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WO2025050121A1 - Biometric monitoring and treatment device - Google Patents

Biometric monitoring and treatment device
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WO2025050121A1
WO2025050121A1PCT/US2024/045034US2024045034WWO2025050121A1WO 2025050121 A1WO2025050121 A1WO 2025050121A1US 2024045034 WUS2024045034 WUS 2024045034WWO 2025050121 A1WO2025050121 A1WO 2025050121A1
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sensor elements
electrodes
machine controller
muscle
array
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French (fr)
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Darryl D'lima
Heinz HOENECKE
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Active4d Inc
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Active4d Inc
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Abstract

Typically, the human joints and muscles are complex regions of the body that have to satisfy several demands such as mobility, stability, and strength. Therefore, capturing these subtleties requires advanced techniques. Accordingly, a biometric device, comprising; an adhesive patch; a power supply; an electrode array with one or more sensor elements configured to measure electrical signals generated by one or more muscles; and a machine controller communicatively coupled to the electrode array configured to receive signals from the electrode array based on the electrical signals generated by one or more muscles measured by the sensor elements, process the signals to assess the patient's health conditions, trigger a response based on a set criteria including whether the patient is not using a muscle, over-using a muscle, or not complying with recommended muscle activity, or generating health or disease-related signals, and provide related feedback based on the response is disclosed.

Description

BIOMETRIC MONITORING AND TREATMENT DEVICE
TECHNICAL FIELD
[ 1 ] The embodiments described herein are generally directed to a biometric monitoring system, and, more particularly, to methods and apparatuses for biological and environmental sensors.
BACKGROUND
[2] The human joints and muscles are complex regions of the body that have to satisfy several demands such as mobility, stability, and strength. These demands may often conflict with one another and can result in muscular or joint problems. Comprising a convergence of bones, muscles, cartilage, ligaments, tendons, and synovial fluid, monitoring joint activity in human biometrics presents a complex and nuanced challenge due to the intricate nature of muscular physiology and the need for accurate and real-time measurement. Therefore, capturing these subtleties requires advanced techniques like electromyography (EMG), which involves the placement of electrodes on the skin to detect electrical signals generated by muscles.
[3] Monitoring and treatment problems may vary and can include, for example, issues such as electrode placement accuracy, signal interference, and signal interpretation can affect the reliability of measurements. Moreover, the non-stationary nature of muscle and joint signals, which change over time and under different conditions, necessitates sophisticated signal processing and analysis methods. Furthermore, treatment and rehabilitation for joint and muscle problems may require only non-invasive methods such as physical therapy, or in some cases a combination of invasive methods (i.e. surgery) and non-invasive methods. Traditional methods of rehabilitation for joint and muscle problems can span several months if not years.
[4] Accordingly, a biometric monitoring and treatment device would offer a variety of benefits. The methods of rehabilitation for a patient involve supervised and unsupervised activities and exercises based upon instructions specified by the surgeon, physician, or physical therapist. However, traditional methods have varying levels of success due to various reasons including the absence of reliable methods and devices for monitoring and keeping track of a patient's joint motion, relevant muscle activity, and reaction forces around the joints during the treatment process. SUMMARY
[5] The present disclosure is directed toward a biometric monitoring system with methods and apparatuses for biological and environmental sensors, in the context of treatment and similar tasks, that overcomes this and other problems discovered by the inventors.
[6] While the present disclosure is directed towards joints and muscles, this monitoring system can also be applied to other conditions and diseases including cardiovascular, neurological, metabolic diseases, cancer, etc., as well as monitoring health, exercise, recreational activities, and monitoring environmental conditions.
[7] In an embodiment, a biometric device, comprises: an adhesive patch; a power supply; an electrode array with one or more sensor elements comprising biological and environmental sensors configured to selected biological and/or environmental conditions, for example, measure electrical signals generated by one or more muscles. A machine controller is communicatively coupled to the electrode array configured to receive signals from the electrode array based on the electrical signals generated by one or more muscles or measured by diverse sensor elements, process the signals to assess the patient’s health conditions, trigger a response based on a set criteria including whether the patient is not using a muscle, overusing a muscle, or not complying with recommended muscle activity7, and provide related feedback based on the response.
[8] In an embodiment, a method of using an array of electrodes to measure muscle activity and tissue bioimpedance, the method comprising: adhering to a patient’s body an adhesive patch with an array of electrodes; powering the array of electrodes with a power supply; measuring the muscle activity through electrical signals generated by muscles with the array of electrodes with one or more sensor elements; and communicating the array of electrodes with a machine controller, wherein the machine controller is configured to receiving signals from the array of electrodes based on the muscle activity and tissue bioimpedance measured by the sensor elements, processing the signals to assess the patient’s health conditions, triggering a response based on a set criteria including one or more of whether the patient is not using a muscle, over-using a muscle, or not complying with recommended muscle activity7, and providing related feedback based on the response.
[9] In an embodiment, a biometric electrode array system, comprises: an adhesive patch; a power supply; a configuration of electrodes with one or more sensor elements located on the adhesive patch configured to measure muscle activity and tissue bioimpedance through electrical signals generated by muscles; and a machine controller communicatively coupled to the sensor elements configured to receive signals from the sensor elements based on measurements of the muscle activity and tissue bioimpedance, process the signals to assess the patient’s health conditions, trigger a response based on a set criteria including whether the patient is not using a muscle, over-using a muscle, or not complying with recommended muscle activity, and provide related feedback based on the response.
BRIEF DESCRIPTION OF THE DRAWINGS
[10] The details of embodiments of the present disclosure, both as to their structure and operation, may be gleaned in part by study of the accompanying drawings, in which like reference numerals refer to like parts, and in which:
[11] FIG. 1 illustrates a biometric device in the form of an adhesive patch with multiple sensors and a machine controller, according to an embodiment;
[12] FIG. 2 illustrates an example architecture of a machine controller, according to an embodiment;
[13] FIG. 3 illustrates a process for measuring a patient’s muscle activity and tissue bioimpedance, according to an embodiment; and
[14] FIG. 4 illustrates a schematic representation of a monitoring and treatment system, according to an embodiment.
DETAILED DESCRIPTION
[15] The detailed description set forth below, in connection with the accompanying drawings, is intended as a description of various embodiments, and is not intended to represent the only embodiments in which the disclosure may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the embodiments. However, it will be apparent to those skilled in the art that embodiments of the invention can be practiced without these specific details.
[16] In some instances, well-known structures and components are shown in simplified form for brevity of description. For clarity and ease of explanation, some surfaces and details may be omitted in the present description and figures. It should also be understood that the various components illustrated herein are not necessarily drawn to scale. In other words, the features disclosed in various embodiments may be implemented using different relative dimensions within and between components than those illustrated in the drawings.
[17] FIG. 1 illustrates a biometric device 100 in the form of an adhesive patch 110 with multiple sensors 122 and a machine controller 130. Biometric device 100 can be a biometric electrode array 120 with sensor elements 122 communicatively coupled to the controller 130 to measure one or more biological conditions of a patient wearing the array. Though it is depicted as part of biometric device 100. controller 130 can be located remotely from biometric device 100. Sensor elements 122 can measure muscle activity and tissue bioimpedance. Biometric electrode array 120 can be a universal electrode array that can be used on more than one joint or anatomic location. Further, biometric device 100 can be used in a method of using electrode array 120 to measure muscle activity and tissue bioimpedance. Biometric device 100 can involve a universal electrode patch that can be used on more than one joint or anatomic location. For example, biometric device 100 can be used in shoulder, spine, hip, knee, among other body parts and transmit signals to machine controller 130 and processed in connection with a computer system 420.
[18] Furthermore, biometric device 100 applications can include a method of analyzing the signal and selecting the optimal electrode array 120 or subset of electrodes to optimize or amplify the signal, or select the signal with the least noise. Other applications of biometric device 100 include a method of measuring and analyzing local tissue bioimpedance by providing an excitation voltage through one or more electrode array 120 which is measured from one or more electrodes in the array. These electrodes can be part of sensor elements 122, as shown in FIG. 1. The benefits of biometric device 100 can include a universal electrode array 120 that optimizes the local signal by sampling across multiple electrodes. This application makes it possible to have a single design than can be utilized across multiple muscles, muscle groups, or anatomic locations, reducing user error in placing electrodes in electrode array 120. Additionally, biometric device 100 applications allow for differentiating the signal over different muscles or regional analysis of muscle activity within a muscle. Other signals such as timing of muscle activation (e.g.. baseball pitching) and joint motion can be detected with biometric device 100. Finally, biometric device 100 monitors changes with joint motion and can measure local tissue bioimpedance, detect loss of signal, lead off detection and compliance, continuous monitoring (e.g. as position of limb changes, and skin bioimpedance changes, e.g. because of sweating) and switch to best group of electrodes while driving all electrodes or groups (electrode array 120). [19] An electrode array 120, exemplified by biometric device 100 in FIG. 1, can comprise multiple individual sensor elements 122 organized in a specific arrangement. Sensor elements 122 can detect varying physical properties, such as temperature or pressure, generating electrical signals proportional to the changes and transmitting those signals to machine controller 130. Biometric device 100 signals can be then converted into digital data through analog-to-digital converters (ADCs) for processing by a central unit, like a microcontroller. The organized layout of sensor elements 122 influences their combined sensitivity and spatial resolution. By fusing data from multiple sensor elements 122, biometric device 100 can provide a more comprehensive understanding of the monitored environment, with potential applications in real-time displays, data logging, and triggering specific responses based on set criteria.
[20] Additionally, biometric device 100 can include a patch 110 or band with a front face and a rear face. The rear face of patch 110 can contact or face a patient's body when worn. In this regard, at least a portion of the rear face of patch 110 can be equipped with an attachment element configured to secure at least a portion of patch 110 to the patient's body. For example, the attachment element can be an adhesive or other type of element configured to attach to the patient's body. The attachment element can be a suction cup. Also, if adhesive is used, the adhesive can be re-positionable skin adhesive such as 3M's 2749P silicone adhesive. The use of re-positionable adhesives allows the patient to remove patch 110 for bathing/hygiene purposes. This can extend the time that a patient can wear a given device. This also allows for re-positioning for proper alignment if needed. Alternatively, the patch can he held in contact with the skin without adhesives, e.g. a band or a strap, or integrated with an item of clothing, shoes, hat or cap. belt, jewelry, or accessory, such as a watch. The patch could also be handheld against the skin, or be held in the hand, feet, or fingertips to monitor local signals. The patch could also be integrated into another device e.g. a mobile phone which is then held against the skin. Patch 110 can be made of any of a variety of materials such as durable, flexible polymer. For example, polyether block amide (PEBAX).
[21] Biometric device 100 can include its own power supply, such as a battery 140. In an embodiment, it includes a coin cell battery 140 although the type of battery 140 can vary. Battery 140 can be a rechargeable battery'. In another embodiment, battery 140 is capable of being inductively charged. In another embodiment, battery 140 can be charged by attaching it to a wired connector. Battery' 140 can also be an energy harvesting battery. [22] FIG. 1 illustrates a biometric device 100 capable of having multiple sensor elements 122. The applications of multiple sensor elements 122 can include an application where biometric device 100 is capable of using multiple sensors elements 122 to measure different parameters of one or more biological conditions of a patient wearing the array. For example, EMG, motion, temperature, bioimpedance, ultrasound, oximetry, glucose concentration, sweat, among other parameters. Multiple sensor elements 122 can also include environmental sensors. For example, sensor elements 122 to measure external temperature, humidity, oxygen, carbon dioxide, carbon monoxide concentration, other gases and noxious agents. These can be applicable in industrial, military, or harsh environments. Biometric device 100 can be wearable on the skin or clothing or incorporated in a brace, orthosis, sling or similar. There can be combinations of wearable and non-wearable sensor elements 122, which can be capable of be read off from the body and could be checked periodically. A wearable version of biometric device 100 would be anything capable of being worn, suitable, or ready for wearing. Another application can include a method of analyzing the combined signal from multiple sensors 122 to assess health and disease. For example, monitoring skin temperature, local bioimpedance, oxygen saturation, and ultrasound. This application would be more accurate in monitoring risk for infection than one single sensor element 122. As an example, this can include monitoring skin temperature, local bioimpedance, oxygen saturation, electromagnetic signals (e.g. radiofrequency, light), ultrasound, and environmental temperature and humidity would be more accurate in monitoring risk for dehydration and/or heat stroke than one single sensor element 122. In this example of biometric device 100, an ultrasound signal can be used for informing sensor element 122 placement or selection of optimal combination of electrode array 120. Further, biometric device 100 can be capable of developing a method of analyzing the signal and selecting the optimal electrode array 120 or subset of electrodes to optimize or amplify the signal, or select the signal with the least noise. As a benefit of biometric device 100, a combination of sensors elements 122 would be more accurate in detecting loss of signal, lead-off detection and compliance.
[23] Biometric device 100 can be configured to include measurements of muscle activity relative to predetermined criteria to monitor, for example, whether a user is not using a muscle, over-using a muscle, or not meeting or not complying with recommended muscle activity and providing related feedback. In an embodiment, biometric device 100 can monitor muscle movement, such as with respect to predetermined levels or types of motion, and provides data as to whether the muscle movement meets predetermined criteria. Also, biometric device 100 can provide intermitent or constant feedback of different measurements and/or status of the previously described parameters. The feedback, which can be in the form of visual, audio, and/or electronic data, is provided in real time and/or stored for review and analysis over a desired period of time. The feedback is provided locally or remotely over a communication network to a user, which can be party interested in the care and outcome of the rehabilitation process, and can include, for example, the patient, a healthcare provider such as a treating physician or a therapist, or a payor responsible for some or all of the cost of treatment. In other words, the feedback can be received and analyzed by a monitoring system 410 and/or a computer system 420.
[24] Furthermore, biometric device 100 can be designed to serve as an oximetry monitoring device. Biometric device 100 functioning as an oximetry monitoring device can comprise a device or method of measuring local oxygen saturation by measuring the change in red and infrared light reflected by or emited from in the skin and tissues under sensor element 122. In an embodiment, biometric device 100 can also detect skin color such as detecting redness as an indication of infection. Through a predetermine base line color measurement, biometric device 100 can detect a change in red and infrared light reflected. Biometric device 100 can be wearable on the skin or clothing or incorporated in a brace, orthosis, sling or similar. There can be combinations of wearable and non- wearable sensor elements 122 in the oximetry monitoring device. An application of biometric device 100 functioning as an oximetry monitoring device includes a method of analyzing the signal for continuous monitoring and providing feedback. For example, during exercise or exertion, the method of analyzing the signal for continuous monitoring and providing feedback can be achieved. Further, a method of comparing regional differences (or different locations) in blood flow or oxygen saturation (can use multiple detectors at selected locations) would be capable through an oximetry monitoring device. Also, this could be achieved during exercise or exertion activities. Other applications include a method of analyzing skin color (e.g. melanin content) and accounting for changes in signal (base line from other spot on body) and a method of measuring pulse rate and providing feedback during exercise or exertion. Finally, a method of detecting loss of signal can be achieved through lead off detection and compliance.
[25] Another application variation of biometric device 100 is to serve as wearable ultrasound monitoring device. Biometric device 100 functioning as a wearable ultrasound monitoring device can consist of one or more of the sensor elements functioning as a sound wave emiter and one or more of the a sensor elements 122 function as receivers , where the emitter generates a sound wave. Sensor element 122 measures the sound waves transmitted and reflected back from the tissue. The emitter and receiver can be combined in one device or can be separated into one or more devices. However, there can be more than one emitter and more than one receiver. As in the previous applications, there can be combinations of wearable and non-wearable emitter and receivers. Wearable ultrasound monitoring device can be wearable on the skin or clothing or incorporated in a brace, orthosis, sling or similar item. A method of measuring properties of skin, subcutaneous tissue, tendons, ligaments, cartilage, meniscus, among other body parts. As an application, wearable ultrasound monitoring device includes method of measuring the composition of tissue. For example, the volume of water, skin, fat, muscle, and other parameters. Further, these parameters can allow for a method of measuring swelling and abnormal tissue such as inflammation, infection, tumor, among other possible abnormalities in the tissue.
[26] Another possible application of biometric device 100 functioning as a wearable ultrasound monitoring device can include a method of real-time monitoring of tissue for fatigue, injury, risk of injury, or other physiological parameters due to infection, muscle damage during exercise, tendon or ligament damage during athletic activities. Similarly, a wearable ultrasound monitoring device allows a method of real-time monitoring of tissue during exercise, which includes muscle swelling during training for strength and hypertrophy. Finally, wearable ultrasound monitoring device can allow for multiple method applications such as a method for varying the frequency of the emitted sound waves to enhance accuracy of diagnosis or monitoring, a method of spectral analysis of the signals, a method for combining the signals or images from one or more emitters and one or more receivers, a method for combining the signals or images from one or more wearable emitters and one or more wearable receivers with one or more non-wearable emitters and one or more non-wearable receivers, a method for directing or guiding medical procedures e.g. needle placement for injections, biopsies, tissue ablation, a method for analyzing the ultrasound signal and selecting the optimal electrode array 120 or subset of electrodes to optimize or amplify the EMG signal, or select the signal with the least noise, and a method of detecting loss of signal through lead off detection and compliance.
[27] Furthermore, biometric device 100 can be arranged to function as a wearable bioimpedance monitoring device. Wearable bioimpedance monitoring device can consist of a current generator as a function of machine controller 130 and a sensor element 122. The current generator sends an electrical current into the skin. After, sensor element 122 measures the electric impedance of the tissue (bioimpedance). Bioimpedance is the amount of opposition to the flow of electrical current in the tissue. The current generator and receiver can be combined in one device or can be separated into one or more devices. There can be more than one current generator and more than one receiver. Also, there can be combinations of wearable and nonwearable current generators and receivers. Wearable bioimpedance monitoring devices can be wearable on the skin or clothing or incorporated in a brace, orthosis, sling or similar item. As well, biometric device 100 functioning as a wearable bioimpedance monitoring device can allow for a method of measuring bioimpedance of skin, subcutaneous tissue, tendons, ligaments, cartilage, meniscus, among others. An application of wearable bioimpedance monitoring device includes a method of measuring the composition of tissue such as water volume, skin, fat, muscle, and other parameters.
[28] Further, wearable bioimpedance monitoring device can implement a method of measuring swelling by calculating water content. As an application, wearable bioimpedance monitoring device includes method of measuring the composition of tissue. For example, the volume of water, skin, fat, muscle, and other parameters. Further, these parameters can allow for a method of measuring swelling and abnormal tissue such as inflammation, infection, tumor, among other possible abnormalities in the tissue. Another possible application of wearable bioimpedance monitoring device can include a method of real-time monitoring of tissue for fatigue, injury, risk of injury, or other physiological parameters due to infection, muscle damage during exercise, tendon or ligament damage during athletic activities.
[29] Similarly, wearable bioimpedance monitoring device would allow a method of realtime monitoring of tissue during exercise, which includes muscle swelling during training for strength and hypertrophy. Finally, wearable bioimpedance monitoring device allows for multiple method applications such as a method for varying the frequency of the emitted sound waves to enhance accuracy of diagnosis or monitoring, a method for combining the signals or images from one or more emitters and one or more receivers, a method of measuring and analyzing local tissue bioimpedance by generating current through one or more electrodes which is measured from one or more electrodes in electrode array 120, a method of combining the signals or images from one or more wearable current generators and one or more wearable receivers with one or more non-wearable current generators and one or more non-wearable receivers, a method of directing or guiding medical procedures such as needle placement for injections, biopsies, tissue ablation, a method of measuring local bioimpedance to modulate the EMG signal, for example, increasing the gain if skin bioimpedance is high, and a method of detecting loss of signal through lead off detection and compliance.
[30] Wearable monitoring can also be used for local drug or pharmaceutical agent delivery e.g. for pain control, or glucose control. For example by electromechanically or electromagnetically releasing the drug from a surface or compartment, using vibrations or local heating to release the drug, using microneedles to release the drug. Other examples, include implanting the drug as a reservoir and activating drug release from the reservoir by the biometric device when needed.
[31] Each of the plurality7 electrode arrays 120 may be controlled by a machine controller 130. Machine controller 130 may receive data from one or more sensors 122. In particular, each sensor 122 may be configured to measure a parameter and transmit (e.g., periodically, continuously, when polled, etc.) the values of that parameter to machine controller 130. Machine controller 130 may receive these parameter values from sensor(s) 122, analyze these parameter values according to one or more of the disclosed processes, and control one or more electrode array 120 based on this analysis. This analysis and control may be performed in real time to dynamically adjust the operation (e.g.. operating modes) of electrode array 120 in real time. The parameters monitored by machine controller 130 in this manner may include, without limitation, EMG, motion, temperature, bioimpedance, ultrasound, oximetry7, glucose concentration, s eat, and/or the like.
[32] FIG. 2 illustrates an example of a controller, according to an embodiment. Controller 130 may comprise one or more processors 210. Processor(s) 210 may comprise a central processing unit (CPU). Additional processors may be provided, such as a graphics processing unit (GPU), an auxiliary processor to manage input/output, an auxiliary processor to perform floating-point mathematical operations, a special-purpose microprocessor having an architecture suitable for fast execution of signal-processing algorithms (e.g., digital-signal processor), a subordinate processor (e.g., back-end processor), an additional microprocessor or controller for dual or multiple processor systems, and/or a coprocessor. Such auxiliary processors may be discrete processors or may be integrated yvith a main processor 210. Examples of processors yvhich may be used with controller 130 include, without limitation, any of the processors (e g., Pentium™, Core i7™, Xeon™, etc.) available from Intel Corporation of Santa Clara, California, any of the processors available from Advanced Micro Devices, Incorporated (AMD) of Santa Clara, California, any of the processors (e.g., A series, M series, etc.) available from Apple Inc. of Cupertino, any of the processors (e.g., Exynos™) available from Samsung Electronics Co., Ltd., of Seoul, South Korea, any of the processors available fromNXP Semiconductors N.V. of Eindhoven, Netherlands, and/or the like.
[33] Processor 210 may be connected to a communication bus 205. Communication bus 205 may include a data channel for facilitating information transfer between storage and other peripheral components of machine controller 130. Furthermore, communication bus 205 may provide a set of signals used for communication with processor 610. including a data bus, address bus, and/or control bus (not shown). Communication bus 205 may comprise any standard or non-standard bus architecture such as, for example, bus architectures compliant with industry standard architecture (ISA), extended industry standard architecture (EISA), Micro Channel Architecture (MCA), peripheral component interconnect (PCI) local bus, standards promulgated by the Institute of Electrical and Electronics Engineers (IEEE) including IEEE 488 general-purpose interface bus (GPIB), IEEE 696/S-100, and/or the like.
[34] Machine controller 130 may comprise main memory 215. Main memory' 215 provides storage of instructions and data for programs executing on processor 610, such as one or more of the processes or functions discussed herein. It should be understood that programs stored in the memory and executed by processor 210 may be written and/or compiled according to any suitable language, including without limitation C/C++, Java, JavaScript, Perl, Python, Visual Basic, .NET, and the like. Main memory' 215 is ty pically semiconductor-based memory' such as dynamic random access memory (DRAM) and/or static random access memory (SRAM). Other semiconductor-based memory types include, for example, synchronous dynamic random access memory (SDRAM), Rambus dynamic random access memory (RDRAM), ferroelectric random access memory' (FRAM), and the like, including read only memory' (ROM).
[35] Machine controller 130 may comprise secondary memory 220. Secondary memory 220 is a non-transitory computer-readable medium having computer-executable code and/or other data (e.g., software implementing any process or function described herein) stored thereon. In this description, the term “computer-readable medium” is used to refer to any non- transitory computer-readable storage media used to provide computer-executable code and/or other data to or within controller 130. The computer software stored on secondary memory 220 is read into main memory7 215 for execution by processor 210. Secondary memory 220 may include, for example, semiconductor-based memory', such as programmable read-only memory' (PROM), erasable programmable read-only memory (EPROM), electrically erasable read-only memory (EEPROM), and flash memory (block-oriented memory' similar to EEPROM).
[36] Machine controller 130 may comprise an input/output (I/O) interface 235. I/O interface 235 provides an interface between one or more components of controller 130 and one or more input and/or output devices. For example, I/O interface 235 may receive the output of one or more sensors, and/or output control signals to one or more of the components of mobile equipment 100.
[37] Machine controller 130 may comprise a communication interface 240. Communication interface 640 allows signals, such as data and software, to be transferred between machine controller 130 and external devices, networks, or other information sources and/or destinations (e.g., receiver(s)). For example, computer-executable code and/or data may be transferred to machine controller 130, over one or more networks, from a network server via communication interface 240. Examples of communication interface 240 include a built- in network adapter, network interface card (NIC), Personal Computer Memory' Card International Association (PCMCIA) network card, card bus network adapter, wireless network adapter, Universal Serial Bus (USB) network adapter, modem, a wireless data card, a communications port, an infrared interface, an IEEE 1394 fire-wire, and any other device capable of interfacing controller 130 with a network or another computing device. Communication interface 240 preferably implements industry -promulgated protocol standards, such as Ethernet IEEE 802 standards, Fiber Channel, digital subscriber line (DSL), asynchronous digital subscriber line (ADSL), frame relay, asynchronous transfer mode (ATM), integrated digital services network (ISDN), personal communications sendees (PCS), transmission control protocol/Intemet protocol (TCP/IP), serial line Internet protocol/point to point protocol (SLIP/PPP), and so on, but may also implement customized or non-standard interface protocols as well.
[38] Software transferred via communication interface 240 is generally7 in the form of electrical communication signals 255. These signals 255 may be provided to communication interface 240 via a communication channel 250 between communication interface 240 and an external system 245. In an embodiment, communication channel 250 may be a wired or wireless network, or any7 variety7 of other communication links. Communication channel 250 carries signals 255 and can be implemented using a variety' of wired or wireless communication means including wire or cable, fiber optics, conventional phone line, cellular phone link, wireless data communication link, radio frequency (“RF”) link, or infrared link, just to name a few.
[39] Computer-executable code is stored in main memory 215 and/or secondary memory 120. Computer-executable code can also be received from an external system 245 via communication interface 240 and stored in main memory 215 and/or secondary memory 620. Such computer-executable code, when executed by processor(s) 210, enable machine controller 130 to perform the various processes or functions disclosed herein.
[40] FIG. 3 illustrates a process 300 for measuring a patient’s muscle activity and tissue bioimpedance, according to an embodiment. While process 300 is illustrated with a certain arrangement and ordering of subprocesses, process 300 may be implemented with fewer, more, or different subprocesses and a different arrangement and/or ordering of subprocesses. In addition, it should be understood that any subprocess, which does not depend on the completion of another subprocess, may be executed before, after, or in parallel with that other independent subprocess, even if the subprocesses are described or illustrated in a particular order.
[41] In sub process 310, electrode array 120 is adhered to the patient. Electrode array 120 can be adhered to patient via patch 110. As previously mentioned in FIG. 1 , patch 110 can have a rear face that can contact or face a patient's body when worn. In this regard, at least a portion of the rear face of patch 110 can be equipped with an attachment element configured to secure at least a portion of patch 110 to the patient's body. For example, the attachment element can be an adhesive or other type of element configured to attach to the patient's body.
[42] After, in subprocess 320, electrode array 120 can be powered by battery 140. Battery' 140 can include any power supply. Further, after being powered, electrode array 120 can measure the muscle activity through electrical signals generated by muscles with electrode array 120 and one or more sensor elements 122. as shown in subprocess 330.
[43] In subprocess 340, electrode array 120 communicates with a machine controller 130, wherein machine controller 130 is configured to receiving signals from electrode array 120 based on the muscle activity' and tissue bioimpedance measured by sensor elements 122. Furthermore, machine controller 130 is configured to process the signals to assess the patient’s health conditions, as shown in subprocess 350.
[44] Subprocess 360 illustrates the triggering of a response by machine controller 130 based on a set criteria including one or more of whether the patient is not using a muscle, overusing a muscle, or not complying with recommended muscle activity. If none of the criteria is met (NO), then there is no response triggered, as seen in subprocess 365. On the other hand, if any of the criteria is met (YES), then a response is triggered in subprocess 370. This response can include providing feedback, which can be in the form of visual, audio, and/or electronic data, is provided in real time and/or stored for review and analysis over a desired period of time, as shown in subprocess 380. The feedback is provided locally or remotely over a communication network to a user, which can be party7 interested in the care and outcome of the rehabilitation process, and can include, for example, the patient, a healthcare provider such as a treating physician or a therapist, or a payor responsible for some or all of the cost of treatment.
[45] FIG. 4 illustrates a schematic representation of a monitoring and treatment system 400. FIG. 4 shows a schematic representation of the overall system 400, which includes a monitoring system 410 communicatively coupled to a computer system 420, as described in more detail below. The overall system may also include a biometric device 100. for example, the device depicted in Fig. 1 .
[46] Computer system 420 can include, for example, at least one computing device (such as a mobile phone, desktop or laptop computer, or Internet-based computer resource) that is communicatively coupled to monitoring system 410 and/or biometric device 100 (if present.) Monitoring system 410 can be connected to the other systems via a wired or wireless communication link. Moreover, computer system 420 can be locally connected to the other systems or it may be remotely connected and/or distributed over a local area or wide area telecommunication network such as the Internet. Computer system 420 can be configured to process or otherwise analyze, display, and/or archive raw and processed surface electromyography (SEMG data), rectify, filter, and integrate the data with other sensor data that is collected by the shoulder monitoring system 410.
[47] In an embodiment, an enabled or authorized local or remote entity (such as a healthcare provider, a treating physician or a therapist, a payor, or a patient) can access computer system 420 over the telecommunication network.
[48] In an embodiment, system 400 can include one or more wireless communication components that enable communication betw een components of system 400 and another device or just between components of system 400. For example, system 400 can include a Bluetooth or non-Bluetooth radio chip, such as on the exoskeleton, and a non-Bluetooth radio transceiver. The radio chips can be used in place of or in parallel to a smartphone. By using an alternative or proprietary radio chip, the user is permitted to still use his/her smartphone for other uses (e.g., phone, music player or other Bluetooth application). The use of radio chips also permits patients who don't have a smartphone to use the system. Alternatively, system 400 may use a plug-in receiver, such as a micro USB, in combination with a proprietary radio chip that attaches to a mobile phones or other user device.
[49] Computer system 420 can be integrated with or into a mobile user device, such as a smart phone or tablet. A smart phone or the device can be sized and shaped to be positioned in a case that is also sized and shaped to cany7 other components of system 400 including biometric device 100.
[50] With reference still to FIG. 4. monitoring system 410 can include an embedded computer and one or more components, such as sensor elements 122, that are configured to monitor and provide feedback with respect to the targeted region, including, for example, movement, motion, muscle activity and/or forces acting on the targeted region. In an embodiment, monitoring system 410 includes components of a surface electromyogram (EMG) system including one or more sensor elements 122 that are positioned at predetermined locations of the targeted region for recording the electrical activity produced by the body. The EMG system may include an electromyograph that is part of or communicatively coupled to computer system 420. Sensor elements 122 can be attached to various portions of system 400. For example, sensor elements 122 can be placed on the body or connect the body to biometric device 100. Monitoring system 410 may include accelerometers and neuro-feedback capability.
[51] The feedback may be provided to the patient and/or other users in a variety7 of formats including audio feedback, visual feedback, tactile feedback, and data feedback that represent the user's interaction with system 400. The feedback can include measurements of muscle activity^ relative to predetermined criteria to monitor, for example, whether a user is not using a muscle, over-using a muscle, or not meeting or not complying with recommended muscle activity or a physician prescription. In an embodiment, the system monitors muscle movement, such as with respect to predetermined levels or types of motion, and provides data as to whether the muscle movement meets predetermined criteria.
[52] System 400 may also include a user interface that includes one or more mechanical or virtual input mechanisms that permit the user to control any aspect of system 400. For example, the user interface can include an on/off control and a volume or mute control. System 400 can be configured to operate in various modes, including an off mode, a charging mode and a non-mode. The on mode can include, for example, an active mode, a sleep mode, and an alarm mode. The user interface can be presented in whole or in part on any component of the system including computer system 420. Industrial Applicability'
[53] Traditionally, muscle monitoring and treatment methods can have issues because electrode placement accuracy, signal interference, and signal interpretation can affect the reliability of measurements. Moreover, the non-stationary nature of muscle and joint signals, which change over time and under different conditions, necessitates sophisticated signal processing and analysis methods. Accordingly, biometric device 100 for monitoring muscle activity and bioimpedance can have significant industrial applicability across various sectors to mitigate these issues, especially in healthcare and sports. In the medical field, biometric device 100 can assist in diagnosing neuromuscular disorders, guiding rehabilitation processes, and tailoring physical therapy programs. Further, biometric device 100 can provide detailed insights into muscle function and activity patterns through bioimpedance, and assist professionals to detect muscle weaknesses, abnormal muscle behavior, and monitor recovery progress.
[54] On the other hand, biometric device 100 can assist in the sports and fitness industry. Biometric device 100 can help enhance athletic performance and prevent injuries. Athletes and trainers can use biometric device 100 to analyze muscle engagement, identify imbalances, and refine training techniques. Furthermore, biometric device 100 can allow real-time muscle activity' tracking to help in optimizing exercise routines, ensuring proper form, and reducing the risk of overuse injuries.
[55] It will be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments. Aspects described in connection with one embodiment are intended to be able to be used with the other embodiments. Any explanation in connection with one embodiment applies to similar features of the other embodiments, and elements of multiple embodiments can be combined to form other embodiments. The embodiments are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.
[56] The preceding detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. The described embodiments are not limited to usage in conjunction with a particular type of machine or device. Hence, although the present embodiments are, for convenience of explanation, depicted and described as being implemented in a patch, it will be appreciated that it can be implemented in various other means, including adhesive devices, and in various other systems and environments. Furthermore, there is no intention to be bound by any theory presented in any preceding section. It is also understood that the illustrations may include exaggerated dimensions and graphical representation to better illustrate the referenced items shown, and are not considered limiting unless expressly stated as such.

Claims

CLAIMS What is claimed is:
1. A biometric device, comprising: an adhesive patch; a power supply; an electrode array with one or more sensor elements configured to measure one or more biological conditions; and a machine controller communicatively coupled to the electrode array configured to receive signals from the electrode array, and process the signals to assess a condition of a patient wearing the device.
2. The device of claim 1 , wherein the machine controller can be located remotely from the biometric device.
3. The device of claim 1, wherein the sensor elements further monitor one or more of skin temperature, tissue bioimpedance, oxygen saturation, glucose levels, ultrasound, environmental temperature and humidity.
4. The device of claim 1, wherein the machine controller is further configured to analyze a combined signal from multiple sensors to assess health and disease.
5. The device of claim 1, wherein the machine controller is configured to analyze the signals received by the array of electrodes and select an optimal electrode or a subset of electrodes to optimize the signal.
6. The device of claim 1, wherein the machine controller is configured to trigger a response based on a set of criteria including whether the patient is not using a muscle, overusing a muscle, or not complying with recommended muscle activity.
7. The device of claim 1, wherein the machine controller is configured to measure and analyze local tissue bioimpedance by providing an excitation voltage through one or more electrodes which is measured from one or more other electrodes in the array.
8. The device of claim 1, wherein at least one of the one or more sensor elements comprises a sound wave emitter and another one of the one or more sensor elements comprises a sound wave receivers.
9. The device of claim 8. wherein the emitter generates a sound wave and the sound wave receiver measures the sound wave reflected back.
10. A method of using an array of electrodes to measure one or more biological conditions of a patient wearing the array, the method comprising: adhering to a patient’s body an adhesive patch with an array of electrodes comprising one or more sensor elements; powering the array of electrodes with a power supply; measuring one or more biological conditions of the patient with one or more sensor elements; receiving signals from the array of electrodes; processing the signals to assess one or more biological conditions of the patient; and triggering a response based on the assessment.
11. The method of claim 10, wherein the machine controller is located remotely from the biometric device.
12. The method of claim 10, further comprising monitoring one or more of skin temperature, tissue bioimpedance, oxygen saturation, glucose levels, ultrasound, and environmental temperature and humidity.
13. The method of claim 10. further comprising analyzing the signal received by the array of electrodes and selecting an optimal electrode or a subset of electrodes to optimize the signal.
14. The method of claim 10, further comprising measuring and analyzing local tissue bioimpedance by providing an excitation voltage through one or more of the electrodes and measuring the excitation voltage from one or more electrodes in the array.
15. The method of claim 10, further comprising at least one of the one or more sensor elements emitting a sound wave and another one of the one or more sensor elements receiving the emitted sound wave after it is reflected back from a biological tissue.
16. A biometric electrode array system, comprising: an adhesive patch; a power supply; a configuration of electrodes with one or more sensor elements located on the adhesive patch configured to measure muscle activity and tissue bioimpedance through electrical signals generated by muscles; and a machine controller communicatively coupled to the sensor elements configured to receive signals from the sensor elements based on measurements of the muscle activity and tissue bioimpedance, process the signals to assess the patient’s health conditions, trigger a response based on a set criteria including whether the patient is not using a muscle, over-using a muscle, or not complying with recommended muscle activity, and provide related feedback based on the response.
17. The device of claim 16, further comprising one or more sensor elements to monitor one or more of skin temperature, tissue bioimpedance, oxygen saturation, glucose levels, ultrasound, and environmental temperature and humidity.
18. The device of claim 16, wherein the machine controller is configured to analyze the signal received by the sensor elements and select an optimal electrode or a subset of electrodes to optimize or amplify the signal.
19. The device of claim 16, wherein the machine controller is configured to measure and analyze local tissue bioimpedance by providing an excitation voltage through one or more electrodes which is measured from one or more sensor elements.
20. The device of claim 16, wherein the machine controller is further configured to communicate the related feedback to a communication network.
PCT/US2024/0450342023-08-312024-09-03Biometric monitoring and treatment devicePendingWO2025050121A1 (en)

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