[go: up one dir, main page]

WO2025199404A1 - Dispositifs prothétiques dotés de capteurs de pression et leur procédé d'utilisation - Google Patents

Dispositifs prothétiques dotés de capteurs de pression et leur procédé d'utilisation

Info

Publication number
WO2025199404A1
WO2025199404A1 PCT/US2025/020859 US2025020859W WO2025199404A1 WO 2025199404 A1 WO2025199404 A1 WO 2025199404A1 US 2025020859 W US2025020859 W US 2025020859W WO 2025199404 A1 WO2025199404 A1 WO 2025199404A1
Authority
WO
WIPO (PCT)
Prior art keywords
data
sensor
pressure
pressure sensors
prosthetic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/020859
Other languages
English (en)
Inventor
Yinghua Jin
Nancy Ortiz VENEGAS
Arnold Winfield CORNE JR.
Ian Hamilton Alesi FARRAR
Sarah Elizabeth HUBER
Matthew Reilly SPORY
Jasey Joylena CHANDERS
Sam Noah HSIN
Benjamin Gabriel ERICKSON
Ranajit ROY
Amogh Vijay GUPTA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rockytech Ltd
Original Assignee
Rockytech Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rockytech Ltd filed Critical Rockytech Ltd
Publication of WO2025199404A1 publication Critical patent/WO2025199404A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/80—Sockets, e.g. of suction type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4851—Prosthesis assessment or monitoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/60—Artificial legs or feet or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/7812—Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L5/00—Apparatus for, or methods of, measuring force, work, mechanical power, or torque, specially adapted for specific purposes
    • G01L5/16—Apparatus for, or methods of, measuring force, work, mechanical power, or torque, specially adapted for specific purposes for measuring several components of force
    • G01L5/161—Apparatus for, or methods of, measuring force, work, mechanical power, or torque, specially adapted for specific purposes for measuring several components of force using variations in ohmic resistance
    • G01L5/1627—Apparatus for, or methods of, measuring force, work, mechanical power, or torque, specially adapted for specific purposes for measuring several components of force using variations in ohmic resistance of strain gauges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/68—Operating or control means
    • A61F2/70—Operating or control means electrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • A61F2002/7615—Measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • A61F2002/7615—Measuring means
    • A61F2002/7635—Measuring means for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • A61F2002/7615—Measuring means
    • A61F2002/7665—Measuring means for measuring temperatures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
    • A61F2002/7615—Measuring means
    • A61F2002/769—Displaying measured values

Definitions

  • 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.
  • practitioners rely on qualitative feedback from patients and perform manual modifications, making the process largely subjective.
  • 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.
  • 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.
  • the system allows practitioners to make targeted, data-driven adjustments, improving the efficiency of the fitting process and enhancing overall user comfort.
  • 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.
  • FIG. 1 depicts a sensor device for use with a prosthetic socket, in an embodiment.
  • FIGS. 2A - 2H depict several embodiments of a sensor device.
  • FIG. 3 depicts a sensor device and a prosthetic socket, in an embodiment.
  • FIG. 4 depicts sensors for use in a sensor device, in embodiments.
  • FIG. 5 depicts a schematic diagram of spider-inspired sensor layout in a sensor device, in an embodiment.
  • FIG. 6 depicts a schematic diagram of another spider-inspired sensor layout in a sensor device, in an embodiment.
  • FIG. 7 depicts a comfort cell sensor, in an embodiment.
  • FIG. 8 depicts a perforated inner socket with a comfort cell censor, in an embodiment.
  • FIG. 9 depicts a diagram of a pressure sensor, in an embodiment.
  • FIG. 10 depicts an electrical system architecture for sensor integration and data transmission of a sensor device, in an embodiment.
  • FIG. 11 depicts a schematic diagram of software for a sensor device, in an embodiment.
  • FIGS. 12 and 13 depict mesh renderings of pressure sensor readings, in an embodiment.
  • FIG. 14 depicts a visual representation of these rays tracing, in an embodiment.
  • FIG. 15 depicts a block diagram of software for use with a sensor device, in an embodiment.
  • FIG. 16 depicts a visual representation of design and electro-mechanical integration of a prosthetic device, in an embodiment.
  • FIG. 17 depicts 3D model generation and texture mapping, in an embodiment.
  • FIG. 18 depicts a method of evaluating the fit of a prosthetic device using a sensor device, in embodiments.
  • 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.
  • 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.
  • a check socket may begin as a disk of plastic material such as ethylene-vinyl acetate (EVA).
  • EVA ethylene-vinyl acetate
  • the plastic disk is superheated in an oven and then pulled over the mold of the patient’s limb.
  • 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 can take several hours and requires multiple fitting sessions due to the mass fluctuations many patients experience throughout the day or over years.
  • 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.
  • PCBs flexible printed circuit boards
  • FIG. 1 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.
  • 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.
  • 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.
  • 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.
  • 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 sensor layout, 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.
  • 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.
  • FIG. 2C depicts a diagnostic device 120 and FIG. 2D depicts a detailed view of a sensor 106 for use with diagnostic device 120.
  • 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.
  • FIG. 2E depicts a diagnostic device 130
  • FIG. 2F depicts a detailed view of a sensor 106 for use with diagnostic device 130.
  • 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.
  • 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.
  • 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.
  • 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.
  • conductive thread 156 may be stitched into the nylon fabric to display the individual output wires for the sensors and their common ground connection. This design was very thin, less than 0.4 mm including the sensors, and proved to be very flexible.
  • 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.
  • FIG. 5 depicts a schematic diagram of spider- like design sensor layout in a sensor device 100 using a flexible PCB 104 layout.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 6 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.
  • FIG. 7 depicts a comfort cell sensor.
  • a sensor 164 may be integrated 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.
  • the comfort cell may also serve as a localized sensor platform capable of detecting and transmitting pressure data wirelessly.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the combination of comfort-enhancing structures with integrated wireless sensing 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.
  • 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.
  • sensor accuracy constrained to orders of magnitude
  • hardware within prosthetic to maintain ⁇ 2mm thickness wires, etc.
  • robustness BluetoothTM module for 30 ft range
  • wire reduction methods patient comfort, battery and battery life
  • microcontroller capability and ease of use
  • FIG. 9 depicts a diagram of a pressure sensor 106 that may be used in any of the embodiments disclosed herein.
  • force sensitive resistors FSRs
  • FIG. 9 shows a representative FSR 183 that may be used as sensor 106.
  • 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.
  • 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.
  • a resistor is sized for the pressure range of interest.
  • the “noise” in the collected data in the system is somewhat dependent on the capacitor sizes used (on both ends of the voltage regulator).
  • a system may be powered with a lithium ion (Li-Ion) battery, for example, a 3.7V 1200 mAh Li-Ion battery.
  • Li-Ion lithium ion
  • 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.
  • the sensor arrangement is configured to optimize signal processing and data acquisition by strategically positioning sensing elements and associated circuitry.
  • the system is designed to minimize the number of conductive pathways required for data transmission while ensuring accurate signal integrity.
  • 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.
  • 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.
  • 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.
  • MUX device 16-channel analog multiplexers
  • 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.
  • 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.
  • 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 processing unit 180 to manage data acquisition, optimize signal integrity, and facilitate real-time analysis of pressure variations.
  • 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.
  • 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.
  • 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.
  • 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 BluetoothTM 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.
  • 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.
  • 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 (not shown) for further analysis, visualization, or user feedback.
  • the distributed architecture enables customizable sensor placement and scalable sensing density across the monitored surface area.
  • 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.
  • a distributed sensor array system 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.
  • a software system 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.
  • 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 communication interface.
  • Each data packet includes sensor-specific identification information, ensuring structured and accurate data management.
  • 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.
  • 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.
  • 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.
  • the system also incorporates a secure backend infrastructure employing JWT
  • JSON Web Token JSON Web Token authentication, with backend logic implemented in Golang to support efficient 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.
  • 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.
  • 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:
  • the platform may be able to record sensor data. This would add the following functionality:
  • 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.
  • a playback button that allows the user to open the recording file in a separate tab and playback the recorded data.
  • FIGS. 12 and 13 depict mesh renderings of pressure sensor readings.
  • a mesh rendering color shown in FIG. 13 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.
  • sockets may vary in shape and size drastically.
  • several different sockets may be uploaded in the form of STL files, and then converted from the very detailed and large files into a simplified representation.
  • This simplified representation also enables easier color mapping from the sensor values and lowers computation time for displaying the colors.
  • 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 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.
  • FIG. 15 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.
  • FIG. 16 depicts a visual representation of design and electro-mechanical integration of a prosthetic device, in an embodiment.
  • FIG. 17 depicts 3D model generation and texture mapping, in an embodiment.
  • FIG. 18 depicts a method 300 of evaluating the fit of a prosthetic device using a sensor device.
  • 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.
  • Step 310 includes attaching a sensor device to a patient’s limb.
  • 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.
  • Step 314 includes connecting the sensor device to a computer.
  • the computer includes a display.
  • Step 316 includes reading data values from the sensor device.
  • data values are read from the plurality of pressure sensors while a patient moves in the prosthetic socket.
  • Step 318 includes displaying a visual representation of the data values on the display.
  • 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • General Physics & Mathematics (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

Un dispositif capteur destiné à être utilisé avec une emboîture prothétique comprend un matériau de base, au moins une carte de circuit imprimé (PCB) souple étant fixée au matériau de base, la PCB étant pourvue d'une pluralité de capteurs de pression. La PCB peut comprendre un agencement radial de plusieurs PCB ou d'une PCB unique, un réseau de capteurs intégré étant connecté à une unité de traitement principale par un câble plat. Des capteurs cellulaires de confort à capteurs de pression BLE intégrés peuvent également être utilisés. Le dispositif capteur est positionné entre un revêtement de silicone et l'emboîture prothétique pour mesurer la pression d'interface. Les données sont traitées pour générer une carte thermique de pression 3D en temps réel et peuvent également être traitées en modèles de surface 3D à l'aide de pipelines de traitement dorsales. Un logiciel de visualisation permet le mappage UV, l'analyse de pression heuristique et le rendu accéléré par GPU, et une application mobile permet une interaction en temps réel avec les données pour l'évaluation de l'adaptation de la prothèse.
PCT/US2025/020859 2024-03-22 2025-03-21 Dispositifs prothétiques dotés de capteurs de pression et leur procédé d'utilisation Pending WO2025199404A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463568628P 2024-03-22 2024-03-22
US63/568,628 2024-03-22

Publications (1)

Publication Number Publication Date
WO2025199404A1 true WO2025199404A1 (fr) 2025-09-25

Family

ID=97140290

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/020859 Pending WO2025199404A1 (fr) 2024-03-22 2025-03-21 Dispositifs prothétiques dotés de capteurs de pression et leur procédé d'utilisation

Country Status (1)

Country Link
WO (1) WO2025199404A1 (fr)

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080306407A1 (en) * 2005-03-29 2008-12-11 Pressure Medical Ltd. Bandage Pressure Sensor
US20120022667A1 (en) * 2010-07-20 2012-01-26 5280 Prosthetics Llc Intelligent prosthetic socket system with active user feedback interface and real time prosthesis diagnostics
US20160331563A1 (en) * 2015-05-14 2016-11-17 Foot Innovations, Llc Prosthetic device with socket pressure monitoring capability and systems and methods for making custom prosthetics
US20180020973A1 (en) * 2016-07-21 2018-01-25 Lim Innovations, Inc. Prosthetic sockets with sensors
US20180098865A1 (en) * 2016-10-06 2018-04-12 The Board Of Regents Of The University Of Texas System Prosthetic socket fit sensor
US20190021883A1 (en) * 2016-01-08 2019-01-24 Massachusetts Institute Of Technology Method And System For Providing Proprioceptive Feedback And Functionality Mitigating Limb Pathology
US20190307584A1 (en) * 2018-04-09 2019-10-10 Case Western Reserve University Intelligent prosthetic socket
US20210086364A1 (en) * 2019-09-20 2021-03-25 Nvidia Corporation Vision-based teleoperation of dexterous robotic system
US20220175560A1 (en) * 2020-12-04 2022-06-09 United States Government As Represented By The Department Of Veterans Affairs Harness For Coupling To An Upper Arm Prosthesis, And Systems And Methods Of Making And Using Same
US20220322968A1 (en) * 2019-09-10 2022-10-13 John Florence Limited Product for generating a three-dimensional shape and its use in the fabrication of custom orthosis
WO2023118334A1 (fr) * 2021-12-21 2023-06-29 Adapttech Limited Manchon de prothèses avec capteurs
US20230338171A1 (en) * 2022-04-25 2023-10-26 Touch Bionics Limited Sensor system and method for assessing socket fit

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080306407A1 (en) * 2005-03-29 2008-12-11 Pressure Medical Ltd. Bandage Pressure Sensor
US20120022667A1 (en) * 2010-07-20 2012-01-26 5280 Prosthetics Llc Intelligent prosthetic socket system with active user feedback interface and real time prosthesis diagnostics
US20160331563A1 (en) * 2015-05-14 2016-11-17 Foot Innovations, Llc Prosthetic device with socket pressure monitoring capability and systems and methods for making custom prosthetics
US20190021883A1 (en) * 2016-01-08 2019-01-24 Massachusetts Institute Of Technology Method And System For Providing Proprioceptive Feedback And Functionality Mitigating Limb Pathology
US20180020973A1 (en) * 2016-07-21 2018-01-25 Lim Innovations, Inc. Prosthetic sockets with sensors
US20180098865A1 (en) * 2016-10-06 2018-04-12 The Board Of Regents Of The University Of Texas System Prosthetic socket fit sensor
US20190307584A1 (en) * 2018-04-09 2019-10-10 Case Western Reserve University Intelligent prosthetic socket
US20220322968A1 (en) * 2019-09-10 2022-10-13 John Florence Limited Product for generating a three-dimensional shape and its use in the fabrication of custom orthosis
US20210086364A1 (en) * 2019-09-20 2021-03-25 Nvidia Corporation Vision-based teleoperation of dexterous robotic system
US20220175560A1 (en) * 2020-12-04 2022-06-09 United States Government As Represented By The Department Of Veterans Affairs Harness For Coupling To An Upper Arm Prosthesis, And Systems And Methods Of Making And Using Same
WO2023118334A1 (fr) * 2021-12-21 2023-06-29 Adapttech Limited Manchon de prothèses avec capteurs
US20230338171A1 (en) * 2022-04-25 2023-10-26 Touch Bionics Limited Sensor system and method for assessing socket fit

Similar Documents

Publication Publication Date Title
US11986317B1 (en) Device and method for monitoring and assessment of movement disorder symptoms
US8920345B2 (en) System and apparatus for continuous monitoring of movement disorders
US20210082305A1 (en) Data-driven sleep coaching system
US10694992B1 (en) Device and method for monitoring and assessment of movement disorder symptoms
US20150065919A1 (en) Posture training device
US11064910B2 (en) Physical activity monitoring system
Bertolotti et al. A wearable and modular inertial unit for measuring limb movements and balance control abilities
JP2017520358A (ja) 生理学的信号検出および解析システムおよび装置
US9592335B2 (en) Insulin pump data acquisition device
CN108042106A (zh) 一种提高人体体征无创检测设备检测精度的人工智能纠偏方法
KR20160125813A (ko) 헬스케어를 위한 센서 통제 시스템 및 방법
US20160170445A1 (en) Measuring device configured to be worn on the wrist of a user
AU2018267284A1 (en) A system and method for monitoring human performance
CN108720814A (zh) 一种乳腺健康远程监测系统及方法
TW201143712A (en) Methods, devices, and systems for health management
WO2025199404A1 (fr) Dispositifs prothétiques dotés de capteurs de pression et leur procédé d'utilisation
CN113948184A (zh) 一种基于大数据的孕妇健康管理方法
CN203436329U (zh) 可穿戴智能运动监测系统
CN113614838A (zh) 测定促进装置、方法以及程序
US20090221936A1 (en) Activity-contingent weight loss system
Khandakar et al. Design and implementation of a complete wearable smart insole solution to measure plantar pressure and temperature
CN106137205A (zh) 鞋垫式足底压力分布测量装置和系统
US20220354424A1 (en) Apparatus and method for energy expenditure estimation
CN107658021A (zh) 营养状态评估方法和装置
Yang et al. Development of a scalable monitoring system for wheelchair tilt-in-space usage

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 25774276

Country of ref document: EP

Kind code of ref document: A1