Electrode lead anchor system and its use

Abstract

This specification provides devices, systems, and methods for implanting one or more electrode leads, anchored to target tissue, in order to deliver stimuli for treating disease or disorder of one or more tissues. The electrode lead device may include multiple anchors arranged bidirectionally on the lead to reduce lead intrusion and extrusion.

Description

[[Technical Field]]

[0001] Incorporation by Reference to Priority Application This application claims the benefit of U.S. Provisional Application No. 63 / 578338, filed on August 23, 2023, and U.S. Provisional Application No. 63 / 658795, filed on June 11, 2024. The entire disclosures of these documents are hereby incorporated herein by reference in their entireties.

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

[0003] Electrical stimulation has been used to treat incontinence, pelvic pain, sexual dysfunction, or other pelvic disorders. In particular, electrodes can be implanted in the pelvic region of a subject to provide electrical stimulation for clinical treatment and / or disease management. Approaches for providing implanted electrodes for treatment and / or disease management are limited by the ability to secure the implanted position of the electrode lead in the pelvic region relative to tissue, due to forces exerted on the electrode lead by surrounding tissue during implantation and when a subject with the implanted electrode lead moves or ambulates. [[Summary of the Invention]] [[Means for Solving the Problems]]

[0004] Securing the position of an implanted electrode lead at one or more target nerves and / or to tissue adjacent to one or more nerves can improve robustness for delivering spatially controlled stimulation to one or more nerves for treating and / or managing a disease (e.g., a pelvic disorder). In some cases, pelvic disorders include urinary incontinence, fecal incontinence, pain, sexual dysfunction, or any combination thereof.

[0005] While some embodiments are described herein with respect to the pelvic region for treating and / or managing pelvic disorders, they may also be used in other areas of the body or to treat other diseases, as described elsewhere herein.

[0006] As a subject with implanted electrodes moves around throughout the day, the implanted electrode leads may invade (migrate deeper into the subject's tissue) or extrude (migrate to a more superficial position within the subject's tissue). Electrode leads displaced from the target implantation area may lose their usefulness in providing their beneficial effects for treating and / or managing disease. Therefore, some embodiments described herein provide anchoring and / or fixing the electrode leads to target tissue (e.g., an area within the pelvic region or other areas of the subject) to improve the robustness and effectiveness of electrical stimulation for treating and / or managing a subject's disease as the subject moves their body around throughout the day.

[0007] Devices, systems, methods, and / or kits described elsewhere in this specification describe, in some embodiments, electrode lead devices with one or more anchors and methods for implanting them and fixing the position of the electrode lead at the implantation site of a target. In some embodiments, the electrode lead is anchored and / or fixed to tissue at the implantation site of a target, allowing the electrode lead to move with the tissue while still reducing transfer 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 from the target nerve, even with tissue movement. By fixing the position of the electrode lead to the tissue, devices, systems, methods, and / or kits described elsewhere in this specification improve the reliability and robustness of the electrical stimulation provided over a predetermined period of time to treat and / or manage a patient's pelvic disorder when the subject moves or flexes muscles adjacent to the implanted electrode lead.

[0008] In some embodiments, the electrode lead body and surgical method described herein have at least one or more of the following features or advantages: • To resist forces in the axial direction, preventing both intrusion and escape; • Provides stability in at least three directions (including escape, entry, and lateral); • Simplified installation of the electrode lead body; • Provides confirmation that the stimulating electrode is located at the target site before anchor deployment; • Manufacturing flexibility for different indications or patient types; • Techniques to confirm improved surgical access to the pudendal nerve and access to the target site.

[0009] The electrode lead body may include one or more anchors to resist axial forces and prevent displacement (both intrusion and outtrusion). 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 rest on the same anchor or on different anchors. In some configurations, the anchors may provide stability in at least three directions to prevent intrusion, outtrusion, and lateralization. For example, adjacent anchors may be offset in the rotational direction.

[0010] The methods and devices described herein simplify the introduction of the electrode lead body. The anchor can be compressed for delivery to the target site and expanded once proper positioning is confirmed. For example, the anchor can be positioned proximal to the electrode, allowing the electrode to be deployed to confirm proper positioning, while the anchor remains folded within the sheath. The anchor can be semi-rigid, allowing it to be folded or compressed for delivery. In the case of bidirectional anchors, all anchors can be folded in the same direction for delivery through the introducer. Certain methods described herein can utilize a lead positioning guide. The lead positioning guide can position the electrode lead body, while the introducer restrains the anchor until the position of the electrode lead body can be verified.

[0011] The anchors are separately attached to the electrode lead body, providing flexibility in the number and / or orientation of the anchors, allowing for different indications, target sites, or patient sizes. For example, the anchors can be separately attached to the electrode lead body using collars. This allows different numbers of anchors to be provided on the electrode lead body without changing the overall manufacturing technique.

[0012] The electrode lead body can be sufficiently flexible for introduction into the target site and correct placement along the nerve. For example, the lead body can have varying degrees of flexibility along its length by using one or more different materials or the same material density along the lead body. 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 of the lead.

[0013] With respect to the pelvic region, challenges may exist in accessing and confirming the location of target nerves (particularly the pudendal nerve). The pudendal nerve runs a broad caudal course medial to the ischium, then turns anteriorly into the ischiorectal fossa. The methods and instruments described herein may have at least one of the following features or advantages. For example, the electrode lead body may be introduced into the correct location by the use of a marking needle. The marking needle may indicate the point of intersection between a horizontal axis connecting both greater trochanters and a vertical axis medial to the ischial spine. These lines may be identified using X-rays. Furthermore, pudendal nerve stimulation may advantageously provide responses in both the external anal sphincter and the pelvic floor, allowing the location of the electrode lead body to be verified using EMG responses of the external anal sphincter and / or pelvic floor. The location of the electrode lead body may be verified using EMG in combination with one or more measurements or modalities (including urethral manometry, X-rays, visual motion response, and / or ultrasound).

[0014] While specific devices, systems, methods, and kits are described herein in relation to the pelvic region for treating and / or managing pelvic disorders, these methods and devices can also be used to treat other diseases in other areas of the body. Anchors can be used to fix implantable devices in other areas of the body and / or to treat other diseases. In some embodiments, anchors can be applied to electrode lead bodies implanted in the spinal region, for example, to treat chronic or incidental pain. Anchors can be applied to electrode lead bodies in the caudal spinal region of the occipital region. In other embodiments, anchors can be applied to electrode lead bodies implanted near peripheral or cranial nerves. For example, anchors can be applied to electrode lead bodies 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 (e.g., shoulder, knee, or hip)). Anchors can be applied to sutures used in soft tissue repair (e.g., rotator cuff repair) instead of clips. In some embodiments, the anchor can be applied to non-implantable or acute-care devices such as catheters (e.g., drug delivery catheters or drainage catheters).

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

[0016] Multiple anchors can be positioned bidirectionally on the lead. The multiple anchors can include a first set of anchors and a second set of anchors. Each barb on the first set of anchors can extend in a first direction away from one or more stimulating electrodes. Each barb on the second set of anchors can extend in a second direction toward one or more stimulating electrodes. Bidirectional arrangement can reduce axial displacement of the lead both proximal (extrusion) and distal (intrusion). The first set of anchors can be positioned between one or more stimulating electrodes and the second set of anchors. The first set of anchors and the second set of anchors may have different numbers of anchors.

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

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

[0019] Certain aspects of the present disclosure may include a method for attaching an electrode lead device by: advancing the electrode lead device through an introducer to 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 may include a step of advancing a lead positioning guide through an introducer, wherein the lead positioning guide carries the electrode lead device. The step of confirming the location of one or more stimulating electrodes may include a step of measuring an EMG response in the external anal sphincter. The step of confirming the location of one or more stimulating electrodes may include a step of measuring an EMG response in the pelvic floor.

[0020] A particular aspect of this disclosure relates to a method for implanting an electrode lead device near a patient's pudendal nerve. This method may include the steps of: advancing a stimulating member (e.g., a stimulating needle or other elongated structure) toward the pudendal nerve; supplying an electric current to the stimulating member; measuring an EMG response to confirm that the stimulating member is located near the pudendal nerve; and / or, after confirming the location of the stimulating member, implanting an electrode lead device at the confirmed location. The EMG response may be measured in the patient's external anal sphincter and / or pelvic floor. If no EMG response is detected, this method may include the step of adjusting the position of the stimulating member. The step of confirming that the stimulating member is located near the pudendal nerve may include the step of detecting a first EMG response in the patient's pelvic floor; and the step of detecting a second EMG response in the patient's external anal sphincter. This method may include the step of not detecting a response between the first and second EMG responses. The step of confirming that the stimulating member is located near the pudendal nerve may include the step of detecting an EMG response in the patient's pelvic floor before and after adjusting the position of the stimulating member. This method may include the steps of advancing a guidewire through a stimulating member, advancing an introducer over the guidewire, and / or advancing an electrode lead device through the introducer. This method may include the step of detecting intraurethral pressure to confirm the location of the stimulating member. This method may include the step of implanting electrode lead devices bilaterally near the pudendal nerve on the left and right sides of the patient.

[0021] A particular aspect of this disclosure relates to a method for implanting an electrode lead device near the pudendal nerve of a patient. This method may include the step of inserting a marking needle (which in some cases may be a stimulating needle). The needle may be inserted at or near the intersection of a first line corresponding to the edge of the ischium (medial or lateral edge) and a second line crossing the apex of the greater trochanter. This method may include the step of advancing the marking needle into the patient. The needle may be inserted perpendicularly or at an oblique angle to the skin. This method may include the step of inserting a stimulating member (e.g., a stimulating needle or other elongated structure) toward the tip of the marking needle using an ischiorectal approach. This method may include the steps of confirming that the stimulating member is in a location near the pudendal nerve and implanting an electrode lead device at the confirmed location. This method may include the step of drawing the first and second lines on the patient's skin. The step of advancing the stimulating member may include advancing the stimulating member horizontally toward the tip of the marking needle. This method may include the steps of advancing a guidewire through a stimulating member, advancing an introducer over the guidewire, and / or advancing an electrode lead device through the introducer to a confirmed location. The step of confirming that the stimulating member is located near the pudendal nerve may include the step of providing a current of 3 mA or less to the stimulating device member. The step of confirming the location of the stimulating member may include the step of measuring an EMG response of at least 20 mV.

[0022] Certain aspects of this disclosure relate to a method for implanting an electrode lead device as described herein. This method may include the steps of: 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 the introducer until one or more stimulating electrodes are positioned in the distal portion of the introducer; partially withdrawing the introducer to expose one or more stimulating electrodes while the plurality of anchors remain constrained within the introducer; measuring an EMG response to confirm the location 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. This method may include the step of axially adjusting the position of one or more stimulating electrodes in a patient without releasing the plurality of anchors from the introducer. This method may include the step of partially withdrawing the introducer until the handle of the introducer contacts the arm above the lead positioning guide. This method may include a step of rotating the lead positioning guide relative to the introducer to allow further withdrawal of the introducer. This method may include a step of partially withdrawing the introducer until the introducer's handle is coupled to the lead positioning guide. This method may include a step of discouple the lead positioning guide from the introducer to allow the lead positioning guide to release multiple anchors.

[0023] In some 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 can be stimulating electrodes) and two to eight anchors). The lead body may have the same or different materials (e.g., different densities) along the lead body to provide different levels of flexibility along the lead body. The electrodes may be positioned near the distal end of the lead. One or more (or all) of the anchors may be positioned proximal to one or more stimulating electrodes configured to contact or stimulate tissue. Each anchor may include an anchor body portion (e.g., a "collar") having one or more barbs (e.g., one to six barbs), with one or more barbs extending (directly or indirectly) from the collar. For example, each anchor may have two barbs diametrically opposed to each other. The collar may be attached separately to the lead body, allowing different numbers of anchors to be fixed to the lead body depending on the procedure. The barbs can be folded or, otherwise, can be sufficiently flexible / malleable for delivery. The anchors can be arranged bidirectionally, with a first set of anchors having barbs extending distally (e.g., toward the stimulating electrode) and a second set of anchors having barbs extending proximally (e.g., toward 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 another anchor by, for example, 80 to 100 degrees (e.g., 85, 90, 100 degrees, or other values ​​within that range). In some embodiments, adjacent anchors can be circumferentially offset from each other.Optionally, each barb may extend from the end of its respective collar at an oblique angle (e.g., less than 45 degrees, less than 30 degrees, or less than 20 degrees) with respect to the longitudinal axis of the lead body. Each barb may 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 may be at least half the diameter of the lead body. The free end of the barb may have a radially tapered or chamfered edge. The electrode lead body may include one or more stoppers at either end or both ends of the anchor array, or between them. The stoppers may ensure that the anchors do not move or slip off the lead during revision or other high axial forces. The stoppers may be tubular bodies (e.g., made from pellethane). The tubular bodies may be longer than one of the anchors.

[0024] A method for providing access to the pudendal nerve is described herein. This method may include the steps of drawing a first line corresponding to the edge of the ischium (medial or lateral edge) and drawing a second line across the apex of the greater trochanter. This method may include the steps of 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 ischium. 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 in response to stimulation at 3 mA or less or 2 mA or less until EMG activity is present in the external anal sphincter. The EMG response may indicate that the tip of the stimulating needle is positioned on or near the pudendal nerve. This method may include the steps of inserting a stimulating member (e.g., a stimulating needle or other elongated structure) using an ischiorectal approach and toward the marking needle or stimulating needle. The position of the stimulating member may be confirmed using EMG. For example, an EMG response in the external anal sphincter followed by an EMG response in the pelvic floor can indicate the optimal positioning of the stimulator. If no response is detected, the stimulator can be adjusted. In some methodologies, positioning can be confirmed by detecting only an EMG response in the pelvic floor following each adjustment. After the position of the stimulator is confirmed, one of the electrode lead devices described herein can be implanted at the location of the stimulator. In some methodologies, the position of the stimulator can be confirmed based solely on an EMG response in the external anal sphincter.

[0025] The electrode lead device described herein can be delivered using a lead positioning guide, which allows confirmation of the stimulation electrode at the target site before deploying 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 most proximal 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 stimulation electrode is positioned at the distal portion of the introducer. For example, the lead can be locked in the lead positioning guide using a locking nut, and the locking nut can be a tapered nut. The lead positioning guide may include an indicator (e.g., a marker band) to provide an indication when the stimulation electrode is positioned at the distal portion of the introducer. With the anchor remaining constrained within the introducer, the introducer can be withdrawn to expose the stimulation electrode. The lead positioning guide and / or the introducer may have an alignment feature to indicate when only the stimulation electrode is exposed from the distal end of the introducer. In this configuration, the position of the stimulation electrode can be adjusted until the clinician confirms that the stimulation electrode is in the correct position. The lead positioning guide and / or the introducer may have a feature for preventing further withdrawal of the introducer until the position of the stimulation electrode is confirmed. After the position of the stimulation electrode is confirmed, the lead positioning guide can be rotated relative to the introducer to allow further withdrawal of the introducer. The introducer can be further withdrawn to deploy the anchor.

[0026] Aspects of the present disclosure describe electrode lead devices for treating diseases (for example, in the pelvic region), the devices having the following features: a lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; and a plurality of anchors, each anchor comprising a collar and two or more barbs extending from the collar, the plurality of anchors positioned on the lead proximal to one or more stimulating electrodes, the first anchor of the plurality of anchors being adjacent to a second anchor of the plurality of anchors, the two or more barbs of the first anchor being positioned at a predetermined rotational angle from the two or more barbs of the second anchor along the length of the lead, and / or, one or more stimulating electrodes being configured to deliver electrical stimulation to target tissue. In some embodiments, the target tissue comprises the pudendal nerve or tissue adjacent to the pudendal nerve. In some embodiments, the disease is in the pelvic region and comprises urinary incontinence, fecal incontinence, sexual dysfunction, pelvic pain, or any combination thereof. In some embodiments, the first or second anchor is releasably connected to the lead. In some embodiments, the two or more barbs include two, three, four, five, six, seven, eight, nine, or ten barbs. In some embodiments, the two or more barbs are arranged 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, the first barb of two or more barbs of a first anchor or second anchor is positioned at a predetermined rotational angle (for example, between about 1 and about 180 degrees, between about 0 and about 30 degrees, between about 15 and about 45 degrees, between about 30 and about 60 degrees, between about 45 and about 75 degrees, between about 60 and about 90 degrees, between about 75 and about 105 degrees, between about 90 and about 120 degrees, between about 105 and about 135 degrees, between about 120 and about 150 degrees, between about 135 and about 165 degrees, and between about 150 and about 180 degrees) from the second barb of two or more barbs of the first anchor or second anchor. In some embodiments, the anchors include a third anchor, the third anchor being adjacent to a second or first anchor. In some embodiments, the third anchor includes a first barb of two or more barbs positioned at a predetermined rotational angle from the second barb of two or more barbs of the first or second anchor. In some embodiments, the first and second anchors have a gap between them. In some embodiments, the gap includes 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 two or more barbs of the first anchor and the surface of the collar of the second anchor. In some embodiments, the two or more barbs are configured to extend apart at a predetermined angle with respect to the axial axis of the collar. In some embodiments, the collar includes an inner diameter of at least about 1.3 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 maximum length of 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 are extended, 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 collar's cross-section at an angle of about 10 to about 80 degrees from the axial axis of the collar (e.g., 60 degrees or less, 50 degrees or less, 45 degrees or less, 40 degrees or less, or 30 degrees or less). In some embodiments, the free ends of the barbs of the two or more barbs of a first anchor extend toward the distal end of the lead, and the free ends of the barbs of the two or more barbs of a second anchor extend toward the proximal end of the lead. In some embodiments, the two or more barbs include a thermally cured barb, and the thermally cured barb in the extended state extends at an angle of about 20 to about 65 degrees from the axial axis of the collar. In some embodiments, the two or more barbs include a width of at least about 0.2 mm. In some embodiments, two or more barbs include a thickness of at least about 0.2 mm. In some embodiments, two or more barbs include a thickness of up to about 0.35 mm. In some embodiments, two or more barbs include a thickness of about 0.2 mm to about 0.35 mm. In some embodiments, two or more barbs include a rectangular or triangular profile. In some embodiments, two or more barbs include a profile that matches the curvature of the color surface. In some embodiments, one or more edges of the free ends of a pair of tines or barbs are chamfered or filleted edges. In some embodiments, one or more filleted edges of the free ends of two or more barbs include a radius of at least about 0.35 mm. In some embodiments, the first or second anchor is made from 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 from a material having a stiffness of at least about 55D Shore. In some embodiments, the first and second anchors are made from a material having a stiffness of at most about 75D Shore. In some embodiments, the first and second anchors are made from 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 cut features arranged along the edge of one of two or more barbs. In some embodiments, one or more cut features include a circular geometric shape, the circular geometric shape including a diameter of about 0.25 mm to about 0.5 mm. 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 hardness of at least about 60D, 65D, 70D, 75D, 80D, 85D, or 90D Shore hardness. In some embodiments, the device further includes an introducer, which includes a lumen configured to receive a lead and a first or second anchor and to guide the implantation of the lead and the first or second anchor. In some embodiments, the introducer is configured to fold or compact the first or second anchor as the lead 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), which includes a lumen diameter configured to receive a lead, and the LPG fixes the position of the lead as the introducer is retracted over the lead and the first or second anchor.In some embodiments, the introducer includes a lumen diameter configured to accept 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 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, the first and second inner diameters being 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 mm, 1–2 mm, 2–3 mm, 3–4 mm, 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 is recessed over a first or second anchor connected to the lead, thereby extending two or more barbs of the first or second anchor and securing the lead to tissue in or near the pudendal nerve. In some embodiments, the introducer includes sizes ranging from about 1 French (F) to about 15F, for example, 10F or less (3F, 4F, 5F, 6F, 7F, or other values). 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, the fascial tissue and periosteal tissue of the falciform process, 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.

[0027] Aspects of the present disclosure describe a method for attaching an electrode lead to tissue, the method comprising: the steps of: placing the electrode lead in a target tissue, wherein the electrode lead comprises (i) a lead, the lead including one or more stimulating electrodes positioned near the 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, the plurality of anchors being releasably positioned on the lead proximal to one or more stimulating electrodes, the first anchor of the plurality of anchors being adjacent to a second anchor of the plurality of anchors, the two or more barbs of the first anchor being positioned at a predetermined rotational angle from the two or more barbs of the second anchor along the length of the lead, and the one or more stimulating electrodes being configured to deliver electrical stimulation to the target tissue; and removing a sheath covering at least a portion of the first or second anchor, unfolding the first or second anchor, and 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 the step of stimulating the target tissue with electrode leads to treat a disease in the pelvic region. In some embodiments, the disease includes urinary incontinence, fecal incontinence, pain, sexual dysfunction, or any combination thereof. In some embodiments, a first or second anchor is releasably connected to the electrode leads. In some embodiments, the two or more barbs include two, three, four, five, six, seven, eight, nine, or ten barbs. In some embodiments, the two or more barbs are arranged 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, the first barb of two or more barbs of a first anchor or a second anchor is positioned at a predetermined rotational angle from about 1 degree to about 180 degrees from the second barb of two or more barbs of the first anchor or a second anchor. 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 anchors include a third anchor, the third anchor being adjacent to the second anchor or the first anchor. In some embodiments, the third anchor includes the first barb of two or more barbs positioned at a predetermined rotational angle from the second barb of two or more barbs of the first anchor or the second anchor. In some embodiments, the first and second anchors have a gap between them. In some embodiments, the gap includes a length from about 1 mm to about 5 mm. In some embodiments, the gap is between the surface of the free end of one of the two or more 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 a predetermined angle away from the axial axis of the collar. In some embodiments, the collar has an inner diameter of at least about 1.30 mm. In some embodiments, the collar has a thickness of at least about 0.35 mm. In some embodiments, the length of the collar is at least about 2.5 mm. In some embodiments, the length of the collar is up to about 5 mm. In some embodiments, the length of the collar is from 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 have a length of at least about 1.5 mm. In some embodiments, when two or more barbs are extended, 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, two or more barbs extend along the radial axis of the collar's cross-section at an angle of about 10 to about 80 degrees from the collar's axial axis. In some embodiments, the free ends of the barbs among the two or more barbs of a first anchor extend toward the distal end of the electrode lead, and the free ends of the barbs among the two or more barbs of a second anchor extend toward the proximal end of the electrode lead. In some embodiments, the two or more barbs include a thermally cured barb, and the thermally cured barb in the extended state extends at an angle of about 20 to about 65 degrees from the collar's axial axis. 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, two or more barbs include a profile that matches the curvature of the color surface. In some embodiments, one or more edges of the free ends of a pair of horns or barbs are chamfered or filleted. In some embodiments, one or more filleted edges of the free ends of two or more barbs include a radius of at least about 0.35 mm. In some embodiments, the first or second anchor is made from 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 from a material having a stiffness of at least about 55D Shore. In some embodiments, the first and second anchors are made from a material having a stiffness of at most about 75D.In some embodiments, the first and second anchors are made from a material having a stiffness of about Shore 55D to about Shore 75D. In some embodiments, the first and second anchors include a serrated profile. In some embodiments, the serrated profile includes one or more cut features arranged along the edges of the barbs of two or more barbs. In some embodiments, one or more cut features include a circular geometric shape, the circular geometric shape includes a diameter of about 0.25 mm to about 0.5 mm. In some embodiments, the sheath includes a hardness of at least about 60D, 65D, 70D, 75D, 80D, 85D, or 90D Shore hardness. In some embodiments, the sheath is made from an aromatic polyether-based thermoplastic polyurethane. In some embodiments, the method further includes the step of folding or compacting two or more barbs of the first or second anchor when the first or second anchor is translated axially through an introducer. In some embodiments, the introducer is made from a polymer 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 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, the first and second inner diameters being different.In some embodiments, the first inner diameter comprises a diameter of at least about 3.8 mm, and the second inner diameter comprises a diameter of at least about 6.5 mm. In some embodiments, the introducer is retracted over the first anchor or the second anchor connected to the electrode lead, thereby expanding two or more barbs of the first anchor or the second anchor to fix the electrode lead to tissue at or near the pudendal nerve. In some embodiments, the introducer comprises a size from about 1 French (F) to about 15 F. In some embodiments, the method further comprises the step of fixing the position of the electrode lead by a lead positioning guide (LPG) when the sheath covering at least a portion of the first anchor or the second anchor is removed. In some embodiments, the introducer comprises a lumen configured to receive the LPG. In some embodiments, the first anchor or the second anchor is implanted in connective tissue. In some embodiments, the connective tissue comprises 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 anchor or the second anchor is manufactured by additive 3D printing, laser cutting, injection molding, or a combination thereof. In some embodiments, the additive 3D printing comprises selective laser sintering.

[0028] Aspects of the present disclosure describe a kit for treating a disease (for example, in the pelvic region), the kit comprising the following components: (a) an electrode lead device, the electrode lead device comprising (i) a lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; (ii) a plurality of anchors, each anchor comprising a collar and two or more barbs extending from the collar, the plurality of anchors provided in fixed positions on the lead proximal to one or more stimulating electrodes, the first anchor of the plurality of anchors being adjacent to a second anchor of the plurality of anchors, the two or more barbs of the first anchor being positioned at a predetermined rotational angle from the two or more barbs of the second anchor along the length of the lead, and one or more stimulating electrodes being configured to deliver electrical stimulation to target tissue; and (b) instructions for placing or anchoring the electrode lead to target tissue. In some embodiments, the target tissue comprises the pudendal nerve or tissue adjacent to the pudendal nerve. In some embodiments, the disease is in the pelvic region and includes urinary incontinence, fecal incontinence, pain, sexual dysfunction, or any combination thereof. In some embodiments, the instructions include instructions in an insert, instructions on a website, or a combination thereof. In some embodiments, the two or more barbs include two, three, four, five, six, seven, eight, nine, or ten barbs. In some embodiments, the two or more barbs are arranged 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] Aspects of this disclosure describe a method for manufacturing an anchor, the method which may include one or more of the following features or steps: (a) a step of molding a first half and a second half of an anchor body, wherein the first half of the anchor includes a first barb region, the second half of the anchor body includes a second barb region, the first half of the anchor body is made from the same material as the first barb region, and the second half of the anchor is made from the same material as the second barb region; and (b) a step of fixing the first half and the second half of the anchor body to form an anchor body. In some embodiments, the molding includes injection molding. In some embodiments, the first half and the second half of the anchor body include removablely connected features configured to be removed or detached 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 comprises thermoplastic polyurethane elastomer (TPU). In some embodiments, the polymer comprises thermoplastic polyurethane. In some embodiments, the polymer comprises 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 Shore 55D.

[0030] In some aspects, the techniques described herein relate to a system for placing electrodes in the pelvic region, the system comprising: a lead, the lead comprising one or more stimulating electrodes positioned at or near the distal end of the lead; a plurality of anchors, each anchor comprising a collar and two or more barbs extending from the collar, the plurality of anchors positioned on the lead proximal to one or more stimulating electrodes; and an introducer configured to slide over the lead and the plurality of anchors, the introducer The present invention relates to one or more of the following: an introducer having a handle; and a lead positioning guide, the lead positioning guide comprising an elongated guide body having a collet at the proximal end of the elongated guide body, and the lead positioning guide comprising a guide lumen passing through the elongated guide body, and one or more guide arms extending distally from the elongated guide body, and the lead positioning guide comprising a locking cap configured to fit over the collet, and one or more guide arms configured to engage with an introducer handle. In some embodiments, the technique described herein relates to a system, and one or more guide arms are two guide arms. In some embodiments, the technique described herein relates to a system, and the introducer handle has a proximal surface comprising one or more projections including a stem and an overhang above the stem. In some embodiments, the technique described herein relates to a system, and one or more guide arms have a distal end comprising an arm stem and an arm overhang. In some embodiments, the techniques described herein, with respect to the system, have an arm overhang thickness that is substantially the same as or less than the height of the stem of the introducer handle.In some embodiments, the techniques described herein relate to a system in which the arm overhang is configured to fit removably below the overhang of the introducer handle by the stem. In some embodiments, the techniques described herein relate to a system in which the arm overhang is configured to fit removably above the proximal surface of the introducer handle. In some embodiments, the techniques described herein relate to a system in which the introducer handle is firmly fixed to the lead positioning guide when the arm overhang is below the overhang of the introducer handle by the stem. In some embodiments, the techniques described herein relate to a system in which the introducer is firmly fixed to the lead positioning guide in the proximal-distal direction. In some embodiments, the techniques described herein relate to a system in which rotation of the lead positioning guide around the proximal-distal axis relative to the introducer handle changes the level of engagement between one or more guide arms and the introducer handle. In some embodiments, the techniques described herein relate to a system in which rotation of the lead positioning guide disengages one or more guide arms from the introducer handle. In some embodiments, the techniques described herein relate to a system in which the introducer is movable in a proximal-distal direction relative to the lead positioning guide. In some embodiments, the techniques described herein relate to a system in which the arm overhang is at a predetermined angle from the arm step (e.g., L-shaped). In some embodiments, the techniques described herein relate to a system in which the arm overhang includes a curved surface, a hook-shaped surface, a rectangular surface, or a combination thereof. In some embodiments, the techniques described herein relate to a system in which the overhang of the introducer handle engages with the arm overhang. In some embodiments, the techniques described herein relate to a system in which the guide lumen is configured to slidably fit onto the lead.In some embodiments, the technique described herein relates to a system in which the collet has a tapered proximal end. In some embodiments, the technique described herein relates to a system in which the collet has a diameter that is reduced when the locking cap moves distally over the collet from the unlocked position to the locked position. In some embodiments, the technique described herein relates to a system in which the guide lumen in the collet has a diameter that is reduced when the locking cap moves distally over the collet from the unlocked position to the locked position. In some embodiments, the technique described herein relates to a system in which, when the lead is installed through the guide lumen, the lead is fixed within the guide lumen of the elongated guide body by the locking cap being in the locked position over the collet. In some embodiments, the technique described herein relates to a system in which the lead is fixed within the guide lumen of the collet in the proximal-distal direction. In some embodiments, the technique described herein relates to a system in which the elongated guide body has threads. In some embodiments, the technique described herein relates to a system in which the locking cap has threads that fit with the threads of an elongated guide body and is configured to move the locking cap in a proximal-distal direction. In some embodiments, the technique described herein relates to a system in which the lead is fixed in the guide lumen of the elongated guide body by the locking cap when the lead is installed through the guide lumen. In some embodiments, the technique described herein relates to a system in which the lead includes a wire that is variably rotated along a portion of the lead. In some embodiments, the technique described herein relates to a system in which the wire has about 2 to about 15 turns per 70 mm of lead. In some embodiments, the technique described herein relates to a system in which the wire has about 7 to about 10 turns per 70 mm of lead.In some embodiments, the techniques described herein, with respect to the system, the wire has about 8 turns per 70 mm of lead. In some embodiments, the techniques described herein, with respect to the system, the wire has about 1 full turn to about 5 full turns per 70 mm of lead. In some embodiments, the techniques described herein, with respect to the system, the wire has about 1.5 full turns to about 2.5 full turns per 70 mm of lead. In some embodiments, the techniques described herein, with respect to the system, the wire has about 2 full turns per 70 mm of lead. In some embodiments, the techniques described herein, with respect to the system, the wire varies by at least about 0.1 turns, 0.5 turns, 1 turn, 1.5 turns, 2 turns, 2.5 turns, 3 turns, 3.5 turns, 4 turns, 4.5 turns, 5 turns, 5.5 turns, 6 turns, 6.5 turns, 7 turns, 7.5 turns, or 8 turns per 70 mm in two different parts of the lead. In some embodiments, the techniques described herein relate to a system in which the rotation of the wire is reduced in or near a connector, stiffener, or electrode, or a combination thereof. In some embodiments, the techniques described herein relate to a system in which the wire comprises a sufficiently malleable material to allow variable coiling. In some embodiments, the techniques described herein relate to a system in which the wire comprises a platinum alloy. In some embodiments, the techniques described herein relate to a system in which the wire comprises platinum-iridium. In some embodiments, the techniques described herein relate to a system in which the elongated guide body comprises at least two radiopaque markers.

[0031] In some embodiments, the techniques described herein relate to a method, the method comprising: having multiple anchors on the lead and a portion of the elongated guide body of the lead positioning guide, with one or more stimulating electrodes on the lead and multiple anchors in a guide lumen, up to the proximal anchor of multiple anchors; using the introducer handle of the introducer and the lead positioning guide to deliver the lead and the distal portion of the introducer having multiple anchors into a target location in the pelvic region; and sliding the introducer handle proximal to one or more guide arms of the lead positioning guide. The method includes: engaging with the introducer and fixing it in a proximal-distal direction, exposing one or more stimulating electrodes on the lead while covering multiple anchors; verifying delivery of the exposed one or more stimulating electrodes to a target location; moving the lead positioning guide to disengage from the introducer handle; sliding the introducer handle proximal to expose multiple anchors and fixing the lead in a predetermined location in the pelvic region; moving the locking cap from a locked position to an unlocked position; and withdrawing the introducer and lead positioning guide from the pelvic region. In some embodiments, the technique described herein relates to a method, the method further including the step of adjusting the location of one or more stimulating electrodes, and repeating step (f). In some embodiments, the technique described herein relates to a method, the locking cap is moved distally over the collet of the lead positioning guide in the locked position. In some embodiments, the techniques described herein relate to a method in which the locking cap is rotated distally over the collet of the reed positioning guide in the locked position. In some embodiments, the techniques described herein relate to a method in which the locking cap is moved proximal over the collet of the reed positioning guide in the unlocked position.In some embodiments, the techniques described herein relate to a method in which the locking cap is rotated proximal to the collet of the lead positioning guide in the unlocked position. In some embodiments, the techniques described herein relate to a method in which, in step (h), two or more barbs of an anchor among a plurality of anchors extend outward to fix the lead into the surrounding tissue. In some embodiments, the techniques described herein relate to a method in which verification in step (f) includes the use of EMG. In some embodiments, the techniques described herein relate to a method in which the elongated guide body includes a radiopaque marker to indicate the location for setting up the introducer in step (c).

[0032] Novel features of this disclosure are specifically described in the attached claims. A better understanding of the features and merits of this disclosure will be obtained by referring to the following detailed description, which describes non-limiting embodiments for illustrative purposes (in which the principles of this disclosure are utilized), and to the attached drawings described below. Features from one drawing can be combined with features from other drawings. [Brief explanation of the drawing]

[0033] [Figure 1A] This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 1B] This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 1C] This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 1D] This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 1E]This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 1F] This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 1G] This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 1H] This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 1I] This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 1J] This figure shows an embodiment of an electrode lead introducer, as described in some embodiments herein. [Figure 2A] This figure shows an embodiment of an anchor, as described in some embodiments herein, in various figures or detail drawings. [Figure 2B] This figure shows an embodiment of an anchor, as described in some embodiments herein, in various figures or detail drawings. [Figure 2C] This figure shows an embodiment of an anchor, as described in some embodiments herein, in various figures or detail drawings. [Figure 2D] This figure shows an embodiment of an anchor, as described in some embodiments herein, in various figures or detail drawings. [Figure 2E] This figure shows an embodiment of an anchor, as described in some embodiments herein, in various figures or detail drawings. [Figure 2F] This figure shows an embodiment of an anchor, as described in some embodiments herein, in various figures or detail drawings. [Figure 2G] This figure shows an embodiment of an anchor, as described in some embodiments herein, in various figures or detail drawings. [Figure 3A] This figure shows embodiments of multiple anchors in a closed and / or compressed state on an electrode lead, as described in some embodiments herein. [Figure 3B] This figure shows embodiments of multiple anchors in a closed and / or compressed state on an electrode lead, as described in some embodiments herein. [Figure 3C] This figure shows embodiments of multiple anchors in a closed and / or compressed state on an electrode lead, as described in some embodiments herein. [Figure 3D] This figure shows embodiments of multiple anchors in a closed and / or compressed state on an electrode lead, as described in some embodiments herein. [Figure 4A] This figure shows embodiments of multiple anchors in an open and / or spread-out state on an electrode lead, as described in some embodiments herein. [Figure 4B] This figure shows embodiments of multiple anchors in an open and / or spread-out state on an electrode lead, as described in some embodiments herein. [Figure 4C] This figure shows embodiments of multiple anchors in an open and / or spread-out state on an electrode lead, as described in some embodiments herein. [Figure 4D] This figure shows embodiments of multiple anchors in an open and / or spread-out state on an electrode lead, as described in some embodiments herein. [Figure 5]This figure shows embodiments of electrode leads and the spacing of one or more anchors on the electrode leads, as described in some embodiments herein. [Figure 6A] This figure shows embodiments of serrated (Figures 6A-6B) barb anchors and anchors having a triangular profile, as described in some embodiments herein. [Figure 6B] This figure shows embodiments of serrated (Figures 6A-6B) barb anchors and anchors having a triangular profile, as described in some embodiments herein. [Figure 6C] This figure shows embodiments of serrated (Figures 6A-6B) barb anchors and anchors having a triangular profile, as described in some embodiments herein. [Figure 7A] This figure shows an embodiment of a molded anchor, as described in some embodiments herein. [Figure 7B] This figure shows an embodiment of a molded anchor, as described in some embodiments herein. [Figure 8A] This figure shows embodiments of multiple anchors on an electrode, with elongated bodies of pushers and introducers, as described in some embodiments herein. [Figure 8B] This figure shows embodiments of multiple anchors on an electrode, with elongated bodies of pushers and introducers, as described in some embodiments herein. [Figure 8C] This figure shows embodiments of multiple anchors on an electrode, with elongated bodies of pushers and introducers, as described in some embodiments herein. [Figure 9A]This figure shows embodiments of multiple anchors on an electrode lead that is compressed or closed, as the electrode lead and multiple anchors are pushed through the elongated body lumen of the introducer by a pusher, as described in some embodiments herein. [Figure 9B] This figure shows embodiments of multiple anchors on an electrode lead that is compressed or closed, as the electrode lead and multiple anchors are pushed through the elongated body lumen of the introducer by a pusher, as described in some embodiments herein. [Figure 9C] This figure shows embodiments of multiple anchors on an electrode lead that is compressed or closed, as the electrode lead and multiple anchors are pushed through the elongated body lumen of the introducer by a pusher, as described in some embodiments herein. [Figure 10A] This figure shows embodiments of the multiple anchors on the electrode leads exiting the lumen of the elongated body of the introducer as the introducer is removed and / or pulled back over the pusher, electrode leads, and multiple anchors on the electrode leads. [Figure 10B] This figure shows embodiments of the multiple anchors on the electrode leads exiting the lumen of the elongated body of the introducer as the introducer is removed and / or pulled back over the pusher, electrode leads, and multiple anchors on the electrode leads. [Figure 10C] This figure shows embodiments of the multiple anchors on the electrode leads exiting the lumen of the elongated body of the introducer as the introducer is removed and / or pulled back over the pusher, electrode leads, and multiple anchors on the electrode leads. [Figure 11] This figure shows the flow of attaching an electrode lead to tissue, as described in some embodiments herein. [Figure 12] This is a flowchart of the steps for performing the implantation of electrode leads and implantable pulse generators (IPGs), as described in some embodiments herein. [Figure 13] This is a schematic diagram of the anatomical structure and arrangement of the lead and IPG within an individual, as described in some embodiments herein. [Figure 14] This is a schematic diagram of the anatomical structures within an individual and the implanted lead and IPG, as described in some embodiments herein. [Figure 15] This is a schematic diagram of the anatomical structures within an individual and the implanted lead and IPG, as described in some embodiments herein. [Figure 16A] This figure shows embodiments of the anatomical pathway of a lead using an anatomical model, as described in some embodiments herein. [Figure 16B] This figure shows embodiments of the anatomical pathway of a lead using an anatomical model, as described in some embodiments herein. [Figure 17] This figure shows an embodiment of a lead positioning guide (LPG), as described in some embodiments herein. [Figure 18A] This figure shows an embodiment in which a lead is secured in a lead positioning guide (LPG) by a locking cap, as described in some embodiments herein. [Figure 18B] This figure shows an embodiment in which a lead is secured in a lead positioning guide (LPG) by a locking cap, as described in some embodiments herein. [Figure 18C]This figure shows an embodiment in which a lead is secured in a lead positioning guide (LPG) by a locking cap, as described in some embodiments herein. [Figure 19] This figure shows embodiments of a lead positioning guide (LPG) and sheath handle having a small overhang configuration, as described in some embodiments herein. [Figure 20] This figure shows embodiments of a lead positioning guide (LPG) and sheath handle having an extended overhang configuration, as described in some embodiments herein. [Figure 21] This figure shows embodiments of a lead positioning guide (LPG) and sheath handle having a curved surface overhang configuration, as described in some embodiments herein. [Figure 22] This figure shows embodiments of a lead positioning guide (LPG) and sheath handle having a pin-lock configuration, as described in some embodiments herein. [Figure 23A] This figure shows embodiments of a lead positioning guide (LPG) and sheath handle having a wide locking configuration, as described in some embodiments herein. [Figure 23B] This figure shows embodiments of a lead positioning guide (LPG) and sheath handle having a wide locking configuration, as described in some embodiments herein. [Figure 24A] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24B] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24C] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24D] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24E] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24F] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24G] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24H] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24I] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24J]This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 24K] This figure shows an embodiment of positioning a lead by an anchor fixing device using a lead positioning guide (LPG) and introducer, as described in some embodiments herein. [Figure 25] This figure shows an embodiment of the helical lead body, as described in some embodiments herein. [Figure 26] This figure shows an embodiment of positioning a lead or needle using an obturator and introducer, as described in some embodiments. [Figure 27] This is a schematic diagram of surface markings drawn on an individual to locate the pudendal nerve, as described in some embodiments herein. [Figure 28] This is a schematic diagram of a lateral view of the anatomical structures within an individual and the inserted marking needle, as described in some embodiments herein. [Figure 29] This is a schematic diagram of bilateral lead placement in the pudendal nerve, as described in some embodiments herein. [Figure 30] This figure shows embodiments of modular anchor assemblies (Figures 30A-30B) and helical anchor assemblies, as described in some embodiments herein. [Figure 31] This figure shows an embodiment of an anchor including a mating feature, as described in some embodiments herein. [Modes for carrying out the invention]

[0034] Electrical stimulation has clinical applications in providing treatment and / or management for a variety of clinical conditions (e.g., within the pelvic region). For example, electrical stimulation can be used to treat medical conditions and / or diseases within the pelvic region such as urinary incontinence, fecal incontinence, pain, sexual dysfunction, or any combination thereof.

[0035] While specific devices, systems, methods, and kits are described herein in relation to the pelvic region for treating and / or managing pelvic disorders, these methods and devices can also be used to treat other disorders in other areas of the body. Anchors can be used to fix implantable devices in other areas of the body and / or to treat other disorders. In some embodiments, anchors can be applied to an electrode lead body implanted in the spinal region, for example, to treat chronic or incidental pain. Anchors can be applied to an electrode lead body in or near the spine to treat pain (e.g., the caudal spinal region of the occipital region or other spinal regions). In other embodiments, anchors can be applied to an electrode lead body implanted near a peripheral or cranial nerve. For example, anchors can be applied to an electrode lead body implanted near the vagus nerve (e.g., in the facial / cranial region) for the treatment of several disorders (including, but not limited to, balance problems, headaches, and migraines). In some embodiments, anchors can be applied to implantable devices used outside the field of neuromodulation. For example, anchors can be applied to sutures used in soft tissue repair (e.g., rotator cuff repair) instead of clips. In some embodiments, anchors can be applied to non-implantable or acute-care devices such as catheters (e.g., drug delivery catheters or drainage catheters).

[0036] Electrode leads can be implanted in one or more target tissues and / or anatomical features (e.g., in the pelvic region) to provide electrical stimulation for therapeutic and / or management purposes. However, implanted electrode leads may experience axial tensile, compressive, torque, bending, or any combination thereof during activities such as deep flexion or femoral rotation caused by movements such as sitting to standing, climbing stairs, and / or movement during sleep, particularly due to the anatomical structure of the pelvis in the pelvic region. Furthermore, implanted electrode leads also experience compressive forces from surrounding soft tissues in cases where the subject with the implanted electrode is sitting or supine. Forces acting on the electrode lead can move and / or displace the electrode lead away from its target implantation site in the pelvis, and thus reduce the therapeutic effect provided by electrical stimulation to the target implantation site. Devices, systems, methods, and / or kits described elsewhere in this specification provide solutions for fixing and / or anchoring electrode leads at the target implantation site. Devices, systems, methods, and / or kits may include one or more anchors having one or more barbs capable of securing an electrode lead and / or preventing unwanted displacement of the electrode lead from its targeted implantation site, as described elsewhere herein. The orientation and / or rotation angle of one or more anchors and / or one or more barbs may, as described elsewhere herein, provide better-than-expected fixation of the electrode lead in or near spatially heterogeneous tissue (e.g., ligaments and / or other connective tissue in the pelvis where the electrode lead is implanted).

[0037] This specification provides devices, systems, methods, and / or kits for accessing target tissue (for example, in the pelvic cavity) and for anchoring electrical leads to targeted tissue for treatment by electrical nerve stimulation. The tissue may include connective tissue, nerve tissue, muscle tissue, ligamentous tissue, fascial tissue, fat, or any combination thereof. Connective tissue may include the sacrotuberous ligament, sacrospinous ligament, fascial and periosteal tissue of the falciform process, other dense tissues in the medial region of the ischial tuberosity, or any combination thereof. Target tissue may include the pudendal nerve or tissue adjacent to the pudendal nerve. This specification also describes devices, systems, methods, and / or kits for providing electrical nerve stimulation to an individual in need for preventing episodes of incontinence, treating pain, treating sexual dysfunction, or any combination thereof. Devices, systems, and methods for placing electrical leads in a target nerve site may include introducer sheaths, obturators, and needles and / or pushers, as described elsewhere in this specification. Pushers may also be referred herein to as lead positioning guides (LPGs) or anchor positioning guides (APGs). Pushers (also referred herein to as LPGs or APGs) may be used to stabilize the position or to create an axial force (pushing force) on the anchor when the sheath is removed. An introducer sheath may include an elongated shaft of a sheath having a lumen and a sheath handle at the distal end of the elongated body, and the introducer sheath is configured to receive an electrode on the outer surface of the elongated shaft of the sheath. An obturator may include an elongated shaft of an obturator having a lumen and an obturator handle at the distal end of the elongated shaft of the obturator, and the elongated shaft of the obturator is configured to fit inside a sheath lumen.The needle may include an elongated shaft, a needle handle at the distal end of the elongated shaft, and a needle tip at the proximal end of the elongated shaft, the elongated shaft of the needle being configured to fit inside the obturator lumen. The devices, systems, and methods for placing electrical leads in target tissue described herein can enable easier access to target tissue and more accurate electrode placement despite the complex three-dimensional anatomical structure of the pelvic region. The use of closed-loop and / or feedforward algorithmic stimulation of the electrode leads can reduce or minimize problems associated with stimulation tolerance issues that may reduce the effectiveness of nerve stimulation (e.g., PNS) over time. The devices, systems, methods, and / or kits provided herein can be compatible with electrophysiological guidance, either alone or in combination with radiological guidance, for accurate and reproducible electrode placement in target tissue (e.g., pudendal nerve). The devices, systems, and methods provided herein can enable more precise and reproducible placement of electrodes on hard-to-reach tissues of the pelvic cavity, which are less affected by the skill of the healthcare professional performing the procedure.

[0038] This specification describes devices, systems, methods, and / or kits for accessing a region within a subject (e.g., the pelvic region) to place and fix an electrical lead over a target tissue. The electrical lead can deliver 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 deliver electrical nerve stimulation to prevent episodes of incontinence in an individual who needs it. The devices, systems, and methods provided herein can access the pudendal nerve by a sciaticorectal approach. In some cases, the sciaticorectal approach may include a lead introducer that penetrates or passes near the sacrotuberous ligament and directs the lead to the pudendal trunk at a location proximal to Alcock's canal. The devices, systems, and methods provided herein can access the pudendal nerve by a lower gluteal approach (also referred herein to as a lower posterior approach). The lower gluteal approach can involve the lead introducer and lead passing through the space between the sacrotuberous and sacrospinous ligaments and anteriorly through the ischiorectal fossa in the lower part of the pelvic floor. Leads placed using the lower gluteal approach can stimulate the anterior branch of the pudendal nerve (including the dorsal genital nerve).

[0039] Electrode lead introducer This specification provides devices, systems, and methods for introducing and placing one or more electrode leads in one or more target tissues (for example, in the pelvic region). The target tissues may include the pudendal nerve for treating incontinence. The target tissues may include target tissues for receiving electrical stimulation for sexual dysfunction. The target tissues may include target tissues for receiving electrical stimulation for the treatment and / or management of pain. While specific devices, systems, methods, and kits are described herein in relation to the pelvic region for treating and / or managing pelvic disorders, these methods and devices may also be used to treat other diseases in other areas of the body, as described elsewhere in this specification.

[0040] An electrode lead introducer used to place an electrode into target tissue may include an introducer sheath, a dilator (also referred to herein as an obturator), and a needle. Figures 1A to 1F show embodiments of an electrode lead introducer 100. The electrode lead introducer may include an introducer sheath 114, an elongated body 116, an obturator 119, a needle 115, one or more electrodes (110, 120), one or more regions of electrode insulators (108, 123), or any combination thereof. The elongated body 116 may be partially or entirely covered, coated, or surrounded by the introducer sheath 114.

[0041] The introducer sheath may include an elongated shaft of the sheath having lumens and a sheath handle at the distal end of the sheath shaft. The introducer sheath may be configured to receive an electrode on the outer surface of the elongated shaft of the sheath. In some embodiments, the proximal end of the elongated shaft of the sheath may be angled. The angle of the proximal end of the elongated shaft of the sheath may allow the device to be advanced with little or no damage to surrounding tissue. The introducer sheath may have a diameter ranging from about 0.5 mm to about 5 mm.

[0042] The obturator may include an elongated shaft having a lumen and an obturator handle at the distal end of the elongated shaft. The elongated shaft of the obturator may be configured to fit inside a see-through lumen. The obturator may have a diameter ranging from approximately 0.5 mm to approximately 5 mm.

[0043] The needle may include an elongated shaft, a needle handle at the distal end of the elongated shaft, and a needle tip at the proximal end of the elongated shaft. The elongated shaft may be configured to fit inside the obturator lumen. The obturator handle may include a latch configured to attach to a sheath handle. In some embodiments, the needle tip may be configured to protrude beyond the end of the obturator lumen. The needle tip may protrude at least 1 mm beyond the end of the obturator lumen. The needle tip may be configured to protrude by the movement of the needle handle. The needle tip may be configured to retract into the obturator lumen. The needle tip may be angled from the elongated shaft. The needle tip angle may be configured to advance the needle tip through soft tissue. The needle may have a diameter from about 0.4 mm to about 2 mm. In some embodiments, the needle may have a diameter between 12 gauge and 26 gauge.

[0044] The elongated body portion 116 can be attached to, fastened to, and / or fused to the sheath handle 106 at one end of the elongated body portion 116 (also referred to herein as the elongated shaft), as shown in Figures 1A, 1C, 1E, and 1F. The introducer sheath 114 can be integrated with one or more electrodes and / or conductive regions (110, 120) and / or regions of one or more electrode insulators (108, 123). In some embodiments, the introducer sheath 114 can cover or surround the non-conductive regions (108, 123) of one or more electrodes (110, 120) integrated within the elongated body portion 116, either entirely or partially. The introducer sheath 114 can be made of a non-conductive biocompatible material (including, but not limited to, high-density polyethylene (HDPE), fluorinated ethylene propylene (FEP), polycarbonate, plastic, or any combination thereof). In some embodiments, at least a portion of the introducer sheath 114 may contain radiopaque additives (including, but not limited to, barium sulfate (BaSO4), bismuth subcarbonate (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 contain a barium sulfate (BaSO4) additive, allowing the user, healthcare professional, and / or surgeon to visualize the tip inside the patient's body. In some cases, one or more radiopaque markers may be present on the introducer sheath 114. In some cases, the introducer sheath 114 may be single-use and / or disposable. The introducer sheath 114 may be autoclavable and / or can be cleaned by conventional sterilization methodologies used for other similar medical devices (i.e., obturators, trocars, endoscopes, etc.).

[0045] The sheath handle 106 can be configured to allow a user, healthcare worker, and / or surgeon to operate and / or navigate the electrode lead inserter as it is advanced into the patient or subject. The sheath handle 106 can include an ergonomic geometric shape, such as one that can be operated by one hand of the user, healthcare worker, and / or surgeon, leaving the other hand completely free for other tasks. While the techniques described herein can be performed manually, in other embodiments the instrument can be incorporated into or controlled by a robotic system and / or facilitated using augmented reality.

[0046] The mechanical rigidity of the materials for the elongated body 116 and introducer sheath 114 can be selected to allow for easy insertion of the electrode lead introducer 100 into the patient. The Young's modulus of the introducer sheath 114 and elongated body 116 can allow the user, medical professional, and / or surgeon to maneuver the electrode lead inserter into the deep surgical plane of the pelvic region. The Young's modulus of the introducer sheath 114 and / or elongated body 116 can prevent bending or flexing of the combined elongated body 116 and introducer sheath when the user, medical professional, 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 elongated body 116 can reduce the total mechanical work required to insert the electrode lead introducer into the deep muscular and / or fatty surgical plane in the pelvic region while maintaining the position of the guidewire. The flexibility of the assembly allows the introducer and lead to follow the course of the guidewire without disturbing their position near the nerve. Higher sheath rigidity can allow for easier delivery of the lead in areas with high tissue density or tissue resistance. Higher sheath rigidity can allow for more precise placement of the lead to the target site in areas with high tissue density or tissue resistance around the target site. The rigidity of the material can be characterized by its Young's modulus. The introducer sheath 114 can have a Young's modulus from about 10 megapascals (MPa) to about 10,000 MPa. The elongated body 116 can have a Young's modulus from about 10 MPa to about 10,000 MPa. The introducer sheath can have higher rigidity than the introducer sheath typically used for accessing the sacral nerve. Higher rigidity can allow for easier access to the target tissue (e.g., the pudendal nerve) and easier placement of the electrode lead over the target anatomical structure.The sheath and needle combination can have a rigidity similar to that of a combined sheath and dilator of introducers typically used to access sacral nerves. In some cases, the sheath and needle combination of introducers can have a higher rigidity than a combined sheath and dilator of introducers typically used to access sacral nerves.

[0047] The elongated body portion 116 may include a length 112. The length 112 of the device may allow for proper operation of the device in patients with a variety of anatomical features to properly position one or more electrode leads, as described elsewhere in this specification. The length of the elongated body portion may refer to the insertable length. In some cases, variations in anatomical features between subjects may include enlargement or reduction in anatomical features surrounding or adjacent to the pudendal nerve, sacral nerve, or any combination or branch thereof.

[0048] The length of the elongated body portion 116 can range from approximately 10 centimeters (cm) to approximately 20 centimeters (cm). For example, the length of the elongated body portion 116 can range from approximately 12 cm to approximately 20 cm, approximately 13 cm to approximately 20 cm, or approximately 14 cm to approximately 20 cm. The length of the elongated body portion 116 can range from approximately 12 cm, approximately 13 cm, approximately 14 cm, approximately 15 cm, approximately 16 cm, approximately 17 cm, approximately 18 cm, approximately 19 cm, or approximately 20 cm. In some cases, the length of the elongated body portion 116 can range from at least approximately 12 cm, approximately 13 cm, approximately 14 cm, approximately 15 cm, approximately 16 cm, approximately 17 cm, approximately 18 cm, or approximately 19 cm. In some cases, the length of the elongated main body 116 can include a maximum distance of approximately 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, or 20 cm.

[0049] Figure 1D shows, in some embodiments, an elongated body portion 116, which includes an inner lumen diameter 150 configured such that the outer diameter 140 of the obturator 119 passes through the inner lumen of the elongated body portion by a slip-fit ​​mechanical interface.

[0050] The internal lumen diameter of the elongated body of 150 can range from approximately 0.5 mm to approximately 3 mm. In some cases, the internal lumen diameter of the elongated body of 150 can include distances of approximately 0.5 to approximately 4 mm, or approximately 0.5 mm to approximately 5 mm. The internal lumen diameter of the elongated body of 150 can include distances of approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, approximately 1 mm, approximately 1.1 mm, approximately 1.2 mm, approximately 1.3 mm, approximately 1.4 mm, approximately 1.5 mm, approximately 1.6 mm, approximately 1.7 mm, approximately 1.8 mm, approximately 2 mm, approximately 2.5 mm, or approximately 3 mm. In some cases, the elongated body's inner lumen diameter 150 can include distances of at least approximately 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 2 mm, or 2.5 mm. In some cases, the inner lumen diameter 150 can include distances of at most approximately 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 2 mm, 2.5 mm, or 3 mm. In some cases, the elongated body's inner lumen diameter 150 can be the diameter for receiving a guide wire, and the guide wire and the inner lumen diameter 150 are configured to include a slip-fit ​​mechanical interface.

[0051] The elongated outer diameter 142 can include diameters ranging from approximately 0.5 mm to approximately 10 mm. For example, the elongated outer diameter 142 can include diameters ranging from approximately 1 mm to approximately 10 mm, approximately 2 mm to approximately 10 mm, or approximately 3 mm to approximately 10 mm. The elongated outer diameter 142 can include diameters ranging from approximately 0.5 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 3.5 mm, approximately 4 mm, approximately 4.5 mm, approximately 5 mm, approximately 6 mm, approximately 8 mm, or approximately 10 mm. In some cases, the elongated outer diameter 142 can include diameters ranging from at least approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 3.5 mm, approximately 4 mm, approximately 4.5 mm, approximately 5 mm, approximately 6 mm, or approximately 8 mm. In some cases, the elongated outer diameter 142 of the main body can include diameters of up to approximately 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 6 mm, 8 mm, or 10 mm.

[0052] The elongated body portion 116 may include an angled facet 145 at one end of the elongated body portion 116, as shown in Figure 1D. The angled facet 145 of the elongated body portion 116 may be configured to allow the electrode lead introducer 100 to penetrate into a subject that accepts an electrode implanted in a manner similar to a pointed needle. The angled facet 145 at the proximal end of the elongated shaft of the sheath may allow the device to advance with little or no damage to surrounding tissue. The angled facet 145 may be angled at an angle 144 with respect to an angled facet 149 that is a mirror image of the elongated body portion 116 and is separated by only 180 degrees.

[0053] Angle 144 can include values ​​ranging from approximately 30 to 90 degrees. For example, angle 144 can include values ​​ranging from approximately 45 to 90 degrees, or approximately 60 degrees. Angle 144 can include values ​​ranging from approximately 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, or approximately 90 degrees. In some cases, angle 144 can include values ​​ranging from at least approximately 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, or approximately 80 degrees. In some cases, angle 144 can include values ​​of approximately 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, or 90 degrees at most.

[0054] The obturator 119 may include an elongated body portion 117 of the obturator having lumens, as shown in Figure 1F, and an obturator handle 104 at the end of the elongated body portion of the obturator. The elongated body portion 117 of the obturator may be made of plastic (e.g., ABS), metal, or any combination thereof. For example, the metal may include stainless steel, aluminum, titanium, or any combination thereof. The obturator may be made of stainless steel, aluminum, titanium, or any combination thereof with respect to the elongated body portion 117 of the obturator, and may further include a plastic handle 104. The elongated body portion 117 of the obturator may be configured to fit inside the elongated body portion 116 lumens.

[0055] The obturator 119 may further include a stiffening tube 2602, as shown in Figures 1G and 1J. The stiffening tube 2602 may be made of plastic (e.g., ABS), metal, or any combination thereof. For example, the stiffening tube 2602 may be made of stainless steel. The stiffening tube 2602 may run along the center of the elongated body 117. In some cases, the stiffening tube may be molded into the elongated body 117. The stiffening tube 2602 may be configured to improve the rigidity of the obturator 119. The stiffening tube may improve the control and positioning of the obturator 119. The obturator 119 may include a tapered distal tip 2604.

[0056] The elongated body portion 117 of the obturator can include an outer diameter 140. The outer diameter 140 of the elongated body portion 117 of the obturator can include a diameter of approximately 0.5 mm to approximately 5 mm. For example, the outer diameter 140 of the elongated body portion 117 of the obturator can include a diameter of approximately 0.6 mm to approximately 5 mm, or approximately 1 mm to approximately 5 mm. The outer diameter 140 of the elongated body portion 117 of the obturator can include a diameter of approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 4 mm, or approximately 5 mm. In some cases, the outer diameter 140 of the elongated body portion 117 of the obturator can include diameters of at least approximately 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, or 4 mm. In some cases, the outer diameter 140 of the elongated body portion 117 of the obturator can include diameters of at most approximately 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, or 5 mm.

[0057] The obturator 119 may include an inner lumen, as shown in Figure 1D. The inner lumen may include an inner diameter 148. The inner lumen of the obturator 119 may include a diameter such that the needle body 102 and the obturator inner lumen can be mechanically connected by a slip-fit ​​interface.

[0058] The inner diameter 148 of the inner lumen of the obturator 119 can include a diameter of approximately 0.2 mm to approximately 1.4 mm. For example, the inner diameter 148 of the inner lumen of the obturator 119 can include a diameter of approximately 0.3 mm to approximately 1.4 mm, or approximately 0.5 mm to approximately 1.4 mm. The inner diameter 148 of the inner lumen of the obturator 119 can include a diameter of approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, approximately 1 mm, approximately 1.2 mm, or approximately 1.4 mm. In some cases, the inner diameter 148 of the inner lumen of the obturator 119 can include diameters of at least approximately 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, or 1.2 mm. In some cases, the inner diameter 148 of the inner lumen of the obturator 119 can include diameters of at most approximately 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.2 mm, or 1.4 mm.

[0059] The obturator 119 can be configured to assist in the insertion of the elongated body 116 into the patient / subject receiving the electrode lead implant by providing structural rigidity. The elongated body 117 of the obturator can include a region 151 that protrudes a predetermined distance from the elongated body 116, as seen in Figure 1D. The region 151 that protrudes a predetermined distance from the elongated body 116 can include a blunt projection. The region 151 that protrudes a predetermined distance from the elongated body 116 can include a projection having an angle parallel to the angle of the angular facet 145 of the elongated body 116 as described elsewhere in this specification. The region 151 can include a tapered tip. The tapered tip can include a slender, bullet-shaped tip configured to penetrate a region having high tissue density.

[0060] The distance of the protrusion 151 that can extend beyond the end of the elongated main body 116 can be approximately 0.2 mm to approximately 3 mm. For example, the distance of the protrusion 151 that can extend beyond the end of the elongated main body 116 can be 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 distance of the protrusion 151 that can extend beyond the end of the elongated main body 116 can be 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 cases, the distance of the projection 151 that can extend beyond the end of the elongated main body 116 can be 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 cases, the distance of the projection 151 that can extend beyond the end of the elongated main body 116 can be 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.

[0061] The obturator handle 104 can be mechanically coupled to the sheath handle 106, as shown in Figures 1A and 1E. The mechanical coupling between the obturator handle 104 and the sheath handle 106 can include a hook and latch, a quick release, or any combination thereof. The obturator handle 104 can include a coupling receiver 105 configured to receive and fasten to the coupling mechanism of the needle handle 129, as seen in Figure 1E. The coupling receiver 105 can include a coupling feature 121, which is configured to interface with the needle handle 129 when the needle body 102 is inserted into the inner lumen of the elongated body 117 of the obturator. For example, the coupling feature 121 can be configured to slide along a track on the needle handle 129. The connecting feature 121 can interface with the track of the needle handle 129 by an interference fit at a predetermined location on the track, thereby providing an interference fit-based mechanical fastening between the needle 115 and the obturator 119.

[0062] The obturator handle 104 can be mechanically coupled to the sheath handle 106, as shown in Figure 1H. The mechanical coupling between the obturator handle 104 and the sheath handle 106 can include hooks and latches, quick releases, or any combination thereof. For example, the obturator handle 104 can include an overhang 2606. The introducer handle 106 can include a receiving tab 2608, which is configured to receive and fasten to the overhang 2606 of the obturator handle 104. The receiving tab 2608 can be configured to fasten to receive and connect the LPG, as shown in Figures 20-21.

[0063] The obturator 119 may include an elongated body portion 117 of the obturator having a stiffening tube 2602, and an obturator handle 104 at the end of the elongated body portion of the obturator. The stiffening 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 stiffening tube of the obturator may be made of stainless steel, aluminum, titanium, or any combination thereof, while the obturator handle 104 may include plastic. The obturator handle may include a high-viscosity polyamide. For example, the obturator handle may include vestamid.

[0064] The obturator 119 may include an elongated body 117 of the obturator having lumens, as shown in Figure 1F, and an obturator handle 104 at the end of the elongated body of the obturator. The elongated body 117 of the obturator may be made of plastic (e.g., ABS), metal, or any combination thereof.

[0065] The needle 115 may include an elongated body portion 102, a needle handle 129 at one end of the elongated shaft of the needle, and a needle tip portion 118 at the other end of the elongated shaft of the needle. The elongated body portion 102 may be configured to fit into the inner lumen of the obturator (specified by the inner diameter 148 of the inner lumen of the obturator). The elongated body portion may include an outer diameter 138, as seen in Figure 1D. This fit may include a slip fit between the inner diameter 148 of the inner lumen of the obturator and the outer diameter 138 of the elongated body portion of the needle. The needle 115 may be constructed from stainless steel, aluminum, titanium, or any combination thereof. The needle 115 may be hollow, or partially hollow and / or partially solid. The needle 115 may be constructed from rigid, indeformable plastic and / or polymer.

[0066] The outer diameter 138 of the elongated body of the needle can include a diameter of approximately 0.1 mm to approximately 3 mm. For example, the outer diameter 138 of the elongated body of the needle can include a diameter of approximately 0.3 mm to approximately 3 mm, approximately 0.5 mm to approximately 3 mm, or approximately 1 mm to approximately 3 mm. The outer diameter 138 of the elongated body of the needle can include a diameter of approximately 0.1 mm, approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.8 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, or approximately 3 mm. In some cases, the outer diameter 138 of the elongated body of the needle can include a diameter of at least approximately 0.1 mm, approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.8 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, or approximately 2.5 mm. In some cases, the outer diameter 138 of the elongated body of the needle can include a maximum diameter of approximately 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.8 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, or 3 mm.

[0067] The elongated outer diameter 138 of the needle body can include diameters ranging from approximately 12 American Wire Gauge (AWG) to approximately 26 AWG. For example, the elongated outer diameter 138 of the needle body can include diameters ranging from 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 24 AWG, approximately 12 AWG to approximately 26 AWG, and approximately 16 AWG to approximately 18 AWG. G can include diameters of approximately 16AWG to 20AWG, 16AWG to 22AWG, 16AWG to 24AWG, 16AWG to 26AWG, 18AWG to 20AWG, 18AWG to 22AWG, 18AWG to 24AWG, 18AWG to 26AWG, 20AWG to 22AWG, 20AWG to 24AWG, 20AWG to 26AWG, 22AWG to 24AWG, 22AWG to 26AWG, or 24AWG to 26AWG. The elongated outer diameter 138 of the needle body can include diameters of approximately 12AWG, 14AWG, 16AWG, 18AWG, 20AWG, 22AWG, 24AWG, or 26AWG. In some cases, the elongated outer diameter 138 of the needle body can include diameters of at least approximately 12AWG, 14AWG, 16AWG, 18AWG, 20AWG, 22AWG, or 24AWG. In some cases, the elongated outer diameter 138 of the needle body can include diameters of at most approximately 14AWG, 16AWG, 18AWG, 20AWG, 22AWG, 24AWG, or 26AWG.

[0068] The needle handle 129 may include a connecting feature 130 configured to connect to an obturator connecting feature 121, as described elsewhere in this specification. The needle handle connecting feature 130 may include a path or slot feature, thereby allowing the obturator connecting feature 121 to travel within it when inserting the needle 115 into the inner lumen of the obturator, and to apply tension and / or retaining force when rotated around the central axis of the needle 115 and the obturator 119. The needle handle may be rotated by rotating one or more flanges 131 of the needle handle 129. Rotation may be achieved by a user, a medical professional, a surgeon, or any combination thereof. In some embodiments, rotation may be achieved by a motor.

[0069] The needle tip 118 can be configured to protrude beyond the end of the obturator lumen. The needle tip 118 can protrude at least 1 mm beyond the end of the obturator lumen. The needle tip can be configured to protrude by the movement of the needle handle 129. The needle tip 118 can be configured to retract into the obturator lumen.

[0070] The needle tip 118 can have an angle 146 from the elongated body of the needle in the range of about 15 to about 45 degrees. In some embodiments, the needle tip 118 can have an angle 146 in the range of about 25 to about 50 degrees, or about 35 to about 50 degrees. The needle tip 118 can have an angle 146 from the elongated body of the needle in the range of about 15 to about 45 degrees, and can have an angle 146 of 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 can have an angle 146 from the elongated body of the needle in the range of about 15 to about 45 degrees, and can have an angle 146 of at least about 15 degrees, about 25 degrees, about 35 degrees, about 40 degrees, about 45 degrees, or about 50 degrees. The needle tip 118 can have an angle 146 ranging from approximately 15 to 45 degrees from the elongated body of the needle, and can have a maximum angle 146 of approximately 25, 35, 40, 45, 50, or 1 degree. The angle 146 of the needle tip 118 can be configured to advance the needle tip through soft tissue.

[0071] The electrode lead introducer 100 may include one or more electrodes (120, 110), as seen in Figures 1A, 1B, 1E, and 1F, and one or more electrodes (120, 110) may be configured to provide electrical stimulation adjacent to target tissue in the patient's pelvic region and / or to measure electrical signals. For example, the 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, healthcare professional, and / or surgeon in navigating the target area in the patient's pelvic region. The target area in the patient's pelvic region may include 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.

[0072] The electrode lead introducer 100 may include two sets of one or more electrodes (120, 110) and two sets of one or more insulators (108, 123), so that the electrodes and / or insulators of each set are positioned at both ends of the electrode lead introducer, as seen in Figures 1A and 1B. For illustrative purposes only, if we designate the needle tip 118 as the proximal end of the electrode lead introducer 100, then one or more electrodes 120 of the first set and / or one or more insulators 108 of the first set may be positioned at the proximal end of the electrode lead introducer, as shown in Figure 1B. For illustrative purposes only, if we designate the sheath handle 106 as the distal end of the electrode lead introducer 100, then one or more electrodes 110 of the second set and / or one or more insulators 123 of the second set may be positioned at the distal end of the electrode lead introducer. One or more electrodes located at the proximal end of the electrode lead introducer 100 can electrically communicate with one or more electrodes located at the distal end of the electrode lead introducer 100. One or more electrodes 120 at the proximal end can be configured to detect electrical signals and / or deliver electrical signals to target tissue in the patient's pelvic region. For example, target tissue in the patient's pelvic region may include the pudendal nerve, sacral nerve, or a combination thereof. Target tissue in the patient's pelvic region may include nerve trunks, nerve branches, 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 at most one, at most two, at most three, at most four, at most five, or at most six electrodes. One or more distal electrodes may be configured to be connected to the end of a hook-type probe, which may provide and / or detect electrical stimulation signals via one or more electrodes 120 at its distal end. The hook-type probe may be electrically communicating with one or more distal and / or proximal electrodes.

[0073] One or more electrodes positioned at the distal end 110 and proximal end 120 of the electrode lead introducer, and / or one or more insulators positioned at the distal end 123 and proximal end 108, can include electrodes and insulators of various lengths, as can be seen in Figure 1B. One or more proximal electrodes 120 can include a length 128. The length 128 of one or more proximal electrodes 120 can range from about 0.8 mm to about 2 mm. For example, the length 128 of one or more proximal electrodes 120 can range from about 1 mm to about 2 mm, or from about 1.3 mm to about 2 mm. The length 128 of one or more proximal electrodes 120 can 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 one or more proximal electrodes 120 can 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 can include at most 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.

[0074] The length 126 of one or more proximal insulators 108 can range from about 5 mm to about 7 mm. For example, the length 126 of one or more proximal insulators 108 can range from about 5.5 mm to about 7 mm, or from about 6 mm to about 7 mm. The length 126 of one or more proximal insulators 108 can 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 proximal insulators 108 can 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 proximal insulators 108 can include at most 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.

[0075] The length 124 of one or more distal electrodes 110 can include lengths from about 2.5 mm to about 4 mm. For example, the length 124 of one or more distal electrodes 110 can include lengths from about 2.6 mm to about 4 mm, or from 3 mm to about 4 mm. The length 124 of one or more distal electrodes 110 can include lengths 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 can include lengths of at least 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, or about 3.5 mm. In some cases, the length 124 of one or more distal electrodes 110 can include lengths of at most about 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3 mm, 3.1 mm, 3.5 mm, or 4 mm. The first electrode of one or more distal electrodes 110 can be positioned at a distance of at least about 1.5 mm from the most distal part of the elongated body 116.

[0076] The length 122 of one or more distal insulators 123 can include lengths from about 1.2 mm to about 3 mm. For example, the length 122 of one or more distal insulators 123 can include lengths from about 1.5 mm to about 3 mm, or from about 1.8 mm to about 3 mm. The length 122 of one or more distal insulators 123 can include lengths 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 can include lengths 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 can include lengths of at most about 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.5 mm, or 3 mm.

[0077] Typically, electrodes can be manufactured by various methods. Electrodes can include flexible printed circuits. Electrodes can be wrapped around the outer surface of an elongated shaft in a sheath. In some embodiments, electrodes can be bonded to the outer surface of an elongated shaft in a sheath. The chosen manufacturing method can facilitate large-scale production of large quantities of electrodes. In some embodiments, the chosen manufacturing method can facilitate the precise manufacturing of electrodes with low tolerances.

[0078] Electrodes can be designed to deliver varying 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 voltages of at least approximately 0.1V, 0.2V, 0.3V, 0.4V, 0.5V, 0.6V, 0.7V, 0.8V, 0.9V, 1V, 2V, 3V, 4V, 5V, 6V, 7V, 8V, 9V, 10V, 11V, 12V, 13V, 14V, 15V, 16V, 17V, 18V, 19V, or 20V per electrode. In some embodiments, electrodes can be designed to deliver voltages of at most approximately 5V, 10V, 15V, 20V, 25V, 30V, 35V, 40V, 45V, or 50V per electrode. The electrodes can be designed to deliver voltages of approximately 1V to 50V per electrode, approximately 1V to 40V per electrode, approximately 1V to 30V per electrode, or approximately 1V to 20V per electrode. The electrodes can be designed to deliver a current of approximately 10mA per electrode. In some embodiments, the electrodes can be designed to deliver currents of at least approximately 0.1mA, 0.2mA, 0.3mA, 0.4mA, 0.5mA, 0.6mA, 0.7mA, 0.8mA, 0.9mA, 1mA, 2mA, 3mA, 4mA, 5mA, 6mA, 7mA, 8mA, 9mA, 10mA, 11mA, 12mA, 13mA, 14mA, 15mA, 16mA, 17mA, 18mA, 19mA, or 20mA per electrode. The electrodes can be designed to deliver a maximum current of approximately 5mA, 10mA, 15mA, 20mA, 25mA, 30mA, 35mA, 40mA, 45mA, or 50mA per electrode. The electrodes can be designed to deliver a current of approximately 1mA to 50mA per electrode, approximately 1mA to 40mA per electrode, approximately 1mA to 30mA per electrode, or approximately 1mA to 20mA per electrode. The electrodes can be designed to deliver approximately 0.1W of power (VA) per electrode.In some embodiments, electrodes can be designed to deliver at least about 0.01W, 0.05W, 0.1W, 0.5W, 1W, 2W, 3W, 4W, or 5W of power (VA) per electrode. In some embodiments, electrodes can be designed to deliver at most about 0.05W, 0.1W, 0.5W, 1W, 2W, 3W, 4W, 5W, 6W, 7W, 8W, 9W, or 10W of power (VA) per electrode. Electrodes can be designed to deliver about 0.01W to about 10W per electrode, about 0.01W to about 5W per electrode, or about 0.01W to about 1W of power (VA) per electrode.

[0079] This specification provides a device for placing an electrode lead in a target tissue within the pelvic region of a patient, the device comprising: an introducer sheath having an elongated shaft of a sheath having a lumen, and a sheath handle at the distal end of the sheath shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated shaft of the sheath; and an obturator comprising an elongated shaft of an obturator having a lumen, and an obturator handle at the distal end of the elongated shaft of the obturator, the elongated shaft of the obturator being, A device is provided comprising a needle having an obturator and a lumen configured to fit inside a sheath lumen, a needle handle at the distal end of the obturator lumen, and a needle tip at the proximal end of the obturator lumen, wherein the obturator lumen is configured to fit inside the obturator lumen, and the lumen of the obturator lumen is configured to allow an electrode lead to pass through, and 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 can be sufficient to enable secure and accurate placement of the electrode lead in the target tissue within the patient's pelvic region. For example, the target tissue can include the pudendal nerve. In some embodiments, the rigidity of the sheath can be sufficient to enable secure and accurate placement of the electrode lead in the target tissue within the patient's pelvic region. For example, the target tissue can include the pudendal nerve.

[0080] This specification provides a device for placing an electrode lead in a target tissue within the pelvic region of a patient, the device having the following features: an introducer sheath having an elongated shaft of a sheath having a lumen and a sheath handle at the distal end of the sheath shaft, the introducer sheath being configured to carry an electrode on the outer surface of the elongated shaft of the sheath; and an obturator having an elongated shaft of an obturator having a lumen and an obturator handle at the distal end of the elongated shaft of the obturator, the elongated shaft of the obturator being sheath A device is described comprising: an obturator configured to fit inside a lumen; an elongated shaft of a needle having a lumen; a needle handle at the distal end of the elongated shaft of the needle; and a needle tip at the proximal end of the elongated shaft of the needle, wherein the elongated shaft of the needle is configured to fit inside the obturator lumen, and the lumen of the elongated shaft of the needle is configured to allow an electrode lead to pass through; and an introducer sheath having sufficient rigidity to guide the placement of the electrode lead at the target site. The needle may be removable from the introducer sheath. The insertable length of the sheath may be about 10 cm to about 20 cm. The introducer sheath may have an outer diameter of about 1 mm to about 5 mm. The introducer sheath may have an inner diameter of about 1 mm to about 3 mm. The introducer sheath may have an inner diameter sufficient for the obturator and needle to pass through. The inner diameter of the needle shaft may be sufficient for the guidewire to pass through. The needle tip may be blunt and may have a lumen. The needle tip may extend approximately 1 mm to 5 mm beyond the end of the elongated shaft of the sheath. The rigidity of the sheath and needle together may be sufficient to enable secure and accurate placement of the electrode lead in the target tissue within the patient's pelvic region.For example, the target tissue may include the pudendal nerve. In some embodiments, the stiffness of the sheath may be sufficient to allow for secure and precise placement of the electrode lead in the target tissue within the patient's pelvic region. For example, the target tissue may include the pudendal nerve. In some embodiments, the stiffness of the sheath is greater than that of the sheath for sacral nerve lead placement.

[0081] This specification provides a device for placing an electrode lead in a target tissue within the pelvic region of a patient, the device having the following features: an introducer sheath having an elongated shaft of a sheath having a lumen and a sheath handle at the distal end of the sheath shaft, the introducer sheath being configured to carry an electrode on the outer surface of the elongated shaft of the sheath; and an obturator having an elongated shaft of an obturator having a lumen and an obturator handle at the distal end of the elongated shaft of the obturator, the elongated shaft of the obturator being sheath A device is described comprising: an obturator configured to fit inside a lumen; an elongated shaft of a needle having a lumen; a needle handle at the distal end of the elongated shaft of the needle; and a needle tip at the proximal end of the elongated shaft of the needle, wherein the elongated shaft of the needle is configured to fit inside the obturator lumen, and the lumen of the elongated shaft of the needle is configured to allow an electrode lead to pass through; and an introducer sheath having sufficient rigidity to guide the placement of the electrode lead at the target site. The needle may be removable from the introducer sheath. The insertable length of the sheath may be about 10 cm to about 20 cm. The introducer sheath may have an outer diameter of about 1 mm to about 5 mm. For example, the introducer sheath may have an inner diameter of about 1 mm to about 3 mm. The introducer sheath may have an inner diameter sufficient for the obturator and needle to pass through. The inner diameter of the needle shaft may be sufficient for the guide wire to pass through. The needle tip may be blunt and may have a lumen. The needle tip may extend approximately 1 mm to 5 mm beyond the end of the elongated shaft of the sheath. The sheath may contain multiple electrically isolated electrodes.Multiple electrodes can be formed as multiple broad bands around a sheath, with gaps between the electrodes, and the first band being at least 1 mm from the end of the elongated shaft of the sheath. The stiffness of the sheath and needle can be sufficient together to allow for secure and accurate placement of the electrode lead in target tissue within 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 for secure and accurate placement of the electrode lead in target tissue within the patient's pelvic region. For example, the target tissue can include the pudendal nerve. The stiffness of the sheath for pudendal nerve lead placement can be higher than that of the sheath for sacral nerve lead placement. The electrodes can be configured to deliver a voltage of about 5V to about 15V per electrode. The electrodes can be configured to deliver a current of about 5mA to about 15mA per electrode. The electrodes can be configured to deliver a power of about 0.05W to about 0.5W per electrode.

[0082] This specification provides a device for placing an electrode lead in a target tissue within the pelvic region of a patient, the device comprising: an introducer sheath having an elongated shaft of a sheath having a lumen, and a sheath handle at the distal end of the sheath shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated shaft of the sheath; and an obturator comprising an elongated shaft of an obturator having a lumen, and an obturator handle at the distal end of the elongated shaft of the obturator, wherein the elongated shaft of the obturator is a sheath A device is provided comprising a needle and an obturator configured to fit inside a slubmen; an elongated shaft of a needle having a lumen; a needle handle at the distal end of the elongated shaft of the needle; and a needle tip at the proximal end of the elongated shaft of the needle, wherein the elongated shaft of the needle is configured to fit inside the obturator lumen, and the lumen of the elongated shaft of the needle is configured to allow an electrode lead to pass through; and the introducer sheath is sufficiently rigid to guide the placement of the electrode lead at the target site. The needle may be removable from the introducer sheath. The insertable length of the sheath may be about 15 cm. The introducer sheath may have a maximum outer diameter of about 5 mm. The introducer sheath may have an inner diameter of about 1 mm to about 2 mm. The introducer sheath may have an inner diameter sufficient for the obturator and needle to pass through. The inner diameter of the needle shaft may be sufficient for the guide wire to pass through. The needle tip can be blunt and may have lumens. The needle tip can extend more than 3 mm beyond the end of the elongated shaft of the sheath.The sheath may contain four electrically isolated electrodes, the four electrically isolated electrodes forming a wide band of approximately 1.5 mm around the sheath, with a gap of approximately 5 mm between the electrodes, and the first band being approximately 1.5 mm from the end of the elongated shaft of the sheath. The stiffness of the sheath and needle together may be sufficient to allow for secure and accurate placement of the electrode lead in the target tissue within the patient's pelvic region. For example, the target tissue may include the pudendal nerve. In some embodiments, the stiffness of the sheath may be sufficient to allow for secure and accurate placement of the electrode lead in the target tissue within the patient's pelvic region. For example, the target tissue within the patient's pelvic region may include the pudendal nerve. The stiffness of the sheath for pudendal nerve lead placement may be greater than the stiffness of the sheath for sacral nerve lead placement. The electrodes may be configured to deliver a voltage of approximately 10 V per electrode. The electrodes may be configured to deliver a current of approximately 10 mA per electrode. The electrodes can be configured to deliver approximately 0.1W of power per electrode.

[0083] This specification provides a device for placing an electrode lead in a target tissue within the pelvic region of a patient, the device comprising: an introducer sheath having an elongated shaft of a sheath having a lumen, and a sheath handle at the distal end of the sheath shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated shaft of the sheath; and an obturator comprising an elongated shaft of an obturator having a lumen, and an obturator handle at the distal end of the elongated shaft of the obturator, wherein the elongated shaft of the obturator is sheath A device is described comprising: an obturator configured to fit inside a lumen; an elongated shaft of a needle having a lumen; a needle handle at the distal end of the elongated shaft of the needle; and a needle tip at the proximal end of the elongated shaft of the needle, wherein the elongated shaft of the needle is configured to fit inside the obturator lumen, and the lumen of the elongated shaft of the needle is configured to allow an electrode lead to pass through; and an introducer sheath having 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 may be configured to protrude only about 1 mm to 5 mm beyond the end of the obturator lumen. The needle tip may be configured to be retractable into the obturator lumen. The needle tip angle may be configured to advance the needle tip through the tissue. The angle of the proximal end of the elongated shaft of the sheath can allow the device to be advanced with little to no damage to surrounding tissue. The electrodes can be wrapped around the outer surface of the elongated shaft of the sheath.

[0084] This specification provides a device for placing an electrode lead in a target tissue within the pelvic region of a patient, the device comprising: an introducer sheath having an elongated shaft of a sheath having a lumen, and a sheath handle at the distal end of the sheath shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated shaft of the sheath; and an obturator comprising an elongated shaft of an obturator having a lumen, and an obturator handle at the distal end of the elongated shaft of the obturator, wherein the elongated shaft of the obturator is a sheath A device is provided comprising a needle and an elongated shaft having an obturator and a lumen, configured to fit inside a thru-men, a needle handle at the distal end of the elongated shaft of the needle, and a needle tip at the proximal end of the elongated shaft of the needle, wherein the elongated shaft of the needle is configured to fit inside the obturator lumen, and the lumen of the elongated shaft of the needle is configured to allow an electrode lead to pass through, and the introducer sheath is sufficiently rigid 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 may be configured to protrude only about 1 mm to 5 mm beyond the end of the obturator lumen. The needle tip may be configured to be retractable into the obturator lumen. The needle tip angle may be configured to advance the needle tip through the tissue. The angle of the proximal end of the elongated shaft of the sheath can allow the device to be advanced with little to no damage to surrounding tissue. The electrodes can be wrapped around the outer surface of the elongated shaft of the sheath.

[0085] This specification provides a device for placing an electrode lead in a target tissue within the pelvic region of a patient, the device comprising: an introducer sheath having an elongated shaft of a sheath having a lumen, and a sheath handle at the distal end of the sheath shaft, wherein the introducer sheath is configured to carry an electrode on the outer surface of the elongated shaft of the sheath; and an obturator comprising an elongated shaft of an obturator having a lumen, and an obturator handle at the distal end of the elongated shaft of the obturator, wherein the elongated shaft of the obturator is sheath A device is described comprising: an obturator configured to fit inside a lumen; an elongated shaft of a needle having a lumen; a needle handle at the distal end of the elongated shaft of the needle; and a needle tip at the proximal end of the elongated shaft of the needle, wherein the elongated shaft of the needle is configured to fit inside the obturator lumen, and the lumen of the elongated shaft of the needle is configured to allow an electrode lead to pass through; and an introducer sheath having 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 may be configured to protrude only about 1 mm to 5 mm beyond the end of the obturator lumen. The needle may be removable from the introducer sheath. The insertable length of the sheath may be about 10 cm to about 20 cm. The introducer sheath may have an outer diameter of about 1 mm to about 5 mm. The introducer sheath can have an inner diameter of approximately 1 mm to 3 mm. The introducer sheath can have an inner diameter sufficient for the obturator and needle to pass through. The inner diameter of the needle shaft can be sufficient for the guide wire to pass through. The needle tip can be blunt and can have lumens.The needle tip can extend approximately 1 mm to 5 mm beyond the end of the elongated shaft of the sheath. The sheath can contain multiple electrically isolated electrodes. The electrodes can be formed as multiple broad bands around the sheath, with gaps between the electrodes, and the first band being at least 1 mm from the end of the elongated shaft of the sheath. The needle tip can be configured to retract into the obturator lumen. The electrodes can be wrapped around the outer surface of the elongated shaft of the sheath. The needle tip angle can be configured to advance the needle tip through the tissue. The angle at the proximal end of the elongated shaft of the sheath can allow the device to advance with little to no damage to the surrounding tissue. The obturator can have a diameter of approximately 1 mm to 4 mm. The introducer sheath can have a diameter of approximately 1 mm to 5 mm. The introducer sheath and needle can have a combined Young's modulus sufficient to allow the device to penetrate the deep surgical plane in the individual. The deep surgical plane can include a surgical plane of muscle, fat, or any combination thereof. The introducer sheath can have a Young's modulus of approximately 10 megapascals (MPa) to approximately 10,000 MPa. The introducer sheath and needle can have a combined Young's modulus sufficient to allow the user to place the lead adjacent to the 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 stiffness of the sheath and needle together can be sufficient to allow for secure and accurate placement of the electrode lead in 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 for secure and accurate placement of the electrode lead in the target tissue in the patient's pelvic region. For example, the target tissue can include the pudendal nerve.The rigidity of the sheath for pudendal nerve lead placement can be higher than that of the sheath for sacral nerve lead placement. The electrodes can be configured to deliver a voltage of approximately 5V to 15V per electrode. The electrodes can be configured to deliver a current of approximately 5mA to 15mA per electrode. The electrodes can be configured to deliver a power of approximately 0.05W to 0.5W per electrode. The needle tip can be configured to retract into the obturator lumen. The needle tip angle can be configured to advance the needle tip through the tissue. The angle of the proximal end of the elongated shaft of the sheath can be configured to advance the device with little to no damage to surrounding tissue. The electrodes can be wrapped around the outer surface of the elongated shaft of the sheath.

[0086] Electrode lead installation This specification describes methods, devices, systems, and / or kits for placing at least one electrode lead in a target tissue (for example, 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 a target tissue for receiving electrical stimulation for sexual dysfunction. In some cases, the target tissue may include a target tissue for receiving electrical stimulation for the treatment and / or management of pain. While specific devices, systems, methods, and kits are described herein in relation to the pelvic region for the treatment and / or management of pelvic disorders, these methods and devices may also be used to treat other diseases in other areas of the body, as described elsewhere in this specification.

[0087] The methods, devices, systems, and / or kits provided herein can be used to place at least one electrode lead on a nerve innervating one or more muscles that control urination in order 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 innervating one or more muscles used for urination in order 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 in a nerve innervating one or more muscles that control or are 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. In many cases, accessing the pudendal nerve and placing electrodes or electrode leads with minimal damage to surrounding tissues may be difficult due to anatomical structures close to the pudendal nerve. The introducer can enable access to the pudendal nerve via one or more anatomical pathways with minimal damage to surrounding tissues. In some cases, the introducer can access the pudendal nerve via a sciatical approach, where they are instructed to penetrate or pass near the sacrotuberous ligament and place a lead on the pudendal trunk at a target location proximal to Alcock's canal. In some cases, the introducer can access the pudendal nerve via a lower gluteal approach, where they are instructed to pass through the space between the sacrotuberous and sacrospinous ligaments, traverse anteriorly through the ischiorectal fossa below the pelvic floor, place a lead over the anterior branch of the pudendal nerve, and stimulate the pudendal nerve and the dorsal genital nerve.

[0088] This specification provides methods, devices, 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: pre-adjustment, patient preparation, nerve location, placement of one or more leads, lead fixation, IPG pocket formation, lead tunneling, connecting one or more leads to the IPG, IPG placement, impedance check, and tissue closure. Figure 12 shows a flowchart 1000 of the steps for performing the implantation of an electrode lead and an implantable pulse generator (IPG). In some embodiments, the implantation procedure involves the sequential steps of pre-adjustment 1002, patient preparation 1004, placement of one or more leads 1006, lead fixation 1008, IPG pocket formation 1010, lead tunneling 1012, connecting one or more leads to the IPG 1014, IPG placement 1016, impedance check 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, the steps can be performed or controlled by a robotic system and / or facilitated using augmented reality.

[0089] This specification provides methods, devices, and systems for enabling access to the pudendal nerve via one or more anatomical routes. First, the patient can be positioned prone and have their buttocks raised to allow lead insertion via a posterior or gluteal approach. In many cases, the buttocks are marked using surface landmarks (including, but not limited to, the greater trochanter and ischial tuberosity) and the surface location of the ischial spine can be localized. Using these landmarks and simple radiographic imaging (C-arm image intensifier or equivalent), a marking needle and / or needle electrode can be inserted to localize the pudendal nerve at each target location. In some cases, the target location can include the distal / pelvic floor via a lower gluteal approach, and can also include the proximal trunk of the pudendal nerve via a gluteal approach. The nerve can be additionally or alternatively localized by intraoperative electrophysiology (EMG response). The nerve can be additionally or alternatively localized by visual motor response. Nerves can be located additionally or alternatively by urethral manometry. Once nerves are located, an introducer can be used to guide the needle path to each target location. The introducer can be advanced at that location, and fine adjustments can be made to those positions so that stimulation via a defined proportion of the total number of electrodes leads to a pelvic floor EMG response, a urethral sphincter EMG response, or anal EMG response. Fine adjustments can be made to the positions of the introducer and electrodes so that stimulation by at least one of the electrodes leads to a genital EMG response. In some cases, fine adjustments can be made to the positions of the introducer and electrodes so that stimulation by most or all of the electrodes leads to a response.Once the introducer is properly positioned, the obturator can be withdrawn and replaced with electrode leads using the provided markings, allowing the lead electrodes to be precisely aligned with the ring on top of the introducer. The introducer can be carefully removed (under image magnification) so as not to disturb the lead positioning. To facilitate access to the leads, a small skin incision can be made, and the leads can then be fixed in place, for example, by fixing them to the local fascia using a fixation device (screwed onto the leads) and standard non-absorbable monofilament sutures. The leads can then be tunneled into the future IPG site.

[0090] Electrode leads can be placed over a target area of ​​a target nerve for treating incontinence using an introducer device as described herein. Electrode leads can be placed over a target area of ​​a target nerve for treating incontinence using a guidewire and / or sheath. The target nerve can include the pudendal nerve. Electrode needles can include Ciba needles. Lead or guidewire introducers can include a metal obturator or stiffening wire and an insulating plastic sheath. Lead or guidewire introducers can be modified to allow easier access to the pudendal nerve. Lead or guidewire introducers can be configured to perforate a ligament. Lead or guidewire introducers can be configured to allow access near the sacrotuberous ligament. The sheath of an introducer for accessing the pudendal nerve can have higher rigidity than the sheath of an introducer typically used for accessing the sacral nerve.

[0091] The lead may include a sensor capable of acquiring neurophysiological recordings from a nerve (e.g., the pudendal nerve). In some embodiments, the method described herein may include the step of placing a sensor on the pudendal nerve to acquire electrical signals from the pudendal nerve. The acquired electrical signals can be used to determine the level of nerve stimulation of the pudendal nerve to prevent an incontinence episode. In some embodiments, the stimulation can be controlled by the individual performing a pelvic squeeze, and a sensor that receives a threshold EMG signal resulting from the pelvic squeeze can activate the electrical stimulation.

[0092] Pudendal nerve The pudendal nerve is the primary nerve in the pelvic region. Normally, the pudendal nerve can run through the pelvic floor muscles that support the organs and terminates in the external genitalia. In many cases, the pudendal nerve can transmit motor and sensory information from the genital area. The pudendal nerve can be extremely important for sensation and function in the pelvic region. The pudendal nerve can be part of the peripheral nervous system.

[0093] Typically, the pudendal nerve is found bidirectionally, one on each side of the body, left and right. The pudendal nerve can usually originate from the sacral plexus at the lowest part of the spine. The sacral plexus contains a bundle of nerves located on the posterior side of the pelvis. The sacral plexus can contain a complex network of nerves that provide and receive feedback regarding movement and sensation to the thigh, lower leg, leg, and part of the pelvis. Typically, the pudendal nerve connects to the S2–S4 sacral spinal nerve roots within the sacral plexus and runs through the pelvic and gluteal regions at the upper end of the femur. In many cases, the pudendal nerve passes through the larger sciatic foramen, exits the gluteal region through the smaller sciatic foramen, travels along the pudendal artery and vein, and enters the pudendal canal (also referred herein as Alcock's canal) (a narrow, tunnel-like opening in the pelvis). After entering the pudendal canal, the pudendal nerve can divide into smaller nerve branches. The pudendal nerve can branch into the inferior rectal nerve, the perineal nerve, and the dorsal genital nerve. The pudendal nerve can run medially and medially to the ischium. The pudendal nerve can be difficult to access surgically because it runs in three different planes. The inferior rectal nerve can control the anal sphincter and transmits sensory and motor information to the anal sphincter and anal canal. The pudendal nerve can play a role in controlling bladder contraction and urination reflexes. The perineal nerve can control 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 transmit sensory information (including, but not limited to, touch, pleasure, and pain) to the skin of the penis or clitoris.

[0094] The motor function of the pudendal nerve can control the movement of one or more muscles. The motor function of the pudendal nerve can control the movement of one or more of the anal sphincter and urethral sphincter. The anal sphincter can assist in the retention and release of feces. The urethral sphincter can assist in the retention and release of urine. The pudendal nerve can provide sensory information about touch, pleasure, pain, and temperature of various anatomical structures (including, but not limited to, the penis, vagina, perineum, anus, and anal canal). Injury to the pudendal nerve can result in one or more of the following: loss of sensation in the nerve's distribution, fecal and urinary incontinence, sexual dysfunction, or a combination thereof.

[0095] Pre-arrangement Individuals experiencing incontinence and being prepared for treatment with electrical nerve stimulation may undergo various pre-adjustment steps before the commencement of the implantation procedure. The implantation procedure can 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. The equipment used for the procedure (including, but not limited to, the introducer) can be sterilized before the procedure. The introducer may include materials compatible with standard sterilization procedures (including, but not limited to, ethylene oxide gas, gamma irradiation, and autoclave sterilization). The surgical table may allow for various patient positioning and X-ray C-arm access. In some embodiments, a radiographer (also known as a radiotechnologist) may be present during the procedure to handle the image intensifier. One or more non-invasive imaging methods may be used along the anatomical pathway 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 can be fully charged and linked to the IPG before surgery. The IPG can be linked and charged through its packaging to maintain sterility. In some embodiments, the patient controller can be placed in a sterile bag and linked during surgery.

[0096] patient preparation The individual may be prepared for treatment with electrical nerve stimulation before the start of the implantation procedure. The IPG implantation site may be marked in advance in relation to posture and clothing to enhance the individual's comfort in daily life after the procedure. The individual may be given general anesthesia before the procedure. In some embodiments, the individual may be appropriately positioned in a prone jackknife position to allow surgical access. In some embodiments, left / right tilt and correct position may be checked before the procedure. A urethral transducer may be inserted into the individual to monitor and improve the accuracy of lead placement. In some embodiments, a transducer on a urinary catheter may be used to monitor the progress of lead placement. A transvaginal probe may be safely inserted into the individual's vagina for the purpose of measuring EMG. The transvaginal probe may be used to monitor and improve the accuracy of lead placement. The transvaginal probe may be used additionally or alternatively to monitor the progress of lead placement. An electrical grounding pad may be placed on the individual away from the surgical site. The individual's skin (including, but not limited to, the vaginal opening) may be prepared and covered with a drape before the procedure to reduce infection and surgical complications. A needle electrode may be inserted into the individual's external anal sphincter for the purpose of measuring EMG. In some embodiments, an adhesive surface electrode may be applied to the individual's perianal skin for the purpose of measuring EMG.

[0097] Nerve location and lead placement This specification provides methods, devices, and systems for enabling access to the pudendal nerve by one or more anatomical pathways with minimal damage to the surrounding tissues. In many cases, accessing the pudendal nerve and placing one or more leads with minimal damage to surrounding tissues may be difficult due to anatomical structures close to the pudendal nerve, and also because the pudendal nerve may run in three different planes of the body. For example, the pudendal nerve runs a broad caudal course medial to the ischium, and then turns anteriorly into the ischiorectal fossa. This specification describes imaging-guided markings on the skin for guiding the anatomical pathway of an introducer to access the pudendal nerve. Radiographic images of the individual's buttock area can be taken using a metal guide placed on the skin. The radiographic images can be used to determine the location of a series of surface markings on the skin in the buttock region, providing the orientation of the anatomical pathway of an introducer within the individual to access the pudendal nerve. Radiographic images can be acquired by fluoroscopy. In some embodiments, radiographic images can be acquired additionally or alternatively by radiography. The introducer can access the pudendal nerve by a sciaticorectal approach, in which the introducer is instructed to penetrate or pass near the sacrotuberous ligament and place a lead on the pudendal trunk at a target location proximal to Alcock's canal in the region of the ischial spine. In some embodiments, the introducer can access the pudendal nerve by a lower gluteal approach, in which the introducer is instructed to pass through the space between the sacrotuberous and sacrospinous ligaments, pass anteriorly through the sciaticorectal fossa below the pelvic floor, place a lead on the anterior branch of the pudendal nerve, and stimulate the pudendal nerve and the dorsal genital nerve.

[0098] Localizing the target nerve before inserting any leads can, beneficially, allow one or more leads to be optimally positioned for stimulation. For example, localizing the pudendal nerve can allow leads to be positioned more accurately and parallel to the pudendal nerve (e.g., in the pudendal trunk). Positioning leads parallel to the pudendal trunk rather than crossing the nerve at a single point can allow for a greater length of interaction between the electrode leads and the nerve, so that each electrode along the length of the lead is optimally ranged and / or positioned to stimulate the nerve. Nerves can be localized using one or more needles. One or more needles can include a marking needle and / or a stimulating member (e.g., a stimulating needle). The marking needle can indicate the horizontal and / or vertical levels of the nerve to be targeted for stimulation (e.g., the pudendal nerve). The marking needle can be inserted using one or more lines (e.g., a first line and a second line). The marking needle can be inserted at or near the intersection of the first line and the second line. The first and second lines may include one or more surface markings drawn on the skin. One or more of the surface markings may be guided by imaging. For example, the patient or subject may be placed in a prone position, and the surface markings may be drawn using radiological techniques (e.g., X-ray or fluoroscopy). In some embodiments, the surface markings may be guided by palpation of the buttock region. In some embodiments, the surface markings may include radiopaque markers. In some embodiments, the approach may utilize two stimulating members. The first stimulating member may be used to mark a nerve and will generally cross the nerve.The second stimulator approaches the pudendal nerve generally parallel to it and can be used to position a lead parallel to the pudendal nerve, as described above.

[0099] Figure 27 shows a schematic diagram of surface markings drawn on an individual to locate the pudendal nerve. Surface marking 2704 can be made by palpating and marking the ischial tuberosity. Anterior-posterior radiographic images or radiographic fluoroscopy can be used to draw a vertical line surface marking 2708 corresponding to the medial edge of the ischium. A similar technique can be used to draw a horizontal line surface marking 2712 passing through the apex of the greater trochanter and intersecting the vertical line surface marking 2708. The intersection 2716 between the two surface markings can indicate a location closely related to the ischial spine. In some embodiments, one or more surface markings can be drawn on lateral body parts 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, a marking needle can be inserted into a location adjacent to the intersection of surface markings. For example, a marking needle can be inserted approximately 1 cm outside the intersection 2716.

[0100] Figure 28 shows a schematic diagram of the anatomical structure within an individual and a lateral view of the inserted marking needle. The marking needle 2804 is inserted until it contacts the ischium and can indicate the horizontal level of the ischial spine for guidance on lateral X-rays. Thus, the tip of the marking needle 2804 is easily visible in the lateral view and can indicate the vertical level 2808 where the pudendal nerve turns inward at the ischial spine. The marking 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 marking needle 2804 can range from about 6 cm to 20 cm. In some embodiments, the length of the marking needle 2804 can include lengths of approximately 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, 20 cm, or within a 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 through which the pudendal nerve runs when activating external anal sphincter EMG activity. The stimulating needle can be advanced slowly immediately inward from the transecting point of the X-ray line and perpendicular to the skin. When there is stimulation (e.g., less than 3 mA or less or less than 2 mA), an EMG response of 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 another approach, the marking needle 2804 can be introduced at an oblique angle, with the needle positioned medially to the obturator internus muscle and adjacent to Alcock's canal.

[0101] One or more needles used to locate a target nerve may include a stimulating needle. The stimulating needle can define a pathway for an introducer and / or lead for implantation in the target nerve. The stimulating needle can be used to deliver a constant low level of stimulation while inserted into an individual, so that the response can be measured. For example, the stimulating needle can be used for the purpose of measuring an EMG response to monitor and verify the desired pathway for lead implantation. To reach the pudendal nerve, the stimulating needle can be inserted using an ischiorectal approach, starting in the ischiorectal fossa and medial to the ischial tuberosity. The stimulating needle can generally be advanced cranially, passing through the smaller ischial foramen toward the ischial spine. The stimulating needle can penetrate the skin about 5 to 10 mm medial to the ischial tuberosity at a level determined by the marking needle. Under the ischiorectal approach, the stimulating needle can be advanced oriented in a horizontal plane toward the tip of the marking needle, using a transverse view X-ray as guidance. Once it is confirmed that the initial orientation of the stimulating needle in the transverse view X-ray is nearly horizontal to the tip of the marking needle, the stimulating needle can be further directed and advanced towards the tip of the marking needle using guidance from the anterior-posterior view X-ray.

[0102] The stimulating needle can be connected to an external stimulator. The stimulator can supply a current of approximately 6 mA or less to the stimulating needle. The stimulator can supply currents of approximately 1 mA, 2 mA, 3 mA, 4 mA, 5 mA, or 6 mA. Using higher stimulating currents may result in non-selective contractions throughout the surrounding area, hindering the effectiveness of measuring EMG response as a positioning tool. The threshold for a measured EMG response indicating proper placement can be in the range of 10 mV to 30 mV. For example, threshold EMG responses 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. Threshold EMG responses can be 20 mV or higher. Pudendal nerve stimulation can advantageously provide responses in both the external anal sphincter (EAS) and the pelvic floor, while sacral nerve stimulation may result in a pelvic floor response only. To locate the pudendal nerve, the stimulating needle can be advanced along a cranial trajectory using an ischiorectal approach, and EMG responses can be measured at least in the EAS and pelvic floor to verify correct placement at the pudendal nerve. EMG responses at the EAS can be measured using a recording needle. EMG responses at the pelvic floor can be measured using a transvaginal probe or EMG needle (e.g., passing outside the anus until pelvic floor activity is measured). As the stimulating needle is advanced, the needle stimulation pathway can include directly stimulating the pelvic floor, then stimulating the adipose tissue, and then stimulating the pudendal nerve, in that order. Thus, 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 stimulating 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 stimulating needle can result in an EAS response but not a pelvic floor response.If no EAS response is to be measured, the placement of the stimulating needle can be guided by imaging and adjusted axially and / or vertically. If the needle position is adjusted multiple times without resulting in an EAS response, the placement of the stimulating needle to result only in a pelvic floor response may be acceptable. For example, if the stimulating needle position is adjusted at least five times without achieving an EAS response, a stimulating needle position that gives only a pelvic floor response may be acceptable. Once a proper EMG response is obtained, the position of the stimulating needle can be confirmed by lateral radiography and / or by marking the needle. A well-positioned stimulating needle relative to the pudendal nerve can be located just behind the ischial spine and just inside the marking needle. In some methodologies, the position of the stimulating element can be confirmed based solely on the EMG response in the external anal sphincter.

[0103] Once the stimulating needle is properly positioned, the guidewire can be fully inserted through the stimulating needle. Tactile feedback or fluoroscopy can indicate when the guidewire has reached the distal end of the stimulating needle. The stimulating needle can then be withdrawn and removed from the patient. The guidewire should be carefully held in place, and any further withdrawal or advance should be avoided. The introducer can then be placed over the guidewire, allowing the guidewire to be removed and the lead to be inserted. The introducer can include an introducer sheath and an obturator. Proper placement of the introducer can be confirmed by visualization of a radiopaque introducer sheath and / or one or more radiopaque markers on the introducer sheath. The lead can be implanted parallel to the pudendal nerve using the introducer and / or lead positioning guide, using the devices and methods described herein, so that the tip of the lead is implanted in the same position reached by the tip of the stimulating needle.

[0104] In some embodiments, lead placement can include bilateral placement on one or more target nerves, where one or more leads are placed on or near both sides of the target nerve. Thus, the devices and methods described herein with respect to nerve localization and lead placement can be used or implemented in a similar manner in lateral body regions 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 both the sacral and pudendal nerves on one or both sides of the body. For example, one or more leads may be placed on the pudendal nerve on one side of the body, and one or more leads may be placed on the sacral nerve in a lateral body region. Another example is where one or more leads may be placed on the pudendal nerve on one side of the body, and one or more leads may be placed on the sacral nerve on the same side of the body.

[0105] Figure 29 shows a schematic diagram of bilateral lead placement in the pudendal nerve. The first lead 2904 can be positioned on the left side of the body in the trunk of the left pudendal nerve. The second lead 2908 can be positioned on the right side of the body in the trunk of the right pudendal nerve, opposite to the first lead 2904. The first and second leads 2904 and 2908 can be tunneled through the gluteal region and connected to a unilateral IPG 2912. The length of the lead opposite to the IPG can be greater than the length of the lead ipsilateral to the IPG. As illustrated in Figure 29, 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, and the length of the second lead 2908 can be approximately 400 mm. The length difference between the first lead 2904 and the second lead 2908 can be between approximately 100 mm and 200 mm. For example, the length difference between two bilateral leads can be approximately 100 mm, 110 mm, 120 mm, 130 mm, 140 mm, 150 mm, 160 mm, 170 mm, 180 mm, 190 mm, 200 mm, or within the range defined by any of these values.

[0106] The lower gluteal approach allows for the use of surface markings on the skin, traversing the gluteal muscles to reach the ischial spine, at which point electrophysiological responses are used to guide further placement. The ischiorectal approach allows for entry into the skin outside the anus near the ischial tuberosity, using transvaginal or transrectal palpation of the ischial spine and + / - electrophysiological responses to place electrode leads. Both the lower gluteal and ischiorectal approaches for accessing the pudendal nerve can benefit from guidance by radiological imaging. It is generally believed that such approaches can target areas of the pudendal nerve in or proximal to the Alcock canal (i.e., nerve trunk). The proximal pudendal trunk can have an anatomical structure of nerve bundles, in which its distal branching is represented as individual nerve bundles or separate groups of nerve bundles. The anatomical structure of the pudendal nerve bundles can affect the precision of lead placement, and even small changes in lead position may favor certain nerve bundles, thus producing different motor or afferent effects.

[0107] In many cases, the pudendal nerve may be accessible for electrical stimulation, but the effectiveness of treating incontinence with PNS may be influenced by the site of stimulation. Proximal stimulation of the PN trunk (i.e., above Alcock's canal) can provide direct motor stimulation to both the urethral and anal sphincters. In some embodiments, proximal stimulation of the PN trunk can lead to some contraction of the pelvic floor / levator ani muscles, based on the fact that stimulation is provided proximal to both the inferior rectal nerve branch and the perineal nerve branch. In some embodiments, stimulation in the region of Alcock's canal may provide urethral sphincter contraction but less anal sphincter contraction. In some embodiments, the region of Alcock's canal is still proximal to the perineal nerve, and some contraction of the pelvic floor / levator ani muscles may be expected from stimulation of this region. Unilateral stimulation may lead to bilateral motor effects based on anatomical dissection. More distal stimulation (i.e., stimulation of the dorsal genital nerves) may lead only to effects mediated by afferent stimulation. The anatomical structure of the nerve bundles in the PN trunk may be important for the accuracy of lead placement.

[0108] Figures 13–16B show the desired anatomical pathways for lead placement in several embodiments. Figure 13 shows a schematic diagram of the anatomical structure and placement of leads and IPGs within an individual. Figure 13 shows the iliac crest 1202 of the ilium, gluteus minimus 1204, piriformis muscle 1206, sacrotuberous ligament 1208, pudendal nerve 1210, and sciatic nerve 1212. Leads 1214 and 1216 can be placed at one or more locations along the length of the pudendal nerve 1210. The wires 1218 of leads 1214 and 1216 can be connected to the IPG 1220. Placement of leads 1214 and 1216 over the pudendal nerve can be verified and secured before their wires are connected to the IPG.

[0109] Figures 14 and 15 show schematic diagrams of the anatomical structures within an individual, as well as the implanted leads and IPGs. Figure 14 shows two leads 1302 and 1304 placed on two sections of the pudendal nerve 1314, each lead equipped with four electrodes (shown as dark circles). Wires 1306 of leads 1302 and 1304 can be connected to IPG 1308. Shown in Figure 14 are the inferior gluteal nerve 1312, the pudendal nerve 1314, the obturator internus muscle 1316, the sacrotuberous ligament 1318, the posterior femoral cutaneous nerve 1320, the gluteus medius muscle 1322, the gluteus minimus muscle 1324, the piriformis muscle 1326, the quadratus femoris muscle 1328, the gluteus maximus muscle 1330, and the sciatic nerve 1332. Figure 15 shows IPG 1308 placed in a pocket within the buttock fat covering the gluteal muscles. Figure 15 shows the iliac crest 1334, the gluteal cleft 1336, the greater trochanter of the femur 1338, the ischial tuberosity of the pelvis 1340, and the gluteal groove 1342.

[0110] Figures 16A and 16B illustrate embodiments of the anatomical pathways of the lead using anatomical models. Figure 16A illustrates an embodiment of the ischiorectal approach, where needle 1402 (representing the introducer needle) is directed to pass through the sacrotuberous ligament 1404 to access the pudendal nerve 1406. In some embodiments, the introducer needle is capable of puncturing or passing near the sacrotuberous ligament 1404 within the body. Figure 16B illustrates an embodiment of the inferior gluteal approach, where needle 1402 is directed to approximate the inferior gluteal approach to access the pudendal nerve 1406.

[0111] Lead fixing device One or more leads (e.g., electrode leads) can be fixed in target tissue (e.g., the pudendal nerve or tissue adjacent to the pudendal nerve) by a fixation method. For example, one or more leads can be fixed in the tissue surrounding the pudendal nerve. The electrode leads can be fixed in the pudendal nerve or tissue adjacent to the pudendal nerve by one or more anchors 201, as shown in Figures 2A to 2G. The anchors 201 may include a body 200 (e.g., a cylindrical body or collar), the body 200 may include a lumen 204, the lumen 204 configured to receive a lead as described elsewhere in this specification. The anchors may include a first end 205 and a second end 207. The first end 205 may include a rounded and / or filleted edge 203 on the surface of the first end 205. The rounded and / or filleted edge 203 allows the anchor 201 to travel into and through the elongated body lumen of the introducer, as described elsewhere in this specification, and to compact or fold the anchor before delivering and / or implanting the anchor and electrode leads. The rounded and / or filleted edge 203 reduces friction between the inner surface geometry of the elongated body lumen of the introducer and the rounded and / or filleted edge 203 of the first end, making it possible to fold or compact the anchor without damaging the anchor or compromising the structural integrity of the anchor. The second end 207 may include the free end of one or more barbs 202, as shown in Figure 2A. The free end of one or more barbs may include a filleted, chamfered, curved, and / or rounded edge 209, as shown in Figure 2B.The filleted, curved, and / or rounded edges 209 can provide a curvature that minimizes the frictional force acting between, for example, the filleted surface of the free end of one or more barbs 202 and the inner surface of the elongated body lumen of the introducer (as described elsewhere herein) when one or more barbs and electrode leads are translated into and out of the elongated body lumen of the introducer. Depending on the indication for one or more leads, one or more parameters of the anchors and / or barbs described herein can be modified (including, but not limited to, material, profile, length, distance to the electrode, angle, number, etc.).

[0112] One or more anchors can be made from and / or manufactured from a polymer. The polymer can include thermoplastic polyurethane elastomer (TPU). For example, the polymer can include thermoplastic polyurethane (i.e., Pellethane®). In some embodiments, the polymer can include polytetrafluoroethylene (PTFE). In some embodiments, the anchor can include a deformable material.

[0113] One or more anchors can be fabricated from materials having a Shore hardness of approximately 50D to approximately 80D. Shore hardness as indicated elsewhere in this specification can include hardness measured by a durometer. A durometer can measure Shore hardness by determining the penetration of the durometer indenter foot into a sample test. One or more anchors can be fabricated from materials having a Shore hardness of approximately 40D to approximately 90D, approximately 50D to approximately 80D, approximately 50D to approximately 70D, or approximately 60D to approximately 70D. One or more anchors can be fabricated from materials having a Shore hardness of approximately 50D, approximately 52D, approximately 54D, approximately 56D, approximately 58D, approximately 60D, approximately 65D, approximately 70D, approximately 75D, or approximately 80D. One or more anchors can be fabricated from materials having a Shore stiffness of at least approximately 50D, 52D, 54D, 56D, 58D, 60D, 65D, 70D, or 75D. In some cases, one or more anchors can be fabricated from materials having a Shore stiffness of at most approximately 52D, 54D, 56D, 58D, 60D, 65D, 70D, 75D, or 80D.

[0114] The rounded and / or filleted edges 203 of the main body 200 can include radii 214 ranging from approximately 0.01 mm to approximately 0.3 mm. For example, the rounded and / or filleted edges 203 of the main body 200 can include radii 214 ranging from approximately 0.08 mm to approximately 0.3 mm, or from approximately 0.1 mm to approximately 0.3 mm. In some cases, the rounded and / or filleted edges 203 of the main body 200 can include radii 214 ranging from approximately 0.01 mm, approximately 0.05 mm, approximately 0.08 mm, approximately 0.1 mm, approximately 0.15 mm, approximately 0.2 mm, or approximately 0.3 mm. In some cases, the rounded and / or filleted edges 203 of the main body 200 can include radii 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 filleted edges 203 of the main body 200 can include radii 214 of at most 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 main body 200 can be tapered in a similar manner to the introducer to facilitate the introduction of the anchor into the introducer. In some cases, the main body 200 can include a deformable material shaped like a donut.

[0115] The anchor body 200 can include lengths 216 of approximately 0.5 mm to 6 mm. For example, the anchor body 200 can include lengths 216 of approximately 1 mm to 6 mm, 2 mm to 6 mm, or 3 mm to 6 mm. The anchor body 200 can include lengths 216 of approximately 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, 5 mm, or 6 mm. In some cases, the anchor body 200 can include lengths 216 of at least approximately 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, or 5 mm. In some cases, the anchor body 200 can include lengths 216 of at most approximately 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, 5 mm, or 6 mm.

[0116] The anchor body 200 can include an outer diameter 210 of approximately 0.5 mm to approximately 6 mm. The outer diameter can include the diameter of the circular cross-section of the anchor body 200. The anchor body 200 can include an outer diameter 210 of approximately 1 mm to approximately 6 mm, approximately 2 mm to approximately 6 mm, or approximately 3 mm to approximately 6 mm. The anchor body 200 can include an outer diameter 210 of approximately 0.5 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, or approximately 6 mm. In some cases, the anchor body 200 can include an outer diameter 210 of at least approximately 0.5 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 4 mm, or approximately 5 mm. In some cases, the anchor body 200 can include an outer diameter 210 of up to approximately 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, 5 mm, or 6 mm.

[0117] The anchor body 200 can include an inner diameter 228 of approximately 0.5 mm to approximately 6 mm. For example, the anchor body 200 can include an inner diameter 228 of approximately 1 mm to approximately 6 mm, approximately 2 mm to approximately 6 mm, or approximately 3 mm to approximately 6 mm. The anchor body 200 can include an inner diameter 228 of approximately 0.5 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, or approximately 6 mm. In some cases, the anchor body 200 can include an inner diameter 228 of at least approximately 0.5 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 4 mm, or approximately 5 mm. In some cases, the anchor body 200 can include an inner diameter 228 of up to approximately 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 4 mm, 5 mm, or 6 mm.

[0118] An anchor 201 may include one or more barbs 202 (for example, 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 two, three, four, five, six, seven, eight, nine, or ten barbs. The barbs 202 of the anchor may be made from the same material as the body 200 (for example, a unibody material). The unibody material may include injection-molded plastic material. 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 around the body of the anchor 200. In some cases, the two or more barbs of the anchor may not be radially symmetrical around the body of the anchor 200. The two or more barbs of the anchor may be arranged at equal intervals along the periphery of the cross-section of the anchor body (for example, at equal intervals at a given angle of rotation). Each of the two or more barbs 202 can be configured to extend along the radius of the circular cross-section of the main body of the anchor 200.

[0119] One or more barbs 202 may include a thermally curable barb. The thermally curable barb may include a material configured to maintain, retain, and / or fix the geometric shape and / or form of the barb when exposed to a given temperature or temperature range. The thermally curable barb may include a shape memory polymer material configured to maintain its shape and / or geometric form when exposed to a given temperature or temperature range, as described elsewhere in this specification. The shape memory polymer material may include a thermoplastic resin, (meth)acrylate, polyurethane, a blend of polyurethane and polyvinyl chloride, or any combination thereof.

[0120] The barb 202 can include rectangular, oval, or triangular profiles. For example, a rectangular profile of barb 202 is shown in Figures 2A and 2C. In some cases, the barbs (600, 602) can include triangular profiles, as shown in Figure 6C. The barb 600 of one or more first triangular profiles can be connected to the first body segment 604, and the barb 602 of one or more second triangular profiles can be positioned on the second body segment 605. The first body segment 604 and the second body segment 605 can be connected to each other to form the anchor body. In some cases, one of the two or more barbs of the anchor can include a serrated barb 502, which can include one or more cut features 504 or profiles with projections, as shown in Figures 6A and 6B. One or more cut features can include circular geometric shapes. The circular geometric shape can include diameters ranging from approximately 0.25 mm to approximately 0.5 mm. The serrated barb 502 can be mechanically coupled and / or fixed to the anchor body 500. The serrated barb 502 and the associated anchor body 500 can include dimensions as described elsewhere in this specification with respect to the barb and anchor body. In some cases, the surface of the serrated barb 502 can increase friction between the surface of the serrated barb 502 and the surface of the surrounding tissue. Increased friction can maintain and / or fix the position of the electrode lead to which the serrated barb 502 is coupled.

[0121] One or more barbs of anchor 201 may include lengths 208 ranging from about 0.2 mm to about 5 mm. One or more barbs of anchor 201 may include lengths 208 ranging from 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 lengths 208 ranging from 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 at least lengths 208 ranging from 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 lengths of up to approximately 0.5 mm, 0.8 mm, 1 mm, 1.5 mm, 2 mm, 3 mm, 4 mm, or 5 mm.

[0122] The cross-section of the barb 202, as shown in Figures 2B, 2D, and 2E, can include a radius of curvature 212. The radius of curvature 212 can include radii from approximately 0.5 mm to approximately 3 mm. The radius of curvature 212 can include radii from approximately 1 mm to approximately 3 mm, or from approximately 1.5 mm to approximately 3 mm. The radius of curvature 212 can include radii of approximately 0.5 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, or approximately 3 mm. In some cases, the radius of curvature 212 can include radii of at least approximately 0.5 mm, approximately 1 mm, approximately 1.5 mm, approximately 2 mm, or approximately 2.5 mm. In some cases, the radius of curvature 212 can include radii of at most approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, or approximately 3 mm.

[0123] Barb 202 can include thicknesses 232 ranging from approximately 0.1 mm to approximately 1.5 mm. For example, barb 202 can include thicknesses 232 ranging from approximately 0.2 mm to approximately 1.5 mm, or from approximately 0.3 mm to approximately 1.5 mm. Barb 202 can include thicknesses 232 of approximately 0.1 mm, approximately 0.2 mm, approximately 0.3 mm, approximately 0.35 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.7 mm, approximately 1 mm, or approximately 1.5 mm. In some cases, barb 202 can include thicknesses 232 of at least approximately 0.1 mm, approximately 0.2 mm, approximately 0.3 mm, approximately 0.35 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.7 mm, or approximately 1 mm. In some cases, barb 202 can include thicknesses of up to approximately 0.2 mm, 0.3 mm, 0.35 mm, 0.4 mm, 0.5 mm, 0.7 mm, 1 mm, or 1.5 mm.

[0124] The barb 202 can form a curved surface 225 between the barb 202 and the anchor body 200 when it is in an extended, expanded, and / or elongated state. The curved surface 225 can include radii from about 0.5 mm to about 2 mm. For example, the curved surface 225 can include radii from about 0.7 mm to about 2 mm, or from about 1 mm to about 2 mm. The curved surface 225 can 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 curved surface 225 can 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 can have radii of up to approximately 0.7 mm, 1 mm, 1.1 mm, 1.25 mm, 1.3 mm, 1.4 mm, 1.5 mm, or 2 mm.

[0125] The barb 202 can form an internally curved surface 230 between the barb 202 and the anchor body 200 when it is in an extended, expanded, and / or elongated state. The internally curved surface 230 includes a radius of approximately 0.01 mm to approximately 0.4 mm. For example, the internally curved surface 230 includes a radius of approximately 0.05 mm to approximately 0.4 mm, or approximately 0.2 mm to approximately 0.4 mm. The internally curved surface 230 includes a radius of approximately 0.01 mm, approximately 0.05 mm, approximately 0.1 mm, approximately 0.15 mm, approximately 0.2 mm, approximately 0.25 mm, approximately 0.3 mm, or approximately 0.4 mm. In some cases, the internally curved surface 230 includes a radius of at least approximately 0.01 mm, approximately 0.05 mm, approximately 0.1 mm, approximately 0.15 mm, approximately 0.2 mm, approximately 0.25 mm, or approximately 0.3 mm. In some cases, the internally curved surface 230 includes radii of at most about 0.05 mm, 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm, 0.3 mm, or 0.4 mm.

[0126] The second or free end 207 of the barb 202 may include a filleted, curved, and / or rounded edge 209 having 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 filleted, curved, and / or rounded edge 209 having 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 filleted, curved, and / or rounded edge 209 having 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 filleted, curved, and / or rounded edge 209 having 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.

[0127] As shown in Figures 2A-2C and 2G, when two or more of the barbs 202 are in an extended, unfolded, and / or extended state, they can include a distance 224 between the outer surface of the first barb and the outer surface of the second barb of two or more barbs 202. The distance 224 can range from about 1 mm to about 5 mm. For example, the distance 224 can range 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, a distance of 224 can include a maximum of approximately 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm.

[0128] As shown in Figures 2A-2C and 2G, when two or more of the barbs 202 are in an extended, unfolded, and / or extended state, they can form an angle 222 between the outer surface of the first barb and the outer surface of the second barb of the two or more barbs 202. The angle 222 can range from about 20 degrees to about 180 degrees. For example, the 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. The angle 222 can range from 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 approximately 20 degrees, approximately 25 degrees, approximately 30 degrees, approximately 40 degrees, approximately 50 degrees, approximately 60 degrees, approximately 70 degrees, approximately 80 degrees, approximately 90 degrees, approximately 120 degrees, or approximately 160 degrees. In some cases, angle 222 can include at most approximately 25 degrees, approximately 30 degrees, approximately 40 degrees, approximately 50 degrees, approximately 60 degrees, approximately 70 degrees, approximately 80 degrees, approximately 90 degrees, approximately 120 degrees, approximately 160 degrees, or approximately 180 degrees.

[0129] Figures 3A to 3D illustrate an electrode lead device having a lead 310 and one or more anchors (302, 304). The lead 310 may include one or more electrodes. In some embodiments, the stimulating electrode may be positioned 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 stimulate tissue. However, in other configurations, the one or more anchors may be positioned elsewhere (for example, between electrodes).

[0130] As illustrated, each anchor (302, 304) includes a collar with one or more barbs (e.g., two, three, four, or more), where one or more barbs extend from the end of the collar at an oblique angle to the longitudinal axis of the lead body. Barbs (306, 308) may extend from only one end of the collar. All barbs (306, 308) on an individual anchor may extend in the same axial direction. Barbs (306, 308) may be foldable for introduction into the body. In some configurations, all barbs (306, 308) may be foldable in the same direction so that all barbs (306, 308) are oriented in the same direction for delivery. Anchors (302, 304) may be positioned such that the barbs (306, 308) on adjacent anchors (302, 304) are offset circumferentially. For example, the barb on the first anchor can be offset 90 degrees circumferentially from the barb on the second adjacent anchor. The barb on the first anchor can be offset completely from the barb on the second anchor. For example, if the anchor has only two barbs, the barb on the first anchor will be offset completely from the barb on the second anchor. In other configurations, the barbs can be offset 30, 45, or 60 degrees circumferentially. The barb on the first anchor can extend in the same axial direction as the barb on the second anchor or in a different axial direction. The anchors (302, 304) can be equidistant from each other.

[0131] As illustrated, there are multiple anchors (302, 304) having bidirectional orientation. The first set of anchors 302 can be oriented in a first direction, and the second set of anchors 304 can be oriented in a second direction that is different from or opposite to the first direction. Together, the first set of anchors 302 and the second set of anchors 304 constitute all 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 can be oriented in the other of the proximal or distal direction. In a bidirectional configuration, the barb 306 on the first set of anchors 302 can extend in a first direction, while the barb 308 on the second set of anchors 304 can extend in a second direction. In other words, the barb 306 on the first set of anchors 302 can extend in the opposite direction to the barb 308 on the second set of anchors 304. As shown, the first set of anchors 302 can be positioned adjacent to each other, and the second set of anchors 304 can be positioned adjacent to each other. The first set of anchors 302 can be perfectly positioned between the stimulating electrode and the second set of anchors 304. The barb 306 on the first set of anchors 302 can extend proximally, and the barb 308 on the second set of anchors 304 can extend distally. The barb 306 on the first set of anchors 302 can extend toward the second set of anchors 304, and the barb 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 may be the same or different. For example, the overall arrangement of anchors (302, 304) may be asymmetrical along the length of lead 310.In other embodiments described below, a single anchor (302, 304) can incorporate bidirectional barbs (306, 308).

[0132] One or more anchors (302, 304, 306, 608) can be connected to a lead 310 (e.g., an electrode lead) as shown in Figures 3A-3D and 4A-4D. Depending on the indication, the number of anchors used to secure the electrode lead can be changed. For example, four anchors can be connected to the lead 310 instead of the six anchors shown in Figures 3A-3D and 4A-4D. One or more anchors (302, 304, 306, 308) can include an anchor body (302, 304) and one or more barbs (306, 308), as described elsewhere in this specification. One or more anchors (302, 304, 306, 308) can be fixed in place on the lead 310. One or more anchors can be fixed to the lead by adhesive. In some cases, one or more anchors (302, 304, 306, 308) can be removably coupled to the lead 310. One or more anchors can include one or more mating features on the inner surface of the anchor body, as shown in Figure 31. The mating feature 3112 of anchor 3102 can be configured to mate with the corresponding mating feature of the lead 3116. For example, the inner surface of each body of one or more anchors can include a raised portion or thread configured to mate with the corresponding groove or screw hole of the lead body. Anchor 3102 can include one or more gripping features 3108 configured to be gripped by a finger or tool during attachment of anchor 3102 to the lead 3116. In some cases, anchor 3102 can include one or more teeth 3104, which are disposed on the outer surface of the anchor configured to grip bone and / or tissue. The electrode lead body may include one or more stoppers at either end or both ends of the anchor array, or between them.The stopper can ensure that the anchor does not move or slip off the lead during revisions or other high axial forces. The stopper can be a tubular body (for example, made from pellethane). The tubular body can be longer than one of the anchors. For example, the tubular body can be at least 3 mm long. The tubular body can be at least 0.5 mm longer than any one of the anchors.

[0133] One or more anchors (302, 304, 306, 608) may include a first or second orientation. The first orientation of one or more anchors (302, 306) may include two or more barbs 306 extending toward the proximal end 311 of the lead 310, as shown in Figure 4A. The second orientation of one or more anchors (304, 308) may include two or more barbs 308 extending toward the distal end 309 of the lead 310, as shown in Figure 4A. The proximal orientation of the two or more extended barbs in the first orientation relative to the distal orientation of the two or more extended barbs in the second orientation may provide a beneficial effect in stabilizing and fixing the position of the lead 310 to the target implanted tissue or anatomical feature (e.g., the pudendal nerve). The opposing orientations of two or more barbs in the first and second orientations enable and / or fix the position of the implanted electrode lead despite any force applied to it (e.g., pushing, compressive, or tensile forces). One or more anchors and / or barbs in the opposing orientations enable the fixing of the electrode lead position against applied forces directed inward, outward, and / or laterally. One or more anchors and / or barbs in the opposing orientations enable stability in at least three different directions, preventing intrusion, outward, and lateral displacement. As described elsewhere in this specification, such benefits provided by this orientation of the anchor can improve targeted treatment for subjects with implanted leads by reducing the transfer of the leads to tissue when the subject contracts and flexes muscles, when the subject moves, or during active loading (e.g., exercising) or passive loading (e.g., sitting or sleeping) in the area of ​​their body where the leads are implanted, and thus improve the robustness and effectiveness of treating incontinence by electrical stimulation.

[0134] One or more anchors of the first orientation can be provided adjacent to one or more anchors of the second orientation on the lead, and / or spaced apart from them by any number of anchors. For example, two anchors of the first orientation can be provided adjacent to one anchor of the second orientation on the lead, or two anchors of the second orientation can be provided adjacent to one anchor of the first orientation on the lead.

[0135] In the anchor assembly of the lead, one or more anchors may each include a separate collar with one or more barbs. One or more barbs may extend from a portion of the collar of the anchor. As shown in Figures 30A to 30C, 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 end or both ends of the collar. As shown in Figure 30A, one or more anchors 3004 may be spaced apart from each other by a distance 3008 along the length of the lead 3012. The distance 3008 may range from about 1 mm to 20 mm. For example, the distance can include distances within a range defined by 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 any of the preceding values. In some cases, the distance can include less than 1 mm. As shown in Figure 30B, one or more anchors 3004 can be arranged directly adjacent to one another so that they are joined to a single unit. In some embodiments, the collar of each anchor 3004 can include one or more mating features so that the collar can interlock with adjacent collars having corresponding mating features. The mating features can include rectangular cutouts or similar interlocking patterns. One or more barbs on individual anchors 3004 can extend in different axial directions. For example, the barbs on individual anchors 3004 can have bidirectional orientation. A first set of barbs 3002A on a single anchor 3004 can be oriented in a first direction, and a second set of barbs 3002B on the same anchor can be oriented in a second direction that is different from or opposite to the first direction.For example, the first set of barbs 3002A can be oriented proximal or distal, while the second set of barbs 3002B can be oriented proximal or distal, the other of the two directions. One or more barbs can be positioned on the collar such that each barb is adjacent only to barbs of a different direction. For example, anchor 3004 has one or more barbs with alternating directions along the periphery of the collar. In some embodiments, barbs can be positioned such that two barbs of the same direction are adjacent to each other. For example, anchor can 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. Barbs can be positioned to suit the specific human anatomical structure in which the barbs will unfold. One or more anchors 3004 and bidirectional barbs 3002A, 3002B may share any of the characteristics of the anchor and barb embodiments described herein, including but not limited to material, angle, profile, length, distance to electrodes, number, etc.

[0136] One or more anchors (302, 304, 306, 608) may include a length 312 measured from the surface of the most distal anchor body 302 to the surface of the most proximal anchor body 304, as shown in Figures 3C and 4C. The length 312 may include a distance of approximately 20 mm to approximately 50 mm. For example, the length 312 may include a distance of approximately 24 mm to approximately 50 mm, or approximately 30 mm to approximately 50 mm. The length 312 may include distances 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 312 may include distances 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, a length of 312 can include distances of up to approximately 22 mm, 24 mm, 26 mm, 28 mm, 30 mm, 40 mm, or 50 mm.

[0137] Two or more barbs 306 of one or more anchors (302, 306) of the first orientation or one or more anchors (304, 308) of the second orientation can be positioned at a predetermined rotational angle from one another, as shown in Figures 3A and 4A. The rotational angle can include angles from about 1 degree to about 180 degrees. For example, the rotational 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 rotational angle can include angles of 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 of at least approximately 1 degree, approximately 5 degrees, approximately 10 degrees, approximately 20 degrees, approximately 30 degrees, approximately 40 degrees, approximately 50 degrees, approximately 90 degrees, approximately 120 degrees, or approximately 140 degrees. In some cases, the rotation angle can include angles of at most approximately 5 degrees, approximately 10 degrees, approximately 20 degrees, approximately 30 degrees, approximately 40 degrees, approximately 50 degrees, approximately 90 degrees, approximately 120 degrees, approximately 140 degrees, or approximately 180 degrees.

[0138] Two or more barbs of adjacent anchors can be rotated at an angle of at least approximately 90 degrees from each other. In some cases, two or more barbs of adjacent anchors can be rotated at an angle of less than 90 degrees from each other. In some cases, as shown in Figure 30C, the barbs on anchor 3004 can form a helical pattern, which can facilitate embedding into the tissue.

[0139] The first and second anchors in the first or second orientation can be provided at a distance 314 on the lead 310, as shown in Figures 3C and 4C. With respect to the first and second anchors (302, 306) in the first orientation, the 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, with respect to the first and second anchors (304, 308) in the second orientation, the 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 lengths from about 1.8 mm to about 5 mm. For example, the distance 314 can include lengths from about 2 mm to about 5 mm, or from about 3 mm to about 5 mm. In some cases, distance 314 can include lengths of at least approximately 1.8 mm, 2 mm, 2.1 mm, 2.2 mm, 2.4 mm, 2.5 mm, 3 mm, or 4 mm. In some cases, distance 314 can include lengths of at most approximately 2 mm, 2.1 mm, 2.2 mm, 2.4 mm, 2.5 mm, 3 mm, 4 mm, or 5 mm.

[0140] The first anchors (302, 306) in the first orientation can be provided at a distance 316 from the second anchors (304, 310) in the second orientation, as shown in Figures 3D and 4D. The distance 316 can be measured from the proximal surface 323 of the first anchor in the first orientation to the distal surface 322 of the second anchor in the second orientation. The distance 316 can include lengths from about 2.5 mm to about 5 mm. For example, the distance 316 can include lengths from 3 mm to about 5 mm, or from about 4 mm to about 5 mm. The distance 316 can include lengths 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 cases, distance 316 can include lengths of at least approximately 2.5 mm, 3 mm, 3.1 mm, 3.2 mm, 3.4 mm, 3.5 mm, or 4 mm. In some cases, distance 316 can include lengths of at most approximately 3 mm, 3.1 mm, 3.2 mm, 3.4 mm, 3.5 mm, 4 mm, or 5 mm.

[0141] One or more anchors in the first orientation (302, 306) and the second orientation (304, 308) can be positioned at a distance (402, 404) from one or more electrodes 400 of the lead 310, as shown in Figure 5. The distance 404 can include the length from the most proximal electrode 401 of one or more electrodes 400 to the proximal surface of the anchor in the second orientation 325. One or more anchors can be positioned so that they are separated from each other by a distance of up to three different sets of distances. One or more anchors can be releasably coupled to the lead at one or more distances from one or more electrodes 400. The distance of the anchors from one or more electrodes 400 can be chosen to avoid one or more target (e.g., sensitive) anatomical locations along the axis of the lead. The rotation angle of one or more anchors coupled to the lead can 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 can be adjusted to avoid the barbs extending into sensitive tissue and damaging sensitive tissue. One or more anchors as described elsewhere herein may include one or more barbs that do not extend and / or spread at a predetermined angle from the axial axis of the anchor. One or more barbs that do not extend and / or spread can be pre-set before implantation to avoid the barbs extending or spreading into sensitive target tissue or anatomical structures surrounding the implanted lead.

[0142] Distance 404 can include lengths from approximately 40 mm to approximately 100 mm. For example, distance 404 can include lengths from approximately 50 mm to approximately 100 mm, from approximately 60 mm to approximately 100 mm, or from approximately 70 mm to approximately 100 mm. Distance 404 can include lengths 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, distance 404 can include lengths 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, distance 404 can include lengths 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.

[0143] The distance 402 can include the length from the most proximal electrode 401 of one or more electrodes 400 to the distal surface of the anchor of the first orientation 324. The distance 402 can include lengths from about 5 mm to about 12 mm. The distance 402 can include lengths from about 6 mm to about 12 mm, or from about 8 mm to about 12 mm. The distance 402 can include lengths 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, the distance 402 can include lengths 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, the distance 402 can include lengths 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.

[0144] Figures 8A–8C, 9A–9C, and 10A–10C show embodiments 800 of the electrode lead 310, the elongated body 116 of the introducer, the pusher 808, and one or more anchors (302, 304, 306, 308) at various points in operation, when they interact with each other, or at points in time when the above components are used. The lumen geometry of the elongated body 116 of the introducer can include various geometric shapes from the first end to the second end of the elongated body 116. The lumen geometry of the introducer body 116 can include a tapered lumen geometry from the first diameter 806 of the introducer's elongated body lumen to the second diameter 802 of the introducer's elongated body lumen. The tapered lumen geometry may include a funnel configured to facilitate the introduction of the barb into the elongated body lumen of the introducer. For example, a tapered lumen geometry from a first diameter 806 to a second diameter 802 may facilitate the compression of the anchor barb during insertion. The taper may include one or more sections of the tapered geometry, which may be the same length and / or different in diameter. The barb geometry of the anchors (306, 308) as described elsewhere in this specification may reduce and / or minimize the force acting on the barb of the anchors (306, 308) by the inner lumen of the elongated body of the introducer when one or more anchors (302, 304, 306, 308) on the lead 310 are pushed through the elongated body lumen by the pusher 808. The pusher 808 may include an elongated body having a lumen configured to receive the outer diameter of the electrode lead. The pusher 808 may also include a distal surface 810 configured to contact the proximal surface 813 of the second orientation anchor (304, 308).The pusher can push one or more anchors (302, 304, 306, 308) and / or leads into the slender body lumens of the introducer.

[0145] Figures 9A to 9C show embodiments of one or more anchors (302, 304, 306, 308) on the lead 310 inserted into and / or translated into the lumen of the elongated body 116 of the introducer. The cross-sectional view in Figure 9C shows embodiments of one or more anchors (302, 304, 306, 308) and the pusher in a compressed and / or compacted state when inserted into the lumen of the elongated body 116 of the introducer.

[0146] Figures 10A to 10C show embodiments of one or more anchors (302, 304, 306, 308) on the lead 310, inserted through and exiting the second diameter 802 of the lumen of the elongated body 116 of the introducer. As they exit the second diameter 802 of the lumen, one or more barbs (306, 308) of the one or more anchors (302, 304, 306, 308) can extend and / or protrude outward at a predetermined angle with respect to the central axis of the anchor, for example, as shown in Figure 10A.

[0147] Lead fixing method This specification provides a method for fixing the position of an electrode lead once it is placed at a site targeted for pudendal nerve stimulation, the method comprising: (a) expanding soft tissue deep into the site of a skin incision using an oversheath device that can be advanced by sharp dissection or by sliding over the electrode lead; (b) advancing one or more anchor fixation devices over the electrode lead and positioning one or more anchor fixation devices in the soft tissue space created by the expansion; and (c) deploying one or more anchor fixation devices so that one or more anchor fixation devices grip both the electrode lead and the soft tissue space, thereby preventing the electrode lead from moving into 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 completed, achieved, and / or realized using standard surgical instruments (e.g., a scalpel). The expansion of the soft tissue in step (a) of this method can be achieved, completed, and / or realized by an oversheath device, which can bluntly generate a tunnel of sufficient diameter to allow for the subsequent smooth advancement of the anchors over the electrode leads. The soft tissue deep within the site of the skin incision can include the tissue adjacent to the ischium, as well as the attachments of fascia and / or ligaments. One or more anchor fixation devices can include one of a plurality of passive anchors. The advancement of one or more anchor fixation devices over the electrode leads can be achieved, completed, and / or realized by manually advancing one or more anchor fixation devices over the electrode leads (e.g., by hand or by pushing with basic surgical instruments (e.g., clips, etc.)). In some embodiments, the advancement of one or more anchor fixation devices can be achieved, completed, and / or realized using an oversheath device, which can advance one or more anchor fixation devices into place over the electrode leads.One or more anchor fixation devices can be contained within the oversheath device before deployment. One or more anchor fixation devices can be fixed to the electrode lead by one or more fixation methods. One or more anchor fixation devices can be fixed to the soft tissue space by one or more fixation methods. One or more anchor fixation devices can be fixed to the soft tissue space, where the soft tissue space can include natural human tissue (e.g., ligamentous tissue, fascial tissue, periosteal tissue, or any combination thereof). One or more anchor fixation devices can be fixed to the soft tissue space using a standard surgical approach (e.g., suturing). The physical characteristics of one or more anchor fixation devices allow them to be fixed and / or attached to natural human tissue. One or more anchor fixation devices can be fixed to the electrode lead by one or more fixation methods. One or more anchor fixation devices can be fixed to the electrode lead by frictional force acting between one or more anchor devices and the electrode lead. In some embodiments, ligatures can be used to compress one or more anchor fixation devices over the electrode lead. Standard suture materials can provide ligatures for compressing one or more anchor fixation devices onto electrode leads, thereby enabling the fixation and / or attachment of one or more anchor fixation devices to the electrode leads. In some embodiments, small mounting screw assemblies can provide compression of one or more anchor fixation devices onto electrodes, thereby enabling the fixation and / or attachment of one or more anchor fixation devices onto electrode leads. Small mounting screw assemblies can be tightened to a predetermined pressure limit using a small torque wrench.A small torque wrench can enable deep tightening of small, fitted screw assemblies into soft tissue. In some embodiments, a standard surgical ligation clip can be used to compress one or more anchor fixation devices onto the electrode lead, thereby enabling the one or more anchor fixation devices to be fixed and / or secured onto the electrode lead. A standard surgical ligation clip can be applied using a ligation clip applicator. One or more anchor fixation devices can be secured to the electrode lead and / or surrounding soft tissue by an activation mechanism (e.g., a spring-loaded tine) as described elsewhere in this specification. The general anchor fixation mechanism of one or more anchor fixation devices can be automatically deployed when one or more anchor fixation devices are pushed out of the oversheath device. In some embodiments, the retraction of the oversheath device can activate the general anchor fixation mechanism of one or more anchor fixation devices. The activation of anchor fixation and / or fixation of one or more anchor fixation devices can be activated when one or more anchor fixation devices are pushed out of the oversheath device. One or more anchor fixation devices can be pushed out of the oversheath device by a pushing device. One or more anchor fixation devices may include one or more mechanisms that are automatically activated when one or more anchor fixation devices are pushed out from the oversheath device. One or more mechanisms may include activation of spring-loaded tines of one or more anchor fixation devices. The activation mechanism may include a clipping function of one or more anchor fixation devices to electrode leads and soft tissue spaces.While specific devices, systems, methods, and kits are described herein in relation to the pelvic region for treating and / or managing pelvic disorders, these methods and devices may also be used to treat other areas of the body or other disorders, as described elsewhere herein.

[0148] The elongated body of the introducer can be inserted through an incision site as described elsewhere in this specification, guided to a target implantation area, and into which one or more leads can be implanted. Leads with 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 can include a conical or tapered cross-sectional profile. In some cases, the introducer can include sizes from about 1 French (F) to about 15 (F). Once one or more anchors and leads are compressed and / or folded into a closed configuration, the introducer can then be translated and / or maneuvered to the target implantation site (e.g., in the pudendal nerve or adjacent tissue). Next, as shown in Figures 10A to 10C, one or more anchors (302, 304, 306, 308) and leads can be deployed and / or extended by translating and / or removing the elongated body 116 of the introducer proximal while applying a pushing force distally by the pusher 808 toward the distal tip of one or more anchors and leads. By applying force by the pusher 808, the position of one or more deployed anchors (302, 304, 306, 308) can remain fixed, and thus the leads can be anchored in the target area. The precise positioning of one or more anchors and leads provides targeted electrical stimulation to treat incontinence, as described elsewhere in this specification. The elongated body of the introducer can include polymer, metal, or a combination thereof. The metal can include stainless steel, aluminum, titanium, or any combination thereof. The polymer material may include thermoplastic polyurethane (TPU), polytetrafluoroethylene (PTFE), or any combination thereof.

[0149] The elongated body of the introducer can include lengths ranging from approximately 140 mm to approximately 500 mm. For example, the elongated body of the introducer can include lengths ranging from approximately 150 mm to approximately 500 mm, approximately 180 mm to approximately 500 mm, or approximately 250 mm to approximately 500 mm. The elongated body of the introducer can include lengths ranging from 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 elongated body of the introducer can include lengths ranging from 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 slender body of the introducer can include lengths of up to approximately 150mm, 160mm, 180mm, 200mm, 250mm, 300mm, 350mm, 400mm, 450mm, or 500mm.

[0150] This disclosure describes a method for attaching an electrode lead to tissue 900, as shown in Figure 11. The method may include the steps of: placing the electrode lead to target tissue, the electrode lead comprising: (i) a lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; and (ii) a plurality of anchors, each anchor comprising a collar and two or more barbs extending from the collar, the plurality of anchors being releasably positioned on the lead proximal to one or more stimulating electrodes, the first anchor of the plurality of anchors being adjacent to a second anchor of the plurality of anchors, the two or more barbs of the first anchor being positioned at a predetermined rotational angle from the two or more barbs of the second anchor along the length of the lead, and one or more stimulating electrodes being configured to deliver electrical stimulation to the target tissue; and the steps of: removing a sheath covering at least a portion of the first or second anchor, unfolding the first or second anchor, and anchoring the electrode lead to the target tissue. 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, the sacral nerve, or any combination thereof. The sheath may include an elongated body portion of the introducer, including the lumen. In some embodiments, the sheath may include an oversheath cover that covers at least a portion of the first anchor and / or the second anchor. The sheath may have a hardness of at least about Shore 75D. The sheath may be made from a thermoplastic polyurethane material (e.g., Pellethane®). The sheath may be made from an aromatic polyether-based thermoplastic polyurethane (TPU) (e.g., Techothane®). In some cases, the sheath may be made from a polyether block amide (e.g., PEBAX®).

[0151] Lead positioning guide (LPG) This specification provides devices, systems, and methods for introducing and placing one or more electrode leads in or near one or more target tissues. The one or more target tissues may be located in the pelvic region. The target tissues include the pudendal nerve. In some cases, the target tissues include one or more branches of the pudendal nerve, the sacral nerve, or any combination thereof. The target tissues may include target tissues for receiving electrical stimulation to treat incontinence. In some cases, the target tissues may include target tissues for receiving electrical stimulation for sexual dysfunction. In some cases, the target tissues may include target tissues for receiving electrical stimulation to treat and / or manage pain.

[0152] A lead positioning guide (LPG) (also referred to as an anchor positioning guide (APG)) used to position a lead including an anchor fixing device may include an LPG 1500, an LPG tube 1520 (also referred to as a sleeve throughout this specification), and a locking cap 1600. The LPG 1500 may include a frame including 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 screw-threaded portion 1506, which is configured to receive the screw-threaded portion 1602 of the locking cap 1600. Figure 17 shows embodiments of the LPG 1500 and the locking cap 1600. Figures 18A to 18D illustrate embodiments of the LPG 1500. The LPG 1500 may include a proximal tip 1508. The proximal tip 1508 may include an opening 1510 configured to receive a lead. The opening may extend into a lumen that extends through the neck 1504 of the LPG 1500. The neck 1504 may include a threaded portion 1506 configured to receive a locking cap 1600. The proximal tip may include a chafer tip. The opening 1510 may be a tapered opening. The tapered opening 1510 may be a tapered slotted opening. The slotted opening may include a split that extends through at least a portion of the proximal tip 1508. The split may stop before the threaded portion 1506 of the neck 1504. The slotted opening 1510 may include two or more slits. The slotted opening 1510 may include three or four slits. The slotted opening 1510 can contain three, four, five, six, seven, eight, nine, or ten slits. The opening can transition into lumens extending through the neck 1504 of the LPG 1500.The proximal tip 1508 may 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 rest of the neck 1504. The LPG includes a flange. The flange may be matched to a hub. The flange may include a small indentation for matching to a hub. Matching the flange and hub may provide rotational stability to the LPG components. Matching the flange and hub may reduce the rotational movement of the LPG components relative to each other.

[0153] LPG systems, as described herein, can enable clinicians to control and manipulate lead and anchor fixation devices without unintended axial displacement of the lead and anchor fixation devices. The use of LPGs can enable users to control and position lead and anchor fixation devices with one hand. The use of LPGs can enable users to maintain the lead position before anchor deployment without needing to hold the lead. This allows clinicians to release the lead during installation without the corresponding anchor fixation device unintentionally deploying from the delivery sleeve.

[0154] As illustrated in Figures 18A to 18C, the locking cap 1600 can be formed as a cylindrical tube including a threaded interior 1602. The locking cap 1600 can be screwed onto the threaded 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 compress the proximal tip 1508 against the lead 1700 in the slotted opening 1510, thereby locking the position of the lead 1700. The locking cap 1600 can be tightened or loosened around the proximal tip 1508 to control the axial movement of the lead 1700 through the LPG 1500. The locking cap may include an upper ridge 1604 on the inner surface of the cap, which is configured to tighten the slotted opening 1510 around the lead 1700 when the locking cap is screwed onto the threaded portion 1506. The locking cap 1600 may include an outer gripping surface 1606, which is configured to assist in tightening and / or loosening the locking cap 1600 to control the movement of the lead 1700. The gripping surface 1606 may include a material having a high coefficient of friction. The gripping surface 1606 may include one or more surface structures (e.g., grooves, bumps, or ridges) to improve grip and static friction on the locking cap. The locking cap 1600 may be configured to lock onto the proximal tip portion 1508 of the LPG 1500 using a non-threaded coupler. For example, the locking cap 1600 can be configured to snap into a locked position on the proximal tip 1508 or the neck 1504, or to use a lock and pin configuration. The locking cap 1600 can be configured to regulate the pressure on the lead 1700 installed through the opening 1510.The locking cap 1600 can be manually loosened and / or tightened to control the mobility of the lead 1700 during positioning. The locking cap can also allow the user to change the resistance of the lead through the LPG 1500. This can allow for better control when positioning the lead to the target position.

[0155] The LPG1500 may include an LPG sleeve 1520. The sleeve 1520 may include an elongated body portion with a lumen configured to receive a lead. The proximal end of the elongated body portion of the LPG sleeve 1520 may be attached to, fastened to, and / or fused to the neck 1504 of the LPG1500, as shown in Figures 18A–18C. The sleeve 1520 may include one or more electrodes and / or conductive regions and / or one or more electrode insulating regions. The sleeve 1520 may include a non-conductive biocompatible material (including, but not limited to, high-density polyethylene, fluorinated ethylene propylene, polycarbonate, plastic, or any combination thereof). The LPG1500 and locking 1600 may be autoclavable and / or can be cleaned by conventional sterilization methods used for other similar medical devices. In some embodiments, the sleeve may include one or more sensors. For example, one or more sensors integrated into the sleeve 1520 may include, but are not limited to, electrical sensors, pressure sensors, gyroscopes, chemical sensors, humidity sensors, accelerometers, or any combination thereof. The sleeve 1520 may extend from the distal end of the neck 1504 between the arms 1502 of the LPG. The sleeve 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. The LPG tube 1520 may be configured to maintain one or more anchors on the lead in a delivery configuration while positioned within the sleeve. One or more anchors may change from a delivery configuration to a deployment configuration when extended through the distal opening of the sleeve. The sleeve 1520 may include an inner lumen. The inner lumen may include a predetermined inner diameter.The inner lumen of the sleeve 1520 can include a predetermined diameter, and the inner lumen of the lead 1700 and the sleeve 1520 are mechanically connected by a slip-fit ​​interface. In some embodiments, the inner lumen of the sleeve 1520 can include a predetermined diameter, and the inner lumen of the lead 1700 and the sleeve 1520 have a loose-fit interface. In some embodiments, the inner lumen of the introducer 111 can include a predetermined diameter, and the outer diameter of the LPG sleeve 1520 and the inner lumen of the introducer are mechanically connected by a slip-fit ​​interface. In some embodiments, the inner lumen of the introducer 111 can include a predetermined diameter, and the outer diameter of the sleeve 1520 and the inner lumen of the introducer have a loose-fit interface.

[0156] The internal lumens of the introducer 111 can include diameters ranging from approximately 0.2 mm to approximately 1.4 mm. For example, the internal lumens of the introducer 111 can include diameters ranging from approximately 0.3 mm to approximately 1.4 mm, or from approximately 0.5 mm to approximately 1.4 mm. The internal lumens of the introducer 111 can include diameters of approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, approximately 1 mm, approximately 1.2 mm, or approximately 1.4 mm. In some cases, the internal lumens of the introducer 111 can include diameters of at least approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, approximately 1 mm, or approximately 1.2 mm. In some cases, the internal lumen of the introducer 111 can include diameters of approximately 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.2 mm, or 1.4 mm at most. The diameter can be measured by the distance of the longest cross-sectional axis. In some cases, the diameter is measured by the distance of the shorter cross-sectional axis (e.g., the minor axis of an ellipse).

[0157] The internal lumens of the introducer 111 can include diameters ranging from approximately 1 mm to approximately 10 mm. For example, the internal lumens of the introducer 111 can include diameters ranging from approximately 1.5 mm to approximately 10 mm, approximately 2 mm to approximately 10 mm, or approximately 3 mm to approximately 10 mm. The internal lumens of the introducer 111 can include diameters ranging from approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 3.5 mm, approximately 4 mm, approximately 4.5 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, or approximately 10 mm. In some cases, the internal lumens of the introducer 111 can include diameters ranging from at least approximately 1 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.5 mm, approximately 3 mm, approximately 3.5 mm, approximately 4 mm, approximately 4.5 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, or approximately 8 mm. In some cases, the internal lumen of the introducer 111 can include diameters of up to approximately 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm. The internal lumen of the introducer 111 can include a diameter of approximately 2.2 ± 0.025 mm. The sleeve 1520 can be configured to be inserted into the inner diameter of the introducer 111. The diameter can be measured by the distance of the shorter cross-sectional axis (e.g., the minor axis of an ellipse). In some embodiments, the diameter can be measured by the distance of the longer cross-sectional axis.

[0158] The inner diameter of the inner lumen of the sleeve 1520 can include a diameter of approximately 0.2 mm to approximately 1.4 mm. For example, the inner diameter of the inner lumen of the sleeve 1520 can include a diameter of approximately 0.3 mm to approximately 1.4 mm, or approximately 0.5 mm to approximately 1.4 mm. The inner diameter of the inner lumen of the sleeve 1520 can include a diameter of approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, approximately 1 mm, approximately 1.2 mm, or approximately 1.4 mm. In some cases, the inner diameter of the inner lumen of the sleeve 1520 can include a diameter of at least approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, approximately 1 mm, or approximately 1.2 mm. In some cases, the inner diameter of the inner lumen of the sleeve 1520 can include diameters of approximately 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.2 mm, or 1.4 mm at most. The diameter can be measured by the distance of the longest cross-sectional axis. In some cases, the diameter is measured by the distance of the shorter cross-sectional axis (e.g., the minor axis of an ellipse).

[0159] The sleeve 1520 may include an outer diameter configured to be inserted through the lumen of the introducer. The introducer may be an introducer as disclosed herein. The outer diameter of the sleeve 1520 may include a diameter from about 1 mm to about 10 mm. The outer diameter of the elongated body of the sleeve 1520 may include a diameter from about 1.5 mm to about 10 mm, from about 2 mm to about 10 mm, or from about 3 mm to about 10 mm. The outer diameter of the elongated body of the sleeve 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 elongated outer diameter of the sleeve 1520 can include diameters of at least approximately 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 6 mm, or 8 mm. The elongated outer diameter of the sleeve 1520 can include diameters of at most approximately 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm. The elongated outer diameter of the sleeve 1520 can include diameters of 2 ± 0.025 mm. The sleeve 1520 can be configured to assist in the insertion of the lead 1700 into a patient / subject accepting the electrode lead implant by providing structural rigidity. The diameter can be measured by the distance of the longest cross-sectional axis. In some cases, the diameter is measured by the distance of the shorter cross-sectional axis (for example, the minor axis of an ellipse).

[0160] LPG sleeve 1520 can be available in lengths ranging from approximately 100mm, 110mm, 120mm, 130mm, 140mm to 500mm. LPG sleeve 1520 can also be available in lengths ranging from approximately 150mm to 500mm, 180mm to 500mm, or 250mm to 500mm. LPG sleeve 1520 can also be available in lengths ranging from approximately 140mm, 150mm, 160mm, 180mm, 200mm, 250mm, 300mm, 350mm, 400mm, 450mm, or 500mm. In some cases, the length of the LPG sleeve 1520 can include lengths of at least approximately 140mm, 150mm, 160mm, 180mm, 200mm, 250mm, 300mm, 350mm, 400mm, or 450mm. In some cases, the length of the LPG sleeve 1520 can include lengths of at most approximately 150mm, 160mm, 180mm, 200mm, 250mm, 300mm, 350mm, 400mm, 450mm, or 500mm.

[0161] The LPG1500 can be configured to be connected to its sheath handle 106, as shown in Figures 19 to 23. The neck 1504 can be connected to the arms 1502 of the LPG1500. The LPG1500 can include two or more arms 1502 extending from the neck 1504 of the LPG. The arms 1502 can extend distally from the neck of the LPG. The arms 1502 can extend slightly away from the sides of the neck 1504 of the LPG, and the distance between the arms is greater than the width of the neck. The arms 1502 can include a connecting feature at the distal end of the arm that is configured to lock into the sheath handle 106. In some cases, the arms 1502 can be disconnected from the sheath handle by rotating the LPG. The arms 1502 can include a locking tab 1512 that is configured to lock into the sheath handle 106. The locking tab 1512 may include a stem 1516 and an overhang 1518 configured to connect to a stem 113 and an overhang 115 on the sheath handle 106. The locking tab 1512 may be lockably connected to a receiving tab 107 on the sheath handle 106. The sheath handle 106 may include a receiving tab 107 configured to mechanically clip onto the locking tab 1512. This allows the position of the LPG relative to the sheath handle 106 to be locked. The locking tab 1512 may include a stem and an overhang configured to connect to the stem and overhang of the receiving tab 107. The arm 1502 may include an extended overhang 1514, which is configured to extend across the width of the sheath handle 106, as shown in Figure 20. The overhang 1514 may include a locking tab configured to lockably connect to the receiving tab 107. The overhang 1514 can be small enough so as not to extend across the width of the sheath handle, as shown in Figure 19.The overhang 1514 may include locking tabs on two or more sides of the overhang 1514. Figure 21 illustrates an alternative embodiment in which the curved overhang 1514 includes locking tabs 1512 on the inner and outer surfaces of the overhang 1514. The sheath handle 106 may include a receiving tab 107 configured to lock into the inner and outer surface locking tabs 1512 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 handle 106. Figure 22 illustrates a pin locking configuration in which the LPG includes a hook / clip 1516 at the distal end of the arm 1502. The hook / clip 1516 may be configured to lock onto a pin 109 on the sheath handle 106. Figure 23 illustrates a wide locking configuration in which the distal end of the 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 an opening facing the opposite side, and the arm 1502 is configured to twist into the appropriate position, so that when the receiving slot is aligned with the handle 106, it clamps the sheath handle 106 and locks the LPG in place. The arm 1502 can be unlocked by rotating the LPG 117 to release the sheath handle 106 from the receiving slot 1519 of the arm 1502, and the LPG can be discoupled from the sheath handle. These embodiments are not limiting, and it should be understood that alternative locking arrangements may be used to connect the LPG to the sheath handle.

[0162] In some cases, the sheath handle can contain high-viscosity polyamide. For example, the sheath handle can contain vestamid.

[0163] The height of the receiving tab 107 can include a height between approximately 1 mm and approximately 5 mm. The height of the receiving tab 107 can include a height between approximately 2 mm and approximately 5 mm, or between approximately 3 mm and approximately 5 mm. The height of the receiving tab 107 can include a height of approximately 2 mm, approximately 2.2 mm, approximately 2.4 mm, approximately 2.6 mm, approximately 2.8 mm, approximately 3 mm, approximately 4 mm, or approximately 5 mm. The height of the receiving tab 107 can include a height of approximately 1.0 mm, approximately 1.5 mm, approximately 2 mm, approximately 2.2 mm, approximately 2.4 mm, approximately 2.6 mm, approximately 2.8 mm, approximately 3.0 mm, 3.2 mm, approximately 3.4 mm, approximately 3.6 mm, approximately 3.8 mm, approximately 4 mm, approximately 4.5 mm, or approximately 5 mm or more. The height of the receiving tab 107 can include a height of at least approximately 0.5 mm, 1 mm, approximately 1.5 mm, approximately 2 mm, 2.2 mm, approximately 2.4 mm, approximately 2.6 mm, approximately 2.8 mm, approximately 3 mm, approximately 4 mm, or approximately 5 mm. The height of the receiving tab 107 can include a height of approximately 2.4 mm.

[0164] The sleeve can have a hardness of at least about 75D Shore. In some cases, the sleeve can have a hardness less than 75D. In some cases, the sleeve can have a hardness greater than 75D. The sleeve can have a hardness of about 75D Shore. The sleeve can be made from thermoplastic polyurethane (e.g., Pellethane®). The sleeve can be made from aromatic polyether-based thermoplastic polyurethane (TPU) (e.g., Techothane®). In some cases, the sleeve can be made from polyether block amide (e.g., PEBAX®).

[0165] This specification provides a method for positioning electrode leads using LPG.

[0166] Positioning an electrode lead using an LPG may include inserting the distal end of the lead through the proximal opening of the LPG. Positioning an electrode lead using an LPG may include advancing the lead through the sleeve of the LPG. The lead may be advanced through the sleeve until the distal portion of the lead extends beyond the distal end of the sleeve. Positioning an electrode lead using an LPG may include positioning one or more anchor fixing devices on the lead so that the proximal end of the anchor contacts the distal end of the sleeve. One or more anchor fixing devices may be coupled to the lead before advancing the lead through the sleeve of the LPG. One or more anchor fixing devices may be part of the lead body. Positioning an electrode lead using an LPG may include placing a locking cap on top of the LPG. The locking cap may restrict the axial movement of the lead within the LPG. The cap may lock the lead in place within the LPG. Positioning an electrode lead using an LPG may include inserting the distal end of the lead and the LPG sleeve into the introducer. The lead and LPG sleeve can be inserted into the introducer until the marker on the sleeve is aligned with the sheath handle. The introducer sheath may include one or more radiopaque markers that indicate the position of the electrode and / or anchor assembly when the LPG sleeve is inserted into the introducer to this point. For example, one or more radiopaque markers on the introducer sheath may indicate the position at or near the distal end of the sheath, as well as the proximal end, center, and / or distal end of the anchor assembly. Positioning the electrode lead using the LPG may include withdrawing the introducer until the sheath handle contacts the arm of the LPG.Withdrawing the introducer can cause the distal tip of the lead to be exposed while one or more anchors remain contained within the introducer. Thus, the lead and LPG can be in a safe zone, where the lead can still be adjusted axially while the anchors have not yet unfolded from the introducer sheath. Positioning the electrode lead using the LPG can include locking the arm of the LPG onto the introducer handle. The LPG handle can be locked onto the introducer handle using one or more locking means as described herein. Positioning the electrode lead using the LPG can include measuring the EMG response and adjusting the position of the locked lead / LPG until the electrode lead receives the desired EMG signal. The EMG signal can indicate that the lead is positioned on or near the target tissue. For example, an external anal sphincter EMG response can indicate that the lead is positioned on or near the pudendal nerve. Positioning the electrode lead using the LPG can include unlocking the LPG from the introducer handle. The LPG can be unlocked by rotating the LPG relative to the introducer handle. Positioning the electrode lead using the LPG can involve withdrawing the introducer towards the proximal end of the LPG, between the arms of the LPG, while keeping the LPG stationary. This allows for the deployment of one or more anchors in or near the target tissue. One or more anchor fixation devices can be deployed to fix the lead position in or near the target site. The LPG locking cap can be unlocked, and the introducer and LPG can be withdrawn. This method can be applied to leads or catheters.The method of positioning electrode leads using LPG allows for the omission and / or repetition of one or more of the steps described above.

[0167] The introducer handle can contain high-viscosity polyamides. For example, the introducer handle can contain vestamid.

[0168] Positioning an electrode lead using an LPG involves: (a) inserting the distal end of the lead through the proximal opening of the LPG; (b) advancing the lead through the sleeve of the LPG until the distal portion of the lead extends beyond the distal end of the sleeve; (c) positioning one or more anchor fixing devices on the lead so that the proximal end of the anchor contacts the distal end of the sleeve; (d) placing a locking cap on the LPG and locking the lead in place within the LPG; (e) inserting the distal end of the lead and the LPG sleeve into the introducer until the sleeve marker aligns with the sheath handle; and (f) positioning the sheath handle on the arm of the LPG. The method may include the steps of: (g) withdrawing the introducer until contact is made, so that the distal tip of the lead is exposed and the anchor remains contained within the introducer; (h) locking the arms of the LPG onto the introducer handle; (i) adjusting the locked lead / LPG position until an EMG signal indicating a target tissue region is received; (j) unlocking the LPG from the introducer handle and rotating the LPG; and (j) withdrawing the introducer towards the LPG between the arms, deploying one or more anchors, and positioning 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.

[0169] The target tissue site can include nerves. For example, the target tissue site can include the pudendal nerve. In some cases, the target tissue site can include the sacral nerve. The target tissue site can be targeted to help treat incontinence.

[0170] Figures 24A to 24H illustrate embodiments of a method for positioning electrode leads and deploying lead anchoring devices. Figure 24A illustrates inserting lead 1700 through LPG 1500 and advancing lead 1700 through LPG sleeve 1520. As the distal end of lead 1700 extends from the distal end of sleeve 1520 and the proximal end of lead anchoring device 1710 contacts the distal end of sleeve 1520, a locking cap is screwed onto the LPG, locking lead 1700 and anchoring device 1710 in place relative to LPG 1500. Figures 24B and 24C illustrate inserting the locked lead 1700 and LPG sleeve 1520 through sheath handle 106 and introducer 111. Figure 24D illustrates inserting the locked lead 1700 and LPG 1500 assembly through the introducer 111 until the markers on the sleeve 1520 are aligned with the opening of the sheath handle 106. One or more markers 1522 can help indicate that the distal end of the lead 1700 is near the distal end of the introducer 111. In some cases, the markers can indicate that the distal end of the lead 1700 coincides with the distal end of the introducer 111. In some cases, the markers can indicate that the distal end of the lead 1700 is at a desired distance proximal to the distal end of the introducer 111. In some cases, the markers can indicate that the distal end of the lead 1700 extends a desired distance past the distal end of the introducer 111. One or more markers 1522 on the LPG sleeve can be radiopaque markers. In some cases, the marker 1522 can indicate the end of the sheath and the proximal range of the lead anchor 1710. The desired proximal distance of the distal tip of the introducer 111 can be approximately 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm.In some embodiments, the desired distance proximal to the distal tip of the introducer 111 can be about 1 cm or more, about 2 cm, about 3 cm, about 4 cm, about 5 cm, or about 10 cm. The desired distance passing through the distal tip of the introducer 111 can be about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, 8 mm, about 9 mm, or 10 mm. In some embodiments, the desired distance passing through the distal tip of the introducer 111 can be about 1 cm or more, about 2 cm, about 3 cm, about 4 cm, about 5 cm, or about 10 cm. The anchor fixing device 1710 can still be inside the introducer 111, and the anchor fixing device 1700 is in the delivery configuration. Figures 24E to 24H illustrate the process of aligning the marker 1522 with the opening of the sheath handle 106 and then withdrawing the sheath handle 106 toward the arm 1502 of the LPG 1500. Withdrawing the sheath handle 106 causes the arm 1502 to connect to the sheath handle. Once the sheath handle 106 is connected to the LPG arm 1502, the LPG and lead can be locked in place relative to the introducer 111 and the sheath handle 106, as shown in Figure 24H. The sheath handle 106 and the LPG 1500 can be connected using any of the connecting means or LPG configurations described above. When the sheath handle 106 contacts the arm 1502 and connects to the LPG 1500, the distal end of the lead 1700 can extend through the distal end of the introducer 111, as shown in Figure 24G, while the anchor fixing device remains positioned within the distal portion of the introducer 111 in the delivery configuration. The distal end of the lead 1700 may include one or more electrodes 1702, which are exposed when the sheath handle connects to the arm of the LPG 1502. Since the anchor remains within the sheath, the locked lead 1700 and LPG 1500 assembly is free to move axially.The user can adjust the locked lead 1700 and LPG 1500 assembly until a desired EMG response is received from one or more electrodes 1702. As illustrated in Figures 24I and 24J, once the desired signal is received, the LPG can be rotated, and rotating the LPG 1500 discouples the sheath handle 106 from the LPG 1500. Before the LPG 1500 can be rotated, the user may be required to release the safety locks on the LPG 1500 and / or the sheath handle 106. After the LPG has been rotated, the sheath handle 106 can be withdrawn between the arms 1502. This allows the anchoring device to be deployed from the introducer 111 into the target tissue area, and the electrode 1702 to be fixed in or near the target tissue. When the sheath handle 106 is withdrawn between the arms 1502 of the LPG 1500, the anchor device 1710 can be exposed and changed from a delivery configuration to a deployment configuration as described herein. After the anchor fixing device is deployed and the lead is anchored in place, the locking cap can be removed and the LPG and introducer 111 can be withdrawn from the lead as shown in Figure 24K.

[0171] A method for positioning the electrode lead and deploying the lead anchoring device may further include the use of an obturator 119. The elongated body 117 of the obturator may be configured to fit inside the lumen of the elongated body 116 of the introducer 111, as illustrated in Figure 26. The obturator handle 104 may be configured to connect to the introducer handle 106. The elongated body 117 of the obturator may include a tapered distal tip 2604, as illustrated in Figure 1I. The tapered distal tip 2604 may 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 slender, bullet-shaped tip configured to penetrate areas with high tissue density. The obturator may include a stiffening tube. The stiffening tube may be molded into the elongated body 117. The stiffening tube can improve the rigidity and stiffness of the obturator to assist in the insertion and positioning of the introducer 111. The elongated body portion 117 of the obturator may include a stiffening tube 2602 that terminates in front of the tapered distal tip portion 2604, as illustrated in Figure 1J.

[0172] The use of the LPG1500 can enable improved control and placement of the lead 1700 and anchor fixing device 1710 to the target position. The use of the LPG1500 can provide easier handling of lead-in placement. The fixed positioning of the contained anchor fixing device can reduce the burden of dexterity during the introduction and manipulation of the lead tip during placement. The use of the LPG as described herein can reduce the need for EMG and damage guidance during lead placement. When the LPG is locked away and coupled to the sheath handle, it can enable precise control and positioning of one or more electrodes at or near the distal tip of the lead. The length of the LPG's arms can allow one or more electrodes at or near the distal end of the lead to extend through the opening of the oversheath device, while at the same time firmly holding the lead to prevent it from sliding freely within the outer sheath. The length of the LPG's arms can be equal to or greater than the length of one or more anchor fixing 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 may be adjustable to accommodate leads with longer or shorter distal electrode regions. The length of arm 1502 can include distances from approximately 20 mm to approximately 50 mm. For example, the length can include distances from approximately 24 mm to approximately 50 mm, or from approximately 30 mm to approximately 50 mm. The length can include distances 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 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 or more.In some cases, the length can include distances of at least approximately 5mm, 10mm, 15mm, 20mm, 22mm, 24mm, 26mm, 28mm, 30mm, 40mm, or 50mm. In some cases, the length of arm 1502 can include distances between approximately 30mm and 35mm. For example, the length of arm 1502 can include distances of approximately 34mm.

[0173] LPGs can be made from one or more rigid materials, such as plastic, metal, carbon, or alloys. The opening of the LPG can be configured to accept multiple sizes of reeds. Reeds can be between 1 French (F) and 18F. In some cases, reeds can be between 1F and 15F. In some cases, reeds can be smaller than 6F. In some cases, reeds can be larger than 12F. Reeds can be 1F, 2F, 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, 11F, 12F, 13F, 14F, or 15F. A locking cap can be configured to tighten the opening to accommodate different sized reeds. The LPG can be configured to lock the sheath handle onto the neck of the LPG when in the pulled-out position. This can help prevent the introducer from sliding the reed back in. After the lead and anchor fixing device are deployed, the locking cap can be removed, and the LPG and introducer can be pulled out over the proximal portion of the lead. The arm of the LPG can be disengaged from the sheath handle by rotating the LPG. In some cases, the arm of the LPG can be disengaged from the sheath handle by applying outward pressure to the arm to disengage the receiving tab on the handle. The LPG may include an indicator to show when the arm is securely locked over the sheath handle. The LPG can be locked over the sheath handle using any one of the locking mechanisms described herein.

[0174] The LPG sleeve may include a biocompatible outer lubricating layer. The LPG sleeve may include a low-friction outer surface. Inserting the LPG sleeve through the introducer's oversheath may further include applying a lubricant. One or more anchor fixation devices may include one or more tines configured to change from a flattened delivery configuration to a deployed configuration when the introducer is withdrawn. One or more anchor fixation devices may be contained within the oversheath device before deployment. The sleeve and / or oversheath device may include an internal fixing element configured to hold the lead in place. For example, an expansion element configured to expand inside the sleeve or sheath to hold the lead in place. One or more anchor fixation devices may be placed on top of the lead after the lead has advanced through the sleeve. One or more anchor fixation devices may be placed on top of the lead such that the proximal end of the anchor fixation device touches the distal end of the sleeve.

[0175] The distal tip of the lead may include one or more markers to indicate when the distal portion of the lead has advanced past the distal tip of the introducer. The LPG may include one or more markers to assist in lead positioning. The LPG may include at least two, three, four, five, six, seven, eight, nine, or ten markers to assist in lead positioning. The LPG sleeve may include a first marker configured to indicate when the electrode on the distal tip of the lead extends past the distal tip of the introducer. The LPG sleeve may further include a second marker configured to indicate the position just before the anchor fixation device exits the introducer. A combination of the first and second markers on the LPG sleeve can allow the user to track the position of the lead, with the electrode on the distal tip of the lead extending past the introducer and becoming exposed to tissue, while the anchor fixation device on the lead remains covered by the introducer and remains in the delivery position. The lead may include a marker immediately distal to one or more anchor fixation devices to indicate that the anchor has not yet been released from the introducer. A second marker on the LPG sleeve 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 may include a marker immediately distal to one or more anchor fixation devices to indicate that the anchor has not yet been released from the introducer. In some cases, the lead may include a marker immediately proximal to one or more anchor fixation devices. The marker may indicate that one or more anchor fixation devices have been deployed from the introducer. The marker on the LPG sleeve may be radiopaque. Radiopaque markers may indicate the end of the sheath and the proximal range of the lead anchor.The marker can be a band. The band can be wrapped around all or part of the outer diameter of the sheath or sleeve. The marker can be a dot, square, arrow, triangle, or any other desired shape. The shape of the marker can be configured to help indicate the orientation or direction of the device.

[0176] The lead may include one or more anchoring devices before being inserted into the LPG and through the LPG sleeve. One or more anchoring devices may be secured to the electrode lead and / or surrounding soft tissue by an activation mechanism (e.g., a spring-loaded tine) as described elsewhere in this specification. A general anchoring mechanism for one or more anchoring devices may be automatically deployed when one or more anchoring devices are pushed out of the oversheath device. Retraction of the oversheath device may activate the general anchoring mechanism for one or more anchoring devices. In some embodiments, the activation of anchoring and / or fixation of one or more anchoring devices may be activated when one or more anchoring devices are pushed out of the oversheath device. One or more anchoring devices may be pushed out of the oversheath device by 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 pushed out of the oversheath device. In some embodiments, one or more mechanisms may include the activation of a spring-loaded tine for one or more anchoring devices. In some embodiments, the activation mechanism may include a clipping function of one or more anchor fixation devices to the electrode lead and soft tissue space.

[0177] Electrode lead This specification provides methods, devices, and systems for implanting at least one electrode lead and an implantable pulse generator (IPG) in an individual to treat incontinence. The lead may have variable density and / or flexibility along the lead body. A portion of the lead body may be configured to have higher rigidity in order to maintain its implanted position. The rigidity of a portion of the lead body may be increased by using a higher density material for that portion of the lead body. For example, the tip of the lead body may be more rigid than the turning portion of the lead. Since the tip of the lead may contain a stimulating electrode, the tip may have increased rigidity and / or density so that it resists forces that would move the tip away from its implanted position in or near the target nerve and resist forces that would reduce the effectiveness of the stimulation. A portion of the lead body may be configured to have higher flexibility in order to adapt to forces and strains from the patient's movement or posture. The flexibility of a portion of the lead body may be increased by using a lower density material with respect to that portion of the lead body. For example, a portion of the lead body that bends when a patient sits or performs other general movements can have greater flexibility and / or lower density to accommodate the strain on the lead body.

[0178] Depending on the indication, the length of the lead body can vary. In some cases, bilateral leads can have different lengths with respect to the lead body. The length of the lead opposite the IPG can be greater than the length of the lead on the same side as the IPG. In some cases, when a bilateral approach is used, the difference in length between the first and second lead bodies can be between approximately 100 mm and 200 mm. In some cases, the difference in length between two bilateral lead bodies can be approximately 100 mm, 110 mm, 120 mm, 130 mm, 140 mm, 150 mm, 160 mm, 170 mm, 180 mm, 190 mm, 200 mm, or a length defined by any of these values.

[0179] At least one electrode lead may include a helical lead. A helical lead may include one or more cables twisted into a helical configuration, as illustrated in Figure 25. In some embodiments, only a portion of the lead may include one or more cables twisted into a helical configuration. The helical body of the lead may provide improved flexibility to the lead. Helical reconstruction may help prevent the lead from twisting as it advances into place. Helical reconstruction may help prevent the lead from twisting during post-implantation patient activity. The flexibility of the lead may be varied based on the twist rate of the lead body in different parts of the lead. The helical configuration of the lead body may allow the internal table of the lead to extend without an elongated outer surface of the lead body. This may improve maneuverability around sharp turns and tortuous vessels.

[0180] One or more twisted cables may include a helix with 8 ± 1 return per 70 mm along the length of the lead body. One or more twisted cables may include a helix with 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 with 9 or more turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix with 2.25 or more turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix with 7 or fewer turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix with 1.75 or fewer turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables may include a helix with 10 ± 1.5 turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables can have a helix containing 3 ± 0.5 turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables can have a helix containing 15 ± 2 turns per 70 mm along the length of the lead body. In some cases, one or more twisted cables can have a helix containing 5 ± 0.75 turns per 70 mm along the lead body. In some cases, one or more twisted cables can have a helix containing 6 ± 1 full turn per 70 mm. In some cases, one or more twisted cables can have a helix containing 4 ± 0.3 full turn per 70 mm along the lead body. In some cases, one or more twisted cables can have a helix containing 3.5 ± 0.25 full turn per 70 mm along the lead body.In some cases, one or more twisted cables may have a helix that includes 7 ± 0.5 full turns per 70 mm along the lead body. In some cases, one or more twisted cables may have a helix that includes 12 ± 1 full turns per 70 mm along the lead body. In some cases, one or more twisted cables may have a helix that includes 5 ± 0.75 full turns per 70 mm.

[0181] 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 higher pitch rate or lower density at the distal end to improve its capabilities at the lead tip. 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 while the lead is advanced and positioned. The lead may include a proximal portion without a helical structure and a distal portion with a helical structure. In some embodiments, the lead may include a proximal portion with a helical structure and a non-helical distal portion. The proximal portion of the lead body may have a less flexible helical structure than the distal portion of the lead. In some embodiments, the proximal portion of the lead body may have a more flexible helical structure than the distal portion of the lead. In some embodiments, the lead may have an intermediate portion of the lead body with a helical structure, while the proximal and distal ends of the lead are non-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, for example, 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 smaller 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 exceeding a threshold rotation speed. The cable may include a material having an impedance value sufficient to allow electrical stimulation. The cable may include a material having an impedance value sufficient to allow electrical signals to be received.The cable may contain a sufficiently malleable material to allow for variable coiling. The cable may also contain a material to prevent radiation exceeding a threshold rotation speed. This can prevent short circuits in the leads and improve the safety of the device. In some cases, any leads used or described herein may include helical leads.

[0182] IPG pocket formation and lead tunneling This specification provides a method, device, and system for implanting at least one electrode lead and an implantable pulse generator (IPG) in an individual to treat incontinence. A small pocket sized to hold the IPG can be created ipsilaterally on the upper buttock. The pocket can be created using a transverse skin incision. The location of the pocket can be pre-marked before the implantation procedure while the individual is awake. The location of the pocket can be chosen to avoid contact with clothing items (including, but not limited to, belts). The pocket can be located close to the skin surface to allow for recharging. The IPG can be located approximately 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm or less from the skin surface. The pocket can be located 2 cm or less from the skin surface. The pocket can be sized to comfortably accommodate the IPG without allowing excessive displacement of the IPG within the pocket. Care may be taken to isolate the IPG from the underlying gluteal muscle epimysium with a layer of fat between the IPG and the epimysium. IPGs should be placed parallel to the skin to ensure efficient recharging.

[0183] This specification provides methods, devices, and systems for tunneling one or more electrode leads from the point where each lead exits the skin after lead placement to the IPG. Tunneling can be performed to avoid penetration while achieving maximum tissue coverage in subcutaneous fat. Tunneling can be performed by a tunneling tool. The tunneling tool can include a stainless steel spike and sheath. The tunneling tool can be inserted through the gluteal fat from the skin exit point of the lead to the IPG pocket. In some embodiments having bilateral leads, the trajectories and distances of the respective lead tunneling paths to the unilateral IPG may differ. The curvature point of the lead opposite to the IPG can be pre-marked by palpation or imaging-guided surface marking of the inferior sacroiliac joint. The tunneling path for the contralateral lead can be curved at the surface marking of the inferior sacroiliac joint so that the path crosses the midline around the level of S3. Once a tunneling path to the IPG is created, the tunneling tool can be retracted while keeping the sheath in place. The lead can be passed through the hollow sheath to the IPG, and then the sheath can be removed. One or more leads can be connected to the IPG, and any excess leads can be coiled so that there is no tension on the lead. Excess leads can be coiled under the IPG away from the skin to ensure that recharging is not impaired.

[0184] kit This disclosure describes a kit comprising devices and components described elsewhere in this specification. In some cases, the kit may comprise a lead, one or more anchors, an IPG, an introducer, and (a) an electrode lead device, the electrode lead device comprising (i) a lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; and (ii) a plurality of anchors, each anchor comprising a collar and two or more barbs extending from the collar, the plurality of anchors provided in fixed positions on the lead proximal to one or more stimulating electrodes, the first anchor of the plurality of anchors being adjacent to a second anchor of the plurality of anchors, the two or more barbs of the first anchor being positioned at a predetermined rotational angle from the two or more barbs of the second anchor along the length of the lead, and the one or more stimulating electrodes being configured to deliver electrical stimulation to target tissue, and the kit also comprises (b) instructions for placing the electrode lead in target tissue or anchoring it. The kit may further comprise an LPG. The LPG may include an LPG frame, an LPG sleeve, 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, the sacral nerve, or any combination thereof. Instructions may be included in the insert and / or on a website (e.g., navigated via a QR code). The kit may further include an introducer and / or a pusher, as described elsewhere in this specification. The kit may include one or more anchors releasably attached to the lead. Instructions may include instructions for setting and / or modifying one or more so that, when implanted in a subject, one or more barbs may be prevented and / or set so as not to expand.

[0185] Manufacturing method One or more anchors described elsewhere in this specification can be manufactured by molding, 3D printing, laser sintering, laser etching, laser cutting, or any combination thereof. A method for manufacturing an anchor may include the steps of: 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 from the same material as the first barb region, and the second half of the anchor is made from the same material as the second barb region; and fixing the first and second halves of the anchor body together to form an anchor body. Exemplary molded anchors may be seen in Figures 7A and 7B. Molding may 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 internal diameter of the anchor as described elsewhere in this specification. 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 in this specification. The first and second halves of the anchor body may include removablely connected features configured to be removed and / or detached 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 can be molded from a material having a rigidity of at least about Shore 55D.In some cases, the first and second halves can be fixed together with adhesive.

[0186] One or more anchors can be manufactured by laser cutting one or more anchors from a single material. The single material can include thermoplastic polyurethane (i.e., Pellethane®). In some cases, the single material can include a tube. The laser-cut anchor barbs can be thermally cured at a predetermined angle, as described elsewhere in this specification, so that the barbs expand to the thermally cured angle when expanded and / or spread in the target tissue. Laser cutting one or more anchors from a single material allows for complex anchor geometries and designs and reduces the cost of manufacturing the anchors.

[0187] The texture of one or more anchor bodies of one or more anchors or one or more surfaces of one or more barbs can be modified by manufacturing and / or processing methods described elsewhere in this specification. The texture of the anchor or barb surface can be modified and / or altered by chemical treatment, laser light, or physical stirring. Changes to the surface of the anchor or barb can alter the static and / or dynamic coefficient of friction of the surface. A surface with an increased coefficient of friction can secure the anchor and connected electrode lead to the target tissue with stronger anchor fixation than a surface without an increased coefficient of friction.

[0188] The manufacturing method may provide one or more textures on one or more surfaces of the anchor as described elsewhere in this specification. One or more textures may include a first texture on the outer surfaces of two or more barbs of one or more anchors, the first texture on the outer surfaces promoting or reducing the force acting on the outer surfaces of the two or more barbs when the barbs are inserted into the elongated body lumen of the introducer, as described elsewhere in this specification. In some cases, one or more textures may include a second texture, the second texture may increase the friction or resistance of movement between the surfaces of two or more barbs of one or more anchors and the tissue surrounding the lead and one or more anchors when implanted. The second texture may improve the robustness of fixing the implanted lead in a target anatomical region (e.g., the pudendal nerve or adjacent tissue) after force has been applied to the lead.

[0189] Electrical stimulation for treating and controlling incontinence This specification 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 are capable of treating subtypes of incontinence. Subtypes of incontinence may include urge incontinence, stress incontinence, overflow incontinence, or mixed incontinence.

[0190] Urinary incontinence can be classified into one of four main types: urge incontinence, stress incontinence, overflow incontinence, and mixed incontinence. Urge incontinence is often caused by an overactive bladder (OAB). Individuals with urge incontinence have a strong, sudden urge to urinate immediately, often leaving them with insufficient time to reach the bathroom. Stress urinary incontinence (SUI) is usually caused by a poorly functioning urethral sphincter or hypermobility of the urethra or bladder neck. Individuals may experience stress incontinence during activities such as coughing, sneezing, laughing, lifting objects, or exercising. Overflow incontinence can typically be caused by poor bladder contraction or urethral obstruction. Mixed urinary incontinence (MUI) may have features of both stress and urge incontinence. Incontinence is often associated with neurological problems, including, but not limited to, inhibited nerve conduction between the brain and / or affected muscles, and neurological disorders or injuries (e.g., multiple sclerosis or stroke), or mental confusion. Other causes of incontinence include, but not limited to, weakness of the pelvic or urethral muscles and pelvic prolapse.

[0191] Fecal incontinence (also known as defecation incontinence) is a loss of control over bowel movements, causing an individual to involuntarily leak stool from the rectum. Fecal incontinence is usually classified into three main types: urge incontinence, passive incontinence, and post-defecation leakage (or a combination thereof). Individuals with urge incontinence have a strong, sudden urge to defecate immediately, often leaving them with insufficient time to reach the bathroom. Passive fecal incontinence is when stool leaks involuntarily. Individuals with passive incontinence are unable to consciously control their bowel movements and may leak stool without realizing it. Incontinence often involves neurological problems, which include, but are not limited to, inhibited nerve conduction between the brain and / or affected muscles, and neurological disorders or injuries (e.g., multiple sclerosis or stroke), or mental confusion. Causes of fecal incontinence include, but are not limited to, nerve damage, anal sphincter damage, constipation, diarrhea, surgery, loss of rectal storage capacity, rectal prolapse, and rectocele.

[0192] In some cases, electrical stimulation of the pelvic floor muscles has been used to treat incontinence by training the muscles, thereby improving the strength and function of the muscles that control urination and defecation. In some cases, electrical stimulation can target the sacral nerves to improve control over urination and defecation. In some cases, the electrical stimulation approach can benefit from stimulating alternative targets.

[0193] Electrical stimulation approaches may only be able to deliver predefined stimulation protocols and may not be able to adapt to an individual's disease and circumstances during a particular episode of incontinence. This may result in over-stimulation or under-stimulation of the target tissue, resulting in inadequate control over the muscles involved in urination or defecation. Conventional approaches to treating incontinence may not adequately mimic the innate human response (i.e., reflex) to prevent incontinence episodes, and may be inadequate. Individuals with incontinence episodes may experience an inadequate prophylactic response. A prophylactic response may include muscle contraction of at least one pelvic floor muscle to prevent a leakage event in response to increased intra-abdominal pressure. Individuals experiencing stress incontinence may exhibit a delayed response in preventing an incontinence episode in response to a stress event. In some cases, individuals may experience stress incontinence related to urethral hypermobility (i.e., inadequate support), which may lead to increased pressure transmitted to the bladder, subsequently leading to an incontinence event.

[0194] The inability to control urination, defecation, incontinence, or any combination thereof is a problem that can impact quality of life and cause social humiliation. Urinary and fecal incontinence can affect individuals of all ages. Generally, older individuals are more likely to exhibit incontinence due to a variety of pathophysiological factors. Urinary incontinence (or loss of bladder control) and fecal incontinence (loss of control over defecation movement) are often associated with neurological problems. Both urinary and fecal incontinence may involve damage, weakness, or hyperactivity of the pelvic floor muscles (including, but not limited to, the urethral and anal sphincters) and the nerves that control these muscles and associated organs (e.g., the bladder, rectum, or anus).

[0195] To treat or reduce the symptoms of incontinence, electrical stimulation of the muscles, sacral nerves, and / or other pelvic nerves (e.g., the pudendal nerve) involved in incontinence has been used to improve control over urination and defecation, and targeting the pudendal nerve provides an improved approach to treating incontinence. In many cases, the pudendal nerve contributes to the motor function and mediated voluntary contraction of the urethral and anal sphincters in maintaining continence. Targeting the pudendal nerve can be combined with closed-loop and / or feedforward capabilities with dynamic adaptive control to provide a more effective treatment for incontinence. In some cases, individuals can control the stimulation by pelvic squeeze, and receiving threshold EMG signals from the pelvic floor can activate the electrical stimulation. However, the pudendal nerve has not been targeted for neuromodulation to the same extent as the sacral nerve, partly due to the difficulty in accessing and fixing leads on or near the pudendal nerve.

[0196] Current electrical stimulation therapies may include sacral neuromodulation (SNM), which can provide a fixed pattern of stimulation to treat "urge" (a sudden need to urinate), but such stimulation may not respond to more common "stress" incontinence events (e.g., coughing, sneezing, and lifting objects). While SNM may reduce the frequency of incontinence episodes, the success of SNM may be limited in scope (e.g., not a complete cure) and may decrease over time. Furthermore, SNM may not be suitable for treating individuals with stress incontinence or mixed urinary incontinence (involving both stress and urge incontinence). SNM may have high long-term costs in managing the electrical stimulation device and may require a high level of skill and precision from the surgeon to place leads over the sacral nerve. Therefore, targeting other nerves, such as the pudendal nerve, may offer an improved approach to treating incontinence.

[0197] Pudendal nerve stimulation (PNS) can provide a more effective treatment for individuals with incontinence than suppository nerve manipulation (SNM). In some cases, PNS may be an effective treatment for incontinence even in individuals where SNM has failed. PNS may be more potent than SNM because the pudendal nerve enters the spinal cord through S2, S3, and S4, while SNM acts only on the S3 nerve root. PNS can provide an effective treatment for urinary incontinence. In some cases, the pudendal nerve may be an effective continence target for closed-loop and / or feedforward stimulation.

[0198] However, despite its dominant role in maintaining urinary continence, the pudendal nerve is not as frequently targeted for neuromodulation as the sacral nerve. The complex 3D anatomical structure of the pudendal nerve, and the heterogeneity of the surrounding tissue, may make it a challenging target for electrical stimulation therapy. The complex 3D anatomical structure of the pudendal nerve may make accurate electrode placement and fixation of implanted electrode leads more difficult. Electrophysiological guidance may be required for accurate electrode placement over the pudendal nerve, rather than or in combination with radiological guidance. There may be uncertainty regarding which section of the pudendal nerve should be targeted (e.g., trunk-pair-branch) to provide effective electrical stimulation therapy. Compared to the sacral nerve, there may be difficulties with lead fixation due to the anatomical structure near the genitals, while the sacral nerve has anatomical structures in the sacrum that facilitate lead fixation. In some cases, there may be concerns that directly targeting peripheral nerves may be limited by issues of stimulation tolerance.

[0199] Electrical stimulation for pain control Devices, systems, methods, and / or kits described elsewhere in this specification may be used to treat pain in the pelvic region. Chronic pelvic pain (CPP) can affect quality of life and often cause severe episodes of discomfort, which can exacerbate the pain. Common symptoms of CPP include, but are not limited to, neuropathic symptoms in the pelvis, anus, and / or genitals, such as paresthesia, numbness, burning, and stabbing pain. Episodes of pain associated with CPP may frequently occur with sitting, urinating, defecating, or sexual intercourse, and may be exacerbated by these activities. Approaches to treating CPP by electrically or percutaneously stimulating large sections of the affected area (e.g., the pelvic area) may have limited success in reducing pain symptoms. Therefore, targeting specific nerves for electrical stimulation that is adapted to an individual's pain response may be a very effective treatment for CPP and other pain symptoms.

[0200] Many electrical nerve stimulation approaches currently in use deliver pre-configured stimulation protocols (i.e., open-loop configurations) and typically cannot adapt to the changing parameters of pain experienced by an individual. Pudendal nerve stimulation (PNS) can provide an effective treatment for chronic pain. In some cases, the inability to adapt to stimulation can result in overstimulation or understimulation of the target area, potentially leading to inefficient or inadequate pain management. Moreover, since the treatment usually does not adapt to the changing parameters of pain, existing pain management often requires patient activation during attacks that exacerbate the pain to provide pain relief. Therefore, it would be highly beneficial to provide electrical stimulation to peripheral nerve targets that adapt to the subject's inherent feedback (e.g., closed-loop and / or feedforward configurations) as the disease changes.

[0201] The systems, methods, and devices described herein are directed to treat episodes of pain associated with chronic pelvic pain (CPP) or other conditions resulting in pelvic pain, using peripheral nerve stimulation. In some embodiments, the systems, methods, and devices include closed-loop and / or feedforward configurations. In some embodiments, adapted stimulation to a target nerve is provided by an implanted stimulator with a basic physiological basis, which includes (a) stimulating motor fibers to alter terminal organ muscle activity at the site where peripheral pain is driven by spasms and / or hypertonia (e.g., pelvic floor pain, some cases of bladder pain syndrome, and urethral pain associated with motor modulation); (b) stimulating larger diameter afferent fibers to modulate the bone marrow gate of nociceptive signals from the peripheral lesion of pain development (e.g., interstitial cystitis, coccygeal pain, and pelvic pain); (c) blocking nerve conduction (e.g., anode blockade), (i) directly blocking peripherally driven pain associated with the disease, and (ii) blocking adverse effects associated with providing adapted stimulation (it promotes higher charge delivery for clinical benefit); and any combination thereof.

[0202] This specification describes targeting one or more peripheral nerves based on the pathogenesis of a pain disorder by adapted electrical stimulation to reduce pain experienced by an individual. Stimulator electrodes can target different nerves (for example, a first stimulator targeting the sacral nerve and a second stimulator targeting the pudendal nerve). In some embodiments, stimulating multiple nerves within the pelvic area can broaden the therapeutic field in pain syndromes with areas of pain diffusion. In some embodiments, the provision of electrical stimulation can be adapted to provide electrical blockage and stimulation of nerve signals on the same nerve. In some embodiments, stimulator electrodes can 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 (for example, a first stimulator implanted at or adjacent to a first anatomical site of the pudendal nerve, and a second stimulator implanted at or adjacent to a second anatomical site of the pudendal nerve). In some embodiments, targeting a single nerve at multiple sites allows for both blockade and stimulation of the same nerve.

[0203] Electrical stimulation to treat sexual dysfunction Devices, systems, methods, and / or kits described elsewhere in this specification may be used to 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 desire disorder (lack of sexual desire or interest in sexual activity), arousal disorder (inability to become 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 have physical and psychological causes. In many cases, sexual dysfunction can be treated using one or more of the following: pharmacotherapy, mechanical aids, psychotherapy, and behavioral therapy. However, the effectiveness of treatment may be limited, especially with regard to sexual dysfunction with physical causes.

[0204] Multiple symptoms are associated with sexual dysfunction. In both men and women, symptoms of sexual dysfunction include, but are not limited to, a lack of interest in or desire for sexual activity, inability to become aroused, and pain during intercourse. In women, some symptoms associated with sexual dysfunction include, but are not limited to, the inability to achieve orgasm, insufficient vaginal lubrication before and during intercourse, and inability to relax the pelvic floor muscles surrounding the vagina to allow 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 refer to the inability to achieve or maintain an erection adequate for intercourse. Delayed ejaculation can refer to the absence or delay of ejaculation despite sufficient sexual stimulation. Premature ejaculation can refer to the inability to control the timing of ejaculation.

[0205] Erectile dysfunction (ED) is the most common form of sexual dysfunction in men. It is estimated that by 2025, 322 million men worldwide will be affected by ED. ED has a variety of etiologies, 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 people per year, and in the United States alone, 20 to 30 million men are affected. A significant proportion of individuals with SCI who experience ED are young, and ED can have a substantial impact on their quality of life.

[0206] Achieving erection of erectile tissue may require contributions from both neural and vascular components. Normal erection may rely on two reflex loops: the pudendal cavernous reflex loop (for expansion) and the bulbocavernosal muscle reflex loop (for rigidity). Appropriate neural activity may include the release of nitric oxide (NO), leading to an increase in cGMP, which induces smooth muscle relaxation in the corpus cavernosum of the penis. The neural configuration for erection can be complex and may rely on both the somatic nervous system (via the pudendal nerve (PN)) and the autonomic nervous system (via the cavernous nerve (CN)).

[0207] Typically, sexual dysfunction is treated using one or more approaches, including but not limited to pharmacotherapy, mechanical support, psychotherapy, and behavioral therapy. In some cases, pharmacotherapy (also referred to herein as medication) includes hormones, injections, tablets, or creams; or phosphodiesterase type 5 (PDE5) inhibitors to increase blood flow to the penis; or injecting papaverine, phentolamine, and / or prostaglandin E1 (PGE1) into or near the erectile tissue. In many cases, PDE5 inhibitors are the first-line treatment and include, but are not limited to, sildenafil, tadalafil, vardenafil, avanafil, rodenafil, udenafil, and mirodenafil. While PDE5 inhibitors are effective in treating sexual function, discontinuation rates can be high, reported to be as high as 50% after 1-2 years of use. If drug therapy is ineffective, intracavernosal injections of papaverine, phentolamine, and / or PGE1 may be administered to the patient. In some cases, intracavernosal injections may result in a high incidence of adverse effects (e.g., priapism, injection site pain, bruising, etc.). In some cases, a high incidence of adverse effects can lead to patient non-compliance with medication. Mechanical aids include, but are not limited to, vacuum devices, penile implants, vaginal dilators, and vibrators. In some cases, implantation of penile prostheses may result in serious complications (e.g., infection, erosion, and pain, etc.). Thus, the effectiveness of treatment may be limited, particularly with respect to sexual dysfunction due to physical etiology, and when patient compliance with or response to medication is reduced.

[0208] Electrical stimulation has been used as a treatment for sexual dysfunction, but with limited success. Sacral nerve stimulation and sacral neuromodulation have also been used as a treatment for sexual dysfunction, but with very limited effectiveness, with reported successful intercourse occurring in only 20-30% of patients. In some cases, presacral root stimulation (SARS) has been used to treat erectile dysfunction. However, SARS procedures can be extremely invasive as they require nerve root resection and should only be used in patients with complete sacral vascular involvement (SCI).

[0209] The difficulty in treating sexual dysfunction with electrical stimulation may stem from the complex structure of the nervous system involved in sexual function (e.g., erection), including but not limited to the pudendal and cavernous nerves. Therefore, electrical stimulation of multiple nerves involved in sexual function (e.g., the pudendal and cavernous nerves) with electrodes may restore sexual function (e.g., erection). Electrical stimulation of both the pudendal and cavernous nerves may treat sexual dysfunction resulting from neurogenic etiologies (e.g., spinal cord injury, post-prostatectomy) or combined neurogenic / vascular etiologies (e.g., diabetes, idiopathic). In some cases, erections produced by electrical stimulation may be enhanced by PDE5 inhibitors (PDE5i). In some cases, the mechanism of action may be directly linked to PDE5i because PDE5i inhibit CGM degradation by inhibiting NOS. The potential side effects of electrical stimulation of somatic nerves may be reduced due to the anatomical structure of somatic nerves. In some cases, the proportion of somatic nerves surrounding the prostatic apex is <5% of the autonomic nerves, which may reduce the potential side effects of electrical stimulation of somatic nerves.

[0210] This specification provides devices, systems, and methods for treating symptoms of sexual dysfunction in individuals using electrical nerve stimulation. The systems, methods, and devices described herein are directed to treat sexual dysfunction by targeted nerve peripheral stimulation and the restoration and / or enhancement of reflex activity involved in sexual function. The adapted stimulation to the target nerve is provided by an implantable stimulator with an underlying physiological basis and is capable of targeting 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, the adapted stimulation to the target nerve is provided by an implantable stimulator and is capable of targeting the autonomic nervous system (e.g., CN), the somatic nervous system (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, systems, methods, and devices may include closed-loop and / or feedforward configurations for providing electrical stimulation.

[0211] definition Unless otherwise defined, all technical terms, notations, and other technical and scientific or specialized terms used herein are intended to have the same meaning as those generally understood by those skilled in the art in which the claimed subject matter pertains. In some cases, terms having a generally understood meaning are defined herein for clarity and / or for easy reference, and the inclusion of such definitions herein should not necessarily be interpreted as representing a substantial difference from the generally understood meaning in the art.

[0212] Throughout this specification, various embodiments may be represented in range format. It should be understood that descriptions in range format are merely for convenience and brevity and should not be interpreted as inflexible limitations on the scope of this disclosure. Therefore, range descriptions should be considered to specifically disclose not only the individual numbers within that range, but also all possible sub-ranges. For example, a range description such as "1 to 6" should be considered to specifically disclose not only the individual numbers within that range (e.g., 1, 2, 3, 4, 5, and 6), but also sub-ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc. This applies regardless of the breadth of the range.

[0213] When used herein and in the claims, the singular forms "a," "an," and "the" include multiple references unless the context explicitly specifies otherwise. For example, the term "a sample" includes multiple samples (including mixtures thereof).

[0214] The term "in vivo" is used to describe events that occur inside a subject's body.

[0215] The terms “approximately,” “abo...

Claims

1. An electrode lead device, wherein the electrode lead device is A lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; A plurality of anchors positioned proximal to one or more stimulating electrodes; Including; Each of the aforementioned anchors includes a collar and a plurality of barbs extending from the collar; The plurality of anchors are arranged bidirectionally on the lead, and the plurality of anchors are A first set of anchors, wherein each barb on the first set of anchors extends in a first direction away from the one or more stimulating electrodes; A second set of anchors, wherein each barb on the second set of anchors extends in a second direction toward the one or more stimulating electrodes; Including; The bidirectional arrangement reduces the intrusion and outtrusion of the lead; The plurality of anchors include at least a first anchor and a second anchor that are adjacent to each other; The plurality of barbs of the first anchor are positioned circumferentially offset from the plurality of barbs of the second anchor; The circumferentially offset arrangement reduces the lateral movement of the leads in the electrode lead device.

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

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

4. The electrode lead device 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, wherein the electrode lead device is A lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; A plurality of anchors positioned proximal to one or more stimulating electrodes; Including; Each of the aforementioned anchors includes a collar and a plurality of barbs extending from the collar; The plurality of anchors are arranged bidirectionally on the lead, and the plurality of anchors are A first set of anchors, wherein each barb on the first set of anchors extends in a first direction away from the one or more stimulating electrodes; A second set of anchors, wherein each barb on the second set of anchors extends in a second direction toward the one or more stimulating electrodes; Including; The aforementioned bidirectional arrangement reduces the intrusion and outtrusion of the leads in the electrode lead device.

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

7. The electrode lead device according to claim 5 or 6, wherein the first set of anchors and the second set 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 plurality of anchors include a first anchor and a second anchor, the first anchor being adjacent to the second anchor; The electrode lead device according to any one of claims 5 to 8, wherein the first anchor is offset circumferentially from the second anchor.

10. An electrode lead device, wherein the electrode lead device is A lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; A plurality of anchors positioned proximal to one or more stimulating electrodes; Including; Each of the aforementioned anchors includes a collar and a plurality of barbs extending from the end of the collar; The plurality of anchors include at least a first anchor and a second anchor; The plurality of barbs of the first anchor are positioned circumferentially offset from the plurality of barbs of the second anchor; The circumferentially offset arrangement reduces the lateral movement of the leads in the electrode lead device.

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

12. The electrode lead device according to claim 10 or 11, wherein the plurality of barbs of the first anchor are offset circumferentially 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 extend in a first direction toward the one or more stimulating electrodes, and the plurality of barbs of the second anchor extend in a second direction toward 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 extend in the same axial direction as the plurality of barbs of the second anchor.

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

16. The electrode lead device 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 with respect to the longitudinal axis of the lead.

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

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 a disorder in the pelvic region, including urinary incontinence, overactive bladder, fecal incontinence, sexual dysfunction, pelvic pain, or any combination thereof.

20. An electrode lead device according to any one of claims 1 to 17 for use in the spinal cord, shoulder, knee, hip, or cranial tissue.

21. A method for attaching an electrode lead according to any one of claims 1 to 20, wherein the method is: The steps include: advancing the electrode lead device through the introducer to the target tissue; The steps include: partially withdrawing the introducer to expose one or more stimulating electrodes; The step of confirming the location of one or more stimulating electrodes; The steps include further withdrawing the introducer to expose the plurality of anchors; Methods that include...

22. The method according to claim 21, further comprising the step of advancing a lead positioning guide through the introducer, wherein the lead positioning guide supports the electrode lead device.

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

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

25. A method for implanting an electrode lead device near the pudendal nerve of a patient, wherein the method is The steps include: advancing the stimulating member toward the pudendal nerve; The steps of providing an electric current to the stimulating member; The steps include: measuring the EMG response and confirming that the stimulating member is located near the pudendal nerve; The steps include: confirming the location of the stimulating member and then implanting the electrode lead device at the confirmed location; Methods that include...

26. The step of confirming that the stimulating member is located near the pudendal nerve is: The steps include detecting a first EMG response in the pelvic floor of the patient; The steps include detecting a second EMG response in the external anal sphincter of the patient; The method according to claim 25, including the method described in claim 25.

27. The method according to claim 26, further comprising the step of not detecting a reaction 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 in 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 reaction is detected.

30. The method according to claim 29, wherein the step of confirming that the stimulating member is located near the pudendal nerve includes detecting an EMG response 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 the step of advancing a guide wire through the stimulating member.

32. The method according to claim 31, further comprising the step of advancing an introducer on the guide wire.

33. The method according to claim 32, further comprising the step of advancing the electrode lead device through the introducer.

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

35. The method according to any one of claims 25 to 34, further comprising the step of 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 the step of implanting electrode lead devices bilaterally 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, wherein the method is The steps include: inserting a marking needle at or near the intersection of a first line corresponding to the edge of the ischium and a second line crossing the apex of the greater trochanter; The steps include: advancing the marking needle into the patient; The steps include inserting the stimulating device using an ischiorectal approach; The steps include: advancing the stimulating member toward the tip of the marking needle; The steps include: confirming that the stimulating member is located near the pudendal nerve; The step of implanting the electrode lead device in the confirmed location; Methods that include...

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

39. The method according to claim 37 or 38, wherein the step of advancing the stimulating member includes 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 the step of advancing a guide wire through the stimulating member.

41. The method according to claim 40, further comprising the step of advancing an introducer on the guide wire.

42. The method according to claim 41, further comprising the step of advancing the electrode lead device through the introducer to the confirmed location.

43. The method according to any one of claims 37 to 42, wherein the step of confirming that the stimulating member is located near the pudendal nerve includes the step of providing the stimulating member with a current of 3 mA or less.

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

45. A method for implanting an electrode lead device comprising one or more stimulating electrodes and a plurality of anchors, wherein the method is: The steps include: introducing the electrode lead device into the lead positioning guide until one or more stimulating electrodes extend beyond the distal end of the lead positioning guide; The steps include: advancing the lead positioning guide through the introducer until one or more stimulating electrodes are positioned in the distal portion of the introducer; The steps include: partially withdrawing the introducer to expose one or more stimulating electrodes while the plurality of anchors remain constrained within the introducer; The steps include measuring the EMG response and confirming the location of one or more stimulation electrodes; The steps include adjusting the position of one or more stimulating electrodes until a desired EMG response is measured; The steps include further withdrawing the introducer and releasing the multiple anchors; Methods that include...

46. The method according to claim 45, further comprising the step of adjusting the position of one or more stimulating electrodes in a patient in the axial direction without releasing the plurality of anchors from the introducer.

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

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

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

50. The method according to claim 49, further comprising the step of uncoupling the lead positioning guide from the introducer, thereby enabling the lead positioning guide to release the plurality of anchors.

51. An electrode lead device for treating diseases in the pelvic region, wherein the device is A lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; Multiple anchors, each anchor comprising a collar and two or more barbs extending from the collar, The plurality of anchors are positioned on the lead proximal to one or more stimulating electrodes, The first anchor of the plurality of anchors is adjacent to the second anchor of the plurality of anchors, The two or more barbs of the first anchor are positioned at a predetermined rotational angle from the two or more barbs of the second anchor along the length of the lead. The one or more stimulating electrodes are configured to deliver electrical stimulation to target tissue and include a plurality of anchors; Electrode lead devices, including those mentioned above.

52. The device according to claim 51, wherein the target tissue includes the pudendal nerve or tissue adjacent to the pudendal nerve.

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

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

55. A kit comprising the device according to any one of claims 51 to 54, the kit further comprising a lead positioning guide (LPG), the LPG comprising a lumen diameter configured to receive the lead, and the LPG fixing the position of the lead when the introducer is retracted over the lead and the first anchor or the second anchor.

56. A method for attaching an electrode lead to tissue, wherein the method is: A step of placing an electrode lead in target tissue, wherein the electrode lead is A lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; Multiple anchors, each anchor comprising a collar and two or more barbs extending from the collar, The plurality of anchors are releasably positioned on the lead proximal to one or more stimulating electrodes, The first anchor of the plurality of anchors is adjacent to the second anchor of the plurality of anchors, The two or more barbs of the first anchor are positioned at a predetermined rotational angle from the two or more barbs of the second anchor along the length of the lead. The one or more stimulating electrodes are configured to deliver electrical stimulation to target tissue and include a plurality of anchors; Steps including; The steps include removing the sheath covering at least a portion of the first anchor or the second anchor, deploying the first anchor or the second anchor, and anchoring the electrode lead to the target tissue; Methods that include...

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

58. The method according to claim 56, wherein the target tissue includes target tissue in the pelvic region.

59. The method according to claim 58, further comprising the step of stimulating the target tissue with the electrode lead in order to treat a disease in the pelvic region.

60. The method according to claim 59, wherein the disease 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 the step of folding or compacting the two or more barbs of the first anchor or the second anchor when the first anchor or the second anchor is translated axially through the introducer.

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

63. A kit for treating diseases in the pelvic region, the kit comprises, An electrode lead device, wherein the electrode lead device is A lead, the lead comprising one or more stimulating electrodes positioned near the distal end of the lead; Multiple anchors, each anchor comprising a collar and two or more barbs extending from the collar, The plurality of anchors are provided in fixed positions on the lead proximal to one or more stimulating electrodes. The first anchor of the plurality of anchors is adjacent to the second anchor of the plurality of anchors, and the two or more barbs of the first anchor are positioned at a predetermined rotational angle from the two or more barbs of the second anchor along the length of the lead. The one or more stimulating electrodes are configured to deliver electrical stimulation to target tissue and include a plurality of anchors; Including electrode lead devices; Instructions for placing or anchoring the electrode lead in the target tissue; A kit that includes this.

64. A method for manufacturing an anchor, wherein the method is A step of forming a first half and a second half of an anchor body, wherein the first half of the anchor includes a first barb region, the second half of the anchor body includes a second barb region, the first half of the anchor body is made from the same material as the first barb region, and the second half of the anchor is made from the same material as the second barb region; The steps include: fixing the first half and the second half of the anchor body to form the anchor body; Methods that include...

65. The method according to claim 64, wherein the molding step includes injection molding.

66. A system for placing electrodes in the pelvic region, wherein the system is A lead, the lead comprising one or more stimulating electrodes positioned at or near the distal end of the lead; A plurality of anchors, each anchor comprising a collar and two or more barbs extending from the collar, wherein the plurality of anchors are positioned on the lead proximal to the one or more stimulating electrodes; An introducer configured to be slidable over the lead and the plurality of anchors, wherein the introducer has an introducer handle; A lead positioning guide comprising an elongated guide body having a collet at its proximal end, and the lead positioning guide comprising a guide lumen passing through the elongated guide body, and one or more guide arms extending distally from the elongated guide body, and the lead positioning guide comprising a locking cap configured to fit over the collet, and the one or more guide arms configured to engage with the introducer handle; A system that includes this.

67. A method for fixing a lead to the pelvic region, wherein the method is The steps include: positioning any lead according to a previous claim, having a plurality of anchors on the lead, into the guide lumen of a lead positioning guide according to any one of claims 148 to 184, until the proximal anchors in the plurality of anchors contact the distal end of the elongated guide body of the lead positioning guide; The steps include: fixing the lead within the lead positioning guide by moving the locking cap of the lead positioning guide from the unlocked position to the locked position; The steps include: placing the introducer of any prior claim on the lead and a portion of the elongated guide body of the lead positioning guide, covering the one or more stimulating electrodes and the plurality of anchors on the lead; The steps include: using the introducer handle and lead positioning guide of the introducer to deliver the lead having the plurality of anchors and the distal portion of the introducer into the target location in the pelvic region; The steps include: sliding the introducer handle proximal to engage with one or more guide arms of the lead positioning guide, fixing the introducer in the proximal-distal direction, and exposing one or more stimulating electrodes on the lead while covering the plurality of anchors; The steps include verifying the delivery of the exposed stimulating electrodes to the target location; The steps include: moving the lead positioning guide to disengage it from the introducer handle; The steps include: sliding the introducer handle proximal to expose the plurality of anchors and securing the lead in a predetermined location in the pelvic region; The steps include: moving the locking cap from the locked position to the unlocked position; The steps include withdrawing the introducer and the lead positioning guide from the pelvic region; Methods that include...

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