Smart prosthetic cooling system

Abstract

A sensor-driven adaptive thermal regulation system for prosthetic sockets is disclosed. The system integrates sensors with active thermoelectric cooling elements to manage heat and moisture accumulation within the prosthetic socket. Thermoelectric modules are positioned in proximity to the user's residual limb and are controlled by a Processing unit via; Logic-based circuitry. A heat transfer material serves as a thermal sink and a prosthetic liner, absorbing heat through state transitions to enhance dissipation. The system supports both manual and autonomous operation. In manual mode, users control cooling via a mobile application featuring biometric authentication, real-time sensor monitoring, and override functionality. In autonomous mode, cooling is triggered automatically when preset environmental thresholds are exceeded. A flexible heat sink further ensures efficient thermal transfer, improving prosthetic fit, comfort, and wearability. The system may be integrated into liners or retrofitted into existing above-knee and below-knee prosthetics.

Description

PATENT Docket No: ROCT.P2006WQ / 00634886SMART PROSTHETIC COOLING SYSTEMCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial Nos.63 / 643,282 filed May 6, 2024, and 63 / 703,058 filed October 3, 2024, both of which are hereby incorporated by reference.TECHNICAL FIELD

[0002] The inventive technology disclosed herein relates to the field of prosthetic devices, and more particularly to smart assistive technology.BACKGROUND

[0003] The demand for rehabilitative and assistive technologies has seen a significant and sustained increase, driven by multiple global trends including the rise in sports -related injuries, increasing obesity rates, a growing elderly population, enhanced life expectancy, and the prevalence of chronic health conditions such as diabetes mellitus and osteoarthritis. As of 2015, approximately 9.0 million individuals were reported to be living with limb loss worldwide, with projections indicating a growth to approximately 45.0 million by the year 2050. In the United States alone, around 1.7 million individuals live with limb loss, with a majority of such cases involving lower extremity amputations.

[0004] Advanced prosthetic devices have been developed to assist both civilian and military amputees in regaining mobility and functionality through extensive rehabilitation. These prosthetic systems typically have multiple structural layers, including a liner and a socket. The socket provides mechanical support and weight-bearing capability, while the liner serves as a cushioning and protective interface between the socket and the residual limb.

[0005] However, despite technological improvements in prosthetic components and functionality, substantial challenges remain in ensuring prolonged comfort and usability. The intimate fit between the socket and residual limb although necessary for load transfer and mechanical stability, inherently creates a confined space that impedes natural airflow and ventilation. As a result, heat and moisture are prone to accumulate within the prosthetic cavity, particularly during prolonged use or in high-activity scenarios.

[0006] This thermally insulated and humid microenvironment around the residual limb can lead to a range of adverse dermatological effects, such as folliculitis, maceration, friction-induced blisters, and microbial or fungal infections. The term "milking" has been used to describe the cyclical displacement of sweat within the socket, which aggravates tissue irritation and compromises skin integrity. Users frequently report discomfort resulting fromDocket No: ROCT.P2006WQ / 00634886 excessive heat buildup and perspiration, which not only affects the wearability of the device but also necessitates frequent removal of the prosthesis for sweat management. This frequent doffing and donning process is disruptive to daily activities and can be a source of social and physical inconvenience.

[0007] Accordingly, there exists a critical and unmet need for prosthetic cooling technologies that effectively regulate the thermal and moisture conditions within the prosthetic socket. Such systems are essential for improving user comfort, preserving skin health, enhancing device adherence, and extending the duration of wear.SUMMARY

[0008] The development of integrated or retrofittable cooling mechanisms tailored to prosthetic applications addresses one of the most cited user pain points and represents a pivotal advancement in prosthetic technology.

[0009] In the first aspect, the disclosed technology introduces a prosthetic cooling system comprising three primary components: a mechanical design, an electromechanical design including a temperature regulation user interface (UI), and advanced heat transfer materials. The mechanical design includes a modular cushioning panel assembly configured for direct attachment to existing prosthetic sockets. The panel incorporates one or more adjustable structural elements to improve anatomical conformity and ergonomic compatibility with the user's residual limb. This configuration enables seamless retrofitting with current prosthetic systems and facilitates scalable functional upgrades.

[0010] The mechanical design further enables integration of thermoelectric cooling components within the structural geometry of the socket. This arrangement allows the thermoelectric elements to be positioned in close proximity to the user's skin, thereby enhancing thermal transfer efficiency while minimizing spatial constraints and preserving the biomechanical integrity of the prosthesis. The system also allows for user- selective engagement or disengagement of the cooling components, improving adaptability and userspecific comfort.

[0011] In a second aspect, the disclosed technology provides a flexible, adaptive thermoregulation system integrated into prosthetic liners or wearable medical applications. The system comprises a flexible thermoelectric (TE) device operatively coupled to a custom control circuit and embedded environmental sensors, enabling localized thermal management. The control circuit includes a feedback mechanism that autonomously actuates the TE device based on predefined temperature thresholds. The system supports dual-mode operation: a manual mode via a mobile application and an autonomous mode governed by anDocket No: ROCT.P2006WQ / 00634886 onboard computing unit. In autonomous mode, the onboard processor monitors sensor data and adjusts cooling in real time. Temperature and humidity data are wirelessly transmitted to a remote server, which processes the data and returns optimized cooling parameters. The mobile application includes biometric access and displays real-time environmental data, enhancing user control and minimizing the need for clinical intervention.

[0012] In a third aspect, the invention relates to advanced thermal management materials comprising a polymeric matrix based on polydimethylsiloxane (PDMS), compositionally integrated with phase change materials (PCMs). These PDMS-PCM composites exhibit high thermal conductivity and latent heat storage capabilities to effectively manage thermal fluctuations within the prosthetic socket. The PDMS-PCM material is configured to serve both as a liner in direct contact with the user's skin and as a flexible heat sink integrated into the socket. This dual functionality enhances heat dissipation, mechanical flexibility, and longterm durability of the prosthetic system, offering a lightweight and efficient solution for temperature regulation in assistive limb technologies.

[0013] A prosthetic cooling system includes a cushioning panel configured for integration into a compression-type prosthetic socket, a thermoelectric (TE) device positioned in the cushioning panel proximate to a skin-contacting surface of the compression-type prosthetic socket, and a flexible heat sink positioned in the cushioning panel and thermally coupled to a hot side of the TE device. The flexible heat sink may be made of PDMS and PCM composite material.

[0014] The prosthetic cooling system may also include a flexible liner formed of a polymeric composite material comprising a base polymer Polydimethylsiloxane (PDMS) and a phase change material (PCM), the liner configured to conform to a residual limb and provide thermal buffering and mechanical cushioning inside the compression-type prosthetic socket.

[0015] The prosthetic cooling system may include a control circuit having a processing unit, a logic device, and one or more switching transistors, wherein the control circuit is configured to modulate electrical current to the TE device based on temperature data.

[0016] The control circuit executes a proportional-integral-derivative (PID) control algorithm to regulate a cooling intensity of the TE device in response to real-time sensor input.

[0017] The prosthetic cooling system may include an onboard computer configured to collect temperature data from distributed sensors within the compression-type prosthetic socket, a wireless communication interface configured to transmit the temperature data to aDocket No: ROCT.P2006WQ / 00634886 remote or portable device; and a control circuit to adjust cooling output based on received target parameters.

[0018] The prosthetic cooling system of claim 7, wherein the wireless communication interface comprises a low-energy communication protocol to maintain data transmission while conserving power.

[0019] The prosthetic cooling system of claim 7, wherein the onboard computer is configured to store temperature data over time and adjust cooling intensity to maintain a target thermal range. The target thermal range is dynamically determined based on user input or historical usage data.

[0020] The system may include a portable device configured to receive and visualize sensor data, transmit user-defined cooling parameters to the control circuit, and connect to a remote server to obtain optimized cooling recommendations. The remote server includes a user authentication module, a recommendation engine for determining optimal cooling parameters based on historical data, and a storage system configured to store user-specific thermal profiles. The remote server may also include an analytics module configured to evaluate performance metrics and recommend adjustments to prosthetic socket thermal settings.

[0021] The prosthetic cooling system includes a user interface configured to receive user input for manual cooling control, display real-time sensor data, and receive user input to switch between manual and autonomous operational modes. The user interface may be a mobile application that includes biometric authentication, visual feedback, and wireless connectivity to the prosthetic socket.

[0022] A cushioning panel for use with the prosthetic socket system may include internal routing channels for wiring, thermally conductive vent slots, and structural brackets for retaining TE devices. Multiple TE devices are distributed within the socket and are selectively activated based on localized sensor readings.

[0023] A method of controlling temperature in a prosthetic socket includes positioning a thermoelectric (TE) device within a cushioning panel adjacent to a user’s residual limb, detecting temperature using one or more embedded thermal sensors in the prosthetic socket, processing data from the one or more embedded thermal sensors using a Proportional-Integral-Derivative (PID)-based algorithm on a microcontroller, and regulating a cooling output of the TE device to maintain a target comfort range.Docket No: ROCT.P2006WQ / 00634886BRIEF DESCRIPTION OF THE FIGURES

[0024] FIG. 1 is a perspective view of a prosthetic cooling system, in an embodiment.

[0025] FIG. 2A depicts a perspective view of a modular cushioning panel, in an embodiment.

[0026] FIG. 2B depicts a top view of a flexible thermoelectric device used in a cushioning panel, in embodiments.

[0027] FIG. 2C depicts a side view of the flexible thermoelectric device of FIG. 2B.

[0028] FIG. 3A depicts an arrangement of cushioning panels inside a compression socket, in embodiments.

[0029] FIG. 3B depicts another arrangement of cushioning panels inside a compression socket along with a control circuit, in an embodiment.

[0030] FIG. 4 depicts an exploded view of the cushioning panel of FIG. 2A and its components, in an embodiment.

[0031] FIG. 5 depicts a controller module along with its enclosure, in an embodiment.

[0032] FIG. 6 depicts an electrical system architecture for sensor integration and data transmission of a thermoelectric device, in an embodiment.

[0033] FIG. 7 depicts an embedded thermal regulation sensor (ETRS), in an embodiment.

[0034] FIG. 8 depicts a methodology of preparing heat transfer material, in an embodiment.

[0035] FIG. 9 depict another methodology of preparing heat transfer material, in an embodiment.

[0036] FIG. 10 depicts a liner made of heat transfer material, in an embodiment.

[0037] FIG. 11 depicts apparatus for conducting a tensile test of flexible heat transfer material, in an embodiment.

[0038] FIG. 12 depicts a visual data representation of a tensile test, in an embodiment.

[0039] FIGS. 13A - 13D depict infrared images of the flexible heat transfer material, in embodiments.

[0040] FIG. 14 depicts a thermoregulation user interface system for a prosthetic device, in embodiments.

[0041] FIG. 15 depicts for a graph of sensor data over time for the cooling system of FIG.1 implemented in a conventional prosthetic liner, in embodiments.

[0042] FIG. 16 depicts data graph of sensor data over time for liner made of heat transfer material, in embodiments.Docket No: ROCT.P2006WQ / 00634886DETAILED DESCRIPTION

[0043] Exemplary embodiments will be described in detail herein, with examples thereof represented in the drawings. When the following descriptions involve the drawings, numerals in different drawings represent like or similar elements unless otherwise indicated.Implementations described in the following exemplary embodiments do not represent all implementations consistent with the present disclosure. Instead, they are merely examples of apparatuses and methods consistent with some aspects of the present disclosure as detailed in the appended claims.

[0044] Reference will now be made in detail to embodiments, examples of which are illustrated in the accompanying drawings. The following description refers to the accompanying drawings in which the same numbers in different drawings represent the same or similar elements unless otherwise represented. The implementations set forth in the following description of embodiments do not represent all implementations consistent with the disclosure. Instead, they are merely examples of apparatuses and methods consistent with aspects related to the disclosure as recited in the appended claims.

[0045] A cooling system is essential in prosthetic sockets to address the significant challenges associated with heat and moisture accumulation, which may lead to user discomfort, skin irritation, and infection. The enclosed configuration of prosthetic sockets, in conjunction with the insulating characteristics of commonly used liner materials such as silicone, often results in elevated internal temperatures and perspiration buildup. This thermally constrained environment can promote dermatological issues, including but not limited to folliculitis, blistering, and microbial growth, thereby adversely affecting user comfort, prosthetic suspension, and long-term fit.

[0046] Prosthetic sockets, adjustable or otherwise, may use a cooling system involving movable cushion panels, which allow for changes in tightness to optimize fit throughout the day as the volume of the residual limb fluctuates, ensuring maximum comfort. As disclosed herein, a cooling system is integrated into these movable cushion panels. In embodiments, flexible thermoelectric (TE) cells and heat sinks are incorporated into the cushion panel structure. More specifically, components include a flexible TE module, a flexible heat sink, an optional metal heat sink, and a cushion panel which integrates the heat sink seamlessly. The heat sink is designed to fit precisely, with its two end fins press-fitted into specific slots in the cushion panel, and the flat surface of the heat sink is positioned parallel to the cushion panel's flat face, on which the TE module is placed. The other side of the cushion panel hasDocket No: ROCT.P2006WQ / 00634886 an opening to allow the heat sink to release heat effectively, ensuring the system remains cool and efficient.

[0047] These user-friendly slots allow the easy insertion and removal of TE modules. Additionally, we incorporated cylindrical channels on the other side of the cushion panel, ensuring a secure and stable fit within prosthetic sockets. The cushion panel housing can be made of lightweight material ideal for prosthetic sockets, ensuring long-term comfort and irritation-free wear. These innovations allow the cushion panel to effectively integrate the cooling components while offering users maximum comfort, convenience, and efficiency.

[0048] To mitigate these adverse effects, the disclosed technology implements a cooling system designed to regulate the internal thermal conditions of the prosthetic socket. By maintaining a thermally stable and dry environment, the system enhances user comfort and reduces the risk of skin-related complications. As a result, users are more likely to wear the prosthesis for extended durations, thereby improving overall mobility and quality of life. Effective thermal management further contributes to the longevity of prosthetic components by preventing damage associated with prolonged exposure to heat and moisture.

[0049] In one embodiment, a cooling device having an integrated cushioning panel and heat transfer material is incorporated during the fitting process. This configuration facilitates efficient heat dissipation and moisture reduction, thereby promoting improved thermal comfort, skin health, and functional durability of the prosthetic system.

[0050] Mechanical Design

[0051] FIG. 1 is a perspective view of a prosthetic cooling system 100 in a compression type above knee socket in accordance with an embodiment of the disclosed technology. FIG.2A depicts a perspective view of a modular cushioning panel for use in system 100, FIG. 2B depicts a top view of a flexible thermoelectric device used in a cushioning panel and FIG. 2C depicts a side view of the flexible thermoelectric device of FIG. 2B. FIGS. 1 and 2A - 2C are best viewed together in the following discussion.

[0052] The system 100 includes a prosthetic socket 102 configured to receive a residual limb, with a silicone liner interposed between the socket's inner surface and the residual limb to enhance suspension and minimize skin irritation. Integrated within the socket structure are one or more cushioning panel 104 and control circuit 106, configured to provide localized thermal management and user comfort during extended prosthetic wear, along with thermoelectric (TE) devices 108, each having a cold side oriented toward the residual limb and a hot side coupled to a heat dissipation mechanism, such as a heat sink or phase change material (PCM) enclosure.Docket No: ROCT.P2006WQ / 00634886

[0053] As disclosed herein, prosthetic cooling system 100 provides a flexible and adaptive thermoregulation system integrated into prosthetic liners or wearable medical applications, wherein thermal control is achieved through a combination of embedded sensors, electromechanical components, and an intelligent software framework. The system includes a flexible TE device 108 operatively coupled to control circuit 106, configured to provide localized thermal management and user comfort during extended prosthetic wear. TE device 108 operates on the principle of the thermoelectric effect, also known as the Peltier effect. When an electric current flows through two dissimilar conductors, heat is absorbed at one junction (the cold junction) and released at the other (the hot junction). This effect allows for the creation of a temperature gradient across the device. When integrated into a prosthetic socket, the cooling side of the cell may be placed against the skin, providing relief from heat and reducing discomfort for the wearer. The temperature drop achieved may be significant, for example, cooling effects of up to 50°F are possible depending on the design and materials used.

[0054] Control circuit 106 incorporates a temperature feedback loop that autonomously actuates the TE device 108 when measured environmental conditions deviate from predefined thermal thresholds, thereby optimizing cooling performance while conserving energy. System 100 operates under a dual-mode control architecture: a manual mode, wherein the user can directly engage or modify system parameters via a mobile application, and an autonomous mode, wherein the onboard computing unit continuously monitors temperature and humidity data from integrated sensors. In autonomous mode, the onboard processor activates or deactivates the thermoelectric cooling subsystem in response to sensor input, maintaining thermal conditions within a user-defined comfort range. Temperature and humidity data collected within the socket are wirelessly transmitted to a remote server via a connected mobile or portable computing device. The remote server processes the incoming data to determine optimized cooling parameters based on time-based analytics or user behavior and transmits these parameters back to the onboard computing module for real-time control adjustments.

[0055] The mobile application further enhances user interaction through secure biometric access, such as facial recognition, and displays real-time environmental data as interactive graphs. This integrated software and hardware framework enhances user autonomy, minimizes the need for clinical adjustment, and ensures consistent thermal regulation tailored to individual physiological and environmental conditions.Docket No: ROCT.P2006WQ / 00634886

[0056] Several components may be included in cooling system 100: a) A wireless microcontroller interface to adjust the temperature of the cooling panels, b) a cushioning panel designed for easily attached to the compression socket, c) a electromechanical device like the thermoelectric generators to provide cooling effect, d) provide precise temperature sensor within the socket, e) an effective heat transfer material to remove excess heat from the system, f) accommodate many cooling device in different locations throughout the socket (approximately 4 cushioning), g) manage wiring and electronic systems within the socket. Other components may be considered in addition to those listed.

[0057] The mechanical design of the disclosed prosthetic cooling system may contain various configurations adapted to satisfy functional and structural requirements of integration within a prosthetic socket. In one embodiment, as illustrated in FIG. 2A, a modular cushioning panel 104 may be configured for use with a compression socket commonly employed in prosthetic applications. The cushioning panel 104 may contain one or more mounting slots 110 configured to receive and retain thermoelectric (TE) devices 108, such that the devices are positioned adjacent to the skin-facing side of the socket for direct thermal regulation of the residual limb. In addition, the cushioning panel may contain wiring slots 112 through which electrical conductors are routed to deliver power and control signals to the TE devices. In certain embodiments, these wiring slots 112 and mounting slots 110 may be adjustable to accommodate variations in limb geometry and socket design, providing flexibility across patient- specific prosthetic configurations. Cushioning panels 104, which are essential in prosthetic sockets, may be used to provide adjustable tightness and ensure a secure fit for the prosthetic liner. The present design may integrate thermal regulation features directly into cushioning panels 104 to leverage their ubiquitous use across compression socket systems. In some embodiments, the cushioning panels 104 may contain embedded TE devices and heat sink structures, including flexible heat transfer materials, to enable efficient heat dissipation without compromising the panel’s compressive or comfortenhancing properties. Further structural enhancements may include the incorporation of mounting slots 110 within cushioning panel 104 for the purpose of venting accumulated heat and accommodating the geometry of both the TE devices 108 and the flexible heat sink 126. These modifications may allow the cushion panel to effectively house the cooling system components while preserving its primary function as a comfort interface, thereby enhancing both prosthetic fit and thermal comfort.

[0058] Electro-Mechanical DesignDocket No: ROCT.P2006WQ / 00634886

[0059] FIG. 2B illustrates a top view of a flexible thermoelectric device 108 that may be integrated within a cushioning panel 104, in accordance with one or more embodiments. The cushioning panel may contain a flexible thermoelectric module configured to conform to the inner surface of a prosthetic socket or liner, thereby improving thermal transfer efficiency and user comfort. The thermoelectric device 108 may contain one or more conductive polymer elements 114 that provide localized cooling functionality when an electric current is applied. The electric current may be delivered through electrical terminals 116, which may be operatively coupled to a control circuit 106 through wiring slots 112 for regulated activation. The conformal and low-profile nature of the flexible TE device 108 may allow for seamless integration within the socket without adversely affecting structural fit or mechanical performance.

[0060] FIG. 2C illustrates a side view of a flexible thermoelectric device 108 for use in a cushioning panel, in accordance with certain embodiments. The device may contain alternative layouts of conductive paths, thermoelectric elements, or polymer substrates to accommodate varying anatomical contours and prosthetic socket geometries, thereby enabling modular design and customizable thermal management solutions.

[0061] FIG. 3A depicts an arrangement of cushioning panels 104 disposed within a compression socket such as socket 102, in accordance with one or more embodiments. The compression socket may be configured to receive a cushioning panel including one or more TE devices 108, integrated heat dissipation structures, and associated control electronics. The cooling module may be embedded between the inner socket wall 118 and the prosthetic liner 120, or alternatively, within a designated cavity formed in the socket structure to facilitate efficient thermal transfer without compromising mechanical integrity.

[0062] FIG. 3B illustrates another arrangement of cushioning panels 104 disposed of within a compression prosthetic socket 102, in accordance with one or more embodiments. The compression prosthetic socket 102 may contain an integrated cushioning panel 104 in combination with a control circuit 106 such as a microcontroller. As described above, cushioning panel 104 may contain one or more flexible thermoelectric devices positioned in proximity to the inner surface of the socket to facilitate direct thermal regulation of the residual limb. In the depicted embodiment, the socket may further contain an embedded control circuit 106 configured to receive input from temperature and humidity sensors and to regulate the operation of the thermoelectric devices 108 via control strategies. The controller may be operatively coupled to the thermoelectric elements through electrically insulated conduits routed through the socket wall or liner structure.Docket No: ROCT.P2006WQ / 00634886

[0063] Additionally, the compression prosthetic socket 102 may contain structural accommodation such as recesses, mounting brackets, or compartmental housing like perforated inner socket 122 to secure the cooling module and control circuit 106 in place during dynamic use. The integration of both thermal and control components within the socket structure may allow for compact, user-responsive thermal regulation without compromising the fit, comfort, or mechanical performance of the prosthetic device.

[0064] FIG. 4 depicts an exploded view of cushioning panel 104 and its constituent components, in accordance with one or more embodiments. The cushioning panel 104 may contain a layered assembly configured to facilitate thermal regulation within a prosthetic socket or liner system. In one embodiment, the cushioning panel 104 may contain a flexible thermoelectric device 108 configured to provide active cooling via the Peltier effect. The thermoelectric device 108 may be positioned between a skin-contacting layer and a thermally conductive support structure to optimize thermal transfer efficiency. Cushioning panel 104 may further contain a flexible heat transfer material layer 124 formed from a polymeric composite comprising polydimethylsiloxane (PDMS) integrated with phase change materials (PCMs). This PCM-PDMS composite layer may be configured to absorb, store, and dissipate thermal energy during operational cycles of the thermoelectric device, thereby maintaining a stable temperature near the limb interface. Additionally, the cushioning panel 104 may contain a customized aluminum heat sink 126 thermally coupled to the hot side of the thermoelectric device 009. The heat sink 126 may be configured with extended surface geometry or fins to improve convective and conductive heat dissipation from the higher-temperature end of TE device 108. The collective configuration of these components within the cushioning panel 104 may allow for efficient, localized cooling while maintaining mechanical flexibility and user comfort.

[0065] FIG. 5 illustrates a perspective view of control circuit 106 along with its corresponding enclosure. FIG. 6 is a block diagram of control circuit 106 and other components that provide an electrical system architecture for sensor integration, data transmission, and intelligent control of a thermoelectric cooling system integrated within a prosthetic device. FIGS. 5 and 6 are best viewed together in the following description.

[0066] Control circuit 106 may include a microcontroller or processing unit 130 connected to power supply 132 on a circuit board 134. A structural housing or board enclosure 128 may be configured to protect and support the internal electronic components during use and integration within a prosthetic system. Enclosure 128 may be formed from a thermally and electrically insulative material and may include mounting features to facilitate secureDocket No: ROCT.P2006WQ / 00634886 placement within or adjacent to the prosthetic socket. Processing unit 130 may be operatively connected to a logic control device 136 configured to modulate the electrical input to cooling unit 138 and TE devices 108. Logic device 136 may include MOSFETS programmed to vary output power based on real-time sensor input, predetermined thermal thresholds, or user-defined settings received from an external user interface, such as a mobile application 142. Power supply 132 may be implemented as a rechargeable or replaceable battery, for example. The power supply 132 such as a rechargeable lithium-ion battery, configured to supply electrical energy to various functional components. The integration of these components within a compact controller module may enable autonomous or user-initiated thermal regulation while preserving the portability and functionality of the prosthetic system.

[0067] Power supply 132 may be electrically coupled to a power converter (not shown), such as a buck-boost converter, that regulates input voltage and current to deliver a stable output — preferably 5V DC at up to 10A — optimized for driving thermoelectric devices 108. In one embodiment, the system may contain an Embedded Thermal Regulation Sensor (ETRS) unit 140, strategically positioned within the prosthetic socket 102 and configured to monitor real-time environmental parameters including temperature and humidity reading. Control circuit 106 may contain a wireless communication module 144 compliant with Bluetooth Low Energy (BLE) protocols, enabling bidirectional communication with a mobile application 142 hosted on a user device. The mobile application 142 may be configured to visualize sensor data, permit manual input of control commands, and define operational thresholds for autonomous cooling behavior.

[0068] Sensor data collected by ETRS 140 may be transmitted to processing unit 130 which is configured to evaluate the data using a software -based Proportional-Integral-Derivative (PID) control algorithm, for example. Based on this analysis, the processing unit 130 may issue control signals to logic device 136, which in turn regulates one or more switching transistors, such as Metal-Oxide-Semiconductor Field-Effect Transistors (MOSFETs), arranged across control channels R1-R4. The logic device 136 may control a cooling unit 138, comprising one or more thermoelectric devices 108 embedded within cushioning panels of the prosthetic socket. These flexible thermoelectric cells may be configured to perform localized active cooling when activated. The system may initiate cooling sequences upon user command via the mobile application 142 or automatically when real-time temperature readings exceed a user-defined threshold, as determined by comparator logic in autonomous mode.Docket No: ROCT.P2006WQ / 00634886

[0069] Power supply 132 may further include a direct connection to an external power bank, providing redundancy and operational flexibility during prolonged use. Optimal power configurations for each thermoelectric cell may be established through empirical testing, with a preferred setting of 5V and 1.5A offering an optimal balance between thermal performance and energy efficiency. Upon system activation — triggered by a user-operated power button, for example, the control circuit 106 may direct the initial cooling phase toward the posterior region of the limb, where thermal buildup is often most significant. The system may then transition to the anterior region, ensuring comprehensive coverage. As the socket temperature approaches a higher threshold (e.g., 84°F), a PID control loop may engage to stabilize the thermal response, maintaining cooling without overcorrection. Once the system reaches a lower threshold (e.g., 57°F), control circuit 106 may initiate current redistribution across the thermoelectric devices 108, thereby minimizing power consumption and reducing local cooling intensity while maintaining user comfort. The integrated control system may contain multiple features to enhance performance and safety, including Dynamic current regulation to balance power distribution and extend battery life. Real-time feedback mechanisms to ensure precise temperature control. Load balancing logic to prevent thermal hotspots or overcooling. BLE-based control for remote actuation and monitoring via mobile applications. Fail-safe protocols including time-based lockout intervals and disconnection alerts.

[0070] In sum, the disclosed system may provide an intelligent, adaptive, and powerefficient thermoelectric control framework for prosthetic applications. By integrating realtime environmental sensing, PID-based temperature control, wireless communication, and flexible power options, the system may deliver customized thermal regulation that enhances user comfort, prosthetic usability, and energy efficiency. The system architecture shown in FIG. 6 may serve as a foundational model for smart prosthetic cooling systems that balance functionality with patient- specific adaptability. Other components in addition those shown in FIG. 6 may be included without departing from the scope disclosed herein.

[0071] FIG. 7 illustrates an embedded thermal regulation sensor (ETRS) 140. The ETRS unit 140 may contain one or more environmental sensing components configured to monitor internal socket conditions, including but not limited to temperature and humidity levels. These sensors may be encapsulated within a compact, protective housing 146, which is designed to be integrated into or positioned within the prosthetic socket structure.

[0072] ETRS housing 146 may contain a wireless communication module, such as a Bluetooth Low Energy (BLE) or Wi-Fi transmitter, enabling real-time data transmission to an external processing unit or mobile applicationl42. The ETRS unit 146 may be powered by anDocket No: ROCT.P2006WQ / 00634886 internal rechargeable power source or externally supplied via a connection port 148, which may support USB-C or magnetic charging interfaces. Additionally, the surface of the housing may contain thermal conduction or vented grill features 150 to facilitate air exchange or heat dissipation, depending on system requirements. ETRS unit 140 may operate autonomously or in conjunction with control circuit 106 to trigger thermoelectric cooling responses, store sensor data logs, or relay alerts to the user or healthcare provider via paired devices.

[0073] ETRS unit 140 may be easily attached to a perforated inner socket 122. A perforated inner socket may be configured to receive and secure one or more units. The perforated inner socket 122 includes a plurality of apertures distributed across the surface of the socket body. These apertures are dimensioned to receive ETRS 140, which may be removably affixed to the inner socket at user-selected positions to enhance comfort and improve localized fit.

[0074] As disclosed herein, a socket liner 122 is formed from a structurally supportive yet flexible material, enabling it to accommodate minor dimensional adjustments together with ETRS units 140 being added or removed. The ETRS 140 may be installed through press-fit engagement, adhesive bonding, mechanical fasteners, or other suitable attachment means to ensure secure positioning within the perforations. The integration of ETRS 140 may enable localized monitoring of temperature and humidity with high spatial resolution. This configuration allows continuous capture of temperature conditions and potential hot spots within the prosthetic socket during both static and dynamic use.

[0075] In one embodiment, system 100 may employ a distributed array of ETRS units 140 with the aforementioned wireless communication capability. This array may form a thermal mapping network across the interior surface of the prosthetic socket. Real-time data from each ETRS unit 140 may be aggregated and displayed via a visualization interface on the mobile application 142 as real-time temperature and humidity reading. The integration of comfort-enhancing structural elements with wirelessly enabled thermal sensing represents a hybrid system for enhancing user comfort and enabling personalized thermal management. The real-time monitoring capability supports dynamic adjustment and clinical evaluation of heat buildup and moisture accumulation, thereby improving socket fit and long-term prosthetic usability. The wireless data transmission functionality of each ETRS unit 140 enables modular installation and custom sensor placement throughout the prosthetic liner or socket 102. This eliminates the need for wired connections and permits flexible configurations adapted to the patient’s limb shape and specific anatomical needs, thereby allowing highly personalized thermal feedback and socket designDocket No: ROCT.P2006WQ / 00634886

[0076] A variety of hardware options may be used. Representative examples are shown in Table 1Component Current SelectionSensors Temperature and HumidityWiring for sensors WiredBluetooth Module Built in module in controller board Microcontroller Board BLE boardTable 1

[0077] Heat-Transfer Material

[0078] A flexible heat-transfer material may be formed by incorporating pyrogenic silica phase change materials (PCMs) into polymer matrices, such as polydimethylsiloxane (PDMS), in a manner that preserves both the thermal energy absorption properties of the PCM and the flexibility of the polymer. Composite materials comprising various weight ratios of PCM (e.g., EnFinit PCM powders) and a PDMS-based elastomer (e.g., EcoFlex™) may be used to achieve optimal thermal and mechanical performance.

[0079] In certain embodiments, the PCM may be incorporated into the PDMS matrix at concentrations ranging from approximately 1 wt% to 30 wt%. Such PCM-PDMS composite materials may be utilized in the fabrication of flexible heat sinks or prosthetic liners, providing improved thermal regulation in combination with mechanical cushioning and user comfort for prosthetic applications.

[0080] In certain embodiments, the fabrication process PCM-PDMS heat transfer materials involve the use of EcoFlex™ PDMS and EnFinit PCM powders. The fabrication of the PCM-PDMS heat transfer materials may involve the following steps: (1) Mixing of PCM powders, such as EnFinit PCM Powders with EcoFlex™ in a specified ratio, and stirring the mixture thoroughly to ensure uniform consistency. (2) Molding into a desired shape by pouring and curing in a mold to form the finished final product. (3) removing from the mold for final quality control inspection. The PCM-PDMS composites may exhibit both elastomeric and thermal conductivity properties, rendering them suitable for use as heat sinks and as liners in prosthetic devices.

[0081] FIGS. 8 - 10 illustrate a methodology for preparing a heat transfer material, in accordance with one or more embodiments. The formulation may contain a flexible polymeric matrix combined with a thermal energy storage medium, wherein the resulting composition is capable of both heat absorption and mechanical flexibility. FIG. 8 showsDocket No: ROCT.P2006WQ / 00634886 blending the components to form a uniform mixture that exhibits desirable thermomechanical characteristics for application within a prosthetic socket environment.

[0082] FIG. 9 illustrates a subsequent stage in the formation of the heat transfer material, wherein the thermally active mixture 152 may be cast or shaped into a desired geometry suitable for integration into prosthetic components. The material may then be subjected to a solidification process under ambient or controlled conditions to form a structurally stable, flexible heat transfer materials. The resulting material exhibits both structural adaptability and thermal functionality. Specifically, it is capable of conforming to complex anatomical geometries, enhancing comfort and interface integration when applied in biomedical or wearable systems. At the same time, it retains efficient heat transfer properties, enabling its use as a functional heat sink or thermal interface layer. These combined properties make the material particularly well-suited for applications such as prosthetic liners, where both ergonomic fit and thermal regulation are critical.

[0083] FIG. 10 illustrates a prosthetic liner 154, in accordance with one or more embodiments. Liner 154 may contain a flexible heat transfer material configured to provide both thermal regulation and mechanical cushioning within the prosthetic socket. The heat transfer material may contain a polymeric matrix integrated with thermally responsive elements capable of absorbing and dissipating heat generated by embedded electronic components, such as thermoelectric (TE) devices 108. The liner may be formed to conform to the shape of the residual limb and may serve as both a heat sink and a user comfort interface.

[0084] By tuning the compositions of PCM-PDMS composites, a more cohesive and resilient materials may be prepared to withstand the stresses of cyclic loading. Reinforcing agents could be introduced to enhance the mechanical properties of the PCM-PDMS composites, such as tensile strength, shear elasticity, and tear resistance, without compromising flexibility or comfort. These reinforcements could address issues of unbonding and improve the overall structural integrity of the layer.

[0085] Surface treatments may also applied to both the PCM and PDMS matrix interfaces to improve the interface interactions between PCM and PDMS, with the intention of increasing adhesion and reducing the likelihood of delamination under stress. These combined material improvements — adjusting compositions, introducing reinforcements, and applying surface treatments — may provide improved resistance to cyclic loading, with reduced occurrences of unbonding and failure.

[0086] A method for producing a liner comprising a PCM-PDMS composite may include the following steps: (1) Component Measurement and Initial Mixing: Part A of a two-partDocket No: ROCT.P2006WQ / 00634886 PDMS elastomer (e.g., EcoFlex™) is measured and transferred into a glass container, followed by sonication for approximately 10 minutes to remove entrapped air. Separately, Part B of the elastomer is measured. Parts A and B are then combined in a 1 :2 volume ratio and mixed using a mechanical mixer for approximately 30 seconds. (2) Incorporation of PCM: Following the initial mixing, a EnFinit PCM powder is incrementally introduced into the elastomeric mixture at a concentration ranging from approximately 10 wt% to 30 wt%. The mixture is stirred mechanically at approximately 150-600 RPM for 15-2 minutes to ensure even dispersion of the PCM within the elastomer matrix. (3) Degassing: The resulting mixture is subjected to degassing treatment (e.g., ultrasonic) for approximately 12 minutes to eliminate residual air bubbles and minimize voids in the final product. (4) Molding and Curing: The degassed composition is poured into a mold having a predetermined shape. The filled mold is allowed to cure to form the liner.

[0087] FIG. 11 depicts apparatus for conducting a tensile test on a specimen 156 composed of the disclosed flexible heat transfer material, using standardized tensile test grips 158, in accordance with one or more embodiments. The specimen may be subjected to mechanical loading to evaluate its elongation characteristics, tensile strength, and elasticity. The flexible heat transfer material may exhibit significant stretchability, making it suitable for dynamic prosthetic environments where mechanical compliance and deformation are required for patient comfort and prosthetic integration.

[0088] FIG. 12 is a graph showing tensile test results comparing the performance of the fabricated flexible heat transfer material 160 to that of a commercially available flexible heat sink material 161, in accordance with one or more embodiments. As shown, the fabricated material may exhibit superior elongation properties, with extension capability up to approximately 100 mm, whereas the commercial alternative may extend only up to approximately 60 mm. The data suggests that the disclosed material may offer enhanced mechanical flexibility while maintaining effective thermal management, making it particularly advantageous for use in wearable prosthetic applications where comfort, adaptability, and durability are critical.

[0089] Nanoporous polyethylene (nanoPE) (e.g., Teklon™, International LLC), having a pore size distribution in the range of approximately 50 to 1000 nanometers, may be employed as a thin layer within a prosthetic liner. NanoPE is capable of transmitting mid-infrared radiation emitted by the human body while simultaneously blocking visible light, thereby facilitating radiative cooling and enabling a reduction in skin temperature of approximately 2.0 to 2.7 °C below ambient conditions. In addition to its radiative properties, nanoPEDocket No: ROCT.P2006WQ / 00634886 exhibits advantageous physical characteristics such as air permeability, water- wicking capability, and mechanical robustness, making it suitable for use in wearable medical devices.

[0090] NanoPE may be integrated into prosthetic liner systems to impart breathability, biocompatibility, flexibility, and durability — features that are essential for extended wear in medical applications. In certain embodiments, a thin nanoPE layer may be incorporated into the interior or exterior of the liner, with one or more thermoelectric cooling elements affixed thereto. This configuration may facilitate active temperature regulation of the prosthetic limb, enhancing user comfort. The functional properties of nanoPE may be further optimized through post-processing techniques including microneedle perforation, coating with polydopamine to improve bio-adhesion and biocompatibility, and lamination for added structural stability and comfort.

[0091] FIGS. 13A - 13D depict a series of infrared thermal images demonstrating the comparative thermal performance of the disclosed flexible heat transfer material under various configurations, in accordance with one or more embodiments. The images illustrate temperature distributions across thermoelectric modules (or similar heat-generating components) under different cooling scenarios.

[0092] In one embodiment, the configuration shown in the image of FIG. 13A may contain no heat sink, resulting in limited heat dissipation and a higher surface temperature. In contrast, the image shown in FIG. 13B may contain a metal heat sink affixed to the thermal interface, resulting in improved thermal regulation through conductive heat dissipation.

[0093] FIG. 13C depicts an image of a configuration wherein the thermoelectric device may contain a PCM-PDMS based heat sink. This configuration demonstrates effective thermal buffering due to the latent heat absorption characteristics of the PCM-PDMS, leading to a lower observed surface temperature.

[0094] FIG. 13D depicts an image of a composite configuration that may contain both a metal heat sink and a PCM-PDMS based heat sink layered in conjunction. This arrangement demonstrates the greatest reduction in temperature, as it leverages both conductive and latent heat transfer mechanisms, thereby achieving superior heat dissipation performance. These thermal profiles collectively demonstrate that the flexible heat transfer material, particularly in embodiments that combine PCM-PDMS and metallic elements, may provide enhanced cooling capacity, making it suitable for thermally dynamic environments such as prosthetic sockets integrated with active electronic systems.Docket No: ROCT.P2006WQ / 00634886

[0095] FIG. 14 depicts a system-level flow diagram of a thermoregulation user interface system configured for use with a prosthetic device, in accordance with one or more embodiments. The system may contain a mobile-based user interface (UI) module 162, a Bluetooth Low Energy (BLE™) communication module 144, a control circuit 106 integrated within the prosthetic socket 102, and at least one temperature sensor 140 positioned to monitor environmental conditions inside the prosthetic socket.

[0096] Upon system initialization, the mobile UI module 162 may present an application mode selector 164, allowing the user to toggle between two distinct control schemes: manual mode 166 and autonomous mode 168. The selected mode may determine the control flow and sensor-actuator interaction pathway for temperature regulation within the prosthetic system.

[0097] In manual mode 166, the system may contain predefined user-selectable control options — such as LOW, MEDIUM, HIGH, or OFF — for regulating thermoelectric cooling intensity. Upon user selection, the mobile UI module 162 may transmit corresponding control commands 170 to the control circuit 106 via communication module 144. The microcontroller may interpret these commands and execute the appropriate cooling response by activating or modulating one or more thermoelectric modules embedded within the prosthetic socket. A confirmation signal or acknowledgment (e.g., ACK:STARTED, ACK:DONE) may be relayed back to the mobile UI to update the user on system status in real-time.

[0098] In autonomous mode 168, the system may operate in a closed-loop configuration. The temperature sensor 140 may continuously measure environmental parameters such as temperature and optional humidity within the prosthetic interface. Sensor readings may be transmitted wirelessly to the comparator logic block via BLE communication. The comparator logic may contain a programmable threshold value, which may be set by the user or determined algorithmically. When the measured temperature exceeds the predefined threshold, a control signal 172 may be issued to activate the thermoelectric cooling module. Conversely, if the temperature remains below the threshold, the system may suspend activation to conserve power and prevent unnecessary cooling cycles.

[0099] The system may contain integrated features for visual and auditory feedback, such as notification tones or push messages triggered upon cooling initiation or completion.Cooling cycles may be governed by timing logic that enforces a minimum cooldown lockout period — such as five minutes — to avoid thermal oscillation and battery depletion.

[0100] Real-time data from the temperature sensor 140 may be graphically rendered within UI module 162 as dynamic line plots or numerical values, enabling the user to monitorDocket No: ROCT.P2006WQ / 00634886 conditions inside the prosthetic socket. The system may support user override functionality, permitting mode switching or emergency shutdown from UI module 162. A “Disconnect” control may be provided to terminate BLE communication cleanly and safely. The system architecture may further include error detection and recovery protocols to handle BLE communication failures, sensor read errors, or actuator command timeouts. Such protocols may trigger alerts, retries, or safe shutdown procedures to preserve system integrity and user safety. The dual-mode thermoregulation framework disclosed herein may enable both patient-directed and autonomous thermal regulation, ensuring adaptability to varying activity levels, ambient environments, and individual comfort preferences. The integration of sensor feedback, embedded control logic, and wireless communication within a unified user interface may provide a robust and intuitive solution for maintaining thermal homeostasis in prosthetic applications.

[0101] The flow diagram shown in FIG. 14 may serve as an operational reference model, visually demonstrating the interaction among hardware modules, user control inputs, sensor data acquisition, BLE-mediated command exchange, and microcontroller-driven actuator execution, thereby supporting both real-time responsiveness and long-term wearability.

[0102] FIG. 15 is a graph of sensor-derived temperature data over time obtained during the evaluation of a conventional prosthetic liner, in accordance with one or more embodiments. The experimental testing protocol may contain the deployment of a thermal monitoring system configured to collect temperature readings from an amputee subject under real- world conditions. Specifically, the system may contain multiple thermocouples affixed to designated anatomical regions within the prosthetic socket, including the anterior side 174, lateral side 176, and posterior side 178 of the residual limb. The thermocouples may be interfaced with a data acquisition and visualization platform such as National Instruments' Lab VIEW™ software, to record and graphically represent real-time temperature fluctuations over an extended period. The data capture system may include an analog-to-digital converter, signal conditioning modules, and temperature calibration routines to ensure high-resolution accuracy. As shown in FIG. 15, the measured temperatures across the three regions — anterior 174, lateral 176, and posterior 178 — may exhibit significant variability, with observed average values for conventional silicone liners approaching 90°F (approximately 32.2°C). This elevated baseline temperature may indicate the inherent thermal retention properties of traditional liner materials, which lack active cooling mechanisms or integrated heat dissipation features. The posterior region 178 in particular may demonstrate higher sustained thermal readings, consistent with known patterns of heat accumulation in enclosed prostheticDocket No: ROCT.P2006WQ / 00634886 environments. The data collected through this methodology may serve as a baseline reference for evaluating the effectiveness of advanced cooling systems, such as those incorporating thermoelectric modules and PCM-PDMS based heat sinks as described in other embodiments of the present disclosure. This experimental setup and dataset may validate the need for integrated thermal regulation within prosthetic liners and sockets, particularly in active users or extended wear scenarios. The system architecture tested in FIG. 15 may be expanded in subsequent embodiments to include real-time closed-loop control logic, BLE-enabled telemetry, and adaptive actuation mechanisms to mitigate heat buildup and enhance user comfort.

[0103] FIG. 16 illustrates a data plot derived from thermocouple-based temperature testing performed on an amputee subject utilizing the disclosed PCM-PDMS liner in combination with the integrated thermoelectric cooling system, in accordance with one or more embodiments. The experimental setup may contain thermocouples positioned at strategic locations within the prosthetic sockets specifically, the anterior side 180 and the posterior and lateral regions 182 — to measure spatial thermal variation during device operation. The temperature readings may be acquired using a data acquisition system, enabling continuous real-time logging and graphical visualization of thermal profiles within the socket interior. The data collection process may involve signal conditioning, calibration, and analog-to-digital conversion to ensure measurement precision and repeatability. As depicted in FIG. 16, the combination of PCM-PDMS based liner and active thermoelectric cooling may result in significantly reduced internal socket temperatures compared to conventional systems. The measured average temperature using the integrated solution may be approximately 80°F (approximately 26.7°C), a notable reduction relative to the ~90°F baseline observed with standard silicone liners as shown in FIG. 15. The anterior side sensor 180 may report stable and consistently lower temperatures than the posterior and lateral regions 182, indicating efficient heat distribution and absorption across the PCM-PDMS liner. This performance may reflect the synergistic effect of the PCM-PDMS ’s latent heat storage properties combined with localized active cooling delivered by embedded thermoelectric cells.

[0104] The collected data may validate the efficacy of the disclosed system in enhancing thermal regulation within prosthetic sockets. The reduced thermal load may contribute to improved user comfort, extended wearability, and lower incidence of heat-related dermatological issues. Furthermore, the integrated nature of the sensors, cooling modules, and PCM-PDMS liner may allow for scalable deployment across various prosthetic geometries and user- specific configurations.Docket No: ROCT.P2006WQ / 00634886

[0105] In contrast to the elevated thermal retention exhibited in FIG. 15, the results in FIG.16 may demonstrate the advantages of the present invention in maintaining thermal equilibrium during prosthetic use, thereby addressing a long-standing need for dynamic and personalized cooling solutions in wearable assistive devices.

[0106] Cushion panel device including flexible TE cells and flexible PCM-PDMS heat sinks may be applied in many other applications that require both flexibility and adaptability, making them highly suitable for environments where traditional rigid cooling solutions would be impractical.

[0107] Their ability to conform to irregular or moving surfaces, combined with their lightweight and adaptable nature, makes flexible cushion panel devices an ideal solution for many applications requiring efficient cooling alongside flexibility, such as in bicycle seats, prosthetics, wearable electronics, body armor, and sports gear.

[0108] As mentioned above, in prosthetics, devices offer localized cooling, helping regulate temperature, enhance wearer comfort, and prevent heat build-up that can cause discomfort or skin irritation.

[0109] For example, in bicycle seats, flexible cushion panel devices provide an innovative cooling solution by actively managing heat build-up during long rides, ensuring comfort and reducing fatigue for cyclists, especially in hot conditions. Similarly, in body armor and sports gear, devices as disclosed herein deliver active cooling to prevent overheating during intense physical activities, ensuring better temperature management without compromising mobility. Protective armor worn by police officers, military soldiers, or firefighters is typically thick and can become uncomfortably hot during extended use. Devices may be integrated into these protective garments to serve as a cooling system, effectively managing heat build-up and improving wearer comfort. By actively cooling the armor, these devices help regulate body temperature, reducing the risk of heat-related fatigue and enhancing performance in demanding environments. This application is particularly beneficial for occupations where prolonged exposure to heat is common, such as firefighting or law enforcement.

[0110] Changes may be made in the above methods and systems without departing from the scope hereof. It should thus be noted that the matter contained in the above description or shown in the accompanying drawings should be interpreted as illustrative and not in a limiting sense. The following claims are intended to cover all generic and specific features described herein, as well as all statements of the scope of the present method and system, which, as a matter of language, might be said to fall therebetween.

Claims

Docket No: ROCT.P2006WQ / 00634886CLAIMSWhat is claimed is:

1. A prosthetic cooling system, comprising:a cushioning panel configured for integration into a compression-type prosthetic socket; a thermoelectric (TE) device positioned in the cushioning panel proximate to a skincontacting surface of the compression-type prosthetic socket; anda flexible heat sink positioned in the cushioning panel and thermally coupled to a hot side of the TE device.

2. The prosthetic cooling system of claim 1, wherein the flexible heat sink is made of PDMS and PCM composite material.

3. The prosthetic cooling system of claim 2, wherein the PDMS and PCM material can be used as a prosthetic liner material to effectively dissipate heat within a socket.

4. The prosthetic cooling system of claim 1, further comprising:a flexible liner formed of a polymeric composite material comprising a base polymer Polydimethylsiloxane (PDMS) and a-_phase change material (PCM), the liner configured to conform to a residual limb and provide thermal buffering and mechanical cushioning inside the compression-type prosthetic socket.

5. The prosthetic cooling system of claim 1, further comprising:a control circuit comprising a processing unit, a logic device, and one or more switching transistors;wherein the control circuit is configured to modulate electrical current to the TE device based on temperature data.

6. The prosthetic cooling system of claim 5, wherein the control circuit executes a proportional-integral-derivative (PID) control algorithm to regulate a cooling intensity of the TE device in response to real-time sensor input.

7. The prosthetic cooling system of claim 1, further comprising:an onboard computer configured to collect temperature data from distributed sensors within the compression-type prosthetic socket;a wireless communication interface configured to transmit the temperature data to a remote or portable device; anda control circuit to adjust cooling output based on received target parameters.Docket No: ROCT.P2006WQ / 00634886 8. The prosthetic cooling system of claim 7, wherein the wireless communication interface comprises a low-energy communication protocol to maintain data transmission while conserving power.

9. The prosthetic cooling system of claim 7, wherein the onboard computer is configured to store temperature data over time and adjust cooling intensity to maintain a target thermal range.

10. The prosthetic cooling system of claim 9, wherein the target thermal range is dynamically determined based on user input or historical usage data.

11. The system of claim 5, further comprising a portable device configured to:receive and visualize sensor data;transmit user-defined cooling parameters to the control circuit; andconnect to a remote server to obtain optimized cooling recommendations.

12. The system of claim 11, wherein the remote server comprises:a user authentication module;a recommendation engine for determining optimal cooling parameters based on historical data; anda storage system configured to store user-specific thermal profiles.

13. The system of claim 11, wherein the remote server includes an analytics module configured to evaluate performance metrics and recommend adjustments to prosthetic socket thermal settings.

14. The prosthetic cooling system of claim 1, wherein the TE device comprises a flexible module integrated with conductive polymer paths and powered via insulated electrical terminals.

15. The prosthetic cooling system of claim 1, further comprising a user interface configured to:receive user input for manual cooling control;display real-time sensor data; andreceive user input to switch between manual and autonomous operational modes.

16. The system of claim 15, wherein the user interface is a mobile application that includes biometric authentication, visual feedback, and wireless connectivity to the prosthetic socket.Docket No: ROCT.P2006WQ / 00634886 17. The prosthetic cooling system of claim 1, wherein the cushioning panel further comprises:internal routing channels for wiring;thermally conductive vent slots; andstructural brackets for retaining TE devices.

18. The prosthetic cooling system of claim 1, wherein multiple TE devices are distributed within the socket and are selectively activated based on localized sensor readings.

19. A method of controlling temperature in a prosthetic socket, comprising:positioning a thermoelectric (TE) device within a cushioning panel adjacent to a user’s residual limb;detecting temperature using one or more embedded thermal sensors in the prosthetic socket;processing data from the one or more embedded thermal sensors using a Proportional- Integral-Derivative (PID)-based algorithm on a microcontroller; and regulating a cooling output of the TE device to maintain a target comfort range.

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