Prosthetic devices having pressure sensors and method of their use

Abstract

A sensor device for use with a prosthetic socket includes a base material with at least one flexible printed circuit board (PCB) secured to the base material, the PCB having a plurality of pressure sensors. The PCB may include a radial arrangement of multiple PCBs or a single PCB with an integrated sensor array connected to a main processing unit via a flat ribbon cable. Comfort cell sensors with embedded BLE pressure sensors may also be used. The sensor device is positioned between a prosthetic silicone liner and socket to measure interface pressure. The data is processed to generate a real-time 3D pressure heatmap and may also be processed into 3D surface models using backend processing pipelines. Visualization software supports UV mapping, heuristic pressure analysis, and GPU-accelerated rendering, while a mobile application enables real-time interaction with the data for prosthetic fit evaluation.

Description

PROSTHETIC DEVICES HAVING PRESSURE SENSORS AND METHOD OF THEIR USECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 568,628 filed March 22, 2024, which is hereby incorporated by reference.BACKGROUND

[0002] Achieving a proper fit for a prosthetic device is a critical yet time-intensive process, often requiring several hours of diagnostic fitting and multiple adjustments to ensure comfort and functionality. Traditionally, practitioners rely on qualitative feedback from patients and perform manual modifications, making the process largely subjective. However, factors such as limb growth, weight fluctuations, and daily variations in limb size can significantly impact prosthetic fit over time, necessitating frequent re-evaluations and adjustments. An ill-fitting prosthetic may result in localized pressure points, discomfort, swelling, or bruising, potentially leading to reduced mobility and long-term health complications. One of the primary challenges in achieving an optimal fit is the lack of an objective and efficient method for assessing and communicating the distribution and magnitude of pressure exerted by the prosthetic socket on the residual limb. This challenge is further compounded for young children and individuals with nerve damage, who may have limited ability to accurately describe discomfort or pressure variations. Accordingly, there is a need for an improved prosthetic fitting system that provides real-time, objective, and quantifiable insights into pressure distribution within the prosthetic socket. Such a system would enhance communication between patients and practitioners, facilitate more precise adjustments, and improve the overall efficiency and effectiveness of the fitting process.SUMMARY

[0003] In a first aspect, the disclosed technology introduces a flexible, spider-inspired sensor array designed to conform to the dynamic contours of a residual limb, enhancing the prosthetic fitting process. The system incorporates a biomimetic, multi-branch sensing structure, inspired by a spider’s ability to detect pressure variations through its web. This adaptive and flexible design enables comprehensive pressure mapping within the prosthetic socket, providing real-time, quantitative feedback on areas of discomfort. By deliveringprecise pressure data, the system allows practitioners to make targeted, data-driven adjustments, improving the efficiency of the fitting process and enhancing overall user comfort.

[0004] In a second aspect, the system allows for post-manufacturing integration of pressure sensors directly into a prosthetic device or liner. This feature enables users to selfmonitor and adjust their prosthetic fit without requiring frequent clinical visits. The system’s adaptive pressure mapping capabilities provide continuous feedback, ensuring optimal fit and enhanced mobility as the limb naturally changes over time.BRIEF DESCRIPTION OF THE FIGURES

[0005] FIG. 1 depicts a sensor device for use with a prosthetic socket, in an embodiment.

[0006] FIGS. 2A - 2H depict several embodiments of a sensor device.

[0007] FIG. 3 depicts a sensor device and a prosthetic socket, in an embodiment.

[0008] FIG. 4 depicts sensors for use in a sensor device, in embodiments.

[0009] FIG. 5 depicts a schematic diagram of spider-inspired sensor layout in a sensor device, in an embodiment.

[0010] FIG. 6 depicts a schematic diagram of another spider-inspired sensor layout in a sensor device, in an embodiment.

[0011] FIG. 7 depicts a comfort cell sensor, in an embodiment.

[0012] FIG. 8 depicts a perforated inner socket with a comfort cell censor, in an embodiment.

[0013] FIG. 9 depicts a diagram of a pressure sensor, in an embodiment.

[0014] FIG. 10 depicts an electrical system architecture for sensor integration and data transmission of a sensor device, in an embodiment.

[0015] FIG. 11 depicts a schematic diagram of software for a sensor device, in an embodiment.

[0016] FIGS. 12 and 13 depict mesh renderings of pressure sensor readings, in an embodiment.

[0017] FIG. 14 depicts a visual representation of these rays tracing, in an embodiment.

[0018] FIG. 15 depicts a block diagram of software for use with a sensor device, in an embodiment.

[0019] FIG. 16 depicts a visual representation of design and electro-mechanical integration of a prosthetic device, in an embodiment.

[0020] FIG. 17 depicts 3D model generation and texture mapping, in an embodiment.

[0021] FIG. 18 depicts a method of evaluating the fit of a prosthetic device using a sensor device, in embodiments.DETAILED DESCRIPTION OF THE EMBODIMENTS

[0022] Exemplary embodiments will be described in detail herein, with examples thereof represented in the drawings. When the following descriptions involve the drawings, like 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.

[0023] 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.

[0024] During the diagnostic fitting process for a prosthetic, a ‘check socket’ may be used to customize the fit and comfort. A check socket is a prosthetic shaped to a mold of the patient’s limb while wearing their preferred silicone liner. As disclosed herein, a sensor device that includes integrated pressure sensors is used during the diagnostic fitting process as a tool to improve communication between the patient and a practitioner.

[0025] Physical Design

[0026] In embodiments, a check socket may begin as a disk of plastic material such as ethylene-vinyl acetate (EVA). To form the socket, the plastic disk is superheated in an oven and then pulled over the mold of the patient’s limb. During a diagnostic fitting process, the patient walks in the diagnostic socket and communicates with the practitioner about areas of discomfort. The practitioner may then take a heat gun, ranging in temperatures from 200- 1000 degrees Fahrenheit, to reshape the socket to accommodate the patient. This process cantake several hours and requires multiple fitting sessions due to the mass fluctuations many patients experience throughout the day or over years.

[0027] FIG. 1 depicts a sensor device 100 for use with a diagnostic socket 102. Sensor device 100 may include flexible printed circuit boards (PCBs) 104 formed as strips and arranged to conform to the inner surface of diagnostic socket 102. Although a specific layout is shown in FIG. 1 , this is for purposes of illustration only and other layouts are possible. Further, flexible PCBs may be formed in other shapes such as squares or circles. Pressure sensors 106 may be integrated into one or more of PCBs 104. The specific arrangement of pressure sensors 106 shown in FIG. 1 is for purposes of illustration only.

[0028] As disclosed herein, a sensor device 100 is a pressure mapping device provided for integration into various diagnostic prosthetic sockets 102, wherein the system is configured to assess pressure distribution without direct skin contact between the silicone liner and the diagnostic socket. The device 100 comprises a network of pressure sensors 106 configured to detect localized pressure variations, wherein said sensors 106 are operatively coupled to a wireless interface to facilitate real-time data transmission to an external computing device. In certain embodiments, the pressure data collected by the sensors is processed and transmitted to a software system configured to generate a visual representation of the sensor readings. The software system includes 3D visualization capabilities, wherein the data is rendered into a live, three-dimensional model that enables practitioners to analyze pressure distribution and identify areas requiring adjustment during the prosthetic fitting process. Sensor device 100 may be utilized not only for diagnostic fitting procedures but also to assist in the design and modification of daily-use prosthetic devices. By providing quantitative pressure data and a real-time visual model, the system facilitates precise adjustments to optimize comfort and functionality. In certain embodiments, the pressure mapping device is designed as a separate sensor device 100 positioned between the silicone liner and the prosthetic socket. In alternative embodiments, the device may be integrated directly into the silicone liner or the prosthetic socket itself, thereby enabling continuous pressure monitoring and adaptive adjustments to accommodate changes in limb volume or socket fit over time.

[0029] Several parameters are considered in the design of device 100: a) A wireless sensor interface to work within the diagnostic fitting process, b) a low profile spider-inspired sensor array that is less than 2 mm in thickness (less than a 3-ply prosthetic sock), c) versatile and reusable for multiple fitting sessions, d) provide precise sensor location within the sensorlayout, e) be useable within the constraints of the current diagnostic fitting process, f) accommodate many sensors in different locations throughout the socket (approximately 80 sensors), g) manage wiring and electronic systems within the sensor array. Other parameters may be considered in addition to those listed.

[0030] As shown in FIGS. 2A - 2H, several possible designs may be considered to meet one or more of these parameters. FIG. 2 A depicts a diagnostic device 110 and FIG. 2B depicts a detailed view of a sensor 106 for use with diagnostic device 110. Diagnostic device 1 10 includes a 3D-printed layer 112 between diagnostic socket 102 and silicon liner 114 that would prevent sensor shearing and allow for sensors 106 and wires 116 to be packaged easily within diagnostic socket 102.

[0031] FIG. 2C depicts a diagnostic device 120 and FIG. 2D depicts a detailed view of a sensor 106 for use with diagnostic device 120. Similarly to FIG. 2A, diagnostic device 120 includes diagnostic socket 102 and silicon liner 114. Diagnostic socket 102 has been modified to allow wires 116 to be routed through diagnostic socket 102. Device 120 may be used for sockets equipped with pressure adjustment dials, where sensors can be integrated into the overall design.

[0032] FIG. 2E depicts a diagnostic device 130 and FIG. 2F depicts a detailed view of a sensor 106 for use with diagnostic device 130. Similarly to FIG. 2A, diagnostic device 130 includes diagnostic socket 102 and a custom silicon liner 132 with sensors 106 embedded in silicon liner 132. This embodiment allows for a thin sensor interface and provide low profile wire routing within the silicon liner to obtain pressure readings as close to the patient’s limb as possible.

[0033] FIG. 2G depicts a diagnostic device 140 and FIG. 2H depicts a detailed view of a sensor 106 for use with diagnostic device 120. FIGS. 2G and 2H are an example of the embodiment of FIG. 1. Diagnostic device 140 includes diagnostic socket 102 and silicon liner 114. Lastly, linear sensor arrays include PCB 104 and sensors 106 that are positioned between silicon liner 114 and diagnostic socket 102 to house the sensors and electronic components within the socket.

[0034] FIG. 3 depicts a sensor device 150 and a prosthetic socket 152, in an embodiment. A series of sensors 154 are positioned on sensor device 150. Sensor device 150 is made of a nylon fabric that may have an elasticity that will fit comfortably over a patient’s limb. Sensors 154 may be attached to the nylon fabric. As shown in FIG. 4, conductive thread 156 may be stitched into the nylon fabric to display the individual output wires for thesensors and their common ground connection. This design was very thin, less than 0.4 mm including the sensors, and proved to be very flexible. Alternatively, ribbon cable 158 may be interwoven within nylon fabric to run wires to the sensors. The ribbon cable provides a simple means of insulating and packaging the wires and sensors, but this layout could be bulky. This embodiment may have an overall thickness of 1 mm.

[0035] FIG. 5 depicts a schematic diagram of spider- like design sensor layout in a sensor device 100 using a flexible PCB 104 layout. As disclosed herein, a sensor device is provided for pressure mapping within a prosthetic socket, wherein the sensor layout incorporates a spider-inspired design to facilitate optimized sensor placement and enhanced data acquisition. The system comprises a flexible and adaptable structure that conforms to the shape of the residual limb while ensuring even distribution of sensing elements across the interface. In certain embodiments, the sensor layout features a multi-branch configuration, wherein linear sensor arrays extend radially along the interior of the socket. The system is designed to be thin, lightweight, and reusable, enabling quick application to the patient’s limb while maintaining minimal impact on overall socket thickness.

[0036] In embodiments, device 100 accommodates standard mounting mechanisms such as pin locks and lanyards. Therefore, the sensor layout includes a hole 160 at the base of the prosthetic to allow for a pin lock connection.

[0037] As shown in FIG. 1, the outstretched legs of the sensor array wrap up and conform to the patient’s limb around the silicon liner. A Velcro strap may be used to retain the sensor layout at the top of the limb, and a Y ply sock may be placed over the silicon liner and sensors to further fix the assembly in place. Within the Velcro strap, multiplexers are placed above the leg to receive readings from each sensor. The multiplexors may reduce the wire count dramatically so that a single ribbon cable can be run to the main PCB and micro controller in a belt or fanny pack that is worn by the patient.

[0038] In some embodiments, such as an above-the-knee socket, there may be no space to run wires out of the medial side of the limb. In this embodiment, 2 sets of 3-4 flex PCB arrays on the medial side may be connected so that the wires for each set may run out of one array. A sample schematic is depicted in FIG. 6 showing 2 sets of 3 connected flex PCB arrays. Each array may be encased in a non- stretchable nylon fabric casing. The ‘crown’ of the assembly may be created from a more stretchable material to ensure a secure fit to the base of the silicone liner, this is consistent with our previous design.

[0039] FIG. 7 depicts a comfort cell sensor. In embodiments, a sensor 164 may beintegrated into comfort cell 162 to provide distributed pressure monitoring across the socket interior, as illustrated in FIG. 7. Each comfort cell 162 is a cushioning structure, designed to enhance user comfort. When a sensor 164 is embedded in a comfort cell 162, the comfort cell may also serve as a localized sensor platform capable of detecting and transmitting pressure data wirelessly.

[0040] Each comfort cell 162 includes a flexible, compliant material body that conforms to the shape of the residual limb, with a pressure sensor 164 embedded directly within the cell structure. The sensor is operatively coupled to a miniature BLE module and a pairing button 166, which continuously acquires pressure data from the embedded sensor and transmits the data to a central processor or external computing device.

[0041] FIG. 8 depicts a perforated inner socket 168 with a comfort cell sensor 162, in an embodiment. A perforated inner socket 168 may be the same component to the 3D-printed layer 112 shown in FIG. 2A. Comfort cell sensors may be easily attached to a perforated inner socket. A perforated inner socket may be configured to receive and secure one or more comfort cells. The perforated inner socket 168 includes a plurality of apertures distributed across the surface of the socket body. These apertures are dimensioned to receive comfort cells, which may be removably affixed to the inner socket at user-selected positions to enhance comfort and improve localized fit.

[0042] Inner socket 168 is formed from a structurally supportive yet flexible material, enabling it to accommodate minor dimensional adjustments together with comfort cells being added or removed. The comfort cells may be installed through press-fit engagement, adhesive bonding, mechanical fasteners, or other suitable attachment means to ensure secure positioning within the perforations.

[0043] The integration of pressure sensors 164 within comfort cells 162 enables localized pressure monitoring with desired spatial resolution, capturing real-time data on socket fit, localized loading, and potential pressure points during both static and dynamic conditions.

[0044] In one embodiment, the system employs a distributed array of comfort cells, each embedded with its own BLE-enabled pressure sensor, to create a comprehensive pressure mapping network across the entire inner surface of the prosthetic socket. The collected data is aggregated and displayed in a real-time visualization interface, which may be rendered as a 3D pressure heatmap using software platforms such as Unity or Three.js.

[0045] The combination of comfort-enhancing structures with integrated wirelesssensing represents a novel hybrid approach to both improving patient comfort and enabling precision fit adjustments based on real-time pressure data analysis, enhancing both clinical outcomes and patient quality of life.

[0046] The wireless data transmission capability of each comfort cell sensor allows for modular installation and flexible sensor placement, eliminating the need for hard-wired connections and enabling custom sensor configurations tailored to individual patient needs.

[0047] Electro-Mechanical Design

[0048] Several parameters are considered in the electro-mechanical design of device 100: sensor accuracy (constrained to orders of magnitude), hardware within prosthetic to maintain < 2mm thickness (wires, etc.), robustness, Bluetooth™ module for 30 ft range, wire reduction methods, patient comfort, battery and battery life, microcontroller (capability and ease of use).

[0049] FIG. 9 depicts a diagram of a pressure sensor 106 that may be used in any of the embodiments disclosed herein. In embodiments, force sensitive resistors (FSRs) may be used to detect pressure. FSRs are very thin, making them easy to integrate. FIG. 9 shows a representative FSR 183 that may be used as sensor 106. In embodiments, FSR 183 may have a diameter D of approximately 6.35 mm for the active area and a thickness of 0.3 mm. FSR 183 may also have a diameter D of up to 12.70 mm and a thickness of 0.53 mm. Other dimensions are contemplated as long as they don’t negatively impact the comfort of the patient.

[0050] In embodiments, a FSR sensor may provide the greatest sensitivity in the higher force range. A resistor used in a standard “voltage divider” set up with the FSRs may change the sensitivity of the sensors themselves. In embodiments, a resistor is sized for the pressure range of interest. In addition, when regulating voltage, the “noise” in the collected data in the system is somewhat dependent on the capacitor sizes used (on both ends of the voltage regulator).

[0051] Due to their wide availability, power ability, and ability to be recharged, a system may be powered with a lithium ion (Li-Ion) battery, for example, a 3.7V 1200 mAh Li-Ion battery. A battery charger such as Adafruit’s Li-Ion battery charger may be used due to its ability to charge the battery while still having the battery connected to the system for ease of use.

[0052] In certain embodiments, the sensor arrangement is configured to optimize signal processing and data acquisition by strategically positioning sensing elements andassociated circuitry. The system is designed to minimize the number of conductive pathways required for data transmission while ensuring accurate signal integrity.

[0053] In one implementation, the sensor elements are arranged such that a centralized processing unit manages multiple sensing inputs while maintaining a streamlined electrical connection. A structured approach is employed to facilitate efficient signal routing, wherein a defined grouping of sensing elements shares a common reference point for signal calibration. To enhance data accuracy and system efficiency, the configuration enables optimized signal interpretation while reducing the number of individual conductive paths. The design further ensures that potential variations in signal processing do not significantly impact measurement accuracy. Empirical testing has demonstrated that this approach maintains consistent signal reliability, even with a reduced wiring infrastructure, thereby improving overall system performance.

[0054] Wire management may be needed to read data from a sensor device including as many as 80 sensors. Also, since the data is being read through a voltage divider, a resistor may be needed for every sensor. This would imply an additional 80 resistors for the sensors. A standard microcontroller comes with 6-10 analog pins capable of reading analog signals. For 80 sensors, this would require at least 8 microcontrollers. A solution to this problem may be to use 16-channel analog multiplexers (MUX device) to take the number of analog signals from a total of 16 channels to 1 output channel. These devices allow up to 16 analog signals to be processed into a single output channel through a series of digital signals sent to the MUX.

[0055] In certain embodiments, as shown in Fig. 10, a sensor interface is positioned between a prosthetic interface layer and an outer structural component, enabling continuous monitoring of pressure distribution. The sensor arrangement 106 is configured to be thin and adaptable, ensuring seamless integration without interfering with user comfort. The system further includes interface connectors 200 that provide a securing mechanism to maintain sensor alignment while allowing for easy attachment and removal.

[0056] The sensor arrays 106 are structured to provide efficient connectivity and precise pressure detection while minimizing the number of conductive pathways required for data transmission. In some embodiments, the sensor layout is attached to the FPC connections 200 and enclosed within a supporting structure 182 to enhance durability and maintain proper alignment. The system further incorporates electrical sensing and processingunit 180 to manage data acquisition, optimize signal integrity, and facilitate real-time analysis of pressure variations.

[0057] In embodiments, FSR Short Tail pressure sensors are integrated into a small layer between the silicon sleeve and the socket. The sensors may be connected to a Velcro strap above the silicon sleeve via flexible PCB, although other methods may be used. The Velcro strap may contain another flexible PCB along with the analog multiplexers. Each analog multiplexer may be configured to manage the sensors from two different arrays, with each array being capable of supporting up to 16 sensors per MUX. Consequently, a single ribbon cable with the up to 11 needed wires as previously mentioned facilitates connectivity with the main PCB unit.

[0058] FIG. 10 depicts a schematic circuit diagram for use in any of the embodiments disclosed herein. FIG. 10 depicts an electrical system architecture for sensor integration and data transmission of a sensor device 100, in an embodiment. The disclosed system comprises electrical sensing and processing unit 180 configured for integration within a prosthetic device, wearable system, or other form-fitting application such as sensor array 196, which are an example of sensor device 100. Electrical sensing and processing unit 180 manages data acquisition, optimize signal integrity, and facilitate real-time analysis of pressure variations.

[0059] A set of sensor arrays 196 is connected to electrical sensing and processing unit 180 via structured conductive pathways and may include arrays of sensors 106 managed by power and signal management unit 182. Each array is capable of supporting multiple sensors 106, allowing for efficient data acquisition and transmission. A centralized connection system streamlines signal transmission, reducing the number of conductive paths required for operation. Power and signal management unit 182 is further provided to manage sensor data processing, communication, and power regulation. Electrical sensing and processing unit 180 may also include wireless communication interface (such as Bluetooth™ Low Energy (BLE)) 184, a battery power source 188, a charger 190 and a pairing button 194. External connectivity may be provided by USB outlet 186, for example. The system is designed to be modular and adaptable, allowing for integration with various prosthetic configurations. By employing an optimized sensor integration strategy, this technology enhances real-time monitoring, precision in prosthetic adjustments, and overall user comfort, while maintaining low-profile integration within the prosthetic system.

[0060] A variety of hardware options may be used. Representative examples are shown in Table 1.Table 1

[0061] Electrical sensing and processing unit 180 further includes a plurality of interface connectors 200 that provide electrical and data communication pathways between power and signal management unit 182 and the sensor arrays 196. Structured conductive pathways 192 may be flexible printed circuit (FPC) connectors or equivalent low-profile interconnects to minimize space requirements. Distributed sensor array assembly including sensor arrays 196 includes a plurality of flexible printed circuit strips (flex PCB strips) 192, each incorporating a linear array of discrete force-sensitive resistor (FSR) sensors 106 or other pressure or force sensing elements. Each flex PCB strip 192 is further equipped with an analog multiplexer component (MUX) 202, electrically coupled to the sensors along the strip. The analog multiplexer is configured to sequentially select individual sensors within its corresponding strip, allowing data from multiple sensors to be transmitted through a reduced number of electrical traces within the flex PCB strip and across the FPC connector to the processing module.

[0062] The use of localized analog multiplexers 202 within the distributed sensor array assembly of sensor arrays 196 reduces the overall conductor count required in each flex PCB strip 192, thereby reducing the size and complexity of both the flex PCB strips 192 and the corresponding connectors 200 on electrical sensing and processing unit 180. This design enhances mechanical flexibility, reduces bulk, and improves reliability within confined or curved installation environments, such as the inner surface of a prosthetic socket or wearable device.

[0063] Power and signal management unit 182 is configured to receive analog sensor data from the distributed sensor array assembly of sensor arrays 196, process the received data, and wirelessly transmit processed data to an external computing or display system (notshown) for further analysis, visualization, or user feedback. The distributed architecture enables customizable sensor placement and scalable sensing density across the monitored surface area.

[0064] Embodiments disclosed herein also include an advanced data processing, visualization, and backend infrastructure system, enabling real-time spatial pressure mapping and interactive user feedback using a multi-sensor array integrated into a flexible, multi-leg sensing platform.

[0065] In certain embodiments, a distributed sensor array system is provided for spatial pressure monitoring within a prosthetic interface. The system comprises a network of comfort cell sensors 162 arranged across multiple flexible extensions radiating from a central structure, thereby facilitating comprehensive coverage of pressure distribution across the prosthetic surface. Each sensor array segment is operatively connected to a data acquisition module, which sequentially processes signals from individual comfort cell sensors and transmits the acquired data to a centralized processing unit. The system is configured to efficiently manage multiple sensor inputs, optimizing the collection and interpretation of pressure data while maintaining minimal wiring complexity. A primary control unit is further provided to regulate sensor selection, data acquisition, and signal processing, ensuring accurate real-time monitoring. The system supports wireless communication protocols, enabling near real-time transmission of processed data to an external computing platform for further analysis and visualization. This sensor architecture allows for adaptive, high- resolution pressure mapping, enhancing prosthetic fit assessment, user comfort, and real-time adjustment capabilities, while maintaining low-profile integration within the prosthetic device.

[0066] Software System

[0067] In certain embodiments, a software system is provided for processing and visualizing sensor data collected from a prosthetic interface. The software system consists of two distinct parts as seen in FIG. 11. The first software module operates on an embedded processing unit as shown in FIG. 10, and a second software module runs on an external computing device 204 to facilitate data interpretation and visualization.

[0068] The first software module, running on electrical sensing and processing unit 180, is configured to systematically scan and retrieve data from multiple sensing elements, process the acquired signals, and transmit the processed data over a wireless communicationinterface. Each data packet includes sensor-specific identification information, ensuring structured and accurate data management.

[0069] The second software module, implemented on a processing platform such as external computing device 204, is designed to receive, process, and display the transmitted data in a user-accessible format. The system may employ graphical visualization techniques to render a real-time representation of pressure distribution, wherein variations in sensor readings are depicted using color-coded gradients. The visualization platform may be configured as a web-based or standalone interface, requiring minimal setup for practitioners to analyze and adjust prosthetic fit parameters effectively. By integrating real-time data acquisition with an interactive visualization framework, this software system enhances prosthetic fit assessment, facilitates efficient sensor calibration, and provides intuitive feedback mechanisms to support precise adjustments for improved user comfort and functionality.

[0070] The data acquisition and processing pipeline further comprises a backend and visualization platform, which receives incoming data from the microcontroller and processes it into interactive 3D pressure maps. Initial data processing workflows incorporated .ply file formats and PyVista libraries, enabling the export of 3D models with vertex coloring to facilitate integration with backend servers and visualization platforms. Backend servers are configured to process raw pressure data into color-mapped 3D surface models, providing a graphical heatmap representation of spatial pressure distribution across the sensor array.

[0071] During the development phase, challenges in extracting scalar values directly from dynamic plots were identified, leading to the incorporation of OpenGL-based processing pipelines to enhance both rendering performance and data accuracy. Specifically, the system implements shader programming using OpenGL Shading Language (GLSL), enabling parallel processing of visual data on the client-side GPU, which enhances rendering efficiency and reduces server load.

[0072] The visualization pipeline further integrates UV mapping algorithms, texture generation processes, and point sensor placement algorithms, enabling accurate positioning of sensor data on 3D model surfaces. The visualization interface, developed using Unity and Three.js, provides a real-time, interactive 3D pressure heatmap accessible via both desktop and mobile platforms.

[0073] The system also incorporates a secure backend infrastructure employing JWT(JSON Web Token) authentication, with backend logic implemented in Golang to supportefficient real-time processing and communication. Sensor data and user interaction logs are stored in a MySQL relational database, ensuring structured and retrievable data storage for analysis, reporting, and historical trend analysis.

[0074] The mobile application component underwent extensive development and testing, incorporating features such as gesture control for rotation and zooming, enhanced touch interaction capabilities, and compatibility across both iOS and Android devices to ensure broad accessibility.

[0075] A user interface may be provided to allow a practitioner to make various selections during visualization of input from pressure sensors. These selections include but are not limited to:

[0076] Select the type of socket (Large above knee, Small above knee, Large below knee, Small below knee)

[0077] Click and drag to rotate the 3D mesh

[0078] Select several different views of the socket including anterior, posterior, and possibly medial and lateral

[0079] Show / hide rulers

[0080] Show / hide sensor locations with direct sensor readings

[0081] Show / hide labels of sensor strips

[0082] Show / hide interpolated color mesh

[0083] In addition, the platform may be able to record sensor data. This would add the following functionality:

[0084] A record button that records all sensor data coming from the socket in a .csv or similar format until the button is clicked a second time.

[0085] A playback button that allows the user to open the recording file in a separate tab and playback the recorded data.

[0086] FIGS. 12 and 13 depict mesh renderings of pressure sensor readings. In embodiments, a mesh rendering color shown in FIG. 13 and is from Matplotlib titled “turbo”. The possibility of using a different colormap choice that is more accessible for colorblind patients may also be considered. This may be achieved through modifying the turbo colormap or adding a separate colormap with a toggle to be used if needed.

[0087] Visual representations have some flexibility in display because sockets may vary in shape and size drastically. In embodiments, several different sockets may be uploaded in the form of STL files, and then converted from the very detailed and large files into asimplified representation. This simplified representation also enables easier color mapping from the sensor values and lowers computation time for displaying the colors. This may be possible with ray tracing, which is an algorithm frequently used by the gaming industry to calculate lighting. A function that can perform this has been built into PyVista and can be applied for this purpose. To use this algorithm, a set of points with specific z-values and angles down the axis of the socket must be calculated. Ray tracing then finds each first intersecting point on a line, or ray, from the central axis to the maximum distance where a point can be, determined with a bounding box function. A visual representation of these rays can be seen on the left side of FIG. 14. Using the intersecting points found, the simplified socket is constructed with faces between each point, as seen on the right of FIG. 14. The points found may also be able to be harnessed to determine sensor locations.

[0088] A block diagram of software for use with sensor device 100 is shown in FIG. 15. Other arrangements of software and functions may also be used.

[0089] FIG. 16 depicts a visual representation of design and electro-mechanical integration of a prosthetic device, in an embodiment.

[0090] FIG. 17 depicts 3D model generation and texture mapping, in an embodiment.

[0091] FIG. 18 depicts a method 300 of evaluating the fit of a prosthetic device using a sensor device. In embodiments, method 300 includes five steps but any of the steps disclosed herein may be combined, or additional steps may be added without departing from the scope disclosed herein.

[0092] Step 310 includes attaching a sensor device to a patient’s limb. In an example of step 310, the sensor device includes a plurality of pressure sensors as disclosed above for assessing the fit of a prosthetic device. Step 312 includes attaching a prosthetic socket to the patient’s limb over the sensor device.

[0093] Step 314 includes connecting the sensor device to a computer. In an example of step 314, the computer includes a display.

[0094] Step 316 includes reading data values from the sensor device. In an example of step 316, data values are read from the plurality of pressure sensors while a patient moves in the prosthetic socket.

[0095] Step 318 includes displaying a visual representation of the data values on the display. In an example of step 318, the visual representation includes a depiction of the prosthetic socket with a selection of colors, where a certain color is associated with a certain data value.

[0096] In embodiments, method 300 may also include a step of attaching a pack including a processor, memory and wireless connection interface to a patient, wherein the pack has a wired connection to the sensor device and a wireless connection to the computer. Further, method 300 may include controlling, by the processor, a plurality of multiplexers to read the data values from the plurality of pressure sensors.

[0097] In an embodiment, method 300 may further include steps of removing the prosthetic socket from the patient, modifying the fit of the prosthetic socket, attaching the modified prosthetic socket to the patient, reading further data values from the plurality of pressure sensors while a patient moves in the modified prosthetic socket, and displaying a visual representation of the further data values on the display.

[0098] 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. Herein, and unless otherwise indicated: (a) the adjective "exemplary" means serving as an example, instance, or illustration, and (b) the phrase “in embodiments” is equivalent to the phrase “in certain embodiments,” and does not refer to all embodiments. 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

CLAIMSWhat is claimed is:

1. A sensor device for use with a prosthetic socket, comprising: a base material; at least one flexible printed circuit boards (PCBs) secured to the base material, the at least one flexible PCB comprising a plurality of pressure sensors; a plurality of multiplexers, each multiplexer receiving input from a subset of the plurality of pressure sensors; and a main PCB connected to the at least one flexible PCB, comprising a microcontroller for controlling the multiplexers to read out data from the plurality of pressure sensors.

2. The device of claim 1, further comprising an attachment mechanism for securing the base material to a wearer’ s leg.

3. The device of claim 1, wherein the plurality of sensors are arranged in a spoke or radial design.

4. The device of claim 1, further comprising: a data acquisition framework configured to utilize a multiplexed sensor network for optimized signal processing and transmission and operatively coupled to a centralized processing unit, which is adapted to manage real-time data collection, processing, and communication and to support wireless data transmission, enabling seamless integration with external computing devices for enhanced data analysis and visualization.

5. The device of claim 1, wherein the at least one flexible PCB comprises a single flexible printed circuit board (flex PCB) with an integrated array of pressure sensors, the flex PCB being electrically coupled to the main PCB via a flat ribbon cable.

6. The device of claim 1, where in the plurality of pressure sensors further comprise a plurality of removable comfort cell sensors with embedded wireless pressure sensors, wherein the comfort sensor are positioned to monitor pressure at select locations and can be used to detect variation in pressure.

7. The device of claim 1, wherein the at least one flexible PCB is positioned between a prosthetic silicone liner and a socket, enabling direct pressure measurement across aliner-to-socket interface.

8. The device of claim 1, wherein the main PCB further comprises: a wireless Bluetooth communication module coupled to the microcontroller for transmitting sensor data to an external computing device; a rechargeable battery with an integrated charging circuit; and a power management system incorporating standard resistors and voltage regulation components.

9. The device of claim 1, wherein the plurality of pressure sensors are force sensitive resistors (FSR).

10. The device of claim 1, wherein the plurality of pressure sensors is between 40 and 100 pressure sensors.

11. The device of claim 1, wherein the microcontroller further comprises a wireless interface for sending data from the plurality of pressure sensors to an external computing device.

12. The device of claim 11 , further comprising a computer for processing the data from the plurality of pressure sensors and providing a visual representation of the sensor device, wherein the computer generates a real-time 3D pressure heatmap.

13. The device of claim 12, wherein the computer is configured to receive pressure data transmitted and display the 3D pressure heatmap as a color-coded spatial map in real time.

14. A system for use with a prosthetic socket, comprising: the device of claim 1 ; and a backend server configured to receive, process, and store sensor data in a structured database, wherein the backend server is adapted to apply a data processing pipeline to generate three-dimensional (3D) models in a structured format with vertex -based data representation; and wherein the backend server further implements secure authentication protocols and backend processing logic to facilitate efficient data management, access control, and computational processing.

15. The system of claim 14, wherein the system is further configured to apply graphicalprocessing techniques, including shader-based rendering, to optimize visualization and vertex processing computations by offloading such operations to a graphical processing unit (GPU), thereby enhancing rendering performance and computational efficiency.

16. The system of claim 14, wherein the system includes UV mapping algorithms and point sensor placement algorithms to accurately map sensor data onto a 3D prosthetic surface model.

17. The system of claim 14, wherein the computer is a mobile device running a mobile application configured to receive sensor data, display a real-time 3D pressure heatmap, and provide gesture-based controls for rotating, zooming, and interacting with the heatmap.

18. A method of evaluating a prosthetic device, comprising: attaching a sensor device comprising a plurality of pressure sensors to a patient’s limb; attaching a prosthetic socket to the patient’s limb over the sensor device; connecting the sensor device to a computer having a display; reading data values from the plurality of pressure sensors while a patient moves in the prosthetic socket; and displaying a visual representation of the data values on the display.

19. The method of claim 18, further comprising attaching a pack including a processor, memory and wireless connection interface to a patient, wherein the pack has a wired connection to the sensor device and a wireless connection to the computer.

20. The method of claim 19, further comprising controlling, by the processor, a plurality of multiplexers to read the data values from the plurality of pressure sensors.

21. The method of claim 18, further comprising: removing the prosthetic socket from the patient; modifying the fit of the prosthetic socket; attaching the modified prosthetic socket to the patient; reading further data values from the plurality of pressure sensors while a patient moves in the modified prosthetic socket; and displaying a visual representation of the further data values on the display.

22. The method of claim 18, wherein the sensor device comprises: a single flexible PCB incorporating a plurality of pressure sensors, wherein the sensor device is connected to a main PCB unit via a flat ribbon cable and wirelessly transmits pressure data to a computing device.

23. The method of claim 18, further comprising applying shader-based rendering techniques to enhance the visualization and real-time rendering of a three-dimensional (3D) heatmap, wherein such rendering techniques utilize graphical processing operations to optimize data representation and computational efficiency.

24. The method of claim 23 wherein the visual representation is displayed on a mobile device supporting gesture controls for rotation, zooming, and interaction with the heatmap.

25. The method of claim 18, wherein the visual representation comprises a real-time 3D heatmap representing a spatial pressure distribution across the sensor device.

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