Method and apparatus for thermoregulation of core body temperature using near-infrared radiation and localized heat transfer

Abstract

The present invention provides a method and device for controlling and altering the core body temperature of a human or other mammal. The device includes an element placed in contact with an individual's skin, such as the palm of a hand or the sole of a foot. The element preferably emits radiation within the red-to-infrared range of 550 nm to 950 nm, inducing vasodilation and increased blood flow in the area below the contact area. A heat exchange element is simultaneously in contact with the skin and can transfer heat to or remove heat from the circulatory vasculature via the skin surface. The circulatory system transports increased or decreased thermal energy to the body's core organs. Thus, the method and device can increase or decrease core body temperature, or maintain a current core body temperature, in the presence of an external thermal element.

Description

[Technical field]

[0001] The present invention relates generally to methods and devices for thermoregulation of a living organism, and more specifically to direct skin contact with a heat transfer mechanism. The methods and devices of the present invention may be applied to both humans and animals. [Background technology]

[0002] The human body has a complex mechanism for regulating its core body temperature, i.e. the temperature of vital organs such as the heart, lungs, liver and kidneys. This process is known as thermoregulation. Thermoregulation is essential for the health and survival of humans and other mammals. Commonly known human thermoregulatory mechanisms include shivering during hypothermia and sweating during hyperthermia.

[0003] Hyperthermia, defined as a state above normal core body temperature, has been treated by many different therapies. Cooling vests, cooling blankets, cold water baths, ice packs and mist systems are some of the many devices intended to cool the body by typical conductive heat transfer at the skin surface. These devices do not attempt to override or manipulate the typical human thermoregulatory response to skin contact with a cold entity. Some of them may cause the opposite of the desired effect, where skin contact with a cold surface may locally decrease skin blood flow, slowing the rate of heat exchange and exacerbating the cooling mechanism. Other modalities effectively reduce skin temperature but are bulky, non-portable, require high energy input and require a significant amount of time to cool the body's core temperature. Only total body cold water immersion has been shown to rapidly cool the body's core temperature.

[0004] Hypothermia is defined as a subnormal core body temperature and has been treated with devices that utilize similar skin conductive heat transfer, such as heating blankets, heated garments, and heat exchange blankets. These devices can be bulky, heavy, and require high energy input. The typical physiological response to hypothermia is a decrease in skin blood flow, decreasing the rate of heat transfer to the body's core.

[0005] Human thermal homeostasis can be defined as a core body temperature in the range of 35.0 °C to 37.5 °C. Core temperatures in this range are referred to as being normothermic.

[0006] For example, invasive treatments designed to modify core body temperature to maintain thermal homeostasis may include intravenous injection of cold or warm fluids such as saline, external blood heat exchangers, and injection of intravenous pharmacological thermoregulatory inhibitors. See U.S. Patent No. 6,572,638(B) to Dae et al. These treatments are generally effective in rapidly cooling or warming core body temperature and have been successfully used to return a person's core body temperature to its normothermic range. They can also be utilized to induce hypothermia for neuroprotection during surgical procedures such as coronary artery bypass, cerebral aneurysm repair, brain injury trauma, and after cardiac arrest. However, invasive treatments require sophisticated equipment and expertise, require hospital space, incur high costs, and expose patients to serious medical risks such as infection and bleeding.

[0007] The primary non-invasive thermoregulatory mechanism in humans is the increase or decrease in blood flow to the skin, which directly regulates heat exchange between the vasculature and the external environment. Cutaneous blood flow is approximately 250 ml / min when the core body temperature is within the normothermic range. Cutaneous blood flow can increase to 8,000 ml / min during extreme hyperthermia and decrease to 25 ml / min during hypothermia or exposure to a cold environment or surface.

[0008] Methods and devices have been described and patented that utilize negative pressure on the hand or foot in combination with simultaneous heating or cooling to induce localized vasodilation. See U.S. Patent No. 5,683,438 to Dennis A Grahn, U.S. Patent No. 8,177,826 to Grahn et al., U.S. Patent No. 6,656,208 to Grahn et al., and U.S. Patent No. 8,066,752 to Hamilton et al. Published results show that they are effective in cooling or warming core body temperature, presumably overriding the body's thermoregulatory mechanisms and opening arteriovenous anastomoses ("AVAs"), which are low resistance vessels that allow high flow directly from arterioles to venules, bypassing capillaries. However, these devices require cumbersome and bulky enclosures that must draw a vacuum on the limb and form an airtight seal around the person's limb while maintaining intimate contact with a heat exchange device within the enclosure. These systems are inherently bulky, require expensive vacuum pumping and sealing systems in addition to heat exchange systems, do not function well on immobile or unconscious individuals, and may have limited portability.

[0009] Although heat exchange can take place on any skin surface, hairless skin areas are particular areas of the body where heat exchange is greatly maximized. In humans, these areas include, but are not limited to, the palms of the hands and the soles of the feet. AVAs are located directly beneath hairless skin sites. AVAs can open and close in response to the body's thermoregulatory mechanisms, causing substantial changes in skin blood flow. It is in these areas that heat exchange with the environment has the greatest impact on core body temperature.

[0010] Those skilled in the art will recognize that core body temperature can be manipulated and controlled by the addition or removal of thermal energy at these hairless skin sites. However, the innate thermoregulatory response of mammals during these efforts often results in the closure of AVAs, reducing or preventing the occurrence of heat exchange. For example, a typical treatment for a person experiencing hyperthermia is to apply a cold object to the surface of the skin. However, the innate thermoregulatory response to a cold object placed against the skin results in local vasoconstriction, narrowing and / or occlusion of local blood vessels, significantly reducing local cutaneous blood flow. This greatly reduces the ability to remove heat from the circulatory system, which in turn reduces the ability to reduce core body temperature.

[0011] Additionally, certain disease states and pharmacological side effects result in a loss of proper thermoregulatory control. Thus, there is a need to develop methods and devices that manipulate and / or override local thermoregulatory mechanisms to force AVAs to remain open. When forced open, rapid heat exchange can occur across the AVAs at these manipulated skin locations to rapidly heat, cool, or maintain core body temperature. Summary of the Invention

[0012] The disclosed invention provides a non-invasive method and device for controlling and modifying an individual's core body temperature.

[0013] The present invention provides for the transfer of heat to or removal of heat from the circulatory vasculature via the skin surface, and also for the overriding of the natural human and mammalian thermoregulatory response to external thermal elements that results in reduced heat transfer across the skin.

[0014] The disclosed invention provides for transferring heat energy to or removing heat from the circulatory vasculature via direct skin contact with a circulating fluid or a heat transfer mechanism such as a thermoelectric heat pump (Peltier element) in an exemplary embodiment. Heat is transferred to or removed from the vasculature directly beneath the skin contact location. In an embodiment, the surface of the heat pump may be in the range of 1°C to 50°C and the circulating fluid may be in the range of 1°C to 50°C as well. The human circulatory system then carries the increase or decrease in heat energy to the core organs of the body. The location of skin contact is bathed in electromagnetic radiation in the range of 550nm to 950nm using a radiation emitting device operating in red and near infrared frequencies.

[0015] Traditionally, infrared electromagnetic radiation devices have been developed and commercialized for the treatment of humans in the areas of enhancing plant growth, improving wound healing, reducing pain, and repairing chronic and acute injuries. These devices have been developed as polychromatic and monochromatic devices utilizing laser and light emitting diode energy sources. Commercial success has been found with monochromatic infrared energy (MIRE) devices utilizing light emitting diode (LED) array energy sources, such as those provided by Anodyne Systems and Quantum Devices.

[0016] In accordance with the present invention, it has been discovered that exposure of the skin to this electromagnetic radiation, through a complex photobiochemical response, results in sustained vasodilation and increased blood flow in the area below the skin contact area, overriding the body's thermoregulatory response to temperature at the skin contact site, regardless of external environmental factors such as heat, cold, or humidity. Physiological testing described herein has shown that exposure of the palm of the hand, located directly above the arteriovenous anastomosis (AVA) vasculature, to monochromatic electromagnetic radiation in the range of 550 nm to 950 nm results in vasodilation and increased blood flow in the AVA vasculature, despite the presence of ice surrounding the hand and cold water circulating over the skin of the palm, which itself causes vasoconstriction. Testing has also demonstrated that heat is removed from the body in the presence of applied monochromatic electromagnetic radiation, and that heat is not removed when monochromatic electromagnetic radiation is not applied. The following is a description of the photobiochemical response mechanism that is initiated by exposure to electromagnetic radiation and results in a local increase in blood flow.

[0017] 1. Skin tissue having substantially localized vasculature is exposed to electromagnetic radiation emitted from a MIRE in the near infrared to infrared spectrum, preferably within the wavelength range of 550 nm to 950 nm. In an embodiment, the peak wavelength is preferably selected within the range of 670 nm to 890 nm. The radiation can be delivered via a laser or an LED. An exemplary method includes a MIRE emitted via an LED array. 2. Skin, tissue and water have minimal absorption of MIRE in the above ranges, therefore MIRE easily penetrates across the skin and into the body. Hemoglobin proteins located in red blood cells in blood vessels under the skin have the greatest absorption of MIRE once it penetrates the body. 3. Hemoglobin protein is known to store significant amounts of nitric oxide. 4. When exposed to MIRE, the hemoglobin protein releases nitric oxide into the bloodstream. 5. Nitric oxide diffuses to smooth muscle cells of the surrounding vasculature where it binds to and activates the enzyme guanylyl cyclase. 6. Guanylyl cyclase catalyzes the conversion of GTP (guanosine triphosphate) to cGMP (cyclic guanosine monophosphate) in smooth muscle cells of the surrounding vasculature. 7. cGMP induces smooth muscle relaxation through multiple mechanisms, particularly through relaxation of contractile proteins located within smooth muscle cells. 8. Smooth muscle relaxation within the vasculature results in local vascular vasodilation. 9. Vasodilation of local blood vessels directly causes an increase in local blood flow, in this case near the surface of the skin.

[0018] Nitric oxide has been demonstrated to be a powerful vasodilator, and only small amounts are required to cause a significant increase in blood flow. It is well known to those skilled in the art that an increased level of cutaneous blood flow is essential to maintain a high heat transfer rate across the skin surface. Research has shown that, compared to normal, an increase of only 8% in cutaneous blood flow rate can result in up to twice the heat transfer rate across the skin.

[0019] In embodiments where the method is performed or the device is applied to a location of hairless skin, the rate of thermal energy transfer is significantly increased and the selective infrared radiation overrides the local thermoregulatory response and keeps the AVA vasculature open, resulting in rapid heating or cooling of core body temperature or maintenance of normothermia during exposure to adverse environmental agents or extreme activities. However, it is understood that in embodiments the present invention may be practiced on any suitable open skin area.

[0020] According to an exemplary embodiment of the present invention, there is provided a device for modifying a core temperature of a mammal, the device comprising: a first infrared energy source capable of emitting a first monochromatic infrared radiation having a central wavelength of 550-950 nm; a first translucent fluid bladder for heat transfer; a first translucent substrate having a first surface in contact with the first translucent fluid bladder and a second surface configured to contact a first open skin area of ​​a mammal having a core temperature; a first fluid perfusion unit capable of circulating the first fluid through the first translucent fluid bladder; and a first fluid set to a temperature higher or lower than the core temperature of the mammal. In this exemplary embodiment, the first monochromatic infrared radiation from the first infrared energy source can be directed through the first translucent fluid bladder and the first translucent substrate. In an embodiment, the first translucent substrate is integral with the first translucent fluid bladder. In an embodiment, the device is configured to fit on a human hand and cover either the palm of the human hand or the palm and finger surfaces of the human hand.

[0021] In another exemplary embodiment, the device is configured to modify the core temperature of a mammal via heat transfer across two skin exterior surfaces, such as the palms of both hands. In this exemplary embodiment, the device further includes a second infrared energy source capable of emitting a second monochromatic infrared radiation having a central wavelength of 550-950 nm, a second translucent fluid bladder for heat transfer, a second translucent substrate having a third surface in contact with the second translucent thermal fluid bladder and a fourth surface configured to contact a second open skin area of ​​the mammal having a core temperature, a second fluid perfusion unit capable of circulating the second fluid through the second translucent fluid bladder, and a second fluid set to a temperature higher or lower than the core temperature of the mammal. In this exemplary embodiment, the second monochromatic infrared radiation from the second infrared energy source can be directed through the second translucent fluid bladder and the second translucent substrate.

[0022] According to an exemplary method practiced in accordance with the present invention, a method for regulating a mammal's core body temperature by the addition or removal of thermal energy includes monitoring the core body temperature of the mammal, contacting an open skin area of ​​the mammal with a first surface of a first translucent substrate, directing a first infrared energy source emitting monochromatic infrared radiant energy having a central wavelength of 550-950 nm through a first translucent heat transfer fluid bladder in contact with a second surface of the first translucent substrate into the open skin area of ​​the mammal, and circulating a first fluid through a first fluid perfusion unit, the first fluid being set at a temperature higher or lower than the monitored core body temperature of the mammal, to raise or lower the core temperature of the mammal. One skilled in the art will appreciate that "monitoring" can be interpreted as a first responder, or a person noting an elevated or lowered core temperature based on physiological signs, and is distinct from "measuring," which requires a thermometer of some kind. In a preferred embodiment, monitoring is performed with or without a thermometer. In one embodiment, the open skin area in contact with the first surface of the first translucent substrate is a site where the AVA blood vessels are below the surface of the skin.

[0023] In accordance with an exemplary method practiced in accordance with the present invention, a method for regulating a core body temperature of a mammal by the addition or removal of thermal energy includes monitoring a core body temperature of the mammal; contacting an open skin area of ​​the mammal with a first surface of a first translucent substrate; directing a first infrared energy source emitting monochromatic infrared radiant energy having a central wavelength of 550-950 nm through a second surface of the first translucent substrate and into the open skin area of ​​the mammal; and setting a temperature of a heat pump disposed in contact with the second surface of the first translucent substrate to a temperature above or below the monitored core body temperature of the mammal to increase or decrease the core temperature of the mammal.

[0024] In embodiments in which thermal energy is transferred exclusively into the mammal's body to increase the core temperature, thermal energy transfer can be provided via resistive electrical elements or electromagnetic radiation emissions. [Brief description of the drawings]

[0025] Exemplary embodiments of the present invention will now be described with reference to the accompanying drawings. [Figure 1] 1 shows a photobiochemical mechanism for localized increase in cutaneous blood flow. [Diagram 2] 1 illustrates a preferred embodiment of the claimed invention. [Diagram 3] FIG. 1 is an exploded view of a preferred embodiment of the claimed invention. [Figure 4] 1 shows a schematic cross-sectional view of an exemplary embodiment of the claimed invention; [Diagram 5] 5 shows the embodiment of the invention disclosed in FIG. 4 in contact with the palm of a human hand. [Figure 6] 1 illustrates a method of emitting infrared radiation through a translucent heat transfer fluid bladder, through the surface of the skin, and into the arteriovenous anastomotic vasculature of a subject in accordance with the present invention. [Figure 7] 1 illustrates the fluid paths within a translucent heat transfer fluid bladder made in accordance with the present invention. [Figure 8] 1 illustrates an exemplary array of multiple light emitting diodes used to deliver monochromatic infrared energy as referred to in the present invention. [Figure 9] 1 illustrates the fluid paths within an alternative embodiment of a translucent heat transfer fluid bladder made in accordance with the present invention. [Figure 10] 1 illustrates a circular, translucent heat transfer fluid bladder made in accordance with an alternative embodiment of the present invention. [Figure 11] 1 illustrates a circular array of multiple light emitting diodes used to deliver monochromatic infrared energy made in accordance with an alternative embodiment of the present invention. [Figure 12] 2 shows a schematic cross-sectional view of a second alternative embodiment of the present invention. [Figure 13] FIG. 13 shows a schematic view along the vertical axis of the alternative embodiment shown in FIG. 12. [Figure 14a] 3 shows a schematic cross-sectional view of a third alternative embodiment of the present invention. [Figure 14b] FIG. 14b shows a schematic view along the vertical axis of the alternative embodiment shown in FIG. 14a. [Figure 15] 1 shows a schematic cross-sectional view of a fourth alternative embodiment of the present invention. [Figure 16] 1 shows a schematic cross-sectional view of a fifth alternative embodiment of the present invention. [Figure 17] 13 shows a schematic cross-sectional view of a sixth alternative embodiment of the present invention. [Figure 18] 13 shows a schematic cross-sectional view of a seventh alternative embodiment of the present invention. [Figure 19] 1 shows a block diagram of an exemplary embodiment of the disclosed method. [Figure 20] 1 shows the positioning of the lower arm and hand during a test method used to investigate the feasibility of the claimed method. [Figure 21] 21 shows a close-up view of the right hand positioning during the test method described in FIG. 20. [Figure 22] 13 shows the positioning of the lower arm and hand during a control test of the second test method used to investigate the feasibility of the claimed method. [Diagram 23] 23 shows a close-up view of the right hand positioning during the control test of the test method described in FIG. [Figure 24] 13 shows the positioning of the lower arm and hand during a procedural test of a second test method used to investigate the feasibility of the claimed method. [Diagram 25] FIG. 25 shows a close-up view of the right hand positioning during the treatment test of the second test method described in FIG. 24. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] First, with reference to FIG. 1, the exact photobiochemical mechanism for the local increase in cutaneous blood flow by the use of the present invention will be described. FIG. 1 shows a schematic diagram of the causative reaction that begins with emitted infrared radiation 142 and results in cellular relaxation 155 of smooth muscle cells 150 located within the intima of an arteriovenous anastomotic vessel. The flow of blood 144 within the vessel is directionally tangential to the endothelial cells 148 that line the inner surface of the vessel. Specifically, a MIRE light source 141 emits infrared radiation 142 that penetrates across the surface of the skin (not shown), through human tissue (not shown), and into the bloodstream flowing through the arteriovenous anastomotic vessel. Such infrared radiation 142 is readily absorbed by hemoglobin proteins 143, typically located within red blood cells (not shown).

[0027] Absorption of this infrared radiation 142 causes nitric oxide molecules 146 to be released 147 from hemoglobin proteins 143 into the blood stream within the arteriovenous anastomosis. The nitric oxide molecules diffuse 149 through the endothelial cell 148 layer of the vascular intima to smooth muscle cells 150 where they bind to and activate guanylyl cyclase enzymes 151. The activated guanylyl cyclase enzymes 151 then catalyze the conversion 152 of guanosine triphosphate 153 to cyclic guanosine monophosphate 154 within the smooth muscle cells 150. The cyclic guanosine monophosphate 154 induces smooth muscle relaxation through multiple mechanisms, particularly through relaxation 155 of contractile proteins 156 located within the smooth muscle cells 150. Multiple smooth muscle relaxation events cause vasodilation of the arteriovenous anastomosis resulting in a sustained increase in local blood flow. The sustained increase in blood flow allows for rapid heat exchange between the subject device and the human cardiovascular system, allowing for regulation of the core temperature of the person in contact with the subject device.

[0028] FIG. 3 shows an exploded view of the near-infrared heat exchange module 219, and FIG. 2 shows an assembled view thereof.

[0029] In an embodiment (not shown), the near infrared heat exchange module 219 includes a fluid perfusion unit and a thermal control unit. Such units may be adapted to provide a flow of a medium, such as water, at high temperature, low temperature, or both, to the module 219. As will be apparent to one skilled in the art, any type of combination of fluid perfusion and thermal regulation units may be used with the module 219. Such a system may provide a high temperature when it is desired to increase the core body temperature, a low temperature when it is desired to cool the core body temperature, or a set temperature of approximately 37° C. when homeostasis is desired.

[0030] As shown in FIG. 3, the module 219 includes a translucent heat transfer fluid bladder 33 that constitutes the bottom portion 32 of the module 219. The fluid bladder 33 can be made of polyvinyl chloride, polyurethane, polytetrafluoroethylene, or any compound that provides suitable transmittance of near infrared light and can be adapted to include a watertight seal 39 along the perimeter between the top surface 34 and the bottom skin-contacting surface 35. The fluid bladder 33 also includes a fluid inlet 36 connected to a fluid perfusion unit (not shown), and a fluid outlet 37 also connected to the fluid perfusion unit. Fluid entering through the inlet 36 follows a fluid path 38 into a long fluid channel 310 defined by a long seal 39b before exiting the bladder 33 through the fluid outlet 37.

[0031] The central portion 311 of the near infrared heat exchange module 219 includes a plurality of near infrared light source devices 312 secured to a mounting panel 314 that contains the necessary electrical circuitry (not shown). In a preferred embodiment, the light source devices 312 consist of near infrared light emitting diodes, although other methods may be used. The electronic circuitry may be of any configuration that would be apparent to one skilled in the art.

[0032] The top portion 315 of the module 219 consists of an outer casing 316, preferably made of plastic or metal, a housing module 317 which may contain additional electronic circuitry (not shown) necessary to control and power the infrared light source device 312, and a conductive electrical cable 318 connected to an external power source (not shown) which may consist of common AC or battery supplied DC with or without power conditioning suitable for the light source device 312, as will be apparent to those skilled in the art.

[0033] 4 illustrates a schematic cross-sectional view 420 of an exemplary embodiment of the near-infrared heat exchange module 219 shown in FIG. 2. In this exemplary embodiment, the near-infrared heat exchange module has a curved surface 421 on an outer bottom surface 422 of the module. Bottom surface 422 represents the skin-contacting surface of the module, which is the bottom surface of a translucent heat transfer fluid bladder 423. A plurality of near-infrared light emitting diodes 424 are mounted in the housing module 417 and connected to an external power source (not shown) via a conductive electrical cable 418. The fluid bladder 423 includes a fluid inlet 46 connected to a fluid perfusion unit (not shown) and a fluid outlet 47 also connected to the fluid perfusion unit.

[0034] Figure 5 illustrates the embodiment of the present invention disclosed in Figure 4 resting on the palm of a human hand. A representative diagram of a human hand 526 including fingers 527 and thumb 528. Those skilled in the art will recognize that although a human hand is shown in Figure 5, the present invention will work in conjunction with any open skin area of ​​any mammal, and more preferably when used at a skin site having AVA vasculature. For ease of reference, throughout this disclosure, the mammal will be described as a human, and the open skin areas referenced will be those of the human hand.

[0035] During use according to one embodiment of the invention, the location of heat transfer occurs at the interface between the surface of the skin 530 and the surface 531 of the module 420. The arteriovenous anastomosis 529 is located below the outer surface of the skin 530.

[0036] Referring to FIG. 6, a representative diagram of human anatomy and vasculature 634 as it would be located in the palm of a hand is shown. The diagram includes the following anatomical features: inner skin layer 635, subcutaneous tissue 636, arterial blood supply 637, venous blood supply 638, and arteriovenous anastomosis 639. A representative diagram of the path of infrared light 633 as it exits module 420 through a translucent fluid bladder and covers arteriovenous anastomosis 639. When treating for hyperthermia therapy, blood exits the arterial supply and enters arteriovenous anastomosis 639 at a temperature higher than the body's desired homeostatic value. Heat exchange occurs at the skin-module surface interface 531 shown in FIG. 5 due to the temperature difference between the blood and the fluid in heat transfer bladder 33 shown in FIGS. 2 and 3, which is regulated to be at a temperature significantly lower than the user's current core temperature.

[0037] In one embodiment (not shown), a translucent substrate is disposed between the translucent fluid bladder and the skin surface. In an embodiment, the translucent substrate is rigid and inflexible. In an embodiment, the translucent substrate is flexible and configured to conform to the palm or other open skin area of ​​a human or other mammal.

[0038] As blood passes through the arteriovenous anastomosis vessels 639, it loses thermal energy, thereby cooling, and enters the venous blood supply 637 at a lower temperature than when it left the arterial blood supply 638. The infrared light 633 maximally vasodilates the arteriovenous anastomosis vessels 639, overriding the body's local thermoregulatory mechanisms that would otherwise result in closure of the arteriovenous anastomosis, thus maximizing heat transfer from the body. The continuous flow of blood through this system, over time, reduces the human user's core temperature until it returns to a state of thermal homeostasis.

[0039] FIG. 7 is a schematic diagram along the vertical axis of a preferred embodiment of the present invention showing the skin contact surface 75 of the translucent heat transfer fluid bladder 33 portion of the heat exchange module 219 shown in FIGS. 2 and 3. When used to reduce the body's core temperature, such as during hyperthermia treatment, a heat transfer fluid 72, preferably purified water, enters through the fluid inlet 76 of the bladder at a temperature substantially lower than the user's current core temperature. The fluid passes through a fluid pathway 78 bounded by an outer portion 79 sealed between the top and bottom surfaces of the fluid bladder and enters a long fluid channel 710 defined by a long portion 73 sealed between the top and bottom surfaces of the fluid bladder. As the fluid traverses the long fluid channel 710, heat exchange occurs with the body via thermal interaction with blood flowing through the arteriovenous anastomosis vessel 639 shown in FIG. 6, as previously described. The fluid exits the bladder through the fluid outlet 77 at a higher temperature than when the fluid entered the bladder through the fluid inlet 76, absorbing heat from the user's body. As previously mentioned, the fluid temperature is adjusted to a lower temperature via a thermal regulation unit (not shown) that resides in the fluid loop between the fluid outlet and the fluid inlet.

[0040] Figure 8 is a schematic view along the vertical axis of a preferred embodiment of the central portion 311 of the heat exchange module 219, as shown in Figure 3. A plurality of near-infrared light emitting diodes 813 are secured to a mounting panel 814 that contains the necessary electrical circuitry (not shown). The diodes 813 emit near-infrared light, which passes through the translucent heat transfer fluid bladder 33 substantially as shown in Figures 2 and 3, and exits the heat exchange module 219. Near-infrared light 633 (representatively shown in Figure 6) covers the arteriovenous anastomosis vessels 639.

[0041] 9 is a schematic view along the vertical axis of the skin contact surface of an alternative embodiment of the translucent heat transfer fluid bladder 960 portion of the near infrared heat exchange module 219 shown in FIG. 2. The components include a sealed outer portion 961 between the top and bottom surfaces of the fluid bladder, a sealed inner portion 961b separating a fluid inlet 962 from a fluid outlet 963 and defining a long fluid path 964, and a sealed post portion 968 between the top and bottom surfaces of the fluid bladder 960. In use, a heat transfer fluid 965, preferably purified water, enters through the fluid inlet 962, travels through the long fluid path 964, encounters an entry point 966 into the main chamber 967 of the fluid bladder, and follows a randomized agitation path 959, shown here by way of representation only, due to the obstruction of the post portion 968, until it reaches a main chamber exit point 969 and exits the bladder through the fluid outlet 963. As previously described, the heat transfer fluid 965 is conditioned by a thermal conditioning unit (not shown) present in the fluid loop between the fluid outlet and the fluid inlet. As previously described, heat exchange with the body occurs while the fluid 965 travels across the chamber 967 along the agitation path 959. The agitation path provides an alternative fluid flow mechanism compared to the long fluid channel 710 described in FIG.

[0042] 10 is a schematic diagram along the vertical axis of the skin-contacting surface of an alternative embodiment of a circular translucent heat transfer fluid bladder 1070 portion of a near-infrared heat exchange module (not shown) that is also substantially circular. Similar to the embodiment shown in FIG. 9, the component includes a sealed outer portion 1021 between the top and bottom surfaces of the fluid bladder, a sealed inner portion 1021b that separates a fluid inlet portion 1022 from a fluid outlet portion 1023 and defines a curved, long fluid path 1024, and a sealed post portion 1028 between the top and bottom surfaces of the fluid bladder 1070. In use, heat transfer fluid 1025, preferably purified water, enters through fluid inlet 1022, travels through a long curved fluid path 1024, encounters an entry point 1026 into the main chamber 1027 of the fluid bladder, and travels through randomized agitation paths 1019, shown here by way of indication only, due to obstruction of post portion 1028, until it reaches a main chamber exit point 1029 and exits the bladder through fluid outlet portion 1023. Thermal conditioning and heat exchange occurs substantially as previously described with respect to FIG.

[0043] 11 is a schematic view along the vertical axis of an alternative embodiment of a circular central portion 1121 of a near-infrared heat exchange module (not shown) that is also substantially circular. Similar to the embodiment shown in FIG. 8, a plurality of near-infrared light emitting diodes 1113 are secured to a mounting panel 1114 that includes necessary electrical circuitry, not shown. The diodes emit near-infrared light that passes through a substantially circular translucent heat transfer fluid bladder 1070 as shown in FIG. 10 and exits the circular heat exchange module. Near-infrared light 633 (representatively shown in FIG. 6) covers the arteriovenous anastomosis vessels 639.

[0044] FIG. 12 is a schematic cross-sectional view of an alternative embodiment of a near infrared heat exchange module 1272, in which the heat transfer mechanism between the module 1272 and the user is provided primarily by a thermoelectric heat pump 1274, as opposed to the heat transfer fluid bladder described in the previous embodiment. In this embodiment, the thermoelectric heat pump 1274 is housed within an outer casing 1273 of the heat exchange module 1272. The heat pump has an underside 1276 that maintains a temperature substantially different from the core temperature of the user, not shown. The temperature of the underside 1276 drives the heat transfer between the module and the user through applicable adjustment of the temperature of components disposed on the skin contacting surface 1275 of the module. Applicable control electronics, not shown, and a power source, not shown, may both be housed within the outer casing 1273, as would be apparent to one of ordinary skill in the art. Alternatively, the control electronics and power source may be housed external to the outer casing 1273 connected via sufficient electronic cables, not shown, as would be apparent to one of ordinary skill in the art. In this alternative configuration, a number of near infrared light emitting diodes 1213 are secured to a mounting panel 1214 that contains the necessary electrical circuitry, not shown. The diodes and mounting panel are disposed on a skin contacting surface 1275 of a heat exchange module 1272. The diodes emit near infrared light, which increases blood flow in the arteriovenous anastomosis vessels, as previously described. Heat exchange occurs at the skin-module surface interface (not shown) due to the temperature difference between the blood and the skin contacting surface of the heat exchange module.

[0045] Figure 13 is a schematic view along the vertical axis of an alternative embodiment 1272 of the near infrared heat exchange module shown in Figure 12. An outer casing 1373 houses a thermoelectric heat pump, not shown. A plurality of near infrared light emitting diodes 1313 are secured to a mounting panel 1314 that includes necessary electrical circuitry, not shown. The diodes and mounting panel are disposed on a skin contacting surface 1375 of the heat exchange module 1272. Although the module outline is shown to be approximately rectangular, it will be apparent to one skilled in the art that the module outline can take a variety of shapes, such as circular, hexagonal, square, etc.

[0046] An alternative embodiment of a near-infrared heat exchange module 1477 in which the heat transfer mechanism between the module and the user is provided primarily by a thermoelectric heat pump is shown in Figures 14a and 14b. Figure 14a is a schematic cross-sectional view of the near-infrared heat exchange module. Figure 14b is a schematic view along the vertical axis of the module, presenting a view of the skin contact surface 1483. The module is generally circular in shape and includes an inner circular location 1479 of a number of near-infrared light emitting diodes 1413 and an outer ring-shaped location 1478 of a number of diodes 1413. The diodes are housed within a generally translucent case 1484 that can be made of glass, plastic, quartz, or any material available to one skilled in the art that allows the transmission of near-infrared light. In this configuration, an annular shaped thermoelectric heat pump 1481 generates a transfer of heat to and from the user at a heat transfer interface 1482 along a skin contact surface 1483 (not shown) with the user. The module 1477 is housed within an outer casing 1480, which also contains electronics, systems, and power supplies, all of which are not shown collectively but will be apparent to one of ordinary skill in the art.

[0047] In an alternative embodiment of the near-infrared heat exchange module described in FIG. 4, the near-infrared light source is disposed at the skin-contacting surface and the heat transfer bladder is disposed behind the near-infrared light source, as shown in the schematic cross-sectional view of the near-infrared heat exchange module 1520 shown in FIG. 15. In this embodiment, the skin-contacting surface 1586 of the module includes a preferred curved surface 1521 defined by an electronics housing module 1517, on which a number of near-infrared light emitting diodes 1524 are mounted. The diodes are connected to an external power source (not shown) via a conductive electrical cable 1518. In this schematic view, a heat transfer fluid bladder 1523, which need not be translucent, is disposed on top of the housing module 1517. In this alternative embodiment, heat exchange occurs between the fluid bladder 1523 and the housing module 1517, and at the skin-contacting surface 1586 between the housing module 1517 and the user's skin (not shown). The housing module 1517 thus acts as a heat transfer conduit between the fluid bladder 1523 and the user's skin.

[0048] 16 is a schematic cross-sectional view of an alternative embodiment of a near infrared heat exchange module 1687 in which both a modular power supply 1690 and a thermal conditioning fluid chamber 1693 are enclosed within a housing 1692 of the heat exchange module 1687. In this embodiment, a plurality of near infrared light emitting diodes 1624 are mounted on an electrical component housing module 1691 and connected to a power supply 1690 via electrical connections 1689, with both the power supply and electrical connections contained within the electrical component housing module 1691. A translucent heat transfer fluid bladder 1623 transfers fluid (not shown) to the thermal conditioning fluid chamber 1693 via a fluid chamber inlet connection 1694. The fluid exits the fluid chamber 1693 after thermal conditioning via a fluid chamber outlet connection 1695, which is drawn via force from a fluid flow pump mechanism 1696, shown in schematic form, before returning to the fluid bladder 1623. The fluid bladder 1623 has an exterior skin contacting surface 1688 along a preferred curved surface 1621.

[0049] In an alternative embodiment shown in the schematic cross-sectional view of FIG. 17, the near-infrared heat exchange module 1797 includes two skin-contacting surfaces 1798a and 1798b. In such an embodiment, heat exchange between the user and the module 1797 can occur simultaneously on two surfaces, e.g., the palm of the left hand and the palm of the right hand, nearly doubling the rate of heat exchange experienced by the user compared to a near-infrared heat exchange module having a single skin-contacting surface. In this alternative embodiment, a plurality of near-infrared light emitting diodes 1724a are mounted on an electronic housing element 1799 disposed inwardly on the module 1797. The diodes 1724a are connected to an external power source (not shown) via a conductive electrical cable 1701a. Similarly, a secondary group of a plurality of near-infrared light emitting diodes 1724b are mounted on the electronic housing element 1799. The diodes are connected to an external power source (not shown) via a conductive electrical cable 1701b and are oriented such that their emitted light is directionally opposite to the emitted light from the oppositely mounted light emitting diode 1724a. Further, translucent heat transfer fluid bladder 1702a is connected to an external fluid regulation unit (not shown) via fluid inlet 1703a and fluid outlet 1704a. Fluid bladder 1702a has an external skin contacting surface that coincides with skin contacting surface 1721a along preferred curved surface 1798a. Similarly, secondary translucent heat transfer fluid bladder 1702b is connected to an external fluid regulation unit (not shown) via fluid inlet 1703b and fluid outlet 1704b. Secondary fluid bladder 1702b has an external skin contacting surface that coincides with skin contacting surface 1798b along secondary preferred curved surface 1721b. In one embodiment, fluid bladder 1702a and fluid bladder 1702b are supplied with fluid by the same fluid regulation unit.

[0050] FIG. 18 illustrates an alternative embodiment of a near-infrared heat exchange module 1805 having two skin contacting surfaces 1806a and 1806b. In this exemplary embodiment, a heat transfer fluid bladder, shown in schematic cross-section 1810, includes upper 1811a and lower 1811b heat transfer fluid channels. The fluid bladder 1810 is connected to an external fluid regulation unit (not shown) via a fluid inlet 1812 and a fluid outlet 1813. Additionally, a number of near-infrared light emitting diodes 1824a are mounted on the housing element 1807. The diodes 1824a are connected to an external power source (not shown) via a conductive electrical cable 1809a. Similarly, a number of near-infrared light emitting diodes 1824b are mounted on the housing element 1807. The diodes 1824b are connected to an external power source (not shown) via a conductive electrical cable 1809b and are oriented such that their emitted light is directionally opposite to the emitted light from the oppositely mounted light emitting diode 1824a. In this embodiment, the heat transfer fluid bladder 1810 is contained within the housing element 1807, and heat exchange occurs between the fluid bladder 1810 and the housing element 1807, and between the housing element 1807 and the user's skin (not shown) at the skin contacting surfaces 1806a and 1806b. Thus, the housing element 1807 acts as a heat transfer conduit between the fluid bladder 1810 and the user's skin. Advantages of this embodiment include the need for two skin contacting surfaces and only one heat transfer fluid bladder, which may reduce complexity.

[0051] In an exemplary embodiment of a method performed in accordance with the present invention, thermal energy is removed from the human circulatory vasculature, specifically at the location of the arteriovenous anastomosis (AVA) 1901, as shown in schematic form in Figure 19. This is accomplished utilizing direct contact between the palm's skin layer 1902 and a heat transfer mechanism consisting of a circulating fluid 1908 enclosed within a thin translucent bladder 1903, which is constantly replenished externally with fluid 1904 at a set temperature significantly lower than 37°C (98.6°F) cooled by an external fluid cooling device 1905. In this exemplary embodiment, the temperature set point of the fluid cooling device is 5°C.

[0052] The human circulatory system transfers the loss of thermal energy to the body's core organs 1906 by utilizing blood 1907, which is at a lower temperature when it leaves the AVA structure than when it arrived, thus rapidly lowering the core body temperature. The palm is covered in electromagnetic radiation 1909 provided by a MIRE light emitting diode array 1910, which in this embodiment has a central wavelength of 670 nm, which penetrates the translucent fluid bladder 1903 beneath the palm's surface and enters the AVA vasculature 1901 of the hand. This infrared energy exposure overrides the local thermoregulatory response, forcing the AVA valves 1911 to remain open, causing sustained vasodilation and increased blood flow in the AVA vasculature, particularly the arteries 1912 and veins 1913, amplifying and sustaining the transfer of heat away from the core organs and out of the body via the warmed fluid 1914 of the heat transfer mechanism, which then returns to the heat transfer mechanism after being cooled by the external fluid cooling device 1905, to begin the cycle again.

[0053] In an alternative embodiment (not shown) of a method performed in accordance with the present invention, the entire hand or a portion of the hand is immersed in a cold water bath, ice bath, or cold water jacket device to remove thermal energy from the AVA vasculature while the palm is exposed to a monochromatic infrared energy source.

[0054] Summary of test results Two physiological tests were performed on human subjects to demonstrate the reduction in core temperature following physical exercise when practicing the methods of the present invention.

[0055] The first study performed on one subject consisted of a control study and a treatment study, separated by approximately 24 hours. Each study consisted of two phases: exercise and recovery. During the exercise and recovery phases, subjects were monitored for core temperature measured rectally.

[0056] The exercise phase of the controlled study consisted of an increase in physical exertion during which subjects rode on a stationary cycle ergometer in a thermally elevated enclosure for 20 minutes. A sustained core temperature of approximately 38.0°C (100.4°F) was achieved. The recovery phase of the controlled study consisted of 20 minutes of seated rest in an environmentally controlled room at approximately 23°C (73.4°F) and 50% relative humidity with no treatment administered.

[0057] The exercise phase of the treatment trial consisted of an increase in the same level of physical exertion during which the subject was on a stationary cycle ergometer for 20 minutes in a heated enclosure to achieve a sustained core temperature of approximately 38.0°C (100.4°F). The recovery phase of the treatment trial consisted of 20 minutes of seated rest in an environmentally controlled room at approximately 23°C (73.4°F) and 50% relative humidity. During the recovery phase, the subject's left hand 2002a and right hand 2002b were placed on top of polyethylene bags 2001a and 2001b, respectively, filled with crushed ice, with the back and sides of the hands in direct contact with the ice bags, as shown in FIG. 20. Devices 2003a and 2003b were placed on the palms of each hand. Each device had a bandwidth of 620 nm to 720 nm and a peak central wavelength of 670 nm, a 50 mw / cm 2 and 7.5 cm 2 The hand included a light emitting diode array providing monochromatic infrared energy having an emitting area of ​​100 nm (WARP 10A, supplied by Quantum Devices, Barneveld, Wisconsin). The radiant infrared energy was directed toward approximately the center of the palm 2101 of the right hand 2002b, as shown in FIG. 21. Utilizing this methodology, the monochromatic infrared energy penetrated the palm and interacted with blood hemoglobin and arteriovenous anastomotic vasculature, as shown in FIG. 1. Infrared exposure was constant throughout the 20 minute recovery phase of the treatment study.

[0058] Results from the first trial, as seen in Table 1 below, showed a rapid increase in core temperature at the beginning of the recovery phase during both the control and treatment trials. This is a common post-exercise phenomenon. During the treatment trial, subjects experienced a relative difference in core temperature of -0.2 to -0.3 °C (-0.4 to -0.5 °F) compared to the control trial. This relative difference was achieved within the first 4 minutes of the treatment trial and was maintained for the remainder of the recovery phase.

[0059] [Table 1]

[0060] During a second physiological study conducted on three subjects, the components of the device shown in Figures 2 and 3 were utilized to cool core body temperature during the recovery phase of the treatment study. In the second study, the hand was exposed to cold by exposing the back and palm of the hand to cold during the recovery phase of both the control and treatment studies. Skin surface temperature measurements were also taken during the recovery phase.

[0061] The second study was designed so that the only difference between the control and treatment studies was the exposure of the palm to infrared energy.

[0062] The second study consisted of a control study and a treatment study separated by approximately 4 hours. Each study consisted of two phases: exercise and recovery. During the exercise and recovery phases, subjects were monitored for core temperature measured rectally.

[0063] The exercise phase of the controlled trial consisted of elevated physical exercise, with each subject on a stationary cycle ergometer in a heated enclosure for approximately 3-5 minutes, just long enough to experience an increase in core temperature of 0.5°C (0.9°F).

[0064] At the start of the recovery phase of the controlled trial, one temperature sensor 2201 was placed on the palm side of the left hand 2202a, located approximately at the ball of the foot 2203, as shown in Figure 22. A second temperature sensor 2204 was placed approximately in the center, palm side, of the left wrist 2205. Skin temperatures at these locations were monitored during the recovery phase of the controlled trial.

[0065] The recovery phase of the controlled study consisted of 18 minutes of seated rest in an environmentally controlled room at approximately 23° C. (73.4° F.) and 50% relative humidity. During the recovery phase, the back of each hand was placed on top of polyethylene bags 2206a and 2206b filled with crushed ice. Additionally, the palms of the left 2202a and right 2202b hands were cooled by direct contact with translucent fluid bladders 2207a and 2207b, respectively, through which water at approximately 2° C. (35.6° F.) was continuously circulated and delivered via fluid transfer tubing sets 2208a and 2208b connected to a fluid perfusion and thermal control device (Therma-Zone Continuous Thermal Therapy Device, Innovative Medical Equipment, Cleveland, Ohio), not shown. Devices 2209a and 2209b, each having a light emitting diode array, were placed in direct contact with translucent fluid bladders 2207a and 2207b located in the palms of left hand 2202a and right hand 2202b. The light emitting diode arrays of devices 2209a and 2209b each had a central wavelength of 670 nm, 50 mw / cm 2 and 7.5 cm 2 (WARP 10A, supplied by Quantum Devices, Barneveld, Wisconsin) during the controlled tests. During the controlled tests, the radiated infrared energy was directed away from the hands and prevented from exiting the device through metal caps 2210a and 2210b, as also shown in FIG. 23. Thus, no infrared energy was received by the hands during the controlled tests.

[0066] The exercise phase of the treatment trial consisted of elevated physical exercise, with each subject on a stationary cycle ergometer in a heated enclosure for approximately 3-5 minutes, just long enough to experience an increase in core temperature of 0.5°C (0.9°F).

[0067] At the start of the recovery phase of the treatment trial, one temperature sensor 2401 was placed on the palm side of the left hand 2402a, located approximately at the ball of the foot 2403, as shown in Figure 24. A second temperature sensor 2404 was placed approximately in the middle, palm side of the left wrist 2405. Skin temperatures at these locations were monitored during the recovery phase of the treatment trial.

[0068] The recovery phase of the treatment trial, consisting of 18 minutes of seated rest in an environmentally controlled room at approximately 23° C. (73.4° F.) and 50% relative humidity, successfully cooled the core body temperature of two subjects utilizing the claimed method. During the recovery phase, the back of each hand was placed on top of polyethylene bags 2406a and 2406b filled with crushed ice. Additionally, the palms of the left hand 2402a and right hand 2402b were cooled by direct contact with translucent fluid bladders 2407a and 2407b, respectively, through which water at approximately 2° C. (35.6° F.) was continuously circulated and delivered via fluid transfer tubing sets 2408a and 2408b connected to a fluid perfusion and thermal control device (Therma-Zone Continuous Thermal Therapy Device, Innovative Medical Equipment, Cleveland, Ohio), not shown. Devices 2409a and 2409b, each having a light emitting diode array, were placed in direct contact with translucent fluid bladders 2407a and 2407b located in the palms of left hand 2402a and right hand 2402b. The light emitting diode arrays of devices 2409a and 2409b emitted light with a central wavelength of 670 nm, 50 mw / cm 2 and 7.5 cm 2The monochromatic infrared energy was provided having a radiating area of ​​100 nm (WARP 10A, supplied by Quantum Devices, Barneveld, Wisconsin). During the treatment trials, the radiant infrared energy was directed through a translucent fluid bladder into the palm of each hand, as also shown in FIG.

[0069] Thus, infrared radiant energy with a central wavelength of 670 nm was applied to the palm of each hand during the recovery phase of the treatment trial but not during the recovery phase of the control trial. All other variables, including exposure of the whole hand to cold, were held constant between the control and treatment trials.

[0070] Two of the three subjects responded to the claimed cooling methods and recorded significant differences in core temperature between the recovery phase of the control study and the recovery phase of the treatment study. The following data is representative of the two subjects who responded to the claimed cooling methods.

[0071] The mean skin temperatures recorded at the wrist and palm of each subject were higher during the recovery phase of the treatment study compared to the recovery phase of the control study, as shown in Tables 2 and 3, respectively. This data suggests that there was increased arteriovenous anastomotic vasculature vasodilation during the recovery phase of the treatment study compared to the recovery phase of the control study.

[0072] [Table 2]

[0073] [Table 3]

[0074] As seen in Table 4 below, the average core temperature data showed a rapid increase in core temperature at the beginning of the recovery phase during both the control and treatment studies. During the treatment study, utilizing the cooling method of the present invention, by the end of the recovery phase, subjects experienced a relative difference in core temperature of -0.2°C (-0.4°F) compared to the control study.

[0075] [Table 4]

[0076] It is anticipated and within the scope of the present invention that the disclosed device and method may be effectively used in a variety of applications. The disclosed device may be configured as a stationary, portable, or wearable system. It may be configured to transfer heat to the body, remove heat from the body, or both. It may be used to treat hypothermia and hyperthermia in medical, outpatient, or home health settings.

[0077] Within the scope of the present invention, it is anticipated that the disclosed invention, when configured for heat removal from the body, can be used for the following purposes: it can remove internal heat buildup during or immediately following physical exercise; it can therefore be used to enhance the physical performance of athletes; it can be incorporated into exercise equipment to increase the length, quality and performance of workouts; it can be used to increase the stamina of soldiers or workers exposed to high temperatures; it can be utilized to prevent or reduce the effects of heat stress on individuals exposed to high temperatures, with or without physical exercise.

[0078] In a medical or home health environment, the present invention can be used as a sole or adjunct therapy for the treatment of diseases that affect the thermoregulatory system, such as fever, diabetes, hypertension, or Parkinson's disease. Newborns and prematurely born children often have compromised thermoregulatory systems. In these cases, the present invention can be used to maintain a normothermic core temperature by adding or removing thermal energy from the body as needed. Core temperature measurement and feedback control mechanisms can be incorporated to form a closed loop system that maintains a normothermic core temperature in children or adults. Those skilled in the art will recognize that this can also be applied to other mammals.

[0079] The present invention, deployed in a hospital environment and configured to transfer heat into the body, can be used to combat post-operative hypothermia, which occurs in 60% of all surgeries and 90% of all cardiothoracic surgeries. It can be used to maintain a normal core temperature during surgery by introducing heat into the body while the patient is in a cooled operating room. This allows for a cool surgical environment that has been proven to reduce the occurrence of life-threatening infections. A normal core temperature during surgery also increases the effectiveness of anesthetic agents, allowing for smaller doses to need to be administered during surgery. Furthermore, a normal core temperature during surgery can eliminate post-operative hypothermia, which would significantly reduce post-operative recovery time. Alternatively, the present invention configured for heat removal from the body can be used to induce surgical hypothermia, which is essential to enhance neuroprotection during certain high-risk surgical procedures.

[0080] Because it is configured to transfer heat into the body, the present invention can be used to extend a person's exposure to cold environments, for example for workers exposed to the elements, or for sportspeople engaged in activities such as skiing, hiking, hunting, fishing, camping, climbing, snowmobiling, ocean swimming, and the like. The present invention can be used to rapidly heat the core temperature of people with severe hypothermia that can cause significant body damage and loss of life. It can be used to aid in warm-up preparations prior to physical activity. It can be used in physical therapy to keep muscles and organs warm during prolonged cryotherapy tissue treatments.

[0081] It is anticipated and within the scope of the present invention that the present invention may be used as an adjunct to weight loss by providing a sustained, continuous removal of heat from the circulatory vasculature, as research has shown that the sustained, moderate removal of heat from the core organs, which places a constant, secondary heat load on the body, must be countered by increased metabolic activity and thus the burning of calories.

[0082] Now that embodiments of the present invention have been shown and described in detail, various modifications and improvements will become readily apparent to those skilled in the art. Accordingly, the exemplary embodiments of the present invention described above are intended to be illustrative rather than limiting. The spirit and scope of the present invention should be broadly construed.

Claims

1. 1. An apparatus for altering the core temperature of a mammal, comprising: a first infrared energy source capable of emitting a first monochromatic infrared radiation having a central wavelength between 550 and 950 nm; a first translucent fluid bladder for heat transfer; a first translucent substrate having a first surface in contact with the first translucent fluid bladder and a second surface configured to contact a first open skin area containing an arteriovenous anastomosis of a mammal having a core temperature; a first fluid perfusion unit capable of circulating a first fluid through the first translucent fluid bladder, the first fluid being set at a temperature above or below the core temperature of the mammal; The apparatus, wherein the first monochromatic infrared radiation from the first infrared energy source can be directed through the first translucent fluid bladder and the first translucent substrate.

2. The device of claim 1 , wherein the first translucent substrate is integral with the fluid bladder.

3. a second infrared energy source capable of emitting a second monochromatic infrared radiation having a central wavelength between 550 and 950 nm; and a second translucent fluid bladder for heat transfer; a second translucent substrate having a third surface in contact with the second translucent thermal fluid bladder and a fourth surface configured to contact a second open skin area containing an arteriovenous anastomosis of the mammal having the core temperature; a second fluid perfusion unit capable of circulating a second fluid through the second translucent fluid bladder, the second fluid being set at a temperature above or below the core temperature of the mammal; 10. The apparatus of claim 1, wherein the second monochromatic infrared radiation from the second infrared energy source can be directed through the second translucent fluid bladder and the second translucent substrate.

4. The apparatus of claim 3 , wherein the first monochromatic infrared radiation and the second monochromatic infrared radiation are provided by a plurality of light emitting diodes.

5. 4. The apparatus of claim 3, wherein the first monochromatic infrared radiation and the second monochromatic infrared radiation each have a central wavelength of 670 nm.

6. The apparatus of claim 3 , wherein the first monochromatic infrared radiation and the second monochromatic infrared radiation are provided by lasers.

7. The device of claim 1 , wherein the first translucent substrate is rigid and inflexible.

8. The device of claim 1 , wherein the first translucent substrate is flexible and configured to conform to the first open skin area of ​​the mammal.

9. 1. A method for regulating the core body temperature of a mammal, except a human, through the addition or removal of thermal energy, said method comprising: monitoring the core body temperature of the mammal; contacting an area of ​​open skin containing an arteriovenous anastomosis of the mammal with a first surface of a first translucent substrate; directing a first infrared energy source emitting monochromatic infrared radiant energy having a central wavelength of 550-950 nm through a first translucent heat transfer fluid bladder in contact with a second surface of the first translucent substrate and into the open skin area of ​​the mammal; circulating a first fluid through a first fluid perfusion unit, the first fluid being set at a temperature higher or lower than the monitored core body temperature of the mammal to raise or lower the core temperature of the mammal; A method comprising:

10. 10. The method of claim 9, wherein the open skin area is located at a site where an arteriovenous anastomotic vessel lies below the surface of the skin.

11. 1. A method for regulating the core body temperature of a mammal, except a human, through the addition or removal of thermal energy, said method comprising: monitoring a core body temperature of said mammal; contacting an area of ​​open skin containing an arteriovenous anastomosis of the mammal with a first surface of a first translucent substrate; directing a first infrared energy source emitting monochromatic infrared radiant energy having a central wavelength between 550 nm and 950 nm through a second surface of the first translucent substrate to the open skin area of ​​the mammal; setting a temperature of a heat pump disposed in contact with a second surface of the first translucent substrate to a temperature above or below the monitored core body temperature of the mammal to increase or decrease the core temperature of the mammal; A method comprising:

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