Wearable therapeutic device for providing temperature and compression therapy

Abstract

In various aspects, the invention includes a wearable therapy delivery device for applying thermal therapy and / or compression therapy. In some cases, a wearable therapy delivery device includes an inner layer configured to contact a body surface of a user; an outer layer; a temperature treatment module surrounding between the inner layer and the outer layer near the inner layer; and / or a compression therapy module located proximate the one or more temperature therapy modules. In some cases, the compression therapy module is configured to urge the temperature therapy module toward a body surface of a user.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 330,429, entitled “Footwear for Providing Temperature and Compression Therapy” and filed on April 13, 2022, which is hereby incorporated by reference in its entirety. Technical Field

[0002] The present disclosure relates generally to the field of therapy, and more particularly to devices, systems, and methods for delivering compression therapy and / or temperature therapy. Background Art

[0003] Conventional compression therapy devices are generally large devices that require the user to remain in a stationary position during use. Conventional temperature therapy devices (such as electric heating pads and ice packs) have limited usefulness duration, such as reusability, after which they become ineffective and / or must be discontinued. Such conventional temperature therapy devices may typically require pre-cooling or pre-heating, such as using an external cooling / heating device such as a refrigerator, microwave oven, etc. In addition, when using such conventional temperature therapy devices, injured users may often feel inconvenienced by having to approach or use external cooling / heating elements to effectively use the temperature therapy device. Therefore, typical temperature therapy devices may interfere with the rest / recovery required by the user and may result in a delay in recovery time. Due to these and other limitations of current compression or temperature therapy devices, these therapy devices may be further difficult to make into smaller form factors and easily transported. In addition, conventional therapy devices are generally limited to applying temperature therapy. Therefore, an improved therapy device is needed. Summary of the invention

[0004] Applicants have invented a technology for improved and in some embodiments combined delivery of both temperature therapy and compressive therapy. In some embodiments, compression can actually be used to promote more therapeutic temperature therapy (e.g., by ensuring that the temperature delivery member maintains an appropriate amount of contact / force with the user's body). It is a delicate balance to deliver the appropriate amount of temperature therapy to achieve the desired result. If the temperature therapy delivered is insufficient, the desired physiological result may not occur. As an example, the applicant understands that for some physical activities, it may be desirable that the lubricating fluid between the skin surface and the muscle surface is viscous. Such liquids tend to be thinner the closer to the skin surface, and the closer to the muscle surface, the more gel-like. For some physical activities, it may be desirable that the liquid near the muscle surface is heated so as to convert from a gel-like substance to a more viscous substance. If the temperature therapy is delivered with too little heat or with too little force, the result may not be achieved (or it may take longer to achieve). On the other hand, if the temperature therapy is too hot or delivered with too much pressure, the user may be unbearable (and in some cases even cause burns, injuries, etc.).

[0005] Applicants have discovered that strategic use of compressive therapeutic forces can enable improved delivery of temperature therapy, and can be done in a manner such that the desired results described in the preceding paragraphs are achieved. This is different from conventional devices that have both temperature and compressive aspects, as such devices focus solely on temperature therapy and compressive therapy. Furthermore, the delivery of temperature therapy in such devices is solely for the comfort or massage effect of the user. This is distinct from the inventive method described herein, in which compression is strategically applied at a pressure value determined to be effective in achieving a therapeutic effect (e.g., converting a gel-like lubricating fluid into a more viscous state).

[0006] While the present application may sometimes describe the concepts supported herein within the context of example embodiments of articles of footwear, skilled artisans will appreciate that the present invention may be implemented into any wearable garment for delivering therapy to any body part. As a few non-limiting examples: a vest for delivering therapy to the chest / chest area, pants / shorts for delivering therapy to the legs, a belt for delivering therapy to the back, a wristband for delivering therapy to the arms or shoulders, and many other options.

[0007] Temperature therapy or "thermal therapy" (e.g., cold and heat therapy) and compression therapy (or compressive therapy) have been shown to be effective for injury recovery, thereby helping to speed up the healing process while reducing pain, inflammation, and joint stiffness. Local cooling can induce vasoconstriction and reflex vasodilation and / or reduce bleeding, inflammation, metabolism, muscle spasm, pain, enzyme activity, oxygen demand, and / or swelling in areas of the body affected by soft tissue trauma or injury. Local heating can increase blood flow, reduce pain sensation, increase local tissue metabolic rate, increase healing rate, and / or promote tissue stretching. Local compression can increase blood flow through the leg veins for the purpose of preventing blood clots, helping to treat lymphedema or chronic venous insufficiency, and reducing edema and helping venous blood return to the heart.

[0008] The invention disclosed herein includes devices, systems and methods for applying and / or delivering compression therapy and / or temperature therapy.

[0009] In general, in one aspect, embodiments of the present invention feature a wearable therapeutic delivery device. The device may include: an inner layer configured to contact a user's body surface; an outer layer; one or more temperature therapy modules enclosed between the inner layer and the outer layer near the inner layer; and one or more compressive therapy modules located near the one or more temperature therapy modules. In some cases, the one or more compressive therapy modules are configured to push the one or more temperature therapy modules toward the user's body surface.

[0010] In some embodiments, the temperature therapy module includes at least one of a thermoelectric cooler (TEC) and a heat generating unit.

[0011] In some embodiments, the temperature therapy module is configured to operate within a range of from 100°F to 140°F.

[0012] In some embodiments, the compression therapy module comprises an inflatable bladder.

[0013] In some embodiments, the compression therapy module is configured to operate within a range from 120 psi to 200 psi.

[0014] In some embodiments, the device further comprises a spacer disposed between the compression therapy module and the temperature therapy module. In some cases, the spacer comprises at least one wing arranged around its periphery. In some cases, the spacer comprises 5 wings.

[0015] In some embodiments, the device further comprises a control unit configured to control the operation of the temperature therapy module and the compression therapy module.

[0016] In some embodiments, the apparatus includes an article of footwear.

[0017] In general, in another aspect, embodiments of the invention feature a method for delivering therapy. The method may include the following steps: providing a wearable therapy delivery device, the device comprising: an inner layer configured to contact a body surface of a user; an outer layer; one or more temperature therapy modules enclosed between the inner layer and the outer layer near the inner layer; and one or more compressive therapy modules located near the one or more temperature therapy modules; applying the inner layer of the device to the body surface; and activating the one or more temperature therapy modules and the one or more compressive therapy modules. In some cases, the one or more compressive therapy modules are configured to push the one or more temperature therapy modules toward the body surface of the user;

[0018] In some embodiments, the temperature therapy module includes at least one of a thermoelectric cooler (TEC) and a heat generating unit.

[0019] In some embodiments, the temperature therapy module is configured to operate within a range of from 100°F to 140°F.

[0020] In some embodiments, the compression therapy module comprises an inflatable bladder.

[0021] In some embodiments, the compression therapy module is configured to operate within a range from 120 psi to 200 psi.

[0022] In some embodiments, the device further comprises a spacer disposed between the compression therapy module and the temperature therapy module. In some cases, the spacer comprises at least one wing arranged around its periphery. In some cases, the spacer comprises 5 wings.

[0023] In some embodiments, the device further comprises a control unit configured to control the operation of the temperature therapy module and the compression therapy module.

[0024] In some embodiments, the apparatus includes an article of footwear.

[0025] The above and other preferred features (including various novel implementation details and event combinations) will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the specific systems and methods described herein are shown only by way of illustration, not as a limitation. As will be understood by those skilled in the art, the principles and features described herein can be adopted in various and many embodiments without departing from any scope of the present invention. As can be appreciated from the above and following descriptions, each feature described herein and each combination of two or more such features are included within the scope of the present disclosure, provided that the features included in such a combination are not inconsistent with each other. In addition, any feature or combination of features can be specifically excluded from any of any embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying drawings, which are included and constitute a part of this specification, illustrate presently preferred embodiments, and together with the general description given above and the detailed description of the preferred embodiments given below, serve to explain and teach the principles described herein.

[0027] Figure 1A A block diagram of a temperature therapy device is illustrated, according to some embodiments.

[0028] Figure 1B A perspective view of an exemplary temperature regulation assembly is shown in accordance with some embodiments.

[0029] Figure 1C A diagram illustrating an exemplary temperature regulation assembly according to some embodiments is shown.

[0030] Figure 1D The temperature regulating assembly is shown without its cover and cap, according to some embodiments.

[0031] Figure 1E is an image of a temperature regulation assembly according to some embodiments.

[0032] Figure 2A A top view of a mounting plate of a temperature regulation assembly is shown in accordance with some embodiments.

[0033] Figure 2B A bottom view of a mounting plate is shown in accordance with some embodiments.

[0034] Figure 2C Illustrated is a cross-sectional view of a mounting plate according to some embodiments.

[0035] Figure 2D An enlarged view of an opening of a mounting plate is shown in accordance with some embodiments.

[0036] Figure 3A A heat spreader of a temperature regulation assembly is illustrated, according to some embodiments.

[0037] Figure 3B A block diagram illustrating a cross-section of a heat spreader according to some embodiments.

[0038] Figure 4 A thermoelectric cooler (TEC) of a temperature regulation assembly is illustrated in accordance with some embodiments.

[0039] Figure 5A A spacer of a temperature regulation assembly is illustrated according to some embodiments.

[0040] Figure 5B FIG. 1 shows an example of a method according to some embodiments. Figure 5A A top view of the spacer shown in FIG.

[0041] Figure 5C FIG. 1 shows an example of a method according to some embodiments. Figure 5A Bottom view of the spacer shown in .

[0042] Figure 5D FIG. 1 shows an example of a method according to some embodiments. Figure 5A A side view of the spacer shown in FIG.

[0043] Figure 5E A spacer of a temperature regulation assembly is illustrated according to some embodiments.

[0044] Fig. 5F The diagram includes, according to some embodiments, Figure 5E The temperature regulating assembly of the spacer is shown in FIG.

[0045] Figure 5G The diagram includes, according to some embodiments, Figure 5E The temperature regulating assembly of the spacer is shown in FIG.

[0046] Fig. 6A A heat sink for a temperature regulation assembly is shown in accordance with some embodiments.

[0047] Figure 6B Illustrated is a cross-sectional view of a heat sink according to some embodiments.

[0048] Figure 6C A bottom view of a heat sink is shown in accordance with some embodiments.

[0049] Figure 7 A fan of a temperature regulation assembly is illustrated in accordance with some embodiments.

[0050] Fig. 8A A cover of a temperature regulation assembly is illustrated, according to some embodiments.

[0051] Figure 8B A side view of a cover is shown according to some embodiments.

[0052] Figure 8C A top view of a cover is shown according to some embodiments.

[0053] Fig.8D Another side view of a cover is shown according to some embodiments.

[0054] Fig. 8E An enlarged view of a locking mechanism of a cover is shown in accordance with some embodiments.

[0055] Fig. 9A A cap of a temperature regulating assembly is illustrated, according to some embodiments.

[0056] Fig. 9B A top view of a cap according to some embodiments is shown.

[0057] Fig. 9C A bottom view of a cap is shown according to some embodiments.

[0058] Fig.9D A cross-sectional view of a cap according to some embodiments is shown.

[0059] Fig. 10A An upper perspective view of a vibration chamber is shown in accordance with some embodiments.

[0060] Fig. 10B An exploded perspective view of a vibration chamber showing an upper surface of a component is illustrated in accordance with some embodiments.

[0061] Fig.11 An exploded perspective view of a vibration chamber showing a lower surface of a component is illustrated in accordance with some embodiments.

[0062] Fig.12 illustrates an upper perspective view of a lower cover of a vibration chamber according to some embodiments, the lower cover being rotated at a small angle to show additional features of the cavity of the lower cover;

[0063] Fig.13 An exploded upper perspective view of a heat generation unit is shown, according to some embodiments.

[0064] Fig.14 A plan view illustrating an electric heating wire on a lower sheet of a heat generating unit according to some embodiments.

[0065] Fig.15A An article of footwear is illustrated according to some embodiments.

[0066] Fig. 15B An article of footwear is illustrated according to some embodiments.

[0067] Fig. 15C Components of an article of footwear are illustrated according to some embodiments.

[0068] Fig.16 Illustrated are views of a therapeutic device according to some embodiments.

[0069] Fig.17 Illustrated are views of an article of footwear according to some embodiments.

[0070] Fig.18 is a block diagram of an example computer system in accordance with some embodiments.

[0071] Although the present disclosure has various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the accompanying drawings and will be described in detail herein. The present disclosure should be understood not to be limited to the particular form disclosed, and on the contrary, it is intended to cover all modifications, equivalents and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0072] Generally, the present invention relates to devices, systems and methods including components or modules that can deliver temperature (e.g., heat, cold and / or desired temperature) therapy and / or compression therapy to one or more portions of a user's body (e.g., the foot, ankle and / or lower extremity area).

[0073] In some embodiments, temperature therapy as described herein is applied using a thermoelectric cooler (TEC) as described herein (e.g., in Figures 1-9) and in, for example, U.S. Patent Publication No. 20190350752, U.S. Patent Application No. 17 / 308012, and U.S. Patent Application No. 17 / 307981, all of which are incorporated herein by reference in their entirety.

[0074] In some embodiments, temperature therapy as described herein is applied using a polyimide or other type of heater as described, for example, in U.S. Patent Publication No. 20200170880, U.S. Provisional Patent Application No. 63 / 182703, and U.S. Provisional Patent Application No. 63 / 243546, all of which are incorporated herein by reference in their entirety.

[0075] In some embodiments, compressive therapy as described herein is applied using a pneumatic system as described in, for example, US Provisional Patent Application No. 63 / 248,077, which is incorporated herein by reference in its entirety.

[0076] Advantageously, the therapeutic device can be worn for resting and recovering from high ankle injuries. In addition, the therapeutic device can deliver a treatment that causes faster or improved recovery from the injury. For example, the typical healing time for a broken ankle that requires wearing a stabilizing boot can take 6 weeks or more. In various embodiments, the healing time can be shortened to a range from about 1 day to about 5 weeks (e.g., 2 weeks, 3 weeks, or 4 weeks) using the systems and / or methods described herein. In addition, the therapeutic device as described herein can provide a certain level of mobility of the user's foot in use. In addition, the therapeutic device as described herein can provide a pre-exercise warm-up device by delivering heat and / or compression. Overview of treatment devices

[0077] In general, therapeutic devices and systems as described herein include one or more modules that, when activated, can deliver temperature (e.g., heat, cold, and / or customized temperature) therapy and / or compression therapy to a body region of a user (e.g., a foot, ankle, and / or lower extremity region).

[0078] In some embodiments, each therapy module of the devices and systems as described herein can be selectively activated for delivering compression therapy, thermal therapy, or a combination thereof.

[0079] In general, any number of modules for delivering thermal treatment may be used.In some embodiments, a treatment device as described herein comprises 1, 2, 3, 4, 5, 6 or more modules for delivering thermal treatment.

[0080] In general, any number of modules for delivering compressive therapy may be used.In some embodiments, a treatment device as described herein comprises 1, 2, 3, 4, 5, 6 or more modules for delivering compressive therapy.

[0081] In general, the therapeutic devices and systems can be configured to provide any suitable or desired level of therapy (e.g., temperature and / or compression) to a user. In some embodiments, the temperature therapy module is configured to operate in a range of from about 50° F. to about 150° F., from about 75° F. to about 150° F., from about 100° F. to about 140° F. In some embodiments, the compressive therapy module is configured to operate in a range of from about 100 psi. to about 300 psi., from about 110 psi. to about 250 psi., or from about 120 psi. to about 200 psi.

[0082] In some embodiments, a therapeutic device as described herein further comprises a battery pack. In some embodiments, the battery pack is enclosed in a box (e.g., a plastic box) that is mounted to the outer surface of the therapeutic device against the ankle that contacts the same area on the inner surface of the therapeutic device. In some embodiments, the box further comprises a user interface to communicate with the user (e.g., display information to the user). In some embodiments, the box encloses a control unit that is operatively connected to the battery pack and / or one or more therapeutic modules.

[0083] In use, a user can wear the therapeutic device by inserting the foot from the opening at the top portion of the therapeutic device down into the front portion of the therapeutic device. In some embodiments, the therapeutic device includes one or more zippers, straps, hooks and loops (e.g., products) and / or other suitable components to secure the therapeutic device to the foot area during treatment.

[0084] In general, a method for delivering thermal or compression therapy includes providing a treatment device to a user, applying an inner layer of the treatment device to a body surface of the user, and activating one or more treatment modules to deliver thermal or compression therapy to the body surface. In some embodiments, the treatment module is attached to the user's body using one or more zippers, straps, hooks and loops (e.g., products) and / or other suitable components to apply the inner layer of the therapeutic device to the user's body surface.

[0085] refer to Figure 1A , presents a block diagram of a treatment device 100 according to some embodiments. In some embodiments, the treatment device 100 may include a multi-layer holding mechanism 102, a temperature regulating component 104 held 111 by the multi-layer holding mechanism 102 (e.g., one or more straps, buckles, fabric layers, etc.), and a control module 106 communicatively coupled to the temperature regulating component 104 and also held by the multi-layer holding mechanism 102. In some embodiments, the multi-layer holding mechanism 102 may include one or more (e.g., all) flexible and / or elastic components of the treatment device 100. In an example, the multi-layer holding mechanism may include a flexible substrate. In some embodiments, the temperature regulating component 104 may include a fan, a heat sink, and a thermoelectric cooler (TEC). In some embodiments, the temperature regulating component 104 may be configured to couple and secure multiple components of the treatment device 100 in a compact arrangement. In some embodiments, the temperature regulating component 104 may include (e.g., coupled to) a portion of the multi-layer holding mechanism 102. In some embodiments, the treatment device 100 may include one or more temperature regulating components 104, as shown. In some embodiments, the therapeutic device 100 may also include a power supply module 108 held by the multi-layer holding mechanism 102. The power supply module 108 may be electrically coupled to the temperature regulating assembly 104 and the control module 106. In some embodiments, the power supply module 108 may not be held by the multi-layer holding mechanism 102. In an example, the power supply module 108 may instead be built into the control module 106. In one example, the power supply module 108 may be optional, wherein the control module 106 may include and / or perform all functions of the power supply module 108. The therapeutic device 100 may also include a client application executed at a mobile device 112 that communicates with the control module 106, and any other suitable components. In some embodiments, the therapeutic device 100 may include and / or may also be referred to as a wearable cooling and heating system.

[0086] Reference again Figure 1A, the treatment device 100 can deliver temperature-regulated cold therapy and / or heat therapy to a body region 114 of a user 116. In a specific example, the treatment device 100 can provide both cold therapy and heat therapy to a user 116, with rapid transitions between heat therapy and cold therapy providing operating modes (e.g., heating mode, cooling mode, etc.). In an example, the treatment device 100 can use a multi-layer retaining mechanism 102 and a temperature regulating component 104 to provide temperature therapy to a body region 114 of a user 116. The treatment device 100 can also be used to adjust the temperature of the heat therapy or cold therapy based on received control instructions (e.g., from a mobile application-based controller, a computing device, a mobile computing platform 112, a client application executing thereon, etc.). The treatment device 100 can also be used to monitor and / or track parameters of the treatment delivery, such as the temperature of the heat therapy or cold therapy provided, the power and / or energy usage of the system during the treatment delivery, and / or any other suitable parameters. Therapeutic device 100 can also be used to track user data, such as frequency of use (e.g., daily, hourly, monthly, etc.), duration of use (e.g., total duration in minutes, duration based on each operating mode, duration based on each continuous use, etc.), and treatment selections (e.g., heat therapy, cold therapy), and provide the tracked user data to an entity (e.g., a user, a physical therapist associated with the user, etc.) to guide an automated mode of providing treatment to the user.

[0087] The therapeutic device 100 may be worn by a user 116. In some embodiments, the therapeutic device 100 may be positioned at an area of ​​the user (e.g., a foot area 115, a knee area 117, a lower back area, an elbow area 118, etc.). In certain embodiments, the therapeutic device 100 is preferably a footwear that may be placed around a foot area of ​​the user, such that one or more temperature regulation subsystems are disposed proximal to a kneecap area of ​​the user.

[0088] In order to effectively position temperature treatment components of a treatment device relative to a user and provide temperature-regulated treatment to a body region of the user, it may be beneficial to package some of the non-elastic and elastic components of the treatment device together in a compact and / or portable arrangement. Module for delivering thermal and / or compression therapy

[0089] In general, as further discussed below, the systems, methods, and devices described herein may be or include: 1) a temperature therapy module for applying or delivering thermal therapy (e.g., a temperature regulation component such as a TEC and / or a heat generating unit), 2) a compression therapy module for applying or delivering compression therapy (e.g., a compression pad or inflatable bladder, and / or a vibrating chamber), and / or 3) a control unit for operating the treatment device, and / or combinations thereof.

[0090] In some embodiments, the devices, systems and / or methods as described herein may be configured differently with additional or fewer modules or components. Or in some embodiments, the controller may be configured so as to operate only a certain subset of modules. For example, in some embodiments, the treatment device may only apply temperature therapy or compression therapy.

[0091] In some embodiments, the module delivers one or more levels of compression therapy and / or temperature therapy. In some embodiments, a level of compression therapy captures a portion of a user's body region (e.g., a foot region or ankle region or other region).

[0092] In some embodiments, a module as described herein may be disposed at any portion of the treatment device. For example, the module may be disposed at an inner surface of the treatment device. In another example, the module may be disposed at an outer surface of the treatment device. In another example, the module may be disposed between the inner and outer surfaces of the treatment device. In another example, the module is disposed in an area configured to contact a user's foot portion. In some embodiments, the module is located on the outside of a user's ankle portion. In another example, the module is disposed in an area configured to contact a user's foot and ankle portion. (i) Temperature therapy module

[0093] In general, a temperature therapy module (sometimes referred to herein as a temperature regulation assembly) may be configured to couple and secure multiple components for a temperature therapy device. The temperature regulation assembly may include one or more of a mounting plate, a heat diffuser, a thermoelectric cooler (TEC), a spacer, a heat sink, a fan, a cover, and / or a cap, which may be packaged together in a compact arrangement. In some embodiments, the mounting plate may be mounted to the spacer, and the heat diffuser may be secured between the mounting plate and the spacer. In an example, the mounting plate may be an aluminum mounting plate. In some embodiments, the heat diffuser may include 3 layers: a top layer including a first adhesive layer (e.g., a first silicone adhesive layer), an intermediate layer including graphite / graphene, and a bottom layer also including a second adhesive layer (e.g., a second silicone adhesive layer). In some embodiments, a primer may be provided on the bottom layer of the heat diffuser, wherein the primer may be configured to bond a silicone adhesive on the mounting plate and / or the silicone overmolded insert to a bottom layer of the heat diffuser (e.g., also a silicone adhesive layer). In some embodiments, the heat sink can be mated and / or secured to the treatment device by mounting the fan to the spacer, wherein the heat sink can be secured between the fan and the spacer. In some embodiments, a cover can be placed over the spacer, the heat sink, and the fan, wherein the cover can include vents (e.g., vents configured to allow air flow to and / or from the heat sink). In some embodiments, the cover can also secure a portion of the flexible fabric (e.g., a top layer of a multi-layer retaining mechanism) to the spacer. In some embodiments, a cap can be placed over the cap, wherein the cap can include an opening configured to allow additional structural support and air intake into the temperature regulation assembly.

[0094] In some embodiments, the multi-layer retaining mechanism is configured to retain a component (e.g., a flexible component) of a temperature treatment device. The multi-layer retaining mechanism may include a top layer (which includes a control module) and a bottom layer (which includes a silicone overmolded insert). In some embodiments, the top layer may also include a flexible fabric and / or an elastic material. In one example, the top layer may include spandex. In some embodiments, the control module may include an electronic device housing and electronic components inside the electronic device housing. In some embodiments, the bottom layer may include one or more binding mechanisms, one or more structural supports, one or more straps, and one or more locking mechanisms. In some embodiments, the bottom layer may include polyester and / or spandex. In some embodiments, the bottom layer may include only polyester. In some embodiments, the strap may be indirectly coupled to the binding mechanism. In one example, the strap may be sewn into the bottom layer adjacent to the binding mechanism to mechanically couple the strap, the bottom layer, and the binding mechanism together. In some embodiments, the binding mechanism may include a flat spring that is flexible in one direction but non-flexible in another direction (e.g., a vertical direction). In some embodiments, the binding mechanism may include metal and / or a metal spring. In some examples, the binding mechanism may include a steel spring.

[0095] refer to Figure 1B-1D , presents multiple views of a temperature regulation assembly 140 according to some embodiments. Figure 1B A perspective view of a temperature regulation assembly is shown. Figure 1C A plan view of a temperature regulating assembly is shown. Figure 1D The temperature regulating assembly is shown with the cap and cover removed. Figure 1D The configuration and connections of the underlying components housed within the temperature regulation assembly 140 are depicted.

[0096] like Figure 1B and Figure 1C As shown in FIG. 1 , in some embodiments, the temperature regulating assembly 140 may include a cap 158 and a cover 154 . Figure 1C Also shown is the direction of the air flow used by the thermostat assembly 140 to adjust the temperature of the components contained within the thermostat assembly 140. In some embodiments, for air intake 131 into the thermostat assembly 140, air is pulled into the heat sink by a fan through the cap 158, for example, Figure 1D 154 and heat sink 152 are shown in FIG. In some embodiments, for air flow 133 out of the thermostat assembly 140, the fan pushes air over the heat sink and out of the thermostat assembly 140 through the vents 155 of the cover 154. In addition, although the air flow Figure 1C In the example shown in one direction, such as air intake 131 through cap 158 and exhaust through vent 155, the air can flow in the opposite direction. For example, air can flow into the temperature regulating assembly through vent 155 and leave the temperature regulating assembly through cap 158.

[0097] Figure 1D A plan view of the thermostat assembly is shown without the cover and cap. Figure 1E A perspective view of the temperature regulation assembly is shown. Figure 1D and Figure 1E As shown in FIG. 1 , the temperature adjustment assembly 140 may include a spacer 148, a heat sink 152, and a fan 154. The spacer 148 may also be referred to as a mounting member or the like. Figure 1D and Figure 1E An exemplary mounting configuration of the fan 154 to the spacer 148 is shown. In an example, the fan 154 can be fixed by a screw 149 inserted into the columnar structure 147 of the spacer 148. Although not shown, the screw 149 can also be inserted through the spacer 148. Figure 1C The heat sink 152 is positioned by corresponding holes in the cover 158. In some embodiments, as shown, the heat sink 152 can be fixed between the fan 154 and the spacer 148. In an example, the heat sink 152 can be fixed by a clamping force between the fan 154 and the spacer 148.

[0098] Each component of the treatment device in FIG. 1 according to some embodiments is described in detail below. Figures 2A-2D The mounting plate 124 is described in detail. In another example, reference Figure 3A and Figure 3B The heat spreader 126 is described in detail.

[0099] refer to Figures 2A-2D , showing various views of a mounting plate for a temperature regulation assembly according to some embodiments. Figure 2A A top view of a mounting plate for a temperature regulating assembly is shown, and Figure 2B A bottom view of the mounting plate of the thermostat assembly is shown. Figure 2C shows a cross-sectional view of the mounting plate, and Figure 2D An enlarged view of the opening showing the mounting plate is shown.

[0100] refer to Figure 2A and Figure 2B , present a top view and a bottom view, respectively, of a mounting plate of a temperature regulating assembly according to some embodiments. As shown, the mounting plate 200 may have a top portion 202 and a bottom portion 204. Figure 2A The mounting plate 200 is shown from a top view, for example, a top portion 202 of the mounting plate 200 is shown. Figure 2B The mounting plate 200 is shown from a bottom view, for example, showing a bottom portion 204 of the mounting plate 200. In some embodiments, the mounting plate 200 may include one or more openings 206. In some embodiments, the one or more openings 206 may be configured to receive one or more screws that may be used to mount the mounting plate 200 to the heat spreader and the spacer. In some embodiments, the mounting plate 200 may be cut into any suitable shape: circular, oval, polygonal, etc. In an example, the mounting plate 200 may be hexagonal in shape, such as Figure 2A and Figure 2B . The mounting plate 200 may also include a tab feature 208. In embodiments, the tab feature 208 may be in any shape: triangular, circular, square, etc. In an example, the tab feature 208 may be in a teardrop shape, as shown. In some embodiments, the mounting plate 200 may include aluminum (e.g., anodized aluminum, 6061 aluminum, etc.). In some embodiments, the aluminum used in the mounting plate 200 is untreated, for example, the aluminum is not anodized. In some embodiments, the mounting plate 200 may include any metal and / or alloy, for example, copper, steel, etc.

[0101] References Figure 2C and Figure 2D , presents a cross-sectional view of a mounting plate and an enlarged view of an opening of the mounting plate according to some embodiments. Figure 2C and Figure 2D, the top portion 202 of the mounting board 200 is shown facing downward. In some embodiments, the mounting board 200 may include a first adhesive 205 disposed above (e.g., on) the top portion 202 of the mounting board 200. In some embodiments, the first adhesive 205 may include or be a double-sided tape. In an example, the first adhesive 205 may include acrylic on one side and a silicone adhesive on the other side. In some embodiments, the acrylic side of the first adhesive 205 may face the top portion 202 of the mounting board 200, and the silicone adhesive side may face the silicone overmolded insert. In an example, the first adhesive 205 may include a 3M TM Tape 9731. In some embodiments, a release liner can be disposed over the first adhesive 205 to protect the first adhesive 205 during manufacturing. A second adhesive 207 can be disposed over (e.g., on) the bottom portion 204 of the mounting board 200. In some embodiments, the bottom portion 204 of the mounting board 200 can be coupled to the heat spreader 146 via the second adhesive 205. In an example, the second adhesive 205 can support adhering the mounting board 200 to the heat spreader. Figure 2D Shown in Figure 2C An enlarged view of the opening 212 of FIG. Figure 2D In some embodiments, the mounting plate 200 may have a thickness 214 in the range of 0.2 mm to 1 mm. In an example, the mounting plate 200 may have a thickness 214 of approximately 0.40 mm. Figure 2D , first adhesive 205 can be disposed over opening 212 (e.g., representing opening 206), wherein a gap 215 can be disposed between opening 206 and first adhesive 205. In some embodiments, mounting plate 200 can be configured to anchor and / or stabilize thermostat assembly 140. Additionally, bottom portion 204 of mounting plate 200 can face upward toward a bottom portion of a heat spreader when mounted with the remaining thermostat assembly components, as further described below.

[0102] refer to Figure 3A and Figure 3B , showing various views of a heat spreader of a temperature regulation assembly according to some embodiments. Figure 3A A heat spreader of a temperature regulation assembly is shown. Figure 3B A cross-sectional view of a heat spreader is shown.

[0103] refer to Figure 3A , presents a heat spreader for a temperature regulating assembly according to some embodiments. The heat spreader 300 may have a top portion 302 and a bottom portion 304. An interior region 306 of the bottom portion 302 of the heat spreader 300 may be coupled to a mounting plate (e.g., Figures 2A-2DThe heat diffuser 300 may be attached to the bottom portion 204 of the mounting plate 200 at the interior region 306 when mounted together. In some embodiments, the heat diffuser 300 may be configured to diffuse temperature in horizontal and vertical directions (e.g., along the x, y, and z directions). In embodiments, the heat diffuser 300 may be configured to provide efficient heat application, which may enable the treatment device to deliver a desired amount and / or rate of heat therapy or cold therapy using fewer TECs than would otherwise be required. In some embodiments, the heat diffuser 300 may arrive as a roll at the beginning of the manufacturing process. In some embodiments, during manufacturing, the bottom portion 304 of the heat diffuser 300 may include a pad that may be later removed to expose an adhesive disposed at the bottom portion 304 of the heat diffuser 300.

[0104] Reference again Figure 3A , the heat diffuser 300 may include one or more fingers 310 extending from one end 312 of the heat diffuser 300. In one example, 11 fingers 310 may be formed at one end 312 of the heat diffuser 300. In some embodiments, at least one finger 310 may extend from a side 312 (e.g., a tapered side) of the heat diffuser 300 toward a central portion 314 of the heat diffuser. The finger 310 may be a cutout (e.g., a narrow, elongated gap) in the heat diffuser material itself. In some embodiments, the finger 310 may be configured to provide mechanical stress relief and / or strain relief when the treatment device is in use. In an embodiment, the average length of the finger 310 may be less than or equal to 1 / 2 and / or 1 / 4 of the length of the side 315 of the heat diffuser 300. In some embodiments, the length of the finger 310 may be in the range of approximately 5-25 mm. In one example, the length of the finger 310 may be in the range of approximately 10-20 mm (e.g., 10-15 mm). In some embodiments, the length of the finger 310 is selected to provide as much surface area of ​​the heat diffuser as possible around the user's knee. In some embodiments, one or more fingers 310 may include a longer finger 316 located at an outer portion of the heat diffuser 300 and a shorter finger 318 located at an inner portion of the heat diffuser 300. In some embodiments, the finger 310 may include one or more openings 322, 324 located at one end of each finger 310. In an embodiment, the openings 322, 324 may vary in size. In an example, an opening 324 located at one end of one finger may have a diameter that is smaller than the diameter of another opening 322 located at the end of another finger. In some embodiments, the openings may be configured to relieve mechanical stress from the finger and / or one end 312 of the heat diffuser 300.

[0105] Still refer to Figure 3A, the heat spreader 300 may have one or more openings 326. The one or more openings 326 may be connected to the Figures 2A-2D The mounting plate 200 is aligned with the corresponding opening 206 of the heat spreader 300. In some embodiments, the one or more openings 326 can be configured to receive one or more screws that can be used to mount the mounting plate 200 and the heat spreader 300 to the spacer 148.

[0106] Refer again Figure 3A , the heat diffuser 300 may include a notch 328. In an example, the notch 328 may be used to help an operator determine which temperature regulating assembly will be attached to the corresponding heat diffuser during manufacturing or preparation. In an example, although one heat diffuser is shown, as described herein, multiple (e.g., different / unique) heat diffusers and / or multiple (e.g., different / unique) temperature regulating assemblies may be used. In some embodiments, the heat diffuser 300 may have one or more notches. Each individual notch or notch group may be different and / or unique from each other. In an example, as shown, the heat diffuser 300 may include one notch 328. In another example, another heat diffuser corresponding to another temperature regulating assembly may have two notches. In yet another example, another heat diffuser corresponding to another temperature regulating assembly may have three notches, and so on. Therefore, in some embodiments, the number of notches may determine which temperature regulating assembly will be connected to the corresponding heat diffuser. For example, a first temperature regulating assembly can be mounted to a heat diffuser 300 including a single notch 328, a second temperature regulating assembly can be mounted to another heat diffuser including two notches, and so on. In some embodiments, there can be one to five notches, for example, corresponding to up to five temperature regulating assemblies. As described above, in some embodiments, a therapeutic device can include one or more (e.g., greater than five) temperature regulating assemblies.

[0107] Still refer to it again Figure 3A , the heat spreader 300 may include an alignment opening 330. In an embodiment, the alignment opening 330 may be located adjacent to the at least one mounting opening 326. In some embodiments, the alignment opening 330 may correspond to a bottom alignment feature 533 of the spacer 500 (e.g., reference Figure 5C ). In an example, the alignment opening 330 and the bottom alignment feature 533 can be used to help an operator determine the proper alignment and / or placement between the spacer 500 and the heat spreader 300 during manufacturing and / or preparation of the temperature regulation assembly. In an example, the bottom alignment feature 533 can fit into and / or align with the alignment opening 330.

[0108] refer to Figure 3B, illustrating a cross-section of a heat diffuser according to some embodiments. In some embodiments, the heat diffuser 300 may include 3 layers (340, 342, 344). In an example, the heat diffuser may include a top layer 340, an intermediate layer 342, and a bottom layer 344. In some embodiments, the top layer 340 may be or include a first adhesive layer, the intermediate layer 342 may be or include a graphite / graphene layer, and the bottom layer 346 may be or include a second adhesive layer. In some embodiments, the first adhesive layer and / or the second adhesive layer may include a silicone adhesive. In some embodiments, the top layer 340 and / or the bottom layer 344 may have a thickness in the range of approximately 8-12 microns. In some examples, the top layer and / or the bottom layer may have a thickness of approximately 10 microns. In some embodiments, a PET (polyethylene terephthalate) layer may be disposed above the top layer 340 and / or the bottom layer 344. In an example, the intermediate layer 342 may include a graphene layer including a synthetic graphite sheet. In some examples, the intermediate layer 342 may include small particles (e.g., graphene particles). In some embodiments, the graphene layer may include a metal-based powder for thermal energy transfer. In an example, the heat spreader 300 may include DSN5050-10DC10SB synthetic graphite sheet from DASEN Corporation.

[0109] Reference again Figure 3B In some embodiments, a primer may be applied to the heat diffuser. As shown, a primer 346 may be applied to the bottom layer 344 of the heat diffuser 300. In some embodiments, the primer is applied to the bottom layer 344 to form a primer layer 346 over the bottom layer 344. In some embodiments, the primer may be mixed with a catalyst and then applied (e.g., evenly spread) over the bottom layer 344 of the heat diffuser 300. In an example, the primer may act as another layer disposed directly on the bottom layer 344. In some embodiments, the primer may be applied to the bottom layer 344 to form a primer layer 346 over the bottom layer 344. Figure 3B In contrast to the embodiment shown in , primer can be applied to the top layer 340 of the heat diffuser 300, rather than to the bottom layer 344. In some embodiments, primer can be applied to both the bottom layer 344 and the top layer 340 of the heat diffuser. In some embodiments, the primer can be applied immediately after mixing with the catalyst. In an example, a ratio of 30:1 between the primer and the catalyst can be used. In some embodiments, the primer can be diluted with toluene. In some embodiments, a thin cloth and / or latex gloves can be used to apply primer to the bottom layer 344 and / or the top layer 340 of the heat diffuser 300. In an example, the inventors found that cloth and / or latex gloves are effective application tools compared to brushes, wherein a brush can produce marks, such as brush marks, on the primer after application. In some embodiments, primer can be applied with a thickness of approximately 1 mm. In some embodiments, the entire bottom portion 304 and / or the top portion 302 of the heat diffuser can be covered by a corresponding layer of primer 346.

[0110] Still refer to Figure 3B After the primer is mixed with the catalyst and applied to the bottom layer and / or top layer, the primer may be allowed to dry. In some embodiments, the primer may be allowed to dry for approximately 10-20 minutes. In some embodiments, once the primer is dry, the primer may be allowed to cure for any suitable amount of time before the mounting plate is applied and / or adhered to the heat diffuser 300. In some embodiments, the primer may be configured to allow the silicone adhesive on the mounting plate to uniformly adhere to, for example, the first layer 340 or the third layer 344 of the heat diffuser 300. In some embodiments, the primer may include Momentive's SilGripPSA529 silicone pressure sensitive adhesive.

[0111] refer to Figure 3A , Figure 3B and Figures 2A-2D In some embodiments, the primer layer 346 may be used to couple the heat spreader 300 to a mounting plate (eg, Figures 2A-2D 200) and the silicone overmolded insert. In an example, the silicone-based adhesive disposed on the mounting board 200 can be directly coupled to the primer layer 346. In some examples, the interior region 306 of the bottom portion 302 of the heat spreader 300 can be coupled to the bottom portion 204 of the mounting board 200 via the primer layer 346 and via the silicone adhesive above the mounting board 200. In a similar manner, in some embodiments, the heat spreader 300 can be coupled to the silicone overmolded insert 142 via the silicone adhesive on the silicone overmolded insert 142 at an area of ​​the bottom portion 304 outside the interior region 306 and via the primer layer 346. Therefore, in the same embodiment, the primer layer 346 can achieve the coupling between the heat spreader 300, the mounting board 200, and the silicone overmolded insert 142 via the primer layer 346 and the silicone adhesive disposed above the mounting board 200 and the silicone adhesive disposed above the silicone overmolded insert 142. In a specific example, primer 346 can be configured to uniformly bond heat diffuser 300 to mounting plate 200 and / or silicone overmold insert 142. In some embodiments, the above-described configuration that allows heat diffuser 300 and / or mounting plate 200 to be bonded to silicone overmold insert 142 (e.g., silicone substrate) can be referred to as a system for mounting a rigid member to a silicone substrate of a temperature therapy device.

[0112] refer to Figure 4, presents a thermoelectric cooler (TEC) of a temperature regulating assembly according to some embodiments. In an embodiment, a TEC 400 may be selected based on a thermal conductivity level of the TEC 400. In an example, a TEC 400 having a high thermal conductivity level (e.g., greater than or equal to the thermal conductivity of a ceramic material) may be used. The TEC 400 may have a top portion 402 and a bottom portion 404. In some embodiments, a length 406 of the TEC may be approximately equal to its width 408. In an example, the length 406 of the TEC 400 may be 40 mm, and the width 408 may be 40 mm. Thermal grease may be provided between a heat spreader and the TEC 400. In an example, a thermal grease having a high thermal conductivity (e.g., in the range of approximately 1-15 w / mk (e.g., 1 w / mk)) may be used. In an embodiment, a thermal grease from Halnziye Corporation may be used.

[0113] refer to Figures 5A-5D , showing various views of a spacer according to some embodiments. In some embodiments, the spacer may include a mounting system for connecting an elastic / flexible portion of a therapeutic device to a non-elastic, rigid and / or solid element. In examples, the spacer may include various mechanical features configured to mount / connect a rigid or solid element to a flexible object. In one example, the spacer may also be referred to as a mounting system. Figure 5A Illustration of the spacer of the temperature regulating assembly. Figure 5B A top view of the spacer is shown. Figure 5C A bottom view of the spacer is shown. Figure 5D A side view of the spacer is shown.

[0114] refer to Figure 5A and Figure 5B , presents multiple views of a spacer according to some embodiments. In some embodiments, the spacer 500 may include a top portion 502 and a bottom portion 504. In some embodiments, the spacer 500 may include a central opening 506 configured to receive a TEC (e.g., from Figure 4TEC). In some embodiments, the central opening 506 may include dimensions 524, 526 that allow the TEC to fit into the central opening 506. In an example, the central opening 506 may have a length 524 in the range of approximately 30-60 mm and a width 526 in the range of approximately 30-60 mm. In some embodiments, the central opening 506 may include a shape similar to and / or the same as the TEC, for example, a square opening. Although the central opening 506 may include a square opening, other shapes may be used, such as a circular opening, a polygonal opening, etc. As shown, the spacer 500 may have an outer diameter 522 in the range of approximately 50-70 mm. In some embodiments, the spacer 500 may have an outer wall 528. In some embodiments, the outer wall 528 may have a thickness in the range of approximately 0.5-2.5 mm.

[0115] Reference again Figure 5A and Figure 5B In some embodiments, the spacer 500 may include one or more columnar structures 508 extending from the top portion 502 of the spacer 500. As referred to herein, the one or more columnar structures 508 may be referred to as a columnar structure or a plurality of columnar structures. In an example, the spacer 500 may include one or more columnar structures 508. Exemplary columnar structures are Figure 5A and Figure 5B In some embodiments, a pair of columnar structures 510, 512 may be used, for example, Figure 5A and Figure 5B As shown in FIG. 5 , there is a pair on either side of the spacer 500. In the example, Figure 5A and Figure 5B 510 and a second pair of columnar structures 512 are shown in FIG. In some embodiments, the spacer 500 may include a notch 514. In an embodiment, the notch 514 may be configured to align the placement of a heat sink over the spacer 500 and to secure a heat sink (e.g., heat sink 152) within the temperature regulating assembly. In some embodiments, the notch 514 may be located between two columnar structures in the pair of columnar structures 510, 512, such as Figure 5A and Figure 5B 500. In some embodiments, one or more notches 514 may be used. In an example, if there are two pairs of columnar features 510, 512, there may be two corresponding notches, one for each pair of columnar features. In some embodiments, a heat sink may be placed above the spacer 500. In some embodiments, when the heat sink is positioned above the spacer 500, the tabs of the heat sink (e.g., Figures 6A-6C) can be aligned and / or placed into the recess 514. In some embodiments, the recess 514 and the protrusion of the heat sink can hold the heat sink in place above the spacer 500, thereby preventing any movement of the heat sink. In an example, the recess 514 and the protrusion combination can lock and / or hold the heat sink in place between the paired columnar structures 510, 512 of the spacer in a horizontal direction. In some embodiments, the heat sink may include one or more protrusions. In an example, the heat sink may have two protrusions, and the two protrusions can align with two corresponding recesses 514 (e.g., Figure 5A and Figure 5B In some embodiments, one or more notches 514 may be configured to prevent the heat sink from twisting in place and maintain a desired heat sink orientation, for example, maintaining the orientation or alignment of the heat sink fins during and after assembly of the temperature therapy device.

[0116] Still refer to Figure 5A and Figure 5B In some embodiments, each columnar structure 508 may include a top opening 516 configured to receive a screw to be inserted from the top portion 502 of the spacer 500. In some embodiments, the columnar structure 508 may be configured to receive a screw for mounting a fan. In an example, the columnar structure 508 may be configured to receive a screw for mounting a fan from FIG. 1 and FIG. Figure 7 In some embodiments, the top opening 516 may be used to place the screws of the fan. In an example, the screws may be placed through corresponding openings in the fan and placed into the top opening 516. In some embodiments, one or more top openings 516 may be used. In an example, there may be a top opening 516 corresponding to each columnar structure 508. In some embodiments, a top alignment feature 518 may be located at the top end of one or more columnar structures 508 beside the top opening. In some embodiments, the top alignment feature 518 may be configured to ensure that the operator inserts the screws into the top opening 516 in the correct direction and / or configuration. In an example, the operator may refer to the top alignment feature 518 when placing the screws in the top opening 516 for installing the fan. In some embodiments, not all columnar structures 508 may include the top alignment feature 518. In an example, only the columnar structures 508 used to install the fan may include the top alignment feature 518. In an embodiment, the operator may be instructed to locate the top alignment feature 518 and only place the screws (e.g., for installing the fan) where the top alignment feature 518 is located. In some embodiments, the alignment feature 518 located on the first pair of columnar structures 510 may not be aligned with another alignment feature 518 located on the second pair of columnar features 512. In an example, the alignment feature 518 may be located on a first columnar structure in the first pair of columnar structures 510, and the other alignment feature 518 may be located on a different second columnar structure in the second pair of columnar structures 512, such as Figure 5A and Figure 5B In some embodiments, the top alignment feature 518 may have various shapes, such as a circle, a square, a rectangle, an oblong, a polygon, etc. In an example, as shown in FIG. Figure 5A and Figure 5B As shown in , the top alignment feature 518 may include a semicircular and / or half-moon shape. Therefore, in some embodiments, the top alignment feature 518 may be configured to help the operator position and / or place the fan. In some embodiments, the fan may be mounted above the heat sink and the spacer using one or more screws to hold the heat sink in place, such as described above. For example, during assembly of the mounting system, the heat sink may move and / or twist. Therefore, in an example, the fan may be mounted above the heat sink and the spacer so that the heat sink is held in place by the fan. In the same example, the fan may hold the heat sink in place and prevent the heat sink from moving during and after assembly of the temperature regulating assembly. In some embodiments, not all top openings 516 may correspond to or be located at the columnar structure 508. In an example, some top openings 517 may be located on the underside of the top portion 502.

[0117] Refer again Figure 5A and Figure 5B In an embodiment, the spacer 500 may include one or more wire management features. In an example, the spacer 500 may include a wire management feature configured to receive at least one wire from a temperature sensor, a TEC, and / or a fan. In some embodiments, the wire management feature may include grooves, recessed holes, burrs, and / or cutouts built into the spacer 500 that include dimensions for wires for electronic devices (e.g., from a temperature sensor, a TEC, and / or a fan). In an example, the wire management feature may be configured to receive one or more wires and may secure the wires in place during and after assembly of the temperature treatment device. In an embodiment, the spacer 500 may include a first wire management feature 527 configured to receive and secure one or more wires from a TEC. In an embodiment, the spacer 500 may include a second wire management member 529 configured to receive and secure one or more wires from a fan. In an example, the wire management member 529 for the fan may act as a hook and secure the wires from the fan in place.

[0118] Reference again Figure 5A and Figure 5B, in an embodiment, the spacer 500 may include one or more receiving features for various elements of the temperature regulating assembly. In some embodiments, the spacer 500 may include a receiving portion in the form of a cutout 520 for a temperature sensor. In an example, the temperature sensor may be coupled to the TEC, and the temperature sensor may fit into the cutout 520 of the spacer 500. The spacer 500 may include a plurality of receiving portions 531, which may also be referred to as channels, for example, to receive corresponding alignment features of the top layer. In addition, the spacer 500 may include an edge 515 adjacent to the alignment feature 531. In some embodiments, the edge 515 of the spacer 500 may be aligned with a flat edge of the alignment feature of the top layer.

[0119] See also Figure 5C , presenting a bottom view of a spacer according to some embodiments. In some embodiments, the spacer 500 may include one or more bottom openings 519 located at the bottom portion 504 of the spacer 500, and the bottom openings 519 may be configured to receive screws from the bottom portion 504 of the spacer 500. In some embodiments, the bottom openings 519 may be configured to receive screws from the bottom portion 504 of the spacer 500. Figures 2A-2D The mounting plate can be mounted to the bottom portion 504 of the spacer 500 by inserting one or more screws through the bottom openings 519 in the spacer 500 and the corresponding openings in the mounting plate. In some embodiments, the spacer 500 may include 7 bottom openings 519. In an example, the total number of bottom openings 519 may add up to an odd number, for example, the number of bottom openings 519 is not designed to be symmetrical or even. In some embodiments, the bottom openings 519 may have an asymmetric configuration. In an embodiment, the asymmetric configuration of the bottom openings 519 can ensure that the mounting plates are installed in a specific order, for example, to prevent an operator from installing the mounting plates by mistake or opposite to the intended configuration. In some embodiments, the bottom portion 504 of the spacer 500 may have an embossed and / or chamfered edge 521. In some embodiments, the edge 521 of the bottom portion 504 may be configured to receive and / or align with the edge of the mounting plate. In some embodiments, the distance between the opposing bottom openings 532 may be in the range of approximately 30-60 mm. In some embodiments, the distance between adjacent bottom openings 534, 536 may be in the range of approximately 5-30 mm.

[0120] Reference again Figure 5C In some embodiments, the spacer 500 can include a bottom alignment feature 533. In some embodiments, the bottom alignment feature 533 can be located adjacent to at least one bottom opening 519. In some embodiments, the bottom alignment feature 533 can correspond to (e.g., Figure 3A and Figure 3BThe bottom alignment feature 533 and the alignment opening 330 of the heat spreader 300 can be used to help an operator determine the proper alignment and / or placement between the spacer 500 and the heat spreader 300 during manufacturing and / or preparation of the temperature regulating assembly. In an example, the bottom alignment feature 533 can fit into and / or align with the alignment opening 330.

[0121] refer to Figure 5D , presents a side view of a spacer according to some embodiments. Figure 5D Shown in Figure 5A and Figure 5B A cross-sectional view of a columnar structure 508. As shown, Figure 5D An exemplary columnar structure is circled in 509. In addition, Figure 5D A side view of the top alignment feature 518 is shown in FIG. Figure 5D The top openings 516 are shown to extend through the spacer and intersect with corresponding bottom openings 519. In some embodiments, each of the top openings 516 may have a corresponding bottom opening 519 (e.g., from Figures 5A-5D In some embodiments, each of the top opening 516 and the bottom opening 519 can be a through hole, for example, an opening can extend from the top opening 516 through the spacer 500 and out through the corresponding bottom opening 519 .

[0122] Still refer to it again Figures 5A-5D In some embodiments, the spacer may include a material such as plastic, resin, and / or fire-resistant plastic / resin. In an example, the spacer may include a material selected from the group consisting of nylon 66, DuPont 801, and DuPont 2801.

[0123] Figure 5E 550 of a temperature regulating assembly according to some embodiments is shown. Figure 5E As shown in , spacer 550 includes a similar structure as spacer 500 and further includes one or more wings 552 disposed at the outer periphery of spacer 500 .

[0124] Applicants have discovered that in some cases, particularly when a compressive therapy module that is not in direct contact with a temperature therapy module is activated (e.g., when a bladder as described in U.S. Patent Application No. 17 / 384,501 is inflated, which is incorporated herein by reference in its entirety), it can cause the contact force between the temperature therapy module and the body surface to decrease (or create a gap in some cases). This is because the compressive force applied directly to the body surface is not also applied correspondingly to the temperature therapy module. To address this situation, Applicants incorporate features / protrusions that are in direct contact with the compressive therapy module into the temperature therapy module, so that the temperature therapy module and the body surface are compressed at the same time. In general, the feature / protrusion can take any suitable form, an example of which is Figure 5E Wings 552 are shown in FIG. In use, wings 552 can enable and / or stabilize the temperature regulation assembly toward the user's body to deliver temperature therapy.

[0125] The wings can have any number and can be arranged in any suitable orientation (e.g., symmetrical or asymmetrical, equidistant or non-equidistant). In some embodiments, the distance between any two adjacent wings 552 is the same. Therefore, the spacer 550 can have radial symmetry.

[0126] In some embodiments, the spacer 550 includes one or more (eg, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more) wings. In some embodiments, 5 or more wings are preferred.

[0127] Fig. 5F and Figure 5G are various views of a temperature regulating assembly including a spacer 550 according to some embodiments. Figure 5G Also shown are additional components assembled with the spacer 550, such as a mounting plate (e.g., mounting plate 200) and / or a heat spreader 300. In some embodiments, the mounting plate comprises any suitable shape: circular, oval, polygonal, etc. In some embodiments, the heat spreader comprises any suitable shape: circular, oval, polygonal, etc. In some embodiments, the thermostat assembly 140 further comprises an annular member 554 operatively connected to the outer perimeter of a cap (e.g., cap 900) of the thermostat assembly.

[0128] refer to Figures 6A-6C , showing various views of a heat sink according to some embodiments. In some embodiments, a heat sink may include components and / or materials configured to draw heat away from a TEC and / or other elements of a temperature regulation assembly. Fig. 6A Figure 2 shows a heat sink for a temperature regulation assembly. Figure 6B A cross-sectional view of a heat sink is shown. Figure 6C A bottom view of the heat sink is shown.

[0129] refer to Fig. 6A , presenting a heat sink according to some embodiments. In some embodiments, the heat sink 600 includes a plurality of fins 602 extending from a base portion 604 of the heat sink 600. In some embodiments, the plurality of fins 602 may be formed by a scraping technique. In some embodiments, the plurality of fins 602 may be referred to as scraped fins. In some embodiments, in contrast to using extrusion (which is a way to form a conventional heat sink), the entire heat sink 600 may be formed using a scraping technique. In some embodiments, the heat sink 600 may be referred to as a scraped heat sink. In an example, a metal workpiece scraping process may be used to form the heat sink 600 and / or the plurality of fins 602. As mentioned herein, the plurality of fins 602 may also be individually referred to as, for example, each fin 602 or as one or more fins 602. In some embodiments, the heat sink 600 may include a first protrusion 606. In some embodiments, one or more protrusions may be used, such as Figure 6B and Figure 6C As shown in .

[0130] refer to Figure 6B , presents a cross-sectional view of a heat sink according to some embodiments. In order to maximize heat dissipation for a temperature treatment device, it may be useful to form the fins 602 as thin as possible. In some embodiments, each fin 608 may include a thickness 610 in the range of approximately 0.2-0.4 mm. In an example, each fin 608 may have a thickness 610 of approximately 0.3 mm. In some embodiments, each fin 602 may have a height 608 in the range of approximately 9-11 mm. In an example, each fin 602 may have a height 608 of approximately 10 mm. In some embodiments, the distance 612 between each fin 608 may be in the range of approximately 0.80 mm-1.0 mm. In an example, the distance 612 between each fin 608 may be approximately 0.95 mm. In some embodiments, the distance 614 between a fin on one side of the heat sink to another fin on the other opposite side of the heat sink may be in the range of 39-41 mm. In some embodiments, the distance 614 between a fin on one end of the heat sink to the last fin on the corresponding opposite end of the heat sink may be approximately 40.3 mm. In some embodiments, the heat sink 600 may include approximately 10-50 fins. In an example, the heat sink 600 may include 33 fins. In some embodiments, the heat sink may have 27 fins. In some embodiments, the base 604 of the heat sink 600 may have a thickness 616 in the range of approximately 1.5-2.5 mm. In an example, the base 604 of the heat sink 600 may have a thickness 616 of approximately 2.0 mm. In some embodiments, the base 604 may have a substantially smooth bottom surface. The heat sink 600 may also have protrusions 606, 607, which will be described below. Figure 6C discussed in.

[0131] refer to Figure 6C , presenting a bottom view of a heat sink according to some embodiments. The heat sink 600 may include a first tab 606 and a second tab 607, as shown. In embodiments, as discussed above, the tabs 606, 607 of the heat sink 600 may be configured to Figures 5A-5D One or more notches 514 of the spacer 500 of the heat sink 600 are aligned and / or fit into them. As shown, the tabs 606, 607 may not be aligned along the horizontal direction of the figure. In some embodiments, the first tab 606 and the second tab 607 may be offset from each other. In some embodiments, the first tab 606 may be offset from the second tab 607 by a distance 618 in the range of approximately 4.5-6.5 mm. In an example, the first tab 606 may be offset from the second tab 607 by a distance 618 of approximately 5.6 mm. In some embodiments, the tabs 606, 607 may extend 620 from the heat sink 600. In some embodiments, the extension 620 of the tabs 606, 607 from the heat sink 600 may be in the range of approximately 1.5-3.5 mm. In an example, the extension 620 of the tabs 606, 607 from the heat sink 600 may be approximately 2.70 mm. In some embodiments, the first tab 606 and the second tab 607 may have a width 622 in the range of approximately 3.5-5.5 mm. In an example, the first tab 606 and the second tab 607 may have a width 622 of approximately 4.4 mm. In some embodiments, the heat sink 600 may have a width 624 in the range of approximately 35-45 mm. In an example, the heat sink 600 may have a width 624 of approximately 40.70 mm. In some embodiments, the heat sink 600 may have a length 626 in the range of approximately 50-60 mm. In an example, the heat sink 600 may have a length 626 of approximately 57.50 mm.

[0132] refer to Figures 6A-6C In some embodiments, the heat sink may include aluminum. In an example, the heat sink may include anodized aluminum. In some embodiments, the heat sink may include aluminum 6063.

[0133] refer to Figure 7 , presents a fan of a temperature regulation assembly according to some embodiments. In some embodiments, the fan 700 includes a plurality of openings 702. In some embodiments, the openings 702 can be configured to receive a fan for mounting to a Figures 5A-5D In some embodiments, the width 704 of the fan 700 may be in the range of approximately 35-45 mm. In an example, the width 704 of the fan 700 may be approximately 40 mm. In some embodiments, the length 706 of the fan 700 may be in the range of approximately 35-45 mm. In an example, the length 706 of the fan 700 may be approximately 40 mm. The fan 700 may include a wire 708 for electrical power.

[0134] refer to Figures 8A-8E , presents various views of a cover according to some embodiments. In some embodiments, the cover can be an intermediate structure configured to enclose and / or contain a Figures 5A-5D Spacers from Figures 6A-6C The heat sink and Figure 7 The cover can also be configured to Fig. 10A -10D top layer fixed to Figures 5A-5D spacer. Fig. 8A The cover of the temperature regulation assembly is shown. Figure 8B A side view of the cover is shown. Figure 8C A top view of the cover is shown. Fig.8D Another side view of the cover is shown. Fig. 8E An enlarged view of the locking mechanism of the cover is shown.

[0135] refer to Fig. 8A , presents a cover for a temperature regulating assembly according to some embodiments. In some embodiments, the cover 800 may include a top portion 802 and a bottom portion 804. In some embodiments, the cover 800 may include a central opening 806 (e.g., similar to Figures 5A-5D In some embodiments, the central opening 806 may include a central opening of a spacer. Figure 7 The fan of the central opening 806 may be similar and / or the same shape, such as a square opening. Although the central opening 806 may include a square opening, other shapes such as a circular opening 806, a polygonal opening, etc. may be used. In some embodiments, during the installation and / or assembly of the temperature regulating assembly, the cover 800 may be positioned above the spacer, the heat sink, and the fan. In some embodiments, the cover 800 may include one or more vents 808. In some examples, the vents 808 are used as exhaust vents, thereby allowing air that has been circulating near the fins of the heat sink to flow out of the temperature regulating assembly. In some examples, the vents are used as intake vents, thereby allowing air to flow into the temperature regulating assembly before circulating near the fins of the heat sink. In some embodiments, the vents 808 may also be referred to herein as a plurality of vents 808, or individually referred to as, for example, each vent 808. In some embodiments, as shown, the vents 808 may include a pseudo-square shape, as shown. In some embodiments, the vents 808 may include any suitable shape, such as a rectangular, square, circular, and the like.

[0136] Reference again Fig. 8AIn some embodiments, the cap 800 may include a locking mechanism 810. In some embodiments, the locking mechanism 810 may be shaped like a wedge. In some embodiments, the locking mechanism 810 may be configured to fit into and / or lock into a corresponding feature of the cap. In some embodiments, the cap 800 may include an alignment feature 812. In some embodiments, the alignment feature 812 may be configured to align the cap (e.g., from Figures 9A-9D In some embodiments, the alignment feature 812 may include a short wall extending from the cover, for example, in contrast to the locking mechanism 810, without a wedge or vertically extending feature. In some embodiments, the cover 800 may include a first opening 814 and a second opening 816. In some embodiments, the openings 814, 816 may be used to mount the cover 800 to the spacer. In some embodiments, the first opening 814 and the second opening 816 may be configured to receive a screw that may be used to mount to the spacer. Figure 5A and Figure 5B The top opening of the spacer and / or mounted to Figure 7 the opening in the fan.

[0137] refer to Figure 8B , presenting a side view of a cover according to some embodiments. As shown, the cover 800 may include a locking mechanism 810 and an alignment feature 812. In some embodiments, the cover 800 may include one or more vents 808, such as: a first vent 818, a second vent 820, a third vent 822, and a fourth vent 824. In some embodiments, the width of the first vent 818 may be greater than the width of the second vent 820, the third vent 822, and the fourth vent 824. In some embodiments, the width of the second vent 820 may be less than the width of the first vent 818 but greater than the width of the third vent 822 and the fourth vent 824. In some embodiments, the third vent 824 may have a width less than the width of the first vent 818 and the second vent 820, and a width greater than the width of the fourth vent 824. In some embodiments, the fourth vent 824 may have a width less than the width of the first vent 818, the second vent 820, and the third vent 822. In an example, the width of the first or most central vent 818 may be greater than the widths of the other vents 820, 822, 824, wherein each subsequent vent further from the central vent 818 may have a width less than the width of the vent closer to the center. In an example, the widths of the vents 818-824 may be in the range of approximately 3.00-5.00 mm.

[0138] refer to Figure 8C , presents a top view of a cover according to some embodiments. In some embodiments, the cover 800 may include a central opening 806 as discussed above. In some embodiments, the cover 800 is shown from Fig. 8AAs described above, the first opening 814 and the second opening 816 can be configured to Figures 5A-5D In some embodiments, it is also shown that Fig. 8A and Figure 8B The central opening 806 may have an additional notch 826 configured to allow wires from the fan to pass under the cover. In some embodiments, the notch 826 of the central opening may extend approximately 2.80 mm-3.20 mm from the central opening 806. In some embodiments, the central opening 806 may have a width 830 in the range of approximately 40-41 mm. In some embodiments, the central opening 806 may have a width 830 of approximately 40.50 mm.

[0139] refer to Fig.8D , presents another side view of the cover according to some embodiments. As shown, the cover may be slightly tapered. In some embodiments, the cover may have a top width 832 that may be in the range of approximately 62-64 mm and a bottom width 834 that may be in the range of approximately 63-65 mm. In some embodiments, the top width 832 may be approximately 63 mm and the bottom width 834 may be approximately 64 mm. In an example, the bottom width may be approximately 1 mm smaller than the top width. In some embodiments, the cover 800 may include one or more groups of vents 835, 837. In some embodiments, one or more groups of vents 835, 837 may be positioned along a wall portion 839 of the cover 800. In some embodiments, one or more groups of vents 835, 837 may be located at sides that are separated (e.g., opposite) from each other. In an example, a first group of openings 835 may be positioned along one side of the wall portion 839 of the cover 800, separated and opposite from the second group of vents 837, as shown. An exemplary locking mechanism is encircled in 834 and is Fig. 8E Further described in .

[0140] refer to Fig. 8E , presenting an enlarged view of a locking mechanism of a cover according to some embodiments. In some embodiments, the locking mechanism 810 may have a height 836 in the range of approximately 2.70-3.10 mm. In an example, the locking mechanism may have a height 836 of approximately 2.90 mm. In some embodiments, the wedge portion of the locking mechanism 810 may extend 838 outwardly from the cover 800 approximately 0.90 mm-1.10 mm. In an example, the wedge portion of the locking mechanism 810 may extend 838 outwardly from the cover 800 approximately 1.00 mm. In some embodiments, the wedge portion of the locking mechanism 810 may have a height 840 in the range of approximately 1.20-1.40 mm. In an example, the wedge portion of the locking mechanism 810 may have a height 840 of approximately 1.30 mm.

[0141] Still refer to it again Figures 8A-8E In some embodiments, the cover 800 may include materials such as plastic and / or resin. In a specific example, the cover 800 may include materials such as DuPont 801 resin, DuPont 2801, acrylonitrile butadiene styrene (ABS) plastic, and the like.

[0142] refer to Figures 9A-9D , presents various views of a cap according to some embodiments. In some embodiments, the cap can surround a temperature regulating assembly and be configured to allow air to flow into the temperature regulating assembly for device cooling. In some embodiments, the cap can be directly coupled to Figures 8A-8E The cover. Fig. 9A The cap of the temperature regulating assembly is shown. Fig. 9B A top view of the cap is shown. Fig. 9C Shown is a bottom view of the cap. Fig.9D A cross-sectional view of the cap is shown.

[0143] refer to Fig. 9A and 9B , presents multiple views of a cap according to some embodiments. In some embodiments, the cap 900 may include a top portion 902 and a bottom portion 904. In some embodiments, the cap 900 may be secured to Figures 8A-8E of a cap. In an example, the cap 900 may be secured by a snap fit. In some embodiments, the cap may include one or more openings 906. In some embodiments, the openings 906 of the cap 900 may be referred to as a plurality of openings 906 and / or individually referred to as, for example, each opening 906. In some embodiments, the openings 906 of the cap 900 may be hexagonal in shape. In some embodiments, the openings 906 may be configured to provide structural support to the cap 900. In some embodiments, although the openings 906 may have a hexagonal shape as shown, other shapes may be used for the openings 906. In some embodiments, the openings 906 may include a shape selected from a group consisting of a circular shape, a square shape, a polygonal shape, and the like. In some embodiments, the openings 906 may allow air to flow into the temperature therapy device. In an embodiment, the cap 900 may not reach or touch a fan (e.g., from a Figure 7 top of the fan).

[0144] refer to Fig. 9C , presents a bottom view of a cap according to some embodiments. A bottom portion 904 of the cap 900 is shown. In some embodiments, a receiving portion 906 of the cap 900 can be seen in this view. In some embodiments, the receiving portion 906 of the cap 900 can have corresponding features to receive a Figures 8A-8E In some embodiments, the receiving portion 906 may include a receptacle. In some embodiments, the receiving portion 906 may be a Figures 8A-8EIn some embodiments, the receiving portion 906 may extend 910 inwardly from the outer wall 912 of the cap 900. In some embodiments, the extension 910 of the receiving portion 906 may be in the range of approximately 0.70 mm-0.90 mm. In some embodiments, the extension 910 of the receiving portion 906 may be approximately 0.80 mm. In some embodiments, the receiving portion 906 may have a bend length 908 in the range of approximately 95-105 mm. In some embodiments, the cap 900 may have a bend length 908 of approximately 100 mm.

[0145] See also Fig.9D , showing the Figures 9A-9C 914. In some embodiments, the cap 900 may have a width 914 of approximately 62 mm-64 mm. In some embodiments, the cap 900 may have a width 914 of approximately 63 mm. In some embodiments, the cap 900 may have a height 916 of approximately 12 mm-13 mm. In some embodiments, the cap 900 may have a height 916 of approximately 12.5 mm. In some embodiments, the receiving portion 906 may have a height 918 in the range of approximately 1.3 mm-1.5 mm. In some embodiments, the receiving portion 906 may have a height 918 of approximately 1.5 mm. In some embodiments, the outer wall 912 may have a thickness 913 in the range of approximately 1.60 mm-1.80 mm. In some embodiments, the outer wall 912 may have a thickness 913 of approximately 1.70 mm. In some embodiments, the bottom portion 904 of the cap 900 may include an extruded portion 920. In some embodiments, the extruded portion 920 may extend outwardly 922 away from the cap 900 in the range of approximately 1.40 mm-1.60 mm. In some embodiments, the extruded portion 920 can extend 922 approximately 1.50 mm outwardly away from the cap 900. In some embodiments, the extruded portion 920 can be offset 924 from the outer wall 912 by approximately a range of 2.00 mm - 3.00 mm.

[0146] refer to Figures 9A-9D In some embodiments, the cap 900 may include materials such as plastic and / or resin. In a specific example, the cap 900 may include materials such as DuPont 801 resin, DuPont 2801, acrylonitrile butadiene styrene (ABS) plastic, etc. In some embodiments, the temperature therapy module may include a heat generating unit. Fig.13 An exploded upper perspective view of a heat generation unit is shown, according to some embodiments. Fig.14 A plan view illustrating an electric heating wire on a lower sheet of a heat generating unit according to some embodiments.

[0147] like Fig.13 and Fig.14As shown in the figure, in the illustrated embodiment, the heat generating unit 130 includes a first (lower) rectangular cloth sheet 1330 and a second (upper) rectangular cloth sheet 332. Each sheet has an outer dimension of approximately 250 mm by approximately 200 mm. In the illustrated embodiment, each sheet includes 200g of needle punched material (i.e., a nonwoven material formed by a conventional needle punching process) having a thickness of approximately 1.5 mm. The material has a density of approximately 200 grams per square meter. At least one resistor wire is positioned between the two sheets. In the illustrated embodiment, the first resistor wire 334 and the second resistor wire 336 are fixed to the upper surface of the lower sheet by a lock seam (not shown) in a conventional manner. The resistor wire can also be fixed to the upper sheet in a similar manner. In one embodiment, each resistor wire includes a thin flat resistor wire, such as, for example, a titanium resistor wire available on the market. In the illustrated embodiment, the cross-sectional dimensions of the resistor wire are selected to provide a resistance of approximately 16 ohms per meter. Each resistive wire had a length of approximately 1.25 meters, so that each wire had a total resistance of approximately 20 ohms.

[0148] The two resistance wires 334, 336 form two maze-like patterns that are substantially symmetrical about the center line 1340 of the lower sheet 1330. Each resistance wire extends from a first common terminal 1342 to a second common terminal 1344, so that the two segments are connected in parallel. The first common terminal of the resistance wire is directly connected to the first supply line 1346. The second common terminal of the resistance wire is connected to the second supply line 1348 via a thermal cut-off switch 350. The thermal cut-off switch has a first terminal 352 connected to the second common terminal of the resistance wire, and has a second terminal 354 connected to the second supply line via a connector 356. The thermal cut-off switch 350 is normally closed, so that the control unit 140 is electrically connected to the second common terminal 1344 of the resistance wires 1334, 1336. The first common terminal 1342 of the resistance wire is always connected to the control unit. Therefore, the current is conducted in parallel around each of the first resistance wire and the second resistance wire from the first terminal. Since each resistor wire has a resistance of approximately 20 ohms, each resistor wire generates approximately 14 watts of heat at a voltage of approximately 16.8 volts. The two resistor wires generate a total of approximately 28 watts of heat.

[0149] The thermal cut-off switch 350 is set to open the circuit when the temperature near the thermal cut-off switch exceeds approximately 80 degrees Celsius + / - 5 degrees, and remain open until the temperature drops to approximately 55 degrees Celsius + / - 10 degrees. In one embodiment, the thermal cut-off switch comprises a KLS-KSD9700 thermal fuse, which is commercially available from Ningbo KLS Import and Export Co., Ltd. of Beilun, Ningbo, Zhejiang, China. The thermal cut-off switch is positioned across a portion of the heating wire so that the thermal cut-off switch directly senses the temperature of the heating wire and opens the electrical path long before the heat from the heating wire is transferred through the lower sheet and the material of the lower structure 112 to a user (not shown).

[0150] like Fig.13 and Fig.14 As further shown in FIG. 1 , the thermistor 360 is fixed to the first (lower) cloth sheet 1330. The thermistor is also positioned near the center of the first sheet; however, the thermistor is positioned between two adjacent segments of the first resistance wire 334, rather than directly on the resistance wire. The first wire 362 and the second wire 364 extend from the thermistor and are connected to the control unit 140. In one embodiment, the thermistor is a negative temperature coefficient (NTC) thermistor. For example, the thermistor may be a MF52-104F-3950-600L thermistor commercially available from Dongguan Xinxiang Electronic Technology Co., Ltd., China. The thermistor has a resistance that varies over a wide temperature range. For example, at 55 degrees Celsius, the thermistor has a resistance of approximately 29,733 ohms; at 60 degrees Celsius, the thermistor has a resistance of approximately 24,753 ohms; and at 71 degrees Celsius, the thermistor has a resistance of approximately 16,794 ohms. The resistance of the thermistor can be readily sensed in a conventional manner to determine when the temperature of the thermistor exceeds a selected temperature.

[0151] After positioning the thermal cut-off switch 350 and thermistor 360 on the first (lower) sheet 1330, and after connecting the first common terminal 1342 to the first supply line 1346 and the second common terminal 1344 to the second supply line 348, the second (upper) sheet 332 is secured to the first sheet. In the illustrated embodiment, the lower surface of the second sheet includes an adhesive to removably attach the second sheet to the first sheet.

[0152] Some non-limiting examples of treatment devices have been described. Additional embodiments of temperature treatment devices are described in U.S. Provisional Patent Application No. 63 / 090987, which is incorporated herein by reference. In addition, some non-limiting examples of components of treatment devices have been described. Additional embodiments of such components (including flexible heat spreaders (e.g., heat spreaders 146, 300), heating and / or cooling elements (e.g., thermoelectric coolers (TECs) 150, 400), flexible substrates (e.g., flexible layers of multi-layer retaining mechanisms 102), and connecting materials (e.g., adhesives, tapes, etc.)) are also described in U.S. Provisional Patent Application No. 63 / 090987.

[0153] Some embodiments of therapeutic devices that include a thermoelectric cooler (TEC) have been described. A TEC is one example of a temperature control (e.g., heating and / or cooling) component that can be used in a temperature therapeutic device. In some embodiments, a heating and / or cooling component other than a TEC can be used. For example, a Peltier device, a Peltier heater, a Peltier heat pump, or any other suitable heating and / or cooling component can be used. (ii) Compression therapy module

[0154] In many cases, the present disclosure describes compressive therapy modules (sometimes referred to herein as compression pads) as inflatable bladders and / or vibrating chambers; however, generally any element capable of applying compressive forces (e.g., gel-filled bags, shape memory materials, etc.) may be used.

[0155] In general, the bladder is configured to effectively control the position of the treatment device relative to the user's body part and evenly apply compression therapy and / or thermal therapy to the user's body part. In some embodiments, the bladder is configured to wrap substantially evenly around the user's body part. In certain embodiments, the bladder is configured to wrap around the user's foot area (e.g., Fig.15A and Fig. 15B ).

[0156] In some examples, the bladder includes one or more (e.g., 1, 2, 3, 4, or more) layers of air-impermeable media, which may include portions (sometimes referred to as stays) bonded together in a particular pattern. In contrast, embodiments without a bladder may sometimes only partially surround a user's body part and / or include a large amount of air gap between the user's body part and the temperature therapy device.

[0157] In some embodiments, the pouch is positioned between the top and bottom layers of the multi-layer retaining mechanism.

[0158] In some embodiments, the bladder is configured to allow the temperature from the temperature therapy module to contact the user's body part substantially evenly. In an example, a portion of the bladder can be inflated, and once inflated, the bladder can be pressed against the bottom layer. When pressed, the pressure applied by the bladder to the bottom layer can allow the bottom layer 124 to evenly surround the user's body part.

[0159] In some embodiments, the pouch is coupled to the top layer and / or bottom layer via an adhesive and / or one or more locking features (eg, snaps).

[0160] In some embodiments, bonding the bladder to the outer periphery of the top layer and / or bottom layer enables the bladder to wrap around a user's body part (e.g., a user's ankle) when the bladder is inflated, rather than lifting the user's body part and merely contracting around the user's body part.

[0161] In some embodiments, the bladder material comprises a thermal polyurethane (TPU) material.

[0162] In some embodiments, the pouch is securely and / or removably attached to the top and / or bottom layers using a zipper attachment. For example, the zipper attachment may allow the pouch to be removed, for example, after unzipping the zipper attachment between the pouch and the top and / or bottom layers.

[0163] In some embodiments, the bladder is operatively connected to at least one tube (e.g., Fig.15A and Fig. 15B In some embodiments, the tube 1510 in the embodiment of the present invention can be used to input air into the bladder or remove air from the bladder to inflate and / or deflate the bladder. In some embodiments, the tube is operatively connected to an air compressor. In some embodiments, the air compressor is part of a control module as described herein or is located within the control module. In some embodiments, the air compressor is located outside the control module.

[0164] Fig. 10A and Fig. 10BThe first vibration chamber 120 according to some embodiments is shown. In some embodiments, the treatment device includes a second, third, fourth, or more vibration chambers that are identical or substantially identical. The first vibration chamber includes an upper cover 180. In the illustrated embodiment, the top surface 182 of the upper cover is square or substantially square, wherein each side of the square has a length of approximately 45 millimeters. The upper cover has a thickness of approximately 4.25 millimeters to the lower surface 184. One or more protrusions 186 extend from the lower surface of the upper cover. The diameter of each protrusion is selected so that each protrusion fits through one of the mounting holes 170 selected in the left rear mounting hole group. For example, in the illustrated embodiment, the protrusion has a diameter of approximately 5 millimeters. Each protrusion has a length of approximately 16.5 millimeters. The end of each protrusion opposite the top of the upper cover has a center hole 188, which can be threaded to receive a machine screw (not shown). Alternatively, the center hole can be tappable to receive a self-tapping screw.

[0165] The first vibration chamber 120 may include a lower cover 2000 having a central cavity 2020. The lower cover may have a generally square upper surface 2040 surrounding the central cavity. In the illustrated embodiment, the peripheral dimensions of the upper surface of the lower cover generally correspond to the peripheral dimensions of the upper cover 180. The lower cover has an arcuate lower surface in which one or more through holes 2060 are formed. The through holes are spaced apart by a distance corresponding to the spacing of the protrusions 186 of the upper cover 180. The through holes are counterbored relative to the lower cover to receive the heads of screws (not shown) that secure the lower cover to the upper cover.

[0166] The lower inner surface 2100 of the lower cover 2000 may correspond to the lower surface of the central cavity 2020. Each of the through holes 2060 may be surrounded by a corresponding inner protrusion 2120 extending from the lower inner surface of the central cavity. The top surface of each inner protrusion may have a corresponding counterbore 2140 that surrounds the through hole and extends a selected distance into the protrusion. The diameter of each counterbore may be selected to correspond to the outer diameter of the protrusion 186 extending from the top cover 180 (e.g., approximately 5 mm in the illustrated embodiment) so that each protrusion of the top cover fits tightly into a corresponding counterbore of one of the inner protrusions of the lower cover. The depth of the counterbore in each inner protrusion in the central cavity is selected so that when the protrusion of the top cover engages with the counterbore, the lower surface 184 of the top cover is spaced apart from the upper surface 2040 of the bottom cover by a distance less than the thickness of the upper support structure 116. For example, in the illustrated embodiment, the two surfaces are spaced approximately 1.85 mm apart, which is significantly less than the thickness of the upper support structure (e.g., approximately 5 mm). Thus, when the top cover is secured to the bottom cover by one or more screws (not shown) passing through the through holes 2060 of the lower cover and engaging the central holes 188 of the protrusions extending from the upper cover, the portion of the upper support structure that contacts the upper and lower covers is squeezed between the two covers to secure the first vibration capsule 120 to the upper support structure. In some embodiments, multiple vibration capsules are secured to the upper support structure in a similar manner.

[0167] The lower inner surface 2100 of the lower cover 2000 includes a first motor bearing support 230 and a second motor bearing support 232. Each motor bearing support is sized and positioned to receive a corresponding motor bearing, as described below. The lower inner surface further includes three raised ribs 234, which are positioned between the first and second bearing supports. Each rib has a corresponding upper surface, which is positioned a selected distance from the lower inner surface.

[0168] The first bearing support 230 includes a generally semicircular upper surface sized to receive a front bearing 242 of a motor 240. The second bearing support 232 includes a generally semicircular upper surface sized to receive a rear bearing 244 of the motor. The motor has a generally horizontal lower surface 246 that rests on three raised ribs 234 when the bearings of the motor are positioned in the respective bearing supports. The motor also has a generally horizontal upper surface 248 that is parallel to the upper surface in the illustrated embodiment. The motor includes a shaft 250. A forward portion of the shaft extends from the front bearing to support an eccentric mass 252. The eccentric mass is positioned within an unobstructed portion of the inner cavity and is able to move freely within that portion of the cavity when the shaft of the motor rotates.

[0169] The lower cover 2000 further includes a motor clamp 260 having an upper surface 262 and a lower surface 264. The motor clamp rests on one or more clamp support protrusions 270 extending upward from the lower inner surface 2100. Each clamp support protrusion has a corresponding central hole 272. Each central hole can be threaded to receive the threads of a machine screw (not shown). Alternatively, each central hole can be threaded by a self-tapping screw.

[0170] The motor clamp plate 260 is sized to fit within the lower cover 2000 and rest on the clamp plate support protrusion 270. The motor clamp plate includes one or more plate mounting through holes 280 that align with the central hole of the clamp plate support protrusion. Each plate mounting through hole is countersunk on the upper surface 262 of the motor clamp plate so that the head of a machine (or self-tapping) screw (not shown) does not extend above the upper surface of the motor clamp plate.

[0171] The lower surface 264 of the motor clamp plate 260 includes a corresponding protrusion 282 surrounding each plate mounting through hole 280. Each protrusion extends a short distance below the lower surface (e.g., approximately 2 mm; approximately 0.08 inches). Each protrusion is countersunk to have an inner diameter corresponding to the outer diameter of the clamp plate support protrusion 270 (e.g., approximately 2.3 mm; approximately 0.09 inches in the illustrated embodiment). Therefore, when the motor clamp plate is secured to the clamp plate protrusions, the motor clamp plate cannot be displaced laterally relative to the lower cover.

[0172] The motor clamp plate 260 may further include one or more clearance holes 284 that are positioned and sized to provide clearance for one or more protrusions 186 extending from the lower surface 184 of the upper cover 180. For example, in the illustrated embodiment, the clearance holes have a diameter slightly greater than approximately 5 mm (approximately 0.2 inches) to provide a tight fit relative to the protrusions.

[0173] The motor clamp plate 260 includes two motor engagement ribs 290 extending from the lower surface 264. The engagement ribs are positioned to engage with the generally horizontal upper surface 248 of the motor 240 when the motor clamp plate is positioned on the lower cover 2000 of the first vibration capsule 120. The thickness of each rib relative to the lower surface of the motor clamp plate is selected so that when the motor clamp plate is fully secured by screws (not shown), the rib is pressed against the horizontal upper surface of the motor. Thus, the motor is tightly secured between the ribs of the motor clamp plate and the three raised ribs 234 of the lower inner surface 2100 of the lower cover 2000.

[0174] In the illustrated embodiment, the motor 240 comprises a permanent magnet DC motor that operates at approximately 5300 revolutions per minute (RPM) from a 12 volt DC supply. In one embodiment, the motor comprises a model FC130 motor, which is commercially available from many sources. The motor consumes approximately 0.09 amps of current at rated RPM.

[0175] The motor 240 and eccentric mass 252 together have an overall length of approximately 38 millimeters. The motor has an overall diameter of approximately 20.2 millimeters and is flattened so that the lower surface 246 and upper surface 248 are spaced approximately 15.4 millimeters apart.

[0176] The eccentric block 252 is generally cylindrical. The eccentric block has an overall diameter of approximately 10 mm and has a length along the shaft of the motor of approximately 7 mm. In the illustrated embodiment, the block includes powdered metal (e.g., iron) that is compacted to have a mass (weight) of approximately 3.5 grams. The eccentric block is mounted on the shaft 250 of the motor 240 via an axial hole 254 having a diameter of approximately 2.1 mm. In the illustrated embodiment, the axial hole is offset approximately 2.2 mm from the center of the eccentric block to apply vibration to the block. The vibration is transmitted from the shaft of the motor and transmitted to the bearing supports 230, 232 through the bearings 242, 244 to vibrate the lower cover 2000 of the vibration chamber 120. (iii) Control unit

[0177] In general, one or more control units (or modules) may be operatively (eg, electrically, pneumatically and / or mechanically) connected to one or more modules (i) to (iv) (or components thereof) using a wired or wireless connection.

[0178] In general, the control unit may include or house various electromechanical components to drive the system as described herein, including, for example, a micro DC compressor, a plurality (e.g., 2, 3, 4, 5, 6, 7, 8 or more) of solenoid valves (or manifolds), a pressure sensor, a battery, a battery charging interface (or power jack), a printed circuit board (PCB), a low-power Bluetooth (BLE) component, a user interface, a programming or debugging interface (e.g., a Bluetooth, USB or other serial communication port for manufacturing and / or service). In a particular embodiment, the battery charging interface is a USB-C charging port with a cover (e.g., a rubber-like material) for ingress protection. The cover can be tied to the housing of the USB-C charging port so that the cover is not lost when the cover is removed (e.g., for access to the USB-C port). In a particular embodiment, the debugging interface is managed by a Bluetooth connection. In a particular embodiment, the debugging interface can be managed by a USB connection.

[0179] The control unit may be compact, lightweight, wireless and / or Bluetooth enabled.

[0180] In some embodiments, the control unit may include a length ranging from 0.5 inches to 6 inches, and / or a weight ranging from up to 8 ounces, 9 ounces, 10 ounces, 11 ounces, or 12 ounces. In a specific embodiment, the control unit includes dimensions of 4.75 inches by 2.75 inches by 1 inch.

[0181] In some embodiments, the control unit can be used to enable a Bluetooth connection between the module and the mobile device using a mobile application. The Bluetooth feature can enhance the user's experience. An example mobile application is described in U.S. Patent Application No. 17 / 372,237, which is incorporated herein by reference in its entirety.

[0182] In some embodiments, a module (or a component thereof) synchronizes with another module (or a component thereof) by sending and / or receiving data in radio frequency signals and / or Bluetooth signals using the control unit(s).

[0183] In some embodiments, the control unit may include a box (e.g., Fig. 15B The control unit may further include a display, one or more minimal user interfaces, including a pressure level button, a session time button, a start / stop button, a power button (or an on / off button) for enabling a user to set personalized parameters (e.g., pressure level, session time, start / stop or other suitable parameters) to control the operation of the module.

[0184] In some embodiments, biosensors and / or thermal sensors may additionally be used in the system, thereby making an electrical connection between the control unit and the air compression pack.

[0185] In some embodiments, a mobile device (eg, a smartphone) may replace and / or supplement a dedicated control unit. (iv) Combination of multiple modules

[0186] In some embodiments, the systems and devices as described herein include 2, 3, 4 or more of the above-mentioned modules (i)-(iv) for delivering, applying and / or operating thermal therapy and / or compression therapy, as further described below.

[0187] In some embodiments, the therapeutic device includes an inner layer that contacts the user's body surface.

[0188] In some embodiments, the therapeutic device further comprises an outer layer.

[0189] In some embodiments, one or more therapeutic modules (e.g., temperature regulation components and / or vibration chambers) as described herein are operatively connected to and located on the outer layer of the therapeutic device. In some embodiments, one or more therapeutic modules (e.g., compression pads, heat generating units, temperature regulation components, and / or vibration chambers) are securely located (e.g., surrounded) between the outer layer and the inner layer of the therapeutic device. Thus, thermal therapy and / or compression therapy can be delivered to the body surface of the user from an exterior portion of the therapeutic device (e.g., the outer layer or between the outer layer and the inner layer) without the therapeutic module contacting the body surface of the user and causing discomfort to the user.

[0190] In certain embodiments, the therapeutic device is footwear.

[0191] Fig.15A and Fig. 15B Footwear 1500 is illustrated that includes one or more (e.g., two) temperature regulation components 1540 operatively attached to an outer layer surrounding one or more compression pads 1520 to deliver at least one of thermal (heat and / or cold) therapy and compression therapy.

[0192] In some embodiments, the footwear further includes one or more tubes 1510 operatively connected to one or more compression pads 1520 to facilitate inflation and / or deflation of the one or more compression pads during treatment.

[0193] In some embodiments, the footwear is configured to include one or more openings. In some embodiments, the opening is located at the top portion of the footwear for receiving a foot from a user. In some embodiments, the opening is located at the bottom front portion of the footwear for providing mobility and / or comfort to the foot. In some embodiments, the tube 1510 is disposed adjacent to the opening of the footwear. For example, Fig.15A and Fig. 15B As shown in FIG. 1 , at least one tube 1510 is disposed adjacent an opening of footwear 1500 and is operatively connected to compression pad 1520 .

[0194] In some embodiments, the footwear further includes a case 1550. The case 1550 may include a control unit, a battery pack, a user interface, and / or other components for operating the therapeutic device and / or communicating with a user.

[0195] Fig. 15C Components of footwear according to some embodiments are shown. Fig. 15C As shown in , footwear may include a compression pad (eg, compression pad 1520 ) and a temperature regulation assembly 1540 .

[0196] refer to Figures 15A-15C In some embodiments, the temperature regulating assembly 1540 is the same as the temperature regulating assembly 140 described above. In some embodiments, the temperature regulating assembly 1540 includes the same as the temperature regulating assembly 140 described above. Figure 5E-5G15. In some embodiments, spacer 1560 includes one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) wings that enable bladder 1520 to push temperature regulation assembly 1540 toward the user's body during inflation of bladder 1520. Thus, the temperature generated by temperature regulation assembly 1540 can be delivered to the user's body. In some embodiments, 5 or more wings are preferably used to stabilize temperature regulation assembly 1540 toward the user's body during operation of the footwear (e.g., during inflation of bladder 1520).

[0197] Fig.16 A therapeutic device (e.g., footwear) is illustrated that includes one or more (e.g., four) compression therapy modules (e.g., vibration chambers 120) that are operably attached to one or more temperature therapy modules (e.g., heat generation 130) to deliver at least one of thermal therapy and compression therapy.

[0198] Fig.17 A therapeutic device (e.g., footwear) is illustrated that includes one or more (e.g., four) temperature therapy modules (e.g., temperature regulation assembly 140) operatively attached to an outer layer that may include or surround one or more compression therapy modules (e.g., compression pads) to deliver at least one of heat (heat and / or cold) and compression therapy to the entire area of ​​a user's foot and / or ankle (e.g., from front to back, from an upper portion to a lower portion, and / or from outside to inside).

[0199] In some embodiments, the footwear includes a piece of cloth to wrap around the user's foot area and further includes one or more hooks and loops (e.g., The product) and shoelaces are provided so that the footwear is securely in contact with the user's foot area. Advantageously, the hooks and loops and / or shoelaces may be stretchable to provide comfort to the user's foot. In some embodiments, the hooks and loops and / or shoelaces may be replaced by one or more zippers. Computer Systems

[0200] Fig.183300. A general purpose computer, network device, mobile device, or other electronic system may also include at least a portion of the system 3300. The system 3300 includes a processor 3310, a memory 3320, a storage device 3330, and an input / output device 3340. Each of the components 3310, 3320, 3330, and 3340 may be interconnected, for example, using a system bus 3350. The processor 3310 is capable of processing instructions for execution within the system 3300. In some embodiments, the processor 3310 is a single-threaded processor. In some embodiments, the processor 3310 is a multi-threaded processor. The processor 3310 is capable of processing instructions stored in the memory 3320 or on the storage device 3330.

[0201] Memory 3320 stores information within system 3300. In some embodiments, memory 3320 is a non-transitory computer-readable medium. In some embodiments, memory 3320 is a volatile memory unit. In some embodiments, memory 3320 is a non-volatile memory unit.

[0202] The storage device 3330 is capable of providing mass storage for the system 3300. In some embodiments, the storage device 3330 is a non-transitory computer-readable medium. In various embodiments, the storage device 3330 may include, for example, a hard disk device, an optical disk device, a solid-state drive, a flash drive, or some other large-capacity storage device. For example, the storage device may store long-term data (e.g., database data, file system data, etc.). The input / output device 3340 provides input / output operations for the system 3300. In some embodiments, the input / output device 3340 may include one or more of a network interface device (e.g., an Ethernet card), a serial communication device (e.g., an RS-232 port), and / or a wireless interface device (e.g., an 802.11 card, a 3G wireless modem, or a 4G wireless modem). In some embodiments, the input / output device may include a driver device configured to receive input data and send output data to other input / output devices, such as a keyboard, a printer, and a display device 3360. In some examples, mobile computing devices, mobile communication devices, and other devices may be used.

[0203] In some embodiments, at least part of the methods described above may be implemented by instructions that, when executed, cause one or more processing devices to perform the processes and functions described above. Such instructions may include, for example, interpretive instructions (such as script instructions) or executable code, or other instructions stored in a non-transitory computer-readable medium. Storage device 3330 may be implemented in a distributed manner over a network, such as as a server farm or group of widely distributed servers, or may be implemented in a single computing device.

[0204] Despite Fig.18 An example processing system has been described in the specification, but embodiments of the subject matter, functional operations, and processes described in this specification may be implemented in other types of digital electronic circuits, in tangibly embodied computer software or firmware, in computer hardware (including the structures disclosed in this specification and their structural equivalents), or in a combination of one or more of them. Embodiments of the subject matter described in this specification may be implemented as one or more computer programs, that is, one or more computer program instruction modules, which are encoded on a tangible, non-volatile program carrier for execution by a data processing device or to control the operation of the data processing device. Alternatively or in addition, the program instructions may be encoded on an artificially generated propagated signal, such as a machine-generated electrical, optical, or electromagnetic signal, which is generated to encode information for transmission to a suitable receiver device for execution by the data processing device. The computer storage medium may be a machine-readable storage device, a machine-readable storage substrate, a random or serial access memory device, or a combination of one or more of them.

[0205] The term "system" may encompass all kinds of equipment, devices and machines for processing data, including by way of example a programmable processor, a computer or multiple processors or computers. A processing system may include special-purpose logic circuits, such as an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit). In addition to hardware, a processing system may also include code that creates an execution environment for the computer program in question, such as code constituting processor firmware, a protocol stack, a database management system, an operating system, or a combination of one or more of them.

[0206] A computer program (which may also be referred to or described as a program, software, software application, module, software module, script, or code) may be written in any form of programming language (including compiled or interpreted languages, or declarative or procedural languages), and it may be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program may, but need not, correspond to a file in a file system. A program may be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files storing one or more modules, subroutines, or code portions). A computer program may be deployed to execute on one computer or on multiple computers located at one site or distributed across multiple sites and interconnected by a communications network.

[0207] The processes and logic flows described in this specification may be performed by one or more programmable computers executing one or more computer programs to perform functions by operating on input data and generating output. The processes and logic flows may also be performed by, and the apparatus may be implemented as, special purpose logic circuits such as FPGAs (field programmable gate arrays) or ASICs (application specific integrated circuits).

[0208] A computer suitable for executing a computer program may include a general or special purpose microprocessor or both, or any other kind of central processing unit by way of example. Generally, the central processing unit will receive instructions and data from a read-only memory or a random access memory or both. The computer generally includes a central processing unit for implementing or executing instructions and one or more memory devices for storing instructions and data. Generally, the computer will also include one or more mass storage devices (such as magnetic disks, magneto-optical disks or optical disks) for storing data or operatively connected to receive data from it or transmit data to it or both. However, the computer does not need to have such a device. In addition, the computer may be embedded in another device, such as a mobile phone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a global positioning system (GPS) receiver, or a portable storage device (such as a universal serial bus (USB) flash drive), to name a few.

[0209] Computer-readable media suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices such as EPROM, EEPROM and flash memory devices; magnetic disks, such as internal hard disks or removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and memory may be supplemented by or incorporated in special purpose logic circuitry.

[0210] To provide interaction with a user, embodiments of the subject matter described in this specification may be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user, and a keyboard and pointing device (e.g., a mouse or trackball) through which the user can provide input to the computer. Other kinds of devices may also be used to provide interaction with a user; for example, the feedback provided to the user may be any form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback; and the input from the user may be received in any form, including acoustic, voice, or tactile input. In addition, a computer may interact with a user by sending documents to and receiving documents from a device used by a user; for example, by sending a web page to a web browser on a user device of a user in response to a request received from the web browser.

[0211] Embodiments of the subject matter described in this specification may be implemented in a computing system that includes a back-end component, such as a data server, or includes a middleware component, such as an application server, or includes a front-end component, such as a client computer with a graphical user interface or a web browser, through which a user can interact with the implementation of the subject matter described in this specification, or any combination of one or more such back-ends, middleware, or front-end components. The components of the system may be interconnected by digital data communication (e.g., a communication network) of any form or medium. Examples of communication networks include local area networks ("LANs") and wide area networks ("WANs"), such as the Internet.

[0212] A computing system may include clients and servers. Clients and servers are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

[0213] Although this specification contains many specific implementation details, these details should not be interpreted as limitations on the scope of what may be claimed, but rather should be interpreted as descriptions of features that may be specific to a particular embodiment. Certain features described in this specification in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, the various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. In addition, although features may be described above as working in certain combinations and even initially claimed as such, in some cases, one or more features from the claimed combination may be deleted from the combination, and the claimed combination may be directed to a sub-combination or a variation of the sub-combination.

[0214] Similarly, although the operations are depicted in a particular order in the accompanying drawings, this should not be understood as requiring such operations to be performed in the particular order shown or in a continuous order, or to perform all illustrated operations, to achieve the desired results. In some cases, multitasking and parallel processing may be advantageous. In addition, the separation of the various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the program components and systems described can be integrated together in a single software product or packaged into multiple software products in general.

[0215] Specific embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve the desired results. As an example, the processes depicted in the accompanying drawings do not necessarily require the specific order or sequential order shown to achieve the desired results. In certain embodiments, multitasking and parallel processing may be advantageous. Other steps or stages may be provided, or steps or stages may be eliminated from the described processes. Therefore, other embodiments are within the scope of the following claims. limited

[0216] The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0217] Measurements, dimensions, quantities, etc. may be presented in range format herein. The description in range format is provided only for convenience and brevity, and should not be construed as a strict limitation of the scope of the present invention. Therefore, the description of a range should be considered to have specifically disclosed all possible sub-ranges and individual numerical values ​​within the range. For example, a description such as a range of 1-20 meters should be considered to have specifically disclosed sub-ranges such as 1 meter, 2 meters, 1-2 meters, less than 2 meters, 10-11 meters, 10-12 meters, 10-13 meters, 10-14 meters, 11-12 meters, 11-13 meters, etc.

[0218] In addition, the connections between components or systems in the figure are not intended to be limited to direct connections. Instead, the data or signals between these components may be modified, reformatted or otherwise changed by intermediate components. In addition, additional or fewer connections may be used. The terms "connection", "connection" or "communication connection" should be understood to include direct connections, indirect connections through one or more intermediate devices, wireless connections, etc.

[0219] The term "approximately", the phrase "approximately equal to" and other similar phrases (e.g., "X has a value of approximately Y" or "X is approximately equal to Y") as used in the specification and claims should be understood to mean that one value (X) is within a predetermined range of another value (Y). Unless otherwise indicated, the predetermined range may be plus or minus 20%, 10%, 5%, 3%, 1%, 0.1%, or less than 0.1%.

[0220] The term "treatment" or "therapy" refers to any action, hobby, task, procedure that relieves tension, the handling of an illness or disorder through some remedial, healing or curative process, healing power or quality, or psychotherapy.

[0221] The term "temperature therapy" may be used interchangeably with "thermal therapy" or similar terms.

[0222] The term "compression therapy" is interchangeable with "compression treatment" or similar terms.

[0223] The term "bladder" or "inflatable bladder" refers to a bladder that can be filled with air and applied to specific area(s) of the human body. In some embodiments, the bladder is inflatable and / or deflated.

[0224] The term "module," "therapy module," or similar terms refers to a device or portion of a device used to deliver therapy, such as compression therapy and / or thermal therapy.

[0225] Unless clearly indicated to the contrary, the indefinite articles "a" and "an" as used in the specification and in the claims should be understood to mean "at least one". The phrase "and / or" as used in the specification and in the claims should be understood to mean "either or both" of the elements so connected, i.e., elements that exist in connection in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so connected. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether or not they are related to those specifically identified. Thus, as a non-limiting example, when used in conjunction with an open language such as "including", a reference to "A and / or B" may refer to only A (optionally including elements other than B) in one embodiment; to only B (optionally including elements other than A) in another embodiment; to both A and B (optionally including other elements) in yet another embodiment; and so on.

[0226] As used in the specification and in the claims, "or" shall be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" shall be interpreted as inclusive, i.e., including at least one of a plurality of elements or a list of elements, but also including more than one of them, and optionally, including additional items that are not listed. Only terms that clearly indicate the opposite, such as "only one of..." or "exactly one of...", or "consisting of..." when used in the claims, will refer to including exactly one element of a plurality of elements or a list of elements. In general, when the term "or" as used is preceded by an exclusive term (such as "either", "one of...", "only one of..." or "exactly one of..."), the term "or" as used shall only be interpreted as indicating an exclusive alternative (i.e., "one or the other but not both"). "Consisting essentially of...", when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0227] As used in the specification and in the claims, the phrase "at least one" when referring to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but does not necessarily include at least one of each element specifically listed in the list of elements, and does not exclude any combination of elements in the list of elements. This limitation also allows for the optional presence of elements in addition to the elements specifically identified in the list of elements to which the phrase "at least one" refers, whether or not they are related to those specifically identified. Thus, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B", or equivalently, "at least one of A and / or B") may refer to at least one A, optionally including more than one A, without B (and optionally including elements other than B) in one embodiment; to at least one B, optionally including more than one B, without A (and optionally including elements other than A) in another embodiment; to at least one A, optionally including more than one A, and at least one B, optionally including more than one B (and optionally including other elements) in yet another embodiment; and so on.

[0228] The use of "including," "comprising," "having," "containing," "involving," and variations thereof are meant to encompass the items listed thereafter as well as additional items.

[0229] The use of ordinal terms (such as "first," "second," "third," etc.) in the claims to modify claim elements does not in itself indicate any priority, precedence, or order of one claim element over another claim element, nor does it indicate a temporal order in which method actions may be performed. Ordinal terms are used merely as labels to distinguish one claim element having a certain name from another element having the same name (except for the use of the ordinal term) to distinguish the claim elements.

[0230] Having thus described several aspects of at least one embodiment of the present invention, it will be appreciated that various changes, modifications and improvements will readily occur to those skilled in the art. Such changes, modifications and improvements are intended to be part of this disclosure and are intended to be within the spirit and scope of the present invention. Therefore, the foregoing description and drawings are by way of example only.

Claims

1. A wearable therapeutic delivery device, the device comprising: an inner layer configured to contact a body surface of a user; Outer layer; one or more temperature therapy modules enclosed between the inner layer and the outer layer adjacent the inner layer; and one or more compression therapy modules located adjacent to the one or more temperature therapy modules, Wherein, the one or more compressive therapy modules are configured to push the one or more temperature therapy modules toward the body surface of the user.

2. The device according to claim 1, wherein: The temperature therapy module includes at least one of a thermoelectric cooler (TEC) and a heat generating unit.

3. The device according to claim 1, wherein: The temperature therapy module is configured to operate within a range of from 100°F to 140°F.

4. The device according to claim 1, wherein: The compression therapy module includes an inflatable bladder.

5. The device according to claim 1, wherein: The compression therapy module is configured to operate within a range from 120 psi to 200 psi.

6. The device according to claim 1 further includes a spacer disposed between the compression therapy module and the temperature therapy module.

7. The device according to claim 6, wherein: The spacer includes at least one wing disposed around a periphery thereof.

8. The device according to claim 7, wherein: The spacer comprises 5 wings.

9. The device according to claim 1 further comprises a control unit configured to control the operation of the temperature therapy module and the compression therapy module.

10. The device according to claim 1, wherein: The apparatus includes an article of footwear.

11. A method for delivering a therapy, the method comprising the steps of: A wearable therapeutic delivery device is provided, comprising: an inner layer configured to contact a body surface of a user; Outer layer; one or more temperature therapy modules enclosed between the inner layer and the outer layer adjacent the inner layer; and one or more compressive therapy modules located proximate to the one or more temperature therapy modules, wherein the one or more compressive therapy modules are configured to urge the one or more temperature therapy modules toward the body surface of the user; applying the inner layer of the device to the body surface; and Activate the one or more temperature therapy modules and the one or more compression therapy modules.

12. The method according to claim 11, wherein: The temperature therapy module includes at least one of a thermoelectric cooler (TEC) and a heat generating unit.

13. The method according to claim 11, wherein: The temperature therapy module is configured to operate within a range of from 100°F to 140°F.

14. The method according to claim 11, wherein: The compression therapy module includes an inflatable bladder.

15. The method according to claim 11, wherein: The compression therapy module is configured to operate within a range from 120 psi to 200 psi.

16. The method according to claim 11, wherein: The wearable therapy delivery device further includes a spacer disposed between the compressive therapy module and the temperature therapy module.

17. The method according to claim 16, wherein: The spacer includes at least one wing disposed around a periphery thereof.

18. The method according to claim 17, wherein: The spacer comprises 5 wings.

19. The method according to claim 11, wherein: The wearable therapy delivery device further includes a control unit configured to control operation of the temperature therapy module and the compression therapy module.

20. The method according to claim 11, wherein: The wearable therapeutic delivery device includes an article of footwear.

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