Optimized water channels and flexible coolers for use in heat exchange modules, systems, and methods thereof

Abstract

Disclosed herein are an optimized fluid channel, a flexible thermoelectric cooler ("TEC"), and a stationary frame therapy station, along with methods for fabricating the same. As a result, the optimized fluid channel provides an improved HEM, resulting in a tighter fluid seal and easier completed manufacturing. Furthermore, the flexible TEC provides a more conformal design to the end user, allowing for more focused and efficient heat transfer. Finally, the stationary frame therapy station provides a stationary frame, which allows for differential heating and cooling over hairless areas of human skin, providing additional benefits during heating and cooling therapy regimens.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 974,547, filed December 9, 2019, the contents of which are incorporated herein by reference in their entirety.

[0002] STATEMENT OF RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH Not applicable.

[0003] Notice of copyrighted material Portions of the material in this patent document are subject to copyright protection under the copyright laws of the United States and other countries. The copyright owner has no objection to the verbatim facsimile reproduction of either the patent document or the patent disclosure, as it appears in the U.S. Patent and Trademark Office publicly available files or records, but otherwise reserves any and all copyright rights. The copyright owner hereby does not waive any of its rights to have this patent document maintained in confidence, including, but not limited to, its rights pursuant to 37 C.FR § 1.14.

[0004] The invention described herein primarily relates to an optimized flexible heat exchange module (HEM) containing multiple components, including, but not limited to, a thermoelectric cooler and a series of fluid channels, which can be used for heating and cooling. The invention further relates to prognostic, preventative, and therapeutic methods useful in cryo- and hyperthermia treatments for various injuries and disorders. [Background technology]

[0005]

[0006] Thus far, we have described novel methods, systems, modules, and apparatus for use in heating and cooling, and for various industrial and healthcare applications. See WO2018 / 064428 published April 5, 2017, WO2018 / 064220 published April 5, 2018, WO2017 / 172836 published October 5, 2017, WO2017 / 171719 published October 5, 2017, US2016 / 0270952 published September 22, 2016, US2017 / 0190102 published July 6, 2017, and US2018 / 0098903 published April 12, 2018. In addition, we are committed to promoting cutting-edge heating and cooling applications, such as those related to the treatment of injuries and disorders in humans.As known in the art, freezing and heating treatment of patients is used for a variety of purposes, including but not limited to, the treatment of brain injury, spinal cord injury, muscle injury, joint injury, avoidance of side effects during chemotherapy treatment such as hair loss, and for neuroprotection after cardiac arrest and neonatal hypoxic-ischemic encephalopathy.These treatments are typically achieved by using ice packs and / or chemical cooling packs, which provide incomplete and short-lived cooling, or by pads or caps in which cooling is achieved by circulating refrigerated fluid.

[0006] Aspects of the disclosed technology generally relate to flexible heat exchange modules (HEMs) containing thermoelectric coolers (TECs) and can be used for heating or cooling. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] International Publication No. 2018 / 064428 [Patent Document 2] International Publication No. 2018 / 064220 [Patent Document 3] International Publication No. 2017 / 172836 [Patent Document 4] International Publication No. 2017 / 171719 [Patent Document 5] US Patent Application Publication No. 2016 / 0270952 [Patent Document 6] US Patent Application Publication No. 2017 / 0190102 [Patent Document 7] US Patent Application Publication No. 2018 / 0098903 Summary of the Invention [Means for solving the problem]

[0008] Disclosed herein are three innovations or improvements to a heat exchange module, comprising a module or device having fluid channels and a heat transfer plate in heat transfer relationship with the fluid in the channels. The module is configured to be operably positionable with thermally conductive tiles associated with a patient's skin, thereby achieving efficient and effective heat transfer. The first innovation or improvement relates to an optimized "pressure-fit" type plate in the fluid channel component of the HEM. As disclosed herein, the advantages of the optimized fluid channels will be apparent to those skilled in the art. The second innovation or improvement relates to a flexible TEC that can be ergonomically conformed and deliver precise heat doses to target areas of an individual with efficiency and accuracy. As disclosed herein, the advantages of the flexible TEC will be apparent to those skilled in the art. The third innovation or improvement relates to a unique heating and cooling treatment station (i.e., for hands and feet) that provides ergonomically consistent heating and cooling. As disclosed herein, the advantages of the heating and cooling station will be apparent to those skilled in the art.

[0009] Further aspects of the technology described herein are provided in the remainder of the specification, and the detailed description discloses preferred embodiments of the technology without imposing limitations thereon. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is an exploded view comparison of a prior art fluid channel with bilateral implantation (FIG. 1A) and an improved fluid channel with crimped implantation (FIG. 1B). [Figure 2] FIG. 2 is an exploded view of the improved fluid channel with crimp implant. [Figure 3] FIG. 3 is an exploded view of a prior art fluid channel with double-sided embedding. [Figure 4] FIG. 4 is a cross-sectional comparison of a prior art fluid channel with double-sided implantation (FIG. 4A) and an improved fluid channel with crimped implantation (FIG. 4B). [Figure 5] FIG. 5 is a cross-sectional view of an improved fluid channel with crimp implantation. [Figure 6] FIG. 6 is a cross-sectional view of a prior art fluid channel with double-sided embedding. [Figure 7] FIG. 7 is an exploded view of the hand treatment station. [Figure 8] FIG. 8 shows a "crimped" type fluid channel thermal test. [Figure 9] Figure 9 shows simulated HEM data using a heating pad. [Figure 10] FIG. 10 is the simulated HEM data without the heating pad. [Figure 11] FIG. 11 is a cross-sectional view of a flexible thermoelectric cooler embodiment. [Figure 12] FIG. 12 is an exploded view of a flexible thermoelectric cooler embodiment. [Figure 13] Figure 13 shows the parameters for differential temperature modeling. [Figure 14] FIG. 14 is the differential temperature model at time=0 minutes (approximately 10 seconds). [Figure 15] FIG. 15 is the differential temperature model at time=2 minutes. [Figure 16] FIG. 16 is the differential temperature model at time=10 minutes. [Figure 17] FIG. 17 is the differential temperature model at time=20 minutes. [Figure 18]FIG. 18 is the differential temperature model Z-axis at time=2 minutes. [Figure 19] FIG. 19 is the differential temperature model Z-axis at time=10 minutes. [Figure 20] FIG. 20 is the differential temperature model Z-axis at time=20 minutes. [Figure 21] FIG. 21 is a diagram of an alternative hand station embodiment. [Figure 22] FIG. 22 is a top view layout of various hand station schemes. [Figure 23] FIG. 23 shows various configurations of hand station embodiments. [Figure 24] FIG. 24 is an alternative design of the hand station user interface (UI). [Figure 25] FIG. 25 is a schematic diagram of a fluid block section. [Figure 26] FIG. 26 is an exploded view of the fluid block. [Figure 27] FIG. 27 is a schematic of the fluid block assembly. [Figure 28] FIG. 28 shows the water channel thermal test average temperature data. [Figure 29] FIG. 29 is a summary of the water channel thermal test data. [Figure 30] FIG. 30 shows exemplary peel test results. [Figure 31] FIG. 31 shows examples of measurable parameters and test results. [Figure 32] FIG. 32 is a peel test pattern for the bond test. [Figure 33] Figure 33 shows the appearance of the peel test results depending on the embedding temperature. [Figure 34] Figure 34 is a peel test using a square plate design. [Figure 35] Figure 35 is a peel test using a round plate design. DETAILED DESCRIPTION OF THE INVENTION

[0011] Section Overview I.) Overview II.) New and Improved Fluidic Channels III.) Fluid Block Assembly IV.) Flexible Thermoelectric Cooler (“TEC”) V.) Fixed Treatment Station for Thermoregulation of Hairless Skin VI.) Kits / Products I. Overview

[0012] The present disclosure includes three innovations or improvements to the previously disclosed HEM, which comprises multiple TECs and a fluid channel system specifically designed to transfer heat through direct contact with a contoured object. The first innovation is a "crimped" type fluid channel, which possesses several significant advantages over the prior art. The second innovation is a flexible TEC, which allows for more targeted and ergonomic heating and cooling. The third innovation is a unique heating and cooling station for specific body parts (e.g., hands and feet). Those skilled in the art will understand and be able to design and construct the presently disclosed innovations or improvements of any size, shape, and consistency depending on the desired purpose. In the primary embodiment, the HEM is an ergonomic unit optimized for heat transfer through the skin for the induction of therapeutic hypothermia and hyperthermia. II. New and improved crimped fluid channels

[0013] New and various components for the improved "crimped" style fluid channel (110) are depicted in Figures 2 and 5. As discussed in this disclosure, the improved "crimped" style fluid channel offers several advantages over the prior art, which will be discussed below. A comparison of the prior art fluid channel and the improved "crimped" style fluid channel is shown in Figures 1 and 4.

[0014] To better understand the advantages of the improved fluid channel, those skilled in the art should consider the differences compared to the prior art fluid channel (100) shown in Figures 3 and 6. Briefly, the prior art comprises a first layer (300) that can be made of any flexible material, including, but not limited to, a thermoplastic polyurethane sheet ("TPU"). The first layer of material has a cutout (330) directly below the plate to allow the plate to come into direct contact with the fluid, thus increasing heat transfer. The plate (310), which comes into direct contact with the fluid flowing through the channel, is embedded between two layers of material. Generally speaking, the plate can be made of any thermally conductive material, including, but not limited to, aluminum, and may or may not include an adhesive primer coating. Similar to the first layer, a second layer (320) may be any flexible material, including, but not limited to, a lined TPU. Additionally, standoffs (340) may be attached via RF welding 600 or otherwise to the material on the side of the plate facing the lifting platform 610 to maintain fluid flow and prevent channel collapse when the fluid channel assembly is flexed. A third sheet of material (350) is attached via RF welding 600 or otherwise onto the assembly to create a persistent fluid pathway 620. Finally, inlet and outlet tubes (360), made from the same material similar to the first, second, and third layers, including but not limited to TPU, may be joined into the assembly by RF welding 600 or other process to connect to the external interfaces.

[0015] In an exemplary embodiment, the circulating fluid may be water, distilled water, or distilled water with an antimicrobial agent to prevent long-term growth of microorganisms that may interfere with the operation of the system. In other embodiments, additional additives may be included in the fluid, such as (among other things) agents to reduce the surface tension of the water, agents to protect the longevity of internal components, agents to buffer against pH changes, and colorants for visualization of long-term chemical changes. In still other embodiments, the system may take advantage of synthetic fluids with improved thermal conductivity over that of water.

[0016] The various components of the improved "crimped" fluid channel (110) include the following elements that significantly differ in form compared to the prior art (110), resulting in significantly better quality and stability. Briefly, a first layer (200) can be made from any flexible material, including, but not limited to, a thermoplastic polyurethane sheet ("TPU"). The first layer of material has cutouts (210) in a shape that can comprise a uniform grid or can be modified to any shape necessary to achieve uniform heat transfer properties and conform to the surface being treated. A first plate (220) and a second plate (230), which are "crimped" together at the points of the cutouts (210), may be crimped by any means known in the art, including, but not limited to, mechanical fasteners (e.g., bolts or integral male / female threads on upper and lower crimpers), snap hooks, adhesive glue, pressure sensitive adhesive, ultrasonic welding, friction welding, or heat welding. The second plate (230) is in direct contact with the fluid flowing through the channels and is embedded between the first layer (200) of material (240) and a second layer similar to the first layer (200), which may be made from any flexible material, including, but not limited to, thermoplastic polyurethane sheet ("TPU"). Generally speaking, the plate may be made from any thermally conductive material, including, but not limited to, aluminum, with or without an adhesive primer coating. The fluid channel assembly may include a thermally conductive compressible material or paste at the interface between the first and second plates to ensure adequate surface contact for heat transfer. Additionally, standoffs (250) may be attached to the material on the side of the plate facing the lift platform 510 via RF welds 500 or otherwise to maintain fluid flow and prevent channel collapse when the fluid channel assembly is flexed. A second sheet of material (240) is attached via RF welding 500 or otherwise onto the assembly to create a permanent fluid path (520).Finally, inlet and outlet tubes (260) made from the same material as the first and second layers, including but not limited to TPU, are joined into the assembly by RF welding 500 or other process to connect to the external interfaces.

[0017] In an exemplary embodiment, the circulating fluid may be water, distilled water, or distilled water with an antimicrobial agent to prevent long-term growth of microorganisms that may interfere with the operation of the system. In other embodiments, additional additives may be included in the fluid, such as (among other things) agents to reduce the surface tension of the water, agents to protect the longevity of internal components, agents to buffer against pH changes, and colorants for visualization of long-term chemical changes. In still other embodiments, the system may take advantage of synthetic fluids with improved thermal conductivity over that of water.

[0018] It will be apparent to those skilled in the art that the new and improved "crimp" mold offers several advantages over the prior art. First, the prior art double-sided embedding does not provide a tight seal compared to the improved "crimp" mold. This will be apparent because the prior art provides two layers on the top and bottom of the plates. The improved "crimp" embedding provides a "crimp" of the first and second plates surrounding the first layer of material, thereby creating a significantly tighter seal. This non-obvious property of a tighter seal became public knowledge after significant failures of prior art double-sided embeddings during production. Notably, prior art double-sided embeddings had an approximately thirty percent (30%) failure rate during manufacturing, which represented a significant cost in wasted production steps. This is due, in part, to the fact that the tooling used to manufacture the prior art double-sided embedding consisted of high-temperature tooling equipment that came into contact with the layered TPU during the sealing process. Direct contact caused damage to the exposed edges of the TPU layer, allowing fluid to penetrate through the cross section of the material. This made the manufacturing process very time consuming and had a significant failure rate.

[0019] Conversely, the new and improved "crimp-bonded" type mounting offers several advantages. First, in addition to the tighter seal resulting from the "crimp-bonded" embodiment, production can be performed much faster than prior art double-sided mounting. Second, the plate geometry covers the exposed edges of the TPU material, so only high-temperature tooling comes into contact with the plate, minimizing material degradation and preventing water ingress. Third, because of this, the failure rate during manufacturing is significantly lower. Finally, because prior art double-sided mounting requires post-processing steps to prevent fluid leakage due to material degradation and water ingress, the overall cost of "crimp-bonded" mounting production is reduced because the improved embodiment does not experience this issue; therefore, no post-processing steps are required.

[0020] In one embodiment, the present invention comprises an improved "crimped" type fluid channel device comprising: (i) a first layer; (ii) a first water plate; (iii) a second water plate; and (iv) a second layer, whereby the first water plate and the second water plate are "crimped" to create a seal against the first layer.

[0021] In a further embodiment, the present invention comprises an improved "crimped" type fluid channel device comprising (i) a first layer, (ii) a first water plate, (iii) a second water plate, and (iv) a second layer, substantially as shown in FIG. 2, whereby the first water plate and the second water plate are "crimped" to create a seal against the first layer, substantially as shown in FIG. 5.

[0022] In one embodiment, the present invention comprises an improved "crimped" type fluid channel device comprising: (i) a first layer; (ii) a first water plate; (iii) a second water plate; and (iv) a second layer, whereby the first water plate and the second water plate are "crimped" to create a seal against the first layer; and further comprising standoffs, whereby the standoffs are attached to material on the side of the plates facing the lifting platform to maintain fluid flow and prevent channel collapse when the fluid channel assembly is flexed.

[0023] In one embodiment, the present invention comprises an improved "crimped" type fluid channel device comprising: (i) a first layer; (ii) a first water plate; (iii) a second water plate; and (iv) a second layer, whereby the first water plate and the second water plate are "crimped" to create a seal against the first layer; and further comprising standoffs, whereby the standoffs are attached to material on the side of the plates facing the lifting platform to maintain fluid flow and prevent channel collapse when the fluid channel assembly is flexed; and further comprising inlet and outlet tubes connecting to the assembly to connect to the external interface.

[0024] In another aspect of the disclosure, the present invention comprises a method of fabricating an improved "crimped" type fluid channel embedded substantially in the configuration of FIG.

[0025] In another embodiment, the present invention provides (i) a first layer is placed between upper and lower metal plates;

[0026] (ii) external heat and counter pressure are applied to each plate, resulting in localized melting of the layer; (iii) the molten material of the layer forms a bond with both plates on both sides, sealing the crimp joint; The present invention includes a "crimped" type fluid channel embedded by a process comprising:

[0027] In another embodiment, the present invention provides (i) a first layer is placed between upper and lower metal plates coated with an adhesion promoter; (ii) external heat and counter pressure are applied to each plate, resulting in localized melting of the layer; (iii) the molten material of the layer forms a bond with both plates on both sides, which is enhanced by the adhesion promoter, sealing the crimp joint; The present invention includes a "crimped" type fluid channel embedded by a process comprising:

[0028] Those skilled in the art will recognize and be able to make variations and modifications to the disclosed embodiments without altering the function and purpose of the invention disclosed herein, and such variations and modifications are intended to be within the scope of the present disclosure. III. Fluid Block Assembly

[0029] In another embodiment, the present disclosure teaches a new and improved fluid channel assembly, illustrated in FIGS. 25, 26, and 27. Those skilled in the art will recognize that the improved embodiment provides a modular solution for fluid channel production and prototyping. In this method of fabricating fluid channels, a thermally conductive metal platform is adhesively bonded to a rigid plastic frame, creating an enclosure that allows fluids, such as water, to pass through. See FIGS. 25 and 26. Each fluid block features clearance holes that allow the block to be fastened through the TEC into threaded holes in the tile or any thermally conductive material that forms the patient-contacting surface. Note that mounting holes are not required on the patient-facing side of the contact surface, improving aesthetic appearance and making the surface easier to clean and maintain. Thus, a series of rigid blocks can be joined together with flexible tubing that connects to the fluid blocks with integral barbed joints. See FIG. 27. This allows for an infinite number of possible configurations for the fluid channels. Those skilled in the art will recognize several advantages over the current state of the art. First, no tooling is required to assemble the unique configuration. Second, the improved design allows for more efficient design of flush configurations (i.e., to mount to 3D topography). Third, there are no mounting holes visible to the patient / end user, resulting in a better aesthetic appearance. Fourth, the improved fluid channel design allows for easy removal and repair, thereby increasing useful life and product integrity. IV. Flexible Thermoelectric Cooler (“TEC”)

[0030] The second innovation of this disclosure relates to an improved thermoelectric cooler ("TEC") that is flexible and conforms more easily to contact surfaces while minimizing heat loss. Based on a brief review of our previous work (see WO 2018 / 064428), we demonstrate that our heat exchange module (HEM) comprises a TEC used for heating and cooling in a variety of applications. Generally speaking, as previously taught, an individual TEC, or multiple TECs organized in an array, acts as a direct-contact heat pumping element. In a typical embodiment, the outer surface of the TEC exchanges heat through fluid channels (see the new and improved pressure-bonded fluid channels, above). Furthermore, the HEM is based around an array of TECs that transfer heat to and from the user at skin level. The TECs are wired in various arrays to provide uniform control of temperature across the area of ​​the HEM. Each TEC is paired with a temperature sensor that provides feedback by measuring the temperature of the thermally conductive surface in contact with the user, known as a tile.

[0031] The tiles are constrained in a geometric pattern appropriate to the anatomical structure for which the HEM is intended by attachment to a flexible frame. The flexible frame can be made from any flexible material, including but not limited to, thermoplastic polyurethane sheet (TPU). The frame retains the tiles and provides a persistent surface barrier between the user and the TEC and other interiors of the HEM.

[0032] A waterproof bladder, known as the fluid channel, connects to the TEC array and provides a method of heat extraction from the system. Thermally conductive plates are embedded within the TPU bladder in a pattern that mirrors the geometry of the tiles. Each TEC is mounted on a plate, which transfers heat from the TEC into a circulating fluid. The fluid transports the heat away from the TEC and dissipates it through a radiator in the console that connects to the outside.

[0033] In one embodiment, the TEC subassemblies, tiles, and fluid channels are packaged for use inside a soft article of clothing that provides a comfort layer of biocompatible material between the user, the tiles, hook and loop straps and / or elements necessary to secure the device to the user's body, and an air bladder for pressure regulation and fit.

[0034] Based on the foregoing, one skilled in the art will be able to understand, design and construct TECs of the present disclosure of any size, shape and consistency depending on the desired purpose.

[0035] In light of the above, researchers have shown that a portion of energy is wasted by conventional TEC designs due to insufficient contact with body tissues caused by their rigidity. Additionally, applications for personal thermoregulation devices are gaining popularity. However, the development of active heating and cooling garments is much more challenging and has not been extensively explored, as most heating and cooling devices are bulky and difficult to integrate into clothing or other soft goods. Additionally, previous attempts to deploy TEC improvements have not demonstrated sustained active cooling performance without the assistance of a water heat sink. See HONG, et. al., Sci. Adv. 2019;5.

[0036] As mentioned above, the HEMs of the present disclosure generally comprise an array of TECs. In previous embodiments, the TECs are made from rigid, non-flexible materials.

[0037] Therefore, there is a need in the art for a flexible TEC that can provide targeted, focused heating and cooling to a user while maintaining sustained heating and cooling. In one aspect of the present disclosure, a hybrid approach is found to be new and useful. The approach utilizes a fluid-based fluid channel and a solid-state flexible TEC. The flexible TEC is placed on the non-water plate side of the HEM. The result is a precise heat dose delivered to a targeted area of ​​an individual while simultaneously maintaining consistent, long-term heating and cooling for the user.

[0038] In one embodiment, the flexible TEC comprises solid-state thermoelectric cooling technology. Briefly, the thermoelectric effect refers to the phenomenon whereby either a temperature difference creates an electric potential or an electric potential creates a temperature difference. These phenomena are more specifically known as the Seebeck effect (where a voltage is created from a temperature difference), the Peltier effect (where an electric current is used to drive heat flow), and the Thomson effect (where reversible heating or cooling occurs within a conductor when both an electric current and a temperature gradient are present). Generally speaking, all materials have a nonzero thermoelectric effect, but most materials have a nonzero thermoelectric effect that is too small to be useful. However, low-cost materials with sufficiently strong thermoelectric effects (and other desired properties) are also being considered for applications including power generation and refrigeration. The most commonly used thermoelectric material is based on bismuth telluride (Bi2Te3). Note that any material can be used as long as it possesses (i) high electrical conductivity, (ii) low thermal conductivity, and (iii) a high Seebeck coefficient.

[0039] Additionally, elastomers are polymers with "elastic" properties, generally notably having a low Young's modulus and a high yield strain compared to other materials. The term is often used synonymously with the term "rubber." Elastomers are amorphous polymers that exist above their glass transition temperature so that significant segmental motion of the polymer chains is possible; therefore, they are also expected to be highly permeable. Examples of elastomers include natural rubber, styrene-butadiene block copolymers, polyisoprene, polybutadiene, ethylene propylene rubber, ethylene propylene diene-based rubbers, silicone elastomers, fluoroelastomers, polyurethane elastomers, and nitrile rubber.

[0040] Additionally, copolymers are polymers derived from more than one species of monomer. The polymerization of monomers into copolymers is called copolymerization. Copolymerization is used to modify the properties of the plastic being produced, for example, to meet specific needs of reducing crystallinity, modifying the glass transition temperature, controlling wetting properties, or improving solubility. Commercial copolymers include acrylonitrile butadiene styrene (ABS), styrene / butadiene copolymer (SBR), nitrile rubber, styrene-acrylonitrile, styrene-isoprene-styrene (SIS), and ethylene-vinyl acetate, all formed by chain growth polymerization.

[0041] Therefore, there is a need for thermoelectric materials that can be integrated with flexible materials to create flexible TECs.

[0042] In one embodiment, the present invention provides Bi2Te3, Bi2Se3, PbTe (thallium doped lead telluride alloy), Ba8Ga 16 Ge 30 , Ba8Ga 16 Si 30 , Mg2B IV (B IV=Si, Ge, Sn), ZnO, MnO2, NbO2, NbFeSb, NbCoSn, and VFeSb.

[0043] In one embodiment, the present invention comprises a flexible TEC comprising an elastomer.

[0044] In one embodiment, the present invention comprises a flexible TEC comprising a copolymer.

[0045] Methods for fabricating flexible TECs are known in the art. See, for example, HONG, et al., Sci. Adv. 2019;5 and KISHORE, et al., Nature Communications 10:1765 (2019).

[0046] Thus, in one embodiment, a previously disclosed HEM (WO 2018 / 064428) is equipped with a flexible TEC of the present invention. In a further embodiment, a previously disclosed HEM is equipped with a flexible TEC, as shown in FIGS. 11 and 12. Briefly, a flexible TEC of the present invention (1200) is positioned between a body part (e.g., an arm) and a fluid-barrier plastic sheet (e.g., TPU, etc.) (1210). The flexible TEC may be in indirect contact with the skin or in contact with a thermally conductive biocompatible layer (1220). The result is optimized targeted heating and cooling for the user while maintaining sustained heating and cooling over the target area. An additional advantage of using a flexible TEC in this embodiment is that it can be ergonomically placed in direct contact (or through a thin thermally conductive interface layer) with body parts that exhibit curvatures that are difficult to overcome using rigid plates, thereby increasing the effectiveness of treatment. This intimate physical contact clearly allows for optimization of the heat exchange process necessary for cooling / heating of body parts, allowing for uniform skin contact, fewer pressure points and a higher degree of patient comfort. See Figures 11 and 12. V. Fixed treatment station for thermoregulation of hairless skin

[0047] A third innovation of the present disclosure relates to a fixed-frame therapy station (e.g., for hands, feet, etc.) used to improve the controlled radiator function of glabrous skin in humans. Research has shown that heat loss through glabrous skin is more variable and can reach higher values ​​than through non-glabrous skin. Furthermore, vacuum-enhanced heat extraction from glabrous skin reduces the rate of core temperature rise during heat exposure and exercise, thus improving performance. See HELLER, et. al., Disruptive Sci. and Tech., vol. 1, no. 1 (2012). See also U.S. Patent No. 7,122,047. Thus, it will be apparent to those skilled in the art that targeted thermoregulation of glabrous skin in humans could be beneficial on several levels. First, it would greatly aid the design of thermal protection devices, such as soft goods for exercise and military use. Second, the ability to effectively manage and thermoregulate hairless skin may also reduce fatigue during sports / competitions and enable more effective recovery during physical therapy. Research has shown that the effects of cooling (or heating) multiple areas of hairless skin are additive. See GRAHN, et. al. J. Biomech. Eng., 131:071005 (2009). Third, utilizing the additive effects of thermoregulating hairless skin may also impact medical conditions affected by temperature changes. For example, cooling cancer patients for chemotherapy or radiation therapy, or maintaining a steady state temperature during surgery, such as for peripheral neuropathy. In fact, research has shown that inserting heat into the core of hypothermic patients recovering from the effects of anesthesia may offer several benefits. See GRAHN, et. al., J. Appl. Physio., 85:pp. 1643-1648 (1998).

[0048] The prior art teaches several types of embodiments that purport to use a vacuum-enhanced system to heat and cool hairless skin surfaces. See, for example, U.S. Pat. Nos. 7,122,047, 7,947,068, 2016 / 0374853, and 2007 / 0060987. However, these systems are disadvantageous compared to the embodiments of the present disclosure for the following reasons: First, prior art systems require constant monitoring of vasoconstriction and / or vasodilation. Second, the systems are bulky and not mobile due to the fact that they possess a vacuum-enhanced system. Third, there is no capability to provide differential temperature to various areas of the body.

[0049] In contrast, the present disclosure provides a fixed-frame therapy station used for heating and cooling therapy. The embodiment disclosed herein builds on the previous HEM system (see Hypothermia Devices, Inc., Los Angeles, CA) and is further described in FIGS. 7 and 21. As shown, FIG. 7 is an exploded view of the fixed-frame hand station (700) of the present disclosure. Referring to it, the TEC array is captured between the fixed-frame thermal interface layer (710) and the fluid channel subassembly (720). As shown, a compressible thermally conductive material or thermally conductive paste can be used to ensure thermal contact between the TEC array and both the fluid channel subassembly and the fixed-frame thermal interface layer of the hand station (730). The fixed frame can be made from any thermally conductive material, but a preferred embodiment is aluminum. Finally, inlet and outlet tubes (740) are joined into the assembly by RF welding or other processes to connect to the external interfaces. It will be apparent to one skilled in the art that the fixation frame may be molded to any suitable body part with a hairless skin surface (eg, hands and feet).

[0050] The hand stations of the present disclosure can be arranged to maximize spacing and efficiency for end users. For example, as shown in FIG. 22, the hand stations can be arranged in multiple formats depending on the available space, number of end users, and activity. These "hubs" can be located within a gym or built portable for use at sports subdivisions or events. Each hub concept shown is rated based on the number of square feet it occupies per user (sf / user). Additionally, as shown in FIG. 23, each hand station of the present disclosure can be configured for a specific type of product modality depending on the user's needs. For example, non-limiting examples of product configurations are wheeled (freestanding system), pop-up, wall-mounted, or stationary (e.g., on the gym floor).

[0051] In one embodiment, the hand station of the present disclosure can be integrated with multiple hygiene modalities, allowing the user to clean the unit before and after each use. Those skilled in the art will understand and appreciate that the hygiene modalities can be automatic or manual, and may be portable or permanently fixed to the hand station.

[0052] In further embodiments, the hand station of the present disclosure can be integrated with multiple sensors and measurements to monitor and analyze various aspects of the user's performance. For example, treatment time can be tracked, and optionally, the user is notified when the recommended recovery period has elapsed. Notably, a capacitance sensor can be used to detect when the user begins treatment. In addition, heart rate (pulse) measurements can be employed. Pulse can be measured by detecting electrical pulses measured by two electrodes attached to the user (preferably directly under the hand or wrist). Alternatively, LEDs and photosensitive diodes can detect pulses. Additionally, electrocardiograms (EKG / ECK), blood oxygen saturation (SpO2), and body mass index (BMI) can also be recorded using methods known in the art.

[0053] In further embodiments, multiple user interface (UI) designs can be employed. For example, the UI can be integrated via a modular console, a mounting plate, or a HEM console. A non-limiting example UI is shown in FIG. 24.

[0054] In one embodiment, the present invention comprises a fixed frame treatment station apparatus comprising: (i) a fixed frame station; (ii) a fluid channel subassembly; and (iii) a controller.

[0055] In one embodiment, the present invention comprises a fixed frame treatment station apparatus comprising: (i) a fixed frame station, where the fixed frame is molded to the shape of a human hand; (ii) a fluid channel subassembly, where the fluid channel subassembly comprises the "crimped" type fluid channels of the present disclosure; and (iii) a controller.

[0056] In one embodiment, the present invention comprises a fixed frame treatment station apparatus comprising: (i) a fixed frame station, where the fixed frame is molded to the shape of a human foot; (ii) a fluid channel subassembly, where the fluid channel subassembly comprises the "crimped" type fluid channels of the present disclosure; and (iii) a controller.

[0057] In one embodiment, the present invention comprises a fixed frame treatment station apparatus comprising: (i) a fixed frame station; (ii) a fluid channel subassembly; and (iii) a controller, substantially as shown in FIG.

[0058] In one embodiment, the present invention comprises a fixed frame treatment station apparatus comprising: (i) a fixed frame station; (ii) a fluid channel subassembly; and (iii) a controller substantially as shown in FIG. 7, wherein the fluid channel comprises a "crimped" type fluid channel substantially as shown in FIG. 5.

[0059] In one embodiment, the present invention comprises a fixed frame treatment station apparatus comprising: (i) a fixed frame station, wherein the fixed frame is molded to the shape of a human hand; (ii) a fluid channel subassembly, wherein the fluid channel subassembly comprises a "crimped" type fluid channel of the present disclosure; and (iii) a controller, substantially as shown in FIG. 7, wherein the fluid channel comprises a "crimped" type fluid channel substantially as shown in FIG. 5.

[0060] In one embodiment, the present invention comprises a fixed frame treatment station apparatus comprising: (i) a fixed frame station, wherein the fixed frame is molded to the shape of a human foot; (ii) a fluid channel subassembly, wherein the fluid channel subassembly comprises a "crimped" type fluid channel of the present disclosure; and (iii) a controller, substantially as shown in FIG. 7, wherein the fluid channel comprises a "crimped" type fluid channel substantially as shown in FIG. 5.

[0061] In one embodiment, the present invention comprises a fixed frame treatment station apparatus comprising: (i) a fixed frame station with multiple contact areas; (ii) a fluid channel subassembly; and (iii) a controller, substantially as shown in FIG. 21.

[0062] In one embodiment, the present invention comprises a fixed frame treatment station apparatus comprising: (i) a fixed frame station with multiple contact areas; (ii) a fluid channel subassembly; and (iii) a controller substantially as shown in FIG. 21, wherein the fluid channel comprises a "crimped" type fluid channel substantially as shown in FIG. 5.

[0063] Those skilled in the art will recognize and be able to make variations and modifications to the disclosed embodiments without altering the function and purpose of the invention disclosed herein, and such variations and modifications are intended to be within the scope of the present disclosure. VI. Kits / Products

[0064] Kits for use in the heat exchange module and heating and cooling therapy are within the scope of this disclosure. Such kits include a carrier, package, or container compartmentalized to receive one or more containers, such as a box, shrink wrap, and the like, each of which may include one of the separate components used in this disclosure, along with a program or insert with instructions for use, such as those described herein.

[0065] Kits of the present disclosure will typically include the container described above and one or more other containers associated therewith that contain materials desirable from a commercial and user standpoint, a list listing the contents and / or instructions for use, and a package insert with the instructions for use.

[0066] Instructions and / or other information may also be included on an insert included with or on the kit. The terms "kit" and "article of manufacture" may be used synonymously.

[0067] The product typically includes at least one container and at least one program. The container can be made from a variety of materials, such as glass, metal, or plastic.

[0068] Although the description herein contains many details, these should not be construed as limiting the scope of the present disclosure, but merely providing illustrations of some of the presently preferred embodiments, and therefore, it should be appreciated that the scope of the present disclosure fully encompasses other embodiments that may be apparent to those skilled in the art.

[0069] In the claims, reference to an element in the singular is not intended to mean "one and only one," but rather "one or more," unless expressly stated otherwise. All structural, chemical, and functional equivalents of the elements of the disclosed embodiments known to those of ordinary skill in the art that are expressly incorporated herein by reference are intended to be covered by the claims. Furthermore, no element, component, or method step in this disclosure is intended to be made public, regardless of whether the element, component, or method step is explicitly recited in the claims. Claim elements herein are not construed as "means-plus-function" elements unless the element is explicitly recited using the phrase "means for." Claim elements herein are not construed as "step-plus-function" elements unless the element is explicitly recited using the phrase "step for." Exemplary Embodiments

[0070] Among other things, the following embodiments are provided: 1) An apparatus comprising: a. a first layer; b. a first plate; c. a second plate; d. a second layer; Equipped with The first plate and the second plate are thereby "crimped" to create a seal against the first layer, the device.

[0071] 2) A device comprising: a. a first layer; b. a first plate; c. a second plate; d. a second layer; Equipped with The first plate and second plate are thereby "crimped" to create a seal against the first layer, substantially as shown in FIG. 5, the apparatus.

[0072] 3) An apparatus comprising a fluid channel subassembly for use in a HEM, the improvement comprising: a. a first layer; b. a first plate; c. a second plate; d. a second layer; Equipped with The first plate and second plate are thereby "crimped" to create a seal against the first layer, an apparatus substantially as shown in FIG.

[0073] 4) A heat exchange module device, a. a first thermoelectric cooler (TEC) assembly including a thermally conductive first tile and a first TEC having a first user side and a first reference side, the first user side being thermally conductively attached to the first tile; b. a second thermoelectric cooler (TEC) assembly including a thermally conductive second tile and a second TEC having a second user side and a second reference side, wherein the second user side is thermally conductively attached to the second tile, a thermally conductive first plate is thermally conductively attached to the first reference side, and a thermally conductive second plate is thermally conductively attached to the second reference side, a top sheet defining at least a top portion of a liquid channel, and a bottom sheet having a first hole within which the first plate is positioned and which contacts the liquid upon flowing through the channel, and a second hole within which the second plate is positioned and which contacts the liquid upon flowing through the channel; A heat exchange module apparatus comprising:

[0074] 5) The TEC of embodiment 4, wherein the TEC is flexible.

[0075] 6) Bi2Te3, Bi2Se3, PbTe (thallium-doped lead telluride alloy), Ba8Ga 16 Ge 30 , Ba8Ga 16 Si 30 , Mg2B IV (B IV=Si, Ge, Sn), ZnO, MnO2, NbO2, NbFeSb, NbCoSn, and VFeSb.

[0076] 7) The TEC of embodiment 6, further comprising an elastomer.

[0077] 8) The TEC of embodiment 6, further comprising a copolymer.

[0078] 9) It is a HEM device, and the improvements are as follows: a. a fixed frame treatment station, the fixed frame being molded to the shape of a human hand; b. a fluid channel subassembly, the subassembly comprising a "crimped" type fluid channel; c. a controller; A HEM device comprising:

[0079] 10) It is a HEM device, and the improvements are as follows: a. a fixed frame treatment station, the fixed frame being molded to the shape of a human foot; b. a fluid channel subassembly, the subassembly comprising a "crimped" type fluid channel; c. a controller; A HEM device comprising:

[0080] 11) The apparatus of embodiment 1, whereby the first plate and the second plate are "crimped" to create a seal against the first layer, substantially as shown in FIG. 2.

[0081] 12) The device of embodiment 1, whereby the first layer is made from a commercially available flexible material.

[0082] 13) The first layer of embodiment 12, whereby the first layer is a thermoplastic polyurethane (TPU).

[0083] 14) The first layer of embodiment 12, whereby the first layer comprises cutouts, whereby the cutouts are modified and shaped to achieve uniform heat transfer properties.

[0084] 15) The apparatus of embodiment 1, whereby the first plate and second plate are "crimped" to create a seal against the first layer, substantially as shown in FIG. 2.

[0085] 16) The device of embodiment 1, whereby the second layer is made from a commercially available flexible material.

[0086] 17) The second layer of embodiment 15, whereby the first layer is a thermoplastic polyurethane (TPU).

[0087] 18) The apparatus of embodiment 2, whereby the first plate and second plate are "crimped" to create a seal against the first layer, substantially as shown in FIG. 2.

[0088] 19) The device of embodiment 2, whereby the first layer is made from a commercially available flexible material.

[0089] 20) The first layer of embodiment 18, whereby the first layer is a thermoplastic polyurethane (TPU).

[0090] 21) The first layer of embodiment 18, whereby the first layer comprises cutouts, whereby the cutouts are modified and shaped to achieve uniform heat transfer properties.

[0091] 22) The device of embodiment 2, whereby the second layer is made from a commercially available flexible material.

[0092] 23) The second layer of embodiment 22, whereby the first layer is a thermoplastic polyurethane (TPU).

[0093] 24) The apparatus of embodiment 3, whereby the first plate and second plate are "crimped" to create a seal against the first layer, substantially as shown in FIG. 2.

[0094] 25) The device of embodiment 3, whereby the first layer is made from a commercially available flexible material.

[0095] 26) The first layer of embodiment 25, whereby the first layer is a thermoplastic polyurethane (TPU).

[0096] 27) The first layer of embodiment 25, whereby the first layer comprises cutouts, whereby the cutouts are modified and shaped to achieve uniform heat transfer properties.

[0097] 28) The device of embodiment 3, whereby the second layer is made from a commercially available flexible material.

[0098] 29) The second layer of embodiment 28, whereby the first layer is a thermoplastic polyurethane (TPU).

[0099] 30) The apparatus of embodiment 1, further comprising a standoff, whereby the standoff is attached to the material on the side opposite the plate lifting platform to maintain fluid flow and prevent channel collapse.

[0100] 31) The apparatus of embodiment 2, further comprising a standoff, whereby the standoff is attached to the material on the side opposite the plate lifting platform to maintain fluid flow and prevent channel collapse.

[0101] 32) The apparatus of embodiment 3, further comprising a standoff, whereby the standoff is attached to the material on the side opposite the plate lifting platform to maintain fluid flow and prevent channel collapse.

[0102] 33) A product comprising embodiment 1.

[0103] 34) A product comprising embodiment 2.

[0104] 35) A product comprising embodiment 3.

[0105] 36) The TEC subassembly of embodiment 4, wherein the TEC subassembly is flexible and further comprises differential heating on the x-axis.

[0106] 37) The TEC subassembly of embodiment 4, wherein the TEC subassembly is flexible and further comprises differential heating on the y-axis.

[0107] 38) The TEC subassembly of embodiment 4, wherein the TEC subassembly is flexible and further comprises differential heating on the z-axis.

[0108] 39) A product comprising embodiment 4.

[0109] 40) The HEM device of embodiment 9, substantially as shown in FIG. 7.

[0110] 41) The HEM device of embodiment 9, substantially as shown in FIG. 21.

[0111] 42) The HEM device of embodiment 9, substantially as shown in FIG. 22.

[0112] 43) The HEM device of embodiment 9, substantially as shown in FIG. 23.

[0113] 44) An HEM device as described in embodiment 40, further comprising a user interface (UI) substantially as shown in FIG. 24.

[0114] 45) An HEM device as described in embodiment 41, further comprising a user interface (UI) substantially as shown in FIG. 24.

[0115] 46) An HEM device as described in embodiment 42, further comprising a user interface (UI) substantially as shown in FIG. 24.

[0116] 47) An HEM device as described in embodiment 43, further comprising a user interface (UI) substantially as shown in FIG. 24.

[0117] 48) A product comprising embodiment 9.

[0118] 49) A product comprising embodiment 40.

[0119] 50) A product comprising embodiment 41.

[0120] 51) A product comprising embodiment 42.

[0121] 52) A product comprising embodiment 43.

[0122] 53) A product comprising embodiment 10. [Example]

[0123] Various aspects of the present invention are further described and illustrated by means of several examples that follow, none of which are intended to limit the scope of the invention. Example 1

[0124] Example 1: "Crimped" Fluid Channel Thermal Testing Thermal testing of "crimped" fluid channels was performed to determine whether the "crimped" modality could perform better than previous embodiments. Many variations of the "crimped" modality were tested, including plates with varying areas of contact between the plates and the use of thermally conductive paste between the two plates. By way of background, previous testing showed that a plate design designated "C" with thermally conductive paste between the plates performed slightly better than previous embodiments. [ka]

[0125] The goal was to obtain sufficient data to determine which plate type would perform better than previous designs. Experiments were conducted using the following materials and methods.

[0126] Equipment used: (i) DC variable power supply (KELVI ID 0024) (ii) Flowmeter (KELVI ID 0049) (iii) Dual temperature sensor (KELVI ID 0016) (iv) AC variable power supply (KELVI ID 0075) (v) Wattmeter (KELVI ID 0079)

[0127] Briefly, (i) working fluid channels were fabricated using various plate configurations. Then, (ii) the fluid channels were crimped onto a thermal test fixture. Then, (ii) a heating pad was placed on top of the thermal test fixture. Then, (iii) a fixed volume of water was circulated through the fluid channels at a constant 2.0 LPM flow rate while the temperature of the thermal test fixture was measured. Then, (iv) the heating pad was turned on at test time = 1 minute and held constant at 450 W for the duration of the test (6 minutes).

[0128] As shown in FIG. 8, the heat transfer compared using each design is as follows: The "C" design, which does not use thermally conductive paste between the plates, does not perform as well as the previous design and is therefore not considered a suitable alternative. However, the "C" design, which uses thermally conductive paste between the plates, and the "D" design, which does not use thermally conductive paste between the plates, perform equal to or better than the previous design. Finally, the "D" design, which uses thermally conductive paste between the plates, shows a significant improvement over the previous design. Example 2

[0129] Example 2: Simulated HEM Test To further evaluate the results of the previous examples, a simulated HEM test was performed using the following protocol.

[0130] Equipment used: (i) DC variable power supply (KELVI ID 0036) (ii) DC variable power supply (KELVI ID 0048) (iii) Flowmeter (KELVI ID 0049) (iv) Dual temperature sensor (KELVI ID 0016) (v) AC variable power supply (KELVI ID 0075) (vi) Power meter (KELVI ID 0079)

[0131] Briefly, (i) a working fluid channel using the previous embodiment plate design was pressed onto a thermal test fixture with a TEC array using thermally conductive paste. Then, (ii) a fan-based radiator (at a constant 7 V) was added to the water circulation loop. Then, (iii) a heating pad was placed on top of the thermal test fixture. Then, (iv) a fixed volume of water was circulated through the fluid channel at a constant 2.0 LPM flow rate. Then, (iv) the heating pad was turned on for test time = 1 minute and held constant at 450 W. Then, (v) the TEC was turned on for test time = 90 seconds and held constant at 24 V. Then, (vi) the temperature on the thermal test fixture was measured for the duration of the 30-minute test. Then, (vii) the test was repeated using a working fluid channel with a "C" design plate using thermally conductive paste between the plates. Finally, (viii) the previous two tests were repeated with the heating pad turned off for the duration of the test.

[0132] Results of tests with a heating pad showed that the "C" design with paste performed better than the previous design (Figure 9). Additionally, identical experiments without a heating pad showed similar results to the previous results, with the "C" design with thermally conductive paste performing better than the previous design (Figure 10). Example 3

[0133] Example 3: Differential Temperature Test To further evaluate the ability to provide differential temperatures with multiple TECs, a differential temperature model is developed. Briefly, for the purposes of this model, a dorsal HEM is used with a geometry comprising 24 skin-contact plates, spaced at centers (approximately 4.5 cm 2 Each plate has one TEC located at 26.35 cm. The area / contact plate is approximately 26.35 cm. 2 The total skin contact area is approximately 598 cm 2Furthermore, the model parameters are assumed to be skin approximately 1 mm thick, muscle layer approximately 25 mm thick, and initial temperature of the study 36° C. (see FIG. 13).

[0134] The results show that at time = 0 minutes, the surface temperature is equal to 36°C (Figure 14). Furthermore, at time = 2 minutes, the surface temperature of the center plate drops, thereby causing the surface temperatures of the side plates to remain the same (Figure 15). At time = 10 minutes, the surface temperature of the center plate continues to drop, while the outer plates increase in temperature (Figure 16). Finally, at time = 20 minutes, the surface temperature of the center plate achieves a set (or preset) temperature drop of 6°C, while the surface temperature of the outer plates achieves a set (or preset) temperature of 41°C (Figure 17).

[0135] In addition, Figures 18, 19, and 20 show slice patterns that measure z-axis temperature.

[0136] The model results further demonstrate that utilizing a conventional HEM, a HEM utilizing a flexible TEC, or a differential temperature system within a fixed-frame hand or foot station allows the user to target specific temperatures at specific times in body parts. A key advantage of this approach is that it allows the end user or patient to access a rich spectrum of personalized thermal therapy modalities to various body parts using an ergonomically designed device that includes cyclic cooling and heating phases not only on the target area, but also on multiple proximal target areas.

[0137] Those skilled in the art will recognize and understand the unique advantages of using the disclosed "differential" modality, in which the contact area can be in a "cooling" phase while the contour is in a "heating" phase.

[0138] The present disclosure discloses a novel and useful means of thermal therapy that applies sequential application of heating and cooling phases, allowing for more effective recovery from injury than the known standard treatment (known as contrast therapy). Example 4

[0139] Example 4: Fluid Channel Thermal Testing An additional array of experiments was performed using conductive thermal paste (Example 1) in the fluid plate. Crimped Fluid Channel Thermal Test Briefly, multiple back wraps were tested with three types of water plates: (i) square water plates, (ii) "press-on" (round) water plates with thermally conductive paste at the interface between the first and second plates to ensure adequate surface contact for heat transfer, and (iii) round water plates without conductive paste. [ka]

[0140] First, a heating pad was placed on top of the skin interface layer. The stack was crimped together to ensure consistent thermal contact. Water circulation was limited to 2.12 LPM using a ball valve for consistency. In parallel, an external ambient temperature sensor was used to maintain a consistent ambient temperature. The heating pad was placed on the back at 0.12 W / cm. 2 The power was changed to 100 W, equal to (as measured by both the ammeter and voltmeter). After 1 minute, cooling was initiated on the back package at a constant 18.1 V. The test was run for 30 minutes to allow steady-state conditions to be reached. At the 30 minute mark, data was collected and analyzed into CSV format using a Parlay data processor, which allows new collection of data at the individual tile level over periods of >30 seconds.

[0141] The results in Figure 28 show that utilizing a round plate with conductive thermal paste performed significantly better than a round plate without thermal paste. In addition, the square plate performed within an acceptable range as the round plate with thermal paste. However, upon inspection of the round plate, it was determined that the embedding temperature was too low. Thus, in the round plate with paste, it was shown that the conductive paste effectively bridged the gap between the plates to allow sufficient heat transfer despite suboptimal embedding on the round plate. See Figure 29. Therefore, the temperature of the embedding tool must be increased during production. Example 5

[0142] Example 5: Evaluation of bonding strength (embedding) within fluidic channels In another set of experiments, the bond strength (embedding) between the TPU and metal fluid plates was evaluated via a "peel test," in which a sheet of backed TPU was hot-pressed onto a set of fluid plates (known as embedding) and then removed by force, leaving the material pattern visible on the metal plate. When viewing the material pattern, if the bond strength is high, the TPU will separate from its backing and remain on the metal plate. However, if the bond strength is low, the TPU will separate from the metal and remain with the fabric. Examples of peel test results and measurable parameters are described in Figures 30 and 31.

[0143] Bond strength testing was performed using the following protocol: First, full embedding was performed according to the water channel pattern. The embedded layers were then numbered and cut into strips so that each plate could be peeled off individually. See FIG. 32. For square plates, only one sheet was embedded and peeled off. For round "crimp-bonded" plates as described in this disclosure, only one plate was coated with an adhesive primer, which allows for embedding. This allows the unbonded plate to be removed so the bonded side can be inspected. Note that if both sides are bonded, it is impossible to perform a peel test without damaging the bonded surface. The plates are held in place, and the TPU strips are peeled off to reveal the bonded surface. Information can be determined by the appearance of the peeled bonded surface via physical inspection (see FIGS. 30 and 31). A consistent texture and lack of air bubbles in the TPU indicate that the tool temperature was within the correct range. Note that too low a temperature and the TPU will not bond to the metal, and too high a temperature and the TPU will boil, leaving air gaps that can cause water leaks in the finished channel.

[0144] The results in Figure 33 show the peel test appearance of the round plates at different embedding temperatures. The results show that the acceptable range of embedding temperatures is approximately 150-160°C.

[0145] The results in Figure 34 show a square plate featuring TPU bonded to both sides of a single metal plate. Direct compression of the TPU during embedding displaces much more of the TPU, leading to a weaker bond. Testing also reveals that the direction of the force applied to the TPU can affect the separation pattern. Additionally, where perforations are cut, there is no mechanical protection or coverage of the bonded area, which can allow water ingress through the exposed edges of the TPU material.

[0146] The results in Figure 35 show a round plate featuring a single sheet of TPU bonded to metal on both sides. The redundant metal bond provides physical protection for the bond area and is less likely to result in a single persistent leak. The fixed gap size between the top and bottom plates prevents excessive displacement of the TPU during embedding, resulting in a stronger bond. Force applied from any direction produces consistent stress in the round shape. Additionally, the cut edges of the TPU are hidden from water, preventing water intrusion through the fabric.

[0147] Overall, these results indicate that the round plate design (i) is more likely to form a stronger bond, (ii) distributes the stress applied to the fluid channel evenly, which reduces the probability of failure caused by concentrated stress, and (iii) hides the cut edges of the TPU from direct exposure to water, thereby preventing infiltration through the material, which can lead to material degradation or fluid leakage.

[0148] Although the description herein contains many details, these should not be construed as limiting the scope of the disclosure, but merely providing illustrations of some of the presently preferred embodiments, and therefore, it should be understood that the scope of the present disclosure fully encompasses other embodiments that may be apparent to those skilled in the art.

Claims

1. 1. An apparatus, comprising: a. a first layer, said first layer comprising a flexible material, said first layer comprising a cutout, said cutout shaped to achieve uniform heat transfer properties; b. a first plate; c. a second plate; d. a second layer; Equipped with the first plate and the second plate are "crimped" together with circular fasteners at the points of the cutouts to create a seal against the first layer, the first layer being bonded to both the first plate and the second plate to form sealed crimp points, and there is thermally conductive paste between the first plate and the second plate.

2. The apparatus of claim 1 , further comprising a fluid channel subassembly for use in a heat exchange module (HEM).

3. The apparatus of claim 1 , wherein the second layer is attached to the first layer to create a continuous fluid path around the periphery of the second plate.

4. The device of claim 1 , wherein the first layer is thermoplastic polyurethane (TPU).

5. The device of claim 2 , wherein the first layer is made from a commercially available flexible material.

6. The device of claim 2 , wherein the first layer is thermoplastic polyurethane (TPU).

7. The apparatus of claim 2 , wherein the first layer comprises cutouts, the cutouts being modified and shaped to achieve uniform heat transfer properties.

8. 10. The apparatus of claim 1, further comprising standoffs attached to the second layer on sides of the first plate and the second plate facing a lift platform to maintain fluid flow and prevent channel collapse.

9. 3. The apparatus of claim 2, further comprising standoffs attached to the second layer on sides of the first plate and the second plate facing a lift platform to maintain fluid flow and prevent channel collapse.

10. An article comprising the device of claim 1.

11. An article comprising the device of claim 2.

12. A HEM device, the HEM device having an improvement: a. a fixed frame therapy station comprising aluminum, said fixed frame therapy station being molded to the shape of a human hand; b) a fluid channel subassembly comprising a first layer with a cutout, a second layer, a first plate and a second plate, the second plate being embedded between the first and second layers and in direct contact with fluid flowing through the fluid channel subassembly, the first and second plates being crimped together by circular fasteners at the cutouts to create a seal against the first layer, the first layer being bonded to both the first and second plates to form sealed crimp points, and a thermally conductive paste between the first and second plates; c. a controller, the controller controlling a plurality of thermoelectric coolers to provide a plurality of different temperatures to different areas of the person's hand; A HEM device comprising:

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