Systems and methods for the remaining limb of an amputee.

Abstract

Various aspects of the present disclosure relate to a prosthetic limb cover comprising a sensor array that transmits signals to an electrode array in a liner fitted over the remaining limb of an amputee. Various interactions with the prosthetic limb cover result in various activations of the electrodes, transmitting currents through different regions of the remaining limb and modulating neurons in the remaining limb in various ways. Various aspects of the present disclosure also relate to a prosthetic limb liner comprising a substrate containing electrodes for transcutaneous electroneurostimulation and / or electromuscular stimulation of the remaining limb.

Description

Technical Field

[0005] ,

[0006] ,

[0001] (Cross - References to Related Applications) This patent application claims priority to U.S. Patent Application No. 18 / 510337, filed Nov. 15, 2023, and U.S. Patent No. 18 / 296970, filed Apr. 6, 2023, all of which are hereby incorporated by reference in their entirety.

Background Art

[0002] Amputees are frequently troubled by phantom limb syndrome, which involves experiencing sensations resulting from the missing limbs. These sensations are generally not desirable, often accompanied by pain, and in some cases, debilitating.

[0003] Phantom limb syndrome can sometimes be treated by mirror therapy. When a mirror is placed between the healthy limb and the missing limb, the mirror provides a visual representation of the missing limb. When the patient moves the healthy limb, it appears as if both limbs are moving simultaneously. This provides the patient with a visual representation of the missing limb and, after repeated treatment, affects the patient's perception of feeling the missing limb. However, clinical studies on mirror therapy have not demonstrated a statistically significant effect on pain reduction.

[0004] Another non - pharmacological intervention for reducing the symptoms of phantom limb syndrome has remained desired.

Summary of the Invention

Means for Solving the Problems

[0005] Various aspects of the present disclosure relate to the discovery that neural feedback from the interaction with a prosthetic limb and / or a prosthetic liner can help alleviate the symptoms of phantom limb syndrome. [[ID=​Some embodiments relate to a prosthetic cover equipped with a sensor array, which transmits signals to an electrode array in a liner fitted over the amputee's remaining limb. Various interactions with the prosthetic cover produce various activations of the electrodes, transmitting currents through different regions of the remaining limb and modulating neurons within the remaining limb in various ways. Thus, the amputee can interact with the prosthesis by touching the cover, observing its interaction, and modulating various neurons in response to the touch. Without limiting the claims arising from this specification or this disclosure, simultaneous sensory feedback from touch, vision, and electrical currents effectively induces neuroplasticity in the somatosensory cortex of the amputee's brain, generating a new topographic map of the prosthesis through repeated interactions, which alleviates the symptoms of phantom limb syndrome. Without limiting the claims arising from this specification or this disclosure, the new topographic map allows the amputee to associate specific symptoms of phantom limb syndrome with specific interactions with the prosthetic cover, thereby enabling the amputee to treat specific symptoms that arise through specific interactions.

[0007] Various aspects of this disclosure include systems and methods comprising a prosthetic liner configured for electrical communication (e.g., electrical stimulation) with a surviving limb of an amputee. In some embodiments, the system is a system for modulating neural activity or muscle stimulation in the surviving limb. In some specific embodiments, the system is a system for stimulating Aβ nerve fibers in the surviving limb.

[0008] In some embodiments, the system includes a prosthetic liner, or a substrate (or insert) incorporated into the prosthetic liner, which houses electrodes. In some embodiments, the prosthetic liner may be molded (e.g., overmolded, insert molded) onto the substrate.

[0009] The substrate may include electrodes embedded in the substrate or liner, or otherwise incorporated. In some specific embodiments, the substrate is a polymer (e.g., silicone).

[0010] In some embodiments, the substrate may include a conductor. In some embodiments, the conductor may be a plurality of wires at least partially incorporated into the substrate. In some embodiments, the conductor may be a conductive material (e.g., an elastomer).

[0011] In some embodiments, a system for regulating neural activity in the remaining limb of an amputee comprises a prosthetic liner with a polymer substrate including electrodes, The prosthetic liner is configured to receive the remaining limb, Each electrode within the polymer substrate is electrically connected to the remaining limbs. The electrodes are configured to stimulate the Aβ nerve fibers of the remaining limb by transmitting an electric current through the remaining limb using an electrode controller that is electrically connected to each electrode.

[0012] In some embodiments, an amputee exhibits phantom limb syndrome, and the system is configured so that an electric current treats one or more symptoms of phantom limb syndrome.

[0013] In some embodiments, the electrodes have a three-dimensional electrode configuration relative to the liner. A three-dimensional configuration is any configuration in which two or more electrodes form a ring around the remaining limb. In some embodiments, the plurality of electrodes are configured in a ring shape including at least two electrodes spaced apart within the liner to transmit current to various locations on the remaining limb. In some embodiments, the plurality of electrodes include electrodes A, B, C, and D. In some embodiments, the controller transmits electricity from electrode A through the remaining limb to both electrodes B and D. In some embodiments, the plurality of electrodes include an anterior-proximal electrode, an anterior-distal electrode, an lateral-proximal electrode, and an lateral-distal electrode. In some embodiments, the plurality of electrodes include an anterior-lateral-proximal electrode, a posterior-lateral-proximal electrode, a posterior-inside-proximal electrode, and an anterior-inside-proximal electrode. In some embodiments, the configuration does not surround the remaining limb. In some embodiments, the current is a pulsed current. The pulsed current may have a pulse frequency of at least 20 pulses / second and up to 180 pulses / second, a pulse width of up to 100 microseconds, and an amplitude of up to 100 milliamperes.

[0014] In some embodiments, the system includes a secondary controller wirelessly communicating with the electrodes, configured to transmit current from one or more electrodes to the remaining limbs. The secondary controller may also be a mobile computer device wirelessly communicating with the electrodes, and the wireless communication is mediated by either or both a Bluetooth connection or a Wi-Fi connection between the mobile computer device and the electrodes.

[0015] In some embodiments, the method includes regulating neural activity in the remaining limb of an amputee. A step of preparing a system with a prosthetic limb liner, wherein the prosthetic limb liner includes a polymer substrate having a plurality of electrodes that are in electrical communication with an electrode controller, and is configured to be attached to the remaining limb so that the plurality of electrodes are in electrical communication with the remaining limb; The steps include: transmitting current via the remaining limbs using an electrode controller that is electrically connected to each electrode; The procedure may also include the step of stimulating Aβ nerve fibers in the remaining limb in response to the transmission of electric current using multiple electrodes.

[0016] In some embodiments, the method includes the step of stimulating the muscles of the remaining limb in response to the transmission of an electric current using multiple electrodes. Amputees may exhibit phantom limb syndrome, and the method further includes the step of treating one or more symptoms of phantom limb syndrome using the transmission of an electric current. One or more symptoms of phantom limb syndrome are further treated by applying an electric current.

[0017] In some embodiments, the method includes the step of transmitting a pulsed current having a pulse frequency of at least 20 pulses / second and up to 180 pulses / second, a pulse width of up to 100 microseconds, and an amplitude of up to 100 milliamperes.

[0018] In some embodiments, the method includes the step of transmitting current to the remaining limb using a secondary controller that wirelessly communicates with an electrode controller.

[0019] In some embodiments, the system includes regulating neural activity in the remaining limb of an amputee. A user interface configured to receive input from amputees and display output, Processor and A memory that electronically communicates with the processor, Instructions stored in memory and executable by a processor, provided for the device, a) Transmitting current through the remaining limb using an electrode controller that is electrically connected to electrodes in the prosthetic limb liner substrate, and b) Stimulating the Aβ nerve fibers of the remaining limb in response to the transmission of current using electrodes, It includes an instruction to execute and

[0020] In some embodiments, the disclosed technology is In the processor, a) Using an electrode controller in electrical communication with an electrode within a prosthetic liner substrate to transmit current through the residual limb of an amputee, and b) Stimulating Aβ nerve fibers of the residual limb in response to transmitting current using the electrodes, comprises a non - transient computer - readable medium including instructions to cause the execution of. The processor further detects physiological parameters using at least one sensor, measures physiological data from the physiological parameters, stores the measured physiological data, processes the measured physiological data, and may be configured to provide an output to a user or another computer device in response to processing the measured physiological data.

[0021] Various other aspects of the invention of the present disclosure will become apparent upon consideration of the following detailed description and claims. The scope of the present disclosure should not be limited by the above summary and background. The scope of each patent claim arising from the present disclosure should not be limited by the above summary and background or the following detailed description, but instead the scope of each patent claim arising from the present disclosure should be limited only by the explicit language of the claim in the context of its dependency relationship.

Brief Description of the Drawings

[0022] [Figure 1] Shows a system comprising a liner including an embedded electrode array and a prosthetic cover including an array of sensors. [Figure 2] Shows a substrate and a mold for manufacturing the liner. [Figure 3] Shows the substrate and the electrode controller. [Figure 4] Shows a housing for housing the liner and the electrode controller. [Figure 5] Shows the liner and housing of FIG. 4 partially transparent, with the substrate and electrode controller visible. [Figure 6] This shows an exploded view of a cover designed to be worn over a prosthetic limb. [Figure 7] Figure 6 shows the cover in its assembled state without the outer surface. [Figure 8] Figures 6 and 7 show the cover in its assembled state without the outer surface; the outer layer is semi-transparent, the spacers are transparent, and the sensors and sensor controllers underneath are visible. [Figure 9] Figure 3 shows the substrate and electrode controller, and the cover partially assembled according to Figures 6-8. [Figure 10] This flowchart shows how to support and demonstrate system usage. [Figure 11] This disclosure shows a device supporting a residual limb electrical stimulation system and method according to aspects of this disclosure. [Modes for carrying out the invention]

[0023] The disclosed technology includes a system and method for treating phantom limb syndrome by treating the symptoms of phantom limb pain and increasing proprioceptive sensation of a prosthesis in an amputee.

[0024] After limb amputation surgery, amputees may report the perception of sensation in the missing limb, known as phantom limb sensation (PLS). In some cases, they may experience pain or discomfort in the missing limb, known as phantom limb pain (PLP). In extreme cases, PLP can lead to debilitation.

[0025] Various aspects of this disclosure relate to a prosthetic (prosthesis) cover including a sensor array, which transmits signals to an electrode array in a liner fitted to the remaining limb of an amputee. Different interactions with the prosthetic cover result in different activations of the electrodes, transmitting currents to different regions within the remaining limb and differently modulating neurons within the remaining limb. As a result of the interaction with the prosthetic cover, electrical stimulation of underlying nerve fibers provides the amputee with the ability to feel the stimulation. This stimulation can evoke somatosensation alone or in combination with other PLP therapeutic applications (e.g., artificial visualization such as mirror therapy). As a result, the amputee may perceive the missing limb as intact and / or functional, potentially reducing or eliminating PLP.

[0026] In some embodiments, interaction with the prosthetic cover is any interaction, event, or modality detected by a sensor that causes the electrode to activate. In some embodiments, the modality is a tactile modality such as touch, force, pressure, flutter, or vibration.

[0027] Various aspects of this disclosure relate to systems for use by amputees. In some embodiments, the systems are for regulating neural activity in the amputee's remaining limb.

[0028] In some embodiments, the system comprises a prosthetic liner or substrate within a liner equipped with electrodes. The substrate may be incorporated into the liner. In some specific embodiments, the system comprises a prosthetic liner or substrate including an electrode array. In even more specific embodiments, the system comprises a liner or substrate including an embedded electrode array. The liner or substrate generally comprises or consists of a non-conductive polymer, such as silicone.

[0029] In some embodiments, the system comprises an electrode array. In some specific embodiments, the system comprises an electrode array embedded in a liner. The electrode array may be embedded in, for example, a silicone liner. Medical-grade electrodes capable of conducting a pulsed current of at least 30 milliamperes are generally suitable for use with the systems and methods described herein. In some specific embodiments, the electrodes are suitable for electromuscular stimulation. In some specific embodiments, the electrodes are suitable for transcutaneous electronervous stimulation. In some specific embodiments, the electrodes are suitable for both electromuscular stimulation and transcutaneous electronervous stimulation. In some even more specific embodiments, the electrodes are carbon rubber electrodes.

[0030] The electrodes of this disclosure are generally suitable for continuous and prolonged contact with human skin, which may be mediated by a conductive gel as needed. In some embodiments, continuous and prolonged contact refers to continuous contact for at least 2 hours. In some specific embodiments, continuous and prolonged contact refers to continuous contact for at least 12 hours. In some even more specific embodiments, continuous and prolonged contact refers to continuous contact for at least 48 hours.

[0031] In some embodiments, the liner or substrate within the liner is a single, integrated structure. In some specific embodiments, the liner or substrate within the liner is a single, integrated structure with an electrode array embedded within it. In some even more specific embodiments, the liner or substrate within the liner is a single, integrated structure with an electrode array and wires embedded within it, where each electrode in the electrode array is connected to at least one wire, so that the wire can mediate electrical communication between the electrode array and the electrode controller. The electrodes may include, for example, 2 mm pin connectors for generating electrical communication between the electrodes and the wires. The liner may be formed, for example, by preparing a substrate containing electrodes and wires, inserting the substrate into a mold, pouring liquid silicone into the mold, and embedding the electrodes and wires within the silicone.

[0032] The liner or substrate within the liner is generally configured to receive the surviving limb of an amputee. In some specific embodiments, the liner or substrate within the liner is configured to receive the surviving limb and to allow each electrode in an electrode array to be in electrical communication with the surviving limb. For example, a conductive gel can be applied between the electrodes of the electrode array and the surviving limb to facilitate electrical communication between the electrodes and the surviving limb.

[0033] The Disclosure and Claims should not be construed as implying that the Systems of the Disclosure and Claims include amputees, surviving limbs, nerve fibers, etc. (except where express language states that the Systems comprise amputees, surviving limbs, nerve fibers, etc.). And where any express language states that the Systems comprise amputees, surviving limbs, nerve fibers, etc., that express language should be limited to its immediate context and should not be used to interpret any other section of the Disclosure that lacks such express language, or to interpret any patent claim arising from the Disclosure that lacks such express language.

[0034] In some embodiments, each electrode in the electrode array is paired with at least two other electrodes in the electrode array, so that when the electrode array is electrically connected to the remaining limb, each electrode can (1) transmit current via the remaining limb to both a first negative electrode with which it is paired and, independently, to a second negative electrode with which it is paired, and / or (2) receive current via the remaining limb to both a first positive electrode with which it is paired and, independently, to a second positive electrode with which it is paired. In such embodiments, each electrode in the electrode array can transmit current via at least two other electrodes and / or receive current from at least two other electrodes, for example, in response to different sensors and / or to differentially modulate nerve fibers in the remaining limb, providing different paths for current flowing through the remaining limb.

[0035] In some embodiments, the system is configured such that (1) when two or more electrodes are driven, and (2) when two or more electrodes are in electrical communication with a remaining limb, one of the two or more driven electrodes transmits current through the remaining limb, and the other of the two or more driven electrodes receives the current transmitted through the remaining limb. In some specific embodiments, the system is configured such that (1) when two electrodes are driven, and (2) when two electrodes are in electrical communication with a remaining limb, one of the two driven electrodes transmits current through the remaining limb, and the other of the two driven electrodes receives the current transmitted through the remaining limb. An electrode is driven when it is transmitting or receiving current.

[0036] In some embodiments, the system includes an electrode controller that is in electrical communication with each electrode of the electrode array.

[0037] In some embodiments, the electrode controller is configured to control whether each electrode capable of transmitting current transmits current to the negative electrode. In some embodiments, the electrode controller is configured to control whether each electrode capable of receiving current receives current from the positive electrode. In some specific embodiments, the electrode controller is configured to control both whether each electrode capable of transmitting current transmits current to the negative electrode, and whether each electrode capable of receiving current receives current from the positive electrode. Thus, the electrode controller can control which electrodes in the electrode array transmit and receive current, for example, in response to different sensors and / or to transmit current to different regions of a remaining limb.

[0038] In some embodiments, the electrode controller is configured to control whether each electrode capable of transmitting current transmits current to one or both of the first and second negative electrodes through the remaining limbs. In some embodiments, the electrode controller is configured to control whether each electrode capable of receiving current can receive current from one or both of the first and second positive electrodes. In some specific embodiments, the electrode controller is configured to control both whether each electrode capable of transmitting current transmits current to one or both of the first and second negative electrodes through the remaining limbs, and whether each electrode capable of receiving current receives current from one or both of the first and second positive electrodes.

[0039] In some embodiments, the electrode controller controls the current transmitted or received by each electrode in the electrode array.

[0040] In some embodiments, the system is configured to modulate nerve fibers within the remaining limb by transmitting and receiving electrical currents through the remaining limb. In some specific embodiments, the system is configured to stimulate nerve fibers in the remaining limb by transmitting and receiving electrical currents through the remaining limb. In some even more specific embodiments, the system is configured to stimulate myelinated Aβ nerve fibers in the remaining limb by transmitting and receiving electrical currents through the remaining limb. In some even more specific embodiments, the system is configured to modulate the activation of myelinated Aδ nerve fibers in the remaining limb by transmitting and receiving electrical currents through the remaining limb. In some even more specific embodiments, the system is configured to modulate the activation of unmyelinated C nerve fibers in the remaining limb by transmitting and receiving electrical currents through the remaining limb.

[0041] In some embodiments, the electrode array is configured to modulate nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb. In some specific embodiments, the electrode array is configured to stimulate nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb. In some even more specific embodiments, the electrode array is configured to stimulate myelinated Aβ nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb. In some even more specific embodiments, the electrode array is configured to modulate the activation of myelinated Aδ nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb. In some even more specific embodiments, the electrode array is configured to modulate the activation of unmyelinated C nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb.

[0042] In some embodiments, each electrode in the electrode array is configured to modulate nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb. In some further embodiments, each electrode in the electrode array is configured to stimulate nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb. In some even more specific embodiments, each electrode in the electrode array is configured to stimulate myelinated Aβ nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb. In some even more specific embodiments, each electrode in the electrode array is configured to modulate the activation of myelinated Aδ nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb. In some even more specific embodiments, each electrode in the electrode array is configured to modulate the activation of unmyelinated C nerve fibers in the remaining limb by transmitting and receiving electric current through the remaining limb.

[0043] In some embodiments, the current is a pulsed current.

[0044] In some embodiments, the pulse current has a pulse frequency of at least 2 pulses / second and up to 200 pulses / second. In some specific embodiments, the pulse current has a pulse frequency of at least 20 pulses / second and up to 180 pulses / second. In some even more specific embodiments, the pulse current has a pulse frequency of at least 135 pulses / second and up to 155 pulses / second.

[0045] In some embodiments, the pulsed current has a pulse width of up to 400 microseconds. In some specific embodiments, the pulsed current has a pulse width of up to 100 microseconds. In some even more specific embodiments, the pulsed current has a pulse width of up to 50 microseconds.

[0046] In some embodiments, the pulsed current has an amplitude of up to 150 milliamperes. In some specific embodiments, the pulsed current has an amplitude of up to 100 milliamperes. In some even more specific embodiments, the pulsed current has an amplitude of at least 10 milliamperes and up to 30 milliamperes.

[0047] In some embodiments, the electrode array comprises at least 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, 128, or 256 electrodes. In some specific embodiments, the electrode array comprises at least 8 and up to 512 electrodes. In some specific embodiments, the electrode array comprises 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, 128, 256, or 512 electrodes. In some more specific embodiments, the electrode array comprises 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, 128, 256, or 512 electrodes, and the system comprises several additional electrodes not included in the electrode array.

[0048] In some embodiments, the system comprises one or more electrodes not included in the electrode array. These one or more electrodes not included may, for example, be electrodes not used for transmitting current to and / or receiving current from the remaining limbs, or electrodes that a potential infringer of one or more claims arising from this disclosure might envision including in the system in an attempt to develop a non-infringement legal theory.

[0049] In some embodiments, the system includes a cover. In some specific embodiments, the system includes a cover configured to receive a prosthesis. In some even more specific embodiments, the system includes a cover configured to receive a leg or arm prosthesis.

[0050] In some embodiments, the system lacks a prosthesis. Unless express language states that the system includes a prosthesis, the claims of this disclosure or the claims of this disclosure should not be construed as implying that the system includes a prosthesis, and where express language states that the system includes a prosthesis, such express language should be limited to its immediate context and should not be used to interpret other sections of this disclosure that lack such express language, or to interpret patent claims arising from this disclosure that lack such express language.

[0051] In some embodiments, the system includes a prosthetic limb.

[0052] In some embodiments, the cover is configured to cover the outer surface of the prosthesis.

[0053] In some embodiments, the system comprises a polymer foam. In some specific embodiments, the system comprises a polyurethane foam. In some even more specific embodiments, the system comprises a two-component polyurethane expandable foam.

[0054] In some embodiments, the foam is configured to adhere the cover to the prosthesis. In some specific embodiments, the foam is configured to fill the gap between the cover and the prosthesis. In some even more specific embodiments, the foam is configured to adhere the cover to the prosthesis and to fill the gap between the cover and the prosthesis.

[0055] In some embodiments, the foam comes into contact with the inner surface of the cover. In some specific embodiments, the foam comes into contact with the inner surface of the cover to adhere the cover to the prosthesis. In some even more specific embodiments, the foam comes into contact with the inner surface of the cover to adhere the cover to the prosthesis and fill the gap between the cover and the prosthesis.

[0056] In some embodiments, the system comprises a polymer foam, and the cover is attached to the prosthesis using the polymer foam. In some specific embodiments, the system comprises a polyurethane foam, and the cover is attached to the prosthesis using the polyurethane foam. In some even more specific embodiments, the system comprises a two-component polyurethane expandable foam, and the cover is attached to the prosthesis using the two-component polyurethane expandable foam. The cover may be attached to the prosthesis by, for example, positioning the cover around the prosthesis and inserting the expandable foam between the cover and the prosthesis to fill the gap between the cover and the prosthesis. This allows the cover to be attached to prostheses of various shapes and sizes.

[0057] In some embodiments, the foam (or its components) is provided in one or more containers. In some specific embodiments, the foam (or its components) is provided in one or more containers for the purpose of attaching a cover to a prosthesis. In some even more specific embodiments, the foam (or its components) is provided in one or more containers for the purpose of attaching a cover to a prosthesis by inserting the foam (or its components) between the cover and the prosthesis and filling the gap between the cover and the prosthesis.

[0058] In some embodiments, the system comprises one or more containers for containing inflatable foam. In some specific embodiments, the system comprises one or more containers, which are bags, for containing the inflatable foam. The inflatable foam may be provided, for example, in one or more containers, which are bags, and the inflatable foam may be inflated inside one or more bags, with one or more bags positioned between the prosthesis and the cover, to fill the gap between the prosthesis and the cover, thereby adhering the cover to the prosthesis. Thus, one or more bags can be used, for example, to hold the inflatable foam in the gap between the prosthesis and the cover, and / or to prevent the inflatable foam from entering the gap in the prosthesis or cover, and / or to prevent the inflatable foam from coming out of the cover.

[0059] In some embodiments, the system includes one or more straps for attaching the cover to the prosthesis. The straps can be used, for example, to position the cover relative to the prosthesis before inflating the foam in the gap between the prosthesis and the cover.

[0060] In some embodiments, the cover includes a sensor array.

[0061] In some embodiments, each sensor in the sensor array is configured to detect at least one modality (e.g., force and / or pressure). Each sensor may be, for example, a force-sensing resistor.

[0062] In some embodiments, each sensor in the sensor array comprises a resistor configured to detect at least one modality (e.g., force and / or pressure). The exact type of modality sensor is not limited.

[0063] In some embodiments, the system is configured such that the amplitude of the current transmitted and received by the electrodes of the electrode array via the remaining limb directly correlates with a modality (e.g., pressure or force) detected by a sensor, for example, an increased modality (e.g., increased pressure or increased force) correlates with an increased amplitude.

[0064] In some embodiments, the electrode array communicates with a sensor array, so that two or more electrodes are activated in response to detection by one or more sensors. In some specific embodiments, the electrode array communicates with a sensor array, so that two electrodes are activated in response to detection by one sensor.

[0065] In some embodiments, each sensor corresponds to at least two electrodes. In some specific embodiments, each sensor corresponds to two electrodes.

[0066] In some embodiments, each electrode corresponds to at least one sensor. In some specific embodiments, each electrode corresponds to at least two sensors.

[0067] When a sensor detects a modality (e.g., force or pressure) and the electrode is electrically connected to the remaining limb, the sensor is considered to correspond to the electrode if the electrode is connected to the electrode in such a way that it transmits or receives current from the remaining limb.

[0068] When a sensor detects a modality (e.g., force or pressure) and the electrode is electrically connected to the remaining limb, the electrode is considered to correspond to the sensor if the sensor is connected to the electrode in such a way that the electrode transmits current to or receives current from the remaining limb.

[0069] In some embodiments, the sensor array has a three-dimensional sensor configuration relative to the cover.

[0070] In some embodiments, when a cover is attached to the outer surface of the prosthesis, the sensor array has a three-dimensional sensor configuration relative to the outer surface of the prosthesis.

[0071] In some embodiments, the electrode array has a three-dimensional electrode configuration relative to the liner.

[0072] In some embodiments, the electrode array has a three-dimensional electrode configuration with respect to the remaining limb when each electrode is in electrical communication with the remaining limb.

[0073] In some embodiments, each sensor has a sensor relative position in a sensor 3D configuration with respect to all other sensors in a sensor array, and each electrode has an electrode relative position in an electrode 3D configuration with respect to all other electrodes in an electrode array, and the system comprises sensor electrode pairs, each consisting of one or more sensors and two or more electrodes, where these sensors and electrodes correspond to each other, and the sensor relative position of each sensor in the sensor electrode pair in a sensor 3D configuration correlates with the electrode relative position of each electrode in the same sensor electrode pair in an electrode 3D configuration. In some specific embodiments, the system comprises sensor electrode pairs, each containing one sensor and two electrodes, where these sensors and electrodes correspond to each other.

[0074] The sensor relative position correlates with the electrode relative position in the following cases, for example: (a) If the sensor includes an anterior-proximal sensor, an anterior-distal sensor, a lateral-proximal sensor, a lateral-distal sensor, a posterior-proximal sensor, a posterior-distal sensor, a medial-proximal sensor, and a medial-distal sensor. (b) When the electrodes include an anterior-proximal electrode, anterior-distal electrode, lateral-proximal electrode, lateral-distal electrode, posterior-proximal electrode, posterior-distal electrode, medial-proximal electrode, and medial-distal electrode. (c) If the sensor electrode pair includes each of the following: an anterior-proximal pair including an anterior-proximal sensor and an anterior-proximal electrode; an anterior-distal pair including an anterior-distal sensor and an anterior-distal electrode; an lateral-proximal pair including an lateral-proximal sensor and an lateral-proximal electrode; an lateral-distal pair including an lateral-distal sensor and an lateral-distal electrode; a posterior-proximal pair including a posterior-proximal sensor and a posterior-proximal electrode; a posterior-distal pair including a posterior-distal sensor and a posterior-distal electrode; an lateral-proximal pair including an lateral-proximal sensor and an lateral-proximal electrode; and an lateral-distal pair including an lateral-distal sensor and an lateral-distal electrode. (d) The sensor relative position of the anterior-proximal sensor is (1) closer to the anterior-distal sensor than both the lateral-distal sensor and the medial-distal sensor, (2) closer to both the lateral-distal sensor and the medial-distal sensor than the posterior-distal sensor, (3) closer to both the lateral-proximal sensor and the medial-proximal sensor than the posterior-proximal sensor, and (4) closer to the posterior-proximal sensor than the posterior-distal sensor. (e) when the electrode relative position of the anterior-proximal electrode is (1) closer to the anterior-distal electrode than both the lateral-distal electrode and the medial-distal electrode, (2) closer to both the lateral-distal electrode and the medial-distal electrode than the posterior-distal electrode, (3) closer to both the lateral-proximal electrode and the medial-proximal electrode than the posterior-proximal electrode, and (4) closer to the posterior-proximal electrode than the posterior-distal electrode. (f) The relative sensor position of the anterior-distal sensor is (1) closer to the anterior-proximal sensor than both the lateral-proximal sensor and the medial-proximal sensor, (2) closer to both the lateral-proximal sensor and the medial-proximal sensor than the posterior-proximal sensor, (3) closer to both the lateral-distal sensor and the medial-distal sensor than the posterior-distal sensor, and (4) closer to the posterior-distal sensor than the posterior-proximal sensor. (g) when the electrode relative position of the anterior-distal electrode is (1) closer to the anterior-proximal electrode than both the lateral-proximal electrode and the medial-proximal electrode, (2) closer to both the lateral-proximal electrode and the medial-proximal electrode than the posterior-proximal electrode, (3) closer to both the lateral-distal electrode and the medial-distal electrode than the posterior-distal electrode, and (4) closer to the posterior-distal electrode than the posterior-proximal electrode. (h) When the relative position of the medial-proximal sensor is (1) closer to the medial-distal sensor than both the anterior-distal sensor and the posterior-distal sensor, (2) closer to both the anterior-distal sensor and the posterior-distal sensor than the lateral-distal sensor, (3) closer to both the anterior-proximal sensor and the posterior-proximal sensor than the lateral-proximal sensor, and (4) closer to the lateral-proximal sensor than the lateral-distal sensor. (i) The electrode relative position of the medial-proximal electrode is (1) closer to the medial-distal electrode than both the anterior-distal electrode and the posterior-distal electrode, (2) closer to both the anterior-distal electrode and the posterior-distal electrode than the lateral-distal electrode, (3) closer to both the anterior-proximal electrode and the posterior-proximal electrode than the lateral-proximal electrode, and (4) closer to the lateral-proximal electrode than the lateral-distal electrode. (j) The relative position of the medial-distal sensor is (1) closer to the medial-proximal sensor than both the anterior-proximal sensor and the posterior-proximal sensor, (2) closer to both the anterior-proximal sensor and the posterior-proximal sensor than the lateral-proximal sensor, (3) closer to both the anterior-distal sensor and the posterior-distal sensor than the lateral-distal sensor, and (4) closer to the lateral-distal sensor than the lateral-proximal sensor. (k) The electrode relative position of the medial-distal electrode is (1) closer to the medial-proximal electrode than both the anterior-proximal electrode and the posterior-proximal electrode, (2) closer to the anterior-proximal electrode and the posterior-proximal electrode than the lateral-proximal electrode, (3) closer to both the anterior-distal electrode and the posterior-distal electrode than the lateral-distal electrode, and (4) closer to the lateral-distal electrode than the lateral-proximal electrode. (l) When the sensor relative position of the posterior-proximal sensor is (1) closer to the posterior-distal sensor than both the lateral-distal sensor and the medial-distal sensor, (2) closer to both the lateral-distal sensor and the medial-distal sensor than the anterior-distal sensor, (3) closer to both the lateral-proximal sensor and the medial-proximal sensor than the anterior-proximal sensor, and (4) closer to the anterior-proximal sensor than the anterior-distal sensor. (m) When the electrode relative position of the posterior-proximal electrode is (1) closer to the posterior-distal electrode than both the lateral-distal electrode and the medial-distal electrode, (2) closer to both the lateral-distal electrode and the medial-distal electrode than the anterior-distal electrode, (3) closer to both the lateral-proximal electrode and the medial-proximal electrode than the anterior-proximal electrode, and (4) closer to the anterior-proximal electrode than the anterior-distal electrode. (n) The relative sensor position of the posterior-distal sensor is (1) closer to the posterior-proximal sensor than both the lateral-proximal sensor and the medial-proximal sensor, (2) closer to both the lateral-proximal sensor and the medial-proximal sensor than the anterior-proximal sensor, (3) closer to both the lateral-distal sensor and the medial-distal sensor than the anterior-distal sensor, and (4) closer to the anterior-distal sensor than the anterior-proximal sensor. (o) When the electrode relative position of the posterior-distal electrode is (1) closer to the posterior-proximal electrode than both the lateral-proximal electrode and the medial-proximal electrode, (2) closer to both the lateral-proximal electrode and the medial-proximal electrode than the anterior-proximal electrode, (3) closer to both the lateral-distal electrode and the medial-distal electrode than the anterior-distal electrode, and (4) closer to the anterior-distal electrode than the anterior-proximal electrode. (p) When the sensor relative position of the lateral-proximal sensor is (1) closer to the lateral-distal sensor than both the anterior-distal sensor and the posterior-distal sensor, (2) closer to both the anterior-distal sensor and the posterior-distal sensor than the medial-distal sensor, (3) closer to both the anterior-proximal sensor and the posterior-proximal sensor than the medial-proximal sensor, and (4) closer to the medial-proximal sensor than the medial-distal sensor. (q) When the electrode relative position of the lateral-proximal electrode is (1) closer to the lateral-distal electrode than both the anterior-distal electrode and the posterior-distal electrode, (2) closer to both the anterior-distal electrode and the posterior-distal electrode than the medial-distal electrode, (3) closer to both the anterior-proximal electrode and the posterior-proximal electrode than the medial-proximal electrode, and (4) closer to the medial-proximal electrode than the medial-distal electrode. (r) The relative position of the lateral-distal sensor is (1) closer to the lateral-proximal sensor than both the anterior-proximal sensor and the posterior-proximal sensor, (2) closer to both the anterior-proximal sensor and the posterior-proximal sensor than the medial-proximal sensor, (3) closer to both the anterior-distal sensor and the posterior-distal sensor than the medial-distal sensor, and (4) closer to the medial-distal sensor than the medial-proximal sensor. (s) When the electrode relative position of the lateral-distal electrode is (1) closer to the lateral-proximal electrode than both the anterior-proximal electrode and the posterior-proximal electrode, (2) closer to both the anterior-proximal electrode and the posterior-proximal electrode than the medial-proximal electrode, (3) closer to both the anterior-distal electrode and the posterior-distal electrode than the medial-distal electrode, and (4) closer to the medial-distal electrode than the medial-proximal electrode.

[0075] The preceding paragraph describes exemplary correlations between the relative positions of each sensor in a three-dimensional sensor configuration and the relative positions of each electrode in a three-dimensional electrode configuration. The relative positions of sensors in different sensor arrays may correlate with the relative positions of electrodes in different electrode arrays in similar but different correlations, for example, to enable different sensor and / or electrode patterns. Sensor relative positions are typically correlated with electrode relative positions, for example, anterior sensors activate anterior electrodes, posterior sensors activate posterior electrodes, medial sensors activate medial electrodes, and lateral sensors activate lateral electrodes. Thus, pressing the anterior part of the lower limb prosthesis transmits current through the anterior part of the upper remaining leg, and pressing the posterior part of the lower limb prosthesis transmits current through the posterior part of the upper remaining leg. Still, other patterns are also compatible with the systems of this disclosure. Without limiting the claims herein or arising from this disclosure, the correlations between the relative positions of sensors and paired electrodes can facilitate topographic mapping and more effectively treat phantom limb syndrome.

[0076] In some embodiments, the sensor 3D configuration defines the sensor surface, and the electrode 3D configuration defines the electrode surface, and proximity is measured along the sensor surface and electrode surface, rather than in Cartesian space. In some embodiments, the sensor surface is the surface of the cover. In some specific embodiments, the sensor surface is the outer surface of the cover. In some embodiments, the electrode surface is the surface of the liner. In some specific embodiments, the electrode surface is the inner surface of the liner.

[0077] The adjectives anterior, lateral, posterior, medial, distal, and proximal indicate (1) the relative position of the sensor to both the cover (or prosthesis) and another sensor, and (2) the relative position of the electrode to both the liner (or remaining limb) and another electrode. Anterior-distal sensors are, for example, closer to the front of the cover (or prosthesis) than lateral-distal sensors, posterior-distal sensors, and medial-distal sensors. Anterior-distal sensors are, for example, lower to the leg or arm prosthesis cover (or leg or arm prosthesis) than anterior-proximal sensors.

[0078] Terms such as forward-proximal sensor, forward-distal sensor, lateral-proximal sensor, lateral-distal sensor, posterior-proximal sensor, posterior-distal sensor, medial-proximal sensor, and medial-distal sensor should be interpreted (1) solely to identify the relative position of the sensors, (2) not to imply a three-dimensional configuration of the sensors by, for example, implying a regular grid, and (3) not to imply the presence or absence of any other sensor in the sensor array.

[0079] Terms such as anterior-proximal electrode, anterior-distal electrode, lateral-proximal electrode, lateral-distal electrode, posterior-proximal electrode, posterior-distal electrode, medial-proximal electrode, and medial-distal electrode should (1) be interpreted solely to identify the relative position of the electrodes, (2) not to imply a three-dimensional configuration of the electrodes by, for example, implying a structural grid, and (3) not to imply the presence or absence of any other electrode in the electrode array.

[0080] In some embodiments, each sensor corresponds to exactly two electrodes, and each sensor electrode pair consists of (1) the sensor and (2) two electrodes corresponding to the sensor. In some specific embodiments, each sensor corresponds to exactly two electrodes, and each sensor electrode pair consists of (1) the sensor and (2) two electrodes corresponding to the sensor, where one of the two electrodes is a positive electrode configured to transmit current and the other electrode is a negative electrode configured to receive current from the positive electrode. In some even more specific embodiments, each sensor corresponds to exactly two electrodes, and each sensor electrode pair consists of (1) the sensor and (2) two electrodes corresponding to the sensor, where one of the two electrodes is a positive electrode configured to transmit current to the remaining limb and the other electrode is a negative electrode configured to receive current from the positive electrode via the remaining limb.

[0081] In some embodiments, the electrode array includes at least one electrode ring, the electrode ring consisting of four or more electrodes, each paired with exactly two other electrodes on the ring. In some specific embodiments, the electrode array includes at least two, three, four, five, or six electrode rings. In some very specific embodiments, the electrode array includes at least eight electrodes and at least six electrode rings. For example, if the anterior-proximal electrode and the anterior-distal electrode are paired with the anterior-distal electrode and the lateral-proximal electrode, then the anterior-proximal electrode, the anterior-distal electrode, the lateral-proximal electrode, and the lateral-distal electrode are electrode rings.

[0082] In some embodiments, at least one electrode ring is configured to surround the remaining limb. The anterior-distal electrode, lateral-distal electrode, posterior-distal electrode, and medial-distal electrode are electrode rings configured to surround the remaining limb, for example, when the anterior-distal electrode and posterior-distal electrode are paired with the lateral-distal electrode and medial-distal electrode, respectively. In some specific embodiments, at least two electrode rings are configured to surround the remaining limb.

[0083] In some embodiments, the sensor array includes one, two, three, four, five, six, seven, or each of the following: forward-proximal sensor, forward-distal sensor, outside-proximal sensor, outside-distal sensor, rear-proximal sensor, rear-distal sensor, inside-proximal sensor, and inside-distal sensor.

[0084] In some embodiments, the electrode array includes one, two, three, four, five, six, seven, or each of the following: anterior-proximal electrode, anterior-distal electrode, lateral-proximal electrode, lateral-distal electrode, posterior-proximal electrode, posterior-distal electrode, medial-proximal electrode, and medial-distal electrode.

[0085] In some embodiments, the sensor electrode pair includes one, two, three, four, five, six, seven, or each of the following: an anterior-proximal pair including an anterior-proximal sensor and an anterior-proximal electrode; an anterior-distal pair including an anterior-distal sensor and an anterior-distal electrode; an lateral-proximal pair including an lateral-proximal sensor and an lateral-proximal electrode; an lateral-distal pair including an lateral-distal sensor and an lateral-distal electrode; a posterior-proximal pair including a posterior-proximal sensor and a posterior-proximal electrode; a posterior-distal pair including a posterior-distal sensor and a posterior-distal electrode; an lateral-proximal pair including an lateral-proximal sensor and an lateral-distal electrode; and an lateral-distal pair including an lateral-distal sensor and an lateral-distal electrode. Each of the sensor electrode pairs identified in the preamble also includes additional electrodes; that is, an anterior-proximal pair includes, for example, one or more of a second anterior-proximal electrode, an anterior-distal electrode, an lateral-proximal electrode, an lateral-proximal electrode, or a completely different electrode.

[0086] In some embodiments, each sensor in a sensor array communicates with two or more electrodes in an electrode array, so that the two or more electrodes are configured to send and receive current through the remaining limb in each of the following cases: (1) when a sensor detects force or pressure, (2) when the two or more electrodes are electrically connected to the remaining limb, and (3) when the prosthesis is removed from the remaining limb. This configuration allows amputees to transmit current through their remaining limb when they are not wearing a covered prosthesis, for example, after removing the prosthesis for sleep, and can treat symptoms of phantom limb syndrome as needed.

[0087] In some embodiments, the sensor array includes at least 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, or 32 sensors. In some specific embodiments, the sensor array includes at least 4 to a maximum of 128 sensors. In some specific embodiments, the sensor array includes 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, or 128 sensors. In some more specific embodiments, the sensor array comprises 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, or 128 sensors, and the system comprises several additional sensors not included in the sensor array.

[0088] In some embodiments, the system comprises one or more sensors that are not included in the sensor array. These one or more sensors are, for example, sensors not used to detect force or pressure, or sensors that a potential infringer of one or more patent claims arising from this disclosure might envision including in the system in order to construct a legal theory of non-infringement.

[0089] In some embodiments, the system includes a controller that communicates with an electrode array, and so when the electrodes are electrically connected to a remaining limb, the controller can bypass the sensor array and cause each electrode in the electrode array to transmit current to or receive current from the amputee's remaining limb. Such a controller allows the amputee to transmit current through their amputated limb when they are not wearing a covered prosthesis, for example, after they have removed such a prosthesis for sleep. The controller also allows the amputee to run a program specifically designed to treat phantom limb syndrome. The amputee may develop specific patterns of transmitting current through their remaining limb that are particularly effective in treating phantom limb syndrome, and the system may track the amputee's system usage and develop specific patterns that show a high probability of being effective in treating phantom limb syndrome, or crowdsourced usage records or other data from multiple amputees may identify specific patterns that show a high probability of being effective in treating phantom limb syndrome, and a program on the controller can drive the electrode array to implement those specific patterns. These controllers may be electrode controllers or secondary controllers as described here, depending on the requirements.

[0090] In some embodiments, the system includes a secondary controller that communicates wirelessly with the electrode array, and when the electrode array is in electrical communication with the remaining limb, the secondary controller can bypass the sensor array and cause each electrode in the electrode array to transmit current to or receive current from the remaining limb.

[0091] In some embodiments, the secondary controller is a computer device. In some specific embodiments, the secondary controller is a mobile computer device. In some even more specific embodiments, the secondary controller is a cellphone.

[0092] In some embodiments, the secondary controller communicates wirelessly with the electrode array. In some specific embodiments, the secondary controller communicates wirelessly with the electrode controller. In some even more specific embodiments, the secondary controller communicates wirelessly with the electrode controller that controls the electrode array.

[0093] In some embodiments, wireless communication is mediated by either a Bluetooth connection or a Wi-Fi connection, or both, between the secondary controller and the electrode array. In some specific embodiments, wireless communication is mediated by either a Bluetooth connection or a Wi-Fi connection, or both, between the secondary controller and the electrode array, which is mediated by the electrode controller that controls the electrode array.

[0094] In some embodiments, the secondary controller communicates wirelessly with the electrode controller.

[0095] In some embodiments, the cover is configured to be fitted to the outer surface of various prosthetic limbs having various different shapes, and the cover is configured to adapt to various different shapes, so that the relative position of each sensor remains constant for different shapes. In some specific embodiments, the cover is configured to be fitted to the outer surface of various prosthetic limbs having various different shapes, and the cover is configured to adapt to various different shapes, so that the three-dimensional configuration of each sensor remains constant for different shapes.

[0096] In some embodiments, the cover has the shape of the missing body part. In some specific embodiments, the cover has the shape of the missing body part, and the sensor 3D configuration includes the shape of the missing body part. Without limiting the claims arising from this specification or this disclosure, a cover having the shape of a missing body part and a sensor 3D configuration including that shape induces better neuroplasticity in the somatosensory cortex of the brain of an amputee than other shapes, and treats phantom limb syndrome more effectively.

[0097] In some embodiments, the system lacks a sensor function to detect the relative position of the prosthesis. In some specific embodiments, the sensor array is generally configured to detect pressure and / or force from contact, and is not configured to detect the position or movement of the prosthesis.

[0098] In some embodiments, the system lacks the mechanical capability to move the prosthesis. In some specific embodiments, the system is generally independent of the mechanical properties of the prosthesis for, for example, movement, positioning, or load-bearing.

[0099] In some embodiments, the system lacks the structural ability to support the weight of the amputee. In some specific embodiments, the system is generally independent of the structural properties of the prosthesis for, for example, movement, positioning, or load-bearing.

[0100] Figure 1 shows a system 100 comprising a prosthetic liner 101 containing implantable electrode arrays 102a-d. The prosthetic liner 101 receives the remaining limb (not shown), and therefore the liner 101 fits below the area of ​​the prosthesis 103 that receives the remaining limb. The prosthetic liner provides support, protection, and cushioning to the remaining limb of the amputee.

[0101] Each electrode 102a-d in the electrode array 102a-d within the prosthetic liner 101 is electrically connected to an electrode controller 104, and this electrical connection is mediated by a wire 105 embedded in the prosthetic liner 101. In some embodiments, the electrical connection can also be mediated by a conductor other than the wire, such as a conductive material.

[0102] The prosthetic liner may comprise a tube including a wall, an edge defining the end of the wall, an open end enclosed by the edge, and a gap defined by the wall, the gap configured to receive the remaining limb through the open end. In some specific embodiments, the tube comprises a closed end continuous with the wall, for example, the gap is defined by the closed end, the wall, and the open end.

[0103] In some embodiments, the liner generally comprises a concave inner surface and a convex outer surface of the tube, with an edge defining the boundary between the concave inner surface and the convex outer surface.

[0104] Figure 1 shows system 100, which also includes a cover 106 containing an array of implantable sensors 107a-d. The cover 106 fits over the area of ​​the prosthesis 103 that replaces the missing limb and is attached to the prosthesis 103 along with a polymer foam (not shown) that fills the gap between the cover 106 and the prosthesis 103 as needed. The sensors 107a-d communicate with a sensor controller 108 which interfaces with an electrode controller 104.

[0105] Figure 1 shows a wireless Bluetooth intermediary interface 109 between the sensor controller 108 and the electrode controller 104. The wireless Bluetooth intermediary interface 109 between the sensor controller 108 and the electrode controller 104 allows an amputee to stimulate their remaining limb by touching the sensors 107a-d and activating the electrodes 102a-d of the electrode array, even when not wearing the prosthesis 103 and cover 106, for example, when removing the prosthesis 103 for sleep. In another embodiment, the system 100 lacks the sensor controller 108, and the sensors 107a-d are directly connected to the electrode controller 104.

[0106] The liner 101 in Figure 1 includes a substrate 110 that houses the implantable electrode arrays 102a-d. Figure 1 also shows the joint 111 of the prosthesis 103, the outer layer 112 of the cover 106 (this outer layer 112 is shown in the exploded view), and the sheath 113 that bundles the wires 105 extending from the liner 101.

[0107] The electrodes 102a-d shown in Figure 1 include the anterior-lateral-proximal electrode 102a, the anterior-lateral-distal electrode 102b, the posterior-lateral-distal electrode 102c, and the posterior-lateral-proximal electrode 102d. The opposite side of the liner may include, for example, an anterior-medial-proximal electrode, anterior-medial-distal electrode, a posterior-medial-distal electrode, and a posterior-medial-proximal electrode, which are mirror images of the illustrated side.

[0108] The sensors 107a to 107d shown in Figure 1 include anterior-outer-proximal sensor 107a, anterior-outer-distal sensor 107b, a rear-outer-distal sensor 107c, and a rear-outer-proximal sensor 107d. The opposite side of the cover may include, for example, an anterior-inner-proximal sensor, an anterior-inner-distal sensor, a rear-inner-distal sensor, and a rear-inner-proximal sensor, which are mirror images of the illustrated side.

[0109] In some embodiments, pressing the anterior-lateral-proximal sensor 107a transmits electricity via the remaining limb between the anterior-lateral-proximal electrode 102a and at least one other electrode.

[0110] In some embodiments, pressing the anterior-lateral-distal sensor 107b transmits electricity via a residual limb between the anterior-lateral-distal electrode 102b and at least one other electrode.

[0111] In some embodiments, pressing the posterior-lateral-distal sensor 107c transmits electricity via the remaining limb between the posterior-lateral-distal electrode 102c and at least one other electrode.

[0112] In some embodiments, pressing the posterior-lateral-proximal sensor 107d transmits electricity via the remaining limb between the posterior-lateral-proximal electrode 102d and at least one other electrode.

[0113] In some specific embodiments, (1) by pressing both the front-outside-proximal sensor 107a and the front-inside-proximal sensor (not shown), electricity is transmitted between the front-outside-proximal electrode 102a and the front-inside-proximal electrode (not shown), and (2) by pressing both the front-inside-proximal sensor (not shown) and the rear-inside-proximal sensor (not shown), electricity is transmitted between the front-inside-proximal electrode (not shown) and the rear-inside-proximal electrode (not shown), ( 3) By pressing both the posterior-internal-proximal sensor (not shown) and the posterior-external-proximal sensor 107d, electricity is transmitted between the posterior-internal-proximal electrode (not shown) and the posterior-external-proximal electrode 102d, and (4) by pressing both the posterior-external-proximal sensor 107d and the anterior-external-proximal sensor 107a, electricity is transmitted between the posterior-external-proximal electrode 102d and the anterior-external-proximal electrode 102a, thereby creating a "ring" around the remaining limb. The electricity may be transmitted simultaneously in series or in other ways. Alternatively, a secondary controller (e.g., a mobile app on a wireless device) can be used to bypass the sensors and achieve a similar electrical transmission pattern through the remaining limb.

[0114] In some specific embodiments, (1) by pressing both the anterior-outer-proximal sensor 107a and the anterior-outer-distal sensor 107b, electricity is transmitted between the anterior-outer-proximal electrode 102a and the anterior-outer-distal electrode 102b; (2) by pressing both the anterior-outer-distal sensor 107b and the posterior-outer-distal sensor 102c, electricity is transmitted between the anterior-outer-distal electrode 102b and the posterior-outer-distal electrode 102c; (3) By pressing both the posterior-lateral-distal sensor 102c and the posterior-lateral-proximal sensor 107d, electricity is transmitted between the posterior-lateral-distal electrode 102c and the posterior-lateral-proximal electrode 102d, (4) by pressing both the posterior-lateral-proximal sensor 107d and the anterior-lateral-proximal sensor 107a, electricity is transmitted between the posterior-lateral-proximal electrode 102d and the anterior-lateral-proximal electrode 102a, thereby creating a "ring" on the outside of the remaining limb. The electricity may be transmitted simultaneously in series or in other ways. Alternatively, a secondary controller (e.g., a mobile app on a wireless device) can be used to bypass the sensors and achieve a similar electrical transmission pattern through the remaining limb.

[0115] Figure 2 shows a substrate 110 with an implantable electrode array 102 and an implantable wire 105. In some embodiments, the substrate 110 may be incorporated into a prosthetic liner; in some embodiments, the prosthetic liner may be overmolded onto the substrate, embedded in the substrate, or mounted on the substrate.

[0116] Referring to Figure 2, the substrate 110 is positioned inside the mold 120. In some embodiments, liquid silicone (not shown) can be injected into the mold 120 to form a liner (not shown) containing an embedded electrode array 102 and embedded wires 105.

[0117] In some embodiments, the substrate is a fabric, such as a fabric mesh array configured to stimulate partial or complete coverage around the remaining limb.

[0118] In some embodiments, the substrate may include a conductor. The conductor may be any component that carries current from a power source to electrodes in the substrate. The conductor may also be a wire at least partially incorporated into the substrate. In some embodiments, the conductor may be a conductive material (e.g., an elastomer).

[0119] Figure 3 shows a substrate 110 with an embedded electrode array (not shown) and embedded wires 105. Figure 3 also shows an electrode controller 104, which comprises a printed circuit board assembly 130 and a battery 131 that is electrically connected to the printed circuit board assembly 130. When the electrode controller 104 is electrically connected to the embedded wires 105, a microprocessor (not shown) in the printed circuit board assembly 130 of the electrode controller 104 controls the transmission of current between the battery 131 and the embedded wires 105, whether the electrodes of the electrode array transmit the current received from the battery 131, and whether the electrodes of the electrode array receive the current that the electrodes transmit to the battery 131. Figure 4 shows a liner 101 with the substrate (not shown) of Figure 3 and an electrode controller housing 140 that houses the electrode controller (not shown) of Figure 3.

[0120] Figure 5 shows the liner 101 and electrode controller housing 140 from Figure 4 in partial transparency, with the substrate 110 and electrode controller 104 visible.

[0121] Figure 6 shows an exploded view of a cover 106 equipped with a sensor 107. The cover 106 comprises an inner layer 160, which is illustrated together with an embedded sensor 107 configured to detect a modality (e.g., force or pressure). The inner layer 160 can be manufactured from, for example, plastic. The inner layer 160 optionally includes one or more tabs 161 or other mounting mechanisms for receiving an outer layer 162. The outer layer 162 can be manufactured from, for example, plastic. The outer layer 162 may optionally have actuators 163, each configured to press against one or more sensors 107. Each actuator 163 can be configured, for example, as a flexible panel having a larger surface area than any of the sensors 107, and by pressing any part of the actuator 163, the modality (e.g., force or pressure) is converted and output to one or more of the miniature sensors 107. The outer layer 162 optionally includes one or more slots 164 or other mounting mechanisms for receiving the inner layer 160. As shown in Figure 6, the outer layer 162 has four slots 164 shaped to receive the four tabs 161 of the inner layer 160 and mount the outer layer 162 and the inner layer 160. The mechanical mounting mechanism (e.g., tabs) may include a detent, barb, or another catch or clamp mechanism to prevent separation of the inner layer 160 and the outer layer 162.

[0122] The cover 106 may optionally include a spacer 165 between the inner layer 160 and the outer layer 162. The spacer 165 may include, for example, foam. The spacer 165 may include one or more void spaces 166. One or more void spaces 166 allow, for example, an actuator 163 to contact the sensor 107. One or more void spaces 166 also allow a mounting mechanism (e.g., one or more tabs 161 and one or more slots 164) to mount the inner layer 160 and the outer layer 162.

[0123] The cover 106 may optionally include a sensor controller 108. The sensor controller 108 typically comprises a printed circuit board assembly 167 with an interface and a microprocessor. The microprocessor is configured, for example, to receive signals from the sensor 107 and instruct the interface to transmit the corresponding signals to the electrode array or its controller. The interface may be a wireless interface, such as an integrated Wi-Fi Bluetooth chip. The exact type of interface is not limited and generally depends on market factors, including the manufacturer's suggested retail price of the system. The controller 108 typically comprises a controller housing 168, which may optionally include an access panel 169 that allows access to the printed circuit board assembly 167. The sensor controller 108 typically comprises a power supply (usually a battery 170) or is electrically connected to a power supply.

[0124] In some embodiments, the cover lacks a dedicated sensor controller (not shown). The system may have, for example, a hardware interface between the cover and the liner, thus eliminating the need for a sensor controller.

[0125] The cover 106 may optionally have an outer surface 171, which may be, for example, foam and / or a texture (woven fabric) suitable for physical interaction with the actuator 163.

[0126] Figure 7 shows the cover 106 of Figure 6 in its assembled state without the outer surface (not shown). The four tabs 161 of the inner layer 160 attach the outer layer 162 and the inner layer 160. The outer layer 162 covers the controller housing 168.

[0127] Figure 8 shows the cover 106 of Figures 6 and 7 in an assembled state without the outer surface (not shown), with the outer layer 162 being semi-transparent and the spacer 165 being transparent, revealing the sensor 107 and printed circuit board assembly 167 underneath.

[0128] Figure 9 shows the electrode controller 104 and substrate 110 from Figure 3, and the partially assembled cover 106 from Figures 6 to 8.

[0129] Various aspects of this disclosure relate to methods of using the systems described in any of these disclosures.

[0130] In some embodiments, this method is a way to modulate neural activation in the remaining limb of an amputee.

[0131] Each amputee has a missing body part. In some embodiments, amputees exhibit phantom limb syndrome.

[0132] In some embodiments, the system comprises a cover, and the method includes attaching the cover to the prosthesis. In some specific embodiments, the method includes attaching the cover to the prosthesis by inserting a foam between the cover and the prosthesis. In some even more specific embodiments, the method includes attaching the cover to the prosthesis by inserting an inflatable foam between the cover and the prosthesis.

[0133] In some embodiments, the system comprises a liner, and the method includes mounting the liner onto the remaining limb. In some specific embodiments, the liner comprises an electrode array, and the method includes mounting the liner onto the remaining limb so that each electrode of the electrode array communicates with the remaining limb. In some even more specific embodiments, mounting the liner onto the remaining limb includes mounting each electrode of the electrode array onto the remaining limb so that each electrode communicates with the remaining limb electrically.

[0134] In some embodiments, the method includes bringing the remaining limbs into contact with a conductive gel to facilitate electrical communication between each electrode of the electrode array and the remaining limbs.

[0135] In some embodiments, the method includes attaching the prosthesis to the remaining limb. In some specific embodiments, the method includes attaching a cover to the prosthesis and then attaching the prosthesis to the remaining limb. In some specific embodiments, the method includes attaching the prosthesis to the remaining limb so that the prosthesis fits into the liner. In some even more specific embodiments, the method includes attaching a cover to the prosthesis, then attaching a liner to the remaining limb, and then attaching the prosthesis to the remaining limb so that the prosthesis fits into the liner.

[0136] In some embodiments, the system comprises a sensor array, and the method includes making contact with one or more of the sensors. In some specific embodiments, the cover comprises a sensor array, and the method includes making contact with one or more of the sensors. In some even more specific embodiments, making contact with one or more of the sensors includes applying at least one modality (e.g., force and / or pressure) to one or more of the sensors.

[0137] In some embodiments, the method includes attaching the cover to the prosthesis and then contacting one or more sensors. In some embodiments, the method includes attaching the prosthesis to the remaining limb and then contacting one or more sensors. In some specific embodiments, the method includes attaching the cover to the prosthesis and then attaching the prosthesis to the remaining limb and then contacting one or more sensors. In some even more specific embodiments, the method includes attaching the liner to the remaining limb, attaching the cover to the prosthesis, then attaching the prosthesis to the remaining limb and then contacting one or more sensors.

[0138] In some embodiments, the method includes removing the prosthesis from the remaining limb and then contacting one or more sensors after the prosthesis has been removed from the remaining limb. The method of the present disclosure conveniently allows the amputee to transmit an electric current through their remaining limb when they are not wearing a covered prosthesis, for example, after they have removed the prosthesis for sleep, and, if necessary, to treat symptoms of phantom limb syndrome.

[0139] In some embodiments, by contacting one or more sensors, an electrode in an electrode array transmits current to the remaining limb, and other electrodes in the electrode array receive current from the remaining limb.

[0140] In some embodiments, after the cover is attached to the prosthesis, contact with one or more sensors causes one electrode of the electrode array to transmit current to the remaining limb and other electrodes of the electrode array to receive current from the remaining limb. In some embodiments, after the prosthesis is attached to the remaining limb, contact with one or more sensors causes one electrode to transmit current to the remaining limb and other electrodes to receive current from the remaining limb. In some specific embodiments, after the cover is attached to the prosthesis and the prosthesis is attached to the remaining limb, contact with one or more sensors causes one electrode to transmit current to the remaining limb and other electrodes to receive current from the remaining limb. In some even more specific embodiments, after the liner is attached to the remaining limb, the cover is attached to the prosthesis and the prosthesis is attached to the remaining limb, contact with one or more sensors causes one electrode to transmit current to the remaining limb and other electrodes to receive current from the remaining limb.

[0141] In some embodiments, after the prosthesis is removed from the remaining limb, one or more sensors are brought into contact so that one electrode transmits an electric current to the remaining limb and other electrodes receive an electric current from the remaining limb.

[0142] In some embodiments, the method includes stimulating Aβ nerve fibers in the remaining limb. In some specific embodiments, the method includes stimulating myelinated Aβ nerve fibers in the remaining limb by transmitting an electric current to the remaining limb.

[0143] In some embodiments, the method includes modulating the activation of Aδ nerve fibers in the remaining limb. In some specific embodiments, the method includes modulating the activation of myelinated Aδ nerve fibers in the remaining limb by transmitting an electric current to the remaining limb.

[0144] In some embodiments, the method includes modulating the activation of C nerve fibers in the remaining limb. In some specific embodiments, the method includes modulating the activation of unmyelinated C nerve fibers in the remaining limb, by transmitting an electric current to the remaining limb.

[0145] In some embodiments, the system is configured so that an electric current treats one or more symptoms of phantom limb syndrome. In some specific embodiments, the system is configured so that an electric current treats one or more symptoms of phantom limb syndrome, and so that one or more symptoms are treated by causing the transmission of the electric current through the remaining limb by contact with one or more sensors.

[0146] In some embodiments, the method includes removing the prosthesis from the remaining limb, contacting one or more sensors after removing the prosthesis from the remaining limb, and treating one or more symptoms by contacting one or more sensors after removing the prosthesis from the remaining limb and transmitting an electric current through the remaining limb.

[0147] In some embodiments, the method includes instructing a secondary controller to transmit current to one electrode and to another electrode to receive current from the remaining limb. In some specific embodiments, the method includes instructing a secondary controller to transmit current to one electrode and to another electrode to receive current from the remaining limb without contacting one or more sensors (i.e., the secondary controller bypasses the sensor array).

[0148] Directing a secondary controller may include, for example, pressing an icon on the graphical user interface of the controller or the secondary controller's touchscreen.

[0149] In some embodiments, one or more symptoms are treated by transmitting current through the remaining limb, by instructing a secondary controller to transmit current to an electrode and to receive current from the remaining limb to another electrode.

[0150] In some embodiments, the method includes communicating wirelessly with the system to a secondary controller to instruct one or more positive electrodes of an electrode array to transmit current to the remaining limb and one or more negative electrodes of the electrode array to receive current from the remaining limb. In some specific embodiments, one or more symptoms of phantom limb syndrome are treated by transmitting current through the remaining limb by instructing the secondary controller to transmit current to one or more positive electrodes and to receive current to one or more negative electrodes.

[0151] In some embodiments, the method includes (1) contacting one or more sensors to transmit current to one or more positive electrodes to the remaining limb and to receive current from the remaining limb to one or more negative electrodes in response to symptoms of phantom limb syndrome, or (2) instructing a secondary controller to transmit current to one or more positive electrodes to the remaining limb and to receive current from the remaining limb to one or more negative electrodes in response to symptoms, wherein the method treats phantom limb syndrome by transmitting current through the remaining limb in response to symptoms.

[0152] In some embodiments, the method includes periodically transmitting an electric current from the positive electrode of an electrode array to the negative electrode of an electrode array via the remaining limb over a period of time, such as a period of at least 28 days. In some specific embodiments, the method includes periodically transmitting an electric current from the positive electrode to the negative electrode via the remaining limb over a period of time, and the method is effective in alleviating symptoms of phantom limb syndrome, such as those assessed on a visual analog scale after a period of time.

[0153] In some embodiments, "regularly" means at least three times a week, at least four times a week, at least five times a week, at least six times a week, at least seven times a week, at least daily, or at least twice a day.

[0154] In some embodiments, "regularly" means three times a week, four times a week, five times a week, six times a week, seven times a week, daily, or twice a day.

[0155] In some embodiments, the period is at least 1 hour, at least 24 hours, at least 48 hours, at least 1 week, at least 28 days, at least 1 month, at least 6 months, or at least 1 year.

[0156] In some embodiments, the period is 1 hour, 24 hours, 48 ​​hours, 1 week, 28 days, 1 month, 6 months, or 1 year.

[0157] In some embodiments, the method involves contacting one or more sensors of a sensor array and periodically transmitting an electric current from the positive electrode of the electrode array to the negative electrode of the electrode array via the remaining limb over a period of time, such as a period of at least 28 days. In some specific embodiments, the method involves contacting one or more sensors and periodically transmitting an electric current from the positive electrode to the negative electrode of the remaining limb over a period of time, and the method is effective in alleviating symptoms of phantom limb syndrome, such as those assessed on a visual analog scale after a period of time.

[0158] In some embodiments, phantom limb syndrome has a first symptom and a second symptom.

[0159] In some embodiments, transmitting current from a first positive electrode of an electrode array to a first negative electrode of an electrode array via a residual limb is more effective in treating a first symptom than transmitting and receiving current from another electrode of the electrode array, and the method includes transmitting current from a first positive electrode to a first negative electrode via a residual limb in response to a first symptom.

[0160] In some embodiments, the first positive electrode has a first positive relative position, and the first negative electrode has a first negative relative position, and the amputee associates the first symptom with one or both of the first positive relative position and the first negative relative position.

[0161] In some embodiments, transmitting current from a second positive electrode of an electrode array to a second negative electrode of an electrode array via a residual limb is more effective in treating the second symptom than transmitting and receiving current from another electrode of the electrode array, and the method includes transmitting current from a second positive electrode to a second negative electrode via a residual limb in response to the second symptom.

[0162] In some embodiments, the second positive electrode has a second positive relative position, and the second negative electrode has a first negative relative position, and the amputee associates the second symptom with one or both of the second positive relative position and the second negative relative position.

[0163] In some embodiments, the method includes contacting a first sensor of a sensor array corresponding to a first positive and a first negative electrode in response to a first symptom.

[0164] In some embodiments, the first sensor has a first sensor relative position, and the amputee associates the first symptom with the first sensor relative position. In some specific embodiments, the first sensor has a first sensor relative position, the first positive electrode has a first positive electrode relative position, and the first negative electrode has a first negative electrode relative position, and the amputee associates the first symptom with one, two, or each of the first sensor relative position, the first positive electrode relative position, and the first negative electrode relative position.

[0165] In some embodiments, the method includes contacting a second sensor of a sensor array corresponding to a second positive and second negative electrode in response to a second symptom.

[0166] In some embodiments, the second sensor has a second sensor relative position, and the amputee associates the second symptom with the second sensor relative position. In some specific embodiments, the second sensor has a second sensor relative position, the second positive electrode has a second positive electrode relative position, and the second negative electrode has a second negative electrode relative position, and the amputee associates the second symptom with one, two, or each of the second sensor relative position, the second positive electrode relative position, and the second negative electrode relative position.

[0167] In some embodiments, the method includes instructing an electrode controller (and, if necessary, a secondary controller) to transmit current to the first positive electrode and receive current to the first negative electrode in response to a first symptom.

[0168] In some embodiments, the method includes instructing an electrode controller (and, if necessary, a secondary controller) to transmit current to the second positive electrode and receive current to the second negative electrode in response to a second symptom.

[0169] In some embodiments, the method includes, for example, contacting a first sensor in response to a first symptom and contacting a second sensor in response to a second symptom over a period of time, such as a period of at least 28 days, and the method is effective in reducing the chronic symptoms of phantom limb syndrome independently of treating acute symptoms by generating an electric current in the remaining limb over a period of time. In some specific embodiments, the reduction of the chronic symptoms of phantom limb syndrome is evaluated using a visual analog scale. Without limiting the claims arising herein or from this disclosure, repeated use of the system of this disclosure can reduce the chronic symptoms of phantom limb syndrome, which can be evaluated using a visual analog scale as necessary.

[0170] Treatment of acute symptoms refers to treating symptoms while the subject is experiencing them, and acute efficacy refers to real-time efficacy in alleviating acute symptoms. Reduction of chronic symptoms refers to a reduction in either the frequency and / or severity of symptoms over time. Reduction of chronic symptoms of phantom limb syndrome independently of treatment of acute symptoms refers to a reduction in either the frequency and / or severity of symptoms over time, independently of treatment of acute symptoms. For example, after using the system described here for a period of time (e.g., at least 28 days), it may be found that the subject experiences phantom limb syndrome symptoms less frequently and the severity of symptoms less frequently, independently of whether the subject actually uses the system to treat a given symptom.

[0171] Each amputee has a brain that includes a somatosensory cortex. In some embodiments, the method is effective in activating different areas of the somatosensory cortex when various electrodes of an electrode array transmit and receive electrical currents to and from the remaining limb.

[0172] Without limiting the claims arising from this specification or this disclosure, repeated use of the system of this disclosure reduces the chronic symptoms of phantom limb syndrome by neural modulation of the somatosensory cortex.

[0173] The somatosensory cortex of the brain of an amputee typically includes areas that process sensation from the missing body part. In some embodiments, the method involves periodically transmitting an electric current from an electrode array through the remaining limb over a period of time, such as a period of at least 28 days, and the method is effective in causing neuromodulation such that after the period the current activates the areas that process sensation from the missing body part. In some specific embodiments, the method involves contacting one or more sensors and periodically transmitting an electric current from two or more corresponding electrodes through the remaining limb over a period of time, and the method is effective in causing neuromodulation such that after the period the current causes activation in the areas that process sensation from the missing body part. In some even more specific embodiments, the method involves contacting one or more sensors in response to symptoms of phantom limb syndrome.

[0174] In some embodiments, the method involves contacting two or more sensors to transmit an electric current through the remaining limb from two or more different positive electrodes to two or more different negative electrodes over a period of time, such as a period of at least 28 days, and the method is effective in causing neuroplastic-driven cortical remapping in the somatosensory cortex of the amputee's brain after the period so that the electric current transmitted through the remaining limb activates different areas of the somatosensory cortex after the period compared to before the period.

[0175] In some embodiments, each wire is electrically connected to at least one electrode in the electrode array or pad.

[0176] In some embodiments, the liner is configured to receive the remaining limbs and for each electrode to be electrically connected to the remaining limbs.

[0177] In some embodiments, the inner surface of the substrate is provided with electrode apertures for each electrode in the electrode array or pad, so that each electrode aperture exposes the conductive surface of each electrode and makes contact with the remaining limb when it is inside the liner.

[0178] In some embodiments, the electrode array is configured within a substrate, so that each electrode in the electrode array is a paired electrode that can be paired with at least one other electrode in the electrode array, and when the electrode array is in electrical communication with the remaining limb, each paired electrode can (1) transmit current via the remaining limb to the negative electrode of the electrode array with which the paired electrode is paired, and / or (2) receive current via the remaining limb from the positive electrode of the electrode array with which the paired electrode is paired. In some specific embodiments, the electrode array is configured within a polymer liner, so that each electrode in the electrode array is a paired electrode that can be paired with at least two other other electrodes in the electrode array, and when the electrode array is in electrical communication with the remaining limb, each paired electrode can (1) transmit current via the remaining limb to both the first negative electrode with which the paired electrode is paired and independently to the second negative electrode with which the paired electrode is paired, and / or (2) receive current via the remaining limb to both the first positive electrode with which the paired electrode is paired and independently to the second positive electrode with which the paired electrode is paired.

[0179] In some embodiments, the electrodes or electrode arrays are configured to stimulate nerve fibers in the remaining limb by transmitting and receiving electrical currents through the remaining limb.

[0180] In some embodiments, the electrode array is configured such that (1) when two or more electrodes of the electrode array are activated, and (2) when the two or more electrodes are in electrical communication with the remaining limb, one of the two or more activated electrodes transmits a current through the remaining limb, and the other of the two or more activated electrodes receives the current transmitted through the remaining limb.

[0181] In some embodiments, the liner is a product manufactured by a process in which (a) a substrate containing wires and electrodes is placed in a mold, and (b) a liquid polymer is injected into the mold, embedding the wire and electrode array within the polymer, thereby manufacturing the liner. For example, the liner may be a polymer liner manufactured by injecting a liquid polymer or its monomer into a mold.

[0182] In some embodiments, the liner is a polymer liner comprising a polymer selected from silicone, polyurethane, and thermoplastic elastomer.

[0183] In some embodiments, the substrate is a polymer comprising a polymer selected from silicone, polyurethane, and thermoplastic elastomer. By selecting a substrate polymer compatible with the liner polymer, better fusion between the substrate and the liner is achieved, and spatial delamination is avoided.

[0184] In some embodiments, the substrate is one or more substrates containing wires and electrodes. For example, the substrate may be a single substrate with 4 to 16 electrodes, or two substrates, each having 2 to 8 electrodes.

[0185] In some embodiments, each electrode in the electrode array is a stimulating electrode configured to transmit and / or receive an electric current that stimulates neurons in the remaining limb when electrically connected to it. Suitable stimulating electrodes include, for example, carbon rubber electrodes.

[0186] In some embodiments, each electrode in the electrode array is configured to transmit, receive, or both transmit and receive pulsed currents having an amplitude of at least 30 milliamperes. In some specific embodiments, each electrode in the electrode array is configured to transmit, receive, or both transmit and receive pulsed currents having a pulse frequency of at least 20 pulses / second up to 180 pulses / second, a pulse width of up to 100 microseconds, and an amplitude of up to 100 milliamperes.

[0187] In some embodiments, each electrode in the electrode array is a stimulating electrode configured to transmit and / or receive an electric current that stimulates the Aβ nerve fibers of the remaining limb when the stimulating electrode is in electrical communication with the remaining limb.

[0188] In some embodiments, each electrode in the electrode array is configured to modulate the activation of myelinated Aδ nerve fibers and / or unmyelinated C nerve fibers in the remaining limb.

[0189] In some embodiments, the electrode array comprises an electrode ring. The electrode ring consists of four or more electrodes of the electrode array, each precisely paired with exactly two other electrodes of the electrode ring. The electrode ring comprises a first electrode, a second electrode, a third electrode, and a fourth electrode, and the electrode array is configured to transmit current via residual limbs in (1) between the first electrode and the second electrode, (2) between the second electrode and the third electrode, and (3) between the third electrode and the fourth electrode. In some specific embodiments, the electrode array is configured to transmit current via residual limbs between the fourth electrode and the first electrode. In some specific embodiments, the electrode ring surrounds the inner surface of the liner, and thus the electrode ring surrounds the void or residual limbs within the void.

[0190] In some embodiments, the electrode array comprises a second electrode ring, the second electrode ring being paired with exactly two other electrodes of the second electrode ring, and the electrode array comprises a first electrode, a second electrode, a fifth electrode, and a sixth electrode, and the electrode array is configured to transmit current via remaining limbs (4) between the first electrode and the fifth electrode, and (5) between the fifth electrode and the sixth electrode. In some specific embodiments, the electrode array is configured to transmit current via remaining limbs (6) between the sixth electrode and the second electrode.

[0191] In some embodiments, the electrode array includes a third electrode ring, the third electrode ring comprising four or more electrodes of the electrode array, each paired with exactly two other electrodes of the third electrode ring, the third electrode ring comprising a fifth electrode, a sixth electrode, a seventh electrode, and an eighth electrode, and the electrode array is configured to transmit current via remaining limbs between (7) the sixth electrode and the seventh electrode, and between (8) the seventh electrode and the eighth electrode. In some specific embodiments, the electrode array is configured to transmit current via remaining limbs between (9) the eighth electrode and the fifth electrode.

[0192] In some embodiments, the electrode array includes one, two, three, four, five, six, seven, or eight of the following: anterior-lateral-proximal electrode, posterior-lateral-proximal electrode, anterior-lateral-distal electrode, posterior-lateral-distal electrode, anterior-medial-proximal electrode, posterior-medial-proximal electrode, anterior-medial-distal electrode, and posterior-medial-distal electrode.

[0193] Various aspects of this disclosure relate to methods of using the systems described herein, (a) providing the liners described herein, (b) inserting the remaining limbs into the gaps so that each electrode of the electrode array is in contact with the remaining limbs, and (c) (1) anterior-lateral-proximal electrode and posterior-lateral-proximal electrode, (2) posterior-lateral-proximal electrode and posterior-medial-proximal electrode, (3) posterior-medial-proximal electrode and anterior-medial-proximal electrode, (4) anterior-medial-proximal electrode and anterior-lateral-proximal electrode, (5) anterior-lateral-distal electrode and posterior-lateral-distal electrode, ( (6) a posterior-lateral-distal electrode and a posterior-medial-distal electrode, (7) a posterior-medial-distal electrode and an anterior-medial-distal electrode, (8) an anterior-medial-distal electrode and an anterior-lateral-distal electrode, (9) an anterior-lateral-proximal electrode and an anterior-lateral-distal electrode, (10) a posterior-lateral-proximal electrode and a posterior-lateral-distal electrode, (11) a posterior-medial-proximal electrode and a posterior-medial-distal electrode, and (12) an anterior-medial-proximal electrode and an anterior-medial-distal electrode, comprising transmitting current via a remaining limb between one, two, three, four, five, six, seven, eight, nine, ten, eleven, or twelve of these electrodes.

[0194] Various aspects of the present disclosure relate to methods of using the systems described herein, and include (a) providing the liners described herein, (b) inserting the remaining limbs into the gaps so that each electrode of the electrode array is in contact with the remaining limbs, (c) transmitting current between the first two electrodes of the electrode array via the remaining limbs, (d) transmitting current between the second two electrodes of the electrode array via the remaining limbs, (e) transmitting current between the third two electrodes of the electrode array via the remaining limbs, and (f) transmitting current between the fourth two electrodes of the electrode array via the remaining limbs. In some embodiments, the electrodes of the first two electrodes, the second two electrodes, the third two electrodes, and the fourth two electrodes are each independently selected from four, five, six, seven, or eight different electrodes of the electrode array, so that the first two electrodes, the second two electrodes, the third two electrodes, and the fourth two electrodes each consist of two different electrodes. In some specific embodiments, the first two electrodes consist of a first electrode and a second electrode, the second two electrodes consist of a second electrode and a third electrode, the third two electrodes consist of a third electrode and a fourth electrode, and the fourth two electrodes consist of a fourth electrode and a first electrode.

[0195] Various aspects of this disclosure relate to a system for regulating nerve activation in the remaining limb of an amputee, comprising a polymer liner, a wire at least partially embedded in the polymer liner, and an electrode array partially embedded in the liner. (1) The liner comprises silicone, polyurethane, or thermoplastic elastomer. (2) The liner is a single, integrated structure comprising a tube containing a wall, a closed end continuous with the wall, an edge defining the end of the wall, a two-dimensional open end bounded by the edge, and a three-dimensional void bounded by the closed end, the wall, and the open end. (3) The gap is configured to receive the remaining limb through the open end, (4) The liner comprises a concave inner surface and a convex outer surface of the tube, and the edge defines the boundary between the concave inner surface and the convex outer surface. (5) The liner comprises one or more wire apertures surrounding the wire, and the wire exits the liner through one or more wire apertures. (6) Each wire of the wire is electrically connected to at least one electrode of the electrode array, (7) The inner surface of the polymer liner is provided with an electrode aperture for each electrode of the electrode array, each electrode aperture exposing the conductive surface of the electrode to either a void or a remaining limb within the void. (8) The liner is configured to receive the remaining limb, and each electrode of the electrode array is in electrical communication with the remaining limb. (9) The electrode array is configured such that, within the liner, each electrode of the electrode array is a paired electrode that can be paired with at least one other electrode of the electrode array, and when the electrode array is in electrical communication with the remaining limb, each paired electrode can (a) transmit current via the remaining limb to the negative electrode of the electrode array with which it is paired, and / or (b) receive current via the remaining limb from the positive electrode of the electrode array with which it is paired. (10) The electrode array is configured to stimulate the nerve fibers of the remaining limb by transmitting and receiving electric current through the remaining limb. (11) The electrode array is configured such that (a) two or more electrodes of the electrode array are activated, and (b) two or more electrodes are in electrical communication with the remaining limb, one of the two or more activated electrodes transmits a current through the remaining limb, and the other activated electrodes of the two or more activated electrodes receive the current transmitted through the remaining limb. (12) Each electrode in the electrode array is a stimulating electrode configured to transmit and / or receive an electric current that stimulates the Aβ nerve fibers of the remaining limb when the stimulating electrode is in electrical communication with the remaining limb, (13) Each electrode in the electrode array is configured to transmit, receive, or both transmit and receive a pulsed current having an amplitude of at least 30 milliamperes, and / or (14) The electrode array comprises four or more electrodes of the electrode array, each having at least one electrode ring, the electrode ring being paired with exactly two other electrodes of the electrode ring.

[0196] Various aspects of this disclosure relate to a system for regulating nerve activation in the remaining limb of an amputee, comprising a polymer liner, a wire at least partially embedded in the polymer liner, and an electrode array partially embedded in the polymer liner. (1) The liner comprises silicone, polyurethane, or thermoplastic elastomer. (2) The liner is non-conductive, (3) The liner is a single, integrated structure comprising a tube containing a wall, a closed end continuous with the wall, an edge defining the end of the wall, a two-dimensional open end bounded by the edge, and a three-dimensional void bounded by the closed end, the wall, and the open end. (4) The void is configured to receive the remaining limb, which exits the tube through the open end. (5) The polymer liner comprises a concave inner surface and a convex outer surface of the tube, and the edge defines the boundary between the concave inner surface and the convex outer surface. (6) The edge of the tube is provided with one or more wire apertures surrounding the wire, and the wire exits the polymer liner through the edge. (7) Since the wire exits the polymer liner via the edge, the wire is at least partially embedded in the polymer liner. (8) The inner surface of the polymer liner is provided with an electrode aperture for each electrode of the electrode array, each electrode aperture exposing the conductive surface of the electrode to either a void or a remaining limb within the void. (9) The electrode array is partially embedded in the polymer liner so that each electrode aperture exposes the conductive surface of the electrode to either the void or the remaining limb within the void. (10) Each electrode in the electrode array is a medical-grade carbon rubber electrode capable of conducting a pulsed current of at least 30 milliamperes, (11) Each electrode in the electrode array is electrically connected to at least one wire, (12) The electrode array comprises at least eight electrodes, (13) The four distal electrodes of the electrode array are positioned closer to the closed end of the tube than to the open end. (14) The four proximal electrodes of the electrode array are positioned between the four distal electrodes and the open end of the tube. (15) The polymer liner is configured to receive the remaining limbs so that each electrode of the electrode array is in electrical communication with the remaining limbs, (16) Each electrode in the electrode array is a paired electrode, paired with at least two other electrodes in the electrode array, so that the electrode array is in electrical communication with the remaining limb, each paired electrode can (a) transmit current via the remaining limb to the negative electrode of the electrode array to which it is paired, and / or (b) receive current via the remaining limb from the positive electrode of the electrode array to which it is paired. (17) The electrode array is configured to stimulate the Aβ nerve fibers of the remaining limb by transmitting and receiving current through the remaining limb, and / or (18) A polymer liner is a product manufactured by a process in which (a) a substrate containing wires and electrode arrays is placed in a mold, and (b) liquid polymer is injected into the mold, embedding the wires and electrode arrays in the polymer, thereby manufacturing a polymer liner.

[0197] Various aspects of this disclosure relate to a system for regulating nerve activation in the remaining limb of an amputee, comprising a liner, a wire at least partially embedded in the liner, and an electrode array partially embedded in the liner. (1) The liner is a tube comprising a wall, a closed end continuous with the wall, an edge defining the end of the wall, a two-dimensional open end bounded by the edge, and a three-dimensional void bounded by the closed end, the wall, and the open end. (2) The void is configured to receive the remaining limb, which exits the tube through the open end. (3) The liner comprises a concave inner surface and a convex outer surface of the tube, and the edge defines the boundary between the concave inner surface and the convex outer surface. (4) The liner is provided with one or more wire apertures for connecting wires to an external controller, (5) The inner surface of the liner is provided with an electrode aperture for each electrode of the electrode array, each electrode aperture exposing the conductive surface of the electrode to either a void or a remaining limb within the void. (6) The electrode array is partially embedded in the polymer liner so that each electrode aperture exposes the conductive surface of the electrode to either the void or the remaining limb within the void. (7) Each electrode in the electrode array is configured to conduct current, (8) Each electrode in the electrode array is electrically connected to at least one wire, (9) The polymer liner is configured to receive the remaining limb, and each electrode of the electrode array is in electrical communication with the remaining limb. (10) Each electrode in the electrode array is a paired electrode, paired with at least one other electrode in the electrode array, so that the electrode array is in electrical communication with the remaining limb, each electrode can (a) transmit current via the remaining limb to the negative electrode with which it is paired, and / or (b) receive current via the remaining limb to the positive electrode with which it is paired.

[0198] Various aspects of this disclosure relate to a system for regulating neural activity in the remaining limb of an amputee, comprising a liner including an electrode array, (1) The liner comprises a tube including walls, edges defining the ends of the walls, two-dimensional open ends bounded by the edges, and three-dimensional voids bounded by the walls, (2) The void is configured to receive the remaining limb, and each electrode of the electrode array is in electrical communication with the remaining limb. (3) The liner is provided with an electrode aperture for each electrode in the electrode array, each electrode aperture exposing the conductive surface of the electrode to either the void or the remaining limb within the void. (4) If each electrode in the electrode array is paired with at least one other electrode in the electrode array, and the electrode array is electrically connected to the remaining limb, then each electrode can (a) transmit current via the remaining limb to the negative electrode with which it is paired, and / or (b) receive current via the remaining limb to the positive electrode with which it is paired. (5) The electrode array is configured to stimulate the nerve fibers of the remaining limb by transmitting and receiving electrical currents through the remaining limb.

[0199] Figure 10 shows how to use the system described herein. The amputee first attaches the liner to their remaining limb so that each electrode in the electrode array is electrically connected to the remaining limb (1001), or attaches the cover to their prosthesis (1002). After the amputee attaches the liner to their remaining limb 1001 (1001), the amputee instructs the controller to transmit current to one electrode and receive current from the remaining limb to the other electrode (1003). The controller may be either an electrode controller or a secondary controller as described herein. After attaching the cover to the prosthesis (1002), by contacting one or more sensors on the sensor array of the cover, current is transmitted to one electrode and received from the remaining limb to the other electrode (1004). By transmitting current to the remaining limb, the Aβ nerve fibers in the remaining limb are stimulated (1006), which can treat one or more symptoms of phantom limb syndrome as described herein. Conveniently, even after removing the prosthesis from the remaining limb 1007, the amputee can instruct the controller to transmit an electric current to the remaining limb (1003), and can also transmit an electric current to the remaining limb by contacting one or more sensors (1004), thereby treating the symptoms of phantom limb syndrome when the amputee is not wearing the prosthesis, for example, after the amputee has removed the prosthesis for sleep. Repeated use of the system over a period of time is generally effective in reducing the chronic symptoms of phantom limb syndrome, as assessed, for example, on a visual analog scale, independently of treating acute symptoms, by generating an electric current in the remaining limb (1008). Without limiting the claims arising from this specification or this disclosure, the reduction of the chronic symptoms of phantom limb syndrome (1008) is caused by neuroplastic-driven cortical remapping in the somatosensory cortex of the brain, which can be assessed by scalp electroencephalography (EEG).

[0200] In some embodiments, the method includes simultaneously performing a scalp EEG on a limb amputee and generating an electrical recording by transmitting a current from a first positive electrode to a first negative electrode via the remaining limb during the EEG.

[0201] In some embodiments, the method includes performing an EEG on an amputee while simultaneously transmitting an electric current from the positive electrode of an electrode array to the negative electrode of an electrode array via the remaining limb during the EEG, generating an electrocardiogram showing activation of the somatosensory cortex in response to the current, and the system is configured such that the areas that process sensation in the missing body part show activation in response to the current in the electrocardiogram. In some specific embodiments, performing an EEG on an amputee while simultaneously transmitting an electric current via the remaining limb is performed over a period of time, such as at least 28 days, after the amputee first begins using the system. In some even more specific embodiments, the method includes transmitting an electric current via the remaining limb over a period of time, such as at least 28 days, by bringing one or more sensors of a sensor array into contact with the remaining limb, and the EEG is performed after that period.

[0202] In some embodiments, the method includes performing an EEG on a limb amputee simultaneously, transmitting a current from a first positive electrode to a first negative electrode via the remaining limb during the EEG, and generating an electrorecording showing activation of the somatosensory cortex in response to the current; the method includes performing an EEG on a limb amputee simultaneously, transmitting a current from a second positive electrode to a second negative electrode via the remaining limb during the EEG, and generating an electrorecording showing activation of the somatosensory cortex in response to the current; the system is configured such that the first positive and first negative electrodes activate a first location in the somatosensory cortex, and the second positive and second negative electrodes activate a second location in the somatosensory cortex; and the electrorecording shows that the current transmitted from the first positive electrode to the first negative electrode via the remaining limb activates a different region of the somatosensory cortex than the current transmitted from the second positive electrode to the second negative electrode via the remaining limb. In some specific embodiments, the method includes contacting first sensors corresponding to a first positive and first negative electrode and periodically transmitting an electric current through the remaining limb over a period of time, such as a period of at least 28 days; and the method includes contacting second sensors corresponding to a second positive and second negative electrode and periodically transmitting an electric current through the remaining limb over the same period, after which an EEG examination is performed. Without limiting the claims arising from this specification or this disclosure, somatosensory cortical neural modulation by the systems of this disclosure can be detected by EEG.

[0203] In some embodiments, the method includes performing a specific process using at least one controller or electronic device (e.g., a computer). In some embodiments, the method includes performing various programs for applying electrical stimulation to a remaining limb, including transcutaneous electroneurotherapy or electromuscular stimulation. The electronic device may include any electronic device known in the art, including wearable devices and user devices (e.g., smartphones, laptops, tablets, personal computers, desktop computer devices).

[0204] Another example of a user device may include a server computer device that can communicate with other electronic devices (e.g., via the Internet). In some implementations, the computer device may also include medical devices such as external wearable computer devices (e.g., Holter ECG monitors). Medical devices may also include implantable medical devices such as pacemakers, electrodefibrillators, and defibrillators. Another example of a user device may include home computer devices such as Internet of Things (IoT) devices (e.g., IoT devices), smart TVs, smart speakers, smart displays (e.g., video call displays), hubs (e.g., wireless communication hubs), security systems, smart appliances (e.g., thermostats and refrigerators), and fitness equipment.

[0205] An electronic device associated with a user may include one or more of the following functions: 1) measurement of physiological data, 2) storage of measurement data, 3) processing of data, 4) providing output to the user based on the processed data (e.g., via a GUI), and 5) communication of data between and / or with other computer devices. Various electronic devices may perform one or more of these functions.

[0206] Some electronic devices may measure the user's physiological parameters, such as photoplethysmography waveforms, continuous skin temperature, pulse wave waveforms, respiratory rate, heart rate, heart rate variability (HRV), actigraphy, skin electrical response, pulse oximetry, blood oxygen saturation (SpO2), blood glucose levels (e.g., glucose metrics), and / or other physiological parameters. Some electronic devices that measure physiological parameters may perform some or all of the calculations described herein. Some electronic devices may not measure physiological parameters and may perform some or all of the calculations described herein. For example, a mobile device application or a server computer device may process physiological data measured and received by another device. SpO2

[0207] In some embodiments, a user may operate or be associated with multiple electronic devices, some of which may measure physiological parameters, and some of which may process the measured physiological parameters. In some implementations, a user may have an electronic device that measures physiological parameters. A user may also have a user device (e.g., a mobile device, a smartphone), which may be associated with the user device, and the electronic devices and user devices are connected to each other in a communicative manner. In some cases, the user device may receive data from the electronic device and perform some or all of the calculations described herein. In some implementations, the user device may also measure physiological parameters (e.g., behavioral / activity parameters) described herein.

[0208] Figure 11 shows a diagram of a system 1100 including a device 1105 supporting a residual limb electrical stimulation system and method according to an aspect of the present disclosure. Device 1105 may be an example of the system described herein, or may include components of the system. Device 1105 may include components for bidirectional data communication, including components for sending and receiving communications, e.g., a matching manager 1120, an I / O controller (e.g., an I / O controller 1110), a database controller 1115, at least one memory 1125, at least one processor 1130, and a database 1135. These components may communicate electronically via one or more buses (e.g., bus 1140), or may be connected in other ways (e.g., operational, communicative, functional, electronic, or electrically).

[0209] The I / O controller 1110 can manage input signals 1145 and output signals 1150 for device 1105. The I / O controller 1110 may also manage peripherals not integrated into device 1105. In some cases, the I / O controller 1110 may represent a physical connection or port to an external peripheral. In some cases, the I / O controller 1110 may utilize an operating system such as iOS®, ANDROID®, MS-DOS®, MS-WINDOWS®, OS / 2®, UNIX®, LINUX®, or other known operating systems. In other cases, the I / O controller 1110 may represent and interact with a modem, keyboard, mouse, touchscreen, or similar device. In some cases, the I / O controller 1110 may be implemented as part of processor 1130. In some examples, the user may interact with the device 1105 via the I / O controller 1110 or via hardware components controlled by the I / O controller 1110.

[0210] The database controller 1115 can manage data storage and processing in the database 1135. In some cases, a user can interact with the database controller 1115. In other cases, the database controller 1115 can operate automatically without user interaction. The database 1135 may be a single database, a distributed database, multiple distributed databases, a data store, a data lake, or an emergency backup database.

[0211] Memory 1125 may include random access memory (RAM) and read-only memory (ROM). Memory 1125 can store computer-readable and computer-executable software, including instructions that cause at least one processor 1130 to perform the various functions described herein at runtime. In some cases, memory 1125 may include a basic I / O system (BIOS) that can control the operation of basic hardware or software, such as interactions with peripheral components or devices. Memory 1125 may be a single memory or, for example, multiple memories. For example, device 1105 may include one or more memories 1125.

[0212] The processor 1130 may include intelligent hardware devices (e.g., general-purpose processors, digital signal processors (DSPs), central processing units (CPUs), microcontrollers, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), programmable logic devices, discrete gate or transistor logic components, discrete hardware components, or any combination thereof). In some cases, the processor 1130 may be configured to operate a memory array using a memory controller. In other cases, the memory controller may be integrated into the processor 1130. The processor 1130 may be configured to execute computer-readable instructions stored in at least one memory 1125 to perform various functions (e.g., functions or tasks that support stimulus systems and methods). The processor 1130 may be a single processor or an example of multiple processors. For example, device 1105 may include one or more processors 1130.

[0213] The stimulation manager 1120 can support data processing according to the examples disclosed herein. For example, the stimulation manager 1120 can be configured to support receiving sensor feedback for electrical stimulation or biomeasurements from electrodes from a computer device associated with an electrode controller, control pack, or sensor to a server. The stimulation manager 1120 can be configured to support generating activity, results, and measurements of a stimulation program. The stimulation manager 1120 can be configured to support determining whether to modify, repeat, or omit a stimulation program. The stimulation manager 1120 can be configured to support communicating the results of determining whether to modify, repeat, or omit a stimulation program.

[0214] In some embodiments, the system includes a processor, a memory that electronically communicates with the processor, and instructions stored in the memory and executable by the processor, which cause the device to transmit an electric current through the remaining limb using an electrode controller that is electrically connected to electrodes in a prosthetic liner substrate, and to stimulate Aβ nerve fibers in the remaining limb in response to the transmission of the electric current using the electrodes.

[0215] In some embodiments, the disclosed technology is In the processor, a) Using an electrode controller that is electrically connected to electrodes in the prosthetic limb liner substrate, to transmit electric current through the remaining limb of the amputee, and b) Stimulating the Aβ nerve fibers of the remaining limb in response to the transmission of current using electrodes, Includes non-temporary computer-readable media containing instructions for executing [something]. The processor further, Using at least one sensor, physiological parameters are detected. Physiological data is measured from physiological parameters. The measured physiological data is stored, Process the measured physiological data, The system may be configured to provide output to the user or another computer device in response to the processing of the measured physiological data.

[0216] It should be noted that the methods described above describe possible embodiments, and that the operations and steps may be rearranged, omitted, or otherwise modified, and that other embodiments are possible. Furthermore, two or more aspects of the methods may be combined.

[0217] The descriptions provided herein, together with the accompanying drawings, describe exemplary configurations and do not represent all implementable examples or examples within the scope of the claims. The term “exemplary” as used herein means “serving as an example, case, or illustration,” and does not mean “preferred” or “advantageous over another example.” Detailed descriptions include specific details for the purpose of providing an understanding of the described techniques; however, these techniques are implementable without these specific details. In some cases, well-known structures and devices are shown in block diagram form to avoid any room for obscuring the concepts of the described examples.

[0218] In the attached drawings, similar components or features may have the same reference label. Furthermore, components of the same type may be distinguished by a dash following the reference label and a second label that distinguishes similar components. Where a first reference label is used in the specification, its description may apply to any one of the similar components having the same first reference label, regardless of the second reference label.

[0219] The information and signals described here can be represented using a variety of technologies and methods. For example, the data, instructions, commands, information, signals, bits, symbols, and chips referenced throughout the above description can be represented by voltage, current, electromagnetic waves, magnetic fields or particles, light fields or particles, or any combination thereof.

[0220] The various exemplary blocks and modules described herein can be implemented or run by a general-purpose processor, DSP, ASIC, FPGA or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. The general-purpose processor may be a microprocessor, but alternatively, the processor may be any conventional processor, controller, microcontroller, or state machine. The processor may be implemented as a combination of computer devices (e.g., a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration).

[0221] The functions described herein can be implemented by hardware, software executed by a processor, firmware, or any combination thereof. When implemented by software executed by a processor, the functions can be stored or transmitted as one or more instructions or codes on a computer-readable medium. Other examples and implementations are within the scope of this disclosure and the accompanying claims. For example, due to the nature of the software, the functions described above can be implemented using software executed by a processor, hardware, firmware, hardwiring, or any combination thereof. Features for implementing the functions can be physically installed in various locations, and some of the functions are distributed so that they are implemented in different physical locations.

[0222] Furthermore, as used herein (including in the claims), "or" used in a list of items (e.g., a list of items beginning with a phrase such as "at least one" or "one or more") indicates an inclusive list, for example, a list of at least one A, B, or C means A or B or C or AB or AC or BC or ABC (i.e., A and B and C). Also, as used herein, the phrase "based on" should not be interpreted as a reference to a closed set of conditions. For example, an exemplary step described as "based on condition A" may be based on both condition A and condition B without departing from the scope of this disclosure. In other words, as used herein, the phrase "based on" should be interpreted in the same way as the phrase "based on at least part."

[0223] Computer-readable media include both non-temporary computer storage media and communication media, and any media that facilitates the transfer of computer programs from one location to another. Non-temporary storage media may be any available media accessible by a general-purpose computer or a dedicated computer. For example, but not limited to, non-temporary computer-readable media may include RAM, ROM, electrically erasable programmable ROM (EEPROM), compact disk (CD)ROM or other optical disk storage devices, magnetic disk storage devices or other magnetic storage devices, or any other non-temporary media that can be used to carry or store desired program code means in the form of instructions or data structures, and that can be accessed by a general-purpose computer or a dedicated computer, or a general-purpose processor or a dedicated processor. Any connection is also appropriately referred to as computer-readable media. For example, if software is transmitted from a website, server, or another remote source using coaxial cable, fiber optic cable, twisted pair cable, digital subscriber line (DSL), or wireless technologies such as infrared, radio, or microwave, then coaxial cable, fiber optic cable, twisted pair cable, DSL, or wireless technologies such as infrared, radio, or microwave are included in the definition of media. The terms "disk" as used herein include CDs, laserdiscs, optical discs, digital multipurpose discs (DVDs), floppy disks, and Blu-ray discs, where discs typically reproduce data magnetically, and discs reproduce data optically using a laser. Combinations of the above are also included within the scope of computer-readable media.

[0224] As used here (including in claims), the article “a” preceding a noun is open-ended and is understood to refer to “at least one” of those nouns or “one or more” of those nouns. Thus the terms “a,” “at least one,” “one or more,” and “at least one of one or more” are interchangeable. For example, if a claim states “a component” that performs one or more functions, each of the individual functions may be performed by a single component or by any combination of multiple components. Thus the term “a component” having a characteristic or performing a function may refer to “at least one of one or more components” having a particular characteristic or performing a particular function. A component introduced with the article “a” followed by the term “the” or “said” may refer to any or all of one or more components. For example, a component introduced with the article “a” may be understood to mean “one or more components,” and later referring to “the component” in a claim is understood to be equivalent to meaning “at least one of one or more components.” Similarly, referring to a component introduced as "one or more components" using the term "the" or "said" may refer to any or all of the one or more components. For example, referring to "one or more components" in a claim is understood to be equivalent to referring to "at least one of the one or more components."

[0225] The descriptions herein are provided to enable those skilled in the art to implement or use the disclosure. Various modifications to the disclosure will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other modifications without departing from the scope of the disclosure. Thus, the disclosure is not limited to the examples and designs described herein, and the broadest scope that is consistent with the principles and novel features disclosed herein should be accepted.

[0226] The following examples illustrate hypothetical pilot clinical trials to illustrate specific aspects of the Disclosure, and the examples should not be construed as limiting the Disclosure or any claims arising therefrom.

[0227] (Example) Pilot clinical trials have demonstrated that transcutaneous electrical stimulation of the remaining limb in response to touching the prosthetic limb can alleviate symptoms of phantom limb syndrome.

[0228] A group of 15 amputees experiencing symptoms of phantom limb syndrome as a result of limb amputation is enrolled in a pilot clinical trial. Each participant has a healthy limb that corresponds to the amputated limb. Participants assess their pain levels associated with phantom limb syndrome using a visual analog scale.

[0229] Each subject is provided with a system as described in the detailed explanation. In short, the system comprises a prosthetic cover containing a sensor array, which controls the activation of an electrode array in a liner that is fitted over the remaining limb of the amputee.

[0230] Each subject is fitted with a liner, ensuring that each electrode in the electrode array is electrically connected to their remaining limb. Each subject has an existing prosthesis, which is fitted with a cover containing a sensor array.

[0231] Each subject is fitted with EEG electrodes. Various areas of the healthy limb are touched by the researcher, and the electrophoresis of the healthy limb is recorded. Then, with each subject wearing their existing prosthesis, various areas of the prosthetic cover are touched by the researcher, driving an electric current through the remaining limb, and the electrophoresis of the prosthetic cover is recorded. The subjects are instructed to observe how the healthy limb and the cover come into contact. The various areas of the healthy limb and the cover that are touched correspond to each other spatially and temporally.

[0232] Each subject is instructed to apply pressure to their healthy limb in the same spatial and temporal patterns as the researchers, while focusing their gaze on the area of ​​applied pressure, and an electrophysiogram is recorded. The subjects are also instructed to apply pressure to their prosthetic limb cover in the same spatial and temporal patterns as the researchers, while focusing their gaze on the area of ​​applied pressure, and an electrophysiogram is recorded.

[0233] Each participant is then instructed to take the system home. Participants are given written instructions to apply pressure daily to their healthy limb and prosthetic cover in spatial and temporal patterns, and to apply pressure to the prosthetic cover in response to symptoms of phantom limb syndrome, and as needed. System usage is recorded in computer memory by the system. Each participant is also instructed to assess their pain level related to phantom limb syndrome daily using a visual analog scale, both before and after performing the written instructions.

[0234] Four weeks later, each subject returns for a follow-up EEG. This is performed using substantially the same spatial and temporal contact patterns as those used for the initial EEG described above, for both the healthy limb and the prosthesis. The initial and follow-up EEGs are identical for each healthy limb. The initial and follow-up EEGs differ significantly for each amputated limb. In subjects with leg amputations, the differences are greater for gamma waves detected near the medial region of the somatosensory cortex. The magnitude of the differences between the initial and follow-up EEGs correlates with the frequency of system use as recorded by the system. These results indicate that the intervention results in a neuroplasticity-driven cortical remapping in the subjects.

[0235] Four weeks after the intervention, all subjects reported lower levels of phantom limb pain on the visual analog scale compared to before the intervention, indicating the long-term effectiveness of the intervention. The magnitude of pain reduction reported on the visual analog scale correlated with the frequency of system use recorded by the system. Four weeks after the intervention, all subjects reported lower levels of phantom limb pain on the visual analog scale after the implementation of the spatial and temporal pattern intervention compared to immediately before the intervention, indicating the acute efficacy of the intervention.

Claims

1. A system for regulating neural activity in the remaining limb of a person who has had an amputation, The prosthetic limb liner includes a polymer substrate containing multiple electrodes, The prosthetic liner is configured to receive the remaining limb, Each electrode within the polymer substrate is electrically connected to the remaining limbs. A system in which multiple electrodes are configured to stimulate Aβ nerve fibers in the remaining limb by transmitting an electric current through the remaining limb using an electrode controller that is electrically connected to each electrode.

2. Amputees often exhibit phantom limb syndrome. The system according to claim 1, wherein the system is configured such that the electric current treats one or more symptoms of phantom limb syndrome.

3. The system according to claim 1, wherein the multiple electrodes have a three-dimensional electrode configuration relative to the liner.

4. The system according to claim 3, wherein the multiple electrodes are arranged in a ring shape including an anterior-lateral-proximal electrode, a posterior-lateral-proximal electrode, a posterior-medial-proximal electrode, and an anterior-medial-proximal electrode, surrounding the remaining limb.

5. The system according to claim 1, wherein the current is a pulsed current.

6. The system according to claim 1, wherein the pulsed current has a pulse frequency of at least 20 pulses / second and up to 180 pulses / second, a pulse width of up to 100 microseconds, and an amplitude of up to 100 milliamperes.

7. The system according to claim 1, further comprising a secondary controller in wireless communication with a plurality of electrodes configured to transmit current to one or more electrodes to the remaining limb.

8. The secondary controller is a mobile computer device, The secondary controller is in wireless communication with the electrode array. The system according to claim 7, wherein wireless communication is mediated by either a Bluetooth connection or a Wi-Fi connection between a mobile computer device and a plurality of electrodes, or both.

9. The system according to claim 1, wherein the liner is a polymer liner comprising a polymer selected from silicone, polyurethane, and thermoplastic elastomer.

10. The system according to claim 1, wherein the prosthetic limb liner is molded onto a substrate.

11. The substrate further includes a conductor, The system according to claim 1, wherein the conductor is a wire or a conductive material.

12. A method for regulating neural activity in the remaining limb of a person who has had an amputation, A step of preparing a system with a prosthetic limb liner, wherein the prosthetic limb liner includes a polymer substrate having a plurality of electrodes that are in electrical communication with an electrode controller, and is configured to be attached to the remaining limb so that the plurality of electrodes are in electrical communication with the remaining limb; The steps include: transmitting current via the remaining limbs using an electrode controller that is electrically connected to each electrode; A method comprising the steps of stimulating Aβ nerve fibers of a remaining limb in response to the transmission of an electric current using multiple electrodes.

13. The method according to claim 12, further comprising the step of stimulating the muscles of the remaining limb in response to transmitting an electric current using a plurality of electrodes.

14. Amputees often exhibit phantom limb syndrome. The method according to claim 12, further comprising the step of treating one or more symptoms of phantom limb syndrome using the transmission of electric current.

15. The method according to claim 12, further comprising the step of transmitting a pulsed current.

16. The method according to claim 12, further comprising the step of transmitting a pulsed current having a pulse frequency of at least 20 pulses / second and up to 180 pulses / second, a pulse width of up to 100 microseconds, and an amplitude of up to 100 milliamperes.

17. The method according to claim 12, further comprising the step of transmitting current to the remaining limb using a secondary controller that wirelessly communicates with the electrode controller.

18. A system for regulating neural activity in the remaining limb of a person who has had an amputation, A user interface configured to receive input from amputees and display output, Processor and A memory that electronically communicates with the processor, Instructions stored in memory and executable by a processor, provided for the device, a) Transmitting electric current through the remaining limb using an electrode controller that is electrically connected to electrodes in the prosthetic limb liner substrate, and b) Stimulating the Aβ nerve fibers of the remaining limb in response to the transmission of electric current using electrodes, A system that includes commands to execute [something].

19. In the processor, a) Using an electrode controller that is electrically connected to electrodes in the prosthetic limb liner substrate, to transmit electric current through the remaining limb of the amputee, and b) Stimulating the Aβ nerve fibers of the remaining limb in response to the transmission of electric current using electrodes, A non-temporary computer-readable medium containing instructions to execute something.

20. The processor is, Using at least one sensor, physiological parameters are detected. Physiological data is measured from physiological parameters. The measured physiological data is stored, Process the measured physiological data, A non-temporary computer-readable medium according to claim 19, which provides output to a user or another computer device in response to processing of measured physiological data.

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