WO2025072668A1

WO2025072668A1 - Minimally invasive nerve regeneration systems and method

Info

Publication number: WO2025072668A1
Application number: PCT/US2024/048847
Authority: WO
Inventors: Ethan Miller; Mauricio CASTILLO; Eric Walker; Ben Cottrill
Original assignee: Checkpoint Surgical Inc
Current assignee: Checkpoint Surgical Inc
Priority date: 2023-09-29
Filing date: 2024-09-27
Publication date: 2025-04-03
Anticipated expiration: 2026-03-29

Abstract

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 devices, systems, and methods may be utilized to apply electrical stimulation closer in time to an injury or after a surgical repair and do not require exposure of the nerve, e.g., by surgery, prior to electrical stimulation of the nerve. The devices, systems, and methods may be used to apply electrical stimulation to a nerve for accelerating or enhancing regrowth or recovery of injured or potentially injured nerves before, during, after, or independent of a minimally invasive surgical approach.

Description

PATENT APPLICATION

Inventors: Ethan Miller

Mauricio Castillo

Eric Walker

Ben Cottrill Docket No.: 37694-00221

TITLE

MINIMALLY INVASIVE NERVE REGENERATION SYSTEMS AND METHOD

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The application claims priority to U.S. Patent Application No. 63/541,375, filed on September 29, 2023, entitled ‘’MINIMALLY INVASIVE NERVE REGENERATION SYSTEMS AND METHOD,” which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] The present disclosure relates generally to nerve regeneration devices, systems, and methods and. more particularly, to devices, systems, and methods that provide brief electrical stimulation therapy to a nerve for accelerating or enhancing regrowth or recovery of injured or potentially inj ured nen es before, during, after, or independent of a minimally invasive surgical approach.

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 damaged nerve fibers must re-grow from the point of intervention or repair to the target muscle. Nen e fibers grow at a rate of 1 mm/day, with a staggered initiation of re-growth, and have difficulty re-growing across long distances. Thus, recovery' takes a significant amount of time with full functional recovery seldom achieved.

[0006] Electrical stimulation is a therapeutic technique that can be used to promote nen e regeneration and recovery⁷. 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 or produce a muscle contraction, direct stimulation may allow for more precise, targeted, and localized electrical stimulation. Conventional systems and methods of direct nerve stimulation encompass electrical stimulation of the nerve prior to or following repair, preferably while still in the operating room, to improve functional outcome. As a result, application of direct nerve stimulation occurs as part of the medical care of nerve injuries, often concurrent with surgical repair, both of which can occur some time after initial injury and entail more invasive procedures.

[0007] There is a need to provide a method for delivering a period of electrical stimulation as soon as possible or reasonably soon following injury⁷. The present disclosure provides devices, systems, and methods where it may alternatively or additionally be desirable to initiate stimulation as part of a minimally invasive surgical procedure without the need to fully dissect and expose the nerve prior to electrical stimulation to promote nerve healing.

SUMMARY

[0008] The following presents a summary' of this disclosure to provide a basic understanding of 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.

[0009] 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 healing to improve functional outcomes. The devices, systems, and methods may be utilized to apply electrical stimulation closer in time to an injury'. This therapeutic stimulation may be before, during, or after a surgical repair or intervention and does not require exposure of the nerve, e.g., during a minimally-invasive carpal tunnel release surgery where the median nerve is not fully exposed. The devices, systems, and methods may be used to apply electrical stimulation to a nerve for accelerating or enhancing regrowth or recovery of injured or potentially injured nerves before, during, after, or independent of a minimally invasive surgical approach.

[0010] The devices, systems, and methods may be used to provide brief electrical stimulation therapy (BEST) to a nerve that has been decompressed or repaired in a minimally invasive surgery. The devices, systems, and methods may’ provide one or more (or all) of the following: an added component or adaptor to an existing minimally invasive surgery system such as an endoscopic carpal tunnel release tool, a sheath or insulator (e.g., an open ended sheath) that is positionable over an endoscopic tool or instrument (e.g., an instrument having a metal rod) such as a camera or scope and which may be able to adapt the instrument to provide targeted electrical stimulation (e.g., by an adaptor), a sheath (e g., a close ended sheath) that may serve or otherw ise be coupled to a lead to provide electrical stimulation, and several embodiments of leads having varying shapes of the lead body or anchor thereof to maintain a position of the lead in a patient’s body while also being able to be selectively removed from its position, such as a straight, spiral, fishbone/leaf, fin shape, shapes having adjustable shapes for insertion and/or removal positions and stationary, anchor, and/or stimulation positions, etc. as herein described.

[0011] Disclosed is an electrical stimulation system. In an embodiment, the electrical stimulation system may comprise a stimulator, an endoscopic device including a metal rod and a first distal end, and an insulator sheath. In an embodiment, the insulator sheath may comprise an open distal end and an open proximal end. In an embodiment, the sheath may be configured to insert over the metal rod of the endoscopic device leaving the first distal end exposed. In an embodiment, the stimulator may be configured to selectively couple to the metal rod through an adaptor.

[0012] In an embodiment, the exposed distal end of the endoscopic device may serve as an electrode. In an embodiment, the exposed distal end of the endoscopic device may be configured to provide electrical stimulation to a desired area.

[0013] Disclosed is an electrical stimulation system. In an embodiment, the electrical stimulation system may comprise a stimulator, an endoscopic device including an elongated portion and a first distal end, and a closed sheath. In an embodiment, the closed sheath may comprise a closed distal end and an open proximal end. In an embodiment, the sheath may be configured to insert over the elongated portion of the endoscopic device including the first distal end. In an embodiment, the stimulator may be configured to selectively couple to the closed sheath through a connector. [0014] In an embodiment, the closed sheath may include at least one electrode at the closed distal end. In an embodiment, the closed sheath may include a lead wire embedded through the closed sheath configured to electrically couple with the stimulator through the connector. In an embodiment, the connector may be a touch free plug. In an embodiment, the closed sheath may include a transparent portion at the closed distal end. In an embodiment, the transparent portion may be configured to allow view into the surgical area by a camera surrounded by the closed sheath.

[0015] Disclosed is an electrical stimulation system. In an embodiment, the electrical stimulation system may comprise a lead and an anchor. In an embodiment, the lead and anchor may comprise expanded and contracted positions to facilitate insertion of the lead and anchor into a target nerve area and anchoring of the lead and anchor into the target nerve area.

[0016] In an embodiment, the lead and anchor may comprise a leaf shape including one or more electrodes as a vein on the leaf. In an embodiment, the lead and anchor may comprise a spiral shape formed by a lead wire. In an embodiment, the lead and anchor may comprise a fishbone shape including one or more electrodes as a bone on the fishbone. In an embodiment, the lead and anchor may comprise a fin shape that is selectively expandable from and contractable into a sheath.

[0017] In an embodiment, the electrical stimulation system may further include a dilator. In an embodiment, the electrical stimulation system may further include an introducer.

[0018] Disclosed is a method for stimulating tissue. In an embodiment, the method for stimulating tissue may comprise providing a stimulation device selectively attachable to a therapy delivery device; placing the therapy delivery device within range of a target tissue region, wherein the therapy delivery device may be operatively attached to the stimulation device; applying a stimulation signal to the target tissue region with the therapy delivery device and the stimulation device; terminating the applying the stimulation signal. [0019] In an embodiment, the therapy delivery device may be an endoscopic carpal tunnel release tool including a connector to selectively attach to the stimulation device, and a stimulation electrode for delivering the electrical stimulation therapy to the target tissue region. In an embodiment, the therapy delivery' device may be a sheath covering an endoscope and wherein the sheath includes a connector to selectively attach to the stimulation device and a contact for therapy delivery⁷. In an embodiment, the therapy delivery⁷ device may be a lead including a connector to selectively attach to the stimulation device, and a stimulation electrode for delivering the electrical stimulation therapy to the target tissue region.

[0020] In an embodiment, the lead may⁷ include an anchor. In an embodiment, the anchor (or lead thereof) may have a leaf shape. In an embodiment, the anchor (or lead thereof) may⁷ have a fish shape. In an embodiment, the anchor (or lead thereof) may have a spiral shape. In an embodiment, the anchor (or lead thereof) may⁷ have a fin shape.

[0021] In an embodiment, the stimulation may be monopolar and may further include a return electrode. In an embodiment, the stimulation may be bipolar, and the sheath or lead may include both an anode and a cathode.

[0022] 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

[0023] 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:

[0024] FIG. 1 shows an embodiment of a first electrical stimulation system comprising an adaptor and insulator that may allow use of any tool (such as a carpal tunnel release tool) in conjunction with a stimulator to provide therapeutic stimulation in accordance with aspects disclosed herein;

[0025] FIGs. 2 shows an embodiment of a second electrical stimulation system comprising a sheath and lead that may be used in conjunction with a stimulator to provide therapeutic stimulation in accordance with aspects disclosed herein;

[0026] FIGs. 3-4 show enlarged partial views of an embodiment of a second electrical stimulation system comprising a sheath and lead that may be used in conjunction with a stimulator to provide therapeutic stimulation in accordance with aspects disclosed herein

[0027] FIG. 5 shows an embodiment of a second electrical stimulation system as inserted into a patient’s wrist in accordance with aspects disclosed herein;

[0028] FIGs. 6-8 show embodiments of an introducer that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0029] FIG. 9 shows an embodiment of an electrical stimulation lead that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0030] FIGs. 10-12 show an embodiment of an electrical stimulation lead and an anchor that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0031] FIGs. 13-15 show an embodiment of an electrical stimulation lead and an anchor that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0032] FIG. 16 shows an embodiment of an electrical stimulation lead and an anchor that may be used in an electrical stimulation system in accordance with aspects disclosed herein;

[0033] FIGs. 17-20 show a minimally invasive carpal tunnel release tool including two keyways allowing passage of a lead or cutting instrument in the top keyway and of an assembled endoscopic system in the bottom keyway;

[0034] FIGs. 21-22 show an embodiment of an electrical stimulation lead and an anchor that may be used in an electrical stimulation system in accordance with aspects disclosed herein [0035] FIG. 23 shows an embodiment of a method of using an electrical stimulation system in accordance with aspects disclosed herein.

[0036] The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, 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

[0037] 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.

[0038] 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.

[0039] As used herein, the words “example⁷’ 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.

[0040] Further, unless context suggests otherwise, descriptions of shapes (e.g., circular, rectangular, triangular, etc.) refer to shapes meeting the definition of such shapes and general representation 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.

[0041] Disclosed are devices, systems, and methods for deliver}' of electrical stimulation. Electrical stimulation may be applied directly to a site of nerve injury or damage to promote nerve growth and healing to improve functional outcomes. The devices, systems, and methods may be utilized to apply electrical stimulation closer in time to an injury. This therapeutic stimulation may be before, during, or after a surgical repair or intervention and does not require exposure of the nerve, e g., during a minimally-invasive carpal tunnel release surgery where the median nerve is not fully exposed. The devices, systems, and methods may be used to apply electrical stimulation to a nerve for accelerating or enhancing regrowth or recovery of injured or potentially injured nerves before, during, after, or independent of a minimally invasive surgical approach.

[0042] The devices, systems, and methods may be used to provide brief electrical stimulation therapy (BEST) to a nerve that has been decompressed or repaired in a minimally invasive surgery. The devices, systems, and methods may provide one or more (or all) of the following: an added component or adaptor to an existing minimally invasive surgery system such as an endoscopic carpal tunnel release tool, a sheath or insulator (e.g., an open ended sheath) that is positionable over an endoscopic tool or instrument (e.g., an instrument having a metal rod) such as a camera or scope and which may be able to adapt the instrument to provide targeted electrical stimulation (e.g., by an adaptor), a sheath (e.g., a close ended sheath) that may serve or otherw ise be coupled to a lead to provide electrical stimulation, and several embodiments of leads having varying shapes of the lead body or anchor thereof to maintain a position of the lead in a patient’s body while also being able to be selectively removed from its position, such as a straight, spiral, fishbone/leaf, fin shape, shapes having adjustable shapes for insertion and/or removal positions and stationary’, anchor, and/or stimulation positions, etc. as herein described.

[0043] The devices, systems, and methods may work with and use other compatible devices, for example, or the devices may be provided as a complete or integrated system. In an embodiment, an insulator (e.g., an open ended sheath) may be provided, see FIG. 1, wherein the insulator is positionable over an instrument and the instrument may be electrically insulated with the insulator except for the tip that, since exposed, can serve as an electrode to provide the electrical stimulation to a nen e site. An adaptor may be positioned on the instrument to couple the instrument to a stimulator and electrify the instrument, or more specifically, electrify a predetermined portion of the instrument, which may be at an end portion, mid-portion or any where along its length. In an embodiment, a combination sheath (e.g., close ended sheath) and lead, see FIGs. 2-5, may be provided wherein the sheath is positionable over an instrument and may include conductive wires and/or electrodes or may otherwise be coupled to a lead including electrodes to provide the electrical stimulation to a nerve site.

[0044] FIGs. 6-22 show embodiments of other components that may be used with the devices as part of a system, including embodiments of introducers, leads, and the like, which may be provided independently or for use with other compatible devices, for example. FIG. 23 shows an embodiment of a method thereof.

[0045] Turning to FIG. l, shown is a first electrical stimulation system 100 including an insulator or open ended sheath 110 and adaptor 120. In an embodiment the first electrical stimulation system 100 may be used with an instrument 6. In an embodiment, the first electrical stimulation system 100 may be used with an existing metallic endoscopic instrument(s) such as a carpal tunnel, cubital tunnel, or tarsal tunnel release tool. It is noted that any other instrument 6 may also be used as may be suitable or desired for a particular application or purpose. For example, the described systems 100 may be used with a dilator, blade assembly or other cutting instrument, scope, camera, light cord, etc. used in an endoscopic or other minimally invasive surgical approach. In an embodiment, the instrument 6 may include a metal rod.

[0046] The metal rod of instrument 6 may be used with the insulator or open ended sheath 110 and adaptor 120. In an embodiment, insulator 110 may comprise a first end and a second end, wherein both the first end and the second end are open. In an embodiment, insulator 110 may comprise a channel therethrough from the first open end to the second open end. In an embodiment, insulator 1 10 may comprise an electrically insulating material, including, without limitation rubber. In an embodiment, insulator 110 may comprise a generally tubular shape and may be sized and sized to fit over the corresponding metal rod of instrument 6. For example, insulator 110 may have the same or smaller diameter as the metal rod of instrument 6 and insulator 1 10 may be adapted to stretch or snugly fit over the metal rod of instrument 6 and remain in a desired position.

[0047] In an embodiment, insulator 110 may generally extend over and cover a portion (less than a majority thereof) or majority of the metal rod of instrument 6 excluding a distal area 113 and a proximal area 116.

[0048] For example, a portion of the metal rod of instrument 6 near a distal end 113 of the metal rod of instrument 6 may be exposed after insulator 110 is coupled to the metal rod of instrument 6. This exposed distal area 113 may serve as an electrode to provide electrical stimulation through a stimulator 5 as herein described. The stimulator 5 can comprise any appropriate configuration, including, without limitation, the stimulator described in U.S. Patent No. 10,470,678, which is incorporated herein by reference. It is noted that when inserted into a patient, the entire exposed distal area 113 may be inserted into the patient and positioned relative to or near the target nerve to guide stimulation to the target tissue. It is noted that when inserted into a patient, the insulated portion of the metal rod of instrument 6 covered by insulator 110 may be positioned at the surgical site and outside the surgical site so that undesired areas (including the surgical area) are not activated by the electrical stimulation.

[0049] For example, a portion of the metal rod of instrument 6 near a handle of instrument 6 or at a more proximal location 116 of the metal rod of instrument 6 may be exposed after insulator 110 is coupled to the metal rod of instrument 6. This exposed proximal area 1 16 may be coupled with adaptor 120. In an embodiment, adaptor 120 may be an alligator clip, hook, micro-grabber, or other attachment adaptor that allows attachment of a stimulator 5 to proximal area 1 16 and which facilitates electrical stimulation from stimulator 5, through adaptor 120 to proximal area 116, through metal rod of instmment 116 (including area covered by insulator 110), and to distal area 113 to provide electrical stimulation to a nerve of a patient. As described, the distal area 113 may be fully insertable into the patient so that electrical stimulation is only applicable to a desired area relative the target nerve and not to other undesired areas in the patient, surgical area, or general environment. In an embodiment, insulator 120 may be configured so that electrical current may only come out of the distal area 113 of instrument 6 through attachment with adaptor 120 at the proximal area 116 or instrument 6. Insulator 120 may provide insulation from the electrical cunent across the remainder or majority of the metal rod of instrument 6 excluding the distal area 113. Insulator 120 may provide insulation from the electrical current across the remainder or majority of the metal rod of instrument 6 excluding the distal area 113 and the proximal area 116.

[0050] In an embodiment, adaptor 120 may facilitate universal connectivity to any device(s), including, without limitation the stimulator 5. In an embodiment, adaptor 120 and insulator 110 may be used with an existing instrument 6, such as an endoscopic tool or carpal tunnel release tool. In an embodiment, adaptor 120 and open ended insulator 110 may allow use of electrical stimulation with a metal instrument 6, using and adapting the instrument 6 (which would not otherwise be able to provide electrical stimulation) to provide electrical stimulation and deliver therapy through stimulator 5.

[0051] In an embodiment, insulator 110 may be disposable and fit over an instrument, such as an endoscopic instrument, prior to its insertion through an incision and into a patient. In an embodiment, insulator 110 may serve both as a protector for the scope (or for the patient from the scope) and may facilitate electrical stimulation through the instrument by forming an electrode (e.g., through the exposed distal area 113 of the metal rod of instrument 6) to deliver electrical stimulation therapy. In such embodiments, the insulator 110 may be slid over the instrument 6.

[0052] Stimulator 5 may include a housing 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 5 may comprise one or more channels, such as two channels, which may provide two or more different electrical stimulation having different stimulation parameters.

[0053] Stimulator 5 may include a user interface. User interface may include one or more (or all) of the following: a power button, level or arrow buttons 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 5 may allow for a user to adjust stimulation parameters and monitor the real-time response on a display screen, for example. Stimulator 5 may include pulse algorithms to generate a pattern of pulses and multiple stimulation modes, including continuous, burst, and modulated modes. Stimulator 5 may also offer data storage capabilities, allowing for the recording and analysis of stimulation sessions for further assessment and documentation. It is noted that any stimulator may be used as may be suitable or desired for a particular purpose or intended application.

[0054] Turning to FIGs. 2-5 shown is a second electrical stimulation system 200 including a close ended sheath 230, one or more (or a plurality of) electrodes 240, and connector 210. In an embodiment the second electrical stimulation system 200 may be used with a scope 7. It is noted that the second electrical stimulation system 200 may also be used with any other instrument as may be suitable or desired for a particular application or purpose. For example, the described systems 200 may be used with a dilator, blade assembly or other cutting instrument, scope, camera, light cord, other endoscopic tool, a carpal tunnel release tool, etc. In an embodiment, the scope 7 or instrument may include an elongated portion or rod.

[0055] The elongated portion of scope 7 (or other instrument) may be used with the close ended sheath 230 and connector 210. In an embodiment, sheath 230 may comprise a distal end 229 and a proximal end 227. wherein the distal end 229 is closed and the proximal end is open 227. In an embodiment, sheath 230 may comprise a channel therethrough from the proximal open end 227 to the distal closed end 229. In an embodiment, sheath 230 may comprise an electrically insulating material. In an embodiment, sheath 230 may comprise a generally tubular shape and may be sized and sized to fit over the corresponding elongated portion of scope 7 (or other instrument). For example, sheath 230 may have the same or smaller diameter as the elongated portion of scope 7 (or other instrument) and sheath 230 may be adapted to stretch or snugly fit over the elongated portion of scope 7 (or other instrument) and remain in a desired position.

[0056] In an embodiment, sheath 230 may generally extend over and cover a portion or majority of the elongated portion of scope 7 (or other instrument) including its respective distal end. In an embodiment, sheath 230 may include a lead wire 242. In an embodiment, the lead wire 242 may be embedded in a wall of sheath 230, a second lumen, or may be coupled thereto through other attachment or general proximity. In an embodiment, sheath 230 may serve as a lead and may provide electrical stimulation through electrodes 240 at the distal end 229 of sheath 230 through lead wire 242 and attachment of a stimulator to the second electrical system 200. For example, stimulator (such as stimulator 5) may be attached or coupled to the second electrical system 200 through connector 210 located at the proximal end 227 of sheath 230, the stimulator and connection therefrom which electrifies lead wire 242 in sheath 230 and enables electrical stimulation to be applied through electrodes 240 at the sheath’s 230 distal end 229. In an embodiment, sheath 230 may serve as a lead and sheath 230 may deliver electrical stimulation therapy.

[0057] Scope 7 (or other endoscopic instrument) may selectively couple with sheath 230 and lead wire 242 to deliver electncal stimulation to a targeted area or nerve site. In an embodiment, a stimulator (such as stimulator 5) may include a first end configured to selectively couple with a mating first end of connector or plug 210. Connector 210 may include a second end configured to selectively couple with a proximal end 227 of sheath 230 or to lead wire 242. The sheath 230 may include lead wire 242 or may be otherwise coupled to a lead. Sheath 230 may be an insulating sheath that covers or embeds lead wire 242 or other lead and which covers a portion thereof but that leaves a distal end 229 of sheath 230 including one or more electrodes 240, coupled to lead wire 242 or other lead, exposed to provide electrical stimulation to the surrounding area.

[0058] As described, connector 210 may include first and second ends configured to selectively couple with each scope 7 (or other endoscopic instrument) and lead wire 242 and/or sheath 230. Connector 210 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. In an embodiment, the connector 210 may be a touch-proof plug. In an embodiment, connector 210 may be a receptacle plug. In an embodiment, connector 210 may be touch free. Connector 210 may be used to connect a stimulator to an instrument such as a scope or endoscopic carpal tunnel release tool. In an embodiment, a sheath 230 may include a plug 210, lead wire 242, and electrode 240 for electrical connection to a stimulator (such as stimulator 5).

[0059] As described, closed sheath 230 may generally circumscribe or be provided over a scope 7 (or other endoscopic instrument). It is noted that other endoscopic instruments can include a may a dilator, blade assembly or other cutting instrument, scope, camera, light cord, other endoscopic tool, a carpal tunnel release tool, etc. It is noted that a combination of endoscopic instruments may be referred to as an assembly. In an embodiment, sheath 230 may be disposable and fit over an endoscopic system prior to its insertion through an incision and into a patient. In an embodiment, sheath 230 may serve both as a protector for the scope (or for the patient from the scope) and as a lead (e.g., through lead wire 242) to deliver electrical stimulation therapy. In such embodiments, the sheath 230 may be slid over the scope 7.

[0060] In an embodiment, the sheath 230 may comprise an electrode 240 at an appropriate location on the sheath 230, such as at a distal end 229 that is first inserted into the body of a patient. Further, the sheath 230 may comprise a plurality of electrodes, which may be positioned around the sheath 230 in defined locations to apply electrical stimulation at a predefined location. In an embodiment, sheath 230 may include proximal 227 and distal 229 ends, wherein the proximal end 227 may include or be coupled to connector 210 and the distal end 229 may be configured to be inserted into a patient’s body and deliver electrical stimulation to a desired nerve location. Sheath 230 may provide a protective covering to the scope 7 and lead wire 242 that surrounds and isolates the one or more electrodes 240 on the distal end 229 of the sheath 230.

[0061] In an embodiment, the sheath 230 may have a transparent portion or window that facilitates an endoscopic system to see through sheath 230 while sheath 230 is positioned over the endoscopic system. In an embodiment, device may include an endoscopic sheath with a receptacle plug, a lumen housing one or more conductors, and a contact at the end or tip. Sheath 230 may provide one or more (or all) of the following: electrical insulation, mechanical protection, and user safety. Sheath 230 may comprise any insulating material as may be suitable or desired for a particular purpose or intended application, including, but not limited to, silicone, urethane, rubber, plastic, or any other biocompatible materials. Sheath 230 may be sized and shaped to conform to an endoscopic system or other endoscopic instrument and may be sufficiently flexible and durable to navigate to the desired nerve location as well as soft and malleable to navigate safely through the patient. For example, sheath 230 may include a material having a low durometer. In an embodiment, sheath 230 may ensure electrical stimulation is targeted at the instrument tip, e.g., distal end 229 of sheath 230.

[0062] FIGs. 17-20 shows an embodiment of a minimally invasive carpal tunnel release (CTR) system 330 where a series of dilators 340 are used for blunt dissection parallel to a median nerve. The CTR system 330 may include a cannula 332 and introducer 334. In an embodiment, cannula 332 may include two or more keyways or channels 336 to allow passage of different instruments, for example, a cutting instrument, a scope, a lead, sheaths applied thereon, and the like. In an embodiment, for example, the cannula 332 and introducer 334 may be inserted into a desired location. The introducer 334 may be placed inside cannula 332. The tip of the introducer 334 may be blunt to avoid tissue damage during insertion of the cannula 332 and introducer 334 assembly. The introducer 334 may provide mechanical support to the cannula 332 during insertion. The introducer 334 may be removed once placed in a desired location and an endoscopic system or device may be inserted through one of the keyways 336 of cannula 332. In an embodiment, a bottom keyway may be used for an endoscopic system and a top key way may be used for a cutting tool, such as a transverse carpal ligament cutting tool.

[0063] In an embodiment, cannula 332 and introducer 334 may be provided as two separate components. In an embodiment, cannula 332 and introducer 334 may be provided as a single unit. In an embodiment, the components of a minimally invasive carpal tunnel release system 330 may include a mating portion to connect to a stimulator as well as electrical contacts to act as anode or cathode for stimulation delivery.

[0064] In an embodiment, the components of a minimally invasive carpal tunnel release system 330 may include stimulator circuitry as well as anode or cathode for stimulation delivery. Generally, the CTR system 330 and cannula 332 may be used to visualize the transverse carpal ligament. In an embodiment, the CTR system 330 and cannula 332 may be used to visualize both the transverse carpal ligament and the median nerve.

[0065] System may allow for endoscopic placement of an electrode to a desired nerve site. As shown in FIG. 6. system may include an introducer 450. Introducer 450 may include a needle that is hollow and that includes a lumen 452 therein. In an example, the needle may be a Tuohy needle, modified Tuohy needle, or other similar needle. Introducer 450 may include a beveled or sharp-pointed distal end 451. In an embodiment, an ultrasonic device may be used to locate a nerve. Introducer 450 may be inserted in an area distanced from the nerve by its distal end 451 and navigated to a desired area adjacent or near the nerve. In an embodiment, a guidewire 453 may be inserted through the lumen 452 of the introducer 450 and the introducer 450 may be removed. The guidewire 453 may facilitate the placement of a subsequently inserted device, such as lead, sheaths, or other electrode device. In an embodiment, lead, sheaths, or other electrode device may be inserted through the lumen 452 of the introducer 450 directly and the introducer 450 may be sized and shaped to accommodate lead, sheaths, or other electrode device. Introducer 450 may provide single-stick percutaneous targeting.

[0066] As shown in FIG. 7, system may include an introducer 555 and sheath 559. Introducer 555 may be used to open a path proximal to a nerve and may include a distal end 557. In an embodiment, introducer 555 may be removed upon insertion of lead, sheaths, or other electrode device. In an embodiment, sheath 559 may remain in place during and following insertion of lead, sheaths, or other electrode device. In an embodiment, sheath 559 may itself include one or more electrodes to provide electrical stimulation to a desired nerve site, e.g., the introducing or delivery device and the electrical stimulation device may comprise a singular device. In an embodiment, sheath 559 or an included or embedded contact may be used as a return electrode for electrical stimulation. In an embodiment, the sheath 559 may be provided as a part of the lead so that the sheath 559 may be used as the body and/or anchor of the lead.

[0067] As shown in FIG. 8, lead 625 may be a spiral shaped lead. The lead 625 may be placed endoscopically through a break-away sheath 559 to provide stimulus to nerves that have been surgically exposed and decompressed. The lead 625 may have a conductive tip (e.g.. 629) that can be left in contact with the targeted nerve, allowing surgeons to stimulate the nerve after the surgical procedure is complete. It is noted that the lead 625 may also be used under direct visualization during open surgical cases on exposed nerves without utilizing the break-away sheath 559.

[0068] In an embodiment, tissue dilator 340 may be configured to create space and bluntly dissect tissue around the targeted nerve and may be made of biocompatible ABS material. The break-away sheath 559 and introducer 555 may be made of biocompatible high-density polyethylene, polytetrafluoroethylene, and low-density polyethylene. In an embodiment, the tip of the break-away sheath 559 may include a stainless-steel marker detectable under fluoroscopy for placement.

[0069] After the lead 625 is placed at a desired nerve site, the break-away sheath 559 can break away leaving the lead on top of the targeted nerve. In an embodiment, the lead may comprise a stainless-steel core and a stainless-steel coil. The conductive tip (e.g., at the distal end 629) may comprise a spiral shape. In an embodiment, the spiral shape may comprise approximately four revolutions as shown in FIG. 8. The approximately four revolutions may provide for a greater nerve contact area. In an embodiment, the lead 625 may be covered with medical grade heat shrink except for the spiral contact tip. The lead 625 may include a touch-proof connector (e.g. connector 210) at the proximal end 627 of the lead 625 to connect with a stimulator (e.g., stimulator 5). A straightener may be provided to guide and straighten the spiral tip of the lead 625 through the break-away sheath 559 to the desired nerve site.

[0070] Turning to FIG. 9, shown is an embodiment of a lead 25. Lead 25 may generally include an elongated body or shaft and one or more electrodes 40 on its distal end 29. It is noted that the one or more electrodes 40 may be separate electrodes 40. In an embodiment, the multiple electrodes may be individually or selectively activated, activated in a pattern, and the like. Lead 25 may be unipolar. Lead 25 (or system or other components thereof) may include one cathode and one anode. In an embodiment, the multiple contacts and/or the multiple electrodes may have a larger surface area to reduce charge density. For example, the described anchor 80 having fishbone shape and electrodes 40 thereon (shown in FIG. 16) may allow more contact of the nerve where the nerve is smaller than the anchor 80 and electrode 40 surface area.

[0071] Lead 25 may be generally cylindrical. Lead 25 may have a rounded or smooth distal end 29. In an embodiment, lead 25 may have a diameter of approximately 0.5 mm. In an embodiment, lead 25 may have a diameter of approximately 0. 1 to 0.9 mm. In an embodiment, lead 25 may include one or more annular rings. The one or more annular rings may serve as electrodes 40. In an embodiment, the one or more annular rings may be stainless steel. In an embodiment, the one or more annular rings may be platinum or platinum: iridium. In an embodiment, the one or more annular rings may be any biocompatible electrical conductor. In an embodiment, the one or more annular rings may have a length of approximately 1 mm. In an embodiment, the one or more annular rings may have a length that is greater than the diameter of the lead 25. In an embodiment, lead 25 may include medical grade barium sulfate or other biocompatible contrast agents.

[0072] The described lead 25 and systems thereof may be used in nen e decompression cases where the nerve is not circumferentially freed from or accessible due to the surrounding tissue. Lead 25 and systems thereof may provide a low-profile (e.g., thin) insertion and placement. Lead 25 and systems thereof may be used for non-invasive procedures while still providing desired access to the nerve site for electrical stimulation.

[0073] FIGs. 10-16 and 21-22 show various embodiments of leads and anchors 60, 70, 80, 90 which can facilitate reliable, consistent, and/or uniform electrical stimulation of the nerve during or after minimally invasive surgery without the need for full 360° exposure of the nerve. Anchors 60, 70, 80, 90 (which may include electrodes of varying shapes and sizes integrated or incorporated thereon into the respective anchor portions of the lead) may ensure that the lead does not migrate or disconnect from its position relative the nerve. It is noted that the anchors 60. 70, 80, 90 having electrodes thereon may also be referred to as leads. It is noted that leads and anchors may be used interchangeably in these embodiments. It is noted that the anchors may be integrated with the leads. In an embodiment, the leads and anchors may be fully integrated. In an embodiment, the leads (e.g.. designs and shapes of the leads) may form the anchors. In an embodiment, the leads (e.g., designs and shapes of the leads) may comprise anchors. In an embodiment, the anchors may incorporate the electrodes (and, in an embodiment, may form the leads).

[0074] In an embodiment, the leads (e.g., leads 25, 625 and anchors 60, 70, 80, 90) may be placed endoscopically through a break-away sheath 559 to provide stimulus to nerves that have been surgically exposed and decompressed. The spiral lead 625, for example, may be left in contact with the targeted nerve, allowing surgeons to stimulate the nerve before, during, and/or after the surgical procedure is complete. A connector 210 at the proximal end of the lead will mate with a stimulator. An alternative to this design is to place the spiral lead 625 under direct visualization during open surgical cases on exposed nerves without utilizing the break-away sheath 559.

[0075] The lead body 625 comprises a medical grade wire with a spiral shape tip with multiple concentric revolutions for greater nerve contact area. In an embodiment, the coil tip may be stainless steel and the non-contacting portion of the spiral lead 625 may be insulated with a polytetrafluoroethylene insulator.

[0076] In some embodiments the lead introducer 555 may be comprised of biocompatible high- density polyethylene, polytetrafluoroethylene, and low-density polyethylene. The tip of the sheath 559 may include a radio-opaque marker.

[0077] Turning to FIGs. 10-12, shown is an embodiment of lead including anchor 60 in expanded and contracted states. In an embodiment, anchor 60 may have an inflatable mechanism that facilitates transition between contracted and expanded states and vice versa. As described, lead and anchor 60 may comprise one or more electrodes 40 at its distal end 29. In a proximal configuration, the one or more electrodes 40 may be located closer to the body or proximal end 27 of the lead, e.g., “behind” the anchor 60. For example, anchor 60, may be positioned at, near, or adjacent distal end 29 of lead. In an embodiment, the one or more electrodes 40 may be placed closer to the distal end 29 of lead than anchor 60. In an embodiment, the one or more electrodes 40 may be integrated onto anchor 60. [0078] Anchor 60 may be selectively expandable and contractible. In an embodiment, actuation of the anchor 60 may comprise a cable or wire 64 within a lumen 65. The cable 64 and lumen 65 may extend from anchor 60 at, near, or adjacent distal end 29 and to a trigger 66 that may be actuated by a user. For example, trigger 66 may be provided as a handle or lever that pulls and releases wire 64 and thereby expands and contracts anchor 60. Trigger 66 may be distanced from the one or more electrodes 40 so that control of anchor 60 may be provided outside of the body by a user while the one or more electrodes are inserted and positioned in the body at the desired nerve site. For example, trigger 66 may be provided at, near, or adjacent the proximal end 27 of lead or at a proximal end of the device generally. In an embodiment, anchor 60 may be able to provide a small force to interact with the surrounding tissue and provide access to and reliable stimulation of the nerve during or after minimally invasive surgery compared to conventional methods that can require full exposure of the nerve to provide electrical stimulation. In an embodiment, anchor 60 may allow the one or more electrodes 40 to make contact with the nerve or nerve site. In an embodiment, anchor 60 may secure or anchor the lead in a desired position during delivery of the electrical stimulation.

[0079] Although a mechanically actuated anchor 60 comprising a cable 64 and lever 66 mechanism to selectively expand and contract a mechanical linkage assembly is described, it is noted that other actuating mechanisms may also be used. For example, anchor 60 may be provided with an isolated hydraulic actuator that inflates anchor 60. Anchor 60, for example, may be selectively expanded with fluid, such as saline. In an embodiment anchor 60 may resemble a balloon.

[0080] As shown in FIG. 12, anchor 60 may have a generally rounded, planar shape. In an embodiment, anchor 60 may have a generally ovular, planar shape (e.g.. may have a 2- dimensional shape). In an embodiment, anchor 60 may not be planar and may have a 3- dimensional shape, such as an ovoid. Anchor 60 (e.g., provided as a balloon) may comprise a unique shape that may conform to any specific needs as desired, such as the location, depth, and access to the nerve site, the anatomy of the patient, incision placement and size, delivery method, surgical exposure, nen e size, the type of minimally invasive surgery or medical intervention, and the like. It is noted that other shapes may also be used as may be suitable or desired for a particular purpose or intended application. In an embodiment, anchor 60 may taper on a distal side (e.g., toward the one or more electrodes 40 or the distal end 29 of lead) and/or taper on a proximal side (e.g., toward the proximal end 27 of lead). A midpoint between the distal and proximal sides of the anchor may have the largest width of anchor 60 (and of the device generally) when in an expanded state. Anchor 60 may fold onto itself in a contracted state. The contracted state may be similar to that shown in FIG. 13, in an example.

[0081] Generally, anchors 60, 70, 80, 90 may be configured to be fed through a small insertion for minimally invasive surgery (e.g., in a contracted state) or separate access portal and deployed during electrical stimulation (e.g., in an expanded state) to provide reliable, consistent, and/or uniform electrical stimulation of the nerve during or after minimally invasive surgery without having to otherwise directly expose the nerve. After electrical stimulation the anchors 60, 70, 80, 90 may be configured to re-collapsed (e.g., to a contracted state or as part of a retrieval mechanism) such that the lead can be removed through the same small insertion as it was inserted without requiring additional expansion of the insertion point to accommodate the lead and/or anchors 60, 70, 80, 90 during removal. In the contracted state, the anchors 60, 70. 80, 90 may have a generally tubular or cylindrical shape, in an example. In an embodiment, the forces from pulling the device for removal may cause the collapse or retraction of the anchors 60, 70. 80. 90 to allow for removal. In an embodiment, the trigger mechanism 66 may be used to collapse or retract the anchors 60, 70. 80. 90 to allow for removal.

[0082] It is noted that the lead and electrodes 40 may be left in the patient following surgery so that electrical stimulation may be applied at a later time and/or enable multiple doses. For example, the electrodes 40 may be left in the patient immediately after a surgical procedure. Electrical stimulation may be applied to a target nerve for the purposes of nen e regeneration for a period of time that is greater than 5 minutes but less than 30 minutes, e.g., 10-20 minutes. The described anchors 60, 70, 80, 90 may assist in preventing migration of the lead and electrodes 40 during application of electrical stimulation or thereafter.

[0083] Anchor 60 (or lead or portion of the lead thereof) may comprise any material as may be suitable or desired for a particular purpose or intended application, including, but not limited to, silicone, Nylon, Pebax, PET, Pellethane, urethane, rubber, plastic, or any other biocompatible materials and may comprise materials with high compliance and burst pressure such as polyurethane, silicone, PEBA or other biocompatible thermoplastic elastomers for example. Anchor 60 may be sufficiently flexible and durable to navigate to the desired nen e location in a contracted state, expand to a desired size and shape to allow consistent positioning and anchoring of the lead to the nerve site to facilitate reliable electrical stimulation of the nerve prior to and during electrical stimulation in a minimally invasive surgery without the need for 360 exposure of the nerve, and re-contract to facilitate removal of the device from the body. For example, anchor 60 may include a material having a low durometer. Anchor 60 may be soft and malleable for compressibility. In an embodiment, anchor 60 may be covered by or comprise a biocompatible insulation. In an embodiment, anchor 60 may be covered by or comprise the same biocompatible insulation as sheath 230. In an embodiment, anchor 60 and sheath 230 may be continuous or monolithically formed. In an embodiment, anchor 60 may be covered by or comprise a different biocompatible insulation compared to sheath 230. In an embodiment, anchor 60 and sheath 230 may be separately formed and positioned adjacent or near one another on lead.

[0084] Turning to FIGs. 13-15, shown is an embodiment of lead, including anchor 70 in an expanded and a contracted state. In an embodiment, anchor 70 may have a mechanical mechanism that facilitates transition between contracted and expanded states and vice versa.

Anchor 70 may be generally similar to anchor 60 except in the actuation (e.g., inflation vs. mechanical mechanism).

[0085] FIGs. 13-15 show a mechanical mechanism that may provide an expandable and contractible anchor 70. It is noted that the number of joints and flex points and the resulting shape (2-dimensional or 3-dimensional) of the anchor 70 may be modified and that the mechanical actuation shown and described may be utilized to provide an anchor having any size and shape as may be suitable or desired for a particular purpose or intended application. For example, anchor 70 may be positioned at, near, or adjacent distal end 29 of lead. In an embodiment, the one or more electrodes 40 may be placed closer to the distal end 29 of lead than anchor 70. Anchor 70 may be selectively expandable and contractible. Anchor 70 may include mechanical actuation using a wire within a lumen and a lever to remotely trigger anchor 70 inside of the body to expanded and contracted states by an actuator that is outside of the body. Anchor 70 may be provided with an isolated pneumatic actuator that inflates anchor 70 to provide an expanded state. Anchor 70 (or lead or portion of the lead thereof) may comprise any material as may be suitable or desired for a particular purpose or intended application, including, but not limited to, silicone, urethane, rubber, plastic, or any other biocompatible materials. Anchor 70 may be sufficiently flexible and durable to navigate to the desired nen e location in a contracted state, expand to a desired size and shape to allow' consistent positioning and anchoring of the lead to the nerve site to facilitate reliable electrical stimulation of the nerve prior to and during electrical stimulation in a minimally invasive surgery without the need for 360 exposure of the nerve, and re-contract to facilitate removal of the device from the body. For example, anchor 70 may include a material having a low durometer. Anchor 70 may be soft and malleable for compressibility. Anchor 70 may be provided integral to sheath 230 or separate from sheath 230. [0086] As shown in FIGs. 13-15, anchor 70 may have a generally triangular, planar shape. In an embodiment, anchor 60 may have a kite or diamond, planar shape (e g., may have a 2- dimensional shape). In an embodiment, anchor 70 may not be planar and may have a 3- dimensional shape. Anchor 70 may comprise a unique shape that may conform to any specific needs as desired, such as the location, depth, and access to the nerve site, the anatomy of the patient, incision placement and size, delivery method, surgical exposure, nerve size, the t pe of minimally invasive surgery or medical intervention, and the like. It is noted that other shapes may also be used as may be suitable or desired for a particular purpose or intended application. In an embodiment, anchor 70 may taper on a distal side (e.g., toward the one or more electrodes 40 or the distal end 29 of lead) and/or taper on a proximal side (e.g., toward the proximal end 27 of lead). Anchor 70 may taper more gradually towards on the proximal side and more severely on the distal side. A midpoint between the distal and proximal sides of the anchor may have the largest width of anchor 70 (and of the device generally) when in an expanded state. Anchor 70 may fold onto itself in a contracted state.

[0087] In an embodiment, anchor 70 may have a triangular or octahedral shape, see also FIG. 12 and anchor 60. In an embodiment, anchor 70 may have a lead or fishbone shape, see also FIG. 16 and anchor 80. Generally, the tapering of the shapes may allow lead to be inserted and translated through introducer 55 (e.g.. in a contracted state) and deployed outside of the introducer for delivery of electrical stimulation (e.g., in an expanded state). Generally, the tapering of the shapes may allow lead to be re-collapsed for retrieval and removal from the patient.

[0088] Turning to FIG. 16, shown is an embodiment of lead, including anchor 80. As described, lead may comprise one or more electrodes 40 at its distal end 29. Anchor 80, for example, may be positioned at, near, or adjacent distal end 29 of lead and may include the one or more electrodes 40. For example, the one or more electrodes 40 may be integrated onto anchor 80. The one or more electrodes 40, in an embodiment, may resemble a “fishbone'’ or “leaf veining” with the electrodes 40 comprising the “bones” or “veins” positioned on the leafshaped lead. Similar to anchors 60, 70, anchor 80 may be contractible and expandable for insertion into and removal from a patient in a minimally invasive manner and during electrical stimulation when positioned at the target nerve site. In an example, anchor 80 may appear flat from the side, e.g., may be generally planar, and the wire 84 may appear cylindrical.

[0089] Anchor 80 may be used in endoscopic applications. In an embodiment, anchor 80 (and lead thereof) may be provided as an intraoperative single-patient disposable device. In an embodiment, anchor 80 (and lead thereof) may be placed endoscopically (or open) to provide stimulus to nerves that have been surgically exposed, allowing the surgeons to stimulate a targeted nen e under direct visualization with the aid of an endoscope or an ultrasound machine. In an embodiment, anchor 80 (and lead thereof) may be inserted inside a deliver}⁷ catheter system and under direct visualization placing the lead on top of the desired nerves.

[0090] In an embodiment, anchor 80 may include a flexible substrate body. The body may provide the surface area necessary for the fishbone electrode to have good contact with the targeted nerves. In an embodiment, anchor 80 may include a flexible fishbone contact, e.g. the one or more electrodes 40. The fishbone contacts 40 may interface with the nerve and deliver the desired electrical stimulus. In an embodiment, anchor 80 (or lead) may include a retrieval mechanism 86. for example suture material, wire, or braided polyester (such as braid polyester coated with polybutylate for easier handling). Atouch proof pigtail connector (e.g., 210 in FIG. 2 and 627 in FIG. 8) may be able to interface with a variety of stimulators 5, for example, or other devices. It is noted that connectors are shown in FIGs. 1, 2, 8. 11. 12. for example.

[0091] As shown in FIG. 16, anchor 80 may have a generally rounded, planar shape. In an embodiment, anchor 80 may have a generally ovular, planar shape. In an embodiment, anchor 80 may resemble a “leaf.” Anchor 80 may have smooth edges. Anchor 80 may comprise a unique shape that may conform to any specific needs as desired, such as the location, depth, and access to the nerve site, the anatomy of the patient, incision placement and size, delivery method, surgical exposure, nen e size, the type of minimally invasive surgery or medical intervention, and the like. It is noted that other shapes may also be used as may be suitable or desired for a particular purpose or intended application. In an embodiment, anchor 80 may taper on a distal side (e.g., toward the one or more electrodes 40 or the distal end 29 of lead) and/or taper on a proximal side (e.g., toward the proximal end 27 of lead). Anchor 80 may taper more gradually towards the proximal side and more severely on the distal side. A midpoint between the distal and proximal sides of the anchor may have the largest width of anchor 80 (and of the device generally).

[0092] Anchor 80 (or lead or portion of the lead thereol) may comprise any material as may be suitable or desired for a particular purpose or intended appl icati on, including, but not limited to, silicone, urethane, rubber, plastic, or any other biocompatible materials. Anchor 80 may be sufficiently flexible and durable to navigate to the desired nerve location, allow consistent positioning and anchoring of the lead to the nerve site to facilitate reliable electrical stimulation of the nerve prior to and during electrical stimulation in a minimally invasive surgery without the need for 360 exposure of the nerve, and re-contract to facilitate removal of the device from the body. For example, anchor 80 may include a material having a low durometer. Anchor 80 may be soft and malleable for compressibility. In an embodiment, anchor 80 may be covered by or comprise a biocompatible insulation. For example, anchor 80 (or other component of lead) may comprise materials with high compliance and burst pressure such as polyurethane, silicone, PEBA or other biocompatible thermoplastic elastomers for example. In an embodiment, anchor 80 may be covered by or comprise the same biocompatible insulation as sheath 230. In an embodiment, anchor 80 and sheath 230 may be continuous or monolithically formed. In an embodiment, anchor 80 may be covered by or comprise a different biocompatible insulation compared to sheath 230. In an embodiment, anchor 80 and sheath 230 may be separately formed and positioned adjacent or near one another on lead.

[0093] Turning to FIGs. 21-22, shown is an embodiment of lead, including anchor 90. As described, lead may comprise one or more electrodes 40 at its distal end 29. Anchor 90, for example, may be positioned at, near, or adjacent distal end 29 of lead and may include the one or more electrodes 40. For example, the one or more electrodes 40 may be integrated onto anchor 90. The one or more electrodes 40, in an embodiment, may resemble a “fin.” Similar to anchors 60, 70, 80, anchor 90 may be contractible and expandable for insertion into and removal from a patient in a minimally invasive surgery or manner and during electrical stimulation when positioned at the target nerve site. In an example, anchor 90 may include backwards shark fin shape that is biased with a spring towards an extended position. While in a sheath the fin/anchor 90 may be folded down to the size of the sheath but then w hen the fin is pushed out of the sheath, the fin pops out w ith an electrode contact/contacts. The fin can be rotated in place or pulled back into the sheath.

[0094] Anchor 90 may be used in endoscopic application. In an embodiment, anchor 90 (and lead thereof) may be provided as an intraoperative single-patient disposable device. In an embodiment, anchor 90 (and lead thereof) may be placed endoscopically (or open) to provide stimulus to nerves that have been surgically exposed, allowing the surgeons to stimulate a targeted nerve under direct visualization or with the aid of an endoscope or an ultrasound machine. In an embodiment, anchor 90 (and lead thereof) may be inserted inside a delivery catheter system and under direct visualization placing the lead on top of the desired nerves.

[0095] In an embodiment, anchor 90 (or lead) may include a retrieval mechanism 96, such as a touch proof pigtail connector, e.g.. plug 210. The touch proof pigtail connector may be able to interface with a variety of stimulators 5, for example, or other devices.

[0096] As shown in FIG. 21. anchor 90 may have a generally rounded, protruding shape. In an embodiment, anchor 90 may resemble a “fin.’' In an embodiment, anchor 90 may have smooth edges. In an embodiment, anchor 90 may comprise a fin protruding 90 degrees from the length of the lead. In an embodiment, the tip of the anchor 90 fin may include an electrode 40. Anchor 90 may comprise a unique shape that may conform to any specific needs as desired, such as the location, depth, and access to the nerve site, the anatomy of the patient, incision placement and size, delivery' method, surgical exposure, nerve size, the type of minimally invasive surgery or medical intervention, and the like. It is noted that other shapes may also be used as may be suitable or desired for a particular purpose or intended application.

[0097] Anchor 90 (or lead or portion of the lead thereof) may comprise any material as may be suitable or desired for a particular purpose or intended application, including, but not limited to, silicone, Nylon, Pebax, PET, Pellethane, urethane, rubber, plastic, or any other biocompatible materials and may comprise materials with high compliance and burst pressure such as polyurethane, silicone, PEBA or other biocompatible thermoplastic elastomers for example. Anchor 90 may be sufficiently flexible and durable to navigate to the desired nen e location in a contracted state, expand to a desired size and shape to allow consistent positioning and anchoring of the lead to the nerve site to facilitate reliable electrical stimulation of the nerve prior to and during electrical stimulation in a minimally invasive surgery' without the need for 360 exposure of the nerve, and re-contract to facilitate removal of the device from the body. For example, anchor 90 may include a material having a low durometer. Anchor 90 may be soft and malleable for compressibility. In an embodiment, anchor 90 may be covered by or comprise a biocompatible insulation. In an embodiment, anchor 90 may be covered by or comprise the same biocompatible insulation as sheath 230. In an embodiment, anchor 90 and sheath 230 may’ be continuous or monolithically formed. In an embodiment, anchor 90 may be covered by or comprise a different biocompatible insulation compared to sheath 230. In an embodiment, anchor 90 and sheath 230 may be separately formed and positioned adjacent or near one another on lead.

[0098] Turning to FIG. 23, shown is method 1200. Method 1200 may be utilized for the positioning and deployment of lead for electrical stimulation using the described system. For example, step 1210 may comprise inserting a cannula with an introducer to a desired nerve site. For example, step 1220 may comprise removing the introducer from the cannula and inserting a lead comprising an anchor in a contracted state through the cannula to a targeted nerve. For example, step 1230 may comprise expanding the anchor to a desired size. It is noted that the anchor may be re-contracted, adjusted, and re-expanded as may be desired for placement and anchoring of the lead and electrodes. For example, step 1240 may comprise applying electrical stimulation through a stimulator to one or more electrodes on the lead. For example, step 1250 may comprise re-contracting the anchor and withdrawing the lead from the nerve site. For example, step 1260 may comprise re-inserting the introducer into the cannula and removing the introducer and cannula from the desired nen e site. In an embodiment, methods of use may include non-operative uses. In an embodiment, methods of use may include endoscopic release delivery (e.g., for lead delivery). In an embodiment, methods of use may include non-operative delivery, post-operative delivery, pre-operative delivery, and/or delivery after an anesthesia nerve block wears off (e.g., for stimulation therapy delivery). In an embodiment, methods of use may include non-operative electrode placement though ultrasound or electrical stimulation localization of motor targets.

[0099] In an embodiment, the described anchors 60, 70, 80. 90 and leads 25, 625, corresponding systems, and methods 1200 thereof may allow for electrical stimulation before, during, and/or after a neurolysis such as. but not limited to, decompression of the median nerve in the carpal tunnel, decompression of the ulnar nerve in the cubital tunnel, decompression of tibial nerve at the tarsal tunnel, and the like. In another embodiment this treatment and use described herein including the described anchors 60, 70, 80. 90 and leads 25, 625, corresponding systems, and methods 1200 thereof, may be applied to a target nen e during endoscopic surgery of the shoulder, knee, or wrist (or other body area) where an endoscope is in use.

[00100] In an embodiment, the described anchors 60, 70, 80, 90 leads 25, 625, corresponding systems, and methods 1200 thereof may allow for electrical stimulation after WALANT procedures, such as trigger finger, carpal tunnel syndrome, De Quervain tenosynovitis, other forms of tendonitis, and the like. In an embodiment, the described anchors 60, 70, 80, 90 leads 25, 625, corresponding systems, and methods 1200 thereof may allow for electrical stimulation in non-invasive procedures such as an endoscopic nerve/tendon release. These systems and methods may also be used in other procedures where a nerve may be injured, enabling treatment at the time or soon after nerve injury potentially to avoid an additional surgical intervention.

[00101] 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 nerves 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 intensity 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 nerve 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 waveform.

[00102] In an embodiment, the minimally invasive carpal tunnel release system 330 described anode or cathode for stimulation delivery thereof may be used for the assessment activity above. These stimulation waveforms could be delivered through the same lead, or through different leads for each different waveform or use. The system may include the ability to move or remove the lead for the delivery of the assessment or therapeutic waveform(s) to enable performance of other aspects of the surgery, then lead moved or replaced to enable assessment or therapeutic waveform delivery.

[00103] In an embodiment, the stimulation waveforms for location, assessment, and/or therapeutic dose may be delivered using contacts built into carpal tunnel release system cannula or introducer.

[00104] 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 be configured 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.

[00105] 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

CLAIMS What is claimed is:

1. An electrical stimulation system, comprising: a stimulator; an endoscopic device comprising a metal rod and a first distal end; and an insulator sheath, wherein the insulator sheath comprises an open distal end and an open proximal end, wherein the insulator sheath is configured to insert over the metal rod of the endoscopic device leaving the first distal end exposed, and wherein the stimulator is configured to selectively couple to the metal rod through an adaptor.

2. The electrical stimulation system of claim 1 wherein the exposed distal end of the endoscopic device serves as an electrode.

3. The electrical stimulation system of claim 1 wherein the exposed distal end of the endoscopic device is configured to provide electrical stimulation to a target area.

4. An electrical stimulation system, comprising: a stimulator; an endoscopic device including an elongated portion and a first distal end; and a closed sheath, wherein the closed sheath comprises a closed distal end and an open proximal end, wherein the sheath is configured to insert over the elongated portion of the endoscopic device including the first distal end, and wherein the stimulator is configured to selectively couple to the closed sheath through a connector.

5. The electrical stimulation system of claim 4 wherein the closed sheath includes at least one electrode at the closed distal end and a lead wire embedded through the closed sheath configured to electrically couple wi th the stimulator through the connector.

6. The electrical stimulation system of claim 4 wherein the connector is a touch free plug.

7. The electrical stimulation system of claim 4 wherein the closed sheath includes a transparent portion at the closed distal end.

8. The electrical stimulation system of claim 7 wherein the transparent portion is configured to allow view into a surgical area by a camera surrounded by the closed sheath.

9. An electrical stimulation system, comprising: a lead and an anchor, wherein the lead and the anchor comprise expanded and contracted positions to facilitate insertion of the lead and the anchor into a target nerve area and anchoring of the lead and the anchor into the target nerve area.

10. The electrical stimulation system of claim 9 wherein the lead and the anchor comprise a leaf shape comprising one or more electrodes as a vein on the lead and the anchor.

11. The electrical stimulation system of claim 9 wherein the lead and the anchor comprise a spiral shape formed by a lead wire.

12. The electrical stimulation system of claim 9 wherein the lead and the anchor comprise a fishbone shape comprising one or more electrodes as a bone on the lead and the anchor.

13. The electrical stimulation system of claim 9 wherein the lead and the anchor comprise a fin shape that is selectively expandable from and contractable into a sheath.

14. The electrical stimulation system of claim 9 further including a dilator.

15. The electrical stimulation system of claim 9 further including an introducer.

16. A method for stimulating tissue, compnsing: providing a stimulation device selectively attachable to a therapy delivery device; placing the therapy delivery device within range of a target tissue region, wherein the therapy delivery⁷ device is operatively attached to the stimulation device; applying a stimulation signal to the target tissue region with the therapy delivery⁷ device and the stimulation device; and terminating the applying the stimulation signal.

17. The method of stimulating tissue of claim 16 wherein the therapy delivery⁷ device is an endoscopic carpal tunnel release tool comprising a connector to selectively attach to the stimulation device, and a stimulation electrode for delivering electrical stimulation therapy to the target tissue region.

18. The method of stimulating tissue of claim 16 wherein the therapy⁷ delivery device is a sheath covering an endoscope and wherein the sheath includes a connector to selectively attach to the stimulation device and a contact for therapy⁷ delivery.

19. The method of stimulating tissue of claim 16 wherein the therapy delivery device is a lead comprising a connector to selectively attach to the stimulation device, and a stimulation electrode for delivering electrical stimulation therapy to the target tissue region.

20. The method of stimulating tissue of claim 19 wherein the lead includes an anchor.

21. The method of stimulating tissue of claim 20 wherein the anchor has a leaf shape.

22. The method of stimulating tissue of claim 20 wherein the anchor has a fish shape.

23. The method of stimulating tissue of claim 20 wherein the anchor has a spiral shape.

24. The method of stimulating tissue of claim 20 wherein the anchor has a fin shape.

25. The method of stimulating tissue of claim 16 wherein the stimulation signal is monopolar and the stimulation device further comprises a return electrode.

26. The method of stimulating tissue of claims 18 or 19 wherein the stimulation signal is bipolar, and the sheath or the lead comprise both an anode and a cathode.