Introducer system

Abstract

This application relates to introducer systems. An introducer device for positioning a tissue region and deploying an electrode is shown and described. The introducer device can include an outer sheath. An inner sheath can be disposed within the outer sheath. The inner sheath can be configured to engage an implantable electrode. In an example, the inner sheath can include a stimulation probe having an uninsulated portion at or proximate to a distal end of the delivery sheath. The outer sheath can be coupled to a power source or stimulation signal that generates an electrical circuit at a proximal end. A clinician can control application of the stimulation signal to the tissue region via the outer sheath.

Description

[0001] This application is a divisional application of the invention application filed on October 17, 2016, with application number 201680072140.7 and entitled "Device and method for positioning, implanting and using stimulation leads".

[0002] Cross-references to related applications

[0003] This application claims priority to U.S. Patent Application No. 62 / 242,205, filed October 15, 2015. The disclosure of that application, as well as any other U.S. patents and U.S. patent publications identified in this specification, are incorporated herein by reference. Technical Field

[0004] This disclosure generally relates to locating target organization and deploying leads, and more specifically, to systems, apparatus, and methods for locating target organization areas and deploying leads via a one-handed device. Background Technology

[0005] Electrical stimulation systems have been used to relieve chronic and acute pain, as well as for many other medical purposes. External and implantable devices exist for delivering electrical stimulation to activate nerves and / or muscles to provide therapeutic treatment. These “neurostimulators” are capable of delivering treatment and / or therapy to various parts of the body. Operation of these devices typically involves the use of one or more electrodes placed on the outer surface of the skin or surgically implanted leads with one or more electrodes. In many cases, surface electrodes, cuff electrodes, paddle electrodes, or epidural or cylindrical electrodes and / or leads can be used to deliver electrical stimulation to selected parts of the patient’s body.

[0006] In some systems, electrodes can be inserted percutaneously into the body. In these systems, one or more electrodes can be operatively positioned on leads inserted percutaneously into the patient's body. There is a need for several devices that improve the positioning and deployment capabilities of electrode leads for various medical applications, including electrical stimulation systems.

[0007] As extensively described in the literature, existing systems and devices for peripheral nerve stimulation may fail to meet the needs of clinicians and patients. Existing systems can be inefficient, time-consuming, and too invasive. They may require very extensive training and skills to use; exhibit (or cause) poor device performance / failure and suboptimal efficacy / effectiveness / safety; and prevent use in patient and clinical settings where electrical stimulation could benefit. Given these shortcomings, there is a significant and unmet need for devices, systems, and methods that allow for the safe, effective, reliable, easy-to-use, and minimally invasive delivery of electrical stimulation leads to treat pain and other conditions.

[0008] Some conventional systems for electrode deployment or implantation involve two completely separate procedures and devices—a first test needle followed by a second introducer / lead. These systems with two separate steps can be inefficient, time-consuming, and unsuitable for patients because they may require two separate needle insertions. Furthermore, clinicians have reported the need to see which direction the lead anchor of the electrode is facing once the introducer has been inserted into the patient's tissue. This ability to see can contribute to effective lead deployment and improve the efficiency of the procedure. These systems rely on carrying the lead within a single needle and deploying the needle by extruding the lead beyond the open end of the needle. Due to the relatively fragile nature of the lead itself, the ability to adjust the lead's positioning (even minimally) is rather limited.

[0009] Another system is described in U.S. Patent Publication No. 2007 / 0255368. Here, a coiled lead is positioned at the desired location via a small-diameter needle. The lead is carried within the needle and has forked teeth or sutures made of a non-conductive material that expand after the lead is deployed outside the needle. The forked teeth / sutures hold the lead in place, but due to the lead's positioning within the needle and the non-conductive nature of its forked teeth / sutures, repositioning the lead during insertion is difficult (if not impossible). Furthermore, movement or removal of the lead after its deployment will result in tissue damage and destruction.

[0010] In view of the foregoing, there is a need for improved systems for electrode deployment or implantation that allow for test stimulation and repositioning of leads during positioning. Summary of the Invention

[0011] Several different, interrelated aspects of the invention have been described. Features of any particular embodiment disclosed or shown herein may be applied to other embodiments, and additional features and aspects of the system will be understood by those skilled in the art.

[0012] In one aspect of the invention, an introducer system has any combination of the following features:

[0013] • Electrical stimulation generator unit;

[0014] • A needle assembly having an axial length, the needle assembly including an outer sheath having a distal opening and an inner deployment mechanism;

[0015] • A stimulation electrode made of conductive material, comprising a distal end having a curved anchor portion and a terminal end, and a proximal end communicating with a stimulation generator unit;

[0016] • wherein the curved anchor portion extends partially from the distal opening, and the terminal is held within the needle assembly between the inner deployment mechanism and the inner surface of the outer sheath;

[0017] • The inner deployment mechanism is positionable relative to the outer sheath along its axial length so as to: (i) allow free movement between a proximal protection position and a test position, in which the electrode is substantially housed within the needle assembly, and in which the curved anchor portion extends sufficiently to deliver test stimulation from the stimulation generator unit, while the terminal remains within the needle assembly; and (ii) deploy the electrode at a final distal position such that the terminal is released from the needle assembly;

[0018] • The internal deployment mechanism includes an inner sheath having a terminal opening having a first edge that engages with a partially protruding curved anchor portion;

[0019] • The inner sheath includes an aperture positioned on the proximal side of the terminal opening, and the aperture has a second edge that engages with a partially protruding curved anchor portion.

[0020] • Wherein, at least one of the first edge and the second edge is completely rounded;

[0021] • The first edge is completely rounded;

[0022] • The groove extends between the terminal opening and the orifice, and at least a portion of the partially protruding curved anchor is fitted within the groove to minimize the outer diameter of the distal portion of the needle assembly;

[0023] • The outer diameter at the distal end of the distal portion of the needle assembly is approximately similar to the outer diameter at the second point along the axial length of the needle assembly.

[0024] • The terminal opening includes a bevel;

[0025] • A portion of the distal end of the outer sheath is thinned to accommodate the partially protruding curved anchor portion;

[0026] • The thinned portion includes grooves;

[0027] • The internal deployment mechanism mentioned above includes a core needle;

[0028] • The outer sheath includes a slot extending along the axial length of the outer sheath, defined at its proximal end by the distal opening;

[0029] • When the internal deployment mechanism is repositioned from the proximal protection position and the test position, the partially protruding curved anchor portion moves through the slot;

[0030] • A rapid separation mechanism is used to maintain contact between the electrode and the stimulation generator unit;

[0031] • The rapid separation mechanism includes at least one orifice or slot, and the proximal end of the electrode is received in the orifice or slot;

[0032] The rapid separation mechanism described therein includes at least one magnet;

[0033] • The quick separation mechanism mentioned above includes an insulation compression connector;

[0034] The rapid separation mechanism mentioned above includes at least one biasing member;

[0035] • A positioning block, selectively coupled to the needle assembly with adjustable angle and rotation, the positioning block being selectively attachable to a receptor to facilitate insertion, repositioning, and testing of the stimulus by the introducer system;

[0036] • The positioning block includes at least one adhesive surface;

[0037] • The positioning block includes a locking mechanism that selectively inhibits changes to at least one of the adjustable angle and rotation;

[0038] • A user controller connected to the stimulation generator unit;

[0039] The user controller mentioned above includes a graphical user interface;

[0040] • The user controller is wirelessly connected to the stimulation generator unit;

[0041] • The needle assembly includes a spacer;

[0042] • The spacer is removable;

[0043] • The spacer moves along its axial length to at least retract the outer sheath;

[0044] The electrodes described herein include coil-shaped or spiral-shaped structures;

[0045] • The coil-like or spiral structure described therein promotes inward tissue growth;

[0046] • The internal deployment mechanism includes a core needle that is at least partially positioned on the innermost portion of the coil-like or spiral structure;

[0047] • The electrodes described herein include bio-absorbable materials;

[0048] • The curved anchor portion of the device comprises a bio-absorbable material;

[0049] • The proximal end of the stimulating electrode is integrally connected to the distal portion of the lead, and the proximal portion of the lead is in communication with the stimulation generating unit;

[0050] The lead wire also includes an electrical insulating material.

[0051] • At least one test electrode is positioned on the outer sheath;

[0052] Multiple test electrodes are positioned on the outer sheath;

[0053] • At least one of the test electrodes is in communication with the stimulation generator unit;

[0054] • Multiple test electrodes are positioned at spaced intervals along the axial length of the outer sheath; and

[0055] • The stimulation can be delivered individually, synergistically, and / or in any combination of the test electrodes.

[0056] On the other hand, a method for delivering stimulation to the peripheral nervous system is envisioned, which includes any combination of the following aspects:

[0057] • Attaching a stimulation electrode with a conductive distal anchor to an internal deployment mechanism, including bending a portion of the electrode, including the distal anchor, around the distal end of the internal deployment mechanism;

[0058] • Position the electrodes and internal deployment mechanism within the outer sheath to create a two-part needle assembly;

[0059] • Connect the proximal end of the needle assembly to the stimulation generator unit;

[0060] • Insert the distal end of the needle assembly into the peripheral region of the human recipient;

[0061] • Expose the distal anchor to tissue within the human receptor and deliver therapeutic stimulation via the electrode;

[0062] • Deploy the remote anchor and remove the needle assembly;

[0063] • Reposition the needle assembly before deploying the distal anchor to maximize therapeutic effect;

[0064] • Connecting the proximal end of the needle assembly to the stimulation generator unit includes establishing at least one disconnected connection between the electrode and the stimulation generator unit;

[0065] • Provide a controller unit for human receptors to optimize at least one of the following: delivery of test stimuli and subsequent therapeutic delivery after deployment of a distal anchor;

[0066] • The electrode is a coil-shaped or spiral structure with an inner diameter, and the inner deployment mechanism is provided in the innermost portion of the coil-shaped or spiral electrode;

[0067] • The electrodes are provided within the inner lumen of the internal deployment mechanism;

[0068] • The lumen includes an orifice adjacent to, but not communicating with, an opening at the distal end of the lumen, and wherein the electrode passes through the orifice such that the distal end is positioned between the inner deployment mechanism and the inward surface of the outer sheath; and

[0069] • The distal anchor is exposed by advancing the inner lumen relative to the outer sheath into the tissue without releasing the distal anchor from the needle assembly.

[0070] On the other hand, consider an introducer system that has any combination of the following characteristics:

[0071] • Electrical stimulation generator unit;

[0072] • A needle assembly having an axial length and an outer periphery, the needle assembly including an outer sheath having a distal opening, an inner deployment mechanism carried within the outer sheath, and at least one test electrode positioned along the outer periphery;

[0073] • A stimulation electrode having a distal anchor and a proximal end communicating with the stimulation generator unit, the electrode being carried within the needle assembly;

[0074] • The at least one test electrode delivers test stimulation from the stimulation generator unit without the need to deploy the distal anchor.

[0075] • The portion of the electrode located on or adjacent to the distal anchor extends out of the inner deployment mechanism and serves as a test electrode;

[0076] • A seam, positioned along the axial length of the needle assembly, through which the test electrode protrudes;

[0077] • The internal deployment mechanism includes a plunger that moves along its axial length in coordination with the test electrode;

[0078] • A locking mechanism to prevent further movement of the test electrode before final deployment of the distal anchor and removal of the needle assembly; and

[0079] • Multiple test electrodes are positioned on the outer periphery.

[0080] Consider, on the other hand, an introducer system having any combination of the following characteristics:

[0081] • Electrical stimulation generator unit;

[0082] • A needle assembly having a longitudinal axis, the needle assembly including an outer sheath having a distal opening and an inner sheath having a deployment mechanism;

[0083] • A helical, open coil-shaped stimulation electrode made of conductive material, the electrode including a terminal portion with a conductive anchor and a proximal end that communicates with a stimulation generator unit;

[0084] • wherein at least a portion of the terminal and the conductive anchor portion is held within the needle assembly between the inner sheath and the inner surface of the outer sheath;

[0085] • The deployment mechanism and the outer sheath are selectively movable in opposite directions along a longitudinal axis in a cooperative manner between a proximal protection position and a midpoint test position, wherein the electrode is fully housed within the outer sheath in the proximal protection position, and the conductive anchor portion extends through the distal opening in the midpoint test position to deliver test stimulation from the stimulation generator unit, while the terminal remains within the needle assembly;

[0086] • When the deployment mechanism and the outer sheath move in opposite directions to the release distal position and then retract in a coordinated manner, the conductive anchor portion and the terminal are released from the needle assembly;

[0087] • The entire curved anchor is held within the needle assembly; and

[0088] • At least one of the midpoint test position and the release distal position includes the inner sheath rotating about the longitudinal axis relative to the outer sheath so that the conductive anchor portion extends through an orifice in the outer sheath positioned adjacent to the distal opening.

[0089] Consider, on the other hand, an introducer system having any combination of the following characteristics:

[0090] • Electrical stimulation generator unit;

[0091] • A needle assembly having a longitudinal axis, the needle assembly comprising an outer sheath having a distal opening and an inner core needle that moves freely within the outer sheath;

[0092] • A helical, open coil-shaped stimulation electrode made of conductive material, which is detachably connected to the inner tube needle and includes a terminal with a conductive anchor portion and a proximal end that communicates with the stimulation generator unit;

[0093] • Wherein at least a portion of the terminal and the conductive anchor portion is held within the outer sheath; • Wherein the inner core needle and the outer sheath are selectively movable in opposite directions along a longitudinal axis in a cooperative manner between a proximal protection position and a midpoint test position, in which the electrode is fully contained within the outer sheath, and in which the conductive anchor portion extends through the distal opening to deliver test stimulation from the stimulation generator unit, while the terminal is held within the needle assembly;

[0094] • When the inner tube core needle and the outer sheath move in opposite directions to the release distal position and then retract in a coordinated manner, the conductive anchor portion and the terminal are released from the needle assembly;

[0095] • The core needle is positioned within the innermost portion of the spiral, open coil-shaped electrode;

[0096] • The entire curved anchor is held within the needle assembly; and

[0097] • At least one of the midpoint test position and the release distal position includes the inner sheath rotating about the longitudinal axis relative to the outer sheath so that the conductive anchor portion extends through an orifice in the outer sheath positioned adjacent to the distal opening.

[0098] On the other hand, consider an introducer system that has any combination of the following characteristics:

[0099] • Electrical stimulation generator unit;

[0100] • A needle assembly comprising an outer sheath having a distal opening, an inner deployment mechanism carried within the outer sheath, and at least one test electrode positioned along the outer periphery of the needle assembly and in communication with a stimulation generator unit;

[0101] • A stimulation lead, comprising a monopolar electrode forming part of a selectively deployable anchor at the distal end of the lead, the stimulation lead communicating with the stimulation generator unit;

[0102] • The unipolar electrode comprises multiple strands of conductive material that are mechanically integrated and wound together in a spiral shape with a central void space.

[0103] • The needle assembly is inserted into the patient's body, and at least one test electrode, based on the delivery of test stimulation from the stimulation generator unit, is optionally repositioned until an optimal position is determined; • As the inner deployment mechanism moves relative to the outer sheath, the distal end releases the needle assembly, and the deployable anchor is secured at the optimal position to deliver periodic stimulation from the stimulation generator unit to the optimal position.

[0104] • Multiple test electrodes are positioned along the outer periphery;

[0105] • Test stimulation is delivered via the plurality of electrodes to determine the optimal position without needing to reposition the needle assembly, and wherein the internal deployment mechanism is moved to position the deployable anchor in the optimal position when the needle assembly is withdrawn from the patient’s body.

[0106] • The deployment mechanism mentioned above includes an inner sheath;

[0107] • The deployable anchor extends beyond the distal opening in the inner sheath, and the distal end is positioned between the inner and outer sheaths prior to release of the distal end; and

[0108] • At least a portion of the deployment mechanism is carried in the central void.

[0109] Consider, for one aspect, an introducer system having any combination of the following characteristics:

[0110] • Electrical stimulation generator unit;

[0111] • A needle assembly having an axial length and an outer periphery, the needle assembly including an outer sheath having a distal opening, an inner sheath or inner core needle deployment mechanism carried within the outer sheath, and at least one test electrode positioned along the outer periphery and capable of electrical communication with a stimulation generator unit.

[0112] A spiral, open coil-shaped stimulation lead, made of a conductive material at least partially covered by an electrically insulating material and having electrodes, comprising a coil-shaped segment of conductive material, forming a mechanical anchor at a distal end connected to the lead, and the lead also having a proximal end capable of electrical communication with a stimulation generator unit; and

[0113] • At least one of the test electrodes delivers test stimulation from the stimulation generator unit without the need for deployment of a distal anchor, and allows the entire needle assembly to be fully repositionable until the terminal is released from the needle assembly.

[0114] Finally, consider an introducer system that has any combination of the following characteristics:

[0115] • Electrical stimulation generator unit;

[0116] • A needle assembly having an axial length and an outer periphery, the needle assembly including an outer sheath having a distal opening, an inner deployment mechanism carried within the outer sheath, and at least one test electrode positioned along the outer periphery and capable of electrical communication with a stimulation generator unit;

[0117] • A stimulation lead, made of conductive and electrically insulating materials, having electrodes including a bent anchor portion at a distal end coupled to the lead, and the lead including a proximal end capable of electrical communication with a stimulation generator unit; and

[0118] • The at least one test electrode delivers test stimulation from the stimulation generator unit without the need to deploy the distal anchor.

[0119] While individual aspects of the invention have been described above, it is possible to combine specific features and limitations associated with one aspect with features and limitations of another. Furthermore, functions and effects associated with method aspects may further inform structural features of the apparatus aspects pointed out herein. Any of these foregoing features may form the basis for subsequent claims concerning further aspects of the invention, even if all those aspects may not be separately described herein. Attached Figure Description

[0120] A better understanding of the operation of the invention can be achieved by referring to the detailed description and the following figures. These figures form part of this specification, and the written information in the figures should be considered part of this disclosure. In the figures:

[0121] Figure 1 It is a partial cross-sectional view of the introduction system with undeployed leads based on the described aspects;

[0122] Figures 2A to 2D It is a partial cross-sectional view of the introduced system based on the described aspects as the lead wire is being deployed, and Figure 2E Includes partial sectional views of the introduction system as the lead wires are being deployed along the orthogonal axis (i.e., side view, front view, and top view relative to the first set of images);

[0123] Figure 3A and 3B It is a cross-sectional side view of an introduction pin having multiple test electrodes positioned around the outer surface of an outer sheath;

[0124] Figure 3CIt is a combination of lateral and axial cross-sectional views of an introduction needle having a series of slits for providing test stimulation through the electrode itself; according to the described aspects, the inner sheath has a first bevel level and the outer sheath has a second bevel level.

[0125] Figure 4 It is a cross-sectional view of an introduction system with an outer sheath according to the described aspects, the outer sheath having a groove formed in an inner surface;

[0126] Figure 5 It is a perspective view of an introduction system having an outer sheath and an inner sheath with a window-like structure, based on the described aspects;

[0127] Figure 6 , 7 Views 8 and 9 are provided based on the described aspects, showing the introduction system of the alternative conveying mechanism;

[0128] Figure 9A It is a perspective view of multiple different bevels of the sheath based on the described aspects;

[0129] Figure 9B These are perspective and sectional views of the modified outer sheath that minimizes the overall outline of the needle / distal electrode assembly based on the described aspects.

[0130] Figure 9C This is a perspective view of an embodiment in which the distal end segment of the electrode is fixed to the sheath according to the described aspects;

[0131] Figure 9D These are top and sectional side views of an embodiment in which the distal end portion of the electrode is fixed to the sheath according to the described aspects;

[0132] Figure 10 It is a perspective view of the introduction system within the inclined member of the inner sheath, based on the described aspects;

[0133] Figure 11 It is a perspective view of the proximal end of the outer sheath of the system introduced according to the described aspects;

[0134] Figure 12A and 12B This is a perspective view of certain embodiments of the connection between the lead and the lead connector according to the described aspects;

[0135] Figure 13 These are perspective views of certain embodiments of the ergonomic features of the introducer system based on the described aspects;

[0136] Figures 14A to 14E These are views of certain embodiments of a conveying mechanism based on the described aspects;

[0137] Figure 15A and 15B The spacer mechanism is shown according to the described aspects;

[0138] Figure 16A , 16B 16C shows useful exemplary stimulation patterns based on the aspects described;

[0139] Figure 17 The types of graphical user interfaces that can be included based on the described aspects are shown;

[0140] Figure 18A and 18B A method for adjusting the intensity of a stimulus, based on the aspects described, is shown;

[0141] Figure 19 is a cross-sectional side view of two individual prior art needles;

[0142] Figure 20A It is a cross-sectional side view of a needle with a fully rounded surface to accommodate the electrode, based on the described aspect. Figure 20B It is a partial sectional perspective view, and Figure 20C It is its full perspective view;

[0143] Figure 21A and 21B An exemplary embodiment of an insulation compression-break connector according to the described aspects is shown;

[0144] Figures 22A to 22D Several different configurations for rapid feature separation are shown, based on the aspects described.

[0145] Figure 23 It is a perspective view of the bandage system based on the described aspects;

[0146] Figures 24A to 24F The bandage system described herein is shown in how it can be applied or replaced; and

[0147] Figures 25A to 25C This is a schematic diagram of the rapid separation features envisioned based on the described aspects. Detailed Implementation

[0148] Reference will now be made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. It should be understood that other embodiments may also be employed, and structural and functional changes may be made without departing from the corresponding scope of the invention. Furthermore, features of the various embodiments may be combined or modified without departing from the scope of the invention. Thus, the following description is given by way of illustration only and should not in any way limit the various alternatives and modifications that may be made to the illustrated embodiments and which remain within the spirit and scope of the invention.

[0149] Any element described herein as singular may be pluralized (i.e., anything described as "a" may be more than one). Any subordinate element of a superior element may have features or elements of any other subordinate element of that superior element. The described constructions, elements, or complete components and methods, as well as variations thereof for carrying out the invention and aspects thereof, can be combined and modified with each other in any combination. As used herein, the terms "example" and "exemplary" mean instance or illustration. The terms "example" or "exemplary" do not indicate key or preferred aspects or embodiments. The term "or" is intended to be inclusive rather than exclusive unless the context otherwise indicates. As an example, the statement "A adopts B or C" includes any inclusive combination (e.g., A adopts B; A adopts C; or A adopts B and C). On the other hand, the articles "a" and "an" are generally intended to mean "one or more" unless the context otherwise indicates.

[0150] This document describes systems, devices, and methods that can conveniently provide and / or facilitate the implantation of a single deployment device containing a lead. The lead (also referred to as a microlead, fine wire lead, or simply an electrode) can have a generally smaller diameter compared to prior art systems, with a preferred size of less than 1.0 mm, and more preferably less than 0.6 mm. Furthermore, the electrode can have a generally coiled or helical structure rather than a smooth cylinder. However, this teaching is not limited to this structure of the lead. Any suitable construction can be employed without departing from this teaching. In one aspect, the embodiments described herein can conveniently provide a single device that can locate a desired tissue region, test stimulation of the tissue region, locate (or relocate) a test signal, and / or deploy an electrode or lead. Exemplary embodiments can allow relocation of the device and lead within human or animal tissue without deploying the electrode or lead until its deployment is required by a user (e.g., a clinician). Embodiments can provide easy-to-use and safe systems, devices, and / or methods.

[0151] For clarity, the term "proximal" in the context of this application generally refers to the end of the electrode that is not inserted into the body, and "distal" generally refers to the end of the electrode inserted into the body near a nerve. Depending on the manufacture of the electrode structure, the proximal end may be wrapped in an insulating or protective coating or cladding. The components involved will allow for the removal of this coating / cladding to the extent that an electrical connection with the proximal end must be made. The coating / cladding may include markings serving as indicators of mobility, which help to assess whether the electrode has undergone repositioning or displacement during system use and, particularly, outside of clinician supervision.

[0152] As used herein, the terms inner sheath, introducer, introducer needle, inner needle, inner probe, introducer member, and / or similar terms are used interchangeably unless the context otherwise requires or it is necessary to make a specific distinction between these terms. The terms outer sheath, delivery needle, outer needle, outer probe, outer member, and / or similar terms are used interchangeably unless the context otherwise requires or it is necessary to make a specific distinction between these terms.

[0153] The device allows the lead to be percutaneously placed at a safe distance from the surgical site, which can increase safety, minimize the risk to the anatomical structures that are the focus of the surgery, minimize the risk of infection, and minimize the potential impact of any infection if it may occur. As a non-limiting example, the device may allow the lead to be placed to deliver stimulation to nerves innervating a region that may be painful or expected to be painful due to surgery (e.g., the device may allow the lead to be placed to deliver stimulation to the femoral nerve, sciatic nerve, or lumbar plexus innervating a region, such as a knee that may be undergoing knee replacement surgery), and ideally, the device allows the lead to be placed at a safe distance from the surgical site (e.g., the knee) (e.g., in the upper thigh, upper leg, or lower back) and / or outside the surgical site.

[0154] The introduction device allows the target nerve to be identified before suture placement and deployment, as part of a non-surgical procedure.

[0155] There is a clinical need for a device that delivers therapeutic electrical stimulation (e.g., peripheral nerve stimulation (PNS)) to nerves innervating a painful area (e.g., peripheral nerves) to provide pain relief. The device can deliver stimulation to nerves that transmit pain signals, or it can deliver stimulation to nerves that do not transmit pain signals, but when stimulation is delivered, the condition or symptom, such as pain, can be relieved or improved, and / or function can be improved or restored. The device can deliver peripheral nerve stimulation for pain relief or functional restoration in a variety of different settings, including chronic, acute, postoperative, post-traumatic, and intermittent pain and / or loss of function and other conditions (e.g., other types of pain and / or loss of function); and across a range of anatomical regions, including but not limited to the limbs (e.g., arms, legs, etc.), extremities (e.g., hands, feet, fingers, toes, etc.), joints (e.g., hips, knees, shoulders, elbows, ankles, wrists, etc.), back, neck, head, face, and other areas.

[0156] The device can allow the delivery of electrical stimulation immediately following surgery to provide pain relief or functional improvement. It can also improve function, strength, and range of motion post-surgery, as well as accelerate postoperative recovery. The device can allow the delivery of stimulation before, during, and after surgery, as well as in situations not involving surgery, such as acute or chronic conditions within or outside the surgical context.

[0157] Additional embodiments of the transcutaneous stimulation system according to this teaching are described below. In this description, not all details and components may be fully described or shown. Instead, key features or components are described, and in some cases, differences from the embodiments described above may be pointed out. Furthermore, it should be understood that these additional embodiments may include elements or components employed in the embodiments described above but not illustrated or described. Therefore, the description of these additional embodiments is merely exemplary and is not exhaustive or exclusive. Additionally, it should be understood that features, components, elements, and functions of various different embodiments may be combined or modified to achieve the desired transcutaneous stimulation system without departing from the spirit and scope of the invention.

[0158] The described invention reduces the duration of lead placement and testing procedures when placing one or more self-anchored leads. Specifically, placement and testing time is reduced compared to prior art systems by reducing the number of percutaneous insertions required (e.g., insertion of a needle for testing stimulation and a separate needle for lead deployment, or a system in which multiple percutaneous needles / tubes / catheters are inserted to increase the size of the percutaneous inlet and allow lead insertion). Therefore, in contrast to prior systems requiring multiple insertions and / or separate leads to deliver stimulation, this system allows for greater maneuverability of the introducer system, particularly along its axial length (i.e., the depth to which the needle can be inserted and repositioned without deploying lead anchors). Furthermore, while some prior systems rely on self-anchored leads made of flexible coils with distal anchors electrically and mechanically integrated within the electrodes, this system marks a further improvement in the fracture resistance of flexible helical coils by protecting them from stress and metal fatigue during the insertion process (coupled with the anti-migration and anti-infection qualities of such flexible coil-like or helical structures).

[0159] A non-limiting example of this system includes an introduction and testing system that reduces the number of percutaneous insertions required and / or allows the goals of introduction, testing, and / or lead deployment to be achieved with a minimum number of insertions (e.g., as few as one). Specifically, stimulation testing and lead insertion / deployment can both be combined into a single system, which may require as few as one percutaneous insertion, injection, or placement. The invention described herein eliminates these problems while still allowing the deployment of anti-migration coiled leads with distal anchors.

[0160] The introduction device may include an outer sheath or a delivery sheath. An inner sheath, a core needle, or an introduction member may be disposed within the outer sheath. The inner sheath is configured to engage and / or manipulate the implantable electrode. In one example, the delivery sheath may include a stimulation probe having an uninsulated portion located at or adjacent to the distal end of the delivery sheath. The outer sheath may be coupled to a power source or stimulation signal that generates a circuit at the proximal end. Clinicians may control the application of the stimulation signal to the tissue area via the outer sheath. Clinicians may needle the tissue area to apply the stimulation signal and observe a response to the stimulation signal (e.g., a neural response, a muscle response, etc.) or the absence of a response. When the clinician observes the desired response at the target tissue area (e.g., the area where the desired response is observed), the clinician may facilitate electrode deployment. For example, the clinician may press, twist, or otherwise manipulate a mechanical / hydraulic / electrical mechanism (or other suitable mechanism) to translate the inner sheath and electrode leads relative to the distal end of the outer sheath. When the anchoring region of the electrode (e.g., a terminal portion having a bend, barb, hook, etc.) is at least partially deployed, the clinician can withdraw the inner and / or outer sheaths while the electrode remains in or near the desired tissue area. The anchoring region may be uninsulated to allow stimulation signals to be delivered. Alternatively, the electrode may include microleads or insulating regions that extend from the anchoring region and can be connected to a stimulation source. It should be noted that the stimulation source may be wearable, implantable, or of various other suitable types, such as those disclosed in U.S. Patent Publication No. 20150073496A1, which is incorporated herein by reference in its entirety.

[0161] Now go to Figure 1 and 2A In 2D, one embodiment of the lead introduction system 100 is shown, with particular emphasis on how the lead is deployed. While the same system is shown in each of these figures, certain reference elements are omitted in some views in an attempt to highlight specific aspects of the view shown in the figure. The introduction device 100 includes an inner sheath 102, an implantable electrode 130, and an outer sheath 150. The outer sheath 150 may include a hollow tube or needle having an outer sheath cavity 154. In one embodiment, the outer sheath 150 may be a 19-gauge needle with an inner diameter of approximately 0.5-1.0 mm and an outer diameter of approximately 0.8-1.20 mm. In one embodiment, the outer sheath 150 may have an inner diameter of approximately 0.85 mm and an outer diameter of approximately 1.03 mm. The outer sheath 150 may be between approximately 100-150 mm in length. In one embodiment, the outer sheath 150 may have a length of approximately 125 mm.

[0162] The outer sheath 150 may be made of an echogenic (i.e., highly visible under ultrasonic conditions) material to facilitate the use of the system 100. Such materials include, but are not limited to, polymers, metals, stainless steel, or combinations of two or more materials. Additionally or alternatively, the shape of the outer sheath itself may be configured to be effectively echogenic. Furthermore, only certain parts of the introducer system (including, but not limited to, the outer sheath) may have echogenic characteristics (through material or construction / shape).

[0163] The inner sheath 102 is disposed within the outer sheath 150 to allow it to extend from the cavity 154, as follows: Figures 2A-2D The inner sheath, as shown and described herein, includes an inner sheath cavity 104. In one embodiment, the inner sheath 102 may be a 21-gauge needle with an inner diameter of approximately 0.5-0.9 mm and an outer diameter of approximately 0.7-1.10 mm. In another embodiment, the inner sheath 102 may have an inner diameter of approximately 0.61 mm and an outer diameter of approximately 0.8 mm.

[0164] The inner sheath 102 comprises any suitable material, including but not limited to polymers, metals, stainless steel, or combinations of two or more materials. An implantable electrode 130 is at least partially disposed within the cavity 104 and along a portion of the interior of the inner sheath 102 to allow free movement of the electrode 130 relative to the inner surface. In an alternative embodiment described in detail below, the electrode 130 has a coil-like structure with a centrally located axial clearance space that can receive a mandrel, which serves as a deployment mechanism and / or structural support prior to electrode 130 deployment. In this alternative embodiment, the mandrel engages with the electrode along the axial clearance, but under certain conditions, independent movement of the mandrel relative to the electrode is again permitted.

[0165] The implantable electrode 130 may include microleads 138 disposed within at least the outer sheath 150. The electrode 130 itself is deployed via cavity 104. The microleads 138 may extend from a distal lead anchor 134 and be coupled (e.g., removably or non-removably) to a stimulation signal generator (not shown). The lead anchor 134 may include an uninsulated portion of the electrode 130, which may be curved, hooked, barbed, or similar. Thus, the lead anchor 134 may deliver stimulation signals during and after its positioning and deployment. Furthermore, the electrode 130 (including the lead 138 and the anchor 134) may have any combination of the following characteristics on some or all of its components: unipolar nature; helical and / or open coil-like structure with a central gap capable of receiving a core needle; and / or multiple strands of conductive material wound together and electrically connected in parallel with each other.

[0166] While the specific disclosure of the implantable electrode 130 envisions sub-components including microleads 138 and anchors 134, the more general term "lead" can refer to a stimulation device extending from its distal anchor to its proximal connector to a stimulation-generating unit, including portions that may be sheathed, covered, or coated with insulating material. In contrast, the general term "electrode" can refer to the exposed conductive portion of the lead inserted into the body to deliver stimulation.

[0167] like Figure 1 and 2A As shown, the lead anchor 134 may include a bent or hooked portion such that a portion of the lead anchor can wrap around or hook around the distal end 108 of the inner sheath 102. When the lead anchor 134 is not deployed, a portion of the lead anchor 134 may be disposed in the region 120 between the inner sheath 102 and the outer sheath 150. The lead anchor 134 may be made of any suitable material, including but not limited to polymers, metals, stainless steel, or two or more of these or combinations thereof. As an aspect, the lead anchor 134 may be electrically and mechanically integrated with the electrode (through which stimulation is delivered).

[0168] Figures 2A to 2C The 2D diagram illustrates the relative movement of the inner sheath 102 and the outer sheath 150. After insertion ( Figure 2A and Figure 2D (See small figure (A)). These elements move in a coordinated manner. To deploy electrode 130, the relative movement of one of the sheaths is caught or reversed, causing the electrode to extend outside cavity 154. Once the inner sheath 102 extends sufficiently outside cavity 154 ( Figure 2C and Figure 2D In the small diagram (D), the distal anchor 134 is released from region 120 and embeds itself into the tissue adjacent to the introducer system 100. The inner and outer sheaths are retracted (together or separately), and the electrodes are thus released (e.g., temporarily detached from the pulse generator to allow the sheaths to slide away, thereby physically removing the sheaths, etc.). Figure 2E As can be seen and will be described in more detail below, deployment may also involve rotational movement (indicated by arrows), which allows the anchor to be released and protrude through channels or slits in the sheath.

[0169] The outer sheath 150 has an inner diameter that is sufficiently larger than the outer diameter of the inner sheath 102 to establish region 120, where a portion of the lead anchor 134 is positioned prior to the deployment of the electrode 130. The distal end 158 of the outer sheath 150 may be uninsulated, while the body 162 of the outer sheath 150 may be insulated to allow current to be delivered to the distal end 158 without the body 162 directly stimulating tissue. It should be noted that the area of ​​the uninsulated distal end 158 may be approximately equal to the area of ​​the uninsulated portion of the lead anchor (e.g., electrode) 134 to ensure equivalent testing of stimulation on the target tissue region.

[0170] This invention includes a lead insertion / deployment system and a test stimulation system that can be combined into a single system, wherein electrodes (integrated into the needle) are employed to deliver test stimulation current. In several non-limiting examples, the exterior of the system is insulated or non-conductive, except for one or more portions that are uninsulated and conductive to serve as stimulation test electrode contacts. The stimulation test electrode contacts can be mechanically integrated with the outer needle, and the electrode contacts are appropriately positioned, for example, at locations that provide information to guide the lead to correct / optimal positioning prior to lead deployment.

[0171] The characteristics of the electrode contacts can be designed to represent, predict, or otherwise provide information about the performance of the lead prior to lead deployment, particularly regarding size, shape, material, and surface area. For example, by selecting mechanical and / or electrical characteristics similar to or representative of the lead electrode contacts (e.g., similar impedance, contact material such as stainless steel, and / or similar surface area such as 10 mm²), the characteristics of the test electrode contacts will represent the expected performance of the lead. The test electrode position should be at or near the distal end (or tip) of the introducer needle such that when the self-anchored lead is deployed, the lead remains in a position adjacent to the position occupied by the stimulation electrode being tested. Alternatively, multiple electrode contacts can advantageously be spaced apart along the needle / sheath (e.g., 1 mm to 30 mm intervals, preferably 1 mm), allowing test stimulation to be delivered on the same needle from one or more different test electrode contacts, thereby allowing the optimal position for stimulation to be determined while minimizing or eliminating the need to move and reposition the lead introduction system during the test stimulation / optimal position identification process. In this multi-test electrode configuration, test stimuli are delivered from multiple locations via a single percutaneous insertion to determine the optimal deployment location of the coiled leads with distal anchors / electrodes that provide self-anchoring, infection resistance, and migration resistance.

[0172] In one embodiment, the lead anchor 134 can be folded onto the inner sheath 102, for example, at the distal end 108 of the inner sheath 102, so that the lead anchor 134 can be accommodated in the region 120 between the inner sheath 102 and the outer sheath 150 prior to deployment of the lead anchor, such as during testing and / or positioning of the target tissue region. This accommodation of the lead anchor 134 allows for repositioning of the delivery location and testing of tissue stimulation prior to deployment of the lead anchor 134, as well as other potential uses.

[0173] Test stimulation for lead deployment can be achieved by transmitting current into the surrounding tissue via a needle and / or sheath or a test electrode located on its outer surface. The test electrode can be formed via an opening in an insulating polymer sheath positioned around an outer sheath 150 (or, in some embodiments, an inner sheath 102), with current transmission through the sheath itself for stimulation, or the electrode can be a discretely formed element (possibly including discrete wiring for stimulation signals). Other configurations are conceivable using a conductive coating (making appropriate contact with a pulse generator / signal source) disposed along selected outer surfaces of one or both sheaths. Alternatively, test stimulation can be achieved via an exposed portion of the electrode 130 itself. In this configuration, a portion of the distal end of the lead extends through a cavity 154 (and, in some embodiments, a cavity 104), while the lead itself remains in a non-deployed state (i.e., in some embodiments, the anchor portion 134 is still securely held within region 120). In either instance, the test stimulation is delivered after the introducer device 100 is inserted into the tissue, before the lead is deployed and anchored in the tissue.

[0174] exist Figure 3A and 3BIn this configuration, one or more exposed outer portions of the needle 150 include a plurality of test electrodes 152. The test electrodes 152 may be positioned at intervals along the length of the needle and / or radially around the periphery of the needle at different locations. While some embodiments may include only a single test electrode, the use of multiple electrodes is advantageous because it allows test stimulation to be achieved at multiple locations in the tissue with as few (e.g., single) needle insertions and / or injections and / or movements as possible, ensuring the procedure is simple and time-efficient while avoiding the need to reposition the introducer or lead to evaluate other potential electrode locations. Although an outer sheath 150 is shown, an inner sheath (if used) may contain similar test electrodes. In this configuration, it should be understood that the inner sheath must be adequately extruded through the cavity 154 to expose the test electrodes 152 to the tissue intended to receive the test stimulation, but in this configuration, the inner sheath should not be extruded too far beyond the outer sheath, causing the anchoring system 134 to become embedded in the tissue. Electrode 152 can be positioned at regular or irregular intervals along a straight linear line or around some or all of the periphery of the needle. Although multiple electrodes are shown, some embodiments may require only a single test electrode. Furthermore, while the electrode is shown extending along the length of the needle, it may be possible to position the electrode at different locations around the periphery, or even use a fully circumferential electrode at one or more locations.

[0175] In another embodiment, the electrodes (e.g., analog electrodes surrounded by insulating material or conductive electrodes on the surface of the needle and / or sheath) may be repositionable (e.g., via a pull or twist control mechanism in the needle hub or handle) and may be used for test stimulation at multiple locations, thus providing the advantage that multiple locations of test stimulation can be applied in a single insertion without the need for lead deployment. In another embodiment, a coating (e.g., insulating, polymeric) may be applied locally or comprehensively to any surface (e.g., conductive, metallic) in contact with the lead and / or outer needle (e.g., the interior of the inner needle or the exterior of the outer needle) to prevent current discharge from undesirable locations and to allow appropriate stimulation to be used to determine the location for lead deployment.

[0176] In all embodiments, a lubricating coating (e.g., a hydrophobic coating such as polytetrafluoroethylene) and / or a biocompatible lubricant (e.g., a silicone-based material) is applied along any portion of the needle and / or along other moving parts within system 100 to improve the ease of handling of the introducer components (e.g., the sheath and / or the needle) as directed by the clinician. This configuration enables ease of movement and helps avoid the need for a larger diameter in the introducer design, minimizes the risk of improper needle movement (which could damage the lead), and improves the simplicity of the lead placement process, eliminating the possibility of technical difficulties for the clinician.

[0177] exist Figure 3C (and) Figures 2A to 3B In the view shown (rotated to eliminate the distal edge of the needle), a slit 160 is provided along the length of the outer needle 150. Although shown extending along the underside of the sheath 150 to the end 154 of the sheath 150, it should be understood that the channel 160 may be formed as a line or pattern only along a portion of the sheath 150, or it may comprise a series of slits, channels, or orifices to accommodate lead anchors (in...) as described herein. Figure 3C (Not shown in the image). Furthermore, channels, slits, or openings can be formed along any axis of the sheath, not just limited to the top or bottom side. Optional test electrodes 152 can also be positioned adjacent to the slit to facilitate the positioning of the introducer system. After appropriate test stimulation and positioning, the electrodes are rotated relative to the outer sheath 150 to allow the anchor (not shown) to be released and deployed into the tissue. The clinician will ensure that this deployment corresponds to the optimal test electrode 152 as determined during the test stimulation procedure.

[0178] In one aspect, for example, the insertion device 100 can be designed to include two needles, with minimal increase in size compared to a single-needle design. For example... Figure 4 As shown, the outer sheath 150 may have a groove 156 along at least a portion of its inner surface 158, thereby forming a lead anchor (in Figure 4 (Not shown in the image) space. This design allows the lead anchor 134 to be assembled and / or translated into the recess 156. In one aspect, the recess 156 can allow for a smaller diameter of the outer sheath 150 because the additional space for the lead anchor 134 (e.g., region 120) is reduced.

[0179] In such Figure 5In one embodiment shown, the diameter of the sheath can be reduced by having a slot 110 on the inner sheath 102, allowing the lead anchor 134 to re-enter the inner sheath 102 after its deployment, thereby allowing the outer sheath 150 to be positioned close to or even in direct contact with the inner sheath 102. The distal end 108 of the inner sheath 102, including the slot 110 and the lead anchor 134 extending beyond the inner sheath 102 and re-entering the slot 110, can be located outside the outer sheath 150, allowing the remainder of the inner sheath 150 to remain in direct or near-direct contact with the outer sheath 150. Furthermore, the inner sheath 102 can be composed of any suitable material, including but not limited to thin-walled polymers, metals, stainless steel, or combinations thereof. A thinner material for the inner sheath 102 can allow the outer sheath 150 to have a smaller diameter while still accommodating the inner sheath 102 or a portion thereof.

[0180] The application of test stimuli representing stimulation performed through the lead itself (e.g., stimulation performed before or during lead deployment and / or repositioning) is advantageous because it allows clinicians to quickly and easily determine the desired location for lead deployment with a minimal number of needle insertions, thus avoiding the need for repositioning needles and / or leads. Minimizing needle insertions minimizes risk and discomfort for the patient and generally provides a more reliable method for lead deployment than existing systems.

[0181] Although shown as having a tapered edge similar to that of the outer sheath 150, the distal end of the inner sheath 102 need not be cylindrical; rather, it can be any suitable size and shape. For example, the distal end 108 can be beveled, cylindrical, partially cylindrical, slitted, rectangular, or similar.

[0182] In such Figure 6 In one embodiment shown, the function of the inner sheath 602 can be implemented / replaced by an axis having a bent arm or end 656. The bent end can be locked across the inner sheath cavity 504 to hold the bent anchor of the lead 634. When ready for deployment, the inner sheath 602 can be pushed forward to engage or de-position the anchor 634 in the tissue. The inner sheath 602 can be rotated to the side and retracted into the inner sheath cavity 504. The bent arm 656 can then rest against the inner wall of the inner sheath 602, or can be otherwise positioned to allow the inner sheath 602 to be retracted while retaining the deployed anchor 634 in place.

[0183] Lead insertion / deployment systems and testing stimulation systems can be combined into a single system, wherein the lead deployment mechanism is housed within a single sheath / needle / tube that contains the lead. This example may include a core needle that extends through and / or alongside the lead within the insertion needle / sheath. Figure 7 As can be seen, the core 170 can provide increased stiffness to the flexible coiled lead, thereby allowing the lead to be manipulated within the core. In this example, the lead anchor can be fully accommodated within the entry core and / or secured such that the system can be repositioned without deploying the anchor until the lead and anchor need to be deployed. A release mechanism can engage the electrode / lead at one or any number of points, and the release mechanism is accessible to the clinician to allow selective withdrawal of the core 170 after the system 100 has been properly positioned.

[0184] This core system solves the problem of selectively deploying self-anchored leads, thus establishing a selective self-anchored lead deployment system with significant advantages over existing technologies. These advantages include leads with design benefits such as anti-infection, anti-migration, anti-breakage, and selective self-anchoring mechanisms; anchors integrated with electrode contacts that allow stimulation to be delivered through the anchors (further ensuring proper contact positioning is maintained as needed); and a design and / or manufacture that allows the lead to be held in the desired location within the tissue during treatment and / or testing, and then easily, safely, comfortably, and / or reliably withdrawn / removed when needed. While the core or needle can be used in embodiments with a single sheath / needle / tube, it can also be used with systems containing multiple sheaths, one or more for receiving / secured leads and / or for delivering test stimulation, and the core / needle for positioning / deploying the self-anchored lead in the optimal location. Non-limiting examples of methods for lead and / or anchor deployment are described in other sections.

[0185] In another embodiment, the lead and / or electrode anchor may be held in place (e.g., within one of the needle and / or sheath) by a balloon (e.g., an inflatable and / or deflateable or expandable and / or compressible material or device), thereby manipulating (e.g., inflating, deflating, compressing) to allow the lead to be released, exposed, and / or deployed (e.g., exposure of the lead anchor, release of the outer sheath needle, thereby allowing it to be retracted and the lead deployed). The use of a balloon is advantageous because it prevents premature movement of the lead, sheath, and / or needle, stabilizes the lead and / or anchor to protect the lead or tip from damage, and allows the electrode lead anchor to be fully deployed (e.g., into surrounding tissue) to secure the lead and prevent lead movement (e.g., after needle deployment or during needle withdrawal).

[0186] Furthermore, as a non-limiting example, the uninsulated lead end can be manufactured or bent into the shape of an anchor, but loaded into a needle and arranged as shown in... Figure 8The straight posture observed is maintained. In this case, the lead end anchor 134 will be designed and manufactured to return to its initial shape during lead deployment. When exposed by the withdrawal of the outer needle 150 or the advancement of the inner sheath or core needle 170 (e.g.) Figure 8 (As shown by the arrows in the diagram), the end of the lead can be bent to anchor into nearby tissue.

[0187] Straight lead ends can also be pushed or pulled into the anchoring position (e.g., bent) by an airbag or sheath. In an alternative embodiment, the lead can be composed of, coated with, or framed a shape memory alloy (e.g., a nickel-titanium alloy) that returns to the desired shape upon exposure to temperature changes or the heat of the human body. Lead breakage rates can also be reduced by eliminating the need to store leads with bent ends, which eliminates excessive forces placed on the lead end anchors during storage and lead placement.

[0188] Once the desired location for placing the lead anchor 134 has been determined through testing, the inner sheath 102 can be pushed forward relative to the distal end 158 of the outer sheath 150. In one aspect, the inner sheath 102 can be pushed forward until the lead anchor 134 is exposed. The inner sheath 102 and the outer sheath 150 can slide relative to each other to expose part or all of the lead anchor 134. In one embodiment, the lead anchor 134 can be moved from its initial position by approximately 0.1-0.3 mm. In one embodiment, the lead anchor 134 can be moved from its initial position by approximately 0.2 mm. In one aspect, the outer sheath 150 can be pulled back / retracted until the lead anchor 134 is exposed. This aspect requires the lead anchor 134 to remain stationary throughout the placement process, i.e., in the same position relative to the target tissue (e.g., nerve or nerve fiber) and non-target tissue. Once the lead anchor 134 is exposed from the inner sheath 102 and / or outer sheath 150, the microlead 138 can be deployed and / or anchored to a target tissue region. Furthermore, the inner sheath 102 and outer sheath 150 can also slide to re-cover the lead anchor 134 and / or microlead 138 to reposition the lead closer to or further away from the target tissue region, such as a nerve. In one embodiment, the lead 134 may be exposed without deployment. In one embodiment, the lead 134 may initially be exposed without deployment and then be deployed later. In one embodiment, the lead 134 may be repositioned multiple times.

[0189] Clinically, it may be advantageous to limit the positional difference between the final lead deployment site and the test stimulation site, such that the clinical outcome of stimulation with the final lead deployed in place is substantially equivalent to the outcome of stimulation during test stimulation at the optimal location. In at least one embodiment, the distal end 158 of the outer sheath 150 may include a slope that is substantially different from the slope of the distal end 108 of the inner sheath 102 (e.g., a deeper slope or a larger angle of the slope). This can allow the lead anchor 134 to be deployed without pushing the inner sheath 102 beyond the end of the outer sheath 150. The slopes of the distal end 158 of the outer sheath 150 and the slopes of the distal end 108 of the inner sheath 102 may be inclined in directly or partially opposite directions. This particular configuration can limit how far the inner sheath 102 must be manipulated (e.g., pushed, etc.) to allow the deployment of the lead anchor 134. In one embodiment, the bevel of the outer sheath 150 may be shallower or at a smaller angle compared to the bevel of the inner sheath 102.

[0190] Figure 9A Various beveled ends for either sheath 102 or 150 are illustrated. In one embodiment, a short bevel with a steeper angle, or a true short bevel, may be used as the bevel of the inner sheath 102, while a standard bevel or a longer bevel (with a more gradual, less steep angle) is used on the bevel of the outer sheath 150. This provides significant advantages, such as allowing less movement of the needle / tube relative to each other during lead deployment, and allowing test stimuli to be effectively predicted to produce stimulation results for the final (e.g., deployed) lead, which delivers stimulation via a self-anchoring component at the distal end of the lead.

[0191] This invention includes systems that combine test stimuli and lead insertion / deployment into a single system. A non-limiting example (in which the lead insertion / deployment system and the test stimulus system can be combined into a single system) is such a non-limiting example in which a self-anchored lead is employed to deliver a test stimulus current before being selectively deployed at an optimal location determined by the test stimulus. In this example, the self-anchored lead includes one or more anchors located on the distal portion of the lead, which is also the active / electrode portion of the lead (e.g., the stimulation current is delivered through the anchored portion of the lead), allowing the test stimulus delivered through the lead (and thus through the lead anchors) to be optimally similar to the final stimulus when the self-anchored lead has been deployed, since the anchors themselves are delivering the stimulus at the location where the lead is secured in the tissue. This example may include lead anchor / active electrode portions secured relative to the insertion needle, such that all or a portion of the non-insulated portion of the lead (e.g., the electrode / anchor, through which current is delivered to the target tissue) is exposed to the stimulated target tissue. In this example, the anchors for the leads can be fixed in such a way that the system can be repositioned without deploying the anchors until the leads and anchors need to be deployed.

[0192] In summary, lead fixation can be achieved through the following features: a sheath that secures the distal end of the anchor while leaving a portion of the lead (e.g., the bend of the anchor) exposed to the tissue; a cover or sheath that secures the anchor of the lead and can be opened / destroyed to deploy the lead anchor; and / or housing the end of the lead within an insertion needle, with a portion of the anchor (e.g., the bend of the anchor) extending beyond the proximal side of the needle bevel. These examples provide systems for delivering test stimuli within the same system used for lead introduction / deployment, thereby eliminating the need for a separate system while still allowing the lead to be positioned / repositioned as needed until final deployment. This embodiment can be effectively combined with other parts of the invention described herein so that the objectives of introduction, testing, and / or lead deployment can be achieved with a minimum number of insertions (e.g., as few as one (single) insertion).

[0193] The introduction device can allow multiple or additional lead locations or potential lead locations to be tested and evaluated prior to lead deployment. In one aspect, the introduction device can allow the introducer to be advanced, retracted, or otherwise repositioned (e.g., moved forward, backward, or in other directions) without lead deployment. The introduction device can allow systems and methods for advancing, retracting, or otherwise repositioning (e.g., in any three-dimensional tissue volume) selectively self-anchored leads. A non-limiting example of a non-selective self-anchored lead (e.g., a lead that is self-anchored but not selectively self-anchored) may include a lead with a distal electrode that may be mechanically and electrically integrated with a distal anchoring mechanism.

[0194] In prior art, non-selective self-anchoring leads typically undergo undesirable deployment retraction or repositioning of the introducer. That is, if the non-selective self-anchoring lead and introducer system advances beyond the optimal position (e.g., undesirably too far, too close to the target nerve or structure, etc.), the non-selective self-anchoring lead will still be deployed in a suboptimal position because the lead can self-anchor and self-deploy when the introducer retracts. Previously, non-selective self-anchoring leads and delivery systems could not be withdrawn, retracted, or otherwise moved backward without lead deployment. This introduction device allows the use of selective self-anchoring leads and delivery systems, including associated devices and techniques.

[0195] The insertion device includes a selective self-anchoring lead and an insertion system that can position the lead in the optimal location for deployment. In this way, the lead is deployed only when needed, and it can be easily and / or non-invasively retracted when needed (e.g., when pain relief or functional recovery is no longer required).

[0196] The introduction device provides a redirectable or steerable introducer and lead system. Prior art does not teach a technique that allows the introducer to be steered in one direction and then redirected and steered in another (i.e., different) direction without deploying a self-anchoring lead. The introduction device enables the steerable selective self-anchoring lead and introducer system, as well as redirecting lead and introducer system, in multiple directions without the need for lead deployment.

[0197] The introduction device can also allow and facilitate the use of imaging guidance, such as ultrasound guidance and / or fluoroscopic guidance, during lead placement, testing, and / or lead repositioning procedures. Visualization of the position, orientation, and / or trajectory of the introducer and / or lead is crucial for clinicians to successfully place the lead.

[0198] Manufacturing the introducer system, and particularly the outer sheath 150 and / or the lead 130, to include easily visible / identifiable markings simplifies the lead placement process, reduces patient risk, improves the reliability of lead placement, and avoids inappropriate or premature deployment of self-anchored leads. The ends of the leads and / or other sections or lengths of the leads can be manufactured using alternative materials (e.g., coatings, markings, textures, etc.) that are easily detectable under medical imaging, as this is important for improving ease of lead placement and for detection by imaging devices. As a non-limiting example, the ends of the leads or portions or sections of the leads can be textured to increase echo intensity, thereby improving visibility under ultrasound. In another embodiment, a tightly coiled and twisted structure of multiple strands of lead wire can be braided, coiled, or woven at the ends to increase reflectivity and echo intensity. Furthermore, texturing smooth metal or adding a textured conductive coating will allow for better detection under ultrasound while allowing for electrical stimulation. In another embodiment, the lead tip may be textured to increase echo intensity, but coated with a conductive material to achieve a smooth surface, which reduces the likelihood of tissue damage, patient discomfort, and allows for easier removal from the tissue. Alternatively, in another non-limiting example, a length of the needle or tip may be coated, textured, or marked to improve visibility under ultrasound. Modifying the tip to increase echo intensity (which increases surface area) can also reduce the electrode impedance at the needle tip, thereby allowing selective stimulation of desired neural targets. In another embodiment, two introducer needles or sheaths may be marked, coated, or etched in a band-like pattern to mark lengths along an axis. In this embodiment, the band or marking can be used to assist in deploying the lead at the desired depth, to guide the movement of the needles or sheaths relative to each other, and to distinguish them under ultrasound imaging and facilitate lead placement. Furthermore, the marking of the sheath or needle can be used as a scale for distance and depth during the lead placement process, which is important for estimating distances, such as the distance to or insertion depth of nearby or non-target structures. In another embodiment, the introducer needle or sheath may be made of a material that allows magnetization (e.g., ferritic stainless steel or non-metallic magnets) to enable detection using an advanced ultrasonic needle positioning system.

[0199] The position, orientation, and / or trajectory of the introducer and / or lead are important for clinicians to successfully place leads under imaging conditions such as fluorescein, X-ray, or CT. Modifying existing introducer systems and / or leads by adding radiopaque markers can simplify the lead placement process, reduce patient risk, and improve the reliability of lead placement, thereby allowing visualization of lead placement and avoiding inappropriate or premature deployment of self-anchored leads. Furthermore, the lead tip or needle can be coated with a radiopaque or radio-dense material (e.g., barium, radiopaque polymers) to improve visibility under X-ray imaging (e.g., fluorescein, X-ray, CT). Radio-dense metals, such as platinum, gold, tantalum, or radiopaque conductive polymers, can be applied to the lead tip to allow visualization under X-ray imaging while still allowing the flow of current for stimulation. As a non-limiting example, a portion of the lead (including uninsulated or insulated wire) can be coated or fabricated with a radiopaque material, such as titanium, tungsten, barium sulfate, and zirconium oxide, to allow for better detection under fluorescein or X-ray. This allows for the visualization of potential debris on X-rays, enabling better detection of lead debris left after lead removal. In one embodiment, the coating can be sprayed or electroplated onto the lead tip. In another non-limiting example, radiopaque markers can also be applied along the length of the needle and / or lead in some bands or segments to identify the location and depth of the lead or needle in the tissue under X-ray imaging. In another embodiment, radiopaque markers along the length of the lead can be used to assess lead depth and track lead migration during treatment, making it easier to confirm lead placement stability for consecutive treatments. As another non-limiting example, the inner and / or outer sheaths can be marked or labeled with a radiopaque material to assist in the visualization of lead placement and needle depth under fluorescence microscopy, monitoring the corresponding position of the needle or sheath, and proper deployment and anchoring of the lead.

[0200] The introduction device can also enable selective self-anchoring leads and insertion systems that can place selective self-anchoring leads in movable anatomical locations (including but not limited to limbs, joints, back, neck, head, abdomen, trunk, face, and extremities), promote inward tissue growth at the sealed skin exit site, and prevent the lead from positioning in and out of the skin, which can further minimize the risk of infection.

[0201] The introduction of a device can also prevent interference with the normal function, rehabilitation, or restoration to normal function of the body or body parts. As a non-limiting example, the introduction of a device can prevent interference with the use of a joint (e.g., before, during, and / or after joint repair or replacement surgery) and prevent interference with the use of a joint (e.g., including the original joint, the repaired joint, and / or the replacement joint) during postoperative rehabilitation and daily activities.

[0202] Some embodiments may employ different designs to provide different exposures of the leads. In one embodiment, the opening at the distal end of the outer sheath has a beveled or angled edge, as in... Figure 9A As can be seen, rotating the outer sheath allows the exposed anchor lead to be either uncovered or re-covered. This can allow clinicians to expose part or all of the anchor lead, such as a portion of a barb or fork. In one embodiment, a stop can be added at a predetermined location to allow easy exposure of a portion of the lead without deploying the entire lead. In one embodiment, clinicians can apply a rotating or sliding type of mechanism to deploy part or all of the lead. In one embodiment, the insertion device can employ a rotating technique to partially expose the lead without fully deploying it, and a sliding sheath can fully expose and deploy the lead, as in channel and / or lock designs.

[0203] In such Figure 10 In one embodiment shown, the inner sheath 802 may include a beveled portion 824 that facilitates deployment when the sheath 802 is retracted. This can alter (e.g., reduce) the likelihood that the lead 834 is compressed or otherwise retained within the sheath 802. For example, it can reduce the likelihood that hook-shaped, fork-shaped, or barbed portions of the lead are retained or attached to the inner sheath 802. On the other hand, the beveled portion 824 can alter (e.g., enhance) the ability to anchor the lead 834 in the desired location. The use of small-diameter, self-anchored coiled or spiral leads allows for minimization of the duration of lead placement and stimulation testing procedures, limits the number of percutaneous insertions required, reduces patient risk, allows for efficient positioning and repositioning of leads for stimulation testing and lead deployment, allows clinicians to correctly and optimally position and deploy leads with minimal or no additional training, and reduces the time required to form an electrical connection for testing.

[0204] Test stimulation via an introducer system requires an electric current to be delivered from an external stimulator to the stimulating electrodes and / or lead ends. This invention is novel and advantageous because it allows the introducer system to be coupled to an external stimulator used by the patient, thereby ensuring that responses achieved during test stimulation (e.g., in clinics, hospitals, etc.) represent responses expected and / or achieved during treatment (e.g., typical home use by the patient), and further avoiding the need to reprogram the stimulator between test and home stimuli.

[0205] The insertion device can be removably connected to the stimulator via the use of a lead connector. The stimulator can be powered by a battery embedded in the stimulator itself or in the attached electrodes.

[0206] The battery can be of any suitable size, allowing for continuous delivery of treatment to consistently relieve the user's pain. Furthermore, the stimulator can be wirelessly programmable and controllable. In one embodiment, the stimulator can be wired. In one embodiment, the stimulator and delivery device can have a custom wireless interface for clinicians and / or patients.

[0207] exist Figure 11 In one aspect shown, the proximal end 512 of the introduction device 500 may include a connector plug 560, which may be coupled to a power source and / or a current source (not shown). Current can be transmitted from the power source through the connector plug 560 and to the outer sheath 550. Current can be transmitted through the outer sheath 550 and applied to a tissue region at the distal end 558 of the outer sheath 550.

[0208] This invention includes designs to facilitate testing using leads. A non-limiting example is a connector that allows for quick and efficient electrical connection of the proximal end of a lead to an external stimulator via a wire in an advantageous manner (e.g., a robust / stable mechanical and / or electrical connection), reducing procedure duration. The ability to easily remove the connector also reduces procedure time, as in the prior art, after lead deployment, the introducer system must retract the lead, whereas the connector prevents this and necessitates removal because the introducer needle / sheath cannot retract onto the lead without first separating it. While simple connectors (e.g., commercial alligator clips) can be used, such connectors can be difficult to use in operational settings with coiled leads of extremely small diameters. Clinicians or staff may find it difficult to connect the fine end of the lead to typical / mechanical electrical connectors. A non-limiting example addressing these problems is a custom connector that includes a funnel into which the end of the lead can be easily inserted. The funnel guides the lead wire into the connector area, where spring-loaded teeth, rings, or surfaces can be actuated by the user via a lever or button to clamp onto the lead wire and establish an electrical connection. The connector may have lead wires and attached plugs for connection to an external stimulator.

[0209] The lead connector can be designed for easy connection to a perforated lead. In a non-limiting example, the lead 934 can be inserted into the lead connector 956 through an aperture or slot 952, and the lead cable can pass through it partially or completely. The aperture may include a funnel shape, through which the lead 934 is inserted to allow easy insertion, such as... Figure 12A and 12BAs indicated by the arrows in the diagram. In another non-limiting example, the lead connector 956 may consist of two or more components, with the lead positioned between and / or within these components, and these components may be secured together (e.g., sliding together, snapping into place, twisting / screwing onto each other, etc.) to engage with the lead. In some embodiments, the lead connector may allow easy one-handed insertion and engagement of the lead to the system while maintaining mechanical and electrical safety and preventing the patient from intentionally or unintentionally disengaging the lead (or electrode).

[0210] Leads can be electrically and mechanically connected to lead connectors. The mechanism by which leads are mechanically connected to lead connectors can be different from or the same as the mechanism by which leads are electrically connected to lead connectors. Users can connect leads to lead connectors using components including, but not limited to, knobs, buttons, switches, or dials.

[0211] The lead connector can be detached from the lead and can allow the lead to be reattached to the lead connector at different points along the lead (e.g., closer to or further away from the stimulation portion of the lead or electrode). In one non-limiting example, the lead connector may include a locking element to prevent the patient from disengaging the lead. The locking element can be opened using, for example (but not limited to), a key, a tool (e.g., a torque wrench), a combination (e.g., a combination), or without tools. In another non-limiting example, the lead connector can minimize or eliminate damage or alteration to the structure of the lead, thereby allowing the lead to remain sufficiently intact to substantially reduce the risk of lead breakage or damage and allowing current to flow through the entire lead. In another non-limiting example, the lead connector can be attached to the lead before or after insertion of the introducer system, thereby allowing stimulation through the lead tip during the lead placement process. In one embodiment, the connector can be attached to the lead by inserting the lead into a slot or hole on the block and closing a cover that enables an insulation compression connection (e.g., cutting through the insulation to one side to form a connection with the conductive lead wire). This lead connector improves the speed and convenience of lead connection because it allows attachment without the need for tools (e.g., no wire cutter, scissors, or screwdriver). For example, in this embodiment, the lead can be placed into a slot in the lead connector block and secured using a lockable, reversible one-handed mechanism to crimp the insulation layer on the lead body. The insulation crimping mechanism within the lead connector can also cut the lead on the distal side of the electrical connection. Once the connection is complete and excess lead has been trimmed, locking (e.g., sliding, twisting, button pressing) ensures that the cover on the block cannot be accidentally reopened. This feature prevents the connection between the lead connector and the lead from breaking, which would result in the loss of therapeutic benefit. This lead connector can mate with another lead connector (e.g., a lead or plug to a stimulator) to complete a loop from the stimulator to the lead end electrode.

[0212] In one embodiment, the connection between the two lead connectors can be magnetic. In this case, the shape of the lead connectors will prevent improper alignment of the lead connectors (e.g., lead connectors assembled together only along one orientation). Magnetic connections can be used for temporary and permanent stimulation delivery (e.g., during lead placement or during treatment at the patient's home). After achieving proper lead placement, the lead connector block can be removed and replaced following the removal of the introducer system needle and sheath. In one embodiment, the connection can be deactivated by pressing or sliding open the suture that houses the lead. In this example, the lead connector block can be removed or cut off before removing the introducer and then quickly reattached to a more proximal position on the lead. After removing the introducer, the lead can be placed in the suture and engaged with a one-touch mechanism (e.g., press, slide), and then the lead connector can be attached to the stimulator cable.

[0213] Magnetic connections can be used as quick-release connections, preventing accidental lead (or electrode) displacement due to pulling on the lead and / or leads. Instead of transferring force to the lead exit portion and the lead, any force on the lead will be released due to the breaking of the magnetic connection between the lead and the lead connector block. If desired by the clinician, a permanent connection can be established by locking the two connector pieces together using a push-button locking mechanism (or any other suitable locking mechanism). In addition to mating with the lead connector block, in another embodiment, the magnetic cable connector for the stimulator can also mate with a lead connector block of the same type (which is connected to the test stimulator via a cable). In another embodiment, the magnetic cable connector derived from the stimulator can branch to connect with multiple lead connector blocks (e.g., for achieving stimulation of two leads with one stimulator).

[0214] This invention reduces discomfort during suture placement by limiting the diameter of the percutaneous system. Resistance to insertion through the skin or tissue can cause additional pressure to be placed on the patient's skin and / or the device, leading to potential discomfort (e.g., pain or bruising from insertion pressure or from multiple failed needle attempts) and / or strain or damage to the device (e.g., damage to the suture or introducer, malfunction of the suture deployment mechanism). Reducing resistance to insertion can be achieved by limiting the diameter of the introducer system, designing or manufacturing the needle to be sharper (e.g., a sharper heel edge and / or additional bevels), or coating the needle surface (e.g., an outer shaft). Modifying the bevel shape or sharpness of the needle in the introducer system (e.g., by adding multiple bevels during needle manufacturing or grinding or shaping) can make insertion easier (e.g., requiring less force) and ensure a more comfortable suture placement process for the patient. Multiple bevels and increased needle sharpness are advantageous because they minimize patient risk, achieve reliable insertion, and allow insertion that avoids unnecessary pressure on the suture or device. In another embodiment, a coating may be applied partially or completely along the surface of the introducer needle to reduce resistance to tissue penetration (e.g., a polymer coating that glides more easily through the tissue). In one embodiment, the coating may be hydrophobic (e.g., polytetrafluoroethylene, silicone rubber), hydrophilic (e.g., polyvinylpyrrolidone, polyurethane, polyacrylic acid, polyethylene oxide), or liquid-impregnated to improve ease of insertion and maneuverability within the tissue by reducing friction between the skin or tissue and the needle. Modifications to the needle's exterior that minimize the insertion force required by the clinician (e.g., allow the clinician to place the lead) and do not result in a significant increase in outer diameter will ensure selective lead deployment via a minimally invasive approach, using the fewest possible insertions and further minimizing risk and discomfort for the patient.

[0215] One method for limiting and / or minimizing the diameter of the system is by using a needle / shroud, and removing a portion along the inner wall of the needle / shroud to allow space for the lead anchor. An example of this construction is... Figure 9B As shown in the diagram. A portion of the wall N of the needle / shroud 150 is advantageously removed / thinned so that the lead anchor 134 can be accommodated (e.g., a 1-10 mm wall along the length of the needle from the proximal end of the bevel, preferably 5 mm, and a width sufficient to allow the anchor to be accommodated (e.g., 0.1-0.5 mm, preferably 0.2 mm), but the mechanical strength of the needle is minimally affected. In systems comprising two needles / shrouds, this can also be achieved by similarly removing a portion of the outer wall of the inner needle (in... Figure 9B(not shown in the image), or by performing both, a portion of the outer needle and a portion of the inner needle wall are removed to form a complete seam for the lead wire anchor to be accommodated therein.

[0216] Figure 9B Another example shown is the use of a plastic inner tube P, which is rigid enough to allow deployment, yet flexible enough to allow the outer anchor hook (not shown in the perspective view) to press into the end of the plastic sheath, thus allowing the outer pin to be just larger than the inner tube and fully accommodate the undeployed lead. The flexible plastic sheath must also be flexible enough so that it can retract on the lead without getting caught. Avoiding the lead getting caught inside the inner tube will be an important issue in these diameter-limited solutions, where the inner pin may result in very little space around the lead, which could lead to excessive friction. A non-limiting example of a solution to this would be the use of a biocompatible lubricant, such as a silicone-based (or other suitable) lubricant, applied between the parts that must move relative to each other.

[0217] refer to Figure 9C and 9D Embodiments of the invention have a slit or window S ground, cut, or otherwise created in the sheath / needle 102, allowing the end of the anchor of the self-anchored lead 134 to re-enter the lumen of the needle / sheath. This allows a second sheath / needle or receiving mechanism to be positioned over the portion of the anchor that has re-entered the needle lumen, thereby securing the lead to the test / introduction system until the lead is desired to be deployed. Ideally, this embodiment of the invention can be combined with one or more of the other examples described, including but not limited to delivering stimulation via the distal anchor of the self-anchored lead, and / or using one or more contact electrodes in an outer sheath for delivering test stimulation. Note that in Figure 9C In the figure, system 100 is shown in multiple stages of its assembly, with small figure (a) showing only the inner sheath, small figure (b) showing the sheath 150 and lead / anchor 134, and small figure (c) showing the inner sheath 102, lead anchor 134 and outer sheath 150.

[0218] Reducing the outer diameter of the system is desirable because it limits patient discomfort during the procedure. In an example where a sheath fitted over the needle is used to secure the lead anchor of a self-anchored coiled lead during placement / testing / repositioning, a tight fit of the outer sheath on the inner needle (which will both limit the outer diameter and better secure the lead anchor) can be achieved by using a sheath material that can shrink, for example by applying heat or other means that cause the sheath tube diameter to shrink. This also reduces the burden of manufacturing and assembling the system, as a tightly fitted sheath will not need to be screwed onto the inner needle and lead anchor. A larger diameter outer sheath can easily slide into place and then shrink to provide a tight fit.

[0219] Ideally, limiting the outer diameter of a system for percutaneous or transdermal insertion can be implemented to minimize pain and / or discomfort during insertion, stimulation testing, and / or deployment of a self-anchored anti-migration lead. This can preferably be achieved by employing thin-walled needles or sheaths to accommodate the lead during placement / testing / deployment. Using one or more needles or sheaths of a suitable material (e.g., metal, plastic) with a certain wall thickness is desirable and advantageous. This provides sufficient lumen space for accommodating the lead, minimizing the outer diameter of the system, and providing sufficient resistance to bending and / or other forces experienced by such a system during lead placement and testing. Preferred embodiments of the described invention employ one or more thin-walled needles / sheaths, as described in conjunction with one or more of the examples and embodiments discussed. This also allows the invention to minimize the duration of lead placement and stimulation testing procedures, limit the number of percutaneous insertions required, reduce patient risk, allow efficient positioning and repositioning of leads for stimulation testing and lead deployment, allow clinicians to correctly and optimally position and deploy leads with minimal or no additional training, and reduce the time required to form electrical connections for testing.

[0220] A sheath tightly fitted onto the needle can pose potential problems for lead deployment. For example, the sheath may adhere more strongly to the needle surface than intended, hindering movement of the sheath on the needle or requiring such force that the device becomes unsafe or user-unfriendly, and may additionally cause delays or prolongations in the process. A non-limiting example of overcoming this problem is to apply a lubricant between the sheath and the needle, thereby enhancing the sliding of the sheath on the needle or requiring less or minimal force. This lubricant can be silicone-based, but can also be made from other suitable materials. Another non-limiting example of a method for overcoming this problem is having a mechanism by which the sheath can be broken open. This can be achieved by embedding a fine wire in the sheath, which can be pulled during lead deployment, causing the sheath to break open and allowing the lead anchor to be released. These aspects of the invention can be advantageously combined with other embodiments described herein.

[0221] Another embodiment of one aspect of the invention, used to overcome the potential problem of improper attachment of components to each other, is described in a non-limiting example as using a manufacturing method in which a placeholder is used during the manufacture of multiple different, tightly assembled components (e.g., such a placeholder, like a solid metal wire, preferably slightly larger than the diameter of the lead used during the manufacture / assembly of the multiple different components, which are designed as anchors for securing the lead (e.g., an outer sheath, with or without seams or removed or ground-backed sections, particularly for accommodating the lead anchors)). This is advantageous because it allows the final components to be tightly / securely assembled together, but prevents overly tight assembly that hinders or impedes deployment and / or positioning and / or testing.

[0222] This invention can prevent / reduce user errors and accidents during lead placement and stimulation testing by allowing single-handed lead placement and deployment. For example, the lead deployment mechanism can be operated with one hand, eliminating the need for the other hand to deploy the lead. This embodiment is advantageous because it reduces the difficulty for clinicians to use the system and allows them to use their other (non-deployment) hand for another purpose, such as manipulating the ultrasound probe during lead deployment so that the lead's position can be observed. This can be advantageous because it can be used to reassure clinicians in real time that the distal anchor of the self-anchored lead remains in the desired position during lead deployment and / or retraction of the testing / introduction system. As a non-limiting example, preferred embodiments of the lead deployment mechanism may include levers, buttons, gears, sliders, push buttons, torsion knobs, handles with gripping surfaces for pulling or pressing, handles / levers that are squeezed together, and / or other devices that mechanically and / or electrically actuate the deployment components. Embodiments of deployment components (e.g., outer sheath and / or inner core or mandrel) are described in other sections, and one or more of these may be advantageously combined with one or more lead deployment mechanisms to allow clinicians easy and effective control over the deployment of self-anchored leads.

[0223] In one embodiment of the invention, lead placement and repositioning are assisted by design elements that enhance controllability or convenience, allowing clinicians to handle the system before, during, and / or after stimulation testing and lead deployment, during percutaneous placement, retraction, and / or repositioning of the system. This embodiment can limit process time, thus providing significant benefits to both patients and clinicians. A non-limiting example of this embodiment is the application of ergonomic, gripping, textured, and / or other tactile features, which may be located on the proximal end of the needle / system and / or the deployment mechanism, to facilitate lead placement through the patient's skin and tissues, such as in… Figure 13This can be seen in the example. This embodiment can provide significant benefits to patients with tough or thick skin, as clinicians may otherwise have difficulty applying the necessary pressure to quickly insert the system through the skin at the desired location.

[0224] Figure 14A and 14B Embodiments of the introducing devices 400 and 500 are shown. In such... Figure 14A In one aspect shown, the introduction device 400 includes a proximal end 412 having a body 414 having a locking member 416. The body 414 can be made of any suitable material, including polymers, metals, stainless steel, or combinations of two or more of these. The locking member 416 can be any suitable type of locking member or divider, including but not limited to levers, triggers, plungers, buttons, wheels, switches, threaded members, or the like. When engaged, the locking member 416 can prevent the inner sheath from advancing or moving to any extent. This can occur using a threaded system, locking member, divider, etc. By releasing the locking member 416 via pushing, pulling, twisting, or any other suitable mechanism, the inner sheath can disengage from the locking system and be advanced forward, for example, beyond the outer sheath 450. As the inner sheath advances, the lead can be deployed. The locking member 416 can be made of any suitable material, including polymers, metals, stainless steel, or combinations of two or more of these. The locking members 416 can be made of the same material as the body 414, or they can be made of different materials. The body 414 includes a ring 418 and a handle 422, configured to engage with a clinician's finger during use. The ring 418 can engage with a locking member 416, and when engaged, allows the inner sheath to move outside the outer sheath 450.

[0225] The handle 422 can be made of any suitable material, including polymers, metals, stainless steel, or a combination of two or more of these. The handle 422 can be designed to support the clinician's fingers and can therefore be etched or have rubberized or comfort-enhancing features to improve the user's traction and comfort.

[0226] In one embodiment, body 414 may include several rings configured to engage with a clinician's fingers during use, such as the thumb, as well as the index and ring fingers, or, for different users, the thumb, index, and middle fingers. In another aspect, body 414 may not include any rings.

[0227] Lead deployment can also be initiated via a locking element or divider on the proximal end 512 of the introduction device 500, as in Figure 14B and 14EThe inner sheath 502 can be seen in the diagram (the latter generally shows the device 500, along with arrows indicating the expected range of motion). By releasing the locking element or divider, the inner sheath 502 can be advanced by pushing or using a lever, button, wheel, switch, threaded member, or the like. The inner sheath 502 may have a locking element or divider to prevent it from being deployed too far. The end of the inner sheath 502 may be open, allowing it to retract onto the deployed lead anchor 534 and potentially the microlead. The system helps prevent user errors and / or accidents during lead placement and stimulation testing of the self-anchored lead, while reducing or limiting the process duration by ensuring the system's positioning is reliably maintained throughout the process, regardless of the depth to which the lead and the insertion / testing system have been inserted. Existing technology relies on tissue resistance to maintain the position of the inserted system and self-anchored lead during the testing process, raising concerns when the system is not placed deep enough in the tissue to allow the tissue to prevent movement of the system. Non-limiting examples of embodiments that maintain the location of the introduced system throughout testing and / or lead deployment are described in the following sections, such that multiple different embodiments may provide additional significant benefits in combination with one or more of the other embodiments / examples described throughout this specification.

[0228] As in Figure 14C and 14D As seen in the diagram, the system, and more specifically, the needle 150, is inserted into the target tissue / through the skin. The needle is mechanically secured to component X, which in turn can be secured / fastened to the patient's body / skin, for example via adhesive Y. The component is secured to both the system and the patient's body such that the system remains firmly in place relative to the patient until the clinician determines that the system will be repositioned and / or removed. The component can be attached to the system via any suitable mechanical connection (e.g., clamps, locking elements, torsion, or other fixation mechanisms) that can be secured and / or removed with minimal time and effort. Furthermore, the component can be attached to the patient's body via any suitable mechanical connection (e.g., tape, bandages, gels, hydrogels, or other fixation mechanisms compatible with temporary use on the skin) that limits patient discomfort and can be secured and / or removed with minimal time and effort. The component is secured to both the patient and the system such that movement of the system relative to the patient's body is minimized during the test stimulation procedure and / or lead deployment.

[0229] In this non-limiting example, a component (such as the one described above, which mechanically engages with the system to introduce / insert a self-anchored lead and deliver test stimulation to the patient's body) is implemented such that the component can rotate freely relative to the patient's body while being locked in place relative to the system, until the desired locked position is determined. Alternatively, the component can be locked relative to the patient's body before locking into the final position, while allowing free rotation / positioning of the system. Such a component may also allow the locking / fixation of the position to be released as needed for repositioning or removal of the system.

[0230] The component X described above mechanically engages with the system to introduce / insert a self-anchored lead and deliver test stimulation to the patient's body. It is implemented such that the component is fixedly positioned against the patient's body, and the component includes a mechanism that allows the angle of the lead insertion / stimulation test / lead deployment system to be adjusted and locked in place as needed. This component also allows the locking / fixation of the position to be released as needed for system repositioning or removal.

[0231] This system includes the design of an objective repositioning percutaneous system. A potential problem with delivering test stimuli via a system in which the lead anchor is partially or completely housed is that the lead may be inadvertently deployed, i.e., by moving the inner and / or outer needles in an unexpected manner or relative distance and / or by other methods of lead deployment (e.g., the lead advances further than expected or at an unexpected time). An example of a method to mitigate this risk is a system in which the relative position of the inner and outer needles (or other deployment mechanisms such as core needles) can be locked, blocked, or revealed during insertion, testing, and / or deployment. One embodiment of this solution has a series of stops in the proximal portion of the deployment system that allow the needles to be positioned relative to each other by twisting, pushing, clicking, rolling, sliding, or other means of control implemented by levers, locking mechanisms, or other devices.

[0232] This non-limiting example of an embodiment of the invention (which allows for objective repositioning of the percutaneous system) includes mechanical and / or visual markings indicating the relative positions of the percutaneous introduction system and the lead and / or core and / or inner sheath / positioning mechanism. Such markings may indicate the position of the lead relative to its location in the introducer (e.g., the distance between the distal end of the lead and the distal end of the introducer sheath) and / or the position of the end of the introduction system in the tissue / body (e.g., the distal depth of the introducer system and / or the angle relative to the skin at the insertion / entry site). Alternative or supplementary marking embodiments may include clearly marked locations (e.g., markings for deployment, locking, and / or other desired system and / or lead positions). This invention may preferably combine these aspects of the embodiments to allow the depth and angle of the introducer system and lead relative to each other and / or the skin / insertion site to be easily identifiable. This embodiment allows for objective repositioning of the percutaneous system and may be combined with one or more other examples discussed in this disclosure to reduce or limit the time and difficulty of placing a spiral, migration-resistant, and infection-resistant lead in an optimal position. It may include multiple arcuate channels orthogonally positioned to each other. One or more threaded elements, clips, or spring-loaded pins cooperate within a channel (which may be along one or more arcs including sutures or other predetermined points) to fix the angular position and the rotation of the introducer needle relative to the surface of the patient's skin (i.e., the injection site for the needle).

[0233] This invention includes the design of an objectively repositioning percutaneous system. A potential problem with delivering test stimuli via a system in which the lead anchor is partially or fully contained is that the lead may be inadvertently deployed, i.e., by moving the inner and / or outer needles in an unintended manner or relative distance and / or by other methods of lead deployment (e.g., the lead advances further than expected or at an unintended time). One embodiment of this solution has a series of stops in the proximal portion of the deployment system that allow the needles to be positioned relative to each other by twisting, pushing, clicking, rolling, sliding, or other means of control implemented by levers, locking mechanisms, or other devices. This embodiment can allow the lead to be moved to several different positions, such as, but not limited to, a locked / fixed position for insertion, a partially deployed position for testing, a retracted position for repositioning, and a deployed position. This embodiment allows for objective repositioning of the percutaneous system and can be combined with one or more other examples discussed in this disclosure to reduce or limit the time and difficulty of placing a spiral, migration-resistant, and infection-resistant lead in the optimal position.

[0234] In a non-limiting example of a concentric needle or sheath, a mechanism is needed to control the movement of the needle and sheath relative to each other and to surrounding tissue, thereby ensuring proper placement of the lead and preventing damage to the lead. Selective lead deployment can be achieved by sliding the outer needle to expose the bevel of the inner needle and the end of the lead, and by retracting the needle to position the lead end or anchor into nearby tissue. However, in this non-limiting example, the device for controlling the distance the needles move is crucial for accurate lead placement and to ensure that the needles do not move or slide relative to each other before or after lead deployment, preventing shearing, breakage, or bending of the lead or lead end.

[0235] To achieve this level of control, methods such as... can be used. Figure 15A and 15B The spacers or position-holding mechanisms S shown herein lock two needles together during insertion through the skin by a clinician, allowing the lead to be deployed at the desired location. In one embodiment, the spacer may be a partial or complete cylinder and located between the hubs of the inner and outer needles. In this embodiment, the spacer may be removable and threaded at its ends, allowing it to be locked onto the hub of each needle (e.g., the spacer can be removed by twisting it through the threads on the needle hub and causing it to slide off). In another embodiment, the spacer may remain in place and collapse to allow retraction of the outer needle. For example, in this embodiment, twisting or pressing a button on the spacer (as indicated by the arrow) will allow the spacer to shorten, thereby allowing directional retraction of the outer needle.

[0236] In another non-limiting example, the hub of the outer or inner needle can be retracted into the introducer handle a specific distance. In another non-limiting example, a component of the introducer handle can be twisted to retract any one of the needle, sheath, or lead a specific distance. This allows for controlled retraction of the needle and proper placement of the lead. In one embodiment, the handle for controlling the retraction and movement of the needle can be ergonomically designed with a smooth profile to fit the clinician's hand and uses buttons or sliders to enable one-handed operation of the introducer system. One-handed operation further enables proper lead placement, for example, allowing the clinician to visualize the target with ultrasound using one hand while advancing, retracting, or repositioning the introducer system, and then deploy the lead with the other hand. Furthermore, the introducer handle can be marked to indicate the direction or side of the needle where the lead will be deployed, further assisting the clinician in proper lead placement.

[0237] In a non-limiting example of an introducer with multiple stimulating electrodes, the entire system or its components can be withdrawn to the desired position for effective test stimulation, the outer needle is withdrawn, and the lead tip is deployed. Here, the lead can be deployed at any location along the length of the outer test needle without having to redirect the needle. A slit or opening along the length of the outer needle (also as described above) will allow the lead to be repositioned without having to move the outer needle. In this embodiment, the lead can be repositioned with an inner sheath or needle, which allows the lead to be repositioned within the needle and then deployed at any depth along the needle.

[0238] One non-limiting example is an embodiment in which multiple contacts can be positioned on the introducer at specific intervals, such that only one needle insertion and one repositioning of the system may be required before lead deployment. In one non-limiting example, the contacts are spaced apart (e.g., 1 mm) (+ / -) on the outer needle. The needle can be inserted to a distance of Y mm (e.g., 5 mm) from the nerve. Test stimuli can be delivered individually or in combination from each contact as desired or needed, for example, starting with the most distal contact. If stimulation at the Zth (e.g., the 4th) contact provides an optimal response, the clinician can retract the introducer system by Z mm (e.g., 4 mm) and deploy the lead (retesting may or may not be required—both or either of which may be desirable in several different situations, potentially providing the clinician with options).

[0239] In another non-limiting example, there may be software to speed up, accelerate, or automate the procedure, including the sequential delivery of test stimuli at multiple contacts. In one non-limiting example, once information such as calibration points or ranges (e.g., the range of physiological response to stimulus intensity, the range of distances from target or non-target tissue, etc.) is known from the first (or other) contact being tested, the software may allow the testing to gradually accelerate or become more rapid for subsequent contacts. It may be advantageous not to fully automate this (e.g., to ensure that the stimulus does not produce unwanted responses, such as pain, discomfort, or unwanted muscle contractions).

[0240] This invention can prevent / reduce user errors and accidents during lead placement and stimulation testing by automatically incorporating patient feedback during stimulation testing via a patient-controlled testing system, a simplified parametric testing process, and / or a system that operates solely on patient feedback. This can advantageously reduce testing time and / or limit the number of position changes required before the system discovers the optimal or desired lead placement location.

[0241] A non-limiting example of incorporating patient feedback into stimulation testing is an example in which the test stimulus is controlled by a patient. A controller (e.g., a handheld remote control, tablet, smartphone, or other suitable interface) is handled by the patient and may be capable of delivering stimulation current directly to the test stimulation system via a cable, or may control the stimulation generator via wired and / or wireless technologies (e.g., Bluetooth, radio frequency). Furthermore, the generator is mechanically and / or electrically connected to the test stimulation system, allowing the electrical stimulation current to be delivered to the target tissue through the system. The patient controller may allow the patient to adjust one or more parameters (e.g., pulse width, amplitude, frequency, and / or waveform of the current / signal / test stimulus) to enable the patient to obtain the desired physiological response (e.g., paresthesia, muscle contraction, and / or pain relief). Alternatively, such a controller may be handled by a clinician, and adjustments may be made based on the results of the test stimulus (e.g., based on verbal feedback from the patient, direct and / or ultrasound visualization of contraction, and / or clinical experience). The non-limiting examples described herein may be advantageously combined with one or more of the examples / embodiments of the described invention.

[0242] In situations where stimulation testing is patient-controlled, one aspect of the present invention (reducing the overall duration of the procedure) may be hampered by complex stimulation testing controls and / or parameters, and / or by providing the patient (or clinician) with more options than necessary to test and determine the optimal or desired lead placement location. These risks can be minimized by simplifying the methods and / or controls used to adjust parameters during stimulation testing. Figure 16A , 16B Figure 16C illustrates several parameters (i.e., the pulse width and amplitude of the stimulus) and how these parameters are regulated by the patient controller. For example... Figure 16A , 16B The straight arrows in each of the 16C represent only a limited number of inputs / buttons / knobs / controls (e.g., 1 to 5 functional features, and more preferably 3). These inputs correspond to increasing and / or decreasing, such as... Figure 16A , 16B The capabilities of the parameters shown in 16C. In one embodiment, a single button increases one or more parameters (e.g., pulse duration, amplitude, frequency, and / or combinations of parameters), another button decreases one or more parameters, and a third button allows the test stimulus to be turned on and off. The controls can be advantageously calibrated or designed specifically for a given type or style of stimulus (e.g., high or low frequency, causing or avoiding muscle contraction vs. sensory nerve fiber activation, etc.) before use during placement and testing.

[0243] Additionally or alternatively, patient feedback can be incorporated into the testing process, i.e., by using software / programming to adjust the test stimulus parameters based on input / feedback from the patient and / or clinician. This adjustment allows for a minimized testing duration while avoiding any potential uncertainty regarding stimulus parameter adjustment. In this non-limiting embodiment, the patient and / or clinician use a graphical interface mechanism to obtain feedback, such as... Figure 17 The controller or tablet GUI shown allows information about the results of a test stimulus to be relayed to or communicated with the stimulus generator. Such a controller may include, for example, input devices whereby a patient can communicate sensations (e.g., paresthesia), pain, and / or contraction intensity to a clinician, as well as the location of such sensations, pain, or contractions on the patient's body. For example, the tablet GUI displays an image representing part or all of the patient's body, and allows the patient to select / highlight / draw or otherwise indicate areas where the stimulus is felt / seen / results. The software determines appropriate adjustments to the test stimulus parameters and / or advises the clinician on how to redirect or reposition the system to a new test location and / or where to deploy leads (e.g., at the current location, at the new test location, etc.). Such procedures, systems, and / or methods may be combined with one or more of other embodiments of the invention, such combination being advantageous to the objectives of the invention.

[0244] An exemplary stimulator may be able to provide at least the following parameters: an amplitude of 0.2-20 mA; a pulse duration of 10-200 μs; and a frequency of 5-100 Hz. The stimulator can connect to wireless clinician-programmed software for treatment, software and hardware for a wireless patient controller, and firmware and hardware for a miniature, body-mounted stimulator. This configuration allows clinicians and patients to view and adjust treatment parameters without having to interact directly with the stimulator. This prevents patients from having to remove clothing, etc., to access the stimulator during use. In one embodiment, the stimulator may communicate via a physical cable, wire, Bluetooth, or other wireless technology. This teaching is not limited to any particular construction.

[0245] The patient controller can also provide a broader graphical user interface, including various other options (e.g., information specific to a particular time of day / type of pain / type of expected patient activity, access to information on pain management, means of communication with healthcare professionals, etc.), thus making it a primary means of initiating and modifying treatment. Like the stimulator, the controller communicates with the stimulator (or multiple stimulators, if multiple stimulators are included in the system) and optional programmer unit via physical wires / cables or wirelessly, as described below. The controller can be relatively larger than the stimulator; however, wireless connectivity will allow the user to carry the controller in clothing and / or at a convenient distance and location compared to the electrode 934 and the stimulator. The connection between the controller, stimulator, and introducer system can include any of those described herein (e.g., standard wired connection, wireless connection—particularly between the controller and the stimulator, wired connection relying on a quick-release mechanism, etc.).

[0246] The stimulator allows for adjustment of stimulus intensity by controlling the stimulus amplitude and pulse duration, preferably with a single programmable parameter for intensity. The stimulus intensity itself can be determined by multiple parameters, including (but not limited to) the stimulus amplitude and pulse duration. For example, stimulus intensity can be increased by increasing the stimulus amplitude, pulse duration, or a combination of both. Using a single parameter to control multiple parameters, such as stimulus amplitude and pulse duration, reduces the complexity of the process for programming the stimulus parameters by reducing the number of parameters that can be changed from 2 or more to 1. As a non-limiting example, a minimum value (e.g., 0) for the stimulus intensity parameter can set the stimulus amplitude and pulse duration to their minimum values ​​(e.g., 0.2 mA and 10 microseconds). As another non-limiting example, increasing the stimulus intensity parameter can change the stimulus amplitude, pulse duration, or both.

[0247] In yet another embodiment, increasing the stimulation intensity parameter from a minimum can begin by increasing the stimulation amplitude while keeping the pulse duration at a minimum, until the maximum stimulation amplitude (e.g., 20-30 mA) is reached. Then, continuing to increase the stimulation intensity parameter can keep the stimulation amplitude fixed at the maximum while increasing the pulse duration until the maximum pulse duration is reached. In these embodiments, the stimulation intensity is easily programmable and can be increased while keeping the pulse duration as low as possible, so that the stimulation charge required to activate nerve fibers is kept as low as possible, and the patient / clinician's ability to selectively stimulate larger diameter fibers preferentially over smaller diameter fibers is enhanced. In another non-limiting example, increasing the stimulation intensity parameter from a minimum can begin by increasing the stimulation amplitude while keeping the stimulation amplitude at a minimum. Then, continuing to increase the stimulation intensity parameter beyond the maximum pulse duration (e.g., 200 microseconds) can keep the pulse duration fixed at the maximum while increasing the amplitude until the maximum stimulation amplitude is reached. In this example, the stimulation intensity is increased while keeping the stimulation amplitude as low as possible, which keeps the power consumption of the pulse as low as possible for a given charge per pulse.

[0248] Figure 18A This is the first example given, keeping the pulse duration low. Figure 18B This is the second example, keeping the stimulus amplitude low.

[0249] The introducer system described herein also reduces the risk of post-placement problems by decreasing the risk of lead breakage. This risk reduction stems from the shape of the electrode itself, namely its self-anchoring, migration-resistant, and infection-resistant small-diameter spiral / coil and its distal anchoring system, and from the reduced stress level applied to the lead during insertion and testing stimulation procedures, through the ability to withdraw and protect the electrode during insertion and repositioning.

[0250] Other advantages include the ability to minimize the duration of lead placement and stimulation testing procedures. The system also limits the number of percutaneous insertions required, reducing patient risk, allowing for efficient lead localization and repositioning for stimulation testing and lead deployment, enabling clinicians to correctly and optimally localize and deploy leads with minimal or no additional training, and reducing the time required to form the electrical connection for testing. As a result, treatment can be delivered to patients by clinicians in environments / scenarios that were previously cumbersome, impractical, and / or impossible (e.g., for preoperative, perioperative, and / or postoperative pain). The introducer also overcomes the limitations of prior systems by minimizing or eliminating the need for: a) insertion via multiple percutaneous devices; b) lead repositioning; and / or c) the extended time required for stimulation testing and / or lead placement procedures.

[0251] One embodiment involves increasing the strength of the coil / spiral lead, for example, by incorporating one or more strands of a high tensile strength material (such as, but not limited to, MP35N, nickel-chromium-molybdenum superalloy) into the lead. Increasing such strands and / or replacing the current lead conductor strands with such strands or conductors increases the lead's resistance to breakage, thereby increasing the utility of small-diameter coil / spiral leads for self-anchoring, anti-migration, and anti-infection purposes in electrical stimulation systems.

[0252] Another non-limiting embodiment includes increasing the strength of the lead by adding a new strand / filament within the open core / center of the spirally coiled lead. In this non-limiting example, the new strand / filament will not completely fill the opening. A gap will be maintained between the outside of the new strand / filament and the inside of the coiled conductor. Additionally, the new strand / filament will not extend the entire length of the coiled lead. In this non-limiting example, these two measures help the lead maintain flexibility, exhibiting axial and radial forces during normal use. When the lead is retracted, the inner diameter of the lead coil will decrease due to the straightening of the coiled conductor, and the coiled conductor will become bonded to the central strand / filament. Therefore, the lead exhibits higher tensile strength and reduced flexibility during removal procedures compared to the normal use configuration. The new strand / filament in the core can be metal (e.g., 316L or MP35N), or it can be a polymer (e.g., aramid). This embodiment can be advantageously combined with other aspects disclosed herein (e.g., using a core adjacent to the strand / filament—or even as part of it).

[0253] As noted above, the risk of lead breakage before, during, and / or after peripheral nerve stimulation therapy with self-anchored, migration-resistant, and infection-resistant small-diameter coil / spiral leads is minimized because the stress on the leads during lead placement, testing, and / or repositioning and deployment is limited. One non-limiting example of an embodiment that results in this reduction of mechanical stress is a design that includes a contour treatment (e.g., rounding or smoothing) of the needle / sheath that may contact the inner edge of the lead where the lead exits the needle / sheath's hole / lumen.

[0254] Preventing breakage and / or damage to any portion of the lead and / or the self-anchoring electrode tip is crucial to ensure maximum therapeutic benefit and reduce the risk of adverse events for the patient. The innovative coiled lead is designed to move with the tissue and skin and prevent breakage while still within the tissue during treatment. However, methods to eliminate other harmful forces encountered by the lead during placement can further reduce the risk of lead breakage, thereby improving system safety and avoiding the need for lead replacement. This can be achieved through features designed to reduce the forces applied from the needle and / or transmitted to the lead and / or anchor tip during lead insertion, and modifications to the method used to shape the anchor to reduce strain on the conductor within the lead.

[0255] For example, the boundaries of the needle and / or sheath (e.g., heel, edge, border, bevel) can be smooth or rounded to prevent sharp contact with portions of the lead and / or other components of the introducer (e.g., sheath, airbag, which may be negatively affected by the sharp edges of the needle or sheath). In a non-limiting example, manufacturing and / or preparing the introducer needle heel with rounded edges (e.g., by grinding, sandblasting, or smoothing the surface) eliminates sharp edges that may press against or contact the lead (which weaken the mechanical or electrical connection in the lead), thereby reducing the risk of lead breakage. The design and use of rounded edges in the introducer prevents breakage or strain that arises from the lead being confined against sharp edges (e.g., the heel of the needle) during insertion, which may weaken the tensile strength of the lead and lead breakage. The lead can alternatively be manufactured to reduce the likelihood of lead breakage by reducing the strain placed on the lead end during the creation of the lead anchor. In the prior art, anchors are made using uninsulated lead anchors (e.g., by folding them to create sharp bends), establishing points of high strain at the bends (e.g., anchors, hooks) in the lead. To prevent such points of maximum strain, lead anchors can be made by gradually rolling the lead around a ball or pulley system to create curved (e.g., rounded) anchors (without sharp bends) in the lead. In another embodiment, bending the anchor lead end can be used to secure the lead to tissue after deployment during lead placement. Alternatively, the lead anchor end can be manufactured in other shapes (e.g., straight, rounded, coiled, serpentine) that allow the lead to be deployed and anchored in tissue, thereby improving the strength and performance of the conductor due to the avoidance of sharp bends in the lead end.

[0256] The inner and / or outer needles of this introducer system use fully rounded edge surfaces that can contact the lead. The fully rounded shape extends throughout the entire cross-sectional shape (e.g., by maintaining a substantially constant radius) to eliminate or reduce the risk of lead impact, which may subsequently increase the risk of lead breakage. The use of rounded or substantially rounded edges, optionally coupled with the elimination of edges or sharp points on the lead within the introducer and throughout the insertion process, increases lead reliability and performance and improves safety profiles and safety margins for patients.

[0257] A prior art description of the cutting edge for a needle or other lumen is shown in Figure 19, which includes an exploded thumbnail view at the top. These illustrations also reflect European Patent No. EP0929330B1 belonging to Gravelee. Generally, the beveled cutting edge E2 is positioned at the distal end of the needle / lumen E. In some embodiments, the sharpness of the cutting edge in the anterior portion may be positioned along the inner diameter of the lumen E, rather than on its outer periphery as shown. In contrast to other conventional needles having a top edge E3 that substantially replicates the bottom edge E2, the top posterior edge E4 may be partially rounded along its inner diameter edge (i.e., not as sharp as the cutting edge 38). This rounded posterior cutting edge E4 allows tissue to be punctured without a small piece of tissue being cut off by the posterior cutting edge of the needle, which could then be injected into the patient's tissue or bloodstream and could potentially lead to downstream embolism (blockage of a blood vessel) or abscess. In this configuration, the partially rounded edge E4 of the needle E extends from 1% to 60% around the periphery of the needle E, and preferably to about 50%. Note that most of the cutting edge E4 remains flattened, presumably to facilitate cutting, so that edges E3 and E4 both provide potential "narrow spots" when needle E is used as an inner sheath. In the two illustrations in Figure 19, a curved or arc-shaped incision is made through the tissue at the anterior cutting edge E2, and this is easier to seal and heal than a curved incision in the blood vessel if a small piece of tissue is removed.

[0258] As in Figure 20A(Including an exploded small view of the rear edge R4) as seen in 20C, the introducer system has a more fully rounded edge R4 or transition between the inner diameter of the lumen R and the outer surface of the curved opening R6 on a portion of the rear edge R4. The lead-cutting edge R2 is positioned along the opposite side of the opening R6. This property is a significant advantage, particularly at the heel of the bevel or at the rear edge, where the lead anchor (not shown) is bent or folded during development, manufacturing, assembly, delivery, use, insertion, positioning, and / or repositioning in part or all of the tissue. Through this area of ​​the rounded needle (and / or other areas where the electrode is bent or folded at an acute angle while potentially contacting the edge surface), the sharpness of the edge is reduced to completely eliminate any edge that could cut, sever, scratch, create unwanted notches, or otherwise damage or impair the function of the lead that may and / or will contact the heel of the bevel. Another desirable property of the invention is that it allows the bevel to combine with the rounded edge, enabling the introducer and lead to be inserted into the tissue without the risk of damaging the lead, while remaining sufficiently sharp (e.g., not blunt) at the leading edge and interface, thereby allowing it to advance through the tissue.

[0259] As in Figure 20C As can be seen, the fully rounded edge can also be replicated along any portion of edge R14 associated with the seam R16, through which the distal end of the electrode (not shown) can be confined. In contrast, edge R12 can be fully rounded, or it can more closely mimic the sharper cut edge at the leading edge R2. The seam R16 can have a similar curved shape to the opening R6, but it is also possible to form the seam R16 into an elongated, elliptical, slit-like, or polygonal shape, positioned off-center, parallel, or orthogonal to the axis defined by the cylindrical shape associated with the needle R.

[0260] The complete rounding of a needle or edge in the prior art differs from the rounded edge in this invention. The prior art describes edge E4 as extending only along the inner periphery of the needle, thus retaining a narrow point (but one with a slightly less sharp edge). In contrast, rounded edge R4 extends from the inside to the outside of the needle (i.e., maintaining a substantially constant diameter relative to the arc formed by the rounded edge), thereby uniformly distributing the force applied to the electrode along the entire surface of edge R4. In another embodiment, rounded edge R4 is orthogonal or perpendicular to the periphery of the needle (i.e., the edge extending from the inner diameter to the outer diameter), thus encompassing an elliptical shape whose radius may vary. In both cases, edge R4 establishes a smooth transition without any narrow points, and the term complete rounding encompasses both an arc of constant radius and an ellipse.

[0261] As another example of the difference between prior art and this introducer, the objectives of the prior art and the present invention are different. Prior art is designed to allow insertion into blood vessels, while the introducer described herein intentionally seeks to avoid contact with blood vessels and is instead designed to puncture tissue adjacent to nerves. Prior art is also designed to avoid cutting a small piece of tissue, while the fully rounded edges are designed to avoid or reduce damage to the self-anchored electrode before and during lead placement, testing, repositioning, and / or deployment processes.

[0262] In contrast to existing technologies, fully rounded edges or surfaces at points of contact or potential contact with the lead eliminate or reduce the risk of lead damage (which may increase the risk of lead breakage). The use of fully rounded edges effectively eliminates sharp or pointed edges, increases lead reliability and performance, and improves patient safety profiles and safety margins.

[0263] Tuohy needles and modified Tuohy needles known in the art have blunt bevels to allow catheters to pass through them more safely. These catheters have substantially larger diameters, to the point that they must accommodate fluid flow without causing obstruction. In contrast, introducer systems are not designed for catheters but instead employ ideally fine-gauge needles with an inner diameter (e.g., lumen) large enough to accommodate a thin lead to allow the system to puncture and advance through tissue. Thus, Tuohy needles are incompatible with the design intent of introducer systems, and their excessive diameter makes it difficult to accommodate the lead without excessive movement and potential damage. Furthermore, the distal end anchor of the lead rests against the heel of the bevel in a manner that allows the introducer to maintain the lead's posture and position relative to the introducer when the introducer is manipulated within human or animal tissue.

[0264] This system for percutaneous placement of small-diameter coiled leads also reduces the risk of accidental lead displacement. This avoidance of lead displacement is achieved with self-anchoring, migration-resistant, and infection-resistant small-diameter coil / spiral leads. Furthermore, these advantages are particularly advantageous during the initial period (compared to prior art systems) in which the lead remains in place within the desired tissue (e.g., before the lead is fully encapsulated within connective tissue or during a period of indwelling from 1 day to several months). Other advantages (possibly in addition to those noted herein) include: the ability to minimize the duration of lead placement and stimulation testing procedures; a reduction in the number of percutaneous insertions required; reduced risk to the patient, namely by allowing efficient positioning and repositioning of the lead used for stimulation testing and correct / optimal lead deployment by the clinician with minimal or no additional training; and by reducing the time required to form the electrical connection for testing. Treatment can be delivered to patients by the clinician in environments / scenarios that were previously cumbersome, impractical, and / or impossible (e.g., for the treatment of preoperative, perioperative, and / or postoperative pain).

[0265] In some embodiments, accidental lead displacement is also prevented by relying on an anchoring mechanism made of a bioresorbable material (e.g., polyglycolic acid:trimethylene carbonate, polylactic acid, or other suitable bioresorbable material with sufficient mechanical properties to serve as an anchoring mechanism) in at least some portions of the lead / electrode. The use of such a bioresorbable anchor promotes lead fixation in the tissue, thereby preventing accidental displacement. The use of such an anchor can also be designed so that as the lead becomes encapsulated / fixed by tissue growth, the anchor becomes absorbed, thereby reducing the risk of lead breakage upon removal at the end of active treatment. Over time, the bioresorbable portion is then naturally accommodated by the body, leaving only the stimulating portion of the lead firmly in place.

[0266] Monofilaments of the material (e.g., similar to dissolving sutures) can supplement the distal anchor with any number of optional barbs to aid in short-term fixation. These filaments and / or barbs can have varying or constant geometries, including a variety of different shapes and thicknesses, and can be manufactured using standard molding methods. These ends can be attached to the lead wire mechanically by several suitable methods, examples of which include integration within the open coil of the lead wire by overmolding the lead wire or by covering the existing insulating coating of the lead wire with a secondary extrusion layer of bioabsorbable material. Furthermore, bioabsorbable ends can be attached to the lead wire via a thermal melting approach (using an absorbable material as an adhesive). This approach allows the invention to enhance short-term fixation and prevent accidental displacement when using or placing self-anchoring, migration-resistant, and infection-resistant coiled / spiral lead wires. These bioabsorbable aspects can be used alone or advantageously in combination with one or more aspects of the invention described elsewhere in this disclosure.

[0267] refer to Figure 12A Once the lead is placed in the patient's body, the delivery device can be detached and removed. The proximal portion of lead 934 can then engage with lead connector unit 950, as indicated by the arrow. Lead connector 950 may have an insulation compression connector (IDC) (in... Figure 12A and 12B (not shown) and a groove 952 configured to receive lead 934. Groove 952 may include a contact strip having receiving members (e.g., microstructure barbs, snap-fit ​​elements, magnets, etc.) (not shown) to hold lead 934 in place.

[0268] exist Figure 12B Another embodiment of the lead connector is shown, which eliminates the need for a separate tool because it allows for a one-handed push-button mechanism for clinicians and / or patients. A lead (not shown) is received in an aperture 952, which may have a tapered, funnel-shaped, or cylindrical shape, terminating at a connection point on the main housing of unit 950. Lead connector unit 950 may also include a split connection, for example, where the lead connector end 954 includes a magnet, and the opposite end, i.e., the lead connector cable end 956, has a magnet with opposite charge (in...). Figure 12B In the embodiment shown, this allows clinicians, patients, etc., to easily separate cable 958 from unit 950. The magnet-type or other type of connection can be integrated anywhere along the body of unit 950. Other removable connection types are also envisioned for the connection mechanism, including snap-fit, adhesive, clip, etc. Force-fitting components, or any other suitable connecting devices.

[0269] Additionally or alternatively, connector 950 may have a rotating element, such as a knob, dial, reel, or post 953. The rotating element may mechanically and / or electrically engage the leads to assist in adjusting the tension of the separable connection, which is formed by the electrodes, lead connector, and leads. The rotating element may include a predetermined tension release or recoil mechanism that responds to a separation force by releasing excess leads wound around the element. In the same manner, lead connector 950 may achieve this tension release via a slider or other movement that is not necessarily rotational in nature. As with the separable aspect of the lead connection, tension release may occur with a force less than or equal to half the force required to displace or move the electrodes from their initial position.

[0270] The IDC mechanism assists in connecting the lead 934 to the recess 952 to establish a connection between the receiving member and the lead 934. In this embodiment, the clinician relies on his or her dominant or non-dominant hand to insert and connect the lead. The IDC mechanism is also able to strip any insulation from the lead 934 to establish better electrical contact between the lead 934 and the unit 950 / recess 952. The IDC can be integrally formed with or separately attached to the lead connector unit.

[0271] Exemplary alternative embodiments of IDC in Figure 21A and 21B As shown in the image. Figure 21A The IDC 989 shown may include a drawer mechanism 990, such as a pivot disk that rotates relative to a pivot point PP and in a pivoting direction indicated by arrow PD, which can be inserted into and removed from the body of the IDC. A slot 952 (functionally similar to...) Figure 12A This is part of the bisected disc (as described in the text). The slot 952 has a suitable shape and size to securely engage the lead wire within the disc and may include a sliding portion, jaws, barbs, or the like. The disc 990 rotates such that the proximal end of the lead wire is completely within the IDC 989, while the remaining portion protrudes outside the unit 989. Springs, locking elements, and guiding mechanisms may also be provided to offer better control of the disc 990 during operation.

[0272] exist Figure 21B In another embodiment shown, IDC 1089 may have a generally cylindrical shape. IDC 1089 may include a aperture, slot, or opening 1990 into which a lead wire can be inserted (similar in function and feature to the slot 952 described above). IDC 1089 may include an actuating rod AL for twisting or rotating the body of IDC 1089 relative to the portion containing slot 1090 (i.e., as indicated by the pivot direction arrow PD), such that the lead wire is secured within IDC 1089. If necessary, barbs (not shown) may be included inside IDC 1089 to remove insulation from the lead wire to expose the underlying conductor. Cooperatively operating guides or grooves (not shown) may facilitate relative movement of the bodies 1089, 1090, and may also include stops and locking mechanisms to prevent accidental movement.

[0273] The lead connector 950 can be branched to receive multiple leads 934. For example, multiple slits or funnels can connect multiple leads to a single stimulator to allow therapeutic stimulation to be delivered to different parts of the body.

[0274] The connection between the lead connector 950 and the electrode 934 can be separable. Separability can include, but is not limited to, a magnet, such as an insert-molded neodymium magnet, which can be formed on one or both ends of the connector and the lead (if on both ends, the stimulator will also have a separable connection as described herein). Depending on the manufacturing process, the magnet and how it is assembled can allow for differentiation of the connection points. For example, the lead connector can have a stepped connection port that mates with a corresponding stepped connection on one of the leads, such as... Figure 22A As shown in the diagram. Alternatively, a circular magnet can be placed on top of the connector leads, also... Figure 22B As shown in the diagram, slight indentations or grooves or other releasable force-fitting elements can be provided to achieve the experience of a "click" feel.

[0275] In addition to or instead of a magnet, a spring-loaded mating component can be used. An example of such a mating component is... Figure 22C The mating parts are shown in the diagram. The mating parts are generally described such that they can be used on any of the components, but specific utility is anticipated at the connection between the lead connector 950 and the electrode 934. End A has an inverted Y shape, which mates with a correspondingly shaped end B. Additional shapes, tips, or components may be included. The outermost arm C moves, preferably spring-loaded or magnetically, to receive and release end A (a single-ended arrow indicates the preferred range of motion). Ends A and B may be fitted in a plane parallel to the double-headed arrow, and / or they may be recessed or snapped into place and then released in a direction different from, preferably, perpendicular to, the release direction.

[0276] In some embodiments, the lead connector and lead may include a detachable connection configured such that the stimulator or lead is not displaced when an unwanted force is applied to them or their connection. For example, the connection between the lead and the stimulator may be detachable upon application of a predetermined force. The predetermined force may be calculated to substantially prevent movement of the electrode once it has been placed in the appropriate position within the patient's body.

[0277] Alternatively or additionally, the leads may be separable (e.g., in the middle, making it effectively multiple leads, such as two or more). The leads may be separable at any point between the lead and the stimulator; for example, the lead may detach at either end. Furthermore, the predetermined separable portion may be along any part of the lead's length between the lead and the stimulator. For example, two or more leads may be selectively attached at the separation point to separate upon application of a predetermined force. Furthermore, while this disclosure indicates that multiple portions are separable, they may also be reattachable. This can allow the system to function as a fail-safe mechanism to prevent damage and / or injury to the system, components, and / or the patient.

[0278] In addition to safe dissociation, circuitry in the lead (and / or other components, such as lead connectors) can prevent the delivery of unwanted stimulation during dissociation. By way of a non-limiting example, the lead could be a “smart lead” with components plus a path for electrical conduction that minimizes the risk of the patient experiencing unwanted stimulation (e.g., minimizes or eliminates the possibility of the patient experiencing shock) when the lead is accidentally dissociated during use.

[0279] All the connections described above rely on mating parts. To avoid improper installation, each in the mating pair can be given a unique shape. Sensors or other circuitry can be incorporated at the connection points to enhance the user alarm features described herein. Such sensors or circuitry may be inherent to the electrical signals that deliver the stimuli, or separate signals may be established.

[0280] In one embodiment, such as Figure 22D As shown, the connection may include a lead connector lead end plug having at least two or three pointed steel electrical contacts that attract a magnetic armature at the lead connector end.

[0281] Leads may optionally be connected to a stimulator (not shown). The stimulator may include a battery (not shown), a programmable storage unit, and circuitry inherent to the delivery system required for therapeutic stimulation. In one embodiment, the battery may be embedded within a lead connector or another electrode. The battery may be thin, flexible, and powerful. The battery may contain enough power for at least 24 hours of use to maximize usage without the need for charging or replacement. The stimulator may also include a graphical user interface for communication with the patient and / or clinician. It may include LEDs or other visual markers to convey motion, errors, or other relevant information about the operation of the stimulation system. The stimulator may allow patient and / or clinician adjustments for the operation of the system. Furthermore, the stimulator may be worn on the patient, thereby minimizing cabling and making the system easier to wear than conventional external stimulators. The stimulator may also be waterproof for all-day wear.

[0282] Furthermore, the insertion device can be paired with a custom-designed bandage system, minimizing the risk of lead wire displacement during use. For example... Figure 23As shown, lead 934 and lead connector unit 950 can be protected and attached to the patient via a custom bandage 1060. Bandage 1060 eliminates the need to secure lead 934 and lead connector 950 with separate adhesive tape. Bandage 1060 can be integrated with lead connector unit 1050 to allow clinicians and / or patients to easily and consistently remove and replace bandage 1060 without worrying about accidentally pulling out the lead and / or otherwise displacing it. Bandage 1060 can consist of the same membrane material used in standard bandages, such as porous or non-porous membranes, including but not limited to any polymeric materials, including but not limited to polyethylene, metallocene-catalyzed polyethylene, polypropylene, polyolefin copolymers, and ethylene vinyl acetate copolymers. Bandage 1060 may also include an adhesive material. Suitable adhesives may include, but are not limited to, acrylic-based, dextrin-based, and urethane-based adhesives, as well as natural and synthetic elastomers. Adhesives may also include amorphous polyolefins, including amorphous polypropylene. In one embodiment, the bandage 1060 may have an adhesive periphery 1062 that includes an optional removable patch 1064. The adhesive periphery 1062 prevents the lead 1034 from being exposed to any adhesive surface and adheres unintentionally to the bandage 1060. The center of the bandage 1060 may include an absorbent pad 1066 configured to cover the point of entry of the lead 1034 into the patient's body. The absorbent pad 1066 may be configured to absorb any fluid exiting the lead insertion site, such as any type of liquid (including but not limited to blood, pus), which may seep from the lead insertion site. The size of the pad 1066 may allow the patient and / or clinician to view the area around the lead exit site to determine the presence of any infection or abnormality. The absorbent pad 1060 may be surrounded by a transparent polyethylene segment 1068 of the bandage 1060, which allows the clinician and / or patient to better see the placement of the bandage 1060. A cutout 1070 in the adhesive periphery 1062 of the bandage 1060 covers the lead connector 1050, thereby eliminating gaps in the bandage seal, but allowing direct contact between the clinician and / or patient and the lead connector 1050 during removal / attachment procedures. During removal, the patient and / or clinician can place his or her fingers on the pad 1066 and the lead connector unit 950 to generally prevent the lead 934 from pulling on the patient's skin. This can be particularly advantageous on the patient's body and on hard-to-reach locations in frequently moving body parts such as the arms, legs, back, head, etc.

[0283] When Figures 24A to 24FWhen applying or changing the bandage 1060 as shown, the clinician and / or patient can disconnect the lead connector cable 1056 from the stimulator (not shown) and apply temporary adhesive tape 1072 to apply pressure to the lead connector 1056. The clinician and / or patient can apply additional pressure to the lead connector 1056 while removing the bandage 1060 from the patient. The site can then be examined and cleaned. A new bandage can be applied to the site, the temporary adhesive tape 1072 can be removed, and the lead connector 1050 can be reconnected to the stimulator.

[0284] This instruction is not limited to any specific treatment or indication. The system can be applied to any type of treatment, including but not limited to patients with postoperative pain or any type of pain, especially those with chronic pain (e.g., neuropathic pain, headache, and / or back pain).

[0285] The lead connector unit may include a lead storage mechanism for storing excess lead length (e.g., when the lead is attached to the lead connector). This mechanism reduces excess lead length between the lead connector and the point where the lead leaves the body. This reduces the risk of snagging on objects and being pulled out and / or damaged. If the lead gets caught, such as on an external object or from a body part, the excess lead stored in the mechanism can be released, rather than displaced or moved from the tissue, causing the lead to break (inside or outside the body), and / or pulled out and separated from the lead connector. In a non-limiting example, the mechanism may be a reel around which the lead is wound, manually or automatically (e.g., using a spring). In another non-limiting example, the mechanism may be located outside or inside the lead connector. Additionally, the lead connector may have padding on one or more sides to provide comfort while wearing the lead connector.

[0286] The lead connector can also be designed to be easily attached to the stimulator and can allow for one-handed connection, such as via a magnetic connection as noted herein. However, it should be understood that while a magnetic connection is described, the connection can be any mechanical connection other than or replacing a magnetic connection. The connection can be oriented at several different angles relative to the skin surface. In one non-limiting example, the connection is oriented generally perpendicular to the skin. In another non-limiting example, the connection is generally parallel to the skin surface. In yet another embodiment, the connection can be easy for the user to make (e.g., requiring little dexterity, even without looking at the connector) and strong enough to prevent unintentional separation (e.g., due to common body movements or small forces, etc.) and separation under stronger forces that could displace the lead (e.g., from an external object or body part that pulls or drags the lead connector or the stimulator attached to the lead connector). The connection can prevent lead displacement or breakage by separating the lead connector and the lead when the lead is pulled, rather than transmitting force along the lead. In a non-limiting example, the magnetic connector may be configured such that the surrounding magnetic field is reduced and interference with objects (e.g., credit cards, cell phones) placed near the magnetic connector is avoided.

[0287] Furthermore, the lead can be directly connected to the stimulator (i.e., the lead connector can be built into or integrally formed with the stimulator). The stimulator can be positioned directly above or adjacent to the lead exit site to protect the exit site. A transparent window can be provided through which the lead exit site can be monitored for safety (e.g., infection, irritation).

[0288] In another non-limiting example, the lead can be connected to the lead connector using a socket and a plug, with the socket located on the lead and oriented at an angle (e.g., 90 degrees) relative to it. The socket can be connected to the plug on the lead connector using a downward force, allowing for one-handed connection. The very small distance between the magnetic armature of the plug and the permanent magnet structure of the lead connector means that the residual field outside the lead connector is very small.

[0289] The cable can be attached to the stimulator and stored or organized (e.g., wound, coiled, or coiled) to reduce the length of the lead (or wire) that might become snagged on, for example, an external object or body part. In a non-limiting example, excess cable can be stored in a storage device attached to the cable, lead connector, and / or stimulator. In a non-limiting example, the storage device is a reel around which the cable can be wound manually or automatically (e.g., via a spring). In one embodiment, the cable can be coiled or wound around a reel on the stimulator, and forces on the lead cause the cable to unwind from the reel rather than detach from the stimulator, transferring the force to the lead connector and / or cable.

[0290] The stimulation system may include leads attached to the stimulator, which are available in various lengths. In a non-limiting example, a lead with a minimum length that allows connection between the stimulator and the lead connector may be selected to reduce the risk of the lead getting caught on an object or body part and to disconnect the system, displace the lead, and / or break the lead.

[0291] In some embodiments, the stimulator can achieve coordinated stimulation across two or more stimulators. Alternatively or additionally, the controller and / or programmer unit can achieve coordinated stimulation across two or more stimulators. Coordinated stimulation can allow stimulation across multiple stimulators to be initiated and stopped in a cooperative manner to avoid asynchronous activation of muscles on opposite sides of the body (e.g., back or trunk), which may lead to loss of balance or discomfort. Control of stimulation across multiple stimulators can also prevent synchronous stimulation, for example, to avoid activation of opposing muscles (e.g., biceps and triceps), which may lead to discomfort. In a non-limiting example, one of the stimulators, controller, and / or programmer unit can communicate directly with the other stimulators. In another non-limiting example, each stimulator can be connected to a central control unit, which may be another stimulator or a non-stimulation control unit. In a non-limiting example, communication between the stimulators and / or control unit (controller or programmer unit) can be wireless (e.g., via Bluetooth, Wi-Fi) or wired (e.g., cable).

[0292] A battery-powered, body-worn stimulator can generate an electric current, which can be applied via leads and / or introducers. In one embodiment, the stimulator is a small box (e.g., with a circular outline and minimal profile height) worn on the body via gel patch electrodes that serve as return electrodes and are connected to two snaps that also provide electrical connection. In one embodiment, the stimulator has a minimal user interface (e.g., a press-button start / stop, an LED light, and a speaker or buzzer) to provide critical feedback to the patient. For example, the light may flash or illuminate (e.g., different colors or different flashing patterns) if the battery is low or if there is a problem with the stimulation. This critical feedback will alert the patient or clinician to address any issues, such as battery failure, gel pad detachment, or a disconnected connection. In a non-limiting example with a magnetic lead connector, it is important that the stimulator generates an alarm if the quick-release cable is accidentally displaced without the patient's knowledge. Furthermore, lead errors, which can cause stimulation to stop due to issues such as high electrode impedance (e.g., loss of connection between the skin and the return electrode), and may affect treatment usage time and the therapeutic benefits received by the patient, can be mitigated by audible or visual alarms from the stimulator. In one embodiment, the stimulator memory generates an activity log to record stimulator usage and errors during treatment. The stimulator log may include a list of errors that occurred, along with timestamps of the times the errors occurred, a history of usage time including amplitude and stimulation parameter settings used. These features are important to ensure that patients can use the stimulation effectively and that clinicians can effectively manage their stimulation use.

[0293] An additional embodiment of the breaking mechanism is in Figures 25A to 25C As shown in [the image]. Figure 25A In the diagram, a portion of the disconnecting mechanism is shown as a receiver section, including a wire / lead contact point CW. The receiver section may include a magnet M, including the contact point, according to any suitable embodiment. The receiver section may include a ferromagnetic stator 1110, which can be used as a path retainer. Figure 25B The mating part of the breaking mechanism is shown, which is plug 1112. The plug may include a ferromagnetic retainer path 1113 and a contact 1114. A lead may be operatively attached to plug 1112.

[0294] like Figure 25CAs shown, the disconnecting mechanism may include a spring-loaded plunger mechanism PM. The plunger mechanism employs a pair of biasing members BM that push the plungers toward each other when the plug is inserted into the receiver. This holds the disconnecting mechanism together. The force used to hold the disconnecting mechanism together is limited such that any force applied to the system exceeding this force will cause the plug to separate from the receiver, for example, if a force is applied to the lead due to the lead being caught on something. This generally protects the system. Specifically, it generally prevents the leads and / or electrodes from becoming separated or moving from their intended positions.

[0295] Although embodiments of this disclosure have been shown in the accompanying drawings and described in the foregoing detailed description, it should be understood that this disclosure is not limited to the described embodiments, but rather that the embodiments described herein are capable of many reconfigurations, modifications, and substitutions without departing from the scope of the following claims. It is certainly impossible to describe every conceivable combination of components or methods of operation for the purposes of this specification, but those skilled in the art will recognize that many further combinations and substitutions are possible. Each of the components described above can be combined or added together in any substitution to define the introduction device and / or introduction system. Accordingly, this specification is intended to include all such variations, modifications, and modifications that fall within the spirit and scope of the appended claims. Furthermore, with regard to the use of the term "comprising" in the specification or claims, such term is intended to be inclusive, in a manner similar to the term "including," as interpreted when "comprising" is used as a transitional term in the claims. The following claims are intended to include all modifications and variations, provided they fall within the scope of the claims or their equivalents.

Claims

1. An introducer system for locating, testing, and deploying leads for percutaneous peripheral nerve stimulation, said introducer system comprising: Electrical stimulation generator unit; An open coil-shaped stimulation lead has a conductive distal anchor, a body with an open coil structure, and a proximal end that communicates with the electrical stimulation generator unit. The needle assembly includes: an outer sheath having a beveled end and an outer periphery, and the outer sheath defining a cavity; an inner deployment mechanism being fully carried within the cavity during positioning and testing; and at least one test electrode positioned along the outer periphery and electrically connected to the electrical stimulation generator unit. The stimulation lead is carried by the internal deployment mechanism during the positioning and testing of the needle assembly until the stimulation lead is deployed and anchored. When the test mode of the electrical stimulation generator unit is enabled, the at least one test electrode delivers test stimulation at one or more desired locations; The needle assembly can be repeatedly repositioned without deploying the stimulation lead; and As the stimulation lead is deployed from the needle assembly, the distal anchor is exposed from the needle assembly and anchored at one of the desired locations.

2. The introducer system according to claim 1, wherein, The internal deployment mechanism includes an inner sheath having a terminal opening having a first edge that engages with a partially protruding, curved anchor portion of the stimulation lead.

3. The introducer system according to claim 1, wherein, The internal deployment mechanism includes a plunger that moves along its axial length in coordination with the test electrode.

4. The introducer system according to claim 3, further comprising: A locking element is used to restrict the movement of the plunger before the stimulation lead is deployed.

5. The introducer system according to claim 3, wherein, Multiple test electrodes are positioned at spaced intervals along the axial length of the outer sheath.

6. The introducer system according to claim 1, wherein, Multiple test electrodes are positioned on the outer periphery.

7. The introducer system according to claim 6, wherein, The plurality of test electrodes are coupled to associate a desired location with a specific test electrode, wherein the internal deployment mechanism deploys the stimulation lead at a predetermined location.

8. The introducer system according to claim 1, further comprising: A rapid separation mechanism is used to maintain contact between the proximal end and the electrical stimulation generator unit.

9. The introducer system according to claim 8, wherein, The rapid separation mechanism includes at least one orifice or slit, and the proximal end of the stimulation lead is received in the orifice or slit.

10. The introducer system according to claim 8, wherein, The rapid separation mechanism includes at least one magnet.

11. The introducer system according to claim 8, wherein, The rapid separation mechanism includes an insulation compression connector.

12. The introducer system according to claim 8, wherein, The rapid separation mechanism includes at least one biasing member.

13. The introducer system according to claim 1, further comprising: A user controller connected to the electrical stimulation generator unit.

14. The introducer system according to claim 13, wherein, The user controller includes a graphical user interface.

15. The introducer system according to claim 13, wherein, The user controller is wirelessly connected to the electrical stimulation generator unit.

16. The introducer system according to claim 1, wherein, The needle assembly includes a spacer.

17. The introducer system according to claim 16, wherein, The spacer moves along the axis of the needle assembly to at least retract the outer sheath.

18. The introducer system according to claim 1, wherein, The stimulation lead comprises a bioabsorbable material.

19. The introducer system according to claim 1, wherein, The open coil-like structure promotes inward tissue growth.

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