Periurethral stimulation system leads and methods for treating bladder and / or bowel dysfunction

Abstract

Systems and methods for treating bladder and / or bowel dysfunction of a patient includes implanting a lead carrying one or more stimulation elements to apply stimulation energy to one or more target sites in the periurethral space. In some examples, the target site(s) can be one or more of the deep perineal nerve and the external urethral sphincter.

Description

PERIURETHRAL STIMULATION SYSTEM LEADS AND METHODS FOR TREATING BLADDER AND / OR BOWEL DYSFUNCTION

[0001] A portion of the population suffers from bladder and / or bowel dysfunction, such as one or both of urinary incontinence (or bladder incontinence) and fecal incontinence (or bowel incontinence). Diet, training, slings, and drug therapies may fail to treat incontinence.Brief Description of Drawings

[0002] FIG. 1 is a schematic illustration of anatomy of a human pelvic region.

[0003] FIG. 2 is a schematic illustration of the pelvic region of FIG. 1 and various nerves.

[0004] FIG. 3 is a block diagram of a treatment system in accordance with principles of the present disclosure.

[0005] FIG. 4A is an illustration of portions of a human female pelvic region anatomy.

[0006] FIG. 4B is an enlarged, perspective view of portions of a human female pelvic region anatomy.

[0007] FIG. 4C is a highly simplified end view of a human urethra and external urethral sphincter.

[0008] FIG. 5A is a simplified view of a portion of a treatment system in accordance with principles of the present disclosure implanted relative to the anatomy of FIG. 4C.

[0009] FIG. 5B is a simplified view of a portion of a treatment system in accordance with principles of the present disclosure implanted relative to the anatomy of FIG. 4C.

[0010] FIG. 5C is a simplified view of a portion of a treatment system in accordance with principles of the present disclosure implanted relative to the anatomy of FIG. 4C.

[0011] FIG. 5D is a simplified view of a portion of a treatment system in accordance with principles of the present disclosure implanted relative to the anatomy of FIG. 4C.

[0012] FIG. 6 is a side view of portions of a treatment system in accordance with principles of the present disclosure implanted relative to the anatomy of FIG. 4A.

[0013] FIG. 7 is a side view of an introducer needle useful with some methods of the present disclosure.

[0014] FIG. 8 illustrates use of the introducer needle of FIG. 7 relative to an external urethral sphincter and other patient anatomy as part of a trialing method in accordance with principles of the present disclosure.

[0015] FIG. 9 illustrates arrangement of two leads relative to an external urethral sphincter in accordance with methods of the present disclosure.

[0016] FIGS. 10A and 10B illustrate implantation of portions of a treatment system in accordance with principles of the present disclosure.

[0017] FIG. 11 A is a simplified side view of a portion of a lead useful with systems and methods of the present disclosure.

[0018] FIG. 11 B is a simplified cross-sectional view of the lead of FIG. 11 A taken at a first location along a length of the lead.

[0019] FIG. 11 C is a simplified cross-sectional view of the lead of FIG. 11 A taken at a second location along a length of the lead.

[0020] FIG. 12A is a simplified side view of a portion of a lead useful with systems and methods of the present disclosure.

[0021] FIG. 12B is a simplified cross-sectional view of the lead of FIG. 12A.

[0022] FIG. 12C is a simplified cross-sectional view of the lead of FIG. 12B installed to an introducer.

[0023] FIG. 13 is a simplified side view of portions of a treatment system in accordance with principles of the present disclosure implanted relative to the anatomy of FIG. 4A.

[0024] FIG. 14 is a perspective view of portions of a lead useful with systems and methods of the present disclosure.

[0025] FIG. 15A is a cross-sectional view of the lead portion of FIG. 14.

[0026] FIG. 15B is a cross-sectional view of portions of a lead useful with systems and methods of the present disclosure.

[0027] FIG. 15C is a cross-sectional view of portions of a lead useful with systems and methods of the present disclosure.

[0028] FIGS. 16A and 16B illustrate, in simplified form, lead anchoring devices and methods in accordance with principles of the present disclosure.

[0029] FIG. 17 illustrates, in simplified form, portions of test stimulation methods in accordance with principles of the present disclosure.

[0030] FIG. 18 is a perspective view of portions of a lead useful with systems and methods of the present disclosure.

[0031] FIG. 19 is a simplified side view of a lead arranged relative to a target site along an external urethral sphincter of a human patient in accordance with principles of the present disclosure.

[0032] FIG. 20 illustrates methods for anchoring the lead in the arrangement of FIG.19.

[0033] FIG. 21 illustrates methods for anchoring the lead in the arrangement of FIG. 19.

[0034] FIGS. 22 and 23 illustrate methods for anchoring the lead in the arrangement of FIG. 19.

[0035] FIG. 24 illustrates methods for anchoring the lead in the arrangement of FIG. 19.

[0036] FIG. 25A is a simplified cross-sectional view of a lead arranged relative to a target nerve and other anatomical structures.

[0037] FIGS. 25B and 25C illustrate methods for anchoring the lead in the arrangement of FIG. 25A.

[0038] FIGS. 26A-26D illustrate methods for implanting a lead to a target site of a periurethral space of a human patient, including use of a guide in accordance with principles of the present disclosure.

[0039] FIG. 27 is a plot of an example stimulation pulse train useful with methods of the present disclosure.

[0040] FIGS. 28A-28C illustrate devices and methods for stabilizing periurethral tissue in accordance with principles of the present disclosure.

[0041] FIG. 29 is a simplified illustration of a portion of a method for implanting a lead to a periurethral space of a human patient in accordance with principles of the present disclosure.

[0042] FIG. 30 is a perspective view of a lead implanted to a nerve in accordance with principles of the present disclosure.

[0043] FIG. 31 is a simplified view of portions of a lead implanted relative to an external urethral sphincter of a human patient in accordance with principles of the present disclosure.

[0044] FIG. 32 is a side view of portions of a human female pelvic region anatomy and identifying stimulation target sites in accordance with principles of the present disclosure.Detailed Description

[0045] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific examples in which the disclosure may be practiced. It is to be understood that other examples may be utilized and structural or logical changes may be made without departing from the scope of the present disclosure. The following detailed description, therefore, is not to be taken in a limiting sense. It is to be understood that features of the various examples described herein may be combined, in part or whole, with each other, unless specifically noted otherwise.

[0046] At least some examples of the present disclosure are directed to implantable devices for diagnosis, therapy, and / or other care of medical conditions. At least some examples may comprise implantable devices and / or methods of implanting devices useful for treating bladder or bowel dysfunctions, including one or both of urinary incontinence and fecal incontinence of a patient, or other pelvic disorders. At least some such examples comprise implanting an electrode to deliver a nerve-stimulation signal to one or more nerves or nerve branches to activate a corresponding sphincter, such as a branch of the pudendal nerve that activates the external urethral sphincter and / or the external anal sphincter. In some embodiments, operation of the implantable device is controlled in response to sensed information.

[0047] With reference to the greatly simplified view of FIG. 1 , the human pelvic region includes a bladder 10 and a rectum 12. Contents of the bladder 10 are evacuated through a urethra 14, whereas contents of the rectum 12 are evacuated through the anus 16. Pelvic floor muscles 18 support the pelvic organs and span the bottom of the pelvis. The pelvic floor muscle layer 18 has holes for passage of the urethra 14 and the anus 16, and normally wraps quite firmly around these holes to help keep the passages shut.

[0048] With additional references to the greatly simplified view of FIG. 2, the bladder 10 is a hollow muscular organ connected to the kidneys by the ureters. The detrusor 30 muscle (referenced generally) is smooth muscle found in the wall of the bladder 10. The urethra 14 is a tube or duct by which urine is conveyed out of the body from the bladder 10. Internal and external sphincters control flow of urine through the urethra 14; under normal conditions, when either of these muscles contracts, the urethra 14 is sealed shut. In particular, an internal urethral sphincter (IUS) 32 (referenced generally) is a smooth muscle that constricts the urethra 14. The IUS 32 is located near the junction of the urethra 14 with the bladder 10 and is continuous with the detrusor muscle 30, but is anatomically and functionally fully independent from the detrusor muscle 30. An external urethral sphincter (EUS) 34 is located in the deep perineal pouch, at the bladder’s 10 distal inferior end around the mid urethra in females and inferior to the prostate in males. Urine is excreted from the kidneys and stored in the bladder 10 before elimination via the urethra 14 during what is known as micturition. During periods of bladder filling, the storage of urine is promoted by the actions of the internal and external urethral sphincters 32, 34 and the pelvic floor musculature 18. During micturition, these sphincters 32, 34 relax and the smooth muscle of the bladder (the detrusor muscle 30) contracts, resulting in the expulsion of urine.

[0049] The body of the bladder 10 is directly innervated by efferent fibers that arise from parasympathetic postganglionic neurons in the pelvic ganglia and intramural ganglia and by efferent fibers that arise from sympathetic postganglionic neurons in the lumbosacral sympathetic chain and hypogastric ganglia / pelvic ganglia. This isgenerally reflected in FIG. 2 by reference to a pelvic nerve 40 and a hypogastric nerve 42. The internal urethral sphincter 32 receives innervation from the hypogastric nerve 42. The external urethral sphincter 34 is directly innervated by motor neurons in the sacral segments of the spinal cord via the pudendal nerve 44.

[0050] Urinary continence is generally defined as the act of storing urine in the bladder 10 until the bladder 10 can be appropriately evacuated. Urinary continence requires control of the detrusor muscle 30 and is the result of complex coordination between multiple centers in the brain, brain stem, spinal cord, and peripheral nerves. As described above, micturition is a coordinated act of bladder elimination that involves relaxing the pelvic floor muscles 18, contracting the detrusor muscle 30, and simultaneously opening the urethral sphincters 32, 34 to achieve emptying of the bladder 10. Stress incontinence can be defined as the involuntary leakage of urine from the bladder 10 accompanying physical activity (e.g., laughing, coughing, sneezing, etc.) which places increased pressure on the abdomen. The leakage occurs even though the bladder muscles (detrusor muscle 30) are not contracting and an urge to urinate is not present. Stress incontinence can develop when the urethral sphincters 32, 34, the pelvic floor muscles 18, or all of these structures have been weakened or damaged and cannot dependably hold in urine. With urethral hypermobility, the bladder 10 and urethra 14 shift downward when abdominal pressure rises, and there is no hammock-like support for the urethra 14 to be compressed against to keep it closed. With urethral incompetence, problems in the urinary sphincter 32, 34 keep it from closing fully or allow it to pop open under pressure. Urinary urge incontinence (“UUI”) (sometimes referred to as overactive bladder (“OAB”) or detrusor overactivity) entails the involuntary leakage of urine from the bladder 10 when a sudden strong need to urinate is felt. There is a sudden involuntary contraction of the muscular wall (the detrusor 30) of the bladder that signals an immediate need to urinate, which can happen even when the bladder 10 is not full. Mixed incontinence is the term used for a combination of both urinary urge incontinence and stress incontinence.

[0051] Internal and external sphincters are similarly provided with the anus 16 (i.e., the internal anal sphincter and the external anal sphincter), acting to keep the anal canal and orifice closed. Action of the internal anal sphincter (IAS) is entirely involuntary, and it is usually in a state of continuous maximal contraction. The external anal sphincter (EAS) is always in a state of contraction, but can be voluntarily put into a condition of greater contraction so as to more firmly occlude the anal orifice. Similar to urinary continence, bowel continence is the act of storing feces until an acceptable time and opportunity for elimination. Bowel continence requires competent internal and external sphincters, pelvic floor musculature, and intact neurological pathways. Neurological control of bowel continence is complex and requires coordinated reflex activities from the autonomic and enteric nervous systems. The colon can be visualized as a closed, pliant tube bounded by the ileocecal valve and the anal sphincter. The continuous, smooth muscle layer at the end of the rectum 12 thickens to form the internal anal sphincter (IAS); the external anal sphincter (EAS) is a circular band of striated muscle that contracts with the pelvic floor. Parasympathetic stimulation of the IAS from the pelvic plexus originates from the sacral cord (S1 to S2). Sympathetic stimulation of the IAS causes contraction. The EAS is composed of both smooth and striated muscle. The smooth muscle of the EAS is innervated by the enteric nervous system. The striated component of the EAS is innervated by the pudendal nerve that exits the cord at sacral levels S2, S3, and S4.

[0052] Fecal incontinence can be defined as the involuntary loss of rectal contents (feces, gas) through the anal canal and the inability to postpone an evacuation until socially convenient. For example, injuries to one or both of the EAS and IAS may make it difficult to hold stool back properly. Injury to the nerves that sense stool in the rectum or those that control the anal sphincter can also lead to fecal incontinence. A generalized weakness of the pelvic floor 18 can lead to an impaired barrier to stool in the rectum 12 entering the anal canal, and this is associated with incontinence to solids. The pelvic floor 18 is innervated by the pudendal nerve and the S3 and S4 branches of the pelvic plexus. If the pelvic floor muscles 18 lose their innervation,they cease to contract and their muscle fibers are in time replaced by fibrous tissue, which is associated with pelvic floor weakness and incontinence.

[0053] With the above in mind, various treatment systems and methods have been disclosed that treat bladder and / or bowel dysfunction (e.g., one or more of urinary incontinence, UUI and fecal incontinence) by supplying stimulation signals to an electrode implanted to apply the stimulation signal to one or more nerves and / or muscles of the patient that, for example, influence the behavior of musculature of the pelvic region of the patient, for example musculature relating to one or both of urinary incontinence and fecal incontinence (e.g., the external urethral sphincter 34, the internal urethral sphincter 32, pelvic floor muscles 18, the external anal sphincter, the internal anal sphincter, etc.). Examples of such systems and methods are provided in PCT Publication No. 2020 / 243104 (Rondoni, et al.) and PCT Publication No. WO 2022 / 192726 (Rondoni, et al.) the entire teachings of each of which are incorporated herein by reference.

[0054] One example of a treatment system 50 for treatment of bladder and / or bowel dysfunction in accordance with principles of the present disclosure is provided in FIG. 3 and includes an implantable medical device (IMD) 60 (referenced generally) and optionally one or more sensors 62 (e.g., one or more of an accelerometer, a pressure sensor, a strain sensor, bioimpedance sensor, etc.). In general terms, the IMD 60 includes an implantable pulse generator or implantable component of a pulse generator (collectively identified as “IPG”) 64 and one or more stimulation elements (e.g., electrode or electrode assembly) 66. The IPG 64 is configured for implantation into a patient, and is configured to provide and / or assist in the performance of therapy to the patient. With formats in which the IPG 64 is an implantable pulse generator, a power source (e.g., battery) is carried within a housing of the implantable pulse generator and from which stimulation energy is generated. With formats in which the IPG 64 is an implantable component of a pulse generator, the implantable component(s) can include a receiver unit (e.g., receiver coil or similar device) that receives a signal from an external device (external the patient) that typically would be positioned on top of the skin over the location of the receiver coil. The externaldevice can generate / deliver the stimulation energy at a desired setting (e.g., amplitude, pulse width, frequency, pulse train length, etc.) to be received by the implanted receiver unit and conducted to the stimulation element(s) 66 for activation of tissue. The implanted receiver unit may or may not operate to modify the signal it receives prior to delivery to the stimulation element(s) 66. The external transmitter / controller may receive sensing signals from external sensor, receive sensing signals from the implanted portion of the implantable component via telemetry, etc. Unless stated otherwise, reference to “IPG 64” is inclusive of both an implantable pulse generator and an implantable component of a pulse generator as described above. The stimulation element 66 is configured to be implanted proximate a selected segment or region of the patient’s anatomy, and is electrically connected to the IPG 64, for example via a lead. In other embodiments, the IPG 64 and the stimulation element 66 can be provided as components of a single or integral device, such as a microstimulator, as are known in the art. The IPG 64 is programmed to deliver (or is prompted to deliver) stimulation signals to the stimulation element 66 that in turn apply the signal. In some embodiments, the IPG 64 is programmed (or is prompted) to initiate, cease and / or modulate (e.g., titrate) delivered stimulation signals based upon one or more physical parameters of the patient. In this regard, the sensor(s) 62 sense the physical parameter of interest, and signal the so-sensed parameter to the IPG 64 (or other component controlling operation of the IPG 64). The sensor(s) 62 can be carried by the IPG 64, can be connected to the IPG 64, or can be a standalone component not physically connected to the IPG 64. The sensor(s) 62 can be self-contained, and communicate with the IPG 64 in some optional embodiments. In some embodiments, the sensor(s) 62, the IPG 64, and the stimulation element 66 can be provided as components of a single or integral device. In some embodiments, the treatment system 50 can further include an optional external device 68. Where provided, the external device 68 can, in some non-limiting embodiments, wirelessly communicate with the IMD 60.

[0055] The IPG 64 can assume various forms known in the art for generating a nerve-stimulating signal for delivery to the stimulation element(s) 66. For example,the IPG 64 can include a sealed case or enclosure maintaining a power source (e.g., battery) and electrical / circuitry components appropriate for formatting energy from the power source as the desired stimulation signal (e.g., a nerve-stimulation signal). In some embodiments, the IPG 64 is provided as part of, or is electronically linked to, a control system that includes a control portion 70 providing one example implementation of a control portion forming a part of, implementing, and / or generally managing stimulation element(s), power / control elements (e.g., pulse generators, microstimulators), sensors, and related elements, devices, user interfaces, instructions, information, engines, elements, functions, actions, and / or methods, as described throughout examples of the present disclosure. In some examples, the control portion 70 includes a controller and a memory. In general terms, the controller comprises at least one processor and associated memories. The controller is electrically couplable to, and in communication with, memory to generate control signals to direct operation of at least some of the stimulation elements, power / control elements (e.g., pulse generators, microstimulators) sensors, and related elements, devices, user interfaces, instructions, information, engines, elements, functions, actions, and / or methods, as described throughout examples of the present disclosure. In some non-limiting examples, these generated control signals include, but are not limited to, employing instructions and / or information stored in the memory to at least direct and manage treatment of bladder and / or bowel dysfunction by stimulating nerve(s), nerve branch(es) and / or muscle(s), for example to activate one or more of the external urethral sphincter 34 and the external anal sphincter, and / or pelvic floor nerves (e.g., the pudendal nerve 44, the sacral nerve) to relax the detrusor muscle 30 and prevent or reduce urgency or frequency.

[0056] In some instances, the controller or control portion 70 may sometimes be referred to as being programmed to perform the actions, functions, routines, etc. of the present disclosure. In some examples, at least some of the stored instructions are implemented as, or may be referred to as, a care engine, a sensing engine, monitoring engine, and / or treatment engine. In some examples, at least some of the stored instructions and / or information may form at least part of, and / or, may bereferred to as a care engine, sensing engine, monitoring engine, and / or treatment engine.

[0057] In response to or based upon commands received via a user interface and / or via machine readable instructions, the controller generates control signals as described above in accordance with at least some of the examples of the present disclosure. In some examples, the controller is embodied in a general purpose computing device while in some examples, the controller is incorporated into or associated with at least some of the stimulation elements, power / control elements (e.g., pulse generators, microstimulators), sensors, and related elements, devices, user interfaces, instructions, information, engines, functions, actions, and / or method, etc. as described throughout examples of the present disclosure.

[0058] For purposes of the present disclosure, in reference to the controller, the term “processor” shall mean a presently developed or future developed processor (or processing resources) that executes machine readable instructions contained in a memory. In some examples, execution of the machine readable instructions, such as those provided via the memory of the control portion 70 cause the processor to perform the above-identified actions, such as operating the controller to implement the sensing, monitoring, treatment, etc. as generally described in (or consistent with) at least some examples of the present disclosure. The machine readable instructions may be loaded in a random access memory (RAM) for execution by the processor from their stored location in a read only memory (ROM), a mass storage device, or some other persistent storage (e.g., non-transitory tangible medium or non-volatile tangible medium), as represented by the memory. In some examples, the machine readable instructions may comprise a sequence of instructions, a processorexecutable machine learning model, or the like. In some examples, the memory comprises a computer readable tangible medium providing non-volatile storage of the machine readable instructions executable by a process of the controller. In some examples, the computer readable tangible medium may sometimes be referred to as, and / or comprise at least a portion of, a computer program product. In other examples, hard wired circuitry may be used in place of or in combination withmachine readable instructions to implement the functions described. For example, the controller may be embodied as part of at least one application-specific integrated circuit (ASIC), at least one field-programmable gate array (FPGA), and / or the like. In at least some examples, the controller is not limited to any specific combination of hardware circuitry and machine readable instructions, nor limited to any particular source for the machine readable instructions executed by the controller.

[0059] In some examples, the control portion 70 may be entirely implemented within or by a stand-alone device.

[0060] In some examples, the control portion 70 may be partially implemented in the IPG 64 and partially implemented in a computing resource separate from, and independent of, the IPG 64. For instance, in some examples the control portion 70 may be implemented via a server accessible via the cloud and / or other network pathways. In some examples, the control portion 70 may be distributed or apportioned among multiple devices or resources such as among a server, a treatment device (or portion thereof), and / or a user interface.

[0061] In some examples, the control portion 70 is entirely implemented within or by the IPG 64 (thereby defining an IPG assembly), which has at least some of substantially the same features and attributes as a pulse generator (e.g., power / control element, microstimulator) as previously described throughout the present disclosure. In some examples, the control portion 70 is entirely implemented within or by a remote control (e.g., a programmer) external to the patient’s body, such as a patient control and / or a physician control (e.g., the external device 68). In some examples, the control portion 70 is partially implemented in the IPG 64 assembly and partially implemented in the remote control (at least one of the patient control and the physician control).

[0062] The systems and methods of the present disclosure are in no way limited to a particular stimulation target site(s) or a particular stimulation therapy regimen. The stimulation therapies or algorithms programmed to, or implemented by, the control portion 70 can be of any format deemed useful for the patient being treated, and may or may not act upon information from the sensor(s) 62. With reference betweenFIGS. 1 -3, the system 50 can be configured and implanted to provide stimulation therapy to one or more nerves and / or muscles that, for example, influence the behavior of musculature of the pelvic region of the patient, for example musculature relating to one or both of urinary incontinence and fecal incontinence (e.g., the external urethral sphincter 34, the internal urethral sphincter 32, pelvic floor muscles 18, the external anal sphincter, the internal anal sphincter, etc.). For example, stimulation can be provided to one or more of the pudendal nerve 44, the pelvic nerve 40, the sacral nerve, hypogastric, or branches thereof. For example, stimulation can be provided to a deep branch of the pudendal nerve 44 or other nerve, for example applied to a distal-most branch of the pudendal nerve 44 (or other nerve) at or in highly close proximity to a location where the branch contacts or terminates a muscle (or other anatomical feature) of interest. With optional embodiments in which the treatment system 50 is configured and implanted to deliver stimulation to two (or more) target sites (e.g., two or more of the pudendal nerve 44, the pelvic nerve 50, the sacral nerve, the hypogastric nerve, etc., and / or two or more different locations along one incontinence amelioration-related nerve and / or different incontinence amelioration-related nerves, etc.), the so-applied simulation can be toggled (e.g., simultaneous, alternating, overlapping, unilateral, bilateral, selective), optionally while additionally toggling / adjusting one or more stimulation parameters e.g.., amplitude, frequency, pulse width, duty cycle, pulse shape, etc.). Alternatively or in addition, the system 50 can apply electrical stimulation to tissue sites proximate a nerve or nerve branch of interest. In yet other embodiments, stimulation can be applied directly to a muscle. Various, non-limiting examples of stimulation protocols or algorithms are described in PCT Publication No. 2020 / 243104 (Rondoni, et al.) and PCT Publication No. WO 2022 / 192726 (Rondoni, et al.) the entire teachings of each of which are incorporated herein by reference.

[0063] The stimulation element(s) 66 can assume various forms appropriate for applying electrical stimulation to the anatomical feature (e.g., nerve) of interest, and can be provided as part of, or carried by a lead or lead assembly or the like. The stimulation element(s) 66 can be or include one or more electrodes in the form ofring electrodes, segmented electrodes, and partial ring electrodes. In some examples, the stimulation element(s) may be, include, or be provided a part of a cuff electrode, comprising at least some of substantially the same features and attributes as described in Bonde et al., U.S. Patent No. 8,340,785, Self Expanding Electrode Cuff, issued on December 25, 2012 and Bonde et al., U.S. Patent No. 9,227,053, Self Expanding Electrode Cuff, issued on January 5, 2016, both which are hereby incorporated by reference in their entirety. Moreover, in some examples a stimulation lead, which may comprise one example implementation of a stimulation element, may comprise at least some of substantially the same features and attributes as the stimulation lead described in U.S. Patent No. 6,572,543 to Christopherson et al., and which is incorporated herein by reference in its entirety. Other non-limiting examples of stimulation elements and leads useful with the present disclosure are provided in PCT Publication No. 2020 / 243104 (Rondoni, et al.) and PCT Publication No. WO 2022 / 192726 (Rondoni, et al.) the entire teachings of each of which are incorporated herein by reference.

[0064] With the above generalities in mind, the lead can be delivered and implanted in various manners to position the stimulation element(s) 66 at an intended target site. Aspects of the present disclosure provide for systems and methods for delivering / implanting a lead as part of the bladder and / or bowel disorder treatment system 50, so as to locate the stimulation element 66 (as provided, for example, as part of a lead, a cuff electrode, a microstimulator, etc.) at an intended target site, such as in the periurethral anatomy. Unless stated otherwise, the stimulation element(s) 66 can be delivered to the intended target site via a variety of different surgical techniques as would be apparent to one of ordinary skill (e.g., locating a device carrying the stimulation element(s), such as a lead, cuff electrode, microstimulator, etc.). In yet other embodiments, the stimulation element(s) can be provided as part of a trialing system or testing system that need not necessarily include the sensor(s) 62.

[0065] In some embodiments, systems and methods of the present disclosure relate to locating one or more small diameter leads (e.g., percutaneous lead) in theperiurethral space, for example at, along, around, or near the external urethral sphincter (EUS) 34. As used in the present disclosure, a “percutaneous lead” is in general reference to a lead having a cylindrically-shaped lead body with a relatively small outer diameter (e.g., for insertion through an introducer needle) and carrying one or more stimulation elements or electrodes. As a point of reference, various aspects of the female anatomy of the periurethral space are shown in FIGS. 4A and 4B. With some systems and methods of the present disclosure, treatment can include or entail delivering stimulation to the EUS 34. With these and related embodiments, it can be beneficial to locate one or more stimulation elements on or along the EUS 34. The anatomical constraints of, and proximate to, an EUS target site (designated as “T1” in FIG. 4A and “T1” and “T2” in FIG. 4B) can make delivery of the stimulation element-carrying lead challenging. FIG. 4C is a highly simplified end view of the urethra 14 as surrounded by the EUS 34.

[0066] With the above in mind, portions of one example of a treatment system 100 as implanted to a patient in accordance with principles of the present disclosure are shown in FIG. 5A. The treatment system 100 includes a lead 110 having a lead body 112 and a head 114 carrying stimulation elements or electrodes 116. The head 114 is configured to maintain the electrodes 116 (as well as other optional electrical components) in an electrically isolated manner, and can have the curved shape reflected by the view. In the example of FIG. 5A, the lead 110 has been delivered to the periurethral space, locating the head 114 about a segment of the EUS 34. With this arrangement, the stimulation elements 116 are positioned to deliver stimulation energy to the EUS 34. The head 114 can be secured or anchored relative to the EUS 34 in various manners, for example via sutures 118. In some examples, the head 114 can have a flexible configuration, allowing a clinician the ability to form or shape the head 114 to a curvature of the EUS 34. In other examples, the head 114 can more rigidly retain the curved shape. Regardless, the lead body 112 is routed to a stimulation energy source, such as the IPG 64 (FIG. 3).

[0067] Portions of another treatment system 130 as implanted to a patient in accordance with principles of the present disclosure are shown in FIG. 5B. Thetreatment system 130 includes a lead 140 having a lead body 142 and a head 144 carrying a stimulation element or electrode 146. The head 146 can have the curved shape reflected by the view. In the example of FIG. 5B, the lead 140 has been delivered to the periurethral space, locating the head 144 about a segment of the EUS 34. With this arrangement, the stimulation element 146 is positioned to deliver stimulation energy to the EUS 34. The head 144 can be secured or anchored relative to the EUS 34 in various manners, for example via sutures 148. In some examples, the head 144 can have a flexible configuration, allowing a clinician the ability to form or shape the head 144 to a curvature of the EUS 34. In other examples, the head 144 can more rigidly retain the curved shape. Regardless, the lead body 142 is routed to a stimulation energy source, such as the IPG 64 (FIG. 3).

[0068] Portions of another treatment system 160 as implanted to a patient in accordance with principles of the present disclosure are shown in FIG. 5C. The treatment system 160 includes a lead 170 providing a lead body 172 defining a distal region 174 carrying one or more stimulation elements or electrodes. Though not visible in FIG. 5C, the stimulation element(s) can have a conventional configuration and are arranged along the distal region 174 such that an energy emitting face thereof is exposed relative to an outer surface of the lead body 172. In the example of FIG. 5C, the lead body 172 has been delivered to the periurethral space and the distal region 174 partially wrapped or wound about a segment of the EUS 34. With this arrangement, the stimulation element(s) carried by the lead body 172 is positioned to deliver stimulation energy to the EUS 34. The distal region 174 can be secured or anchored relative to the EUS 34 in various manners, for example via one or more anchors 176, such as self-deploying tines. In some examples, the distal region 174 can have a flexible configuration, allowing a clinician the ability to form or shape the distal region 174 to a curvature of the EUS 34. In other examples, the distal region 174 can more rigidly retain the curved shape (e.g., when deployed from a delivery catheter, the distal region 174 self-assumes the curved shape shown). Regardless, the lead body 172 is routed to a stimulation energy source, such as the IPG 64 (FIG. 3).

[0069] Portions of another treatment system 190 as implanted to a patient in accordance with principles of the present disclosure are shown in FIG. 5D. The treatment system 190 includes a lead 200 providing a lead body 202 defining a distal region 204 carrying one or more stimulation elements or electrodes. Though not visible in FIG. 5D, the stimulation element(s) can have a conventional configuration and are arranged along the distal region 204 such that an energy emitting face thereof is exposed relative to an outer surface of the lead body 202. In the example of FIG. 5D, the lead body 202 has been delivered to the periurethral space and the distal region 204 partially wrapped or wound about a segment of the EUS 34. With this arrangement, the stimulation element(s) carried by the lead body 202 is positioned to deliver stimulation energy to the EUS 34. The distal region 204 can be secured or anchored relative to the EUS 34 in various manners, for example via sutures 206. In some examples, the distal region 204 can have a flexible configuration, allowing a clinician the ability to form or shape the distal region 204 to a curvature of the EUS 34. In other examples, the distal region 204 can more rigidly retain the curved shape (e.g., when deployed from a delivery catheter, the distal region 204 self-assumes the curved shape shown). Regardless, the lead body 202 is routed to a stimulation energy source, such as the IPG 64 (FIG. 3).

[0070] Portions of another treatment system 210 as implanted to a patient in accordance with principles of the present disclosure are shown in FIG. 6. The treatment system 210 includes the IPG 64 and a percutaneous lead 220 providing a lead body 222 having a distal region 224 carrying one or more stimulation elements or electrodes 226. In the example of FIG. 6, the lead body 222 has been delivered to the periurethral space and the distal region 224 arranged generally parallel to the urethra 14. The stimulation element(s) 226 carried by the lead body 222 are positioned to deliver stimulation energy to the EUS 34. While the lead 220 is illustrated as having two of the stimulation elements or electrodes 226 that can be operable in tandem, any other number, either greater or lesser, is equally acceptable. The distal region 224 can be secured or anchored relative to the EUS 34 in various manners, for example via an anchor 228 provided with the lead 220. The anchor 228is generally shown as having a tab-like shape; various anchoring or fixation arrangements and techniques are described in greater detail below. Regardless, the lead body 222 is routed or tunneled to the IPG 64. With some methods and techniques of the present disclosure, and as implicated by the FIG. 18, during placement of a permanent lead (e.g., akin to the lead 500), an incision will likely be necessary to allow for tunneling to the implanted IPG 64. Under these and other circumstances, some aspects of the present disclosure include or entail devices and / or methods for promoting anchoring of the lead where the incision is close to the target site in the periurethral space. For example, one possible incision site is indicated generally at 530 in FIG. 19 as described in greater detail below.

[0071] Some systems and methods of the present disclosure include a curved introducer needle for facilitating placement of a percutaneous lead around the EUS 34. One non-limiting example of a curved introducer needle 250 in accordance with principles of the present disclosure and useful with these and related embodiments is shown in FIG. 7. The curved introducer needle 250 can include a handle 260 and a needle body 262 terminating at a tip 264. A lumen or bore (hidden) extends through the introducer needle 250, and is open at the handle 260 and the tip 264. The needle body 262 forms or defines a pre-determined curvature in extension from the handle 260 to the tip 264, corresponding with expected anatomy and shapes of the periurethral space and in particular the EUS 34 (FIG. 2). For example, the needle body 262 can form or define a linear or straight region 270 proximate the handle 260 and at least one curved region 272 proximate the tip 264. The curved region 272 forms or defines at least one smooth curve that deviates or curves away from a centerline defined along the linear region 270. In some embodiments, a shape of the curved region 272 generally corresponds with an expected curvature of the EUS 34 about the urethra 14 (FIG. 2).

[0072] Regardless of an exact configuration, the curved introducer needle 250 can be employed to access a target site at or along the EUS 34. For example, and with additional reference to FIGS. 4A and 4B, in some embodiments, test or trialing stimulation at the target site can be beneficial, for example prior to installing apermanently implanted treatment system. With these and related embodiments, methods for providing test stimulation can include inserting the tip 264 in the periurethral skin lateral to the meatus, and manipulating the curved introducer needle 250 to approach the EUS 34 and then effect a curving motion such that the tip 264 creates a helical trajectory around one side of the EUS 34 (e.g., approaching the target location T1 ). A final arrangement of the curved introducer needle 250 is generally reflected in FIG. 8. A test stimulation lead (not shown) is then introduced through the curved introducer needle 250 to the target site T1 . The curved introducer needle 250 can then be removed, leaving the test lead in position. A second test stimulation lead (not shown) can be similarly placed at or along an opposite side of the EUS 34 (i.e., the target site T2 in FIG. 4B) using the same techniques. Once complete, both sides of the EUS 34 are surrounded by the helically-placed leads. As a point of reference, FIG. 9 illustrates first and second leads 280, 282 arranged at or along opposite sides of the EUS 34, with each of the leads 280, 282 carrying one or more of the stimulation elements 66.

[0073] Following test stimulation, or with other scenarios where test stimulation is not desired, a permanently implanted system can be provided. For example, and with additional reference to FIGS. 10A and 10B, one or two small incisions can be made in the periurethral skin. The curved introducer needle 250 (FIG. 7) can then be inserted within the incision(s). This allows for tunneling of the leads 280, 282 in a direction of an implanted IPG (referenced generally in FIGS. 10A and 10B at 290). After tunneling, the incisions can be closed. In related embodiments, following distal end placement, an introducer could be employed to tunnel from the periurethral incision site (e.g., a plastic sleeve could be deployed from an outside of the tunneling tool to push the lead through to the IPG site or similar technique / device could be used to transition the lead to the IPG site). Optionally, a carrier could also be used as part of the tunneling tool.

[0074] While the methods and techniques of FIGS. 7-10B have been described with reference to insertion points through the periurethral skin, other approaches can beemployed. For example, in other embodiments, the methods and techniques of FIGS. 7-1 OB can be completed through the vaginal wall instead of the perineal skin. [075J The curved introducer needle 250 (FIG. 7) and corresponding techniques are non-limiting examples of devices and methods for introducing a lead, such as the leads 280, 282, to the periurethral space, for example at or along the EUS 34. In other examples of the present disclosure, the lead can be introduced to the periurethral space (or other target location) by advancement over a previously- positioned tool or device. In some embodiments, a small diameter guide wire or needle can be placed or positioned as desired (e.g., an acupuncture-sized wire or needle), for example to perform test stimulation at the target site. The lead can then be advanced over the small diameter guide wire or needle to locate stimulating element(s) carried by the lead at the target site (e.g., the lead can be relatively stiff, a sheath can be utilized with the lead during advancement over the guide wire or needle, etc.). Once a desired position of the lead is attained, the small diameter guide wire or needle can then be withdrawn or removed.

[0076] Percutaneous leads conducive to deployment in the periurethral space, for example at or along the EUS 34, can assume various forms that may or may not be directly implicated by the leads 280, 282 shown in FIGS. 10A and 10B. For example, another lead 300 in accordance with principles of the present disclosure and useful, for example, for placement and use at a target site in the periurethral space is shown in FIGS. 11 A-11 C. The lead 300 can be generally akin to a percutaneous lead, and includes a lead body 302 and a plurality of stimulation elements or electrodes 304. The lead body 302 is configured to maintain the electrodes 304 (as well as other optional electrical components) in an electrically isolated manner, and can have the cylindrical shape as best reflected in FIGS. 11 B and 11 C. The lead body 302 is formed of a biocompatible material appropriate for implantation into the human body.

[0077] Each of the stimulation electrodes 304 are formed of an electrically conductive material appropriate for delivering stimulation energy within the human body. The stimulation electrodes 304 can assume any of the constructions of the present disclosure. The stimulation electrodes 304 are arranged along the lead body 302 soas to provide an exposed surface from which stimulation energy is emitted. The stimulation electrodes 304 are encapsulated and electrically isolated from one another by the lead body 302.

[0078] In some embodiments, and as best reflected by FIG. 11 B, one or more of the stimulation electrodes, for example the stimulation electrode 304a, can be a complete ring-type electrode. As reflected by FIG. 11 C, one or more or all of the stimulation electrodes, for example the stimulation electrode 304b, can be, or can be akin to, a split ring-type electrode, comprised of two or more electrode segments 306. Though not visible in the views, individual, electrically isolated wire(s) can extend from each of the stimulation electrode segments 306 within a thickness of the lead body 302. With these and related examples, the electrode segments 306 are individually selectable and provide anti-rotation attributes. The selectable nature of the electrode segments 306 allows for the ability to include or exclude various tissue (e.g., nerves) upon final implant / use. The segmented leads of the present disclosure, such as the lead 300, can include or carry additional anchoring-type features or bodies (e.g., ridge, tines, fins, etc.) that maintain both axial and rotational stability.

[0079] Another lead 320 in accordance with principles of the present disclosure and useful, for example, for placement and use at a target site in the periurethral space is shown in FIGS. 12A and 12B. The lead 320 can be generally akin to a percutaneous lead, and includes a lead body 322 and a plurality of stimulation elements or electrodes 324. The lead body 322 is configured to maintain the electrodes 324 (as well as other optional electrical components) in an electrically isolated manner. The lead body 322 is formed of a biocompatible material appropriate for implantation into the human body.

[0080] The lead body 322 has a non-circular shape in transverse cross-section, as shown in FIG. 12B. With the non-limiting example, the electrodes 324 can be placed on one side of the lead body 322. Upon final implant, an electrical field generated by the electrodes 324 can be preferentially directed. For example, and with additional reference to FIGS. 4A and 4B, by optionally arranging all of the electrodes 324 on a single side of the lead body 322, the electrical field generated by the electrodes 324can be preferentially directed at the EUS 34 or nerve(s) innervating the EUS 34 or other target nerves while excluding tissue / structures located at the opposite side of the lead body 322. In some examples, the non-circular percutaneous leads of the present disclosure, such as the lead 320, are well-suited for introduction into the patient in a desired orientation via a non-circular introducer, such as the introducer 330 shown in FIG. 12C.

[0081] Portions of another treatment system 350 as implanted to a patient in accordance with principles of the present disclosure are shown in FIG. 13. The system 350 includes an array 360 of multiple, separate percutaneous leads, for example percutaneous leads 362a, 362b, 362c, 362d. While the array 360 shown in FIG. 13 includes four percutaneous leads, any other number, either greater or lesser, is also acceptable. Regardless of an exact number, the array 360 is akin to a fine- wire array, with each of the percutaneous leads of the array 360 connected to the IPG (generally indicated at 364 in FIG. 13). In some embodiments, the percutaneous leads of the array 360 can be commonly connected to a multiport adaptor 366; a cable or extension 368 extends from the adaptor 366 and is connected to the IPG 364. The multiport adapter 366 can allow multiple ones of the percutaneous leads to be connected to the extension cable 368, with the single extension cable 368 being tunneled to the IPG 364. The multiport adapter 366 can include set screw connections, spring contact connections or manually operated electrical contacts. The multiport adapter 366 can optionally contain an electronically controlled multiplexer to switch between the individual electrodes of the array 360, for example to minimize the cabling conductors and number of IPG outputs required. In other examples, the percutaneous lead of the array 360 can be directly connected to the IPG 364. Moreover, each of the percutaneous leads of the array 360 can have a relatively small profile, conducive to implantation within targeted tissue. The percutaneous leads of the array 360 can, in some examples, have a monopolar or unipolar configuration, providing a stimulation element or electrode (not shown) at a distal region thereof that is operable to deliver stimulation energy on a monopolar basis. The array 360 of percutaneous leads can, in some non-limiting examples, beconfigured in a way that includes lead(s) more distal from the urethra 14 that have longer cylindrical electrodes that are intended to be anodes, and lead(s) more proximal to the urethra 14 that have a larger number of shorter cylindrical electrodes that might be assigned to be the cathode(s). This optional arrangement could allow greater selectivity nearer the nerve branches and small fibers innervating the EUS 34. In addition, the assignment of cathodes and anodes can, in some embodiments, shape the stimulation field to avoid unwanted effects and provide a field steering arrangement. For example, the more distal leads might have cylindrical electrodes that are roughly 1 .0 cm to 4.0 cm long and have only one or two on a lead. The more proximal leads to the urethra 14 might have between two and eight electrodes that are between 5 mm and 2 cm long. Typical percutaneous lead diameters could be between 2 French and 5 French.

[0082] In some examples, two or more of the percutaneous leads of the array can be placed in the periurethral tissue (e.g., the leads 362a, 362b, 362c with the nonlimiting example of FIG. 13) and / or in the perineum adjacent to targeted structure(s) such as the EUS 34 (e.g., as with the lead 362d in FIG. 13). With these and related embodiments, the therapeutic effect of stimulation delivered by each of the leads of the array 360 can be evaluated; based on this evaluation, a clinician is afforded the ability to “tune” the degree of stimulation delivered to a target structure and / or guarding against stimulation being applied to other structures as the therapy is adjusted during initial trialing and / or over time. Viable therapy can be provided to the patient via the array 360 alone, or in combination with other devices (e.g., one or more other stimulation leads). For example, some systems of the present disclosure can include the array 360 as described above along with a separate stimulation lead arranged to deliver stimulation therapy to another target site, such as the main trunk of the pudendal nerve and / or branches of the pudendal nerve such as the perineal branch, inferior rectal nerve (IRN) or the dorsal genital nerve (DGN).

[0083] The placement of each lead of the array 360 can be performed in various manners. In some examples, delivery and / or placement can be assisted by the use of a nerve integrity monitoring system (“NIMS”), electrical muscle stimulation (“EMS”)needles, and / or surface electrodes to confirm which muscle(s) is / are being stimulated by the individual leads. In other examples, ultrasound and / or fluoroscopic imaging can be employed.

[0084] An example of another lead 400 useful with systems and methods of the present disclosure is shown in FIG. 14. The lead 400 includes a lead body 402 formed from one or more coiled conductors or coiled cables and exhibits high flexibility. As a point of reference, because of the high degree of mobility at some targeted treatment sites of the present disclosure, for example in the periurethral space and in the perineum in general, useful leads may be highly accommodating, as well as fatigue and migration resistant. The coiled format of the lead body 402 provides these and other attributes. In some examples, the lead body 402 can be formed into a sigmoid shape or other redundant shape that further reduces stress on the materials and reduces overall bending and axial stiffness of the assembly.

[0085] With reference to FIG. 15A, in some embodiments, the lead body 402 includes a monofilar coil or stranded electrically conductive cable or wire 410. The wire 410 is encased within an electrically insulating covering 412. Apart from the covering 412, the lead body 402 is free of an outer jacket, allowing the individual coils (referenced generally at 414) to readily flex or move relative to one another, rendering the lead body 402 highly flexible. Moreover, tissue ingrowth can occur around / between the individual coils 414. A simulation element or electrode 416 is provided with the lead 400, for example formed by removal (e.g., ablation) of the insulating covering 412 at to expose a section of the wire 410. The exposed section or electrode 416 can provide significant surface area for conduction to tissue. While FIG. 15A illustrates a single electrode 416 defined along a segment of a single one of the coils 414, in other examples, multiple electrodes can be formed and / or aligned segments of two (or more) immediately adjacent coils 414 can be exposed to define an enlarged electrode. In other examples, the conductors 410 could be elastic or flexible polymers that allow electrical conductivity while maintaining or achieving a high degree of flexibility to accommodate tissue movements. In some examples, the leadsmay initially be ridged to facilitate placement but become more flexible once implanted.

[0086] In other examples, the coil-type leads of the present disclosure can include an outer jacket. For example, FIG. 15B illustrates portions of a lead 400’. The lead 400’ can be highly akin to the lead 400 (FIG. 15A) and includes a lead body 402’ having the monofilar coil wire 410 and an outer jacket 420. The outer jacket 420 is formed of a flexible, biocompatible material, and can be configured to prevent the individual coils 414 from uncoiling (e.g., during removal when a pulling force is applied onto the lead 400’). In some embodiments, the monofilar coil wire 410 can be encased within the insulating covering 412, with a portion of the insulating covering 412 removed to define the stimulation element or electrode 416 as described above. With these and related embodiments, a passage 422 can be formed through a thickness of the outer jacket 420; the passage 422 is aligned with the uncovered wire segment 416 to permit passage of stimulation energy emitted by the electrode 416. In other embodiments, the insulating covering 412 can be omitted, with the outer jacket 420 electrically insulating the coil wire 410 (apart from the passage 422).

[0087] FIG. 15C illustrates portions of another example coil-type lead 400” of the present disclosure. The lead 400” includes a lead body 402”. The lead body 402” is formed, in part, by a bifilar coil having first and second stranded electrically conductive cables or wires 430, 432. The wires 430, 432 are each encased within an electrically insulating covering 434, 436, respectively, and are wound into intermeshing coils 438, 440. At least one first simulation element or electrode 442 is provided by the first coiled wire 430, for example formed by removal (e.g., ablation) of the insulating covering 434 to expose a section of the first coiled wire 430. Similarly, at least one second simulation element or electrode 444 is provided by the second coiled wire 432, for example formed by removal (e.g., ablation) of the insulating covering 436 to expose a section of the second coiled wire 432. The first and second electrodes 442, 444 can be longitudinally spaced from one another along a length of the lead 400”. Regardless, the lead 400” can be operated to selectivelyenergize the first and second coiled wires 430, 432, and thus the electrodes 442, 444, on an individual or collective basis. In other examples, an outer jacket (e.g., the outer jacket 420 (FIG. 14B) can be provided with the bifilar coil lead 400”.

[0088] While the lead bodies 400, 400’, 400” have been illustrated as including single wires encased within an electrically insulating covering, other configurations are also acceptable. For example, the coiled lead bodies can be formed from cables made of multiple conductive strands, such as a cable made up of seven strands of conductors (1 X 7) or a higher strand count such as 19 strands (1 X 19) or higher strand counts. As the number of conductors (strands) in a cable increases, their size decreases, reducing the bending stresses in the wire and increases bending stiffness.

[0089] The percutaneous leads of the present disclosure can be anchored relative to a target site (e.g., periurethral tissue) in various fashions. In some non-limiting embodiments, and with reference to FIG. 4A, leads of the present disclosure can be anchored into membrane or muscle fascia 450 (referenced generally) proximate the urethra 14 and the external urethral sphincter 34 via a flexible attachment. The flexible attachment devices and techniques can assume a wide variety of forms. One example of a flexible attachment device 460 is shown in FIG. 16A and includes a tether 462 and an anchor 464. As a point of reference, FIG. 16A illustrates securement of the attachment device 460 to the membrane or muscle fascia 450 proximate the urethra 14; other target locations are equally acceptable. At least a distal portion of the tether 462 is a flexible, high tensile strength body (e.g., suture, permanent braided suture, thread, small diameter wire, etc.). In other embodiments, an entirety of the tether 462 is highly flexible. The anchor 464 is a rigid, rod like body connected to the tether 462. An arrangement and configuration of the tether 462 and the anchor 464 is such that in the absence of external forces, the anchor 464 can pivot relative to a length of the tether 462. For example, FIG. 16A illustrates the attachment device 460 in conjunction with a delivery needle 470. During use, the needle 470 is deployed such that a tip 472 thereof initially contacts a first side 480 of the membrane or muscle fascia 450, then pierces through the membrane or muscle fascia 450, and is finally located beyond a second side 484 as shown. Theattachment device 460 is then advanced through a lumen of the needle 470, deploying the anchor 464 from the tip 472 at a location beyond the second side 484 of the membrane or muscle fascia 450. In this regard, the flexible nature of the tether 462 readily facilitates slidable arrangement of the anchor 464 within the lumen. By way of further explanation, in the view of FIG. 16A, the anchor 464 is oriented such that a major axis of the anchor 464 is substantially parallel with an axis of the needle 470 (and thus the needle lumen); a flexibility of the tether 462 permits the anchor 464 to freely rotate or pivot such that the major axis is aligned with the needle lumen for passage through the needle 470.

[0090] With the anchor 464 now located beyond the second side 484 of the membrane or muscle fascia 450, the needle 470 can be removed from the patient, leaving the attachment device 460 in place. As shown in FIG. 16B, the anchor 464 is arranged against the second side 484 of the membrane or muscle fascia 450 (e.g., a pulling force is applied onto the tether 462, with the anchor 464 naturally moving to the arrangement of FIG. 16B). With the tether 464 under tension, a lead 490 can then be inserted over the tether 462 and slidably advanced toward the membrane or muscle fascia 450. The lead 490 can generally have any of the configurations of the present disclosure, and can provide an open central lumen for slidably receiving the tether 464. Once a desired location of the lead 490 is achieved, the lead 490 can then be locked to the tether 462, thereby fixing the lead 490 relative to the target site. In some examples, as the lead 490 is being advanced along the tether 462, the lead 490 can be periodically operated to deliver stimulation energy, allowing the clinician to confirm a desired location of the lead 490. The lead 490 can be locked onto the tether 462 in various manners. For example, the lead 490 can include or carry a locking feature configured to be crimped or clenched onto the tether 462. Alternatively or in addition, the tether 462 can be tied onto the lead 490. In yet other embodiments, an adhesive bonding agent can be applied to lock the lead 490 to the tether 462.

[0091] The flexible attachment devices of the present disclosure can assume a variety of other forms. For example, in some embodiments, the tether 462 can havea multi-component structure, such as a rigid rod proximal section and a small, flexible body distal section (e.g., suture). With these and related embodiments, the lead 490 may more easily slide over the rigid rod proximal section, with the flexible body distal section permitting desired rotation or pivoting of the anchor 464 as described above. Further, while the anchor 464 has been shown and described as being a rod-like body, other constructions are also envisioned. For example, the anchor 464 can have or carry one or more barbs that expand after piercing into the membrane or muscle fascia 450. Alternatively or in addition, the anchor 464 can include or consist of a mesh-type body that, after deployment, will promote tissue growth, providing a secure attachment point for the tether 462 over time. Alternatively or in addition, the anchor 464 can include or carry a staple or similar bendable structure configured to clinch into tissue. Alternatively or in addition, the anchor 464 can include or carry a shape-memory material configured to capture tissue after deployment when it selfreverts to a predetermined shape. Alternatively or in addition, the anchor 464 can include or carry a coil that clinches into tissue (e.g., the perineal membrane).

[0092] In some embodiments, the delivery needle 470 (FIG. 16A) can be configured to perform one or more procedures in addition to delivering the attachment device 460. For example, the delivery needle 470 can be configured as a test stimulation needle. As generally shown in FIG. 17, with these and related embodiments, prior to deployment of the attachment device 460 (FIG. 16A), the needle 470 can be operated to emit stimulation energy at various locations relative to an intended target site (e.g., the urethra 14), allowing the clinician to confirm a desired stimulation location.

[0093] FIG. 18 illustrates portions of a lead 500 incorporating another non-limiting example of percutaneous lead anchoring in accordance with principles of the present disclosure. The lead 500 includes a lead body 502 that generally can assume any of the formats of the present disclosure and carries one or more stimulation elements or electrodes 504. A distal end 506 of the lead body 502 forms or defines an open slot 508 (referenced generally). A capture element 510 (e.g., an anchor wire such as monofilament wire) extends through a lumen of the lead body 502 and is attached tothe distal end 506 distally beyond the slot 508. With this construction, then, a section 512 of the capture element 510 extends across, and is exposed outside of, the slot 508. The capture element 510 can have a relatively rigid construction, and can be biased to assume the arrangement shown in which the exposed section 512 bows outwardly relative to the lead body 502. For example, a shoulder 514 can be formed in or along the capture element 510 that is retained by the lead body 502 at a location at which an extent of the exposed section 512 projects outwardly. A proximal or pulling force applied to the capture element 510 reduces the length of the exposed section 512, drawing the exposed section 512 toward or into the slot 508). With this construction, tissue can be captured and released by the capture element 510, akin to a “lock stitch” in machine sewing.

[0094] For example, and with additional reference to the anatomy of FIG. 6, with the capture element 510 in a retracted state (e.g., minimal, if any, outward extension from the lead body 502), the lead 500 can be advanced toward a target site in the periurethral space, such as the EUS 34. Once the lead 500 has been desirably located, the capture element 510 is distally advanced, forcing the exposed section 512 into tissue at the target site. The so-deployed capture element section 512 effectively captures tissue of the target site, anchoring the lead 500 in place (e.g., akin to the arrangement of the lead 220 in FIG. 6). Where removal of the lead 500 is desired, the capture element 510 is proximally retracted to release the section 512 from the tissue.

[0095] With some methods and techniques of the present disclosure, and as generally implicated by FIG. 6, during placement of a permanent lead (e.g., akin to the lead 220), an incision will likely be necessary to allow for tunneling to the implanted IPG 64. Under these and other circumstances, some aspects of the present disclosure include or entail devices and / or methods for promoting anchoring of the lead where the incision is close to the target site in the periurethral space. For example, one possible incision site is indicated generally at 530 in FIG. 6.

[0096] With the above in mind, a simplified, enlarged representation of a lead 540 implanted to, in one example, deliver stimulation therapy to a target site 550 alongthe EUS 34 is shown in FIG. 19. The lead 540 can generally have any of the configurations of the present disclosure, and has been tunneled through the incision 530 otherwise formed in fascia 552 of the periurethral space. In some embodiments and with reference to FIG. 20, an anchor 560 (e.g., tab, sleeve, or similar feature) is provided with or placed over the lead 540 and arranged to abut the fascia 552 (or other tissue) at site of the incision 530. For example, the anchor 560 can be slidably advanced along the lead 540; once in contact with the fascia 552, the anchor 560 is then affixed to the lead 540 (e.g., crimp, collet, adhesive, etc.). Regardless, the anchor 560 is then secured to the fascia 552 by one or more attachment members 562 (e.g., suture, staple, etc.) to fix the lead body 540 relative to the fascia 552 and thus relative to the target site 550.

[0097] In other examples, and as shown in FIG. 21 , a mesh tab 570 can be fixed on the lead 540 and disposed within the incision 530. With these and related embodiments, the attachment member 562 can provide temporary fixation, and tissue ingrowth into the mesh tab 570 can provide long-term fixation. The mesh tab 570 can assume various forms and can alternatively be formatted or provided as bioresorbable mesh (providing mid-term fixation), bioresorbable temporary tines with long-term loop features, etc.

[0098] In yet other examples of the present disclosure, lead fixation can be facilitated by an anchor device provided apart from the lead. For example, a simplified, enlarged representation of a lead 580 implanted to, in one example, deliver stimulation therapy to a target site 590 along the EUS 34 is shown in FIG. 22. The lead 580 can generally have any of the configurations of the present disclosure, and has been routed near the perineal membrane 592. An anchor device 600 is provided apart from the lead 580 and includes a tubular base 602 carrying one or more tines 604 (or similar bodies). Once a desired position of the lead 580 relative to the target site 590 has been confirmed, the anchor device 600 is slid over the lead 580 (e.g., the lead 580 is slidably received within a lumen of the tubular base 602) and advance toward the perineal membrane 592. FIG. 23 illustrates a final arrangement in which the tines 604 are engaged with or into the perineal membrane 592. The tubular base602 can then be locked onto the lead 580 in various manners, such as via a collet, crimp, adhesive bond, etc.

[0099] Another anchor device 610 useful with the leads of the present disclosure is shown in final, deployed state in FIG. 24. The anchor device 610 is akin to the anchor device 600 (FIG. 23), and is configured to be slidably received over the lead 580. The anchor device 610 includes a tubular base 612 carrying one or more elastic tines 61 . The elastic tines 614 are configured to self-revert from a collapsed state to the expanded state of FIG. 24. With this construction, the anchor device 610 can be disposed within a sheath (not shown) upon initial assembly over the lead 580, with the delivery sheath holding the elastic tines 614 in a collapsed state. In the collapsed state, a footprint of the anchor device 610 is reduced, facilitating ready advancement along the lead 580. Once the anchor device 610 has been directed to a desired position, the sheath is retracted to deploy the tines 614. Once released from the confines of the sheath, the tines 614 self-revert to the expanded state and engage the perineal membrane 592. The anchor device 610 can then be locked to the lead 580 as described above.

[0100] In related embodiments, other anchor devices of the present disclosure are generally configured for slidable advancement over the lead 580 (e.g., as with the anchor devices 600, 610) and incorporate various features to effect deployment of an engagement surface into tissue (e.g., the perineal membrane 592) other than the self-deploying tines 614. For example, an anchor device akin to the anchor devices 600, 610 can include an expandable member generally configured to engage tissue. The expandable member is retained in a retracted state for advancement over the lead 580. Once a desired position of the anchor device relative to the lead 580 (and targeted tissue such as the perineal membrane 592) is attained, the expandable member is caused to assume an expanded state, for example via operation of a pullwire, pushing forward against a feature on the lead 580 (e.g., a shoulder), etc., and engage tissue. The anchor device can then be locked to the lead 580 as described above. While the slidable anchor devices (e.g., anchor devices 600, 610) have beendescribed as being useful for engaging the perineal membrane 592, a wide variety of other tissue or anatomy can be engaged with other procedures.

[0101] In some examples of the present disclosure, a percutaneous-type lead can be deployed and anchored to deliver stimulation energy to a nerve. For example, in the simplified representation of FIG. 25A, a percutaneous-type lead 620 has been deployed to deliver stimulation to a targeted nerve 630 (e.g., a deep perineal nerve or other nerve of the periurethral space). FIG. 25A further reflects that various anatomical structures 632 (e.g., muscles, nerves, etc.) can naturally exist in close proximity to the targeted nerve 630.

[0102] The lead 620 can be secured relative to the targeted nerve 630 in various fashions. In one embodiment, and with reference to FIG. 25B, a material strip 622 is employed. The material strip 622 can be formed of a biocompatible, electrically insulative material (e.g., silicone), and can be provided to a clinician apart from the lead 620. The material strip 622 is formatted to self-assume or self-revert toward the scroll or spiral shape shown. With the lead 620 in a desired location relative to the targeted nerve 630, a clinician can unwind the material strip 622 and place the material strip 622 around both the lead 620 and the targeted nerve 630 as shown in FIG. 25C, with the material strip 622 self-assuming the wrapped configuration. The so-deployed material strip 622 assists in maintaining stability of the lead 620 relative to the targeted nerve 630 and limits unwanted stimulation of adjacent tissues, such as the anatomical structure 632.

[0103] The material strip 622 can be, in an unwound state, straight of flat. Further, the material strip 622 can have serrated edges to prevent migration. One or more of the material strips 622 can be deployed between targeted tissue and adjacent tissue with which stimulation is not desired.

[0104] The percutaneous leads of the present disclosure can be delivered (and anchored) relative to a target site (e.g., periurethral space) in various fashions. With some examples of the present disclosure, one or more guides or other instruments are provided that facilitate a desired lead insertion location, insertion angle and / or clocking angle. For example, as shown in FIG. 26A, some methods of the presentdisclosure can include placement of an elongated tool 650 into the urethra 14 of the patient. The tool 650 can have various configurations, and can be used as part of the implantation procedure for a variety of purposes. For example, in some embodiments, the tool 650 can be a urethral catheter carrying one or more sensors (e.g., pressure sensor, EMG sensor, transducer, etc.) that is operable to assist in evaluating urinary-related anatomy (e.g., bladder pressure, EUS activity, etc.). The tool 650 can have other formats (e.g., catheter, probe, etc.) and / or serve other purposes. Regardless, a guide 660 is then inserted over the tool 650 as illustrated in FIG. 26B.

[0105] The guide 660 can assume various forms and, in some examples, is provided apart from the tool 650, and forms a central passage sized to slidably receive the tool 650. In other embodiments, the guide 660 can be integrally formed with, or permanently attached to, the tool 650. In more general terms, the guide 660 includes a guide body 670 sized and shaped for convenient handling by a clinician. At least one guide structure 672 is formed or carried by the guide body 670 at a known location relative to a center or other element / location of the guide body 670 (and thus at a known location relative to the tool 650 as maintained by the guide body 670). The guide structure 672 can assume various forms and is generally configured to slidably receive and guide an elongated body useful with percutaneous lead implantation procedure (e.g., an introducer, test needle, lead, etc.). In the nonlimiting example of FIG. 26B, the guide structure 672 is a lumen formed through a thickness of the guide body 670. In other examples, the guide structure 672 can be or include a slot, a rib, etc.

[0106] Because the tool 650 is effectively centered relative to the urethra 14, the guide 660, as placed over the tool 650, is also effectively centered relative to the urethra 14. With this arrangement, and as reflected by FIG. 26C, a device 680 can then be inserted along the guide structure 672 at a controlled location relative to the urethra 14. The device 680 can assume various forms useful as part of a lead implantation procedure. For example, the device 680 can be a needle, such as a test needle (as part of a stimulation testing assembly operable to apply stimulationenergy from an end of the test needle), a lead introducer needle, etc. In this regard, the guide 660 can include various features that assist a clinician in positioning of the guide structure 672, and thus the device 680 inserted there along, relative to the patient’s anatomy. For example, the guide body 670 can have markings on a face thereof intended to correspond with anatomical structure(s) that in turn assist the clinician in visualizing a desired spatial location of the guide structure 672. In some embodiments, the markings include a mark indicative of a 12:00 o’clock position that is otherwise intended to be visually aligned with the clitoris. A circumferential location of the guide structure 672 relative to this 12:00 o’clock mark can thus correspond with a preferred insertion position of the device 680 relative to the clitoris. Other markings / anatomical structure relationships can also be employed. Regardless, the guide 660 is useful for guiding the device 680 to a desired anatomical position both unilaterally and bilaterally.

[0107] In some embodiments, a center line of the guide structure 672 is parallel with an axis (e.g., a central axis) of the guide body 670. With this construction, an insertion angle of the device 680 will be parallel with the central axis of the tool 650 (and thus generally parallel relative to the urethra 14). Other angular relationships are also acceptable. For example, the guide structure 672 can be formed at a predetermined, non-parallel angle with respect to the central axis of the guide body 670 for certain procedures deemed appropriate by a clinician. For example, in some embodiments, the guide body 670 could be used to help facilitate placing the leads in a spiral or helical shape encircling the urethra 14.

[0108] In some embodiments, the device 680 can include depth markings along a length thereof. As the device 680 is being advanced (via the guide structure 672) into the patient, the clinician can visually monitor or measure a depth of insertion by comparing the depth markings relative to the guide body 670.

[0109] In some embodiments, the guide 660 can include one or more additional features that facilitate use with a test needle (i.e., where the device 680 is a stimulation test needle). For example, electronics can be carried by the guide body 670 that are adapted for connection to a sensor (e.g., pressure transducer, EMG)carried by the tool 650 (as otherwise inserted into the urethra 14), such as via a wired or wireless connection. When the test stimulation needle 680 has been advanced to a position that successfully delivers desired stimulation (e.g., sufficient to cause contraction of the EUS 34) as determined by information from the sensor, the electronics can be programmed to generate a visual and / or audio indication to the clinician.

[0110] Regardless of whether test stimulation (or other, related procedures) is performed, the guide 660 is useful for facilitating desired delivery of a lead, such as the lead 690 as shown in FIG. 26D. As a point of reference, with the arrangement of FIG. 26D, the device 680 is an introducer needle. Once the introducer needle 680 has been arranged relative to the patient’s anatomy, and in particular relative to a target site, via the guide 660, the lead 690 can be inserted through the introducer needle 680 and deployed relative to the target site (e.g., placed between the EUS 34 and bulbospongiosis (not shown) and other muscles such as the urethrovaginal muscle). Because the introducer needle 680 insertion angle, lateral location and / or clocking angle relative to the target site has been controlled by the guide 660, deployment of the lead 690 is also better controlled. In some embodiments, the guide 660 can include one or more additional features that facilitate desired arrangement of the lead 690 upon final implant. For example, electronics can be carried by the guide body 670 that are adapted for connection to a sensor (e.g., pressure transducer, EMG) carried by the tool 650 and / or the introducer needle 680 for measuring and displaying pressure and / or EMG at designated anatomy, such as the EUS, IUS, or along the urethra. Alternatively or in addition, an ultrasound transducer or similar device can be carried by the guide body 670 and operated to identify anatomical structure(s) that otherwise assist with placement of the lead 690, for example depth. In yet other embodiments, the guide 660 can include electronics appropriate for determining a location of the introducer needle 680 and / or the lead 690 relative to the guide body 670 and / or anatomical structures and provide the information to the clinician during placement of the lead 690. Location information can include one or more of depth, clocking angle, lateral distance from the urethra14, etc. The clinician can then use this position information, as well as other optional data (e.g., pressure and / or EMG response from test stimulation) to determine if the introducer needle 680 and / or the lead 690 needs to be moved (e.g., distance and / or direction).

[0111] To assist with identifying when the stimulation lead 690 or test needle 680 is approaching the target nerve, a pattern of stimulation can be delivered, for example lower frequency pulses can be delivered at a higher stimulation intensity and higher frequency pattern delivery at a lower intensity. In this way, as the active electrode approaches the target tissue, the measured response to stimulation (such as urethral pressure pulses or EMG) will increase in frequency. As an example, if a stimulation pulse train at a current of 10 mA is delivered at 3 Hz, 5 mA is delivered at 15 Hz and 1 mA is delivered at 30Hz from the same electrode, as the electrode first achieves nerve capture, the 3 Hz response will be measured by the test system. Furthermore, as the electrode is moved again closer to the target nerve, the test system will be able to observe (measure) the 15 Hz response, followed by the addition of the 30 Hz response when the electrode is close enough to the target nerve to achieve activation with 1 mA. It will be understood that the frequencies of this example are useful, but are in no way limiting. The pulse train need not be unique. For example, in a one second interval, thirty pulses could be delivered, three at the highest amplitude, twelve at the middle amplitude, and fifteen at the lowest amplitude as generally reflected by the example pulse train 692 of FIG. 27. A similar strategy could be employed using stimulation intensity as an indicator of electrode or test needle proximity to the target nerve. As the electrode or test needle is moved closer to the target nerve while delivering stimulation energy, the pressure or EMG signal will increase which could be indicated to the clinician in various manners, for example a progressively more rapidly flashing light, more intense light, more intense sound, changing sound pitch, digital readout, etc. In another example of an electrode placement assisting device, a standard pattern of stimulating electrodes can be inserted into the paraurethral tissue and also combined with surface stimulating electrodes, transurethral, transvaginal or transrectal stimulating electrodes. Theplacement assisting device can be programmed to deliver a pattern of stimulation between each electrode and every other electrode in sequence or between combinations of electrodes. In this way, a prediction can be made as to the most ideal location for a permanently placed electrode based on which combination of electrodes produced the greatest improvement in EUS pressure, EUS EMG, or other output signal indicating a benefit to the patient. In some examples, the optimal stimulation lead location can be displayed on a monitor relative to the test electrodes or other landmarks to assist the clinician with placement.

[0112] Other example percutaneous lead delivery methods of the present disclosure can include stabilizing periurethral tissue to assist in test needle and / or or lead introducer piercing through tissue during an implantation procedure, such as tissue of the periurethral space, for example the perineal membrane, fascia, etc. In some embodiments, periurethral tissue stabilization techniques of the present disclosure can include use of a urethral catheter-type device. One example of a urethral catheter device 700 is shown in simplified form in FIG. 28A upon initial advancement through the urethra 14 and into the bladder 10. The urethral catheter device 700 includes a catheter body 702 that terminates at a distal end 704. The catheter device 700 further includes one or more features operable to effect tissue stabilization. One feature can include a primary balloon (or inflatable region) 706 carried or formed by the catheter body 702 proximate the distal end 704 as shown in FIG. 28B. As a point of reference, FIG. 28B illustrates the balloon 706 an inflated or expanded state; prior to placement into the bladder 10, the balloon 706 is deflated. The balloon 706 is sized and shaped to have, in the inflated state, an outer dimension (e.g., diameter) that is greater than at least an expected size of the opening at the bladder neck. The balloon 706 can be inflated away from the bladder neck and then manipulated into the position of FIG. 28B (e.g., with proximal retraction of the catheter body 702), or can be positioned at the location shown and then inflated. Regardless, the inflated balloon 706 exerts a constant, radially outward force onto the bladder neck / proximal urethra, with this force serving to stabilize or render more rigid, the bladder neck and proximal urethra. With this anatomy stabilized, a test needle and / or lead introducer(not shown) can more readily be inserted through surrounding tissue (e.g., perineal membrane and fascia). In some embodiments, the urethral catheter device 700 can be akin to a Foley catheter, and can be configured to sense / transmit information indicative or pressure and / or EMG. With these and related embodiments, in addition to stabilizing tissue, the urethral catheter device 700 (alone or in combination with other components) can sense or determine information useful for viable lead placement relative to a target site, such as EUS pressure increases, EMG, etc.

[0113] The urethral catheter device 700 can optionally include one or more additional features useful for lead implantation procedures, for example in the periurethral space. As shown in FIG. 28C, a secondary balloon (or inflatable region) 710 can be carried or formed by the catheter body 702 proximal the primary balloon 706. More particularly, the secondary balloon 710 is located along a length of the catheter body 702 at a position expected to be within the urethra 14 when the primary balloon 706 is lodged against the bladder neck. When inflated, the secondary balloon 710 exerts a constant, outward force onto the urethra 14. The urethra 14 is caused to expand, thereby increasing friction and supporting the periurethral tissue to facilitate needle insertion through the skin and various fascia and membrane material.

[0114] The urethral catheter device 700 can optionally include electronics appropriate for determining a location of an introducer needle (not shown) and / or lead (not shown) relative to the urethral catheter device 700 and provide the information to the clinician during placement of the lead. Location information can include one or more of depth, clocking angle, lateral distance from the urethra 14, etc. The clinician can then use this position information, as well as other optional data (e.g., pressure and / or EMG response from test stimulation) to determine if the introducer needle and / or the lead needs to be moved (e.g., distance and / or direction).

[0115] Other example percutaneous lead delivery methods of the present disclosure, for example those in the periurethral space, can include use of an auxiliary device carrying one or more sensors that provide positioning information of a test needle,deployment tool, and / or lead relative to the EUS 34 and / or other muscle structures. Some examples include optional features of the guide 660 (FIG. 26B) and the urethral catheter device 700 as described above. In other embodiments, and with reference to FIG. 29, a sensor device 720 can be provided. The sensor device 720 includes a shaft 722 and at least one sensor 724. The shaft 722 can assume various forms conducive to delivery / placement at a desired anatomical site. With the nonlimiting example of FIG. 29, the shaft 722 is sized and shaped for insertion into the urethra 14. In some embodiments, the shaft 722 can be tubular (e.g., akin to a urethral catheter); in other examples, the shaft 722 can have a more solid construction. In yet other embodiments, the shaft 722 can be sized and shaped for placement at anatomical locations other than within the urethra 14.

[0116] The sensor(s) 724 is carried by the shaft 722 and can assume a variety of forms. In general terms, the sensor(s) 724 is formatted to detect, or facilitate the detection of, a designated portion of a lead. For example, lead 730 is shown in FIG. 28 and terminates at a tip 732. In some embodiments, the sensor(s) 724 is formatted to detect, or facilitate the detection of, the tip 732 of the lead 730. Examples of the sensor(s) 724 useful with the sensor device 720 include a proximity sensor, ultrasound positioning component(s), etc. With the example of FIG. 29, the sensor device 720 has been manipulated such that the sensor 724 is generally aligned with the EUS 34. The sensor 724 can “detect” the lead tip 732, and thus generates information indicative of a distance between the lead tip 732 and the sensor 724, and thus of a distance between the lead tip 732 and the EUS 34. Relationships between the lead tip 732 and other anatomical locations can alternatively be obtained. Regardless, the distance information between the sensor device 720 and the lead tip 732 (or other segment of the lead 730) can be reported to the clinician to assist with desired lead placement.

[0117] While several examples of the present disclosure relate to percutaneous-type (e.g., cylindrical) leads, other formats are also acceptable. For example, cuff devices can alternatively be employed (e.g., a cuff body carrying one or more stimulation elements or electrodes). One example of a cuff-type arrangement in accordance withprinciples of the present disclosure is shown as part of a lead 800 of FIG. 30. The lead 800 includes a lead body 810 carrying various wiring and terminating at a cuff device 812. The cuff device 812 includes a cuff body 820 carrying various electrodes as described below. The cuff body 820 can assume various forms appropriate for placement about or around a nerve (e.g., a flexible, biocompatible body configured to self-revert to the wound or circumferential state shown). In a final wrapped arrangement, the cuff body 820 defines an internal side or face 822 opposite an external side or face 824 (i.e., the internal side 822 is directly proximate or closest to the target nerve about which the cuff body 820 has been deployed; the external side 824 is opposite or faces away from the target nerve).

[0118] As a point of reference, with the non-limiting example of FIG. 30, the cuff body 820 has been deployed about a branch 830 of a perineal nerve 832 (e.g., deep perineal nerve). The cuff device 812 is equally useful with other nerves (or nerve branches) of the periurethral space. The periurethral space, and the perineal space in general, is quite complex, with multiple muscles and / or nerves likely in close proximity to a targeted stimulation site, and one or more of these muscles and / or implicating different functions in promoting or inhibiting micturition. For example, in the arrangement of FIG. 30 in which the cuff device 812 is deployed about the deep perineal nerve 832, an urethrovaginal muscle 834 (as well as the EUS 34) is in close proximity to the cuff device 812. With these and similar anatomical constraints in mind, in some examples, the cuff device 812 includes one or more internal electrodes 826 exposed at the internal side 822 of the cuff body 820, and one or more external electrodes 828 exposed at the external side 824. With this configuration, the internal electrode(s) 826 is arranged to deliver stimulation energy to the targeted nerve (e.g., the deep perineal nerve 830 with the non-limiting example of FIG. 30) and / or sense activity along the targeted nerve. The external electrode(s) 828 is arranged to sense activity at anatomical structures apart from, but in close proximity to, the targeted nerve (e.g., the urethrovaginal muscle 834 with the non-limiting example of FIG. 30). The external electrode(s) 828 can be operated to sense adjacent muscle EMG, ENG of adjacent nerves, etc. By integrating the internal and external electrodes 826, 828,the cuff device 812 can be useful in sensing and / or stimulating targeted tissue, such as the deep perineal nerve, as well as avoiding other nerves and muscles that promote micturition and potential leakage events. In other embodiments, the internal and external electrodes 826, 828 can be utilized to measure local EMG activity that might be used to trigger stimulation to produce an EUS contraction and / or might be used to inhibit micturition-promoting physiology.

[0119] The cuff device 812, as well as other cuff-type arrangements that may or may not include the external electrodes 828 but that are otherwise configured to encircle a section of tissue containing fine terminal nerve fibers can be delivered to the target site in various manners. In some examples, after identifying a section or volume of tissue containing fibers leading to the EUS 34 in the periurethral or periurethral tissue (e.g., using a stimulation needle), surgical incisions can be made at a safe distance lateral to the EUS 34 and above / below the target site. A surgical tool can then be utilized to provide communication between the two incisions to allow passing of the cuff body and / or a tow strap of a cuff. Regardless of how delivered, the cuff devices of the present disclosure can have multiple electrodes that can be individually activated (thus affording the clinician the ability to select one or more of the electrodes for delivering stimulation therapy).

[0120] In other embodiments, the cuff devices of the present disclosure can have a miniaturized configuration, conducive, for example, for deployment about a nerve that directly innervates the EUS 34. As generally reflected by FIG. 30, fibers and nerves innervating the EUS 34 are relatively small. A miniaturized cuff device that is flexible and self-sizing can be deployed to one of these small nerves. The miniaturized cuff devices of the present disclosure can carry one (or more) small electrodes that are operable in a bipolar or monopolar mode. With monopolar applications, a return electrode could be provided with the IPG 64 (FIG. 3) and / or elsewhere in the patient. In some embodiments, the miniaturized cuff devices of the present disclosure can include a coiled conductor within the corresponding cuff body. The coiled conductor can, in some embodiments, be a small pitch coil via a single, bifilar, or multifilar coil design. With these and related embodiments, the coiledconductor format can exhibit high flexibility and long fatigue life. In related embodiments, the conductor(s) maintained within the cuff body can be highly stranded cables formed into a coil for enhanced flexibility and durability. With other lead designs of the present disclosure that include a miniaturized cuff device, the lead body attached to the cuff body can have a sigmoid or other redundant shape to provide a high degree of mobility and minimize mechanical loading on the targeted nerve.

[0121] In yet other embodiments, the cuff devices of the present disclosure can have a wireless configuration (e.g., a “smart” cuff device). For example, the lead body 810 can be omitted. With these and related embodiments, the wireless cuff devices of the present disclosure can include or carry electrical components appropriate for wireless charging and / or communication. As a point of reference, stimulation therapy target sites of the periurethral space are well-suited for “smart” wireless cuff devices due, at least in part, to the high degree of tissue mobility. For example, a miniaturized, wireless, flexible cuff device can be deployed in the perineal space on branch(es) of nerves going to the EUS 34 or on the deep perineal branch 830 using laparoscopic or open surgical techniques. The so-delivered cuff device can include miniaturized electronics and can be formatted to sense one or more parameters, such as local EMG, ENG, accelerometer, etc.; information from the sensor(s) can be utilized to trigger stimulation delivery by the wireless cuff device and / or could be wirelessly communicated to a separate device (e.g., sensing unit).

[0122] In yet other embodiments, the cuff devices of the present disclosure can be utilized with other continence-related treatments, for example in combination with a urethral sling. For example, a urethral sling can conventionally be placed or implanted underneath the urethra 14. During the sling placement procedure, the perineal nerve or branches to the EUS are typically easily accessible. Thus, delivery / implantation of a cuff device to a targeted nerve of the periurethral space (e.g., perineal nerve or branch(es) to the EUS 34) can readily be accomplished. In this regard, the cuff device can be integrated into the sling in some embodiments.For patients with whom minimal sling support is indicated, EUS neuromodulation (or other stimulation therapy) can provided substantive added benefit.

[0123] In some embodiments, the cuff devices of the present disclosure can be configured for deployment about anatomy other than a nerve. For example, FIG. 31 illustrates, in simplified form, another lead 900 in accordance with principles of the present disclosure. The lead 900 includes a lead body 902 terminating at a cuff device 904. The cuff device 904 includes a cuff body 910 maintaining one or more electrodes 912. The cuff body 910 is sized and shaped for deployment about the EUS 34. Delivery and deployment of the cuff device 904 can be achieved in various manner. In some examples, surgical access can be achieved by two separate incisions and tunneling between the incisions to place the cuff body 910 around the EUS 34. In this regard, the surgical techniques of the present disclosure can entail carefully placing the cuff body 910 superficial to the small branches of the nerves (not shown) innervating the EUS 34 so as to prevent damage to the nerve(s).

[0124] Some treatment systems and methods of the present disclosure entail delivering stimulation energy to two (or more) target sites within the periurethral space, with stimulation at the first target site effecting efferent-type or functional stimulation to cause a desired action to occur, and stimulation at the second target side effecting afferent-type stimulation for blocking pain. For example, and with reference to FIG. 32, at least one first stimulation element or electrode can be located in the perineum, with energy delivered to the first stimulation element(s) formatted to effect functional activation of targeted anatomy (e.g., location “A” in FIG. 32 generally corresponding with the deep perineal nerve). At least one second stimulation element or electrode can be located along the common pudendal nerve (generally indicated as location “B” in FIG. 32), with energy delivered to the second stimulation element(s) formatted to effect blocking of afferent neurons in the small sensory fibers. The first stimulation element(s) can be carried by a first lead (e.g., percutaneous-type lead, cuff-type lead, etc.), and the second stimulation element(s) can be carried by a separate, second lead (e.g., percutaneous-type lead, cuff-typelead, etc.). Alternatively, the first and second stimulation elements can be carried by a single lead.

[0125] In other embodiments, at least one first stimulation element or electrode can be located on or at the EUS (generally indicated as location “C” in FIG. 32), with energy delivered to the first stimulation element(s) formatted to effect direct EUS muscle stimulation. At least one second stimulation element or electrode can be located proximal the first stimulation element (generally indicated as location “D” in FIG. 32), with energy delivered to the second stimulation element(s) formatted to effect an afferent nerve block. The first stimulation element(s) can be carried by a first lead (e.g., percutaneous-type lead, cuff-type lead, etc.), and the second stimulation element(s) can be carried by a separate, second lead (e.g., percutaneous-type lead, cuff-type lead, etc.). Alternatively, the first and second stimulation elements can be carried by a single lead.

[0126] In other embodiments, at least one first stimulation element or electrode can be located along efferent branching fibers going to the EUS (generally indicated as location “E” in FIG. 32), with energy delivered to the first stimulation element(s) formatted to effect activation of the EUS. At least one second stimulation element or electrode can be located along small sensory fibers of the dorsal genital nerve in the perineum (generally indicated as location “F” in FIG. 32), with energy delivered to the second stimulation element(s) formatted to effect an afferent nerve block. The first stimulation element(s) can be carried by a first lead (e.g., percutaneous-type lead, cuff-type lead, etc.), and the second stimulation element(s) can be carried by a separate, second lead (e.g., percutaneous-type lead, cuff-type lead, etc.). Alternatively, the first and second stimulation elements can be carried by a single lead.

[0127] Regardless of how the stimulation elements are delivered to and maintained at the two target sites, various programs or algorithms or models can be employed for delivering stimulation energy. For example, stimulation energy can be delivered to the two target sites together or simultaneously, coincidently triggered by a sensed parameter, event, or signal (e.g., via the sensor(s) 62 (FIG. 3)) indicative of an eventor circumstance of interest. In other embodiments, the simulation applied to the two target sites can be toggled (e.g., simultaneous, alternating, overlapping, unilateral, bilateral, selective), optionally while additionally toggling / adjusting one or more stimulation parameters (e.g., amplitude, frequency, pulse width, duty cycle, pulse shape, etc.).

[0128] Although specific examples have been illustrated and described herein, a variety of alternate and / or equivalent implementations may be substituted for the specific examples shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific examples discussed herein.

Claims

CLAIMS1 . A system for treating a bladder and / or bowel dysfunction of a patient, the system comprising: a lead configured for placement into a periurethral space of the patient, the lead carrying at least one stimulation element; and a pulse generator programmed to apply stimulation energy to a target site in the periurethral space via the stimulation element.

2. The system of claim 1 , wherein the target site is an external urethral sphincter of the patient.

3. The system of claim 1 , wherein the target site is one of a nerve and muscle tissue.

4. The system of claim 3, wherein the target site is selected from the group consisting of a perineal nerve, a deep perineal nerve, a pudendal nerve, a branch of a pudendal nerve, a dorsal genital nerve, a pelvic nerve, a branch of a pelvic nerve, a hypogastric nerve, and a branch of a hypogastric nerve.

5. The system of claim 1 , wherein the lead is a percutaneous lead.

6. The system of claim 1 , wherein the percutaneous lead is configured for placement in close proximity to an external urethral sphincter of the patient.

7. The system of claim 6, wherein the percutaneous lead is configured for placement around at least a segment of the external urethral sphincter.

8. The system of claim 7, further comprising a needle configured for insertion helically around the external urethral sphincter.

9. The system of claim 8, wherein the needle is a curved needle.

10. The system of claim 9, wherein the percutaneous lead is configured for deployment through the curved needle.11 . The system of claim 5, wherein: the percutaneous lead is configured to be arranged at a target location; the system further comprising an anchor configured to be slidably received over the percutaneous lead and to secure the lead relative to the target location.

12. The system of claim 5, wherein: the lead is configured to be tunneled through an incision in the periurethral space to an implantable pulse generator; and the system further comprising an anchor device configured to secure the lead to the tissue at the incision.

13. The system of claim 5, wherein the percutaneous lead is one lead of an array of percutaneous leads configured to be implanted into the periurethral space.

14. The system of claim 5, wherein the percutaneous lead includes a highly flexible lead body.

15. The system of claim 14, wherein the highly flexible lead body is a coil.

16. The system of claim 15, wherein the coil is one of a monofilar coil, a bifilar coil, and a multifilar coil.

17. The system of claim 16, wherein one or more of the filars are non-conductive spacers.

18. The system of claim 5, further comprising: an elongated tool configured for insertion into a urethra of the patient; a guide configured for placement over the elongated tool; and a device configured for advancement along a guide structure of the guide and into the patient.

19. The system of claim 18, wherein the elongated tool is selected from the group consisting of a catheter and a probe.

20. The system of claim 18, wherein the guide structure is selected from the group consisting of a lumen, a slot and a rib.21 . The system of claim 18, wherein the guide is configured to control a clocking angle of the device about a center axis of the elongated tool by referencing an anatomical feature of the patient.

22. The system of claim 18, wherein the guide includes a marking formed at a predetermined location relative to the elongated tool and the guide structure for spatially aligning with an anatomical feature of the patient.

23. The system of claim 22, wherein the anatomical feature is a clitoris of the patient.

24. The system of claim 22, wherein the guide structure is configured to be spatially aligned with a predetermined insertion location of an anatomy of the patient relative to the target site.

24. The system of claim 18, wherein a centerline of the guide structure is configured to be parallel with an axis of the tool upon placement of the guide over the tool.

25. The system of claim 18, wherein the guide is configured such that upon placement of the guide over the elongated tool, a centerline of the guide structure is at a predetermined, non-parallel angle with respect to an axis of the tool.

26. The system of claim 18, wherein the device is selected from the group consisting of an introducer, a needle, a test needle, and the percutaneous lead.

27. The system of claim 18, wherein the device is an introducer configured to receive the percutaneous lead.

28. The system of claim 18, wherein the device includes at least one electrode, and wherein the system is configured to assist in evaluating a location of the at least one electrode relative to at least one of the target site and the urethra.

29. The system of claim 28, wherein the system is configured to generate feedback information selected from the group consisting of sensed urethral pressure of the patient, ultrasound imaging of the patient, sensed bioimpedance of the patient, sensed urethral sphincter electromyography (EMG) of the patient, and sensed pelvic floor muscle EMG of the patient.

30. The system of claim 29, wherein the feedback information is based upon a sensor signal generated by a sensor carried by the elongated tool.31 . The system of claim 29, wherein the feedback information is based upon a sensor signal generated by a sensor carried by a guide body of the guide.

32. The system of claim 29, wherein the feedback information is provided to a robotic surgical system.

33. The system of claim 29, wherein the feedback information is provided in a format selected from the group consisting of haptic feedback, audio, and visual.

34. The system of claim 28, wherein the system is programmed to deliver a test stimulation pattern from the at least one electrode.

35. The system of claim 34, wherein the test stimulation pattern includes low frequency pulses at a first stimulation intensity and high frequency pulses at a second stimulation intensity less than the first stimulation intensity.

36. The system of claim 34, wherein the delivered test stimulation pattern is configured to cause a reviewable response by the patient.

37. The system of claim 36, wherein the response is based upon a sensed pressure or electromyography of the patient.

38. The system of claim 36, wherein the response is conveyed to a clinician by at least one of a flashing light, sound, and a digital readout.

39. The system of claim 5, further comprising: a catheter configured to be advanced into a bladder of the patient; an inflatable balloon carried by the catheter and configured to contact a neck of the bladder to stabilize the neck and promote piercing tissue of the periurethral space with the neck of the bladder stabilized.

40. The system of claim 5, further comprising:an anchor device including a portion configured to be deployed into one of a membrane and fascia of the periurethral space, the anchor device further configured for securement to the lead.41 . The system of claim 40, wherein: the anchor device is configured to be slidably received over the lead.

42. The system of claim 40, wherein the portion of the anchor device is configured for deployment into a perineal membrane of the patient.

43. The system of claim 5, further comprising: a flexible attachment device configured to be secured to an anatomical structure of the patient selected from the group consisting of a membrane and muscle fascia, and further configured to be locked to the lead.

44. The system of claim 43, wherein the flexible attachment device includes a tether and an anchor.

45. The system of claim 44, further comprising: a needle configured for directing a tip of the needle to a first side of the anatomical structure, piercing the tip through a thickness of the anatomical structure to a second side of the anatomical structure;, and receiving the an wherein the anchor is configured to be advanced through the needle, deployed from the needle tip at a location beyond the second side of the anatomical structure, and arranged to abut the second side.

46. The system of claim 45, wherein the tether is configured to receive an applied a tensioning force.

47. The system of claim 44, wherein the lead is configured to be slidably received over the tether.

48. The system of claim 5, wherein the lead includes a lead body carrying the at least one stimulation element electrode and a capture element, wherein the capture element is slidably retained by the lead body and is configured to be articulated relative to the lead body to capture tissue of the patient.

49. The system of claim 48, wherein the capture element is a wire.

50. The system of claim 48, wherein: the capture element is further configured to be articulated relative to the lead body to release the captured tissue.51 . The system of claim 1 , wherein the lead includes a lead body and cuff device.

52. The system of claim 51 , wherein the cuff device includes a cuff body carrying the stimulation element, and wherein the cuff body is configured to be deployable around an external urethral sphincter of the patient.

53. The system of claim 51 , wherein the cuff device includes a cuff body carrying at least one internal electrode and at least one external electrode.

54. The system of claim 51 , wherein the cuff device includes a cuff body carrying the stimulation element, and further wherein the cuff body is configured to be deployable about a section of tissue containing fine terminal nerve fibers leading to the external urethral sphincter.

55. A method of treating a bladder and / or bowel dysfunction of a patient, the method comprising: implanting a lead into a periurethral space of the patient, the lead carrying at least one stimulation element; and applying stimulation energy to a target site in the periurethral space via the stimulation element.

56. The method of claim 55, wherein the target site is an external urethral sphincter.

57. The method of claim 55, wherein the target site is one of a nerve and muscle tissue.

58. The method of claim 57, wherein the target site is selected from the group consisting of a perineal nerve, a deep perineal nerve, a pudendal nerve, a branch of a pudendal nerve, a dorsal genital nerve, a pelvic nerve, a branch of a pelvic nerve, a hypogastric nerve, and a branch of a hypogastric nerve.

59. The method of claim 55, wherein the lead is a percutaneous lead.

60. The method of claim 55, wherein the step of implanting includes delivering the percutaneous lead in close proximity to an external urethral sphincter of the patient.61 . The method of claim 60, wherein the step of implanting includes delivering the percutaneous lead around at least a segment of the external urethral sphincter.

62. The method of claim 61 , wherein the step of implanting includes inserting a needle helically around the external urethral sphincter.

63. The method of claim 62, wherein the needle is a curved needle.

64. The method of claim 63, wherein the step of implanting further includes deploying the percutaneous lead through the curved needle.

65. The method of claim 59, wherein the step of implanting includes: arranging the percutaneous lead at a target location; sliding an anchor over the percutaneous lead; and arranging the anchor to secure the lead relative to the target location.

66. The method of claim 59, further comprising: forming an incision through tissue of the periurethral space; tunneling the lead through the incision to an implantable pulse generator; and deploying an anchor device to secure the lead to the tissue at the incision.

67. The method of claim 59, wherein the percutaneous lead is one lead of an array of percutaneous leads implanted into the periurethral space.

68. The method of claim 59, wherein the percutaneous lead includes a highly flexible lead body.

69. The method of claim 68, wherein the highly flexible lead body is a coil.

70. The method of claim 69, wherein the coil is one of a monofilar coil, a bifilar coil, and a multifilar coil.71 . The method of claim 70, wherein one or more of the filars are non-conductive spacers.

72. The method of claim 59, wherein the step of implanting further comprises: inserting an elongated tool into a urethra of the patient;placing a guide over the elongated tool; and advancing a device along a guide structure of the guide and into the patient.

73. The method of claim 72, wherein the elongated tool is selected from the group consisting of a catheter and a probe.

74. The method of claim 72, wherein the guide structure is selected from the group consisting of a lumen, a slot and a rib.

75. The method of claim 72, wherein the guide is configured to control a clocking angle of the device about a center axis of the elongated tool by referencing an anatomical feature of the patient.

76. The method of claim 72, wherein the guide includes a marking formed at a predetermined location relative to the elongated tool and the guide structure, and wherein the method further includes: prior to the step of advancing a device along the guide structure, spatially aligning the marking with an anatomical feature of the patient.

77. The method of claim 76, wherein the anatomical feature is a clitoris of the patient.

78. The method of claim 76, wherein following the step of spatially aligning, the guide structure is spatially aligned with a predetermined insertion location of an anatomy of the patient relative to the target site.

79. The method of claim 72, wherein following the step of placing the guide over the elongated tool, a centerline of the guide structure is parallel with an axis of the tool.

80. The method of claim 72, wherein following the step of placing the guide over the elongated tool, a centerline of the guide structure is at a predetermined, nonparallel angle with respect to an axis of the tool.

81. The method of claim 72, wherein the device is selected from the group consisting of an introducer, a needle, a test needle, and the percutaneous lead.

82. The method of claim 72, wherein the device is an introducer, the method further comprising: following the step of advancing a device along a guide structure of the guide and into the patient, advancing the percutaneous lead through the introducer.

83. The method of claim 72, wherein the device includes at least one electrode, the method further comprising: evaluating a location of the at least one electrode relative to at least one of the target site and the urethra.

84. The method of claim 83, wherein the step of evaluating include reviewing feedback information selected from the group consisting of sensed urethral pressure of the patient, ultrasound imaging of the patient, sensed bioimpedance of the patient, sensed urethral sphincter electromyography (EMG) of the patient, and sensed pelvic floor muscle EMG of the patient.

85. The method of claim 84, wherein the feedback information is based upon a sensor signal generated by a sensor carried by the elongated tool.

86. The method of claim 84, wherein the feedback information is based upon a sensor signal generated by a sensor carried by a guide body of the guide.

87. The method of claim 84, wherein the feedback information is provided to a robotic surgical system.

88. The method of claim 84, wherein the feedback information is provided in a format selected from the group consisting of haptic feedback, audio, and visual.

89. The method of claim 83, wherein the step of evaluating includes delivering a test stimulation pattern from the at least one electrode.

90. The method of claim 89, wherein the test stimulation pattern includes low frequency pulses at a first stimulation intensity and high frequency pulses at a second stimulation intensity less than the first stimulation intensity.

91. The method of claim 89, wherein the step of evaluating further includes reviewing a response of the patient to the delivered test stimulation pattern.

92. The method of claim 91 , wherein the response is based upon a sensed pressure or electromyography of the patient.

93. The method of claim 91 , wherein the response is conveyed to a clinician by at least one of a flashing light, sound, and a digital readout.

94. The method of claim 59, wherein the step of implanting further comprises: advancing a catheter into a bladder of the patient; inflating a balloon carried by the catheter; wherein the inflated balloon contacts a neck of the bladder to stabilize the neck; and piercing tissue of the periurethral space with the neck of the bladder stabilized.

95. The method of claim 59, wherein the step of implanting further comprises:deploying a portion of an anchor device into one of a membrane and fascia of the periurethral space; and securing the anchor device to the lead.

96. The method of claim 95, further comprising: prior to the step of securing the anchor device to the lead, sliding the anchor device over the lead.

97. The method of claim 95, wherein the portion of the anchor device is deployed into a perineal membrane of the patient.

98. The method of claim 59, wherein the step of implanting includes: securing a flexible attachment device to an anatomical structure of the patient selected from the group consisting of a membrane and muscle fascia; and locking the lead to the flexible attachment device.

99. The method of claim 98, wherein the flexible attachment device includes a tether and an anchor.

100. The method of claim 99, wherein the step of securing includes: directing a tip of a needle to a first side of the anatomical structure; piercing the tip through a thickness of the anatomical structure to a second side of the anatomical structure; advancing the anchor through the needle; deploying the anchor from the needle tip at a location beyond the second side of the anatomical structure; and arranging the anchor to abut the second side.

101. The method of claim 100, wherein the step of arranging includes applying a tensioning force onto the tether.

102. The method of claim 99, wherein following the step of securing and prior to the step of locking, the method further comprising sliding the lead over the tether.

103. The method of claim 59, wherein the lead includes a lead body carrying the at least one stimulation element electrode and a capture element, wherein the capture element is slidably retained by the lead body, and wherein step of implanting includes: advancing the lead to position the at least one stimulation element proximate the target site; and articulating the capture element relative to the lead body such that the capture element captures tissue of the patient.

104. The method of claim 103, wherein the capture element is a wire.

105. The method of claim 103, further comprising: following the step of capturing tissue of the patient, articulating the capture element relative to the lead body to release the captured tissue; and removing the lead from the patient.

106. The method of claim 55, wherein the lead includes a lead body and cuff device.

107. The method of claim 106, wherein the cuff device includes a cuff body carrying the stimulation element, and further wherein the step of implanting includes deploying the cuff body around an external urethral sphincter of the patient.

108. The method of claim 106, wherein the cuff device includes a cuff body carrying at least one internal electrode and at least one external electrode.

109. The method of claim 106, wherein the cuff device includes a cuff body carrying the stimulation element, and further wherein the step of implanting includes deploying the cuff body about a section of tissue containing fine terminal nerve fibers leading to the external urethral sphincter.

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