System and method for nerve regeneration therapy

Abstract

A nerve stimulation system comprising includes a housing, circuitry that generates an electrical stimulation signal, a microcontroller, one or more leads connected to the circuitry in the housing, and a return electrode electrically coupled to the circuitry, where the return electrode provides an electrical flow path for the stimulation signal from the one or more leads back to the housing. The system also includes a first control device and a second control device that cause the circuitry to generate the stimulation signal over a first channel or the second channel through the one or more leads. The system also includes one or more indicators fixed with the housing and electrically coupled to the microcontroller, where the one or more indicators generate visual indications, audio indications, or haptic indications that vary according to different status conditions of the circuitry on a per channel basis.

Description

TITLESYSTEM AND METHOD FOR NERVE REGENERATION THERAPYCROSS REFERENCE TO RELATED APPLICATIONS

[0001] The application claims priority to U.S. Patent Application No. 63 / 633,083. filed on April 12, 2024, entitled “SYSTEM AND METHOD FOR NERVE REGENERATION THERAPY," which is incorporated herein by reference in its entirety.FIELD OF TECHNOLOGY

[0002] The present disclosure relates generally to electrical nerve stimulation, and more particularly, to devices, systems, and methods for accelerating or enhancing regrowth or recovery of injured or potentially injured nerves using electrostimulation before, during, after, in lieu of, or independent of surgical procedures.BACKGROUND

[0003] Nerve injuries may generally refer to damage or trauma to the nerves, which can occur due to various causes such as accidents, surgeries, infections, medical conditions, and the like. Nerve injuries can present clinicians with significant challenges in determining the proper course of treatment to restore impaired motor and / or sensory function. Ultimately, the severity of the nerve injury' and time post injury' can influence the treatment plan and potential for success.

[0004] Mild cases of nerve injury may be treated with or resolved by conservative management, entailing one or more of immobilization, rest, and the use of pain medications or anti-inflammatory drugs to manage pain and reduce inflammation. Other external or non- invasive treatments may also be utilized including physical therapy, for example.

[0005] In many cases, however, surgical intervention may be needed to increase the likelihood that control of muscle function or sensation can be regained. Surgical treatment of nerve injuries typically cannot provide immediate restoration of function, as nerve fibers must grow from the point of intervention or repair to the target muscle. Nerve fibers grow at a rate of 1-3 mm / day, and thus recover}' can take a significant amount of time.

[0006] Electrical stimulation is a therapeutic technique that can be used to promote nen e regeneration and recover}'. Generally, electrical stimulation can involve the application of electrical currents to the affected nerves or surrounding tissues to elicit specific physiological responses and encourage nerve growth and repair. While non-invasive forms of electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS), may be utilized for certain nerve conditions to promote pain relief and nerve healing, direct stimulation may allow for more precise, targeted, and localized electrical stimulation.

[0007] Despite advancements in surgical technique and medical device technology, the rate of growth and organization of fiber growth direction remains a significant factor limiting functional outcomes of nerve injuries and nerve repair.

[0008] There is a need to provide improved electrical nerve stimulation, and more particularly, to provide improved devices, systems, and methods for accelerating or enhancing regrowth or recovery of injured or potentially injured nerves using electrostimulation before, during, after, in lieu of, or independent of surgical procedures.SUMMARY

[0009] The following presents a summary of this disclosure to provide a basic understandingof some aspects. This summary is intended to neither identify key or critical elements nor define any limitations of embodiments or claims. Furthermore, this summary may provide a simplified overview of some aspects that may be described in greater detail in other portions of this disclosure. Any of the described aspects may be isolated or combined with other described aspects without limitation to the same effect as if they had been described separately and in every' possible combination explicitly.

[0010] Disclosed are devices, systems, and methods for delivery' of electrical stimulation. Electrical stimulation may be applied directly to a site of nerve injury or damage to promote nerve growth and repair and improve functional outcome. The disclosed devices, systems, and methods may accelerate or enhance regrowth or recovery' of injured or potentially injured nerves using electrostimulation before, during, after, in lieu of, or independent of surgical procedures.

[0011] Disclosed are devices, systems, and methods for an electrical stimulation system. The system may include a two-channel, single patient stimulator 100. In an embodiment, the system may be intended for intraoperative use (—10 minutes) by a physician during peripheral nerve repair surgeries. In an embodiment, the system may be disposable or single use. In an embodiment, the system may deliver electrical stimulation through up to two disposable, sterile, intraoperative leads, which are connected to disposable, sterile, external pulse generating stimulator. The stimulator may have a single set of fixed stimulation parameters. Leads may be sized to fit a variety of nerves in the upper and lower extremities, from digital up to femoral nerves. Stimulation status may be monitored to ensure that current is delivered throughout the specified treatment duration, and the stimulation delivery will turn off at the completion of the treatment duration.

[0012] In an embodiment, an electrical stimulation system may include a stimulation device or stimulator configured to selectively apply electrical stimulation including a housing; controlcircuitry' operatively generating a stimulation signal, wherein the control circuitry is disposed within the housing; and a container housing the stimulation device, the container including at least one port.

[0013] In an embodiment, a method for stimulating tissue may include providing a stimulation device or stimulator; placing a lead within range of a target tissue region, wherein the lead is operatively attached to the stimulation device; applying a stimulation signal to the target tissue region with the lead and the stimulation device; terminating the applying stimulation signal; and performing a subcutaneous surgery after terminating the applying stimulation signal.

[0014] In an embodiment, a method for stimulating tissue may include providing a stimulation device or stimulator, placing the stimulation device w ithin a container or housing including at least one port, placing a lead within range of a target tissue region, wherein the lead is operatively7attached to the stimulation device through the at least one port, and applying a stimulation signal to the target tissue region with the lead and the stimulation device for treatment of the target tissue region.

[0015] In an embodiment, a nerve stimulation system includes a housing, and circuitry positioned entirely within the housing, where the circuitry generates an electrical stimulation signal having an amplitude and a duration. The system also includes a microcontroller electrically coupled to the circuitry7, where the microcontroller causes the circuitry to generate the stimulation signal. The system also includes one or more leads connected to the circuitry in the housing. The one or more leads each have an electrically conductive surface coupled to the circuitry, where the electrically conductive surface contacts a targeted tissue region and, when in contact, applies the stimulation signal from the circuitry to the targeted tissue region. The system also includes a return electrode electrically coupled to the circuitry, where the return electrode provides an electrical flow path for the stimulation signal from the one or more leads back to the housing. The system also includes a first control device positioned within thehousing and electrically coupled to the microcontroller, where the first control device transmits a signal to the microcontroller that causes the circuitry to generate the stimulation signal over a first channel, through the one or more leads. The system also includes a second control device positioned within the housing separate from the first control device, and electrically coupled to the microcontroller, where the second control device transmits a signal to the microcontroller that causes the circuitry to generate the stimulation signal over a second channel, through the one or more leads. The system also includes one or more indicators fixed with the housing and electrically coupled to the microcontroller, where the one or more indicators generate visual indications, audio indications, or haptic indications that vary’ according to different status conditions of the circuitry on a per channel basis.

[0016] In an embodiment, a nen e stimulation system includes a housing sized and configured to be held and controlled entirely within a surgical field and in a single hand by a user perioperatively. The system also includes circuitry positioned entirely within the housing, where the circuitry generates an electrical stimulation signal having an amplitude and a duration. The system also includes one or more leads connected to the circuitry and extended from the housing. Each of the one or more leads have an electrically conductive surface coupled to the circuitry. The electrically conductive surface is sized and configured for contact with a targeted tissue region and, when in contact, applying the stimulation signal to the targeted tissue region. The system also includes a return electrode electrically coupled to the signal generating circuitry. The return electrode is sized and configured for contact with tissue to provide an electrical flow path for the stimulation signal from each of the one or more leads back to the stimulation control device. The system also includes a first control device fixed within the housing, where the first control device causes the circuitry to generate the stimulation signal over a first channel for a predetermined total single use period. The system also includes a second control device fixed within the housing separate from the first control device, wherethe second control device causes the circuitry to generate the stimulation signal over a second channel for a predetermined total single use period. The system also includes one or more visual indicators fixed on the housing, wherein the one or more visual indicators indicate status conditions during the total single use period of the stimulation signal over the first channel or the second channel. The one or more visual indicators display a first predetermined color or flash rate of light when power to the circuitry is on due to operation of the first control device or the second control device. The one or more visual indicators also display a second predetermined color or flash rate of light different than the first predetermined color or flash rate of light when the circuitry receives the stimulation signal from the targeted tissue region through the return electrode due to operation of the first control device or the second control device. The one or more visual indicators a third predetermined color or flash rate of light different than the first predetermined color or flash rate of light and the second predetermined color or flash rate of light when the circuitry is transmitting the stimulation signal to the targeted tissue region, and the circuitry is not receiving the stimulation signal through the return electrode.

[0017] In an embodiment, a hand-held nerve stimulation system includes a housing sized and configured to be held and controlled by a user using a single hand, entirely within a surgical field. The system also includes circuitry housed within the housing, where the circuitry generates an electrical stimulation signal having a biphasic waveform and a net DC current of less than 10 microamps. The system also includes an operative element extended from a distal end of the housing, where the operative element contacts a targeted tissue region, and conveys the stimulation signal from the circuitry in the housing to the targeted tissue region. The system also includes a return electrode providing an electrical flow path for the stimulation signal from the operative element, through the targeted tissue region, and back to the circuitry. The system also includes a return lead electrically coupling the circuitry with the return electrode, returnlead extending from the distal end of the housing. The system also includes one or more indicators on the housing and electrically coupled to the circuitry, where the one or more indicators indicate confirm status conditions of the circuitry or the stimulation signal. The circuitry determines whether the electrical stimulation signal completes the electrical flow path by passing through the operative element, to the targeted tissue region, and back through the return electrode at a specified stimulation intensity. The circuitry also operates the one or more indicators to provide, in response to determining a stimulation intensity of the electrical stimulation signal is at the specified stimulation intensity, a first indication signal indicating delivery of the electrical stimulation signal completing the electrical flow path to the targeted tissue region and back through the return electrode. The circuitry also operates the one or more indicators to provide, in response to determining the stimulation intensity is not at the specified stimulation intensity, a second indication signal indicating an absence or an inadequate delivery of the stimulation signal through the operative element, to the targeted tissue region, and back to the circuitry through the return electrode.

[0018] A nerve stimulation system may comprise a housing, circuitry positioned entirely within the housing, wherein the circuitry generates an electrical stimulation signal having an amplitude and a duration and a microcontroller electrically coupled to the circuitry, wherein the microcontroller causes the circuitry to generate the stimulation signal. The nerve stimulation system may also comprise one or more leads connected to the circuitry in the housing, the one or more leads each having an electrically conductive surface coupled to the circuitry, wherein the electrically conductive surface contacts a targeted tissue region and, when in contact, applies the stimulation signal from the circuitry to the targeted tissue region, a return electrode electrically coupled to the circuitry, wherein the return electrode provides an electrical flow path for the stimulation signal from the one or more leads back to the housing, a first control device positioned within the housing and electrically coupled to themicrocontroller, wherein the first control device transmits a signal to the microcontroller that causes the circuitry' to generate the stimulation signal over a first channel, through the one or more leads, a second control device positioned within the housing separate from the first control device, and electrically coupled to the microcontroller, wherein the second control device transmits a signal to the microcontroller that causes the circuitry' to generate the stimulation signal over a second channel, through the one or more leads, and one or more indicators fixed with the housing and electrically coupled to the microcontroller, wherein the one or more indicators generate visual indications, audio indications, or haptic indications that vary according to different status conditions of the circuitry on a per channel basis.

[0019] The nerve stimulation system may' comprise any of the foregoing in any combination:• the microcontroller causes the one or more indicators to produce, a first indication comprising a predetermined light, sound, or vibration when, independent of contact between the one or more leads and the targeted tissue region, power to the circuitry is on due to operation of the first control device or the second control device, a second indication including a predetermined light, sound, or vibration different than the first indication when the circuitry receives the stimulation signal from the targeted tissue region through the return electrode due to operation of the first control device or the second control device, and a third indication comprising a predetermined light, sound, or vibration different than the first indication and the second indication when the circuitry is transmitting the stimulation signal to the targeted tissue region, and the circuitry is not receiving the stimulation signal through the return electrode.• the one or more indicators generate the first indication, the second indication, or the third indication in an off state.• the one or more indicators is a single visual indicator. a display fixed with the housing and operatively connected to the microcontroller, whereinthe housing is sized and shaped to be held and controlled entirely within a single hand by a user, and the display indicates an operation selection of the stimulation system including a timing, a waveform, a pulse duration, a frequency, an amplitude, an intensity, or a predefined limit of the stimulation signal.• a first section of the display indicates the first channel at a location closer to a first lateral side of the housing as compared to a second lateral side of the housing opposite the first lateral side, and a second section of the display indicates the second channel at a location closer to the second lateral side as compared to the first lateral side.• one or more ports at a distal end of the housing, wherein the one or more ports convey the stimulation signal through the housing to the one or more leads, or from the return electrode, and the display is located closer to the distal end of the housing as compared to a proximal end of the housing opposite the distal end.• the one or more indicators are interposed between and separate the one or more ports and the display along the housing, in a direction taken from the proximal end of the housing toward the distal end of the housing.• a first button and a second button supported on the housing, wherein the first button actuates the first control device, causing the first control device to generate the stimulation signal over the first channel, the second button actuates the second control device, causing the second control device to generate the stimulation signal over the second channel, the first button is located closer to the first lateral side of the housing as compared to the second lateral side of the housing, the second button is located closer to the second lateral side of the housing as compared to the first lateral side of the housing, and both the first button and the second button are located at a side of the display opposite the one or more indicators. one or more ports at a distal end of the housing, wherein the one or more ports convey the stimulation signal through the housing to the one or more leads, or from the returnelectrode, the housing includes a proximal end opposite the distal end, and both the first button and the second button are located closer to a proximal end of the housing as compared to the distal end of the housing.• the one or more indicators includes a first indicator that indicates a status condition of the circuitry' or the stimulation signal over the first channel, and the one or more indicators further include a second indicator that indicates a status condition of the circuitry or the stimulation signal over the second channel, wherein the first indicator is fixed to the housing at a location closer to a first lateral side of the housing as compared to a second lateral side of the housing opposite the first lateral side, and the second indicator is fixed to the housing at a location closer to the second lateral side as compared to the first lateral side.• a first port that conveys the stimulation signal through the first channel, and a second port that conveys the stimulation signal through the second channel, wherein the first port is located closer to the first lateral side of the housing as compared to the second lateral side of the housing, and the second port is located closer to the second lateral side of the housing as compared to the first lateral side of the housing.• the stimulation signal conveyed through the first channel has a different stimulation parameter than the stimulation signal conveyed through the second channel.

[0020] A nerve stimulation system may comprise a housing sized and configured to be held and controlled entirely within a surgical field and in a single hand by a user perioperatively, circuitry positioned entirely within the housing, where the circuitry generates an electrical stimulation signal having an amplitude and a duration, one or more leads connected to the circuitry, and extended from the housing, each of the one or more leads having an electrically conductive surface coupled to the circuitry, the electrically conductive surface being sized and configured for contact with a targeted tissue region and, when in contact, applying thestimulation signal to the targeted tissue region and a return electrode electrically coupled to the signal generating circuitry7, wherein the return electrode is sized and configured for contact with tissue to provide an electrical flow path for the stimulation signal from each of the one or more leads back to the stimulation control device. The nerve stimulation system may also comprise a first control device fixed within the housing, wherein the first control device causes the circuitry to generate the stimulation signal over a first channel for a predetermined total single use period, a second control device fixed within the housing separate from the first control device, where the second control device causes the circuitry to generate the stimulation signal over a second channel for a predetermined total single use period, and one or more visual indicators fixed on the housing, wherein the one or more visual indicators indicate status conditions during the total single use period of the stimulation signal over the first channel or the second channel, wherein the one or more visual indicators display: a first predetermined color or flash rate of light when power to the circuitry is on due to operation of the first control device or the second control device, a second predetermined color or flash rate of light different than the first predetermined color or flash rate of light when the circuitry receives the stimulation signal from the targeted tissue region through the return electrode due to operation of the first control device or the second control device, and a third predetermined color or flash rate of light different than the first predetermined color or flash rate of light and the second predetermined color or flash rate of light when the circuitry is transmitting the stimulation signal to the targeted tissue region, and the circuitry is not receiving the stimulation signal through the return electrode.

[0021] The nerve stimulation system may comprise any of the foregoing in any combination:• a first port that conveys the electrical stimulation signal from the housing through the first channel, and a second port that conveys the electrical stimulation signal from the housing through the second channel, wherein the first port is located closer to a first lateral side ofthe housing as compared to a second lateral side of the housing opposite the first lateral side, and the second port is located closer to the second lateral side of the housing as compared to the first lateral side of the housing, the one or more leads includes a first lead that receives the stimulation signal from the first port, and a second lead that receives the stimulation signal from the second port, the one or more visual indicators comprises a first visual indicator that indicates a status condition of the circuitry or the stimulation signal over the first channel, and the one or more visual indicators further include a second visual indicator that indicates a status condition of the circuitry or the stimulation signal over the second channel, and the first visual indicator is fixed to the housing at a location closer to the first lateral side of the housing as compared to the second lateral side of the housing, and the second visual indicator is fixed to the housing at a location closer to the second lateral side as compared to the first lateral side.• a first button and a second button supported on the housing, wherein the first button actuates the first control device, causing the first control device to generate the stimulation signal over the first channel, the second button actuates the second control device, causing the second control device to generate the stimulation signal over the second channel, the first button is located closer to the first lateral side of the housing as compared to the second lateral side of the housing, the second button is located closer to the second lateral side of the housing as compared to the first lateral side of the housing, and the first visual indicator is interposed between the first port and the first button along the housing, and the second visual indicator is interposed between the second port and the second button along the housing.• the first button actuates the first control device, causing the first control device to cycle through stimulation modes executed by the first control device over the first channel, or the second button actuates the second control device, causing the second control device to cyclethrough stimulation modes executed by the second control device over the second channel.• the one or more visual indicators includes a first visual indicator that indicates a status condition of the circuitry or the stimulation signal over the first channel, the one or more visual indicators further include a second visual indicator that indicates a status condition of the circuitry or the stimulation signal over the second channel, and the first visual indicator or the second visual indicator includes a set of two differently colored lights.• a power source positioned entirely within the housing.

[0022] A hand-held nerve stimulation sy stem may comprise a housing sized and configured to be held and controlled by a user using a single hand, entirely within a surgical field, circuitry housed within the housing, wherein the circuitry generates an electrical stimulation signal having a biphasic waveform and a net DC current of less than 10 microamps, an operative element extended from a distal end of the housing, wherein the operative element contacts a targeted tissue region, and conveys the stimulation signal from the circuitry in the housing to the targeted tissue region and a return electrode providing an electrical flow path for the stimulation signal from the operative element, through the targeted tissue region, and back to the circuitry. The hand-held nerve stimulation system may also comprise a return lead electrically coupling the circuitry with the return electrode, return lead extending from the distal end of the housing, and one or more indicators on the housing and electrically coupled to the circuitry, wherein the one or more indicators indicate confirm status conditions of the circuitry or the stimulation signal, wherein the circuitry : determines whether the electrical stimulation signal completes the electrical flow path by passing through the operative element, to the targeted tissue region, and back through the return electrode at a specified stimulation intensity, operates the one or more indicators to provide, in response to determining a stimulation intensity of the electrical stimulation signal is at the specified stimulation intensity, a first indication signal indicating delivery of the electrical stimulation signal completing theelectrical flow path to the targeted tissue region and back through the return electrode, and operates the one or more indicators to provide, in response to determining the stimulation intensity7is not at the specified stimulation intensity7, a second indication signal indicating an absence or an inadequate delivery7of the stimulation signal through the operative element, to the targeted tissue region, and back to the circuitry7through the return electrode.

[0023] The following description and the drawings disclose various illustrative aspects. Some improvements and novel aspects may be expressly identified, while others may be apparent from the description and drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present teachings may be better understood by reference to the following detailed description taken in connection with the following illustrations, in which like reference characters refer to like parts throughout, wherein:

[0025] FIG. 1 shows a perspective view of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0026] FIG. 2 shows a top view of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0027] FIG. 3A-B show side views of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0028] FIGs. 4A-B show s a perspective view of an embodiment of a stimulator and various attachment or standing components that may be used in an electrical stimulation system in accordance w ith aspects disclosed herein;

[0029] FIG. 5 shows various view s of embodiments of indicators of a stimulator and system that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0030] FIG. 6 shows various views of embodiments of connectors of a stimulator and system that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0031] FIGs. 7A-E shows percutaneous leads that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0032] FIGs. 8A-C shows various views of embodiments of splitter devices with an electrical stimulation system in accordance with aspects disclosed herein;

[0033] FIG. 9 shows an embodiment of connectors of a stimulator and system that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0034] FIG. 10 shows an embodiment of a stimulation waveform that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0035] FIG. 11 shows a block diagram of an embodiment of components of an electrical stimulation system in accordance with aspects disclosed herein;

[0036] FIG. 12 shows various embodiments of raw and rectified signals that may be fed back into an electrical stimulation system in accordance with aspects disclosed herein;

[0037] FIGs. 13A-B show an embodiment of an intraoperative lead that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0038] FIG. 14 shows an embodiment of an intraoperative lead that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0039] FIG. 15 shows an embodiment of an intraoperative lead that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0040] FIG. 16 shows an embodiment of an intraoperative lead that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0041] FIG. 17 shows an embodiment of an intraoperative lead that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0042] FIG. 18 shows an embodiment of an intraoperative lead that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0043] FIG. 19 shows an embodiment of an intraoperative lead that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0044] FIG. 20 shows an embodiment of an intraoperative lead that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0045] FIG. 21 shows an embodiment of an intraoperative lead that may be used in an electrical stimulation system in accordance wi th aspects disclosed herein;

[0046] FIG. 22 shows a perspective view of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with another aspect disclosed herein;

[0047] FIG. 23 shows a top view of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with another aspect disclosed herein;

[0048] FIG. 24 shows a right side view of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with another aspect disclosed herein;

[0049] FIG. 25 shows a left side view of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with another aspect disclosed herein;

[0050] FIG. 26 shows a back view of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with another aspect disclosed herein;

[0051] FIG. 27 shows a front perspective view of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with another aspect disclosed herein; and

[0052] FIG. 28 shows a back perspective view of an embodiment of a stimulator that may be used in an electrical stimulation system in accordance with another aspect disclosed herein.

[0053] The present disclosure may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the present disclosure is defined in the appendedclaims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.DETAILED DESCRIPTION

[0054] Reference will now be made in detail to exemplary embodiments of the present teachings, examples of which are illustrated in the accompanying drawings, wherein like numbered aspects refer to a common feature throughout. It is to be understood that other embodiments may be utilized, and structural and functional changes may be made without departing from the respective scope of the present teachings. Moreover, features of the various embodiments may be combined or altered without departing from the scope of the present teachings. As such, the following description is presented by way of illustration only and should not limit in any way the various alternatives and modifications that may be made to the illustrated embodiments and still be within the spirit and scope of the present teachings.

[0055] In this disclosure, numerous specific details provide a thorough understanding of the subject disclosure. It should be understood that aspects of this disclosure may be practiced with other embodiments not necessarily including all aspects described herein, etc.

[0056] As used herein, the words '‘example’’ and "exemplary” means an instance, or illustration. The words “example” or “exemplary” do not indicate a key or preferred aspect or embodiment. The word “or” is intended to be inclusive rather than exclusive unless context suggests otherwise. As an example, the phrase “A employs B or C.” includes any inclusive permutation (e.g., A employs B; A employs C: or A employs both B and C). As another matter, the articles “a” and “an” are generally intended to mean “one or more” unless context suggests otherwise.

[0057] Further, unless context suggests otherwise, descriptions of shapes (e.g., circular, rectangular, triangular, etc.) refer to shapes meeting the definition of such shapes and generalrepresentation of such shapes. For instance, a triangular shape or generally triangular shape may include a shape that has three sides and three vertices or a shape that generally represents a triangle, such as a shape having three major sides that may or may not have straight edges, triangular like shapes with rounded vertices, etc.

[0058] It is noted that the various embodiments described herein may include other components and / or functionality7. It is further noted that while various embodiments refer to a stimulator or stimulation device, various other systems may be utilized in view of embodiments described herein. For example, embodiments may be utilized in a variety7of surgical procedures, other medical procedures or as a stand-alone procedure. As such, embodiments may refer to a particular surgical procedure for purposes of explanation. It is noted that aspects of embodiments, however, may' be utilized for various other procedures or as a stand-alone procedure.

[0059] This disclosure generally relates to devices, systems, and methods that may improve nerve healing, including nerve regeneration, Wallerian degeneration, axonal regeneration, or neuro-regeneration of tissue via electrical stimulation to increase the speed or amount of nen e growth. The terms ‘'nerve” or “nerve tissue” generally refer to any portion of a nerve including, but not limited to, axons, axon terminals, somas, dendrites, or the like, unless context suggests otherwise. Moreover, aspects disclosed herein may be applicable to nerve tissue throughout a body, whether peripheral nervous tissue or otherwise. Electrical stimulation of a nerve may include application of electrical stimulation at. near, or adjacent the target nerve. Additionally, the disclosed devices, systems, and methods may also promote angiogenesis, supporting vascular growth in a treated area. Further, while embodiments may reference a surgeon performing a particular action(s), it is noted that other clinicians or users, automated machines, or the like may perform such actions.

[0060] Disclosed are devices, systems, and methods for delivery of electrical stimulation.Electrical stimulation may be applied directly to a site of nerve injury or damage to promote nen e growth and repair and improve functional outcome. The disclosed devices, systems, and methods may accelerate or enhance regrowth or recovery of injured or potentially injured nerves using electrostimulation before, during, after, in lieu of, or independent of surgical procedures.Turning to FIGs. 1-6, shown is an electrical stimulation device or stimulator 100. The stimulator 100 may be used as a component of an electrical stimulation system or method to deliver and apply electrical stimulation to a targeted area or nerve site, such as for a nen e regeneration therapy such as that disclosed in U.S. Patent No. 11,766,567, which is incorporated herein by reference in its entirety. The stimulator 100 may be selectively coupled to a lead, an adaptor, or a combination thereof as described in greater detail below-, and in this manner operatively connected to an endoscopic instrument such as, for example and without limitation, a dilator, blade assembly or other cutting instrument, cannula, sheath, or camera.

[0061] The nerve regeneration therapy may comprise placing a lead at or near a target nerve that is proximal to a site of a nerve injury, where the lead is operatively attachable to the electrical stimulation device shown. The electrical stimulation device may apply an electrical stimulation pulse comprising a waveform directly to the target nerve through the lead and the electrical stimulation device. This electrical stimulation may directly activate excitable tissue of the target nerve for a therapy duration that comprises one minute or greater but less than 30 minutes in order to alter recovery of the target nerve. In some embodiments, the electrical stimulation is applied 10 minutes or greater but less than 30 minutes, e.g., 29 minutes or 29 minutes and 30 seconds. The electrical stimulation applied may have a frequency of between 10 Hz and 100 Hz, between 10 Hz and 40 Hz, or between 15 Hz to 20 Hz. The electrical stimulation applied may have an amplitude between 0.1 mA and 20 mA, an amplitude between1 mA and 10 mA or an amplitude between 1 mA and 3 mA. Further, in some embodiments,the stimulation method may comprise placing a lead at or near a target nerve that is proximal to a site of a nerve injury, where the lead is operatively attachable to an electrical stimulation device. The electrical stimulation device may apply electrical stimulation having a waveform directly to the target nerve through the lead and the electrical stimulation device directly activating excitable tissue of the target nerve for a therapy duration that comprises one minute or greater but less than or equal to 10 minutes in order to alter recovery of the target nen e. The electrical stimulation applied may have a frequency of between 10 Hz and 100 Hz, 10 Hz and 40 Hz, or 15 Hz to 20 Hz. The electrical stimulation applied may have an amplitude between 0.1 mA and 20 mA, 1 mA and 10 mA, or 1 mA and 3 mA. The electrical stimulation may comprise a biphasic waveform with controlled current during a cathodic phase. The electrical stimulation device may provide stimulation through a lead placed at or near a target nerve, where the lead is operatively attachable to the electrical stimulation device. The electrical stimulation device may apply electrical stimulation directly to the target nerve through the lead and the electrical stimulation device, and directly activate excitable tissue of the target nerve for a therapy duration that comprises about 10 minutes (i.e., within 90 seconds of 10 minutes) in order to alter recovery of the target nerve, where the electrical stimulation applied has a frequency of between 10 Hz and 40 Hz, an amplitude between 1 mA and 3 mA and a pulse duration of 75 microseconds to 125 microseconds. The electrical stimulation device may be disposable. The electrical stimulation may be a biphasic waveform with controlled current during a cathodic phase.

[0062] Turning to FIGs. 13-21, shown are various embodiments of a lead 200 that may be used in conjunction with an electrical stimulation device or stimulator 100. The lead 200 may be used as a component of an electrical stimulation system or method to deliver and apply electrical stimulation to a targeted area or nerve site, such as for a nerve regeneration therapy such as that disclosed in U.S. PatentNo. 11,766,567, which is incorporated herein by referencein its entirety. The lead 200 may be selectively coupled to a stimulator 100 as described herein.

[0063] Stimulator 100 may include a housing 110 that encloses electrical components used to provide electrical stimulation. Electrical components may include one or more (or all) of the following: a power source or connection to an external power supply; a controller or microcontroller to control operation of the stimulator and execute programmed functions, such as timing, intensity, etc. of the electrical stimulation; a signal generator to generate the electrical stimulation, e.g., in waveforms or pulses, with desired parameters such as specific amplitude, pulse duration, frequency, shape values of the waveforms, dose duration, and dose scheduling; current limiting circuitry to prevent the electrical stimulation from exceeding predefined limits; other stimulation and safety features, and the like. In a non-limiting example, the stimulator 100 may include one or more channels, such as two channels, which may provide two or more different electrical stimulation signals having different stimulation parameters.

[0064] In an embodiment, housing 110 may include two main halves, e.g., top and bottom housing portions, which may be operatively connected to one another to form housing 1 10, see FIG. 3A. For example, top and bottom housing portions may include mating surfaces that interlock. For example, top and bottom housing portions may include one or both protrusions and recesses that are configured to mate with corresponding recesses and protrusions on the other housing portion. For example, top and bottom housing portions may be connected with fasteners, such as screws (e.g., four screws). The fasteners may be hidden with inserts over the fasteners and the fasteners may be located on the bottom of the device. It is noted that housing 110 may further include adhesives, other fasteners, or other interlocks as may be suitable or desired for a particular purpose or intended application. In an embodiment, housing 110 and mating connections thereof may form a seal. In an embodiment, housing 110 may be hermetically sealed. It is noted that the housing 110, and top and bottom housing portions thereof, may include any suitable material as may be desired. In an embodiment, housing 110may include a thermoplastic polymer material, for example, acrylonitrile butadiene styrene (ABS). In an embodiment, housing 110, and top and bottom housing portions thereof, may be injection molded or formed by additive manufacturing. The top and bottom housing portions may be attached to form the housing 110 in such a way that if a user were to try' to open or separate the top and bottom housing portions at least one of the electrical components may become inoperative preventing the stimulator 100 from functioning. This may prevent the stimulator 100 from being reused.

[0065] In an embodiment, housing 110 may include any suitable shape as may be desired. For example, housing 110 may be generally ergonomic in the hand of a user or to rest on a flat surface. More specifically, the housing is sized and shaped to be held and controlled entirely within a single hand by a user.

[0066] Housing 110 may be generally sleek and simple, including, for example, minimal external or visible protrusions, ridges, or recesses, a generally flat surface or continuous surface, e g., top and bottom places, (excluding minimal buttons, if any), modest contours, rounded edges, and the like, see, for example, FIGs. 1-6. As shown in FIG. 4B, housing 110 may include one or more attachments or standing components 111. For example, housing 110 (or stimulator 100) may include a kickstand that positions the housing 110 so that it is easily grasped by the user and angled so that it may assist the user in checking any read outs on the stimulator 100. The kickstand may be integrated into the stimulator 100 or separate and selectively attachable to the stimulator 100. In addition or alternatively, the housing 110 (or stimulator 100) may include one or more clips for attachment to a surgical drape. The one or more clips may’ be integrated into the stimulator 100 or separate and selectively attachable to the stimulator 100. In an embodiment, the kickstand and / or clips may aid placement within the surgical environment. Further, housing 110 may include a strap for tethering to the patient. The strap may aid post-surgical use in the recovery unit environment.

[0067] Stimulator 100 may include multiple channels where the lead corresponding to each channel may include its own return electrode or where multiple leads share a single return electrode. In this case the stimulator interleaves pulses from multiple channels. In the case of a shared return electrode, the stimulator may be designed to limit the rate of stimulation between channels to allow full charge recovery on the shared return electrode. In the case where a return electrode is provided per channel, the stimulator may be designed with independent pairs of stimulation and return channels.

[0068] Stimulator 100 may include a user interface 113. User interface 113 may include one or more (or all) of the following: a power button, level or arrow button(s) to increase or decrease electrical stimulation, selection buttons to select pre-defined parameters of the waveforms or a specific program of electrical stimulation, and the like. Stimulator 100 may allow for a user to adjust stimulation parameters and monitor the real-time response on a display, for example, display 116 fixed with the housing 110 and operatively connected to the microcontroller. Stimulator 100 may have one button, two buttons, three buttons or more. In an embodiment, stimulator 100 may have no more than one button. Stimulator 100 may have no more than two buttons. In an embodiment, stimulator 100 may have no more than three buttons. It is noted that other quantities of buttons are also herein contemplated. Generally, stimulator 100 may have minimal buttons to provide one or more (or all) of simplicity in design, ease of use, improved seal, and the like. As described herein, in an embodiment, stimulator 100 may include a touch screen in addition to or instead of buttons.

[0069] In the depicted embodiment, the buttons 114 include a first button and a second button supported on the housing 110. The first button of the buttons 114 actuates the first control device, causing the first control device to generate the stimulation signal over the first channel conveyed by the one or more ports 122. The second button of the buttons 114 actuates the second control device, causing the second control device to generate the stimulation signal overthe second channel by the one or more ports 122. The first button of the buttons 114 is located closer to the left side of the housing 110 as compared to the right side of the housing 110, and the second button of the buttons 114 is located closer to the right side of the housing 110 as compared to the first lateral side of the housing 110.

[0070] As shown in FIGs. 1 -2, user interface 113 of the stimulator 100 may include two buttons 114. In an embodiment, the buttons 114 may be push buttons. In an embodiment, the buttons 114 may have a convex profile. In another embodiment, the buttons may have a concave profile. The profile may enable a user to feel, locate, and press the buttons 114 without having to look at the stimulator 100. The profile may allows for tactile functionality. In an embodiment, the buttons 114 may have a textured surface. The textured surface may enable a user to feel, locate, and press the buttons 114 without having to look at the stimulator 100. The textured surface may allow- for tactile functionality. In an embodiment, the buttons 114 may be a different material than the material of the housing 110 or surrounding surface. The different material may enable a user to feel, locate, and press the buttons 1 14 without having to look at the stimulator 100. The different material may allow for tactile functionality. It is noted that the buttons 114 may include any suitable material as may be desired. In an embodiment, the buttons 114 may include a rubber material. It is noted that the buttons 1 14 may have an embossed surface with numbers, symbols, or the like, that indicate their corresponding use (e.g., channel 1, 2, power symbol, arrow, etc.). In a non-limiting example, buttons 114 may correspond to one or more channels, such as two channels, which may provide two or more different electrical stimulation having different stimulation parameters.

[0071] Stimulator 100 may include a display 116. Display 116 may be configured to display information to a user. For example, display 116 may describe one or more (or all) of the following: power status, battery status or connectivity to an external power supply; operation selection of the stimulator and selection to execute programmed functions, such as timing,intensity, etc. of the electrical stimulation; stimulation selection or the stimulator to generate, select, and cease the electrical stimulation, e.g., in waveforms or pulses, with desired parameters such as specific amplitude, pulse duration, frequency, shape values of the waveforms, dose duration, and dose scheduling; indicators of predefined limits and notice of exceeding predefined limits; other stimulation and safety features, and the like. In a nonlimiting example, the display 116 may correspond to one or more channels, such as two channels, which may provide two or more different electrical stimulation signals having different stimulation parameters. As described, each button 114 may similarly correspond to one or more channels. In a non-limiting example, each button 114 may also correspond to a section of the display 11 .

[0072] In an embodiment, display 116 may include any suitable shape as may be desired. Display 116 may have a seamless transition to the body of the device (e.g., the surrounding housing 110) see, for example, FIGs. 1, 3 A, and 4. The display 116 may be covered by a cover (e.g., a transparent or translucent plastic or glass cover) and the cover may have a seamless transition to the body of the device (e.g., the surrounding housing 110), see, for example, FIGs. 1, 3 A, and 4. In an embodiment, display 116 may further include a touch capability so that display 116 or portion of display 1 16 thereof, is atouch screen. In an embodiment, buttons 114 (or touch screen) may be used to toggle and select menus and options on display 116.

[0073] In an embodiment, the screen 1 16 may indicate if the stimulator 100 is completing pulse or if there is an open circuit in the connection, error, time past or remaining of electrical stimulation, intensity of electrical stimulation, etc. The screen 116 may indicate dose progression, showing the status of the device corresponding to pre-stimulation state, stimulus dose progress, and completion of the stimulation dose. The stimulus dose progress may be presented graphically, for example as a bar graph or a dial gauge, or via characters showing for example elapsed time, remaining time, or percentage complete.

[0074] Stimulator 100 may include one or more indicators 119. Indicators 119 may include light or visual indicators, for example. It is noted that other indicators are also herein contemplated such as auditory (sound) or tactile (vibration) indicators. The indicators 119 may include one or more or different light indicators, for example, such as red and yellow lights. As shown in FIGs. 1-6, stimulator 100 may include two yellow indicators and two red indicators. As shown in FIGs. 1-6, the indicators 119 may be paired so that each set has one yellow and one red indicator. It is noted that other quantities of indicators and colors are also herein contemplated, such as green, blue, orange, etc., colors and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more indicators.

[0075] As such, in an embodiment, the indicators 119 include a first indicator that indicates a status condition of the circuitry or the stimulation signal over the first channel, and the indicators 119 further include a second indicator that indicates a status condition of the circuitry or the stimulation signal over the second channel. The first indicator is fixed to the housing 110 at a location closer to the left lateral side of the housing 1 10 as compared to the right side of the housing 110, and the second indicator is fixed to the housing 110 at a location closer to the right side as compared to the left side.

[0076] In an embodiment, the stimulator 100 may include a visual, audio, haptic, tactile, or other indicator 119 for the surgeon or user for the purpose of allowing the surgeon to confirm, for example, that the stimulator 100 is delivering the full intended stimulus current to the tissue it is contacting. Through the use of different tones, colors, different flash rates, vibrations, etc., the indicators 119 (which can take the form, e.g., of a light emitting diode (LED)) may allow the surgeon to confirm that the lead and return electrode are in place, the device is turned ON, and that stimulus current is flowing, and the like. The surgeon can have improved confidence that the stimulator 100 is delivering current to a damaged nerve where a muscle contraction may not be possible due to physiological damage. In an embodiment, a first color indicationgenerated by the indicator 119 is dark or unenergized, i.e. in an OFF state, as compared to a second color indication. In this manner, the indicator 119 may communicate information to a user without consuming energy'.

[0077] In a non-limiting example, the indicator 119 may be configured to illuminate continuously in one color when there is applied potential between the lead and return electrode but one of the two applied parts is not in contact with tissue. After contact with tissue is made, completing the circuit, an indicator may flash (i.e., blink) to indicate that stimulation is being delivered. If the stimulation has been requested, i.e., there is potential between applied parts, but there is no stimulation being delivered because of a lack of continuity betw een the operative element and the return electrode, or an inadequate connection of the operative element or the return electrode to the patient tissue, the same indicator or a different indicator may illuminate in a different color, and may illuminate continuously, or may flash. In such an embodiment, the flash rate may be zero, i.e., the indicator may generate an indication where the indicator 1 19 is continuously in an ON or an OFF state.

[0078] In the embodiments in which indicators 119 indicate completion of a pulse, the indicators 119 will confirm that the stimulator 100 outputted the requested stimulation parameters, that these simulation parameters were delivered to the applicable tissue and that a return electrical current passed through the tissue and back to the return electrode (if present). The indicator 119 confirms that the requested stimulation charge was applied to the tissue rather than stimulation was merely attempted.

[0079] In an embodiment, the indicator 119 may include a pair of light sources, separated in space, shape, output color, and blink rate. The indicator may also include a reflective element to improve and focus the illumination effect of the light emitting source, e.g., one or moreLEDs. The indicator and the reflective element may be a single component, or more than one component. In an embodiment, the light indicators 119 may be isolated so that colors of thelight cannot bleed between them. For example, stimulator 100 may include a mold design or insertable barriers that isolate each of the light indicators 119. In an alternative embodiment, the indicator 119 is a single visual indicator that communicates various condition statuses with various output light intensities and pulse frequencies, simplifying an overall design of the indicator 119.

[0080] In an embodiment, indicators 119 on the stimulator 100 may correspond to indicators on another component of the system. For example, indicators 119 on the stimulator 100 may illuminate under certain conditions to notify a user of the conditions and the stimulator 100 may cause a different component of the system to also illuminate under certain conditions to notify a user of the conditions. For example, corresponding indicators may also be located on a lead, wired probe connection, or the like, see FIG. 5 and may operate as set forth above. The stimulator 100 may include any one of the indicators 119 and / or the indicators shown in FIG. 5. Any combination of such is contemplated herein. Since the stimulator 100 may not always be in the field of view of a user during stimulation, components closer to the nerve site may illuminate to provide visual indication in an area that may be more likely in the field of view of the user and vice versa when set up of the stimulator 100 and selection of electrical stimulation may be made without the rest of the system necessarily in the field of view' of a user.

[0081] In a non-limiting example, the indicators 119 (e.g., each set of one yellow and one red indicator) may correspond to one or more channels, such as two channels, which may provide two or more different electrical stimulation having different stimulation parameters. In a nonlimiting example, button 114 may correspond to a section of the display screen 116 and to each set of the indicators 119. For example, each channel may include a button 114, section of the display screen 116, and set of indicators 119 on the left or the right side of the stimulator 100, see FIG. 2. In this regard, the left side and the right side of the stimulator 100 are respectivelya first lateral side of the housing 110 and a second lateral side of the housing 110 opposite the first lateral side.

[0082] As depicted, a first section of the display 116 indicates a first channel at a location closer to the left side of the housing 110 as compared to the right side of the housing 110 opposite the left side. A second section of the display 116 opposite the first section indicates a second channel at a location closer to the right side of the housing 110 as compared to the left side of the housing 110.

[0083] Audio or tactile feedback and indicators can also allow the surgeon to continue other efforts in a complex surgery while monitoring the status of the electrical stimulation without necessarily having the stimulator or other component of the electrical stimulation in the field of view. The stimulation control device incorporated within the housing may be programmed to provide an audio tone when connectivity to the patient is lost, or when the full therapeutic stimulation dose has been delivered. This may allow the surgeon to maximize the use of operating room time rather than waiting for stimulation to be completed.

[0084] In an embodiment, the stimulation control device includes a first control device positioned within the housing 1 10 and electrically coupled to the microcontroller, where the first control device transmits a signal to the microcontroller that causes the circuitry to generate the stimulation signal over a first channel, through the lead. In a further embodiment, the stimulation control device includes a second control device positioned within the housing 110, separate from the first control device, and electrically coupled to the microcontroller. In such an embodiment, the second control device transmits a signal to the microcontroller that causes the circuitry to generate the stimulation signal over a second channel, through the lead.

[0085] It is noted that the indicators 119 may include any suitable material as may be desired. In an embodiment, indicators 119 may include a thermoplastic polymer material, for example, polycarbonate. In an embodiment, indicators 119 may include LEDs that are covered by a cover(e.g., a transparent, opaque, or translucent plastic or glass cover) and the cover may have a seamless transition to the body of the device (e.g., the surrounding housing 110), see, for example, FIGs. 1 and 3A-B. As described, housing 110, and top and bottom housing portions thereof, may be injection molded. In an embodiment, the top housing portion may be a multi shot mold including a clear component for the light indicators or LEDs. In an embodiment, the cover for display 116 may be attachable to the top housing portion after injection molding to cover display 116.

[0086] Stimulator 100 may include one or more ports 122 at a first or distal end 120 of the housing 110, where the one or more ports 122 convey the stimulation signal through the housing 110 to the lead, or from the return electrode 124. In an embodiment, ports 122 may be referred to as plug-in connectors or receptacles. In an embodiment, stimulator 100 may include two ports 122. In an embodiment, stimulator 100 may include a left port and a right port. More specifically, the one or more ports 122 includes a first port that conveys the stimulation signal through the first channel, and a second port that conveys the stimulation signal through the second channel. The first port is located closer to the left side of the housing 110 as compared to the right side of the housing 110, and the second port is located closer to the right side of the housing 110 as compared to the left side of the housing 110.

[0087] With this construction, the first port of the one or more ports 122, the first indicator of the indicators 119, the first section of the display 116, and the first button of the buttons 114 are aligned in the longitudinal direction along the left side of the housing 110 from the distal end 120 to the proximal end. Also, the second port of the one or more ports 122, the second indicator of the indicators 119. the second section of the display 116, and the second button of the buttons 114 are aligned in the longitudinal direction along the right side of the housing 110 from the distal end 120 to the proximal end. As such, a user operating the stimulator 100 more easily associates elements on the housing 110 with aspects of the stimulation signal on a perchannel basis, along the left side and the right side of the housing 110.

[0088] It is noted that other quantities of ports 122 are also herein contemplated, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more ports 122. Stimulator may include a port for a return electrode or return electrode 124, where the return electrode 124 provides an electrical flow path for the stimulation signal from a lead back to the housing 110. In an embodiment, stimulator 100 may include multiple electrical contacts for each lead in a connector to allow for type recognition of the different leads. In an embodiment, stimulator 100 may include multiple electrical contacts for various types of lead stimulation or contacts.

[0089] The display 116 is located closer to the distal end 120 of the housing 110 as compared to a proximal end of the housing 110 opposite the distal end 120. The one or more indicators 119 are interposed between and separate the one or more ports 122 and the display 116 along the housing 110, in a longitudinal direction taken from the proximal end of the housing 110 toward the distal end 120 of the housing 110. Both the buttons 114 are located closer to the proximal end of the housing 1 10 as compared to the distal end 120 of the housing 110. With this construction, the buttons 114 are located on the housing 110, at a side of the display 116 opposite the indicators 119 in the longitudinal direction. As such, a user operating the stimulator 100 from the housing 110 as a handheld device may maintain visual contact of the display 1 16 and the indicators 119 while actuating the circuitry from the buttons 114 and delivering the stimulation signal from the distal end 120 of the housing 110. More specifically, a user may grip the housing 110 around the bottom housing and press the buttons 114, optionally with a thumb, without block view of the display 116 or the indicators 119, and without unnecessarily bending or twisting leads from the one or more ports 122. Furthermore, the indicators 119 are provided adjacent the one or more ports 122 at corresponding channel, where a user may most likely view an urgent notification associated with the corresponding channel.

[0090] Stimulator 100 may include a first or distal end 120 configured to selectively couple with a mating first end of a plug 190 or a proximal end of an intraoperative lead, for example. Plug 190 may include a second mating end configured to selectively couple with a proximal end of lead, or to an endoscopic instrument. More specifically, the stimulator 100 may be selectively coupled to a lead, an adaptor, or a combination thereof, and operatively connected to an endoscopic instrument. The adaptor may be selectively attached to the operative element and may include a lead electrically coupled to the stimulation device 100 through at least one electrode, such as the return electrode 124.

[0091] Lead may include a sheath, which covers a portion of lead but that leaves a distal end of lead including one or more electrodes, exposed to provide electrical stimulation. Plug and any other connections herein described may include any mating mechanism and structure as may be suitable or desired for a particular purpose or intended application, including, for example, threading, friction fit, pressure fit, snap-fit, bayonet attachments, cam locks, latches, magnets, tabs, pins, interlocks, and the like. Plug 190 may be touch proof plugs, in an embodiment. Ports 122 may be touchproof receptacles, in an embodiment.

[0092] In an embodiment, a stimulator may include a return electrode wire either soldered directly onto the printed circuit board, or a plug-in connector at the end of the wire with a mating jack mounted into the housing (also can be touchproof). In an embodiment, stimulator 100 may include one or more removable leads and a removable common return electrode to prevent tangling, for example. The patient contacting parts may be connected via touch proof connectors to reduce the likelihood of unintended electric shock, for example.

[0093] In a non-limiting example, the ports 122 may correspond to one or more channels, such as two channels, which may provide two or more different electrical stimulation having different stimulation parameters. In a non-limiting example, a port may correspond to a return electrode of a different configuration. In a non-limiting example, button 114 may correspondto a section of the display screen 116, to each set of the indicators 119, and to each port 122. For example, each channel may include a button 114, section of the display screen 116, set of indicators 119, and port 122 on the left or the right side of the stimulator 100, see FIG. 2.

[0094] In an embodiment, the stimulator receptacle and lead plug may be configured such that the stimulator hardware may detect whether a lead is connected. This may be implemented using electrical contacts to complete a circuit, a mechanical switch, RFID, an optical sensor, or other similar means to detect that a lead is connected. In an embodiment, the stimulator receptacle and lead plug may be configured using the methods above to identify the lead type or lead model, adjusting available stimulation parameters accordingly.

[0095] In an embodiment, housing 110 including top and bottom housing portions, display 116, and indicators 119, excluding buttons 114 and ports 122, may include a generally continuous surface. In an embodiment, housing 110 including top and bottom housing portion, display 116, and indicators 119, excluding buttons 114 and ports 122, may be hermetically sealed. In an embodiment, housing 1 10 including top and bottom housing portion, display 11 , and indicators 119, and including buttons 114 and ports 112, may be hermetically sealed. In an embodiment, the entire stimulator 100 may be hermetically sealed or liquid tight.

[0096] As described, housing 110 may be generally ergonomic in the hand or rest on a flat surface and may include minimal external or visible protrusions, ridges, or recesses, a generally flat surface or continuous surface, e.g., top and bottom places, (excluding minimal buttons, if any), modest contours, rounded edges, and the like, see. for example. FIGs. 1-6. Not including such protrusions, ridges or recesses may help keep the stimulator 100 sterile and may make a re-sterilization process easier to accomplish. As described, display screen 116 and / or cover thereof may have a seamless transition to the body of the device (e.g.. the surrounding housing110 see, for example. FIGs. 1, 3 A, and 4. In an embodiment, indicators 119 and / or cover thereof may have a seamless transition to the body of the device (e.g., the surrounding housing 110see, for example. FIGs. 1 and 3A-B). In an embodiment, indicators 119 may extend over the rounded comers and / or rounded sides of the profile of stimulator 100. In an embodiment, indicators 119 may be visible from a multitude of angles and directions, e.g., top of stimulator 100, front of stimulator 100, side of stimulator 100, and the like, see FIGs. 2 and 3A-3B. In an embodiment, at least the red indicators 119 may be visible from a multitude of angles and directions, e.g., top of stimulator 100, front of stimulator 100, side of stimulator 100, and the like, see FIGs. 2 and 3A-3B. In an embodiment, at least the yellow indicators 119 may be visible from a multitude of angles and directions, e.g., top of stimulator 100, front of stimulator 100, and the like, see FIGs. 2 and 3A-3B.

[0097] Disclosed are devices, systems, and methods for an electrical stimulation system. The system may include a two-channel, single patient stimulator 100. In an embodiment, the system may be intended for intraoperative use (2-30 minutes, or desirably approximately 10 minutes or for example any period between 2 and 10 minutes of non-stop or continuous stimulation) by a physician during peripheral nerve repair surgeries. In an embodiment, the system may be disposable or single use. The system may deliver electrical stimulation through up to two disposable, sterile, intraoperative leads, which are connected to disposable, sterile, external pulse generating stimulator. In some embodiments, the external pulse generator may also include a reusable system that can be sterilized after each use thereof. The stimulator may have a single set of fixed stimulation parameters.

[0098] Turning to FIG. 11 showing an electrical block diagram, the stimulator output stage may be implemented using a voltage controlled current source used to generate several currents based on a microcontroller output. This may involve selecting a reference voltage in conjunction with cunent limiting resistor, where either the reference voltage or current limiting resistor is varied.

[0099] In an embodiment, stimulator 100 may be used intraoperatively for a dosage periodgreater than several minutes (e.g., 9 minutes to 30 minutes, but more specifically about 10 minutes). In an embodiment, the stimulator 100 may include hardware-based mitigations to protect device functionality such as TVS diodes or Varistors. In an embodiment, the stimulator 100 may include filtering on pulse monitoring hardware to protect from transient voltages caused by e.g., Bovie, ultrasound knife, ESD. In an embodiment, the stimulator 100 may include software-based mitigations to monitor and filter pulse completion and inter-chip communication on the device to allow fault tolerance for ESD, Bovie, etc. where errors are counted, and the device limits further use after a pre-specified number of errors and / or subsequent retries. The status of the system (in a non-limiting example, therapy delivery, dose completion, number of errors) may be logged in the system using non-volatile memory, and that information may be used to allow restart or resumption of therapy in the event of sporadic operation.

[0100] In an embodiment, stimulator 100 may include measurement circuitry used to ensure that the full current of a single pulse was delivered for the full intended duration of that pulse. In an embodiment, the successful delivery of each pulse may be quantified by simple time of therapy delivery (e.g., time only). In an embodiment, the successful delivery of each pulse may be counted or a measurement of each pulse may be accumulated to ensure delivery of the full dose of the stimulation therapy, allowing for missed pulses to extend the temporal duration of the dose (e.g., pulse counting). In an embodiment, the amount of stimulation may use charge delivered (pulse duration * pulse amplitude) to quantify the amount stimulation therapy delivered, where pulse duration and charge are varied (e.g., integral of total charge). In an embodiment, circuitry may be included to measure a physiological response such as a chemical response, an action potential, or a motor response (e.g., integral of physiological response) as the marker of successful stimulation delivery. The measurements of physiological responses may be treated as a single event with the number of occurrences tracked, or themeasurement may be accumulated (integrated) over a time and tracked until a preset amount or level is reached to ensure that the prescribed therapeutic dose has been provided. In an embodiment, circuitry7included in the stimulator 100 is positioned entirely within the housing110.

[0101] In an example, stimulator 100 may count action potentials via EMG or ENG as a physiologic marker of successful stimulation pulses delivered. The device may count the number of events or activations when the measured activity7is above a defined threshold. This threshold may be pre-defined, adjustable, and / or set each use based on initial measurements for the patient or nerve stimulated. The detection may only count events occurring within a defined time window after each stimulation pulse, to avoid counting non-therapy associated activations. This time window may be adjusted based upon the physiologic modality being measured; as a non-limiting example, l-20ms for ENG and 10- 100ms for EMG. In another example, the device may measure or track the accumulated activation of the measured activity, such as the area under a series of measured action potentials or muscle activity, to determine the delivered therapeutic dose.

[0102] In an example, stimulator 100 can check or track whether a lead is electrically connected / disconnected to stimulator 100. In an example, stimulator 100 can check whether a lead is electrically connected / disconnected to stimulator 100 whether or not the system is connected to a patient. In an embodiment, if stimulator 100 determines that a lead is not connected or connected improperly, stimulator 100 may prevent electrical stimulation until proper connection. In an embodiment, if stimulator 100 determines that a lead is connected or disconnected, stimulator 100 may provide an indication, such as a visual or auditory7indication as described herein. In an embodiment, if stimulator 100 determines that a lead is not connected or connected improperly, stimulator 100 may provide an error message or alert to the user.

[0103] In a further embodiment, the indicator 119 generates a first indication includinga predetermined light, sound, or vibration when, independent of contact between the one or more leads and the targeted tissue region, power to the circuitry' in the housing 110 is on due to operation of the first control device or the second control device. In a further embodiment, the indicator 119 generates a second indication including a predetermined light, sound, or vibration different than the first indication when the circuitry' receives the stimulation signal from the targeted tissue region through the return electrode 124 due to operation of the first control device or the second control device. In a further embodiment, the indicator 119 generates a third indication including a predetermined light, sound, or vibration different than the first indication and the second indication when the circuitry' is transmitting the stimulation signal from the housing 110 to the targeted tissue region, and the circuitry is not receiving the stimulation signal through the return electrode 124.

[0104] Leads may be sized to fit a variety of nerves in the upper and lower extremities, from digital up to femoral nerves. Stimulation status may' be monitored to ensure that current is delivered throughout the specified treatment duration, and the stimulation delivery will turn off at the completion of the treatment duration. Leads are included of a distal end including one or more electrode contacts, electrically connected via insulated wire to a connector at the proximal end of the lead, where the connector may be plugged into or otherw ise electrically connected to a stimulator 100. In some embodiments the lead may include an insulating component that ensures stimulation is applied to the target tissue while reducing or preventing delivery of stimulation current to the surrounding tissue.

[0105] A single contact lead may be used to provide monopolar stimulation to a target location. In some embodiments additional contacts may be used to provide stimulation to multiple targets. In some embodiments multiple contacts may be used for a bipolar configuration, where one serves as the stimulation electrode and the other serves as the return electrode. In some embodiments one or more return electrodes may be used in conjunction withone or more stimulation electrodes to steer stimulation current.

[0106] Referring now to FIGs. 7A-B, shown are percutaneous electrodes 300 and 400 in accordance with various disclosed aspects. Percutaneous electrodes 300 and 400 may generally include an insulated body 302 / 402, an anchor 304 / 404, and one or more uninsulated portions 306 / 406. It is noted that percutaneous electrode 300 may include similar aspects as percutaneous electrode 400, unless context suggest otherwise or specific reference is made to a difference between the two. As such, while examples may refer to one of the percutaneous electrodes 300 and 400 for simplicity of explanation, the other may be utilized. Moreover, various other percutaneous electrodes may be utilized by embodiments disclosed herein.

[0107] In an example, percutaneous electrode 300 may be placed at or near a target tissue region and may be coupled with a percutaneous lead or ware, as described herein. It is noted that percutaneous electrode 300 may be positioned while an incision is open and may be left in place while the incision is closed. In at least one other embodiment, percutaneous electrode 300 may be positioned when an incision is closed or by deploying the percutaneous electrode 300.

[0108] In embodiments, percutaneous electrode 300 may include strands of stainless- steel wire insulated with a biocompatible polymer. Each wire strand may have a diameter of approximately 34 pm and the insulated multi-strand lead wire may have a diameter of approximately 250 pm. It should be understood, however, that these dimensions are merely exemplary, and the present teachings are not limited to such. Any appropriately sized, shaped and configured electrode and percutaneous lead may be used. The insulated wire may be formed into a spiral or helix as has been found to accommodate high dynamic stress upon muscle flexion and extension, while simultaneously retaining low susceptibility to fatigue. The outer diameter of the percutaneous electrode 300 may be approximately 580 pm and it may be encased or filled with silicone or the like. In at least some embodiments, percutaneous electrode300 may be made out of a different material (e.g., another metal, conducting polymer), may be insulated with another material, or may not be insulated. Further, the lead may be cylindrical or paddle-like.

[0109] Unlike surface electrodes that are applied to the surface of the patient's skin using an adhesive, percutaneous electrode 300 may be surgically implanted or otherwise inserted into select tissue. The terminal end or anchor 304 may include one or more tines 308 (e.g., tines 408 of percutaneous electrode 400). The anchor 304 may be insulated or uninsulated. In at least some embodiments, the anchor 304 may be inserted directly into tissue and may deliver stimulation signals to the tissue. In another aspect, the anchor 304 may generally hold the percutaneous electrode 300 in place. For instance, the one or more tines 308 may include a bend, curve, barb, etc., that prevents the percutaneous electrode 300 from substantially moving or unintentionally coming loose.

[0110] As shown in FIGs. 7A-B, disclosed embodiments may include different types of anchors 304 / 404. For instance, an anchor may include ) tines, where ) is a number. In an exemplary embodiment, a patch assembly may be utilized in conjunction with the percutaneous electrode 300. The patch assembly may include several layers, including an adhesive layer, an electrode layer, a reinforcement layer and a cover layer. In one embodiment, the patch assembly may include a power source for the stimulation device. Further, the patch assembly may act as a surface electrode. In one embodiment, the patch assembly may include engagement member or members that electrically couple the stimulation device to the percutaneous electrode 300 to provide stimulation for nerve regeneration. The engagement member may include a snap, a magnetic male and female member capable of operable engagement, a bayonet engagement device, or any know engagement mechanisms capable of electrically coupling the stimulation device with the percutaneous electrode 300. The present disclosure contemplates any such configuration of the patch assembly.

[0111] In another aspect, an anchor may include threaded members (e.g., screws) or the like. Further still, the percutaneous electrode 300 may not include any tines or anchors. In these embodiments, the percutaneous electrode 300 may be placed near or around, i.e., generally circumscribing all of or a portion of the applicable nen e. Further, the percutaneous electrode 300 may be placed over, i.e., on top of or at the bottom of, the applicable nen e, or near, i.e., in an operative distance from the applicable nen e in any manner. The present teachings are not limited to a specific configuration. Embodiments may include a nen e cuff, a coiled lead, a straight lead, lead with a hook, lead with a tine or tines, or the like.

[0112] According to embodiments, percutaneous electrode 300 may include flexible materials that allow some or all of the percutaneous electrode 300 to bend or deform. In an example, the insulated portion 302 may be a lead that is generally flexible to allow removal, positioning, or other manipulation of the percutaneous electrode 300.

[0113] In embodiments, sections of the uninsulated portion 306 may be separated by insulated portions 310 (e.g., insulation portions 410 in FIG. 7B). It is noted that different sections of the uninsulated portions 306 may be electrically isolated from each other to allow for bipolar stimulation. In another aspect, the insulated portions 310 may allow for increased strength, positioning, or the like of the percutaneous electrode 300. The uninsulated portion 306 may operatively deliver a stimulation current. It is noted that the uninsulated portion 306 may be disposed anywhere along the percutaneous electrode 300. For instance, the uninsulated portion 306 may be disposed at one or more tines 308, at anchor 304. or the like.

[0114] FIG. 7C illustrates another percutaneous electrode 450 including an insulated body 452 and an anchor 454. The anchor 454 may include a twisted or braided wire. The anchor 454 may be electrically conducting and not insulated such that it may apply a stimulation signal to tissue. In an aspect, the anchor 454 may include a helical portion 458. In another aspect, body 452 may include twisted, braided or helical portion 460. The helical portion 458 andhelical portion 460 may anchor the percutaneous electrode 450 in places. In an aspect, the percutaneous electrode 450 may allow for extended use or implantation. For example, tissue may heal around the helical portion 458 or helical portion 460. The shape of these portions allows tissue to grasp and grow in between turns or bends of the helical portion 458 and helical portion 460. The tissue growth will anchor the percutaneous electrode 450 and may prevent or reduce chances of developing infections as the tissue heals around the percutaneous electrode 450. This may allow" the electrode 450 to remain in place for an extended period of time or for a short period of time. Further, the helical portion 460 may include a fine-coiled wire with a insulative material surrounding such.

[0115] Turning now" to FIGs. 7D-E, with reference to FIGs. 7A-C, there are adaptor 500 (which includes percutaneous electrode 400 (and may also include electrode 300 and 450) and a lead wire 502), adaptor 600 (which may be coupled to a stimulation device and / or percutaneous electrode), and stimulation system (which may include stimulator). It is noted that liked named components of the various embodiments may include similar aspects, unless context suggests otherwise or a particular distinction is made.

[0116] In an embodiment, adaptor 500 may primarily include percutaneous electrode 400, wire 502 and connector 512. Wire 502 may connect terminal end 412 of the percutaneous electrode 400 with connector 512. In an aspect, wire 502 may include an insulated wire that is removably or irremovably attached to the percutaneous electrode 400 and / or connector 512. As described herein, the adaptor 500 may be configured to allow a stimulator to deliver a stimulation signal below the skin of a subject patient, the stimulation signal having an amplitude and a duration.

[0117] In an aspect, connector 512 may include an opening 514 that may receive an operative element. The opening 514 may receive a probe of a stimulation device. The opening514 may be tapered to maintain the probe in a friction fit within the connector 512. Theconnector may further include other retaining features, such as a fastener (e.g., screw, clasp, threaded portions, VELCRO, magnet, etc.) to retain the connection between the connector 512 and the probe. It is noted that connector 512 may include an electrical connection disposed within the connector 512 that may operatively couple an uninsulated or stimulating portion of the probe with the wire 502.

[0118] Wire 502 may extend from the connector 512. Wire 502 may be an electrical conductor in electrical connection with probe when probe is operatively inserted into the connector 512. It is noted that the wire 502 may be any appropriate length, such as 24 inches or a length between 12 inches and 48 inches. The lead wire may further be any appropriate gauge, such as 24 AWG wire.

[0119] Percutaneous electrode 400 may be coupled to the wire 502 at a terminal end 412. According to an embodiment, the wire 502 may be removably or irremovably coupled to the terminal end. It is noted that the wire 502 may be coupled directly to the terminal end 412 and / or may be coupled indirectly to the terminal end 412, such as through one or more other connectors (not shown). Moreover, wire 502 may be coupled to other portions of the percutaneous electrode 400. In an aspect, the connection between the wire 502 and the percutaneous electrode 400 may be insulated or uninsulated.

[0120] As shown in FIG. 7E, adaptor 600 may include a wire 602 and one or more connectors 612 / 622. Each connector 612 / 622 may include an opening 614 / 624. In an aspect, openings 614 / 624 may include similar or different dimensions. For instance, openings 614 / 624 may be operatively sized and shaped to receive an operative element and / or a percutaneous electrode (e.g.. percutaneous electrode 300 / 400). In at least one embodiment, opening 614 is operatively sized to receive an operative element, and opening 624 is operatively sized to receive a percutaneous electrode. In another aspect, connectors 612 / 622 may include elastomeric materials that may stretch, compress, or otherwise fit different sized components.Moreover, while embodiments disclose connectors 612 / 622 as female connectors, it is noted that one or more of connectors 612 / 622 may be a male connector. In another aspect, wire 602 (or 502) may include one or more branches or pathways such that connector 614, for example, may be electrically coupled with one or more other connectors through wire 602.

[0121] In an embodiment, the light or visual indicators included in the indicators 119, or the display 116, indicate a status of deliver}' of the stimulation signal. In such an embodiment, the control circuitry in the housing 110 may detect a feedback signal conveyed from the return electrode 124, the feedback signal indicating that a corresponding pulse of the stimulation signal has been delivered to the target tissue region from the stimulator 100.

[0122] FIGs. 8A-C illustrate a splitter device 1200 that may operatively split a stimulation signal and / or return signal. According to embodiments, the stimulation device 1200 generally include a housing 1202 that houses circuitry 1220. The housing 1202 may include an input port 1206 and one or more output ports 1212, 1214, 1216, and 1218. It is noted that splitter device 1200 may include any number of input or output ports. Internal circuity therein may be utilized to deliver one input signal to multiple output channels, maintain current level at set output, such as for example at 1.0 or 2.0 mA.

[0123] Splitter device 1200 may receive a first wire 1230 via input port 1206. In an aspect, the first wire 1230 may be coupled to a stimulation device (not shown) that may operatively apply a stimulation signal to the input port 1206. The circuitry 1220 may split the stimulation signal to one or more of the output port(s) 1212, 1214, 1216. 1218. which may be coupled to one or more operative elements, percutaneous leads (e.g.. percutaneous leads 300, 400, etc.), non-percutaneous leads, or connectors as described herein. In an example, a surgeon may place percutaneous leads 400 in different target tissue in one or more patients. The surgeon may attach the percutaneous leads 400 to the splitter device 1200 and may attach a stimulation device to the splitter device. The stimulation device may apply a prolonged stimulation signalto multiple tissue regions based via the splitter device 1200 and / or percutaneous leads 400.

[0124] As described herein, the circuitry 1220 may be an interface between a stimulation signal (received at input port 1206) and divides the input signal to one or more output signals with attached electrodes, selectively output at one or more of output port(s) 1212, 1214, 1216, and 1218. This may allow' the stimulation device to utilize additional channels or contacts than otherwise available.

[0125] It is noted that the circuitry' 1220 may include a power source (e.g., battery') or may receive power from the stimulation device or other external source. In an example, the circuitry may include an inductive circuit that operatively stores pow'er in one or more capacitors. According to another embodiment, the input signal received at input port 1206 may supply the pow er. The circuitry may include the components to ensure output remains within a specified range (e.g. 2.0mA) whenever a stimulation pulse is delivered to the input port. Moreover, the circuitry' 1220 may include a demodulator (e.g. to receive and decode information) and one or more switches or registers that control output to percutaneous leads 400 or other electrical contacts, or the like. In an aspect, the switches may be utilized to detect whether an electrical contact is connected to output port(s) 1212, 1214, 1216, and 1218 such that power may be selectively applied to the ports.

[0126] In embodiments the splitter device 1200, or aspects thereof, may be disposed on or within a container, or placed on the body outside the container. For instance, the housing 1202 may be disposed within layers of material in the container 800. In another aspect, the circuitry 1220 may be disposed within the material of the container 800 (e.g.. the housing may include the material of the container). The splitter device 1200 may be sterilized.

[0127] According to various embodiments, splitter device 1200 may include a clip, fastener, magnet, etc., that operatively attach the splitter device to a patient, clothing, hospital equipment, or the like.

[0128] FIG. 9 illustrates a stimulation system 1500 primarily including a simulation device 1501. The stimulation device 1501 may operatively control stimulation of tissue via one or more stimulating medical devices including, for example, simulation device 1501, probe, percutaneous electrodes 400, cutting devices, drilling devices, augers, fixation devices or the like. The stimulation system 1500 may include an external stimulator that is selectively attachable ex-vivo a patient. The stimulation system 1500 may include a box that may be attached to a patient, such as by adhering to a patch assembly or other adhesive device attached to a patient, selectively attaching the box to clothing of a patient, including a strap or necklace that a patient can wear to hold the box, using hook and loop fasteners to attach the box to the patient or patient’s clothes, and the like.

[0129] In an aspect, the stimulation device 1501 may include circuitry that operatively generates an electrical stimulation signal to be applied to a tissue. In an aspect, the stimulation device 1501 may include similar functionality as described with reference to other stimulation devices.

[0130] Moreover, stimulation device 1501 may include a user interface 1508, including a display 1502. As described herein, the user interface 1508 may include input / output devices that operatively receive user input. A user may interact with the user interface 1508 to adjust parameters of the stimulation signal and / or receive information from the display 1502. For example, the display 1502 may indicate to a user the length of time of the current therapy has left, the time the therapy has been applied, the number of doses of therapy applied and / or number of therapies yet to be applied. By way of a non-limiting example, if the therapy has an intended duration of an hour and twenty minutes of therapy has been applied, the display 1502 may show that there are forty minutes left on the therapy. In another non-limiting example, if the therapy has an intended duration of thirty minutes of therapy has been applied, the display1502 may show that there are fifteen minutes left on the therapy.

[0131] The display 1502 may include an LED screen that can provide any of the information indicated in the present disclosure to the user, patient and / or clinician. Moreover, stimulation device 1501 may include a user interface 1508, including a display 1502 and audio feedback. In at least some embodiments, the user interface 1508 may generate an alert that is audible, visual, tactile (e.g., vibration), or combination of the above. For instance, the user interface 1508 may generate alerts to indicate that therapy is complete, a lead has moved, a lead has become disengage, stimulation has been disrupted, an error has occurred, a warning (e.g., power supply is low), or the like.

[0132] As described herein, the user interface 1508 may include input / output devices that operatively receive user input. The display 1502 with or without additional audio tones may display to the user signals recorded on the one or more input ports 1506, which may be connected to other sensors or systems to record physiologic signals such as pressure, electromyograms, stretch, force, or the like. In an aspect, the stimulation device 1501 may include a communication component that may be wired or wireless. For example, the stimulation device 1501 may include a wireless transmi tter / recei ver configured to communicate via one or more communication protocols (e.g., Wi-Fi, BLUETOOTH, NFC, etc.).

[0133] Stimulation device 1501 may include one or more output ports that may be operatively coupled with an operative element (e.g., a probe 100), one or more percutaneous leads 400 and / or connectors 500 (e.g., as shown in FIG. 9), or other components. According to one or more embodiments, the stimulation device 1501 may include one or more output ports that may be coupled to a return electrode 1802 via a wire 1804. It is noted that the return electrode 1802 may include a pad-type, needle, or other style electrode as described herein.

[0134] FIGs. 13-21 show various embodiments of intraoperative leads 200 that may be used with the described system and stimulator 100. In some embodiments, the distal end 1900of a cylindrical lead may include of one or more annular contact rings, where current is applied circumferentially around the entirety of a lead body 1902.

[0135] In other embodiments a primarily cylindrical lead 200 may include contacts where an arc around the lead body 1902 serves as the electrical contact. This may be achieved by several means of assembly including placement of a metallic contact 1904 onto a cylindrical body. The primarily cylindrical lead may include a rigid body as the lead body 1902 at its distal end 1900, attached to a flexible wire 1910. The primarily cylindrical lead may include a distal end 1900 that is indistinguishable from the length of wire or cable that attaches it to the stimulator 100. In an embodiment, an electrical contact, such as the metallic contact 1904, may be added to a lead body 1902. In an embodiment, the lead body 1902 may serve as an electrical contact itself. In an embodiment, contact material (e.g., metal) may be formed of a desired shape and insulated. Before use, some insulation 1912 may be removed, exposing the contact material to provide an electrical contact at the exposed portion. For example, the lead body 1902 may exposed 90° or 180° circumferentially then along a desired length to provide an exposed surface area to provide an electrical contact and charge.

[0136] In another embodiment a cylindrical lead 200 may be included of a conductive rod or wire 1910, with the insulation 1912 applied in all locations except for a therapeutically appropriate contact area, which allows the stimulation current to be delivered to the tissue target. Methods of construction may include coating the conductive metal member 1904 with insulating material, such as the insulation 1912. and then skiving or ablating an appropriately sized contact hole or window.

[0137] In another embodiment a primarily cylindrical lead 200 may include features to ensure placement of a limited contact area in proximity to the targeted tissue while preventing a rotation along a lead axis 1922, see FIGs. 15-16, for example, showing leads 200 including an overmolded winged wire 1910 and an overmolded winged button 1924 respectively. FIG.17 shows lead 200 including the overmolded winged button 1924 and a lip 1930.

[0138] In some examples this may include the use of flat stabilization wings 1932 at or around the electrical contact 1904 to keep a window oriented and direct the majority of stimulation to the nen e while insulating surrounding tissue. In cases where there is limited access to the target tissue, a similar feature to prevent rotation may be placed proximal to the contact 1904 (i.e. closer to the stimulator connector), where it may be attached to shallower tissue or skin in the case of intraoperative or perioperative stimulation.

[0139] In some embodiments a primarily cylindrical lead body 1902, with annular or semi-annular contacts may include a securement feature to prevent pistoning relative to the targeted tissue. As shown in FIGS. 15 and 16, the feature may include a loop defined in wings 1932 for suturing, a flat piece for clipping, or the like.

[0140] In some embodiments a primarily cylindrical lead body 1902, with annular or semi-annular contacts may include tines to prevent pistoning or movement relative to the targeted tissue. In some configurations, a lead 200 may be designed for placement proximal to the target nerve through a skin surface of the patient via an incision. Such a lead 200 may be designed either without retention features, or with retention features designed to break away from their target with a minimum of force to allow temporary peri-operative use.

[0141] In some embodiments the lead 200 may include a flat insulative body 1902 with an exposed electrical contact 1904 on the side intended for placement in contact with the target tissue, see FIG. 14. for example, showing a bendable flat lead 200. This electrical contact 1904 may be an exposed portion of a primary conductive member as described above, or by attachment (such as crimping or welding) to a purpose-built contact of the same or another conductive material. For example, the contact 1904 may be a machined cylindrical “button'’ with features to aid in a welding process, or a piece of film, foil, or other flat stock formed to provide the desired shape and size.

[0142] In another embodiment, a nominally flat lead body 1902 with one or more contacts 1904 on one face may be designed with extended flexible members that extend perpendicular to the lead wire 1910 that may be wrapped around the nerve, and be clipped or sutured together, allowing the lead 1910 wire to run parallel to the nerve, see FIG. 18, for example, showing a lead 200 including a thin-winged structure as the button 1924.

[0143] In another embodiment, a coiled or spiraled lead body 1902 may be designed that wraps around a nen e of a wider range of sizes, with one or more thin and flexible spiraling members that constrain the nerve for contact with the electrical contact 1904.

[0144] In another embodiment, a flexible lead body 1902 including of one lower flat or curved member 1940 and an upper flat or curved member 1942 create an "alligator" or clip shape. The electrical contact 1904 may be located on either the upper flexible member 1942 or the lower flexible member 1940. The ends of each member 1940, 1942 may be touching when the lead 200 is at rest or ‘‘closed,’’ with ends that curve outward to allow the user to easily slide the lead body 1902 onto the nen e.

[0145] In some embodiments, the lead 200 may include features to constrain the device around circumference of the nerve itself, see FIG. 13 and FIG. 17, for example, which show leads 200 including a J hook 1944 and a lip 1930 respectively. These features may surround the bulk of the nerve in the form of a J hook 1944, or may include a lip 1930 to allow easier placement. As shown in FIG. 13B, the J hook 1944 includes holes 1950 that may facilitate connection to the wire 1910, or may receive sutures that further fix the J hook 144 at or proximal the target tissue region.

[0146] In a case where the lead body 1902 is inconveniently large or shaped inappropriately for use in the surgical site, the lead body 1902 may be included of a material that is safe for the user to cut to an appropriate size and shape. These features may include certain materials that are malleable, such as annealed biocompatible wire (for example stainlesssteel) that facilitates wrapping of the lead body 1902 around the nerve and holds the lead body 1902 in the desired shape. FIGs. 19-20 show leads 200 including a lead body 1902 having a crescent moon or curved shape and channel aligned or parallel with the device (FIG. 19) or perpendicular to the device (FIG. 20). FIG. 21 shows a lead 200 that includes a lead body 1902 forming an alligator ty pe clip. The lead 200 may include tabs at opening that are configured to be parted or separable for placement on a desired nerve.

[0147] It is noted that any of the lead 200 embodiments may include a stamped contact, wire, or button unless context or this disclosure suggests otherwise. In an embodiment, the lead 200 may be designed with a contact surface area such that when paired with its intended stimulator, the system delivers the maximum pulse duration and amplitude, the charge density on the contact will not exceed 40 pC / cm2In an embodiment, the button may be 1.54 mm in diameter or greater. In an embodiment, the device may include an annealed wire to bend lead body 1902 to a desired shape. In an embodiment, lead body 1902 may be cut, bent, molded, or formed to a desired shape by the user. In an embodiment, lead body 1902 may include a coil or preformed coil shape.

[0148] In one embodiment, this distal end of the lead body may be included of an annealed biocompatible wire of (for example) stainless-steel grades 304, 316, 316L, 316LVM, with the entirety of the lead body 1902 insulated except for a contact with surface area of 0.5 - 10 square millimeters, desirably 3-4 square millimeters.

[0149] FS. 22 - 28 illustrate an alternate embodiment of the stimulator 100 of FIGs. 1 - 6. In the embodiment of FIGs. 22 - 28, like elements with the stimulator 100 of FIGs. 1 - 6 are denoted with the same reference numerals but followed by a primed suffix ('). As shown in FIG. 22, stimulator 100 includes a housing 110' that encloses electrical components used to provide electrical stimulation, including a power source or connection to an external power supply; a controller or microcontroller that controls operation of the stimulator 100 andexecutes programmed functions of the electrical stimulation; a first control device and a second control device in operative communication with the microcontroller for generating the stimulation signal; a signal generator that generates the electrical stimulation in waveforms or pulses with desired parameters; current limiting circuitry' that prevents the electrical stimulation from exceeding predefined limits; and other stimulation and safety features.

[0150] As shown in FIGs. 22 - 24, stimulator 100 includes a user interface 113’, including buttons 114’, which may actuate the first control device and the second control device in the housing 110‘. More specifically, the buttons 114’ include the first button and the second button which respectively cause the first control device and the second control device to generate the stimulation signal. The first control device and the second control device respectively generate the stimulation signal over the first channel and the second channel. A display 1 16’ and indicators 119’ at or adjacent a distal end 120’ of the housing 110’ indicate information associated with the stimulator 100 and the stimulation signal generated from the housing 11 O’. The first channel and the second channel are conveyed by one or more ports 122’ from the distal end 120’ of the housing 110’ to a target tissue region. Referring to FIGs. 22 and 23, the one or more ports 122’ include a return electrode 124’ that provides an electrical flow path for the stimulation signal from a lead back to the housing 11 O’.

[0151] FIG. 26 depicts a back view of the stimulator 100, including the housing 110’. As depicted in FIG. 26, a back side of the housing 110’ extends flatly between left and right sides of the housing 110’. The back side of the housing 110’ also forms rounded comers with the left side and the right side of the housing 110’. With this construction, the housing 110’ is configured for being gripped by a user around the back side of the housing 110, providing the user an unobstructed view of the display 116’ and the indicators 119’ at a front side of the housing 110’ opposite the back side.

[0152] FIG. 27 depicts a perspective top back perspective view of stimulator 100,including the indicators 119’ and the one or more ports 122’ at the distal end 120’ of the housing 110’. FIG. 28 depicts a bottom front perspective view of the stimulator 100, including the display 116’ and the user interface 113’. As shown in FIG. 28, the front side of the housing 110’ extends flatly between the left side and the right side of the housing 110’, opposite the back side of the housing 110’. With this construction, the housing 110’ is configured for being gripped by a user around the front side of the housing 110’, at a location closer to the proximal end as compared to the distal end 120’ of the housing 110’, providing the user an unobstructed view of the display 116’ and the indicators 119’ at the front side of the housing 110’.

[0153] Stimulator 100 may include pulse algorithms (e.g., pre-programmed or programmable) to generate a pattern of pulses and multiple stimulation modes, including continuous, burst, and modulated modes. Stimulator 100 may also offer data storage capabilities, allowing for the recording and analysis of stimulation sessions for further assessment and documentation.

[0154] In an embodiment, stimulator 100 may be pre-configured for therapy and include variations in stimulation and design based on injuries. For example, stimulator 100 may include a configuration for transection, a configuration for decompression, may vary based on clinical study data, and the like. For example, in nerve decompression as the distal muscles are still innervated by the target nerve, the device may be configured to account for distal muscle contractions, either by adjusting amplitude based on a perception or movement threshold, tracking stimulation delivery by the presence of contractions, or vary the stimulation parameters (e.g. amplitude, pulse duration, frequency). In an embodiment, each therapy time may have its own corresponding configuration file or may include an injury type selection by, for example, a switch or button or a phone application or radio control.

[0155] In an embodiment, the lead and stimulation system may be used to deliver one or more doses of the therapeutic stimulation post-operatively. The stimulator may beconfigured to initiate one or more doses of a time duration after a delay. This delay may be included to enable delivery of the therapeutic stimulation after the conclusion of the procedure, after anesthetic block wears off, or after individual is at home. This delay may be fixed or adjustable and could be on the order of hours to days.

[0156] As described, stimulator 100 and the described devices, systems, and methods may be used intraoperatively. The stimulator 100 and the described devices, systems, and methods may also be used perioperatively to deliver therapy. In an embodiment, a lead with one or more electrodes may be placed intraoperatively or percutaneously and connected to a port located on the housing. Any other type of electrode can be used, as desired or required. After the electrode is placed and connected to the stimulator 100, the prescribed therapy may be initiated by the practitioner. As patients’ tolerance to the prescribed stimulation therapy parameters may vary, it may be desirable to take steps to improve tolerance. In an embodiment, the therapy may be delivered after a tolerance threshold for a patient is identified. This may be based on motor response, patient feedback of feeling of paresthesia or pain, or other indications of patient discomfort. The device may automatically adjust the parameter of interest (e g. stimulation amplitude) until the user input, such as a button press, indicates the tolerance and / or perception threshold, or the device may enable the user to adjust the stimulation parameter directly to find the individualized settings.

[0157] In an embodiment, the therapy may be delivered after a soft start, where the charge per pulse is ramped from a lower value to the final prescribed value. This may be executed using a change in amplitude, a change in pulse width, or duty cycling of the pulse train until the prescribed steady state is reached. For example, the stimulator 100 may provide soft start functionality by ramping tissue stimulation signal duration between about zero microseconds and about 100 microseconds, for example, with increments of 10 microseconds pulse duration per one second of stimulation delivery. For example, the stimulator 100 mayprovide soft start functionality by ramping the stimulation duty cycle, for example, with increments of 25% per two seconds of stimulation delivery . For example, the stimulator 100 may provide soft start functionality by interleaving pulse with lower or higher amplitude in varying ratios. For example, the stimulator 100 may provide soft start functionality by using any combination of parameter changes at the initiation of therapy delivery. In an embodiment, the stimulator 100 may deliver the same therapy by varying stimulation parameters, but integrating the entirety of the charge delivered.

[0158] In an example, stimulator 100 may vary timing of pulse duration, use a variable amplitude setting to discrete current limiting resistors or a continuous amplitude output, alternate between low, medium, and higher, and provide patterned stimulation such as including skips. In an example, the stimulation pulse may have a biphasic waveform with controlled current during the cathodic (leading) phase, and net DC current less than 10 microamps. In an example, the stimulation pulse may have a non-adjustable frequency in the range of about 10 Hz to about 20 Hz, and desirably about 16 Hz. In an example, the nominal stimulation case may be fixed at or ramped up from about 0 to 4.0 milliamps. In an example, the nominal stimulation case may be fixed at or ramped up from about 0 to 2.0 milliamps. In an example, the nominal stimulation case may be fixed at or ramped up from about 10 to 200 microseconds. In an example, the nominal stimulation case may be fixed at or ramped up from about 100 microseconds.

[0159] The therapy may include post operative therapy delivery as a patient comes out of anesthesia, for example, or as the patient discomfort increases over the course of the therapy due to. e.g.. muscle cramping. In an embodiment, stimulator 100 may ramp down the stimulation intensity (charge per pulse as controlled by current amplitude and / or pulse duration, or pulse frequency) over the course of the therapy. This may be executed using a change in amplitude, a change in pulse width, or duty cycling of the pulse train until the prescribed steadystate is reached. For example, ramp down therapy may generally include changing parameters in the opposite direction from a ramp up therapy. In an example the nominal stimulation case may be fixed at or ramped down from about 4.0 milliamps to 0.5 milliamps, and desirably 2.0 milliamps. In an example the nominal stimulation case may be fixed at or ramped down from 200 to 50 microseconds, and desirably 100 microseconds.

[0160] In an embodiment, the stimulator system may be configured to provide two or more different stimulation waveforms. The first waveform can be used to locate or identify nen es within the operative area to aid in protecting the nerves in later portions of the procedure from accidental injury or transection. Once identified the first or a second waveform could be used to evaluate nerve excitability, finding the minimum intensify necessary to produce a response (threshold), to provide a baseline measure of function. This baseline measure of excitability may be used to determine or alter the surgical plan or decide if the therapeutic dose is needed. Assessment of nen e excitability may be completed after decompression or initial surgical intervention to decide whether the therapeutic dose is necessary. The stimulator can then be used to deliver the therapeutic w aveform.

[0161] In an embodiment, stimulator 100 may record and export patient data including: amount of therapy delivered, e.g., dose length, number of doses, stimulation parameters, threshold test levels, e.g., intensity of stimulation pre and post therapy, total hours operated, and the like. The data may be de-identified patient data. Exportation of data may be achieved by plug in or connected retrieval, for example, or radio.

[0162] Stimulator 100 may offer both diagnostic and therapeutic stimulation (e.g., as a dual diagnostic and therapeutic device). For example, stimulator 100 may be used to evaluate a nerve or provide therapy to a nerve site. In addition, stimulator 100 may be configured as nominally a therapeutic regeneration system with an accessory consisting of a removable probe where the device distinguished between diagnostic probe and therapeutic lead. For example,stimulator 100 may be configured as nominally a diagnostic stimulator with an accessory consisting of a removable probe where the device distinguished between diagnostic probe and therapeutic lead. Stimulator 100 may use the same output for diagnostic purposes and therapy purposes with the same user interface. Stimulator 100 may use alternate output (plug lead in rather than hand on probe). The configuration may be switchable by the user. In an embodiment, the configuration may be automatically detected by using, e.g., 1-wire interface, different plug pins, RFID, or otherwise detecting what components are plugged in or coupled to stimulator 100. In an embodiment, stimulator 100 may use a diagnostic lead or therapeutic probe on a wire. In another embodiment the system may be designed where stimulation related circuitry is decoupled from user interface and / or power supply circuitry, and the parts are connected at the time of use. In some embodiments, one portion of the system control circuitry (e.g. power supply) may be reusable with minimal processing while the other portion of the system is disposable or requires a rebuild.

[0163] Stimulator 100 may include features to limit patient exposure to stimulation consistent with therapy delivery when applied with the diagnostic lead-probe combination. For example, a device configured for diagnostic stimulation may monitor for continuous stimulation pulses and temporarily cease delivery until an open circuit of a minimum duration or number of pulses is detected.

[0164] Stimulator 100 may be controlled remotely. For example, stimulator 100 may allow or include, post-operative electrical stimulation delivery at home, a dedicated patient controller, phone applications to control device or to provide reminders, recording completion of therapy, and / or allowing titration of therapy.

[0165] In an embodiment, stimulator 100 may be designed to minimize e- waste. In an embodiment, the stimulator may be designed to allow the circuit board to be reprocessed including extraction from the assembly. Stimulator assembly may include for examplemodularized components to decouple battery pack and main circuitry' from easily contaminated or high-wear parts such as user interface components (buttons, switches, and indicators).

[0166] In an embodiment designed to allow reuse of high-value or resource intensive components, the stimulator 100 may prevent unauthorized reprocessing or reconditioning of the device to ensure that it remains unadulterated in its delivery' of nerve stimulation therapy, meeting specifications around safety and efficacy. For example, the following may be prevented: reuse of non-sterile device components, use of unverified or unvalidated components, and / or unvalidated manufacturing processes.

[0167] In an embodiment, stimulator 100 may include a common return electrode permanently attached to the control circuitry' through the housing to discourage re-use. Stimulator 100 may include software interlocks to prevent delivery' of stimulation pulses after a fixed run time or a fixed amount of therapy is delivered. The interlocks may' be further protected via physically destroying a replaceable component such as a fuse. In an embodiment, stimulator 100 may include mechanical means of destruction of the enclosure or control circuitry if the enclosure is disassembled for access to the control circuitry.

[0168] In an embodiment, stimulator 100 may be reusable and allow for sterilization between patients or surgeries. In an embodiment, patient contacting parts, such as the leads, may be disposable or single use. In an embodiment, stimulator 100 may record doses delivered.

[0169] Although the embodiments of the present teachings have been illustrated in the accompanying drawings and described in the foregoing detailed description, it is to be understood that the present teachings are not to be limited to just the embodiments disclosed, but that the present teachings described herein are capable of numerous rearrangements, modifications and substitutions without departing from the scope of the claims hereafter. The claims as follows are intended to include all modifications and alterations insofar as they come within the scope of the claims or the equivalent thereof.

Claims

CLAIMSWhat is claimed is:

1. A nerve stimulation system comprising: a housing; circuitry positioned entirely within the housing, wherein the circuitry generates an electrical stimulation signal having an amplitude and a duration; a microcontroller electrically coupled to the circuitry, wherein the microcontroller causes the circuitry to generate the stimulation signal; one or more leads connected to the circuitry in the housing, the one or more leads each having an electrically conductive surface coupled to the circuitry’, wherein the electrically conductive surface contacts a targeted tissue region and. when in contact, applies the stimulation signal from the circuitry to the targeted tissue region; a return electrode electrically coupled to the circuitry, wherein the return electrode provides an electrical flow path for the stimulation signal from the one or more leads back to the housing; a first control device positioned within the housing and electrically coupled to the microcontroller, wherein the first control device transmits a signal to the microcontroller that causes the circuitry to generate the stimulation signal over a first channel, through the one or more leads; a second control device positioned within the housing separate from the first control device, and electrically coupled to the microcontroller, wherein the second control device transmits a signal to the microcontroller that causes the circni try to generate the stimulation signal over a second channel, through the one or more leads; and one or more indicators fixed with the housing and electrically coupled to the microcontroller, wherein the one or more indicators generate visual indications, audioindications, or haptic indications that vary according to different status conditions of the circuitry7on a per channel basis.

2. The nerve stimulation system of claim 1 , wherein the microcontroller causes the one or more indicators to produce: a first indication comprising a predetermined light, sound, or vibration when, independent of contact between the one or more leads and the targeted tissue region, power to the circuitry is on due to operation of the first control device or the second control device; a second indication including a predetermined light, sound, or vibration different than the first indication when the circuitry receives the stimulation signal from the targeted tissue region through the return electrode due to operation of the first control device or the second control device; and a third indication comprising a predetermined light, sound, or vibration different than the first indication and the second indication when the circuitry is transmitting the stimulation signal to the targeted tissue region, and the circuitry is not receiving the stimulation signal through the return electrode.

3. The nerve stimulation system of claim 2, wherein the one or more indicators generate the first indication, the second indication, or the third indication in an off state.

4. The nerve stimulation system of claim 2. wherein the one or more indicators is a single visual indicator.

5. The nerve stimulation system of claim 1, further comprising a display fixed with the housing and operatively connected to the microcontroller.wherein the housing is sized and shaped to be held and controlled entirely within a single hand by a user, and the display indicates an operation selection of the stimulation system including a timing, a waveform, a pulse duration, a frequency, an amplitude, an intensity, or a predefined limit of the stimulation signal.

6. The nerve stimulation system of claim 5, wherein a first section of the display indicates the first channel at a location closer to a first lateral side of the housing as compared to a second lateral side of the housing opposite the first lateral side, and a second section of the display indicates the second channel at a location closer to the second lateral side as compared to the first lateral side.

7. The nerve stimulation system of claim 6, further comprising one or more ports at a distal end of the housing, wherein the one or more ports convey the stimulation signal through the housing to the one or more leads, or from the return electrode, and the display is located closer to the distal end of the housing as compared to a proximal end of the housing opposite the distal end.

8. The nerve stimulation system of claim 7, wherein the one or more indicators are interposed between and separate the one or more ports and the display along the housing, in a direction taken from the proximal end of the housing toward the distal end of the housing.

9. The nerve stimulation system of claim 6. further comprising a first button and a second button supported on the housing. wherein the first button actuates the first control device, causing the first control device to generate the stimulation signal over the first channel,the second button actuates the second control device, causing the second control device to generate the stimulation signal over the second channel, the first button is located closer to the first lateral side of the housing as compared to the second lateral side of the housing, the second button is located closer to the second lateral side of the housing as compared to the first lateral side of the housing, and both the first button and the second button are located at a side of the display opposite the one or more indicators.

10. The nerve stimulation system of claim 9, further comprising one or more ports at a distal end of the housing, wherein the one or more ports convey the stimulation signal through the housing to the one or more leads, or from the return electrode, the housing includes a proximal end opposite the distal end, and both the first button and the second button are located closer to a proximal end of the housing as compared to the distal end of the housing.

11. The nerve stimulation system of claim 1, wherein the one or more indicators includes a first indicator that indicates a status condition of the circuitry or the stimulation signal over the first channel, and the one or more indicators further include a second indicator that indicates a status condition of the circuitry or the stimulation signal over the second channel, wherein the first indicator is fixed to the housing at a location closer to a first lateral side of the housing as compared to a second lateral side of the housing opposite the first lateral side, and the second indicator is fixed to the housing at a location closer to the second lateral side as compared to the first lateral side.

12. The nerve stimulation system of claim 11, further comprising a first port that conveys the stimulation signal through the first channel, and a second port that conveys the stimulation signal through the second channel, wherein the first port is located closer to the first lateral side of the housing as compared to the second lateral side of the housing, and the second port is located closer to the second lateral side of the housing as compared to the first lateral side of the housing.

13. The nerve stimulation system of claim 1, wherein the stimulation signal conveyed through the first channel has a different stimulation parameter than the stimulation signal conveyed through the second channel.

14. A nerve stimulation system comprising: a housing sized and configured to be held and controlled entirely within a surgical field and in a single hand by a user perioperatively; circuitry positioned entirely within the housing, where the circuitry generates an electrical stimulation signal having an amplitude and a duration; one or more leads connected to the circuitry, and extended from the housing, each of the one or more leads having an electrically conductive surface coupled to the circuitry, the electrically conductive surface being sized and configured for contact with a targeted tissue region and. when in contact, applying the stimulation signal to the targeted tissue region; a return electrode electrically coupled to the signal generating circuitry, wherein the return electrode is sized and configured for contact with tissue to provide an electrical flow path for the stimulation signal from each of the one or more leads back to the stimulation control device;a first control device fixed within the housing, wherein the first control device causes the circuitry7to generate the stimulation signal over a first channel for a predetermined total single use period; a second control device fixed within the housing separate from the first control device, where the second control device causes the circuitry' to generate the stimulation signal over a second channel for a predetermined total single use period; and one or more visual indicators fixed on the housing, wherein the one or more visual indicators indicate status conditions during the total single use period of the stimulation signal over the first channel or the second channel, wherein the one or more visual indicators display: a first predetermined color or flash rate of light when power to the circuitry is on due to operation of the first control device or the second control device, a second predetermined color or flash rate of light different than the first predetermined color or flash rate of light when the circuitry' receives the stimulation signal from the targeted tissue region through the return electrode due to operation of the first control device or the second control device, and a third predetermined color or flash rate of light different than the first predetermined color or flash rate of light and the second predetermined color or flash rate of light when the circuitry is transmitting the stimulation signal to the targeted tissue region, and the circuitry is not receiving the stimulation signal through the return electrode.

15. The nerve stimulation system of claim 14, further comprising a first port that conveys the electrical stimulation signal from the housing through the first channel, and a second port that conveys the electrical stimulation signal from the housing through the second channel, wherein the first port is located closer to a first lateral side of the housing as comparedto a second lateral side of the housing opposite the first lateral side, and the second port is located closer to the second lateral side of the housing as compared to the first lateral side of the housing, the one or more leads includes a first lead that receives the stimulation signal from the first port, and a second lead that receives the stimulation signal from the second port, the one or more visual indicators comprises a first visual indicator that indicates a status condition of the circuitry’ or the stimulation signal over the first channel, and the one or more visual indicators further include a second visual indicator that indicates a status condition of the circuitry or the stimulation signal over the second channel, and the first visual indicator is fixed to the housing at a location closer to the first lateral side of the housing as compared to the second lateral side of the housing, and the second visual indicator is fixed to the housing at a location closer to the second lateral side as compared to the first lateral side.

16. The nerve stimulation system of claim 15, further comprising a first button and a second button supported on the housing, wherein the first button actuates the first control device, causing the first control device to generate the stimulation signal over the first channel, the second button actuates the second control device, causing the second control device to generate the stimulation signal over the second channel, the first button is located closer to the first lateral side of the housing as compared to the second lateral side of the housing, the second button is located closer to the second lateral side of the housing as compared to the first lateral side of the housing, and the first visual indicator is interposed between the first port and the first button alongthe housing, and the second visual indicator is interposed between the second port and the second button along the housing.

17. The nerve stimulation system of claim 16, wherein the first button actuates the first control device, causing the first control device to cycle through stimulation modes executed by the first control device over the first channel, or the second button actuates the second control device, causing the second control device to cycle through stimulation modes executed by the second control device over the second channel.

18. The nerve stimulation system of claim 14, wherein the one or more visual indicators includes a first visual indicator that indicates a status condition of the circuitry or the stimulation signal over the first channel, the one or more visual indicators further include a second visual indicator that indicates a status condition of the circuitry or the stimulation signal over the second channel, and the first visual indicator or the second visual indicator includes a set of two differently colored lights.

19. The nerve stimulation system of claim 14, further comprising a power source positioned entirely within the housing.

20. A hand-held nerve stimulation system comprising: a housing sized and configured to be held and controlled by a user using a single hand, entirely within a surgical field: circuitry housed within the housing, wherein the circuitry generates an electricalstimulation signal having a biphasic waveform and anet DC current of less than 10 microamps; an operative element extended from a distal end of the housing, wherein the operative element contacts a targeted tissue region, and conveys the stimulation signal from the circuitry7in the housing to the targeted tissue region; a return electrode providing an electrical flow path for the stimulation signal from the operative element, through the targeted tissue region, and back to the circuitry: a return lead electrically coupling the circuitry with the return electrode, return lead extending from the distal end of the housing; and one or more indicators on the housing and electrically coupled to the circuitry7, wherein the one or more indicators indicate confirm status conditions of the circuitry or the stimulation signal, wherein the circuitry: determines whether the electrical stimulation signal completes the electrical flow path by passing through the operative element, to the targeted tissue region, and back through the return electrode at a specified stimulation intensity, operates the one or more indicators to provide, in response to determining a stimulation intensity of the electrical stimulation signal is at the specified stimulation intensity, a first indication signal indicating delivery of the electrical stimulation signal completing the electrical flow path to the targeted tissue region and back through the return electrode, and operates the one or more indicators to provide, in response to determining the stimulation intensity is not at the specified stimulation intensity, a second indication signal indicating an absence or an inadequate delivery of the stimulation signal through the operative element, to the targeted tissue region, and back to the circuitry through the return electrode.

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