WO2018064220A1

WO2018064220A1 - Heat exchange module, system and method

Info

Publication number: WO2018064220A1
Application number: PCT/US2017/053812
Authority: WO
Inventors: Julio L. Vergara; Daniel ESTRADA; Mayank KALRA; Andrew PADULA
Original assignee: Hypothermia Devices, Inc.
Priority date: 2016-09-28
Filing date: 2017-09-27
Publication date: 2018-04-05

Abstract

A heat exchange module (HEM) (100, 1110) alone or part of a system (1100) including a control console (1114). The HEM can include a channel enclosure assembly (320), a thermoelectric cooler (TEC) assembly (500), and a heat transfer (cover) assembly (600). The enclosure assembly includes a channel for a heat-transfer liquid. The module can be constructed to provide for flexibility to better conform and fit on rounded and/or angular body parts and to efficiently transfer heat between the adjacent body part and the heat-transfer liquid via the TECs (510) of the TEC assembly.

Description

HEAT EXCHANGE MODULE, SYSTEM AND METHOD

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the filing date benefit and incorporates by reference provisional application 62/400,836, filed September 28, 2016.

NOTICE OF MATERIAL SUBJECT TO COPYRIGHT PROTECTION

A portion of the material in this patent document is subject to copyright protection under the copyright laws of the United States and of other countries. The owner of the copyright rights has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office publicly available file or records, but otherwise reserves all copyright rights whatsoever. The copyright owner does not hereby waive any of its rights to have this patent document maintained in secrecy, including without limitation its rights pursuant to 37 C. F. R. § 1 .14.

BACKGROUND

The technology of this disclosure pertains generally to flexible heat exchange modules (HEMs) that contain thermoelectric coolers (TECs) and can be used for heating and/or cooling.

Hypothermia treatment of patients is used for a variety of applications, including but not limited to treatment of brain injuries, spinal cord injuries, muscle injuries, joint injuries, and as a neuroprotective agent for cardiac arrest and neonatal hypoxic ischemic encephalopathy. This treatment is typically afforded by the use of ice packs and/or chemical cool packs that provide incomplete and short-lived cooling, or by pads or caps in which cooling is afforded by circulating chilled water. SUMMARY

A heat exchange module (HEM) is disclosed herein having a channel enclosure assembly, a thermoelectric cooler (TEC) assembly and a heat transfer (or cover) assembly. The enclosure assembly includes a liquid channel, and can be formed from radio frequency (RF) or ultrasonically welded plastic films. Every TEC of the TEC assembly transfers heat to the liquid directly or indirectly through a sealed window in the channel wall. For example, the reference side of the TEC can be mounted in the window thereby closing the window and forming a part of the channel wall, or a thermally-conductive (typically copper or aluminum) plate piece can be mounted in the window with the reference side of the TEC in thermal contact with the backside of the plate piece. The heat transfer (cover) assembly can include a slotted heat transfer plate (typically copper, aluminum, or other very high thermal conductivity material), or a plurality of interconnected tiles (small plates made of copper, aluminum, or other heat conductive material) for positioning against a body part. The user side of the TEC is in heat transfer relation with the slotted plate or one of the tiles, depending on the embodiment. A thermistor (or a thermocouple) is positioned on an inward face of the slotted plate or the tile. Thereby, the TEC assembly controllably, using input from a thermistor or thermocouple, or a plurality of thermistors or thermocouples, adjusts the temperature of the body part by expelling heat into, or withdrawing heat from, the heat- transfer liquid.

The channel enclosure assembly can be constructed of three flexible sheets. The first and second sheets have aligned holes and the above-mentioned plate piece is embedded in and between the sheets, covering the holes. The first and second sheets are secured to a third (top) sheet (such as a reinforced TPU sheet) which is heat compressed, or RF welded, or ultrasonically welded, to the second sheet to form a serpentine channel therebetween with the second sheet. A top surface of the plate piece is at a hole in a channel portion of the second sheet, thereby forming part of the wall of the channel and in direct contact with the liquid flowing in the channel for heat transfer therebetween. Multiple plate pieces are typically embedded in and between the first and second sheet, spaced from the previously-mentioned plate piece and also forming parts of the channel wall. Reference sides of respective TECs of the TEC assembly are attached to the back sides of each of the plate pieces, through respective holes in the first sheet. For the tile embodiment, the cover (heat transfer) assembly can include a flexible

(plastic) frame having open windows. Trays arranged in an array are each

interconnected to adjacent trays by flexible bridges. Each tray has a hole for receiving and holding a respective TEC, and through which the user faces of the TECs are secured to respective ones of the tiles. The matrix of interconnected trays and the plurality of tiles are held together by snapping or hooking into the frame at respective ones of the windows. The frame keeps the tiles spaced such that the layer of tiles is flexible along one or more X-axes between tiles, as well as one or more Y-axes.

Thereby the HEM is flexible and conformable against rounded and/or angular body parts by flexing on the axes between the tiles as well as axes between the plate pieces. Separate thermistors (or thermocouples) can be mounted on inward surfaces of each tile but not so as to interfere with the TEC attachments.

The liquid that is passed through the channel in the enclosure assembly acts as a heat sink for the TECs contained within the HEM. Power is supplied by a controller to the TECs to induce cooling or heating.

The controller can be located in a console of a system of the present disclosure which also includes the HEM and an umbilical providing electrical, signal and water (fluid) connection between the HEM and the console. The console contains a

combination of radiator and fans that efficiently dissipates the heat transferred to and from the fluid circulating at the HEM by using the umbilical as a conduit. The HEM may be used for heating, cooling or cycling between heating and cooling for various medical uses. One or more temperature sensors (e.g., thermistors or thermocouples) detect the temperature of the cooling or heating surface and may be used as feedback to the control unit. The present disclosure includes a number of different definitions of the disclosures including the module or device, subassemblies of the method or device (such as the water channel enclosure assembly, the heat transfer (or cover) assembly, methods of making the module or device, methods of making the subassemblies, the console, the umbilical, the overall system, methods of making the devices and subassemblies, and methods of using the devices, systems and subassemblies thereof.

Further aspects of the technology described herein will be brought out in the following portions of the specification, wherein the detailed description discloses preferred embodiments of the technology without placing limitations thereon.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded perspective view of a heat exchange module of the present disclosure.

FIG. 2 is a top perspective view of the assembled module of FIG. 1 showing the movement of water (or other heat transfer fluid) into and out of the channel of the module.

FIG. 3 is a bottom perspective view of the module of FIG. 2.

FIG. 4 is an enlarged cross-sectional view of the module of FIG. 2 against a body part of a patient.

FIG. 5 is an enlarged view taken on circle 5 of FIG. 4.

FIG. 6 is a top perspective view of the module of FIG. 2 showing the water channel enclosure in exploded relation. FIG. 7 is a cross-sectional view through the water channel enclosure of FIG 6.

FIG. 8 is a cross-sectional view, similar to that of FIG. 7 but with a TEC layer attached thereto.

FIG. 9 is an exploded view of a heat transfer (cover) assembly of the module of FIG. 14.

FIG. 10 is an enlarged perspective view of a bottom corner of the module showing a removable coating being peeled away.

FIG. 1 1 is a top plan view of an exemplary TEC assembly of the module wherein the TECs are in a single bank and connected in series. FIG. 12 is a perspective view showing a module of the disclosure in position on a body part of a user and operatively connected to a control and power unit of the disclosure.

FIG. 13 is a perspective view of an alternative heat transfer (cover) plate of the disclosure illustrated in isolation.

FIG. 14 is a simplified exploded perspective view of a module of the present disclosure having an alternative heat transfer cover assembly. FIG. 15 is an enlarged perspective view of a portion of the cover assembly of

FIG. 14 shown assembled.

FIG. 16 is an enlarged cross-sectional view taken on line 16-16 of FIG. 15.

FIG. 17 is a bottom perspective view of an alternative cover assembly having bottom biocompatible layer, shown being peeled back. FIG. 18 is a block diagram of a system of the present disclosure including a heat exchange module, a console and an umbilical connecting them, with components of the console being illustrated in block form, and which shows the signal, power and fluid connections.

FIG. 19 is a perspective view of a console of the present disclosure with the console housing shown as being transparent for illustrative purposes.

DETAILED DESCRIPTION

Referring to FIG. 1 , a heat exchange module of the present disclosure is illustrated in exploded view generally at 100. The fluid hoses 1 10, thermoelectric cooler (TEC) wires 120, and thermistor (or thermocouple) wires 130 can pass through an umbilical 140 to the console 150 (FIGS. 1 1 and 18-19). (For further explanation of the console, see also FIGS. 18 and 19 and the explanation of their components later in this application.) The HEM system of the present disclosure shown generally at 200 thus includes HEM 100, umbilical 140 and console 150. FIG. 12 shows system 200 with the HEM 100 in position, wrapped around a body part 220 of a patient. The HEM 100 can be adapted and used on generally any body part 220 including for example the head. As can be appreciated, the HEM 100 for many applications should be constructed to be able to flex in all three directions to be fitted by the medical personnel against any body part no matter how rounded, angular, large and small.

The HEM 100 and the alternative embodiment HEM shown generally at 300 in exploded view in FIG. 14 include many novel constructions to provide for increased flexibility. Although pictured as being flat when in its natural state, the HEM 100 (or 300) of the present disclosure also includes cylindrical and cup configurations, and any combination of shapes afforded to follow the contours of various body parts. The HEMs disclosed herein also have novel constructions providing for improved transmission of heat to and from the circulating liquid in the channels and the body parts.

The channel enclosure assembly 320 of the HEM 100 can include first, second and third TPU (or other thermoplastic) sheets 330, 340, 350. The first and second sheets 330 and 340 include a plurality of holes 350, 360, which mate with one another when the sheets are attached together. A plate assembly shown generally at 370 is positioned between sheets 330, 340. It can comprise a plurality of plate pieces shown at 380. There is one plate piece 380 for each of the mating holes 350, 360. For example, the holes 350, 360 and plate pieces can be arranged in a three-by-four array. But then the number and arrangement will be selected as desired for the HEM factoring in the requirements of the TEC assembly and its TECs. As an example, the HEM 300 is illustrated as having a three-by-three array. The first and second sheets 330, 340 are thermally sealed together with each of the plate pieces 380 embedded in the two sheets and covering both of the respective mating holes 350, 360. See FIG. 7, for example. The plate pieces 380 can have one or more slots, openings or notches 390 along their perimeters. This aids in the plate pieces 380 being embedded into the (plastic) of the first and second sheets, as can be seen by embedded plastic pieces 400 in FIGS. 5, 7 and 8.

With the first and second sheets 330, 340 secured together, for example by thermal compression or ultrasonic welding, and the plate pieces 380 embedded in the sheets at the holes (or windows), the third sheet 350 is secured thereto. It can be secured by thermal compression, ultrasonic welding, RF welding or similar means. The welding, etc. is configured to form the perimeter 400 of a water (or other thermally- conductive liquid) channel 410 between the second and third sheets 340, 350. Holes 430, 440 (FIG. 1 ) can be formed in the third sheet at opposite ends of the channel 410. And angled connectors 450, 460 attached to the third sheet 350 at the respective holes and through which water delivered through tubing 470 is delivered (arrows 480, 490 in FIG. 2) between the console 150 and the channel 410. The design of the RF weld can be customized to the specifications of each different HEM. As an example each thermoplastic sheet, either urethane (TPU), or vinyl or other thermoplastic sheets, can have a thickness of 15-40 mils, and the RF weld line can be three mils. The TPU inlets/outlets 450, 460 (typically in the form of elbows) are also RF welded at the ends of the designed water channel to allow the inlet and outlet of the water to be circulated. These inlets/outlets vary in size and can have an inner diameter (ID) of either 1/4" or 3/8", for example, depending on the specifications of each HEM.

The third flexible sheet 350 can be a reinforced TPU sheet or multi-layer with an internal cloth layer, strong enough to withstand pressures of the water in the channel of fifteen to twenty-five psi. As example, the pressure in the channel should be kept at less than twenty-five psi so as to not cause the sheet 450 to rupture. Exemplary flow rates in the channel 410 are two liters per minute, and can range from 0.5 to 3.5 liters per minute.

Holes 360 in the second sheet 340 are positioned so as to be at the channel 410, as can be seen in FIGS. 7 and 8. Thereby each of the plate pieces 380 forms a portion of the wall of the channel 410. Further, each plate piece 380 is in direct contact with the water flowing through the channel 410 for direct thermal transfer therebetween.

An alternative configuration omits the plate assembly (plate pieces 380) and positions the reference (ceramic) face of the TEC directly in/to the hole 350 of the second sheet 340, and thereby in direct physical contact with the water in the channel for thermal transfer therebetween.

A further alternative does not include a first sheet 330. Rather, the plate piece 380 is secured directly to an inward face of the second sheet 340 and over the hole. It can be secured, for example, using an adhesive. It is within the scope of the present disclosure for the plate assembly 370 to comprise a single large plate. However, by providing a plurality of smaller plate pieces 380 spaced from one another in both x and y directions, as described above, additional flexibility/bending of the HEM is possible. This flexibility/bending can be along one or more x axes between the plate pieces 380 and/or along one or more y axes between the plate pieces. Alternatively but less preferably, the plate pieces 380 can be interconnected with a flexible webbing.

A TEC assembly 500 of the HEM 100 can be seen in FIGS. 1 and 1 1 comprising a plurality of TECs 510. They can be formed in a single bank as illustrated in FIG. 1 1 and connected in series, or in a plurality of banks (e.g., three or four), each connected in series or in parallel. The number of banks can depend on the type of TECs used, and the voltage ranges optimally controlled by the console unit. Reference faces of each of the TECs 510 are attached to a respective plate piece 380 in a manner to provide effective heat transmission, as shown in FIGS. 5 and 8, for example. For example, a thin layer of thermally-conductive adhesive, paste or putty 530 can be used. The TEC assembly 500 can be operatively connected to the console 150 by wires 120.

The HEM 100 can include a heat transfer (cover) assembly shown generally at 600 in FIG. 1. Cover assembly 600 transmits heat between the body part and the user faces of the TECs 510. The heat transmission vehicle of the cover assembly 600 can be a copper or aluminum (or other highly thermally-conductive material) plate 620 as can be seen in FIGS. 1 and 9. Short, spaced x and y slots 630 can be formed in the cover plate 620 to give it greater flexibility and bendability to better conform to rounded and/or angular body parts. A thin sheet or film of plastic 640 can be adjacent to an inward face of the cover plate 620. Sheet 640 can be plasticized to the inward face. It also can extend out beyond the perimeter of the cover plate 620 and the third sheet 350 can be sewn or otherwise mechanically secured to the extension perimeter of the plastic sheet to hold at least in part the HEM 100 together. The sewing is shown by reference numerals 650 and 660 in FIG. 1 . Other mechanical means in addition to or in lieu of sewing can be used such as snaps, tacks or the like. Additional sewing can be provided through a central part of the HEM 100 such as through the adhered portions of the third sheet 350 (outside of the channel) as shown by sewing lines 670 in FIG. 2. Mechanical attachment means can allow for more flexibility of the layers/components of the HEM than by affixing them with an adhesive, for example.

One or more thermistors (or thermocouples) 700 (FIG. 5) can be positioned between the cover plate 620 and the plastic sheet 640 to accurately measure the temperature of the adjacent body part and transmit this temperature signal to the console 150 via the wire 130.

The substance(s) 530, 710 used to attach the reference face of the TEC to the copper piece and/or the user face of the TEC to the plate assembly can be a thermally- conductive putty or similar substance (e.g., a thermally-conductive paste, pad or flexible adhesive) which may allow for some planar movement of the TEC, thereby increasing the flexibility/bendability of the HEM 100. The substance can be very thin on the order of fifty to one hundred microns, and have high thermal conductivity, for example greater than three W/m. This substance can be in lieu of a rigid adhesive affixation.

A biocompatibility layer 770 can be secured to the outward face of the cover plate 620. This provides for a smoother, more comfortable and more sanitary contact of the HEM to the body part. Layer 770 can be considered to be part of the cover assembly 600 or as an addition thereto. The layer 770 can be affixed to the plate 620 or it can be a replaceable film or it can be a gel, such as a thermally-conductive silicone gel.

A filler layer 780 surrounding the TECs 510 of the TEC assembly can be used. It can be, for example, a foam layer or a core composite layer with pre-formed holes for receiving therein respective ones of the TECs. This layer 780 can be seen in FIGS. 1 and 1 1 . The core composite material can provide interstitial insulation and structural stability to the HEM.

As mentioned above, the cover plate 620 can be formed with X and/or Y direction slots 630 to provide for flexibility/bendability. Another construction of the cover plate is shown by plate 800 in FIG. 13, which has a tic-tac-toe arrangement of bridges 820 forming an array of interconnected rectangular plates 840. The intersections of the x and y bridges 820 can be holes 850. If the plate 800 is made of metal, e.g., copper, then so are the bridges 820 according to the construction of the embodiment depicted in FIG. 13.

An alternative heat distribution cover assembly (or heat transfer assembly) 900 is illustrated in FIGS. 14 and 17. Cover assembly 900 can include a frame 910 which holds the cover assembly together and can be made of a flexible plastic, while the plate assembly 920 can be made of metal. This plastic construction can have greater flexibility than the copper of plate 800, for example, and be less subject to bending fatigue. In addition to the frame 910 and the plate assembly 920 the alternative cover assembly 900 can include a tray assembly 930, as discussed in detail below. The tray assembly 930 can include a plurality of trays 934, one for each TEC

510. Each tray 934 has a through-hole 936 for receiving therein a respective TEC 510 (FIGS. 15 and 16). Each tray also has a perimeter rim 940. Elongate flexible bridges 946 interconnect rims 940 of the long side of adjacent trays 934. Wider and shorter flexible bridges 950 interconnect rims 940 of the short sides of adjacent trays 934. As can be seen in FIG. 16, smooth curves can connect the bridges with the adjacent rims 940. The bridges interconnect the trays 934 such that tray assembly 830 has a matrix- type construction.

The frame 810 has x and y bars 960 forming window-openings 964. The bars in cross section can be shaped as shown in FIG. 16 with enlarged heads 970 at both ends connected by a smoothly-curved hump or bridge 974. The plate assembly 920 can include a plurality of thermally-conductive tiles 980 (copper, aluminum, or any other material with high thermal conductivity) which have flat body members 984 with raised perimeter lips 988. The enlarged heads 970 hook onto or snap onto the perimeter lips 988 when the cover assembly is assembled as shown in FIGS. 15 and 16. The enlarged heads 970 are within the rims 940. The bridges 950 are on the humps 974 in conforming relation. As can be understood, each of the plate assembly (tiles), the tray assembly (tiles) and the frame (windows) forms the same arrays, e.g., a three-by-three array, which are aligned when assembled such that each TEC can penetrate to thermally contact (directly or using an adhesive or the like) with a respective tile 980.

Each of the tiles 980 can have its own thermistor (or thermocouple) 996 secured to an inward surface thereof. The temperature sensors 996 collectively and accurately measure the temperature of the adjacent body part.

A number of ways of providing a smooth, comfortable, cleanable, thermally- conductive surface on the bottoms of the tiles for direct contact with the body part and are within the scope of the present disclosure. One is to provide a biocompatible thermally-conductive layer 998, which for example can be reinforced with carbon fiber/nanotubes/copper mesh (anything to optimize thermal conductivity) to optimize heat extraction via proximity to skin. The layer can be permanently affixed and able to be wiped clean. Or it can be a removable layer 998 (FIG. 17) which can be applied, used, removed and replaced with a fresh layer.

Another embodiment is to apply a suitable thermally-conductive lacquer directly on the bottom surfaces of the (metal) tiles 980, and which can be wiped clean. A thin, biocompatible, thermally-conductive gel, such as a silicone gel, can also provide the coating according to another embodiment. A further embodiment is to provide a sleeve or bag (not shown) in which the HEM can be inserted. The bag can have a thin biocompatible film (along the lines of those discussed above) on its user contact surface. After each use the bag can be removed, washed and reused.

Illustrated in the system overviews of FIGS. 20 and 21 are the heat exchange system shown generally at 1 100 and including a heat exchange module shown generally at 1 1 10, a console shown generally at 1 1 14 and an umbilical 1 120 operatively connecting them. The console 1 1 14 can include an enclosure 1 130, fans 1 140, radiator 1 150, screen drive board 1 160, touch screen 1 170, pump 1 180, jack 1 190, power/signal plug 1200, port connector 1 120, rotary encoder 1220, H-bridge 1230, DC-to-DC power supply 1240, reservoir 1250, battery 1260, USB 1270, power outlet 1280, flow meter 1290, and microcontroller assembly 1300. And FIG. 20 shows the following

connections: signal 1320, power 1330, fluid 1340 and heat 1350.

Although the description herein contains many details, these should not be construed as limiting the scope of the disclosure but as merely providing illustrations of some of the presently preferred embodiments. Therefore, it will be appreciated that the scope of the disclosure fully encompasses other embodiments which may become obvious to those skilled in the art. In the claims, reference to an element in the singular is not intended to mean "one and only one" unless explicitly so stated, but rather "one or more." All structural, chemical, and functional equivalents to the elements of the disclosed embodiments that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed as a "means plus function" element unless the element is expressly recited using the phrase "means for". No claim element herein is to be construed as a "step plus function" element unless the element is expressly recited using the phrase "step for".

Claims

THE CLAIMS

1 . An enclosure assembly, comprising: a flexible first sheet having a first hole; a flexible second sheet having a second hole aligned with the first hole; a thermally-conductive plate piece embedded between the first and second sheets at the first and second holes and covering at least the second hole; a flexible third sheet attached to the second sheet so as to form a channel for heat-transfer liquid between the second and third sheets with a face of the plate piece positioned so as to be in direct contact with liquid when present and flowing through the channel for heat transfer between the plate piece and the flowing liquid; and the face of the plate piece forming a portion of a wall of the channel.

2. The assembly of claim 1 wherein the plate piece has an embedment notch or embedment hole adjacent a perimeter of the piece.

3. The assembly of claim 1 wherein the first hole defines one of a plurality of holes in the first sheet, and the second hole defines one of a plurality of holes in the second sheet, each of the holes in the second sheet aligned with a respective one of the holes in the first sheet to define a plurality of aligned pairs of holes, and the plate piece defines a first of a plurality of thermally-conductive plate pieces, each of which is embedded in and between the first and second sheets at a respective one of the pairs of holes and having a face in direct thermal-exchange contact with liquid when present and flowing through the channel.

4. The assembly of claim 1 wherein the third sheet is RF or ultrasonically welded to the second sheet to form the channel.

5. The assembly of claim 1 wherein the third sheet is thermal/heat pressed to the second sheet to form the channel.

6. The assembly of claim 1 wherein the plate piece is a copper plate piece, an aluminum plate piece or a carbon fiber plate piece.

7. The assembly of claim 1 wherein the third sheet has an opening at a first end of the channel for a first outlet/inlet member and an opening at a second opposite end of the channel for a second outlet/inlet member.

8. The assembly of claim 1 wherein the first and second sheets are heat pressed, ultrasonic welded or RF welded together.

9. The assembly of claim 1 wherein the third sheet is a reinforced thermoplastic sheet, reinforced to resist pressure from liquid when present and flowing in the channel.

10. An enclosure assembly, comprising: a flexible inner sheet having a hole; a thermally-conductive plate piece whose perimeter is secured to the inner sheet and which is positioned at and covering the hole; and a flexible outer sheet attached to the inner sheet via RF or ultrasonic welding or thermal compression to form a channel therebetween for liquid flow between the inner and outer sheets with an exposed surface of the plate piece forming a portion of a wall of the channel so as to be in direct contact with liquid when present and flowing through the channel for heat transfer between the plate piece and the flowing liquid.

1 1 . The assembly of claim 10 wherein the perimeter is embedded in the inner sheet or glued thereto.

12. The assembly of claim 10 wherein the plate piece has an embedment notch or embedment hole adjacent a perimeter of the plate piece.

13. The assembly of claim 10 wherein the hole defines one of a plurality of holes in the inner sheet, and the plate piece defines one of a plurality of thermally-conductive plate pieces, each of which is embedded in the inner sheet at and covering a respective one of the plurality of holes and in direct contact with the liquid when present and flowing through the channel.

14. The assembly of claim 10 wherein the plate piece is a copper plate piece, an aluminum plate piece or a carbon fiber plate piece.

15. The assembly of claim 10 wherein the outer sheet has an opening at a first end of the channel for a first connector and an opening at a second opposite end of the channel for a second connector.

16. An enclosure assembly, comprising: a flexible inner sheet having a hole; a thermoelectric cooler (TEC) assembly which includes a TEC whose reference side is at and covering the hole; and a flexible outer sheet attached to the inner sheet via RF or ultrasonic welding or thermal compression to form a channel therebetween for liquid flow between the inner and outer sheets with the reference side forming a portion of a wall of the channel so as to be in direct contact with liquid when present and flowing through the channel for direct heat transfer between the TEC and the flowing liquid.

17. A heat exchange module, comprising: an enclosure assembly which includes: a flexible first sheet having a first hole; a flexible second sheet having a second hole aligned with the first hole; a thermally- conductive plate piece embedded in and between the first and second sheets at the first and second holes and covering at least the second hole; and a flexible third sheet attached to the second sheet so as to form a channel for liquid between the second and third sheets with an exposed surface of the plate piece forming a portion of a wall of the channel so as to be in direct contact with liquid when present and flowing through the channel for heat transfer between the plate piece and the liquid; a plate assembly which includes the plate piece; a thermoelectric cooler (TEC) assembly which includes a TEC whose reference side is in heat transfer relation with the plate piece; and a heat distribution cover assembly in heat transfer relation with a user side of the

TEC.

18. The module of claim 17 further comprising a biocompatible layer on an outward surface of the cover assembly.

19. The module of claim 18 wherein the biocompatible layer is a removable film.

20. The module of claim 17 wherein: the plate assembly includes a plurality of thermally-conductive plate pieces, the plate piece being one of the plurality of plate pieces; the first hole defines one of a plurality of holes in the first sheet; the second hole defines one of a plurality of holes in the second sheet, each of the holes in the second sheet being aligned with a respective one of the holes in the first sheet to define a plurality of aligned pairs of holes; and each of the plate pieces is embedded in and between the first and second sheets at a respective one of the pairs of holes, covering the respective hole in the second sheet and in direct contact with liquid when present and flowing in the channel.

21 . The module of claim 17 wherein the third sheet is RF welded to the second sheet to form the channel.

22. The module of claim 17 wherein the third sheet is thermal pressed to the second sheet to form the channel.

23. The module of claim 17 wherein the first and second sheets are heat pressed together.

24. The module of claim 17 wherein the cover assembly includes a plate having a plurality of module-flexibility weakened areas, and an inner-surface plastic layer on an inward surface of the plate.

25. The module of claim 24 wherein the weakened areas are spaced slots in the plate.

26. The module of claim 17 wherein the cover assembly includes a plate and an inner-surface plastic layer on an inward surface of the plate, and a thermistor (or thermocouple) is positioned between the cover and the plastic layer.

27. The module of claim 17 wherein the plate assembly includes a mesh or screen.

28. The module of claim 17 wherein the plate piece covers the second hole.

29. The module of claim 17 wherein the third flexible sheet is a reinforced so as to withstand a liquid pressure in the channel of at least 15 psi.

30. The module of claim 29 wherein the third flexible sheet is a reinforced TPU sheet, reinforced so can withstand 15 - 25 psi in the channel.

31 . The module of claim 17 wherein the third flexible sheet is a multi-layer sheet with a middle cloth layer.

32. The module of claim 17 wherein the TEC assembly includes a single bank of TECs connected in series.

33. The module of claim 17 wherein the TEC assembly includes a plurality of banks of TECs, wherein the TECs in each of the banks are separately connected in series.

34. The module of claim 17 wherein the cover assembly includes a slotted thermally- conductive plate and a plastic sheet adhered to an inward face of the plate.

35. The module of claim 17 wherein the module has a naturally flat configuration but is flexible so can be conformed to a rounded and/or angular body part.

36. The module of claim 17 wherein the module has a natural cup configuration.

37. A heat exchange module, comprising: a channel enclosure including a channel for heat-transfer liquid and a thermally- conductive plate assembly which includes thermally-conductive first and second plate pieces for heat transfer with the liquid when present and flowing in the channel; a thermoelectric cooler (TEC) assembly which includes a first TEC whose reference side is in heat transfer relation with the first plate piece and a second TEC whose reference side is in heat transfer relation with the second plate piece; a heat distribution cover assembly which is in heat transfer relation with user sides of the first and second TECs; the cover assembly including a plate having a plurality of module-flexibility weakened areas; the cover assembly having an inner-surface plastic layer on the plate.

38. The module of claim 37 wherein the weakened areas include a matrix of hinged lines or bridges.

39. The module of claim 37 further comprising a filler layer between the plastic layer and the channel enclosure and through which the first and second TECs pass.

40. The module of claim 39 wherein the filler layer includes a core composite layer having a first pre-formed hole for the first TEC and a second pre-formed hole for the second TEC.

41 . The module of claim 39 wherein the filler layer comprises a foam.

42. The module of claim 37 wherein the module-flexibility weakened areas include slots in the plate.

43. The module of claim 37 wherein the plate is an aluminum, copper or carbon fiber plate.

44. The module of claim 37 further comprising a thermistor or thermocouple positioned between the plastic layer and the plate.

45. A heat exchange module, comprising: a channel enclosure including a channel for heat-transfer liquid and a thermally- conductive plate assembly which includes thermally-conductive first and second plate pieces configured for heat transfer with the liquid when present and flowing in the channel; a thermoelectric cooler (TEC) assembly which includes a first TEC whose reference side is in heat transfer relation with the first plate piece and a second TEC whose reference side is in heat transfer relation with the second plate piece; a heat transfer assembly having a plate assembly which is in heat transfer relation with user sides of the first and second TECs; a heat transfer substance between (a) the reference sides of the first and second TECs and the first and second plate pieces, respectively, and/or (b) the user sides of the first and second TECs and the plate assembly; the heat transfer substance not rigidly affixing the TECs and allowing for relative lateral movement; and the cover assembly and the channel enclosure being attached together in a manner so as to not block all of the relative movement.

46. The module of claim 45 wherein mechanical securement attaches the cover assembly and the channel enclosure together.

47. The module of claim 46 wherein the mechanical securement includes sewing thread, tacks or snaps.

48. The module of claim 45 wherein the heat transfer substance is between said (a) or said (b) but not both, and affixing adhesive is between the other of (a) or (b).

49. The module of claim 45 wherein the heat transfer substance is a putty.

50. The module of claim 45 wherein the heat transfer substance is a thin layer of a thermally conductive adhesive or a thermally conductive paste or a thin thermally conductive pad.

51 . The module of claim 45 further comprising a biocompatible layer on an outer surface of the cover.

52. The module of claim 51 wherein the biocompatible layer is a removable film.

53. The module of claim 45 wherein the plate has a matrix of hinged flexibility lines.

54. The module of claim 45 wherein the heat transfer assembly includes a plastic layer on an inward surface of the plate assembly.

55. A method of assembling a heat exchange module, comprising: forming an enclosure assembly including a channel for a heat-transfer liquid and a plate assembly; the plate assembly including a plate piece having a first face forming a portion of a wall of the channel and in direct contact with the liquid when present and flowing in the channel and an opposite exposed second face; applying a thermally-conductive first substance between the second face and a reference face of a thermoelectric cooler (TEC) of a TEC assembly; applying a thermally-conductive second substance between an opposite user face of the TEC and a heat transfer assembly; and attaching the heat transfer assembly and the enclosure assembly together.

56. The method of claim 55 wherein at least one of the first and second substances allows for relative lateral movement between the TEC and at least one of the plate piece and the heat transfer assembly.

57. The method of claim 55 wherein the attaching includes mechanically securing the enclosure assembly and heat transfer assembly together.

58. The method of claim 55 wherein the attaching includes a core composite layer having a preformed hole and positioned between the heat transfer assembly and the enclosure assembly with the TEC positioned in the hole.

59. The method of claim 55 applying a biocompatible layer to the heat transfer assembly.

60. The method of claim 55 wherein the first and/or second substances comprise a thin layer of a thermally conductive adhesive or a thermally conductive paste or a thin thermally conductive pad.

61 . The method of claim 60 wherein the thermal conductivity is greater than 3 Watts/m.

62. A method of assembling a heat exchange module, comprising: forming an enclosure assembly including a channel for a heat-transfer liquid and a plate assembly; the plate assembly including a plate piece having a first face forming a portion of a wall of the channel and in direct contact with the liquid when present and flowing in the channel and an opposite exposed second face; connecting the second face and a reference face of a thermoelectric cooler (TEC) of a TEC assembly together in heat conductive relation; connecting an opposite user face of the TEC and a heat distribution cover assembly together in heat conductive relation; the cover assembly including a flexible heat distribution plate and a plastic layer on an inward face of the plate with a thermistor (or thermocouple) disposed between the plate and the layer; and attaching the cover assembly and the enclosure assembly together.

63. The method of claim 62 wherein the attaching includes heat sealing the cover and the enclosure assembly together.

64. The method of claim 62 wherein the attaching includes mechanically securing the cover and the enclosure assembly together.

65. The method of claim 62 wherein the attaching includes filler material surrounding the TEC.

66. The method of claim 65 wherein the filler material comprises a core composite layer with a pre-formed hole in which the TEC is positioned.

67. A method of assembling a heat exchange module, comprising: forming an enclosure assembly including a channel for a heat-transfer liquid and a plate assembly; the plate assembly including a plate piece having a first face forming a portion of a wall of the channel and thereby in direct contact with the liquid when present and flowing in the channel and an opposite exposed second face; connecting the second face and a reference face of a thermoelectric cooler (TEC) of a TEC assembly together in heat conductive relation; connecting an opposite user face of the TEC and a heat distribution cover assembly together in heat conductive relation; at least one of the connecting steps including a core composite layer disposed between the cover assembly and the enclosure assembly, the layer having a preformed opening in which the TEC is positioned; and attaching the cover assembly and the enclosure assembly together.

68. The method of claim 67 wherein at least one of the connecting steps uses a thin layer of a thermally conductive adhesive or a thermally conductive paste or a thin thermally conductive pad.

69. A heat exchange module, comprising: a channel enclosure including a channel for heat-transfer liquid and a thermally- conductive plate assembly which includes thermally-conductive first and second plate pieces for heat transfer with the liquid when present and flowing in the channel; a thermoelectric cooler (TEC) assembly which includes a first TEC whose reference side is in heat transfer relation with the first plate piece and a second TEC whose reference side is in heat transfer relation with the second plate piece; a heat distribution cover assembly which includes a tray assembly, a plurality of tiles and a frame which holds the tray assembly and the plurality of tiles together; the tray assembly including a first tray having a first opening through which a user side of the first TEC is accessible and a second tray having a second opening through which a user side of the second TEC is accessible; and the plurality of tiles including a thermally-conductive first tile which is in heat transfer relation with the user side of the first TEC and a thermally-conductive second tile which is in heat transfer relation with the user side of the second TEC.

70. The module of claim 69 wherein a first temperature sensor is mounted to the first tile and a second temperature sensor is mounted to the second tile.

71 . The module of claim 69 wherein the tray assembly includes a flexible hinge connecting the first and second trays.

72. The module of claim 69 wherein the tray assembly includes a flexible elongate bridge connecting adjacent edges of the first and second trays.

73. The module of claim 69 wherein the first opening is configured to hold the first TEC therein.

74. The module of claim 69 wherein the frame is a flexible frame allowing the first and second tiles to bend relative to one another about an axis between them.

75. The module of claim 69 wherein: the plate assembly includes thermally- conductive third and fourth plate pieces for heat transfer with the liquid when present and flowing in the channel; the TEC assembly includes a third TEC whose reference side is in heat transfer relation with the third plate piece and a fourth TEC whose reference side is in heat transfer relation with the fourth plate piece; the tray assembly including a first tray having a first opening through which a user side of the first TEC passes and a second tray having a second opening through which a user side of the second TEC passes; the plurality of tiles includes a thermally-conductive third tile which is in heat transfer relation with the user side of the third TEC and a thermally-conductive fourth tile which is in heat transfer relation with the user side of the second TEC.

76. The module of claim 75 wherein the tray assembly includes the first, second, third and fourth trays being arranged in a 2 x 2 array, a first hinge operatively between adjacent edges of the first and second trays, a second hinge operatively between adjacent edges of the first and third trays, a third hinge operatively between adjacent edges of the third tray and the fourth tray and a fourth hinge operatively between adjacent edges of the fourth tray and the second tray.

77. The module of claim 75 wherein the tiles are arranged in a 2 x 2 array having an x- axis between the first and second tiles and the third and four tiles, and a y-axis between the first and third tiles and the second and fourth tiles, and the frame is a flexible frame allowing the 2 x 2 array to bend about the x-axis and about the y-axis.

78. The module of claim 69 wherein the trays each have a tray perimeter rim, and the tiles each have a tile perimeter rim.

79. The module of claim 78 herein the frame snap-fit or hook-fit holds the plurality of trays and the tiles together via the tray and tile perimeter rims.

80. The module of claim 69 wherein the cover assembly includes a biocompatible coating on outer surface of the tiles.

81 . The module of claim 69 wherein: the frame is a flexible frame; the tray assembly includes the first tray having a first raised edge, the second tray having a second raised edge and a flexible bridge connecting the first and second raised edges; the frame includes a connector member whose cross-section includes first and second enlarged heads on opposite ends of a raised bridge; and the first tile including a raised edge first lip and the second tile including a raised edge second lip.

82. The module of claim 81 wherein the cover assembly when assembled includes: the first lip hooking onto the first enlarged head, the second lip hooking onto the second enlarged head, the raised bridge holding the first and second trays in spaced relation, the flexible bridge being positioned against the raised bridge, the first enlarged head being in the first raised edge and the second enlarged head being in the second raised edge.

83. A heat exchange module, comprising: a channel enclosure including a channel for heat-transfer liquid and a thermally- conductive plate assembly which includes thermally-conductive first and second plate pieces for heat transfer with the liquid when present and flowing in the channel; a thermoelectric cooler (TEC) assembly which includes a first TEC whose reference side is in heat transfer relation with the first plate piece and a second TEC whose reference side is in heat transfer relation with the second plate piece; a heat distribution cover assembly which includes plurality of thermally- conductive tiles and a flexible plastic frame which snap-fit or hook-fit holds the plurality of tiles together; and the plurality of thermally-conductive tiles including a thermally-conductive first tile which is in heat transfer relation with the user side of the first TEC and a thermally- conductive second tile which is in heat transfer relation with the user side of the second TEC.

84. The module of claim 83 further comprising a first temperature sensor secured to an inward side of the first tile and a second temperature sensor secured to an inward side of the second tile.

85. A heat transfer assembly, comprising: a thermoelectric cooler (TEC) assembly which includes a first TEC whose reference side is configured to be positionable in heat transfer relation with a flow of heat transfer liquid and a second TEC whose reference side is configured to be positionable in heat transfer relation with the flow of the heat transfer liquid; a heat distribution cover assembly which includes a tray assembly, a plurality of heat-conductive tiles and a frame which holds the tray assembly and the plurality of tiles together; the tray assembly including a first tray having a first opening through which a user side of the first TEC passes and a second tray having a second opening through which a user side of the second TEC passes; and the plurality of tiles including a thermally-conductive first tile which is in heat transfer relation with the user side of the first TEC and a thermally-conductive second tile which is in heat transfer relation with the user side of the second TEC.

86. The assembly of claim 85 wherein the first and second trays each include tray perimeter rims and the first and second tiles each include tile perimeter rims, and the frame snap-fit or hook-fit holds the first and second trays and the first and second tiles together via the tray and tile perimeter rims, allowing flexing between the tiles along an axis between them.

87. The assembly of claim 85 wherein the frame is a flexible plastic frame including a plurality of open windows, each for a respective tray of the tray assembly.

88. A method comprising: positioning a heat distribution cover assembly of a heat exchange module against a body part of a patient; the module further including: a channel for a heat transfer liquid; a thermally- conductive plate piece; a thermoelectric cooler (TEC) assembly which includes a TEC having a reference side and a user side which is positioned in heat transfer relation with the cover assembly; a wall of the channel including the plate piece which is thereby in direct contact with the liquid on one side thereof and with the TEC reference side on an opposite side thereof; the module including at least one thermistor (or thermocouple) adjacent a thermally-conductive plate assembly of the cover assembly to measure a temperature of the adjacent body part; circulating a heat transfer liquid through the channel; and controlling the TEC assembly using temperature signal(s) from the at least one thermistor (or thermocouple) so as to maintain a surface of the body part at a desired temperature by transferring heat to and/or from the body part and the heat transfer liquid in the channel through the cover assembly.

89. The method of claim 88 wherein the circulating includes circulating the liquid in the channel at between .1 and .2 liter per minute or 0.5 to 3.5 liters per minute.

90. The method of claim 88 wherein the circulating includes maintaining the liquid in the channel at less than 25 psi.

91 . The method of claim 88 wherein the body part is rounded and/or angular and the positioning includes flexing the module so as to match the rounded and/or angular configuration.

92. The method of claim 91 wherein the cover assembly includes an array of thermally-conductive tiles and the flexing includes flexing the array about an x-axis between adjacent tiles and a y-axis between adjacent tiles.

93. The method of claim 88 wherein the cover assembly includes a plurality of thermally-conductive tiles including a plurality of thermistors (or thermocouples), each mounted to a respective one of the tiles on inward faces of the tiles.