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Title:
METHODS AND DEVICES FOR CORE BODY TEMPERATURE MANAGEMENT
Document Type and Number:
WIPO Patent Application WO/2017/035341
Kind Code:
A1
Abstract:
A core body temperature adjustment system includes a thermal housing operable to transfer heat between the thermal housing and a glabrous area of a patient's appendage. The appendage is a hand or foot. A garment is sized to at least partially enclose the appendage, and includes a flap operable to removably secure a first side of the thermal housing against the glabrous area. A control circuit is operable to control a temperature within the thermal housing.

Inventors:
MARQUETTE DAVID BRIAN (US)
STEINMAN ADAM JOSEPH (US)
Application Number:
PCT/US2016/048669
Publication Date:
March 02, 2017
Filing Date:
August 25, 2016
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
GENTHERM INC (US)
International Classes:
A61F7/00; A41D1/00; A41D13/005; A41D19/015; A61F7/02
Domestic Patent References:
WO2015117063A12015-08-06
WO2014180975A12014-11-13
WO1998007397A11998-02-26
Foreign References:
EP1929980A12008-06-11
US20140364777A12014-12-11
US20100025009A12010-02-04
US6268595B12001-07-31
US20050103353A12005-05-19
Attorney, Agent or Firm:
BRADLEY, Timothy C. (US)
Download PDF:
Claims:
CLAIMS

5 claimed is:

A core body temperature adjustment system comprising:

a thermal housing operable to transfer heat between the thermal housing and a glabrous area of a patient' s appendage, wherein the appendage is a hand or foot; a garment sized to at least partially enclose the appendage, the garment comprising a flap operable to removably secure a first side of the thermal housing against the glabrous area; and

a control circuit operable to control a temperature within the thermal housing.

2. The core body temperature adjustment system of claim 1:

wherein the garment comprises an opening sized to expose the glabrous area; and wherein the flap is operable to removably secure the first side of the thermal housing against the glabrous area through the opening.

3. The core body temperature adjustment system of claim 2, comprising:

a pump operable to apply negative pressure to the glabrous area through the opening.

4. The core body temperature adjustment system of claim 3, comprising a seal ring that surrounds a perimeter of the opening, and is operable to maintain the negative pressure.

5. The core body temperature adjustment system of claim 3, comprising

a top layer that at least partially covers a second side of the thermal housing that is opposite to the first side of the thermal housing; and

a spacing layer that is situated between the top layer and the glabrous area, and is operable to space the top layer away from the glabrous area when negative pressure is applied to the glabrous area through the opening.

6. The core body temperature adjustment system of claim 5, wherein the spacing layer is situated between the thermal housing and the glabrous area, and is also operable to space the thermal housing away from the glabrous area when negative pressure is applied to the glabrous area through the opening.

7. The core body temperature adjustment system of claim 5, wherein the spacing layer comprises a mesh with air pockets.

8. The core body temperature adjustment system of claim 1, comprising:

a spacing material situated within the thermal housing; and

a pump operable to circulate a fluid through the spacing material within the thermal housing.

9. The core body temperature adjustment system of claim 8, wherein the pump is a peristaltic pump, a centrifugal pump, or a hand pump.

10. The core body temperature adjustment system of claim 1, wherein the glove comprises a forearm sleeve sized to at least partially enclose a patient' s forearm; and wherein the pump is situated on the forearm sleeve.

11. The core body temperature adjustment system of claim 1, comprising:

an additional second housing that encloses the control circuit and a power supply, and is mounted to a second side of the thermal housing that is opposite to the first side of the thermal housing.

12. The core body temperature adjustment system of claim 1, comprising an electric heat source situated within the thermal housing.

13. The core body temperature adjustment system of claim 1, comprising at least one sensor situated within the garment, wherein the control circuit is operable to control the temperature within the thermal housing based on input received from the at least one sensor.

14. The core body temperature adjustment system of claim 13, wherein the at least one sensor includes a heat flux sensor, a temperature sensor, a blood flow sensor, or a combination thereof.

15. The core body temperature adjustment system of claim 1:

wherein the thermal housing is one of a plurality of thermal housings, each of which is secured against a different glabrous area of the patient, and is operable to transfer heat between itself and its associated glabrous area;

wherein each of the thermal housings are operably connected to a shared resource; wherein the control circuit is operable to control a temperature within the plurality of the thermal housings by controlling the shared resource; and

wherein the shared resource comprises either a shared power source that is electrically connected to the plurality of thermal housings or a shared fluid reservoir that is in fluid communication with the plurality of thermal housings.

16. The core body temperature adjustment system of claim 1:

wherein the thermal housing is a first thermal housing, the glabrous area is a first glabrous area, and the control circuit is a first control circuit;

the system comprising:

a different, second thermal housing that is secured against a different, second area of the patient, and is operable to transfer heat between itself and the second glabrous area; and

a different, second control circuit that is operable to control a temperature within the second thermal housing.

17. The core body temperature adjustment system of claim 1, wherein the thermal housing comprise a first conduit, and wherein the system comprises:

a second conduit that connects to the first conduit to form a circulation loop; and a Peltier device having opposing first and second faces, and being operable, when a voltage is applied to the Peltier device, to provide heating to the first face and to provide cooling to the second face;

wherein one of the first or second faces include one or more thermally conductive sleeves, each of which surrounds a portion of the second conduit, to provide a heating or cooling effect to its surrounded portion of the second conduit.

18. A method of controlling the core body temperature of a patient, comprising:

situating a thermal housing on a glabrous area of the patient;

situating at least one sensor near the patient;

applying heat from the thermal housing to the glabrous area to effectuate core temperature heating of the patient;

controlling a temperature of the thermal housing based on data received from the at least one sensor; and

separately applying a warming blanket to a non-glabrous torso area of the patient to enable patient thermal comfort, wherein the warming blanket is not controlled based on the data received from the at least one sensor.

19. The method of claim 18, wherein the non-glabrous torso area comprises the patient's chest.

20. The method of claim 18, wherein the non-glabrous torso area comprises the patient's back.

Description:
METHODS AND DEVICES FOR CORE BODY TEMPERATURE MANAGEMENT

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application No. 62/209,783, filed 08/25/2015.

TECHNICAL FIELD

[0002] The present disclosure relates to thermophysiology, and more particularly to methods and devices for managing the core body temperature of patients based on applying targeted heating or cooling to glabrous skin areas.

BACKGROUND

[0003] Cooling of human or other mammalian skin can provide one or more benefits, particularly in situations or circumstances where a subject's skin and/or body temperature is elevated relative to normal, acceptable, comfortable and/or safe levels. For example, in some instances, a person's skin and/or body temperature may be dangerously high because of fever and/or another medical condition (e.g., infection, allergy or other adverse reaction, disease, etc.). In other cases, a subject's temperature may be elevated due to exposure to heat or sun and/or other source of heat (e.g., workspace). In other circumstances, it may be desirable to heat a person's skin or other anatomical location, either in lieu of or in addition to cooling, as desired or required. For example, heating can be used to treat hypothermia, chills and/or any other condition or ailment.

[0004] Another situation where it may be useful to alter the bodily temperature of individuals is during and/or after surgery. Anesthesia compromises patients' ability to thermoregulate to their normal core body temperature. Because anesthesia can cause the bodily temperature of patients to drop, medical practitioners may wish to control a patient's core temperature during and/or after a surgical procedure.

[0005] Yet another example where it may be desirable to adjust core body temperature is reducing muscle fatigue in athletes. Researchers have found that temperature can be a primary limiting factor for athletic performance. Reducing the core temperature of athletes during periods of physical exertion can enable athletes to partake in greater physical exertion without damaging muscles from overwork.

[0006] In the context of surgical procedures, one device that has been used to control core temperature is the "BAIR HUGGER" from 3M. The device, which works like a forced-air heater, carries warmed air through a hose to a special blanket that is draped over a patient. The BAIR HUGGER is often used to cover large bodily areas (e.g., a patient's entire torso or entire lower body), which can obstruct access to various bodily areas during a surgical procedure. Also, because of its size, the BAIR HUGGER can be impractical to use in many environments.

[0007] Researchers have recently discovered that the major sites of heat exchange in the human body (and other mammals) are limited to the non-hairy (glabrous) skin areas. These areas include the palms of the hands, the soles of the feet, and non-hairy parts of the face. These areas of skin are underlain by unique sets of blood vessels that have the capacity to circulate a large portion of the total blood volume (up to 60% of the total cardiac output) directly beneath the skin surface. This thermoregulatory structure facilitates direct heat transfer between the body core and the external environment.

[0008] Underlying glabrous skin areas - the palms of hands, soles of the feet, and parts of the face and ears - are natural heat exchange portals with unique vascular network structures beneath the surface of the skin. These specialized networks of the thermoregulatory system, which allow blood flow from the arteries to the veins, are called arteriovenous anastomoses (AVAs). When the pathway is opened, the AVAs enable a significant increase in blood flow beneath the skin in glabrous regions. The function of these vascular structures has only recently been appreciated, and fine anatomy of unique vascular structures has only recently been characterized. Dilation and contraction of the AVAs are controlled by the body's thermoregulatory system. When the body perceives conditions which would cause its temperature to rise above normal, the AVAs dilate to increase blood flow near the skin surface, thereby increasing heat loss to the environment. When the body perceives conditions leading to a decrease in core temperature, the AVAs constrict, decreasing blood flow, allowing the body to conserve more of its metabolic heat.

[0009] Special vascular structures enable these adjustments of blood flow to glabrous skin. As noted above, the unique vascular structures— only recently recognized and characterized — are composed of AVAs and a dense network of interwoven venous structures. The AVAs are direct shunts between arteries and veins that bypass capillaries, and provide a low-resistance pathway for the movement of blood through the glabrous skin regions. The receiving venous structures (retia venosa) are arranged in a plexus or large network of vessels that have a large surface-to- volume ratio and can contain a large volume of blood. Thus, the venous plexus acts as a radiator. The AVAs are gated by smooth muscle. When open, there is a very high blood flow, and therefore heat transport, into the low resistance venous radiators. When the AVAs are closed, a greatly reduced blood flow goes through the high-resistance nutritive capillaries of the skin. It is those capillaries that "nourish" cells with blood. In the normothermic individual, a person whose thermoregulation is within the normal range, proportional control of the AVAs balances internal heat production and heat loss. The relative blood flow through these radiator-like structures is referred to as vasomotor tone. Vasodilation defines the condition in which the AVAs are open and blood is flowing freely through the venous plexuses. Vasoconstriction defines the condition in which the AVAs are closed and blood is not flowing through the venous plexuses.

SUMMARY

[0010] One example embodiment of a core body temperature adjustment system includes a thermal housing operable to transfer heat between the thermal housing and a glabrous area of a patient' s appendage, wherein the appendage is a hand or foot. A garment sized to at least partially enclose the appendage includes a flap operable to removably secure a first side of the thermal housing against the glabrous area. A control circuit is operable to control a temperature within the thermal housing.

[0011] In another example embodiment of the above described system, the garment comprises an opening sized to expose the glabrous area, the flap is operable to removably secure the first side of the thermal housing against the glabrous area through the opening.

[0012] In another example embodiment of any of the above described systems, a pump is operable to apply negative pressure to the glabrous area through the opening.

In another example embodiment of any of the above described systems [0013] In another example embodiment of any of the above described systems, a seal ring that surrounds a perimeter of the opening, and is operable to maintain the negative pressure.

[0014] In another example embodiment of any of the above described systems, a top layer at least partially covers a second side of the thermal housing that is opposite to the first side of the thermal housing, and spacing layer that is situated between the top layer and the glabrous area is operable to space the top layer away from the glabrous area when negative pressure is applied to the glabrous area through the opening.

[0015] In another example embodiment of any of the above described systems, the spacing layer is situated between the thermal housing and the glabrous area, and is also operable to space the thermal housing away from the glabrous area when negative pressure is applied to the glabrous area through the opening.

[0016] In another example embodiment of any of the above described systems, the spacing layer comprises a mesh with air pockets.

[0017] In another example embodiment of any of the above described systems, a spacing material is situated within the thermal housing, and a pump is operable to circulate a fluid through the spacing material within the thermal housing.

[0018] In another example embodiment of any of the above described systems, the pump is a peristaltic pump, a centrifugal pump, or a hand pump.

[0019] In another example embodiment of any of the above described systems, the glove includes a forearm sleeve sized to at least partially enclose a patient' s forearm, and the pump is situated on the forearm sleeve.

[0020] In another example embodiment of any of the above described systems, an additional second housing encloses the control circuit and a power supply, and is mounted to a second side of the thermal housing that is opposite to the first side of the thermal housing.

[0021] In another example embodiment of any of the above described systems, an electric heat source is situated within the thermal housing.

[0022] In another example embodiment of any of the above described systems, at least one sensor is situated within the garment, and the control circuit is operable to control the temperature within the thermal housing based on input received from the at least one sensor. [0023] In another example embodiment of any of the above described systems, the at least one sensor includes a heat flux sensor, a temperature sensor, a blood flow sensor, or a combination thereof.

[0024] In another example embodiment of any of the above described systems, the thermal housing is one of a plurality of thermal housings, each of which is secured against a different glabrous area of the patient, and is operable to transfer heat between itself and its associated glabrous area. Each of the thermal housings are operably connected to a shared resource, and the control circuit is operable to control a temperature within the plurality of the thermal housings by controlling the shared resource. The shared resource includes either a shared power source that is electrically connected to the plurality of thermal housings or a shared fluid reservoir that is in fluid communication with the plurality of thermal housings.

[0025] In another example embodiment of any of the above described systems, the thermal housing is a first thermal housing, the glabrous area is a first glabrous area, and the control circuit is a first control circuit. A different, second thermal housing is secured against a different, second area of the patient, and is operable to transfer heat between itself and the second glabrous area. A different, second control circuit that is operable to control a temperature within the second thermal housing.

[0026] In another example embodiment of any of the above described systems the thermal housing comprise a first conduit, and the system includes a second conduit that connects to the first conduit to form a circulation loop. A Peltier device has opposing first and second faces, and is operable, when a voltage is applied to the Peltier device, to provide heating to the first face and to provide cooling to the second face. One of the first or second faces include one or more thermally conductive sleeves, each of which surrounds a portion of the second conduit, to provide a heating or cooling effect to its surrounded portion of the second conduit.

[0027] One example embodiment of a method of controlling the core body temperature of a patient includes situating a thermal housing on a glabrous area of the patient, situating at least one sensor near the patient, and applying heat from the thermal housing to the glabrous area to effectuate core temperature heating of the patient. A temperature of the thermal housing is controlled based on data received from the at least one sensor. A warming blanket is separately applied to a non-glabrous torso area of the patient to enable patient thermal comfort, wherein the warming blanket is not controlled based on the data received from the at least one sensor.

[0028] In another example embodiment of the above described method, the non- glabrous torso area includes the patient' s chest.

[0029] In another example embodiment of any of the above described methods, the non-glabrous torso area includes the patient' s back.

[0030] The embodiments described herein may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible.

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The disclosure can be further understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein:

[0032] Fig. 1 depicts target areas for core body temperature management with interface electronics.

[0033] Fig. 2 schematically depicts an example glove that includes a thermal transfer element for heating and/or cooling a patient' s hand.

[0034] Fig. 3 schematically depicts an example foot garment that includes a thermal transfer element for heating and/or cooling a patient's foot.

[0035] Figs. 4-6 schematically depict additional foot garment embodiments.

[0036] Fig. 7 schematically depicts an example mask that includes a thermal transfer element for heating and/or cooling a patient' s face.

[0037] Figs. 8A-B, 9, and 10 schematically illustrate other example mask features.

[0038] Fig. 11 schematically depicts a core body temperature adjustment system with a related fluid pumping configuration.

[0039] Fig. 12 schematically depicts an enlarged view of the pumping configuration of Fig. 8.

[0040] Fig. 13 schematically illustrates an example pumping configuration.

[0041] Fig. 14 schematically illustrates an arrangement for pumping fluid to heat or cool a patient' s hand. [0042] Fig. 15 schematically illustrates an example peristaltic pump that may be used in the embodiment of Fig. 14.

[0043] Fig. 16 schematically illustrates another example arrangement for pumping fluid to heat or cool a patient' s hand

[0044] Figs. 17-18 schematically illustrate example thermoelectric device configurations.

[0045] Figs. 19-21 schematically illustrate embodiments in which a glove includes a flap for securing a thermal transfer element to a patient' s palm.

[0046] Figs. 22-25 schematically illustrate additional example features for heating or cooling a patient' s palm.

[0047] Figs. 26-27 schematically illustrate embodiments in which a temperature distribution medium comprises a fluid, and a pump is configured to circulate the fluid.

[0048] Figs. 28-31 schematically illustrate embodiments in which negative pressure can be applied to a patient' s palm.

[0049] Figs. 32-33 schematically illustrate embodiments in which a thermoelectric device is mounted to a palm area of a glove.

[0050] Fig. 34 is a flowchart of an example method of controlling the core body temperature of a patient.

DETAILED DESCRIPTION

[0051] The present disclosure describes techniques for adjusting the core temperature of patients based on applying targeted heating or cooling to glabrous bodily areas at which arteriovenous anastomoses (AVAs) are located. Because these areas are natural heat exchange portals, applying heating and/or cooling to them can yield considerable efficiency improvements over the prior art. For example, some of the devices and techniques discussed herein can be implemented without limiting access to a patient's hands and/or fingers, as such access may be needed for common field medicine assessments, such as blood pressure monitoring.

[0052] The devices and techniques discussed herein are also effective if contact is only possible with only one limb or facial interface, as in the case of casualties with multiple traumas affecting one or more limbs. Still further, these devices and techniques can facilitate a greater variety of patient postures (e.g., upright, seated, or lying down) than was possible in the prior art. The devices and techniques discussed herein can be used to maintain patient warming at a level of performance seen in current standard of care systems, but with reduced package size, and reduced power consumption.

[0053] According to another aspect of the present disclosure, a heating and/or cooling loop is attached to a flexible fluid pack (containing, e.g., a gas, liquid, gel and/or conductive slurry) that can conform to the palm of the hand (or foot or face). Circulation within the loop facilitates heat transfer with a glabrous skin area. Power can be provided onboard via batteries or from an external power source (e.g., an electrical outlet). Similarly, pumps, a control unit, and other related components can be part of the onboard pack or accessed through a remote connection (i.e., tube, wire, etc.).

[0054] According to one aspect of the present disclosure, techniques are disclosed for controlling a patient's core body temperature without applying heating or cooling directly to the patient' s core. This can be achieved by instead applying heat to one or more glabrous areas of the patient's body via thermal transfer elements. Such core body temperature control can be useful for perioperative care (i.e., preoperative, intraoperative, and postoperative care). In some embodiments, heating and/or cooling is still provided to a patient's torso area (e.g., stomach or back) to provide comfort.

[0055] The various thermal transfer elements may be centrally controlled by a shared control circuit, or may have individual localized control circuits. In some embodiments, the localized control circuits are configured to communicate with each other using wireless signaling.

[0056] A system for core body temperature adjustment system may comprise a disposable portion, and a reusable portion. For example, in some embodiments the thermal transfer element comprises a circulation loop that circulates fluid on glabrous areas. In some such embodiments, the circulation loop is detachable into first and second conduits, with one portion of the conduit being disposable, and the other portion being reusable.

[0057] Fig. 1 depicts target areas for core body temperature management with interface electronics for a core body temperature adjustment system 10. The target areas of patient 12 are glabrous areas, and they include portions of the patient's hands 14, feet 16, and head 18. In particular, the glabrous areas include a palm of the hands 14, a sole of the feet 16, and a cheek and/or forehead area of the head 18.

[0058] The system 10 includes a set of discrete, thermal transfer elements 24, each of which is mounted to a different glabrous area of a patient's body, and is configured to heat and/or cool its associated glabrous area (see Figs. 2-7). Electronic control circuitry (shown as electronic control unit "ECU" 20 in Fig. 1) is operatively connected to the thermal transfer elements 24, and is configured to control a temperature of the thermal transfer elements 24. In some embodiments, each thermal transfer element 24 is detachable from its operative connection to its associated control circuitry via one or more detachable connectors (e.g., electrical or fluid connectors).

[0059] Each thermal transfer element 24 is part of a respective garment, such that the set of thermal transfer elements corresponds to a set of thermal garments. In embodiments in which more than one garment is used, the set of thermal garments may include at least two of the following:

a right hand glove configured to situate its thermal transfer element on a palm of patient's right hand 14A;

a left hand glove configured to situate its thermal transfer element on a palm of a patient's left hand 14B;

a right foot covering configured to situate its thermal transfer element on a sole of a patient's right foot 16A;

a left foot covering configured to situate its thermal transfer element on a sole of a patient's left foot 16B; and

a mask configured to situate its thermal transfer element on a patient's forehead, cheek, or both.

[0060] Fig. 2 schematically depicts an example glove 22 sized to at least partially enclose a patient's hand 14. The glove 22 includes a thermal transfer element (TTE) 24 for heating and/or cooling the patient's hand 14. The TTE 24 is mounted to the glove 22, and includes detachable connectors 26. In some embodiments, the TTE 24 is embedded within the glove 22. In other embodiments, the TTE 24 is mounted to an interior or exterior of the glove 22. In Fig. 2, the TTE 24 follows a winding (e.g., serpentine) path along the palm of the hand 14, which is a glabrous area. The glove 22 also includes straps 25 for securing the glove to the hand 14 (e.g., using a snap, a hook and loop fastener, or some other fastener).

[0061] Throughout this disclosure, reference numeral 24 will be generically used to refer to a TTE. In some embodiments discussed herein, the TTE 24 is an electrical heat exchanger (e.g., for heating and/or cooling), and its associated connectors 26 are electrical connectors. In other embodiments, the TTE 24 includes a conduit through which a fluid can flow for heating and/or cooling the palm of a patient' s hand, and its associated connectors 26 facilitate a flow of fluid through the conduit. For example, in some conduit embodiments, if disconnected, the connectors 26 prevent fluid from flowing into and out of the conduit (e.g., water, air, a gel, etc.). In such embodiments, connector 26A can serve as a fluid inlet, and connectors 26B can serve as a fluid outlet (or vice versa).

[0062] Fig. 3 schematically depicts an example foot garment 28A that includes a TTE 24 for heating and/or cooling a patient's foot 16. In Fig. 3, the TTE 24 follows a winding path along a sole of the foot 16, which is a glabrous area. Here too, the TTE 24 could comprise an electrical heat exchanger or a conduit, and includes connectors 26. In Fig. 3, the foot garment comprises a sock that includes a heel opening 29A, and also includes a toe opening 29B that is sized for a plurality of the patient' s toes to extend through. Although not shown, it would be possible for the foot garment to include a thong member that would be inserted between two toes to prevent the sock from sliding up the patient's leg. Although a toeless foot garment is shown in Fig. 3 and various other figures, it is understood that a foot garment including toe coverings could be used instead.

[0063] Figs. 4-6 schematically illustrate some alternative embodiments of the foot garment. In Figs. 4-5 the foot garments 28B-C include a slip-on shoe. In Fig. 5 the TTE 24 winds along a heel area at the rear of the garment 28C and an upper foot area on the top of the garment 28C. Although not shown in Fig. 5, it is understood that the TTE 24 would also wind along a sole area of the garment 28C as shown in Fig. 4. Fig. 6 depicts a sock foot garment 28D in which the TTE 24 also winds along a top and heel of a patient's foot 16.

[0064] Fig. 7 schematically depicts an example mask 30A that includes a TTE 24 for heating and/or cooling a patient's face. In Fig. 7, the TTE 24 follows a winding path along a cheek of a patient, which is a glabrous area. In other embodiments, the TTE 24 may follow a path along the patient's forehead instead of, or in addition to, the cheek. The mask 30A may be used in conjunction with a breathing mask 31 A. In Fig. 7, the mask 30A includes a chinstrap 32 for placement on the patient's head 18.

[0065] Figs. 8A-B and 9-10 illustrate other example mask features. In Figs. 8A-B, the mask 30B has a TTE 24 that follows a winding path along a patient's forehead. Also, the mask 30B omits the chinstrap 32 of Fig. 7. Fig. 9 illustrates a breathing mask 3 IB, and Fig. 10 illustrates how a seal portion 36 of the breathing mask 3 IB may abut a patient's nose 35 along cross-section A-A of Fig. 9.

[0066] Referring again to Fig. 1, the ECU 20 is connected to a thermal element 33 and a power supply 34. In some embodiments, the thermal element 33 includes an electrical connection to an electrical heat exchanger TTE 24. In some embodiments, the thermal element includes a heating or cooling device for heating and/or cooling a fluid in a conduit TTE 24. In some embodiments, a combination of these may be used (e.g., use electrical heat exchanger TTE 24 for hands 14, but conduit TTE 24 for feet 16, or some other combination). The power supply 34 includes at least one of the following: a rechargeable or non- rechargeable battery (e.g. a 12 volt battery), a connection to an AC or a DC power source (e.g., 120 VAC), or the like.

[0067] The ECU may optionally also be connected to one or more of the following: a fluid pump 38, a fan or blower (generically referred to as 40 herein), a communication circuit 42, and one or more sensors 44.

[0068] In embodiments in which sensor(s) 44 are included, the ECU 20 is configured to control the temperature of the TTE 24 based on input received from the sensor(s). Some example sensors that may be used include a heat flux sensor, a temperature sensor, a blood flow sensor (e.g., a perfusion sensor), or a combination thereof. In some embodiments, a remote sensor is used, such as esophageal temperature sensor 45, which communicates wirelessly with ECU 20 via communication circuit 42 (the wireless communication is shown schematically as 46 in Fig. 1). Of course other temperature sensors could be used. In some embodiments, "local" temperature sensors are used that are either on, or in close proximity to a glabrous area (e.g., on a palm, or forearm, on a foot or lower leg, etc.). Such local temperature sensors could be an alternative to an esophageal temperature sensor 45, for example. If a pump 38 is included for circulating fluid within one or more of the TTEs 24, the pump may be a peristaltic pump, a centrifugal pump, a hand pump, or any other kind of pump.

[0069] An optional warming blanket 19 is also shown in Fig. 1 on a torso area of the patient 12. The blanket 19 is not intended to achieve core body temperature adjustment, but rather is intended (if it is used at all) to give a pleasant warm sensation to a patient while that patient's body is being warmed (e.g., after a general anesthesia if the patient is cognitive). The blanket 19 is controlled and powered by circuitry 21 that is separate from the ECU 20 and its related components, but may be similarly controlled (e.g., using a TTE 24 as discussed in the other embodiments). Although illustrated on a patient's chest (anterior torso area), the blanket 19 could be used in other locations, such as on the patient's back (posterior torso area).

[0070] Figs. 11-12 schematically depict a pumping configuration 46 for circulating fluid through the TTEs 24 in embodiments in which the TTEs 24 comprise conduits, with Fig. 11 depicting the configuration 46 in its system context, and Fig. 12 depicting the configuration 46 in an enlarged view. Referring to Fig. 12, the configuration includes a pump 38, supply manifold 50, a return manifold / reservoir 52, thermostat 54, bypass 56, and restriction 58. Optionally, these components may be situated within a housing 47. Although Fig. 11 shows the housing 47 situated on a torso area of the patient 12, it is understood that the housing 47 could be situated away from the patient 12, and that warming blanket 19 could instead be situated on the torso area of the patient 12 (e.g., as shown in Fig. 1).

[0071] In the configuration 46, fluid circulates through the pump 38 and through the bypass 56. ECU 20 is operatively connected to the pump 38 to control operation of the pump 38. In one or more embodiments, the thermostat 54 comprises a wax thermostatic element configured to selectively shutoff a flow of fluid to the supply manifold 50 based on a temperature (e.g., a temperature of the fluid being pumped and/or a patient temperature). In this regard, the thermostat 54 can be configured to act as a valve. The bypass 56 may be utilized, in some embodiments, to ensure that the pump 38 does not deadhead or cavitate when the valve of thermostat 54 is shut.

[0072] Of course, a single pump 38 does not have to be used for multiple TTEs 24 as shown in Fig. 11. Instead, individual pumps 38 could be used, and those pumps could optionally be situated in closer proximity to the glabrous areas being heated and/or cooled (e.g., on a forearm and/or on a leg). As an example, Fig. 13 depicts a pumping configuration 46' that is the same as configuration 46, but includes less supply and return lines because pumping is only being performed for a single TTE 24.

[0073] Fig. 14 illustrates an arrangement for pumping fluid to heat and/or cool a patient' s hand, in which TTE 24 is a first conduit having a fluid inlet at connector 26 A, and a fluid outlet at connector 26B (of course these roles could be reversed, so connector 26A has a fluid outlet and connector 26B has a fluid inlet). A second conduit 60 connects to the fluid inlet and fluid outlet of the first conduit (TTE 24) to form a circulation loop 61. The second conduit 60 is secured to a forearm sleeve 68 (e.g., secured on or within the forearm sleeve 68). A pump 38 is configured to circulate fluid in the circulation loop 61. A thermal element 33 is configured to adjust a temperature of a fluid in the circulation loop 61, and ECU 20 is configured to control the pump 38 and is configured to control a temperature of the thermal element 33. In one or more embodiments, the thermal element 33 and ECU 20 are located within housing 64. ECU 20 may be situated within the housing 64 (as shown in Fig. 14), or may be situated outside of the housing 64.

[0074] As shown in Fig. 14, a majority of the circulation loop 61 has a generally uniform radius and circumference, but the circulation loop 61 also includes an enlarged portion 66 sized to be a fluid reservoir in the circulation loop 61. Use of a reservoir (e.g., a bladder) can be helpful in maintaining a consistent pressure in the circulation loop 61, for example. In one or more embodiments, the forearm sleeve 68 and glove 22 are detachable (e.g., along dotted line 70). In some such embodiments, the glove 22 may be a disposable piece, while the forearm sleeve 68 is reusable. Of course, it is also possible that the forearm sleeve 68 and glove 22 may be permanently secured to each other and be non-detachable. Fig. 15 illustrates an example peristaltic fluid pump 38' that could be used in the embodiment of Fig. 14.

[0075] Fig. 16 illustrates another example arrangement for pumping fluid to heat or cool a patient's hand. Here too, TTE 24 is a first conduit having a fluid inlet at connector 26A, and a fluid outlet at connector 26B (of course these roles could be reversed, so connector 26A has a fluid outlet and connector 26B has a fluid inlet). Also, forearm sleeve 68 includes a second conduit 60 that connects to the first conduit to form circulation loop 61. A reservoir 66 and fluid pump 38 are also included.

[0076] In Fig. 16, a thermoelectric device (TED) 72 acts as the thermal element 33. The TED 72 is configured to heat or cool fluid in circulation loop 61. The TED 72 may be a Peltier device, for example. The TED 72 includes thermally conductive sleeves 74, each of which surrounds a portion of the second conduit 60, to provide a heating and/or cooling effect to the surrounded portions of the second conduit 60. In one or more embodiments, the TED 72 is a Peltier device having opposing first and second faces 73A-B (see Fig. 17), and is configured, when a voltage is applied to the Peltier device, to provide heating to the first face 73A and to provide cooling to the second face 73B (or vice versa). In one or more embodiments, the thermally conductive sleeves 74 are part of the first or second face of the Peltier device. The ECU 20 and power supply 34 may be situated within housing 75, for example.

[0077] Figs. 17-18 illustrate example TED configurations that utilize a fan or blower (generically referred to as 40 herein). In each of these figures, a heat exchanger 76 (e.g., a heat sink) is mounted to one of the first or second faces 73A-B, and comprises fins 80 that define a plurality of channels 81 in the heat exchanger 76. In Fig. 17, a fan 40 is situated on top of the heat exchanger 76 for either drawing air into the air channels 81 from opposing ends of the channels 81, or for forcing air from above the heat exchanger 76 out of the opposing ends of the channels 81. An axis of rotation Al of the fan 40 extends through the TED 72 in Fig. 17. In Fig. 18, a blower 40 is used to blow air into the air channels formed by the fins 80. An axis of rotation A2 of the blower 40 is offset from the TED 72 and does not extend through the TED 72 in Fig. 18.

[0078] Figs. 19-31 schematically illustrate embodiments in which a glove 22 includes a flap 90 for securing a thermal housing 92 to a patient' s palm (although the flap 90 is not shown in every one of these figures). Reference numeral 92 is generically used herein to refer to a thermal housing that is situated against a glabrous area. Referring first to Fig. 19, the thermal housing 92 encloses TTE 24 within a temperature distribution medium 93. In one or more embodiments, the temperature distribution medium 93 comprises a fluid (e.g., gas, water, a gel, or a slurry). In one or more embodiments, a spacing material is situated within the thermal housing 92, and the temperature distribution medium 93 flows through the spacing material. Some example spacing materials may include a mesh with air pockets (e.g., a three-dimensional spacer fabric from Miiller Textil). The spacing material, which will be discussed in more detail below, provides spacing between an item (e.g., a face of thermal housing 92) and a glabrous skin area. In some embodiments, the temperature distribution medium 93 includes a solid plate (e.g., a foil or plate).

[0079] A second housing 94 encloses ECU 20 and a power supply 34. The ECU 20 is configured to control a temperature of the TTE 24 situated in a palm area of the glove 22. In the example of Fig. 19, the second housing 94 is mounted to a top face of the thermal housing 92. The glove 22 includes a strap 90 for securing the glove 22 (e.g., using a snap, or a hook and loop fastener, or some other fastener). The thermal housing 92 and second housing 94 form an assembly 96 that may be removably secured to a glabrous palm area through an opening 95 (see Fig. 20). This could be useful to facilitate sanitization or disposal of the glove 22 and/or to facilitate charging of the power supply 34 in the second housing 94. Flap 90 can be closed over the assembly 96 and fastened using its own straps 25, to place the assembly 96 directly against the glabrous palm area of the glove 22 through the opening 95. Alternatively, in place of the opening 95 a fabric membrane may be used that is situated between the thermal housing 92 and the glabrous palm area. An adhesive layer may be used on a bottom side of the thermal housing 92 that is opposite to the second housing 94 to further secure the assembly 96 to the glove 22 or patient's palm. Fig. 20 schematically illustrates the assembly 96 when separated from the glove 22.

[0080] Fig. 21 schematically illustrates how a sensor 44 may be utilized in conjunction with the embodiment of Fig. 19-20. In Fig. 21, the thermal housing 92 includes an opening 97 that the sensor 44 can reside within when the thermal housing 92 is situated in the glove 22. If the sensor 44 is not directly connected to ECU 20 within the second housing 94, then sensor circuitry 98 may be used to obtain readings from the sensor 44, and communicate them to the ECU 20 (e.g., through wireless signal transmissions to communication circuit 42).

[0081] Fig. 22 illustrates another embodiment that uses an alternate thermal housing 92 with its sensor opening 97 in a different location. Here, ECU 20 could be mounted to the thermal housing 92, or could be separately mounted to the glove 22. The sensor 44 in this embodiment could be a heat flux sensor, for example. [0082] Fig. 23 schematically illustrates other example features for heating and/or cooling a patient's palm. In particular, Fig. 23 illustrates another example path that the TTE 24 can follow within the thermal housing 92 (e.g., a spiral). Also, Fig. 23 illustrates how the ECU 20 and power supply 34 can be located in a wrist area, while the thermal housing 92 is located in a patient's palm. In Fig. 23 a sensor 44 (e.g., a temperature sensor) is situated in the palm area to measure a patient temperature. The ECU 20 may control the TTE 24 based on sensor data from the sensor 44. An elongated flap 90' may be used to secure the housings 92, 94 to the glove 22. Figs. 24-25 provide alternate views of the thermal housing 92 and/or second housing 94. Of course, although Fig. 25 illustrates TTE 24 being on top of thermal housing 92, it is understood that the TTE 24 may alternatively be situated within the thermal housing 92.

[0083] Figs. 26-27 schematically illustrate embodiments in which the temperature distribution medium 93 comprises a fluid, and a fluid pump 38 is configured to circulate the fluid, which may favorably achieve a more uniform temperature within the temperature distribution medium 93.

[0084] Fig. 27 schematically illustrates an adhesive layer 100 that may be situated on a bottom of the housing 92, for securing the thermal housing 92 to the glove 22 or to the patient's palm. An adhesive backing 102 may be peeled away to expose the adhesive layer 100.

[0085] Figs. 28-31 schematically illustrate examples of how negative pressure can be applied to a patient's palm to facilitate greater heat transfer with the palm. In Figs. 28-29, a seal ring 110 surrounds a perimeter of an opening 95 in the glove 22. A pump 38 is configured to apply negative pressure to an area between the flap 90 and a palm of a patient's hand, such that the seal ring 110 abuts the palm of the patient's hand, and the negative pressure is applied to the palm from a palm-facing side of the thermal housing 92.

[0086] In the example of Fig. 30, a spacing material 114 (e.g., a mesh with air pockets such as a reticulated fabric) is situated within thermal housing 92 to space a top of the thermal housing 92 away from the palm of the hand 14 when negative pressure is applied. In some examples, the opening 95 facilitates direct skin contact from a thermal housing (e.g., a TTE 24 or a housing within which the TTE resides 24). In the example of Fig. 31, instead of using seal ring 110, an adhesive 116 is used along a perimeter of the housing 92 to provide a seal.

[0087] Figs. 32-33 schematically illustrate example embodiments in which a TED 72 and heat exchanger 76 similar to the ones shown in Fig. 17 are utilized, but instead of exchanging heat with a conduit that is on a forearm and that carries a fluid to a patient's palm, in these embodiments the TED 72 is situated on a patient's palm (via glove 22) and exchanges heat with the patient's palm without requiring use of a fluid conduit. A fan 40 is situated on the TED 72 and facilitates heat transfer by the TED 72. In one example, airflow is drawn upwards away from the TED 72. Of course, the opposite configuration could be used instead, in which airflow is drawn downwards onto the TED 72.

[0088] Fig. 34 schematically illustrates a method 200 of controlling the core body temperature of a patient. A TTE 24 is situated on glabrous area of the patient 12 (block 202). An example of this is shown in Fig. 1. At least one sensor is situated near the patient (block 204) (see, e.g., Figs. 1 and 21-22). Heat from the TTE 24 is applied to the glabrous area to effectuate core temperature heating of the patient (block 206). A temperature of the thermal housing is controlled based on data received from the at least one sensor (block 208). A warming blanket is separately applied to a non- glabrous torso area of the patient 12 to enable patient thermal comfort, wherein the warming blanket is not controlled based on the data received from the at least one sensor (block 210). Although the method 200 has been described with a single TTE 24, it is understood that the method could be performed using a plurality of TTEs 24 that are each on different glabrous areas of a patient and are controlled based on the same or different sensors.

[0089] Also, although human patients have been depicted and discussed above, it is understood that the techniques disclosed herein could also be used to control the core body temperature of non-human mammals.

[0090] Additionally, although some specific types of sensors and pumps have been disclosed, it is understood that these are non-limiting examples.

[0091] Although example embodiments have been disclosed, a worker of ordinary skill in this art would recognize that certain modifications would come within the scope of the claims. For that reason, the following claims should be studied to determine their true scope and content.