch 105 and its enclosed volume containing a PCM.

[0037] Still referring to FIG. 1A, absorbent material or hydrogel intervening material 300 may be attached to a surface of pouch 105 by any means known in the art such as chemical bonding or equivalent means. The surface of pouch 105 to which material 300 is attached may be a lower exterior surface of pouch 105, which may be formed by a lower exterior surface of layer 102. Intervening material 300 may be any material, but is preferably a material that is able to be sterilized, including but not limited to hydrogel or absorbent material. In an embodiment, intervening material 300 is an absorbent spunbond material, and is attached to a surface of pouch 105 by any means known in the art such as chemical bonding or equivalent means. In yet a further embodiment, intervening material 300 is a hydrogel, or an adhesive hydrogel.

[0038] Still referring to FIG. 1A, adhesive coating 200 may be disposed upon an exterior surface of pouch 105, such as a lower exterior surface of layer 102. In an embodiment, adhesive coating 200 may be disposed on a lower surface of pouch 105. Preferably, adhesive surface 200 is disposed on the same surface of pouch 105 as material 300, as is depicted in FIG. 1, however this is not necessary for all embodiments. Adhesive 200 may be covered by a removable covering 201, which may be any plastic, paper or equivalent covering material, that may be peeled away from adhesive 200 without damaging the ability of adhesive 200 to be removably attached to a surface such the skin of a patient. In this manner, when it is desired to apply a sterile temperature controlling bandage of the invention 001, covering(s) 201 may be removed from adhesive 200, and adhesive 200 may be pressed against a surface of an object that is desired to be thermally managed creating a removable attachment to the surface of an object that is desired to be thermally managed. In the case in which it is desired to apply a sterile temperature controlling bandage of the invention 001 to a patient post-operatively, the adhesive is pressed against the skin of the patient, creating a removable attachment to the skin of the patient, and heat may be transferred from the post-operative site to the PCM thereby cooling the post-operative site as further depicted in FIGs. 3A and 3B.

[0039] Still referring to FIG. 1A, a sterile temperature controlling bandage 001 of the invention may be enclosed by sterile packaging formed by sterile packaging first layer 400 and second layer 401 which are attached continuously around their periphery, for example at area E, to provide a sterile interior volume 106, which may be sealed at area E. In this manner, a sterile temperature controlling bandage 001 may be sterilized, placed within the sterile packaging formed by first layer 400 and second layer 401, and may be shipped and stored while maintaining the temperature controlling bandage in a sterile state.

[0040] Still referring to FIG. 1A, the invention may comprise item 301 as is further defined below.

[0041] Referring now to FIG. IB, an embodiment of a package of a reusable package 500 that may be re-used for storing a temperature controlling bandage of the invention is depicted. A temperature controlling bandage 001 of the invention (not shown in FIG. IB) may be enclosed by reusable package 500 formed by reusable package first layer 501 and reusable package second layer 502 which are attached continuously around three sides of their periphery 504a, 504b and 504c to create an interior volume 505 for containing a temperature controlling bandage of the invention 001. The reusable package 500 may be removably closed at sealed area F by use of an adhesive suitable for creating a removable attachment forming a closable opening 503 at area F between surfaces of reusable package first layer 501 and reusable package second layer 502. In this manner a temperature controlling bandage 001 may be placed within the packaging formed by first layer 501 and second layer 502, making the temperature controlling bandage available for quick use. Package 500 provides a convenient covering and protection for handling of a temperature controlling bandage 001 between uses, such as the period of time when the temperature controlling bandage 001 is being charged. First layer 501 and second layer 502 may be fabricated from spunbond material, or in an embodiment, spunbond polyethylene or polypropylene. A temperature controlling bandage 001 may be housed with the reusable package, removed when desired, and placed back into the reusable package in the direction of arrow G through closable opening 503.

[0042] Referring now to FIG. 2, a bottom view of an embodiment of the sterile temperature controlling bandage of the invention is shown, showing an exemplary placement of adhesive 200 disposed on a bottom surface of layer 102 of pouch 105 (not depicted in FIG. 2), removable covering(s) 201, and material 300, which may be absorbent material fabricated from spunbond material, or may be hydrogel or hydrogel adhevise, on a bottom surface of the pouch is depicted. While a rectangular shape is depicted for the periphery B of sterile temperature controlling bandage 001, sterile temperature controlling bandage 001 may take any shape desired. For example, and not by way of limitation, sterile temperature controlling bandage 001 may take on a rectangular, hexagonal, square, circular or any other desired shape.

[0043] Referring now to FIG. 3A, an exemplary embodiment of the sterile temperature controlling bandage of the invention in a typical application is depicted. A temperature controlling bandage 001 has been removed from sterile packaging 400 (not shown in FIG. 3A) and is removably attached to a surface A of an object to be thermally managed. In an embodiment, and as an example of the many uses of the invention, the object to be thermally managed may be an area in proximity to a post-operative site on the body of a person. A first layer 101 and a second layer 102 have been attached and sealed as hereinbefore described forming pouch 105 having an enclosed volume containing PCM 100. PCM at least partially fills the enclosed volume of pouch 105. Adhesive 200 removably attaches the sterile temperature controlling bandage 001 to surface A of an object to be thermally managed. Heat is removed from the object to be thermally managed by conduction of heat energy H from the object to be thermally managed, through optional material 300, through layer 102, and into PCM 100 contained in the enclosed volume of pouch 105. In the exemplary use shown in FIG. 3A, temperature controlling bandage 001 has a phase transition temperature T that is lower than the temperature of the object to be thermally managed, thus heat energy flows in the direction of arrow H from the object to be thermally managed to PCM 100, cooling the object to be thermally managed while the PCM material absorbs heat during phase transition from, for example, a solid state to a liquid state. In an alternative embodiment and method of use, the transfer of heat energy may be reversed, i.e., may run in a direction opposite the direction depicted by arrow H. In this alternative embodiment, the phase transition temperature T of PCM 100 is higher than that of the object to be thermally managed, and heat energy flows in a direction opposite arrow H from PCM 100 to the object to be thermally managed, warming the object to be thermally managed while PCM 100 gives off heat during phase transition from liquid state to solid state.

[0044] Still referring to FIG. 3A, the invention may comprise item 301 as is further defined below.

[0045] Referring now to Fig. 3B, an exemplary embodiment of the sterile temperature controlling bandage of the invention in a typical application is depicted. Sterile temperature controlling bandage 001 has been removed from sterile packaging 400 (not shown in FIG. 3B) and is removably attached to a surface A of an object to be thermally managed, which may be, but is not necessarily, a wound site of a person. In an embodiment, the object to be thermally managed may be an area in proximity to a post-operative site on the body of a person. A first layer 101 and a second layer 102 have been attached and sealed as hereinbefore described forming pouch having an enclosed volume that is at least partially filled, or may be fully filled, with PCM 100. Optional intervening material 300 may be a hydrogel that further comprises a adhesive, or may be an adhesive hydrogel, that removably attaches the sterile temperature controlling bandage 001 to surface A of an object to be thermally managed. Heat is removed from the object to be thermally managed by conduction of heat energy H from the object to be thermally managed, through optional material 300, through layer 102, and into PCM 100 contained in the enclosed volume of pouch 105. In the example use shown in FIG. 3B, the sterile temperature controlling bandage has a phase transition temperature T that is lower than the temperature of the object to be thermally managed, thus heat energy flows in the direction of arrow H from the object to be thermally managed to PCM 100, cooling the object to be thermally managed while the PCM material absorbs heat during phase transition from, for example, a solid state to a liquid state. In an alternative embodiment, the transfer of heat energy may be reversed, i.e., may run in a direction opposite the direction depicted by arrow H. In this alternative embodiment, the phase transition temperature T of PCM 100 is higher than that of the object to be thermally managed, and heat energy flows in a direction opposite arrow H from PCM 100 to the object to be thermally managed, warming the object to be thermally managed while the PCM gives off heat during phase transition from liquid state to solid state.

[0046] Still referring to FIG. 3B, the invention may comprise item 301 as is further defined below.

[0047] In any of the embodiments, intervening material 300 may optionally comprise the invention. Intervening material 300 may be any absorbent or hydrogel material, but is preferably a material that is able to be sterilized, including but not limited to hydrogel or absorbent material. In an embodiment, intervening material 300 is an absorbent spunbond material, and is attached to a surface of pouch 105 by any means known in the art such as chemical bonding or equivalent means. In yet a further embodiment, intervening material 300 is a hydrogel, or an adhesive hydrogel. Material 300 may be further defined as a hydrogel adhesive for removably attaching sterile temperature controlling bandage 001 to any surface, including but not limited to the skin of a person. The hydrogel adhesive comprising intervening material 300 may be as described in United States patent no. 4,768,523, or many be any material classified as a hydrogel or hydrogel adhesive material. Preferably, the hydrogel adhesive is suitable for creating a removable attachment between sterile temperature controlling bandage 001 and the surface A to which is it attached, while also providing a moist environment for the promotion of wound healing. The use of hydrogels or adhesive hydrogels provides certain benefits for wound healing, such as providing a moist wound environment to promote the formation of new tissue during the granulation phase. An exemplary hydrogel adhesive is known by the trade name Aquaclear, manufactured by Hartman USA, Inc., 481 Lakeshore Parkway, Rock Hill, SC 29730, USA. Still further, in an embodiment, item 300 may be further defined as an absorbent hydrogel adhesive such as the one known by the trade name Aquasorb®, manufactured by DeRoyal Industries, Inc. La Follette, Tennessee, U.S.A. [0048] In any of the embodiments, item 301 may optionally comprise the invention. Item 301 may be either a hook portion or a loop portion of a hook and loop fastener arrangement for fastening a surface of the temperature controlling bandage of the invention to another surface, such as an interior surface of a piece of clothing. The clothing may incorporate the matching fastening portion of the hook and loop and fastener arrangement: i.e., if item 301 is a hook portion, then the clothing may incorporate a loop portion. Alternatively, if item 301 is a loop portion, then the clothing may incorporate a hook portion. In this manner, a temperature controlling bandage of the invention 001 may be attached to the clothing of a person, on the surface of the clothing facing the person's skin, such bandage 001 is located at or near an area of the person' s skin that is desired to be thermally managed and comes into contact with the skin of the person in that area. In this arrangement it is not necessary that bandage 001 comprise intervening material 300. A non-limiting example of a hook or loop fastener portion that may comprise the invention is any of such fastener portions as described in U.S. patent publication number US20140298627. Item 301 may attach to any surface of the invention, for example to layer 101 as shown in Figs. 1A, 3A and 3B, by any means known in the art, but preferably by chemical bonding such as an adhesive that form a removable or a permanent bond with layer 101.

[0049] In any of the embodiments, PCM 100 is in thermal communication with a surface of an object to be thermally managed, such the objects depicted as having surface A in FIGs. 3A and 3B albeit such thermal communication may experience a thermal resistance in layer 102 and intervening material 300.

[0050] Typically, prior to use in a case where it is desired to cool an object to be thermally managed, the temperature controlling bandage 001 is "charged" to a temperature below a predetermined selected PCM phase transition temperature T. The predetermined PCM phase transition temperature T may be a temperature at which, given the temperature differential between the object to be thermally managed and the PCM caused by the thermal loss of the intervening material layers, which may comprise second layer 102, absorbent material 300 and any other intervening materials, presents a desired temperature to the object to be thermally managed while the PCM is transitioning states. For example, if it is desired to apply a temperature of 49°F to a surface of the object to be thermally managed, the thermal losses (and thus the temperature differential) between the patient's body and the PCM may be calculated using the known thermal properties of the intervening materials. In the example, assume a three degree (3°) F drop in temperature between the surface of the object to be thermally managed and PCM 100. Thus it would be desired that the phase change material contained within pouch 105 transition phase at 46°F, and a suitable phase change material exhibiting this phase transition temperature T is selected. The sterile temperature controlling bandage 001 may then be charged to a temperature slightly below 46 °F, causing the PCM material 001 in temperature controlling bandage 001 to harden, or freeze. The temperature controlling bandage 001 may then be removably attached to the surface of the object to be thermally managed as hereinbefore described such that it is in thermal communication with the skin of the patient at the post-operative site. As the sterile temperature controlling bandage 001 warms to 46 °F, it will absorb heat as the PCM 100 transitions state from solid to liquid, and will continue to absorbthis heat for as long as the PCM continues to transition physical state. Thus, a constant temperature of 49°F, or any other temperature desired as determined by the selection of PCM or mixture of PCM comprising the invention, is applied to the surface of the object to be thermally managed for as long as the PCM continues to change state. This same analysis, only in reverse, may be used in the case in which the temperature controlling bandage is used to heat an object. Thus, for example, if it is desired to apply a temperature of 100°F to an object that is currently at a temperature of 80°F, the thermal losses (and thus the temperature differential) between the patient's body and the PCM may be calculated using the known thermal properties of the intervening materials. In the example, assume a three degree (3°) F rise in temperature between the surface of the object to be thermally managed at and the PCM 100. Thus it would be desired that the phase change material contained within pouch 105 transition phase at 103°F, and a suitable phase change material exhibiting this phase transition temperature T is selected. The sterile temperature controlling bandage 001 may then be charged to a temperature slightly above 103 °F, causing the PCM material 001 in sterile temperature controlling bandage 001 to melt. The temperature controlling bandage 001 may then be removably attached to the surface of the object to be thermally managed as hereinbefore described such that it is in thermal communication with the surface of the object to be thermally managed. As the temperature controlling bandage 001 cools to 103 °F, it will produce heat as PCM 100 transitions state from liquid to solid, and will continue to give off this heat for as long as PCM 100 continues to transition physical state. Thus, a constant temperature of 100°F, or any other temperature desired as determined by the selection of PCM or mixture of PCM comprising the invention, is applied to the surface of the object to be thermally managed as the PCM continues to change state. Thus, both cooling and heating examples are given.

[0051] Referring now to FIG. 4, the present invention also comprises a method forming a series of steps for controlling the temperature of a surface of an object to be thermally managed, for example the portion of a person's body comprising a post-operative site, utilizing the phase change material temperature control bandage 100 of the invention, said method comprising the following steps: 1) determining a desired temperature to apply to an area of a body of a person in order to achieve a desired temperature of the area, such as providing cooling to a wound to facilitate wound healing and to inhibit infection 400; 2) selecting temperature control bandage covering 102 material and thickness, and determining the temperature control pad covering material and graphene coating thermal resistance 401; 3) selecting a PCM material for use in the temperature control bandage for maintaining a constant bandage temperature T while the PCM in the temperature control bandage 100 is transitioning state, such that heat transferred from the body of a patient to the temperature control bandage through the covering materials 102 and graphene coating results in a desired temperature being applied to a portion of the person's body, given the thermal losses 402; 4) providing a temperature control bandage comprising the selected PCM enclosed with the selected temperature control pad covering material and thickness 403; 5) charging the PCM material to a desired temperature that is above the PCM phase change temperature T in the case where it is desired to transfer heat to a portion of the body of a user from the temperature control pad, or charging the PCM material to a desired temperature that is below the PCM phase transition temperature T in the case where it is desired to transfer heat from a portion of the body of a user to the temperature control pad 404; and 6) causing temperature controlling bandage of the invention to be applied to a desired portion of the body of a person, such as, for example, a wound site, while the PCM material is undergoing phase transition 405.

[0052] In alternate embodiments of the method, more than one PCM may comprise the PCM utilized in the invention, resulting in the use of a PCM mixture, as may be necessary to achieve a specific desired PCM phase change temperature T, or to achieve any desired step function in, or duality of, PCM phase transition temperature T. In further alternate embodiments of the invention, one or more covering materials may be utilized, and each may be analyzed for thermal conductivity in order to achieve the desired thermal transfer between the body of a user and the temperature control pad.

[0053] In an embodiment of the invention, the phase transition temperature T is defined to be between 40 °F and 70 °F, inclusive. This embodiment provides temperature control, or thermal management, by cooling the skin of a person.

[0054] In a further embodiment of the invention, the phase transition temperature T is defined to be between 80 °F and 110 °F, inclusive. This embodiment provides temperature control, or thermal management, by warming the skin of a person. These temperature ranges have been found to be therapeutic.

INDUSTRIAL APPLICABILITY

[0055] The invention described and claimed herein provides a novel and useful temperature controlling bandage comprising phase change material that is able to thermally manage an object with which it is in thermal communication. The phase change material may be selected to transition physical state at a predetermined temperature, thus enabling both heating and cooling of objects.

[0056] In a specific embodiment of the invention, the object to be thermally managed may be a wound site such as a post operative wound site on a person. The application of cooling or warming temperature operates to promote and to accelerate wound healing. The bandage is able to be packaged in a sterile package and is also able to be packaged in a reusable package. The temperature controlling bandage is reusable practically indefinitely.

Claims

CLAIMS What is claimed is:

1. A temperature controlling bandage, comprising:

a pouch comprising an enclosed volume;

a phase change material disposed within said enclosed volume of said pouch;

adhesive for attaching to a surface of an object to be thermally managed disposed on an exterior surface of said pouch; wherein

when said exterior surface of said pouch is attached to said surface of an object to be thermally managed using said adhesive, said phase change material is in thermal communication with said surface of an object to be thermally managed.

2. The bandage of claim 1, further comprising an intervening material attached to said exterior surface, said material being disposed between said exterior surface of said pouch and said surface of an object to be thermally managed, wherein said intervening material is further defined as selected from the group consisting of an absorbent spunbond material, a hydrogel, or an adhesive hydrogel.

3. The bandage of claim 1, wherein said bandage is completely enclosed by sterile packaging.

4. The bandage of claim 2, wherein said bandage is completely enclosed by sterile packaging.

5. The bandage of claim 1, further comprising a reusable package for containing said bandage, said reusable package comprising a first reusable package layer and a second reusable package layer that are attached along a portion of their periphery, forming a partially enclosed volume having an closable opening through which said bandage may be inserted into and removed through the partially enclosed volume.

6. The bandage of claim 2, further comprising a reusable package for containing said bandage, said reusable package comprising a first reusable package layer and a second reusable package layer that are attached along a portion of their periphery, forming a partially enclosed volume having an closable opening through which said bandage may be inserted into and removed through the partially enclosed volume.

7. The bandage of claim 1, wherein said pouch is comprised of a first layer of material and second layer of material that have been overlaid forming a periphery, and wherein said first layer and said second layer are sealingly attached along said periphery forming said enclosed volume of said pouch.

8. The bandage of claim 2, wherein said pouch is comprised of a first layer of material and second layer of material that have been overlaid forming a periphery, and wherein said first layer and said second layer are sealingly attached along said periphery forming said enclosed volume of said pouch.

9. The bandage of claim 7 wherein said first layer of material and said second layer of material are comprised of a plastic material.

10. The bandage of claim 7 wherein said attachment of said first layer of material and said second layer of material is achieved by an attachment means selected from the group consisting of chemical bonding, heat sealing, and ultrasonic welding.

11. The bandage of claim 8 wherein said first layer of material and said second layer of material are comprised of a plastic material.

12. The bandage of claim 8 wherein said attachment of said first layer of material and said second layer of material is achieved by an attachment means selected from the group consisting of chemical bonding, heat sealing, and ultrasonic welding.

13. The bandage of claim 1, wherein said phase change material is further defined as transitioning phase between solid to liquid at a temperature between 40° Fahrenheit and 70° Fahrenheit.

14. The bandage of claim 2, wherein said phase change material is further defined as transitioning phase between solid and liquid at a temperature between 40° Fahrenheit and 70° Fahrenheit.

15. The bandage of claim 1, wherein said phase change material is further defined as transitioning phase between solid and liquid at 49° Fahrenheit.

16. The bandage of claim 2, wherein said phase change material is further defined as transitioning phase between solid and liquid at 49° Fahrenheit.

17. The bandage of claim 1, wherein said phase change material is further defined as transitioning phase between solid and liquid at a temperature between 80° Fahrenheit and 110° Fahrenheit.

18. The bandage of claim 2, wherein said phase change material is further defined as transitioning phase between solid and liquid at a temperature between 80° Fahrenheit and 110° Fahrenheit.

19. The bandage of claim 1, further comprising either a loop portion or a hook portion of a hook and loop fastener system attached to an exterior surface of the bandage for attaching said exterior surface of said bandage to an structure in proximity to said surface of an object to be thermally managed.

20. The bandage of claim 2, further comprising either a loop portion or a hook portion of a hook and loop fastener system attached to an exterior surface of the bandage for attaching said exterior surface of said bandage to an structure in proximity to said surface of an object to be thermally managed.

21. A temperature controlling bandage, comprising:

a pouch comprising an enclosed volume;

a phase change material disposed within said enclosed volume of said pouch;

an adhesive hydrogel for attaching to a surface of an object to be thermally managed disposed on an exterior surface of said pouch; wherein

when said exterior surface of said pouch is attached to said surface of an object to be thermally managed using said adhesive hydrogel, said phase change material is in thermal communication with said surface of an object to be thermally managed.

22. The bandage of claim 21, wherein said bandage is completely enclosed by sterile packaging.

23. The bandage of claim 21, further comprising a reusable package for containing said bandage, said reusable package comprising a first reusable package layer and a second reusable package layer that are attached along a portion of their periphery, forming a partially enclosed volume having an closable opening through which said bandage may be inserted into and removed through the partially enclosed volume.

24. The bandage of claim 22, further comprising a reusable package for containing said bandage, said reusable package comprising a first reusable package layer and a second reusable package layer that are attached along a portion of their periphery, forming a partially enclosed volume having an closable opening through which said bandage may be inserted into and removed through the partially enclosed volume.

25. The bandage of claim 21, wherein said pouch is comprised of a first layer of material and second layer of material that have been overlaid forming a periphery, and wherein said first layer and said second layer are sealingly attached along said periphery forming said enclosed volume of said pouch.

26. The bandage of claim 22, wherein said pouch is comprised of a first layer of material and second layer of material that have been overlaid forming a periphery, and wherein said first layer and said second layer are sealingly attached along said periphery forming said enclosed volume of said pouch.

27. The bandage of claim 25 wherein said first layer of material and said second layer of material are comprised of a plastic material.

28. The bandage of claim 25 wherein said attachment of said first layer of material and said second layer of material is achieved by an attachment means selected from the group consisting of chemical bonding, heat sealing, and ultrasonic welding.

29. The bandage of claim 26 wherein said first layer of material and said second layer of material are comprised of a plastic material.

30. The bandage of claim 26 wherein said attachment of said first layer of material and said second layer of material is achieved by an attachment means selected from the group consisting of chemical bonding, heat sealing, and ultrasonic welding.

31. The bandage of claim 21, wherein said phase change material is further defined as transitioning phase between solid to liquid at a temperature between 40° Fahrenheit and 70° Fahrenheit.

32. The bandage of claim 22, wherein said phase change material is further defined as transitioning phase between solid and liquid at a temperature between 40° Fahrenheit and 70° Fahrenheit.

33. The bandage of claim 21, wherein said phase change material is further defined as transitioning phase between solid and liquid at 49° Fahrenheit.

34. The bandage of claim 22, wherein said phase change material is further defined as transitioning phase between solid and liquid at 49° Fahrenheit.

35. The bandage of claim 21, wherein said phase change material is further defined as transitioning phase between solid and liquid at a temperature between 80° Fahrenheit and 110° Fahrenheit.

36. The bandage of claim 22, wherein said phase change material is further defined as transitioning phase between solid and liquid at a temperature between 80° Fahrenheit and 110° Fahrenheit.

37. The bandage of claim 21, further comprising either a loop portion or a hook portion of a hook and loop fastener system attached to an exterior surface of the bandage for attaching said exterior surface of said bandage to an structure in proximity to said surface of an object to be thermally managed.

38. The bandage of claim 22, further comprising either a loop portion or a hook portion of a hook and loop fastener system attached to an exterior surface of the bandage for attaching said exterior surface of said bandage to an structure in proximity to said surface of an object to be thermally managed.

39. A method for thermally managing an area of a body of a person, comprising the steps of: providing a temperature controlling bandage comprising:

a pouch comprising an enclosed volume;

a phase change material disposed within said enclosed volume of said pouch; adhesive for attaching to the skin of a person disposed on an exterior surface of said pouch; and

placing said temperature controlling bandage on an area of a person's body such that said adhesive causes a removable attachment between said exterior surface of said temperature controlling bandage and said area of a person's body, and said phase change material is in thermal communication with said area of a person' s body while said phase change material is undergoing phase transition.

40. The method for thermally managing an area of a body of a person of claim 39, wherein said adhesive is a hydrogel adhesive.

41. The method for thermally managing an area of a body of a person of claim 39, wherein said area of a body of a person is further defined as a wound site.

42. The method for thermally managing an area of a body of a person of claim 40, wherein said area of a body of a person is further defined as a wound site.

43. The method for thermally managing an area of a body of a person of claim 39, wherein said phase transition temperature is between 40° Fahrenheit and 70° Fahrenheit.

44. The method for thermally managing an area of a body of a person of claim 40, wherein said phase transition temperature is between 40° Fahrenheit and 70° Fahrenheit.

45. The method for thermally managing an area of a body of a person of claim 39, wherein said phase transition temperature is 49° Fahrenheit.

46. The method for thermally managing an area of a body of a person of claim 40, wherein said phase transition temperature is 49° Fahrenheit.

47. The method for thermally managing an area of a body of a person of claim 39, wherein said phase transition temperature is between 80° Fahrenheit and 110° Fahrenheit.

48. The method for thermally managing an area of a body of a person of claim 40, wherein said phase transition temperature is between 80° Fahrenheit and 110° Fahrenheit.

49. A method for controlling the temperature of a area of a person's body, comprising: determining a desired temperature for said area of a person' s body;

determining a thermal resistance arising from intervening materials between skin comprising said area of a person' s body and a phase change material; selecting said phase change material for use in a temperature controlling bandage for maintaining a constant a temperature controlling bandage temperature T while the phase change material is transitioning physical state, such that heat transferred from the post-operative area the body of a patient from the temperature control pad through the temperature control pad materials, or heat transfer from the body of a patient to the temperature control pad through the temperature control pad materials, results in a desired temperature being applied to said area of a person' s body;

providing a temperature controlling bandage having an enclosed volume containing the selected phase change material;

charging the temperature controlling bandage comprising the selected phase change material to a desired temperature that is above the phase change material phase transition temperature T in the case where it is desired to transfer heat to the body of a user from the temperature control pad, or charging the temperature control pad comprising the selected phase change material to a desired temperature that is below the phase change material phase transition temperature T in the case where it is desired to transfer heat from the body of a user to the temperature control pad; and

disposing temperature controlling bandage on a post-operative area of a body of a person such that said PCM is in thermal communication with said area of a person's body while the PCM is transitioning state, thereby causing thermal management of said post-operative area.

50. The method for thermally managing an area of a body of a person of claim 49, wherein said area of a body of a person is further defined as a wound site.

51. The method for thermally managing an area of a body of a person of claim 49, wherein said phase transition temperature is between 40° Fahrenheit and 70° Fahrenheit.

52. The method for thermally managing an area of a body of a person of claim 50, wherein said phase transition temperature is between 40° Fahrenheit and 70° Fahrenheit.

53. The method for thermally managing an area of a body of a person of claim 49, wherein said phase transition temperature is 49° Fahrenheit.

54. The method for thermally managing an area of a body of a person of claim 50, wherein said phase transition temperature is 49° Fahrenheit.

55. The method for thermally managing an area of a body of a person of claim 49, wherein said phase transition temperature is between 80° Fahrenheit and 110° Fahrenheit.

56. The method for thermally managing an area of a body of a person of claim 50, wherein said phase transition temperature is between 80° Fahrenheit and 110° Fahrenheit.