WO2009147413A1

WO2009147413A1 - Thermal transfer device for human body

Info

Publication number: WO2009147413A1
Application number: PCT/GB2009/001428
Authority: WO
Inventors: Klayton Franklin Palmer
Original assignee: Individual
Current assignee: Individual
Priority date: 2008-06-06
Filing date: 2009-06-08
Publication date: 2009-12-10
Anticipated expiration: 2010-12-06
Also published as: GB0909840D0; GB201100050D0; GB0810386D0

Abstract

A thermal transfer device is described which has a body of material configured to cover at least a portion of a human body and having a plurality of protrusions made of a thermally conductive material providing means for heat transfer from and/or too the human body and through the body of material. The protrusions are integrally molded or bonded to the surface of the body of material. The device may be used for the cooling or heating of patients with various forms of commercially available devices. The device is particularly suitable for use with cool caps to prevent hair loss during chemotherapy, for infant head cooling after traumatic childbirth and for patient brain cooling during operative procedures where there is a risk of injury caused by ischemia

Description

THERMAL TRANSFER DEVICE FOR HUMAN BODY

FIELD OF INVENTION

[0001] The present invention relates to a device, method and system for inducing cooling and/or hypothermia and/or heating in the brain and/or the human body.

BACKGROUND ART

[0002] There is considerable scientific evidence that artificially induced mild hypothermia of the human body may have significant benefits in a number of medical situations including acute emergency situations and planned surgical procedures and/or methods of treatment.

[0003] It is well known that patients suffering from stroke, cardiac arrest, or head trauma, or have undergone invasive brain or vascular surgery are at risk from secondary ischemic brain injury. Secondary ischemic brain injury is a result of the innate healing response of the brain to the original insult caused by several not completely understood mechanisms. Regardless of the specific mechanisms involved, the end result is swelling of the brain caused by edema, which can lead to a critical or terminal rise in intra-cranial pressure, or ceil death and loss of brain function.

[0004] Patients suffering heart attack often suffer damage to their heart due to secondary injury caused by ischemia. Ischemic damage to the heart is the main cause of death and disability following heart attack.

[0005] It has long been known that hypothermia is neuroprotective and has a positive affect on all know mechanisms that lead to secondary brain injury. Hypothermia is routinely used during brain and other invasive surgeries to protect the brain from surgical interruptions in blood flow. Hypothermia has also been shown to be effective in controlling swelling of the brain in trauma and stroke patients. It has also been discovered that hypothermia is effective at protecting the heart from secondary ischemic injury due to heart attack. This phenomenon has been demonstrated repeatedly in humans subjected to profound hypothermia and circulatory arrest to facilitate the surgical repair of complex cardiac or cerebrovascular anomalies. When temperature is reduced to 17-20 DEG C, the human brain can tolerate approximately one hour of circulatory arrest without sustaining permanent injury. Although the exact physiologic basis by which small temperature changes produce significant alterations in post-ischemic neurologic outcome is not clear, it is apparent such changes can have a significant effect on functional outcome and histopathology following cerebral ischemia.

[0006] In these treatments conditions the effectiveness of hypothermia is a function of depth, duration, and the amount of time that elapses between the original insult and achievement of protective levels of hypothermia; the earlier, deeper and/or the longer hypothermia is applied the more protective it is. However, hypothermia has historically been applied systemically, and the depth and duration of hypothermia is limited by the patient's ability to tolerate the therapy.

[0007] Systemic hypothermia has historically been accomplished by immersion of the patient's body in a cool bath. Today there are several commercial systemic hypothermia systems available. They consist of blankets or pads where cooled water is circulated through channels in the walls of the blanket or pad, and the patient's body is maintained in intimate contact. Medivan Corp. manufactures an example of a modern hypothermia system under the trade name Arctic Sun Cooling System.

[0008] Systemic hypothermia has been demonstrated to be effective in reducing secondary injury from stroke, trauma, and surgery however; there are several drawbacks to this approach: 1) it may take several hours to lower a patient's body to therapeutic temperatures. This delay in achieving therapeutic temperatures allows for the progression of irreversible secondary injury to the brain and heart. 2) Hypothermia cannot be initiated until after the patient has been admitted to the hospital. 3) The entire patient's body is cooled in a slow and uniform manner; protective levels of hypothermia in the brain is not achieved until the whole body reaches protective levels of hypothermia.

[0009] Attempts have been made to induce hypothermia by cooling the surface of the head. One product marketed was by Flexoversal from Hiden, Germany was a head cooling device under the trade name of "Hypotherm Gel Cap" This device is a head cap with a gel substance within its walls. The "Gel Cap" is placed into a freezer prior to use, and then is fitted to the head of a patient. The gel within the walls of the cap absorbs heat from the head. Also, described in the art are cooling caps that have cold fluid circulating through the walls of the cap to absorb heat from the head. Reports from clinical trials using such devices have been disappointing in that they have not been effective in inducing hypothermia in patients. Although, theoretically these devises should be capable in inducing hypothermia, there are several practical limitations in design of the devices, and in the way they are used that limits effectiveness. A significant problem is that hair; especially dry hair is a very effective insulator. There is significant variation from patient to patient in the thickness of hair on the head, and its distribution. A device that does not address the insulating effect of hair, and its variability among patients is will ineffective in inducing hypothermia in a consistent manner. A second significant problem with head cooling described in the art is that the cooling medium (gel or circulating water) is separated from the head by the material that the device is made of. Most devices described in the art are made of plastic or woven material, both of which are highly insulative and greatly reduce the amount of heat that is transferred from the head into the cooling medium.

[0010] One solution proposed in US2006/0030916 is the directing of evenly distributed jets of saline at near 0⁰C. at the scalp in a vigorous manner. This is a particularly complex solution and is not easily undertaken by patients. A further complex solution to this problem is provided in U.S. Pat. No 6126 680.

[0011] The use of cytotoxic agents in, for example, chemotherapy of cancer patients almost always leads to hair loss known as alopecia. Alopecia can be prevented by cooling the hair bearing scalp because drug uptake by hair follicles is reduced as a consequence of cutaneous vasoconstriction and the inhibition of cellular metabolic pathways. Other treatments are known for different medical conditions, which require heating the scalp of the user.

[0012] Conventional apparatus for achieving regulation of the temperature of the scalp of a wearer entails direct cooling or heating of the scalp of the user. Conventional apparatus falls into three basic categories, which for sake of explanation, are described for cooling the scalp of a wearer. [0013] U.S. Pat. No. 5603728 describes a scalp apparatus for regulating the temperature of the scalp of a wearer in which the temperature of the scalp of the wearer is regulated by natural convection.

[0014] U.S. Pat. No. 4,552,149 includes the application of crushed ice compresses or shaped cryogen packs against the scalp of the wearer. In a similar application for facilitating post-traumatic, post-surgical and/or post-inflammatory healing of tissue.

[0015] U.S. Pat No. 5,169,384 teaches the use of thermoelectric elements for cooling fluid filled deformable members, which are in physical engagement with an underlying skin surface.

[0016] U.S. Pat. No. 4,566,455 includes the circulation of chilled liquid in close thermal contact with the scalp.

[0017] WO 89/09583 includes the forced circulation of cold air in a closed air space surrounding the scalp of the wearer for cooling the scalp through the wind-chill effect.

[0018] These techniques suffer from a number of disadvantages. First, they often require pre-treatment in the form of hair-wetting for improving cooling. Second, condensation typically forms on the inside and/or outside of the head-cooling implement, which eventually forms dewdrops, which run down onto the wearer's face. Third, the wearer often suffers uncomfortable sensations of either "cold-shock" by the application of cold assemblies against his scalp or "wind-chill" by the forced circulation of cold air. And finally, the head-cooling implement often has to be provided in several sizes for fitting a wide range of wearers.

[0019] Furthermore despite the advanced state of today's medical care, brain injury to newborn infants, e.g., after a difficult labor resulting in permanent neurological damage because the infant's brain did not receive sufficient oxygen-rich blood, occurs in an estimated 1 or 2 per 1000 births in the United States. Following the deprivation of the much needed oxygenated blood, neurons in the brain die over the course of minutes to days and are not capable of regeneration. In addition, glial cells, which are essential for normal brain functioning, can be lost. There is scientific evidence that mild hypothermia of the affected infant's brain protects against neuronal damage in the case of hypoxic-ischemic insults to the brain. It has been reported that lowering the brain temperature to levels that are protective for neuronal damage facilitates improving the neurological and thus psycho-motor developmental outcome.

[0020] In view of the foregoing, the need exists for an improved design for a device to cool human bodies and in particular brains so that effective utilization of the hypothermia treatment can be achieved.

DISCLOSURE OF THE INVENTION

[0021] The present invention and its specific embodiments aim to provide effective and even cooling to the human body and especially the head of a human.

[0022] In one embodiment the present invention provides a thermal transfer device for heat transfer from and/or too the human body comprising: a body of material having a surface proximate to the human body during use said surface having a plurality of protrusions that make point contact with the human body during use of the device, the protrusions being molded from thermally conductive material and providing means for heat transfer from and/or too the human body through the device.

[0023] Preferably the body of the device and the protrusions are integrally molded from the same thermally conductive material. The body of the thermal transfer device may be substantially in the form of a sheet of material. Preferably. the thermal transfer device is configured in the form of a cap to cover a significant portion of the human head. The cap may be shaped to provide contact along the brow, around the ears and down the neck to/or below the hairline of a human head.

[0024] In one embodiment the body of the device and the protrusions are separately formed and are bonded to each other to form the thermal transfer device. In this embodiment the body of the device and the protrusions may be made of the same material or they may be made of different materials. It may be that the material for the protrusions is selected to be of higher thermal conductivity compared to that used for the body of the device. In one arrangement the protrusions being of different material compared to the body are also independently made of two or more materials of the same or differing thermal conductivities.

[0025] In one arrangement the plurality of protrusions are grouped on the device in sections of like thermal conductivity. In a further arrangement the device ideally in the form of a cap may have a plurality of sections for contact with different regions of the human head and each section having a plurality of protrusions.

[0026] The protrusions of the device may be spaced apart at regular intervals. They may terminate in a flat surface, an angular point or may be rounded at their point of contact with the human body. The protrusions are ideally substantially circular in cross-section taken in a plane parallel to the body surface. They may have a Gaussian profile when viewed in a cross-section perpendicular to the plane of contact the protrusions with the body surface. They may have the appearance of circular pyramids when viewed in perspective. Ideally the protrusions are of a size and density on the device surface such that when in the form of a cap for application to a human head they may be forced through the hair to make contact with the scalp.

[0027] The thermal transfer device of the present invention may be used in conjunction with conventional head cooling devices. When used in this way the thermal transfer device of the present invention may enhance the performance of the conventional device or its effectiveness or ease of use. In these arrangements the thermal transfer device of the present invention may comprise material for the device body and protrusions that is of the same or similar thermal conductivity to that of any material used in the conventional a co-operating device for cooling of the human body. Preferably the thermal conductivity is higher than that of the material used in the conventional device.

[0028] The invention further provides for a thermal treatment apparatus comprising: (a) a thermal transfer device according to the present invention and (b) means to apply and/or remove heat from the thermal transfer device.

[0029] The thermal transfer device of the present invention may be manufactured to be integral with the components of the means for applying and/or removing heat. For example a conventional cooling cap or cooling system (as described briefly below) may have the relevant component for contact with the human skin modified to incorporate a plurality of protrusions in accordance with the present invention.

[0030] The thermal transfer device may be in the form of a sheet or mattress onto which a patient may lay in order to reduce or raise total body temperature.

Examples of such general sheet and mattress arrangements are know in the art and may be modified to incorporate protrusions according to the present invention.

[0031] The thermal transfer device may be in the form of a bandage, which may be placed around a patient's limb(s). Then cooling or heating means may be brought into contact with the device as a bandage.

[0032] The present invention also provides a device for cooling the brain of an infant whose brain has suffered a hypoxic shock, the device comprising: a thermal transfer device according to the present invention and a cooling liner for placement against the thermal transfer device, the cooling liner having a top and comprising only one fluid conduit for receiving a cooling fluid, the fluid conduit beginning at an inlet located at the top and terminating at an outlet located at the top, being serpentine in shape between the inlet and the outlet and configured so that the fluid conduit travels from the inlet adjacent a first hemisphere of the infant's brain in a general direction toward an opposite hemisphere of the infant's brain where the conduit reverses its direction and a serpentine portion of the conduit travels in a direction from the opposite hemisphere to the first hemisphere where it terminates at the outlet. The thermal transfer device according to the present invention may be secured to the cooling liner. The cooling liner may have a modified surface to incorporate a plurality of protrusions according to the thermal contact device of the present invention and this modified cooling liner replaces the separate thermal transfer device and cooling liner.

[0033] In a further aspect the present invention provides a method for inducing hypothermia in a patient, comprising: bringing into contact with at least a portion of a patient's body a thermal transfer device according to the present invention and applying or withdrawing heat to/from the patient's body through the thermal transfer device.

[0034] In accordance with a further aspect there is provided a thermal regulation system, comprising: a console having: a fluid reservoir configured to hold a thermal exchange fluid, a pressure source in fluid communication with the fluid reservoir, and a suction source in fluid communication with the fluid reservoir; and a thermal regulation device having: a thermal contact device according to the present invention within a cap configured to cover at least a portion of a patient's head to define a fluid circulation space into which the thermal exchange fluid can be introduced to contact the surface of the thermal contact device remote from the patients head; at least one inlet coupled to the pressure source and configured to introduce the thermal exchange fluid into the fluid circulation space under positive gage pressure; and at least one outlet coupled to the suction source and configured to withdraw the thermal exchange fluid from the fluid circulation space under negative gage pressure.

[0035] The thermal transfer device of the present invention may be adapted for use with a range of commercially available solutions for patient cooling. Such systems are as described in US6312453 (infant brain cooling), US6126680, US5603728, US 4,552,149, US 4, 566, 455 and WO98/16176, and European Journal of Oncology Nursing (2004) 8, 121-130, Title "A multicentre study to determine the efficacy and patient acceptability of the Paxman Scalp Cooler to prevent hair loss in patients receiving chemotherapy", Author: Carolyn S. Massey. The disclosures of all of these references is incorporated by reference. Indicative commercial devices are the Paxman Scalp Cooler, Paxman Coolers Limited, Huddersfield, UK; the Olympic Cool Cap, Olympic Medical Corporation of Seattle, WA; the Penguin Cold Cap, MSC, Medical Specialities of California, London UK. All of these commercial devices may be adapted to incorporate the thermal transfer device of the present invention. The thermal transfer device of the present invention may also be used in conjunction with the thermal cushion as described in WO2005046540A1 also published as US2007130840A1.

[0036] In one arrangement the thermal transfer device may have a body in the form of a skin, which encapsulates a cryogenic material, e.g. a cryogenic gel material. In this and other embodiments the outer layer of the thermal transfer device, being the surface of the device remote from the human body may comprise a layer of insulating material. In this embodiment the device may be cooled to bring the gel to the required temperature and when applied to the human head the insulation ensures that that the device extracts heat from the human head through the protrusions and extracts the minimum amount of heat possible from the surrounding environment. [0037] The thermal transfer device of the present invention may be manufactured from any suitable thermally conductive material. In one arrangement the body of the device may be manufactured from a relatively thin layer if polymeric material of low thermal conductivity but relatively high physical integrity with flexibility. The thickness of the thin layer being such that the layer is not an effective insulator. The protrusions may be made of a material of high thermal conductivity e.g. aluminium, copper, gold, silver or a thermally conductive polymer, and bonded to the surface of the polymeric film of relatively low thermal conductivity. Alternatively, the protrusions of aluminium, copper, gold, or silver may be bonded to a body layer of thermally conductive polymer. In a preferred arrangement both the device body and protrusions are made of the same material, which preferably is a thermally conductive polymer, and are integrally molded or formed. Conventional plastics typically have a thermal conductivity of 0.2 W/mK. Thermally conductive polymers typically have ? thermal conductivities of at least 1 W/mK, and within the range of 1 to 100, more typically within the range 1 to 20 W/mK. Examples of such materials are CoolPoly^® thermally conductive plastics as manufactured by Cool Polymers Inc, Warwick, Rl 02886, USA. These include for example CoolPoly^® D4302 thermally conductive co- polyester elastomer, D3604 and D3606 thermally conductive polyamide 4, 6, D1202 thermally conductive polypropylene, D5108, D5510, D5112 thermally conductive polyphenyle ne sulphide, and D8102 and D8104 thermally conductive thermoplastic elastomers. Preferably the device of the present invention is manufactured from a thermally conductive polymer of 1 W/mK or greater, preferably greater than 5 W/mK, more preferably greater than 10 W/mK, and more preferably greater than 15 W/mK. It is preferred that the thermal conductivity of the polymer is within the range of 1 to 100 W/mK , more preferably between 5 to 100 W/mK, more preferably 5 to 50 W/mK, most preferably 5 to 20 W/mK.

DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to various specific embodiments of the invention as shown in the accompanying diagrammatic drawings, in which: FIG. 1 shows in perspective view, a section of a thermal transfer device according to the present invention,

FIG. 2 show in perspective and cross-section view, an outer gel cap for use with the device according to the present invention,

FIG 3, shows the thermal transfer device according to the present invention in the form of a cap with an outer gel cap, being worn by a patient,

FIG. 4, is the side view of Figure 3,

FIG. 5 is the rear view of Figure 3, and

DETAILED DESCRIPTION OF THE INVENTION

[0038] Referring to Figure 1 a small section of a thermal transfer device (1) is shown. This example has a device body in the form of a sheet (2) having a plurality of regular spaced protrusions (3) providing point contacts at their tips (4) for the patients skin. The device is made of a thermally conductive material. In use the point contacts (3, 4) enable heat to be transferred to or from the patient and through the device body (2). In this example the protrusions are of similar height (x) to the depth (y) of the device body (2). When in the form of a cap (see below) and placed in contact with a patients head the protrusions (3) are of such dimension and spatial regularity that they may be forced through the patients hair to make contact with the patients scalp.

[0039] Referring to Figure 2 a small section (10) of an outer gel cap (11) is shown. The gel cap (11) is made of a skin (12) of thermally conductive material with a coolant gel filing (13). Referring to Figures 3, 4 and 5, a thermal transfer device in the form of a cooling cap (20) is illustrated with an outer gel cap (21). The thermal transfer device cap is arranged to cover most as much of the patients scalp as possible, either covering or extending past the patients hairline. The outer gel cap is formed to make close and extensive contact with the inner thermal transfer device cap and is shaped for easy use and removal from the thermal transfer device cap. During a chemotherapy treatment it is normally necessary to replace the outer gel cap a number of times during treatment and so ease of application and removal of the outer gel cap is important. The thermal transfer device cap and outer gel cap combination may be supplemented with a further insulating cap, which assists in keeping the gel clap in close proximity to the thermal transfer cap and at the same time reduces the amount of wasted cooling effect from the gel cap.

[0040] The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

1. A thermal transfer device for heat transfer from and/or too the human body comprising: a body of material having a surface proximate to the human body during use said surface having a plurality of protrusions that make point contact with the human body during use of the device, the protrusions being molded from thermally conductive material and providing means for heat transfer from and/or too the human body through the device.

2. A thermal transfer device as claimed in claim 1 wherein the body of the device and the protrusions are integrally molded from the same thermally conductive material.

3. A thermal transfer device as claimed in claim 1 or claim 2 wherein the body of the material is substantially in the form of a sheet of material.

4. A thermal transfer device as claimed in any one of claims 1 to 3 wherein the device is configured in the form of a cap to cover a significant portion of the human head.

5. The device according to claim 4, wherein the cap is shaped to provide contact along the brow, around the ears and down the neck to/or below the hairline of a human head.

6. A thermal transfer device as claimed in claim 1 wherein the body of the device and the protrusions are separately formed and are bonded to each other to form the device.

7. A thermal device as claimed in claim 6 wherein the body of the device and the protrusions are made of the same material.

8. A thermal device as claimed in claim 6 wherein the body of the device and the protrusions are made of different materials.

9. A thermal device as claimed in claim 6 or claim 8 wherein the protrusions are made of a material of higher thermal conductivity than the body of the device.

10. A thermal transfer device as claimed in claim 6 or 8 or 9, wherein the protrusions are independently made of two or more materials of the same or differing thermal conductivities.

11. A thermal transfer device as claimed in claim 10, wherein the plurality of protrusions are grouped on the device in sections of like thermal conductivity.

12. A thermal transfer device as claimed in claim 4 wherein the cap has a plurality of sections for contact with different regions of the human head with each section having a plurality of protrusions.

13. A thermal transfer device as claimed in claim 1 wherein the protrusions are spaced apart at regular intervals.

14. A thermal transfer device as claimed in any one of the preceding claims wherein the contact points terminate in a flat surface.

15. A thermal transfer device as claimed in any one of claims 1 to 13 wherein the protrusions terminate in an angular point.

16. A thermal transfer device as claimed in any one of claims 1 to 13 wherein the protrusions are rounded at their point of contact with the human body.

17. A thermal transfer device as claimed in any one of claims 4 to 16 wherein the protrusions are of a size and density on the device surface such that when in the form of a cap for application to a human head they may be forced through the hair to make contact with the scalp.

18. A thermal transfer device as claimed in claim 1 wherein the protrusions are substantially circular in cross-section taken in a plane parallel to the body surface.

19. A thermal transfer device as claimed in claim 1 wherein the protrusions have a Gaussian profile when viewed in a cross-section perpendicular to the plane of contact the protrusions with the body surface.

20. A thermal transfer device as claimed in claim 1 wherein the protrusions have the appearance of circular pyramids when viewed in perspective.

21. A thermal transfer device as claimed in claim 1 wherein the body of the device is in the form of a skin, which encapsulates a cryogenic material, e.g. a cryogenic gel material.

22. A thermal transfer device as claimed in claim 1 wherein the surface remote form the human body is in contact with or proximate to a layer of insulating material.

23. A thermal transfer device as claimed in any one of claims 1 to 22, wherein the material of the device body and protrusions is of the same or similar thermal conductivity to that of any material used in a co-operating device for cooling of the human body.

24. A thermal transfer device as claimed in any one of claims 1 to 22, wherein the protrusions are made of a thermally conductive polymeric material.

25. A thermal transfer device as claimed in claim 24, wherein the device body is made if a thermally conductive polymeric material.

26. A thermal treatment apparatus comprising: (a) a thermal transfer device according to any one of claims 1 to 25 and (b) means to apply and/or remove heat from the thermal transfer device.

27. A thermal treatment apparatus according to claim 26 wherein the means is as provided in the Olympic Medical Corporation cool cap system.

28. A thermal treatment apparatus according to claim 26 wherein the means is as provided in the Penguin Cool Cap System.

29. A thermal treatment apparatus according to claim 26 wherein the thermal transfer device of claims 1 to 24 is integral with a component of the means for applying and/or removing heat.

30. The device according to any one of claims 1 to 25 in the form of a sheet or mattress onto which a patient may lay in order to reduce or raise total body temperature.

31. The device according to any one of claims 1 to 25 in the form of a bandage, which may be placed around a patients limb(s).

32. A device for cooling the brain of an infant whose brain has suffered a hypoxic shock, the device comprising: a thermal transfer device according to any one of claims 1 to 25 and a cooling liner for placement against the thermal transfer device, the cooling liner having a top and comprising only one fluid conduit for receiving a cooling fluid, the fluid conduit beginning at an inlet located at the top and terminating at an outlet located at the top, being serpentine in shape between the inlet and the outlet and configured so that the fluid conduit travels from the inlet adjacent a first hemisphere of the infant's brain in a general direction toward an opposite hemisphere of the infant's brain where the conduit reverses its direction and a serpentine portion of the conduit travels in a direction from the opposite hemisphere to the first hemisphere where it terminates at the outlet.

33. A device according to claim 32 wherein the thermal transfer device is secured to the cooling liner.

34. A device according to claim 32or 33 wherein the cooling liner has a modified surface to incorporate a plurality of protrusions according to the thermal contact device of the present invention and this modified cooling liner replaces the separate thermal transfer device and cooling liner.

35. A method for inducing hypothermia in a patient, comprising: bringing into contact with at least a portion of a patient's body a thermal transfer device according to any one of claims 1 to 25 and applying or withdrawing heat to/from the patients body through the thermal transfer device.

36. A thermal regulation system, comprising: a console having: a fluid reservoir configured to hold a thermal exchange fluid, a pressure source in fluid communication with the fluid reservoir, and a suction source in fluid communication with the fluid reservoir; and a thermal regulation device having: a thermal contact device according to any one of claims 1 to 25 within a cap configured to cover at least a portion of a patient's head to define a fluid circulation space into which the thermal exchange fluid can be introduced to contact the surface of the thermal contact device remote from the patients head; at least one inlet coupled to the pressure source and configured to introduce the thermal exchange fluid into the fluid circulation space under positive gage pressure; and at least one outlet coupled to the suction source and configured to withdraw the thermal exchange fluid from the fluid circulation space under negative gage pressure.