Systems and Methods for Residual Limbs of Amputees

Abstract

The present disclosure relates to a prosthetic cover having a sensor array that transmits signals to an electrode array within a liner that fits over a stump of an amputee. Through various interactions with the prosthetic cover, various activations of the electrodes are caused, currents are transmitted to various regions of the stump, and neurons within the stump are modulated in various ways.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the priority of U.S. Patent Application No. 18 / 296,970, filed on April 6, 2023, U.S. Patent Application No. 18 / 296,972, filed on April 6, 2023, and U.S. Provisional Patent Application No. 63 / 348,967, filed on June 3, 2022, and the entire contents of these applications are incorporated herein by reference.

Background Art

[0002] Amputees are frequently troubled by phantom limb syndrome, which involves experiencing sensations due to missing limbs. These sensations are generally unpleasant, often accompanied by pain, and in some cases, debilitating.

[0003] Phantom limb syndrome can be treated by mirror therapy, which provides a visual representation of the missing limb by placing a mirror between the intact limb and the missing limb. When the patient moves the intact hand or foot, it appears as if both hands or feet are moving simultaneously. This enables the patient to visually represent the lost limb, and over time with repeated treatment, the patient may start to feel the lost limb. However, clinical studies of mirror therapy have not demonstrated a statistically significant effect in reducing pain.

[0004] Other non - pharmacological interventions for reducing the symptoms of phantom limb syndrome are still desirable.

Summary of the Invention

[0005] Various aspects of the present disclosure relate to the discovery that neural feedback from interactions with a prosthesis can help alleviate the symptoms of phantom limb syndrome. Some embodiments relate to a prosthetic cover including a sensor array that transmits signals to an electrode array within a liner worn on the residual limb of an amputee. Different interactions with the prosthetic cover result in different activations of the electrodes, different currents being transmitted to different regions of the residual limb, and different modulations of the neurons within the residual limb. Thus, the amputee can interact with the prosthetic device by touching the cover, observing the interaction, and reacting tactilely to adjust various neurons. Although not limiting the specification or the claims of this application, simultaneous sensory feedback from touch, vision, and current advantageously induces neuroplasticity in the somatosensory cortex of the amputee's brain, creates a new topographical map of the prosthesis through repeated interactions, and reduces the symptoms of phantom limb syndrome. Also, although not limiting the specification or the claims of this application, the new topographical map allows the amputee to associate specific symptoms of phantom limb syndrome with specific interactions with the prosthetic cover, whereby the amputee can treat the specific symptoms that occur through the specific interactions.

[0006] Various other aspects of the invention of the present disclosure will become apparent from the following detailed description and the claims. The scope of the present disclosure is not limited by the foregoing summary and background. Each claim of this application is not limited by the foregoing summary and background or the following detailed description, and each claim of this application is limited only by the explicit language of the claim in the context of the claim.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0008] The technology disclosed herein includes systems and methods for treating phantom limb syndrome by treating the symptoms of phantom limb pain and increasing the proprioceptive sense of amputees' prosthetic limbs.

[0009] After amputation of a limb, amputees may report the perception of sensations in the missing limb, known as phantom limb sensation (PLS). They may also experience pain or discomfort in the missing limb, called phantom limb pain (PLP). In extreme cases, PLP can be debilitating.

[0010] Various aspects of the present disclosure relate to a prosthesis cover (prosthetic cover or prosthetic limb cover) that includes a sensor array that transmits signals to an electrode array within a liner that conforms to the residual limb of an amputee. Different interactions with the prosthetic limb cover result in different activations of the electrodes, different currents being transmitted to different regions of the residual limb, and different modulations of the neurons within the residual limb. As a result of the interaction with the prosthetic limb cover, electrical stimulation of the underlying nerve fibers provides the amputee with the ability to feel a stimulus. This stimulation can evoke somatic sensation either alone or in combination with other PLP treatment applications (e.g., artificial visualization such as mirror therapy). As a result, the amputee may perceive the missing limb as intact and / or functional, and the PLP may be reduced or eliminated.

[0011] In some embodiments, the interaction with the prosthetic cover is any interaction, event, or pattern sensed by a sensor that causes activation of the electrodes. In some embodiments, the modality is a touch modality such as touch, force, pressure, flutter, vibration, etc.

[0012] Various aspects of the present disclosure relate to a system used by an amputee. In some embodiments, the system is for regulating the neural activation of the amputee's residual limb.

[0013] In some embodiments, the system includes a liner. In some specific embodiments, the system includes a liner that consists of an electrode array. In some very specific embodiments, the system includes a liner that includes an embedded array of electrodes. The liner is generally composed of a non-conductive polymer such as silicone.

[0014] In some embodiments, the system consists of an electrode array. In some specific embodiments, the system consists of an electrode array embedded in a liner. The electrode array can be embedded, for example, in a silicon liner. Generally, any medical-grade electrode capable of passing a pulsed current of at least 30 milliamperes is suitable for use in the systems and methods described herein. In some specific embodiments, the electrodes are suitable for transcutaneous electrical nerve stimulation. In very specific embodiments, the electrodes are carbon rubber electrodes.

[0015] The electrodes of the present disclosure are generally suitable for continuous and long-term contact with human skin, which contact is optionally mediated by a conductive gel. In some embodiments, continuous and long-term contact refers to continuous contact for at least 2 hours. In some specific embodiments, continuous and long-term contact refers to continuous contact for at least 12 hours. In some very specific embodiments, continuous and long-term contact refers to continuous contact for at least 48 hours.

[0016] In some embodiments, the liner is a single integral structure. In some specific embodiments, the liner is a single integral structure in which the electrode array is embedded. In some very specific embodiments, the liner is a single integral structure in which the electrode array and wires are embedded, and each electrode of the electrode array is connected to at least one wire such that the wire can mediate electrical communication between the electrode array and the electrode controller. The electrodes can be composed of, for example, 2-millimeter pin connectors for making electrical communication between the electrode and the wire. The liner can be formed, for example, by providing a substrate that constitutes the electrodes and wires, inserting the substrate into a mold, and pouring liquid silicone into the mold such that the electrodes and wires are embedded in the silicone.

[0017] The liner is generally configured to receive the residual limb of an amputee. In some specific embodiments, the liner is configured to receive the residual limb such that each electrode of the electrode array is in electrical communication with the residual limb. A conductive gel can be applied, for example, between the electrodes of the electrode array and the residual limb to facilitate electrical communication between the electrodes and the residual limb.

[0018] The present disclosure and the claims should not be construed as suggesting that the systems of the present disclosure or the claims include an amputee, a residual limb, nerve fibers, etc. Also, if there is explicit language stating that the system is composed of an amputee, a residual limb, nerve fibers, etc., such explicit language shall be limited to its direct context and shall not be used in the interpretation of other parts of the present disclosure lacking such explicit language or in the interpretation of the claims maturing from the present disclosure and lacking such explicit language.

[0019] In some embodiments, each electrode of the electrode array, when the electrode array is in electrical communication with the residual limb, each electrode is (1) paired with at least two other electrodes of the electrode array such that the electrode can transmit current through the residual limb to both a first negative electrode with which the electrode is paired and, independently, a second negative electrode with which the electrode is paired, and (2) can receive current through the residual limb from both a first positive electrode with which the electrode is paired and, independently, a second positive electrode with which the electrode is paired. In such embodiments, each electrode of the electrode array can transmit current through at least two other electrodes and / or receive current from at least two other electrodes, for example, to provide different current paths through the residual limb in response to different sensors and / or to differentially modulate the nerve fibers of the residual limb.

[0020] In some embodiments, the system is configured such that when (1) two or more electrodes are activated and (2) the two or more electrodes are in electrical communication with the residual limb, one of the two or more activated electrodes transmits a current through the residual limb and another of the two or more activated electrodes receives the current transmitted through the residual limb. In some specific embodiments, the system is configured such that when (1) two electrodes are activated and (2) the two electrodes are in electrical communication with the residual limb, one of the two activated electrodes transmits a current through the residual limb and the other of the two activated electrodes receives the current transmitted through the residual limb. An electrode is activated when it is transmitting and receiving current.

[0021] In some embodiments, the system includes an electrode controller that communicates electrically with each electrode of the electrode array.

[0022] In some embodiments, the electrode controller controls whether each electrode can transmit current to the negative electrode. In some embodiments, the electrode controller controls whether each electrode that can receive current receives current from the positive electrode. In some specific embodiments, the electrode controller controls both whether each electrode that can transmit current transmits current to the negative electrode and whether each electrode that can receive current receives current from the positive electrode. Thus, the electrode controller controls, for example, in response to different sensors, which electrodes of the electrode array transmit and receive current, this being, and / or, to transmit current through different regions of the residual limb.

[0023] In some embodiments, the electrode controller controls whether each electrode capable of transmitting current transmits current to one or both of the first negative electrode and the second negative electrode via the residual limb. In some embodiments, the electrode controller controls whether each electrode capable of receiving current receives current from one or both of the first positive electrode and the second positive electrode. In some specific embodiments, the electrode controller controls both whether each electrode capable of transmitting current transmits current to one or both of the first negative electrode and the second negative electrode via the residual limb and whether each electrode capable of receiving current receives current from one or both of the first positive electrode and the second positive electrode.

[0024] In some embodiments, the electrode controller controls the current transmitted and received by each electrode of the electrode array.

[0025] In some embodiments, the system regulates the nerve fibers of the residual limb by transmitting and receiving current via the residual limb. In some specific embodiments, the system stimulates the nerve fibers of the residual limb by transmitting and receiving current via the residual limb. In some highly specific embodiments, the system stimulates the myelinated Aβ nerve fibers of the residual limb by transmitting and receiving current via the residual limb. In some highly specific embodiments, the system regulates the activation of the myelinated Aδ nerve fibers of the residual limb by transmitting and receiving current via the residual limb. In some highly specific embodiments, the system regulates the activation of the unmyelinated C nerve fibers of the residual limb by transmitting and receiving current via the residual limb.

[0026] In some embodiments, the electrode array regulates the nerve fibers of the residual limb by transmitting and receiving current through the residual limb. In some specific embodiments, the electrode array stimulates the nerve fibers of the residual limb by transmitting and receiving current through the residual limb. In some highly specific embodiments, the electrode array stimulates the myelinated Aβ nerve fibers of the residual limb by transmitting and receiving current through the residual limb. In some very specific embodiments, the electrode array regulates the activation of the myelinated Aδ nerve fibers of the residual limb by transmitting and receiving current through the residual limb. In some very specific embodiments, the electrode array regulates the activation of the unmyelinated C nerve fibers of the residual limb by transmitting and receiving current through the residual limb.

[0027] In some embodiments, each electrode of the electrode array regulates the nerve fibers of the residual limb by transmitting and receiving current through the residual limb. In some specific embodiments, each electrode of the electrode array stimulates the nerve fibers of the residual limb by transmitting and receiving current through the residual limb. In some highly specific embodiments, each electrode of the electrode array stimulates the myelinated Aβ nerve fibers of the residual limb by transmitting and receiving current through the residual limb. In some very specific embodiments, each electrode of the electrode array regulates the activation of the myelinated Aδ nerve fibers of the residual limb by transmitting and receiving current through the residual limb. In some very specific embodiments, each electrode of the electrode array is configured to regulate the activation of the unmyelinated C nerve fibers of the residual limb by transmitting and receiving current through the residual limb.

[0028] In some embodiments, the current is a pulsed current.

[0029] In some embodiments, the pulsed current has a pulse frequency of at least 2 pulses per second and a maximum of 200 pulses per second. In some specific embodiments, the pulsed current has a pulse frequency of at least 20 pulses per second and a maximum of 180 pulses per second. In highly specific embodiments, the pulsed current has a pulse frequency of at least 135 pulses per second and a maximum of 155 pulses per second.

[0030] 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 very specific embodiments, the pulsed current has a pulse width of up to 50 microseconds.

[0031] 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 very specific embodiments, the pulsed current has an amplitude of at least 10 milliamperes and up to 30 milliamperes.

[0032] In some embodiments, the electrode array consists of 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 consists of at least 8 and up to 512 electrodes. In some specific embodiments, the electrode array consists of 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, 128, 256, or 512 electrodes. In some very specific embodiments, the electrode array consists of 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 consists of a plurality of additional electrodes not included in the electrode array.

[0033] In some embodiments, the system comprises one or more electrodes not included in the electrode array. The one or more electrodes not included may be, for example, electrodes not used for transmitting and / or receiving current to and / or from the residual limb, or electrodes that an infringer in the future might attempt to include in the system in an attempt to develop a non-infringing legal theory against the claims of this application.

[0034] In some embodiments, the system comprises a cover. In some specific embodiments, the system comprises a cover configured to receive a prosthesis (prosthesis or limb). In some very specific embodiments, the system comprises a cover configured to receive a prosthetic leg or arm.

[0035] In some embodiments, the system lacks a prosthesis. The present disclosure and the appended claims are not to be construed as suggesting that the system of the present disclosure or the appended claims includes a prosthesis unless expressly stated in the language, and if expressly stated in the language that the system includes a prosthesis, that express language is limited to its immediate context and is not to be used for the interpretation of other sections of the present disclosure where express language is absent or for the interpretation of claims that mature from the present disclosure and where express language is absent.

[0036] In some embodiments, the system includes a prosthesis.

[0037] In some embodiments, the cover is configured to cover the outer surface of the prosthesis.

[0038] In some embodiments, the system is made of a polymer foam. In some specific embodiments, the system is made of a polyurethane foam. In very specific embodiments, the system is made of a two-component polyurethane foam.

[0039] In some embodiments, the foam is configured to attach 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 very specific embodiments, the foam is configured to fix the cover to the prosthesis and fill the gap between the cover and the prosthesis.

[0040] In some embodiments, the foam contacts the inner surface of the cover. In some specific embodiments, the foam contacts the inner surface of the cover to fix the cover to the prosthesis. In very specific embodiments, the foam contacts the inner surface of the cover to fix the cover to the prosthesis and fill the gap between the cover and the prosthesis.

[0041] In some embodiments, the system is made of a polymer foam, and the cover is fixed to the prosthesis with the polymer foam. In some specific embodiments, the system is made of a polyurethane foam, and the cover is fixed to the artificial joint with the polyurethane foam. In some very specific embodiments, the system is made of a two-component polyurethane foam expansion foam, and the cover is fixed to the artificial joint with the two-component polyurethane foam expansion foam. For example, the cover can be attached to the prosthesis by placing the cover around the prosthesis and inserting polystyrene foam between the cover and the prosthesis to fill the gap between the cover and the prosthesis.

[0042] 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 use in attaching the cover to the prosthesis. In some very specific embodiments, the foam (or its components) is provided in one or more containers for use in fixing the cover to the prosthesis by inserting the foam (or its components) between the cover and the prosthesis to fill the gap between the cover and the prosthesis.

[0043] In some embodiments, the system comprises one or more containers containing an inflatable foam. In some specific embodiments, the system comprises one or more containers that are bags containing an inflatable foam. The inflatable foam may be provided, for example, within one or more containers that are bags, and the inflatable foam may be inflated within the one or more bags while the one or more bags are disposed between the prosthesis and the cover to fill the gap between the prosthesis and the cover, thereby fixing the cover to the prosthesis. Thus, the one or more bags are used, for example, to hold the inflatable foam within the gap between the prosthesis and the cover and / or to prevent the inflatable foam from entering the gaps within the prosthesis or the cover and / or to prevent the inflatable foam from exiting the cover.

[0044] In some embodiments, the system comprises one or more straps for fixing the cover to the prosthesis. The straps are used, for example, to position the cover relative to the prosthesis before inflating the foam within the gap between the prosthesis and the cover.

[0045] In some embodiments, the cover is composed of a sensor array.

[0046] In some embodiments, each sensor of the sensor array is configured to sense at least one modality (e.g., one or both of force and pressure). Each sensor may be, for example, a force sensing resistor.

[0047] In some embodiments, each sensor of the sensor array consists of a resistor configured to sense at least one modality (e.g., one or both of force and pressure). The exact type of modality sensor is not limited.

[0048] In some embodiments, the system is configured such that, for example, the amplitude of the current transmitted and received by the electrodes of the electrode array through the residual limb is directly correlated with a modality (e.g., pressure or force) sensed by the sensor, and an increase in the modality (e.g., an increase in pressure or force) correlates with an increase in the amplitude.

[0049] In some embodiments, the electrode array is in communication with a sensor array such that, in response to sensing by one or more sensors, two or more electrodes are activated. In some specific embodiments, the electrode array is in communication with the sensor array such that, in response to sensing by one sensor, two electrodes are activated.

[0050] In some embodiments, each sensor corresponds to at least two electrodes. In some specific embodiments, each sensor corresponds to two electrodes.

[0051] In some embodiments, each electrode corresponds to at least one sensor. In some specific embodiments, each electrode corresponds to at least two sensors.

[0052] When the sensor senses a modality (e.g., force or pressure) and the electrodes are in electrical communication with the residual limb, the sensor corresponds to the electrodes if the sensor is in communication with the electrodes such that the electrodes transmit and receive current to and from the residual limb.

[0053] When the sensor senses a modality (e.g., force or pressure) and the electrodes are in electrical communication with the residual limb, the electrode corresponds to the sensor if the sensor is in communication with the electrodes such that the electrodes transmit and receive current to and from the residual limb.

[0054] In some embodiments, the sensor array has a sensor three-dimensional configuration with respect to the cover.

[0055] In some embodiments, the sensor array has a sensor three-dimensional configuration with respect to the outer surface of the prosthetic limb when the cover is attached to the outer surface of the prosthetic limb.

[0056] In some embodiments, the electrode array has a three-dimensional configuration of electrodes relative to the liner.

[0057] In some embodiments, the array of electrodes has a three-dimensional configuration of electrodes relative to the stump when each of the electrodes is in electrical communication with the stump.

[0058] In some embodiments, each sensor has a sensor relative position in a sensor three-dimensional arrangement relative to all other sensors of the sensor array; each electrode has an electrode relative position in an electrode three-dimensional configuration relative to all other electrodes of the electrode array; the system includes sensor-electrode pairs each consisting of one or more sensors and two or more electrodes, and these sensors and electrodes correspond to each other; and the sensor relative position of each sensor of the sensor-electrode pair within the sensor three-dimensional configuration correlates with the electrode relative position of each electrode of the same sensor-electrode pair within the electrode three-dimensional configuration. In some specific embodiments, the system consists of sensor-electrode pairs each consisting of one sensor and two electrodes, and these sensors and electrodes correspond to each other.

[0059] The relative position of the sensors is correlated with the relative position of the electrodes. For example, (a) when the sensor group consists of a front-proximal sensor, a front-distal sensor, a lateral-proximal sensor, a lateral-distal sensor, a rear-proximal sensor, a rear-distal sensor, a medial-proximal sensor, and a medial-distal sensor; (b) when the electrode group consists of a front-proximal electrode, a front-distal electrode, a lateral-proximal electrode, a lateral-distal electrode, a rear-proximal electrode, a rear-distal electrode, a medial-proximal electrode, and a medial-distal electrode; (c) when the sensor-electrode pair group consists of a front-proximal pair consisting of a front-proximal sensor and a front-proximal electrode, a front-distal pair consisting of a front-distal sensor and a front-distal electrode, a lateral-proximal pair consisting of a lateral-proximal sensor and a lateral-proximal electrode, a lateral-distal pair consisting of a lateral-distal sensor and a lateral-distal electrode, a rear-proximal pair consisting of a rear-proximal sensor and a rear-proximal electrode, a rear-distal pair consisting of a rear-distal sensor and a rear-distal electrode, a medial-proximal pair consisting of a medial-proximal sensor and a medial-proximal electrode, and a medial-distal pair consisting of a medial-distal sensor and a medial-distal electrode; (d) the relative sensor position of the front-proximal sensor is (1) closer to the front-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 rear-distal sensor, (3) closer to both the lateral-proximal sensor and the medial-proximal sensor than the rear-proximal sensor, and (4) closer to the rear-proximal sensor than the rear-distal sensor; in a relationship, (e) the relative electrode position of the front-proximal electrode is (1) closer to the front-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 rear-distal electrode, (3) closer to both the lateral-proximal electrode and the medial-proximal electrode than the rear-proximal electrode, and (4) closer to the rear-proximal electrode than the rear-distal electrode; in a relationship, (f) the relative position of the front-distal sensor is (1) closer to the front-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 rear-proximal sensor, (3) closer to both the lateral-distal sensor and the medial-distal sensor than the rear-distal sensor, and (4) the rear-distal sensor is closer to the rear-proximal sensor than the rear-proximal sensor;is related such that (g) the electrode relative position of the front - distal electrode is (1) closer to the front - proximal electrode than both the outer - proximal electrode and the inner - proximal electrode, (2) closer to both the outer - proximal electrode and the inner - proximal electrode than the rear - proximal electrode, (3) closer to both the outer - distal electrode and the inner - distal electrode than the rear - distal electrode, and (4) the rear - distal electrode is closer to the rear - proximal electrode than the front - distal electrode; is related such that (h) the sensor relative position of the inner - proximal sensor is (1) closer to the inner - distal sensor than both the front - distal sensor and the rear - distal sensor, (2) closer to both the front - distal sensor and the rear - distal sensor than the outer - distal sensor, (3) closer to both the front - proximal sensor and the rear - proximal sensor than the outer - proximal sensor, and (4) closer to the outer - proximal sensor than the outer - distal sensor; is related such that (i) the electrode relative position of the inner - proximal electrode is (1) closer to the inner - distal electrode than both the front - distal electrode and the rear - distal electrode, (2) closer to both the front - distal electrode and the rear - distal electrode than the outer - distal electrode, (3) closer to both the front - proximal electrode and the rear - proximal electrode than the outer - proximal electrode, and (4) closer to the outer - proximal electrode than the outer - distal electrode; is related such that (j) the sensor relative position of the inner - distal sensor is (1) closer to the inner - proximal sensor than both the front - proximal sensor and the rear - proximal sensor, (2) closer to both the front - proximal sensor and the rear - proximal sensor than the outer - proximal sensor, (3) closer to both the front - distal sensor and the rear - distal sensor than the outer - distal sensor, (4) closer to the outer - distal sensor than the outer - proximal sensor; is related such that (k) the electrode relative position of the inner - distal electrode is (1) closer to the inner - proximal electrode than both the front - proximal electrode and the rear - proximal electrode, (2) closer to both the front - proximal electrode and the rear - proximal electrode than the outer - proximal electrode, (3) closer to both the front - distal electrode and the rear - distal electrode than the outer - distal electrode, and (4) closer to the outer - distal electrode than the outer - proximal electrode; is related such that (l) the sensor relative position of the rear - proximal sensor is (1) closer to the rear - distal sensor than both the outer - distal sensor and the inner - distal sensor, (2) closer to both the outer - distal sensor and the inner - distal sensor than the front - distal sensor, (3) closer to both the outer - proximal sensor and the inner - proximal sensor than the front - proximal sensor, and (4) closer to the front - proximal sensor than the front - distal sensor;is related such that (m) 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; is related such that (n) the sensor relative 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; is related such that (o) 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) the anterior-distal electrode is closer than the anterior-proximal electrode; is related such that (p) 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, (4) closer to the medial-proximal sensor than the medial-distal sensor; is related such that (q) 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; is related such that (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;is related, and (s) the electrode relative position of the outer - distal electrode is (1) closer to the outer - proximal electrode than both the front - proximal electrode and the rear - proximal electrode, (2) closer to both the front - proximal electrode and the rear - proximal electrode than the inner - proximal electrode, (3) closer to both the front - distal electrode and the rear - distal electrode than the inner - distal electrode, and (4) closer to the inner - distal electrode than the inner - proximal electrode; is related.;

[0060] The above paragraph defines an exemplary correlation between each sensor relative position of the sensor three - dimensional arrangement and each electrode relative position of the electrode three - dimensional arrangement. The sensor relative positions of different sensor arrays can have a clear and analogous correlation with the electrode relative positions of different electrode arrays, for example, to enable different patterns of sensors and / or electrodes. The relative positions of the sensors are usually correlated with the relative positions of the electrodes. For example, a front sensor activates a front electrode, a rear sensor activates a rear electrode, an inner sensor activates an inner electrode, and an outer sensor activates an outer electrode. Thus, if the front of the below - knee prosthesis is pressed, current will flow through the front of the above - knee prosthesis, and if the back of the below - knee prosthesis is pressed, current will flow through the back of the above - knee prosthesis. Nevertheless, other patterns are also compatible with the systems of the present disclosure. Without limiting the claims from this specification or the present disclosure, the correlation of the relative positions of the electrodes paired with the sensors can facilitate topographic mapping and more effectively treat phantom limb syndrome.

[0061] In some embodiments, the three - dimensional configuration of the sensor defines a sensor surface, the three - dimensional configuration of the electrode defines an electrode surface, and the proximity is measured along the sensor surface and the electrode surface rather than in orthogonal space. In some embodiments, the sensor surface is the surface of a 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 a liner. In some specific embodiments, the electrode surface is the inner surface of the liner.

[0062] The adjectives anterior, lateral, posterior, medial, distal, and proximal indicate (1) the relative position of the sensor with respect to both the cover (or prosthesis) and other sensors, and (2) the relative position of the electrode with respect to both the liner (or residual limb) and other electrodes. The anterior-distal sensor, for example, is closer to the front surface of the cover (or prosthesis) than, for example, the lateral-distal sensor, the posterior-distal sensor, and the medial-distal sensor. The anterior distal sensor is at a lower position of the prosthetic cover of the leg or arm (or the prosthesis of the leg or arm), for example, than the anterior proximal sensor.

[0063] Terms such as anterior-proximal sensor, anterior-distal sensor, lateral-proximal sensor, lateral-distal sensor, posterior-proximal sensor, posterior-distal sensor, medial-proximal sensor, and medial-distal sensor shall be interpreted only for the purpose of specifying the relative position of the sensors, and shall not be interpreted to imply a three-dimensional configuration of the sensors, such as implying a regular grid, and shall not be interpreted to imply the presence or absence of other sensors in the sensor array.

[0064] 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 shall be interpreted only for the purpose of specifying the relative position of the electrodes, and shall not be interpreted to imply a three-dimensional configuration of the electrodes, such as implying a regular grid, and shall not be interpreted to imply the presence or absence of other electrodes in the electrode array.

[0065] In some embodiments, each sensor corresponds to exactly two electrodes, and each sensor - electrode pair is composed of (1) a 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 is composed of (1) a 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 of the two electrodes is a negative electrode configured to receive current from the positive electrode. In some very specific embodiments, each sensor corresponds to exactly two electrodes, and each sensor - electrode pair is composed of (1) a 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 residual limb, and the other of the two electrodes is a negative electrode configured to receive current from the positive electrode through the residual limb.

[0066] In some embodiments, the array of electrodes consists of at least one ring of electrodes, and the ring of electrodes consists of four or more electrodes, each of which pairs with exactly two other electrodes of the ring. In some specific embodiments, the array of electrodes consists of at least two, three, four, five, or six ring - shaped electrodes. In some very specific embodiments, the array of electrodes consists of at least eight electrodes and at least six ring - shaped electrodes. The anterior - proximal electrode, anterior - distal electrode, lateral - proximal electrode, and lateral - distal electrode are, for example, ring - shaped electrodes when the anterior - proximal electrode and the lateral - distal electrode pair with each other.

[0067] In some embodiments, at least one of the rings of electrodes is configured to surround the residual limb. The anterior - distal electrode, lateral - distal electrode, posterior - distal electrode, and medial - distal electrode are, for example, ring - shaped electrodes configured to surround the residual limb when the anterior - distal electrode and the posterior - distal electrode pair with the lateral - distal electrode and the medial - distal electrode, respectively. In some specific embodiments, at least two of the rings of electrodes are configured to surround the residual limb.

[0068] In some embodiments, the sensor array is composed of one, two, three, four, five, six, or seven sensors, or is composed of each of a front-proximal sensor, a front-distal sensor, an outer-proximal sensor, an outer-distal sensor, a rear-proximal sensor, a rear-distal sensor, an inner-proximal sensor, and an inner-distal sensor.

[0069] In some embodiments, the electrode array is composed of one, two, three, four, five, six, or seven electrodes, or is composed of each of a front-proximal electrode, a front-distal electrode, an outer-proximal electrode, an outer-distal electrode, a rear-proximal electrode, a rear-distal electrode, an inner-proximal electrode, and an inner-distal electrode.

[0070] In some embodiments, the sensor-electrode pair is composed of one pair, two pairs, three pairs, four pairs, five pairs, six pairs, or seven pairs, or is composed of each of a front-proximal pair consisting of a front-proximal sensor and a front-proximal electrode, a front-distal pair consisting of a front-distal sensor and a front-distal electrode, an outer-proximal pair consisting of an outer-proximal sensor and an outer-proximal electrode, an outer-distal pair consisting of an outer-distal sensor and an outer-distal electrode, a rear-proximal pair consisting of a rear-proximal sensor and a rear-proximal electrode, a rear-distal pair consisting of a rear-distal sensor and a rear-distal electrode, an inner-proximal pair consisting of an inner-proximal sensor and an inner-proximal electrode, and an inner-distal pair consisting of an inner-distal sensor and an inner-distal electrode. Each of the sensor-electrode pairs specified above also includes additional electrodes, and the front-proximal pair is also composed of, for example, one or more of a second front-proximal electrode, a front-distal electrode, an outer-proximal electrode, an inner-proximal electrode, or a completely different electrode.

[0071] In some embodiments, each sensor of the sensor array communicates with two or more electrodes of the electrode array such that when the sensor senses force or pressure, when two or more electrodes are in electrical communication with the residual limb, and when the prosthetic limb is removed from the residual limb, the two or more electrodes transmit and receive current through the residual limb. With such a configuration, when the amputee is not wearing the prosthetic limb with the cover, for example, after the amputee has removed such a prosthetic limb and gone to bed, current can be passed through the amputee's residual limb to optionally treat the symptoms of phantom limb syndrome.

[0072] In some embodiments, the sensor array is composed of 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 is composed of at least 4 and up to 128 sensors. In some specific embodiments, the sensor array is composed of 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, or 128 sensors. In some very specific embodiments, the sensor array is composed of 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, or 128 sensors, and the system is composed of a plurality of additional sensors not included in the sensor array.

[0073] In some embodiments, the system includes one or more sensors not included in the sensor array. The one or more sensors not included may be, for example, sensors not used to detect force or pressure, or sensors that a future infringer of one or more of the claims of this disclosure may attempt to include in the system to develop a non-infringing legal theory.

[0074] In some embodiments, the system includes a controller that communicates with an array of electrodes such that when the electrodes are in electrical communication with the residual limb, the controller can bypass the sensor array and transmit and receive current between each electrode of the electrode array and the amputee's residual limb. Such a controller allows current to be passed through the amputee's residual limb when the amputee is not wearing a covered prosthetic limb, for example, after the amputee has removed such a prosthetic limb to sleep. Using the controller, the amputee can also execute a program to treat phantom limb syndrome. The amputee may develop a specific pattern of transmitting current through the residual limb that is particularly effective in treating phantom limb syndrome, and the system may track the use of the amputee's system and develop a specific pattern that shows a high probability of being effective in treating phantom limb syndrome, or, from usage records and other data from multiple amputees through crowdsourcing, identify a specific pattern with a high probability of being effective in treating phantom limb syndrome and drive the electrode array with a program on the controller to execute the specific pattern. Such a controller can optionally be an electrode controller or a secondary controller as described herein.

[0075] In some embodiments, the system includes a secondary controller that wirelessly communicates with the electrode array, and the secondary controller can bypass the sensor array and transmit and receive current between each electrode of the electrode array and the residual limb when the electrode array is in electrical communication with the residual limb.

[0076] In some embodiments, the secondary controller is a computing device. In some specific embodiments, the secondary controller is a mobile computing device. In very specific embodiments, the secondary controller is a mobile phone.

[0077] In some embodiments, the secondary controller wirelessly communicates with the electrode array. In some specific embodiments, the secondary controller is wirelessly communicating with the electrode controller. In very specific embodiments, the secondary controller performs wireless communication with the electrode controller that controls the electrode array.

[0078] In some embodiments, the wireless communication is mediated by one or both of a Bluetooth connection or a Wi-Fi connection between the secondary controller and the electrode array. In some specific embodiments, the wireless communication is mediated by one or both of a Bluetooth connection or a Wi-Fi connection between the secondary controller and the electrode array, which is mediated by the electrode controller that controls the electrode array.

[0079] In some embodiments, the secondary controller wirelessly communicates with the electrode controller.

[0080] In some embodiments, the cover is configured to be attached to the outer surface of different artificial joints having various different shapes, and the cover is configured to adapt to various different shapes such that the relative positions of the respective sensors remain constant with respect to different shapes. In some specific embodiments, the cover is configured to be attached to the outer surface of different artificial joints having various different shapes, and the cover is configured to adapt to various different shapes such that the three-dimensional configuration of each sensor remains constant with respect to different shapes.

[0081] 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 three-dimensional configuration of the sensor consists of the shape of the missing body part. Without limiting the present specification or the claims of the present disclosure, the cover having the shape of the defect and the three-dimensional configuration of the sensor constituting the shape thereof induces better neuroplasticity in the somatosensory cortex of the amputee's brain and treats phantom limb syndrome more effectively compared to other shapes.

[0082] In some embodiments, the system lacks the sensor capabilities to sense the relative position of the prosthesis. In some specific embodiments, the sensor array is generally configured to sense pressure and / or forces from touch, and the sensor array is generally not configured to sense the position or performance of the artificial joint.

[0083] In some embodiments, the system lacks the mechanical ability to move the artificial joint. In some specific embodiments, the system is generally independent of the mechanical characteristics of the artificial joint, for example, to support movement, positioning, or load.

[0084] 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 characteristics of the artificial joint, for example, to support movement, positioning, or load.

[0085] Figure 1 shows a system 100 consisting of a liner 101 with electrodes 102 of an embedded array. The liner 101 receives the residual limb (not shown) and the prosthetic limb 103 also receives the residual limb such that the liner 101 fits inside the area of the prosthetic limb 103. Each electrode 102 of the electrode array 102 is in electrical communication with an electrode controller 104, and this electrical communication is mediated by a wire 105 that is also embedded in the liner 101. Figure 1 depicts the system 100, which also has a cover 106 that includes sensors 107 of the embedded array. The cover 106 is worn to cover the area of the prosthetic appliance 103 that replaces the missing limb, and optionally, the cover 106 is attached to the prosthetic appliance 103 with a polymeric foam (not shown) that fills the void between the cover 106 and the prosthetic appliance 103. The sensors 107 communicate with a sensor controller 108, and the sensor controller 108 interfaces with the electrode controller 104.

[0086] Figure 1 depicts a Bluetooth - based wireless interface 109 between a sensor controller 108 and an electrode controller 104. The wireless, Bluetooth - mediated interface 109 between the sensor controller 108 and the electrode controller 104 enables the amputee to activate the electrodes 102 of the electrode array 102 by contacting the sensor 107 and stimulate the residual limb even when the amputee is not wearing the prosthetic device 103 and the cover 106. For example, when the amputee has removed the prosthetic device 103 and is sleeping. In other embodiments, the system 100 does not include a sensor controller 108, and the sensor 107 is directly connected to the electrode controller 104.

[0087] The liner 101 of Figure 1 includes a substrate 110 that houses the embedded electrode array 102. Also shown in Figure 1 are the joint 111 of the prosthetic device 103, the outer layer 112 of the cover 106 (this outer layer 112 is shown in an exploded view), and a sheath 113 that bundles the wires 105 emerging from the liner 101.

[0088] Figure 2 depicts a substrate 110 having an embedded electrode array 102 and an embedded wire 105. The substrate 110 is disposed within a mold 120. Liquid silicone (not shown) can be poured into the mold 120 to form a liner (not shown) having the embedded electrode array 102 and the embedded wire 105.

[0089] Figure 3 depicts a substrate 110 having an embedded electrode array (not shown) and an embedded wire 105. Figure 3 also depicts an electrode controller 104 having a printed circuit board assembly 130 and a battery 131 that is electrically energized with the printed circuit board assembly 130. When the electrode controller 104 is in electrical communication with the embedded wire 105, a microprocessor (not shown) of the printed circuit board assembly 130 of the electrode controller 104 controls the transmission of current between the battery 131 and the embedded wire 105 to control 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 transmitted to the battery 131.

[0090] Figure 4 depicts a liner 101 having the substrate (not shown) of Figure 3 and an electrode controller housing 140 that houses the electrode controller (not shown) of Figure 3.

[0091] Figure 5 shows the liner 101 and the electrode controller housing 140 of Figure 4, drawn partially transparent so that the substrate 110 and the electrode controller 104 are visible.

[0092] Figure 6 shows an exploded perspective view of cover 106 including sensor 107. Cover 106 has an inner layer 160, in which an embedded sensor 107 configured to sense a modality (e.g., force or pressure) is depicted. The inner layer 160 can be manufactured from, for example, plastic. The inner layer 160 optionally includes one or more tabs 161 or other attachment features for receiving an outer layer 162. The outer layer 162 can be manufactured from, for example, plastic. The outer layer 162 optionally has an actuator 163, each of the actuators 163 being configured to press against one or more sensors 107. Each actuator 163 is composed of a flex panel having a surface area larger than any of the sensors 107, such that, for example, depressing any part of the actuator 163 transmits a modality (e.g., force or pressure) to one or more of the small sensors 107. The outer layer 162 optionally includes one or more slots 164 or other attachment features for receiving the inner layer 160. As shown in Figure 6, the outer layer 162 is provided with four slots 164 for attaching the outer layer 162 to the inner layer 160, which have a shape for receiving the four tabs 161 of the inner layer 160. As a mechanical attachment feature such as a tab, it can include a detent, barb, or other catch or clamp function to inhibit detachment of the inner layer 160 and the outer layer 162.

[0093] Cover 106 may optionally include a spacer 165 between the inner layer 160 and the outer layer 162. The spacer 165 can be composed of, for example, foam. The spacer 165 can include one or more windows 166. The one or more windows 166 can, for example, enable the actuator 163 to contact the sensor 107. The one or more windows 166 also enable attachment features such as, for example, one or more tabs 161 and one or more slots 164 for attaching the inner layer 160 and the outer layer 162.

[0094] Cover 106 includes, as an option, a sensor controller 108. The sensor controller 108 typically consists of a printed circuit board assembly 167 comprising an interface and a microprocessor. The microprocessor is configured to, for example, receive signals from the sensor 107 and instruct the interface to transmit corresponding signals to the electrode array or its controller. The interface may be, for example, a wireless interface such as a combination of a Wi-Fi and Bluetooth chip. The exact type of the interface is not limited and generally depends on market factors including the manufacturer's desired retail price of the system. The controller 108 typically consists of a controller housing 168, which may optionally include an access panel 169 that enables access to the printed circuit board assembly 167. The sensor controller 108 is typically in electrical communication with a power source that is a battery 170, or else is in electrical communication with the battery 170.

[0095] In some embodiments, the cover does not have a dedicated sensor controller (not shown). The system is configured, for example, with a hardwired interface between the cover and the liner that does not require a sensor controller.

[0096] Cover 106 may optionally include an outer surface 171 consisting of, for example, a foam and / or a texture that is advantageous for physical interaction with the actuator 163.

[0097] Figure 7 shows the assembled configuration of the cover 106 of Figure 6 without the outer surface (not shown). The four tabs 161 of the inner layer 160 attach the outer layer 162 to the inner layer 160. The outer layer 162 covers the controller housing 168.

[0098] Figure 8 shows the assembled configuration of the cover 106 of Figures 6 and 7 without the outer surface (not shown), where the outer layer 162 is translucent and the spacer 165 is shown transparent to reveal the underlying sensor 107 and printed circuit board assembly 167.

[0099] FIG. 9 shows the electrode controller 104 and the liner 110 of FIG. 3, and also shows the partially assembled cover 106 of FIGS. 6-8.

[0100] Various aspects of the present disclosure relate to methods of using the systems described anywhere in the present disclosure.

[0101] In some embodiments, the method is a method of regulating the neural activation of the stump of an amputee.

[0102] Each amputee has a part of the body missing. In some embodiments, the amputee exhibits phantom limb syndrome.

[0103] In some embodiments, the system includes a cover, and the method includes attaching the cover to a prosthesis. In some specific embodiments, the method includes inserting a foam between the cover and the prosthesis to attach the cover to the prosthesis. In some very specific embodiments, the method includes inserting an expandable foam between the cover and the prosthesis to attach the cover to the prosthesis.

[0104] In some embodiments, the system includes a liner, and the method includes attaching the liner to the stump. In some particular embodiments, the liner includes an electrode array, and the method includes attaching the liner to the stump such that each electrode of the electrode array is in electrical communication with the stump. In some very specific embodiments, the step of attaching the liner to the stump includes attaching each electrode of the electrode array to the stump such that each electrode is in electrical communication with the stump.

[0105] In some embodiments, the method includes contacting the stump with a conductive gel to facilitate electrical communication between each electrode of the electrode array and the stump.

[0106] In some embodiments, the method includes attaching a prosthetic limb to the residual limb. In some specific embodiments, the method includes attaching a prosthetic limb to the residual limb after attaching a cover to the prosthetic limb. In some specific embodiments, the method includes attaching the prosthetic limb to the residual limb such that the prosthetic limb fits over a liner. In some very specific embodiments, the method includes attaching a cover to the prosthetic limb, then further attaching a liner to the residual limb such that the prosthetic limb fits over the liner, and then attaching the prosthetic limb to the residual limb.

[0107] In some embodiments, the system includes a sensor array and the method includes contacting one or more sensors. In some specific embodiments, the cover includes a sensor array and the method includes contacting one or more sensors. In some very specific embodiments, contacting one or more sensors includes applying at least one modality (e.g., one or both of force and pressure) to the one or more sensors.

[0108] In some embodiments, the method includes contacting one or more sensors after attaching a cover to the prosthetic limb. In some embodiments, the method includes contacting one or more sensors after attaching the prosthetic limb to the residual limb. In some specific embodiments, the method includes attaching a cover to the prosthetic limb, attaching the prosthetic limb to the residual limb, and then contacting one or more sensors. In some very specific embodiments, the method includes attaching a liner to the residual limb, attaching a cover to the prosthetic limb, attaching the prosthetic limb to the residual limb, and then contacting one or more sensors.

[0109] In some embodiments, the method includes removing the prosthetic limb from the residual limb and contacting one or more sensors after removing the prosthetic limb from the residual limb. The method of the present disclosure advantageously enables a amputee to pass an electric current through the residual limb, optionally to treat symptoms of phantom limb syndrome, when the amputee is not wearing a covered prosthetic limb, e.g., after removing such a prosthetic limb to sleep.

[0110] In some embodiments, when contacting one or more sensors, one electrode of the electrode array transmits current to the residual limb and another electrode of the electrode array receives current from the residual limb.

[0111] In some embodiments, after attaching the cover to the prosthesis and then contacting one or more sensors, one electrode of the electrode array transmits current to the residual limb and another electrode of the electrode array receives current from the residual limb. In some embodiments, after attaching the prosthesis to the residual limb and then contacting one or more sensors, the electrode transmits current to the residual limb and another electrode receives current from the residual limb. In some particular embodiments, after attaching the cover to the prosthesis and then attaching the prosthesis to the residual limb and contacting one or more sensors, the electrode transmits current to the residual limb and another electrode receives current from the residual limb. In some very specific embodiments, after attaching the liner to the residual limb, attaching the cover to the prosthesis, and then attaching the prosthesis to the residual limb and contacting one or more sensors, the electrode transmits current to the residual limb and another electrode receives current from the residual limb.

[0112] In some embodiments, after removing the prosthesis from the residual limb and then contacting one or more sensors, the electrode transmits current to the residual limb and another electrode receives current from the residual limb.

[0113] In some embodiments, the method includes stimulating the Aβ nerve fibers of the residual limb. In some particular embodiments, the method includes stimulating the myelinated Aβ nerve fibers of the residual limb, and by transmitting current to the residual limb, the myelinated Aβ nerve fibers of the residual limb are stimulated.

[0114] In some embodiments, the method includes regulating the activation of Aδ nerve fibers in the residual limb. In some specific embodiments, the method includes regulating the activation of myelinated Aδ nerve fibers in the residual limb, and by transmitting current to the residual limb, the activation of myelinated Aδ nerve fibers in the residual limb is regulated.

[0115] In some embodiments, the method includes modulating the activation of C nerve fibers in the residual limb. In some particular embodiments, the method includes modulating the activation of unmyelinated C nerve fibers in the residual limb, and the activation of unmyelinated C nerve fibers in the residual limb is modulated by transmitting an electric current through the residual limb.

[0116] In some embodiments, the system is configured such that the electric current treats one or more symptoms of phantom limb syndrome. In some specific embodiments, the system is configured such that the electric current treats one or more symptoms of phantom limb syndrome and, when contacting one or more sensors, an electric current is transmitted through the residual limb to treat one or more symptoms.

[0117] In some embodiments, the method includes removing the prosthesis from the residual limb and, after removing the prosthesis from the residual limb, contacting one or more sensors. After removing the prosthesis from the residual limb, contacting one or more sensors transmits an electric current through the residual limb to treat one or more symptoms.

[0118] In some embodiments, the method includes instructing a secondary controller to cause an electrode to transmit an electric current to the residual limb and another electrode to receive an electric current from the residual limb. In some specific embodiments, the method includes instructing a secondary controller to cause an electrode to transmit an electric current to the residual limb and another electrode to receive an electric current from the residual limb without contacting one or more sensors (i.e., the secondary controller bypasses the sensor array).

[0119] Instructing the secondary controller can include, for example, pressing an icon on a graphical user interface on the touch screen of the secondary controller.

[0120] In some embodiments, by instructing a secondary controller to cause an electrode to transmit an electric current to the residual limb and another electrode to receive an electric current from the residual limb, an electric current is transmitted through the residual limb to treat one or more symptoms.

[0121] In some embodiments, the method includes instructing a secondary controller in wireless communication with the system such that one or more positive electrodes of the electrode array transmit current to the residual limb and one or more negative electrodes of the electrode array receive current from the residual limb. In some specific embodiments, the secondary controller is instructed to transmit current to one or more positive electrodes and receive current from one or more negative electrodes, thereby transmitting current through the residual limb to treat one or more symptoms of phantom limb syndrome.

[0122] In some embodiments, the method includes (1) contacting one or more sensors such that, in response to symptoms of phantom limb syndrome, one or more positive electrodes transmit current to the residual limb and one or more negative electrodes receive current from the residual limb, or (2) instructing a secondary controller, in response to the symptoms, such that one or more positive electrodes transmit current to the residual limb and one or more negative electrodes receive current from the residual limb, the method treating phantom limb syndrome by transmitting current through the residual limb in response to the symptoms.

[0123] In some embodiments, the method includes periodically sending current through the residual limb from a positive electrode of the electrode array to a negative electrode of the electrode array over a period of at least 28 days. In some specific embodiments, the method includes periodically sending current through the residual limb from the positive electrode to the negative electrode over a period of time and is effective in reducing symptoms of phantom limb syndrome as evaluated on a visual analog scale after a period of time.

[0124] In some embodiments, periodically 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.

[0125] In some embodiments, periodically 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.

[0126] In some embodiments, the period of time 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.

[0127] In some embodiments, the period of time is 1 hour, 24 hours, 48 hours, 1 week, 28 days, 1 month, 6 months, or 1 year.

[0128] In some embodiments, the method includes contacting one or more sensors of the sensor array and periodically transmitting a current from the positive electrode to the negative electrode of the electrode array through the residual limb, for example, over a period of at least 28 days. In some specific embodiments, the method includes contacting one or more sensors and periodically transmitting a current from the positive electrode to the negative electrode through the residual limb over a period of time, and is effective in reducing the symptoms of phantom limb syndrome that are evaluated on a visual analog scale after a period of time.

[0129] In some embodiments, phantom limb syndrome has a first symptom and a second symptom.

[0130] In some embodiments, transmitting a current from the first positive electrode of the electrode array to the first negative electrode through the residual limb is more effective in treating the first symptom than transmitting and receiving a current from other electrodes of the electrode array, and the method includes transmitting a current from the first positive electrode to the first negative electrode through the residual limb in response to the first symptom.

[0131] In some embodiments, the first positive electrode has a first positive electrode relative position, the first negative electrode has a first negative electrode relative position, and the amputee associates the first symptom with one or both of the first positive electrode relative position and the first negative electrode relative position.

[0132] In some embodiments, transmitting current through the residual limb from the second positive electrode of the electrode array to the second negative electrode of the electrode array is more effective in treating the second condition than transmitting current to and from other electrodes of the electrode array, and the method includes transmitting current through the residual limb from the second positive electrode to the second negative electrode in response to the second condition.

[0133] In some embodiments, the second positive electrode has a second positive electrode relative position, the second negative electrode has a second negative electrode relative position, and the amputee associates the second condition with one or both of the second positive electrode relative position and the second negative electrode relative position.

[0134] In some embodiments, the method includes contacting a first sensor of a sensor array corresponding to the first positive electrode and the first negative electrode in response to the first condition.

[0135] In some embodiments, the first sensor has a first sensor relative position, and the amputee associates the first condition 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, the first negative electrode has a first negative electrode relative position, and the amputee associates the first condition with one, two, or each of the first sensor relative position, the first positive electrode relative position, and the first negative electrode relative position.

[0136] In some embodiments, the method includes contacting a second sensor of a sensor array corresponding to the second positive electrode and the second negative electrode in response to the second condition.

[0137] In some embodiments, the second sensor has a second sensor relative position, and the amputee associates the second condition 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, the second negative electrode has a second negative electrode relative position, and the amputee associates the second condition with one, two, or each of the second sensor relative position, the second positive electrode relative position, and the second negative electrode relative position.

[0138] In some embodiments, the method includes, in response to a first symptom, instructing an electrode controller (optionally a secondary controller) to cause a current to be transmitted from a first positive electrode to the residual limb and received at a first negative electrode.

[0139] In some embodiments, the method includes, in response to a second symptom, instructing an electrode controller (optionally a secondary controller) to cause a current to be transmitted from a second positive electrode to the residual limb and received at a second negative electrode.

[0140] In some embodiments, the method includes contacting a first sensor in response to a first symptom and a second sensor in response to a second symptom over a period of at least 28 days, and the method is effective in reducing chronic symptoms of phantom limb syndrome independent of treating acute symptoms by generating a current in the residual limb over a period of time. In some specific embodiments, the reduction of chronic symptoms of phantom limb syndrome is evaluated on a visual analog scale. Without limiting the claims that may develop from this specification or this disclosure, the chronic symptoms of phantom limb syndrome are reduced by repeated use of the system of this disclosure, which can optionally be evaluated on a visual analog scale.

[0141] Treatment of acute symptoms refers to treating the symptoms while the subject is experiencing the symptoms, and acute efficacy refers to the real-time efficacy of alleviating acute symptoms. Reduction of chronic symptoms refers to reducing one or both of the frequency and severity of the symptoms over time. Reducing the chronic symptoms of phantom limb syndrome independent of the treatment of acute symptoms means reducing either or both of the frequency and severity of the symptoms over time independent of the treatment of acute symptoms. For example, after using the system described herein for a period of time (at least 28 days), the subject will notice that the frequency of the symptoms of phantom limb syndrome has decreased and the severity of the symptoms has been reduced, regardless of whether the subject actually uses the system to treat a particular symptom.

[0142] All amputees have a brain that includes the somatosensory cortex. In some embodiments, the method is effective in activating different regions of the somatosensory cortex when different electrodes of the electrode array transmit and receive current with the residual limb.

[0143] Without limiting the claims that develop from this specification or this disclosure, repeated use of the system of this disclosure reduces the chronic symptoms of phantom limb syndrome by neuromodulation of the somatosensory cortex.

[0144] The somatosensory cortex of an amputee's brain typically includes regions that process the sensations of the lost body part. In some embodiments, the method includes periodically sending current from the electrodes of the electrode array to the residual limb over a period such as at least 28 days, the method being effective in causing neuromodulation, and the current causing activation in the region that processes the sensations of the lost body part after that period. In some specific embodiments, the method includes contacting one or more sensors and periodically passing current from the corresponding two or more electrodes to the residual limb over a period of time, the method being effective in causing neuromodulation to activate the region that processes the sensations of the body part that lacks current after a period of time. In some very specific embodiments, the method includes contacting one or more sensors according to the symptoms of phantom limb syndrome.

[0145] In some embodiments, the method includes contacting two or more sensors and periodically transmitting current through the residual limb from two or more different positive electrodes to two or more different negative electrodes over a period of at least 28 days, the method being effective in causing neuroplasticity-driven cortical remapping in the somatosensory cortex of the amputee's brain after the period such that the current transmitted through the residual limb activates different regions of the somatosensory cortex after the period compared to before the period.

[0146] Figure 10 shows how to use the system described in this specification. The amputee first attaches a liner to the residual limb 1001 so that each electrode of the electrode array is in electrical communication with the residual limb, or attaches a cover to the prosthesis 1002. After the amputee attaches the liner to the residual limb 1001, the amputee instructs the controller to cause one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb 1003. The controller is either an electrode controller or a secondary controller as described herein. After the cover is attached to the prosthesis 1002, it contacts one or more sensors of the sensor array of the cover 1004, and one electrode transmits current to the residual limb and another electrode receives current from the residual limb. The amputee typically wears the prosthesis on the residual limb for daily use 1005. The transmission of current to the residual limb stimulates the Aβ nerve fibers of the residual limb and can treat one or more symptoms of the phantom limb syndrome described herein. Passing current through the residual limb stimulates the Aβ nerve fibers of the residual limb 1006 and can treat one or more symptoms of the phantom limb syndrome described herein. The amputee advantageously removes the prosthesis from the residual limb 1007, still instructs the controller to transmit current to the residual limb 1003, and also contacts one or more sensors to transmit current to the residual limb 1004, for example, when the amputee has removed the prosthesis for sleep, etc., and can treat the symptoms of the phantom limb syndrome when not wearing the prosthesis. Repeatedly using the system over a period of time 1008 is generally effective in reducing the chronic symptoms of phantom limb syndrome, as evaluated on a visual analog scale, apart from generating current in the residual limb to treat acute symptoms. Without limiting the scope of the claims developed from this specification or this disclosure, the reduction of the chronic symptoms of phantom limb syndrome is achieved by neuroplasticity-driven cortical remapping in the somatosensory cortex of the brain 1008, which can be evaluated by scalp electroencephalogram (''EEG'').

[0147] In some embodiments, the method includes simultaneously performing a scalp EEG on the amputee and generating an electrogram by passing current from a first positive electrode to a first negative electrode through the residual limb during the EEG.

[0148] In some embodiments, the method includes performing an EEG on an amputee while, during the EEG, passing a current from the positive electrodes of the electrode array, through the residual limb, to the negative electrodes of the electrode array to generate an electrogram indicative of activation of the somatosensory cortex in response to the current, and the system is configured such that the area that processes the sensation of the lost body part is indicative of activation in response to the current of the electrogram. In some specific embodiments, performing an EEG on the amputee and transmitting a current to the residual limb is performed after a certain period, such as at least 28 days, after the amputee first begins to use the system. In some very specific embodiments, the method includes contacting one or more sensors of the sensor array to pass a current through the residual limb over a certain period, such as a period of at least 28 days, after which the EEG is performed.

[0149] In some embodiments, the method includes simultaneously performing EEG on an amputee and passing a current from a first positive electrode to a first negative electrode through a residual limb during the EEG to generate an electrogram indicating activation of the somatosensory cortex in response to the current. The method also includes simultaneously performing EEG on the amputee and passing a current from a second positive electrode to a second negative electrode through the residual limb during the EEG to generate an electrogram indicating activation of the somatosensory cortex in response to the current. Further, the system is configured such that the first positive electrode and the first negative electrode activate a first position of the somatosensory cortex, and the second positive electrode and the second negative electrode activate a second position of the somatosensory cortex, and the electrogram indicates that the current transmitted from the first positive electrode through the residual limb to the first negative electrode activates a different region of the somatosensory cortex than the current transmitted from the second positive electrode through the residual limb to the second negative electrode. In some specific embodiments, the method includes contacting a first sensor corresponding to the first positive electrode and the first negative electrode and periodically sending a current to the residual limb, for example, over a certain period of at least 28 days. The method also includes contacting a second sensor corresponding to the second positive electrode and the second negative electrode, periodically transmitting a current to the residual limb over a certain period, and performing EEG after a certain period. Without limiting the scope of the claims arising from this specification or this disclosure, neuromodulation of the somatosensory cortex by the system of this disclosure can be detected by EEG.

[0150] The following examples describe a pilot clinical trial planned to illustrate certain aspects of the present disclosure, and the examples are not to be construed as limiting the present disclosure or the claims arising therefrom. Case

[0151] In the pilot clinical trial, it has been demonstrated that transcutaneous electrical stimulation of the residual limb by touching the prosthesis reduces the symptoms of phantom limb syndrome.

[0152] A group of 15 amputees who experience symptoms of phantom limb syndrome as a result of limb amputation are enrolled in a pilot clinical trial. Each subject has a healthy limb corresponding to the amputated limb. The subjects use a visual analog scale to evaluate the level of pain associated with phantom limb syndrome.

[0153] The system described in detail is provided to each subject. Briefly, this system consists of a prosthetic cover with a sensor array that controls the activation of an electrode array within a liner that fits over the amputee's residual limb.

[0154] A wire is attached to each subject such that each electrode of the electrode array is in electrical communication with the residual limb. Each subject is wearing an existing prosthetic limb, to which a cover containing an array of sensors is attached.

[0155] Each subject wears EEG electrodes, and the researcher touches various sites on the healthy limb to record the electrophysiological course of the healthy limb. Next, with each subject wearing the existing prosthetic limb, the researcher touches various areas of the prosthetic cover to pass an electric current through the residual limb and records the potential map of the prosthetic cover. The subject is instructed to observe the contact of the intact limb with the cover. The various areas of the contacting healthy limb and the cover correspond to each other both spatially and temporally.

[0156] Next, each subject is instructed to apply pressure to the healthy limb in the same spatial and temporal pattern as the researcher and to focus their line of sight on the area where the pressure is applied, and an electrogram is recorded. Next, each subject is instructed to apply pressure to the prosthetic cover in the same spatial and temporal pattern as the researcher and to focus their line of sight on the area where the pressure is applied, and an electrogram is recorded.

[0157] Afterwards, each subject is instructed to take the system home. Each subject is given written instructions to apply pressure to the healthy limb and the prosthetic cover daily, in a spatial and temporal pattern, and to apply pressure to the prosthetic cover as needed, depending on the symptoms of phantom limb syndrome. The use of the system is recorded in the computer memory by the system. Each subject is instructed to evaluate the level of pain associated with phantom limb syndrome daily on a visual analog scale, before and after executing the written instructions.

[0158] After four weeks, each subject returns for a follow-up EEG examination. The follow-up EEG examination is performed on the healthy limb and the prosthetic cover in substantially the same spatial and temporal contact pattern as that performed in the initial EEG examination above. For each healthy limb, the initial and follow-up electroencephalograms are approximately the same. For each amputated limb, the initial and follow-up electroencephalograms are significantly different. In the case of subjects who had their feet amputated, the difference in gamma waves detected near the inner region of the somatosensory cortex is greater. The magnitude of the difference between the initial EEG and the follow-up EEG correlates with the frequency of system use recorded by the system. These results indicate that the intervention results in cortical remapping due to the neuroplasticity of the subjects.

[0159] Four weeks after the intervention, all subjects reported a decrease in the level of phantom pain on a visual analog scale compared to before the intervention, indicating the long-term effectiveness of the intervention. The degree of pain reduction reported on the visual analog scale correlates with the frequency of system use recorded by the system. Four weeks after the intervention, all subjects reported a decrease in the level of phantom pain on a visual analog scale after the execution of the spatial and temporal pattern intervention compared to immediately before the intervention, indicating the acute effect of the intervention.

Claims

1. A system for regulating nerve activation in a residual limb of an amputee, comprising a liner including an array of electrodes, the liner being configured to receive the residual limb such that each electrode of the electrode array is in electrical communication with the residual limb, each electrode of the electrode array being paired with at least two other electrodes of the electrode array, and when the electrode array is in electrical communication with the residual limb, each electrode being capable of independently transmitting a current through the residual limb to both a first negative electrode and a second negative electrode with which the electrode is paired, and / or capable of independently receiving a current through the residual limb from both a first positive electrode and a second positive electrode with which the electrode is paired, the electrode array being configured to stimulate nerve fibers of the residual limb by transmitting and receiving current through the residual limb, the system.

2. The system comprises a cover including an array of sensors, the cover being configured to cover an outer surface of the prosthesis, the electrode array communicating with the sensor array such that two or more electrodes are activated in response to sensing by one or more sensors, the system being configured such that when (1) two or more electrodes are operative and (2) the two or more electrodes are in electrical communication with the residual limb, one of the operative two or more electrodes transmits a current through the residual limb and another of the operative two or more electrodes receives the current transmitted through the residual limb, each sensor of the sensor array being configured to sense one or both of force and pressure, each electrode of the electrode array being configured to transmit and / or receive a current that stimulates Aβ nerve fibers of the residual limb when the electrode is in electrical communication with the residual limb, each sensor being configured to correspond to at least two electrodes and each electrode being configured to correspond to at least one sensor, the sensor communicating with the electrode when the sensor senses force or pressure and the electrode is in electrical communication with the residual limb such that when the electrode transmits a current to or receives a current from the residual limb, the sensor corresponds to the electrode and the electrode corresponds to the sensor, the sensor array having a three-dimensional configuration of sensors with respect to the cover, the electrode array having a three-dimensional configuration of electrodes with respect to the liner, each sensor having a relative position of the sensor within the three-dimensional configuration of sensors with respect to all other sensors of the sensor array, Each electrode has an electrode relative position within the three-dimensional configuration of the electrode with respect to all other electrodes of the electrode array. The system is composed of one or more sensors corresponding to each other and sensor-electrode pairs composed of two or more electrodes. The sensor relative position of each sensor within the sensor three-dimensional configuration correlates with the electrode relative position of each electrode of the same sensor-electrode pair within the electrode three-dimensional configuration. Each sensor of the sensor array communicates with two or more electrodes of the electrode array. The two or more electrodes are configured to transmit and receive current through the residual limb when (1) the sensor senses force or pressure, (2) the two or more electrodes are in electrical communication with the residual limb, and (3) the prosthesis is removed from the residual limb. The system includes a secondary controller that wirelessly communicates with the electrode array. The secondary controller can bypass the sensor array and cause each electrode of the electrode array to transmit or receive current with the residual limb when the electrode array is in electrical communication with the residual limb. The current is a pulsed current. The pulsed current has a pulse frequency of 20 to 180 times per second, a pulse width of 100 microseconds or less, and an amplitude of 100 milliamperes or less. The cover is configured to be attached to the outer surface of different prostheses having various different shapes. The cover is configured to adapt to various different shapes. As a result, the relative position of each sensor remains constant for different shapes. The sensors include 3, 4, 5, 6, 7, or include a front-proximal sensor, a front-distal sensor, an outer-proximal sensor, an outer-distal sensor, a rear-proximal sensor, a rear-distal sensor, an inner-proximal sensor, and an inner-distal sensor respectively. The electrodes include 3, 4, 5, 6, 7, or include a front-proximal electrode, a front-distal electrode, an outer-proximal electrode, an outer-distal electrode, a rear-proximal electrode, a rear-distal electrode, an inner-proximal electrode, and an inner-distal electrode respectively. The sensor - electrode pairs include three, four, five, six, or seven, or include a front - proximal pair including a front - proximal sensor and a front - proximal electrode, a front - distal pair including a front - distal sensor and a front - distal electrode, an outer - proximal pair including an outer - proximal sensor and an outer - proximal electrode, an outer - distal pair including an outer - distal sensor and an outer - distal electrode, a rear - proximal pair including a rear - proximal sensor and a rear - proximal electrode, a rear - distal pair including a rear - distal sensor and a rear - distal electrode, an inner - proximal pair including an inner - proximal sensor and an inner - proximal electrode, and an inner - distal pair including an inner - distal sensor and an inner - distal electrode, respectively. The electrode array includes at least one electrode ring, the electrode ring is composed of four or more electrodes, and each electrode is exactly paired with two other electrodes within the ring. The system includes an electrode controller that electrically communicates with each electrode of the electrode array. The electrode controller is configured to control whether each electrode capable of transmitting current transmits current to one or both of the first negative electrode and the second negative electrode through the residual limb. The electrode controller is configured to control whether each electrode capable of receiving current receives current from one or both of the first positive electrode and the second positive electrode. The system according to claim 1.

3. The system includes a cover including a sensor array, and the cover is configured to cover the outer surface of the prosthesis. The electrode array communicates with the sensor array, and two or more electrodes are activated in response to sensing by one or more sensors. The system is configured such that when (1) two or more electrodes are operating and (2) two or more electrodes are in electrical communication with the residual limb, one of the operating two or more electrodes transmits current through the residual limb, and another of the operating two or more electrodes receives the current transmitted through the residual limb. Each sensor of the sensor array is configured to sense one or both of force and pressure. Each sensor corresponds to at least two electrodes, and each electrode is configured to correspond to at least one sensor. When the sensor senses force or pressure and the electrode is in electrical communication with the residual limb, if the sensor communicates with the electrode and the electrode transmits current to the residual limb or receives current from the residual limb, the sensor corresponds to the electrode, and the electrode is configured to correspond to the sensor. The sensor array has a three - dimensional configuration of the sensors with respect to the cover. The electrode array has a three-dimensional configuration of electrodes with respect to the liner, each sensor has a sensor relative position within the three-dimensional configuration of the sensor with respect to all other sensors of the sensor array, each electrode has an electrode relative position within the three-dimensional configuration of the electrode with respect to all other electrodes of the electrode array, the system is composed of sensor-electrode pairs each consisting of one or more sensors corresponding to each other and two or more electrodes, the sensor relative position of each sensor of the sensor-electrode pair within the sensor three-dimensional configuration correlates with the electrode relative position of each electrode of the same sensor-electrode pair within the electrode three-dimensional configuration, The system according to claim 1.

4. Each sensor of the sensor array communicates with two or more electrodes of the electrode array, and the two or more electrodes are configured to transmit and receive current through the residual limb when (1) the sensor senses force or pressure, and (2) the two or more electrodes are in electrical communication with the residual limb, and further (3) when the prosthesis is removed from the residual limb. The system includes a secondary controller that wirelessly communicates with the electrode array, and the secondary controller can bypass the sensor array and cause each electrode of the electrode array to transmit or receive current with the residual limb when the electrode array is in electrical communication with the residual limb. The system according to claim 3.

5. The secondary controller is a mobile computing device, the secondary controller wirelessly communicates with the electrode array, the wireless communication between the mobile computing device and the electrode array is mediated by one or both of a Bluetooth or Wi-Fi connection. The system according to claim 4.

6. Each sensor of the sensor array communicates with two or more electrodes of the electrode array, and the two or more electrodes are configured to transmit and receive current through the residual limb when (1) the sensor senses force or pressure, and (2) the two or more electrodes are in electrical communication with the residual limb, and further (3) when the prosthesis is removed from the residual limb. The system according to claim 3.

7. The system includes a controller that communicates with the electrode array, whereby the controller can bypass the sensor array and cause each electrode of the electrode array to transmit or receive current with the residual limb when the electrode is in electrical communication with the residual limb. The system according to claim 3.

8. The controller is a mobile computing device, the controller wirelessly communicates with an electrode array, the wireless communication between the mobile computing device and the electrode array is mediated by one or both of a Bluetooth or Wi-Fi connection, The system according to claim 7.

9. The cover is configured to be attached to the outer surface of prostheses of different shapes, the cover is configured to adapt to various shapes, and the relative positions of the sensors are kept constant for various shapes, The system according to claim 3.

10. The cover has a chipped part, the three-dimensional configuration of the sensor is formed by the shape of the chipped part, The system according to claim 3.

11. The system does not have a sensor function for sensing the relative position of the prosthesis, the system does not have a mechanical ability to move the prosthesis, the system does not have a structural ability to support the weight of the amputee, The system according to claim 3.

12. The current is a pulsed current, the pulsed current has a pulse frequency of 20 or more and 180 or less times per second, a pulse width of 100 microseconds or less, and an amplitude of 100 milliamperes or less, The system according to claim 3.

13. Each sensor corresponds exactly to two electrodes, and each sensor-electrode pair is composed of (1) a sensor and (2) two electrodes corresponding to the sensor, The system according to claim 3.

14. The sensors include a front-proximal sensor, a front-distal sensor, an outer-proximal sensor, an outer-distal sensor, a rear-proximal sensor, a rear-distal sensor, an inner-proximal sensor, and an inner-distal sensor, the electrodes include a front-proximal electrode, a front-distal electrode, an outer-proximal electrode, an outer-distal electrode, a rear-proximal electrode, a rear-distal electrode, an inner-proximal electrode, and an inner-distal electrode, The sensor-electrode pairs include a front-proximal pair including a front-proximal sensor and a front-proximal electrode, a front-distal pair including a front-distal sensor and a front-distal electrode, an outer-proximal pair including an outer-proximal sensor and an outer-proximal electrode, an outer-distal pair including an outer-distal sensor and an outer-distal electrode, a rear-proximal pair including a rear-proximal sensor and a rear-proximal electrode, a rear-distal pair including a rear-distal sensor and a rear-distal electrode, an inner-proximal pair including an inner-proximal sensor and an inner-proximal electrode, and an inner-distal pair including an inner-distal sensor and an inner-distal electrode, The sensor relative position of the front-proximal sensor is such that: (1) the front-distal sensor is closer than both the outer-distal sensor and the inner-distal sensor; (2) it is closer to both the outer-distal sensor and the inner-distal sensor than the rear-distal sensor; (3) it is closer to both the outer-proximal sensor and the inner-proximal sensor than the rear-proximal sensor; and (4) it is closer to the rear-proximal sensor than the rear-distal sensor. The electrode relative position of the front-proximal electrode is such that: (1) the front-distal electrode is closer than both the outer-distal electrode and the inner-distal electrode; (2) it is closer to both the outer-distal electrode and the inner-distal electrode than the rear-distal electrode; (3) it is closer to both the outer-proximal electrode and the inner-proximal electrode than the rear-proximal electrode; and (4) it is closer to the rear-proximal electrode than the rear-distal electrode. The sensor relative position of the front-distal sensor is such that: (1) the front-proximal sensor is closer than both the outer-proximal sensor and the inner-proximal sensor; (2) it is closer to both the outer-proximal sensor and the inner-proximal sensor than the rear-proximal sensor; (3) it is closer to both the outer-distal sensor and the inner-distal sensor than the rear-distal sensor; and (4) it is closer to the rear-distal sensor than the rear-proximal sensor. The electrode relative position of the front-distal electrode is such that: (1) the front-proximal electrode is closer than both the outer-proximal electrode and the inner-proximal electrode; (2) it is closer to both the outer-proximal electrode and the inner-proximal electrode than the rear-proximal electrode; (3) it is closer to both the outer-distal electrode and the inner-distal electrode than the rear-distal electrode; and (4) it is closer to the rear-distal electrode than the rear-proximal electrode. The sensor relative position of the inner-proximal sensor is such that: (1) the inner-distal sensor is closer than both the front-distal sensor and the rear-distal sensor; (2) both the front-distal sensor and the rear-distal sensor are closer than the outer-distal sensor; (3) both the front-proximal sensor and the rear-proximal sensor are closer than the outer-proximal sensor; (4) the outer-proximal sensor is closer than the outer-distal sensor. The electrode relative position of the inner-proximal electrode is such that: (1) the inner-distal electrode is closer than both the front-distal electrode and the rear-distal electrode; (2) it is closer to both the front-distal electrode and the rear-distal electrode than the outer-distal electrode; (3) it is closer to both the front-proximal electrode and the rear-proximal electrode than the outer-proximal electrode; and (4) it is closer to the outer-proximal electrode than the outer-distal electrode. The sensor relative position of the medial-distal sensor is as follows: (1) The medial-proximal sensor is closer than the anterior-proximal sensor and the posterior-proximal sensor; (2) The anterior-proximal sensor and the posterior-proximal sensor are closer than the lateral-proximal sensor; (3) The anterior-distal sensor and the posterior-distal sensor are closer than the lateral-distal sensor; (4) It is closer to the lateral-distal sensor than the lateral-proximal sensor. The electrode relative position of the medial-distal electrode is as follows: (1) The medial-proximal electrode is closer than the anterior-proximal electrode and the posterior-proximal electrode; (2) It is closer to both the anterior-proximal electrode and the posterior-proximal electrode than the lateral-proximal electrode; (3) It is closer to both the anterior-distal electrode and the posterior-distal electrode than the lateral-distal electrode; and (4) It is closer to the lateral-distal electrode than the lateral-proximal electrode. The sensor relative position of the posterior-proximal sensor is as follows: (1) It is closer to the posterior-distal sensor than both the lateral-distal sensor and the medial-distal sensor; (2) It is closer to the anterior-distal sensor than both the lateral-distal sensor and the medial-distal sensor; (3) It is closer to the anterior-proximal sensor than both the lateral-proximal sensor and the medial-proximal sensor; and (4) It is closer to the anterior-proximal sensor than the anterior-distal sensor. The electrode relative position of the posterior-proximal electrode is as follows: (1) It is closer to the posterior-distal electrode than both the lateral-distal electrode and the medial-distal electrode; (2) It is closer to both the lateral-distal electrode and the medial-distal electrode than the anterior-distal electrode; (3) It is closer to both the lateral-proximal electrode and the medial-proximal electrode than the anterior-proximal electrode; and (4) It is closer to the anterior-proximal electrode than the anterior-distal electrode. The sensor relative position of the posterior-distal sensor is as follows: (1) It is closer to the posterior-proximal sensor than both the lateral-proximal sensor and the medial-proximal sensor; (2) It is closer to the anterior-proximal sensor than both the lateral-proximal sensor and the medial-proximal sensor; (3) It is closer to the anterior-distal sensor than both the lateral-distal sensor and the medial-distal sensor; and (4) It is closer to the anterior-distal sensor than the anterior-proximal sensor. The electrode relative position of the posterior-distal electrode is as follows: (1) It is closer to the posterior-proximal electrode than both the lateral-proximal electrode and the medial-proximal electrode; (2) It is closer to the anterior-proximal electrode than both the lateral-proximal electrode and the medial-proximal electrode; (3) It is closer to the anterior-distal electrode than both the lateral-distal electrode and the medial-distal electrode; and (4) It is closer to the anterior-distal electrode than the anterior-proximal electrode. The electrode relative position of the rear - distal electrode is (1) closer to the rear - proximal electrode than both the outer - proximal electrode and the inner - proximal electrode, (2) closer to the front - proximal electrode than both the outer - proximal electrode and the inner - proximal electrode, (3) closer to the front - distal electrode than both the outer - distal electrode and the inner - distal electrode, and (4) closer to the front - distal electrode than the front - proximal electrode, The sensor relative position of the outer - distal sensor is (1) closer to the outer - proximal sensor than both the front - proximal sensor and the rear - proximal sensor, (2) closer to both the front - proximal sensor and the rear - proximal sensor than the inner - proximal sensor, (3) closer to both the front - distal sensor and the rear - distal sensor than the inner - distal sensor, and (4) closer to the inner - distal sensor than the inner - proximal sensor, The electrode relative position of the outer - distal electrode is (1) the outer - proximal electrode is closer than both the front - proximal electrode and the rear - proximal electrode, (2) closer to both the front - proximal electrode and the rear - proximal electrode than the inner - proximal electrode, (3) closer to both the front - distal electrode and the rear - distal electrode than the inner - distal electrode, and (4) closer to the inner - distal electrode than the inner - proximal electrode, The three - dimensional configuration of the sensor specifies the sensor surface, The three - dimensional configuration of the electrode specifies the electrode surface, The proximity is measured along the sensor surface and the electrode surface, rather than in orthogonal space, The system according to claim 1.

15. The sensor array includes one, two, three, four, five, six, seven, or each of a front - proximal sensor, a front - distal sensor, an outer - proximal sensor, an outer - distal sensor, a rear - proximal sensor, a rear - distal sensor, an inner - proximal sensor, and an inner - distal sensor, The electrode array includes one, two, three, four, five, six, seven, or each of a front - proximal electrode, a front - distal electrode, an outer - proximal electrode, an outer - distal electrode, a rear - proximal electrode, a rear - distal electrode, an inner - proximal electrode, and an inner - distal electrode, The sensor - electrode pairs include a front - proximal pair including a front - proximal sensor and a front - proximal electrode, a front - distal pair including a front - distal sensor and a front - distal electrode, an outer - proximal pair including an outer - proximal sensor and an outer - proximal electrode, an outer - distal pair including an outer - distal sensor and an outer - distal electrode, a rear - proximal pair including a rear - proximal sensor and a rear - proximal electrode, a rear - distal pair including a rear - distal sensor and a rear - distal electrode, an inner - proximal pair including an inner - proximal sensor and an inner - proximal electrode, and an inner - distal pair including an inner - distal sensor and an inner - distal electrode, one, two, three, four, five, six, seven, or each including The system according to claim 3.

16. The electrode array includes at least eight electrodes, The electrode array includes at least six electrode rings, The electrode ring is composed of four or more electrodes, and they are exactly paired with two other electrodes within the ring, At least two electrode rings are configured to surround the residual limb, The system according to claim 1.

17. The electrode array includes at least two electrode rings, The electrode ring is composed of four or more electrodes, and they are exactly paired with two other electrodes within the ring, At least one electrode ring is configured to surround the residual limb, The system according to claim 1.

18. The system includes an electrode controller that electrically communicates with each electrode of the electrode array, The electrode controller is configured to control whether each electrode capable of transmitting current transmits current to one or both of a first negative electrode and a second negative electrode via the residual limb, The electrode controller is configured to control whether each electrode capable of receiving current receives current from one or both of a first positive electrode and a second positive electrode, The system according to claim 1.

19. The system includes an electrode controller that electrically communicates with each electrode of the electrode array. The electrode controller controls the current transmitted or received by each electrode of the electrode array. The current is a pulsed current, and the pulsed current has a pulse frequency of 20 or more and 180 or less times per second, a pulse width of 100 microseconds or less, and an amplitude of 100 milliamperes or less. The system according to claim 1.

20. In this system, the Aβ nerve fibers of the residual limb are stimulated by the transmission and reception of current via the residual limb. The system according to claim 1.

21. A method for regulating nerve activation in the stump of an amputee, comprising: providing a system including a cover and a liner, wherein the cover includes an array of sensors and the liner includes an array of electrodes; attaching the cover to the prosthesis; attaching the liner to the stump such that each electrode of the electrode array is in electrical communication with the stump; attaching the prosthesis to the stump; after attaching the cover to the prosthesis and the prosthesis to the stump, contacting one or more sensors; removing the prosthesis from the stump; after removing the prosthesis from the stump, contacting one or more sensors; and stimulating Aβ nerve fibers of the stump. The method further comprises: each sensor is configured to sense one or both of force and pressure; attaching the liner to the stump comprises attaching each electrode of the electrode array to the stump such that each electrode is in electrical communication with the stump; contacting one or more sensors comprises applying both force and pressure to the one or more sensors; each sensor corresponds to at least two electrodes and each electrode corresponds to at least one sensor; when the sensor senses force or pressure and the electrode is in electrical communication with the stump, if the sensor communicates with the electrode and the electrode transmits current to or receives current from the stump, the sensor corresponds to the electrode and the electrode corresponds to the sensor; when contacting one or more sensors after attaching the cover to the prosthesis and the prosthesis to the stump, one electrode transmits current to the stump and another electrode receives current from the stump; when contacting one or more sensors after removing the prosthesis from the stump, one electrode transmits current to the stump and another electrode receives current from the stump; sending current to the stump is configured to stimulate Aβ nerve fibers of the stump. A method as described above. **Claim 22** The amputee exhibits phantom limb syndrome. The system is configured such that the current treats one or more symptoms of phantom limb syndrome. By the step of contacting one or more sensors after attaching the cover to the prosthesis and the prosthesis to the stump, current is sent to the stump to treat one or more symptoms. The method includes removing the prosthesis from the stump and, after removing the prosthesis from the stump, contacting one or more sensors. After removing the prosthesis from the residual limb, a current is sent through the residual limb by contacting one or more sensors to treat one or more symptoms. The system includes an electrode controller that communicates electrically with each electrode of the electrode array. The electrode controller controls whether each electrode capable of transmitting current transmits current to one or both of a first negative electrode and a second negative electrode through the residual limb. The electrode controller controls whether each electrode capable of receiving current receives current from one or both of a first positive electrode and a second positive electrode. The system includes a secondary controller that communicates wirelessly with the electrode controller. The method includes instructing the secondary controller, without contacting one or more sensors, for an electrode to transmit current to the residual limb and another electrode to receive current from the residual limb. One or more symptoms are treated by transmitting a current through the residual limb by instructing the secondary controller for an electrode to transmit current to the residual limb and another electrode to receive current from the residual limb. The current is a pulsed current having a pulse frequency of 20 or more and 180 or less times per second, a pulse width of up to 100 microseconds, and an amplitude of up to 100 milliamperes. The method according to claim 21.

23. The amputee exhibits phantom limb syndrome. A first symptom and a second symptom appear in the phantom limb syndrome. Transmitting a current through the residual limb from the first positive electrode of the electrode array to the first negative electrode of the electrode array is more effective in treating the first symptom than transmitting and receiving current from other electrodes of the electrode array. The method includes contacting a first sensor of a sensor array corresponding to the first positive electrode and the first negative electrode in response to the first symptom. Transmitting a current through the residual limb from the second positive electrode of the electrode array to the second negative electrode of the electrode array is more effective in treating the second symptom than transmitting and receiving current from other electrodes of the electrode array. The method includes contacting a second sensor of a sensor array corresponding to the second positive electrode and the second negative electrode in response to the second symptom. The method according to claim 21.

24. The sensor array has a three-dimensional configuration of sensors with respect to the cover. The electrode array has a three-dimensional configuration of electrodes with respect to the liner. Each sensor has a relative sensor position within the three-dimensional configuration of the sensors with respect to all other sensors. Each electrode has an electrode relative position within the three-dimensional configuration of the electrode with respect to all other electrodes. The system includes sensor-electrode pairs configured such that one or more sensors and two or more electrodes correspond to each other. The sensor relative position of each sensor in the sensor three-dimensional configuration of the sensor-electrode pair correlates with the electrode relative position of each electrode in the same sensor-electrode pair in the electrode three-dimensional configuration. The first sensor has a first sensor relative position. The first positive electrode has a first positive electrode relative position. The first negative electrode has a first negative electrode relative position. The amputee associates the first symptom with each of the first sensor relative position, the first positive electrode relative position, and the first negative electrode relative position. The second sensor has a second sensor relative position. The second positive electrode has a second positive electrode relative position. The second negative electrode has a second negative electrode relative position. The amputee associates the second symptom with each of the second sensor relative position, the second positive electrode relative position, and the second negative electrode relative position. The method according to claim 23.

25. This method includes the steps of contacting the first sensor according to the first symptom and the second sensor according to the second symptom for a certain period of time, thereby generating an electric current in the residual limb after a certain period of time, and obtaining an effect of reducing the chronic symptoms of phantom limb syndrome independently of the treatment of acute symptoms. The method according to claim 23.

26. Evaluate the reduction of the chronic symptoms of phantom limb syndrome on a visual analog scale. The method according to claim 25.

27. The amputee exhibits phantom limb syndrome. The amputee's brain includes a somatosensory cortex. This method includes the steps of contacting two or more sensors and periodically transmitting an electric current through the residual limb from two or more different positive electrodes to two or more different negative electrodes over a certain period of time, and This method includes the step of activating different regions of the somatosensory cortex after a certain period of time and before a certain period of time so that the electric current transmitted through the residual limb causes cortical remapping by neuroplasticity in the somatosensory cortex of the amputated patient's brain after a certain period of time. including The method according to claim 21.

28. The amputee exhibits phantom limb syndrome. The amputee's brain includes a somatosensory cortex. This method includes the step of passing an electric current from the first positive electrode to the first negative electrode through the residual limb during an electroencephalogram (EEG) examination of the scalp for the amputee, and as a result, generating a potential map showing the activation of the somatosensory cortex for the electric current. This method includes a step of passing a current from a second positive electrode to a second negative electrode through the residual limb during an electroencephalogram (EEG) examination of the scalp of an amputee, and as a result, generating a potential map indicating activation of the somatosensory cortex in response to the current. The system is configured such that a first positive electrode and a first negative electrode activate a first position of the somatosensory cortex, and a second positive electrode and a second negative electrode activate a second position of the somatosensory cortex. The electrophysiological map shows that the current transmitted from the first positive electrode to the first negative electrode through the residual limb activates a different region of the somatosensory cortex than the current transmitted from the second positive electrode to the second negative electrode through the residual limb. The method according to claim 21. **Claim 29** This method includes a step of contacting a first sensor corresponding to a first positive electrode and a first negative electrode to periodically send a current through the residual limb over a certain period. includes a step of contacting a second sensor corresponding to a second positive electrode and a second negative electrode to periodically send a current through the residual limb over a certain period. and includes wherein the EEG is performed after a certain period. The method according to claim 28. **Claim 30** The sensor array has a three-dimensional configuration of sensors with respect to the cover. The electrode array has a three-dimensional configuration of electrodes with respect to the liner. Each sensor has a relative sensor position within the three-dimensional configuration of the sensors with respect to all other sensors. Each electrode has a relative electrode position within the three-dimensional configuration of the electrodes with respect to all other electrodes. The system is composed of sensor-electrode pairs each composed of one sensor corresponding to each other and two electrodes. The relative sensor position of each sensor of the sensor-electrode pair within the three-dimensional configuration of the sensors correlates with the relative electrode position of each electrode of the same sensor-electrode pair within the three-dimensional configuration of the electrodes. The method according to claim 21. **Claim 31** The brain of the amputee includes a somatosensory cortex. This method is effective in activating different regions of the somatosensory cortex when different electrodes of the electrode array transmit and receive current with the residual limb. The method according to claim 30. **Claim 32** The amputee exhibits phantom limb syndrome. The amputee has a missing body part. The brain of the amputee includes a somatosensory cortex containing a region for processing the sensation of the lost body part. This method includes a step of contacting one or more sensors of the sensor array and periodically transmitting a current from corresponding two or more electrodes of the electrode array to the residual limb over a certain period. This method is effective in causing neuromodulation such that current is activated in the area that processes the sensation of the body part lost after a certain period of time. The method according to claim 21.

33. Including the step of contacting one or more sensors according to the symptoms of phantom limb syndrome. The method according to claim 32.

34. The amputee exhibits phantom limb syndrome. The amputee has a missing body part. The amputee's brain includes a somatosensory cortex that includes an area that processes the sensation of the lost body part. This method includes the step of passing a current from one positive electrode of the electrode array to one negative electrode of the electrode array through the residual limb during an electroencephalogram (EEG) examination of the scalp of the amputee, as a result of which a potential map indicating the activation of the somatosensory cortex in response to the current is generated. The system is configured such that the area that processes the sensation of the lost body part exhibits activation in response to the current in the electrical diagram. The method according to claim 21.

35. This method includes the step of contacting one or more sensors of the sensor array and passing a current through the residual limb for a certain period of time, and an EEG examination is performed after a certain period of time. The method according to claim 34.

36. The amputee exhibits phantom limb syndrome. This method includes the step of contacting one or more sensors of the sensor array and periodically transmitting a current from the positive electrode of the electrode array to the negative electrode of the electrode array through the residual limb for a certain period of time. This method is effective in reducing the symptoms of phantom limb syndrome when evaluated on a visual analog scale after a certain period of time. The method according to claim 21.

37. The amputee exhibits phantom limb syndrome. This method includes the step of giving instructions to a secondary controller that wirelessly communicates with the system, causing one or more positive electrodes of the electrode array to transmit a current to the residual limb and one or more negative electrodes of the electrode array to receive a current from the residual limb, and Giving instructions to the secondary controller to transmit a current through the residual limb such that one or more positive electrodes transmit a current and one or more negative electrodes receive a current, thereby treating one or more symptoms of phantom limb syndrome. The method according to claim 21.

38. The secondary controller is a mobile computing device. The secondary controller wirelessly communicates with the system. The wireless communication is made by one or both of a Bluetooth or Wi-Fi connection between the secondary controller and the electrode array. The method according to claim 37.

39. The amputee presents with phantom limb syndrome, This method includes (1) contacting one or more sensors according to the symptoms of phantom limb syndrome, such that one or more positive electrodes transmit current to the residual limb and one or more negative electrodes receive current from the residual limb, or (2) instructing a secondary controller according to the symptoms, such that one or more positive electrodes transmit current to the residual limb and one or more negative electrodes receive current from the residual limb, and By this method, phantom limb syndrome is treated by passing a current through the residual limb according to the symptoms, The method according to claim 37.

40. The current is a pulsed current, with a pulse frequency of at least 20 pulses per second, a maximum of 180 pulses, a pulse width of a maximum of 100 microseconds, and an amplitude of a maximum of 100 milliamperes, The method according to claim 21.

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