Locating a superficial neural structure using non-invasive electrical mapping

Abstract

A system can locate a neural structure, such as a superficial nerve having a sensory fiber (also referred to as a "target nerve"). The system can include at least an electrical stimulation device, and optionally a recording device that works with the electrical stimulation device to localize the target nerve. The electrical stimulation device can utilize transcutaneous, non-invasive electrical mapping such that one or more electrodes can be positioned on a subject's skin to apply stimulations with electrical signals. The recording device can detect a location of the target nerve based on recordings of the stimulations. The patient can also indicate a location of the target nerve based on sensations elicited by the stimulations. The system can also include a therapy emitting element that can be positioned relative to the electrical stimulation device and deliver light and / or temperature change therapy to the target nerve upon localization.

Description

NONPROVISIONAL APPLICATIONLOCATING A SUPERFICIAL NEURAL STRUCTURE USING NON-INVASIVE ELECTRICAL MAPPINGCross-Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 668,386, filed July 8, 2024, entitled “LOCATING A SUPERFICIAL NEURAL STRUCTURE USING NON-INVASIVE ELECTRICAL MAPPING”, and U.S. Provisional Application No. 63 / 624,877, filed January 25, 2024, entitled “SYSTEMS AND METHODS TO LOCALIZE A SUPERFICIAL NERVE WITH NON-INVASIVE ELECTRICAL MAPPING AND DELIVER THERAPEUTIC LIGHT”. These provisional applications are hereby incorporated by reference in its entirety for all purposes.Technical Field

[0002] This disclosure relates generally to transcutaneous application of a therapy to a neural structure, and more specifically to systems and methods that can locate a superficial neural structure with non-invasive electrical mapping and then apply the therapy transcutaneously to at least a portion of the superficial neural structure.Background

[0003] Light therapy, heat therapy, and / or electrical stimulation can be applied therapeutically to one or more neural structures. For example, photobiomodulation (PBM) is one example of a light therapy that can be applied (e.g., alone and / or in concert with another type of therapy) to a neural structure to treat a disorder with a therapeutic stimulation. Generally, PBM can be applied transcutaneously or subcutaneously. Fully non-invasive, transcutaneous application of PBM (as well as other therapies like heat therapy) suffers from a difficulty in locating a target nerve and knowing the amount of light (and / or heat) received by the neural structure. Since locating the target nerve is paramount, at least partially invasive subcutaneous PBM (and / or heat therapy) has been used because the exact nerve location and the amount of light (and / or heat) reaching the neural structure are known. However, even partiallyinvasive subcutaneous PBM still requires creating at least a hole or surgical opening. Non-invasive, transcutaneous application of light and / or heat would be preferable for a myriad of reasons including, safety, cost, ability for procedures to be done outside of a clinical environment, and the like. Effectively determining the location and / or depth under the skin of target neural structures is necessary to make these non-invasive, transcutaneous techniques feasible.Summary

[0004] Described herein are systems and methods that can apply therapeutic light and / or heat transcutaneously to a superficial neural structure. In some instances, the superficial neural structure can be superficially located via electrical mapping, which can find the location and / or depth of the superficial neural structure and then, optionally, determine effective transcutaneous dosages of light and / or heat therapy (and / or additional therapy, like electrical therapy) based on the estimates.

[0005] In an aspect, the present disclosure can include a system for electrical mapping of a superficial neural structure. For example, the superficial neural structure can include one or more superficially located nerves including at least one sensory fiber (e.g., a “target nerve”). The system can include an electrical stimulation device and a therapy emitting element. The electrical stimulation device can include one or more electrodes and can be positioned on a skin of a subject near a target nerve and configured to stimulate the target nerve. Optionally, the system can also include a recording device that can sense stimulation of the target nerve. Alternatively, a patient can indicate when a sensation indicative of the target nerve being stimulated is felt. The therapy emitting element can be positioned relative to the electrical stimulation device and configured to deliver therapy (e.g., light, heat, cold, magnetic, pharmaceutical, etc.) therapy to the target nerve.

[0006] In another aspect, the present disclosure can include a method for electrical mapping of a superficial neural structure. For example, the superficial neural structure can include one or more superficially located target nerves. An electrical stimulation device can be positioned relative to the superficial neural structure and the position relative to the neural structure can be tested. The electrical stimulation device can be repositioned relative to the nerve until the electrical stimulation device is at a desiredtranscutaneous position, which can be determined based on one or more recorded neural signals and / or input from the patient (e.g., reflecting that the patient is feeling a sensation indicative of the target nerve being stimulated). Alternatively and / or additionally, one or more stimulation parameters of the electrical stimulation device can be changed until the desired position and a desired stimulation are determined.Brief Description of the Drawings

[0007] The foregoing and other features of the present disclosure will become apparent to those skilled in the art to which the present disclosure relates upon reading the following description with reference to the accompanying drawings, in which:

[0008] FIG. 1 is a block diagram showing a system that can electrically map at least one target nerve through skin;

[0009] FIG. 2 is a block diagram showing an alternative of the system of FIG. 1 with respect to the skin and a nerve;

[0010] FIG. 3 shows illustrations of example electrode and recording device configurations for electrical mapping;

[0011] FIG. 4 illustrates an example system with respect to several hand and wrist nerves;

[0012] FIG. 5 illustrates example stimulation electrodes and orientations of the example electrodes with respect to a nerve;

[0013] FIG. 6 illustrates alternative configurations of stimulation electrodes and a light emitter with respect to a nerve;

[0014] FIG. 7 illustrates an example configuration of a system like FIG 1 when used for a medical application; and

[0015] FIGS. 8 and 9 are process flow diagrams of methods for electrical mapping of one or more superficial nerves.Detailed DescriptionI. Definitions

[0016] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains.

[0017] As used herein, the singular forms “a,” “an,” and “the” can also include the plural forms, unless the context clearly indicates otherwise.

[0018] As used herein, the terms “comprises” and / or “comprising,” can specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups.

[0019] As used herein, the term “and / or” can include any and all combinations of one or more of the associated listed items.

[0020] As used herein, the terms “first,” “second,” etc. should not limit the elements being described by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or acts / steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0021] It will be understood that when an element is referred to as being "on," "attached" to, "connected" to, "coupled" with, "contacting," etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, "directly on," "directly attached" to, "directly connected" to, "directly coupled" with or "directly contacting" another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0022] As used herein, the terms “mapping”, “electrical mapping”, and / or “electrical stimulation mapping” refer to a way of locating at least one target nerve superficially within a subject’s body using an electrical signal (e.g., a subthreshold electrical signal, a suprathreshold electrical signal, an electrical signal of increasing and / or decrease amplitude, or the like). In some instances, electrical mapping can also refer to estimating the depth of the at least one target nerve under the skin. At least one electrical signal can be applied to a patient via at least one electrode connected to at least a generator. The at least one electrode can be moved around until a desiredresponse of the target nerve to the electrical signal is realized (e.g., recorded by at least one recording electrode, sensation reported by the patient, etc.). The current used for electrical mapping can have an amplitude of, but is not limited to, between 0.1 mA and 100 mA, 1 mA and 20 mA, 5 mA and 15 mA, 10 mA and 13 mA, or the like.

[0023] As used herein, the term “therapy” can refer to the delivery of one or more stimulus or agents to a neural structure to at least partially relieve and / or treat a physiological condition and / or a symptom of a physiological condition. Types of therapy can include, but are not limited to, light therapy (such as photobiomodulation, temperature-based therapy (e.g., heat therapy or cold therapy), magnetic therapy, pharmaceutical therapy, or the like.

[0024] As used herein, the term “photobiomodulation”, abbreviated as “PBM”, can refer to the delivery of light signal(s) at one or more prescribed wavelengths and dosing schemes to one or more target nerves for light therapy to achieve a desired physiological response (e.g., to reduce and / or treat acute and / or chronic pain). PBM utilizes non-ionizing light sources, including lasers, light emitting diodes, and / or broadband light sources and can be delivered by one or more emitters. In some examples, the light can have a wavelength between 250 nm and 1600 nm. However, as an example, the wavelength can be in the visible range (e.g., from 400 nm to 700 nm) and / or near-infrared range (e.g., from 700 nm to 1100 nm) of the electromagnetic spectrum.

[0025] As used herein, the term “heat therapy” can refer to the application of one or more heat signals to a patient (e.g., to at least one target nerve). Heat therapy can be applied by the same optical emitter as the photobiomodulation and / or a separate heat mechanism (e.g., another optical emitter, an RF ablation tool, a focused ultrasound, a resistive heating device, a cryogenic cooling device, or the like). It should be understood that heat therapy may refer to optical heating and / or optical cooling.

[0026] As used herein, the term “electrical stimulation” can refer to the application of one or more electrical signals (e.g., current(s)) with one or more predefined parameters) via one or more electrodes to a patient. Various parameters of the one or more electrical signals, such as amplitude, voltage, etc., can be modulated based on if a nerve is being mapped and / or the nerve is being therapeutically stimulated. Forexample, supra-threshold electrical stimulation can be used for electrical mapping to locate and / or estimate the depth of one or more target nerves. In some instances, sub threshold electrical stimulation can be used alternatively for electrical mapping. As another example, supra-threshold or sub-threshold electrical stimulation (e.g., having one or more different parameters than what is used for electrical mapping) can be used for therapeutic effect to achieve a desired physiological response (e.g., to assist PBM and / or heat therapy, or another therapy type, with reducing and / or treating acute and / or chronic pain).

[0027] As used herein, the term “dosing scheme” can refer to a schedule of one or more doses of PBM (e.g., quantities of light of one or more wavelengths), one or more doses of heat therapy, and / or doses of electrical stimulation (e.g., current at one or more parameters) to be delivered to a target area of a patient per a unit of time to treat the patient. A dosing scheme can include whether doses of the PBM, the heat therapy and / or the electrical stimulation are applied simultaneously and / or sequentially, or a mixture thereof, a time between doses of PBM, heat therapy, and / or electrical stimulation, one or more times of day when the dose of PBM, heat therapy, and / or electrical stimulation is to be given, a quantity of PBM, heat therapy, and / or electrical stimulation to be delivered, a target intensity of the light signal(s), heat, and / or current to reach the target area, a luminance of a light source of the PBM, a power associated with the delivery of the PBM, the heat therapy and / or the electrical stimulation, an amount of PBM, heat therapy and / or current in the dose to reach the target area, or the like.

[0028] As used herein, the term “subcutaneous” can refer to something being situated or applied beneath (under) a patient’s skin. For instance, something located subcutaneously is located within the patient’s body under the skin). For example, the one or more target nerves described herein are subcutaneous.

[0029] As used herein, the term “transcutaneous” can refer to something being delivered through / across a patient’s skin without physically disrupting the skin barrier (e.g., light and / or electrical signals can be delivered from an external opto-electrical applicator transcutaneously to one or more subcutaneous target nerves).

[0030] As used herein, the term “physiological condition” can refer to a disorder, disease, or patient state, with a neurological component and / or symptom that is at least partially treated, ameliorated, or has its progression slowed by the application of PBM and / or electrical stimulation to one or more target nerves. Physiological conditions can include, but are not limited to, injuries, surgical wounds, arthritis, hypertension, stroke, neurodegeneration of a part of the nervous system, cardiac disease associated with elevated rostral ventrolateral medulla, headaches, facial neuralgias, or the like.

[0031] As used herein, the term “pain” refers to an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage. There generally two types of peripheral pain, nociceptive and neuropathic. Nociceptive pain is a type of pain caused by damage to body tissue and can be acute or chronic. Acute pain is relatively short in duration and subsides when the cause (e.g., injury, illness, etc.) has healed. Chronic pain may be intermittent or continuous and (1 ) persists beyond a normal recovery period of a cause (e.g., injury, illness, etc.) or (2) occurs with a chronic health condition. Acute pain can become chronic pain through a process known as chronification.

[0032] As used herein, the term “neural structure” refers to any portion of the nervous system, including, but not limited to, nerves, neurons, axons, neural fibers, ganglia, the brain, the spinal cord, or the like.

[0033] As used herein, the term “fiber” refers to an axon, which is a long slender projection of a nerve cell or neuron in vertebrate organisms having a diameter that corresponds to conduction velocity. Generally, a fiber conducts electrical impulses transmitting information in one or more directions throughout the body and is classified depending on the type of fiber (e.g., sensory, motor, etc.), the diameter of the fiber and / or if myelin coating is present.

[0034] As used herein, the term “nerve” refers to a bundle of fibers of different nerve cells. For example, a nerve can be a sensory nerve that includes sensory fibers, a motor nerve that includes motor fibers, a sensorimotor nerve that includes sensory and motor fibers, etc.

[0035] A nerve can be referred to as “superficial” (or “superficially located”) when at least a portion of the nerve is close to a patient’s skin (e.g., at least a portion of thenerve being within 10 mm, 5 mm, 2 mm, 1 mm, or the like, from the skin surface) and can convey neural activity associated with the main sensations (e.g., touch, pressure, vibration, pain, itch, warmth, cold, etc.). It should be noted that as used herein the term superficial nerve can describe nerve endings and / or at least a portion of the trunk of a nerve that branches to a wider distribution of nerve endings.

[0036] As used herein, the term “sensory fiber(s)” refers to part of the peripheral nervous system (PNS) that conduct electrical impulses between a part of the body experiencing sensation and the brain / spinal cord. Sensory fibers have a range of fiber sizes. For example, sensory fibers can be classified as Aa (diameter 13-20 mm, conduction velocity 80-120 m / s, myelinated, associated with muscle spindle fibers and Golgi tendon organ); Ab (diameter 6-12 mm, conduction velocity 33-75 m / s, myelinated, associated with all cutaneous mechanoreceptors); Ad (diameter 1 -5 mm conduction velocity 3-30 m / s, thinly myelinated, associated with free nerve endings of touch and pressure, nociceptors of the neospinothalamic tract, cold thermoreceptors); and C (diameter 0.2-1 .5 mm, conduction velocity 0.5-2.0 m / s, unmyelinated, associated with nociceptors of the paleospinothalmic tract and warmth receptors).

[0037] As used herein, the terms “patient” or “subject” can be used interchangeably and can refer to any warm-blooded organism, including, but not limited to, a human being, a pig, a rat, a mouse, a dog, a cat, a goat, a sheep, a horse, a monkey, an ape, a rabbit, a cow, etc.II. Overview

[0038] In theory, transcutaneous application of a therapeutic signal, such as light therapy, heat therapy, cold therapy, electrical stimulation / block, pharmaceutical treatment, or the like, can be an effective and often entirely non-invasive solution for treating one or more physical conditions mediated by one or more neural structures. Although transcutaneous application provides a non-invasive treatment mechanism, transcutaneous application of certain therapeutic signals has been limited by the imprecision associated without not knowing the exact location of the neural structure and how to optimize therapeutic signals for a safe and efficacious dose to reach the neural structure through intervening tissues. For example, if orientation for electrical mapping, or therapeutic electrical stimulation, is not optimized then the target nerve maybe inadequately treated, the wrong nerve may be treated, and / or the recordings used for electrical mapping may be affected by errors and artifacts potentially causing less optimized treatment. As an example, when light therapy is photobiomodulation (PBM), intervening tissues can prevent a user from seeing the target nerve and can rapidly attenuate light by absorption and / or scattering, making it difficult to get an adequate amount of light to the target nerve. As another example, if delivery optics are not optimized light therapy, heat therapy, or the like, may be delivered to an area that is too small to be effective (e.g., missing one or more fibers), the light therapy, heat therapy, or the like, delivered may have an inadequate power density to achieve the desired therapeutic effect, and / or the light therapy, heat therapy, or the like, may be delivered to an inadequate length of the nerve to achieve the desired therapeutic effect.

[0039] Described herein are systems and methods that can locate a peripheral neural structure with non-invasive electrical mapping and then apply a therapy signal transcutaneously to at least a portion of the peripheral neural structure (e.g., the target nerve with one or more small fibers therewithin). The electrical mapping enables transcutaneous application of the light, heat, and / or electrical stimulation signals. The electrical mapping can be used to determine and / or estimate the location and / or the depth of the one or more target nerves. The electrical mapping can additionally be used to orient the therapy device (e.g., delivering, light, heat, electrical stimulation, or the like) relative to the one or more target nerves to optimize a desired therapeutic effect and effective transcutaneous dosages therapy. The same system used for the electrical mapping can in some instances be used to apply the therapy as well.III. Systems

[0040] FIG. 1 shows a system 100 for electrically mapping a location and / or depth of one or more target nerves that include at least one sensory fiber and are superficial. The location and / or depth can be used as a guide for applying a transcutaneous therapy to the one or more target nerves, which are located under a patient’s skin, estimating a depth of the one or more target nerves under the patient’s skin, and / or optimizing orientation of the therapy device relative to the one or more target nerves. Several types of therapies, including light, heat, and electrical therapies (configured as therapeutic stimulation) can be sensitive to position and may only be efficacious if therapy devicesare positioned and oriented in particular manners with respect to the one or more target nerves. The at least sensory fiber that can conduct, for instance, signals related to pain, inflammation, arthritis, symptoms of arthritis, and / or heat hypersensitivity. For example, the one or more target nerves can be within a hand, finger, and / or wrist of the patient. In another example, the one or more target nerves can be in a foot, ankle, face, head, neck, or the like, of the patient.

[0041] The system 100 can include an electrical stimulation device 10 that can be positioned on the skin near a target nerve to stimulate the target nerve. In some instances, the system 100 can include an optional recording device 12 that can sense the stimulation of the target nerve. The electrical stimulation device 10 and, in some instances, the recording device 12 can be in electrical communication, wired and / or wireless, with a controller 16. The controller 16 can at least communicate one or more instructions to the electrical stimulation device 10 and, in some instances, receive one or more recordings from the recording device 12. The system 100 can also include a separate therapy device 14 that can be, for instance, a light therapy (e.g. PBM therapy) device, a heat therapy device, a cold therapy device, a magnetic therapy device, a pharmaceutical therapy device, or the like, that can stimulate the one or more target nerves. Optionally, the controller 16 can be in wired and / or wireless communication with an external device 18. The external device 18 can be, for instance, a device having a user interface (e.g., touch screen, keyboard, buttons, mouse, microphone, etc.), a visual display, a speaker, and / or a haptic / tactile feedback device to facilitate communication between the user and the controller 16. It should be noted that any and / or all of this functionality and associated components can be, alternatively and / or additionally, embodied within the controller 16. In another instance, the external device 18 can be an imaging device, a medical diagnostic device, another type of therapy delivery device, or the like.

[0042] The electrical stimulation device 10 can include at least two electrodes and at least one electrical signal generator. The at least two electrodes can include at least one source electrode (e.g., an anode) and at least one sink electrode (e.g., a cathode). The electrical stimulation device 10 can provide at least one electrical signal for the purpose of electrical mapping. In some instances, the electrical stimulation device canalso provide at least one electrical signal for therapeutic purpose. The at least one generator can generate the electrical signal and the at least two electrodes can apply the electrical signal. The at least one generator can be in electrical communication, wired and / or wireless, with the at least two electrodes to provide the electrical signal to the at least one source electrodes and / or the at least one sink electrode. The generator can be in communication with the controller 16 that can provide and / or adjust one or more parameters for the electrical signal. The at least two electrodes can be, for instance, at least two skin surface electrodes. The at least two electrodes can be made of any material capable of being used without causing temporary damage and / or lasting damage to the skin and / or underlying tissues, including the one or more target nerve at the parameters of the electrical signal for electrical mapping and / or therapeutic purpose. The at least two electrodes can be any shape, polygon or otherwise, capable of applying the electrical stimulation (e.g., subthreshold electrical stimulation and, in some instances, supra-threshold electrical stimulation) to the at least one target nerve under the skin. The at least two electrodes can include at least one cathode electrode and at least one anode electrode. In some instances, the at least two electrodes can additionally include at least one distant electrode, such as a patch electrode, to enable unbalanced local current between the at least one cathode electrode and at least one anode electrode. In other instances, the at least one distant electrode can be embodied as separate from the electrical stimulation device 10 and may be connected, wired and / or wirelessly, to a separate generator.

[0043] The recording device 12 (which is used in some instances) can be configured to sense stimulation of the target nerve. The recording device 12 can be, for instance, another electrode configured for sensing and recording. The recording device 12 can sense and record electrical potentials from the target nerve (e.g., sensory nerve action potentials (SNAPs) or the like). The recording device 12 can, in another instance, sense electromyogram (EMG) and / or other evidence of stimulation of the target nerve. The recording device 12 can be at least one skin surface electrode. The recording device 12 can be positioned remote from the electrical stimulation device and / or the therapy device along the trajectory of the one or more target nerves. For example, the recording device 12 can be, for instance, positioned along a finger with a downstreambranch of a nerve innervated in the wrist by the electrical stimulation device 10. The recording device 12 can be in electrical communication with the controller 16 to send the stimulation sensed at a given time. A strength of the sensed stimulation of the target nerve can be used to determine if the target nerve has been located (e.g., strength of the sensed stimulation, amount of artifacts in the sensed stimulation, etc.). In one instance, the sensed stimulation can be compared to known values and / or thresholds for stimulation of the target nerve (e.g., known for the target nerve and / or patient, a population to which the patient belongs, or the like). In another example, the recording device 12 can be a manual recording device (e.g., including at least a user interface and a memory) configured to record the self-reported feelings of stimulation from the patient (e.g., paresthesia strength and / or location). The patient, a medical professional, and / or a caretaker can input the reported feelings into the recording device 12, which can be communicated to the controller 16.

[0044] In an alternative instance the patient can self-report, without a recording device 12, whether or not they feel a sensation indicative of the target nerve being stimulated at an appropriate location, and / or intensity. For example, the electrical stimulation device can be moved around on the patient’s skin to find the location and orientation that provides the greatest sensation and / or a sensation in the desired location. The sensation can be, for instance, paresthesia.

[0045] The therapy device 14 can be a light therapy device (e.g., providing PBM therapy) and / or a heat therapy device. In some examples, the light therapy device and the heat therapy device can be the same device (e.g., providing both PBM and optical heating). In other instances, the therapy device 14 can be the electrical stimulation device 10, a magnetic therapy device, a pharmaceutical therapy device, or the any type of therapy device that benefits from electrical mapping to find one or more target nerves. The therapy device 14 can include at least one therapy emitting element to provide the therapy to the user. The therapy device 14 can include, for example, a light emitter positioned relative to the electrical stimulation device and configured to deliver light and / or heat therapy to the one or more target nerves after the position and / or depth of the one or more targets nerves has been mapped. The light emitter can include at least one light emitting diode (LED), at least one laser, at least one vertical cavitysurface emitting laser (VCSEL), or the like. The light emitter can provide light (e.g., PBM) and / or heat therapy. In other instances, the therapy device 14 can include one or more thermal cooling elements (not shown) to dissipate heat generated from use of the light emitter. In further instances, the system can be used with one or more optical clearing solutions (not shown) added between at least the therapy device 14 and the skin and / or between the electrical stimulation device 10 and the skin (in this case the electrical stimulation device 10 (e.g., electrode(s), can be configured to pass sufficient current through the optical clearing solution to aid in light propagation to the nerve). The therapy device 14 can also include at least one source for the therapy, such as a light source, a heat source, a cold source, an electrical generator, or the like, which can be connected to and / or part of the therapy emitting element and connected with the controller 16. The at least one source of the therapy can supply the therapy device with energy, chemicals, etc. for each therapeutic application.

[0046] The controller 16 can be, as mentioned previously, in wired and / or wireless communication with the electrical stimulation device 10, the therapy device 14, the optional recording device 12, and / or the optional external device 18. The controller 16 can include at least a non-transitory memory (not illustrated) that can store one or more instructions and a processor (not illustrated) that can execute the one or more instructions. The instructions can include, but are not limited to: identify a location of the one or more target nerve based on the stimulation sensed by the recording device 1 , estimate a depth of the one or more target nerve under the skin based one the stimulation sensed by the recording device, and / or configure one or more dose parameters for a dose of therapy (e.g., light therapy (e.g., PBM), heat therapy, or the like) be applied to modify conduction in the at least one sensory fiber of the one or more target nerve based on the location and / or the depth of the target nerve. The one or more dose parameters can include, but are not limited to a power, a wavelength, a frequency, pulse width, and a duration of the therapeutic stimulation (e.g., light and / or heat). The controller 16 may include other circuitry and / or power components (not illustrated), such as, but not limited to, a battery, a wall power plug connection, and / or a wireless transceiver or the like for communicating with another wireless transceiver ofthe electrical stimulation device, the therapy device, the recording device, and / or the optional external device.

[0047] FIG. 2 shows an example system 200 for electrical mapping one or more target nerves and, optionally, delivering one or more types of therapy to the one or more target nerves (shown in FIG. 2 as a single nerve under the skin for ease of illustration only). It should be noted that the one or more target nerves can be a trunk of a nerve that branches to a wide distribution of nerve endings downstream (e.g., to treat a broad area) and / or one or more select nerve endings that are sensitive from pain (e.g., to treat smaller, more precise areas). The electrical stimulation device 10 and the recording device 12 can be positioned on the skin of a patient. The recording device 12 can be positioned remote from the electrical stimulation device 10 along the trajectory of the nerve. The electrical stimulation device 10 can be positioned relative to the one or more nerves and can be movable along the surface of the skin of the patient to locate the one or more target nerves. The electrical stimulation device 10 can in this instance include at least two electrodes (e.g., at least one source electrode and at least one sink electrode) and can be in communication with at least one generator (e.g., generator(s)) 26. For example, the electrical stimulation device 10 can include three electrodes arranged in a transverse tripole configuration (described in more detail below) relative to the one or more target nerves. The controller 16, which can include at least memory 22 and processor 24, can communicate one or more parameters (e.g., frequency, amplitude, timing, pulse width, waveform shape, duration, etc.) of an electrical signal for at least electrical mapping to be produced by the at least one generator 26 and applied via the electrical stimulation device 10. The recording device 12 can sense stimulation of the one or more target nerves and send a recording of the stimulation response to the controller 16, which can receive the recording.

[0048] In some instances, the controller 16 can also be in communication with the therapy device 14 (which can be optional) via at least one generator of generator(s) 26, a display 28, a user interface 30, and / or an imaging device 32. It should be noted that while all the components of system 200 are described as in communication (wired and / or wireless) with each other, any and / or all of the components may be co-located within a common housing with at least one other component. The user interface 30 canreceive inputs from one or more users (e.g., patient, caregiver, medical professional). The inputs can include, but are not limited to, manual parameter changes (e.g., within safety and / or efficacy boundaries), notes about the electrical mapping and / or the therapy, or other information. The user interface 30 can be one or more buttons, a touch screen, a keyboard, a microphone, a mouse, or the like) The display 28 can display any information provided from and / or received by the controller 16, including but not limited to, location of one or more target nerves, estimated depth of one or more target nerves, the recording of the stimulation sensed by the recording device 12, the one or more parameters being provided to the electrical stimulation device 10 and / or therapy device 14 at a given time, one or more alerts (e.g., close to a target nerve, far from a target nerve, error or problem has occurred, or the like). The display 28 can include a visual display, an audio display (e.g., a speaker), and / or a tactile / haptic feedback device.

[0049] The imaging device 32 (which can be optional) can include, for instance, a camera or photodetector element capable of providing skin type information and / or skin tone information (e.g., to be determined by the controller 16). The controller 16 can, in some instances, alter one or more parameters of the electrical mapping and / or the therapy based on the skin type and / or tone information (e.g., if the therapy is light therapy skin tone can affect the attenuation of certain wavelengths, if the skin is a different composition, color, etc., then the composition, color, etc. may affect how one or more other types of therapies reach the nerve (e.g., scar tissue, or the like), etc.). The imaging device 32 can in another instance, be a device such as an optical coherence tomography (OCT) system, a magnetic resonance (MR) neurography system, a positron emission tomography (PET), and / or other radiotracer imaging system. The imaging device 32 can, in such instance, be used to generally locate one or more target nerves prior to the electrical mapping (e.g., a location can be marked for the user to position at least the electrical stimulation device 10). The imaging device 32 can, for instance, be used in a clinical setting for setup, calibration, initial mapping, etc. At home electrical mapping (e.g., done by the patient themselves or a caregiver) can then more precisely and / or accurately locate the one or more target nerves and / or estimate the depth under the skin to the one or more target nerves. The imaging device 32 can be used to identify a ground truth and the general location for therapy can be marked on the skin such thatsubsequent electrical mapping can be guided by the location of the mark (e.g., at home use).

[0050] The therapy device 14 (which can be optional) can be separate from the electrical stimulation device 10 (as shown) or, in some instances, co-located with the electrical stimulation device 10 (as described in more detail below). The therapy device 14 can provide light therapy and / or heat therapy to the one or more target nerves through the skin. In another instance the therapy device can provide pharmaceutical (e.g., a lidocaine patch) and / or magnetic therapy, additionally and / or alternatively. The light therapy can be, for example, PBM therapy. The therapy device 14 can include an optical emitter that can apply the light and / or the heat therapy (although heat therapy is not limited to optically produced heat). In some instances, the electrical stimulation device 10 can additionally provide therapeutic electrical stimulation in addition to and / or as an alternative to the therapy delivered by therapy device 14.

[0051] As an example, the location of the one or more target nerves can be obtained by moving the electrical stimulation device 10 (e.g., including the cathode(s) and anodes(s)) left and right across the skin (over the nerve(s)) and finding the position along that line with the lowest threshold for eliciting a response (e.g., a recording, an input from the patient of paresthesia, etc.). Once the location is identified, the system 200 (e.g., controller 16) can make an assumption that the electrical stimulation device 10 is directly above the nerve and can use that same threshold information to estimate the depth of the nerve at that location.

[0052] In some instances, thresholds for initial paresthesia, comfortable paresthesia that covers the intended topography, and maximum comfortable paresthesia (any higher would be painful) can be captured (e.g., by recording device 12) to provide additional information for use in estimates of depth. Additional information can also be gathered by identifying stimulation thresholds with different electrode configurations (i.e., using different sets of electrodes of the electrical stimulation device 10). SNAP or EMG thresholds can also be recorded and used for estimating the depth.

[0053] In one instance, the controller 16 can use real-time recorded data (e.g., from recording device 12) during therapy application to estimate depth and adjust therapy dosing in a closed loop fashion (e.g., in real-time, with only a delay for the transmissionof data and calculations). If the location of the one or more target nerves were lost (e.g., a recording was not detectable anymore), the controller 16 could notify the user (e.g., through display 28, audio indicator, etc.) and can stop therapy delivery until the one or more target nerves are re-located. The controller 16 can track the total dose applied at the target nerve for that session and can stop therapy when the proper dose to be delivered to the one or more target nerves is reached (e.g., not including any dose applied while the location was lost). In some instances, at least the electrode portion of the electrical stimulation device 10 and / or a therapy emitting element(s) of the therapy device 14 can be adhered, suctioned, and / or otherwise removably fixed to the skin above the determined location of the one or more target nerves to better ensure the entire therapy dose is properly received.

[0054] In some other instances, the user can change proposed dose parameters (e.g., using the user interface 30) on the controller 16 before delivering the dose and the controller can provide estimates of the amount of light that will reach the one or more target nerve and / or can calculate changes to other parameters that would have to be made to reach a user-defined target dose.

[0055] Referring now to FIG. 3, examples systems 300, 310, 320, and 330 showing different configurations of an electrical stimulation device and optional recording device are shown with respect to one or more target nerves running through the wrist, hand, and digits. It should be noted that FIG. 3 shows the palmar side of the right hand and the inside of the wrist with the wrist extended and the fingers spread and with illustrations of the ulnar nerve, and associated branches, shown in long dashed lines and the median nerve and associated branches, shown in dotted lines. The illustrations are not intended to be anatomically accurate and are for illustration purposes only. For each of these systems the recording device 12 is shown attached to an index finger and the electrodes of the electrical stimulation device positioned over the median nerve in the wrist, but it should be understood that any configuration with the recording device on the same nerve and / or an associated nerve branch as the electrical stimulation device is considered. It should additionally be noted that, in some instances, the patient can extend the wrist such that the inside of the wrist is tight to decrease the distance from the surface of the wrist to the nerve, which may improve the ability to electrically mapand / or the ability to deliver more light (e.g., by the therapy device). The wrist can be passively held, or a weight and / or tool can be held / used to help extend the wrist. The electrode simulation device 10 is shown as anodes 36 and cathodes 34. In some instances, the electrodes can be hard wired as anodes 36 and cathodes 34. In other instances, the electrodes can be programmable to be anodes 36, cathodes 34, or OFF at any given time as the user sees fit. It is noted that a programmable configuration can advantageously allow a handful of electrodes in the correct positions to yield a number of potentially useful anode-cathode configurations for a number of different circumstances.

[0056] FIG. 3, element A shows example system 300 in a standard bipole configuration with one anode 36 and one cathode 34 positioned at a first and second position along the length of the nerve. It should be noted that the positions of the anode 36 and cathode 34 can be reversed for paresthesia stimulation purposes. For example, if the stimulation applied is 10 mA (from a generator not shown), then the target nerve can have an activating function of 0.0614 and the sensed artifact from the recording device 12 can be -1 .OOmV. FIG. 3, element B shows example system 310 in a transverse bipole configuration. The cathode 34 is positioned over the target nerve and the anode 36 is positioned perpendicular (or transverse) to the cathode 34. The anode 36 can be positioned along another nerve as shown here. Alternatively, the anode 36 can be situated along an axis substantially perpendicular to the orientation of the target nerve. For example, if the stimulation applied is 10 mA (from a generator not shown), then the target nerve can have an activating function of 0.0612 and the sensed artifact from the recording device 12 can be -0.192 mV, which is much lower than the artifact sensed in the standard bipole configurations at the same stimulation level. It should be understood that the alignments and / or orientations of the at least one anode 36 and at least one cathode 34 described throughout this application can be substantially aligned as described (e.g., perpendicular, parallel, etc.) with tolerances for inexact alignments. As non-limiting examples, the alignments can be within ±1 mm, ±5 mm, ±10 mm, or the like of the exact measurement and / or within ±1 degree, ±5 degrees, ±10 degrees, ±20 degrees or the like degrees, of the exact angle.

[0057] FIG. 3, element C shows example system 320 in a tight transverse tripole configuration. The cathode 34 is positioned over the target nerve and the first anode (Anode 1 ) 36(1 ) is positioned on one side of the cathode 34 and the second anode (Anode 2) 36(2) is positioned on the other side of the cathode 34 in a line perpendicular (or approximately perpendicular) to the length of the target nerve. For example, if the stimulation applied is 10 mA (from a generator not shown), then the target nerve can have an activating function of 0.0473 and the sensed artifact from the recording device 12 can be -0.0000036 mV. This tight transverse tripole configuration produces an even lower sensed artifact than the standard bipole or transverse bipole configurations, which can be a significant improvement for sensing small action potentials such as from SNAPs. FIG. 3, element D shows example system 330 in another tight transverse tripole configuration similar to FIG. 3, element C through which a higher stimulation can be applied. For example, if a higher stimulation of 12. 9 mA is applied (from a generator not shown), then the target nerve can have an activating function of 0.0612 and the sensed artifact from the recording device 12 can be -0.0000047 mV.

[0058] While not wishing to be bound by theory, in particular, the transverse configuration substantially reduces artifact, is more sensitive to transverse position (desirable for finding a nerve). Achieving a response may be more difficult, but once obtained, the position of the nerve is quite clear. Transverse tripole electrode configurations have improved specificity as compared to monopolar or bipolar configurations. With regard to the transverse tripole, the distance between the cathode and the anodes will change the sensitivity of the localization and will change the amplitude required to excite the nerve. In particular, smaller anode-cathode distances require higher stimulation current and have increased sensitivity. Reasonable distances to consider range from 1 mm to 10 mm, or up to 35 mm. The amplitude range to consider would be from 1 mA to 100 mA and increments of 0.1 mA are desirable to enable more precision in the estimate of the nerve depth (as an input to the controller that can determine therapeutic dose parameters).

[0059] While not shown in FIG. 3, it should be understood that at least one electrode included in and / or coupled to the electrical stimulation device 10 of FIG. 2 can be a single monopolar electrode positioned relative to the nerve. In the case of amonopolar configuration, a “distant” electrode can be used, such as a patch electrode at a more proximal location on the arm. And the therapy device 14 (e.g., including at least one light emitter) could be oriented above and / or below the electrode along the presumed axis of the nerve. The electrode would ideally be used as a cathode for purposes of detecting nerve location.

[0060] FIG. 4 shows a system 400 that includes a device 40 that can be positioned on the wrist of a patient and can perform electrical mapping and optionally provide light and / or heat therapy. The device 40 can be in electrical communication (wired and / or wireless) with at least one generator (generator(s) 26). In some instances, a single generator 26 can be in communication with each of the at least two electrodes (cathode(s) 34 and anode(s) 36). In other instance the anode(s) 36 and cathode(s) 34 can each be powered by independent generators 26 (such that electrodes of a common polarity can deliver (or sink) different amounts of current. The at least one generator 26 can be in communication (wired and / or wireless) with controller 16. The controller 16 can be in communication (wired and / or wireless) with recording device 12. The device 40 can include at least one anode (anode(s)) 36, at least one cathode (cathode(s)) 34, and optionally at least one light emitter (light emitter(s)) 42. The device 40 can include the at least one anode 36 and / or at least cathode 34 in any of the configurations described with respect to FIG. 3.

[0061] In one example, the electrical stimulation device (e.g., device 40) can include three electrodes arranged in a transverse tripole configuration where an axis of each electrode is perpendicular to a longitudinal axis of the target nerve. The three electrodes can be arranged at a distance from one another, wherein a sensitivity of localization of the target nerve (computed by the controller 16) is based on the distance between the three electrodes and the stimulation sensed by the recording device 12. The localization by the controller 16 can include a determination and / or an estimation of depth of the target nerve. It is noted that the transverse tripole configuration allows the three electrodes to be positioned at a much closer distance to each other than a bipole configuration. In some instance, a distant electrode, such as a patch electrode, can be used to enable unbalanced local current. For example, a central cathode sinking 30 mA might be flanked by two anodes that each source 25 mA (and the additional 20 mA thatare “sinked” are at the distant electrode. This anode intensification can allow for changes in sensitivity to be controlled electrically.

[0062] The system 400 can electrically map the location of one or more target nerves and / or estimate the depth of the one or more target nerves under the skin (in the wrist as shown). The controller 16 can identify a location of the one or more target nerve (not shown in FIG. 4) based on the stimulation sensed by the recording device 12. The controller 16 can include (e.g., in the memory) one or more stored values, ranges, and / or thresholds indicative of the one or more target nerve being stimulated by the given configuration of anode(s) 36 and / or cathode(s) 34 at the given electrical signal parameters. For example, if the stimulation sensed by the recording device 12 is too low or includes too much noise the controller can indicate (e.g., through a display and / or external device) that the device 40 is not near enough to the target nerve and the user should move the device 40 to a new location and try again. In some instances, directions for moving the device 40 may be given (e.g., through the display and / or external device).

[0063] Optionally, once the one or more target nerves have been located the controller 16 can estimate the depth of the one or more target nerves under the skin. The estimation can similarly include comparing stimulation sensed by the recording device 12 with one or more values, ranges, and / or thresholds stored in the memory of the controller. In one example, the controller 16 can adjust the one or more parameters of the electrical signal (e.g., amplitude, frequency, waveform, timing, durations, etc.) in a closed loop until the stimulation sensed by the recording device 12 indicates the estimated depth of the target nerve (e.g., at least one of PID control, or the like). In another example, a user (e.g., a medical professional, trained professional, or the like) can manually input one or more different parameters of the electrical signal until the sensed stimulation indicates the estimated depth of the target nerve. The controller 16 can indicate (e.g., with a display and / or external device) the estimated depth. In some instances, the controller 16 can then utilize the determined location and / or the estimated depth of the one or more target nerves to configure one or more dose parameters for a dose of light therapy (e.g., PBM) and / or heat therapy to be applied via the optical emitter(s) 42 to modify conduction in the at least one sensory fiber of the target nerve.The one or more dose parameters can include at least one or more of a power, a wavelength, a frequency, and a duration.

[0064] FIG. 5 shows example configurations (shapes, dimensions, and orientations) of singular electrodes, cathodes and / or anodes, that can be used in any of the systems described herein. It should be understood that these numbers of electrodes, shapes of electrodes, and orientations are not meant to be limiting and the electrodes described herein can be any other numbers, shapes, dimensions, and / or orientations. Additionally, in some instances, electrodes can be programmably changed between states to be anodes, cathodes, or off (e.g., by a connected controller) depending on the configuration desired at a given time (e.g., additional electrodes to those shown and described in a given configuration may by physically present but programmed to not be active when an electrical signal is applied). For example, X electrodes can exist on a device, but Y electrodes (less than or equal to X) can be chosen to be active at a time in a certain configuration (e.g., A electrodes can be active in B configuration, but C electrodes (different from A) can be active in D configuration).

[0065] FIG. 5, element A shows an example of an oval electrode in two orientations relative to a target nerve (shown as the line). The oval electrode can have a long axis and a short axis. In example (1 ) the long axis is aligned with the longitudinal axis of the target nerve and the short axis is reduced to increase spatial sensitivity of detection. In example (2), the long axis is perpendicular to the longitudinal axis of the target nerve to cover a greater region. As an example, the long axis can be from 1 mm to 15 mm in length and the short axis can be from 1 mm to 8 mm in length.

[0066] FIG. 5, element B shows an example of a circular electrode in two orientations relative to a target nerve (shown as the line). The circular electrode can, in some instances, have a diameter between 1 mm and 8 mm. FIG. 5, element C shows an example of a square electrode in two orientations relative to a target nerve (shown as the line). In one instance, the square electrode can have a side length of between 1 mm and 8 mm. In the cases of both the square electrode and the circular electrode, both shapes may be easier for a patient to utilize on their own (e.g., with a take home type device) as orientation is not as significant a factor to the electrical mapping and / or therapy effectiveness. FIG. 5, element D shows an example of a rectangular electrodein two orientations relative to a target nerve (shown as the line). The rectangular electrode can have a long axis and a short axis. In example (1 ), the long axis is aligned with the longitudinal axis of the target nerve and the short axis is reduced to increase spatial sensitivity of detection. In example (2), the long axis is perpendicular to the longitudinal axis of the target nerve to cover a greater region. As an example, the long axis can be from 1 mm to 15 mm in length and the short axis can be from 1 mm to 8 mm in length. It should be noted that in some instances, the square and rectangleshaped electrodes can have rounded corners to reduce the maximum current density coming off of the electrode.

[0067] It should be noted that smaller electrodes have higher impedance and require a higher compliance voltage, which can add complexity to the system. In the case of electrodes with a long axis parallel to the axis of the nerve, an electrode length of 1 mm to 15 mm and an electrode width of 1 mm to 8 mm could be reasonably considered. Ideally impedances are low, but this will cause trade-offs in sensitivity to nerve location, so a reasonable range is from 10’s of Ohms to 100’s or to 1000’s or even 10,000’s of Ohms, where compliance voltages can range from 1 's of Volts to 100’s of Volts.

[0068] FIG. 6 shows example configurations of the electrode(s) 50 in combination with a light emitter 42 with respect to the nerve for combined electrical mapping and optical therapy application (e.g., light therapy, heat therapy, or the like). The concept is that a combined module can be positioned to achieve electrical stimulation, and in that same position, the combined module can be held or secured, and light and / or heat will be delivered to achieve the therapeutic effect. It should be noted that these configurations assume that the orientation of the nerve (shown in the background as a thick dashed line) is known approximately (e.g., which can generally be known in many instances (e.g., common anatomy) and / or determined through imaging). Each element shows the configurations as if a target nerve has been located.

[0069] FIG. 6, element A, shows an illustration of the electrodes 50 in a transverse tripole configuration with the light emitter 42 in line with the cathode (along the length / longitudinal axis of the nerve). The electrodes 50 can include a first anode electrode and a second anode electrode positioned on opposite sides of a cathodeelectrode. The line of the first anode, the cathode, and the second anode can be perpendicular or substantially perpendicular to the longitudinal direction of the target nerve. The light emitter 42 can be positioned in line with the one cathode electrode (along the length of the nerve) and perpendicular or substantially perpendicular to the axis of the one cathode electrode and the first and second anode electrodes. Without wishing to be bound by theory, it is noted that this configuration can have low artifacts in distally recorded stimulation and high positional sensitivity. This configuration can be useful for accuracy, can use higher amplitude stimulation, and can be a good depth estimator because of high sensitivity.

[0070] FIG. 6, element B, shows an illustration of the electrodes 50 in a standard bipole configuration (for exciting a nerve and recording SNAPs with a recording device) with the light emitter 42 between the anode and the cathode. The anode electrode and the cathode electrode can both be positioned substantially along a longitudinal axis of the target nerve, wherein the light emitter 42 is positioned between the anode electrode and the cathode electrode. The sensitivity can be lower than the transverse tripole configurations and / or the transverse bipole configuration (i.e., accuracy is theoretically lower). The standard bipole configuration can be more prone to artifacts (for recording purposes). Note that SNAPs recording can be optional; self-reported paresthesia can be suitable for identifying the location for light and / or heat application using this configuration. It is noted that the cathode in the distal position is preferred to measure SNAPs in this configuration because the anode won’t stifle orthodromic stimulation (with the reference frame being the spinal cord). But, for the purposes of eliciting paresthesia, the anode should be in the distal position to not stifle antidromic stimulation (with the reference frame being the spinal cord).

[0071] FIG. 6, element C, shows an illustration of the electrodes 50 in a transverse bipole configuration with the light emitter 42 positioned below (which can be proximal or distal depending on the nerve) the cathode. The cathode electrode can be positioned over the target nerve and the anode electrode can be positioned beside the one cathode electrode and perpendicular to the longitudinal axis of the target nerve. The light emitter 42 can be positioned above the target nerve adjacent the one cathode electrode (e.g., proximal or distal) and perpendicular or substantially perpendicular tothe axis of line of the anode electrode and the cathode electrode. It should be noted that the transverse bipole approach can reduce artifacts in the recorded stimulation, compared to the standard bipole configuration.

[0072] FIG. 6, element D shows a configuration that can be a hybrid of the configurations shown in FIG. 6, elements A and B. Without wishing to be bound by theory this configuration would be expected to have intermediate sensitivity and intermediate levels of artifacts. In one instance, the electrodes 50 can include one cathode electrode that is positioned over the target nerve and one anode not positioned over the target nerve. The light emitter 42 can be positioned adjacent the one cathode electrode along or substantially along the longitudinal axis of the target nerve and the one anode can be positioned beside a portion of the light emitter perpendicular or substantially perpendicular to the longitudinal axis of the target nerve. In another instance, the one cathode electrode can be positioned along or substantially along the longitudinal axis of the target nerve, the light emitter 42 can be positioned in line with the one cathode electrode, and a first anode electrode and a second anode electrode can be positioned on opposite sides of the light emitter and perpendicular or substantially perpendicular to the longitudinal axis of the target nerve.

[0073] FIG. 6, element E shows another configuration that can be a hybrid of the configurations shown in FIG. 6, elements A and B. Without wishing to be bound by theory this configuration would be expected to have intermediate sensitivity and intermediate levels of artifacts. The configuration can include a first cathode electrode and a second cathode electrode, each of the first cathode electrode and the second cathode electrode can be positioned over or substantially over the target nerve with the light emitter positioned between first cathode electrode and the second cathode electrode. A first anode electrode and a second anode electrode can be positioned on opposite sides of the light emitter perpendicular or substantially perpendicular to the longitudinal axis of the target nerve. The two cathodes could give an extra opportunity to excite the nerve.

[0074] FIG. 6, element F shows another transverse tripole configuration with at least one of the electrodes 50 co-located with the light emitter 42 (shown by the overlap and thicker lines). In this configuration, the one cathode electrode and the light emittercan be positioned to at least partially overlap over the target nerve and the first anode electrode, and the second anode electrode can be positioned on opposite sides of the light emitter and perpendicular or substantially perpendicular to the longitudinal axis of the target nerve. This configuration may be useful when estimating depth of a nerve with highly variable depth as the cathode and the light emitter 42 overlap.

[0075] It should be noted that for any of the configurations with multiple anodes and cathodes, the electrodes of common polarity can be ganged, or each of the electrodes can be driven by independent electrical sources. It should also be noted that the electrical sources (e.g., generators not shown in FIG. 6) can be ideally current sources, but voltage sources can also be used. It should also be noted that combinations of any of the configurations of FIG. 6 are possible and may afford further flexibility. It should further be noted that an advantage of the configurations of FIG. 6, elements A, E, and F, is that there is not a sensitivity to antidromic vs orthodromic stimulation.

[0076] FIG. 7 shows an example system 500 that includes a preferred configuration for the electrodes 50 and light emitter 42 on the device 52, which includes the transvers tripole electrode configuration (shown in FIG. 6, element A) with the light emitter immediately beneath the cathode, where both the cathode and light emitter region are over the target nerve. The system 500 is shown with respect to stimulation of the median nerve of the wrist and recordings from the index finger, but it should be understood this is for illustration only and the system can be utilized with other target nerves such as, but not limited to those in the legs, ankles, feet, toes, head, face, or the like. It should be noted that components such as the light emitter 42 and the electrodes 50 would be facing the skin but are shown facing out of the page for illustrative purposes only. An example use of the system 500 follows.

[0077] The controller 16 can provide at least one electrical signal parameter and / or parameter configuration to the generator 26 and the generator 26 can generate the electrical signal with the at least one electrical signal parameter and / or parameter configuration. The at least one electrical signal parameter and / or parameter configuration can be predetermined and / or selected (e.g. via the user interface 30) for locating the target nerve (the median nerve as shown in this figure). The electrical signalcan be communicated from the generator to the electrodes 50 and applied by the electrodes through the skin to the target nerve. The recording device 12 can sense the stimulation of the target nerve based on a change in voltage and / or a SNAP. It should be noted that in this example, it is assumed the device 52 is at least near enough the target nerve for the electrical signal to be at least partially applied to the target nerve but this may not always be the case, in which case the electrical signal would be applied to a non-target and the recording would indicate this). The recording device 12 can communicate the sensed stimulation to the controller 16. In a closed loop system, the controller can determine the location of the target nerve based on the sensed stimulation and may indicate that the location of the device 52 is correct and / or needs to be moved (and may, in some instance, indicate a movement direction). Any indications can be displayed (visually, audibly, and / or haptically) via the display 28. The sensed stimulation can also be displayed via the display 28. In an open loop configuration, a user (e.g., a medical profession, trained personnel, or the like) can move the device 52 if the sensed stimulation does not match with a sensed stimulation known for the target nerve. It should be understood that in another instance, such as a take-home version of the system 500, the patient can move the device 52 on their own based on personally sensed stimulation with or without the use of the recording device 12.

[0078] After locating the target nerve, the system 500 can optionally be used to estimate the depth of the one or more target nerves under the skin. The controller 16 can make one or more changes to the at least one electrical signal parameter and / or parameter configuration (predetermined and / or selected by a user, but within safety boundaries). The altered electrical signal can be generated by generator 26 and applied by the electrodes 50 and the stimulation can be sensed by the recording device 12 similarly to the locating described above. In a closed loop situation, the controller 16 can adjust the one or more parameters of the electrical signal (e.g., amplitude, frequency, waveform, timing, durations, etc.) until the stimulation sensed by the recording device 12 indicates the estimated depth of the target nerve (based on a known value, range and / or threshold). In an open loop situation, the user can manually input one or more different parameters of the electrical signal until the sensed stimulation indicates the estimated depth of the target nerve based on a user knowing the value, range, and / orthreshold indicative of the depth. In one instance, the estimated depth can be indicated by the display 28. In some instances, the controller 16 can then utilize the determined location and / or the estimated depth of the target nerve to configure one or more dose parameters for a dose of light therapy (e.g., PBM) and / or heat therapy to be applied via the optical emitter 42 to modify conduction in the at least one sensory fiber of the target nerve. The one or more dose parameters can include at least one or more of a power, a wavelength, a frequency, and a duration. In some instances, the device 52 can be adhered, suctioned, and / or otherwise held against the skin above the location of the target nerve for at least the length of the therapy once the location of the target nerve has been properly determined.IV. Methods

[0079] Another aspect of the present disclosure can include methods 600 and 700 (FIGS. 8 and 9) for electrical mapping of one or more target nerves, and then optionally determining a dose of a therapeutic signal (e.g., light and / or heat therapy). For example, the light therapy can be photobiomodulation (PBM) delivered to the one or more target nerves through the skin.

[0080] For purposes of simplicity, the methods 600 and 700 are shown and described as being executed serially; however, it is to be understood and appreciated that the present disclosure is not limited by the illustrated order as some steps could occur in different orders and / or concurrently with other steps shown and described herein. Moreover, not all illustrated aspects may be required to implement the method, nor is the method necessarily limited to the illustrated aspects.

[0081] Referring now to FIG. 8, illustrated is a method 600 for locating one or more target nerves under the skin using electrical mapping with the systems described above (e.g., systems 100, 200, 500, etc.). At 60, an electrical stimulation device (including at least two electrodes in configurations as described with respect to FIGS. 3, 6, and 7 for example) can be positioned relative to the target nerve. The electrical stimulation device can be positioned on the skin with the at least two electrodes in contact with the skin. At 62, the position of the electrical stimulation device relative to the target nerve can be tested. Testing the position of the electrical stimulation device can include applying electrical signal (which can in some instances be subthreshold and in other instancessuprathreshold) through the skin via the at least two electrodes of the electrical stimulation device. The electrical signal can have one or more parameters that may be stored in a controller’s memory and / or input by a user to the controller. The one or more parameters can be sent to a generator from the controller and the generator can generate the electrical signal and send the electrical signal to the at least two electrodes for application. Optionally, a recording device can sense the stimulation of the target nerve and / or lack of stimulation and / or record the feeling and / or lack of feeling of sensation. The sensed stimulation (e.g., in voltages) can be sent to a controller and / or displayed for a user to determine (compared to known values, ranges, and / or thresholds) if the stimulation represents the electrical stimulation device being at the desired position over the target nerve. In one instance, the stimulation of the target nerve can be self-reported as a paresthesia feeling, and location may be determined based on the location and / or strength of the paresthesia. In this instance, a recording device may not be required, but can be used for record keeping. At 64, the electrical stimulation device can be repositioned until at a desired position relative to the target nerve (e.g., the at least one electrode lined up in a configuration like those described in FIGS. 3, 6, and 7) and / or the one or more stimulation parameters (e.g., signal parameters) for the electrical signal can be altered (in an open loop by a user or in a closed loop via the controller and saved values, ranges, and or thresholds for the sensed stimulation). The one or more parameters can include frequency, amplitude, waveform shape, timing, duration, or the like.

[0082] In some instances, the orientation of the electrical stimulation device can be determined relative to the target nerve while determining the location of the target nerve with respect to the device (e.g., based on the electrode grouping configurations and / or the electrode shapes and / or orientations). Orientation of the electrical stimulation device, and also orientation of the therapeutic delivery device (described with respect to optical therapy) is important and needed for safe and effective transcutaneous therapy applications (particularly, PBM, heat, or the like). For instance, if the orientation of the electrodes of the electrical stimulation device are not optimized then the cathode position may excite the nerve when it is not located directly over the nerve (i.e., inadequate sensitivity). In contrast, an ideal configuration can have a particularly strongsensiti vity . This helps localize the position of the nerve from the wrist surface (or other body part surface where superficial nerves may be found, e.g., a hand, a digit, a foot, an ankle, a leg, a neck, a face, a head, etc.). And the increased sensitivity can facilitate the estimation of nerve depth based on stimulation threshold (either the threshold of first feel, or the threshold to achieve the desired paresthesia coverage). Also, the position of the anode could inhibit nerve excitation that would result in paresthesia or in SNAPs. Further, when recording electrical potentials from nerve (SNAPs), there will be stimulation artifacts (the intensity of which depends on electrode orientation and configuration and if the artifact is too great, it will obscure the SNAPs recorded by the recording device. If the therapy delivery is not optimized, particularly light delivery optics then (1 ) the light may be delivered to too small an area and the neural target may be missed, (2) the light delivered may have inadequate power density to achieve the desired effect, and / or (3) the light may be delivered to an inadequate length of the nerve. Heat delivery faces similar problems.

[0083] In another instance, not shown, closed loop control can be used during therapy application to ensure stability of at least the emitting element of the therapy device relative to the location of the one or more target nerves. A physiological signal (such as a SNAP or EMG or the like) can be recorded (e.g., by recording device 12) while therapy is applied and the controller (e.g., controller 16) can analyze the recordings (e.g., compared to one or more thresholds or the like) and then stop, start, and / or modulate one or more parameters of the therapy based on the recording. The physiological signal can be in response to the therapy (e.g., light therapy, heat therapy, electrical stimulation / block therapy, or the like) and / or to a separate stimulation (e.g., electrical stimulation pulses applied by the electrical stimulation device) in a periodic (e.g., every 30 seconds, every minute, etc.) suprathreshold configuration. For example, therapy can be stopped if the position of the at least the therapy emitting element becomes unstable and / or is not properly applying the dose of the therapy to the one or more target nerves.

[0084] Referring now to FIG. 9, method 700 describes a method for determining one or more dose parameters for applying therapy (e.g., light (PBM) or heat, or potentially electrical and / or magnetic) to the one or more target nerves based on theelectrical mapping. In some instances, method 700 can build on top of method 600 where the location of the target nerve has been determined, and optionally the orientation of the electrical stimulation device relative to the nerve has been determined. At 70, a depth of the target nerve can be estimated. The depth of the target nerve can be estimated based on altering one or more parameters of the electrical signal until a sensed stimulation matches and / or is within a predetermined value, threshold, and / or range indicative of a distance. At 72, one or more therapeutic parameters can be determined (e.g., by a controller) based on the depth of the target nerve (and / or the location). The one or more therapeutic parameters can depend on the therapy to be applied (e.g., the type of therapy device) and the condition being treated, prevented, and / or alleviated. At 74, the therapy having the one or more determined therapeutic parameters can be provided to the target nerve through the skin. The therapy can be, for instance, light therapy, heat / cold therapy, electrical stimulation therapy, magnetic therapy, pharmaceutical therapy, and / or the like. For example, the therapy can be PBM therapy provided by one or more optical emitters. PBM can be noninvasively and transcutaneously applied to one or more target nerves, each including at least one sensory fiber, under a patient’s skin via a handheld applicator, one or more wearable patches, a wearable device, or the like, or any combination thereof. PBM can be applied to treat and / or block nociceptive pain from a variety of sources, prevent or lessen the chronification of pain, treat pain associated with arthritis, block neurogenic inflammation, or the like. The sensory fibers can be nociceptors and can conduct, for instance, signals related to pain, inflammation, arthritis, symptoms of arthritis, and / or heat hypersensitivity. Transcutaneous application of PBM can be preferable as it is a non- invasive treatment method and can in some instances be used outside a clinical environment, but requires additional considerations including, but not limited to, the need for appropriate shielding, proper placement of applicator devices, determining and taking into account skin thickness, skin tone, skin temperature, distance to the one or more target nerves, or the like.

[0085] Transcutaneous PBM can be applied to a plurality of areas of the body to at least partially block one or more target nerves, including at least one sensory fiber that can conduct a signal related to pain, inflammation, arthritis, symptoms of arthritis, and / orheat hypersensitivity. It is known that PBM therapy can effectively block the smalldiameter fibers (Ab and C) responsible for transmitting pain signals, while sparing the larger touch-associated fibers (A ). Although it is noted this has been most successful with invasive methods for reaching the nerves. Not wishing to be bound by theory but the following are example locations and conditions that can be at least partially treated with transcutaneous PBM (optionally with electrical stimulation). For example, the atlanto occipital region can be a location to target the brainstem, spinal nuclei, and / or spinal cord regions. Potential pathologies that may be treated with PBM to one or more target nerves in the atlanto occipital region can include hypertension (including drug resistant hypertension, stroke symptoms, neurodegeneration of the brainstem, or the like. In other instances, activity of the rostral ventrolateral medulla (RVLM) can be reduced and cardiac disease associated with elevated RVLM can be treated (such as heart failure, hypertension, or the like). Alternatively, activity of the RVLM can be increased to treat patients with hemorrhagic or septic shock by elevating blood pressure.

[0086] In another example, sensory facial innervation can be used to reach branches of the trigeminal nerve that are largely superficial an PBM therapy (optionally with electrical stimulation) can be delivered transcutaneously to locations to block the foramen through which nerves come to the face before branching (such as the supraorbital, infraorbital, mental foramen, and supratrochlear ridge / groove). Silencing small fibers of facial nerves can treat headache types such as migraines, cluster headaches, etc., facial neuralgias due to injury and / or infection (e.g., herpetic neuralgia / shingles), or inflammation. In a further example, sites on the back of the head can be innervated with transcutaneous PBM by the greater occipital, lesser occipital, and auriculotemporal nerves to treat headache and neuralgia of the posterior and superior head. As an example, in the lower extremities, foot and ankle pain can be treated by silencing small fibers of nerves such as the sural nerve, superficial peroneal nerve, saphenous nerve or the like. As an example, in the upper extremities, finger and hand pain (such as arthritis pain) can be treated by silencing small fibers of nerves such as the median and palmar ulnar nerves.

[0087] From the above description, those skilled in the art will perceive improvements, changes, and modifications. Such improvements, changes and modifications are within the skill of one in the art and are intended to be covered by the appended claims.

Claims

The following is claimed:1 . A system comprising: an electrical stimulation device configured to be positioned on a skin of a subject near a target nerve and configured to stimulate the target nerve; and a therapy emitting element positioned relative to the electrical stimulation device and configured to deliver light therapy and / or change a temperature for therapy to the target nerve, wherein the target nerve comprises at least one sensory fiber.

2. The system of claim 1 , wherein the electrical stimulation device comprises at least one cathode electrode and at least one anode electrode.

3. The system of claim 2, wherein the at least one anode electrode is one anode electrode and the at least one cathode electrode is one cathode electrode that are both positioned substantially along a longitudinal axis of the target nerve, wherein the therapy emitting element is positioned between the one anode electrode and the one cathode electrode.

4. The system of claim 2, wherein the at least one cathode electrode is one cathode electrode that is positioned over the target nerve and the at least one anode electrode is one anode electrode that is positioned beside the one cathode electrode, where the electrode axis is perpendicular to the longitudinal axis of the target nerve, wherein the therapy emitting element is positioned above the target nerve adjacent the one cathode electrode and perpendicular to the axis of the one anode electrode and the one cathode electrode.

5. The system of claim 2, wherein the at least one cathode electrode is one cathode electrode that is positioned over the target nerve, the therapy emitting element is positioned adjacent the one cathode electrode along the longitudinal axis of the target nerve, and the at least one anode electrode is one anode electrode that is positionedbeside the therapy emitting element perpendicular to the longitudinal axis of the target nerve.

6. The system of claim 2, wherein the at least one anode electrode comprises a first anode electrode and a second anode electrode.

7. The system of claim 6, wherein the first anode electrode and the second anode electrode are positioned on opposite sides of the at least one cathode electrode, which is one cathode electrode, and perpendicular to the longitudinal direction of the target nerve, and the therapy emitting element is positioned in line with the one cathode electrode and perpendicular to the axis of the one cathode electrode and the first and second anode electrodes.

8. The system of claim 6, wherein the at least one cathode electrode is one cathode electrode that is positioned along the longitudinal axis of the target nerve, the therapy emitting element is positioned in line with the one cathode electrode, and the first anode electrode and the second anode electrode are positioned on opposite sides of the therapy emitting element and perpendicular to the longitudinal axis of the target nerve.

9. The system of claim 6, wherein the at least one cathode electrode is one cathode electrode, and the one cathode electrode and the therapy emitting element are positioned to at least partially overlap over the target nerve, the first anode electrode and the second anode electrode are positioned on opposite sides of the therapy emitting element and perpendicular to the longitudinal axis of the target nerve,10. The system of claim 2, wherein the at least one cathode electrode comprises a first cathode electrode and a second cathode electrode, each of the first cathode electrode and the second cathode electrode positioned over the target nerve with the therapy emitting element positioned between first cathode electrode and the second cathode electrode.1 1 . The system of claim 10, wherein the at least one anode electrode is a first anode electrode and second anode electrode positioned on opposite sides of the therapy emitting element perpendicular to the longitudinal axis of the target nerve.

12. The system of claim 1 , further comprising: a recording device configured to sense stimulation of the target nerve; and a controller comprising: a non-transitory memory storing instructions, and a processor configured to execute the instructions to: identify a location of the target nerve based on the stimulation reported by the patient and / or sensed by the recording device, estimate a depth of the target nerve under the skin based on the stimulation reported by the patient and / or sensed by the recording device, and configure dose parameters for a dose of therapy to be applied to modify conduction in the at least one sensory fiber of the target nerve based on the location and the depth of the target nerve, wherein the dose parameters comprise at least one or more of a power, a wavelength, a frequency, and a duration.

13. The system of claim 12, wherein the recording device is configured to detect and record sensory nerve action potentials (SNAPs).

14. The system of claim 12, wherein the recording device is configured to be positioned remote from the electrical stimulation device and the therapy emitting element along a trajectory of the target nerve.

15. The system of claim 1 , wherein the system is movable along the skin of the subject to bring the system in better communication with the target nerve.

16. The system of claim 1 , wherein the electrical stimulation device comprises three electrodes arranged in a transverse tripole configuration where an axis of each electrode is perpendicular to the longitudinal axis of the target nerve.

17. The system of claim 16, wherein at least one of the three electrodes is circular shaped and has a diameter of at least 1 mm and at most 8 mm.

18. The system of claim 16, wherein at least one of the three electrodes is ovalshaped or rectangular-shaped and has a long axis and a short axis.

19. The system of claim 18, wherein the long axis is aligned with the longitudinal axis of the target nerve and the short axis is reduced to increase spatial sensitivity of detection.

20. The system of claim 18, wherein the long axis is from 1 mm to 15 mm and the short axis is from 1 mm to 8 mm.21 . The system of claim 18, wherein the long axis is perpendicular to the longitudinal axis of the target nerve to cover a greater region.

22. The system of claim 16, wherein the three electrodes are arranged at a distance from one another, wherein a sensitivity of localization of the target nerve is based on the distance between the three electrodes.

23. The system of claim 22, wherein the localization comprises a determination and / or estimation of depth of the target nerve.

24. The system of claim 16, wherein the transverse tripole configuration allows the three electrodes to be positioned at a much closer distance to each other than a first and a second electrode in a bipole configuration.

25. The system of claim 1 , wherein the target nerve is within at least one of an arm, a wrist, a hand, or a finger.

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