System and method for stump of amputee

Abstract

Aspects of the present disclosure relate to a prosthetic cover that includes a sensor array that transmits signals to an electrode array in a pad that fits over a stump of an amputee. Different interactions with the prosthetic cover induce different activations of the electrodes, thereby transferring current through different regions of the stump and modulating neurons in different ways within the stump.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims priority to 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, the entire contents of which are incorporated herein by reference. Background Art

[0003] Amputees often suffer from phantom limb syndrome, in which they experience sensations that are attributed to their missing limb. These sensations are usually unwanted, often painful, and in some cases debilitating.

[0004] Phantom limb syndrome can be treated with mirror therapy, in which a mirror provides a visual representation of the missing limb when placed between the intact and missing limb. When the patient moves their intact limb, both limbs appear to move simultaneously. This provides the patient with a visual representation of their missing limb, which influences the way the patient feels about their missing limb after repeated treatment. However, clinical studies on mirror therapy have not shown a statistically significant effect in reducing pain.

[0005] Other nonpharmacological interventions to alleviate the symptoms of phantom limb syndrome remain desirable. Summary of the invention

[0006] Various aspects of the present disclosure relate to the discovery that neural feedback when interacting with a prosthesis can help alleviate symptoms of phantom limb syndrome. Some embodiments relate to a prosthetic cover that includes a sensor array that transmits signals to an electrode array in a pad that fits on an amputee's residual limb. Different interactions with the prosthetic cover trigger different activations of the electrodes, thereby transmitting current through different areas of the residual limb and modulating neurons in different ways within the residual limb. Thus, the amputee can interact with the prosthesis by touching the cover, viewing the interaction, and modulating different neurons in response to the touch. Without limiting this specification or any patent claims derived from this disclosure, simultaneous sensory feedback from touch, vision, and current facilitates inducing neuroplasticity in the somatosensory cortex of the amputee's brain to create a new topological map for the prosthesis through repeated interactions, which alleviates the symptoms of phantom limb syndrome. Without limiting this specification or any patent claims derived from this disclosure, the new topological map allows the amputee to associate specific symptoms of phantom limb syndrome with specific interactions with the prosthetic cover, which enables the amputee to treat specific symptoms through specific interactions when the symptoms occur.

[0007] Various other aspects of the invention in this disclosure will become apparent upon review of the following detailed description and claims. The scope of the disclosure should not be limited by the above summary and background. The scope of each patent claim derived from the disclosure should not be limited by the above summary and background or the following detailed description, but rather, the scope of each patent claim derived from the disclosure should be limited only by the express language of the claim in the context of its claim dependence. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 A system is presented, the system comprising a liner and a prosthetic cover, the liner comprising an embedded electrode array, the prosthetic cover comprising a sensor array;

[0009] Figure 2 The substrate and mold used to make the liner are shown;

[0010] Figure 3 The substrate and electrode controllers are shown;

[0011] Figure 4 The pads and the housing that houses the electrode controller are shown;

[0012] Figure 5 Partially transparent display Figure 4 The pad and housing in the housing allow the substrate and electrode controller to be visible;

[0013] Figure 6 An exploded view of a cover configured to fit over a prosthesis is shown;

[0014] Figure 7 Shown Figure 6 The state of the cover in the assembled configuration, excluding the outer surface;

[0015] Figure 8 Shown Figure 6 and Figure 7 The cover is shown in an assembled configuration, excluding the outer surface, wherein the outer layer is translucent and the spacer layer is transparent so as to show the sensor and sensor controller below.

[0016] Fig. 9 Shown Figure 3 The substrate and electrode controller and according to Figure 6-8 a partially assembled enclosure; and

[0017] Fig.10 is a flow chart illustrating the use of the system. DETAILED DESCRIPTION

[0018] The disclosed technology includes systems and methods for treating phantom limb syndrome by treating the symptoms of phantom limb pain and enhancing proprioception of an amputee's prosthetic limb.

[0019] After a limb amputation, the amputee may report the perception of sensations in the missing limb, which is called phantom limb sensation (PLS). In some cases, this sensation may be pain or discomfort in the missing limb, which is called phantom limb pain (PLP). In extreme cases, PLP manifests as a debilitating condition.

[0020] Various aspects of the present disclosure relate to a prosthetic cover that includes a sensor array that transmits signals to an electrode array in a pad that fits over an amputee's residual limb. Different interactions with the prosthetic cover trigger different activations of the electrodes, thereby transmitting current through different areas of the residual limb and modulating neurons in different ways within the residual limb. As a result of the interaction with the prosthetic cover, electrical stimulation of the underlying nerve fibers enables the amputee to feel the stimulation. These stimulations, used alone or in combination with other PLP treatment applications (e.g., artificial visualization, such as mirror therapy), can evoke somatic sensations. As a result, the amputee may feel that the missing limb is intact and / or functional, which can reduce or resolve PLP.

[0021] In some embodiments, the interaction with the prosthetic cover is any interaction, event, or modality sensed by the sensor that results in activation of the electrode. In some embodiments, the modality is a touch modality, such as touch, force, pressure, vibration, or vibration.

[0022] Various aspects of the present disclosure relate to systems for use by amputees. In some embodiments, the systems are used to modulate neural activation in a residual limb of an amputee.

[0023] In some embodiments, the system comprises a pad. In some specific embodiments, the system comprises a pad, the pad comprises an electrode array. In some very specific embodiments, the system comprises a pad, the pad comprises an embedded electrode array. The pad typically comprises or consists of a non-conductive polymer, such as silicone.

[0024] In some embodiments, the system comprises an electrode array. In some specific embodiments, the system comprises an electrode array embedded in a pad. The electrode array can be embedded in (for example) a silicone pad. Any medical grade electrode capable of conducting a pulsed current of at least 30 milliamperes is generally suitable for use in the systems and methods described herein. In some specific embodiments, the electrode is suitable for transcutaneous electrical nerve stimulation. In some very specific embodiments, the electrode is a carbon rubber electrode.

[0025] The electrodes of the present disclosure are generally suitable for continuous long-term contact with human skin, such contact optionally mediated by a conductive gel. In some embodiments, continuous long-term contact refers to continuous contact for at least two hours. In some specific embodiments, continuous long-term contact refers to continuous contact for at least twelve hours. In some very specific embodiments, continuous long-term contact refers to continuous contact for at least 48 hours.

[0026] In some embodiments, the pad is a single, unified structure. In some specific embodiments, the pad is a single, unified structure in which an electrode array is embedded. In some very specific embodiments, the pad is a single, unified structure in which an electrode array and wires are embedded, wherein each electrode in the electrode array is connected to at least one wire so that the wires can mediate electrical communication between the electrode array and an electrode controller. The electrode can include, for example, a 2 mm pin connector to establish electrical communication between the electrode and the wire. For example, the pad can be formed by providing a substrate including the electrodes and the wires, inserting the substrate into a mold, and pouring liquid silicone into the mold so that the electrodes and the wires are embedded in the silicone.

[0027] The pad is generally configured to receive the residual limb of an amputee. In some embodiments, the pad is configured to receive the residual limb so that each electrode in the electrode array is in electrical communication with the residual limb. A conductive gel can be applied, for example, between the electrodes in the electrode array and the residual limb to facilitate electrical communication between the electrodes and the residual limb.

[0028] The present disclosure and claims should not be interpreted to imply that the systems in the present disclosure or claims include amputees, residual limbs, nerve fibers, etc. unless there is express language indicating that the systems include amputees, residual limbs, nerve fibers, etc., and, if there is any express language indicating that the systems include amputees, residual limbs, nerve fibers, etc., then such express language should be limited to its immediate context and should not be used to interpret other parts of the present disclosure that lack such express language or to interpret any patent claims derived from the present disclosure but that lack such express language.

[0029] In some embodiments, each electrode in the electrode array is paired with at least two other electrodes in the electrode array such that when the electrode array is in electrical communication with the residual limb, each electrode is capable of (1) transmitting current through the residual limb to a first negative electrode paired with the electrode, and also capable of transmitting current solely to a second negative electrode paired with the electrode, and / or (2) receiving current through the residual limb from a first positive electrode paired with the electrode, and also capable of receiving current solely from a second positive electrode paired with the electrode. In such embodiments, each electrode in the electrode array can, for example, transmit current through at least two other electrodes and / or receive current from at least two other electrodes to provide different current paths through the residual limb and / or differentially modulate nerve fibers in the residual limb in response to different sensors.

[0030] In some embodiments, the system is configured such that, (1) when two or more electrodes are activated, and (2) when the two or more electrodes are in electrical communication with the residual limb, then one of the activated two or more electrodes transmits current through the residual limb, and another of the activated two or more electrodes receives 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, then one of the activated two electrodes transmits current through the residual limb, and another of the activated two electrodes receives current transmitted through the residual limb. An electrode is activated when it is transmitting or receiving current.

[0031] In some embodiments, the system includes an electrode controller in electrical communication with each electrode in the electrode array.

[0032] In some embodiments, the electrode controller is configured to control whether each electrode capable of transmitting current transmits current to the negative electrode. In some embodiments, the electrode controller is configured to control whether each electrode capable of receiving current receives current from the positive electrode. In some specific embodiments, the electrode controller is configured to control whether each electrode capable of transmitting current transmits current to the negative electrode, and whether each electrode capable of receiving current receives current from the positive electrode. The electrode controller can thus control which electrodes in the electrode array transmit and receive current in response to different sensors and / or transmit current through different areas of the residual limb, for example.

[0033] In some embodiments, the electrode controller is configured to control whether each electrode capable of transmitting current transmits current to one or both of the first negative electrode and the second negative electrode through the residual limb. In some embodiments, 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. In some specific embodiments, 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, and controls whether each electrode capable of receiving current receives current from one or both of the first positive electrode and the second positive electrode.

[0034] In some embodiments, an electrode controller controls the current transmitted or received by each electrode in the electrode array.

[0035] In some embodiments, the system is configured so that the transmission and reception of electric current through the residual limb modulates nerve fibers in the residual limb. In some specific embodiments, the system is configured so that the transmission and reception of electric current through the residual limb stimulates nerve fibers in the residual limb. In some very specific embodiments, the system is configured so that the transmission and reception of electric current through the residual limb stimulates myelinated Aβ-type nerve fibers in the residual limb. In some very specific embodiments, the system is configured so that the transmission and reception of electric current through the residual limb modulates the activation of myelinated Aδ-type nerve fibers in the residual limb. In some very specific embodiments, the system is configured so that the transmission and reception of electric current through the residual limb modulates the activation of unmyelinated C-type nerve fibers in the residual limb.

[0036] In some embodiments, the electrode array is configured so that the transmission and reception of electrical current through the residual limb modulates nerve fibers in the residual limb. In some specific embodiments, the electrode array is configured so that the transmission and reception of electrical current through the residual limb stimulates nerve fibers in the residual limb. In some very specific embodiments, the electrode array is configured so that the transmission and reception of electrical current through the residual limb stimulates myelinated Aβ-type nerve fibers in the residual limb. In some very specific embodiments, the electrode array is configured so that the transmission and reception of electrical current through the residual limb modulates the activation of myelinated Aδ-type nerve fibers in the residual limb. In some very specific embodiments, the electrode array is configured so that the transmission and reception of electrical current through the residual limb modulates the activation of unmyelinated C-type nerve fibers in the residual limb.

[0037] In some embodiments, each electrode in the electrode array is configured so that transmitting and receiving current through the residual limb modulates nerve fibers in the residual limb. In some specific embodiments, each electrode in the electrode array is configured so that transmitting and receiving current through the residual limb stimulates nerve fibers in the residual limb. In some very specific embodiments, each electrode in the electrode array is configured so that transmitting and receiving current through the residual limb stimulates myelinated Aβ-type nerve fibers in the residual limb. In some very specific embodiments, each electrode in the electrode array is configured so that transmitting and receiving current through the residual limb modulates the activation of myelinated Aδ-type nerve fibers in the residual limb. In some very specific embodiments, each electrode in the electrode array is configured so that transmitting and receiving current through the residual limb modulates the activation of unmyelinated C-type nerve fibers in the residual limb.

[0038] In some embodiments, the electric current is a pulsed current.

[0039] In some embodiments, the pulse frequency of the pulsed current is at least 2 pulses per second and at most 200 pulses per second. In some specific embodiments, the pulse frequency of the pulsed current is at least 20 pulses per second and at most 180 pulses per second. In some very specific embodiments, the pulse frequency of the pulsed current is at least 135 pulses per second and at most 155 pulses per second.

[0040] In some embodiments, the pulse width of the pulsed current is at most 400 microseconds. In some specific embodiments, the pulse width of the pulsed current is at most 100 microseconds. In some very specific embodiments, the pulse width of the pulsed current is at most 50 microseconds.

[0041] In some embodiments, the amplitude of the pulsed current is at most 150 mA. In some specific embodiments, the amplitude of the pulsed current is at most 100 mA. In some very specific embodiments, the amplitude of the pulsed current is at least 10 mA and at most 30 mA.

[0042] In some embodiments, the electrode array comprises at least 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, 128, or 256 electrodes. In some specific embodiments, the electrode array comprises at least 8 and at most 512 electrodes. In some specific embodiments, the electrode array comprises 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, 128, 256, or 512 electrodes. In some very specific embodiments, the electrode array comprises 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, 128, 256, or 512 electrodes, and the system comprises a plurality of additional electrodes not included in the electrode array.

[0043] In some embodiments, the system includes one or more electrodes that are not included in the electrode array. The one or more electrodes that are not included may be, for example, electrodes that are not used to transmit and / or receive current to and from the residual limb, or electrodes that a potential infringer of one or more patent claims derived from the present disclosure may consider including in the system in an attempt to establish a legal basis for non-infringement.

[0044] In some embodiments, the system includes a housing. In some specific embodiments, the system includes a housing configured to receive a prosthesis. In some very specific embodiments, the system includes a housing configured to receive a leg or arm prosthesis.

[0045] In some embodiments, the system lacks a prosthesis. Unless explicit literal expressions indicate that the system of the present disclosure or the appended claims include a prosthesis, the present disclosure and the appended claims should not be interpreted as implying that the system includes a prosthesis; and if there are any explicit literal expressions indicating that the system includes a prosthesis, then these explicit literal expressions should be limited to their immediate context and should not be used to interpret other parts of the present disclosure that lack these explicit literal expressions, nor should they be used to interpret any patent claims derived from the present disclosure but lacking these explicit literal expressions.

[0046] In some embodiments, a system includes a prosthesis.

[0047] In some embodiments, the cover is configured to cover an outer surface of the prosthesis.

[0048] In some embodiments, the system comprises a polymer foam. In some specific embodiments, the system comprises a polyurethane foam. In some very specific embodiments, the system comprises a two-component polyurethane expanding foam.

[0049] In some embodiments, the foam is configured to secure the cover to the prosthesis. In some specific embodiments, the foam is configured to fill the void space between the cover and the prosthesis. In some very specific embodiments, the foam is configured to secure the cover to the prosthesis and fill the void space between the cover and the prosthesis.

[0050] 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 secure the cover to the prosthesis. In some very specific embodiments, the foam contacts the inner surface of the cover to secure the cover to the prosthesis and fills the void space between the cover and the prosthesis.

[0051] In some embodiments, the system includes a polymer foam, and the cover is secured to the prosthesis with the polymer foam. In some specific embodiments, the system includes a polyurethane foam, and the cover is secured to the prosthesis with the polyurethane foam. In some very specific embodiments, the system includes a two-component polyurethane expanding foam, and the cover is secured to the prosthesis with the two-component polyurethane expanding foam. The cover can be secured to the prosthesis, for example, by positioning the cover around the prosthesis and then inserting the expanding foam between the cover and the prosthesis to fill the void space between the cover and the prosthesis; the cover can thereby be secured to different prostheses of different shapes and sizes.

[0052] In some embodiments, the foam (or a component thereof) is provided in one or more containers. In some specific embodiments, the foam (or a component thereof) is provided in one or more containers for securing the cover to the prosthesis. In some very specific embodiments, the foam (or a component thereof) is provided in one or more containers for securing the cover to the prosthesis by inserting the foam (or a component thereof) between the cover and the prosthesis to fill the void space between the cover and the prosthesis.

[0053] In some embodiments, the system includes one or more containers containing expandable foam. In some specific embodiments, the system includes one or more containers, which are bags containing expandable foam. The expandable foam can be provided in, for example, one or more containers, which are bags, and when the one or more bags are placed between the prosthesis and the cover, the expandable foam can expand within the one or more bags to fill the void space between the prosthesis and the cover, thereby securing the cover to the prosthesis. The one or more bags can therefore be used, for example, to keep the expandable foam within the void space between the prosthesis and the cover and / or inhibit the expandable foam from entering the void space within the prosthesis or the cover and / or inhibit the expandable foam from leaving the cover.

[0054] In some embodiments, the system includes one or more straps for securing the cover to the prosthesis. The straps can be used, for example, to position the cover relative to the prosthesis before expanding the foam in the void space between the prosthesis and the cover.

[0055] In some embodiments, the housing includes a sensor array.

[0056] In some embodiments, each sensor in the sensor array is configured to sense at least one modality (eg, one or both of force and pressure). Each sensor can be, for example, a force sensitive resistor.

[0057] In some implementations, each sensor in the sensor array includes a resistor configured to sense at least one modality (eg, one or both of force and pressure).The exact type of modality sensor is not limited.

[0058] In some embodiments, the system is configured such that the amplitude of current transmitted and received by electrodes in the electrode array through the residual limb is directly related to the modality (e.g., pressure or force) sensed by the sensor, for example, such that an increased modality (e.g., increased pressure or increased force) is correlated with increased amplitude.

[0059] In some embodiments, the electrode array communicates with the sensor array such that two or more electrodes are activated in response to sensing by one or more sensors. In some specific embodiments, the electrode array communicates with the sensor array such that two electrodes are activated in response to sensing by one sensor.

[0060] In some embodiments, each sensor corresponds to at least two electrodes. In some specific embodiments, each sensor corresponds to two electrodes.

[0061] In some embodiments, each electrode corresponds to at least one sensor. In some specific embodiments, each electrode corresponds to at least two sensors.

[0062] If a sensor is in communication with an electrode, then the sensor corresponds to the electrode such that when the sensor senses a modality (eg, force or pressure) and the electrode is in electrical communication with the residual limb, the electrode will transmit current to or receive current from the residual limb.

[0063] If the sensor is in communication with the electrode, the electrode corresponds to the sensor such that when the sensor senses a modality (eg, force or pressure) and the electrode is in electrical communication with the residual limb, the electrode will transmit current to or receive current from the residual limb.

[0064] In some embodiments, the sensor array has a three-dimensional configuration of sensors relative to the enclosure.

[0065] In some embodiments, when the cover is attached to the outer surface of the prosthesis, the sensor array has a three-dimensional configuration of sensors relative to the outer surface of the prosthesis.

[0066] In some embodiments, the electrode array has a three-dimensional configuration of electrodes relative to the pads.

[0067] In some embodiments, the electrode array has a three-dimensional configuration of electrodes relative to the residual limb when each of the electrodes is in electrical communication with the residual limb.

[0068] In some embodiments, each sensor has a sensor relative position relative to each other sensor in the sensor array in a three-dimensional sensor configuration; each electrode has an electrode relative position relative to each other electrode in the electrode array in a three-dimensional electrode configuration; the system includes sensor-electrode pairs, each sensor-electrode pair consisting of one or more sensors and two or more electrodes, the sensors and electrodes corresponding to each other; and the sensor relative position of each sensor in the sensor-electrode pair within the sensor three-dimensional configuration is related to the electrode relative position of each electrode in the same sensor-electrode pair within the electrode three-dimensional configuration. In some specific embodiments, the system includes sensor-electrode pairs, each sensor-electrode pair including one sensor and two electrodes, the sensors and electrodes corresponding to each other.

[0069] The relative positions of the sensors are related to the relative positions of the electrodes, for example, when (a) 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; (b) 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; (c) the sensor-electrode pairs include each of the following: 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, and an outer distal pair including an outer distal sensor and an lateral distal pair of electrodes, a posterior proximal pair including a posterior proximal sensor and a posterior proximal electrode, a posterior distal pair including a posterior distal sensor and a posterior distal electrode, an 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; (d) the relative sensor position of the anterior proximal sensor is (1) closer to the anterior distal sensor than to both the lateral proximal sensor and the inner distal sensor, (2) closer to both the lateral distal sensor and the inner distal sensor than to the posterior distal sensor, (3) closer to both the lateral proximal sensor and the inner proximal sensor than to the posterior proximal sensor, and (4) closer to the posterior proximal sensor than to the posterior distal sensor; (e) the relative sensor position of the anterior proximal electrode The relative position of the anterior distal sensor is (1) closer to the anterior distal electrode than to both the lateral distal electrode and the medial distal electrode, (2) closer to both the lateral distal electrode and the medial distal electrode than to the posterior distal electrode, (3) closer to both the lateral proximal electrode and the medial proximal electrode than to the posterior proximal electrode, and (4) closer to the posterior proximal electrode than to the posterior distal electrode; (f) the relative position of the anterior distal sensor is (1) closer to the anterior proximal sensor than to the lateral proximal sensor and the medial proximal sensor, (2) closer to both the lateral proximal sensor and the medial proximal sensor than to the posterior proximal sensor, (3) closer to both the lateral distal sensor and the medial distal sensor than to the posterior distal sensor, and (4) closer to the posterior distal sensor than to the posterior proximal sensor; (g) The electrode relative position of the end electrode is (1) closer to the anterior proximal electrode than to both the lateral proximal electrode and the medial proximal electrode, (2) closer to both the lateral proximal electrode and the medial proximal electrode than to the posterior proximal electrode, (3) closer to both the lateral distal electrode and the medial distal electrode than to the posterior distal electrode, and (4) closer to the posterior distal electrode than to the posterior proximal electrode; (h) the sensor relative position of the medial proximal sensor is (1) closer to the medial distal sensor than to the anterior distal sensor and the posterior distal sensor, (2) closer to both the anterior distal sensor and the posterior distal sensor than to the lateral distal sensor, (3) closer to both the anterior proximal sensor and the posterior proximal sensor than to the lateral proximal sensor, and (4) closer to the lateral proximal sensor than to the lateral distal sensor;(i) the electrode relative position of the medial proximal electrode is (1) closer to the medial distal electrode than to both the anterior distal electrode and the posterior distal electrode, (2) closer to both the anterior distal electrode and the posterior distal electrode than to the lateral distal electrode, (3) closer to both the anterior proximal electrode and the posterior proximal electrode than to the lateral proximal electrode, and (4) closer to the lateral proximal electrode than to the lateral distal electrode; (j) the sensor relative position of the medial distal sensor is (1) closer to the medial proximal sensor than to the anterior proximal sensor and the posterior proximal sensor, (2) closer to both the anterior proximal sensor and the posterior proximal sensor than to the lateral proximal sensor, (3) closer to both the anterior distal sensor and the posterior distal sensor than to the lateral distal sensor, and (4) closer to the lateral distal sensor than to the lateral proximal sensor; k) the electrode relative position of the medial distal electrode is (1) closer to the medial proximal electrode than to both the anterior proximal electrode and the posterior proximal electrode, (2) closer to both the anterior proximal electrode and the posterior proximal electrode than to the lateral proximal electrode, (3) closer to both the anterior distal electrode and the posterior distal electrode than to the lateral distal electrode, and (4) closer to the lateral distal electrode than to the lateral proximal electrode; (l) the sensor relative position of the posterior proximal sensor is (1) closer to the posterior distal sensor than to both the lateral distal sensor and the medial distal sensor, (2) closer to both the lateral distal sensor and the medial distal sensor than to the anterior distal sensor, (3) closer to both the lateral proximal sensor and the medial proximal sensor than to the anterior proximal sensor, and (4) closer to the anterior proximal sensor than to the anterior distal sensor; (m) the electrode relative position of the posterior proximal electrode is (1) closer to the posterior distal electrode than to both the lateral distal electrode and the medial distal electrode, (2) closer to both the lateral distal electrode and the medial distal electrode than to the anterior distal electrode, (3) closer to both the lateral proximal electrode and the medial proximal electrode than to the anterior proximal electrode, and (4) closer to the anterior proximal electrode than to the anterior distal electrode; (n) the sensor relative position of the posterior distal sensor is (1) closer to the posterior proximal sensor than to both the lateral proximal sensor and the medial proximal sensor, (2) closer to both the lateral proximal sensor and the medial proximal sensor than to the anterior proximal sensor, (3) closer to both the lateral distal sensor and the medial distal sensor than to the anterior distal sensor, and (4) closer to the anterior distal sensor than to the anterior proximal sensor ; (o) the electrode relative position of the posterior distal electrode is (1) closer to the posterior proximal electrode than to both the lateral proximal electrode and the medial proximal electrode, (2) closer to both the lateral proximal electrode and the medial proximal electrode than to the anterior proximal electrode, (3) closer to both the lateral distal electrode and the medial distal electrode than to the anterior distal electrode, and (4) closer to the anterior distal electrode than to the anterior proximal electrode; (p) the sensor relative position of the lateral proximal sensor is (1) closer to the lateral distal sensor than to the anterior distal sensor and the posterior distal sensor, (2) closer to both the anterior distal sensor and the posterior distal sensor than to the medial distal sensor, (3) closer to both the anterior proximal sensor and the posterior proximal sensor than to the medial proximal sensor, and (4) closer to the medial proximal sensor than to the medial distal sensor;(q) the electrode relative position of the lateral proximal electrode is (1) closer to the lateral distal electrode than to both the anterior distal electrode and the posterior distal electrode, (2) closer to both the anterior distal electrode and the posterior distal electrode than to the medial distal electrode, (3) closer to both the anterior proximal electrode and the posterior proximal electrode than to the medial proximal electrode, and (4) closer to the medial proximal electrode than to the medial distal electrode; (r) the sensor relative position of the lateral distal sensor is (1) closer to the lateral proximal sensor than to both the anterior proximal sensor and the posterior proximal sensor, (2) closer to the anterior proximal sensor than to the medial proximal sensor and the posterior 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; and (s) the electrode relative position of the lateral distal electrode is (1) closer to the lateral proximal electrode than both the anterior proximal electrode and the posterior proximal electrode, (2) closer to both the anterior proximal electrode and the posterior proximal electrode than the medial proximal electrode, (3) closer to both the anterior distal electrode and the posterior distal electrode than the medial distal electrode, and (4) closer to the medial distal electrode than the medial proximal electrode. ;

[0070] The preceding paragraphs set forth exemplary associations between the relative position of each sensor in a three-dimensional configuration of sensors and the relative position of each electrode in a three-dimensional configuration of electrodes. The relative positions of sensors in different sensor arrays may have similar but different associations with the relative positions of electrodes in different electrode arrays, for example, to accommodate different modes of sensors and / or electrodes. This is to accommodate different modes of sensors and / or electrodes. The relative positions of sensors are typically associated with the relative positions of electrodes, for example, the front sensor activates the front electrode, the rear electrode activates the rear electrode, the medial sensor activates the medial electrode, and the lateral sensor activates the lateral electrode. Pressing the front of the calf prosthesis thus transmits current through the front of the thigh stump, and pressing the rear of the calf prosthesis thus transmits current through the rear of the thigh stump. However, other modes are also compatible with the system of the present disclosure. Without limiting this specification or any patent claims derived from the present disclosure, the correlation between the relative positions of sensors and paired electrodes may be helpful for topological mapping and more effective treatment of phantom limb syndrome.

[0071] In some embodiments, the sensor three-dimensional configuration defines a sensor surface; the electrode three-dimensional configuration defines an electrode surface; and the proximity is measured along the sensor surface and the electrode surface rather than in Cartesian space. In some embodiments, the sensor surface is a surface of the cover. In some embodiments, the sensor surface is an outer surface of the cover. In some embodiments, the electrode surface is a surface of the pad. In some embodiments, the electrode surface is an inner surface of the pad.

[0072] The adjectives anterior, lateral, posterior, medial, distal, and proximal indicate (1) the relative position of the sensor relative to both the housing (or prosthesis) and other sensors and (2) the relative position of the electrode relative to both the pad (or residual limb) and other electrodes. For example, an anterior distal sensor is closer to the front of the housing (or prosthesis) than an lateral distal sensor, a posterior distal sensor, and a medial distal sensor. For example, an anterior distal sensor is located lower on a leg or arm prosthesis housing (or leg or arm prosthesis) than an anterior proximal sensor.

[0073] The terms anterior proximal sensor, anterior distal sensor, lateral proximal sensor, lateral distal sensor, posterior proximal sensor, posterior distal sensor, medial proximal sensor, medial distal sensor, etc. should (1) be interpreted merely as identifying the relative positions of the sensors, (2) should not be interpreted as implying a three dimensional configuration of the sensors (e.g., by implying a regular grid), and (3) should not be interpreted as implying the presence or absence of any other sensor in the sensor array.

[0074] The terms anterior proximal electrode, anterior distal electrode, lateral proximal electrode, lateral distal electrode, posterior proximal electrode, posterior distal electrode, medial proximal electrode, medial distal electrode, etc. should (1) be interpreted merely as identifying the relative positions of the electrodes, (2) should not be interpreted as implying a three-dimensional configuration of the electrodes (such as by implying a regular grid), and (3) should not be interpreted as implying the presence or absence of any other electrodes in the electrode array.

[0075] In some embodiments, each sensor corresponds to exactly two electrodes, and each sensor-electrode pair consists 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 consists of (1) a sensor and (2) two electrodes corresponding to the sensor, wherein 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 consists of (1) a sensor and (2) two electrodes corresponding to the sensor, wherein 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.

[0076] In some embodiments, the electrode array comprises at least one electrode ring, wherein the electrode ring is composed of four or more electrodes, each electrode being paired with exactly two other electrodes of the ring. In some specific embodiments, the electrode array comprises at least two, three, four, five, or six electrode rings. In some very specific embodiments, the electrode array comprises at least eight electrodes and at least six electrode rings. For example, if the front proximal electrode and the outer distal electrode are each paired with the front distal electrode and the outer proximal electrode, then the front proximal electrode, the front distal electrode, the outer proximal electrode, and the outer distal electrode are electrode rings.

[0077] In some embodiments, at least one electrode ring is configured to surround the residual limb. For example, if the front distal electrode and the rear distal electrode are each paired with an outer distal electrode and an inner distal electrode, the front distal electrode, the outer distal electrode, the rear distal electrode, and the inner distal electrode are electrode rings configured to surround the residual limb. In some specific embodiments, at least two electrode rings are configured to surround the residual limb.

[0078] In some embodiments, the sensor array includes one, two, three, four, five, six, seven, or each of the following sensors: an anterior proximal sensor, an anterior distal sensor, an lateral proximal sensor, an lateral distal sensor, a posterior proximal sensor, a posterior distal sensor, an inner proximal sensor, and an inner distal sensor.

[0079] In some embodiments, the electrode array includes one, two, three, four, five, six, seven, or each of the following sensors: an anterior proximal electrode, an anterior distal electrode, an lateral proximal electrode, an lateral distal electrode, a posterior proximal electrode, a posterior distal electrode, an inner proximal electrode, and an inner distal electrode.

[0080] In some embodiments, the sensor-electrode pairs include one, two, three, four, five, six, seven, or each of: 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, a lateral proximal pair including an lateral proximal sensor and an lateral proximal electrode, a lateral distal pair including an lateral distal sensor and an lateral distal electrode, a posterior proximal pair including a posterior proximal sensor and a posterior proximal electrode, a posterior distal pair including a posterior distal sensor and a posterior distal electrode, a medial proximal pair including a medial proximal sensor and a medial proximal electrode, and a medial distal pair including a medial distal sensor and a medial distal electrode. Each of the sensor-electrode pairs identified in the previous sentence also includes additional electrodes; the front proximal pair also includes, for example, one or more of a second front proximal electrode, a front distal electrode, an lateral proximal electrode, an medial proximal electrode, or completely different electrodes.

[0081] In some embodiments, each sensor in the sensor array communicates with two or more electrodes in the electrode array such that the two or more electrodes are configured to transmit and receive current through the residual limb when any of the following conditions are met: (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. This configuration allows the amputee to transmit current through his or her residual limb when the amputee is not wearing the prosthesis with the cover, for example, after the amputee has removed such a prosthesis to sleep, in order to optionally treat the symptoms of phantom limb syndrome.

[0082] In some embodiments, the sensor array comprises 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 comprises at least 4 and at most 128 sensors. In some specific embodiments, the sensor array comprises 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, or 128 sensors. In some very specific embodiments, the sensor array comprises 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 24, 28, 32, 64, or 128 sensors, and the system comprises a plurality of additional sensors not included in the sensor array.

[0083] In some embodiments, the system includes one or more sensors that are not included in the sensor array. The one or more sensors that are not included can be, for example, sensors that are not used to detect force or pressure, or sensors that a potential infringer of one or more patent claims derived from the present disclosure might consider including in the system in an attempt to establish a legal basis for non-infringement.

[0084] In some embodiments, the system includes a controller, wherein the controller communicates with the electrode array so that the controller can bypass the sensor array to cause each electrode in the electrode array to transmit current to or receive current from the amputee's residual limb when the electrode is electrically connected to the amputee's residual limb. Such a controller can allow an amputee to transmit current through his or her residual limb when he or she is not wearing a prosthesis with a cover, for example, after the amputee has removed such a prosthesis to sleep. The controller can also allow the amputee to run a program specifically for treating phantom limb syndrome. The amputee may develop a specific pattern of transmitting current through his or her residual limb that is particularly effective in treating phantom limb syndrome, the system may track the amputee's use of the system and develop a specific pattern that shows a high probability of being effective in treating phantom limb syndrome, or crowdsourced usage records or other data from multiple amputees may identify a specific pattern that shows a high probability of being effective in treating phantom limb syndrome, and a program on the controller can drive the electrode array to implement this specific pattern. Such a controller may optionally be an electrode controller or a secondary controller as described herein.

[0085] In some embodiments, the system includes a secondary controller in wireless communication with the electrode array such that the secondary controller can bypass the sensor array to cause each electrode in the electrode array to transmit current to or receive current from the residual limb when the electrode array is in electrical communication with the residual limb.

[0086] In some embodiments, the secondary controller is a computing device. In some specific embodiments, the secondary controller is a mobile computing device. In some very specific embodiments, the secondary controller is a cell phone.

[0087] In some embodiments, the secondary controller is in wireless communication with the electrode array. In some specific embodiments, the secondary controller is in wireless communication with the electrode controller. In some very specific embodiments, the secondary controller is in wireless communication with the electrode controller that controls the electrode array.

[0088] In some embodiments, the wireless communication is mediated by one or both of a Bluetooth or 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 or Wi-Fi connection between the secondary controller and the electrode array, which is mediated by an electrode controller that controls the electrode array.

[0089] In some embodiments, the secondary controller is in wireless communication with the electrode controller.

[0090] In some embodiments, the cover is configured to be attached to the outer surface of different prostheses having a plurality of different shapes, and the cover is configured to adapt to the plurality of different shapes so that the relative position of each sensor remains unchanged for the different shapes. In some specific embodiments, the cover is configured to be attached to the outer surface of different prostheses having a plurality of different shapes, and the cover is configured to adapt to the plurality of different shapes so that the three-dimensional configuration of each sensor remains unchanged for the different shapes.

[0091] In some embodiments, the cover has the shape of a missing body part. In some specific embodiments, the cover has the shape of a missing body part, and the sensor three-dimensional configuration includes the shape of the missing body part. Without limiting the present disclosure or any patent claims derived from the present disclosure, the cover having the shape of the missing part and the sensor three-dimensional configuration including the shape are more advantageous in inducing neuroplasticity in the somatosensory cortex of the amputee's brain than other shapes, which is more effective in treating phantom limb syndrome.

[0092] In some embodiments, the system lacks any sensor capability to sense the relative position of the prosthesis. In some embodiments, the sensor array is generally configured to sense pressure and / or force from touch, and the sensor array is generally not configured to sense the position or performance of the prosthesis.

[0093] In some embodiments, the system lacks any mechanical ability to move the prosthesis. In some embodiments, the system is generally independent of the mechanical properties of the prosthesis (e.g., supporting movement, positioning, or load).

[0094] In some embodiments, the system lacks any structural ability to support the body weight of an amputee. In some embodiments, the system is generally independent of the structural characteristics of the prosthesis (e.g., supporting movement, positioning, or loads).

[0095] Figure 1 A system 100 is shown that includes a pad 101 that includes an array of embedded electrodes 102. The pad 101 receives a residual limb (not shown) such that the pad 101 fits beneath an area of ​​a prosthesis 103 that also receives the residual limb. Each electrode 102 in the array of electrodes 102 is in electrical communication with an electrode controller 104, the electrical communication being mediated by wires 105 also embedded in the pad 101. Figure 1 The system 100 is shown further comprising a cover 106 containing an array of embedded sensors 107. The cover 106 fits over the area of ​​the prosthesis 103 that replaces the missing limb and is optionally attached to the prosthesis 103 with a polymer foam (not shown) that fills the void space between the cover 106 and the prosthesis 103. The sensors 107 communicate with a sensor controller 108 that interacts with the electrode controller 104.

[0096] Figure 1 A wireless, Bluetooth-mediated interface 109 between the sensor controller 108 and the electrode controller 104 is shown. The wireless, Bluetooth-mediated interface 109 between the sensor controller 108 and the electrode controller 104 allows an amputee to contact the sensors 107 to activate the electrodes 102 in the electrode 102 array, thereby stimulating their residual limb, even when the amputee is not wearing the prosthesis 103 and the cover 106, for example, when the amputee has removed the prosthesis 103 to sleep. In other embodiments, the system 100 lacks the sensor controller 108, and the sensors 107 are directly connected to the electrode controller 104.

[0097] Figure 1 The pad 101 includes a substrate 110 that houses an array of embedded electrodes 102 . Figure 1 Also shown are a joint 111 of the prosthesis 103, an outer layer 112 of the housing 106 (the outer layer 112 is shown in an exploded view), and a sheath 113 that bundles together the wires 105 extending from the cushion 101.

[0098] Figure 2 A substrate 110 is shown with an array of embedded electrodes 102 and embedded wires 105. The substrate 110 is positioned within a mold 120. Liquid silicone (not shown) may be poured into the mold 120 to form a pad (not shown) including the array of embedded electrodes 102 and embedded wires 105.

[0099] Figure 3 A substrate 110 having an embedded electrode array (not shown) and embedded wires 105 is shown. Figure 3 Also shown is an electrode controller 104, which includes a printed circuit board assembly 130 and a battery 131 in electrical communication with the printed circuit board assembly 130. When the electrode controller 104 is in electrical communication with the embedded wires 105, a microprocessor (not shown) in the printed circuit board assembly 130 controls the transmission of current between the battery 131 and the embedded wires 105 to control whether the electrodes in the electrode array transmit current (which is received by the electrodes from the battery 131) and whether the electrodes in the electrode array receive current (which is transmitted by the electrodes to the battery 131).

[0100] Figure 4 Shows include Figure 3 The base (not shown) of the liner 101 and the liner 102 of the liner 102 are provided. Figure 3 An electrode controller housing 140 of an electrode controller (not shown).

[0101] Figure 5 Partially transparent display Figure 4The pad 101 and electrode controller housing 140 are shown in the figure so that the substrate 110 and electrode controller 104 are visible.

[0102] Figure 6 An exploded view of a cover 106 is shown, which includes a sensor 107. The cover 106 includes an inner layer 160, which shows an embedded sensor 107 configured to sense a modality (e.g., force or pressure). The inner layer 160 can be made of plastic, for example. The inner layer 160 optionally includes one or more buckles 161 or other attachment features to receive an outer layer 162. The outer layer 162 can be made of plastic, for example. The outer layer 162 can optionally have actuators 163, each of which is configured to press against one or more sensors 107. Each actuator 163 can be configured, for example, as a flexible panel having a surface area greater than any one sensor 107, so that depressing any portion of the actuator 163 converts the modality (e.g., force or pressure) to one or more smaller sensors 107. The outer layer 162 optionally includes one or more grooves 164 or other attachment features to receive the inner layer 160. As shown Figure 6 As shown, the outer layer 162 includes four slots 164 shaped to receive four buckles 161 of the inner layer 160 to attach the outer layer 162 to the inner layer 160. Mechanical attachment features such as buckles may include detents, barbs, or other gripping or clamping features to inhibit separation of the inner layer 160 and the outer layer 162.

[0103] The shell 106 can optionally include a spacer 165 between the inner layer 160 and the outer layer 162. The spacer 165 can include, for example, foam. The spacer 165 can include one or more voids 166. The one or more voids 166 can allow, for example, the actuator 163 to contact the sensor 107. The one or more voids 166 can also allow, for example, attachment features (such as one or more buckles 161 and one or more slots 164) to attach the inner layer 160 and the outer layer 162.

[0104] The housing 106 may optionally include a sensor controller 108. The sensor controller 108 typically includes a printed circuit board assembly 167 that includes an interface and a microprocessor. The microprocessor is configured, for example, to receive signals from the sensor 107 and direct the interface to transmit corresponding signals to the electrode array or its controller. The interface can be, for example, a wireless interface, such as a combined Wi-Fi Bluetooth chip. The exact type of interface is not limited and typically depends on market factors, including the retail price suggested by the system manufacturer. The controller 108 typically includes a controller housing 168, which may optionally include an access panel 169 to allow access to the printed circuit board assembly 167. The sensor controller 108 typically includes or is electrically connected to a power source, which is typically a battery 170.

[0105] In some embodiments, the cover lacks a dedicated sensor controller (not shown). The system may include, for example, a hardwired interface between the cover and the cushion, such that a sensor controller is unnecessary.

[0106] The shell 106 may optionally include an outer surface 171 that may include, for example, foam and / or a tactile feel for physical interaction with the actuator 163 .

[0107] Figure 7 Shown Figure 6 The cover 106 in the assembled configuration does not include an outer surface (not shown). The four buckles 161 of the inner layer 160 attach the outer layer 162 and the inner layer 160. The outer layer 162 covers the controller housing 168.

[0108] Figure 8 Shown Figure 6 and Figure 7 The cover 106 in the assembled configuration does not include an outer surface (not shown), wherein the outer layer 162 is translucent and the spacer 165 is transparent to show the sensor 107 and printed circuit board assembly 167 below.

[0109] Fig. 9 Shown Figure 3 The electrode controller 104 and the pad 110 and Figures 6 to 8 The partially assembled cover body 106.

[0110] Various aspects of the present disclosure are directed to methods of using the systems described anywhere in this disclosure.

[0111] In some embodiments, the method is a method of modulating neural activation in a residual limb of an amputee.

[0112] Every amputee has a missing body part. In some embodiments, the amputee suffers from phantom limb syndrome.

[0113] In some embodiments, the system includes a cover, and the method includes attaching the cover to the prosthesis. In some specific embodiments, the method includes inserting foam between the cover and the prosthesis to attach the cover to the prosthesis. In some very specific embodiments, the method includes inserting expandable foam between the cover and the prosthesis to attach the cover to the prosthesis.

[0114] In some embodiments, the system includes a pad, and the method includes attaching the pad to the residual limb. In some specific embodiments, the pad includes an electrode array, and the method includes attaching the pad to the residual limb such that each electrode in the electrode array is in electrical communication with the residual limb. In some very specific embodiments, attaching the pad to the residual limb includes attaching each electrode in the electrode array to the residual limb such that each electrode is in electrical communication with the residual limb.

[0115] In some embodiments, the method includes contacting the residual limb with a conductive gel to facilitate electrical communication between each electrode in the electrode array and the residual limb.

[0116] In some embodiments, the method includes attaching the prosthesis to the residual limb. In some specific embodiments, the method includes attaching the prosthesis to the residual limb after attaching the cover to the prosthesis. In some specific embodiments, the method includes attaching the prosthesis to the residual limb such that the prosthesis fits over the liner. In some very specific embodiments, the method includes attaching the prosthesis to the residual limb after attaching the cover to the prosthesis and after attaching the liner to the residual limb such that the prosthesis fits over the liner.

[0117] In some embodiments, the system includes a sensor array, and the method includes contacting one or more sensors. In some specific embodiments, the housing includes a sensor array, and the method includes contacting one or more sensors. In some very specific embodiments, contacting the 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.

[0118] In some embodiments, the method includes contacting one or more sensors after attaching the cover to the prosthesis. In some embodiments, the method includes contacting one or more sensors after attaching the prosthesis to the residual limb. In some specific embodiments, the method includes contacting one or more sensors after attaching the cover to the prosthesis and attaching the prosthesis to the residual limb. In some very specific embodiments, the method includes contacting one or more sensors after attaching the liner to the residual limb, attaching the cover to the prosthesis, and attaching the prosthesis to the residual limb.

[0119] In some embodiments, the method includes removing the prosthesis from the residual limb and contacting the one or more sensors after the prosthesis is removed from the residual limb. The disclosed method advantageously allows an amputee to transmit electrical current through his or her residual limb when the amputee is not wearing a prosthesis with a cover, for example, after the amputee has removed such a prosthesis for sleeping, to optionally treat symptoms of phantom limb syndrome.

[0120] In some embodiments, contacting one or more sensors causes one electrode in the electrode array to transmit current to the residual limb and another electrode in the electrode array to receive current from the residual limb.

[0121] In some embodiments, contacting one or more sensors after attaching the cover to the prosthesis causes one electrode in the electrode array to transmit current to the residual limb and another electrode in the electrode array to receive current from the residual limb. In some embodiments, contacting one or more sensors after attaching the prosthesis to the residual limb causes one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb. In some specific embodiments, contacting one or more sensors after attaching the cover to the prosthesis and attaching the prosthesis to the residual limb causes one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb. In some very specific embodiments, contacting one or more sensors after attaching the pad to the residual limb, attaching the cover to the prosthesis, and attaching the prosthesis to the residual limb causes one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb.

[0122] In some embodiments, one or more sensors are contacted after the prosthesis is removed from the residual limb, causing one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb.

[0123] In some embodiments, the method comprises stimulating Aβ-like nerve fibers in a residual limb. In some specific embodiments, the method comprises stimulating myelinated Aβ-like nerve fibers in a residual limb, wherein an electric current is delivered to the residual limb to stimulate the myelinated Aβ-like nerve fibers in the residual limb.

[0124] In some embodiments, the method comprises modulating activation of Aδ-type nerve fibers in a residual limb. In some specific embodiments, the method comprises modulating activation of myelinated Aδ-type nerve fibers in a residual limb, wherein an electric current is delivered to the residual limb to modulate activation of myelinated Aδ-type nerve fibers in the residual limb.

[0125] In some embodiments, the method comprises modulating activation of type C nerve fibers in a residual limb. In some specific embodiments, the method comprises modulating activation of unmyelinated type C nerve fibers in a residual limb, wherein an electric current is delivered to the residual limb to modulate activation of unmyelinated type C nerve fibers in the residual limb.

[0126] In some embodiments, the system is configured to cause the current to treat one or more symptoms of phantom limb syndrome. In some specific embodiments, the system is configured to cause the current to treat one or more symptoms of phantom limb syndrome, and contacting one or more sensors to treat the one or more symptoms by transmitting the current through the residual limb.

[0127] In some embodiments, the method includes removing the prosthesis from the residual limb and contacting one or more sensors after the prosthesis is removed from the residual limb; and after the prosthesis is removed from the residual limb, contacting the one or more sensors to treat one or more symptoms by transmitting an electric current through the residual limb.

[0128] In some embodiments, the method includes instructing the secondary controller to cause one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb. In some specific embodiments, the method includes instructing the secondary controller to cause one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb without contacting one or more sensors (i.e., the secondary controller bypasses the sensor array).

[0129] Directing the secondary controller may include, for example, pressing an icon on a touch screen graphical user interface of the secondary controller.

[0130] In some embodiments, the secondary controller is directed to cause one electrode to deliver current to the residual limb and another electrode to receive current from the residual limb to treat one or more conditions by delivering current through the residual limb.

[0131] In some embodiments, the method includes directing the secondary controller to wirelessly communicate with the system to cause one or more positive electrodes in the electrode array to transmit current to the residual limb and cause one or more negative electrodes in the electrode array to receive current from the residual limb. In some specific embodiments, the secondary controller is directed to cause one or more positive electrodes to transmit current and one or more negative electrodes to receive current to treat one or more symptoms of phantom limb syndrome by transmitting current through the residual limb.

[0132] In some embodiments, the method includes (1) contacting one or more sensors so that one or more positive electrodes transmit current to the residual limb and one or more negative electrodes receive current from the residual limb in response to a symptom of phantom limb syndrome, or (2) instructing a secondary controller so that one or more positive electrodes transmit current to the residual limb and one or more negative electrodes receive current from the residual limb in response to the symptom, and the method treats phantom limb syndrome by transmitting current through the residual limb in response to the symptom.

[0133] In some embodiments, the method comprises periodically transmitting an electrical current from a positive electrode in an electrode array to a negative electrode in an electrode array through the residual limb over a period of time (e.g., a course of treatment of at least 28 days). In some specific embodiments, the method comprises periodically transmitting an electrical current from a positive electrode to a negative electrode through the residual limb over the period of time, and the method is effective in reducing symptoms of phantom limb syndrome as assessed using a visual analog scale after the period of time.

[0134] In some embodiments, periodically means at least three times per week, at least four times per week, at least five times per week, at least six times per week, at least seven times per week, at least every day, or at least twice per day.

[0135] In some embodiments, periodically refers to 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.

[0136] In some embodiments, the period of time is at least one hour, at least 24 hours, at least 48 hours, at least one week, at least 28 days, at least one month, at least six months, or at least one year.

[0137] In some embodiments, the period of time is one hour, 24 hours, 48 ​​hours, one week, 28 days, one month, six months, or one year.

[0138] In some embodiments, the method comprises contacting one or more sensors in the sensor array and periodically transmitting an electrical current from a positive electrode in the electrode array to a negative electrode in the electrode array through the residual limb over a period of time (e.g., a course of at least 28 days). In some specific embodiments, the method comprises contacting one or more sensors and periodically transmitting an electrical current from a positive electrode to a negative electrode through the residual limb over the period of time, and the method is effective in reducing symptoms of phantom limb syndrome as assessed using a visual analog scale after the period of time.

[0139] In some embodiments, phantom limb syndrome has a first symptom and a second symptom.

[0140] In some embodiments, transmitting current from a first positive electrode in the electrode array to a first negative electrode in the electrode array through the residual limb is more effective in treating the first symptom than transmitting and receiving current through other electrodes in the electrode array, and the method includes transmitting current from the first positive electrode to the first negative electrode through the residual limb in response to the first symptom.

[0141] 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.

[0142] In some embodiments, transmitting current from a second positive electrode in the electrode array to a second negative electrode in the electrode array through the residual limb is more effective in treating the second symptom than transmitting and receiving current through other electrodes in the electrode array, and the method includes transmitting current from the second positive electrode to the second negative electrode through the residual limb in response to the second symptom.

[0143] 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 symptom with one or both of the second positive electrode relative position and the second negative electrode relative position.

[0144] In some embodiments, a method includes contacting a first sensor in the sensor array corresponding to a first positive electrode and a first negative electrode in response to a first symptom.

[0145] In some embodiments, the first sensor has a first sensor relative position, and the amputee associates the first symptom with the first sensor relative position. In some specific embodiments, the first sensor has a first sensor relative position; the first positive electrode has a first positive electrode relative position; the first negative electrode has a first negative electrode relative position; and the amputee associates the first symptom with one, both, or each of the first sensor relative position, the first positive electrode relative position, and the first negative electrode relative position.

[0146] In some embodiments, the method includes contacting a second sensor in the sensor array corresponding to the second positive electrode and the second negative electrode in response to a second symptom.

[0147] In some embodiments, the second sensor has a second sensor relative position, and the amputee associates the second symptom with the second sensor relative position. In some specific embodiments, the second sensor has a second sensor relative position; the second positive electrode has a second positive electrode relative position; the second negative electrode has a second negative electrode relative position; and the amputee associates the second symptom with one, both, or each of the second sensor relative position, the second positive electrode relative position, and the second negative electrode relative position.

[0148] In some embodiments, the method includes, in response to the first symptom, instructing the electrode controller (optionally the secondary controller) to instruct the first positive electrode to deliver current to the residual limb and to instruct the first negative electrode to receive current.

[0149] In some embodiments, the method includes instructing the electrode controller (optionally the secondary controller) to direct the second positive electrode to deliver current to the residual limb and to direct the second negative electrode to receive current in response to the second symptom.

[0150] In some embodiments, the method comprises contacting a first sensor in response to a first symptom, and contacting a second sensor in response to a second symptom for a period of time (e.g., a course of at least 28 days), wherein the method is effective in reducing chronic symptoms of phantom limb syndrome (independent of treating acute symptoms) by generating an electrical current in the residual limb during the period of time. In some specific embodiments, the reduction in chronic symptoms of phantom limb syndrome is assessed by a visual analog scale. Without limiting this specification or any patent claims derived from this disclosure, repeated use of the system of the present disclosure reduces chronic symptoms of phantom limb syndrome, which chronic symptoms can optionally be assessed by a visual analog scale.

[0151] Treating an acute symptom means treating the symptom when the subject experiences it, and an acute benefit means the immediate benefit of alleviating the acute symptom. Alleviating a chronic symptom means reducing the frequency of the symptom, reducing the severity of the symptom, or both, over time. Alleviating the chronic symptoms of phantom limb syndrome, independent of treating the acute symptom, means reducing the frequency of the symptom, reducing the severity of the symptom, or both, over time, independent of treating the acute symptom; for example, after using the system described herein for a period of time (e.g., a course of treatment of at least 28 days), a subject may find that he or she experiences phantom limb syndrome symptoms less frequently and with less severity, regardless of whether the subject actually uses the system to treat a particular symptom.

[0152] Each amputee has a brain that includes a somatosensory cortex. In some embodiments, the method effectively activates different areas of the somatosensory cortex when different electrodes in the electrode array transmit current to the residual limb and receive current from the residual limb.

[0153] Without limiting this specification or any patent claims derived from this disclosure, the disclosed system is reiterated to alleviate chronic symptoms of phantom limb syndrome by neuromodulation in the somatosensory cortex.

[0154] The somatosensory cortex of an amputee's brain typically contains an area for processing sensations of the missing body part. In some embodiments, the method comprises periodically transmitting an electrical current from electrodes in an electrode array through the residual limb over a period of time (e.g., over a course of at least 28 days); and the method is effective to induce neuromodulation such that the electrical current, after the period of time, activates the area for processing sensations of the missing body part. In some specific embodiments, the method comprises contacting one or more sensors and periodically transmitting an electrical current from corresponding two or more electrodes through the residual limb over the period of time; and the method is effective to induce neuromodulation such that the electrical current, after the period of time, activates the area for processing sensations of the missing body part. In some very specific embodiments, the method comprises contacting one or more sensors in response to a symptom of phantom limb syndrome.

[0155] In some embodiments, the method includes contacting two or more sensors to periodically transmit current from two or more different positive electrodes to two or more different negative electrodes through the residual limb over a period of time (such as a course of at least 28 days); and the method effectively induces cortical remapping driven by neuroplasticity in the somatosensory cortex of the amputee's brain after the period of time, such that the current transmitted through the residual limb activates different areas of the somatosensory cortex after the period of time (relative to before the period of time).

[0156] Fig.10A method of using a system as described herein is presented. An amputee may first attach a pad to his or her residual limb so that each electrode in the electrode array is in electrical communication with the residual limb 1001, or attach a cover to his or her prosthesis 1002. After the amputee attaches the pad to his or her residual limb 1001, the amputee may instruct a 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 may be an electrode controller or a secondary controller as described herein. After the cover is attached to the prosthesis 1002, one or more sensors in the sensor array contacting the cover will cause one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb 1004. The amputee typically attaches the prosthesis to his or her residual limb 1005 for daily use. Transmitting current to the residual limb stimulates Aβ-like nerve fibers in the residual limb 1006, which can treat one or more symptoms of phantom limb syndrome as described herein. The amputee may advantageously remove the prosthesis from the residual limb 1007 and, for example, when the amputee is not wearing the prosthesis (after the amputee has removed such prosthesis for sleeping), still direct the controller to transmit current to the residual limb 1003 and also contact one or more sensors to transmit current to the residual limb 1004 to treat the symptoms of phantom limb syndrome. Repeated use of the system over a period of time is generally effective in reducing chronic symptoms of phantom limb syndrome 1008 as assessed by a visual analog scale (independent of treating acute symptoms), which effect is achieved by generating current in the residual limb. Without limiting this specification or any patent claims derived from this disclosure, the reduction of chronic symptoms of phantom limb syndrome 1008 is caused by cortical remapping driven by neuroplasticity in the somatosensory cortex of the brain, which can be assessed by scalp electroencephalography ("EEG") examination.

[0157] In some embodiments, the method includes simultaneously performing a scalp EEG on the amputee and transmitting an electrical current from a first positive electrode to a first negative electrode through the residual limb to generate an electrogram during the EEG.

[0158] In some embodiments, the method includes simultaneously performing an EEG on the amputee and transmitting an electrical current from a positive electrode in an electrode array to a negative electrode in an electrode array through the residual limb during the EEG examination to produce an electrogram that demonstrates activation of the somatosensory cortex in response to the electrical current; and the system is configured so that the area used to process the sensation of the missing body part shows activation in response to the electrical current in the electrogram. In some specific embodiments, the simultaneous performing of the EEG on the amputee and transmitting the electrical current through the residual limb are performed within a period of time (such as a course of at least 28 days) after the amputee first begins using the system. In some very specific embodiments, the method includes contacting one or more sensors in the sensor array to transmit the electrical current through the residual limb for a period of time (such as over the course of at least 28 days), wherein the EEG examination is performed after the period of time.

[0159] In some embodiments, the method includes simultaneously performing an EEG examination on the amputee and transmitting current from a first positive electrode to a first negative electrode through the residual limb during the EEG examination to produce an electrogram, which electrogram shows activation of the somatosensory cortex in response to the current; the method includes simultaneously performing an EEG examination on the amputee and transmitting current from a second positive electrode to a second negative electrode through the residual limb during the EEG examination to produce an electrogram, which electrogram shows activation of the somatosensory cortex in response to the current; and the system is configured so that the first positive electrode and the first negative electrode activate a first location in the somatosensory cortex, the second positive electrode and the second negative electrode activate a second location in the somatosensory cortex, and the electrogram shows that the current transmitted from the first positive electrode to the first negative electrode through the residual limb activates a different area of ​​the somatosensory cortex than the current transmitted from the second positive electrode to the second negative electrode through the residual limb. In some embodiments, the method includes contacting a first sensor corresponding to a first positive electrode and a first negative electrode to periodically transmit current through the residual limb over a period of time (e.g., a course of at least 28 days); and the method includes contacting a second sensor corresponding to a second positive electrode and a second negative electrode to periodically transmit current through the residual limb over the period of time, wherein an EEG examination is performed after the period of time. Without limiting this specification or any patent claims derived from the present disclosure, an EEG examination can be used to detect neuromodulation in the somatosensory cortex by the system of the present disclosure.

[0160] The following example describes a contemplated preliminary clinical trial to illustrate certain aspects of the present disclosure, and the example should not be construed as limiting the present disclosure or any patent claims derived therefrom.

[0161] Example

[0162] Preliminary clinical trials suggest that transcutaneous electrical stimulation of the residual limb in response to touching the prosthesis reduces symptoms of phantom limb syndrome.

[0163] A group of 15 amputee subjects who experienced phantom limb syndrome symptoms due to limb amputation were recruited for a pilot clinical trial. Each subject had an intact limb that corresponded to the amputated limb. The subjects rated their pain intensity related to phantom limb syndrome using a visual analogue scale.

[0164] Each subject was provided with the system described in the detailed description. Briefly, the system includes a prosthetic housing that includes a sensor array that controls the activation of an electrode array in a pad that fits over the amputee's residual limb.

[0165] Each subject was fitted with a wire that placed each electrode in the electrode array in electrical communication with the residual limb. Each subject had an existing prosthesis fitted with a housing that included the sensor array.

[0166] Each subject was fitted with EEG electrodes. The researchers touched various areas of the intact limb and recorded the electrogram of the intact limb. Then, while each subject wore his or her existing prosthesis, the researchers touched different areas of the prosthetic housing to drive current through the residual limb and recorded the electrogram of the prosthetic housing. The subjects were instructed to observe while touching the intact limb and housing. The various areas of the intact limb and housing that were touched corresponded to each other in space and time.

[0167] Each subject was then instructed to apply pressure to his or her intact limb in a similar spatial and temporal pattern as the researcher while focusing his or her gaze on the area of ​​applied pressure, and an electrogram was recorded. Each subject was then instructed to apply pressure to his or her prosthetic limb cover in a similar spatial and temporal pattern as the researcher while focusing his or her gaze on the area of ​​applied pressure, and an electrogram was recorded.

[0168] Each subject was then instructed to take the system home. Each subject was given written instructions to apply pressure to the intact limb and the prosthetic housing in a spatial and temporal pattern daily, and to apply pressure to the prosthetic housing in response to symptoms of phantom limb syndrome and when needed. Use of the system was recorded by the system in its computer memory. Each subject was also instructed to rate his or her level of pain associated with phantom limb syndrome using a visual analog scale daily before and after the written instructions were followed.

[0169] Four weeks later, each subject returned for a follow-up EEG, which, like the initial EEG described above, had essentially identical contact patterns in space and time for both the intact limb and the prosthetic housing. For each intact limb, the initial and follow-up electrograms were largely identical. The initial and follow-up electrograms were significantly different for each amputation. For subjects with leg amputations, gamma waves were detected in the medial region of the somatosensory cortex with greater differences. The magnitude of the difference between the initial and follow-up EEGs correlated with the frequency of system use as recorded by the system. These results suggest that the intervention resulted in cortical remapping driven by neuroplasticity within the subjects.

[0170] After the four-week intervention, all participants reported a decrease in phantom limb pain on a visual analogue scale relative to pre-intervention, suggesting a long-term effect of the intervention. The degree of pain reduction reported on the visual analogue scale correlated with the frequency of system use as recorded by the system. After the four-week intervention, all participants reported a decrease in phantom limb pain on a visual analogue scale relative to pre-intervention immediately after the spatiotemporal patterning intervention, suggesting an immediate effect of the intervention.

Claims

1. A system for modulating neural activation in a residual limb of an amputee, comprising a pad, the pad comprising an electrode array, wherein: The pad is configured to receive the residual limb so that each electrode in the electrode array is in electrical communication with the residual limb; Each electrode in the electrode array is paired with at least two other electrodes in the electrode array, such that when the electrode array is in electrical communication with the residual limb, each electrode is capable of (1) transmitting current through the residual limb to a first negative electrode paired with the electrode, and also capable of transmitting current separately to a second negative electrode paired with the electrode, and / or (2) receiving current through the residual limb from a first positive electrode paired with the electrode, and also capable of receiving current separately from a second positive electrode paired with the electrode; and The electrode array is configured to transmit and receive electrical current through the residual limb to stimulate nerve fibers in the residual limb.

2. The system of claim 1, comprising an enclosure, the enclosure comprising the sensor array, wherein: The cover is configured to cover the outer surface of the prosthesis; The electrode array is in communication with the sensor array such that two or more electrodes are activated in response to sensing by one or more sensors; The system is configured such that, (1) when two or more electrodes are activated, and (2) when the two or more electrodes are in electrical communication with the residual limb, then one of the two or more electrodes that is activated transmits current through the residual limb and another of the two or more electrodes that is activated receives the current transmitted through the residual limb; Each sensor in the sensor array is configured to sense one or both of force and pressure; Each electrode in the electrode array is configured to transmit and / or receive a current that stimulates Aβ-like nerve fibers in the residual limb when the electrode is in electrical communication with the residual limb; Each sensor corresponds to at least two electrodes, and each electrode corresponds to at least one sensor; a sensor corresponding to an electrode, and an electrode corresponding to a sensor, if the sensor is in communication with the electrode, such that when the sensor senses a force or pressure and the electrode is in electrical communication with the residual limb, the electrode transmits an electrical current to or receives an electrical current from the residual limb; The sensor array has a three-dimensional configuration of sensors relative to the cover; The electrode array has a three-dimensional configuration of electrodes relative to the pad; Each sensor has a relative sensor position in the three-dimensional sensor configuration relative to each other sensor in the sensor array; Each electrode has a relative electrode position in the three-dimensional electrode configuration relative to each other electrode in the electrode array; The system includes sensor-electrode pairs, each sensor-electrode pair consisting of one or more sensors and two or more electrodes, the sensors and the electrodes corresponding to each other; The relative sensor position of each sensor of a sensor-electrode pair within the three-dimensional sensor configuration is related to the relative electrode position of each electrode of the same sensor-electrode pair within the three-dimensional electrode configuration; Each sensor in the sensor array communicates with two or more electrodes in the electrode array, such that the two or more electrodes are configured to transmit and receive electrical current through the residual limb when each of the following conditions is met: (1) the sensor senses a force or pressure; (2) the two or more electrodes are in electrical communication with the residual limb; and (3) removing the prosthesis from the residual limb; The system includes a secondary controller in wireless communication with the electrode array, such that the secondary controller can bypass the sensor array to cause each electrode in the electrode array to transmit current to or receive current from the residual limb when the electrode array is in electrical communication with the residual limb; The current is a pulse current; The pulse frequency of the pulse current is at least 20 pulses per second and at most 180 pulses per second, the pulse width of the pulse current is at most 100 microseconds, and the amplitude of the pulse current is at most 100 mA; The cover is configured to be attached to the outer surface of different prostheses having a plurality of different shapes, and the cover is configured to adapt to the plurality of different shapes such that the three-dimensional configuration of each sensor remains unchanged for the different shapes; The sensors include three, four, five, six, seven or each of the following sensors: an anterior proximal sensor, an anterior distal sensor, an lateral proximal sensor, an lateral distal sensor, a posterior proximal sensor, a posterior distal sensor, an inner proximal sensor and an inner distal sensor; The electrodes include three, four, five, six, seven, or each of the following electrodes: an anterior proximal electrode, an anterior distal electrode, an lateral proximal electrode, an lateral distal electrode, a posterior proximal electrode, a posterior distal electrode, an inner proximal electrode, and an inner distal electrode; The sensor-electrode pairs include three, four, five, six, seven or each of: an anterior proximal pair including an anterior proximal sensor and an anterior proximal electrode, an anterior distal pair including an anterior distal sensor and an anterior distal electrode, an lateral proximal pair including an lateral proximal sensor and an lateral proximal electrode, an lateral distal pair including an lateral distal sensor and an lateral distal electrode, a posterior proximal pair including a posterior proximal sensor and a posterior proximal electrode, a posterior distal pair including a posterior distal sensor and a posterior distal electrode, an 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 electrode array comprises at least one electrode ring, wherein the electrode ring is composed of four or more electrodes, and each electrode is paired with exactly two other electrodes of the electrode ring; The system includes an electrode controller in electrical communication with each electrode in the electrode array; The electrode controller is configured to control whether each electrode capable of transmitting current transmits the current through the residual limb to one or both of the first negative electrode and the second negative electrode; and The electrode controller is configured to control whether each electrode capable of receiving an electric current receives the electric current from one or both of the first positive electrode and the second positive electrode.

3. The system of claim 1, comprising an enclosure, the enclosure comprising the sensor array, wherein: The cover is configured to cover the outer surface of the prosthesis; The electrode array is in communication with the sensor array such that two or more electrodes are activated in response to sensing by one or more sensors; The system is configured such that, (1) when two or more electrodes are activated, and (2) when the two or more electrodes are in electrical communication with the residual limb, then one of the two or more electrodes that is activated transmits current through the residual limb and another of the two or more electrodes that is activated receives the current transmitted through the residual limb; Each sensor in 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 corresponds to at least one sensor; a sensor corresponding to an electrode, and an electrode corresponding to a sensor, if the sensor is in communication with the electrode, such that when the sensor senses a force or pressure and the electrode is in electrical communication with the residual limb, the electrode transmits an electrical current to or receives an electrical current from the residual limb; The sensor array has a three-dimensional configuration of sensors relative to the cover; The electrode array has a three-dimensional configuration of electrodes relative to the pad; Each sensor has a relative sensor position in the three-dimensional sensor configuration relative to each other sensor in the sensor array; Each electrode has an electrode relative position in the three-dimensional electrode configuration relative to each other electrode in the electrode array; The system includes sensor-electrode pairs, each sensor-electrode pair consisting of one or more sensors and two or more electrodes, the sensors and the electrodes corresponding to each other; and The relative sensor position of each sensor of the sensor-electrode pair within the three-dimensional sensor configuration is related to the relative electrode position of each electrode of the same sensor-electrode pair within the three-dimensional electrode configuration.

4. The system of claim 3, wherein: Each sensor in the sensor array communicates with two or more electrodes in the electrode array, such that the two or more electrodes are configured to transmit and receive electrical current through the residual limb when each of the following conditions is met: (1) the sensor senses a force or pressure; (2) the two or more electrodes are in electrical communication with the residual limb; and (3) removing the prosthesis from the residual limb; and The system includes a secondary controller in wireless communication with the electrode array so that the secondary controller can bypass the sensor array to cause each electrode in the electrode array to transmit current to or receive current from the residual limb when the electrode array is in electrical communication with the residual limb.

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

6. The system according to claim 3, wherein: Each sensor in the sensor array communicates with two or more electrodes in the electrode array, such that the two or more electrodes are configured to transmit and receive electrical current through the residual limb when each of the following conditions is met: (1) the sensor senses a force or pressure; (2) the two or more electrodes are in electrical communication with the residual limb; and (3) removing the prosthesis from the residual limb.

7. The system of claim 3, comprising a controller, wherein: The controller is in communication with the electrode array such that the controller can bypass the sensor array to cause each electrode in the electrode array to transmit current to or receive current from the residual limb when the electrode is in electrical communication with the residual limb.

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

9. The system of claim 3, wherein: The cover is configured to be attached to the outer surface of different prostheses having a variety of different shapes; and The cover is configured to adapt to a variety of different shapes so that the relative position of each sensor remains unchanged for the different shapes.

10. The system of claim 3, wherein: The cover has a shape of a missing body part; and The three-dimensional sensor configuration includes the shape of the missing body part.

11. The system of claim 3, wherein: The system lacks any sensor capability to sense the relative position of the prosthesis; The system lacks any mechanical ability to move the prosthesis; and The system lacks any structural ability to support the amputee's weight.

12. The system according to claim 3, wherein: The current is a pulse current, the pulse frequency of the pulse current is at least 20 pulses per second and at most 180 pulses per second, the pulse width of the pulse current is at most 100 microseconds, and the amplitude of the pulse current is at most 100 mA.

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

14. The system of claim 1, wherein: 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 each of: an anterior proximal pair including an anterior proximal sensor and an anterior proximal electrode, an anterior distal pair including an anterior distal sensor and an anterior distal electrode, an lateral proximal pair including an lateral proximal sensor and an lateral proximal electrode, an lateral distal pair including an lateral distal sensor and an lateral distal electrode, a posterior proximal pair including a posterior proximal sensor and a posterior proximal electrode, a posterior distal pair including a posterior distal sensor and a posterior distal electrode, an 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 (1) closer to the front distal sensor than to both the outer proximal sensor and the inner distal sensor, (2) closer to both the outer distal sensor and the inner distal sensor than to the rear distal sensor, (3) closer to both the outer proximal sensor and the inner proximal sensor than to the rear proximal sensor, and (4) closer to the rear proximal sensor than to the rear distal sensor; The relative electrode position of the anterior proximal electrode is (1) closer to the anterior distal electrode than to both the lateral distal electrode and the medial distal electrode, (2) closer to both the lateral distal electrode and the medial distal electrode than to the posterior distal electrode, (3) closer to both the lateral proximal electrode and the medial proximal electrode than to the posterior proximal electrode, and (4) closer to the posterior proximal electrode than to the posterior distal electrode; The sensor relative position of the front distal sensor is (1) closer to the front proximal sensor than to both the outer proximal sensor and the inner proximal sensor, (2) closer to both the outer proximal sensor and the inner proximal sensor than to the rear proximal sensor, (3) closer to both the outer distal sensor and the inner distal sensor than to the rear distal sensor, and (4) closer to the rear distal sensor than to the rear proximal sensor; The relative electrode position of the front distal electrode is (1) closer to the front proximal electrode than to both the outer proximal electrode and the inner proximal electrode, (2) closer to both the outer proximal electrode and the inner proximal electrode than to the rear proximal electrode, (3) closer to both the outer distal electrode and the inner distal electrode than to the rear distal electrode, and (4) closer to the rear distal electrode than to the rear proximal electrode; The relative sensor position of the inner proximal sensor is (1) closer to the inner distal sensor than to both the front distal sensor and the rear distal sensor, (2) closer to both the front distal sensor and the rear distal sensor than to the outer distal sensor, (3) closer to both the front proximal sensor and the rear proximal sensor than to the outer proximal sensor, and (4) closer to the outer proximal sensor than to the outer distal sensor; The relative electrode position of the inner proximal electrode is (1) closer to the inner distal electrode than to both the front distal electrode and the rear distal electrode, (2) closer to both the front distal electrode and the rear distal electrode than to the outer distal electrode, (3) closer to both the front proximal electrode and the rear proximal electrode than to the outer proximal electrode, and (4) closer to the outer proximal electrode than to the outer distal electrode; The relative sensor position of the inner distal sensor is (1) closer to the inner proximal sensor than to both the front proximal sensor and the rear proximal sensor, (2) closer to both the front proximal sensor and the rear proximal sensor than to the outer proximal sensor, (3) closer to both the front distal sensor and the rear distal sensor than to the outer distal sensor, and (4) closer to the outer distal sensor than to the outer proximal sensor; The relative electrode position of the inner distal electrode is (1) closer to the inner proximal electrode than to both the front proximal electrode and the rear proximal electrode, (2) closer to both the front proximal electrode and the rear proximal electrode than to the outer proximal electrode, (3) closer to both the front distal electrode and the rear distal electrode than to the outer distal electrode, and (4) closer to the outer distal electrode than to the outer proximal electrode; The sensor relative position of the rear proximal sensor is (1) closer to the rear distal sensor than to both the outer distal sensor and the inner distal sensor, (2) closer to both the outer distal sensor and the inner distal sensor than to the front distal sensor, (3) closer to both the outer proximal sensor and the inner proximal sensor than to the front proximal sensor, and (4) closer to the front proximal sensor than to the front distal sensor; The electrode relative position of the posterior proximal electrode is (1) closer to the posterior distal electrode than to both the lateral distal electrode and the medial distal electrode, (2) closer to both the lateral distal electrode and the medial distal electrode than to the anterior distal electrode, (3) closer to both the lateral proximal electrode and the medial proximal electrode than to the anterior proximal electrode, and (4) closer to the anterior proximal electrode than to the anterior distal electrode; The sensor relative position of the rear distal sensor is (1) closer to the rear proximal sensor than to both the outer proximal sensor and the inner proximal sensor, (2) closer to both the outer proximal sensor and the inner proximal sensor than to the front proximal sensor, (3) closer to both the outer distal sensor and the inner distal sensor than to the front distal sensor, and (4) closer to the front distal sensor than to the front proximal sensor; The electrode relative position of the posterior distal electrode is (1) closer to the posterior proximal electrode than to both the lateral proximal electrode and the medial proximal electrode, (2) closer to both the lateral proximal electrode and the medial proximal electrode than to the anterior proximal electrode, (3) closer to both the lateral distal electrode and the medial distal electrode than to the anterior distal electrode, and (4) closer to the anterior distal electrode than to the anterior proximal electrode; The relative sensor position of the outer proximal sensor is (1) closer to the outer distal sensor than to both the front distal sensor and the rear distal sensor, (2) closer to both the front distal sensor and the rear distal sensor than to the inner distal sensor, (3) closer to both the front proximal sensor and the rear proximal sensor than to the inner proximal sensor, and (4) closer to the inner proximal sensor than to the inner distal sensor; The electrode relative position of the outer proximal electrode is (1) closer to the outer distal electrode than to both the front distal electrode and the rear distal electrode, (2) closer to both the front distal electrode and the rear distal electrode than to the inner distal electrode, (3) closer to both the front proximal electrode and the rear proximal electrode than to the inner proximal electrode, and (4) closer to the inner proximal electrode than to the inner distal electrode; The relative sensor position of the outer distal sensor is (1) closer to the outer proximal sensor than to both the front proximal sensor and the rear proximal sensor, (2) closer to both the front proximal sensor and the rear proximal sensor than to the inner proximal sensor, (3) closer to both the front distal sensor and the rear distal sensor than to the inner distal sensor, and (4) closer to the inner distal sensor than to the inner proximal sensor; and The electrode relative position of the outer distal electrode is (1) closer to the outer proximal electrode than to both the front proximal electrode and the rear proximal electrode, (2) closer to both the front proximal electrode and the rear proximal electrode than to the inner proximal electrode, (3) closer to both the front distal electrode and the rear distal electrode than to the inner distal electrode, and (4) closer to the inner distal electrode than to the inner proximal electrode; The three-dimensional configuration of the sensor defines a sensor surface; The three-dimensional configuration of electrodes defines an electrode surface; and Proximity is measured along the sensor surface and the electrode surface rather than in Cartesian space.

15. The system of claim 3, wherein: The sensor array includes one, two, three, four, five, six, seven, or each of the following sensors: an anterior proximal sensor, an anterior distal sensor, an lateral proximal sensor, an lateral distal sensor, a posterior proximal sensor, a posterior distal sensor, an medial proximal sensor, and a medial distal sensor; The electrode array includes one, two, three, four, five, six, seven, or each of the following electrodes: an anterior proximal electrode, an anterior distal electrode, an lateral proximal electrode, an lateral distal electrode, a posterior proximal electrode, a posterior distal electrode, an inner proximal electrode, and an inner distal electrode; and The sensor-electrode pairs include one, two, three, four, five, six, seven or each of the following: 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.

16. The system of claim 1, wherein: The electrode array comprises at least eight electrodes; The electrode array comprises at least six electrode rings; An electrode ring is composed of four or more electrodes, each electrode being paired with exactly two other electrodes of said electrode ring; and At least two of the electrode rings are configured to surround the residual limb.

17. The system of claim 1, wherein: The electrode array comprises at least two electrode rings; An electrode ring is composed of four or more electrodes, each electrode being paired with exactly two other electrodes of said electrode ring; and At least one of the electrode rings is configured to surround the residual limb.

18. The system of claim 1, comprising an electrode controller in electrical communication with each electrode in the electrode array, wherein: The electrode controller is configured to control whether each electrode capable of transmitting current transmits the current through the residual limb to one or both of the first negative electrode and the second negative electrode; and The electrode controller is configured to control whether each electrode capable of receiving an electric current receives the electric current from one or both of the first positive electrode and the second positive electrode.

19. The system of claim 1, comprising an electrode controller in electrical communication with each electrode in the electrode array, wherein: The electrode controller controls the current transmitted or received by each electrode in the electrode array; The current is a pulse current, the pulse frequency of the pulse current is at least 20 pulses per second and at most 180 pulses per second, the pulse width of the pulse current is at most 100 microseconds, and the amplitude of the pulse current is at most 100 mA.

20. The system of claim 1, wherein: The system is configured such that electrical current is transmitted and received through the residual limb to stimulate Aβ-like nerve fibers in the residual limb.

21. A method of modulating neural activation in an amputee's residual limb, comprising: A system is provided comprising a housing and a pad, wherein the housing comprises a sensor array and the pad comprises an electrode array; attaching the cover to the prosthesis; attaching the pad to the residual limb so that each electrode in the electrode array is in electrical communication with the residual limb; attaching the prosthesis to the residual limb; contacting one or more of the sensors after attaching the cover to the prosthesis and attaching the prosthesis to the residual limb; Removing the prosthesis from the residual limb; contacting the one or more sensors after the prosthesis is removed from the residual limb; and Stimulating Aβ-like nerve fibers in the residual limb, in: Each sensor is configured to sense one or both of force and pressure; Attaching the pad to the residual limb includes attaching each electrode in the electrode array to the residual limb so that each electrode is in electrical communication with the residual limb; contacting the 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; a sensor corresponding to an electrode, and an electrode corresponding to a sensor, such that if the sensor is in communication with the electrode, the electrode will transmit current to or receive current from the residual limb when the sensor senses a force or pressure and the electrode is in electrical communication with the residual limb; After attaching the housing to the prosthesis and the prosthesis to the residual limb, contacting the one or more sensors so that one electrode transmits current to the residual limb and another electrode receives current from the residual limb; After the prosthesis is removed from the residual limb, contacting the one or more sensors causes one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb; and An electric current is transmitted to the residual limb to stimulate Aβ-like nerve fibers in the residual limb.

22. The method of claim 21, wherein: Said amputee developed phantom limb syndrome; The system is configured such that the current treats one or more symptoms of the phantom limb syndrome; after attaching the housing to the prosthesis and the prosthesis to the residual limb, contacting the one or more sensors to treat the one or more symptoms by transmitting an electrical current through the residual limb; The method includes detaching the prosthesis from the residual limb and contacting the one or more sensors after detaching the prosthesis from the residual limb; After the prosthesis is removed from the residual limb, contacting the one or more sensors to transmit an electrical current through the residual limb to treat the one or more symptoms; The system includes an electrode controller in electrical communication with each electrode in the electrode array; The electrode controller is configured to control whether each electrode capable of transmitting an electric current transmits the electric current through the residual limb to one or both of the first negative electrode and the second negative electrode; The electrode controller is configured to control whether each electrode capable of receiving an electric current receives the electric current from one or both of the first positive electrode and the second positive electrode; The system includes a secondary controller in wireless communication with the electrode controller; The method includes directing the secondary controller to cause one electrode to transmit current to the residual limb and another electrode to receive current from the residual limb without contacting the one or more sensors; directing the secondary controller to cause the one electrode to deliver current to the residual limb and the other electrode to receive current from the residual limb to deliver current through the residual limb to treat the one or more symptoms; and The current is a pulse current, the pulse frequency of the pulse current is at least 20 pulses per second and at most 180 pulses per second, the pulse width of the pulse current is at most 100 microseconds, and the amplitude of the pulse current is at most 100 mA.

23. The method of claim 21, wherein: Said amputee developed phantom limb syndrome; The phantom limb syndrome has first and second symptoms; Transmitting current from a first positive electrode in the electrode array to a first negative electrode in the electrode array through the residual limb is more effective in treating the first symptom than transmitting and receiving current through other electrodes in the electrode array; The method includes contacting a first sensor in the sensor array corresponding to the first positive electrode and the first negative electrode in response to the first symptom; Transmitting current from a second positive electrode in the electrode array to a second negative electrode in the electrode array through the residual limb is more effective in treating the second symptom than transmitting and receiving current through other electrodes in the electrode array; and The method includes contacting a second sensor in the sensor array corresponding to the second positive electrode and the second negative electrode in response to the second symptom.

24. The method of claim 23, wherein: The sensor array has a three-dimensional configuration of sensors relative to the cover; The electrode array has a three-dimensional configuration of electrodes relative to the pad; Each sensor has a relative sensor position relative to each other sensor in the three-dimensional sensor configuration; Each electrode has a relative electrode position relative to each other electrode in the three-dimensional configuration of electrodes; The system includes sensor-electrode pairs, each sensor-electrode pair consisting of one or more sensors and two or more electrodes, the sensors and the electrodes corresponding to each other; The relative sensor position of each sensor of a sensor-electrode pair within the three-dimensional sensor configuration is related to the relative electrode position of each electrode of the same sensor-electrode pair within the three-dimensional electrode 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 associating 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; and 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.

25. The method of claim 23, comprising contacting a first sensor in response to the first symptom, and contacting a second sensor for a period of time in response to the second symptom, wherein: The method is effective in alleviating chronic symptoms of phantom limb syndrome independent of treating acute symptoms by generating an electrical current in the residual limb over the period of time.

26. The method according to claim 25, wherein: The reduction of chronic symptoms of phantom limb syndrome was assessed by visual analogue scale.

27. The method of claim 21, wherein: Said amputee developed phantom limb syndrome; The amputee has a brain that includes a somatosensory cortex; The method includes contacting two or more sensors to periodically transmit electrical current from two or more different positive electrodes to two or more different negative electrodes through the residual limb over a period of time; and The method effectively induces cortical remapping driven by neuroplasticity in the somatosensory cortex of the amputee's brain after the period of time, such that an electric current transmitted through the residual limb activates different areas of the somatosensory cortex after the period of time relative to before the period of time.

28. The method of claim 21, wherein: Said amputee developed phantom limb syndrome; The amputee has a brain that includes a somatosensory cortex; The method includes simultaneously performing a scalp electroencephalogram ("EEG") examination on the amputee and transmitting an electric current from a first positive electrode to a first negative electrode through the residual limb during the EEG examination to produce an electrogram, the electrogram demonstrating activation of the somatosensory cortex in response to the electric current; The method comprises simultaneously performing an EEG examination on the amputee and transmitting an electric current from a second positive electrode to a second negative electrode through the residual limb during the EEG examination to produce an electrogram demonstrating activation of the somatosensory cortex in response to the electric current; and The system is configured such that the first positive electrode and the first negative electrode activate a first location in the somatosensory cortex, the second positive electrode and the second negative electrode activate a second location in the somatosensory cortex, and the electrogram demonstrates that current transmitted from the first positive electrode through the residual limb to the first negative electrode activates a different area of ​​the somatosensory cortex than current transmitted from the second positive electrode through the residual limb to the second negative electrode.

29. The method according to claim 28, comprising: contacting a first sensor, the first sensor corresponding to the first positive electrode and the first negative electrode to periodically transmit current through the residual limb over a period of time; as well as contacting a second sensor, the second sensor corresponding to the second positive electrode and the second negative electrode to periodically transmit current through the residual limb during the period of time, Wherein, the EEG examination is performed after the period of time.

30. The method of claim 21, wherein: The sensor array has a three-dimensional configuration of sensors relative to the cover; The electrode array has a three-dimensional configuration of electrodes relative to the pad; Each sensor has a relative sensor position relative to each other sensor in the three-dimensional sensor configuration; Each electrode has a relative electrode position relative to each other electrode in the three-dimensional configuration of electrodes; The system comprises sensor-electrode pairs, each sensor-electrode pair comprising a sensor and two electrodes, the sensor and the electrodes corresponding to each other; and The relative sensor position of each sensor of the sensor-electrode pair within the three-dimensional sensor configuration is related to the relative electrode position of each electrode of the same sensor-electrode pair within the three-dimensional electrode configuration.

31. The method of claim 30, wherein: The amputee has a brain that includes a somatosensory cortex; and The method effectively activates different areas of the somatosensory cortex as different electrodes in the electrode array transmit current to and receive current from the residual limb.

32. The method of claim 21, wherein: Said amputee developed phantom limb syndrome; The amputee has a missing body part; The amputee has a brain that includes a somatosensory cortex, the somatosensory cortex including an area for processing sensations of the missing body part; The method includes contacting one or more sensors in the sensor array and periodically transmitting current from corresponding two or more electrodes in the electrode array through the residual limb over a period of time; and The method is effective to induce neuromodulation such that the current, after the period of time, activates an area that processes sensation in the missing body part.

33. The method of claim 32, comprising contacting the one or more sensors in response to a symptom of phantom limb syndrome.

34. The method of claim 21, wherein: Said amputee developed phantom limb syndrome; The amputee has a missing body part; The amputee has a brain that includes a somatosensory cortex, the somatosensory cortex including an area for processing sensations of the missing body part; The method includes simultaneously performing a scalp electroencephalogram ("EEG") examination on the amputee and transmitting an electrical current from a positive electrode in the electrode array to a negative electrode in the electrode array through the residual limb during the EEG examination to produce an electrogram demonstrating activation of the somatosensory cortex in response to the electrical current; and The system is configured so that the area for processing sensation in the missing body part shows activation in response to the current in the electrogram.

35. The method of claim 34, comprising contacting one or more sensors in the sensor array to transmit an electric current through the residual limb for a period of time, wherein: The EEG examination is performed after the period of time.

36. The method of claim 21, wherein: Said amputee developed phantom limb syndrome; The method includes contacting one or more sensors in the sensor array and periodically transmitting an electric current through the residual limb from a positive electrode in the electrode array to a negative electrode in the electrode array for a period of time; and The method is effective in reducing symptoms of phantom limb syndrome as assessed using a visual analog scale after the period of time.

37. The method of claim 21, wherein: Said amputee developed phantom limb syndrome; The method includes directing a secondary controller to wirelessly communicate with the system to cause one or more positive electrodes in the electrode array to transmit current to the residual limb and one or more negative electrodes in the electrode array to receive the current from the residual limb; and The secondary controller is directed to cause the one or more positive electrodes to deliver the current and the one or more negative electrodes to receive the current to deliver the current through the residual limb to treat one or more symptoms of the phantom limb syndrome.

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

39. The method of claim 37, wherein: Said amputee developed phantom limb syndrome; The method includes (1) contacting one or more sensors to cause one or more positive electrodes to transmit current to the residual limb and cause one or more negative electrodes to receive current from the residual limb in response to a symptom of the phantom limb syndrome, or (2) directing the secondary controller to cause the one or more positive electrodes to transmit current to the residual limb and cause the one or more negative electrodes to receive current from the residual limb in response to the symptom, and The method treats the phantom limb syndrome by delivering the electrical current through the residual limb in response to the symptoms.

40. The method of claim 21, wherein: The current is a pulse current, the pulse frequency of the pulse current is at least 20 pulses per second and at most 180 pulses per second, the pulse width of the pulse current is at most 100 microseconds, and the amplitude of the pulse current is at most 100 mA.

Images