Electrode lead anchor system and use thereof

Abstract

Provided herein are devices, systems, and methods for implanting one or more electrode leads anchored at a target tissue to deliver stimulation to treat a disease or condition of one or more tissues. The electrode lead device may include a plurality of anchors disposed bidirectionally on the lead to reduce inward and outward movement of the lead.

Description

[0001] By incorporating references to any priority claims This application claims the benefit of U.S. Provisional Application No. 63 / 578338, filed August 23, 2023, and U.S. Provisional Application No. 63 / 658795, filed June 11, 2024, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to systems and methods for implanting one or more electrode leads and anchoring the electrode leads to target tissue. Background Technology

[0003] Electrical stimulation has been used to treat incontinence, pelvic pain, sexual dysfunction, or other pelvic conditions. Specifically, electrodes can be implanted in the pelvic region of a subject to provide electrical stimulation as a clinical treatment and / or condition management. The methods of providing implanted electrodes for treatment and / or condition management are limited by the ability to fix the implantation position of the electrode leads relative to the tissue in the pelvic region, due to the forces exerted on the electrode leads by surrounding tissue during implantation and when the subject with implanted electrode leads moves or walks. Summary of the Invention

[0004] Positioning the implanted electrode leads at one or more target nerves and / or adjacent tissues can improve the robustness of delivering spatially controlled stimulation to one or more nerves to treat and / or manage conditions such as pelvic disorders. In some cases, pelvic disorders include urinary incontinence, fecal incontinence, pain, sexual dysfunction, or any combination thereof.

[0005] Although several embodiments are described herein with respect to the pelvic region for treatment and / or management of pelvic conditions, they may also be used in other areas of the body or to treat other conditions described elsewhere herein.

[0006] When a subject with implanted electrodes moves throughout the day, the implanted electrode leads may migrate inward (deeper into the subject's tissues) or outward (shallower into the subject's tissues). Electrode leads that have migrated from the target implantation area may lose their utility in providing the beneficial effects of treating and / or managing conditions. Therefore, several embodiments described herein provide anchoring and / or fixing of electrode leads relative to target tissue (e.g., an area within the pelvic region or other areas of the subject) to improve the robustness and efficacy of electrical stimulation for treating and / or managing the subject's conditions as the subject moves their body throughout the day.

[0007] In some embodiments, the devices, systems, methods, and / or kits described elsewhere herein describe an electrode lead device having one or more anchors and a method of implanting the device to fix the position of the electrode lead at a target implantation site. In some embodiments, the electrode lead is anchored and / or fixed to tissue in the target implantation site to allow the electrode lead to move with the tissue while still minimizing migration relative to the tissue. In some embodiments, the ability of the electrode lead to move with the tissue to which it is anchored and / or fixed allows the electrode lead to maintain a relatively constant distance to the target nerve even if the tissue moves. By fixing the position of the electrode lead relative to the tissue, the devices, systems, methods, and / or kits described elsewhere herein improve the reliability and robustness of the electrical stimulation delivered over a period of time for treating and / or managing pelvic conditions in patients when the subject moves or bends muscles near the implanted electrode lead.

[0008] In several embodiments, the electrode lead body and surgical method described herein have at least one or more of the following features or advantages: • Resisting forces in the axial direction to prevent both inward and outward movement; • Provides stability in at least three directions, including inward, outward, and lateral; • It simplifies the introduction of the electrode lead body; • Provides confirmation of the stimulating electrode's location at the target site; prior to anchor deployment; • Manufacturing flexibility for different indications or patient types; • Improved surgical access to the pudendal nerve and techniques for confirming access to the target site.

[0009] The electrode lead body may include one or more anchors to resist forces in the axial direction and prevent both migration, inward movement, and outward movement. For example, the anchors may be bidirectional. In other words, the free end of a first barb may extend toward the distal end of the lead, while the free end of a second barb may extend toward the proximal end of the lead. The first and second barbs may be on the same or different anchors. In some configurations, the anchors may provide stability in at least three directions to prevent inward movement, outward movement, and lateralization. For example, adjacent anchors may be rotated off-center.

[0010] The methods and apparatus described herein simplify the introduction of electrode lead bodies. Anchors can be compressed for delivery to the target site and expanded once proper positioning has been confirmed. For example, an anchor can be positioned proximal to the electrode, allowing the electrode to be deployed to confirm proper positioning while the anchor remains collapsed within the sheath. Anchors can be semi-rigid, allowing them to collapse or compress for delivery. Using bidirectional anchors, the anchors can collapse entirely in the same direction for delivery via the introducer. Some methods described herein can utilize lead positioning guides. Lead positioning guides can position the electrode lead body while the introducer constrains the anchor until the position of the electrode lead body can be verified.

[0011] Anchors can be individually attached to the electrode lead body to provide flexibility in the number and / or orientation of anchors, thus accommodating different indications, target sites, or patient sizes. For example, anchors can be individually attached to the electrode lead body using collars. This allows for a different number of anchors on the electrode lead body without altering the overall manufacturing process.

[0012] The electrode lead body can be flexible enough to be introduced into the target site and correctly positioned along the nerve. For example, the lead body can have varying degrees of flexibility along its length, using one or more different materials or the same material of different densities. The distal portion of the lead can be stiffer than the proximal portion. For example, the tip of the lead can be stiffer than the anchor portion.

[0013] Approaching and confirming the location of target nerves, particularly the pudendal nerve, can also be challenging in the pelvic region. The pudendal nerve travels along a broad, tail-like route medial to the ischial bone and then turns anteriorly into the ischial fossa. The methods and instruments described herein may have at least one of the following features or advantages. For example, a marking needle can be used to guide the electrode lead body into the correct location. The marking needle can indicate the intersection between the horizontal axis connecting the two greater trochanters and the vertical axis medial to the ischial spine. The line can be identified using X-rays. Furthermore, pudendal nerve stimulation advantageously provides a response in both the external anal sphincter and the pelvic floor, thus allowing the use of EMG responses in the external anal sphincter and / or pelvic floor to verify the location of the electrode lead body. The location of the electrode lead body can be verified using EMG combined with one or more measurements or modalities, including urethral manometry, X-rays, visual-motor responses, and / or ultrasound.

[0014] While certain devices, systems, methods, and kits for treating and / or managing pelvic conditions are described herein with reference to the pelvic region, these methods and devices can be used in other areas of the body or to treat other conditions. Anchors can be used to secure implantable devices in other areas of the body and / or to treat other conditions. In some embodiments, anchors can be applied to electrode lead bodies implanted in the spinal region, for example, to treat chronic or occasional pain. Anchors can be applied to electrode lead bodies in the spinal cord region of the occipital coccyx. In other embodiments, anchors can be applied to electrode lead bodies implanted near peripheral or cranial nerves. For example, an anchor can be applied to an electrode lead body implanted near the vagus nerve for the treatment of migraines. In some embodiments, anchors can be applied to implantable devices used outside the field of neuromodulation (e.g., joint repair, such as shoulder, knee, or hip). Anchors can be used instead of clips for sutures used in soft tissue repair (e.g., rotator cuff repair). In some embodiments, anchors can be applied to non-implantable or acute devices, such as catheters, such as drug delivery catheters or drainage catheters.

[0015] Some aspects of this disclosure relate to an electrode lead device. The electrode lead device may include a lead comprising one or more stimulating electrodes (e.g., two, three, four, or more) for applying stimulation to tissue. The one or more stimulating electrodes may be located near the distal end of the lead. The electrode lead device may include one or more anchors (e.g., two, three, four, five, six, or more). The one or more anchors may be positioned proximal to the one or more stimulating electrodes. Each of the one or more anchors may include a collar and one or more barbs (e.g., two, three, four, or more) extending from the collar. Multiple barbs may extend from an end of the collar. Multiple barbs extend from the end of the collar at an oblique angle relative to the longitudinal axis of the lead. Multiple barbs may be radially inwardly collapsible for delivery.

[0016] Multiple anchors can be arranged bidirectionally on the lead. The multiple anchors may include a first set of anchors and a second set of anchors. Each barb on the first set of anchors may extend in a first direction away from one or more stimulating electrodes. Each barb on the second set of anchors may extend in a second direction toward one or more stimulating electrodes. This bidirectional arrangement reduces both proximal (inward) and distal (outward) axial migration of the lead. The first set of anchors may be positioned between one or more stimulating electrodes and the second set of anchors. The first and second sets of anchors have different numbers of anchors.

[0017] Multiple anchors may include at least a first anchor and a second anchor adjacent to each other. Multiple barbs of the first anchor may be arranged to be circumferentially offset from multiple barbs of the second anchor. This circumferential offset arrangement can reduce lateral and / or rotational migration of the lead wire. The multiple barbs of the first anchor may be circumferentially offset from the multiple barbs of the second anchor by 15 degrees, 30 degrees, 60 degrees, 90 degrees, or other values ​​between these values. The multiple barbs of the first anchor may extend in the same axial direction as the multiple barbs of the second anchor.

[0018] The electrode lead device described herein can be configured for implantation near the pudendal nerve. The electrode lead device can be configured to treat conditions in the pelvic region, including urinary incontinence, overactive bladder, fecal incontinence, sexual dysfunction, pelvic pain, or any combination thereof. The electrode lead device can be implanted in the spine, shoulder, knee, hip, or cranial tissue.

[0019] Certain aspects of this disclosure may include a method of attaching an electrode lead device by advancing the electrode lead device through an introducer to a target tissue; partially withdrawing the introducer to expose one or more stimulating electrodes; confirming the location of one or more stimulating electrodes; and further withdrawing the introducer to expose a plurality of anchors. The method includes advancing a lead positioning guide through the introducer, the lead positioning guide carrying the electrode lead device. Confirming the location of one or more stimulating electrodes may include measuring EMG responses in the external anal sphincter. Confirming the location of one or more stimulating electrodes may include measuring EMG responses in the pelvic floor.

[0020] Certain aspects of this disclosure relate to a method of implanting an electrode lead device near the pudendal nerve of a patient. The method may include advancing a stimulating member (e.g., a stimulating needle or other elongated structure) toward the pudendal nerve; providing an electric current to the stimulating member; measuring an EMG response to confirm the location of the stimulating member near the pudendal nerve; and / or, after confirming the location of the stimulating member, implanting the electrode lead device at the confirmed location. The EMG response may be measured at the patient's external anal sphincter and / or pelvic floor. When no EMG response is detected, the method may include adjusting the position of the stimulating member. Confirming the location of the stimulating member near the pudendal nerve may include detecting a first EMG response at the patient's pelvic floor; and detecting a second EMG response at the patient's external anal sphincter. The method includes the possibility of no response being detected between the first and second EMG responses. Confirming the location of the stimulating member near the pudendal nerve may include detecting an EMG response in the patient's pelvic floor before and after adjusting the position of the stimulating member. The method includes advancing a guidewire through the stimulating member, advancing an introducer over the guidewire, and / or advancing the electrode lead device through the introducer. The method involves detecting urethral pressure to confirm the location of the stimulating component. The method involves bilaterally implanting an electrode lead device near the pudendal nerve on both the left and right sides of the patient.

[0021] Certain aspects of this disclosure relate to a method of implanting an electrode lead device near the pudendal nerve in a patient. The method may include inserting a marking needle, which in some instances may be a stimulating needle. The marking needle may be inserted at or near the intersection of a first line corresponding to the edge of the ischial bone (inner or outer edge) and a second line crossing the top of the greater trochanter. The method includes advancing the marking needle into the patient. The needle may be inserted perpendicular to the skin or at an angle relative to the skin. The method includes inserting a stimulating member (e.g., a stimulating needle or other elongated structure) toward the tip of the marking needle using an ischiorectal approach. The method includes confirming the location of the stimulating member near the pudendal nerve and implanting the electrode lead device at the confirmed location. The method includes drawing a first and second line on the patient's skin. Advancing the stimulating member may include advancing the stimulating member horizontally toward the tip of the marking needle. The method includes advancing a guidewire through the stimulating member, advancing an introducer over the guidewire, and / or advancing the electrode lead device through the introducer to the confirmed location. Confirming the location of the stimulating member near the pudendal nerve may include supplying a current of less than or equal to 3 mA to the stimulating member. Confirming the location of the stimulating component involves measuring an EMG response of at least 20 mV.

[0022] Certain aspects of this disclosure relate to a method of implanting an electrode lead device as described herein. The method includes introducing the electrode lead device into a lead positioning guide until one or more stimulating electrodes extend beyond the distal end of the lead positioning guide; advancing the lead positioning guide through an introducer until one or more stimulating electrodes are positioned at a distal portion of the introducer; partially withdrawing the introducer to expose one or more stimulating electrodes while a plurality of anchors remain constrained within the introducer; measuring an EMG response to confirm the position of one or more stimulating electrodes; adjusting the position of one or more stimulating electrodes until a desired EMG response is measured; and / or further withdrawing the introducer to release the plurality of anchors. The method includes axially adjusting the position of one or more stimulating electrodes within a patient without releasing the plurality of anchors from the introducer. The method includes partially withdrawing the introducer until the shank of the introducer contacts an arm on the lead positioning guide. The method includes rotating the lead positioning guide relative to the introducer to allow further withdrawal of the introducer. The method includes partially withdrawing the introducer until the shank of the introducer is coupled to the lead positioning guide. The method includes disengaging the lead positioning guide from the introducer to allow the lead positioning guide to release multiple anchors.

[0023] In several embodiments, the electrode lead device may have a lead body having one or more electrodes and one or more anchors (e.g., two to eight electrodes (some or all of which may be stimulating) and two to eight anchors). The lead body may have the same or different materials (e.g., different densities) along its length to provide varying levels of flexibility. The electrodes may be located near the distal end of the lead. One or more anchors may be positioned proximal to one or more stimulating electrodes configured to contact or apply stimulation to tissue. Each anchor may include an anchor body portion (such as a “collar”) having one or more barbs (e.g., 1-6 barbs) extending directly or indirectly from the collar. For example, each anchor may have two barbs radially opposite each other. The collar may be individually attached to the lead body, allowing different numbers of anchors to be secured to the lead body according to a procedure. The barbs may be collapsible or otherwise sufficiently flexible / extendable for delivery. The anchors can be arranged bidirectionally, wherein a first set of anchors has barbs extending distally (e.g., toward the stimulating electrode), and a second set of anchors has barbs extending proximally (e.g., away from the stimulating electrode). The second set of anchors can be grouped between the first set of anchors and the stimulating electrode. The first and second sets of anchors can have the same or different numbers of anchors. At least one anchor can be circumferentially offset from the other anchor by, for example, 80 to 100 degrees, such as 85, 90, 100 degrees, or other values ​​within this range. In some embodiments, adjacent anchors can be circumferentially offset from each other. Optionally, each barb can extend from the end of its respective collar at an angle (e.g., less than 45 degrees, less than 30 degrees, or less than 20 degrees) relative to the longitudinal axis of the lead body. Each barb can have a free end with a rounded or generally flat (e.g., perpendicular to the longitudinal axis of the lead body) edge. The length of the edge can be at least half the diameter of the lead body. The free end of the barb may have a tapered or chamfered edge in the radial direction. The electrode lead body may include one or more stops at or between any end or both ends of the anchor array. The stops (one or more) ensure that the anchors do not migrate or slip off the lead during corrections or other high axial forces. The stops may be, for example, tubular bodies made of polyethylene. The tubular bodies may be longer than one of the anchors.

[0024] This document describes a method for providing access to the pudendal nerve. The method may include drawing a first line corresponding to the edge (internal or external edge) of the ischial bone and a second line across the top of the greater trochanter. The method may include inserting a marking needle at the intersection of the first and second lines and advancing the marking needle until it contacts the ischial spine of the ischial bone. The first and second lines may be identified based on X-rays. In some embodiments, the marking needle is a stimulating needle. The stimulating needle may be inserted until EMG activity is present at the external anal sphincter in response to stimulation of 3 mA or less or 2 mA. The EMG response may indicate that the tip of the stimulating needle is positioned at or near the pudendal nerve. The method may include using an ischiorectal approach and inserting a stimulating member (e.g., a stimulating needle or other elongated structure) toward the marking needle or stimulating needle. EMG may be used to confirm the location of the stimulating member. For example, an EMG response in the pelvic floor followed by an EMG response at the external anal sphincter may indicate optimal positioning of the stimulating member. If no response is detected, the stimulating member may be adjusted. In some methods, positioning can be confirmed after each adjustment, once only an EMG response in the pelvic floor is detected. After confirming the location of the stimulation component, any electrode lead device described herein can be implanted at the location of the stimulation component. In some methods, the location of the stimulation component can be confirmed solely based on the EMG response at the external anal sphincter.

[0025] The electrode lead assembly described herein can be delivered using a lead positioning guide, which allows confirmation of the stimulating electrode at the target site before deployment of the anchor. The lead is inserted into the lead positioning guide until contact is established between the distal end of the lead positioning guide and the nearest side anchor on the lead. After the lead is locked within the lead positioning guide, the lead positioning guide is inserted into the introducer until the stimulating electrode is positioned at the distal portion of the introducer. For example, a locking nut, which may be a tapered nut, can be used to lock the lead within the lead positioning guide. The lead positioning guide may have an indicator (e.g., a marking band) to provide indication of when the stimulating electrode is positioned at the distal portion of the introducer. The introducer can be withdrawn to expose the stimulating electrode while the anchor remains restrained within the introducer. The lead positioning guide and / or the introducer may have alignment features to indicate when only the stimulating electrode has been exposed from the distal end of the introducer. In this configuration, the position of the stimulating electrode can be adjusted until the clinician has confirmed that the stimulating electrode is in the correct position. The lead positioning guide and / or introducer may have features that prevent further retraction of the introducer until the position of the stimulating electrode has been confirmed. After the position of the stimulating electrode has been confirmed, the lead positioning guide may be rotated relative to the introducer to allow further retraction of the introducer. The introducer may be further retracted to deploy the anchor.

[0026] This disclosure describes an electrode lead device for treating conditions, such as those in the pelvic region, the device comprising one or more of the following features: a lead including one or more stimulating electrodes located near a distal end of the lead; and a plurality of anchors, each anchor including a collar and two or more barbs extending from the collar, wherein the plurality of anchors are positioned proximal to the one or more stimulating electrodes on the lead, wherein a first anchor of the plurality of anchors is adjacent to a second anchor of the plurality of anchors, wherein the two or more barbs of the first anchor are positioned at a rotational angle along the length of the lead to the two or more barbs of the second anchor, and / or wherein one or more stimulating electrodes are configured to deliver electrical stimulation to target tissue. In some embodiments, the target tissue includes the pudendal nerve or tissue adjacent to the pudendal nerve. In some embodiments, the condition is in the pelvic region and includes urinary incontinence, fecal incontinence, sexual dysfunction, pelvic pain, or any combination thereof. In some embodiments, the first anchor or the second anchor is releasably coupled to the lead. In some embodiments, the two or more barbs include 2, 3, 4, 5, 6, 7, 8, 9, or 10 barbs. In some embodiments, the two or more barbs are equally spaced around the collar. In some embodiments, the two or more barbs are radially symmetrical around the collar. In some embodiments, the two or more barbs are not radially symmetrical around the collar. In some embodiments, a first barb of two or more barbs of a first anchor or a second anchor is positioned at a rotational angle (e.g., between about 1 degree and about 180 degrees, between about 0 degrees and about 30 degrees, between about 15 degrees and about 45 degrees, between about 30 degrees and about 60 degrees, between about 45 degrees and about 75 degrees, between about 60 degrees and about 90 degrees, between about 75 degrees and about 105 degrees, between about 90 degrees and about 120 degrees, between about 105 degrees and about 135 degrees, between about 120 degrees and about 150 degrees, between about 135 degrees and about 165 degrees, between about 150 degrees and about 180 degrees). In some embodiments, each of the two or more barbs is configured to extend along the radius of the circular cross-section of the collar. In some embodiments, the plurality of anchors includes a third anchor, wherein the third anchor is adjacent to a second anchor or a first anchor. In some embodiments, the third anchor includes a first barb of two or more barbs, the first barb being positioned at a rotational angle to a second barb of two or more barbs of the first anchor or the second anchor. In some embodiments, the first anchor and the second anchor have a gap between them. In some embodiments, the gap comprises a length of about 1 mm to about 5 mm. In some embodiments, the gap is between the surface of the free end of one of the barbs of the first anchor and the surface of the collar of the second anchor.In some embodiments, two or more barbs are configured to extend at an angle relative to the axial axis of the collar. In some embodiments, the collar includes an inner diameter of at least about 1.30 mm. In some embodiments, the collar includes a thickness of at least about 0.35 mm. In some embodiments, the length of the collar includes a length of at least about 2.5 mm. In some embodiments, the length of the collar includes a length of up to about 5 mm. In some embodiments, the length of the collar includes a length of about 2 mm to about 5 mm. In some embodiments, the outer diameter of the collar is at least about 2 mm. In some embodiments, two or more barbs include a length of at least about 1.5 mm. In some embodiments, when two or more barbs extend, the two or more barbs form a radius of at least about 1.25 mm between the outer surfaces of the two or more barbs and the outer surface of the collar. In some embodiments, the two or more barbs extend along the radial axis of the cross-section of the collar at an angle of about 10 degrees to about 80 degrees (e.g., less than or equal to 60 degrees, less than or equal to 50 degrees, less than or equal to 45 degrees, less than or equal to 40 degrees, or less than or equal to 30 degrees) relative to the axial axis of the collar. In some embodiments, the free ends of the barbs in two or more of the first anchor extend toward the distal end of the lead wire, and the free ends of the barbs in two or more of the second anchor extend toward the proximal end of the lead wire. In some embodiments, the two or more barbs include heat-set barbs, and the heat-set barbs in the extended state extend from the axial axis of the collar at an angle of about 20 degrees to about 65 degrees. In some embodiments, the two or more barbs include a width of at least about 0.2 mm. In some embodiments, the two or more barbs include a thickness of at least about 0.2 mm. In some embodiments, the two or more barbs include a thickness of up to about 0.35 mm. In some embodiments, the two or more barbs include a thickness of about 0.2 mm to about 0.35 mm. In some embodiments, the two or more barbs include a rectangular or triangular profile. In some embodiments, the two or more barbs include a profile that matches the curvature of the collar surface. In some embodiments, one or more edges of the free ends of the pair (teeth or barbs) are chamfered or beveled edges. In some embodiments, one or more beveled edges of the free ends of the two or more barbs include a radius of at least about 0.35 mm. In some embodiments, the first or second anchor is made of a polymer. In some embodiments, the polymer includes thermoplastic polyurethane elastomer (TPU). In some embodiments, the polymer includes polytetrafluoroethylene (PTFE). In some embodiments, the first and second anchors are made of a material having a stiffness of at least about 55D Shore A. In some embodiments, the first and second anchors are made of a material having a stiffness of up to about 75D.In some embodiments, the first and second anchors are made of a material having a stiffness of about 55D to about 75D Shore. In some embodiments, the first and second anchors include a serrated profile. In some embodiments, the serrated profile includes one or more cutting features disposed along the edges of two or more barbs. In some embodiments, the one or more cutting features include a circular geometry, wherein the circular geometry includes a diameter of about 0.25mm to about 0.5mm. In some embodiments, the device further includes a sheath covering at least a portion of the first or second anchor. In some embodiments, the sheath includes a Shore hardness of at least about 60D, 65D, 70D, 75D, 80D, 85D, or 90D. In some embodiments, the device further includes an introducer, wherein the introducer includes a lumen configured to receive the lead wire and the first or second anchor and guide the implantation of the lead wire and the first or second anchor. In some embodiments, the introducer is configured to cause the first or second anchor to collapse or compress as the lead wire is advanced toward the distal end of the introducer. In some embodiments, the introducer is made of a polymer material or a metal. In some embodiments, the metal includes stainless steel, aluminum, titanium, or any combination thereof. In some embodiments, the device further includes a lead positioning guide (LPG), wherein the LPG includes a lumen diameter configured to receive the lead, and wherein the LPG fixes the position of the lead when the introducer retracts on the lead and a first anchor or a second anchor. In some embodiments, the introducer includes a lumen diameter configured to receive the LPG. In some embodiments, the polymer includes thermoplastic polyurethane. In some embodiments, the polymer includes polytetrafluoroethylene (PTFE). In some embodiments, the introducer includes a length of about 150 mm to about 400 mm. In some embodiments, the introducer includes a conical or tapered cross-sectional profile. In some embodiments, the conical or tapered cross-sectional profile of the introducer and the rounded edges of the free ends of two or more barbs reduce friction between the rounded edges of the free ends of the two or more barbs and the inner lumen of the introducer. In some embodiments, the inner lumen of the introducer includes a first inner diameter and a second inner diameter, wherein the first inner diameter and the second inner diameter are different. In some embodiments, the inner lumen of the introducer has an inner diameter ranging from about 0.5 mm to about 5 mm (e.g., 0.5-1, 1-2, 2-3, 3-4, 4-5 mm and overlapping ranges therein). In some embodiments, the first inner diameter is smaller than the second inner diameter. In some embodiments, the introducer retracts on a first or second anchor coupled to the lead wire, thereby expanding two or more barbs of the first or second anchor to secure the lead wire to the pudendal nerve or nearby tissue.In some embodiments, the introducer comprises a size of about 1 French (F) to about 15 F (e.g., less than or equal to 10 F (3 F, 4 F, 5 F, 6 F, 7 F, or other values)). In some embodiments, the first anchor or the second anchor is implanted in connective tissue. In some embodiments, the connective tissue includes the sacrotuberous ligament, the sacrospinous ligament, the fascia and periosteum of the falciform process, or a combination thereof. In some embodiments, the first anchor or the second anchor is manufactured by additive 3D printing, laser cutting, injection molding, or a combination thereof. In some embodiments, additive 3D printing includes selective laser sintering.

[0027] This disclosure describes a method of attaching an electrode lead to tissue, the method comprising one or more of the following features or steps: placing the electrode lead at a target tissue, wherein the electrode lead comprises: (i) a lead including one or more stimulating electrodes located near a distal end of the lead; and (ii) a plurality of anchors, each anchor including a collar and two or more barbs extending from the collar, wherein the plurality of anchors are releasably positioned on the lead proximal to one or more stimulating electrodes, wherein a first anchor of the plurality of anchors is adjacent to a second anchor of the plurality of anchors, wherein the two or more barbs of the first anchor are positioned at a rotational angle along the length of the lead to the two or more barbs of the second anchor, and wherein one or more stimulating electrodes are configured to deliver electrical stimulation to the target tissue; and removing a sheath covering at least a portion of the first anchor or the second anchor to deploy the first anchor or the second anchor, thereby anchoring the electrode lead to the target tissue. In some embodiments, the target tissue includes the pudendal nerve or tissue adjacent to the pudendal nerve. In some embodiments, the target tissue includes target tissue in the pelvic region. In some embodiments, the method further includes stimulating target tissue with electrode leads to treat a condition in the pelvic region. In some embodiments, the condition includes urinary incontinence, fecal incontinence, pain, sexual dysfunction, or any combination thereof. In some embodiments, a first or second anchor is releasably coupled to the electrode leads. In some embodiments, the two or more barbs include 2, 3, 4, 5, 6, 7, 8, 9, or 10 barbs. In some embodiments, the two or more barbs are equally spaced around a collar. In some embodiments, the two or more barbs are radially symmetrical about the collar. In some embodiments, the two or more barbs are not radially symmetrical about the collar. In some embodiments, the first barb of the two or more barbs of the first or second anchor is positioned at a rotation angle of about 1 degree to about 180 degrees relative to the second barb of the two or more barbs of the first or second anchor. In some embodiments, each of the two or more barbs is configured to extend along the radius of a circular cross-section of the collar. In some embodiments, the plurality of anchors includes a third anchor, wherein the third anchor is adjacent to the second or first anchor. In some embodiments, the third anchor includes a first barb of two or more barbs, the first barb being positioned at a rotational angle to a second barb of two or more barbs of the first anchor or the second anchor. In some embodiments, the first anchor and the second anchor have a gap between them. In some embodiments, the gap comprises a length of about 1 mm to about 5 mm. In some embodiments, the gap is between the surface of the free end of one of the barbs of the first anchor and the surface of the collar of the second anchor.In some embodiments, two or more barbs are configured to extend at an angle relative to the axial axis of the collar. In some embodiments, the collar includes an inner diameter of at least about 1.30 mm. In some embodiments, the collar includes a thickness of at least about 0.35 mm. In some embodiments, the length of the collar includes at least about 2.5 mm. In some embodiments, the length of the collar includes up to about 5 mm. In some embodiments, the length of the collar includes about 2 mm to about 5 mm. In some embodiments, the outer diameter of the collar is at least about 1 mm. In some embodiments, two or more barbs include a length of at least about 1.5 mm. In some embodiments, when two or more barbs extend, the two or more barbs form a radius of at least about 1.25 mm between the outer surfaces of the two or more barbs and the outer surface of the collar. In some embodiments, when two or more barbs extend along the radial axis of the cross-section of the collar at an angle of about 10 degrees to about 80 degrees with respect to the axial axis of the collar. In some embodiments, the free ends of the barbs in two or more of the first anchor extend toward the distal end of the electrode lead, and the free ends of the barbs in two or more of the second anchor extend toward the proximal end of the electrode lead. In some embodiments, the two or more barbs include heat-set barbs, and the heat-set barbs in the extended state extend from the axial axis of the collar at an angle of about 20 degrees to about 65 degrees. In some embodiments, the two or more barbs include a width of at least about 0.2 mm. In some embodiments, the two or more barbs include a thickness of at least about 0.2 mm. In some embodiments, the two or more barbs include a thickness of up to about 0.35 mm. In some embodiments, the two or more barbs include a thickness of about 0.2 mm to about 0.35 mm. In some embodiments, the two or more barbs include a rectangular or triangular profile. In some embodiments, the two or more barbs include a profile that matches the curvature of the collar surface. In some embodiments, one or more edges of the free ends of the pair (teeth or barbs) are chamfered or beveled edges. In some embodiments, one or more chamfered edges at the free ends of two or more barbs include a radius of at least about 0.35 mm. In some embodiments, the first anchor or the second anchor is made of a polymer. In some embodiments, the polymer includes thermoplastic polyurethane elastomer (TPU). In some embodiments, the polymer includes polytetrafluoroethylene (PTFE). In some embodiments, the first anchor and the second anchor are made of a material having a stiffness of at least about 55 D. In some embodiments, the first anchor and the second anchor are made of a material having a stiffness of at most about 75 D. In some embodiments, the first anchor and the second anchor are made of a material having a stiffness of about 55 D to about 75 D. In some embodiments, the first anchor and the second anchor include a serrated profile.In some embodiments, the serrated profile includes one or more cutting features disposed along the edges of two or more barbs. In some embodiments, the one or more cutting features include a circular geometry, wherein the circular geometry includes a diameter of about 0.25 mm to about 0.5 mm. In some embodiments, the sheath includes a Shore hardness of at least about 60D, 65D, 70D, 75D, 80D, 85D, or 90D. In some embodiments, the sheath is made of a thermoplastic polyurethane based on an aromatic polyether. In some embodiments, the method further includes collapsing or compressing two or more barbs of the first anchor or the second anchor as it is axially translated through the introducer. In some embodiments, the introducer is made of a polymeric material or a metal. In some embodiments, the metal includes stainless steel, aluminum, titanium, or any combination thereof. In some embodiments, the polymer includes thermoplastic polyurethane. In some embodiments, the polymer includes polytetrafluoroethylene (PTFE). In some embodiments, the introducer includes a length of about 150 mm to about 400 mm. In some embodiments, the introducer includes a conical or tapered cross-sectional profile. In some embodiments, the conical or tapered cross-sectional profile of the introducer and the rounded edges of the free ends of two or more barbs reduce friction between the rounded edges of the free ends of the two or more barbs and the inner lumen of the introducer. In some embodiments, the inner lumen of the introducer includes a first inner diameter and a second inner diameter, wherein the first inner diameter and the second inner diameter are different. In some embodiments, the first inner diameter includes a diameter of at least about 3.8 mm, and wherein the second inner diameter includes a diameter of at least about 6.5 mm. In some embodiments, the introducer retracts on a first or second anchor coupled to the electrode lead, thereby expanding two or more barbs of the first or second anchor to secure the electrode lead to the pudendal nerve or nearby tissue. In some embodiments, the introducer includes a size of about 1 French (F) to about 15 F. In some embodiments, the method further includes securing the position of the electrode lead using a wire positioning guide (LPG) when a sheath covering at least a portion of the first or second anchor is removed. In some embodiments, the introducer includes a lumen configured to receive LPG. In some embodiments, the first or second anchor is implanted in connective tissue. In some embodiments, the connective tissue includes the sacrotuberous ligament, the sacrospinous ligament, other dense tissue in the medial region of the ischial tuberosity, or a combination thereof. In some embodiments, the first or second anchor is manufactured by additive 3D printing, laser cutting, injection molding, or a combination thereof. In some embodiments, additive 3D printing includes selective laser sintering.

[0028] This disclosure describes a kit for treating conditions, such as those in the pelvic region, the kit comprising one or more of the following components: (a) an electrode lead assembly comprising: (i) a lead including one or more stimulating electrodes located near a distal end of the lead; and (ii) a plurality of anchors, each anchor including a collar and two or more barbs extending from the collar, wherein the plurality of anchors are provided proximal to one or more stimulating electrodes at a fixed position on the lead, wherein a first anchor of the plurality of anchors is adjacent to a second anchor of the plurality of anchors, wherein the two or more barbs of the first anchor are positioned at a rotational angle along the length of the lead to the two or more barbs of the second anchor, and wherein the one or more stimulating electrodes are configured to deliver electrical stimulation to target tissue; and (b) instructions for placing or anchoring the electrode lead to the target tissue. In some embodiments, the target tissue includes the pudendal nerve or tissue adjacent to the pudendal nerve. In some embodiments, the condition is in the pelvic region and includes urinary incontinence, fecal incontinence, pain, sexual dysfunction, or any combination thereof. In some embodiments, the instruction manual includes an insert, a website, or a combination thereof. In some embodiments, the two or more barbs include 2, 3, 4, 5, 6, 7, 8, 9, or 10 barbs. In some embodiments, the two or more barbs are equally spaced around the collar. In some embodiments, the two or more barbs are radially symmetrical around the collar. In some embodiments, the two or more barbs are not radially symmetrical around the collar.

[0029] This disclosure describes a method of manufacturing an anchor, which may include one or more of the following features or steps: (a) molding a first half and a second half of an anchor body, wherein the first half of the anchor body includes a first barb region, and the second half of the anchor body includes a second barb region, wherein the first half of the anchor body is made of the same material as the first barb region, and wherein the second half of the anchor body is made of the same material as the second barb region; and (b) securing the first half and the second half of the anchor body to form the anchor body. In some embodiments, molding includes injection molding. In some embodiments, the first half and the second half of the anchor body include removably coupled features configured to be removed or disconnected from the first half or the second half of the anchor body. In some embodiments, the first half or the second half of the anchor body is molded from a polymer. In some embodiments, the polymer includes a thermoplastic polyurethane elastomer (TPU). In some embodiments, the polymer includes a thermoplastic polyurethane. In some embodiments, the polymer includes polytetrafluoroethylene (PTFE). In some embodiments, the first or second half of the anchor body is molded from a material having a stiffness of at least about 55D Shore.

[0030] In some aspects, the technology described herein relates to a system for placing electrodes in the pelvic region, the system comprising one or more of the following: a lead wire including one or more stimulating electrodes located at or near a distal end of the lead wire; and a plurality of anchors, each anchor including a collar and two or more barbs extending from the collar, wherein the plurality of anchors are positioned proximally to the lead wire by the one or more stimulating electrodes; an introducer configured to slide on the lead wire and the plurality of anchors, the introducer having an introducer handle; and a lead wire positioning guide including an elongated guide body having a clamp at a proximal end of the elongated guide body, a guide lumen through the elongated guide body, and one or more guide arms extending distally from the elongated guide body, and a locking cap configured to engage the clamp, wherein the one or more guide arms are configured to engage the introducer handle. In some aspects, the technology described herein relates to a system in which the one or more guide arms are two guide arms. In some aspects, the technology described herein relates to a system in which an introducer handle has a proximal surface including one or more protrusions, the one or more protrusions including a rod and an extension on the rod. In some aspects, the technology described herein relates to a system in which one or more guide arms have a distal end including an arm rod and an arm extension. In some aspects, the technology described herein relates to a system in which the thickness of the arm extension is substantially similar to or less than the height of the rod of the introducer handle. In some aspects, the technology described herein relates to a system in which the arm extension is configured to removably engage below the extension of the introducer handle via a rod. In some aspects, the technology described herein relates to a system in which the arm extension is configured to removably engage on the proximal surface of the introducer handle. In some aspects, the technology described herein relates to a system in which the introducer handle is securely fixed to a lead wire positioning guide when the arm extension is below the extension of the introducer handle via a rod. In some aspects, the technology described herein relates to a system in which an inserter is securely fixed relative to a lead wire positioning guide in a proximal-distal direction. In some aspects, the technology described herein relates to a system in which rotation of the lead wire positioning guide relative to the inserter shank about a proximal-distal axis alters the engagement level of one or more guide arms with the inserter shank. In some aspects, the technology described herein relates to a system in which rotation of the lead wire positioning guide disengages one or more guide arms from the inserter shank. In some aspects, the technology described herein relates to a system in which the inserter is movable relative to the lead wire positioning guide in a proximal-distal direction. In some aspects, the technology described herein relates to a system in which an arm overhang is angled (e.g., L-shaped) to an arm step.In some aspects, the technology described herein relates to a system in which the arm overhang includes an arcuate surface, a hook-shaped surface, a rectangular surface, or a combination thereof. In some aspects, the technology described herein relates to a system in which the overhang of the introducer handle engages with the arm overhang. In some aspects, the technology described herein relates to a system in which the guide lumen is configured to slidably engage with a lead wire. In some aspects, the technology described herein relates to a system in which the chuck has a tapered proximal end. In some aspects, the technology described herein relates to a system in which the chuck has a diameter that decreases as the locking cap moves distally from the unlocked position to the locked position on the chuck. In some aspects, the technology described herein relates to a system in which the guide lumen at the chuck has a diameter that decreases as the locking cap moves distally from the unlocked position to the locked position on the chuck. In some aspects, the technology described herein relates to a system in which, when a lead wire is placed through the guide lumen, the lead wire is secured in the guide lumen of the elongated guide body by the locking cap being in the locked position on the chuck. In some aspects, the technology described herein relates to a system in which a lead wire is secured in a guide lumen of a chuck in a proximal-distal direction. In some aspects, the technology described herein relates to a system in which an elongated guide body has threads. In some aspects, the technology described herein relates to a system in which a locking cap has threads configured to engage with the threads of the elongated guide body and to move the locking cap in a proximal-distal direction. In some aspects, the technology described herein relates to a system in which the lead wire is secured in the guide lumen of the elongated guide body by a locking cap when the lead wire is placed through the guide lumen. In some aspects, the technology described herein relates to a system in which the lead wire includes a wire that can be variably rotated along a portion of the lead wire. In some aspects, the technology described herein relates to a system in which the wire has approximately 2 to approximately 15 turns per 70 mm of the lead wire. In some aspects, the technology described herein relates to a system in which the wire has approximately 7 to approximately 10 turns per 70 mm of the lead wire. In some aspects, the technology described herein relates to a system in which a wire has approximately 8 turns per 70 mm of the lead. In some aspects, the technology described herein relates to a system in which a wire has approximately 1 to approximately 5 complete rotations per 70 mm of the lead. In some aspects, the technology described herein relates to a system in which a wire has approximately 1.5 to approximately 2.5 complete rotations per 70 mm of the lead. In some aspects, the technology described herein relates to a system in which a wire has approximately 2 complete rotations per 70 mm of the lead. In some aspects, the technology described herein relates to a system in which the wire changes at least approximately 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, or 8 turns per 70 mm at two different portions of the lead.In some aspects, the techniques described herein relate to a system in which the rotation of the wire is lower at or near a connector, reinforcement, or electrode, or a combination thereof. In some aspects, the techniques described herein relate to a system in which the wire comprises a sufficiently malleable material to allow for variable winding. In some aspects, the techniques described herein relate to a system in which the wire comprises a platinum alloy. In some aspects, the techniques described herein relate to a system in which the wire comprises platinum-iridium. In some aspects, the techniques described herein relate to a system in which an elongated guide body comprises at least two transmissive markings.

[0031] In some aspects, the technology described herein relates to a method in which a plurality of external anchors on an inductor are inserted into a guide lumen until a proximal anchor among the plurality of external anchors on the inductor and a portion of an elongated guide of an inductor positioning guide are covered to cover one or more stimulating electrodes on the inductor and the plurality of anchors; the inductor shank of an inductor and the distal portion of the inductor having the plurality of external anchors are delivered to a target location in the pelvic region using the inductor shank of an inductor and the inductor positioning guide; the inductor shank is slid proximally to engage with one or more guide arms of the inductor positioning guide, thereby securing the inductor in a proximal-distal direction and exposing one or more stimulating electrodes on the inductor while covering the plurality of anchors; the delivery of the exposed one or more stimulating electrodes to the target location is verified; the inductor positioning guide is moved to disengage from the inductor shank; the inductor shank is slid proximally to expose the plurality of anchors to secure the inductor in the appropriate location in the pelvic region; a locking cap is moved from a locked position to an unlocked position; and the inductor and the inductor positioning guide are withdrawn from the pelvic region. In some aspects, the techniques described herein relate to a method in which the method further includes adjusting the position of one or more stimulating electrodes and repeating step (f). In some aspects, the techniques described herein relate to a method in which a locking cap moves distally in the clamp of a lead positioning guide in a locked position. In some aspects, the techniques described herein relate to a method in which a locking cap rotates distally in the clamp of a lead positioning guide in a locked position. In some aspects, the techniques described herein relate to a method in which a locking cap moves proximally in the clamp of a lead positioning guide in an unlocked position. In some aspects, the techniques described herein relate to a method in which a locking cap rotates proximally in the clamp of a lead positioning guide in an unlocked position. In some aspects, the techniques described herein relate to a method in which, in step (h), two or more barbs of one of a plurality of anchors extend outward to secure the lead to the surrounding tissue. In some aspects, the techniques described herein relate to a method in which verification in step (f) includes the use of EMG. In some respects, the techniques described herein relate to a method in which an elongated guide body includes a radiopaque marker for indicating the location of the introducer in step (c). Attached Figure Description

[0032] The novel features of this disclosure are specifically set forth in the appended claims. A better understanding of the features and advantages of this disclosure will be obtained by referring to the following detailed description of illustrative, non-limiting embodiments utilizing the principles of this disclosure, and the accompanying drawings described below. Features from one figure can be combined with features from other figures.

[0033] Figures 1A-1J Embodiments of electrode lead introducers are shown, as described in some of the embodiments herein.

[0034] Figures 2A-2G Embodiments of the anchoring element are shown in various views or detailed views, as described in some of the embodiments herein.

[0035] Figures 3A-3D Examples of multiple anchors in a closed and / or compressed state on the electrode leads are shown, as described in some of the embodiments herein.

[0036] Figures 4A-4D Examples of multiple anchors with the electrode leads in an open and / or open state are shown, as described in some of the embodiments herein.

[0037] Figure 5 Examples of electrode leads and spacing of one or more anchors on the electrode leads are shown, as described in some of the embodiments herein.

[0038] Figures 6A-6C It shows a serrated shape ( Figures 6A-6B Examples of barbed anchors and anchors with triangular profiles are described in some of the embodiments herein.

[0039] Figures 7A-7B Examples of molded anchors are shown, as described in some of the embodiments herein.

[0040] Figures 8A-8C illustrate embodiments of multiple anchors on an electrode having an elongated body with a pusher and an introducer, as described in some of the embodiments herein.

[0041] Figures 9A-9C illustrate embodiments of multiple anchors in a compressed or closed state on the electrode leads when the electrode leads and multiple anchors are pushed through the elongated body lumen of the introducer using a pusher, as described in some of the embodiments herein.

[0042] Figures 10A-10C illustrate embodiments of multiple anchors on the electrode leads exiting the elongated body lumen of the introducer when the introducer is removed and / or pulled back on the pusher, electrode leads, and multiple anchors on the electrode leads, as described in some of the embodiments herein.

[0043] Figure 11 illustrates the process of attaching electrode leads to tissue, as described in some embodiments herein.

[0044] Figure 12 shows a flowchart of the steps for performing electrode lead and implantable pulse generator (IPG) implantation, as described in some embodiments herein.

[0045] Figure 13 The diagram illustrates the anatomical structures within the individual, as well as the setup of the leads and IPG, as described in some of the embodiments herein.

[0046] Figure 14 The anatomical structures in the individual are shown in schematic diagrams as well as the implanted leads and IPG, as described in some of the embodiments herein.

[0047] Figure 15 The anatomical structures in the individual are shown in schematic diagrams as well as the implanted leads and IPG, as described in some of the embodiments herein.

[0048] Figure 16A and Figure 16B Examples of anatomical pathways using anatomical models are shown, as described in some of the embodiments herein.

[0049] Figure 17 Embodiments of lead positioning guides (LPGs) are shown, as described in some of the embodiments herein.

[0050] Figures 18A-18C An embodiment of securing the lead wire in the lead positioning guide (LPG) using a locking cap is shown, as described in some of the embodiments herein.

[0051] Figure 19 Embodiments of lead positioning guides (LPGs) and sheath shanks with small overhang configurations are shown, as described in some of the embodiments herein.

[0052] Figure 20 Embodiments of lead positioning guides (LPGs) and sheath shanks with extended overhang configurations are shown, as described in some of the embodiments herein.

[0053] Figure 21 Embodiments of lead positioning guides (LPGs) and sheath shanks with arcuate overhang configurations are shown, as described in some of the embodiments herein.

[0054] Figure 22 Embodiments of a lead positioning guide (LPG) and sheath shank with a pin-lock configuration are shown, as described in some of the embodiments herein.

[0055] Figure 23A and Figure 23B Embodiments of a lead positioning guide (LPG) and sheath shank with a wide-lock configuration are shown, as described in some of the embodiments herein.

[0056] Figures 24A-24K Examples of using lead positioning guides (LPGs) and introducers to position leads using anchoring devices are shown, as described in some of the embodiments herein.

[0057] Figure 25 Embodiments of the spiral lead body are shown, as described in some of the embodiments herein.

[0058] Figure 26 Examples of using a stopper and an introducer to position the lead or pin are shown, as described in some embodiments.

[0059] Figure 27 A schematic diagram of surface markers drawn on an individual to locate the pudendal nerve is shown, as described in some embodiments herein.

[0060] Figure 28 A schematic diagram showing the anatomical structures and inserted marker needles in an individual is illustrated, as described in some embodiments herein.

[0061] Figure 29 A schematic diagram of the placement of bilateral sutures at the pudendal nerve is shown, as described in some embodiments herein.

[0062] Figure 30 shows the modular anchor assembly ( Figures 30A-30B Examples of the helical anchor assembly are described in some of the embodiments herein.

[0063] Figure 31 Embodiments of anchors including mating features are shown, as described in some of the embodiments herein. Detailed Implementation

[0064] Electrical stimulation has clinical applications in providing treatment and / or management of various clinical conditions, such as those in the pelvic region. For example, electrical stimulation can be used to treat urinary incontinence, fecal incontinence, pain, sexual dysfunction or any combination thereof, medical conditions and / or diseases in the pelvic region.

[0065] While certain devices, systems, methods, and kits are described herein with respect to the treatment and / or management of pelvic conditions, these methods and devices can be used in other areas of the body or to treat other conditions. Anchors can be used to secure implantable devices in other areas of the body and / or to treat other conditions. In some embodiments, anchors can be applied to electrode lead bodies implanted in the spinal region, for example, to treat chronic or occasional pain. Anchors can be applied to electrode lead bodies in or near the spine to treat, for example, pain (e.g., the spinal cord region at the coccyx of the occipital bone or other spinal regions). In other embodiments, anchors can be applied to electrode lead bodies implanted in the peripheral region or near cranial nerves. For example, anchors can be applied to electrode lead bodies implanted near the vagus nerve (e.g., in the face / cranial region) for the treatment of several disorders, including but not limited to balance problems, headaches, migraines, etc. In some embodiments, anchors can be applied to implantable devices used outside the field of neuromodulation. For example, anchors can replace clips in the application of sutures used in soft tissue repair (e.g., rotator cuff repair). In some embodiments, the anchor can be applied to non-implantable or acute devices, such as catheters, for example, drug delivery catheters or drainage catheters.

[0066] Electrode leads can be implanted at one or more target tissues and / or anatomical features (e.g., in the pelvic region) to provide treatment and / or manage electrical stimulation. However, during activities involving deep flexion or femoral rotation caused by movements such as from sitting to standing, moving up and down stairs, and / or movement during sleep, particularly in the pelvic region due to the anatomy of the pelvis, one or more implanted electrode leads may experience forces of axial tension, compressive force, torque, bending force, or any combination thereof. Furthermore, when the subject with implanted electrodes is sitting or lying supine, the implanted electrode leads also experience compressive forces from the surrounding soft tissues. Forces acting on the electrode leads can cause them to migrate and / or displace from their target implantation location within the pelvis, thereby reducing the therapeutic effect delivered to the target implantation site by electrical stimulation. Devices, systems, methods, and / or kits described elsewhere herein provide solutions for securing and / or anchoring electrode leads at the target implantation location. Devices, systems, methods, and / or kits described elsewhere herein may include one or more anchors having one or more barbs that can secure and / or prevent unwanted displacement of the electrode lead from its targeted implantation site. The orientation and / or rotation angle of one or more anchors and / or one or more barbs, as described elsewhere herein, may provide better-than-expected fixation of the electrode lead in or near spatially heterogeneous tissues, such as ligaments and / or other connective tissues within the pelvis in which the electrode lead is implanted.

[0067] This document provides devices, systems, methods, and / or kits for accessing, for example, target tissue in the pelvis and anchoring electrical leads at the target tissue for treatment via electroneurial stimulation. Tissue may include connective tissue, nerve tissue, muscle tissue, ligamentous tissue, fascia tissue, fat, or any combination thereof. Connective tissue may include the sacrotuberous ligament, sacrospinous ligament, the fascia and periosteum of the falciform process, other dense tissue in the region medial to the ischial tuberosity, or any combination thereof. Target tissue may include the pudendal nerve or tissue adjacent to the pudendal nerve. This document describes devices, systems, methods, and / or kits for providing electroneurial stimulation in individuals in need to prevent episodes of incontinence, treat pain, treat sexual dysfunction, or any combination thereof. Devices, systems, and methods for placing electrical leads to target nerve sites may include introducer sheaths, occluders, and needles and / or actuators described elsewhere herein. The actuator may also be referred to herein as a lead positioning guide (LPG) or anchor positioning guide (APG). A pusher (also referred to herein as an LPG or APG) can be used to stabilize the position when the sheath is removed or to generate an axial (pushing) force on the anchor. The introducer sheath may include an elongated shaft of sheath having a lumen and a sheath shank at the distal end of the elongated body, wherein the introducer sheath is configured to receive an electrode on the outer surface of the elongated shaft. The occluder may include an elongated occluder shaft having a lumen and an occluder shank at the distal end of the elongated shaft, wherein the elongated shaft is configured to engage within the lumen of the sheath. The needle may include an elongated needle shaft, a shank at the distal end of the elongated shaft, and a needle tip at the proximal end of the elongated shaft, wherein the elongated shaft is configured to engage within the lumen of the occluder. The devices, systems, and methods described herein for placing electrical leads into target tissues allow for easier access to target tissues and allow for accurate electrode placement, despite the complex three-dimensional anatomy of the pelvic region. The use of closed-loop and / or feedforward algorithmic stimulation with electrode leads can reduce or minimize stimulation tolerance issues, which may diminish the effectiveness of neural stimulation (e.g., PNS) over time. The devices, systems, methods, and / or kits provided herein are compatible, alone or in combination with radiological guidance, with electrophysiological guidance to accurately and reproducibly place electrodes at target tissues (e.g., pudendal nerve). The devices, systems, and methods provided herein can allow for more accurate and reproducible placement of electrodes on hard-to-access pelvic tissues that vary less with the skill of the healthcare professional performing the procedure.

[0068] This document describes devices, systems, methods, and / or kits for accessing areas (e.g., the pelvic region) in a subject to place and secure electrical leads to target tissue. The electrical leads can provide electrical stimulation to the target tissue to treat pelvic disorders. Pelvic disorders can include urinary incontinence, fecal incontinence, pain, sexual dysfunction, or any combination thereof. The devices, systems, methods, and / or kits described herein can provide electrical nerve stimulation to prevent incontinence episodes in individuals in need. The devices, systems, and methods provided herein can access the pudendal nerve via an sciatic-rectal approach. In some cases, the sciatic-rectal approach may include a lead introducer passing through or near the sacrotuberous ligament and guiding the lead to the pudendal nerve trunk at a location proximal to Alcock's canal. The devices, systems, and methods provided herein can access the pudendal nerve via a subgluteal approach (also referred to herein as the subposterior approach). The subgluteal approach may include a suture introducer and a suture passing through the space between the sacrotuberous ligament and the sacrospinous ligament and anteriorly in the ischiorectal fossa below the pelvic floor. A suture placed using the subgluteal approach can stimulate the anterior branches of the pudendal nerve (including the dorsal genital nerve).

[0069] Electrode lead introducer This document provides devices, systems, and methods for introducing and placing one or more electrode leads at one or more target tissues, such as in the pelvic region. Target tissues may include the pudendal nerve for the treatment of incontinence. Target tissues may include target tissues receiving electrical stimulation for sexual dysfunction. Target tissues may include target tissues receiving electrical stimulation for the treatment and / or management of pain. Although certain devices, systems, methods, and kits for the treatment and / or management of pelvic conditions are described herein with reference to the pelvic region, these methods and devices may be used in other areas of the body or for the treatment of other conditions, as described elsewhere herein.

[0070] An electrode lead introducer for placing an electrode at a target tissue may include an introducer sheath, a dilator (also referred to herein as an occluder), and a needle. Figures 1A-1F An embodiment of an electrode lead introducer 100 is shown. The electrode lead introducer may include an introducer sheath 114, an elongated body 116, a stopper 119, a needle 115, one or more electrodes (110, 120), one or more electrode insulating regions (108, 123), or any combination thereof. The elongated body 116 may be partially or completely covered, wrapped, or surrounded by the introducer sheath 114.

[0071] The introducer sheath may include an elongated shaft having a lumen and a sheath stalk at the distal end of the shaft. The introducer sheath may be configured to receive electrodes on the outer surface of the elongated shaft. In some embodiments, the proximal end of the elongated shaft may be angled. The angle at the proximal end of the elongated shaft allows for advancement of the device with minimal damage to surrounding tissue. The introducer sheath may have a diameter ranging from about 0.5 mm to about 5 mm.

[0072] The occluder may include an elongated occluder shaft having a lumen and an occluder shank at the distal end of the elongated occluder shaft. The elongated occluder shaft may be configured to fit within the lumen of a sheath. The occluder may have a diameter ranging from about 0.5 mm to about 5 mm.

[0073] The needle may include an elongated needle shaft, a shank at the distal end of the elongated needle shaft, and a needle tip at the proximal end of the elongated needle shaft. The elongated needle shaft may be configured to engage within the lumen of an occluder. The occluder shank may include a latch configured to attach to a sheath shank. In some embodiments, the needle tip may be configured to protrude beyond the end of the occluder lumen. The needle tip may protrude at least 1 mm beyond the end of the occluder lumen. The needle tip may be configured to protrude by movement of the shank. The needle tip may be configured to retract into the occluder lumen. The needle tip may be angled relative to the elongated needle shaft. The needle tip angle may be configured to allow the needle tip to advance through soft tissue. The needle may have a diameter of about 0.4 mm to about 2 mm. In some embodiments, the needle may have a diameter between 12 gauge and 26 gauge.

[0074] The elongated body 116 can be attached, secured, and / or fused to one end of the elongated body 116 (also referred to herein as an elongated shaft), such as Figure 1A , Figure 1C , Figure 1E and Figure 1FAs shown. The introducing sheath 114 may be integrated with one or more electrodes and / or conductive regions (110, 120) and / or one or more electrode insulating regions (108, 123). In some embodiments, the introducing sheath 114 may wholly or partially cover or surround the non-conductive regions (108, 123) of one or more electrodes (110, 120) integrated within the elongated body 116. The introducing sheath 114 may comprise a non-conductive biocompatible material, including but not limited to high-density polyethylene (HDPE), fluorinated ethylene propylene (FEP), polycarbonate, plastics, or any combination thereof. In some embodiments, at least a portion of the introducer sheath 114 may include a radiopaque additive, including but not limited to barium sulfate (BaSO4), bismuth basic carbonate (BiO)2CO3, bismuth oxychloride (BiOCl), bismuth trioxide (Bi2O3), or tungsten (W). For example, the material used for the tip of the introducer sheath 114 may include a barium sulfate (BaSO4) additive, so that the user, healthcare professional, and / or surgeon can see the tip inside the patient's body. In some cases, one or more radiopaque markings may be present on the introducer sheath 114. In some instances, the introducer sheath 114 may be for single use and / or disposable. The introducer sheath 114 may be autoclaved and / or can be cleaned using conventional sterilization methods for other similar medical devices (i.e., occluders, cannulas, endoscopes, etc.).

[0075] The sheath handle 106 can be configured to allow a user, medical professional, and / or surgeon to manipulate and / or navigate the electrode lead inserter as it is advanced into a patient or object. The sheath handle 106 may include ergonomic geometry configured for single-handed operation by the user, medical professional, and / or surgeon, freeing up their other hand for other tasks. While the techniques described herein can be performed manually, in other embodiments, the instrument may be incorporated into or controlled by a robotic system and / or facilitated using augmented reality.

[0076] The mechanical stiffness of the materials used for the elongated body 116 and the introducer sheath 114 can be selected to allow easy insertion of the electrode lead introducer 100 into the patient. The Young's modulus of the introducer sheath 114 and the elongated body 116 allows the user, medical personnel, and / or surgeon to manipulate the electrode lead introducer into a deep surgical plane in the pelvic region. The Young's modulus of the introducer sheath 114 and / or the elongated body 116 prevents bending or deflection of the combined elongated body 116 and introducer sheath when the user, medical personnel, and / or surgeon apply force to the distal end of the device during insertion into the patient. The Young's modulus of the introducer sheath 114 and / or the elongated body 116 reduces the total mechanical work required to insert the electrode lead introducer into a deep muscular and / or fatty surgical plane in the pelvic region while maintaining the guidewire position. The flexibility of this assembly allows the introducer and lead to follow the guidewire's path without interfering with locations near nerves. Higher sheath stiffness allows for easier lead delivery in areas with high tissue density or resistance. Higher sheath stiffness also allows for more accurate lead placement at the target site in areas with high tissue density or resistance around the target site. The stiffness of the material can be characterized by Young's modulus. The introducer sheath 114 can have a Young's modulus of about 10 MPa to about 10,000 MPa. The elongated body 116 can have a Young's modulus of about 10 MPa to about 10,000 MPa. The introducer sheath can have higher stiffness than the sheaths typically used for accessing the sacral nerve. Higher stiffness allows for easier access to target tissue (e.g., the pudendal nerve) and easier placement of the electrode lead on the target anatomy. The combination of sheath and needle can have similar stiffness to the combination of sheath and dilator typically used for accessing the sacral nerve. In some instances, the combination of the sheath and needle in an introducer can have greater stiffness than the combination of the sheath and dilator typically used in introducers for accessing the sacral nerve.

[0077] The elongated body 116 may include a length 112. The length 112 of the device allows for proper manipulation of the device within a patient with varying anatomical features to appropriately place one or more electrode leads, as described elsewhere herein. The length of the elongated body may refer to an insertable length. In some cases, variations in anatomical features between objects may include enlargement or reduction of anatomical features surrounding or adjacent to the pudendal nerve, sacral nerve, or any combination or branch thereof.

[0078] The length of the elongated body 116 may include a distance from about 10 centimeters (cm) to about 20 centimeters. For example, the length of the elongated body 116 may include a distance from about 12 cm to about 20 cm, from about 13 cm to about 20 cm, or from about 14 cm to about 20 cm. The length of the elongated body 116 may include a distance of about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, or about 20 cm. In some cases, the length of the elongated body 116 may include a distance of at least about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, or about 19 cm. In some cases, the length of the elongated body 116 may include a distance of at most about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, or about 20 cm.

[0079] In some embodiments, FIG1D shows an elongated body 116 including an inner lumen diameter 150, which is configured to allow the outer diameter 140 of the occluder 119 to pass through the inner lumen of the elongated body in the case of a sliding fit mechanical interface.

[0080] The diameter 150 of the inner lumen of the elongated body can be from about 0.5 mm to about 3 mm. In some cases, the diameter 150 of the inner lumen of the elongated body can include a distance from about 0.5 mm to about 4 mm, or from about 0.5 mm to about 5 mm. The diameter 150 of the inner lumen of the elongated body can include a distance of about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 2 mm, about 2.5 mm, or about 3 mm. In some cases, the diameter 150 of the inner lumen of the elongated body can include a distance of at least about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 2 mm, or about 2.5 mm. In some cases, the inner lumen diameter 150 may include a distance of up to about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 2 mm, about 2.5 mm, or about 3 mm. In some cases, the elongated body inner lumen diameter 150 may be the diameter for receiving a guidewire, such that the guidewire and the inner lumen diameter 150 include a sliding fit mechanical interface.

[0081] The outer diameter 142 of the elongated body may include a diameter of about 0.5 mm to about 10 mm. For example, the outer diameter 142 of the elongated body may include a diameter of about 1 mm to about 10 mm, about 2 mm to about 10 mm, or about 3 mm to about 10 mm. The outer diameter 142 of the elongated body may include a diameter of about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 6 mm, about 8 mm, or about 10 mm. In some cases, the outer diameter 142 of the elongated body may include a diameter of at least about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 6 mm, or about 8 mm. In some cases, the outer diameter 142 of the elongated body may include a diameter of up to about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 6 mm, about 8 mm, or about 10 mm.

[0082] The elongated body 116 may include a facet 145 on one end of the elongated body 116, as shown in FIG1D. The facet 145 of the elongated body 116 may be configured to allow the electrode lead introducer 100 to penetrate into the object receiving the implanted electrode in a manner similar to a needle. The facet 145 at the proximal end of the elongated sheath axis may allow the device to be advanced with minimal damage to surrounding tissue. The facet 145 may be angled at angle 144 relative to a mirror facet 149 of the elongated body 116, which is 180 degrees apart.

[0083] Angle 144 can include values ​​from about 30 degrees to about 90 degrees. For example, angle 144 can include values ​​from about 45 degrees to about 90 degrees or about 60 degrees. Angle 144 can include values ​​of about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, or about 90 degrees. In some cases, angle 144 can include values ​​of at least about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, or about 80 degrees. In some cases, angle 144 can include values ​​of at most about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, or about 90 degrees.

[0084] The occluder 119 may include an elongated occluder body 117 having a lumen and an occluder handle 104 at the end of the elongated occluder body, such as... Figure 1FAs shown. The elongated body 117 of the occluder can be made of plastic (e.g., ABS), metal, or any combination thereof. For example, metal may include stainless steel, aluminum, titanium, or any combination thereof. The occluder may be made of stainless steel, aluminum, titanium, or any combination thereof for the elongated body 117 of the occluder, but includes a plastic handle 104. The elongated body 117 of the occluder can be configured to fit inside the lumen of the elongated body 116.

[0085] The occluder 119 may further include a reinforcing tube 2602, such as Figure 1G and Figure 1J As shown. The reinforcing tube 2602 can be made of plastic (e.g., ABS), metal, or any combination thereof. For example, the reinforcing tube 2602 can be made of stainless steel. The reinforcing tube 2602 can travel downwards along the center of the elongated body 117. In some cases, the reinforcing tube can be molded into the elongated body 117. The reinforcing tube 2602 can be configured to improve the rigidity of the occluder 119. The reinforcing tube can improve the control and positioning of the occluder 119. The occluder 119 may include a tapered distal tip 2604.

[0086] The elongated body 117 of the occluder may include an outer diameter 140. The outer diameter 140 of the elongated body 117 may include a diameter of about 0.5 mm to about 5 mm. For example, the outer diameter 140 of the elongated body 117 may include a diameter of about 0.6 mm to about 5 mm, or about 1 mm to about 5 mm. The outer diameter 140 of the elongated body 117 may include a diameter of about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, or about 5 mm. In some cases, the outer diameter 140 of the elongated body 117 may include a diameter of at least about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, or about 4 mm. In some cases, the outer diameter 140 of the elongated body 117 of the occluder may include a diameter of up to about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, or about 5 mm.

[0087] The occluder 119 may include an inner lumen, such as Figure 1D As seen, the inner lumen may include an inner diameter of 148. The inner lumen of the occluder 119 may include a diameter such that the needle body 102 and the occluder inner lumen can be mechanically coupled via a sliding fit interface.

[0088] The inner diameter 148 of the inner lumen of the occluder 119 may include a diameter of about 0.2 mm to about 1.4 mm. For example, the inner diameter 148 of the inner lumen of the occluder 119 may include a diameter of about 0.3 mm to about 1.4 mm, or about 0.5 mm to about 1.4 mm. The inner diameter 148 of the inner lumen of the occluder 119 may include a diameter of about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, or about 1.4 mm. In some cases, the inner diameter 148 of the inner lumen of the occluder 119 may include a diameter of at least about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, or about 1.2 mm. In some cases, the inner diameter 148 of the inner lumen of the occluder 119 may include a diameter of up to about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, or about 1.4 mm.

[0089] The occluder 119 can be configured to assist in the insertion of the elongated body 116 into a patient / object receiving an electrode lead implant by providing structural rigidity. The elongated body 117 of the occluder may include a region 151 protruding a distance from the elongated body 116, such as... Figure 1D As seen elsewhere herein, a region 151 protruding a certain distance from the elongated body 116 may include blunt protrusions. A region 151 protruding a certain distance from the elongated body 116 may include protrusions having an angle parallel to the angle of the inclined facet 145 of the elongated body 116. Region 151 may include a tapered tip. The tapered tip may include a thin, bullet-shaped tip configured to penetrate a region with high tissue density.

[0090] The protrusion 151, which may extend beyond the end of the elongated body 116, may extend by a distance of approximately 0.2 mm to approximately 3 mm. For example, the protrusion 151, which may extend beyond the end of the elongated body 116, may extend by a distance of approximately 0.4 mm to approximately 3 mm, approximately 1 mm to approximately 3 mm, or approximately 1.4 mm to approximately 3 mm. The protrusion 151, which may extend beyond the end of the elongated body 116, may extend by a distance of approximately 0.2 mm, approximately 0.4 mm, approximately 0.6 mm, approximately 0.8 mm, approximately 1 mm, approximately 1.2 mm, approximately 1.4 mm, approximately 1.6 mm, approximately 1.8 mm, approximately 2 mm, approximately 2.5 mm, or approximately 3 mm. In some instances, the protrusion 151 extending beyond the end of the elongated body 116 may extend by at least about 0.2 mm, about 0.4 mm, about 0.6 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, or about 2.5 mm. In some instances, the protrusion 151 extending beyond the end of the elongated body 116 may extend by at most about 0.4 mm, about 0.6 mm, about 0.8 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.5 mm, or about 3 mm.

[0091] The occluder handle 104 can be mechanically coupled to the sheath handle 106, such as... Figure 1A and Figure 1E As shown. The mechanical coupling between the occluder handle 104 and the sheath handle 106 may include a hook and latch, a quick-release device, or any combination thereof. The occluder handle 104 may include a coupling socket 105 configured to receive and secure to the coupling mechanism of the needle shank 129, such as... Figure 1E As seen in the diagram, the coupling socket 105 may include a coupling feature 121 configured to interface with the needle shank 129 when the needle body 102 is inserted into the inner lumen of the elongated body 117 of the occluder. For example, the coupling feature 121 may be configured to slide within a track on the needle shank 129. The coupling feature 121 may be connected to the track interface of the needle shank 129 at the track location by an interference fit, thereby providing an interference-fit-based mechanical fastening between the needle 115 and the occluder 119.

[0092] The occluder handle 104 can be mechanically coupled to the sheath handle 106, such as... Figure 1HAs shown. The mechanical coupling between the occluder handle 104 and the sheath handle 106 may include a hook and latch, a quick-release device, or any combination thereof. For example, the occluder handle 104 may include an extension 2606. The inlet handle 106 may include a receiving tab 2608 configured to receive and secure to the extension 2606 of the occluder handle 104. The receiving tab 2608 may be configured to be coupled to receive and couple LPG, such as... Figures 20-21 As shown.

[0093] The occluder 119 may include an elongated occluder body 117 having a reinforcing tube 2602 and an occluder shank 104 at the end of the elongated occluder body. The reinforcing tube 2602 may be made of plastic (e.g., ABS), metal, or any combination thereof. The metal may include stainless steel, aluminum, titanium, or any combination thereof. The occluder reinforcing tube may be made of stainless steel, aluminum, titanium, or any combination thereof, while the occluder shank 104 may include plastic. The occluder shank may include high-viscosity polyamide. For example, the occluder shank may include Vestamid.

[0094] The occluder 119 may include an elongated occluder body 117 having a lumen and an occluder handle 104 at the end of the elongated occluder body, such as... Figure 1F As shown. The elongated body 117 of the occluder can be made of plastic (e.g., ABS), metal, or any combination thereof.

[0095] The needle 115 may include an elongated needle body 102, a shank 129 at one end of the elongated needle shaft, and a needle tip 118 at the other end of the elongated needle shaft. The elongated needle body 102 may be configured to fit into an inner lumen of a occluder, defined by an inner diameter 148. The elongated needle body may include an outer diameter 138, such as... Figure 1D As seen in the image. The fit may include a sliding fit between the inner diameter 148 of the occluder's inner lumen and the outer diameter 138 of the needle's elongated body. The needle 115 may be made of stainless steel, aluminum, titanium, or any combination thereof. The needle 115 may be hollow, or may be partially hollow and / or partially solid. The needle 115 may be made of rigid, non-deformable plastic and / or polymer.

[0096] The outer diameter 138 of the needle elongated body can include a diameter of about 0.1 mm to about 3 mm. For example, the outer diameter 138 of the needle elongated body can include a diameter of about 0.3 mm to about 3 mm, about 0.5 mm to about 3 mm, or about 1 mm to about 3 mm. The outer diameter 138 of the needle elongated body can include a diameter of about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.8 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, or about 3 mm. In some instances, the outer diameter 138 of the needle elongated body can include a diameter of at least about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.8 mm, about 1 mm, about 1.5 mm, about 2 mm, or about 2.5 mm. In some instances, the outer diameter 138 of the needle's slender body may include a diameter of up to about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.8 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, or about 3 mm.

[0097] The needle's slender body has an outer diameter of 138, which can range from approximately 12 American Wire Gauge (AWG) to approximately 26 AWG. For example, the outer diameter 138 of the needle's elongated body can include approximately 12 AWG to approximately 14 AWG, approximately 12 AWG to approximately 16 AWG, approximately 12 AWG to approximately 18 AWG, approximately 12 AWG to approximately 20 AWG, approximately 12 AWG to approximately 22 AWG, approximately 12 AWG to approximately 24 AWG, approximately 12 AWG to approximately 26 AWG, approximately 14 AWG to approximately 16 AWG, approximately 14 AWG to approximately 18 AWG, approximately 14 AWG to approximately 20 AWG, approximately 14 AWG to approximately 22 AWG, approximately 14 AWG to approximately 24 AWG, approximately 16 AWG to approximately 26 AWG, approximately 16 AWG to approximately 20 AWG, approximately 16 AWG to approximately 22 AWG, approximately 18 AWG to approximately 24 AWG, approximately 18 AWG to approximately 20 AWG, approximately 18 ...0 AWG, approximately 18 AWG to approximately 20 AWG, approximately 18 AWG to approximately 20 AWG, approximately 18 AWG to approximately 20 AWG, approximately 18 AWG to approximately 20 AWG, approximately 18 AWG to approximately 20 AWG, approximately 18 AWG to approximately 20 AWG, approximately 18 AWG to approximately 20 AWG, approximately 18 AWG to approximately 20 AWG, The diameter of the needle elongated body 138 may be approximately 12 AWG, approximately 14 AWG, approximately 16 AWG, approximately 18 AWG, approximately 20 AWG, approximately 22 AWG, approximately 22 AWG, approximately 24 AWG, or approximately 24 AWG to approximately 26 AWG. In some instances, the outer diameter of the needle elongated body 138 may include at least approximately 12 AWG, approximately 14 AWG, approximately 16 AWG, approximately 18 AWG, approximately 20 AWG, approximately 22 AWG, or approximately 24 AWG. In some instances, the outer diameter 138 of the needle's slender body may include a diameter of up to about 14 AWG, about 16 AWG, about 18 AWG, about 20 AWG, about 22 AWG, about 24 AWG, or about 26 AWG.

[0098] The needle shank portion 129 may include coupling features 130, as described elsewhere herein, configured to couple to coupling features 121 of the occluder. The needle shank coupling features 130 may include path or slot features, whereby the occluder coupling features 121 may travel within them and apply tension and / or holding force as the needle 115 is inserted into the inner lumen of the occluder. The needle shank portion 129 may be rotated by rotating one or more flanges 131. Rotation may be performed by a user, medical personnel, surgeon, or any combination thereof. In some embodiments, rotation may be achieved by a motor.

[0099] The needle tip 118 can be configured to protrude beyond the end of the occluder lumen. The needle tip 118 can protrude at least 1 mm beyond the end of the occluder lumen. The needle tip can be configured to protrude by movement of the needle shank portion 129. The needle tip 118 can be configured to retract into the occluder lumen.

[0100] The needle tip 118 may have an angle 146 ranging from about 15 degrees to about 45 degrees with respect to the elongated needle body. In some embodiments, the needle tip 118 may have an angle 146 ranging from about 25 degrees to about 50 degrees, or from about 35 degrees to about 50 degrees. The needle tip 118 may have an angle 146 ranging from about 15 degrees to about 45 degrees with respect to the elongated needle body, at least about 15 degrees, about 25 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, or about 1 degree. The needle tip 118 may have an angle 146 ranging from about 15 degrees to about 45 degrees with respect to the elongated needle body, at most about 25 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, or about 1 degree. The angle 146 of the needle tip 118 can be configured to allow the needle tip to advance through soft tissue.

[0101] Electrode lead introducer 100 may include one or more electrodes (120, 110) configured to provide electrical stimulation and / or measure electrical signals near target tissue in the pelvic region of a patient, such as Figure 1A , Figure 1B , Figure 1E and Figure 1FAs seen in the image. For example, target tissue may include the pudendal nerve, sacral nerve, another nerve or nerve branch, or a combination thereof. The electrodes may be configured to assist the user, medical personnel, and / or surgeon in navigating to a target area in the patient's pelvic region. The target area in the patient's pelvic region may include portions of the patient's pudendal nerve, sacral nerve, or any combination thereof, or any branch thereof. In some cases, the electrodes may be adjacent to one or more insulators (108, 123). One or more insulators (108, 123) may be configured not to conduct and / or sense current.

[0102] The electrode lead introducer 100 may include two or more sets of electrodes (120, 110) and two or more sets of insulators (108, 123), such that each set of electrodes and / or insulators is located at opposite ends of the electrode lead introducer, as shown below. Figure 1A-Figure 1B As seen in the illustration. For illustrative purposes only, the needle tip 118 is designated as the proximal end of the electrode lead introducer 100, and the first set of one or more electrodes 120 and / or the first set of one or more insulators 108 may be located at the proximal end of the electrode lead introducer, as shown. Figure 1B As shown. For illustrative purposes only, the sheath handle 106 is designated as the distal end of the electrode lead introducer 100, and a second set of one or more electrodes 110 and / or a second set of one or more insulators 123 may be located at the distal end of the electrode lead introducer. One or more electrodes located at the proximal end of the electrode lead introducer 120 may be electrically connected to one or more electrodes located at the distal end of the electrode lead introducer 110. The one or more proximal electrodes 120 may be configured to detect electrical signals and / or provide electrical signals to target tissue in the patient's pelvic region. For example, target tissue in the patient's pelvic region includes the pudendal nerve, sacral nerve, or a combination thereof. Target tissue in the patient's pelvic region may include the trunk or branches of a nerve, or a combination thereof. One or more electrodes (120, 110) in the distal and / or proximal regions of the electrode lead introducer may include at least one, at least two, at least three, at least four, at least five, or at least six electrodes. One or more electrodes (120, 110) in the distal and / or proximal regions of the electrode lead introducer may include up to one, two, three, four, five, or six electrodes. The distal electrodes may be configured to couple to terminals of a hook probe, wherein the hook probe may provide electrical stimulation and / or detection signals via the one or more electrodes at the distal end 120. The hook probe may be electrically connected to one or more distal and / or proximal electrodes.

[0103] One or more electrodes located at the distal end 110 and the proximal end 120 and / or one or more insulators located at the distal end 120 and the proximal end 108 of the electrode lead introducer may include electrodes and insulators of different lengths, such as those that can be... Figure 1B As seen in the diagram. One or more proximal electrodes 120 may include a length 128. The length 128 of the one or more proximal electrodes 120 may include about 0.8 mm to about 2 mm. For example, the length 128 of the one or more proximal electrodes 120 may include about 1 mm to about 2 mm, or about 1.3 mm to about 2 mm. The length 128 of the one or more proximal electrodes 120 may include about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, or about 2 mm. In some cases, the length 128 of the one or more proximal electrodes 120 may include at least about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, or about 1.5 mm. In some cases, the length 128 of one or more proximal electrodes 120 may include up to about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, or about 2 mm.

[0104] The length 126 of one or more insulators 108 on the proximal side may include about 5 mm to about 7 mm. For example, the length 126 of one or more insulators 108 on the proximal side may include about 5.5 mm to about 7 mm, or about 6 mm to about 7 mm. The length 126 of one or more insulators 108 on the proximal side may include about 5 mm, about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.8 mm, about 6 mm, about 6.5 mm, or about 7 mm. In some cases, the length 126 of one or more insulators 108 on the proximal side may include at least about 5 mm, about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.8 mm, about 6 mm, or about 6.5 mm. In some cases, the length 126 of one or more insulators 108 on the proximal side may include up to about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.8 mm, about 6 mm, about 6.5 mm, or about 7 mm.

[0105] The length 124 of one or more distal electrodes 110 may include a length of about 2.5 mm to about 4 mm. For example, the length 124 of one or more distal electrodes 110 may include a length of about 2.6 mm to about 4 mm, or a length of 3 mm to about 4 mm. The length 124 of one or more distal electrodes 110 may include a length of about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.5 mm, or about 4 mm. In some cases, the length 124 of one or more distal electrodes 110 may include a length of at least about 2.5 mm, about 2.6 mm, about 2.7 mm, 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, or about 3.5 mm. In some cases, the length 124 of one or more distal electrodes 110 may include a length of up to about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.5 mm, or about 4 mm. The first electrode of one or more distal electrodes 108 may be spaced at least about 1.5 mm from the most distal portion of the elongated body 116.

[0106] The length 122 of one or more distal insulators 123 may include a length of about 1.2 mm to about 3 mm. For example, the length 122 of one or more distal insulators 123 may include a length of about 1.5 mm to about 3 mm, or a length of about 1.8 mm to about 3 mm. The length 122 of one or more distal insulators 123 may include a length of about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.5 mm, or about 3 mm. In some cases, the length 122 of one or more distal insulators 123 may include a length of at least about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, or about 2.5 mm. In some cases, the length 122 of one or more distal insulators 123 may include a length of up to about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.5 mm, or about 3 mm.

[0107] Electrodes can typically be manufactured using various methods. Electrodes may include flexible printed circuits. Electrodes may be wound around the outer surface of the elongated shaft of a sheath. In some embodiments, electrodes may be bonded to the outer surface of the elongated shaft of the sheath. The chosen manufacturing method can facilitate large-scale mass production of the electrodes. In some embodiments, the chosen manufacturing method can facilitate the precise manufacture of electrodes with low tolerances.

[0108] Electrodes can be designed to deliver various amounts of voltage, current, and / or power. Electrodes can be designed to deliver a voltage of approximately 10V per electrode. Electrodes can be designed to deliver a voltage of at least approximately 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20V per electrode. In some embodiments, electrodes can be designed to deliver a voltage of up to approximately 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50V per electrode. Electrodes can be designed to deliver a voltage of approximately 1V to approximately 50V, approximately 1V to approximately 40V, approximately 1V to approximately 30V, or approximately 1V to approximately 20V per electrode. Electrodes can be designed to deliver a current of approximately 10mA per electrode. In some embodiments, the electrodes may be designed to deliver a current of at least about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 mA per electrode. The electrodes may be designed to deliver a current of up to about 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 mA per electrode. The electrodes may be designed to deliver a current of about 1 mA to about 50 mA per electrode, about 1 mA to about 40 mA per electrode, about 1 mA to about 30 mA per electrode, or about 1 mA to about 20 mA per electrode. The electrodes may be designed to deliver about 0.1 W of power (VA) per electrode. In some embodiments, the electrodes may be designed to deliver at least about 0.01, 0.05, 0.1, 0.5, 1, 2, 3, 4, or 5 W of power (VA) per electrode. In some embodiments, the electrodes may be designed to deliver up to about 0.05, 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 W of power (VA) per electrode. The electrodes may be designed to deliver about 0.01 to about 10 W per electrode, about 0.01 to about 5 W per electrode, or about 0.01 to about 1 W of power (VA) per electrode.

[0109] This document provides an apparatus for placing an electrode lead at a target tissue site in a patient's pelvic region, the apparatus comprising one or more of the following instruments: an introducer sheath including a sheath elongated shaft having a lumen and a sheath shank at a distal end of the sheath shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the sheath elongated shaft; an occluder including an occluder elongated shaft having a lumen and an occluder shank at a distal end of the occluder elongated shaft, wherein the occluder elongated shaft is configured to engage within the lumen of the sheath; and a needle including a needle elongated shaft having a lumen, a needle shank at a distal end of the needle elongated shaft, and a needle tip at a proximal end of the needle elongated shaft, wherein the needle elongated shaft is configured to engage within the lumen of the occluder, and wherein the lumen of the needle elongated shaft is configured to allow the electrode lead to pass through; wherein the introducer sheath has sufficient rigidity to guide the placement of the electrode lead at the target site. The rigidity of the sheath and needle together is sufficient to allow for secure and accurate placement of the electrode leads at target tissue in the patient's pelvic region. For example, the target tissue may include the pudendal nerve. In some embodiments, the rigidity of the sheath is sufficient to allow for secure and accurate placement of the electrode leads at target tissue in the patient's pelvic region. For example, the target tissue may include the pudendal nerve.

[0110] This document describes an apparatus for placing an electrode lead at a target tissue site in a patient's pelvic region. The apparatus may include one or more of the following features: an introducer sheath comprising an elongated shaft having a lumen and a sheath shank at a distal end of the shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated shaft; an occluder comprising an elongated occluder shaft having a lumen and an occluder shank at a distal end of the shaft, wherein the elongated occluder shaft is configured to engage within the lumen of the sheath; and a needle comprising an elongated needle shaft having a lumen, a needle shank at a distal end of the shaft, and a needle tip at a proximal end of the shaft, wherein the elongated needle shaft is configured to engage within the lumen of the occluder, and wherein the lumen of the elongated needle shaft is configured to allow the electrode lead to pass through; wherein the introducer sheath has sufficient rigidity to guide the placement of the electrode lead at the target site. The needle is removable from the introducer sheath. The insertable length of the sheath can be from about 10 cm to about 20 cm. The introducer sheath can have an outer diameter of about 1 mm to about 5 mm. The introducer sheath can have an inner diameter of about 1 mm to about 3 mm. The introducer sheath can have an inner diameter sufficient to allow the occluder and needle to pass through. The inner diameter of the needle shaft can be sufficient to allow the guidewire to pass through. The needle tip can be blunt and can have a lumen. The needle tip can extend about 1 mm to about 5 mm beyond the end of the sheath's elongated shaft. The stiffness of the sheath and needle together can be sufficient to allow secure and accurate placement of the electrode lead at a target tissue in the patient's pelvic region. For example, the target tissue may include the pudendal nerve. In some embodiments, the stiffness of the sheath can be sufficient to allow secure and accurate placement of the electrode lead at a target tissue in the patient's pelvic region. For example, the target tissue may include the pudendal nerve. In some embodiments, the stiffness of the sheath is higher than that of a sheath used for sacral nerve lead placement.

[0111] This document describes an apparatus for placing an electrode lead at a target tissue site in a patient's pelvic region. The apparatus may include one or more of the following features: an introducer sheath comprising an elongated shaft having a lumen and a sheath shank at a distal end of the shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated shaft; an occluder comprising an elongated occluder shaft having a lumen and an occluder shank at a distal end of the shaft, wherein the elongated occluder shaft is configured to engage within the lumen of the sheath; and a needle comprising an elongated needle shaft having a lumen, a needle shank at a distal end of the shaft, and a needle tip at a proximal end of the shaft, wherein the elongated needle shaft is configured to engage within the lumen of the occluder, and wherein the lumen of the elongated needle shaft is configured to allow the electrode lead to pass through; wherein the introducer sheath has sufficient rigidity to guide the placement of the electrode lead at the target site. The needle is removable from the introducer sheath. The insertable length of the sheath can be from about 10 cm to about 20 cm. The introducer sheath can have an outer diameter of about 1 mm to about 5 mm. For example, the introducer sheath can have an inner diameter of about 1 mm to about 3 mm. The introducer sheath can have an inner diameter sufficient to allow the occluder and needle to pass through. The inner diameter of the needle shaft can be sufficient to allow the guidewire to pass through. The needle tip can be blunt and can have a lumen. The needle tip can extend about 1 mm to about 5 mm beyond the end of the elongated axis of the sheath. The sheath can include multiple electrically isolated electrodes. The multiple electrodes can form about multiple wide bands around the sheath, wherein the gap between the electrodes and the first band is at least about 1 mm from the end of the elongated axis of the sheath. The stiffness of the sheath and needle together can be sufficient to allow the electrode leads to be securely and accurately placed at a target tissue in the patient's pelvic region. For example, the target tissue can include the pudendal nerve. In some embodiments, the stiffness of the sheath can be sufficient to allow the electrode leads to be securely and accurately placed at a target tissue in the patient's pelvic region. For example, the target tissue can include the pudendal nerve. The sheath used for pudendal nerve ligation can be more rigid than that used for sacral nerve ligation. The electrodes can be configured to deliver a voltage of approximately 5V to approximately 15V per electrode. The electrodes can be configured to deliver a current of approximately 5mA to approximately 15mA per electrode. The electrodes can be configured to deliver a power of approximately 0.05W to approximately 0.5W per electrode.

[0112] This document provides an apparatus for placing an electrode lead into target tissue in a patient's pelvic region. The apparatus may include one or more of the following devices: an introducer sheath comprising an elongated shaft having a lumen and a sheath shank distal to the shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated shaft; an occluder comprising an elongated shaft having a lumen and an occluder shank distal to the shaft, wherein the elongated shaft is configured to engage within the lumen of the sheath; and a needle comprising an elongated shaft having a lumen, a shank distal to the shaft, and a tip proximal to the shaft, wherein the elongated shaft is configured to engage within the lumen of the occluder, and wherein the lumen of the elongated shaft is configured to allow the electrode lead to pass through; wherein the introducer sheath has sufficient rigidity to guide the placement of the electrode lead at the target site. The needle is removable from the introducer sheath. The insertable length of the sheath can be approximately 15 cm. The introducer sheath can have a maximum outer diameter of approximately 5 mm. The introducer sheath can have an inner diameter of approximately 1 mm to approximately 2 mm. The introducer sheath can have an inner diameter sufficient to allow the occluder and needle to pass through. The inner diameter of the needle shaft can be sufficient to allow the guidewire to pass through. The needle tip can be blunt and can have a lumen. The needle tip can extend up to 3 mm beyond the end of the elongated axis of the sheath. The sheath can include four electrically isolating electrodes forming a band approximately 1.5 mm wide around the sheath, with a gap of approximately 5 mm between the electrodes, and the first band approximately 1.5 mm from the end of the elongated axis of the sheath. The stiffness of the sheath and needle together can be sufficient to allow secure and accurate placement of the electrode leads at target tissue in the patient's pelvic region. For example, the target tissue can include the pudendal nerve. In some embodiments, the stiffness of the sheath can be sufficient to allow secure and accurate placement of the electrode leads at target tissue in the patient's pelvic region. For example, the target tissue in the patient's pelvic region can include the pudendal nerve. The sheath used for pudendal nerve ligation can be more rigid than that used for sacral nerve ligation. The electrodes can be configured to deliver approximately 10V of voltage per electrode. The electrodes can be configured to deliver approximately 10mA of current per electrode. The electrodes can be configured to deliver approximately 0.1W of power per electrode.

[0113] This document describes an apparatus for placing an electrode lead at a target tissue site in a patient's pelvic region. The apparatus may include one or more of the following devices: an introducer sheath comprising an elongated sheath shaft having a lumen and a sheath shank at a distal end of the sheath shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated sheath shaft; an occluder comprising an elongated occluder shaft having a lumen and an occluder shank at a distal end of the occluder shaft, wherein the elongated occluder shaft is configured to engage within the lumen of the sheath; and a needle comprising an elongated needle shaft having a lumen, a needle shank at a distal end of the elongated needle shaft, and a needle tip at a proximal end of the elongated needle shaft, wherein the elongated needle shaft is configured to engage within the lumen of the occluder, and wherein the lumen of the elongated needle shaft is configured to allow the electrode lead to pass through; wherein the introducer sheath has sufficient rigidity to guide the placement of the electrode lead at the target site. The needle tip may be blunt and have a lumen. The needle tip can be configured to protrude approximately 1 mm to 5 mm beyond the end of the occluder lumen. The needle tip can be configured to retract into the occluder lumen. The needle tip angle can be configured to allow the needle tip to advance through the tissue. The angle of the proximal end of the sheath's elongated shaft allows for advancement of the device with minimal damage to surrounding tissue. The electrode can be wound around the outer surface of the sheath's elongated shaft.

[0114] This document provides an apparatus for placing an electrode lead at a target tissue site in a patient's pelvic region. The apparatus may include one or more of the following devices: an introducer sheath comprising an elongated sheath shaft having a lumen and a sheath shank at a distal end of the sheath shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated sheath shaft; an occluder comprising an elongated occluder shaft having a lumen and an occluder shank at a distal end of the occluder shaft, wherein the elongated occluder shaft is configured to engage within the lumen of the sheath; and a needle comprising an elongated needle shaft having a lumen, a needle shank at a distal end of the elongated needle shaft, and a needle tip at a proximal end of the elongated needle shaft, wherein the elongated needle shaft is configured to engage within the lumen of the occluder, and wherein the lumen of the elongated needle shaft is configured to allow the electrode lead to pass through; wherein the introducer sheath has sufficient rigidity to guide the placement of the electrode lead at the target site. The needle tip may be blunt and have a lumen. The needle tip can be configured to protrude approximately 1 mm to 5 mm beyond the end of the occluder lumen. The needle tip can be configured to retract into the occluder lumen. The needle tip angle can be configured to allow the needle tip to advance through the tissue. The angle of the proximal end of the sheath's elongated shaft allows for advancement of the device with minimal damage to surrounding tissue. The electrode can be wound around the outer surface of the sheath's elongated shaft.

[0115] This document describes an apparatus for placing an electrode lead at a target tissue site in a patient's pelvic region. The apparatus may include one or more of the following devices: an introducer sheath comprising an elongated sheath shaft having a lumen and a sheath shank at a distal end of the sheath shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated sheath shaft; an occluder comprising an elongated occluder shaft having a lumen and an occluder shank at a distal end of the occluder shaft, wherein the elongated occluder shaft is configured to engage within the lumen of the sheath; and a needle comprising an elongated needle shaft having a lumen, a needle shank at a distal end of the elongated needle shaft, and a needle tip at a proximal end of the elongated needle shaft, wherein the elongated needle shaft is configured to engage within the lumen of the occluder, and wherein the lumen of the elongated needle shaft is configured to allow the electrode lead to pass through; wherein the introducer sheath has sufficient rigidity to guide the placement of the electrode lead at the target site. The needle tip may be blunt and may have a lumen. The needle tip can be configured to protrude approximately 1 mm to 5 mm beyond the end of the occluder lumen. The needle is removable from the introducer sheath. The insertable length of the sheath can be approximately 10 cm to approximately 20 cm. The introducer sheath can have an outer diameter of approximately 1 mm to approximately 5 mm. The introducer sheath can have an inner diameter of approximately 1 mm to approximately 3 mm. The introducer sheath can have an inner diameter sufficient for the occluder and needle to pass through. The inner diameter of the needle shaft can be sufficient for a guidewire to pass through. The needle tip can be blunt and can have a lumen. The needle tip can extend approximately 1 mm to approximately 5 mm beyond the end of the elongated shaft of the sheath. The sheath can include multiple electrically isolated electrodes. The multiple electrodes can form approximately multiple wide bands around the sheath, wherein the gap between the electrodes and the first band is at least approximately 1 mm from the end of the elongated shaft of the sheath. The needle tip can be configured to retract into the occluder lumen. The electrodes can be wound around the outer surface of the elongated shaft of the sheath. The needle tip angle can be configured to allow the needle tip to advance through the tissue. The angle of the proximal end of the elongated axis of the sheath allows for device advancement with minimal damage to surrounding tissues. The occluder can have a diameter of about 1 mm to about 4 mm. The introducer sheath can have a diameter of about 1 mm to about 5 mm. The introducer sheath and needle can have a combined Young's modulus sufficient to allow the device to penetrate deep surgical planes within the individual. Deep surgical planes can include surgical planes of muscle, fat, or any combination thereof. The introducer sheath can have a Young's modulus of about 10 MPa to about 10,000 MPa. The introducer sheath and needle can have a combined Young's modulus sufficient to allow the user to place the lead near target tissue in the patient's pelvic region. For example, target tissue in the patient's pelvic region can include the pudendal nerve. The stiffness of the sheath and needle together can be sufficient to allow secure and accurate placement of the electrode lead at the target tissue in the patient's pelvic region. For example, the target tissue can include the pudendal nerve. In some embodiments, the stiffness of the sheath can be sufficient to allow secure and accurate placement of the electrode lead at the target tissue in the patient's pelvic region.For example, the target tissue may include the pudendal nerve. The sheath used for pudendal nerve placement may have a higher stiffness than that used for sacral nerve placement. Electrodes may be configured to deliver a voltage of approximately 5V to approximately 15V per electrode. Electrodes may be configured to deliver a current of approximately 5mA to approximately 15mA per electrode. Electrodes may be configured to deliver a power of approximately 0.05W to approximately 0.5W per electrode. The needle tip may be configured to retract into the occluder lumen. The needle tip angle may be configured to allow the needle tip to advance through the tissue. The angle of the proximal end of the sheath's elongated shaft allows for advancement of the device with minimal damage to surrounding tissue. Electrodes may be wound around the outer surface of the sheath's elongated shaft.

[0116] Electrode lead placement This document describes methods, apparatus, systems, and / or kits for placing at least one electrode lead in a target tissue, such as in the pelvic region. The target tissue may include the pudendal nerve for the treatment of incontinence. In some cases, the target tissue may include target tissue receiving electrical stimulation for sexual dysfunction. In some instances, the target tissue may include target tissue receiving electrical stimulation for pain treatment and / or management. Although certain apparatuses, systems, methods, and kits for the treatment and / or management of pelvic conditions are described herein with reference to the pelvic region, such methods and apparatus may be used in other areas of the body or for the treatment of other conditions, as described elsewhere herein.

[0117] The methods, devices, systems, and / or kits provided herein can be used to place at least one electrode lead on a nerve serving one or more muscles controlling urination to treat urinary incontinence. In some cases, the methods, devices, systems, and / or kits provided herein can be used to place at least one electrode lead on a nerve serving one or more muscles used for urination to treat fecal incontinence. In some cases, the methods, devices, systems, and / or kits provided herein can be used to place at least one electrode lead bilaterally on each side of the body on a nerve serving one or more muscles controlling or used for urination. For example, bilateral stimulation of the pudendal nerve may allow for better control and / or effectiveness in treating urinary or fecal incontinence than unilateral stimulation. Often, access to the pudendal nerve and placement of electrodes or electrode leads with minimal damage to surrounding tissues can be difficult due to the anatomy of the vicinity of the pudendal nerve. The introducer can allow access to the pudendal nerve via one or more anatomical pathways with minimal damage to surrounding tissues. In some cases, the introducer can be accessed via the sciatic-rectal approach, where the introducer is guided to pass through or near the sacrotuberous ligament and place the lead on the pudendal nerve trunk at a target location proximal to Alcohol's canal. In other cases, the introducer can be accessed via the subgluteal approach, where the introducer is guided to pass through the space between the sacrotuberous and sacrospinous ligaments and anteriorly in the ischiorectal fossa below the pelvic floor to place the lead on the anterior branch of the pudendal nerve, thereby stimulating the pudendal nerve and the dorsal genital nerve.

[0118] This document provides methods, apparatus, and systems for implanting at least one electrode lead and an implantable pulse generator (IPG) in an individual. Typically, the implantation procedure may involve one or more of the following steps: pretreatment, patient preparation, neurolocalization, placement of one or more leads, lead fixation, IPG pouch formation, lead tunneling, connection of one or more leads to the IPG, IPG placement, impedance testing, and tissue closure. Figure 12 illustrates a flowchart 1000 for performing the steps of electrode lead and implantable pulse generator (IPG) implantation. In some embodiments, the implantation procedure involves sequential steps of pretreatment 1002, patient preparation 1004, placement of one or more leads 1006, lead fixation 1008, IPG pouch formation 1010, lead tunneling 1012, connection of one or more leads to the IPG 1014, IPG placement 1016, impedance testing 1018, and wound closure 1020. These steps can be performed in an individual by a healthcare professional or surgeon to treat incontinence. In some embodiments, these steps can be performed or controlled by a robotic system and / or facilitated using augmented reality.

[0119] This article describes methods, devices, and systems that allow access to the pudendal nerve via one or more anatomical pathways. First, the patient can be positioned in a prone position with the hips elevated to facilitate suture insertion via a posterior or gluteal approach. Typically, surface landmarks (including, but not limited to, the greater trochanter and ischial tuberosity) are used to mark the hips to locate the surface position of the ischial spine. Using these landmarks and conventional radiographic imaging (equivalent to a C-arm image intensifier), marking needles and / or needle electrodes can be inserted to locate the pudendal nerve at each target location. In some cases, target locations may include the distal / pelvic floor via a subgluteal approach and the proximal trunk of the pudendal nerve via a gluteal approach. The nerve can be located additionally or alternatively via intraoperative electrophysiology (EMG response). The nerve can be located additionally or alternatively via visual-motor response. The nerve can be located additionally or alternatively via urethral manometry. Once the nerve is located, an introducer can be used to follow the needle's path to each target location. The introducer can be advanced to this location and its position can be finely altered so that stimulation via a defined proportion of the total number of electrodes elicits a pelvic floor EMG, urethral sphincter, or anal EMG response. The position of the introducer and electrodes can be finely altered so that stimulation via at least one electrode elicits a pudendal EMG response. In some cases, the position of the introducer and electrodes can be finely altered so that stimulation of most or all electrodes elicits a response. Once the introducer is properly positioned, the occluder can be withdrawn and replaced with an electrode lead using markers provided to precisely align the lead electrodes with the loops on the introducer. The introducer can be carefully removed (under image enhancement) to avoid interfering with lead positioning. A small skin incision can be made to facilitate access to the lead, which can then be secured in place, for example, by using a fixation device (passed through the lead) and standard non-absorbable monofilament sutures to the local fascia. The lead can then be tunneled to a future IPG site.

[0120] Electrode leads can be placed on a target area of ​​a target nerve to treat incontinence using the introducer device described herein. Electrode leads can be placed on a target area of ​​a target nerve using a guidewire and / or sheath to treat incontinence. The target nerve may include the pudendal nerve. Electrode needles may include Chiba needles. Lead or guidewire introducers may include metal occluders or reinforcing wires and an insulating plastic sheath. Lead or guidewire introducers may be modified to allow easier access to the pudendal nerve. Lead or guidewire introducers may be configured to perforate ligaments. Lead or guidewire introducers may be configured to allow access to the sacrotuberous ligament. The sheath of an introducer for accessing the pudendal nerve may have greater stiffness than the sheath of an introducer typically used for accessing the sacral nerve.

[0121] The lead may include a sensor that can acquire neurophysiological recordings from a nerve, such as the pudendal nerve. In some embodiments, the methods described herein may include placing a sensor on the pudendal nerve to acquire an electrical signal from the pudendal nerve. The acquired electrical signal may be used to determine the level of nerve stimulation of the pudendal nerve to prevent incontinence episodes. In some embodiments, the individual may control the stimulation by performing pelvic compression, wherein the sensor receiving a threshold EMG signal due to the pelvic compression may activate the electrical stimulation.

[0122] pudendal nerve The pudendal nerve is a major nerve in the pelvic region. Normally, it travels through the supporting organs and terminates in the pelvic floor muscles of the external genitalia. It typically transmits motor and sensory information from the genital region. The pudendal nerve is likely crucial for sensation and function in the pelvic region. It can be part of the peripheral nervous system.

[0123] Typically, the pudendal nerve is located bilaterally on the left and right sides of the body, one on each side. The pudendal nerve usually originates from the sacral plexus in the lowest part of the spine. The sacral plexus comprises a bundle of nerves located in the posterior part of the pelvis. The sacral plexus can include a complex neural network that provides and receives feedback on movement and sensation to the thigh, lower leg, foot, and part of the pelvis. The pudendal nerve typically connects to the S2 to S4 sacral spinal nerve roots in the sacral plexus and runs parallel through the pelvis and the upper end of the femur in the hip region. The pudendal nerve usually passes through the larger sciatic foramen, exits the hip region through the smaller sciatic foramen, and runs along the pudendal artery and vein into the pudendal canal (also referred to herein as Alcorcía's canal, a narrow tunnel-like opening in the pelvis). After entering the pudendal canal, the pudendal nerve can branch into smaller branches. The pudendal nerve can branch into the inferior rectal nerve, perineal nerve, and dorsal genital nerve. The pudendal nerve runs on and within the medial aspect of the ischium. The pudendal nerve can be difficult to access surgically because it runs in three different planes. The inferior rectal nerve controls the anal sphincter and sends sensory and motor information to the anal sphincter and anal canal. The pudendal nerve plays a role in the reflex control of bladder contraction and emptying. The perineal nerve controls the pelvic floor muscles and urethral sphincter. The perineal nerve can provide sensory and motor information from the perineum and labia or scrotum. The dorsal nerve can send sensory information to the skin of the penis or clitoris, including but not limited to touch, pleasure, and pain.

[0124] The pudendal nerve's motor function controls the movement of one or more muscles. Specifically, it controls the movement of one or more of the anal sphincter and urethral sphincter. The anal sphincter helps retain and release feces. The urethral sphincter helps retain and release urine. The pudendal nerve provides sensory information about touch, pleasure, pain, and temperature related to various anatomical structures, including but not limited to the penis, vagina, perineum, anus, and anal canal. Damage to the pudendal nerve can lead to loss of sensation in its distribution, fecal and urinary incontinence, sexual dysfunction, or one or more combinations thereof.

[0125] Preprocessing Individuals experiencing incontinence and ready for treatment via electrical nerve stimulation may undergo various pre-treatment steps prior to the implantation procedure. The implantation procedure may be performed in a sterile operating room environment with laminar flow or similar conditions. The sterile operating room environment may have limited personnel access and movement. Devices used for the procedure, including but not limited to the introducer, may be sterilized prior to the procedure. The introducer may include materials compatible with standard sterilization procedures, including but not limited to ethylene oxide gas, gamma radiation, and autoclave sterilization. The operating table may allow for various patient positioning and X-ray C-arm access. In some embodiments, a radiologist (also referred to as a radiotechnician) may be present during the procedure to work with the image intensifier. One or more non-invasive imaging methods may be used along the anatomical path of the introducer during the implantation procedure to provide images of one or more of the anatomical structures, needle insertion, introducer, electrodes, and / or leads. The patient controller may be fully charged and linked to the IPG prior to the procedure. The IPG may be linked and charged through its packaging to maintain sterility. In some embodiments, the patient controller may be placed in a sterile bag and linked during the procedure.

[0126] Patient preparation The individual can be prepared for treatment via electrical nerve stimulation before the implantation procedure begins. The IPG implantation site can be pre-marked in relation to posture and clothing to increase the individual's comfort after the procedure in their daily life. General anesthesia can be administered to the individual before the procedure. In some embodiments, the individual can be appropriately positioned in a prone jack-knife position to allow surgical access. In some embodiments, left / right tilt and correct positioning can be checked before the procedure. A urethral transducer can be inserted into the individual to monitor and improve the accuracy of lead placement. In some embodiments, a transducer on a catheter can be used to monitor the progress of lead placement. For EMG measurement purposes, a transvaginal probe can be safely inserted into the individual's vagina. The transvaginal probe can be used to monitor and improve the accuracy of lead placement. The transvaginal probe can be used additionally or alternatively to monitor the progress of lead placement. An electrical grounding pad can be placed on the individual away from the surgical site. The individual's skin (including, but not limited to, the vaginal opening) can be prepared and covered before the procedure to reduce infection and surgical complications. For EMG measurement purposes, a needle electrode can be inserted into the individual's external anal sphincter. In some embodiments, for the purpose of measuring EMG, adhesive surface electrodes may be applied to the perianal skin of an individual.

[0127] Nerve localization and suture placement This document provides methods, apparatus, and systems that allow access to the pudendal nerve via one or more anatomical pathways with minimal damage to the tissues surrounding the pudendal nerve. Access to the pudendal nerve and placement of one or more guides with minimal damage to surrounding tissues can often be difficult due to the anatomical structures near the pudendal nerve and because the pudendal nerve may travel in three different planes of the body. For example, the pudendal nerve travels in a broad-tailed path medially to the ischial bone and then turns anteriorly into the median fossa. This document describes imaging guidance markers on the skin to guide the anatomical path of the guide to access the pudendal nerve. Radiographic images of the individual's hip region can be acquired using a metal guide placed on the skin. The radiographic images can be used to determine the location of a series of surface markers on the skin in the hip region to provide orientation of the anatomical path of the guide to access the pudendal nerve in the individual. The radiographic images can be acquired via fluoroscopy. In some embodiments, the radiographic images can be acquired additionally or alternatively by X-ray. The introducer can access the pudendal nerve via an ischiorectal approach, wherein the introducer is guided to pass through or near the sacrotuberous ligament and place the lead wire to a target location on the pudendal nerve trunk proximal to Alcohol's canal in the ischial spinal region. In some embodiments, the introducer can access the pudendal nerve via a subgluteal approach, wherein the introducer is guided to pass through the space between the sacrotuberous and sacrospinous ligaments and anteriorly in the ischiorectal fossa below the pelvic floor to place the lead wire on the anterior branch of the pudendal nerve to stimulate the pudendal nerve and the dorsal genital nerve.

[0128] Locating the target nerve before inserting any leads can advantageously allow one or more leads to be placed in the optimal location for stimulation. For example, locating the pudendal nerve allows the leads to be positioned more precisely and parallel to the pudendal nerve (e.g., at the pudendal nerve trunk). Placing the leads parallel to the pudendal nerve trunk, rather than intersecting the nerve at a single point, allows for a greater length of interaction between the electrode leads and the nerve, such that each electrode along the length of the lead can be in the optimal range and / or location for stimulating the nerve. One or more needles can be used to locate the nerve. The one or more needles may include a marking needle and / or a stimulating component (e.g., a stimulating needle). The marking needle may indicate the horizontal and / or vertical level of the nerve (such as the pudendal nerve) targeted for stimulation. The marking needle may be inserted using one or more lines (such as a first line and a second line). The marking needle may be inserted at or near the intersection of the first line and the second line. The first line and the second line may include one or more surface marks drawn on the skin. One or more surface marks can be guided by imaging. For example, the patient or subject may be placed in a prone position, and the surface marks may be drawn using radiological techniques such as X-rays or fluoroscopy. In some embodiments, surface marking can be guided by palpating the buttock area. In some embodiments, surface marking may include radiopaque markings. In some embodiments, the method may utilize two stimulating members. A first stimulating member may be used to mark a nerve and will typically intersect with the nerve. A second stimulating member may be used to approach the pudendal nerve approximately parallel to it and to place the guide parallel to the pudendal nerve as described above.

[0129] Figure 27 A schematic diagram is shown of surface markings drawn on an individual to locate the pudendal nerve. Surface markings 2704 can be made by palpating and marking the ischial tuberosities. Vertical surface markings 2708 corresponding to the inner edge of the ischial bone can be drawn using anterior-posterior X-ray images or fluoroscopy. Horizontal surface markings 2712 passing through the top of the greater trochanter and intersecting with the vertical surface markings 2708 can be drawn using a similar technique. The intersection point 2716 between two surface markings can indicate a location closely associated with the ischial spine. In some embodiments, one or more surface markings can be drawn on the opposite side in a similar manner. A marking needle can be inserted vertically into the location indicated by the intersection of one or more surface markings. In some embodiments, the marking needle can be inserted into a location adjacent to the intersection of the surface markings. For example, the marking needle can be inserted approximately 1 cm laterally to the intersection point 2716.

[0130] Figure 28A schematic diagram of the anatomical structures in an individual and an inserted marker needle is shown in a side view. The marker needle 2804 can be inserted until it contacts the ischial bone to indicate the level of the ischial spine for guidance on lateral X-rays. Thus, the tip of the marker needle 2804 can be readily visualized in the side view to indicate the vertical level 2808 of the pudendal nerve rotating inward at the ischial spine. The marker needle 2804 can have a length greater than the distance from the insertion point to the ischial spine of a particular individual. In some embodiments, the length of the marker needle 2804 can include approximately 6 cm to 20 cm. In some embodiments, the length of the marker needle 2804 can include approximately 6 cm, approximately 7 cm, approximately 8 cm, approximately 9 cm, approximately 10 cm, approximately 11 cm, approximately 12 cm, approximately 13 cm, approximately 14 cm, approximately 15 cm, approximately 16 cm, approximately 17 cm, approximately 18 cm, approximately 19 cm, approximately 20 cm, or a length within the range defined by any of these values. If the marking needle is a stimulating needle, the tip of the stimulating needle will mark the vertical level of the pudendal nerve's course when EMG activity of the external anal sphincter is activated. The stimulating needle can be advanced slowly, just medial to the transverse tangent of the X-ray and perpendicular to the skin. Under stimulation (e.g., less than or equal to 3 mA or less than or equal to 2 mA), an EMG response in the external anal sphincter and / or pelvic floor may be present when the needle tip marks the vertical level of the pudendal nerve (in a lateral X-ray view). In other methods, the marking needle 2804 can be introduced at an angle to the needle medial to the internal obturator muscle and close to Alcohol's canal.

[0131] One or more needles used to locate a target nerve may include a stimulating needle. The stimulating needle may define the path for an introducer and / or for implantation of a lead at the target nerve. The stimulating needle may be used to deliver a constant low level of stimulation upon insertion into the individual, allowing for measurement of the response. For example, the stimulating needle may be used for the purpose of measuring EMG responses to monitor and verify the desired path for the lead to be implanted. To reach the pudendal nerve, a stimulating needle may be inserted using an ischiorectal approach, beginning in the ischiorectal fossa and medial to the ischial tuberosity. The stimulating needle may be advanced generally in a cephalic direction, passing through the lesser sciatic foramen toward the ischial spine. The stimulating needle may penetrate the skin approximately 5 mm to 10 mm medial to the ischial tuberosity at a level determined by a marking needle. With the ischiorectal approach, a lateral view X-ray may be used as a guide to guide and advance the stimulating needle toward the tip of the marking needle in a horizontal plane. Once the initial orientation of the stimulating needle in the lateral view X-ray is ensured to be approximately flush with the tip of the marking needle, the stimulating needle may be further guided and advanced toward the tip of the marking needle using anterior-posterior view X-rays.

[0132] The stimulation needle can be connected to an external stimulator. The stimulator can supply a current of approximately 6 mA or less to the stimulation needle. The stimulator can provide currents of approximately 1 mA, 2 mA, 3 mA, 4 mA, 5 mA, or 6 mA. Using higher stimulation currents may cause non-selective contraction of the entire surrounding area, thereby inhibiting the effectiveness of measuring EMG responses as a localization tool. The threshold for the measured EMG response, indicating proper placement, can be in the range of 10 mV to 30 mV. For example, the threshold EMG response can be approximately 10 mV, 12 mV, 14 mV, 16 mV, 18 mV, 20 mV, 22 mV, 24 mV, 26 mV, 28 mV, or 30 mV. The threshold EMG response can be 20 mV or greater. Pudendal nerve stimulation advantageously provides responses in both the external anal sphincter (EAS) and the pelvic floor, while sacral nerve stimulation may only elicit a pelvic floor response. To locate the pudendal nerve, the stimulation needle can be advanced along a cephalic trajectory using an ischiorectal approach, and EMG responses can be measured at least in the EAS and pelvic floor to verify proper placement at the pudendal nerve. A recording needle can be used to measure EMG responses in the EAS. EMG responses in the pelvic floor can be measured using a transvaginal probe or an EMG needle (e.g., lateral to the anus until pelvic floor activity is measured). As the stimulation needle is advanced, the needle stimulation path can include direct stimulation of the pelvic floor, followed by stimulation of the adipose tissue, and then stimulation of the pudendal nerve in that order. Therefore, the corresponding sequence of detected EMG responses can include only the pelvic floor, then no response, followed by EAS and / or pelvic floor responses. Optimal placement of the stimulation needle at or near the pudendal nerve can result in both EAS and pelvic floor EMG responses, indicating effective stimulation of the pudendal nerve. In some embodiments, optimal placement of the stimulation needle can result in an EAS response but no pelvic floor response. If no EAS response is measured, the stimulation needle placement can be adjusted axially and / or vertically, guided by imaging. If multiple adjustments to the needle position have not elicited an EAS response, then placement of the stimulating needle that elicits only a pelvic floor response is acceptable. For example, if the needle position has been adjusted at least five times without achieving an EAS response, then placement of the stimulating needle that elicits only a pelvic floor response is acceptable. Once a suitable EMG response is obtained, the needle position can be confirmed by lateral X-rays and / or by a marker needle. A well-positioned stimulating needle for the pudendal nerve can be positioned just behind the ischial spine and just medial to the marker needle. In some methods, the position of the stimulating element can be confirmed solely based on the EMG response at the external anal sphincter.

[0133] Once the stimulating needle is properly positioned, the guidewire can be fully inserted through it. Tactile feedback or fluoroscopy can indicate when the guidewire has reached the distal end of the stimulating needle. The stimulating needle can then be retracted and removed from the patient. The guidewire should be carefully held in place to avoid any further retraction or advancement. The introducer can then be placed on the guidewire, and the guidewire can be removed to allow insertion of the lead. The introducer may include an introducer sheath and an occluder. Proper placement of the introducer can be confirmed by visualization of the radiopaque introducer sheath and / or one or more radiopaque markings on the introducer sheath. The guidewire can be implanted using the introducer and / or lead, employing the devices and methods described herein, such that the tip of the pudendal nerve leadwire is implanted at the same location reached by the tip of the stimulating needle.

[0134] In some embodiments, lead placement may include bilateral placement at one or more target nerves, wherein the one or more leads are placed on or near the target nerves. Therefore, the apparatus and methods described herein with respect to nerve localization and lead placement can also be used or performed in a similar manner on the contralateral side of an individual. The target nerve may include the pudendal nerve. In some embodiments, the target nerve may include the sacral nerve. In some embodiments, one or more leads may be placed on one or both sides of the body at both the sacral and pudendal nerves. For example, one or more leads may be placed on one side of the body at the pudendal nerve, and one or more leads may be placed on the contralateral side of the body at the sacral nerve. As another example, one or more leads may be placed on one side of the body at the pudendal nerve, and one or more leads may be placed on the same side of the body at the sacral nerve.

[0135] Figure 29 A schematic diagram of the bilateral guide placement at the pudendal nerve is shown. The first guide 2904 can be positioned on the left side of the body at the trunk of the left pudendal nerve. The second guide 2908 can be positioned on the right side of the body, opposite to the first guide 2904 (on the right side of the body), at the trunk of the right pudendal nerve. The first and second guides 2904 and 2908 can tunnel through the gluteal region to connect to the unilateral IPG 2912. The length of the guide on the opposite side of the IPG can be greater than the length of the guide on the same side of the IPG. (Example: via...) Figure 29As shown, the first lead 2904 can be longer than the second lead 2908. For example, the length of the first lead 2904 can be approximately 550 mm, while the length of the second lead 2908 can be approximately 400 mm. The difference between the lengths of the first lead 2904 and the second lead 2908 can be between approximately 100 mm and 200 mm. For example, the difference between the lengths of the two double-sided leads can be approximately 100 mm, approximately 110 mm, approximately 120 mm, approximately 130 mm, approximately 140 mm, approximately 150 mm, approximately 160 mm, approximately 170 mm, approximately 180 mm, approximately 190 mm, approximately 200 mm, or a length within the range defined by any of these values.

[0136] The subgluteal approach uses surface markers on the skin to cross the gluteal muscles to reach the ischial spine, thereby using electrophysiological responses to guide further placement. The ischiorectal approach enters the skin lateral to the anus near the ischial tuberosity and uses transvaginal or transrectal palpation with positive / negative electrophysiological responses of the ischial spine to place electrode leads. Subgluteal and ischiorectal approaches near the pudendal nerve can benefit from guidance via radiographic imaging. These approaches are generally considered to target the region of Alcohol's canal or the region of the proximal pudendal nerve, i.e., the nerve trunk. The proximal pudendal nerve trunk can have a fascicular anatomy, where its distal branches are represented as individual bundles or different groups of bundles. The fascicular anatomy of the pudendal nerve can affect the accuracy of lead placement, where small variations in lead position may favor certain bundles and thus different motor or afferent effects.

[0137] Typically, the pudendal nerve is accessible to electrical stimulation, but the effectiveness of PNS treatment for incontinence can be affected by the site of stimulation. Proximal stimulation of the PN trunk (i.e., above Alcoholic canal) can provide direct motor stimulation to both the urethra and anal sphincter. In some embodiments, proximal stimulation of the PN trunk can result in some contraction of the pelvic floor / levator ani muscles, based on stimulation provided proximal to the branches of the inferior rectal nerve and the perineal nerve. In some embodiments, stimulation in the region of Alcoholic canal can provide urethral sphincter contraction but less anal sphincter contraction. In some embodiments, the region of Alcoholic canal remains proximal to the pudendal nerve, and some contraction of the pelvic floor / levator ani muscles can be expected from stimulation in this region. Based on dissection, unilateral stimulation may result in bilateral motor effects. Stimulation more distally (i.e., stimulation of the dorsal genital nerve) may only result in effects mediated by afferent stimulation. The bundle-like anatomy of the PN trunk can be important for the accuracy of suture placement.

[0138] Figures 13-16B The anatomical paths desired for lead placement are shown in some embodiments. Figure 13A schematic diagram showing the anatomical structures within the individual, as well as the setup of the leads and IPG, is presented. Figure 13 The iliac crest 1202, gluteus minimus 1204, piriformis 1206, sacrotuberous ligament 1208, pudendal nerve 1210, and sciatic nerve 1212 of the ileum are shown. Leads 1214 and 1216 can be placed at one or more locations along the length of the pudendal nerve 1210. Lines 1218 of leads 1214 and 1216 can be connected to the IPG 1220. The placement of leads 1214 and 1216 on the pudendal nerve can be verified and secured before their lines are connected to the IPG.

[0139] Figure 14 and Figure 15 The diagram shows the anatomical structures in the individual, as well as the implanted lead and IPG. Figure 14 Two leads 1302 and 1304, placed on two segments of the pudendal nerve 1314, are shown. Each lead has four electrodes (shown as black circles). Wire 1306 of leads 1302 and 1304 can be connected to IPG 1308. Figure 14 The diagram shows the inferior gluteal nerve 1312, pudendal nerve 1314, obturator internus muscle 1316, sacrotuberous ligament 1318, posterior femoral cutaneous nerve 1320, gluteus medius muscle 1322, gluteus minimus muscle 1324, piriformis muscle 1326, quadratus femoris muscle 1328, gluteus maximus muscle 1330, and sciatic nerve 1332. Figure 15 The image shows an IPG 1308 placed in a pouch within the fat covering the gluteal muscles. Figure 15 The image shows the iliac crest 1334, intergluteal cleft 1336, greater trochanter of the femur 1338, ischial tuberosity of the pelvis 1340, and gluteal fold 1342.

[0140] Figure 16A and Figure 16B An example of an anatomical path using a anatomical model of a guide is shown. Figure 16A An embodiment of the ischiorectal approach is illustrated, wherein a needle 1402 (representing the needle of the introducer) is shown passing through the sacrotuberous ligament 1404 to approach the pudendal nerve 1406. In some embodiments, the needle of the introducer may puncture or pass close to the sacrotuberous ligament 1404 internally. Figure 16B An embodiment of the subgluteal approach is shown, wherein the needle 1402 is guided to approach the subgluteal approach to access the pudendal nerve 1406.

[0141] Lead wire fixing device One or more leads (e.g., electrode leads) can be secured to target tissue (e.g., the pudendal nerve or tissue adjacent to the pudendal nerve) using a fixation method. For example, one or more leads can be secured to tissue surrounding the pudendal nerve. Electrode leads can be secured to the pudendal nerve or tissue adjacent to the pudendal nerve using one or more anchors 201, such as... Figures 2A-2G As shown. Anchor 201 may include a body 200 (e.g., a cylindrical body or collar) that may include a lumen 204 configured to receive leads, as described elsewhere herein. The anchor may include a first end 205 and a second end 207. The first end 205 may include rounded and / or chamfered edges 203 on its surface. The rounded and / or chamfered edges 203 may allow the anchor 201 to travel into and through the elongated body lumen of the introducer, as described elsewhere herein, to compress or collapse the anchor before delivery and / or implantation of the anchor and electrode leads. The rounded and / or chamfered edges 203 may reduce the friction between the inner surface geometry of the elongated body lumen of the introducer, as described elsewhere herein, and the rounded and / or chamfered edges 203 of the first end, so that the anchor collapses or is compressed without damaging the anchor or compressing its structural integrity. The second end 207 may include one or more free ends of the barbs 202, such as Figure 2A As shown. The free end of one or more barbs may include a chamfer, bevel, rounded, and / or rounded edge 209, as shown. Figure 2B As shown, when one or more barbs and electrode leads translate into and out of the elongated body lumen of the introducer, the chamfered, rounded, and / or rounded edges 209 can provide curvature, as described elsewhere herein, that minimizes frictional forces acting on, for example, the chamfered surfaces of the free ends of one or more barbs 202 and the inner surfaces of the elongated body lumen of the introducer. Depending on the indications for the one or more leads, one or more parameters of the anchors and / or barbs described herein can be varied, including but not limited to material, profile, length, distance to the electrode, angle, number, etc.

[0142] One or more anchors may be made and / or manufactured from a polymer. The polymer may include thermoplastic polyurethane elastomer (TPU). For example, the polymer may include thermoplastic polyurethane, i.e., Pellethane. TM In some embodiments, the polymer may include polytetrafluoroethylene (PTFE). In some embodiments, the anchor may include a deformable material.

[0143] One or more anchors may be made of a material with a Shore stiffness of about 50D to about 80D. Shore hardness, as indicated elsewhere in this document, may include hardness measured by a hardness tester. A hardness tester measures Shore stiffness by determining the penetration of the indenter into the sample during testing. One or more anchors may be made of a material with a Shore stiffness of about 40D to about 90D, about 50D to about 80D, about 50D to about 70D, or about 60D to 70D. One or more anchors may be made of a material with a Shore stiffness of about 50D, about 52D, about 54D, about 56D, about 58D, about 60D, about 65D, about 70D, about 75D, about 80D, or about 85D. One or more anchors may be made of a material with a Shore stiffness of about 50D, about 52D, about 54D, about 56D, about 58D, about 60D, about 65D, about 70D, or about 75D. In some cases, one or more anchors may be made of a material with a Shore stiffness of up to about 52D, about 54D, about 56D, about 58D, about 60D, about 65D, about 70D, about 75D, or about 80D.

[0144] The rounded and / or chamfered edges 203 of the body 200 may include a radius 214 of about 0.01 mm to about 0.3 mm. For example, the rounded and / or chamfered edges 203 of the body 200 may include a radius 214 of about 0.08 mm to about 0.3 mm, or about 0.1 mm to about 0.3 mm. In some cases, the rounded and / or chamfered edges 203 of the body 200 may include a radius 214 of about 0.01 mm, about 0.05 mm, about 0.08 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, or about 0.3 mm. In some cases, the rounded and / or chamfered edges 203 of the body 200 may include a radius 214 of at least about 0.01 mm, about 0.05 mm, about 0.08 mm, about 0.1 mm, about 0.15 mm, or about 0.2 mm. In some cases, the rounded and / or chamfered edges 203 of the body 200 may include radii 214 of up to about 0.05 mm, about 0.08 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, or about 0.3 mm. In some cases, the body 200 may taper in a manner similar to that of an introducer to facilitate the introduction of the anchor into the introducer. In some cases, the body 200 may include a deformable material shaped like a donut.

[0145] The body 200 of the anchor may include a length 216 of about 0.5 mm to about 6 mm. For example, the body 200 of the anchor may include a length 216 of about 1 mm to about 6 mm, about 2 mm to about 6 mm, or about 3 mm to about 6 mm. The body 200 of the anchor may include a length 216 of about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, or about 6 mm. In some cases, the body 200 of the anchor may include a length 216 of at least about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, or about 5 mm. In some cases, the body 200 of the anchor may include a length 216 of at most about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, or about 6 mm.

[0146] The body 200 of the anchor may include an outer diameter 210 of about 0.5 mm to about 6 mm. The outer diameter may include the diameter of the circular cross-section of the body 200 of the anchor. The body 200 of the anchor may include an outer diameter 210 of about 1 mm to about 6 mm, about 2 mm to about 6 mm, or about 3 mm to about 6 mm. The body 200 of the anchor may include an outer diameter 210 of about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, or about 6 mm. In some cases, the body 200 of the anchor may include an outer diameter 210 of at least about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, or about 5 mm. In some cases, the body 200 of the anchor may include an outer diameter 210 of up to about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm or about 6 mm.

[0147] The body 200 of the anchor may include an inner diameter 228 of about 0.5 mm to about 6 mm. For example, the body 200 of the anchor may include an inner diameter 228 of about 1 mm to about 6 mm, about 2 mm to about 6 mm, or about 3 mm to about 6 mm. The body 200 of the anchor may include an inner diameter 228 of about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, or about 6 mm. In some cases, the body 200 of the anchor may include an inner diameter 228 of at least about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, or about 5 mm. In some cases, the body 200 of the anchor may include an inner diameter 228 of at most about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, or about 6 mm.

[0148] Anchor 201 may include one or more barbs 202, such as a pair of barbs or two or more barbs. In some cases, the anchor may include two or more barbs. The two or more barbs of the anchor may include 2, 3, 4, 5, 6, 7, 8, 9, or 10 barbs. The barbs 202 of the anchor may be made of the same material as the body 200 (e.g., a monolithic material). The monolithic material may include a material of injection-molded plastic. By manufacturing the anchor body and one or more barbs from the same material, the cost of the anchor can be significantly reduced. The barbs 202 may be radially symmetrical about the body of the anchor 200. In some cases, the two or more barbs of the anchor may not be radially symmetrical about the body of the anchor 200. The two or more barbs of the anchor may be equally spaced along the circumference of the cross-section of the anchor body (e.g., equally spaced by rotational angle). Each of the two or more barbs 202 may be configured to extend along the radius of the circular cross-section of the body of the anchor 200.

[0149] One or more barbs 202 may include heat-set barbs. Heat-set barbs may include materials configured to maintain, retain, and / or fix the geometry and / or shape of the barb when exposed to a temperature or temperature range. Heat-set barbs may include shape memory polymer materials configured to maintain their shape and / or geometry when exposed to a temperature or temperature range as described elsewhere herein. Shape memory polymer materials may include thermoplastics, (meth)acrylates, polyurethanes, blends of polyurethanes and polyvinyl chloride, or any combination thereof.

[0150] The barb 202 can include a rectangular, elliptical, or triangular outline. For example, in Figures 2A-2C The rectangular outline of barb 202 is shown. In some cases, barbs (600, 602) may include a triangular outline, such as... Figure 6C As shown. A first or more triangular profile barbs 600 may be coupled to a first body segment 604, while a second or more triangular profile barbs 602 may be positioned on a second body segment 602. The first body segment 604 and the second body segment 605 may be coupled to each other to form the anchor body. In some instances, the barbs in two or more of the anchor's barbs may include serrated barbs 502, wherein the serrated barbs include profiles having one or more cutting features 504 or protrusions, such as... Figure 6A and Figure 6BAs shown. One or more cutting features may include a circular geometry. The circular geometry may include a diameter of about 0.25 mm to about 0.5 mm. The serrated barb 502 may be mechanically coupled and / or secured to the anchor body 500. The serrated barb 502 and the associated anchor body 500 may include the dimensions described elsewhere herein for the barb and anchor body. In some cases, the surface of the serrated barb 502 may increase friction between the surface of the serrated barb 502 and the surface of the tissue surrounding the serrated barb 502. The increased friction may maintain and / or secure the position of the electrode lead to which the serrated barb 502 is coupled.

[0151] One or more barbs of anchor 201 may include a length 208 of about 0.2 mm to about 5 mm. One or more barbs of anchor 201 may include a length 208 of about 0.5 mm to about 5 mm, about 1 mm to about 5 mm, or about 2 mm to about 5 mm. One or more barbs of anchor 201 may include a length 208 of about 0.2 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.5 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm. One or more barbs of anchor 201 may include a length 208 of at least about 0.2 mm, about 0.5 mm, about 0.8 mm, about 1 mm, about 1.5 mm, about 2 mm, about 3 mm, or about 4 mm. One or more barbs of anchor 201 may include a length 208 of at most about 0.5 mm, about 0.8 mm, about 1 mm, about 1.5 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm.

[0152] like Figure 2B , Figure 2D and Figure 2E The cross-section of the barb 202 shown may include a radius of curvature 212. The radius of curvature 212 may include a radius of about 0.5 mm to about 3 mm. The radius of curvature 212 may include a radius of about 1 mm to about 3 mm, or about 1.5 mm to about 3 mm. The radius of curvature 212 may include a radius of about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, or about 3 mm. In some cases, the radius of curvature 212 may include a radius of at least about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, or about 2.5 mm. In some cases, the radius of curvature 212 may include a radius of at most about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, or about 3 mm.

[0153] The barb 202 may include a thickness 232 of about 0.1 mm to about 1.5 mm. For example, the barb 202 may include a thickness 232 of about 0.2 mm to about 1.5 mm, or about 0.3 mm to about 1.5 mm. The barb 202 may include a thickness 232 of about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.5 mm, about 0.7 mm, about 1 mm, or about 1.5 mm. In some cases, the barb 202 may include a thickness 232 of at least about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.5 mm, about 0.7 mm, or about 1 mm. In some cases, the barb 202 may include a thickness 232 of up to about 0.2 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.5 mm, about 0.7 mm, about 1 mm, or about 1.5 mm.

[0154] When deployed, extended, and / or extended, the barb 202 may form an arcuate surface 225 between the barb 202 of the anchor and the body 200. The arcuate surface 225 may include a radius of about 0.5 mm to about 2 mm. For example, the arcuate surface 225 may include a radius of about 0.7 mm to about 2 mm, or about 1 mm to about 2 mm. The arcuate surface 225 may include radii of about 0.5 mm, about 0.7 mm, about 1 mm, about 1.1 mm, about 1.25 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, or about 2 mm. In some cases, the arcuate surface 225 may include radii of at least about 0.5 mm, about 0.7 mm, about 1 mm, about 1.1 mm, about 1.25 mm, about 1.3 mm, about 1.4 mm, or about 1.5 mm. In some cases, the curved surface 225 may include a radius of up to about 0.7 mm, about 1 mm, about 1.1 mm, about 1.25 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, or about 2 mm.

[0155] When deployed, extended, and / or extended, the barb 202 may form an internal arcuate surface 230 between the barb 202 of the anchor and the body 200. The internal arcuate surface 230 includes a radius of about 0.01 mm to about 0.4 mm. For example, the internal arcuate surface 230 includes a radius of about 0.05 mm to about 0.4 mm, or about 0.2 mm to about 0.4 mm. The internal arcuate surface 230 includes radii of about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, or about 0.4 mm. In some cases, the internal arcuate surface 230 includes radii of at least about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, or about 0.3 mm. In some cases, the inner curved surface 230 includes a radius of up to about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, or about 0.4 mm.

[0156] The second or free end 207 of the barb 202 may include a chamfered, rounded, and / or rounded edge 209 with a radius 226 of about 0.01 mm to about 0.4 mm. For example, the free end 207 of the barb 202 may include a chamfered, rounded, and / or rounded edge 209 with a radius 226 of about 0.05 mm to about 0.4 mm, or about 0.1 mm to about 0.4 mm. The free end 207 of the barb 202 may include a chamfered, rounded, and / or rounded edge 209 with a radius 226 of about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, or about 0.4 mm. In some cases, the free end 207 of the barb 202 may include a chamfered, rounded, and / or rounded edge 209 with a radius 226 of at least about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, or about 0.3 mm. In some cases, the free end 207 of the barb 202 may include a chamfered, rounded, and / or rounded edge 209 with a radius 226 of at most about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, or about 0.4 mm.

[0157] When two or more of the barbs 202 are in an extended, deployed, and / or expanded state, such as Figures 2A-2C and Figure 2GAs shown, these can include a distance 224 between the outer surfaces of the first barb and the second barb in two or more barbs 202. The distance 224 can include from about 1 mm to about 5 mm. For example, the distance 224 can include from about 2.5 mm to about 5 mm, or from 3 mm to about 5 mm. The distance 224 can include about 1 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, or about 5 mm. In some cases, the distance 224 can include at least about 1 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, or about 4.5 mm. In some cases, the distance 224 can include at most about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, or about 5 mm.

[0158] When two or more of the barbs 202 are in an extended, deployed, and / or expanded state, such as Figures 2A-2C and Figure 2G As shown, they can form an angle 222 between the outer surfaces of the first barb and the second barb in two or more barbs 202. Angle 222 can range from about 20 degrees to about 180 degrees. For example, angle 222 can range from about 30 degrees to about 180 degrees, about 40 degrees to about 180 degrees, or about 50 degrees to about 180 degrees. Angle 222 can include about 20 degrees, about 25 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 60 degrees, about 70 degrees, about 80 degrees, about 90 degrees, about 120 degrees, about 160 degrees, or about 180 degrees. In some cases, angle 222 can include at least about 20 degrees, about 25 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 60 degrees, about 70 degrees, about 80 degrees, about 90 degrees, about 120 degrees, or about 160 degrees. In some cases, angle 222 may include up to about 25 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 60 degrees, about 70 degrees, about 80 degrees, about 90 degrees, about 120 degrees, about 160 degrees, or about 180 degrees.

[0159] Figures 3A-3D An electrode lead assembly having a lead 310 and one or more anchors (302, 304) is shown. The lead 310 may include one or more electrodes. In some embodiments, the stimulating electrode may be located near the distal end of the lead. Each of the one or more anchors (302, 304) may be positioned proximal to each of the one or more stimulating electrodes configured to contact or apply stimulation to tissue. However, in other configurations, the one or more anchors may be positioned elsewhere, for example, between the electrodes.

[0160] As shown, each anchor (302, 304) includes a collar with one or more barbs (e.g., two, three, four or more), said barbs extending at an angle relative to the longitudinal axis of the lead body from an end of the collar. The barbs (306, 308) may extend only from one end of the collar. All barbs (306, 308) on an individual anchor may extend in the same axial direction. The barbs (306, 308) may be collapsible for insertion into the body. In some configurations, the barbs (306, 308) may all collapse in the same direction, such that all barbs (306, 308) are oriented in the same direction for delivery. Anchors (302, 304) may be arranged such that the barbs (306, 308) on adjacent anchors (302, 304) are circumferentially offset. For example, the barbs on a first anchor may be circumferentially offset by 90 degrees from the barbs on a second adjacent anchor. The barb on the first anchor can be completely offset from the barb on the second anchor. For example, if the anchor has only two barbs, the barb on the first anchor will be completely offset from the barb on the second anchor. In other configurations, the barbs can be offset circumferentially by 30, 45, or 60 degrees. The barb on the first anchor can extend in the same or different axial direction as the barb on the second anchor. The anchors (302, 304) can be equidistant from each other.

[0161] As shown, there are multiple anchors (302, 304) with bidirectional orientation. The first set of anchors 302 can be oriented in a first direction, while the second set of anchors 304 can be oriented in a second direction different from or opposite to the first direction. The first set of anchors 302 and the second set of anchors 304 together constitute the entirety of the multiple anchors (302, 304). For example, the first set of anchors 302 can be oriented in a proximal or distal direction, while the second set of anchors 304 is oriented in the other direction. In the bidirectional configuration, barbs 306 on the first set of anchors 302 can extend in the first direction, while barbs 308 on the second set of anchors 304 extend in the second direction. In other words, barbs 306 on the first set of anchors 302 can extend in a direction opposite to that of barbs 308 on the second set of anchors 304. As shown, the first set of anchors 304 can be arranged adjacent to each other, and the second set of anchors 306 can be arranged adjacent to each other. The first set of anchors 302 can be completely positioned between the stimulating electrode and the second set of anchors 304. The barbs 306 on the first set of anchors 302 can extend in a proximal direction, and the barbs 308 on the second set of anchors 304 can extend in a distal direction. The barbs 306 on the first set of anchors 302 can extend toward the second set of anchors 304, and the barbs 308 on the second set of anchors 304 can extend toward the first set of anchors 302. The number of anchors in each of the first set of anchors 302 and the second set of anchors 304 can be the same or different. For example, the overall arrangement of the anchors (302, 304) can be asymmetrical along the length of the lead 310. In other embodiments described below, a single anchor (302, 304) can include bidirectional barbs (306, 308).

[0162] One or more anchors (302, 304, 306, 608) can be coupled to lead 310 (e.g., electrode lead), such as Figures 3A-3D and Figures 4A-4D As shown. The number of anchors used to secure the electrode leads can be varied according to the instructions. For example, four anchors can be coupled to lead 310, instead of... Figures 3A-3D and Figures 4A-4DThe six anchors shown are illustrated. One or more anchors (302, 304, 306, 308) may include an anchor body (302, 304) and one or more barbs (306, 308), as described elsewhere herein. One or more anchors (302, 304, 306, 308) may be secured in place on the lead wire 310. One or more anchors may be secured to the lead wire by adhesive. In some cases, one or more anchors (302, 304, 306, 308) may be removably coupled to the lead wire 310. One or more anchors may include one or more mating features on the inner surface of the anchor body, such as... Figure 31 As shown. The mating feature 3112 of the anchor 3102 can be configured to mate with a corresponding mating feature of the lead 3116. For example, the inner surface of the body of each of the one or more anchors may include a ridge or thread configured to mate with a corresponding groove or threaded hole in the lead body. The anchor 3102 may include one or more gripping features 3108 configured to be gripped by fingers or tools during attachment of the anchor 3102 to the lead 3116. In some cases, the anchor 3102 may include one or more teeth 3104 disposed on the outer surface of the anchor, the one or more teeth 3104 being configured to grip bone and / or tissue. The electrode lead body may include one or more stops at or between any end or both ends of the anchor array. The stops (one or more) may ensure that the anchor does not migrate or slip off the lead during correction or other high axial forces. The stops may be, for example, tubular bodies made of polyethylene. The tubular bodies may be longer than one of the anchors. For example, the tubular body can have a length of at least 3 mm. The tubular body can be at least 0.5 times longer than any of the anchors.

[0163] One or more anchors (302, 304, 306, 608) may include a first orientation or a second orientation. The first orientation of one or more anchors (302, 306) may include, for example: Figure 4A Two or more barbs 306 extending toward the proximal end 311 of the lead wire 310, as shown. A second orientation of one or more anchors (304, 308) may include, as shown... Figure 4AThe diagram shows two or more barbs 308 extending toward the distal end 309 of the lead 310. The proximal orientation of the first-oriented extension and / or extension of the two or more barbs relative to the distal orientation of the second-oriented extension of the two or more barbs can provide a beneficial effect in stabilizing and securing the lead 310 to the target implanted tissue or anatomical feature (e.g., the pudendal nerve). Opposite orientations of the first and second orientations of the two or more barbs can maintain and / or secure the lead's position regardless of any forces applied to the implanted electrode lead (e.g., thrust, compression, or tension). One or more anchors and / or barbs with opposite orientations can resist inward, outward, and / or lateral forces to secure the electrode lead's position. One or more anchors and / or barbs with opposite orientations can provide stability in at least three different directions to prevent inward, outward, and lateral displacement. As described elsewhere in this document, this benefit conferred by the orientation of one of the two orientations of the anchor can improve targeted therapy for subjects with implanted leads by reducing lead migration relative to tissue during active loading (e.g., exercise) or passive loading (e.g., sitting or sleeping) in the area of ​​the body in which the lead is implanted, thereby improving the robustness and efficacy of using electrical stimulation to treat incontinence.

[0164] One or more anchors of the first orientation may be provided on the lead line adjacent to and / or spaced apart from one or more anchors of the second orientation, with any number of anchors. For example, two anchors of the first orientation may be provided on the lead line adjacent to one anchor of the second orientation, or two anchors of the second orientation may be provided on the lead line adjacent to one anchor of the first orientation.

[0165] One or more anchors in the lead wire anchoring assembly may include a separate collar with one or more barbs. One or more barbs may extend from a portion of the collar of the anchor. For example... Figures 30A-30C As shown, one or more barbs may extend from the middle portion of the collar of each anchor. In some embodiments, one or more barbs may extend from one or both ends of the collar. Figure 30A As shown, one or more anchors 3004 may be spaced apart from each other by a distance 3008 along the length of the lead wire 3012. The distance 3008 may include a distance from approximately 1 mm to 20 mm. For example, this distance may include approximately 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, or a distance within the range defined by any of the foregoing values. In some cases, this distance may include less than 1 mm. Figure 30BAs shown, one or more anchors 3004 may be arranged adjacent to each other such that they are joined together to form a single unit. In some embodiments, the collar of each anchor 3004 may include one or more mating features such that the collar can interlock with an adjacent collar having a corresponding mating feature. The mating features may include rectangular cutouts or similar interdigital patterns. One or more barbs on an individual anchor 3004 may extend in different axial directions. For example, the barbs on an individual anchor 3004 may have a bidirectional orientation. A first set of barbs 3002A on a single anchor 3004 may be oriented in a first direction, and a second set of barbs 3002B on the same anchor may be oriented in a second direction different from or opposite to the first direction. For example, the first set of barbs 3002A may be oriented in a proximal or distal direction, while the second set of barbs 3002B may be oriented in another direction between the proximal and distal directions. One or more barbs may be arranged on a collar such that each barb is adjacent only to barbs in a different direction. For example, anchor 3004 has one or more barbs alternating in a direction along the circumference of the collar. In some embodiments, the barbs may be arranged such that two barbs in the same direction are adjacent to each other. For example, the anchor may have a first set of barbs in one direction on one half of the collar and a second set of barbs in a second direction on the other half of the collar. The barbs may be arranged to suit the specific human anatomy in which they will be deployed. One or more anchors 3004 and bidirectional barbs 3002A, 3002B may share features of any of the anchor and barb embodiments described herein, including but not limited to material, angle, profile, length, distance to the electrode, number, etc.

[0166] One or more anchors (302, 304, 306, 608) may include a length 312 measured from the surface of the farthest anchor body 302 to the surface of the nearest anchor body 304, such as Figure 3C and Figure 4C As shown. Length 312 may include a distance of approximately 20 mm to approximately 50 mm. For example, length 312 may include a distance of approximately 24 mm to approximately 50 mm, or approximately 30 mm to approximately 50 mm. Length 312 may include a distance of approximately 20 mm, approximately 22 mm, approximately 24 mm, approximately 26 mm, approximately 28 mm, approximately 30 mm, approximately 40 mm, or approximately 50 mm. In some cases, length 312 may include a distance of at least approximately 20 mm, approximately 22 mm, approximately 24 mm, approximately 26 mm, approximately 28 mm, approximately 30 mm, or approximately 40 mm. In some cases, length 312 may include a distance of at most approximately 22 mm, approximately 24 mm, approximately 26 mm, approximately 28 mm, approximately 30 mm, approximately 40 mm, or approximately 50 mm.

[0167] Two or more barbs 306 of each of one or more anchors of the first orientation (302, 306) or one or more anchors of the second orientation (304, 308) can be positioned at a certain rotational angle to each other, such as Figure 3A and Figure 4A As shown. The rotation angle can include angles from about 1 degree to about 180 degrees. For example, the rotation angle can include angles from about 5 degrees to about 180 degrees, from about 20 degrees to about 180 degrees, or from about 30 degrees to about 180 degrees. The rotation angle can include angles from about 1 degree, about 5 degrees, about 10 degrees, about 20 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 90 degrees, about 120 degrees, about 140 degrees, or about 180 degrees. In some cases, the rotation angle can include angles from at least about 1 degree, about 5 degrees, about 10 degrees, about 20 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 90 degrees, about 120 degrees, or about 140 degrees. In some cases, the rotation angle can include angles from at most about 5 degrees, about 10 degrees, about 20 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 90 degrees, about 120 degrees, about 140 degrees, or about 180 degrees.

[0168] Two or more barbs of adjacent anchors may include angular rotation of at least about 90 degrees from each other. In some cases, two or more barbs of adjacent anchors may include angular rotation of less than 90 degrees from each other. In some cases, such as Figure 30C As shown, the barbs on the anchor 3004 can form a spiral pattern that can facilitate embedding into the tissue.

[0169] A first anchor or a second anchor can be provided on the lead 310 at a distance 314, such as a first orientation or a second orientation. Figure 3C and Figure 4C As shown. For the first and second anchors of the first orientation (302, 306), a distance 314 can be measured from the proximal surface 315 of the anchor body 200 of the first anchor to the distal surface 317 of the second anchor. In some cases, for the first and second anchors of the second orientation (304, 308), a distance can be measured from the proximal surface 319 of the anchor body 200 of the first anchor to the distal surface 321 of the second anchor. The distance 314 can include a length of about 1.8 mm to about 5 mm. For example, the distance 314 can include a length of about 2 mm to about 5 mm, or about 3 mm to about 5 mm. In some cases, the distance 314 can include a length of at least about 1.8 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.4 mm, about 2.5 mm, about 3 mm, or about 4 mm. In some cases, distance 314 may include a length of up to about 2 mm, about 2.1 mm, about 2.2 mm, about 2.4 mm, about 2.5 mm, about 3 mm, about 4 mm, or about 5 mm.

[0170] The first anchor (302, 306) of the first orientation can be provided at a distance 316 from the second anchor (304, 310) of the second orientation, such as Figure 3D and Figure 4D As shown. Distance 316 can be measured from the proximal surface 316 of the first anchor member in the first orientation to the distal surface 322 of the second anchor member in the second orientation. Distance 316 can include a length of about 2.5 mm to about 5 mm. For example, distance 316 can include a length of about 3 mm to about 5 mm, or about 4 mm to about 5 mm. Distance 316 can include a length of about 2.5 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.4 mm, about 3.5 mm, about 4 mm, or about 5 mm. In some instances, distance 316 can include a length of about 2.5 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.4 mm, about 3.5 mm, or about 4 mm. In some instances, distance 316 can include a length of up to about 3 mm, about 3.1 mm, about 3.2 mm, about 3.4 mm, about 3.5 mm, about 4 mm, or about 5 mm.

[0171] One or more anchors of the first orientation (302, 306) and the second orientation (304, 308) can be positioned at a certain distance (402, 404) from one or more electrodes 400 of the lead 310, such as... Figure 5 As shown. Distance 404 may include the length from the nearest side electrode 401 of one or more electrodes 400 to the proximal surface of the anchor at the second orientation 325. One or more anchors may be positioned between each other at a distance of up to three different distances. One or more anchors may be releasably coupled to the lead at one or more distances from one or more electrodes 400. The distance of the anchor from the one or more electrodes 400 may be selected to avoid one or more target (e.g., sensitive) anatomical locations along the axis of the lead. The rotation angle of the one or more anchors coupled to the lead may be specifically set to avoid one or more target (e.g., sensitive) anatomical locations along the axis of the lead. For example, the rotation angle of the barbs of one or more anchors may be adjusted to prevent the barbs from extending into and damaging sensitive tissue. One or more anchors described elsewhere herein may include one or more barbs that do not extend and / or open at an angle from the axial axis of the anchor. One or more barbs that do not extend and / or open may be pre-set before implantation to prevent the barbs from extending or extending into sensitive target tissue or anatomical structures around the implanted lead.

[0172] The distance 404 may include a length of approximately 40 mm to approximately 100 mm. For example, the distance 404 may include a length of approximately 50 mm to approximately 100 mm, approximately 60 mm to approximately 100 mm, or approximately 70 mm to approximately 100 mm. The distance 404 may include a length of approximately 40 mm, approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, approximately 70 mm, approximately 80 mm, approximately 90 mm, or approximately 100 mm. In some cases, the distance 404 may include a length of at least approximately 40 mm, approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, approximately 70 mm, approximately 80 mm, or approximately 90 mm. In some cases, the distance 404 may include a length of at most approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, approximately 70 mm, approximately 80 mm, approximately 90 mm, or approximately 100 mm.

[0173] Distance 402 may include the length from the nearest side electrode 401 of one or more electrodes 400 to the distal surface of the anchor of the first orientation 324. Distance 402 may include a length of about 5 mm to about 12 mm. Distance 402 may include a length of about 6 mm to about 12 mm, or about 8 mm to about 12 mm. Distance 402 may include a length of about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, or about 12 mm. In some cases, distance 402 may include a length of at least about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, or about 11 mm. In some cases, distance 402 may include a length of at most about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, or about 12 mm.

[0174] Figures 8A-8C, 9A-9C, and 10A-10C illustrate embodiment 800 of the electrode lead 310, the elongated inserter body 116, the pusher 808, and one or more anchors (302, 304, 306, 308) interacting with each other at various points of operation or time when the aforementioned components are used. The geometry of the lumen of the elongated inserter body 116 may include a varying geometry from a first end to a second end of the elongated body 116. The geometry of the lumen of the inserter body 116 may include a tapered lumen geometry from a first diameter 806 to a second diameter 802 of the elongated inserter body lumen. The tapered lumen geometry may include a funnel configured to facilitate the introduction of barbs into the elongated inserter body lumen. For example, the tapered lumen geometry from the first diameter 806 to the second diameter 802 may facilitate compression of the barbs of the anchors during insertion. The tapered shape may include one or more segments with tapered geometry, the length and / or diameter of which may be the same or different. When one or more anchors (302, 304, 306, 308) on lead 310 are pushed through the elongated body lumen by pusher 808, the geometry of the barbs of the anchors (306, 308), described elsewhere herein, may reduce and / or minimize the forces acting on the barbs of the anchors (306, 308) by the inner lumen of the elongated body of the introducer. Pusher 808 may include an elongated body having a lumen configured to receive the outer diameter of the electrode lead. Pusher 808 may include a distal surface 810 of a proximal surface 813 of an anchor of the second orientation (304, 308) configured to contact the proximal surface 813. The pusher may push one or more anchors (302, 304, 306, 308) and / or leads into the elongated body lumen of the introducer.

[0175] Figures 9A-9C illustrate embodiments of one or more anchors (302, 304, 306, 308) inserted into and / or translated into the lumen of the elongated body 116 of the introducer. A cross-sectional view in Figure 9C shows an embodiment of the compressed and / or clamped state of one or more anchors (302, 304, 306, 308) and the pusher when inserted into the lumen of the elongated body 116 of the introducer.

[0176] Figures 10A-10C illustrate embodiments of one or more anchors (302, 304, 306, 308) inserted into and exiting the lumen of the elongated body 116 of the introducer on a second diameter 802. After exiting the lumen's second diameter 802, one or more barbs (306, 308) of the anchors (302, 304, 306, 308) may extend and / or extend outward at an angle relative to the central axis of the anchor, as shown in Figure 10A.

[0177] Lead wire fixing method This document provides a method for securing an electrode lead once it has been placed at a target location for pudendal nerve stimulation. The method includes (a) expanding soft tissue deep into a skin incision site using a sharp dissection or an external sheath device that can be advanced by sliding onto the electrode lead; (b) advancing one or more anchoring devices onto the electrode lead and positioning the one or more anchoring devices within the soft tissue space created by the expansion; and (c) deploying the one or more anchoring devices such that they grip both the electrode lead and the soft tissue space, thereby preventing migration of the electrode lead relative to the tissue. This method can be applied to both the electrode lead and the insertion site. The sharp dissection in step (a) of this method can be performed, carried out, and / or achieved using standard surgical instruments, such as a scalpel. The expansion of soft tissue in step (a) of this method can be achieved, carried out, and / or performed using an external sheath device to bluntly create a tunnel with a diameter sufficient to allow smooth subsequent advancement of the anchoring device onto the electrode lead. The soft tissue deep into the skin incision site may include tissue adjacent to the ischial bone and fascial and / or ligament inserts. The one or more anchoring devices may include one of a plurality of passive anchoring devices. Advancing one or more anchoring devices onto an electrode lead can be performed, completed, and / or achieved by manually advancing (e.g., by hand or with a basic surgical instrument such as a clamp) one or more anchoring devices onto the electrode lead. In some embodiments, advancing one or more anchoring devices can be performed, completed, and / or achieved using an external sheath device to advance one or more anchoring devices into the appropriate position on the electrode lead. One or more anchoring devices may be housed within an external sheath device prior to deployment. One or more anchoring devices may be secured to the electrode lead using one or more fixation methods. One or more anchoring devices may be secured to a soft tissue space using one or more fixation methods. One or more anchoring devices may be secured to a soft tissue space, wherein the soft tissue space may include natural human tissue, such as ligaments, fascia, periosteum, or any combination thereof. One or more anchoring devices may be secured to a soft tissue space using standard surgical methods (e.g., sutures). The physical characteristics of one or more anchoring devices may allow one or more anchoring devices to be secured and / or secured to natural human tissue. One or more anchoring devices may be secured to the electrode lead using one or more fixation methods. One or more anchoring devices may be secured to the electrode lead by applying frictional force between one or more anchoring devices and the electrode lead. In some embodiments, ligatures can be used to compress one or more anchoring devices onto the electrode leads. Standard suture materials can be provided to provide ligatures for compressing one or more anchoring devices onto the electrode leads, thereby securing and / or stabilizing one or more anchoring devices onto the electrode leads. In some embodiments, a small-scale mounting screw assembly can provide compression of one or more anchoring devices onto the electrode, thereby securing and / or stabilizing one or more anchoring devices onto the electrode leads.A miniaturized torque wrench can be used to tighten a small-mounted screw assembly to a predetermined pressure limit. The miniaturized torque wrench allows for tightening of the small-mounted screw assembly deep within soft tissue. In some embodiments, one or more anchoring devices can be compressed onto an electrode lead using a standard surgical ligation clip, thereby securing and / or fixing one or more anchoring devices to the electrode lead. A standard surgical ligation clip can be applied using a ligation clip applicator. One or more anchoring devices can be secured to the electrode lead and / or surrounding soft tissue using an activation mechanism (e.g., spring-loaded teeth) described elsewhere herein. A common anchoring mechanism for one or more anchoring devices can be automatically deployed as one or more anchoring devices are extruded from the outer sheath device. In some embodiments, retraction of the outer sheath device can activate the common anchoring mechanism for one or more anchoring devices. Activation of anchoring and / or fixing of one or more anchoring devices can be activated when one or more anchoring devices are pushed out of the outer sheath device. One or more anchoring devices can be pushed out of the outer sheath device using a pushing device. One or more anchoring devices may include one or more mechanisms that are automatically activated when one or more anchoring devices are extruded from the outer sheath device. One or more mechanisms may include the activation of spring-loaded teeth of one or more anchoring devices. The activation mechanism may include clamping functionality between one or more anchoring devices and electrode leads and soft tissue spaces. While certain devices, systems, methods, and kits for treating and / or managing pelvic conditions are described herein with respect to the pelvic region, such methods and devices may be used in other areas of the body or to treat other conditions, as described elsewhere herein.

[0178] The elongated body of the introducer can be inserted through an incision site described elsewhere herein and guided to a target implantation area for implantation of one or more leads. Leads having one or more electrodes can be inserted into the lumen of the elongated body of the introducer, as shown in Figures 9A-9C. The lumen of the elongated body of the introducer may include a conical or tapered cross-sectional profile. In some cases, the introducer may include dimensions from about 1 French (F) to about 15 (F). Once one or more anchors and leads are compressed and / or collapsed into a closed configuration, the introducer can then be translated and / or manipulated to the target implantation site (e.g., at the pudendal nerve or adjacent tissue). One or more anchors (302, 304, 306, 308) and leads can then be deployed and / or extended by proximal translation and / or removal of the elongated body 116 of the introducer while simultaneously applying distal thrust toward the distal tips of one or more anchors and leads using a pusher 808, as shown in Figures 10A-10C. By utilizing the force provided by the actuator 808, the position of one or more deployed anchors (302, 304, 306, 308) can be maintained in place, thereby anchoring the lead in the target area. Precise positioning of one or more anchors and the lead provides targeted electrical stimulation for the treatment of incontinence, as described elsewhere herein. The elongated body of the introducer may comprise a polymer, metal, or a combination thereof. Metals may include stainless steel, aluminum, titanium, or any combination thereof. Polymer materials may include thermoplastic polyurethane (TPU), polytetrafluoroethylene (PTFE), or any combination thereof.

[0179] The elongated body of the introducing device may include a length of about 140 mm to about 500 mm. For example, the elongated body of the introducing device may include a length of about 150 mm to about 500 mm, about 180 mm to about 500 mm, or about 250 mm to about 500 mm. The elongated body of the introducing device may include a length of about 140 mm, about 150 mm, about 160 mm, about 180 mm, about 200 mm, about 250 mm, about 300 mm, about 350 mm, about 400 mm, about 450 mm, or about 500 mm. In some cases, the elongated body of the introducing device may include a length of at least about 140 mm, about 150 mm, about 160 mm, about 180 mm, about 200 mm, about 250 mm, about 300 mm, about 350 mm, about 400 mm, or about 450 mm. In some cases, the elongated body of the introducer may include a length of up to about 150 mm, about 160 mm, about 180 mm, about 200 mm, about 250 mm, about 300 mm, about 350 mm, about 400 mm, about 450 mm, or about 500 mm.

[0180] This disclosure describes a method for attaching an electrode lead to tissue 900, as shown in FIG11. The method may include: placing the electrode lead at a target tissue, wherein the electrode lead includes: (i) a lead including one or more stimulating electrodes located near a distal end of the lead; and (ii) a plurality of anchors, each anchor including a collar and two or more barbs extending from the collar, wherein the plurality of anchors are releasably positioned on the lead proximal to one or more stimulating electrodes, wherein a first anchor of the plurality of anchors is adjacent to a second anchor of the plurality of anchors, wherein the two or more barbs of the first anchor are positioned at a rotational angle along the length of the lead to the two or more barbs of the second anchor, and wherein the one or more stimulating electrodes are configured to deliver electrical stimulation to the target tissue 901; and removing a sheath covering at least a portion of the first anchor or the second anchor to deploy the first anchor or the second anchor, thereby anchoring the electrode lead to the target tissue 902. The target tissue may include the pudendal nerve or tissue adjacent to the pudendal nerve. In some cases, the target tissue may include one or more branches of the pudendal nerve, sacral nerve, or any combination thereof. The sheath may include an elongated inserter body comprising a lumen. In some embodiments, the sheath may include an outer sheath covering at least a portion of the first anchor and / or the second anchor. The sheath may have a hardness of at least about 75D on the Shore A hardness scale. The sheath may be made of a thermoplastic polyurethane (such as Pellethane). TM The sheath can be made of materials such as aramid polyether-based thermoplastic polyurethane (TPU) (e.g., Techothane). TM It is made of polyether block amide (PEBAX). In some cases, the sheath can be made of polyether block amide (PEBAX). TM Made from ( ).

[0181] Lead Wire Positioning Guide (LPG) This document provides devices, systems, and methods for introducing and placing one or more electrode leads at or near one or more target tissues. The one or more target tissues may be located in the pelvic region. Target tissues include the pudendal nerve. In some cases, target tissues include one or more branches of the pudendal nerve, sacral nerve, or any combination thereof. Target tissues may include target tissues receiving electrical stimulation for the treatment of incontinence. In some cases, target tissues may include target tissues receiving electrical stimulation for the treatment of sexual dysfunction. In some instances, target tissues may include target tissues receiving electrical stimulation for the treatment and / or management of pain.

[0182] A lead positioning guide (LPG) (also referred to as an anchor positioning guide (APG)) for positioning a lead including an anchoring device may include an LPG 1500, an LPG tube 1520 (also referred to as a sleeve throughout the specification), and a locking cap 1600. The LPG 1500 may include a frame comprising a proximal tip 1508, a neck portion 1504, and two or more arms 1502 extending distally from the neck 1504. The neck 1504 may include a helical thread portion 1506 configured to receive the threaded portion 1602 of the locking cap 1600. Figure 17 An embodiment of LPG 1500 and locking cap 1600 is shown. Figure 18A Figure 18D illustrates an embodiment of LPG 1500. LPG 1500 may include a proximal tip 1508. Proximal tip 1508 may include an opening 1510 configured to receive a lead. The opening may extend into a lumen extending through a neck 1504 of LPG 1500. Neck 1504 may include a helical threaded portion 1506 configured to receive a locking cap 1600. The proximal tip may include a chamfered tip. Opening 1510 may be a tapered opening. Tapered opening 1510 may be a tapered grooved opening. Grooved opening 1510 may include a slit extending through at least a portion of proximal tip 1508. The slit may stop before the threaded portion 1506 of neck 1504. Grooved opening 1510 may include two or more slits. Grooved opening 1510 may include three or four slits. Grooved opening 1510 may include 3, 4, 5, 6, 7, 8, 9, or 10 slits. The opening can transition into a lumen extending through the neck 1504 of the LPG 1500. The proximal tip 1508 can be tapered. The LPG 1500 may include a transition section between the proximal tip 1508 and the threaded portion 1506. The LPG may include a transition section between the threaded portion 1506 and the remainder of the neck 1504. The LPG includes a flange. The flange can mate with a hub. The flange may include a notch to mate with the hub. The mating of the flange and hub can provide rotational stability to the LPG components. The mating of the flange and hub can reduce rotational movement of the LPG components relative to each other.

[0183] The LPG system described herein allows clinicians to control and manipulate the lead and anchor without unintentionally causing axial migration of the lead and anchor. The use of an LPG allows the user to control and position the lead and anchor with one hand. The use of an LPG allows the user to maintain the lead's position before anchor deployment without needing to hold the lead in place. This allows clinicians to release the lead during placement without the corresponding anchor being unintentionally deployed from the delivery cannula.

[0184] like Figures 18A-18CAs shown, the locking cap 1600 can be formed as a cylindrical tube including a helical thread interior 1602. The locking cap 1600 can be screwed onto the helical thread portion 1506 of the neck 1504. The locking cap 1600 can extend over all or part of the proximal tip 1508. The locking cap 1600 is configured to press the proximal tip 1508 against the lead 1700 within the slotted opening 1510 to lock the position of the lead 1700. The locking cap 1600 can be tightened or loosened around the proximal tip 1508 to control the axial mobility of the lead 1700 through the LPG 1500. The locking cap can include an upper ridge 1604 on the inner surface of the cap, wherein the upper ridge 1604 is configured to tighten around the slotted opening 1510 of the lead 1700 when the locking cap is screwed onto the helical thread portion 1506. The locking cap 1600 may include an outer gripping surface 1606 configured to assist in tightening and / or loosening the locking cap 1600 to control movement of the lead 1700. The gripping surface 1606 may include a material with a high coefficient of friction. The gripping surface 1606 may include one or more surface structures to improve gripping and traction on the locking cap (e.g., grooves, protrusions, ridges, or the like). The locking cap 1600 may be configured to lock onto the proximal tip 1508 of the LPG 1500 using a non-threaded coupler. For example, the locking cap 1600 may be configured to snap into a locking position on the proximal tip 1508 or the next tip 1504, or use a lock and pin configuration. The locking cap 1600 may be configured to adjust pressure on the lead 1700 placed through the opening 1510. The locking cap 1600 may be manually loosened and / or tightened to control the mobility of the lead 1700 during positioning. The locking cap allows the user to adjust the resistance of the lead through LPG 1500. This allows for better control when positioning the lead to the target location.

[0185] The LPG 1500 may include an LPG sheath 1520. The sheath 1520 may include an elongated body having a lumen configured to receive leads. The proximal end of the elongated body of the LPG sheath 1520 may be attached, secured, and / or fused to the neck 1504 of the LPG 1500, such as... Figures 18A-18CAs shown. The cannula 1520 may include one or more electrodes and / or conductive regions and / or one or more electrode insulating regions. The cannula 1520 may include non-conductive biocompatible materials, including but not limited to high-density polyethylene, fluorinated ethylene propylene, polycarbonate, plastics, or any combination thereof. The LPG 1500 and locking member 1600 may be autoclaved and / or can be cleaned using conventional sterilization methods used for other similar medical devices. In some embodiments, the cannula may include one or more sensors. For example, one or more sensors integrated into the cannula 1520 may include, but are not limited to, electrical sensors, pressure sensors, gyroscopes, chemical sensors, humidity sensors, accelerometers, or any combination thereof. The cannula 1520 may extend from the distal end of the neck 1508 between the arms 1502 of the LPG. The cannula 1520 may be configured to receive a lead 1700 extending through a slotted opening 1510. The lead 1700 may include one or more anchors 1710. The anchors 1710 may include one or more anchors as described herein. LPG tube 1520 can be configured to maintain one or more anchors on the lead in a delivery configuration when positioned within a sleeve. The one or more anchors can change from a delivery configuration to a deployment configuration as they extend beyond the distal opening of the sleeve. Sleeve 1520 may include an inner lumen. The inner lumen may include an inner diameter. The inner lumen of sleeve 1520 may include a diameter that mechanically couples lead 1700 and the inner lumen of sleeve 1520 using a sliding fit interface. In some embodiments, the inner lumen of sleeve 1520 may include a diameter that provides a loose fit interface between lead 1700 and the inner lumen of sleeve 1520. In some embodiments, the inner lumen of introducer 111 may include a diameter that mechanically couples the outer diameter of LPG sleeve 1520 and the inner lumen of introducer using a sliding fit interface. In some embodiments, the inner lumen of introducer 111 may include a diameter that provides a loose fit interface between the outer diameter of sleeve 1520 and the inner lumen of introducer.

[0186] The inner lumen of the introducer 111 may include a diameter of about 0.2 mm to about 1.4 mm. For example, the inner lumen of the introducer 111 may include a diameter of about 0.3 mm to about 1.4 mm, or about 0.5 mm to about 1.4 mm. The inner lumen of the introducer 111 may include a diameter of about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, or about 1.4 mm. In some cases, the inner lumen of the introducer 111 may include a diameter of at least about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, or about 1.2 mm. In some cases, the inner lumen of the inlet 111 may include a diameter of up to about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, or about 1.4 mm. The diameter can be measured by the distance along the longest cross-sectional axis. In some cases, the diameter is measured by the distance along a shorter cross-sectional axis (e.g., the minor axis of an ellipse).

[0187] The inner lumen of the introducer 111 may include a diameter of about 1 mm to about 10 mm. For example, the inner lumen of the introducer 111 may include a diameter of about 1.5 mm to about 10 mm, about 2 mm to about 10 mm, or about 3 mm to about 10 mm. The inner lumen of the introducer 111 may include a diameter of about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm. In some cases, the inner lumen of the introducer 111 may include a diameter of at least about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 6 mm, about 7 mm, or about 8 mm. In some cases, the inner lumen of the introducer 111 may include a diameter of up to about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm. The inner lumen of the introducer 111 may include a diameter of about 2.2 ± 0.025 mm. The sleeve 1520 may be configured to be inserted into the inner diameter of the introducer 111. The diameter can be measured by the distance of a shorter cross-sectional axis (e.g., the minor axis of an ellipse). In some embodiments, the diameter can be measured by the distance of a longer cross-sectional axis.

[0188] The inner diameter of the inner lumen of the sleeve 1520 may include a diameter of about 0.2 mm to about 1.4 mm. For example, the inner diameter of the inner lumen of the sleeve 1520 may include a diameter of about 0.3 mm to about 1.4 mm, or a diameter of about 0.5 mm to about 1.4 mm. The inner diameter of the inner lumen of the sleeve 1520 may include a diameter of about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, or about 1.4 mm. In some cases, the inner diameter of the inner lumen of the sleeve 1520 may include a diameter of at least about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, or about 1.2 mm. In some cases, the inner diameter of the inner lumen of the sleeve 1520 may include a diameter of up to about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, or about 1.4 mm. The diameter can be measured by the distance along the longest cross-sectional axis. In some cases, the diameter is measured by the distance along a shorter cross-sectional axis (e.g., the minor axis of an ellipse).

[0189] The cannula 1520 may include an outer diameter configured to be inserted through the lumen of an introducer. The introducer may be an introducer as disclosed herein. The outer diameter of the cannula 1520 may include a diameter of about 1 mm to about 10 mm. The outer diameter of the elongated body of the cannula 1520 may include a diameter of about 1.5 mm to about 10 mm, about 2 mm to about 10 mm, or about 3 mm to about 10 mm. The outer diameter of the elongated body of the cannula 1520 may include a diameter of about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 6 mm, about 8 mm, or about 10 mm. The outer diameter of the elongated body of the cannula 1520 may include a diameter of at least about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 6 mm, or about 8 mm. The elongated body outer diameter of the cannula 1520 may include a diameter of up to about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm. The elongated body outer diameter of the cannula 1520 may include a diameter of 2 ± 0.025 mm. The cannula 1520 may be configured to assist in the insertion of the lead 1700 into the patient / object receiving the electrode lead implant by providing structural rigidity. The diameter can be measured by the distance along the longest cross-sectional axis. In some cases, the diameter is measured by the distance along a shorter cross-sectional axis (e.g., the minor axis of an ellipse).

[0190] The length of the LPG sheath 1520 may include lengths of approximately 100 mm, approximately 110 mm, approximately 120 mm, approximately 130 mm, approximately 140 mm, or approximately 500 mm. The length of the LPG sheath 1520 may include lengths of approximately 150 mm to approximately 500 mm, approximately 180 mm to approximately 500 mm, or approximately 250 mm to approximately 500 mm. The length of the LPG sheath 1520 may include lengths of approximately 140 mm, approximately 150 mm, approximately 160 mm, approximately 180 mm, approximately 200 mm, approximately 250 mm, approximately 300 mm, approximately 350 mm, approximately 400 mm, approximately 450 mm, or approximately 500 mm. In some cases, the length of the LPG sheath 1520 may include at least approximately 140 mm, approximately 150 mm, approximately 160 mm, approximately 180 mm, approximately 200 mm, approximately 250 mm, approximately 300 mm, approximately 350 mm, approximately 400 mm, or approximately 450 mm. In some cases, the length of the LPG sleeve 1520 may include up to about 150 mm, about 160 mm, about 180 mm, about 200 mm, about 250 mm, about 300 mm, about 350 mm, about 400 mm, about 450 mm, or about 500 mm.

[0191] The LPG 1500 can be configured to be coupled to its sheath stem 106, such as Figure 19 - As shown in Figure 23. The neck 1504 may be coupled to the arm 1502 of the LPG 1500. The LPG 1500 may include two or more arms 1502 extending from the neck 1504 of the LPG. The arms 1502 may extend distally from the neck of the LPG. The arms 1502 may extend slightly away from the side of the neck 1506 of the LPG, wherein the distance between the arms is greater than the width of the neck. The arm 1502 may include a coupling feature at its distal end configured to be lockedly coupled to the sheath stem 106. In some cases, the arm 1502 may be disengaged from the sheath stem by rotating the LPG. The arm 1502 may include a locking tab 1512 configured to be lockedly coupled to the sheath stem 106. The locking tab 1512 may include a rod 1516 and an extension 1518 configured to be coupled to a rod 113 and an extension 115 on the sheath stem 106. Locking tab 1512 can be lockably coupled to receiving tab 107 of sheath stem 106. Sheath stem 106 may include receiving tab 107 configured to mechanically clamp onto locking tab 1512. This locks the position of LPG relative to sheath stem 106. Locking tab 1512 may include a rod and an extension configured to be coupled to receiving tab 107. Arm 1502 may include an extension extension 1514 configured to extend over the width of sheath stem 106, such as... Figure 20 As shown. The overhang 1514 may include a locking tap configured to be lockedly coupled to the receiving tab 107. The overhang 1514 may be small enough that it does not extend across the width of the sheath stem, such as Figure 19 As shown. The overhang 1514 may include locking tabs on two or more sides of the overhang 1514. Figure 21 An alternative embodiment is shown, wherein the arcuate overhang 1514 includes locking tabs 1512 on the inner and outer surfaces of the overhang 1514. The sheath stem 106 may include receiving tabs 107 configured to be lockably coupled to the locking tabs 1512 on the inner and outer surfaces of the LPG 1500. In some cases, the LPG 1500 may include one or more alternative coupling features for locking the LPG to the sheath stem 106. Figure 22A pin-lock configuration is shown, wherein the LPG includes a hook / clamp 1516 at the distal end of arm 1502. The hook / clamp 1516 can be configured to lock onto a pin 109 on the sheath handle 106. Figure 23 shows a wide-lock configuration, wherein the distal end of arm 1502 includes a retaining end. The retaining end 1518 may include a receiving slot configured to clamp a portion of the sheath handle 106. The receiving slot may have opposing openings, wherein arm 1502 is configured to be twisted into place, and when aligned with handle 106, the receiving slot clamps sheath handle 106, thereby locking the LPG in place. By rotating 117 of the LPG to release sheath handle 105 from the receiving slot 1519 of arm 1502, arm 1502 can be unlocked and the LPG disengaged from sheath handle. It should be understood that these embodiments are not limiting, and alternative locking arrangements may be employed to couple the LPG to the sheath handle.

[0192] In some cases, the sheath stem may comprise a high-viscosity polyamide. For example, the sheath stem may comprise Vestamid.

[0193] The height of the receiving protrusion 107 may include a height between about 1 mm and about 5 mm. The height of the receiving protrusion 107 may include a height between about 2 mm and about 5 mm, or a height between about 3 mm and about 5 mm. The height of the receiving protrusion 107 may include a height of about 2 mm, about 2.2 mm, about 2.4 mm, about 2.6 mm, about 2.8 mm, about 3 mm, about 4 mm, or about 5 mm. The height of the receiving protrusion 107 may include a height greater than or equal to about 1.0 mm, about 1.5 mm, about 2 mm, about 2.2 mm, about 2.4 mm, about 2.6 mm, about 2.8 mm, about 3.0 mm, 3.2 mm, about 3.4 mm, about 3.6 mm, about 3.8 mm, about 4 mm, about 4.5 mm, or about 5 mm. The height of the receiving tab 107 may include at least about 0.5 mm, 1 mm, about 1.5 mm, about 2 mm, 2.2 mm, about 2.4 mm, about 2.6 mm, about 2.8 mm, about 3 mm, about 4 mm, or about 5 mm. The height of the receiving tab 107 may include about 2.4 mm.

[0194] The sleeve may include a hardness of at least about Shore 75D. In some cases, the sleeve may include a hardness less than 75D. In some cases, the sleeve may include a hardness greater than 75D. The sleeve may include a hardness of about Shore 75D. The sleeve may be made of thermoplastic polyurethane (such as Pellethane). TM The tubing can be made of aromatic polyether-based thermoplastic polyurethane (TPU) (such as Techothane). TM It is made of polyether block amide (such as PEBAX). In some cases, the sleeve can be made of polyether block amide (such as PEBAX). TMMade from ).

[0195] This article provides a method for using LPG positioning electrode leads.

[0196] Using an LPG-positioned electrode lead may include inserting the distal end of the lead through a proximal opening in the LPG. Using an LPG-positioned electrode lead may include advancing the lead through a sheath of the LPG. The lead may be advanced through the sheath until the distal portion of the lead extends beyond the distal end of the sheath. Using an LPG-positioned electrode lead may include positioning one or more anchoring devices on the lead such that the proximal end of the anchor contacts the distal end of the sheath. One or more anchoring devices may be coupled to the lead before advancing the lead through the sheath of the LPG. The one or more anchoring devices may be part of the lead body. Using an LPG-positioned electrode lead may include placing a locking cap on the LPG. The locking cap may restrict axial movement of the lead within the LPG. The cap may lock the lead in place within the LPG. Using an LPG-positioned electrode lead may include inserting the distal ends of the lead and the LPG sheath into an introducer. The lead and the LPG sheath may be inserted into the introducer until a mark on the sheath shank aligns with the sheath shank. The introducer sheath may include one or more radiopaque markings indicating the position of the electrode and / or the anchor assembly once the LPG cannula is inserted into the introducer. For example, one or more radiopaque markings on the introducer sheath may indicate the distal end of the sheath and the position at or near the proximal, central, and / or distal end of the anchor assembly. Positioning the electrode lead using LPG may include withdrawing the introducer until the sheath shank contacts the arm of the LPG. Withdrawing the introducer may expose the distal tip of the lead while one or more anchors remain contained within the introducer. Thus, the lead and LPG can be in a safe area where the lead can still be axially adjusted while the anchors have not yet been deployed from the introducer sheath. Positioning the electrode lead using LPG may include locking the arm of the LPG to the shank of the introducer. The LPG shank may be locked to the shank of the introducer using one or more locking means described herein. Positioning the electrode lead using LPG may include measuring the EMG response and adjusting the position of the locking lead / LPG until the electrode lead receives the desired EMG signal. EMG signals can indicate that the lead is positioned at or near the target tissue. For example, an EMG response of the external anal sphincter can indicate that the lead is positioned at or near the pudendal nerve. Using an LPG-positioned electrode lead may include unlocking the LPG from the inserter handle. The LPG can be unlocked by rotating it relative to the inserter handle. Using an LPG-positioned electrode lead may include withdrawing the inserter between the arms of the LPG and toward the proximal end of the LPG while keeping the LPG stationary. This can deploy one or more anchors at or near the target tissue. If the lead is at or near the target site, one or more anchors can be deployed to secure the position. The LPG locking cap can be unlocked, and the inserter and LPG can be withdrawn. This method can be applied to leads or catheters. The method of using an LPG-positioned electrode lead may omit and / or repeat one or more of the steps described above.

[0197] The inlet handle may include a high-viscosity polyamide. For example, the inlet handle may include Vestamid.

[0198] Using an LPG-positioned electrode lead may include (a) inserting the distal end of the lead through a proximal opening in the LPG; (b) advancing the lead through the sheath of the LPG until the distal portion of the lead extends beyond the distal end of the sheath; (c) positioning one or more anchoring devices on the lead such that the proximal end of the anchor contacts the distal end of the sheath; (d) placing a locking cap on the LPG and locking the lead in place within the LPG; and (e) inserting the distal end of the lead and the LPG sheath into the introducer until the sheath markings are aligned with the sheath handle. (f) Withdraw the introducer until the sheath handle contacts the arm of the LPG, exposing the distal tip of the lead and still containing the anchor within the introducer; (g) Lock the arm of the LPG to the handle of the introducer; (h) Adjust the locked lead / LPG position until an EMG signal indicating the target tissue area is received; and (i) Unlock the LPG from the handle and rotate the LPG; (j) Withdraw the introducer between the arms and toward the LPG to deploy one or more anchors and position the lead at or near the target site. The LPG can be any LPG as described herein. In some cases, this method can be applied to any lead type. In some cases, the lead can be a catheter.

[0199] Target tissue sites can include nerves. For example, a target tissue site could include the pudendal nerve. In some cases, a target tissue site could include the sacral nerve. Target tissue sites can be targeted to help treat incontinence.

[0200] Figures 24A-24H An embodiment of a method for positioning electrode leads and deploying anchoring devices for the leads is shown. Figure 24A The diagram shows the insertion of lead 1700 through LPG 1500 and the advancement of lead 1700 through LPG sleeve 1520. Once the distal tip of lead 1700 extends out of the distal end of sleeve 1520 and the proximal end of anchoring device 1710 of lead contacts the distal tip of sleeve 1520, a locking cap is screwed onto the LPG, thereby locking the position of lead 1700 and anchoring device 1710 in place relative to LPG 1500. Figure 24B and Figure 24C The diagram shows the insertion of the locked lead 1700 and LPG sleeve 1520 through the sheath handle 106 and the introducer 111. Figure 24DThe diagram illustrates the insertion of the locked lead 1700 and LPG 1500 assembly through the introducer 111 until a mark on the cannula 1520 aligns with the opening of the sheath handle 106. One or more marks 1522 may help indicate the distal tip of the lead 1700 is close to the distal tip of the introducer 111. In some cases, the mark may indicate alignment of the distal tip of the lead 1700 with the distal tip of the introducer 111. In some cases, the mark may indicate the distal tip of the lead 1700 is at a desired distance proximal to the distal tip of the introducer 111. In some cases, the mark may indicate that the distal tip of the lead 1700 extends beyond a desired distance from the distal tip of the introducer 111. One or more marks 1522 on the LPG cannula may be radiopaque. In some cases, the mark 1522 may indicate the end of the sheath and the proximal extent of the lead anchor 1710. The desired distance proximal to the distal tip of the introducer 111 can be approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, 8 mm, approximately 9 mm, or 10 mm. In some embodiments, the desired distance proximal to the distal tip of the introducer 111 can be approximately 1 cm or more, approximately 2 cm, approximately 3 cm, approximately 4 cm, approximately 5 cm, or approximately 10 cm. The desired distance beyond the distal tip of the introducer 111 can be approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, 8 mm, approximately 9 mm, or 10 mm. In some embodiments, the desired distance beyond the distal tip of the introducer 111 can be approximately 1 cm or more, approximately 2 cm, approximately 3 cm, approximately 4 cm, approximately 5 cm, or approximately 10 cm. The anchoring device 1710 may remain within the introducer 111, wherein the anchoring device 1700 is in a delivery configuration. Figures 24E-24H The diagram illustrates the retraction of the sheath handle 1502 toward the LPG 1500 after aligning the mark 1522 with the opening of the sheath handle 106, wherein retraction of the sheath handle 106 causes the arm 1502 to couple to the sheath handle. Once the sheath handle 106 is coupled to the LPG arm 1502, the LPG and lead wire can be locked in place relative to the introducer 111 and the sheath handle 106, as... Figure 24H As shown. The sheath shank 106 and LPG 1500 can be coupled using any coupling means or LPG configuration described above. When the sheath shank 106 contacts the arm 1502 and is coupled to the LPG 1500, the distal tip of the lead 1700 can extend beyond the distal tip of the introducer 111, while the anchoring device remains positioned in a delivery configuration within the distal portion of the introducer 111, as shown. Figure 24GAs shown. The distal tip of lead 1700 may include one or more electrodes 1702, which are exposed once the sheath shank is coupled to the arm of LPG 1502. Since the anchor remains within the sheath, the locked lead 1700 and LPG 1500 assembly can move freely axially. The user can practically adjust the locked lead 1700 and LPG 1500 assembly until the desired EMG response is received from one or more electrodes 1702. Figure 24I and Figure 24J As shown, once the desired signal is received, the LPG can be rotated, whereby rotating the LPG 1500 disengages the sheath handle 106 and the LPG 1500. Before the LPG 1500 can be rotated, the user may need to release the safety lock on the LPG 1500 and / or the sheath handle 106. After rotating the LPG, the sheath handle 106 can be retracted between the arms 1502. This allows the anchoring device to be deployed from the introducer 111 into the target tissue area, thereby securing the electrode 1702 to or near the target tissue. When the sheath handle 106 is retracted between the arms 1502 of the LPG 1500, the anchoring device 1710 can be exposed and can be changed from a delivery configuration to a deployment configuration as described herein. After deploying the anchoring device and anchoring the lead in place, the locking cap can be removed, and the LPG and introducer 111 can be withdrawn from the lead, as described herein. Figure 24K As shown.

[0201] The method for positioning and deploying the anchoring device for the electrode leads may further include the use of a stopper 119. The elongated body 117 of the stopper may be configured to fit within the lumen of the elongated body 116 of the introducer 111, such as... Figure 26 As shown in the diagram. The occluder shank 104 can be configured to couple to the introducer shank 106. The elongated occluder body 117 may include a tapered distal tip 2604, such as... Figure 1I As shown in the diagram. The tapered distal tip 2604 can be configured to extend distally from the distal end of the introducer 111 when inserted through the introducer. The tapered distal tip 2604 may include a thin, bullet-shaped tip configured to penetrate a region with high tissue density. The occluder may include a reinforcing tube. The reinforcing tube may be molded into the elongated body 117. The reinforcing tube can improve the reinforcement and rigidity of the occluder to aid in the insertion and positioning of the introducer 111. The elongated body 117 of the occluder may include a reinforcing tube 2602 terminating before the tapered distal tip 2604, such as Figure 1J As shown in the image.

[0202] The use of LPG 1500 allows for improved control and placement of lead 1700 and anchoring device 1710 to the target location. The use of LPG 1500 provides easier maneuverability for lead-in placement. The secure positioning of the anchoring device and its housing reduces the dexterity required when introducing and manipulating the lead tip during placement. The use of LPG as described herein reduces the need for EMG and damage to the guide during lead placement. When locked, the LPG coupled to the sheath shank allows for precise control and positioning of one or more electrodes at or near the distal tip of the lead. The length of the LPG arm allows one or more electrodes at or near the distal end of the lead to extend beyond the opening of the outer sheath device while securely holding the lead so that it cannot slide within the outer sheath. The length of the LPG arm can be equal to or greater than the length of one or more anchoring devices on the lead. The length of the LPG arm can include a length greater than or equal to the length from the distal tip of the distal anchor to the proximal end of the proximal anchor. The length of the LPG arm can be adjustable to accommodate leads with longer or shorter distal electrode regions. The length of arm 1502 can include a distance of approximately 20 mm to approximately 50 mm. For example, the length can include a distance of approximately 24 mm to approximately 50 mm, or approximately 30 mm to approximately 50 mm. The length can include a distance of approximately 20 mm, approximately 22 mm, approximately 24 mm, approximately 26 mm, approximately 28 mm, approximately 30 mm, approximately 40 mm, or approximately 50 mm. In some cases, the length can be greater than or equal to approximately 10 mm, approximately 15 mm, approximately 20 mm, approximately 22 mm, approximately 24 mm, approximately 26 mm, approximately 28 mm, approximately 30 mm, 32 mm, approximately 34 mm, approximately 36 mm, approximately 38 mm, approximately 40 mm, approximately 45 mm, or approximately 50 mm. In some cases, the length may include a distance of at least about 5 mm, 10 mm, about 15 mm, about 20 mm, 22 mm, about 24 mm, about 26 mm, about 28 mm, about 30 mm, about 40 mm, or about 50 mm. In some cases, the length of arm 1502 may include a distance between about 30 mm and about 35 mm. For example, the length of arm 1502 may include a distance of about 34 mm.

[0203] The LPG can be made of one or more rigid materials, such as plastic, metal, carbon, or alloy. The LPG opening can be configured to receive lead wires of various sizes. Lead wires can range from 1 French (F) to 18 F. In some cases, lead wires can be between 1 F and 15 F. In some cases, lead wires can be smaller than 6 F. In some cases, lead wires can be larger than 12 F. Lead wires can be 1 F, 2 F, 3 F, 4 F, 5 F, 6 F, 7 F, 8 F, 9 F, 10 F, 11 F, 12 F, 13 F, 14 F, or 15 F. A locking cap can be configured to tighten the opening to accommodate different lead wire sizes. The LPG can be configured to lock the sheath handle to the neck of the LPG when in the retracted position. This helps prevent the introducer from sliding back down along the lead wire. After the lead wire and anchoring device have been deployed, the locking cap can be removed, and the LPG and introducer can be retracted on the proximal portion of the lead wire. The LPG arm can be disengaged from the sheath handle by rotating the LPG. In some cases, the LPG arm can be disengaged from the sheath stem by applying outward pressure to the arm to disengage the receiving tab on the stem. The LPG may include an indicator showing when the arm is securely locked to the sheath stem. Any of the locking mechanisms described herein can be used to lock the LPG to the sheath stem.

[0204] The LPG cannula may include a biocompatible external lubricating layer. The LPG cannula may include a low-friction outer surface. Inserting the LPG cannula through the outer sheath of the introducer may further include applying a lubricant. One or more anchoring devices may include being configured to change from a flat delivery configuration to a deployment configuration once or multiple times when the introducer is withdrawn. One or more anchoring devices may be housed within the outer sheath assembly prior to deployment. The cannula and / or outer sheath assembly may include internal securing elements configured to hold the lead in place. For example, an expansion element is configured to expand within the cannula or sheath and hold the lead in place. After the lead has been advanced through the cannula, one or more anchoring devices may be placed on the lead. One or more anchoring devices may be placed on the lead such that the proximal end of the anchoring device contacts the distal end of the cannula.

[0205] The distal tip of the lead may include one or more markings to indicate when the distal portion of the lead has been advanced beyond the distal tip of the introducer. The LPG may include one or more markings to aid in lead positioning. The LPG may contain at least 2, 3, 4, 5, 6, 7, 8, 9, or 10 markings to aid in lead positioning. The LPG cannula may include a first marking configured to indicate when the electrode at the distal tip of the lead extends beyond the distal tip of the introducer. The LPG cannula may further include a second marking configured to indicate the position just before the anchoring device leaves the introducer. The combination of the first and second markings on the LPG cannula allows the user to track the position of the lead such that the electrode at the distal tip of the lead extends through the introducer and is exposed to tissue, while the anchoring device on the lead remains covered by the introducer and in the delivery position. The lead may include a marking just distal to one or more anchoring devices to indicate that the anchor has not yet been released from the introducer. The second marking on the LPG cannula may be configured to indicate when to stop advancing the LPG through the introducer and instead withdraw the introducer toward the arm of the LPG. The lead wire may include a mark just distal to one or more anchoring devices to indicate that the anchor has not yet been released from the introducer. In some cases, the lead wire may include a mark just proximal to one or more anchoring devices. The mark may indicate that one or more anchoring devices have been deployed from the introducer. The mark on the LPG sheath may be a radiopaque mark. The radiopaque mark may indicate the end of the sheath and the proximal extent of the lead wire anchor. The mark may be a band. The band may be wrapped around all or part of the circumference of the outer diameter of the sheath or sleeve. The mark may be a dot, square, arrow, triangle, or any other desired shape. The shape of the mark may be configured to help indicate the orientation or orientation of the device.

[0206] The lead wire may include one or more anchoring devices before being inserted into the LPG and through the LPG cannula. The one or more anchoring devices may be secured to the electrode lead wire and / or surrounding soft tissue by activation mechanisms (e.g., spring-loaded teeth) described elsewhere herein. A common anchoring mechanism for the one or more anchoring devices may be automatically deployed as the one or more anchoring devices are extruded from the outer sheath device. Retraction of the outer sheath device may activate the common anchoring mechanism for the one or more anchoring devices. In some embodiments, the anchoring and / or securing activation of the one or more anchoring devices may be activated when the one or more anchoring devices are ejected from the outer sheath device. The one or more anchoring devices may be ejected from the outer sheath device by a pushing device. The one or more anchoring devices may include one or more mechanisms that are automatically activated when the one or more anchoring devices are extruded from the outer sheath device. In some embodiments, the one or more mechanisms may include activation of the spring-loaded teeth of the one or more anchoring devices. In some embodiments, the activation mechanism may include clamping functionality of the one or more anchoring devices to the electrode lead wire and to the soft tissue space.

[0207] Electrode leads This document provides methods, apparatus, and systems for implanting at least one electrode lead and an implantable pulse generator (IPG) in an individual to treat incontinence. The lead may include variable density and / or flexibility along its body. A portion of the lead body may be configured to have higher rigidity to maintain its implantation position. The rigidity of this portion of the lead body can be increased by using a higher-density material. For example, the tip of the lead body may be more rigid than the rotating portion of the lead. Since the tip of the lead may include a stimulating electrode, the tip may have increased rigidity and / or density, thus resisting forces that would move the tip away from or near the implantation site at the target nerve and reduce the effectiveness of stimulation. A portion of the lead body may be configured to have higher flexibility to accommodate forces and strains from the patient's movement or posture. The flexibility of this portion of the lead body can be increased by using a lower-density material. For example, a portion of the lead body that bends when the patient is sitting or performing other common movements may have higher flexibility and / or lower density to accommodate strain on the lead body.

[0208] Depending on the instructions, the length of the lead body can vary. In some cases, the two leads can have different lengths for the lead body. The length of the lead on the opposite side of the IPG can be greater than the length of the lead on the same side of the IPG. In some cases with dual-sided access, the difference between the lengths of the first lead body and the second lead body can be between approximately 100 mm and 200 mm. In some cases, the difference between the lengths of the two dual-sided lead bodies can be approximately 100 mm, approximately 110 mm, approximately 120 mm, approximately 130 mm, approximately 140 mm, approximately 150 mm, approximately 160 mm, approximately 170 mm, approximately 180 mm, approximately 190 mm, approximately 200 mm, or a length within the range defined by any of these values.

[0209] At least one electrode lead may include a helical lead. The helical lead may include one or more cables twisted in a helical configuration, such as... Figure 25 As shown. In some embodiments, only a portion of the lead may include one or more cables twisted in a helical configuration. The helical body of the lead can provide improved flexibility. The helical reconfiguration can help prevent the lead from kinking as it is advanced into place. The helical reconfiguration can also help prevent the lead from kinking during patient activity after implantation. The flexibility of the lead can be varied based on the rate of twisting of the lead body at different portions of the lead. The helical configuration of the lead body allows the inner platform of the lead to extend without the extended outer surface of the lead body. This can improve maneuverability around sharp bends and tortuous vessels.

[0210] One or more twisted cables may include a helix comprising 8 ± 1 turns per 70 mm along the lead body. One or more twisted cables may include a helix comprising 2 full turns ± 0.25 full turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix comprising 9 turns or more per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix comprising 2.25 turns or more per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix comprising 7 turns or fewer per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix comprising 1.75 turns or fewer per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix comprising 10 ± 1.5 turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix comprising 3 ± 0.5 turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include 15 ± 2 turns of spiral per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include 5 ± 0.75 turns of spiral per 70 mm along the lead body. In some cases, one or more twisted cables may include 6 ± 1 full turns of spiral per 70 mm. In some cases, one or more twisted cables may include 4 ± 0.3 full turns of spiral per 70 mm along the lead body. In some cases, one or more twisted cables may include 3.5 ± 0.25 full turns of spiral per 70 mm along the lead body. In some cases, one or more twisted cables may include 7 ± 0.5 full turns of spiral per 70 mm along the lead body. In some cases, one or more twisted cables may include 12 ± 1 full turns of spiral per 70 mm along the lead body. In some cases, one or more twisted cables may include 5 ± 0.75 full turns of spiral per 70 mm.

[0211] The lead may include one or more cables having a variable pitch rate and / or coil density along the lead body. A portion of the lead body may be configured to have a larger pitch rate or lower density at its distal end to improve its capabilities at the tip of the lead. One or more portions of the lead body may have a different pitch rate and / or coil density than the rest of the lead body. The pitch rate of the lead may be adjusted during lead advance and positioning. The lead may include a proximal portion without a helical configuration and a distal portion with a helical configuration. In some embodiments, the lead may include a proximal portion with a helical configuration and a distal portion that is not helical. The proximal portion of the lead body may have a less flexible helical configuration than the helical configuration of the distal portion of the lead. In some embodiments, the proximal portion of the lead body may have a more flexible helical configuration than the helical configuration of the distal portion of the lead. In some embodiments, the lead may have a middle portion of the lead body with a helical configuration, wherein the proximal and distal ends of the lead are not helical. Any lead described herein may have a diameter of at least about 1 mm and / or less than or equal to about 10 mm (e.g., less than or equal to about 5 mm, or less than or equal to about 2 mm). In some cases, helical leads may have a diameter of less than 10 mm. One or more cables may include platinum, gold, silver, platinum-iridium, stainless steel, MP35N, conductive metals, alloys, or combinations thereof. One or more cables of a helical lead may be platinum-iridium cables. The cable material may prevent rotation beyond a threshold number of rotations. The cable may include a material with sufficient impedance to allow electrical stimulation. The cable may include a material with sufficient impedance to allow receiving electrical signals. The cable may include a sufficiently malleable material to allow variable winding. The cable may include a material to prevent radiation beyond a threshold number of rotations. This prevents short circuits in the leads and improves device safety. In some cases, any lead used or described herein may include a helical lead.

[0212] IPG bag formation and lead tunneling This document provides methods, devices, and systems for implanting at least one electrode lead and an implantable pulse generator (IPG) in an individual to treat incontinence. A small pouch, sized to hold the IPG, can be created in the ipsilateral upper buttock. The pouch can be created using a transverse skin incision. The location of the pouch can be pre-marked while the individual is awake prior to the implantation procedure. The location of the pouch can be selected to avoid contact with clothing, including but not limited to a belt. The pouch can be close to the skin surface to allow for recharging. The IPG can be no more than about 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm from the skin surface. The pouch can be no more than 2 cm from the skin surface. The pouch can be sized sufficiently to comfortably accommodate the IPG without allowing excessive migration of the IPG within the pouch. The IPG can be carefully separated from the underlying gluteal epimysium, where a layer of fat exists between the IPG and the epimysium. The IPG should be placed parallel to the skin to ensure effective recharging.

[0213] This document provides methods, apparatus, and systems for tunneling one or more electrode leads from the point where each lead leaves the skin after placement to the IPG. Tunneling can be performed to avoid penetration while achieving maximum tissue coverage in the subcutaneous fat. Tunneling can be performed using a tunneling tool. The tunneling tool may include a stainless steel spike and a sheath. The tunneling tool can be inserted from the point where the lead leaves the skin, through the gluteal fat, to reach the IPG pouch. In some embodiments with bilateral leads, the trajectory and distance of the tunneling path for each lead to a unilateral IPG can be different. The bend point of the lead on the contralateral side of the IPG can be pre-marked using imaging-guided surface markings of the lower sacroiliac joint. The tunneling path for the contralateral lead can be bent at the surface markings of the lower sacroiliac joint such that the path crosses the midline of the horizontal plane surrounding S3. Once the tunneling path to the IPG is created, the tunneling tool can be retracted while the sheath remains in place. The lead can pass through the hollow sheath to reach the IPG, and the sheath can then be removed. One or more leads can be connected to the IPG, and any excess leads can be wound up so that there is no tension on the leads. Excess leads can be wound away from the skin and under the IPG to ensure that recharging is not impaired.

[0214] kit This disclosure describes a kit that includes devices and components described elsewhere herein. In some cases, the kit may include a lead wire, one or more anchors, an IPG, an introducer, and an electrode lead assembly comprising: (i) a lead wire including one or more stimulating electrodes located near a distal end of the lead wire; and (ii) a plurality of anchors, each anchor including a collar and two or more barbs extending from the collar, wherein the plurality of anchors are provided proximal to the one or more stimulating electrodes at a fixed position on the lead wire, wherein a first anchor of the plurality of anchors is adjacent to a second anchor of the plurality of anchors, wherein the two or more barbs of the first anchor are positioned at a rotational angle along the length of the lead wire to the two or more barbs of the second anchor, and wherein the one or more stimulating electrodes are configured to deliver electrical stimulation to target tissue; and (b) instructions for placing or anchoring the electrode lead wire to the target tissue. The kit may further include an LPG. The LPG may include an LPG frame, an LPG cannula, and an LPG locking cap. The target tissue may include the pudendal nerve or tissue adjacent to the pudendal nerve. In some cases, the target tissue may include one or more branches of the pudendal nerve, sacral nerve, or any combination thereof. The instruction manual may include inserts and / or instructions on a website (e.g., via QR code navigation). The kit may further include an introducer and / or pusher as described elsewhere herein. The kit may include one or more anchors releasably coupled to the lead. The instruction manual may include instructions for setting and / or modifying one or more of the anchors such that the barbs in one or more anchors can be prevented and / or set not to extend when implanted in the target.

[0215] Manufacturing method One or more anchors described elsewhere in this document may be manufactured by molding, 3D printing, laser sintering, laser etching, laser cutting, or any combination thereof. A method of manufacturing an anchor may include: molding a first half (700, 702) and a second half (704, 706) of an anchor body, wherein the first half (700, 702) of the anchor body includes a first barb region 702, and the second half (704, 706) of the anchor body includes a second barb region 706, wherein the first half of the anchor body is made of the same material as the first barb region, and wherein the second half of the anchor body is made of the same material as the second barb region; and fixing the first and second halves of the anchor body to form the anchor body. Figures 7A-7BAn example molded anchor is shown in the image. Molding can include injection molding. The first half (700, 702) may further include a first lumen 708, and the second half (704, 706) may further include a second lumen 709. The first and second lumens may include structural features of the anchor's inner diameter as described elsewhere herein. The size and geometry of the first and / or second barb regions may include the size, dimensions, and geometry of the barbs as described elsewhere herein. The first and second halves of the anchor body may include removably coupled features configured to be removed and / or disconnected from the first or second half of the anchor body. The first or second half of the anchor body may be molded from a polymer (e.g., thermoplastic polyurethane elastomer (TPU)). In some cases, the polymer may include polytetrafluoroethylene (PTFE). The first or second half of the anchor body may be molded from a material having a stiffness of at least about 55D Shore D. In some cases, the first and second halves can be fixed together using adhesive.

[0216] One or more anchors can be manufactured by laser-cutting one or more anchors from a single material. The single material may include thermoplastic polyurethane, i.e., Pellethane. TM In some cases, a single material may include a tube. As described elsewhere in this document, laser-cut anchor barbs can be heat-set at an angle such that the barbs extend to the heat-set angle as they expand and / or open at the target tissue. Laser-cutting one or more anchors from a single material enables complex anchor geometries and designs, and reduces the cost of manufacturing anchors.

[0217] The texture of one or more surfaces of one or more anchor bodies or one or more barbs of one or more anchor bodies can be modified by manufacturing and / or processing methods described elsewhere herein. The texture of the anchor or barb surface can be modified and / or altered by chemical treatment, laser treatment, or physical stirring. Modification of the anchor or barb surface can change the static and / or dynamic coefficients of friction. A surface with an increased coefficient of friction can provide stronger anchoring for securing the anchor and coupled electrode leads to the target tissue than a surface without an increased coefficient of friction.

[0218] Manufacturing methods may provide one or more textures on one or more surfaces of the anchor, as described elsewhere herein. One or more textures may include a first texture on the outer surfaces of two or more barbs of the one or more anchors, wherein the first texture on the outer surfaces helps to reduce or decrease the forces acting on the outer surfaces of the two or more barbs, as described elsewhere herein, when the barbs are inserted into the elongated body lumen of the introducer. In some instances, one or more textures may include a second texture, wherein the second texture may increase the frictional or kinetic resistance between the surfaces of the two or more barbs of the one or more anchors and the lead and the tissue surrounding the one or more anchors upon implantation. The second texture may improve the robustness of securing the implanted lead to a target anatomical region (e.g., the pudendal nerve or adjacent tissue) after force is applied to the lead.

[0219] Electrical stimulation for the treatment and control of incontinence This document describes devices, systems, and methods for preventing episodes of incontinence in individuals in need by providing electrical nerve stimulation. Episodes of incontinence may include urinary incontinence, fecal incontinence, or any combination thereof. The devices, systems, and methods disclosed herein can treat subtypes of incontinence. Subtypes of incontinence may include urge incontinence, stress incontinence, overflow incontinence, or mixed incontinence.

[0220] Urinary incontinence can be classified into one of four main types: urge incontinence, stress incontinence, overflow incontinence, and mixed incontinence. Urge incontinence is usually due to overactive bladder (OAB). Individuals with urge incontinence have a strong and sudden need to urinate immediately, often leaving them insufficient time to reach the toilet. Stress incontinence (SUI) is usually due to urethral sphincter dysfunction or excessive activity of the urethra or bladder neck. Individuals may experience stress incontinence during activities such as coughing, sneezing, laughing, lifting, or exercising. Overflow incontinence may usually be due to poor bladder contraction or urethral obstruction. Mixed incontinence (MUI) may involve features of both stress and urge incontinence. Incontinence is often associated with neurological problems, including but not limited to impaired nerve conduction between the brain and / or affected muscles, and neurological disorders or injuries (such as multiple sclerosis or stroke), or mental confusion. Other causes of incontinence include, but are not limited to, pelvic or urethral muscle weakness and pelvic prolapse.

[0221] Fecal incontinence (also known as intestinal incontinence) is the loss of bowel control, causing an individual to accidentally expel feces from the rectum. Fecal incontinence is generally classified into three main types: urge incontinence, passive incontinence, and post-defecation leakage (or a combination thereof). Individuals with urge incontinence have an immediate, strong, and sudden need to defecate, often leaving them insufficient time to reach the toilet. Passive fecal incontinence occurs when an individual expels feces without awareness. Individuals with passive incontinence cannot consciously control their defecation, and feces may be expelled without their knowledge. Incontinence often involves neurological problems, including but not limited to impaired nerve conduction between the brain and / or affected muscles, and neurological disorders or injuries (such as multiple sclerosis or stroke), or mental confusion. Causes of fecal incontinence include, but are not limited to, nerve damage, anal sphincter injury, constipation, diarrhea, surgery, loss of rectal storage capacity, rectal prolapse, and rectocele.

[0222] Sometimes, electrical stimulation of muscles has been used to treat incontinence by improving the strength and function of the pelvic floor muscles through training, thereby enhancing urinary and fecal control. In some cases, electrical stimulation can target the sacral nerves to improve urinary and fecal control. In other cases, electrical stimulation methods can benefit from stimulation of alternative targets.

[0223] Electrical stimulation methods may only be able to deliver predefined stimulation protocols and may not be adapted to an individual's condition and circumstances during a specific episode of incontinence. This can lead to overstimulation or understimulation of the target tissue, resulting in insufficient control of the muscles involved in urination or defecation. Often, conventional methods of treating incontinence may fail to adequately mimic innate human responses (i.e., reflexes) to prevent incontinence episodes and may be inadequate. Individuals experiencing incontinence episodes may experience insufficient preventative responses. Preventative responses may include muscular contraction of at least one pelvic floor muscle to prevent leakage events in response to increased intra-abdominal pressure. Individuals experiencing stress incontinence may exhibit delayed responses in preventing incontinence episodes in response to stress events. In some cases, individuals may experience stress incontinence associated with urethral overactivity (i.e., insufficient support) that may lead to increased pressure transmitted to the bladder and subsequently result in incontinence episodes.

[0224] The lack of voluntary control over urination, defecation, incontinence, or any combination thereof is a problem that can impact quality of life and cause social embarrassment. Urinary and fecal incontinence can affect individuals of all ages. Typically, older individuals may exhibit a greater likelihood of incontinence with different pathophysiologies. Urinary incontinence or loss of bladder control, and fecal incontinence or loss of defecation control, are often associated with neurological problems. Both urinary and fecal incontinence can involve damage, weakness, or overactivity of the pelvic floor muscles (including, but not limited to, the urethral and anal sphincter muscles), and the nerves that innervate these muscles and the organs involved (such as the bladder, rectum, or anus).

[0225] To treat or alleviate symptoms of incontinence, electrical stimulation of the muscles involved in incontinence, the sacral nerves, and / or other pelvic nerves (e.g., the pudendal nerve) has been used to improve control of urination and defecation by targeting the pudendal nerve, providing an improved approach to treating incontinence. The pudendal nerve typically contributes to motor function and mediates voluntary contraction of the urethral and anal sphincters to maintain restraint. Targeting the pudendal nerve can be combined with closed-loop and / or feedforward capabilities with dynamic adaptive control to provide more effective treatment for incontinence. In some cases, individuals can control stimulation through pelvic compression, where receiving threshold EMG signals from the pelvic floor can activate electrical stimulation. However, the pudendal nerve has not yet been a target for the same level of neuromodulation as the sacral nerve, partly due to the difficulty in accessing the pudendal nerve and securing leads to or near it.

[0226] Current electrical stimulation therapies may include sacral nerve modulation (SNM) that can provide a fixed stimulation pattern to treat "urgency" (sudden need to urinate), but this stimulation may not respond to more common "stress" incontinence events such as coughing, sneezing, and lifting. While SNM can reduce the frequency of incontinence episodes, its success may be limited in scope (e.g., not curative) and may decrease over time. Furthermore, SNM may not be suitable for treating individuals with stress incontinence or mixed urinary incontinence (having both stress and urge incontinence). SNM can have high long-term costs in terms of managing the electrical stimulation device and may require a high level of skill and precision from the surgeon to place the lead on the sacral nerve. Therefore, targeting another nerve (such as the pudendal nerve) could provide an improved approach to treating incontinence.

[0227] Puddle nerve stimulation (PNS) can provide more effective treatment for individuals with incontinence than non-strip stimuli (SNM). In some cases, PNS may be an effective treatment for incontinence in individuals for whom SNM has failed. PNS may be more potent than SNM because the puddle nerve enters the spinal cord via S2, S3, and S4, while SNM only acts on the S3 root. PNS can provide effective treatment for urinary incontinence. In some cases, the puddle nerve can be an effective control target for closed-loop and / or feedforward stimulation.

[0228] However, despite its dominant role in maintaining urinary control, the pudendal nerve is not a target for neuromodulation to the same extent as the sacral nerve. The complex 3D anatomy of the pudendal region and the heterogeneity of the tissues surrounding the nerve may make it a difficult target for treatment via electrical stimulation. The complex three-dimensional anatomy of the pudendal nerve may make accurate electrode placement and fixation with implanted electrode leads more challenging. Electrophysiological guidance may be required instead of radiological guidance, or a combination thereof, for accurate electrode placement on the pudendal nerve. There may be uncertainty regarding which segment of the pudendal nerve (e.g., the trunk and branches) should be targeted to provide effective electrical stimulation. Lead fixation may be more difficult than with the sacral nerves (which have the skeletal anatomy of the sacrum to facilitate lead fixation) due to the anatomy near the pudendal region. In some cases, there may be concerns that direct targeting of peripheral nerves may be limited by stimulation tolerance issues.

[0229] Electrical stimulation for pain control Devices, systems, methods, and / or kits described elsewhere in this document can treat pain in the pelvic region. Chronic pelvic pain (CPP) can impact quality of life and often causes episodes of severe discomfort and exacerbating pain. Common symptoms of CPP include, but are not limited to, neurological symptoms in the pelvis, anus, and / or genitals, such as paresthesia, numbness, burning, and tingling. Attacks of pain associated with CPP may frequently occur while sitting, urinating, defecating, or engaging in sexual intercourse, and may be exacerbated by these activities. Methods of treating CPP by electrical stimulation of the majority of affected areas (e.g., the pelvic region) or percutaneously may have limited success in relieving pain symptoms. Therefore, targeted nerve stimulation of electrical stimulation tailored to an individual's pain response can provide highly effective treatment for CPP and other pain symptoms.

[0230] Many currently used electrical nerve stimulation methods deliver pre-set stimulation protocols (i.e., open-loop configurations) and are often not adapted to the varying parameters of pain experienced by an individual. Puddle nerve stimulation (PNS) can provide an effective treatment for chronic pain. In some cases, inadequate stimulation can lead to overstimulation or understimulation of the target area, resulting in inefficient or insufficient pain management. Furthermore, because treatment is often not adapted to varying parameters of pain, existing pain management often requires patient-actuation to provide pain relief during exacerbating episodes. Therefore, it would be highly beneficial to provide electrical stimulation to peripheral nerve targets that adapt to innate feedback from the subject when conditions change (e.g., closed-loop and / or feedforward configurations).

[0231] The systems, methods, and apparatus described herein relate to the treatment of pain episodes associated with chronic pelvic pain (CPP) or other conditions leading to pelvic pain using peripheral nerve stimulation. In some embodiments, the systems, methods, and apparatus include closed-loop and / or feedforward configurations. In some embodiments, adaptive stimulation of the target nerve is provided by an implantable stimulator utilizing underlying physiological principles including: (a) stimulating motor fibers to alter peripheral organ muscle activity, wherein peripheral pain is driven by spasm and / or hyperosmolarity (e.g., pelvic floor myalgia, some cases of bladder pain syndrome, and urethral pain associated with motor modulation); (b) stimulating larger diameter afferent fibers to modulate spinal gating of nociceptive signaling from peripheral lesions that generate pain (e.g., interstitial cystitis, coccyx pain, and pelvic myalgia); (c) blocking nerve conduction (e.g., anodic blockade) to (i) directly block disease-associated peripherally driven pain, and (ii) block the detrimental effects associated with the provision of adaptive stimulation, which facilitates higher charge delivery for therapeutic benefit; and any combination thereof.

[0232] This article describes the use of appropriate electrical stimulation to target one or more peripheral nerves based on the etiology of pain symptoms to alleviate pain experienced by an individual. Stimulatory electrodes may target different nerves (e.g., a first stimulator targeting the sacral nerve and a second stimulator targeting the pudendal nerve). In some embodiments, stimulation of multiple nerves within the pelvic region can broaden the therapeutic scope for pain syndromes with diffuse areas of pain. In some embodiments, electrical stimulation can be adapted to provide both blocking and stimulation of electrical nerve signals on the same nerve. In some embodiments, stimulator electrodes may target one or more locations along a single nerve. Targeting multiple points along a nerve can allow for improved control in closed-loop and / or feedforward modulation (e.g., a first stimulator implanted at or near a first anatomical site on the pudendal nerve and a second stimulator implanted at or near a second anatomical site on the pudendal nerve). In some embodiments, targeting a single nerve at multiple sites can allow for both blocking and stimulation of the same nerve.

[0233] Electrical stimulation for treating sexual dysfunction The devices, systems, methods, and / or kits described elsewhere in this document can treat sexual dysfunction in subjects. Sexual dysfunction can affect quality of life and may prevent a person from experiencing satisfaction from sexual activity. Generally, sexual dysfunction can be classified as sexual desire disorder (lack of libido or interest in sex), arousal disorder (inability to be physically aroused or excited during sexual activity), orgasmic disorder (delayed or absent orgasm), or pain disorder (pain during intercourse), or a combination of these disorders. Sexual dysfunction may involve both physical and psychological causes. Typically, sexual dysfunction can be treated with one or more of the following: medication, mechanical aids, psychotherapy, and behavioral therapy. However, the effectiveness of treatment may be limited, especially for sexual dysfunction with physical causes.

[0234] Many symptoms are associated with sexual dysfunction. In both men and women, symptoms of sexual dysfunction include, but are not limited to, lack of interest or desire for sex, inability to be aroused, and pain during intercourse. In women, some symptoms associated with sexual dysfunction include, but are not limited to, inability to achieve orgasm, insufficient vaginal lubrication before and during intercourse, and inability to relax the pelvic floor muscles around the vagina to allow for intercourse. In men, some symptoms associated with sexual dysfunction include, but are not limited to, erectile dysfunction (ED), delayed ejaculation, and premature ejaculation. ED can be defined as the inability to achieve or maintain an erection suitable for sexual intercourse. Delayed ejaculation can be defined as the absence or delay of ejaculation despite sufficient sexual stimulation. Premature ejaculation can be defined as the inability to control the timing of ejaculation.

[0235] Erectile dysfunction (ED) is the most common form of sexual dysfunction in men. It is estimated that 322 million men worldwide will be affected by ED by 2025. ED has a variety of causes, including but not limited to vascular, hormonal, and neurogenic causes. Individuals with neurogenic causes of ED include those with spinal cord injury (SCI) and men who have undergone radical prostatectomy. The global incidence of SCI ranges from 40 to 80 new cases per million population per year, affecting 20 to 30 million men in the United States alone. A significant proportion of individuals with SCI who experience ED are young, and ED can significantly impact their quality of life.

[0236] For erection to occur, contributions from both neural and vascular components may be required. Normal erection may depend on two reflex loops: the pudendocrine reflex loop (for swelling) and the bulbocavernosus reflex loop (for stiffness). Sufficient neural activity can include the release of nitric oxide (NO), leading to an increase in cGMP, which in turn induces relaxation of the smooth muscles in the penile shaft. The neural arrangement of erection can be complex and may depend on both the somatic nervous system (via the pudendal nerve (PN)) and the autonomic nervous system (via the cavernous nerve (CN)).

[0237] Sexual dysfunction is typically treated with one or more of the following methods, including but not limited to medication, mechanical aids, psychotherapy, and behavioral therapy. In some cases, medications (also referred to herein as agents) include hormones, injections, pills, or creams; or phosphodiesterase type 5 (PDE5) inhibitors that increase blood flow to the penis; or injections of papaverine, phentolamine, and / or prostaglandin E1 (PGE1) at or near the erectile tissue. PDE5 inhibitors are typically first-line treatment and include, but are not limited to, sildenafil, tadalafil, vardenafil, avanafil, lodenafil, udenafil, and mirtenafil. Although PDE5 inhibitors are effective in treating sexual dysfunction, discontinuation rates can be high, reportedly up to 50% after 1–2 years of use. If medication is ineffective, intracavernosal injections containing papaverine, phentolamine, and / or PGE1 can be administered. In some cases, intracavernosal injections may lead to a high incidence of adverse reactions such as priapism, injection site pain, and bruising. In some cases, the high incidence of adverse reactions leads to patient non-compliance. Mechanical assistive devices include, but are not limited to, vacuum devices, penile implants, vaginal speculum, and vibrators. In some cases, penile prosthesis implantation may lead to significant complications such as infection, erosion, and pain. Therefore, the effectiveness of treatment may be limited, especially for sexual dysfunction with physical causes and when patient compliance or responsiveness is decreased.

[0238] Electrical stimulation has been used to treat sexual dysfunction, but its success is limited. Sacral nerve stimulation and modulation have also been used to treat sexual dysfunction, but their efficacy is very limited, with reported successful intercourse in only 20-30% of patients. In some cases, presacral root stimulation (SARS) has been used to treat erectile dysfunction (ED). However, the SARS procedure can be quite invasive, requiring root resection, and is only indicated in patients with complete sacral insufficiency (SCI).

[0239] The difficulty in treating sexual dysfunction through electrical stimulation may stem from the complex tissues of the nervous system involved in sexual functions such as erection (including, but not limited to, the pudendal and cavernous nerves). Therefore, electrical stimulation of multiple nerves involved in sexual function (such as the pudendal and cavernous nerves) via electrodes can restore sexual function, such as erection. Electrical stimulation of both the pudendal and cavernous nerves may be able to treat sexual dysfunction caused by neurogenic (e.g., spinal cord injury, post-prostatectomy) or combined neurogenic / vascular causes (e.g., diabetes, idiopathic). In some cases, erections induced by electrical stimulation can be enhanced by PDE5 inhibitors (PDE5i). In some cases, the mechanism of action may be directly related to PDE5i, as PDE5i inhibits CGM degradation by inhibiting NOS. The potential side effects of electrical stimulation of somatic nerves may be reduced due to the anatomy of somatic nerves. In some cases, the potential side effects of electrical stimulation of somatic nerves can be reduced because the proportion of somatic nerves around the apex of the prostate represents <5% of the autonomic nervous system.

[0240] This document provides devices, systems, and methods for treating symptoms of sexual dysfunction in individuals using neuroelectrical stimulation. The systems, methods, and devices described herein relate to treating sexual dysfunction by targeting peripheral nerve stimulation and restoring and / or enhancing reflex activity involved in sexual function. Adaptive stimulation of the target nerve can be provided by an implantable stimulator utilizing underlying physiological principles to target both the somatic nervous system (e.g., PN) and the autonomic nervous system (e.g., CN) involved in erection and sexual function. In some embodiments, adaptive stimulation of the target nerve can be provided by an implantable stimulator to target autonomic nerves (e.g., CN), somatic nerves (e.g., PN), or a combination thereof. The devices, systems, and methods described herein can be configured to restore erection in cases of neurogenic (e.g., spinal cord injury, post-prostatectomy) and combined neurogenic / vascular etiologies (e.g., diabetes, idiopathic). In some embodiments, the systems, methods, and devices may include closed-loop and / or feedforward configurations for providing electrical stimulation.

[0241] definition Unless otherwise defined, all technical terms, symbols, and other technical and scientific terms or terminology used herein are intended to have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and / or for ease of reference, and the inclusion of such definitions herein should not necessarily be construed as indicating a material difference from the commonly understood meaning in the art.

[0242] Throughout this application, various embodiments may be presented in the form of ranges. It should be understood that the description in the form of ranges is merely for convenience and brevity and should not be construed as an immutable limitation on the scope of this disclosure. Therefore, the description of ranges should be considered as having specifically disclosed all possible subranges and individual numerical values ​​within those ranges. For example, a description of a range such as 1 to 6 should be considered as having specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and individual numbers within those ranges (e.g., 1, 2, 3, 4, 5, and 6). This applies regardless of the width of the range.

[0243] As used in the specification and claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. For example, the term “a sample” includes multiple samples, including mixtures thereof.

[0244] The term "in-body" is used to describe events that occur within the body of an object.

[0245] As used herein, the terms “approximately,” “about,” and “substantially” refer to a quantity that is close to a specified amount while still performing the desired function or achieving the desired result. For example, the terms “approximately,” “about,” and “substantially” can refer to a quantity within the range of less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the specified amount. As another example, in some embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that deviates from exact parallelism by less than or equal to 10 degrees.

[0246] As used herein, the terms “treatment” or “being treated” are used in relation to an intervention intended to achieve a beneficial or desired outcome in the recipient. Beneficial or desired outcomes include, but are not limited to, therapeutic benefits and / or preventative benefits. A therapeutic benefit can refer to a reduction, eradication, or alleviation of symptoms or an underlying disorder being treated. Furthermore, a therapeutic benefit can be achieved through a reduction, eradication, or alleviation of one or more physical symptoms associated with the underlying disorder, resulting in an observed improvement in the subject, although the subject may still have the underlying disorder. Preventative effects include delaying, preventing, or eliminating the onset of a disease or condition, delaying or eliminating the onset of symptoms of a disease or condition, slowing, stopping, or reversing the progression of a disease or condition, or any combination thereof. For preventative benefits, subjects at risk of developing a particular disease or reporting one or more physical symptoms of a disease may undergo treatment, even if a diagnosis of the disease may not have been made.

[0247] The chapter headings used in this document are for organizational purposes only and should not be construed as limiting the topics described.

[0248] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. The phrases “in one aspect,” “in one instance,” and “in one situation” should be understood to mean “in one embodiment.” Many variations, alterations, and substitutions will now occur to those skilled in the art without departing from the present disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in the practice of this disclosure.

[0249] All publications, patent applications, granted patents and other documents mentioned in this specification are incorporated herein by reference as if each individual publication, patent application, granted patent or other document were specifically and individually identified and fully incorporated by reference. Definitions contained in the text incorporated by reference are excluded to the extent that they contradict the definitions in this disclosure.

[0250] The terms “including,” “comprising,” “having,” etc., are synonymous and are used inclusively in an open-ended manner, without excluding additional elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive sense (rather than its exclusive sense) such that, when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.

Claims

1. An electrode lead device, comprising: A lead, the lead including one or more stimulating electrodes located near the distal end of the lead; as well as Multiple anchors are positioned proximal to one or more stimulating electrodes; Each of the plurality of anchoring elements includes a collar and a plurality of barbs extending from the collar; The plurality of anchoring elements are arranged bidirectionally on the lead wire, and the plurality of anchoring elements include: A first set of anchors, each barb on the first set of anchors extending in a first direction away from the one or more stimulating electrodes; and The second set of anchors, each barb on the second set of anchors extending in a second direction toward the one or more stimulating electrodes; The bidirectional arrangement reduces the inward and outward movement of the leads; The plurality of anchoring elements includes at least a first anchoring element and a second anchoring element that are adjacent to each other; The plurality of barbs of the first anchor are arranged to be circumferentially offset from the plurality of barbs of the second anchor; and The circumferential offset arrangement reduces the lateral migration of the leads.

2. The electrode lead device according to claim 1, wherein the first set of anchors is positioned between the one or more stimulating electrodes and the second set of anchors.

3. The electrode lead device according to claim 1 or 2, wherein the first group of anchors and the second group of anchors have different numbers of anchors.

4. The electrode lead assembly according to any one of claims 1 to 3, wherein the plurality of barbs extend from the end of the collar.

5. An electrode lead device, comprising: A lead, the lead including one or more stimulating electrodes located near the distal end of the lead; as well as Multiple anchors are positioned proximal to one or more stimulating electrodes; Each of the plurality of anchoring elements includes a collar and a plurality of barbs extending from the collar; The plurality of anchoring elements are arranged bidirectionally on the lead wire, and the plurality of anchoring elements include: A first set of anchors, each barb on the first set of anchors extending in a first direction away from the one or more stimulating electrodes; and A second set of anchors, each barb on the second set of anchors extending in a second direction toward the one or more stimulating electrodes; and The bidirectional arrangement reduces the inward and outward movement of the leads.

6. The electrode lead device according to claim 5, wherein the first set of anchors is positioned between the one or more stimulating electrodes and the second set of anchors.

7. The electrode lead device according to claim 5 or 6, wherein the first group of anchors and the second group of anchors have different numbers of anchors.

8. The electrode lead device according to any one of claims 5 to 7, wherein the plurality of barbs are two barbs.

9. The electrode lead device according to any one of claims 5 to 8, The plurality of anchoring elements includes a first anchoring element and a second anchoring element, wherein the first anchoring element and the second anchoring element are adjacent to each other; and The first anchor is offset circumferentially from the second anchor.

10. An electrode lead device, comprising: A lead, the lead including one or more stimulating electrodes located near the distal end of the lead; as well as Multiple anchors are positioned proximal to one or more stimulating electrodes; Each of the plurality of anchoring elements includes a collar and a plurality of barbs extending from an end of the collar; The plurality of anchoring elements includes at least a first anchoring element and a second anchoring element; The plurality of barbs of the first anchor are arranged to be circumferentially offset from the plurality of barbs of the second anchor; and The circumferential offset arrangement reduces the lateral migration of the leads.

11. The electrode lead device according to claim 10, wherein the first anchoring member is adjacent to the second anchoring member.

12. The electrode lead assembly according to claim 10 or 11, wherein the plurality of barbs of the first anchor are circumferentially offset by 90 degrees from the plurality of barbs of the second anchor.

13. The electrode lead device according to any one of claims 10 to 12, wherein the plurality of barbs of the first anchor member extends in a first direction toward the one or more stimulating electrodes, and the plurality of barbs of the second anchor member extends in a second direction away from the one or more stimulating electrodes.

14. The electrode lead device according to any one of claims 10 to 13, wherein the plurality of barbs of the first anchor member extends in the same axial direction as the plurality of barbs of the second anchor member.

15. The electrode lead device according to any one of claims 10 to 14, wherein each anchor has two barbs.

16. The electrode lead assembly according to any one of claims 1 to 15, wherein the plurality of barbs extend from the end of the collar at an oblique angle relative to the longitudinal axis of the lead.

17. The electrode lead assembly according to any one of claims 1 to 16, wherein the plurality of barbs are collapsible.

18. The electrode lead device according to any one of claims 1 to 17, wherein the electrode lead device is configured to be implanted near the pudendal nerve.

19. The electrode lead device according to any one of claims 1 to 18, wherein the electrode lead device is configured to treat conditions in the pelvic region, said conditions including urinary incontinence, overactive bladder, fecal incontinence, sexual dysfunction, pelvic pain, or any combination thereof.

20. The electrode lead device according to any one of claims 1 to 17 is located in the spine, shoulder, knee, hip, or cranial tissue.

21. A method for attaching an electrode lead according to any one of claims 1 to 20, the method comprising: The electrode lead device is advanced through the introducer to reach the target tissue; Partially withdraw the introducer to expose the one or more stimulation electrodes; Confirm the location of the one or more stimulation electrodes; as well as The introducer is then further withdrawn to expose the plurality of anchors.

22. The method of claim 21, further comprising advancing a lead positioning guide through the introducer, the lead positioning guide carrying the electrode lead assembly.

23. The method of claim 21 or 22, wherein confirming the location of the one or more stimulating electrodes comprises measuring the EMG response in the external anal sphincter.

24. The method according to any one of claims 21 to 23, wherein confirming the location of the one or more stimulating electrodes comprises measuring the EMG response in the pelvic floor.

25. A method for implanting an electrode lead device near the pudendal nerve of a patient, the method comprising: The stimulating component is advanced toward the pudendal nerve; Provide an electric current to the stimulation component; EMG response was measured to confirm the location of the stimulation component near the pudendal nerve; as well as After confirming the location of the stimulation component, the electrode lead device is implanted at the confirmed location.

26. The method of claim 25, wherein confirming the location of the stimulating member near the pudendal nerve comprises: The first EMG response at the pelvic floor of the patient was detected. as well as The second EMG response at the external anal sphincter of the patient was detected.

27. The method of claim 26, further comprising that no reaction was detected between the first EMG reaction and the second EMG reaction.

28. The method according to any one of claims 25 to 27, wherein the EMG response is measured at the external anal sphincter of the patient.

29. The method according to any one of claims 25 to 28, wherein the position of the stimulating member is adjusted when no EMG response is detected.

30. The method of claim 29, wherein confirming the location of the stimulating member near the pudendal nerve includes detecting EMG responses in the patient's pelvic floor before and after adjusting the position of the stimulating member.

31. The method according to any one of claims 25 to 30, further comprising advancing a guidewire through the stimulation member.

32. The method of claim 31, further comprising advancing an introducer on the guidewire.

33. The method of claim 32, further comprising advancing the electrode lead assembly through the introducer.

34. The method according to any one of claims 25 to 33, wherein the stimulating member comprises a stimulating needle.

35. The method according to any one of claims 25 to 34, further comprising detecting urethral pressure to confirm the location of the stimulating member.

36. The method according to any one of claims 25 to 35, further comprising bilaterally implanting the electrode lead device near the pudendal nerve on the left and right sides of the patient.

37. A method for implanting an electrode lead device near the pudendal nerve of a patient, the method comprising: Insert a marker needle at or near the intersection of the first line corresponding to the edge of the ischial bone and the second line that crosses the top of the greater trochanter. The marking needle is advanced into the patient; Stimulating components were inserted via the ischiorectal approach; Advance the stimulation component toward the tip of the marking needle; Confirm the location of the stimulation component near the pudendal nerve; and The electrode lead device is implanted at the confirmed location.

38. The method of claim 37, further comprising drawing the first line and the second line on the patient's skin.

39. The method of claim 37 or 38, wherein advancing the stimulating member comprises advancing the stimulating member horizontally toward the tip of the marking needle.

40. The method according to any one of claims 37 to 39, further comprising advancing a guidewire through the stimulation member.

41. The method of claim 40, further comprising advancing an introducer on the guidewire.

42. The method of claim 41, further comprising advancing the electrode lead assembly through the introducer to the confirmed position.

43. The method according to any one of claims 37 to 42, wherein confirming the location of the stimulating member near the pudendal nerve comprises providing the stimulating member with a current of less than or equal to 3 mA.

44. The method of claim 43, wherein confirming the location of the stimulating member comprises measuring an EMG response of at least 20 mV.

45. A method of implanting an electrode lead device comprising one or more stimulating electrodes and a plurality of anchors, the method comprising: The electrode lead assembly is introduced into the lead positioning guide until the one or more stimulating electrodes extend beyond the distal end of the lead positioning guide; The lead positioning guide is advanced through the introducer until the one or more stimulating electrodes are positioned at the distal portion of the introducer. The introducer is partially withdrawn to expose the one or more stimulation electrodes while the plurality of anchors remain constrained within the introducer; Measure the EMG response to confirm the location of the one or more stimulating electrodes; Adjust the position of the one or more stimulating electrodes until the desired EMG response is measured; and The introducer is then further withdrawn to release the plurality of anchors.

46. ​​The method of claim 45, further comprising axially adjusting the position of the one or more stimulating electrodes within the patient without releasing the plurality of anchors from the introducer.

47. The method of claim 45 or 46, further comprising partially retracting the introducer until the handle of the introducer contacts the arm on the lead positioning guide.

48. The method of claim 47, further comprising rotating the lead positioning guide relative to the introducer to allow further retraction of the introducer.

49. The method according to any one of claims 45 to 48, further comprising partially retracting the introducer until the handle of the introducer is coupled to the lead positioning guide.

50. The method of claim 49, further comprising disengaging the lead positioning guide from the introducer to allow the lead positioning guide to release the plurality of anchors.

51. An electrode lead device for treating conditions in the pelvic region, the device comprising: A lead, the lead including one or more stimulating electrodes located near the distal end of the lead; as well as Multiple anchoring elements, each anchoring element comprising a collar and two or more barbs extending from the collar, The plurality of anchors are positioned proximal to one or more stimulating electrodes on the lead wire. The first anchoring member of the plurality of anchoring members is adjacent to the second anchoring member of the plurality of anchoring members. The two or more barbs of the first anchor are positioned such that they rotate at a certain angle along the length of the lead wire relative to the two or more barbs of the second anchor. The one or more stimulating electrodes are configured to deliver electrical stimulation to the target tissue.

52. The apparatus of claim 51, wherein the target tissue comprises the pudendal nerve or tissue adjacent to the pudendal nerve.

53. The device according to claim 51 or 52, wherein the condition in the pelvic region includes urinary incontinence, fecal incontinence, sexual dysfunction, pelvic pain, or any combination thereof.

54. The apparatus according to any one of claims 51 to 53, wherein the free ends of the barbs of the two or more barbs of the first anchor extend toward the distal end of the lead wire, and wherein the free ends of the barbs of the two or more barbs of the second anchor extend toward the proximal end of the lead wire.

55. A kit comprising the means according to any one of claims 51 to 54, and further comprising a lead positioning guide, i.e., an LPG, wherein the LPG includes a lumen diameter configured to receive the lead, and wherein the LPG fixes the position of the lead when the introducer retracts on the lead and the first anchor or the second anchor.

56. A method of attaching electrode leads to tissue, the method comprising: The electrode leads are placed at the target tissue, wherein the electrode leads include: Leads, the leads including one or more stimulating electrodes located near the distal end of the leads; and Multiple anchoring elements, each anchoring element comprising a collar and two or more barbs extending from the collar, The plurality of anchors are releasably positioned on the lead wire proximal to one or more stimulation electrodes. The first anchoring member of the plurality of anchoring members is adjacent to the second anchoring member of the plurality of anchoring members. The two or more barbs of the first anchor are positioned such that they rotate at a certain angle along the length of the lead wire relative to the two or more barbs of the second anchor. The one or more stimulating electrodes are configured to deliver electrical stimulation to the target tissue; and Remove the sheath covering at least a portion of the first or second anchor to deploy the first or second anchor, thereby anchoring the electrode lead to the target tissue.

57. The method of claim 56, wherein the target tissue comprises the pudendal nerve or tissue adjacent to the pudendal nerve.

58. The method of claim 56, wherein the target tissue comprises target tissue in the pelvic region.

59. The method of claim 58, further comprising stimulating the target tissue using the electrode leads to treat a condition in the pelvic region.

60. The method of claim 59, wherein the condition includes urinary incontinence, fecal incontinence, pain, sexual dysfunction, or any combination thereof.

61. The method according to any one of claims 56 to 60, further comprising collapsing or clamping the two or more barbs of the first anchor or the second anchor as the first anchor or the second anchor is axially translated through the introducer.

62. The method according to any one of claims 56 to 61, further comprising fixing the position of the electrode leads using a lead positioning guide, i.e., LPG, when the sheath covering at least a portion of the first anchor or the second anchor is removed.

63. A kit for treating a condition in the pelvic region, the kit comprising: Electrode lead assembly, the electrode lead assembly comprising: Leads, the leads including one or more stimulating electrodes located near the distal end of the leads; and Multiple anchoring elements, each anchoring element comprising a collar and two or more barbs extending from the collar, The plurality of anchors are provided proximal to one or more stimulation electrodes at a fixed position on the lead. The first anchoring member of the plurality of anchoring members is adjacent to the second anchoring member of the plurality of anchoring members. The two or more barbs of the first anchor are positioned such that they rotate at a certain angle along the length of the lead wire relative to the two or more barbs of the second anchor. The one or more stimulating electrodes are configured to deliver electrical stimulation to the target tissue; and Instructions for placing or anchoring the electrode leads to the target tissue.

64. A method for manufacturing an anchor, the method comprising: A first half and a second half of a molded anchor body, wherein the first half of the anchor body includes a first barb region, and the second half of the anchor body includes a second barb region, wherein the first half of the anchor body is made of the same material as the first barb region, and wherein the second half of the anchor body is made of the same material as the second barb region; and The first half and the second half of the anchor body are fixed to form the anchor body.

65. The method of claim 64, wherein molding comprises injection molding.

66. A system for placing electrodes in the pelvic region, the system comprising: A lead, the lead including one or more stimulating electrodes located at or near the distal end of the lead; as well as Multiple anchors, each anchor including a collar and two or more barbs extending from the collar, wherein the multiple anchors are positioned proximal to one or more stimulating electrodes on the lead; An introducer configured to slide on the lead wire and the plurality of anchors, the introducer having an introducer handle; A lead positioning guide includes an elongated guide body having a clamp at a proximal end of the elongated guide body, a guide lumen through the elongated guide body, and one or more guide arms extending distally from the elongated guide body, and a locking cap configured to engage the clamp, wherein the one or more guide arms are configured to engage the inlet handle.

67. A method for securing a lead wire in the pelvic region, the method comprising: The lead wire having a plurality of external anchors on the lead wire according to any of the preceding claims is placed into the guide lumen of the lead wire positioning guide according to any one of claims 148-184 until the proximal anchor of the plurality of anchors contacts the distal end of the elongated guide body of the lead wire positioning guide. The lead wire is secured in the lead wire positioning guide by moving the locking cap of the lead wire positioning guide from the unlocked position to the locked position; The introducer according to any of the preceding claims is placed on a portion of the elongated guide body of the lead and the lead positioning guide to cover the one or more stimulating electrodes and the plurality of anchors on the lead; The guide wire with multiple external anchors and the distal portion of the guide wire are delivered to a target location in the pelvic region using the guide wire handle and the guide wire positioning guide. The introducer handle is slid proximally to engage with one or more guide arms of the lead positioning guide, thereby securing the introducer in the proximal-distal direction and exposing one or more stimulating electrodes on the lead while covering the plurality of anchors. Verify the delivery of one or more exposed stimulation electrodes to the target location; Move the lead positioning guide to disengage it from the inlet handle; Slide the inlet handle proximally to expose the plurality of anchors to secure the lead wire in the proper position in the pelvic region; as well as Move the locking cap from the locked position to the unlocked position; as well as The introducer and the lead wire positioning guide are withdrawn from the pelvic region.

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