Systems and methods for implantable muscle interfaces

Abstract

Disclosed is a system for implantable human-machine interfaces, including an implantable muscle interface device, including a substrate at least partially surrounding the muscles from which the EMG signals originate, including a first plurality of sensors and a second plurality of amplifiers for respectively capturing and amplifying electromyographic (EMG) signals originating from a motor unit under the control of neural signals representing voluntary limb movement, and a transceiver device connected to the first plurality of sensors for wirelessly transmitting signals to an external decoder for generating decoded signals that discriminate the motor signals representing the motor unit movement; and a receiver device that uses the decoded signals to interact with an external system. The system includes a first plurality of electrodes and a second implantable power source for delivering electrical stimulation to underlying tissue and internal sensory axons for the purposes of sensory feedback and neuromodulation.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 030,778, filed May 27, 2020, which is incorporated by reference herein in its entirety.

[0002] Field The present teachings generally relate to systems and methods for implantable muscle interfaces. [Background technology]

[0003] background Amputation is still considered a last resort for many who lose limb functionality from nerve damage because the functionality of prosthetic and orthotic devices has remained relatively unchanged over the past 40 years or more. This is in part due to the lack of a strong connection between machines and the human nervous system. Because humans have no meaningful way to communicate seamlessly with machines, this has been a bottleneck in the advancement and future potential of prosthetic and orthotic and exoskeleton assistive technologies. Summary of the Invention

[0004] overview According to an embodiment of the present disclosure, an implantable muscle interface system is disclosed, which includes a substrate at least partially surrounding the muscles from which the EMG signals originate, including a first plurality of sensors and a second plurality of amplifiers for respectively capturing and amplifying electromyographic (EMG) signals originating from a motor unit under the control of a neural signal representative of voluntary limb movement, a wireless transceiver device electrically connected to the first plurality of sensors for wirelessly transmitting signals to an external decoder, which generates a decoded signal discriminating the movement signal representative of the motor unit movement, and a receiver device that uses the decoded signal to interact with an external system.

[0005] Various additional features may be included in the implanted muscle interface system, including one or more of the following features: The substrate is flexible, rigid, or semi-rigid. The receiver device includes an amplification component, a filtering component, a wireless communication component, or a combination thereof. The substrate, the first plurality of sensors, the second plurality of amplifiers, and the wireless transceiver device are enclosed within a single hermetically sealed container or encapsulating coating. The implanted muscle interface system may further include a power source that powers the first plurality of sensors, the second plurality of amplifiers, and the wireless transceiver device. The substrate, the first plurality of sensors, the second plurality of amplifiers, the wireless transceiver device, and the power source are enclosed within a single hermetically sealed container or encapsulating coating. The first plurality of sensors, the second plurality of amplifiers, and the wireless transceiver device are externally powered by an electromagnetic, ultrasonic, piezoelectric, or optical power source. The signals transmitted by the wireless transceiver device may be analog signals multiplexed from multiple channels from the first plurality of sensors, or analog signals multiplexed from multiple channels from the first plurality of sensors and digitized by an analog-to-digital converter, or encrypted for secure communication. The substrate is composed of a biocompatible material, including polymers, parylene, plastics, rubber, silicone, polymer fibers, silk fibroin, 3D printing polymers, polyimides, polydimethylsiloxane (PDMS), metals, hydrogels, or acellular scaffolds. The substrate is composed of a biocompatible polymer having conductive electrodes and conductive traces deposited or embedded therein, including biocompatible metals; conductive polymers; conductive carbon-based materials, including fibers, nanotubes, and graphene; gold, platinum, polypyrrole, poly(3,4-ethylenedioxythiophene) (PEDOT), poly(3,4-ethylenedioxythiophene)polystyrenesulfonate (PEDOT:PSS), or combinations thereof.External systems include prosthetic limbs, orthotics, exoskeletons, computers, household appliances, remote controllers, gaming devices, mobile computing devices, acoustic devices, augmented reality systems, virtual reality systems, or human augmentation / augmentation devices. The implantable muscle interface device is compatible with target tissues including muscles in various biological states, including intact, vascularized-innervated, vascularized-deinnervated, devascularized-deinnervated, and devascularized-innervated muscles, or muscle grafts, including autografts, xenografts, allografts, syngeneic grafts, cell cultures, or synthetic substitutes. The substrate includes a first plurality of electrodes (e.g., one or more stimulating electrodes) or ultrasound transducers that provide electrical or ultrasonic stimulation to underlying sensory axons for sensory feedback from the prosthetic limb or exoskeleton.

[0006] According to an embodiment of the present disclosure, a method for controlling an external device using an implanted muscle interface device is disclosed, comprising the steps of: obtaining electromyographic (EMG) signals representative of excitation or contraction of the underlying muscles from one or more sensors deposited or embedded in a substrate at least partially surrounding the underlying muscles, detecting the EMG signals with amplification and filtering electronics that transmit the EMG signals wirelessly via an implanted transceiver, wirelessly transmitting the EMG signals via the implanted transceiver, wirelessly receiving the EMG signals via an external receiver, decoding the detected EMG signals using a decoding algorithm that converts the EMG signals into discrete control signals, and using the separated control signals to operate the device based on a machine learning algorithm that correlates the control signals with a user's intent.

[0007] Various additional features may be included in the implantable muscle interface system, including one or more of the following: The substrate is composed of a biocompatible material including a polymer, plastic, rubber, silicone, polymer fiber, silk fibroin, 3D printing polymer, polyimide, polydimethylsiloxane (PDMS), metal, hydrogel, or acellular scaffold. The substrate is composed of a biocompatible polymer having deposited or embedded therein conductive electrodes and conductive traces, including a biocompatible metal; a conductive polymer; a conductive carbon-based material including fibers, nanotubes, and graphene; gold, platinum, polypyrrole, poly(3,4-ethylenedioxythiophene) (PEDOT), or combinations thereof. The external system includes a prosthetic limb, an orthosis, an exoskeleton, a computer, a consumer appliance, a remote controller, a gaming device, a mobile computing device, an acoustic device, an augmented reality system, a virtual reality system, or a human augmentation / augmentation device. The implantable muscle interface device is compatible with target tissues including muscles in a variety of biological states, including intact, vascularized-innervated, vascularized-deinnervated, devascularized-deinnervated, devascularized-innervated, or muscle grafts, including autografts, xenografts, allografts, syngeneic grafts, cell cultures, or synthetic substitutes.

[0008] According to an embodiment of the present disclosure, a method for attaching an implantable muscle interface device is disclosed. The method for attaching an implantable muscle interface device includes the steps of preparing an implantation site and securing a substrate at the implantation site, the substrate including one or more sensors for detecting electromyographic (EMG) signals representative of the movement of the underlying muscle, the substrate at least partially surrounding the underlying muscle. Preparing the implantation site includes elevating at least a muscle segment of the underlying muscle from surrounding tissue while remaining attached to a blood vessel providing perfusion; identifying a nerve innervating the at least muscle segment with electrical stimulation using one or more stimulating electrodes or one or more ultrasound transducers; dividing the identified at least muscle segment to ensure denervation; wrapping the distal end of a proximal stump of a transected nerve or nerve bundle with the isolated at least muscle segment or placing the distal end of the proximal stump of a transected nerve within a portion of the muscle segment; and securing the proximal stump with sutures or fibrin glue. [The present invention 1001] a first plurality of sensors and a second plurality of amplifiers for respectively capturing and amplifying electromyographic (EMG) signals arising from motor units under the control of neural signals representative of voluntary limb movement; a wireless transceiver device electrically connected to the first plurality of sensors for wirelessly transmitting signals to an external decoder that generates a decoded signal that discriminates the motor signal representative of the motor unit movement; a substrate at least partially surrounding the muscle from which the EMG signal originates; and Receiver device using the decoded signal to interact with an external system An implantable muscle interface system comprising: [The present invention 1002] The implantable muscle interface system of the present invention 1001, wherein the substrate is flexible, stretchable, rigid, or semi-rigid. [The present invention 1003] The implantable muscle interface system of the present invention 1001, wherein the receiver device includes an amplification component, a filtering component, a wireless communication component, or a combination thereof. [The present invention 1004] The implantable muscle interface system of the present invention 1001, wherein the substrate, the first plurality of sensors, the second plurality of amplifiers, and the wireless transceiver device are enclosed within a single hermetically sealed container or encapsulating coating. [The present invention 1005] The implantable muscle interface system of the present invention 1001 further comprising a power source for powering the first plurality of sensors, the second plurality of amplifiers, and the wireless transceiver device. [The present invention 1006] The implantable muscle interface system of the present invention 1005, wherein the substrate, the first plurality of sensors, the second plurality of amplifiers, the wireless transceiver device, and the power source are enclosed within a single hermetically sealed container or encapsulating coating. [The present invention 1007] The implantable muscle interface system of the present invention 1001, wherein the first plurality of sensors, the second plurality of amplifiers, and the wireless transceiver device are externally powered by an electromagnetic, ultrasonic, piezoelectric, or optical power source. [The present invention 1008] The implantable muscle interface system of the present invention 1001, wherein the signal transmitted by the wireless transceiver device is an analog signal multiplexed from multiple channels from a first plurality of sensors, or an analog signal multiplexed from multiple channels from the first plurality of sensors and digitized by an analog-to-digital converter, or an encrypted signal for secure communication. [The present invention 1009] The implantable muscle interface system of the present invention 1001, wherein the substrate is composed of a biocompatible material including a polymer, parylene polyimide, plastic, rubber, silicone, polymer fiber, silk fibroin, 3D printing polymer, polyimide, polydimethylsiloxane (PDMS), metal, hydrogel, or acellular scaffold. [The present invention 1010] Biocompatible metals; conductive polymers; conductive carbon-based materials, including fibers, nanotubes, and graphene; and biocompatible polymers having conductive electrodes and conductive traces deposited or embedded therein, including gold, platinum, polypyrrole, poly(3,4-ethylenedioxythiophene) (PEDOT), poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), or combinations thereof. The implantable muscle interface system of the present invention 1001, wherein the substrate is composed of [The present invention 1011] The implantable muscle interface system of the present invention 1001, wherein the external system comprises a prosthetic limb, an orthosis, an exoskeleton, a computer, a household appliance, a remote controller, a gaming device, a mobile computing device, an acoustic device, an augmented reality system, a virtual reality system, or a human augmentation / augmentation device. [The present invention 1012] Muscles in a variety of biological states, including unchanged, vascularized-innervated, vascularized-deinnervated, nonvascularized-deinnervated, and nonvascularized-innervated muscles; or Muscle grafts, including autografts, xenografts, allografts, syngeneic grafts, cell cultures, or synthetic substitutes The implantable muscle interface system of the present invention 1001 is compatible with target tissue including: [The present invention 1013] 1001, an implantable muscle interface system according to the present invention, wherein the substrate comprises a first plurality of electrodes or ultrasonic transducers that provide electrical or ultrasonic stimulation to underlying sensory axons for sensory feedback from a prosthetic limb or exoskeleton. [The present invention 1014] A method of controlling an external device using an implanted muscle interface device, comprising: obtaining signals from one or more sensors that detect electromyographic (EMG) signals representative of excitation or contraction of the underlying muscle, the sensors being deposited or embedded within a substrate that at least partially surrounds the underlying muscle; detecting the EMG signal with amplification and filtering electronics that transmits the EMG signal wirelessly via an implanted transceiver; wirelessly transmitting the EMG signals by an implanted transceiver; wirelessly receiving the EMG signal by an external receiver; decoding the detected EMG signal using a decoding algorithm that converts the EMG signal into a discrete control signal; and Using the isolated control signals to operate a device based on a machine learning algorithm that correlates the control signals with a user's intent. [The present invention 1015] The method of the present invention 1014, wherein the substrate is composed of a biocompatible material including a polymer, plastic, rubber, silicone, polymer fiber, silk fibroin, 3D printing polymer, polyimide, polydimethylsiloxane (PDMS), metal, hydrogel, or an acellular scaffold. [The present invention 1016] Biocompatible metals; conductive polymers; conductive carbon-based materials, including fibers, nanotubes, and graphene; biocompatible polymers having conductive electrodes and conductive traces deposited or embedded therein, including gold, platinum, polypyrrole, poly(3,4-ethylenedioxythiophene) (PEDOT), or combinations thereof. The method of the present invention 1014, wherein the substrate is composed of [The present invention 1017] The method of the present invention 1014, wherein the external device comprises a prosthetic limb, an orthosis, an exoskeleton, a computer, a household appliance, a remote controller, a gaming device, a mobile computing device, an acoustic device, an augmented reality system, a virtual reality system, or a human augmentation / augmentation device. [The present invention 1018] Implantable muscle interface devices Muscles in a variety of biological states, including unchanged, vascularized-innervated, vascularized-deinnervated, nonvascularized-deinnervated, and nonvascularized-innervated muscles; or Muscle grafts, including autografts, xenografts, allografts, syngeneic grafts, cell cultures, or synthetic substitutes The method of the present invention 1014 is compatible with target tissues comprising: [The present invention 1019] A method of applying an implantable muscle interface device, comprising the steps of: Preparing the implantation site; and A step of securing a substrate to the implantation site, the substrate including one or more sensors for detecting electromyographic (EMG) signals representative of movement of the underlying muscle, the substrate at least partially surrounding the underlying muscle. [The present invention 1020] The method of the present invention 1019, wherein the step of preparing the implantation site includes elevating at least a muscle segment of the underlying muscle from the surrounding tissue while remaining attached to a blood vessel providing perfusion; identifying a nerve innervating the at least muscle segment with electrical stimulation; dividing the identified at least muscle segment to ensure denervation; wrapping the distal end of the proximal stump of the transected nerve or nerve bundle with the isolated at least muscle segment or placing the distal end of the proximal stump of the transected nerve within a portion of the muscle segment; and securing the proximal stump with sutures or fibrin glue. [Brief explanation of the drawings]

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present teachings and, together with the description, serve to explain the principles of the disclosure.

[0010] [Figure 1] FIG. 1A shows a perspective view of a first exemplary implantable muscle interface system according to an embodiment of the present disclosure. FIG. 1B shows a detailed view of a portion of FIG. 1A. FIG. 1C shows a front view of the system of FIG. 1A. FIG. 1D shows a front view of the system of FIG. 1A. FIG. 1E shows another front view of the system of FIG. 1A. [Figure 2] Figure 2A shows a front view of second and third exemplary implantable muscle interface systems according to embodiments of the present disclosure. Figure 2B shows a rear view of the system of Figure 2A. Figure 2C shows a detailed view of the system of Figure 2A. Figure 2D shows another view of the system of Figure 2A. [Figure 3] 1 illustrates example electronic components within an implantable muscle interface system according to an embodiment of the present disclosure. [Figure 4] 10 illustrates a method of transmitting signals to and from an external device using an implanted muscle interface device according to an embodiment of the present disclosure. [Figure 5] 10 illustrates a method for controlling an external device through decomposing a signal transmitted from an implanted muscle interface device according to an embodiment of the present disclosure. [Figure 6] 1 illustrates a method of applying an implantable muscle interface device according to an embodiment of the present disclosure. [Figure 7] 1 illustrates a prosthetic device controlled by multiple muscle units according to an embodiment of the present disclosure. [Figure 8] 1 illustrates a muscle-based controlled prosthetic device with tactile sensors according to an embodiment of the present disclosure. [Figure 9]3 illustrates the installation of the device of FIG. 1 or FIG. 2 on a residual limb according to an embodiment of the present disclosure. [Figure 10] 1 illustrates EMG signals acquired by three separate EMG sensors according to an embodiment of the present disclosure. [Figure 11] FIG. 11A shows a top perspective view 1100 and FIG. 11B shows a side view 1102 of an EMG unit according to an embodiment of the present disclosure. [Figure 12] 1 illustrates an EMG device with a flexible and stretchable polymer electrode array according to an embodiment of the present disclosure. [Figure 13] 1 illustrates an EMG device with a flexible and stretchable mesh electrode array according to an embodiment of the present disclosure. [Figure 14A] The arm is shown with dotted lines depicting cut lines according to an embodiment of the present disclosure. [Figure 14B] FIG. 14A shows a section of the arm with nerve fibers, along with a flexible wireless device wrapped around it in accordance with an embodiment of the present disclosure. [Figure 14C] 1 illustrates a segment of a muscle fiber that is responsive to nerve fiber activation and has a connected blood supply, according to an embodiment of the present disclosure. [Figure 14D] 14D illustrates the segment of muscle fiber of FIG. 14C wrapped with a flexible wireless device (e.g., a neural wrap) according to an embodiment of the present disclosure. [Figure 15] 1 illustrates an example of the use of a flexible wireless device to control both upper and lower limb prosthetics and orthotics according to an embodiment of the present disclosure. [Figure 16] 1 illustrates an example use of a flexible wireless device for a prosthetic hand, according to an embodiment of the present disclosure. [Figure 17] 1 illustrates a flexible wireless device implanted within an uninjured individual for control of technology, which may be used to wirelessly control robotic devices such as exoskeletons, according to an embodiment of the present disclosure. [Figure 18] 1 illustrates a method for preparing an implantation site according to an embodiment of the present disclosure.

[0011] It should be noted that some of the details in the drawings have been simplified and drawn in order to facilitate understanding of the present teachings, while strictly maintaining structural accuracy, detail, and scale. DETAILED DESCRIPTION OF THE INVENTION

[0012] Detailed Description Generally, the present disclosure provides an implantable muscle interface system, a method for controlling an external device using the implantable muscle interface device, and a method for wearing the implantable muscle interface device. In some embodiments, the implantable muscle interface device can be assembled from a component system, such as electrodes or ultrasound transducers, electronics, wireless, and other examples of 3D printing; can be configured as a cuff-like muscle interface that interacts with newly innervated muscle sections after nerve transection; and can both record from the muscle (with one or more sensors, such as recording electrodes) and stimulate the muscle (with one or more stimulating electrodes or one or more ultrasound transducers), as well as affect neural activity in the peripheral nervous system to control the performance of a prosthetic device. The implantable muscle interface device can be used to utilize EMG signals resulting from surgical interventions used to treat / prevent nerve pain after nerve transection, such as single nerve injury or complete limb amputation. The implanted muscle interface device can then be used to control a machine or device through the captured EMG signal, including, but not limited to, a prosthetic limb, an exoskeleton, or an assistive or mobility device such as a powered wheelchair. As used herein, the term "sensor" can be a recording electrode.

[0013] FIG. 1A shows a perspective view of a first exemplary implantable muscle interface system 100 according to an embodiment of the present disclosure. FIG. 1B shows a detailed view of a portion of FIG. 1A. FIG. 1C shows a front view of the system of FIG. 1A. FIG. 1D shows a front view of the system of FIG. 1A. FIG. 1E shows another front view of the system of FIG. 1A. FIG. 2A shows front views of second and third exemplary implantable muscle interface systems 200 according to an embodiment of the present disclosure. FIG. 2B shows a rear view of the system of FIG. 2A. FIG. 2C shows a detailed view of the system of FIG. 2A. FIG. 2D shows another view of the system of FIG. 2A. Implantable muscle interface systems 100 and 200 include an implantable muscle interface device 102. The implantable muscle interface device 102 is compatible with target tissues including muscles in a variety of biological states, including vascularized-innervated, vascularized-non-innervated, non-vascularized-non-innervated, non-vascularized-innervated muscles, or muscle grafts, including autografts, xenografts, allografts, syngeneic grafts, cell cultures, or synthetic substitutes.

[0014] The implantable muscle interface device 102 includes a first substrate 104 or a second substrate 202. The first substrate 104 and the second substrate 202 may be flexible, rigid, or semi-rigid. The first substrate 104 is rigid and the second substrate 202 is flexible. In some embodiments, the first substrate 104 and / or the second substrate 202 are composed of a biocompatible material including a polymer, plastic, rubber, silicone, polymer fiber, silk fibroin, 3D printing polymer, polyimide, polydimethylsiloxane (PDMS), metal, hydrogel, acellular scaffold, or a combination thereof. In some embodiments, the first substrate 104 and / or the second substrate 202 are composed of biocompatible polymers having conductive electrodes or ultrasound transducers and conductive traces deposited or embedded therein, including biocompatible metals; conductive polymers; conductive carbon-based materials including fibers, nanotubes, and graphene; gold, platinum, polypyrrole, poly(3,4-ethylenedioxythiophene) (PEDOT), poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), other conductive polymers, or combinations thereof.

[0015] The first substrate 104 and / or the second substrate 202 include a first plurality of sensors 106 and a first plurality of amplifiers 108. The first plurality of sensors 106 capture, and the first plurality of amplifiers 108 amplify, electromyographic (EMG) signals generated from motor units under the control of neural signals representative of voluntary limb movement. The implantable muscle interface device 102 also includes a wireless transceiver device 110 electrically connected to the first plurality of sensors 106 for wirelessly transmitting signals to an external decoder 112, which generates decoded signals that discriminate the movement signals representative of the motor units' movement. The first substrate 104 and / or the second substrate 202 at least partially surround the muscles from which the EMG signals are generated. In some embodiments, the first substrate 104 and / or the second substrate 202, the first plurality of sensors 106, the first plurality of amplifiers 108, and the wireless transceiver device 110 are enclosed within a single hermetically sealed container. The hermetically sealed enclosure completely encapsulates all components of the interface device that are not, although the base and sensors designed to interact with tissue may be partially encapsulated, and comprises some biocompatible material such as, but not limited to, titanium, alumina, zirconia, or other ceramics. In some examples, the first substrate 104 and / or the second substrate 202 may include a first plurality of electrodes 114 (or ultrasound transducers) that provide electrical stimulation (via one or more stimulating electrodes) (or ultrasonic stimulation via one or more ultrasound transducers) to underlying sensory axons for sensory feedback from the prosthetic limb.

[0016] In some embodiments, the implantable muscle interface device 102 includes a power source 116 that powers one or more of the first plurality of sensors 106, the first plurality of amplifiers 108, the wireless transceiver device 110, or the first plurality of electrodes 114. In some embodiments, one or more of the first plurality of sensors 106, the first plurality of amplifiers 108, the wireless transceiver device 110, or the first plurality of electrodes 114 are externally powered by an electromagnetic, ultrasonic, piezoelectric, or optical power source. FIG. 3 shows an example layout 300 for all these electronic components. The signals transmitted by the wireless transceiver device 110 may be analog signals multiplexed from multiple channels from the first plurality of sensors, or analog signals multiplexed from multiple channels from the first plurality of sensors and digitized with an analog-to-digital converter, or may be encrypted signals for secure communication.

[0017] The implanted muscle interface system 100 also includes a receiver device 118 that uses the decoded signal to interact with an external system 120. The receiver device 118 may include amplification components, filtering components, or both.

[0018] In some embodiments, external system 120 includes a prosthetic limb, a wheelchair, a computer, a mouse cursor, a household appliance, a remote controller, a gaming device, a mobile computing device, an audio device, an augmented reality system, a virtual reality system, or a human augmentation / augmentation device.

[0019] FIG. 4 illustrates a method 400 for controlling an external device using an implanted muscle interface device according to an embodiment of the present disclosure. The method 300 begins at 402 with obtaining signals from one or more sensors that detect electromyographic (EMG) signals representative of excitation or contraction of the underlying muscle. Returning to FIGS. 1 and 2 , one or more sensors, such as the first plurality of sensors 106, are deposited on, embedded within, or attached to a substrate, such as the first substrate 102 or the second substrate 202, that at least partially surrounds the underlying muscle. The first substrate 102 and the second substrate 202 of the implanted muscle interface device 102 may be composed of a biocompatible material, including a polymer, plastic, rubber, silicone, polyimide, perylene, polymer fiber, silk fibroin, 3D printing polymer, polyimide, polydimethylsiloxane (PDMS), metal, hydrogel, acellular scaffold, or a combination thereof. The first substrate 102 and the second substrate 202 may be composed of biocompatible polymers having deposited or embedded therein conductive electrodes and conductive traces, including biocompatible metals; conductive polymers; conductive carbon-based materials, including fibers, nanotubes, and graphene; gold, platinum, polypyrrole, poly(3,4-ethylenedioxythiophene) (PEDOT), or combinations thereof. The implantable muscle interface device 102 may be compatible with target tissues including muscles in various biological states, including vascularized-innervated, vascularized-non-innervated, non-vascularized-non-innervated, and non-vascularized-innervated muscles, or muscle grafts, including autografts, xenografts, allografts, syngrafts, cell cultures, or synthetic substitutes.

[0020] Method 400 continues at 404 with detecting the EMG signals with amplification and filtering electronics that transmit the EMG signals wirelessly via an implanted transceiver. Continuing with the embodiment described with reference to FIGS. 1 and 2 , the EMG signals are detected by a first plurality of sensors 106 and amplified by a first plurality of amplifiers 108. Method 400 continues at 404 with wirelessly receiving the EMG signals with an external receiver. Continuing with the same embodiment, wireless transceiver device 110 receives the EMG signals and wirelessly transmits them to receiver device 118. Method 400 continues at 406 with decoding the detected EMG signals using a decoding algorithm that converts the EMG signals into discrete control signals. Method 400 continues at 408 with using the discrete control signals to operate a device based on a machine learning algorithm that correlates the multiple control signals with a user's intent. For example, the device may include a prosthetic limb, a wheelchair, a computer, a mouse cursor, a household appliance, a remote controller, a gaming device, a mobile computing device, an audio device, an augmented reality system, a virtual reality system, or a human augmentation / augmentation device.

[0021] FIG. 5 illustrates a method 500 for using an implanted muscle interface system to control such an external device. In this example, EMG signals transmitted as a result of neuronal activity in the brachial plexus of an upper limb amputee are received by a receiver device 118 in the prosthetic arm. The signals are decoded to electronically reposition the hand. This method 500 may be a unidirectional forward-looking control system, as indicated at 502. Alternatively, this method 500 may be a two-way communication system with sensory feedback, as indicated at 504. In a two-way system, the implanted muscle interface device 102 has both a wireless transceiver 110 and a receiver for receiving signals from external sensors. These signals are encoded in the form of electrical stimuli and delivered to the nervous system through a first plurality of stimulating electrodes 114 or one or more ultrasound transducers.

[0022] 6 illustrates a method 600 for fitting an implantable muscle interface device according to an embodiment of the present disclosure. Method 600 begins with preparing the implantation site, as at 602. For example, preparing the implantation site may include elevating at least a muscle segment of the underlying muscle from surrounding tissue while remaining attached to a blood vessel providing perfusion; identifying a nerve innervating at least the muscle segment with electrical stimulation; dividing the identified muscle segment to ensure denervation; wrapping at least the muscle segment around the distal end of the proximal stump of a transected nerve or nerve bundle, or placing the distal end of the proximal stump of a transected nerve within a portion of the muscle; and securing the stump with sutures or fibrin glue.

[0023] Method 600 continues with securing the substrate to the implantation site, as shown at 604. The device incorporates suture holes and is secured to the tissue of interest and surrounding tissue bed with at least two sutures (at least four sutures total) at 180 degrees from each other on the proximal and distal ends of the device. These sutures may be secured to muscle, epineurium, perineurium, fascia, tendon, ligament, periosteum, etc. The tissue and location of attachment will vary depending on the anatomical needs of the individual patient. The tissue / device construct may then be encased within some type of protective biodegradable covering, including, but not limited to, bowel for xenografts, acellular wrap, or synthetic wrap. This is done to protect the device from fibrosis and tethering during the healing process. Returning again to FIGS. 1 and 2 , substrates such as first substrate 104 and second substrate 202 include one or more sensors, such as first plurality of sensors 106, that detect electromyographic (EMG) signals representative of underlying muscle movement. The substrate at least partially surrounds the underlying muscle. A wireless transceiver device, such as wireless transceiver device 110, is electrically connected to the one or more sensors and associated / interfacing electronics that wirelessly transmit the EMG signals to a receiver device 118 and / or an external controller, such as external system 120.

[0024] Figure 7 shows a prosthetic device controlled by multiple muscle units according to an embodiment of the present disclosure. Three muscle units 702 are shown in a residual limb 704, where each muscle unit includes a nerve 710 that innervates the muscle and a blood vessel 708 that serves the muscle's vascular pedicle. EMG signals are detected from each muscle unit using the device of Figures 1 or 2 and are amplified, filtered, powered, and wirelessly communicated by associated electronics 712 using a wireless communication module 714 to control the prosthetic device 706.

[0025] FIG. 8 illustrates a muscle-based controlled tactile sensor prosthetic orthosis according to an embodiment of the present disclosure. A muscle unit 702 is shown within a residual limb 704, where the muscle unit includes a nerve 710 that innervates the muscle and a blood vessel 708 that provides the muscle's vascular pedicle. EMG signals are detected from the muscle unit 702 using the device of FIG. 1 or 2 and are amplified, filtered, powered, and wirelessly communicated by associated electronics 802, which uses a wireless communication module 804 to control a tactile sensor prosthetic orthosis 812. A stimulating sensor 810 attached to the residual limb 704 provides sensory feedback for the user that is transmitted to a tactile sensor 808 on the tactile sensor prosthetic orthosis 812 and provided back at 806 by the wireless communication module 804 to the device of FIG. 1 or 2.

[0026] 9 shows the installation of the device of FIG. 1 or 2 onto a residual limb according to an embodiment of the present disclosure. A muscle unit 702 is shown in the residual limb 704, where the muscle unit includes a nerve 710 that innervates the muscle and a blood vessel 708 that provides the muscle's vascular pedicle.

[0027] 10 illustrates control signal processing based on EMG signals acquired by three separate EMG sensors, according to an embodiment of the present disclosure. Sensor 1002 shows EMG1 1004, which represents motor unit activity in muscle 1006 at electrode 1. Sensor 1010 shows EMG2 1012, which represents motor unit activity in muscle 1006 at electrode 2. Sensor 1014 shows EMG3 1016, which represents motor unit activity in muscle 1006 at electrode 3. Each of EMG1 1004, EMG2 1012, and EMG3 1016 is received by EMG electronics 1018 and decoded by decoding electronics 1020 to produce respective control signals 1022, 1024, and 1026. The control signals 1022, 1024, and 1026 are processed by a machine learning algorithm 1028 to control a controller 1030 embedded within a prosthetic limb 1032.

[0028] Figure 11A shows a top perspective view 1100 and Figure 11B shows a side view 1102 of an EMG unit according to an embodiment of the present disclosure. Electrodes 1104 are positioned with their ends in physical contact with muscles 1106. A hermetically sealed package 1108 contains electronics 1110 (silicon chips or circuitry) that are in electrical contact with the electrodes 1104.

[0029] 12 illustrates an EMG device with a flexible, metal electrode, carbon fiber, fiber mesh, or stretchable polymer electrode array 1200 according to an embodiment of the present disclosure. The flexible and stretchable polymer electrode array 1200 includes an array of electrodes 1202 encapsulated within a polymer material 1204 that is in physical contact with muscles 1206.

[0030] 13 illustrates an EMG device with a flexible and stretchable mesh electrode array 1300 according to an embodiment of the present disclosure. The flexible and stretchable mesh electrode array 1300 includes an array of electrodes 1202 encapsulated within a mesh material 1302 that is in physical contact with muscles 1206.

[0031] According to an embodiment of the present disclosure, a flexible wireless device is disclosed that wraps around one or more muscles of any type or size. The flexible wireless device may overlie the muscle, wrap around the entire circumference of the amputation stump, or be sutured or glued around the entire circumference of the amputation stump. The flexible wireless device may include a long electrode sheet that is implanted under the skin and over the underlying muscle. The electrode sheet is flexible and / or stretchable, allowing it to conform to any anatomical structure. As long as the end of the sheet containing the wireless power receiver remains within centimeters of the skin, as shown in Figures 14A, 14B, 14C, and 14D, for example, the remainder of the device can be configured to suit whatever the needs of the individual user. Instead of wrapping a flexible electrode sheet around a discrete piece of muscle with innervation and vascularity, the flexible electrode sheet may be implanted and wrapped around one or more muscles that may or may not be receiving direct manipulation. In this embodiment, the condition of the muscle is irrelevant. The device, which includes a flexible electrode sheet, can pick up any muscle signals generated within the body part in which it is implanted, regardless of whether or not there has been advanced surgical manipulation (muscle reinnervation).The device can conform to any anatomical structure to record electrical activity from the underlying muscle in a desired manner.

[0032] Figure 14A shows an arm with a dotted line 1402 depicting the amputation line. Figure 14B shows the amputation stump of Figure 14A with nerve fibers 1404, 1406, and 1408, along with a flexible wireless device 1410 wrapped around a piece of muscle with the nerve fibers implanted therein. Figure 14C shows a muscle segment 1412 that is responsive to activation of the implanted nerve fiber 1406 and has a connected blood supply 1414. Figure 14D shows the muscle segment of Figure 14C wrapped with a flexible wireless device 1414 (e.g., a nerve wrap). The muscle segment 1412 is activated by respective axonal signals, which are then detected by the flexible wireless device 1414. Wireless control signals are transmitted from the flexible wireless device 1414 to the prosthetic portion 1416 or from the flexible wireless device 1502 to the external link 1514; the external link 1514 can then relay the signals to the machine of interest (i.e., the prosthetic) 1416.

[0033] 18 illustrates a method for preparing an implantation site according to an embodiment of the present disclosure. The steps of preparing the implantation site include elevating at least a muscle segment of the underlying muscle from surrounding tissue while remaining attached to a blood vessel providing perfusion; identifying a nerve innervating the at least muscle segment with electrical stimulation; dividing the identified at least muscle segment to ensure denervation; wrapping the distal end of the proximal stump of a transected nerve or nerve bundle with the isolated at least muscle segment or placing the distal end of the proximal stump of a transected nerve within a portion of the muscle segment; and securing the proximal stump with sutures or fibrin glue.

[0034] 15 illustrates an example use of a flexible wireless device for both upper and lower limb prosthetics, according to an embodiment of the present disclosure. A top view 1504 and a bottom view 1506 of a flexible wireless device 1502 are shown. The top view 1504 shows an inductive power module 1508 (which may also take the form of some alternative means of power transmission, such as piezoelectric ultrasonic interfacing), and the bottom view 1506 shows recording electrodes 1510. The flexible wireless device 1502 surrounds a muscle 1512, where the recording electrodes 1510 detect signals from the muscle 1512. The flexible wireless device 1502 is powered by an external power link 1514, which may include (but is not limited to) a battery, a power transmitter, an ASIC, and an antenna, and the flexible wireless device 1502 wirelessly transmits data in the form of a wireless data stream 1516 to the external link 1514 or directly to a machine (i.e., prosthetics and orthotics for both upper and lower limbs) via commonly available data transmission mechanisms.

[0035] In some embodiments, there may be multiple implants placed within the body part of interest. For example, if one device is insufficient to cover the desired circumference of the amputation stump, multiple implants may be implanted to cover the required area. Again, the wireless receiver portion of the implant remains relatively close to the skin so that it can be powered or recharged through the skin and overlying tissue. Each device may be powered or recharged separately with its own external link, or together via a single overlying coil (or alternative power source, such as an ultrasound transducer).

[0036] 16 illustrates an example use of a flexible wireless device for a prosthetic hand, according to an embodiment of the present disclosure. A top view 1604, a bottom view 1606, and a side view 1608 of a flexible wireless device 1602 are shown. The top view 1604 and the side view 1608 show a transceiver and battery module 1610, and the bottom view 1606 and the side view 1608 show recording electrodes 1612. The flexible wireless device 1602 surrounds a muscle 1614, where the recording electrodes 1612 detect signals from the muscle 1614. The flexible wireless device 1602 is either actively powered or recharged by the transceiver and battery module 1610, and the flexible wireless device 1602 wirelessly transmits data in the form of a wireless data stream from a wireless transmission module 1616. The flexible wireless device may be primarily powered continuously through transcutaneous induction means, or may be intermittently recharged through transcutaneous induction means (or some reasonable alternative power scheme). As shown in FIG. 16, there are two separate flexible wireless devices, each surrounding a different muscle cluster. This is by way of a non-limiting example only. For example, there may be only one flexible wireless device, or more than two, depending on the use case applied to each user based on their needs, e.g., their individual anatomy, such as the particular limb and level of amputation, and their functional needs for limb (or other technology) control.

[0037] The flexible wireless device, as disclosed herein, may be implanted in a healthy, robust (uninjured) individual. The flexible wireless device may be implanted under the skin and connective tissue, around a muscle compartment. The flexible wireless device may then record signals from the underlying healthy muscle and wirelessly relay them outside the body for a desired purpose. The flexible wireless device may be implanted on or around any muscle in the body, depending on the desired use case.

[0038] Flexible wireless devices may operate using an external powered link / hardware held in place via a percutaneous (across the skin) magnetic or radio frequency (wireless) linkage as disclosed herein. The external link may also be held in place via an adhesive film, a sleeve of compression material, clothing, or any other means of securing an external object to a desired location on the body. The implanted device may transmit data wirelessly (such as Bluetooth) to the external powered link on the surface of the body. (registered trademark) or some other means). The external powered link may then wirelessly relay the information to any synchronized device (phone, prosthetic, orthotic, exoskeleton, etc.). The implanted device may also wirelessly relay information directly to the synchronized device without the powered link as an intermediary. In some embodiments, some form of data processing may occur within the external powered link before data transmission to the synchronized device. The implanted system and the external powered link may switch independently or as a unit to which device they are synchronized based on the user's desires.

[0039] As disclosed herein, implantable devices (e.g., flexible wireless devices) may also deliver electrical current into underlying tissue via electrodes present on the device's surface. These electrodes may be either the same electrodes used to record muscle signals or different electrodes incorporated into the device specifically for stimulation. The goal of stimulation is to induce afferent (brain-directed) neural activity to treat pain or generate sensation. Excitation of afferent neural activity may be achieved via ultrasonic or electrical means. Miniature ultrasound transducers may be placed on the surface of the flexible implant, much like electrodes, and may deliver ultrasonic energy into the underlying tissue to achieve the same effect as electrical stimulation. Electrical / ultrasonic stimulation may be focused or targeted to discrete locations based on the desired end effect. This may be achieved via stimulation parameter modulation and spatiotemporal multi-source modulation.

[0040] FIG. 17 shows one or more flexible wireless devices implanted on the internal muscles of either an arm 1702 or leg 1704 of a healthy, strong individual that may be used to wirelessly control a machine / device such as an exoskeleton 1706.

[0041] The foregoing description is illustrative, and variations in configurations and embodiments may occur to those skilled in the art. For example, various illustrative logic, logic blocks, modules, and circuits described in connection with aspects disclosed herein may be implemented or performed by a general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), a cryptographic coprocessor, or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof, designed to perform the functions described herein. A general-purpose processor may be a microprocessor, but alternatively, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, such as, for example, a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in combination with a DSP core, or any other such configuration.

[0042] In one or more exemplary aspects, the functions described herein may be implemented in hardware, software, firmware, or any combination thereof. For software embodiments, the techniques described herein may be implemented with modules (e.g., procedures, functions, subprograms, programs, routines, subroutines, modules, software packages, classes, etc.) that perform the functions described herein. A module may be coupled to another module or a hardware circuit by passing and / or receiving information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, etc. may be passed, forwarded, or transmitted using any suitable means, including memory sharing, message passing, token passing, network transmission, etc. Software code may be stored in a memory unit and executed by a processor. The memory unit may be implemented within the processor or external to the processor, in which case it may be communicatively coupled to the processor via various means as is known in the art.

[0043] In one or more exemplary aspects, the functions described herein may be implemented in hardware, software, firmware, or any combination thereof. For software embodiments, the techniques described herein may be implemented with modules (e.g., procedures, functions, subprograms, programs, routines, subroutines, modules, software packages, classes, etc.) that perform the functions described herein. A module may be coupled to another module or a hardware circuit by passing and / or receiving information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, etc. may be passed, forwarded, or transmitted using any suitable means, including memory sharing, message passing, token passing, network transmission, etc. Software code may be stored in a memory unit and executed by a processor. The memory unit may be implemented within the processor or external to the processor, in which case it may be communicatively coupled to the processor via various means as is known in the art.

Claims

1. a first plurality of sensors and a second plurality of amplifiers for respectively capturing and amplifying electromyographic (EMG) signals arising from muscle units under the control of neural signals representative of voluntary limb movement, the first plurality of sensors including an extendable mesh electrode array; a wireless transceiver device electrically connected to the first plurality of sensors for wirelessly transmitting signals to an external decoder that generates decoded signals that discriminate movement signals representative of the muscle unit movement; a substrate at least partially surrounding the muscle from which the EMG signals originate; and Receiver device using the decoded signal to interact with an external system An implantable muscle interface system comprising:

2. 10. The implantable muscle interface system of claim 1, wherein the substrate is flexible, stretchable, rigid, or semi-rigid.

3. 3. The implantable muscle interface system of claim 1 or 2, wherein the receiver device comprises an amplification component, a filtering component, a wireless communication component, or a combination thereof.

4. 4. The implantable muscle interface system of any one of claims 1 to 3, wherein the substrate, the first plurality of sensors, the second plurality of amplifiers, and the wireless transceiver device are enclosed within a single hermetically sealed container or encapsulating coating.

5. 5. The implantable muscle interface system of claim 1, further comprising a power source that powers the first plurality of sensors, the second plurality of amplifiers, and the wireless transceiver device.

6. 6. The implantable muscle interface system of claim 5, wherein the substrate, the first plurality of sensors, the second plurality of amplifiers, the wireless transceiver device, and the power source are enclosed within a single hermetically sealed container or encapsulating coating.

7. 7. The implantable muscle interface system of any one of claims 1 to 6, wherein the first plurality of sensors, the second plurality of amplifiers, and the wireless transceiver device are externally powered by an electromagnetic, ultrasonic, piezoelectric, or optical power source.

8. 8. The implantable muscle interface system of any one of claims 1 to 7, wherein the signals transmitted by the wireless transceiver device are analog signals multiplexed from multiple channels from the first plurality of sensors, or analog signals multiplexed from multiple channels from the first plurality of sensors and digitized with an analog-to-digital converter, or encrypted signals for secure communication.

9. 9. The implantable muscle interface system of any one of claims 1 to 8, wherein the substrate is composed of a biocompatible material including a polymer, parylene polyimide, plastic, rubber, silicone, polymer fiber, silk fibroin, 3D printing polymer, polyimide, polydimethylsiloxane (PDMS), metal, hydrogel, or an acellular scaffold.

10. Biocompatible metals; conductive polymers; conductive carbon-based materials, including fibers, nanotubes, and graphene; and biocompatible polymers having conductive electrodes and conductive traces deposited or embedded therein, including gold, platinum, polypyrrole, poly(3,4-ethylenedioxythiophene) (PEDOT), poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), or combinations thereof.

10. The implantable muscle interface system of claim 1, wherein the substrate is composed of

11. 11. The implantable muscle interface system of any one of claims 1 to 10, wherein the external system comprises a prosthetic limb, an orthosis, an exoskeleton, a computer, a household appliance, a remote controller, a gaming device, a mobile computing device, an acoustic device, an augmented reality system, a virtual reality system, or a human augmentation / augmentation device.

12. Muscles in a variety of biological states, including unchanged, vascularized-innervated, vascularized-deinnervated, nonvascularized-deinnervated, and nonvascularized-innervated muscles; or Muscle grafts, including autografts, xenografts, allografts, syngeneic grafts, cell cultures, or synthetic substitutes 12. The implantable muscle interface system of any one of claims 1 to 11, which is compatible with a target tissue comprising:

13. 13. The implantable muscle interface system of any one of claims 1-12, wherein the substrate comprises a first plurality of stimulating electrodes or ultrasound transducers that provide electrical or ultrasonic stimulation to underlying sensory axons for sensory feedback from a prosthetic limb or exoskeleton.

14. A method of controlling an external device with an implanted muscle interface device, comprising: obtaining signals from one or more sensors that detect electromyographic (EMG) signals representative of excitation or contraction of the underlying muscle, the one or more sensors comprising an expandable mesh electrode array and deposited or embedded within a substrate that at least partially surrounds the underlying muscle; detecting the EMG signal with amplification and filtering electronics that transmits the EMG signal wirelessly via an implanted transceiver; wirelessly transmitting the EMG signals by an implanted transceiver; wirelessly receiving the EMG signal by an external receiver; decoding the detected EMG signals using a decoding algorithm that converts the EMG signals into discrete control signals; and Using the isolated control signals to operate a device based on a machine learning algorithm that correlates the control signals with a user's intent.

15. 15. The method of claim 14, wherein the substrate is composed of a biocompatible material including a polymer, plastic, rubber, silicone, polymer fiber, silk fibroin, 3D printing polymer, polyimide, polydimethylsiloxane (PDMS), metal, hydrogel, or an acellular scaffold.

16. Biocompatible metals; conductive polymers; conductive carbon-based materials, including fibers, nanotubes, and graphene; and biocompatible polymers having conductive electrodes and conductive traces deposited or embedded therein, including gold, platinum, polypyrrole, poly(3,4-ethylenedioxythiophene) (PEDOT), or combinations thereof.

16. The method of claim 14 or 15, wherein the substrate is composed of

17. 17. The method of any one of claims 14-16, wherein the external device comprises a prosthetic limb, an orthosis, an exoskeleton, a computer, a household appliance, a remote controller, a gaming device, a mobile computing device, an acoustic device, an augmented reality system, a virtual reality system, or a human augmentation / augmentation device.

18. Implantable muscle interface devices Muscles in a variety of biological states, including unchanged, vascularized-innervated, vascularized-deinnervated, nonvascularized-deinnervated, and nonvascularized-innervated muscles; or Muscle grafts, including autografts, xenografts, allografts, syngeneic grafts, cell cultures, or synthetic substitutes 18. The method of any one of claims 14 to 17, wherein the method is compatible with a target tissue comprising:

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