WO2015175194A1

WO2015175194A1 - Devices and methods for transferring heat with a portion of a mammal

Info

Publication number: WO2015175194A1
Application number: PCT/US2015/027768
Authority: WO
Inventors: Jr. Charles A. HIXSON
Original assignee: Avacore Technologies, Inc.
Priority date: 2014-05-15
Filing date: 2015-04-27
Publication date: 2015-11-19

Abstract

Devices and methods for transferring heat with a portion of a mammal are provided. Embodiments of the subject devices include a negative pressure element configured to apply negative pressure to a portion of a mammal and a heat transfer element positioned within the negative pressure element. The disclosed devices and methods find use in a variety of different applications, including both therapeutic and non-therapeutic applications.

Description

DEVICES AND METHODS FOR TRANSFERRING HEAT

WITH A PORTION OF A MAMMAL

CROSS-REFERENCE TO RELATED APPLICATIONS

Pursuant to 35 U.S.C. § 1 19 (e), this application claims priority to the filing date of U.S.

Provisional Patent Application Serial No. 61/993,721 filed May 15, 2014; the disclosure of which application is herein incorporated by reference.

I NTRODUCTION

Mammalian body temperature is normally controlled by an internal autonomic regulatory system referred to herein as the thermoregulatory system. One important effector in this system is controlled by blood flow to specialized skin areas of the body at non-hairy skin surfaces (i.e., at the palms, soles of the feet, cheeks/nose regions). Subcutaneous to these areas, there are unique anatomical vascular structures called venous plexuses. These structures serve to deliver large volumes of blood adjacent the skin surface. By this delivery of blood, significant heat transfer is enabled for the maintenance of internal organs within a functional temperature range. Blood is permitted to pass through the venous plexuses "radiator" structures by way of arterio venous anastamosis, or "AVA's" that gate or control the arterial input side of the venous plexuses. Thus, the AVA's serve an integral part of the heat transfer system, providing thermoregulatory control. Together, the AVA's and venous plexuses comprise a body's relevant heat exchange vasculature.

Normally, when body and/or environmental temperatures are high, dilation of certain blood vessels favors high blood flow to the noted heat exchange surfaces, thus increasing heat loss to the environment and reduction in the deep body core region temperature. As environmental and/or body temperatures fall, vasoconstriction reduces blood flow to these surfaces and minimizes heat loss to the environment.

SUMMARY

Devices and methods for transferring heat with a portion of a mammal are provided. Embodiments of the subject devices include a negative pressure element configured to apply negative pressure to a portion of a mammal and a heat transfer element positioned within the negative pressure element. In certain aspects, the heat transfer element is configured to contact and transfer heat with a portion of a mammal, e.g., either remove heat from or introduce heat into, the contacted portion of the mammal. The disclosed devices and methods find use in a variety of different applications, including both therapeutic and non-therapeutic applications.

BRIEF D ESCRI PTION OF THE FIGURES FIG. 1 provides a partial cross-sectional side view of a device according to an embodiment. FIG. 2 provides a partial cross-sectional top view of a device according to an embodiment.

FIG. 3 provides a partial cross-sectional side view of a device according to an embodiment. FIG. 4 provides a partial cross-sectional side view of a device according to an embodiment. FIG. 5 provides a perspective view of an embodiment of a device that can be employed to practice an embodiment.

DETAILED D ESCRI PTION

Devices and methods for transferring heat with a portion of a mammal are provided.

Embodiments of the subject devices include a negative pressure element configured to apply negative pressure to a portion of a mammal and a heat transfer element positioned within the negative pressure element. In certain aspects, the heat transfer element is configured to contact and transfer heat with a portion of a mammal, e.g., either remove heat from or introduce heat into, the contacted portion of the mammal. The disclosed devices and methods find use in a variety of different applications, including both therapeutic and non-therapeutic applications.

Before the present invention is described in greater detail, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

Certain ranges may be presented herein with numerical values being preceded by the term "about." The term "about" is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes.

In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, representative illustrative methods and materials are now described.

All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or use of a "negative" limitation.

Additionally, certain embodiments of the disclosed devices and/or associated methods can be represented by drawings which may be included in this application. Embodiments of the devices and their specific spatial characteristics and/or abilities include those shown or substantially shown in the drawings or which are reasonably inferable from the drawings. Such characteristics include, for example, one or more (e.g., one, two, three, four, five, six, seven, eight, nine, or ten, etc.) of: symmetries about a plane (e.g., a cross-sectional plane) or axis (e.g., an axis of symmetry), edges, peripheries, surfaces, specific orientations (e.g., proximal; distal), and/or numbers (e.g., three surfaces; four surfaces), or any combinations thereof. Such spatial characteristics also include, for example, the lack (e.g., specific absence of) one or more (e.g., one, two, three, four, five, six, seven, eight, nine, or ten, etc.) of: symmetries about a plane (e.g., a cross-sectional plane) or axis (e.g., an axis of symmetry), edges, peripheries, surfaces, specific orientations (e.g., proximal), and/or numbers (e.g., three surfaces), or any combinations thereof.

As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.

In further describing the subject invention, subject devices for use in practicing the subject methods will be discussed in greater detail, followed by a review of methods and particular applications.

DEVICES

As described above, aspects of the invention include devices configured to transfer, e.g., remove or introduce, energy, e.g., thermal energy, e.g. , heat, from a portion of a mammal.

Embodiments of the devices include a negative pressure element and a heat transfer element, e.g., cooling or heating element, which are integrated components that are configured to operate together to transfer heat from a portion of a mammal. As the negative pressure and heat transfer elements are integrated components, they cannot be separated from each other without altering the physical structure of one or both of the elements. For example, the heat transfer element may be positioned within and/or fixedly attached to the negative pressure element in a manner such that the heat transfer element cannot be removed from the negative pressure element without in some way altering the physical structure of the negative pressure element. As the heat transfer and negative pressure elements are integrated, they are not configured to operate separately from each other for their intended purpose, e.g., to produce a negative pressure environment and contact a surface of a mammal with a reduced temperature surface, e.g., as described in greater detail below. In further describing various aspects of the invention, the negative pressure and heat transfer elements are now described in greater detail, respectively.

Negative Pressure Elements

As summarized above, devices of the disclosed embodiments include a negative pressure element. Negative pressure elements are elements configured to produce and/or retain a negative pressure in a portion or region, e.g., a chamber, of the device. As used herein, the phrase "negative pressure" refers to a pressure lower than ambient pressure under the particular conditions in which the device is employed or the method is performed, e.g., 760 mmHg at sea level. The magnitude of the decrease in pressure from the ambient pressure to negative pressure is, in some instances, 20 mmHg or more, such as 30 mmHg or more, including 35 mmHg or more, where the magnitude of the decrease may be as great as 85 mmHg or more, but also may be 60 mmHg or less, such as 50 mmHg or less. When a method is performed at or about sea level, the negative pressure ranges in some instances from 740 mmHg to 675 mmHg, such as from 730 mmHg to 700 mmHg, including from 725 mmHg to 710 mmHg.

The phrase "negative pressure element", as used herein, refers to a device element configured for inducing and/or maintaining negative pressure, e.g., negative pressure within a specific enclosed area of the device, such as an area enclosed by a portion of a negative pressure element. Such a negative pressure element may be configured for applying negative pressure for a length of time, e.g., a length of time for effective employment of the devices and/or methods described herein, e.g., a length of time sufficient to induce a lower core body temperature of a mammal.

The enclosed portion in which negative pressure is produced is configured or dimensioned to receive and/or produce a portion, e.g., limb or extremity thereof, head, etc., of a mammal. The terms "mammal" and "mammals" are used broadly herein to describe organisms which are within the class mammalia, including the orders carnivore (e.g., dogs and cats), rodentia (e.g., mice, guinea pigs, and rats), and primates (e.g., humans, chimpanzees, and monkeys). Mammals may be subjects or patients, such as human subjects or patients. The terms "human" or "humans" may include human subjects or patients of both genders and at any stage of development (i.e., fetal, neonates, infant, juvenile, adolescent, adult), where in certain embodiments the human subject is a juvenile, adolescent or adult. While the devices and methods described herein may be applied on a human subject, it is to be understood that the subject devices and methods may also be applied on other subjects (that is, in "non-human subjects").

As noted above, negative pressure elements may be configured to produce, or hold and/or receive, an enclosed portion of a mammal. As used herein, the phrase "enclosed portion of a mammal" refers to a portion of a mammal, e.g., a wrist and/or hand, foot and/or ankle, head and/or neck, which lies partially or substantially within, such as between two or more portions, e.g., opposite interior portions of, or encapsulated within, a negative pressure element. An enclosed portion of a mammal may be a portion of a mammal that is contained within or surrounded by a negative pressure environment induced by the negative pressure element. An enclosed portion of a mammal may be, for example, one or more of a hand, and/or a foot, and/or an arm, and/or a leg, and/or a finger, and/or a head, and the like, or any combination, as well as portion, thereof. An enclosed portion of a mammal may include one or more portions of a mammal, e.g., a mammalian heat transfer surface, which is a surface of a mammal through which heat may transfer, with which a heat exchange surface of a heat transfer element, as described in greater detail below, is configured to transfer heat.

A portion of a mammal with which a heat exchange surface of a heat transfer element, as described in greater detail below, is configured to transfer heat may be a surface on and/or in the body of a mammal through which heat may transfer between the core body and the environment of the mammal. Portions of a mammal e.g., mammalian heat transfer surfaces, which are of interest with the subject devices and methods include those found in various regions of the mammal, e.g., extremities. For example, such portions may include one or more of the arms, legs, palms, soles, foreheads, temples, occipital regions, and the like, or any combination thereof.

In some embodiments, negative pressure elements include a sealed enclosure, such as an enclosure for receiving and containing therein a portion of a mammal. In various instances, negative pressure elements are configured to induce and/or maintain negative pressure within the sealed enclosure. The volume of the negative pressure enclosure of the element may vary, ranging in some instances from 5 cm³ to 40 cm³, such as from 10 cm³ to 30 cm³, including from 10 cm³ to 20 cm³. Such a volume may be substantially the same volume as or a slightly larger volume (e.g., greater than by 1 cm³ or less, 5 cm³ or less, 10 cm³ or less, 50 cm³ or less, or 100 cm³ or less) than the volume of a portion of a mammal enclosed within the negative pressure element. Such a volume may be sized to fit, e.g., to encapsulate, 95% of human hand sizes and/or 95% of human foot sizes. Alternatively, it may be sized for more specific groups, such as children.

In some embodiments, the subject devices and/or the negative pressure elements thereof are configured to be portable. For example, the subject devices and/or the negative pressure elements thereof may be sized and shaped to be easily moved from one location to another by an amount of force capable of being exerted by an average child and/or adult human arm and/or hand. In certain aspects, the subject devices, e.g., devices including the negative pressure elements and/or heat transfer elements described herein, have a mass ranging, for example, from 100 g to 3000 g, from 140 g to 2900 g, from 500 g to 2000 g, or from 1300 g to 1400 g.

Various embodiments of negative pressure elements include one or more openings (e.g., two, three, four, five openings) configured to receive a portion of a mammal, e.g., a portion of a mammal including a mammalian heat transfer surface. Such an opening may separate the interior form the exterior of the negative pressure element and may be shaped as any convenient shape, e.g., a circle, oval, square, rectangle, triangle, or any combination thereof. An opening of a negative pressure element may also be sized to receive a portion of a mammal therethrough, e.g., a hand and/or a foot. An opening of a negative pressure element may have, for example, an area of 25 cm² or less, 100 cm² or less, or 225 cm² or less. The opening of a negative pressure element may be the only single opening from the interior to the exterior of the element. If there are a plurality of openings on the element, the openings may also be at opposite first and second ends of the element.

In some embodiments of the disclosed devices, the negative pressure elements include one or more sealing elements (e.g., one, two, three, four, five sealing elements) configured to produce a seal, e.g., a reversible seal, about e.g., around, a portion of a mammal, e.g., a portion of a mammal received into and/or contained within a negative pressure element. By "reversible seal" is meant a seal which can be repeatedly broken (e.g., made to not seal) and re-sealed. A seal may be an airtight and/or water-tight seal and/or a seal between two different pressure levels, e.g., a negative pressure level and another pressure level, e.g., a pressure level immediately surrounding a negative pressure element. Such a seal may separate two pressure levels and maintain the difference between one pressure level and another. A sealing element of a negative pressure element may also form, e.g., be form-fitted, around a portion of a mammal, e.g., an arm and/or a wrist. A sealing element may be a portion of a negative pressure element which contacts a portion of a mammal. A sealing element may close an air and/or water-permeable opening between a negative pressure element and a portion of a mammal, e.g., such that the opening is made air-tight and/or water-tight. Sealing elements may be proximate (e.g., adjacent and/or attached to) an opening, or a plurality of openings, of a negative pressure element. One embodiment of a sealing element is shown, for example in FIG. 1 as sealing element 5, and is described in further detail below.

A seal of a sealing element may be a hard or soft seal. A "hard" seal is characterized as one designed to altogether avoid air leakage past the boundary it provides. In theory, a "hard" seal will allow a single evacuation of a negative pressure chamber for use in the methods. In practice, however, a "hard" seal can produce a tourniquet effect. Also, any inability to maintain a complete seal will be problematic in a device requiring as much. A "soft" seal as described herein is characterized as providing an approximate or imperfect seal at a user/seal interface. Such a seal may be more compliant in its interface with a user. Indeed, in response to user movement, such a seal may leak or pass some air at the user/seal interface. In a negative pressure element designed for use with a soft seal, a regulator or another feedback mechanism/routine may cause a vacuum pump, generator, fan or any such other mechanism capable of drawing a vacuum to respond and evacuate such air as necessary to stabilize the pressure within the element, e.g., within a chamber of the element, returning it to the desired level.

One embodiment of a device for transferring heat with a portion of a mammal for use in practicing the subject methods is provided in FIGS. 1 and 2. The embodiment of the device 1 includes a negative pressure element 2 and a heat transfer element 3 including a phase change material 15 and a heat exchange surface 14. As shown in FIG. 1 , the negative pressure element 2 includes a sealed enclosure 6. The sealed enclosure 6 is dimensioned to fully or partially fit around, e.g., encapsulate, an enclosed portion of a mammal, e.g., a portion of an appendage, e.g., a hand 4.

A sealed enclosure 6 can be made of virtually any non-hazardous material, or combination of materials/structures, which retains the requisite shape while the interior of sealed enclosure 6 is maintained at negative pressures, where in the broadest sense the material may be rigid or flexible (where in certain embodiments when the material is flexible, it is supported by a rigid framework). In some instances, sealed enclosure 6 is configured to support negative pressures down to -85 mmHg, or in certain embodiments, -85 mmHg or lower. In one embodiment, sealed enclosure 6 is flexible and may be made of pliant and elastic materials which can include supporting or reinforcing members. This type of construction easily accommodates movements of a hand 4 and thus provides the mammal with more comfort and freedom during practice of the subject methods than would a rigid enclosure. In some embodiments sealed enclosure 6 is a neoprene-impregnated polyester sheath supported on a spring steel wire helix.

A sealing element 5 may, in some aspects, be flexible and/or be attached at a proximal rim 7 of a sealed enclosure 6. Sealing element 5, in various embodiments, is made of a synthetic material impermeable to air, e.g., Neoprene^®, or substantially impermeable to air. The tubular form of sealing element 5 ensures that it fits snugly around appendage 8 and conforms to the appendage's shape.

In the embodiment shown in FIGS. 1 and 2, sealed enclosure 6 of negative pressure element 2 is provided with a vacuum pump 8. In some embodiments, vacuum pump 8 includes a pressure inlet and/or an adjustable valve 9 configured to guarantee maintenance of a desired pressure inside sealed enclosure 6, for example by allowing air to selectively pass through or not pass through the valve 9. Vacuum pump 8 is, in some aspects, capable of generating negative pressures, e.g., pressures down to -85 mmHg or, in some embodiments -85 mmHg or less, inside sealed enclosure 6.

The delivery of this negative pressure through valve 9 can be regulated for example, in some embodiments, by a vacuum pump having an on/off switch 10 e.g., a manually operable on/off switch, configured to turn the vacuum pump on and/or off. In some embodiments, the on/off switch 10 is operatively connected to a timer which is configured to turn the switch on and/or off after a particular length of time. By "operatively connected" and "operatively connect", as used herein, is meant connected in a specific way, e.g., in a manner allowing electric power and/or thermal energy, e.g., heat, to be transmitted and/or in a manner physically coupling e.g., releasably or fixedly coupling, one aspect to another, that allows the disclosed devices to operate and/or methods to be carried out effectively in the manner described herein. In some embodiments, the on/off switch 10 is operatively connected to a pressure gauge 1 1 and is configured to turn on and/or off, e.g., automatically turn on and/or off, when a particular pressure is reached within the device. In some embodiments, pressure gauge 1 1 includes a display 12 for visually indicating the pressure level inside the sealed enclosure 6. In some variations, a battery and/or adjustable valve 9, and/or pressure gauge 1 1 , and/or display 12, and/or on/off switch 10 are not included in or on a negative pressure element.

In some embodiments, a vacuum pump 8, and/or pressure a gauge 1 1 , or elements thereof, are operatively connected (e.g., electrically coupled) to one another and/or to a power source. A power source may, in some aspects, be a battery 13, e.g., a portable and/or self-contained battery, an outlet, or another source of electrical power. In some aspects, a power source may include one or more electrical cords, e.g., cords configured to operatively connect a device to an outlet. Cords of power sources may be configured to removably connect to a pump and/or an outlet. In some embodiments, a battery 13 and/or vacuum pump 8, and/or adjustable valve 9, and/or pressure gauge 1 1 , and/or display 12 and/or on/off switch 10 are self-contained, e.g., attached and/or positioned in a portable and/or convenient manner, on a negative pressure element 2, e.g., on the exterior of a sealed enclosure 6 of the negative pressure element 2. In some variations of the subject devices, a battery 13 and/or vacuum pump 8, and/or adjustable valve 9, and/or pressure gauge 1 1 , and/or display 12 and/or on/off switch 10 are positioned within e.g., entirely, partially, or substantially within a negative pressure element, e.g., a sealed enclosure 6 of a negative pressure element 2. Accordingly, in some aspects, negative pressure elements include an integrated source of electrical power, e.g., a battery. As such, in some embodiments, the subject devices and the negative pressure elements thereof are configured to be portable. For example, the subject devices and the negative pressure elements thereof may be sized and shaped to be easily moved from one location to another by an amount of force capable of being exerted by an average child and/or adult human arm and/or hand. While the embodiment depicted in FIG. 1 shows pump 8 as an integrated vacuum source, the vacuum source and its associated components may also be separate from but operably connected to the sealed enclosure 6.

As is described further in the methods section below, the subject devices are simple to use. First, a mammal's hand 4 is inserted through sealing element 5 and thereby placed inside sealed enclosure 6 of negative pressure element 2 against a heat transfer element 3. In this position, sealing element 5 wraps around a portion of appendage 8. To ensure that sealing element 5 conforms closely to the contour of the portion of appendage 8, the latter is bare. With hand 4 properly inserted into sealed enclosure 6 of negative pressure element 2, pump 8 is activated to produce a negative pressure, e.g., a pressure between -20 mmHg and -85 mmHg, inside sealed enclosure 6. Sealing element 5, under the influence of negative pressure or suction, seals tightly around a part of appendage 8 to preserve the vacuum inside sealed enclosure 6.

The device for transferring heat shown in FIGS. 1 and 2 is merely one embodiment of devices that can be employed to practice the subject methods. Other device configurations are possible and come within the scope of the subject disclosure. For example, the enclosures may take the form of mittens, gloves, etc., e.g., for enclosing hands or portions thereof; shoes, boots, socks, etc., e.g., for enclosing feet or portions thereof; helmets, hats, caps, etc., e.g., for enclosing heads or portions thereof. For example, a helmet such as a football helmet, batting helmet, lacrosse helmet, hockey helmet, bicycle helmet, ski helmet, snow board helmet, etc., may be configured to include a heating element and negative pressure component, e.g., as described herein.

As noted above, FIGS. 1 and 2 also depict one embodiment of a heat transfer element 3 which can be utilized in accordance with the subject methods. The embodiment of the heat transfer element 3 shown in FIG. 1 is described further below and is merely an example of one type of heat transfer element of interest.

FIG. 5 provides a view of an embodiment of a device including negative pressure element 500 that can be employed to practice the subject methods. The embodiment of the device including the negative pressure element shown in FIG. 5, and variations thereof, portions of which may be used in accordance with the subject devices and methods, are described in greater detail in United States Patent Nos. 6,656,208; 6,974,442; and 8,177,826, the disclosures of which are incorporated by reference herein. Also of interest are devices as described in greater detail in United States Patent Nos. 6,602,277; 7,182,776; 8,277,496; 6,966,922; 7,862,600; 8,287,581 ; 7,122,047; and 7,947,068; as well as Published PCT Application WO/1996/028120; the disclosures of which applications are herein incorporated by reference.

The devices may include a sealing element which may, in some aspects, be flexible and/or be attached at a proximal rim of a sealed enclosure. The tubular form of sealing element of such embodiments ensures that it fits snugly around an appendage and conforms to the appendage's shape during use. Where desired, devices may include a pressure regulator, which may be employed in accordance with the subject methods to, for example, maintain a negative pressure within the device and, in some embodiments, include an adjustable valve and/or a vacuum pump. In some such embodiments, a vacuum pump includes a pressure inlet and/or an adjustable valve configured to guarantee maintenance of a desired pressure inside the sealed enclosure, for example by allowing air to selectively pass through or not pass through the valve. Such devices may include a switch, e.g., a switch configured to a turn vacuum pump on and/or off, e.g., a manually actuable switch. The device may include a variety of power sources, e.g., a battery which may be employed with the subject devices and according to the subject methods. Heat Transfer Elements

Devices of the disclosed embodiments include one or more heat transfer elements, which may be heating and/or cooling elements. Heating elements are elements that are configured to introduce heat to the enclosed portion of the mammal. As such, heating elements are elements that configured to cause energy transfer into a subject from the heating element upon contact of the heating element with a heat exchange surface of the subject, e.g. , a mammalian heat transfer surface. As discussed further below, in some embodiments of the disclosed devices, e.g. , devices including a heating element, the devices are configured to introduce heat into the body core of a mammal to, for example, elevate the core body temperature of a mammal.

Alternatively, cooling elements are elements that are configured to remove heat from the enclosed portion of the mammal. Embodiments of the subject cooling elements are configured to contact a portion of a mammal, such as a mammalian heat transfer surface and operate, for example, with a negative pressure element, to remove heat from the mammal. As such, the cooling elements are configured to cause energy transfer from a subject to the cooling element upon contact of the cooling element with a portion of the subject. Accordingly, and as discussed further below, in some embodiments of the disclosed devices, e.g. , devices including a cooling element, the devices are configured to remove heat from the body core of a mammal to, for example, lower the core body temperature of a mammal. It is also notable that a heat transfer element may be both a heating and a cooling element, as such elements are described herein.

In various embodiments of the subject devices, heat transfer elements are fixedly attached to negative pressure elements. By "fixedly attached", as used herein, is meant attached in an irreversible or substantially irreversible manner such that the aspect and/or the feature to which it is attached must be altered or damaged, e.g. , altered or damaged such that it can no longer perform its intended purpose, in order to separate one from the other. Also, as indicated above, heat transfer elements of some embodiments may be integrated with negative pressure elements and as such, cannot be separated from each other without altering the physical structure of one or both integrated elements. In some embodiments, of devices having an integrated heat transfer element and negative pressure element, the heat transfer element is continuous with, e.g. , composed of the same material e.g. , formed from a continuous piece of the same material, the negative pressure element or a portion thereof, e.g. , a sealed enclosure. Heat transfer elements may also be attached, e.g. , fixedly attached, to negative pressure elements adhesively, by a physical form-fit e.g. , snapedly and/or slidably engaged, by one or more joining elements, e.g. , nails, screws, stables, etc. , by a melted joint resulting from melting the elements together, or by any combination thereof. In addition, in various aspects of the disclosed devices, heat transfer elements are positioned within e.g. , partially or entirely within, negative pressure elements or portions thereof e.g. , a sealed enclosure. A heat transfer element may include one or more surfaces, e.g., a heat exchange surface, for contacting and/or transferring heat with a portion of a mammal e.g., a palm and/or sole. Such heat exchange surfaces, in some embodiments, are sized and shaped to, together with a negative pressure element or a portion thereof, e.g., a sealed enclosure or a portion thereof, e.g., an interior surface of a sealed enclosure, define a smooth, e.g., lacking any distinct edges, interior cavity of a device for transferring heat as described herein. A heat exchange surface of a heat transfer element, in various embodiments, may be composed of the same material or materials, e.g., a heat- conductive material, as a portion of a negative pressure element and/or other portions of a heat transfer element.

Heat transfer elements may have any convenient size or shape to operate for the purposes described herein. As such, a heat transfer element may be a sheet, e.g., a sheet of material, such as a sheet configured to contact a portion of a mammal. A heat transfer element may also be formed as a pouch having an opening for receiving a portion of a mammal therein. In certain aspects, heat transfer elements are shaped substantially like a glove or a mitten or include a cavity therein having such a shape. In certain embodiments, heat transfer elements are substantially planar. Various embodiments of heat transfer elements have an outer periphery defining a shape which is, or substantially is, that of a circle, oval, rectangle (e.g., a rectangle having rounded corners), square, triangle, or any combination thereof. Certain variations of heat transfer elements have an outer periphery defining a single continuous edge. As discussed further below, a heat transfer element may, either alone or with a portion of a negative pressure element, form one or more containers, e.g. , containers configured for retaining therein a phase change material, e.g. , sealed containers. Heat transfer elements may also include one or more sealed or sealable receptacles (e.g., an openable and closable receptacle) for receiving into and/or sealing one or more substances, e.g., a phase change material, within the heat transfer elements. Such receptacles may be actuable between open and closed positions. Also, as is discussed above, in some embodiments, heat transfer elements are configured, e.g., sized and/or shaped, to fit entirely within, e.g., between at least two portions of, a negative pressure element while an enclosed portion of a mammal, e.g., an enclosed portion contacting the heat transfer element, is also within the negative pressure element.

Embodiments of heat transfer elements include one or more, e.g., one, or a plurality of, such as two, three, four, or more, containers, e.g., a sealed container, e.g., a sealed container configured to retain therein a phase change material. A container of a heat transfer element may include one compartment or a plurality, e.g., two, three, four, five, ten or fewer, fifty or fewer, one-hundred or fewer, such as between five and one-hundred, such as between forty and sixty, such as between forty-five and fifty-five, of compartments therein. Compartments of heat transfer elements may be one or more pockets, e.g., sealed pockets, such as air and/or water-tight pockets, within a heat transfer element. In certain embodiments of the disclosed devices, heat transfer elements or portions thereof, e.g., one or more containers, are flexible. For instance, a flexible heat transfer element, or a portion thereof, may be compliant, for example, such that it is configured to form a form-fitted surface, e.g., a heat exchange surface, which is complementary with a portion of a mammal, such as a mammalian heat transfer surface, e.g., a palm, against which it is placed. In various embodiments, flexible heat transfer elements, or portions thereof, such as containers, are polymeric. Polymeric heat transfer elements are heat transfer elements which have one or more portions composed of one or more polymeric materials. Polymeric heat transfer elements may be entirely or partially composed of one or more polymeric materials, e.g., a single polymeric material. Specific polymeric materials of interest include, but are not limited to: plastics, rubbers, silicones, etc.

In various embodiments of the disclosed devices, heat transfer elements or portions thereof, e.g., one or more containers, are rigid. For instance, a rigid heat transfer element may be non- compliant, or substantially non-compliant, for example, such that it does not change its shape when contacted with an aspect, such as a portion of a mammal, such as a mammalian heat transfer surface, such as a palm, against which the rigid heat transfer element is placed. In various embodiments, heat transfer elements, such as rigid heat transfer elements, are polymeric heat transfer elements.

Materials of which heat transfer elements or portions thereof may be composed include materials which have the requisite strength for the disclosed devices and methods to effectively be employed. For example, materials of which heat transfer elements may be composed include materials which are resistant to degrading and/or tearing and/or breaking when heat transfer elements are repeatedly employed according to the subject methods. Materials of which heat transfer elements or portions thereof may be composed also include materials which are sterilizable and/or re-sterilizable. Materials of which heat transfer elements are composed, in various embodiments, also include biodegradable and/or organic materials.

In embodiments of heat transfer elements including a plurality, such as two, three, four, or more, containers, the containers may be affixed to one another at edge portions of the containers. In such embodiments, a heat transfer element may be configured such that the heat transfer element and portions thereof, e.g., the container, may flex despite each individual container or pocket thereof containing therein a solid material, e.g., a phase change material. As noted above, in some embodiments, containers include a network of pockets. Pockets of containers may have a peripheral shape that is or substantially is that of a rectangle, square, triangle, diamond, circle, oval, hexagon, octagon, or any combination thereof. Such pockets may be connected to each other by edge portions of containers. In some embodiments, including embodiments of containers having pockets shaped as hexagons, the pockets may be positioned for example, with respect to one another, in a honeycomb arrangement, e.g., joined to one another, for example at 6 or fewer sides. However, as noted above, any suitable shape may be employed for such pockets, including an octagaonal shape e.g., joined to one another, for example at 8 or fewer sides and/or a triangular shape e.g., joined to one another, for example at 3 or fewer sides.

Heat transfer elements, e.g., cooling elements, or portions thereof, such as containers of heat transfer elements, in certain variations, contain (i.e., seal therein) or are adjacent to, one or more phase change materials. By "phase change material", as used herein, is meant a material which is configured to undergo a change, and in some instances repeated changes, from one phase to another, e.g., solid to liquid and/or liquid to solid, when exposed, e.g., thermally exposed, to one or more mediums, e.g., air, a surface of a mammal, decompressing or decompressed gas, etc., or any combination thereof, at various temperatures. In a broad sense, a phase change material may be a material or composition that is capable of attaining a temperature that, upon contact of the heat transfer element with a mammalian heat transfer surface, results in transfer of energy, e.g., heat energy, from the mammal to the phase change material or from the phase change material to the mammalian heat transfer surface. The phase change material may be a gas, liquid or solid, and may or may not include water.

Various embodiments of phase change materials are configured to change phase from a solid to a liquid (i.e., melt) or from a liquid to a solid after a period of time following contact with a portion of a mammal, such as a mammalian heat transfer surface. Such a period of time may range from 0.1 min to 120 min, such as from 0.5 min to 60 min, including from 1 min to 10 min, such as from 1 min to 12 min, e.g., from 1 min to 30 min.

Certain embodiments of phase change materials have a first "initial" temperature at which the materials are maintained. Such an initial temperature may be a temperature at which the phase change materials are a solid, e.g., maintained entirely in a frozen state. Such an initial temperature may also be a temperature at which the phase change materials are a liquid, e.g., maintained entirely in a melted state. An initial temperature of a phase change material may be achieved by, for example, placing the phase change material in a storage device, e.g., a cold or hot storage device, e.g., a cooler, e.g., a household refrigerator or freezer, for a period of time necessary for the phase change material to change phase, e.g., freeze.

Phase change materials also have a temperature, e.g., a second temperature, and/or a subsequent temperature, at which the materials, or at least a portion thereof, change from a solid to a liquid or, in other embodiments, from a liquid to a solid. In various embodiments, a subsequent temperature at which a phase change material is configured to change phase may range, for example, from 1 °C to 40 °C, from 10 °C to 30 °C, from 10 °C to 25 °C, from 10 °C to 22 °C, from 12 °C to 19 °C, or from 20 °C to 40 °C. The second temperature of phase change materials may occur following or be induced by a period of time of exposure or contact, e.g., thermal exposure, between the phase change material and a portion of a mammal, such as a mammalian heat transfer surface. Such contact or exposure may be through a portion of a heat transfer element, e.g., a heat exchange surface and/or a container containing and/or contacting the phase change material, which is positioned immediately adjacent to and/or contacting a portion of a mammal. A period of time of exposure or contact e.g., thermal exposure, between the phase change material and a portion of a mammal may be a period of time required for energy, such as thermal energy, such as thermal energy from a portion of a mammal, such as heat from a portion of a mammal, to be absorbed by the phase change material. Additionally, in embodiments of phase change materials in liquid form, the materials assume the shape of the heat transfer element or portion thereof, e.g., the interior of the container, within or against which the materials are contained.

Certain variations of phase change materials are configured to maintain the environment immediately surrounding (e.g., contacting, and/or within 1 cm, 2 cm, 5 cm, 10 cm, or 20 cm, or within a negative pressure element, or a portion thereof, such as a sealed enclosure) the material at the same temperature, or substantially the same temperature (e.g., within 1 °C, 2 °C, or 5 °C), as that of the phase change material. Embodiments of phase change materials are configured to maintain the environment immediately surrounding the materials at a substantially constant (e.g., within 0.5 °C, within 1 °C, or within 2°C) temperature, of for example 15.6 °C, for a length of time, e.g., 5 min, 10 min, 30 min, 1 hr, 2 hr, 6 hr, 24 hr, or a length of time required for the materials to fully melt or freeze. Certain embodiments of phase change materials are configured to maintain the environment immediately surrounding the materials at a substantially constant temperature after the phase change materials have been maintained in a solid state (i.e., frozen).

The temperature of phase change materials may vary, but in some aspects is not so low as to cause local vasoconstriction at a surface of a mammal, e.g. a mammalian heat transfer surface. Embodiments of phase change materials may have a temperature, e.g., a first temperature or a second temperature, ranging from 1 °C to 40 °C, from 10 °C to 30 °C, from 10 °C to 25 °C, from 10 °C to 22 °C, from 12 °C to 19 °C, or from 20 °C to 40 °C. In certain embodiments, phase change materials have a temperature, e.g., a first temperature or a second temperature, which is a temperature that provides for thermal energy extraction from the core body of a mammal and not local vasoconstriction.

In various aspects, phase change materials are configured such that exposure or contact, e.g., thermal exposure, may be maintained between the materials and a mammal for a period of time sufficient for a desired amount of core body thermal energy decrease or increase to occur. Such a period of time may be, for example, 1 min or less, 2 min or less, 3 min or less, or 5 min or less, and/or such exposure or contact may be maintained for 10 hr or less, such as 1 hour or less, such as 5 min or less.

In certain embodiments, phase change materials may include one or more oils e.g., a single oil or combination of two or more distinct oils. In embodiments of phase change materials which are oils, the materials may be one or more synthetic oils or naturally occurring oils. Phase change materials may have a variety of colors (e.g., white, green, blue, grey, black, red, yellow, or any combinations thereof) and can be substantially opaque or transparent.

Any convenient phase change material (PCM) may be employed. PCMs of interest, but are not limited to: organic PCMs (including paraffins and non-paraffins), inorganic PCMs, and eutectics, etc. Examples of organic PCMs that may be used include, but are not limited to, n-tetradeca, formic acid, n-pentadeca, acetic acid, n-hexadeca, caprilone, docasyle, n-henicosan, phenol, n-lauric, p- joluidine, cynamide, n-docosane, n-tricosane, hydrocinna, cetyl, o-nitroanili, camphene, diphenyl, n- penta cosane, myristic acid, oxolate, tristearin, o-xylene, β-chloroacetic, n-hexacosane, nitro naphthalene, a-chloroacetic, n-octacosane, palmitic acid, bees wax, glyolic acid, p-bromophenol, azobenzene, acrylic acid, dintro toluene, phenylacetic acid, and/or thiosinamine. Examples of inorganic PCMs that may be used include but are not limited to water, POCI₃, SbCI₅, H₂S0₄, MOF₆, P₄0₆, H3PO4, Cs, Ga, AsBr₃, Bl₃, TiBr₄, H₄P₂0₆, S0₃, and/or SbCI₃. According to another aspect of the disclosure, the PCMs may be solid-solid PCMs. The PCMs store heat energy by transitioning from one crystalline structure to another. Such transitions have the advantage that in some cases they occur with less volume change in the material, and thus may be an appropriate choice for certain applications. Examples of solid-solid PCMs that may be used in embodiments of the invention include, but are not limited to, penterythritol, neopentyl glycol, trihydroxy mthyl-aminomethane, diamnopentacrythritol, trumethylolethane, pentaglycerin, monoaminopentaerythritol,

tris(hydroxymethyl) acetic acid, and combinations of the aforementioned solid-solid PCMs.

Specific PCMs of interest include, but are not limited to, those sold by Phase Change Energy

Solutions (www.phasechange.com) and PCM Products (www.pcmproducts.net).

In various embodiments, phase change materials are materials which may be employed in cold-pack devices. Such cold-pack devices may be those utilized in health-related applications, e.g., to reduce swelling of a portion of a mammal. Such cold-pack devices may also be those utilized in food-related applications, e.g., to retain food in a cool environment which discourages growth of bacteria.

FIGS. 1 and 2 depict one embodiment of a device for transferring heat 1 including a heat transfer element 3 which can be utilized, e.g., within the subject devices, in accordance with the subject methods. More specifically, FIGS. 1 and 2 show a heat transfer element 3 in use with, and positioned entirely within, an embodiment of a negative pressure element 2. FIG. 1 illustrates the heat exchange surface 14 of the heat transfer element 3 adjacent to an enclosed portion of a mammal, e.g., a portion of an appendage, e.g., a hand 4. In FIG. 1 , the heat exchange surface 14 is shown stably associated with the hand 4. The phrase "stably associated" is described further below. FIG. 1 also depicts a phase change material 15 of the heat transfer element 3.

In various aspects of the subject devices, the devices include one or more pads, such as a pad which is attached, e.g., fixedly attached, to or detachable or separate from the remaining portions of the device e.g., the negative pressure element and/or the heat transfer element. Aspects of pads of the disclosed devices may be configured to enhance a subject mammal's comfort, e.g., comfort relating touch and/or temperature, during employment of the subject devices and methods. Various aspects of pads of the disclosed devices are configured to increase the effectiveness of the subject devices and methods, for example, by assisting to maintain a temperature of, or immediately surrounding, a phase change material, e.g., a phase change material within a heat transfer element e.g., a container of a heat transfer element, during operation of the disclosed devices. Embodiments of pads of the subject devices are sized and/or shaped to fit, e.g., comfortably fit, against and/or around a portion of a mammal, e.g., a hand or portion thereof, e.g., a palm. Certain embodiments of pads of the subject devices are sized and/or shaped to fit within a negative pressure element or portion thereof, e.g., a sealed enclosure, while other portions of a device, e.g., a heat transfer element, are retained therein as well. In various embodiments, pads may be composed of any of the same materials as a negative pressure element and/or a heat transfer element, or another material.

In certain aspects, the disclosed devices for transferring heat include one or more mating elements. Such mating elements may include, for example, a cord or channel, e.g., an electrical cord or thermal channel, one or more electrical contacts, an electrical plug and/or plug receptacle, one or more aspects, e.g., clips, for releasably mating with another aspect, e.g., a temperature modulator, or any combination thereof. Mating elements of the subject devices may be affixed to, e.g., fixedly attached or releasably attached, or integral and continuous with, e.g., composed of a single piece of the same material as, other aspects of the device, e.g., a negative pressure element or portion thereof e.g., a sealed enclosure. In some embodiments, mating devices are contained within a negative pressure element or portion thereof e.g., a sealed enclosure. Mating elements of the subject devices may also include one or more thermally conductive materials and/or one or more of the same materials as other aspects of the device, e.g., a negative pressure element.

In various embodiments, mating elements of the subject devices are operatively connected to a temperature modulator, e.g., a temperature modulator that, when operatively connected to the mating element transfers energy, e.g., thermal energy, e.g., heat, with the phase change material of the device. By "temperature modulator", as used herein, is meant a device configured to transfer thermal energy, e.g., heat away or to e.g., heat or cool, another aspect e.g., a phase change material. In some embodiments, temperature modulators are electrical heaters and/or coolers. In some embodiments, temperature modulators are cold-pack or hot-pack devices configured to retain a temperature higher or lower than a separate aspect with which the temperature modulators are configured to heat or cool for a period of time.

In some embodiments, temperature modulators are configured to obtain or maintain a temperature necessary to heat and/or cool the phase change materials described herein. For example, temperature modulators, e.g., a temperature modulator configured to heat a phase change material, may be configured to obtain or maintain for a period of time a temperature higher e.g., higher by 1 °C or less, 5 °C or less, 10 °C or less, or 25 °C or less, than a phase change temperature of a phase change material, as described above. Likewise, temperature modulators, e.g., a temperature modulator configured to cool a phase change material, may, in some embodiments, be configured to obtain or maintain for a period of time a temperature lower e.g., lower by 5 °C or less, 10 °C or less, or 25 °C or less, than a phase change temperature of a phase change material, as described above. In some embodiments, temperature modulators are configured to heat and/or cool the phase change materials described herein when, for example, the temperature modulators are proximate e.g., within thermal conductive range, e.g., contacting and/or within 1 cm, 2 cm, 5 cm, or 10 cm, of the phase change materials. Temperature modulators, in various aspects, are configured to heat and/or cool the phase change materials described herein when the temperature modulators are placed in thermal conductivity e.g., a physical relationship such that heat passes between the temperature modulator and the phase change material, with the phase change materials.

One embodiment of a device having a mating element is shown in FIG. 3. FIG. 3 specifically shows a device 300 for transferring heat with a portion of a mammal. The device 300 includes many of the same elements of the embodiment of the device shown in FIGS. 1 and 2. The device 300 also includes a mating element 310 configured to mate with a temperature modulator 302. Also shown in FIG. 3 is a releasing element 303 e.g., a switch, configured to release the mating element 301 from the temperature modulator 302 upon actuation, e.g., upon manual actuation.

In various embodiments of the disclosed devices for transferring heat, the devices include one or more receivers e.g., a receiver for receiving a container, e.g., a metallic container, of compressed gas, e.g., a compressed gas including carbon dioxide and/or oxygen. In some embodiments, receivers include one or more cavity, e.g., a cylindrical cavity, configured for receiving and retaining therein one or more container, e.g., cylindrical container, of compressed gas. Embodiments of receivers include one or more openings defined by one or more peripheral rims, e.g., a rim having a circular, ovular, rectangular or square shape, which are sized and/or shaped to receive a container of compressed gas therein or therethrough. In some embodiments, openings are defined, e.g., defined by an edge, between the one or more cavity of a receiver and the exterior of the device. In various aspects, one or more peripheral rims may have a holder thereon, e.g., a polymeric, e.g., a rubber or plastic holder, e.g., a door, configured for retaining, e.g., releasably retaining, a container of compressed gas within the receiver. In some aspects, holders of receivers provide a seal, e.g., a seal such that gas is unable to permeate out of the receiver, e.g., permeate through the one or more openings, while a container of compressed gas is retained therein. In some aspects, receivers include one or more opening elements, e.g., a hollow tube and/or a pressuring element, e.g., a screwing apparatus, for applying pressure on an end of a container of compressed gas, e.g., a first end opposite a second end which is proximate the hollow tube, for puncturing and/or otherwise opening a container of compressed gas within the receptacle. Receivers of the subject devices may be affixed to, e.g., fixedly attached or releasably attached, or integral and continuous with, e.g., composed of a single piece of the same material as, other aspects of the device, e.g., a negative pressure element or portion thereof e.g., a sealed enclosure. Receivers of the subject devices may also include one or more thermally conductive materials and/or one or more of the same materials as other aspects of the device, e.g., a negative pressure element.

In some embodiments, receivers are in fluid communication with a heat transfer element of the disclosed devices. In various embodiments of the subject devices, the devices are configured such that fluid e.g., gas, may flow out of a container, e.g., a container of compressed gas, retained in a receiver and against a heat transfer element. As such, in some embodiments, the devices include a chamber, e.g., a hollow chamber, extending between a portion of a receiver, e.g., an opening element, and a heat transfer element or a portion thereof, e.g., a surface of a heat transfer element. In embodiments of the devices having a chamber extending between a portion of a receiver, e.g., an opening element, and a heat transfer element or a portion thereof, the chamber includes a valve, e.g., an adjustable valve and/or an electronic valve, configured for allowing fluid, e.g., gas to pass therethrough, e.g., pass out of the chamber. In some embodiments, such a valve is used, e.g., opened, to maintain a pressure within the chamber that is the same as the pressure on the exterior of the subject devices, e.g., atmospheric pressure. In certain aspects of the disclosed devices, a negative pressure element or a portion thereof, e.g., a sealed enclosure, extends fully or partially between a receiver and a heat transfer element.

An embodiment of a device having a receiver is shown in FIG. 4. FIG. 4 specifically shows a device 400 for transferring heat with a portion of a mammal. The device 400 includes many of the same elements of the embodiment of the device shown in FIGS. 1 and 2. The device 400 also includes a receiver 401 for receiving a container of compressed gas 402. The receiver 401 includes an opening element 403, e.g., a puncturing element, as well as holders 404 for retaining compressed gas container 402. FIG. 4 also depicts a vent 405 e.g., a reversibly sealable vent, as described above, and a chamber 406, e.g., a hollow chamber, extending between a portion of a receiver, e.g., an opening element 403, and a heat transfer element 3 or a portion thereof, e.g., a surface of a heat transfer element 407. The devices shown in the figures may be employed in accordance with any of the subject methods described below.

While the devices disclosed above include devices where the heat transfer element includes a phase change material, embodiments of interest also include those having heat transfer elements that do not include phase change materials. For example, the devices may include thermoelectric elements as heat transfer elements. Of interest are thermoelectric heating elements, e.g., that may include a resistive conductors, Peltier devices, or other element that generates heat. Examples of thermoelectric heating elements of interest include, but are not limited to, those described in U.S. Patent Nos. 8,567,861 ; 7,663,378; 7,500,536; 7,202,444; 6,150,642; 5,894,207; 5,1 1 1 ,025; 4,825,048 and 4,700,046; the disclosure of the heating elements thereof being incorporated herein by reference. Also of interest are thermoelectric cooling elements, e.g., that may include a Peltier device or other element that provides a cooled surface or component. Examples of thermoelectric cooling elements of interest include, but are not limited to, those described in U.S. Patent Nos. 8,269,098; 6,894,215; 6,722,139; 6,574,967; 6,020,671 ; 5,950,067; 5,921 ,087; and 5,456,164; the disclosure of the cooling elements thereof being incorporated herein by reference. In such embodiments, the heat transfer element may include a material, e.g., a pad or analogous compliant structure, configured to be positioned between the heat transfer element and skin of the subject during use of the device, e.g., to improve comfort of the patient and/or decrease tissue damage to the patient.

METHODS

As described above, the subject disclosure provides methods for transferring heat with a portion of a mammal. In certain embodiments, the methods include placing a portion of a mammal into a device, such as any of the devices for transferring heat described herein. Placing a portion of a mammal into a device may include, for example, inserting a portion of the mammal into and/or retaining the portion of the mammal within the device for a period of time.

The methods, in various aspects, include placing a portion of a mammal into a device including a negative pressure element and a heat transfer element, e.g., a heat transfer element positioned within and/or fixedly attached to a negative pressure element. In certain embodiments of the methods, a negative pressure element, such as any of the negative pressure elements described herein, is configured to receive and enclose, e.g., encapsulate, a portion of a mammal and apply negative pressure thereto.

In certain embodiments, the methods include stably associating a portion of a mammal, e.g., a mammalian heat transfer surface, as described above, e.g., a palm, with a heat transfer element or a portion thereof, e.g., a heat exchange surface. By "stably associating" and/or "stably associated" is meant placing in a contacting orientation, e.g., a contacting orientation wherein the surface area of the touching portions are maximized, and/or affixing to, such that the disclosed methods and devices may be effectively employed. Mammalian heat transfer surfaces of interest with the subject methods include those found in various regions of the mammal, e.g., extremities. For example, mammalian heat transfer surfaces may include one or more of the arms, legs, palms, soles, cranial regions, e.g., foreheads, temples, occipital regions, and the like, or any combination thereof. In various embodiments, of the methods, the methods include transferring, e.g., conveying, heat, i.e., thermal energy, through a heat exchange surface of a heat transfer element to and/or from a portion of a mammal, e.g., an enclosed portion of a mammal and/or a mammalian heat transfer surface.

Heat transfer elements of the subject devices, which may be employed with the subject methods include each of the heat transfer element embodiments described herein e.g., heat transfer elements including a phase change material and a heat exchange surface configured to transfer heat with a portion of a mammal. In various embodiments, heat transfer elements are cooling elements or heating elements. Heat exchange surfaces of heat transfer elements, in some embodiments, are sized and shaped to, together with a negative pressure element or a portion thereof, e.g., a sealed enclosure or a portion thereof, e.g., an interior surface of a sealed enclosure, define a smooth, e.g., lacking any distinct edges, interior cavity of a device for transferring heat as described herein.

In some instances, heat transfer elements, either alone or with a portion of a negative pressure element, form one or more containers, e.g., containers configured for retaining therein a phase change material, e.g., sealed containers. For example, in some instances, heat transfer elements include a container, e.g., a sealed container, e.g., a flexible container or a rigid container, e.g., a polymeric container, such as a container configured for retaining therein a phase change material, e.g., an oil, e.g., a synthetic oil. In some embodiments of the methods, a phase change material is configured to change phase from a solid to a liquid or a liquid to a solid after a period of time following or upon exposure, e.g., thermal exposure, or contact with a mammalian heat transfer surface. Such a period of time may range from 0.1 min to 120 min, from 0.5 min to 60 min, from 1 min to 10 min, from 1 min to 12 min, or from 1 min to 30 min. In addition, in certain embodiments of the subject methods, a portion of a mammal is stably associated with a heat transfer element for a period of time ranging, for example, from 0.1 min to 120 min, from 0.5 min to 60 min, from 1 min to 10 min, from 1 min to 12 min, or from 1 min to 30 min. In various embodiments, the temperature at which a phase change material which is utilized with the subject methods is configured to change phase, e.g., from a solid to a liquid or from a liquid to a solid, may range, for example, from 1 °C to 40 °C, from 10 °C to 30 °C, from 10 °C to 25 °C, from 10 °C to 22 °C, from 12 °C to 19 °C, or from 20 °C to 40 °C.

As described above, in various aspects of the methods, the methods include applying negative pressure to, e.g., inducing negative pressure conditions on, a portion of a mammal, e.g., a portion of a mammal enclosed within a negative pressure element. The phrase "negative pressure conditions", as used herein, refers to conditions under negative pressure, as negative pressure is described herein. In some embodiments of the methods, applying negative pressure to a portion of a mammal includes activating, e.g., manually activating a pump, e.g., a vacuum pump, of a negative pressure element. In various embodiments, applying negative pressure to a portion of a mammal, e.g., a portion of a mammal enclosed within a negative pressure element, removes heat from, i.e., cools, or transfers heat to, i.e., heats, the portion of the mammal, e.g., the enclosed portion.

In practicing the subject methods, negative pressure conditions may be provided using any convenient protocol. In certain embodiments, applying negative pressure is achieved, and/or negative pressure conditions are provided, by enclosing a portion of a mammal, e.g., a portion of a mammal that includes a target surface that is to be contacted with a heat transfer element, in a sealed enclosure, e.g., a sealed enclosure of a negative pressure element, where the pressure is then reduced in the sealed enclosure thereby providing the requisite negative pressure conditions. The portion of a mammal that is enclosed in the sealed enclosure is a portion that includes, for example, the target heat exchange surface, e.g., a mammalian heat transfer surface, and may be an appendage, or a portion thereof, in some aspects of the subject invention. As such, the portion of the mammal that is enclosed is an arm or leg, or at least a portion thereof, e.g. hand or foot, in various embodiments of the subject methods.

In some embodiments, negative pressure elements applied in accordance with the disclosed methods provide a sealed enclosure, such as enclosure for receiving and containing therein a portion of a mammal. Negative pressure elements may be configured to induce and/or maintain negative pressure within the sealed enclosure. A sealed enclosure of a negative pressure element may, in various aspects, have a volume ranging, for example, from 5 cm³ to 40 cm³, such as from 10 cm³ to 30 cm³, or from 10 cm³ to 20 cm³. Such a volume may be substantially the same volume as or a slightly larger (e.g., greater than by 1 cm³ or less, 5 cm³ or less, 10 cm³ or less, 50 cm³ or less, or 100 cm³ or less) volume than the volume of a portion of a mammal enclosed within the negative pressure element. A volume of a sealed enclosure may be sized to fit, e.g., to encapsulate, 95% of human hand sizes. In addition, in various embodiments of the subject methods, the devices as applied in the methods, e.g., devices having the negative pressure elements and/or heat transfer elements described herein, have a mass ranging, for example, from 100 g to 3000 g, from 140 g to 2900 g, from 500 g to 2000 g, or from 1300 g to 1400 g.

Additionally, in various embodiments of negative pressure elements, the elements include one or more openings sized and/or shaped to receive a portion of a mammal, e.g., an appendage or portion thereof, therein. In certain embodiments of negative pressure elements employed in accordance with the subject methods, the elements include one or more sealing elements (e.g., one, two, three, four, five sealing elements) configured to produce a seal, e.g., a reversible seal, about e.g., around, a portion of a mammal, e.g., a portion of a mammal received into and/or contained within a device. Furthermore, the subject methods may include making the subject devices according to a suitable method.

The subject methods, in certain aspects, include removing heat from a portion of a mammal e.g., the body core of a mammal. By body core is meant the internal body region or portion of the mammal, as opposed to the surface of the mammal. In various aspects, the methods include removing heat from a specific portion of a mammal, e.g., a hand and/or a foot. Likewise, in various embodiments of the methods, the methods include introducing heat to a portion of a mammal e.g., the body core of a mammal. Accordingly, in various aspects, the methods include introducing heat to a specific portion of a mammal, e.g., a hand and/or a foot. Various embodiments of the subject methods include removing a device from a storage device, e.g., a cold storage device or a hot storage device. Removing a device from a cold storage device or a hot storage device may be performed, for example, prior to stably associating a portion of a mammal, e.g., a mammalian heat transfer surface, with a heat transfer element. Storage devices are devices which are sized and/or shaped to partially or entirely receive therein, e.g., encapsulate, any of the devices for transferring heat with a portion of a mammal which are described herein. Cold and hot storage devices are devices which, in various embodiments, maintain an environment therein which is sufficient to effectively perform the subject methods. An environment within a cold storage device may, in some embodiments, be colder than the environment immediately surrounding the cold storage device. In various aspects of cold storage devices, the temperature within the cold storage device is such that a phase change material of a device for transferring heat is maintained in a solid state therein. An environment within a hot storage device may, in some embodiments, be warmer than the environment immediately surrounding the hot storage device. In some aspects of hot storage devices, the temperature within the hot storage device is such that a phase change material is maintained in a liquid state therein.

Embodiments of cold storage devices include refrigerators and/or freezers of a conventional commercial, industrial, and/or residential type. For example, a cold storage device may be a household freezer and/or refrigerator which may be configured for typical household freezer and/or refrigerator use such as storing food and/or drink. Such a cold storage device may be configured to maintain an environment, including a temperature, therein which is typical of a refrigerator and/or freezer of a conventional commercial, industrial, and/or residential type. Cold storage devices, in various embodiments, are configured to maintain a temperature, e.g., a temperature in one or more internal compartments thereof, in a temperature range, for example, from 1 °C to 35 °C, from 10 °C to 30 °C, from 10 °C to 25 °C, from 10 °C to 22 °C, or from 12 °C to 19 °C.

Embodiments of hot storage devices include heaters and/or ovens of a conventional commercial, industrial, and/or residential type. For example, a hot storage device may be a typical household oven, e.g., a microwave oven, and/or heater which may be configured for typical household oven and/or heater use such as heating food and/or drink. Such a hot storage device may be configured to maintain an environment, including a temperature, therein which is typical of an oven and/or heater of a conventional commercial, industrial, and/or residential type. Hot storage devices, in various embodiments, are configured to maintain a temperature, e.g., a temperature in one or more internal compartments thereof, in a temperature range, for example, from 15 °C to 200 °C, from 25 °C to 60 °C, or from 30 °C to 75 °C.

In some embodiments, removing a subject device for transferring heat with a portion of a mammal, e.g., a device entirely retained with a cold or hot storage device, from a cold or hot storage device includes grabbing the subject device within the cold or hot storage device and thereafter moving the subject device to a location entirely outside the cold or hot storage device. Removing a device for transferring heat with a portion of a mammal from a cold or hot storage device may also, for example, include causing a phase change material of such a device to change, or begin to change, from a solid to a liquid phase or from a liquid to a solid phase.

Some embodiments of the subject methods include placing a subject device for transferring heat with a portion of a mammal within a cold or hot storage device. Placing a subject device for transferring heat with a portion of a mammal within a cold or hot storage device may be performed, for example, after applying negative pressure to an enclosed portion of a mammal and/or removing heat from an enclosed portion of a mammal using a subject device. Placing a subject device for transferring heat with a portion of a mammal within a cold or hot storage device may also be performed prior to any of the other steps of the methods described herein. Placing a subject device for transferring heat with a portion of a mammal within a cold or hot storage device may include causing the phase change material to change, or begin to change, from a liquid to a solid phase or from a liquid to a solid phase.

In certain aspects, of the subject methods, devices for transferring heat with a portion of a mammal include one or more mating elements. Such mating elements may be configured to operatively connect to a temperature modulator that, when operatively connected to the mating element transfers energy with the phase change material. Embodiments of mating elements and temperature modulators which may be employed with the subject methods are described further above.

In some instances, the subject methods include operatively connecting, e.g., placing against and/or physically and/or electrically mating, a mating element, or a portion thereof with a

temperature modulator, or a portion thereof. In addition, the methods, in some versions, include cooling and/or heating, e.g., by transferring thermal energy to or from, a phase change material, e.g., causing the phase change material to change phase, using a temperature modulator, e.g., an operatively connected temperature modulator. In addition, in some embodiments of the methods, the methods include a step of dissociating, e.g. , releasing by, e.g., pressing a switch, a mating element, or a portion thereof with a temperature modulator, or a portion thereof.

In certain embodiments, devices employed with the subject methods include one or more receivers according to any of the embodiments described above, e.g., a receiver for receiving a container, e.g., a metallic container, of compressed gas, e.g., a compressed gas including carbon dioxide and/or oxygen. Accordingly, in some aspects, the methods include inserting a container, e.g., a container of compressed gas, into a receiver of a device. In some embodiments, inserting a container into a receiver includes positioning, e.g., slidably positioning, a container or portion thereof in and/or through an opening of a receiver, e.g. , a proximal opening positioned at a proximal end of a receiver. In some embodiments, inserting a container into a receiver includes pushing the container in a distal direction and/or toward a distal end of the receiver. Pushing the container in a distal direction may, in some aspects, cause a container to contact and/or be retained against one or more distal end, e.g., a proximal surface of a distal end, of a receiver.

Embodiments of the subject methods include decompressing a gas, e.g., a compressed gas, e.g., a gas compressed in a container. Decompressing a gas may include causing a gas to go from a first state, e.g., a compressed state, to a second state, e.g., a decompressed state. In some instances, decompressing a gas includes opening e.g., puncturing, a container, e.g., a sealed container, retaining therein a gas in a first, e.g., compressed, state. Decompressing a gas may include causing a gas to pass from the inside of a container, e.g., a pressurized container, to an outside of a container. Embodiments of the subject methods include opening a container, e.g., a container of compressed gas, by inserting an element, e.g., a puncturing element, e.g., a hollow tube, e.g., a needle, through a portion of a wall of a container. Inserting an element through the wall of a container e.g., a sealed container, may expose the interior of the container to the exterior of the container by creating an opening in the container. In various embodiments of the methods, a container, e.g., a container of compressed gas, is opened by applying pressure in a distal direction to a proximal surface of the container while the container contacts an element, e.g., a puncturing element at the distal end of the container. Applying pressuring in such a manner causes the element to pierce through a wall of the container. In some embodiments of the methods, the subject devices include one or more elements for applying pressure to a container of compressed gas. Such elements may include a surface for contacting a container and a screwing element with which to apply pressure by turning e.g., screwing.

The methods disclosed herein include decompressing a gas at a position adjacent to a heat transfer element of a device, e.g., decompressed in a manner wherein heat is removed from the heat transfer element. In some embodiments, decompressing a gas causes the gas to absorb energy, e.g., thermal energy, e.g., heat from the surrounding environment while it is decompressing. Accordingly, in some aspects decompressing a gas includes lowering the temperature, e.g., lowering the temperature by 5 °C or less, 10 °C or less, 25 °C or less, or 50 °C or less, immediately surrounding the gas and/or within a device for transferring heat with a portion of a mammal or a portion thereof, e.g., a chamber, e.g., a hollow chamber, adjacent to the receptacle. In some aspects decompressing a gas includes lowering the temperature, of the environment surrounding e.g., within 1 cm or less, 2 cm or less, 5 cm or less, or 10 cm or less, of the decompressing gas. In some embodiments, decompressing a gas includes causing the gas to flow out of a container and into and/or through a hollow chamber adjacent to and/or in fluidic communication with, the receptacle. In some embodiments, decompressing a gas includes causing the gas to flow through a chamber adjacent to and/or in fluidic communication with, a receptacle and/or through a valve in a wall of the chamber and/or out of a subject device. In certain instances, decompressing a gas, e.g., decompressing a gas at a position adjacent to a heat transfer element of a device, removes heat from, i.e., cools, the heat transfer element or a portion thereof, e.g., a phase change material. In some embodiments, decompressing a gas, e.g., decompressing a gas at a position adjacent to a heat transfer element of a device, causes a phase change material to change phase, e.g., from a liquid to a solid.

Embodiments of the subject methods include methods for changing the phase e.g., changing from a solid to liquid or from a liquid to solid phase, of a phase change material of a device. Devices for transferring heat with a portion of a mammal and portions thereof, e.g., heat transfer elements and negative pressure elements, according to any of the embodiments described herein may be employed in the subject methods for changing the phase of a phase change material.

According to various embodiments, methods for changing the phase of a phase change material of a device employ a device including a negative pressure element and a heat transfer element, e.g., a heat transfer element including a phase change material. In various aspects of methods, the devices employed include a heat transfer element including an exterior surface, e.g., a heat exchange surface, e.g., an exterior surface configured, e.g., sized and/or shaped, to receive a heat transfer surface of a portion of a mammal, e.g., a mammalian heat transfer surface, as described herein.

In some embodiments, methods for changing the phase of a phase change material of a device include positioning the device fully or partially within a storage device, e.g., a cold and/or hot storage device, as such storage devices are described above. Methods for changing the phase of a phase change material of a device also include retaining a device for transferring heat with a portion of a mammal within a storage device for a period of time, e.g., a period of time sufficient for the phase of a phase change material to change. Such a period of time may range, for example, from 30 sec to 12 hours, such as from 1 min to 2 hrs, such as from 1 min to 1 hr, such as from 5 min to 30 min or be, for example, 5 min or less, 30 min or less, 60 min or less, or 12 hrs or less.

In various methods for changing the phase of a phase change material of a device, the device includes a mating element, as described above, e.g., a mating element configured to operatively connect to a temperature modulator, as described above. In some versions, the temperature modulator includes an electrical heater and/or cooler. Such electrical heaters and/or coolers may include, for example, heaters and/or coolers integrated into, e.g., contained within at least a portion of, a device, or separate, e.g., removably connectable, from a device.

In some aspects, changing the phase of a phase change material includes operatively connecting a mating element to a temperature modulator. In some aspects, the methods include transferring energy, e.g., thermal energy, e.g., heat, to or from a phase change material, by operatively connecting a mating element to a temperature modulator, for example, to change the phase of the phase change material. In various embodiments of the methods, transferring energy with a phase change material includes causing the phase change material from a liquid to a solid phase or from a solid to a liquid phase. Methods for changing the phase of a phase change material of a device, in certain embodiments, include decompressing a compressed gas, e.g., a gas including carbon dioxide, in a manner sufficient to change the phase of the phase change material, e.g., change the phase from a solid to a liquid phase or from a liquid to a solid phase. Such methods may include any of the methods discussed above for decompressing a compressed gas, e.g., opening a container of compressed gas.

In various embodiments, methods for changing the phase of a phase change material of a device employ a device having a receiver e.g., a receiver sized and/or shaped for receiving a container of compressed gas. In some versions, the methods include inserting e.g., placing within by pushing, a container of compressed gas into a receiver. Methods for changing the phase of a phase change material of a device may include decompressing a gas, e.g., carbon dioxide, at a position adjacent or proximate to a heat transfer element or portion thereof, e.g., a heat exchange surface, in a manner wherein energy e.g., thermal energy, e.g., heat is removed from the heat transfer element.

In various embodiments of the methods, the mammal is a female, e.g., a female human, or a male, e.g., a male human. In some aspects of the methods wherein the mammal is female or a male, the methods are methods of treating the female or male for a health condition, e.g., a fever. In certain embodiments, the subject disclosure provides methods for enhancing the ability of mammal to perform a physical procedure. By enhancing is meant improving or bettering the ability of the mammal to perform a particular physical procedure, task or operation.

In practicing the subject methods, thermal energy is extracted from the body core of the mammal at least once during a health condition or during physical activity to result in the desired treatment of the condition or ability enhancement. By "body core" and "core body" is meant the internal region of the mammal, as opposed to the surface of the mammal. The magnitude of core body thermal energy extraction accomplished during practice of the subject methods may vary, and is sufficient to provide for the desired outcome, e.g. reduction in core body temperature, treatment of a health condition, e.g., fever, ability enhancement, relief from hyperthermia, or MS symptoms, etc., and the like. In certain embodiments, the magnitude of heat extraction is 0.5 Kcal/min or less, 1 .0 Kcal/min or less, or 1 .5 Kcal/min or less, where the magnitude may be 50 Kcal/min or greater, but sometimes is 30 Kcal/min or less, such as 20 Kcal/min or less. The period of time that the heat is extracted from the core body may range, for example, from 1 min to 24 hrs, such as from 2 min to 20 min, or from 2 min to 5 min.

In certain embodiments, the core body temperature of the subject is reduced. The magnitude of core body temperature reduction is sufficient to provide for treatment of a condition or ability enhancement, and is, in some aspects, 0.5 °C or less, or 1 .0 °C or greater, or 1 .5 °C or greater, or may be 4 °C or greater, or 4.0 °C or less, or 2.0 °C or less. The period of time that the core body temperature is reduced may range from 1 min to continuous for the duration of a condition or activity. For example, the period of time that the core body temperature is reduced may range from 2 min to 20 min, or from 2 min to 5 min. In some embodiments, the subject methods will prevent or minimize rises in the core body temperature. Nonetheless, in these embodiments the subject methods do extract heat or thermal energy from the core body of the subject, but the amount of energy being produced by or introduced into the core body of the subject from other sources is substantially the same as or exceeds the amount of energy being extracted from the core body by the subject methods.

Where the specific embodiment is a method of treating a health condition or enhancing physical ability, the heat or thermal energy is extracted from the core body at least once during the health condition or physical procedure, where the condition or procedure is measure from a point prior to the beginning of the condition or procedure to the end of the condition or procedure, e.g., to the end of a period of an actual and/or perceived raised body temperature associated with a condition, to the end of a training set, to the end of a game, to the end of given work day, etc. In certain embodiments, core body heat is extracted a plurality of times. Where core body heat is extracted a plurality of times, the number of different times that heat is extracted may, for example, range from 2 to 20, such as from 2 to 15, such as from 5 to 10. In certain embodiments, core body thermal energy is extracted a single time. The term procedure is used broadly to include anything from a single physical movement to a plurality of physical movements that are practiced in a given period of time, e.g. participation in a game, performing a particular training regimen, activity encountered during an entire workday etc.

In extracting core body thermal energy from the mammal, a surface of the mammal may be contacted and/or stably associated with a heat transfer element under negative pressure conditions for a period of time sufficient to achieve the desired reduction in core body temperature. The surface that is contacted and/or stably associated with the heat transfer element is, in some aspects, a heat transfer surface. Heat transfer surfaces of interest with the subject methods include those found in various regions of the mammal, e.g. the arms, legs, palms, soles, head, face, ears, and the like.

As described above, the surface of the mammal is contacted with a heat transfer element under the negative pressure conditions. The heat transfer element, or a portion thereof, e.g., a phase change material, has a temperature that is sufficient to provide the requisite core body thermal energy or heat extraction or removal. The temperature of the heat transfer element may vary, but, in some aspects is not so low as to cause local vasoconstriction at the surface of the mammal, e.g. the heat transfer surface. The low heat transfer element, or a portion thereof, e.g., a phase change material, in some aspects, has a temperature ranging, for example, from 1 °C to 35 °C, from 10 °C to 30 °C, from 10 °C to 25 °C, from 10 °C to 22 °C, or from 12 °C to 19 °C. In certain embodiments, a feature of the subject methods is that the temperature of the heat transfer element is specifically selected to be one that provides for thermal energy extraction from the core body and not local vasoconstriction. Contact and/or stable association may be maintained for a period of time sufficient for the desired amount of core body thermal energy extraction to occur. As such, contact may be maintained for 1 min or more, such as 2 min or more, or 3 min or more, where contact may be maintained for 10 hr or longer. In some embodiments, contact is maintained for 1 hr or less, or 5 min or less.

In practicing the subject methods, the negative pressure conditions during contact and/or stable association may be static/constant or variable. Thus, in certain embodiments, a negative pressure is maintained at a constant value during contact of a portion of a mammal, e.g., a heat transfer surface, with the heat transfer element. In yet other embodiments, the negative pressure value is varied during such contact, e.g. oscillated. Where the negative pressure is varied or oscillated, the magnitude of the pressure change during a given period may be varied and may range from -85 mmHg to 40 mmHg, such as from -40 mmHg to 0 mmHg. In addition, in some aspects, the periodicity of the oscillation may range from .25 sec to 10 min, such as from 1 sec to 5 min, or from 1 sec to 10 sec.

In certain embodiments, the subject methods further include a feedback element that at least partially controls when a heat exchange surface of the mammal is contacted and/or stably associated with a heat transfer element to extract thermal energy from the core body of the mammal. The feedback element may be any convenient element, where a suitable element is a thermosensor, e.g. placed over a heat transfer surface not being contacted with a heat transfer element. In such embodiments, the method, in some aspects, further includes a data processing step for processing the feedback data and activating the contact and/or stable association with the heat transfer element in response thereto, e.g. a computing element that controls the contact of the mammalian heat transfer surface with the heat transfer element. Additionally, as noted above, the subject methods are suitable for use with a variety of mammals.

UTILITY

As demonstrated above, the subject methods are directed to transferring, e.g., removing or introducing, heat from a portion, e.g., the body core, of a mammal. As such, the subject methods are suitable for use in a variety of different applications, where particular applications include the treatment of normal and abnormal physiological conditions, e.g., disease and/or discomfort, where body heat, e.g., core body heat, extraction is desirable. Particular applications in which the subject methods find use include the alleviation or treatment of health conditions, e.g., treatment of fever, treatment of exercise or work induced hyperthermia, treatment of stroke, treatment of cystic fibrosis symptoms, treatment of multiple sclerosis symptoms, and the like. By "treatment" is meant at least an alleviation in one or more of the symptoms associated with the condition being treated, e.g. a reduction in discomfort, amelioration or elimination of symptoms, etc. In various embodiments, the subject devices and methods are applied for alleviation or treatment of a fever. For example, a mammal undergoing a fever and/or a perceived fever may utilize the devices described herein to create a drop in core body temperature of the mammal and thereby provide relief from the fever. Relief and/or treatment of a fever provided by the subject devices and methods may be related to making a mammal, e.g., a mammal experiencing a fever, more comfortable, such as less scared or agitated. Relief and/or treatment of a fever may also be that related to alleviating a health risk, e.g., a significant health risk, to a mammal associated with a fever.

In some aspects, a mammal undergoing a health condition, e.g., a fever, may insert a portion of the mammal including a heat transfer surface into a negative pressure element of the device and thereby stably associate a heat transfer element of a device with a heat transfer surface of the mammal. The mammal may then operate the negative pressure element to lower the core body temperature of the mammal and thereby alleviate the condition. In some aspects, mammals may utilize the devices described and methods disclosed herein in a preemptive manner. For example, a mammal expecting to undergo a health condition may utilize the subject devices and methods to forestall or prevent a condition.

In certain embodiments, the subject methods are employed for enhancing the ability of a mammal to perform a physical procedure or task, e.g., an athletic and/or work related physical procedure or task. As such, the subject methods are suitable for use in a variety of different applications where a variety of different types of physical procedures are performed. Examples of devices and methods which may be used either wholly or partially in connection with the disclosed devices and methods to, for example, enhance the ability of a mammal to perform a physical procedure or task, or for another use, are provided by U.S. Pat. Nos. 6,656,208; 6,974,442; and 8,177,826, the disclosures of which are incorporated by reference herein. The methods and devices as described herein also find use in the applications described in greater detail in United States Patent Nos. 6,602,277; 7,182,776; 8,277,496; 6,966,922; 7,862,600; 8,287,581 ; 7,122,047; and 7,947,068; as well as Published PCT Application WO/1996/028120; the disclosures of which are herein incorporated by reference.

KITS

Also provided are kits that at least include the subject devices and which may be used according to the subject methods. The subject kits may include two or more, e.g., a plurality, three, four, five, ten, etc., devices for transferring heat according to any of the embodiments described herein, or any combinations thereof. In addition, the kits may include any device or other element which may facilitate the operation of any aspect of the kits. For example, a kit may include one or more devices for transferring heat and/or one or more elements of such a device. Kits may also include packaging, e.g., packaging for shipping the devices without breaking. In certain embodiments, the kits which are disclosed herein include instructions, such as instructions for using devices. The instructions for using devices are, in some aspects, recorded on a suitable recording medium. For example, the instructions may be printed on a substrate, such as paper or plastic, etc. As such, the instructions may be present in the kits as a package insert, in the labeling of the container of the kit or components thereof (i.e., associated with the packaging or subpackaging etc.). In other embodiments, the instructions are present as an electronic storage data file present on a suitable computer readable storage medium, e.g., Portable Flash drive, CD- ROM, diskette, etc. The instructions may take any form, including complete instructions for how to use the devices or as a website address with which instructions posted on the world wide web may be accessed.

Notwithstanding the appended clauses, the disclosure is also defined by the following clauses:

1 . A device for transferring heat with a portion of a mammal, the device comprising: (a) a negative pressure element configured to produce an enclosed portion of a mammal and apply negative pressure to the enclosed portion; and (b) a heat transfer element that is positioned within and fixedly attached to the negative pressure element.

2. The device according to Clause 1 , wherein the enclosed portion of the mammal is a hand or foot.

3. The device according to Clause 2, wherein the enclosed portion of the mammal is a hand. 4. The device according to any of Clauses 1 to 3, wherein the portion of the mammal with which the heat exchange surface is configured to transfer heat is a palm.

5. The device according to any of the preceding clauses, wherein the heat transfer element comprises a flexible container.

6. The device according to any of Clauses 1 to 4, wherein the heat transfer element comprises a rigid container.

7. The device according to any of the preceding clauses, wherein the heat transfer element is a cooling element.

8. The device according to any of the preceding clauses, wherein the negative pressure element and the heat exchange surface together define a smooth interior cavity of the device. 9. The device according to any of the preceding clauses, wherein the negative pressure element is configured to provide a sealed enclosure having a volume ranging from 10 cm³ to 20 cm³.

10. The device according to Clause 9, wherein the negative pressure element comprises an opening configured to receive a portion of a mammal and a sealing element configured to produce a reversible seal about the received portion.

11 . The device according to any of the preceding clauses, wherein the device has a mass ranging from 100 g to 3000 g. 12. The device according to any of the preceding clauses, wherein the device is configured to remove heat from the body core of a mammal.

13. The device according to any of Clauses 1 to 1 1 , wherein the device is configured to introduce heat into the body core of a mammal.

14. The device according to any of the preceding clauses, further comprising a mating element configured to operatively connect to a temperature modulator that, when operatively connected to the mating element transfers energy with the phase change material.

15. The device according to any of the preceding clauses, further comprising a receiver for receiving a container of compressed gas.

16. The device according to Clause 15, wherein the receiver is in fluid communication with the heat transfer element.

17. The device according to Clauses 15 or 16, wherein the compressed gas comprises carbon dioxide.

18. The device according to any of the preceding clauses, wherein the heat transfer element comprises: (i) a phase change material; and (ii) a heat exchange surface configured to transfer heat with a portion of a mammal.

19. The device according to any of the preceding clauses, wherein the heat transfer element comprises a thermoelectric element.

20. A method of transferring heat with a portion of a mammal, the method comprising: (a) placing a portion of a mammal into a device comprising a heat transfer element that is positioned within and fixedly attached to a negative pressure element, the negative pressure element configured to receive and enclose the portion of a mammal and apply negative pressure thereto; (b) stably associating a portion of a mammal with the heat transfer element; (c) applying negative pressure to the enclosed portion of the mammal; and (d) transferring heat through the heat exchange surface with the portion of a mammal.

21 . The method according to Clause 20, wherein the enclosed portion of the mammal is a hand or foot.

22. The method according to Clause 21 , wherein the enclosed portion of the mammal is a hand.

23. The method according to any of Clauses 20 to 22, wherein the portion of the mammal with which the heat exchange surface transfers heat is a palm.

24. The method according to any of Clauses 20 to 23, wherein the heat transfer element comprises a flexible container.

25. The method according to any of Clauses 20 to 23, wherein the heat transfer element comprises a rigid container.

26. The method according to any of Clauses 20 to 25, wherein the heat transfer element is a cooling element. 27. The method according to any of Clauses 20 to 26, wherein the negative pressure element and the heat exchange surface together define a smooth interior cavity of the device.

28. The method according to any of Clauses 20 to 27, wherein the negative pressure element is configured to provide a sealed enclosure having a volume ranging from 10 cm³ to 20 cm³.

29. The method according to Clause 28, wherein the negative pressure element comprises an opening configured to receive portion of a mammal and a sealing element configured to produce a reversible seal about the received portion.

30. The method according to any of Clauses 20 to 29, wherein the device has a mass ranging from 100 g to 3000 g.

31 . The method according to any of Clauses 20 to 30, wherein the method comprises removing heat from the body core of a mammal.

32. The method according to any of Clauses 20 to 30, wherein the method comprises introducing heat into the body core of a mammal.

33. The method according to any of Clauses 20 to 31 , wherein the method further comprises removing the device from a cold storage device.

34. The method according to any of Clauses 20 to 30 and 32, wherein the method further comprises removing the device from a hot storage device.

35. The method according to any of Clauses 20 to 34, wherein the device further comprises a mating element configured to operatively connect to a temperature modulator that, when operatively connected to the mating element transfers energy with the phase change material.

36. The method according to any of Clauses 20 to 34, wherein the device further comprises a receiver for receiving a container of compressed gas and the method further comprises inserting the container into the receiver.

37. The method according to Clause 36, wherein the method further comprises decompressing the gas at a position adjacent to the heat transfer element in a manner wherein heat is removed from the heat transfer element.

38. The method according to Clauses 36 or 37, wherein the compressed gas comprises carbon dioxide.

39. The method according to any of Clauses 20 to 38, wherein the heat transfer element comprises: (i) a phase change material; and (ii) a heat exchange surface configured to transfer heat with a portion of a mammal.

40. The method according to any of Clauses 20 to 38, wherein the heat transfer element comprises a thermoelectric element.

41 . A method comprising changing the phase of a phase change material of a device, the device comprising a heat transfer element that is positioned within and fixedly attached to a negative pressure element, wherein the heat transfer element comprises: (i) the phase change material; and (ii) an exterior surface configured to receive a heat transfer surface of a portion of a mammal. 42. The method according to Clause 41 , wherein changing the phase of the phase change material comprises positioning the device within a storage device and retaining the device therein for a period of time.

43. The method according to Clause 42, wherein the storage device is a cold storage device. 44. The method according to Clause 42, wherein the storage device is a hot storage device.

45. The method according to Clause 41 , wherein the device further comprises a mating element configured to operatively connect to a temperature modulator, and wherein changing the phase of the phase change material comprises operatively connecting the mating element to the temperature modulator and thereby transferring energy with the phase change material.

46. The method according to Clause 45, wherein transferring energy with the phase change material comprises causing the phase change material to change from a liquid to a solid phase.

47. The method according to Clause 45, wherein transferring energy with the phase change material comprises causing the phase change material to change from a solid to a liquid phase.

48. The method according to Clause 45, wherein the temperature modulator comprises an electrical cooler. 49. The method according to Clause 48, wherein the electrical cooler is integrated into the device. 50. The method according to Clause 45, wherein the temperature modulator comprises an electrical heater. 51 . The method according to Clause 50, wherein the electrical heater is integrated into the device. 52. The method according to Clause 41 , wherein changing the phase of the phase change material comprises decompressing a compressed gas in a manner sufficient to change the phase of the phase of the phase change material. 53. The method according to Clause 52, wherein the phase change material changes from a liquid to a solid phase. 54. The method according to Clause 52, wherein the compressed gas comprises carbon dioxide. 55. The method according to Clause 52, wherein the device further comprises a receiver for receiving a container of compressed gas and the method further comprises inserting the container into the receiver. 56. The method according to Clause 52, wherein the method comprises decompressing the gas at a position adjacent to the heat transfer element in a manner wherein heat is removed from the heat transfer element.

All publications and patent applications cited in this specification are herein incorporated by reference as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention.

Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it is readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.

Claims

WHAT IS CLAIMED IS:

1 . A device for transferring heat with a portion of a mammal, the device comprising:

(a) a negative pressure element configured to produce an enclosed portion of a mammal and apply negative pressure to the enclosed portion ; and

(b) a heat transfer element that is positioned within and fixedly attached to the negative pressure element.

2. The device according to Claim 1 , wherein the portion of the mammal with which the heat exchange surface is configured to transfer heat is a palm.

3. The device according to any of the preceding claims, wherein the heat transfer element is a cooling element.

4. The device according to any of the preceding claims, wherein the negative pressure element and the heat exchange surface together define a smooth interior cavity of the device.

5. The device according to any of the preceding claims, wherein the negative pressure element comprises an opening configured to receive a portion of a mammal and a sealing element configured to produce a reversible seal about the received portion.

6. The device according to any of the preceding claims, further comprising a mating element configured to operatively connect to a temperature modulator that, when operatively connected to the mating element transfers energy with the phase change material.

7. The device according to any of the preceding claims, further comprising a receiver for receiving a container of compressed gas.

8. The device according to Claim 7, wherein the receiver is in fluid communication with the heat transfer element.

9. The device according to Claims 7 or 8, wherein the compressed gas comprises carbon dioxide.

10. The device according to any of the preceding claims, wherein the heat transfer element comprises: (i) a phase change material; and (ii) a heat exchange surface configured to transfer heat with a portion of a mammal.

11 . The device according to any of the preceding claims, wherein the heat transfer element comprises a thermoelectric element.

12. A method of transferring heat with a portion of a mammal, the method comprising:

(a) placing a portion of a mammal into a device according to any of Claims 1 to 1 1 ;

(b) stably associating a portion of a mammal with the heat transfer element;

(c) applying negative pressure to the enclosed portion of the mammal; and

(d) transferring heat through the heat exchange surface with the portion of a mammal.

13. A method comprising changing the phase of a phase change material of a device, the device comprising a heat transfer element that is positioned within and fixedly attached to a negative pressure element, wherein the heat transfer element comprises:

(i) the phase change material; and

(ii) an exterior surface configured to receive a heat transfer surface of a portion of a mammal.

14. The method according to Claim 13, wherein changing the phase of the phase change material comprises positioning the device within a storage device and retaining the device therein for a period of time.

15. The method according to Claim 13, wherein the device further comprises a mating element configured to operatively connect to a temperature modulator, and wherein changing the phase of the phase change material comprises operatively connecting the mating element to the temperature modulator and thereby transferring energy with the phase change material.

16. The method according to Claim 13, wherein changing the phase of the phase change material comprises decompressing a compressed gas in a manner sufficient to change the phase of the phase of the phase change material.