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

Abstract

To provide optimized water channels and flexible coolers for use in heat exchange modules, systems, and methods thereof. [Solution] An optimized fluid channel, a flexible thermoelectric cooler ("TEC"), and a fixed-frame therapy station are disclosed herein, along with a method for fabricating them. As a result, the optimized fluid channel provides an improved HEM, thereby the fluid seal is more secure and the fabrication is easier to complete. Furthermore, the flexible TEC provides the end user with a more conformal design and enables more concentrated and efficient heat transfer. Finally, the fixed-frame therapy station provides a fixed frame, which enables differential heating and cooling on a human hairless skin area and provides additional benefits during heating and cooling therapy procedures.

Description

[Technical Field]

[0001] (Cross-reference of related applications) This application claims priority to U.S. Provisional Patent Application No. 62 / 974,547, filed on 9 December 2019, the contents of which are incorporated herein by full reference.

[0002] Statement of rights to inventions made under federally funded research Not applicable.

[0003] Notice regarding materials subject to copyright protection Some of the materials in this patent document are subject to copyright protection under the copyright laws of the United States and other countries. The copyright holder has no objection to any complete copy of either the patent document or patent disclosure as it appears in any publicly available file or record of the U.S. Patent and Trademark Office, but otherwise reserves all copyright rights. The copyright holder hereby does not waive any of its rights to keep this patent document confidential, including, but not limited to, its rights under 37 C.F. § 1.14.

[0004] The inventions described herein relate primarily to an optimized flexible heat exchange module (HEM) comprising 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, preventive, and therapeutic methods useful in cryotherapy and thermotherapy for various injuries and disorders. [Background technology]

[0005] To date, we have described novel methods, systems, modules, and apparatus for heating and cooling, as well as for use in various industrial and healthcare applications. See WO2018 / 064428, WO2018 / 064220, WO2017 / 172836, WO2017 / 171719, US2016 / 0270952, US2017 / 0190102, US2017 / 0190102, and US2018 / 0098903, published on 12 April 2018. In addition, we are committed to promoting cutting-edge heating and cooling applications, such as those related to the treatment of injury and disability in humans. As is well known in the art, cryotherapy and thermotherapy for patients are used for a variety of applications, including, but not limited to, the treatment of brain injury, spinal cord injury, muscle injury, joint injury, avoidance of side effects during chemotherapy such as hair loss, and for neuroprotective effects after cardiac arrest and neonatal hypoxic-ischemic encephalopathy. These treatments are typically achieved by the use of ice packs and / or chemical cooling packs, or by pads or caps, in which cooling is achieved by circulating a refrigerating fluid, providing incomplete and short-lived cooling.

[0006] The technical aspects of this disclosure generally relate to flexible heat exchange modules (HEMs) containing thermoelectric coolers (TECs) that 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] U.S. Port and Harbor Patent Application Publication No. 2016 / 0270952 Specification [Patent Document 6] U.S. Port and Harbor Patent Application Publication No. 2017 / 0190102 Specification [Patent Document 7] U.S. Port and Harbor Patent Application Publication No. 2018 / 0098903 Specification [Overview of the Initiative] [Means for solving the problem]

[0008] Three innovations or improvements to a heat exchange module are disclosed herein, comprising a module or device having a fluid channel and a heat transfer plate in a heat transfer relationship with the fluid in the channel. The module is configured to be operably positioned with the patient's skin and associated heat-conducting tiles, thereby achieving efficient and effective heat transfer. The first innovation or improvement relates to an optimized "compression" type plate in the fluid channel component of the HEM. As disclosed herein, the advantages of the optimized fluid channel will be obvious to those skilled in the art. The second innovation or improvement relates to a flexible TEC that can be ergonomically conformed with efficiency and accuracy and can deliver a precise heat dose to an individual's target area. As disclosed herein, the advantages of the flexible TEC will be obvious to those skilled in the art. The third innovation or improvement relates to a specific 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 obvious to those skilled in the art.

[0009] Further aspects of the technology described herein are provided in the following sections of the specification, and the detailed description discloses preferred embodiments of the technology without limitation. [Brief explanation of the drawing]

[0010] [Figure 1] Figure 1 is an exploded view comparison of a prior art fluid channel with bilateral embedding (Figure 1A) and an improved fluid channel with crimp embedding (Figure 1B). [Figure 2] Figure 2 is an exploded view of an improved fluid channel with crimp embedding. [Figure 3] Figure 3 is an exploded view of a prior art fluid channel with bilateral embedding. [Figure 4] Figure 4 is a cross-sectional view comparison of a prior art fluid channel with bilateral embedding (Figure 4A) and an improved fluid channel with crimp embedding (Figure 4B). [Figure 5] Figure 5 is a cross-sectional view of an improved fluid channel with crimp embedding. [Figure 6] Figure 6 is a cross-sectional view of a prior art fluid channel with bilateral embedding. [Figure 7] Figure 7 is an exploded view of a hand treatment station. [Figure 8] Figure 8 is a "crimp" type fluid channel thermal test. [Figure 9] Figure 9 is simulated HEM data using a heating pad. [Figure 10] Figure 10 is simulated HEM data without using a heating pad. [Figure 11] Figure 11 is a cross-sectional view of a flexible thermoelectric cooler embodiment. [Figure 12] Figure 12 is an exploded view of a flexible thermoelectric cooler embodiment. [Figure 13] Figure 13 is a parameter for differential temperature modeling. [Figure 14] Figure 14 is a differential temperature model at time = 0 minutes (about 10 seconds). [Figure 15] Figure 15 is a differential temperature model at time = 2 minutes. [Figure 16] Figure 16 is a differential temperature model at time = 10 minutes. [Figure 17] Figure 17 is a differential temperature model at time = 20 minutes. [Figure 18]Figure 18 shows the Z-axis of the differential temperature model at time = 2 minutes. [Figure 19] Figure 19 shows the Z-axis of the differential temperature model at time = 10 minutes. [Figure 20] Figure 20 shows the Z-axis of the differential temperature model at time = 20 minutes. [Figure 21] Figure 21 shows an embodiment of an alternative hand station. [Figure 22] Figure 22 shows top view layouts of various hand station schemes. [Figure 23] Figure 23 shows various configurations of the hand station embodiment. [Figure 24] Figure 24 shows an alternative design for the station's user interface (UI). [Figure 25] Figure 25 shows a schematic diagram of the fluid block divisions. [Figure 26] Figure 26 is an exploded view of the fluid block. [Figure 27] Figure 27 shows a schematic of the fluid block assembly. [Figure 28] Figure 28 shows the average temperature data from the water channel thermal test. [Figure 29] Figure 29 shows an overview of the water channel thermal test data. [Figure 30] Figure 30 shows the results of an exemplary peel test. [Figure 31] Figure 31 shows examples of measurable parameters and test results. [Figure 32] Figure 32 shows the peel test pattern for bonding testing. [Figure 33] Figure 33 shows the appearance after peeling due to embedding temperature. [Figure 34] Figure 34 shows a peel test using a square plate design. [Figure 35] Figure 35 shows a peel test using a circular plate design. [Modes for carrying out the invention]

[0011] Summary of the section I.) Overview II.) Novel and improved fluid 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] This disclosure includes three innovations or improvements to previously disclosed HEMs, comprising multiple TECs and a fluid channel system, specifically designed to transfer heat through direct contact with a contour-forming object. The first innovation is a “compression” type fluid channel, which has several advantages that significantly outperform the prior art. The second innovation is a flexible TEC, which enables more targeted and ergonomic heating and cooling. The third innovation is a specific 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 innovations or improvements of this disclosure in any size, shape, and consistency, depending on the desired purpose. In a primary embodiment, the HEM is an ergonomic unit optimized for through-skin heat transfer for therapeutic hypothermia and hyperthermia induction. II. Novel and improved crimped fluid channels

[0013] New Various components for the improved "compression" type fluid channel (110) are shown in Figures 2 and 5. As discussed in this disclosure, the improved "compression" type 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 "compression" type 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) which can be made from any flexible material, including, but not limited to, a thermoplastic polyurethane sheet ("TPU"). The first layer of material has a cutout (330) directly beneath the plate, allowing the plate to come into direct contact with the fluid and thus increasing heat transfer. A plate (310) that comes into direct contact with the fluid flowing through the channel is embedded between the two layers of material. Generally speaking, the plate can be made from any thermally conductive material, including, but not limited to, aluminum, and may or may not include an adhesive primer coating. A second layer (320), similar to the first layer, may be made from any flexible material, including, but not limited to, backed TPU. In addition, standoffs (340) may be attached to the material on the side of the plate facing the lifting platform 610, either via RF welding 600 or otherwise, to maintain fluid flow and prevent channel collapse when the fluid channel assembly is bent. A third sheet of material (350) is attached to the assembly either via RF welding 600 or otherwise to create a persistent fluid path 620. Finally, inlet and outlet pipes (360), similar to the first, second, and third layers and made from the same material, may include, but are not limited to, TPU, and may be joined into the assembly to connect to the external interface by RF welding 600 or other processes.

[0015] In a typical embodiment, the circulating fluid may be water, distilled water, or distilled water with an antimicrobial agent to prevent the 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 agents to reduce the surface tension of water, agents to protect the lifespan of internal components, agents to buffer pH changes, and colorants to visualize long-term chemical changes. In yet another embodiment, the system may gain the advantages of a synthetic fluid with improved thermal conductivity compared to water.

[0016] Various components of the improved “compression” type fluid channel (110) have the following elements which differ significantly from the prior art (110) in form, resulting in significantly better quality and stability. Briefly, a first layer (200), which can be made from any flexible material, includes, but is not limited to, a thermoplastic polyurethane sheet ("TPU"). The first layer of material has cutouts (210) in a shape which may have a uniform grid or which may 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 “compressed” together at the cutouts (210), may be compressed by any means known in the art, including, but is not limited to, mechanical fasteners (e.g., bolts or integrated male / female threads on upper and lower crimping devices), snap hooks, adhesive glue, adhesives, ultrasonic welding, friction welding, or thermal welding. The second plate (230) is in direct contact with the fluid flowing through the channel and is embedded between the first layer (200) of material (240) and the second layer, which is similar to the first layer (200), and may be made from any flexible material, but not limited to a thermoplastic polyurethane sheet ("TPU"). Generally speaking, the plates may be made from any thermally conductive material, but not limited to aluminum, and may or may not include an adhesive primer coating. The fluid channel assembly may include a thermally conductive compressible material or thermally conductive paste at the interface between the first and second plates to ensure proper surface contact for heat transfer. In addition, standoffs (250) may be attached to the material on the side of the plate facing the lifting platform 510, either 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 to the assembly via RF welding 500 or otherwise to create a persistent fluid path (520).Finally, inlet and outlet tubes (260) similar to the first and second layers, made from the same material, including but not limited to TPU, are joined into the assembly to connect to the external interface by RF welding 500 or other processes.

[0017] In a typical embodiment, the circulating fluid may be water, distilled water, or distilled water with antimicrobial agents to prevent the 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 agents to reduce the surface tension of water, agents to protect the lifespan of internal components, agents to buffer pH changes, and colorants to visualize long-term chemical changes. In yet another embodiment, the system may gain the advantages of a synthetic fluid with improved thermal conductivity compared to water.

[0018] Those skilled in the art will see that the novel and improved "crimp" type 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" type. This will be evident because the prior art provides two layers on the top and bottom of the plate. The improved "crimp" embedding provides "crimping" of the first and second plates surrounding the first layer of material, thereby creating a significantly tighter seal. The inherently less obvious property of a tighter seal became known after significant failures of the prior art double-sided embedding during production. It should be noted that the prior art double-sided embedding had a failure rate of approximately 30 percent (30%) during manufacturing, which represents a significant cost in the wasteful production process. This is partly due to the fact that the tools used to manufacture the prior art double-sided embedding consist of high-temperature tools and equipment that come into contact with the layered TPU during the sealing process. Direct contact resulted in damage to the exposed edges of the TPU layer, allowing fluid to penetrate through the material's cross-section. Consequently, the manufacturing process was extremely time-consuming and had a significant failure rate.

[0019] Conversely, the novel and improved "compression" type embedding offers several advantages. Firstly, in addition to the tighter seal resulting from the "compression" embodiment, production can be carried out much faster than the prior art double-sided embedding. Secondly, the plate geometry covers the exposed edges of the TPU material, ensuring that only high-temperature tools come into contact with the plate, minimizing material degradation and preventing water intrusion. Thirdly, for this reason, the failure rate during manufacturing is significantly lower. Finally, since the prior art double-sided embedding requires post-processing steps to prevent fluid leakage due to material degradation and water intrusion, the overall cost of "compression" embedding production is reduced because the improved embodiment does not experience this problem, and therefore, post-processing steps are not required.

[0020] In one embodiment, the present invention provides an improved “compression” type fluid channel device comprising (i) a first layer, (ii) a first water plate, (iii) a second water plate, and (iv) a second layer, wherein the first and second water plates are “compressed” to create a seal with respect to the first layer.

[0021] In a further embodiment, the present invention provides an improved “compression” type fluid channel device, as substantially shown in Figure 2, comprising (i) a first layer, (ii) a first water plate, (iii) a second water plate, and (iv) a second layer, wherein the first and second water plates are “compressed” to the first layer, as substantially shown in Figure 5.

[0022] In one embodiment, the present invention provides an improved “compression” type fluid channel device comprising (i) a first layer, (ii) a first water plate, (iii) a second water plate, and (iv) a second layer, wherein the first and second water plates are “compressed” to create a seal with respect to the first layer, and further comprises standoffs, wherein the standoffs are attached to the material on the side of the plate facing the lifting platform so as the fluid channel assembly is flexed, to maintain fluid flow and prevent channel collapse.

[0023] In one embodiment, the present invention provides an improved “compression” type fluid channel device comprising (i) a first layer, (ii) a first water plate, (iii) a second water plate, and (iv) a second layer, wherein the first and second water plates are “compressed” to create a seal with respect to the first layer, and further comprising standoffs, wherein the standoffs are attached to the material on the side of the plate facing the lifting platform, so as the fluid channel assembly is bent, to maintain fluid flow and prevent channel collapse, and further comprising inlet and outlet pipes that connect to the assembly so as to connect to the external interface.

[0024] In another aspect of this disclosure, the present invention provides a method for manufacturing an improved "compression" type fluid channel, which is embedded substantially in the form of Figure 2.

[0025] In another embodiment, the present invention is (i) The first layer is a step that is installed between the upper and lower metal plates,

[0026] (ii) The steps of applying external heat and opposing pressure to each plate, resulting in localized melting of the layers, (iii) The molten material of the layer forms a joint with both upper plates on both sides and seals the crimped joint, It features a "compressed" type fluid channel embedded by the process, including [the component].

[0027] In another embodiment, the present invention is (i) A step in which the first layer is placed between the upper and lower metal plates, which are coated with an adhesion promoter, (ii) The steps of applying external heat and opposing pressure to each plate, resulting in localized melting of the layers, (iii) The molten material of the layer forms a joint with both plates on both sides, which is enhanced by an adhesion promoter and seals the crimped joint, It features a "compressed" type fluid channel embedded by the process, including [the component].

[0028] Those skilled in the art will recognize and enable modifications and alterations of the disclosed embodiments without altering the function and purpose of the invention as disclosed herein. Such modifications and alterations are intended to be within the scope of this disclosure. III. Fluid block assembly

[0029] In another embodiment, the present disclosure teaches a novel and improved fluid channel assembly illustrated in Figures 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 for fabricating a fluid channel, a thermally conductive metal platform is bonded to a rigid plastic frame to create an enclosure through which a fluid such as water can pass. Refer to Figures 25 and 26. Each fluid block features clearance holes that allow the block to be fastened through TEC into threaded holes in any thermally conductive material forming a tile or patient contact surface. Note that mounting holes are not required on the patient-facing side of the contact surface, improving the aesthetic appearance and making it easier to clean and maintain the surface. Thus, a series of rigid blocks can be joined by flexible tubing connected to the fluid block by a single return joint. Refer to Figure 27. This allows for a number of possible positional configurations for the fluid channel. Those skilled in the art will recognize several advantages over current state-of-the-art devices. Firstly, no tools are required to assemble the unique configuration. Secondly, the improved design allows for more efficient design of coplanar configurations (i.e., for mounting on 3D topography). Thirdly, it has a superior aesthetic appearance due to the absence of mounting holes visible to the patient / end-user. Fourthly, the improved fluid channel design allows for easy removal and repair, thereby increasing useful life and product integrity. IV. Flexible Thermoelectric Cooler (“TEC”)

[0030] A second innovation in this disclosure relates to an improved thermoelectric cooler ("TEC") that is flexible and conforms more easily to the contact surface while minimizing heat loss. Building on a brief review of our previous work (see WO2018 / 064428), we demonstrate that our heat exchange module (HEM) comprises TECs used for heating and cooling in a variety of applications. Generally speaking, with respect to what has been previously taught, individual TECs, or multiple TECs organized in an array, act as direct contact heat pumping elements. In a typical embodiment, the outer surface of a TEC exchanges heat through a fluid channel (see Novel and Improved Compression-Type Fluid Channels above). Furthermore, the HEM is based around an array of TECs that transmit heat to or from the user at the skin level. The TECs are wired in various arrays to provide uniform temperature control across the area of ​​the HEM. Each TEC is paired with a temperature sensor that provides feedback by measuring the temperature of a heat-conductive surface that comes into contact with the user, known as a tile.

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

[0032] A waterproof bladder, known as the fluid channel described above, is connected to the TEC array and provides a method for extracting heat from the system. A thermally conductive plate is embedded within the TPU bladder in a pattern that mirrors the geometric shape of the tiles. Each TEC is mounted on the plate, which transfers heat from the TEC into a fluid circulation system. The fluid carries the heat away from the TEC and releases it through a radiator in a console connected to the outside.

[0033] In one embodiment, the TEC subassembly, tile, and fluid channel are packaged for use inside a soft product, providing a comfortable layer of biocompatible material between the user, the tile, the hook and loop straps and / or elements necessary to secure the device to the user's body, and an air bladder for regulating pressure and mating.

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

[0035] In light of the above, researchers have shown that some energy is wasted by conventional TEC designs due to insufficient contact with body tissue, resulting from their rigidity. In addition, the application of personal thermoregulatory devices is gaining popularity. However, the development of active heating and cooling clothing is far 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. Furthermore, previous attempts to develop improvements to TECs 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 described above, the HEM of this disclosure generally comprises an array of TECs. In previous embodiments, the TECs are made from rigid, inflexible materials.

[0037] Therefore, in the field of flexible TECs, there is a need to provide users with targeted, concentrated heating and cooling while maintaining sustained heating and cooling. In one aspect of this disclosure, a hybrid approach is found to be novel and useful. The approach utilizes a fluid-based fluid channel and a solid-state flexible TEC. The flexible TEC is installed on the non-aqueous plate side of the HEM. The result is to provide precise heat doses to an individual target area while simultaneously maintaining consistent, long-term heating and cooling for the user.

[0038] In one embodiment, the flexible TEC incorporates solid-state thermoelectric cooling technology. Briefly, the thermoelectric effect refers to a phenomenon where 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 (creating a voltage from a temperature difference), the Peltier effect (driving heat flow using electric current), and the Thomson effect (reversible heating or cooling within a conductor when both electric current and a temperature gradient are present). Generally speaking, all materials have a non-zero thermoelectric effect, but in most materials, it is too small to be useful. However, low-cost materials with a sufficiently strong thermoelectric effect (and other required properties) are also considered for applications including power generation and refrigeration. The most commonly used thermoelectric material is based on bismuth telluride (Bi₂Te₃). It should be noted 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] In addition, elastomers are polymers that possess "elastic" properties and, notably, have a low Young's modulus and high yield strain compared to other materials. This term is often used synonymously with the term "rubber." Elastomers are amorphous polymers that exist above their glass transition temperature, allowing for significant segmental motion of the polymer chains, and therefore, they are also expected to be highly permeable. Examples of elastomers include natural rubber, styrene-butadiene block copolymer, polyisoprene, polybutadiene, ethylene propylene rubber, ethylene propylene diene-based rubber, silicone elastomers, fluoroelastomers, polyurethane elastomers, and nitrile rubber.

[0040] In addition, a copolymer is a polymer derived from more than one of the monomer species. The polymerization of monomers into copolymers is called copolymerization. Copolymerization is used to modify the properties of manufactured plastics to meet specific needs, such as reducing crystallinity, correcting glass transition temperatures, controlling wettability, 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 of which are formed by chain growth polymerization.

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

[0042] In one embodiment, the present invention relates to Bi2Te3, Bi2Se3, PbTe (thallium-doped lead telluride alloy), Ba8Ga 16 Ge 30 Ba8Ga 16 Si 30 Mg2B IV (B IVThe flexible TEC comprises a thermoelectric material selected from the group consisting of Si, Ge, Sn, ZnO, MnO2, NbO2, NbFeSb, NbCoSn, and VFeSb.

[0043] In one embodiment, the present invention comprises a flexible TEC having 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] Therefore, in one embodiment, a HEM as previously disclosed (WO2018 / 064428) comprises the flexible TEC of the present invention. In a further embodiment, a HEM as previously disclosed comprises the flexible TEC as shown in Figures 11 and 12. Briefly, the flexible TEC (1200) of the present invention is positioned between a body part (e.g., an arm) and a fluid barrier plastic sheet (e.g., TPU, etc.) (1210). The flexible TEC can be in indirect contact with the skin or in contact with a thermally conductive biocompatible layer (1220). The result is that it is possible to maintain sustained heating and cooling on the target area while providing the user with optimized targeted heating and cooling. An additional advantage of using the flexible TEC in this embodiment is that it can be ergonomically in direct contact (or through a thin thermally conductive interface layer) with a body part exhibiting curvature that is difficult to overcome using a rigid plate, thereby increasing the effectiveness of the treatment. This close physical contact clearly allows for the optimization of the heat exchange process, which is necessary for cooling / heating body parts, enabling uniform skin contact, fewer pressure points, and a greater degree of patient comfort. See Figures 11 and 12. V. Fixed treatment station for thermoregulation of hairless skin

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

[0048] The prior art teaches several types of embodiments that intentionally teach the use of heating and cooling hairless skin surfaces using a vacuum enhancement system. See, for example, U.S. Patent Nos. 7,122,047, 7,947,068, 2016 / 0374853, and 2007 / 0060987. However, these systems are disadvantageous compared to the embodiments in this disclosure for the following reasons: First, the prior art systems require continuous monitoring of vasoconstriction and / or vasodilation states. Second, the systems are bulky and immobile due to the fact that they possess a vacuum enhancement system. Third, they lack the ability to provide differential temperature to various areas of the body.

[0049] In contrast, this disclosure provides a fixed-frame therapy station used for heating and cooling therapy. Embodiments disclosed herein are built upon previous HEM systems (see Hypothermia Devices, Inc. (Los Angeles, CA)) and are further described in Figures 7 and 21. As shown, Figure 7 is an exploded view of the fixed-frame hand station (700) of this disclosure. Referring to it, the TEC array is trapped 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 fabricated from any thermally conductive material, but a preferred embodiment is aluminum. Finally, the inlet and outlet pipes (740) are joined into the assembly by RF welding or other processes to connect to the external interface. It will be obvious to those skilled in the art that the fixed frame can be molded to any suitable body part having a hairless skin surface (e.g., hands and feet).

[0050] The hand stations of this disclosure can be arranged to maximize spacing and efficiency for end users. For example, as shown in Figure 22, the hand stations can be arranged in multiple formats depending on the available space, the number of end users, and the activity. These “hubs” can be installed within a gym or constructed to be portable for use with sports augmented goods or events. Each hub concept shown is valued based on the number of square feet (sf / user) it occupies per user. In addition, as shown in Figure 23, each hand station of this disclosure can be configured for specific types of product modalities depending on user needs. For example, non-limiting embodiments of product configurations include 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 sanitary modalities, which allow the user to clean the unit before and after each use. Those skilled in the art will understand and recognize that the sanitary modalities may 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 may be integrated with multiple sensors and measurements to monitor and analyze various aspects of the user's performance. For example, treatment time may be tracked and, optionally, the user may be notified when a recommended recovery period has elapsed. Notably, a volume sensor may be used to detect when the user has initiated treatment. In addition, heart rate (pulse) measurements may be employed. The pulse may be measured by detecting electrical pulses measured by two electrodes attached to the user (preferably on the hand or directly below the wrist). Alternatively, LEDs and photosensitive diodes may be used to detect pulses. In addition, electrocardiogram (EKG / ECK), blood oxygen saturation (SpO2), and body mass index (BMI) may also be recorded using methods known in the art.

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

[0054] In one embodiment, the present invention provides a fixed-frame therapeutic station device comprising (i) a fixed-frame station, (ii) a fluid channel subassembly, and (iii) a controller.

[0055] In one embodiment, the present invention provides a fixed frame treatment station device comprising: (i) a fixed frame station, the fixed frame being molded to the shape of a human hand; (ii) a fluid channel subassembly comprising a fluid channel subassembly having a "compression" type fluid channel as disclosed; and (iii) a controller.

[0056] In one embodiment, the present invention provides a fixed frame treatment station device comprising: (i) a fixed frame station, the fixed frame being molded to the shape of a human foot; (ii) a fluid channel subassembly, the fluid channel subassembly comprising the "compression" type fluid channel of the present disclosure; and (iii) a controller.

[0057] In one embodiment, the present invention provides a fixed-frame therapeutic station apparatus comprising (i) a fixed-frame station, (ii) a fluid channel subassembly, and (iii) a controller substantially as shown in Figure 7.

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

[0059] In one embodiment, the present invention provides a fixed frame treatment station apparatus comprising: (i) a fixed frame station, the fixed frame being molded to the shape of a human hand; (ii) a fluid channel subassembly comprising a “compression” type fluid channel as disclosed; and (iii) a controller substantially shown in Figure 7, the fluid channel comprising a “compression” type fluid channel as substantially shown in Figure 5.

[0060] In one embodiment, the present invention provides a fixed frame treatment station apparatus comprising: (i) a fixed frame station, the fixed frame being molded to the shape of a human foot; (ii) a fluid channel subassembly comprising a “compression” type fluid channel as disclosed; and (iii) a controller substantially shown in Figure 7, the fluid channel comprising a “compression” type fluid channel as substantially shown in Figure 5.

[0061] In one embodiment, the present invention provides a fixed frame therapeutic station apparatus comprising (i) a fixed frame station with a plurality of contact areas, (ii) a fluid channel subassembly, and (iii) a controller substantially as shown in Figure 21.

[0062] In one embodiment, the present invention provides a fixed frame treatment station device comprising (i) a fixed frame station having a plurality of contact areas, (ii) a fluid channel subassembly, and (iii) a controller substantially as shown in Figure 21, wherein the fluid channel comprises a "compression" type fluid channel substantially as shown in Figure 5.

[0063] Those skilled in the art will recognize and enable modifications and alterations of the disclosed embodiments without altering the function and purpose of the invention as disclosed herein. Such modifications and alterations are intended to be within the scope of this disclosure. VI. Kit / Product

[0064] Heat exchange modules and kits for use in heating and cooling therapy are within the scope of this disclosure. Such kits comprise containers partitioned to receive one or more containers such as carriers, packages, or boxes, shrink wraps, and equivalents, each container may comprise one of the distinct components used in this disclosure, along with a program or insert comprising instructions for use, such as those described herein.

[0065] The kits of this disclosure would typically comprise the container described above, and one or more other associated containers containing materials, contents, and / or instructions for use, as well as accompanying documentation with instructions for use, which are desirable from a commercial and user perspective.

[0066] Instructions and / or other information may also be included with the kit, or on top of it, or on inserts. The terms “kit” and “product” may be used as synonyms.

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

[0068] While the description herein contains many details, these should not be construed as limiting the scope of this disclosure, but merely provide illustrations of some of the currently preferred embodiments. Therefore, it should be recognized that the scope of this disclosure fully covers other embodiments that may be obvious to those skilled in the art.

[0069] In the claims, references to elements in the singular are not intended to mean “one and only one” unless expressly stated, but rather “one or more.” All structural, chemical, and functional equivalents of elements of disclosed embodiments known to those skilled in the art, expressly incorporated herein by reference, are intended to be covered by these claims. Furthermore, elements, components, or method steps in this disclosure are not intended to be made public, whether or not they are expressly enumerated in the claims. Claim elements herein are not construed as “means + function” elements unless they are expressly enumerated using the phrase “means for ~.” Claim elements herein are not construed as “step + function” elements unless they are expressly enumerated using the phrase “step for ~.” Exemplary Embodiments

[0070] In particular, the following embodiments are provided. 1) A device, a. The first layer and, b. The first plate and, c. The second plate, d. The second layer, Equipped with, The apparatus thereby "presses" the first plate and the second plate together to create a seal with respect to the first layer.

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

[0072] 3) A device comprising a fluid channel subassembly for use in a HEM, the improvements being: a. A first layer, b. A first plate, c. A second plate, d. A second layer, comprising, whereby the first plate and the second plate are "pressure-bonded" to create a seal with respect to the first layer, substantially as shown in FIG. 5. An apparatus.

[0073] 4) A heat exchange module apparatus, 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, wherein the first user side is attached to the first tile so as to conduct heat. A first thermoelectric cooler (TEC) assembly, 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 attached to the second tile so as to conduct heat, a thermally conductive first plate is thermally attached to the first reference side, a thermally conductive second plate is thermally attached to the second reference side, an upper sheet defines at least an upper portion of a liquid channel, a bottom sheet has a first hole in which the first plate is positioned and contacts the liquid when flowing in the channel, and a second hole in which the second plate is positioned and contacts the liquid when flowing in the channel. A second thermoelectric cooler (TEC) assembly, comprising a heat exchange module apparatus.

[0074] 5) The TEC according to 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 IVThe TEC according to Embodiment 5 further comprises a thermoelectric material selected from the group consisting of (=Si, Ge, Sn), ZnO, MnO2, NbO2, NbFeSb, NbCoSn, and VFeSb.

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

[0077] 8) The TEC according to Embodiment 6, further comprising a copolymer.

[0078] 9) HEM device, with improvements including: a. A fixed frame treatment station, wherein the fixed frame is molded to the shape of a human hand, and the fixed frame treatment station b. A fluid channel subassembly comprising a fluid channel subassembly having a "compression" type fluid channel, c. Controller and, A HEM device equipped with the following features.

[0079] 10) HEM device, the improvements are, a. A fixed frame treatment station, wherein the fixed frame is molded to the shape of a human foot, and the fixed frame treatment station b. A fluid channel subassembly comprising a fluid channel subassembly having a "compression" type fluid channel, c. Controller and, A HEM device equipped with the following features.

[0080] 11) The apparatus according to Embodiment 1, wherein the first plate and the second plate are “pressed together” to create a seal with respect to the first layer, as substantially shown in Figure 2.

[0081] 12) The apparatus according to Embodiment 1, wherein the first layer is made from a commercially available flexible material.

[0082] 13) The first layer according to Embodiment 12, wherein the first layer is thermoplastic polyurethane (TPU).

[0083] 14) The first layer according to Embodiment 12, wherein the first layer comprises a cutout, which is modified and shaped to achieve uniform heat transfer properties.

[0084] 15) The apparatus according to Embodiment 1, wherein the first plate and the second plate are “pressed together” to create a seal with respect to the first layer, as substantially shown in Figure 2.

[0085] 16) The apparatus according to Embodiment 1, wherein the second layer is made from a commercially available flexible material.

[0086] 17) The second layer according to Embodiment 15, wherein the first layer is thermoplastic polyurethane (TPU).

[0087] 18) The apparatus according to Embodiment 2, wherein the first plate and the second plate are “pressed together” to create a seal with respect to the first layer, as substantially shown in Figure 2.

[0088] 19) The apparatus according to Embodiment 2, wherein the first layer is made from a commercially available flexible material.

[0089] 20) The first layer according to Embodiment 18, wherein the first layer is thermoplastic polyurethane (TPU).

[0090] 21) The first layer according to Embodiment 18, wherein the first layer comprises a cutout, which is modified and shaped to achieve uniform heat transfer properties.

[0091] 22) The apparatus according to Embodiment 2, wherein the second layer is made from a commercially available flexible material.

[0092] 23) The second layer according to Embodiment 22, wherein the first layer is thermoplastic polyurethane (TPU).

[0093] 24) The apparatus according to Embodiment 3, wherein the first plate and the second plate are “pressed together” to create a seal with respect to the first layer, as substantially shown in Figure 2.

[0094] 25) The apparatus according to Embodiment 3, wherein the first layer is made from a commercially available flexible material.

[0095] 26) The first layer according to Embodiment 25, wherein the first layer is thermoplastic polyurethane (TPU).

[0096] 27) The first layer according to Embodiment 25, wherein the first layer comprises a cutout, which is modified and shaped to achieve uniform heat transfer properties.

[0097] 28) The apparatus according to Embodiment 3, wherein the second layer is made from a commercially available flexible material.

[0098] 29) The second layer according to Embodiment 28, wherein the first layer is thermoplastic polyurethane (TPU).

[0099] 30) The apparatus according to Embodiment 1, further comprising standoffs, which are attached to the material on the side facing the plate lifting platform to maintain fluid flow and prevent channel collapse.

[0100] 31) The apparatus according to Embodiment 2, further comprising standoffs, which are attached to the material on the side facing the plate lifting platform to maintain fluid flow and prevent channel collapse.

[0101] 32) The apparatus according to Embodiment 3, further comprising standoffs, which are attached to the material on the side facing 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 according to Embodiment 4, wherein the TEC subassembly is flexible and further comprises differential heating on the x-axis.

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

[0107] 38) The TEC subassembly according to 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) A HEM apparatus according to Embodiment 9, substantially as shown in Figure 7.

[0110] 41) A HEM apparatus according to Embodiment 9, substantially as shown in Figure 21.

[0111] 42) A HEM apparatus according to Embodiment 9, substantially as shown in Figure 22.

[0112] 43) A HEM apparatus according to Embodiment 9, substantially as shown in Figure 23.

[0113] 44) The HEM apparatus according to embodiment 40, further comprising a user interface (UI) substantially as shown in Figure 24.

[0114] 45) The HEM apparatus according to embodiment 41, further comprising a user interface (UI) substantially as shown in Figure 24.

[0115] 46) The HEM apparatus according to embodiment 42, further comprising a user interface (UI) substantially as shown in Figure 24.

[0116] 47) The HEM apparatus according to embodiment 43, further comprising a user interface (UI) substantially as shown in Figure 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. [Examples]

[0123] Various aspects of the present invention will be further described and illustrated with several subsequent embodiments, none of which are intended to limit the scope of the invention. (Example 1)

[0124] Example 1: "Crimping" type fluid channel thermal test Thermal testing of "compression" type fluid channels was conducted to determine whether the "compression" type modality could perform better than previous embodiments. Numerous variations of the "compression" type modality were tested, including plates with variations in the contact area between plates and the use of thermally conductive paste between the two plates. As background, previous tests showed that a plate design designated "C" using thermally conductive paste between plates performed slightly better than previous embodiments. [ka]

[0125] The goal was to obtain sufficient data to determine which plate type performed better than previous designs. The 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] In short, (i) a practical fluid channel was manufactured using various plate configurations. Then, (ii) the fluid channel was pressed onto a thermal testing apparatus. Then, (ii) a heating pad was placed on top of the thermal testing apparatus. Then, (iii) the temperature of the thermal testing apparatus was measured while a fixed volume of water was circulated through the fluid channel at a constant flow rate of 2.0 LPM. Then, (iv) the heating pad was turned on for a test time of 1 minute and kept constant at 450 W for the duration of the test (6 minutes).

[0128] As shown in Figure 8, the heat transfer compared using each design is as follows: Design "C," which does not use thermal conductive paste between the plates, does not perform as well as the previous design and is therefore not considered a suitable alternative. However, Design "C" with thermal conductive paste between the plates and Design "D" without thermal conductive paste between the plates perform at or better than the previous design. Finally, Design "D" with thermal 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 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) Flow meter (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] In short, (i) a practical fluid channel using the plate design of the previous embodiment was pressed onto the thermal test apparatus using a TEC array with thermal conductive paste. Then, (ii) a radiator with a fan (at a constant 7V) was added to the water circulation loop. Then, (iii) a heating pad was placed on top of the thermal test apparatus. Then, (iv) a fixed volume of water was circulated through the fluid channel at a constant flow rate of 2.0 LPM. Then, (iv) the heating pad was turned on and kept constant at 450W for a test time of 1 minute. Then, (v) the TEC was turned on and kept constant at 24V for a test time of 90 seconds. Then, (vi) the temperature on the thermal test apparatus was measured over the duration of the test, which was 30 minutes. Then, (vii) the test was repeated using a practical fluid channel with a "C" design plate with thermal conductive paste between the plates. Finally, (viii) the previous two tests were repeated over the duration of the test, with the heating pad powered off.

[0132] Tests with a heating pad showed that the "C" design using the paste performed better than the previous design (Figure 9). Furthermore, the same experiment without the heating pad showed similar results to the previous one, with the "C" design using the thermally conductive paste performing even better than the previous design (Figure 10). (Example 3)

[0133] Example 3: Differential Temperature Test To further evaluate the ability to provide differential temperature through multiple TECs, a differential temperature model is developed. Briefly, for the purposes of this model, a posterior HEM is used with a geometric shape having 24 skin contact plates, which are centered (approximately 4.5 cm). 2 It consists of plates, each having one TEC located at ). The area / contact plate is approximately 26.35 cm². 2 The total skin contact area is approximately 598 cm². 2Furthermore, the model parameters assume that the skin is approximately 1 mm thick, the muscle layer is approximately 25 mm thick, and the initial temperature of the study is 36°C (see Figure 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 central plate decreases, while the surface temperature of the side plates remains the same (Figure 15). At time 10 minutes, the surface temperature of the central plate continues to decrease, while the temperature of the outer plates increases (Figure 16). Finally, at time 20 minutes, the surface temperature of the central plate achieves a set (or pre-set) temperature decrease of 6°C, while the surface temperature of the outer plates reaches a set (or pre-set) temperature of 41°C (Figure 17).

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

[0136] The results of this model further demonstrate that the use of conventional HEMs, HEMs utilizing flexible TECs, or differential temperature systems within fixed-frame hand or foot stations allows users to target specific temperatures to specific body parts at specific times. A key advantage of this approach is that, using ergonomically designed devices that include periodic cooling and heating phases not only on a target area but also on multiple proximal target areas, end-users or patients can access a rich spectrum of individualized thermotherapy modalities for various body parts.

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

[0138] This disclosure reveals a novel and useful means of thermotherapy that enables more effective recovery from injury, which is a known standard treatment (known as control therapy) that applies the sequential application of heating and cooling phases. (Example 4)

[0139] Example 4: Fluid channel thermal test An additional array in the experiment involved conductive thermal paste in a fluid plate (Example 1 " Crimping-type fluid channel thermal testing The study was conducted to determine the optimal arrangement of the (see reference). Briefly, several back-packaged bodies were tested, comprising three types: (i) a square water plate, (ii) a "compression" type (round) water plate with a thermally conductive paste at the interface between the first and second plates to ensure proper surface contact for heat transfer, and (iii) a round water plate without the conductive paste. [ka]

[0140] First, the heating pad was placed on top of the skin interface layer. To ensure consistent thermal contact, the stacks were pressed together. 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 rated at 0.12 W / cm² on the back. 2 The power was converted to 100W, equivalent to (as measured by both an ammeter and a voltmeter). After 1 minute, cooling was initiated on the back packaging at a constant 18.1V. The test was carried out over 30 minutes to allow steady-state conditions to be reached. At the 30-minute mark, data was collected and analyzed in CSV format using a Parlay data processor, which allowed for the acquisition of new data at the individual tile level over periods of >30 seconds.

[0141] The results in Figure 28 show that using a circular plate with conductive thermal paste significantly outperforms a circular plate without thermal paste. In addition, the square plate performed within an acceptable range as a circular plate with thermal paste. However, during inspection of the circular plate, it was determined that the embedding temperature was too low. Therefore, in the circular plate with paste, the conductive paste effectively bridged the gaps between the plates, enabling sufficient heat transfer despite suboptimal embedding on the circular plate. See Figure 29. Consequently, the temperature of the embedding tool must be increased during production. (Example 5)

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

[0143] The bond strength test was performed using the following protocol. First, full embedding is performed according to the water channel pattern. The embedded layer is then numbered and cut into strips so that each plate can be peeled off individually. See Figure 32. For square plates, only one sheet is embedded and peeled off. For round "compressed" type plates as described herein, only one plate is coated with an adhesive primer that allows embedding. This allows the unbonded plate to be removed and thus the bonded side can be inspected. Note that if both sides are bonded, it is impossible to perform the peel test without damaging the bonded surface. The plate is held in place and the TPU strips are peeled off to expose the bonded surface. Information can be determined by the appearance of the peeled bonded surface via physical inspection (see Figures 30 and 31). A consistent texture and the absence of bubbles in the TPU indicate that the tool temperature was within the correct range. Please note that temperatures that are too low and the TPU will not bond to the metal, while temperatures that are too high and the TPU will leave air gaps that can cause boiling and lead to water leakage within the completed channel.

[0144] Figure 33 shows the peel test appearance of the circular plate at different embedding temperatures. The results indicate that the acceptable embedding temperature range 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 TPU, leading to a weaker bond. The test also reveals that the direction of the force applied to the TPU can affect the separation pattern. In addition, there is no mechanical protection or covering of the bonded area, which can allow water intrusion through the exposed edges of the TPU material where perforations are cut.

[0146] The results in Figure 35 show a circular plate featuring a single sheet of TPU bonded to metal on both sides. The redundant metal bonding provides physical protection of the bonding area, making it less likely to result in a single, persistent leak. The fixed gap dimensions between the top and bottom plates prevent excessive displacement of the TPU during embedding, resulting in a stronger bond. Forces applied from any direction produce consistent stress in the circular shape. In addition, the cut edges of the TPU are hidden from water, preventing water intrusion through the fabric.

[0147] Overall, these results indicate that the circular plate design (i) is more likely to form stronger bonds, (ii) distributes stress applied to the fluid channel more uniformly, thereby reducing the probability of failure caused by concentrated stress, and (iii) hides the cut edges of the TPU from direct exposure to water, thereby preventing material intrusion that could lead to material degradation or fluid leakage.

[0148] While the description herein contains many details, these should not be construed as limiting the scope of this disclosure, but merely provide examples of some of the currently preferred embodiments. Therefore, it should be understood that the scope of this disclosure fully covers other embodiments that may be obvious to those skilled in the art.

Claims

[Claim 1] The invention described herein.

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