External urethral sphincter stimulation leads for treating bladder dysfunction

Abstract

Systems and methods for treating bladder dysfunction of a patient includes implanting a lead carrying one or more stimulation elements to apply stimulation energy to an external urethral sphincter (EUS) of the patient, for example on a chronic basis. In some examples, the lead includes a lead body forming a saddle region that is placed at a urethra of the patient in locating the stimulation elements proximate the EUS. In some examples, the leads of the present disclosure can be delivered using techniques akin to urethral sling procedures.

Description

1618.332 1111EXTERNAL URETHRAL SPHINCTER STIMULATION LEADS, SYSTEMS AND METHODS FOR TREATING BLADDER DYSFUNCTIONBackground

[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 the 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 a diagram of portion of the human female anatomy, including the bladder, urethra, and external urethral sphincter (EUS), and identifying possible target locations at or along the EUS.

[0006] FIG. 4B is stylized perspective view of portion of the human female anatomy, including portions of a hip bone shown in phantom, and identifying possible target locations at or along the EUS.

[0007] FIG. 4C schematically illustrates an end view of portion of the human female anatomy, including the urethra, EUS, and vagina, and identifying possible target locations at or along the EUS.

[0008] FIG. 5A is a simplified side view of a lead applied to the anatomy of FIG.4C in accordance with principles of the present disclosure.

[0009] FIG. 5B is a simplified side view of a lead applied to the anatomy of FIG.4G in accordance with principles of the present disclosure.

[0010] FIG. 6 is an enlarged side view of portions of a lead in accordance with principles of the present disclosure.[Oil] FIG. 7 is a simplified perspective view of the lead of FIG. 6 applied to anatomy of a female patient in accordance with principles of the present disclosure.

[0012] FIG. 8 is an enlarged side view of portions of a lead in accordance with principles of the present disclosure.1618.332 1112

[0013] FIG. 9 is a simplified perspective view of the lead of FIG. 8 applied to anatomy of a female patient in accordance with principles of the present disclosure.

[0014] FIG. 10 is a simplified perspective view of portions of a lead assembly in accordance with principles of the present disclosure applied to anatomy of a female patient.

[0015] FIG. 11 is an enlarged top view of portions of a lead in accordance with principles of the present disclosure.

[0016] FIG. 12 is a simplified perspective view of the lead of FIG. 11 applied to anatomy of a female patient in accordance with principles of the present disclosure.

[0017] FIG. 13A is an enlarged perspective view of portions of a lead in accordance with principles of the present disclosure.

[0018] FIG. 13B is a top view of the lead of FIG. 13A.

[0019] FIG. 13C is an enlarged top view of portions of a lead in accordance with principles of the present disclosure.

[0020] FIG. 13D is an enlarged top view of portions of a lead in accordance with principles of the present disclosure.

[0021] FIG. 14 is a simplified perspective view of the lead of FIG. 13A applied to anatomy of a female patient in accordance with principles of the present disclosure.

[0022] FIG. 15 is a simplified perspective view of portions of a treatment system in accordance with principles of the present disclosure applied to anatomy of a female patient.

[0023] FIG. 16 is a simplified perspective view of portions of a treatment system in accordance with principles of the present disclosure applied to anatomy of a female patient.

[0024] FIG. 17 A and 17B illustrate lead delivery methods and tools in accordance with principles of the present disclosure.

[0025] FIG. 18 illustrates a sling placed to support a urethra of a patient 14 on a retropubic basis.1618.332 1113

[0026] FIG. 19 is a simplified perspective view of portions of a treatment system in accordance with principles of the present disclosure applied to anatomy of a female patient.

[0027] FIG. 20 is a simplified perspective view of portions of a treatment system in accordance with principles of the present disclosure, including a lead and anchor units, applied to anatomy of a female patient.

[0028] FIG. 21 is a simplified side view of the anchor unit of FIG. 20 interfacing with obturator facia of the patient.

[0029] FIG. 22 is a simplified end view of portions of a treatment system in accordance with principles of the present disclosure applied to anatomy of a female patient.

[0030] FIG. 23 is perspective view of portions of a probe unit in accordance with principles of the present disclosure relative to anatomy of a female patient.Detailed Description

[0031] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which are 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.

[0032] 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, methods of implanting devices and / or method of operating an implanted device 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 nervestimulation signal to one or more nerves or nerve branches to activate a corresponding external sphincter, such as a branch of the pudendal nerve that activates the external urethral sphincter and / or the external anal sphincter. In1618.332 1114some embodiments, operation of the implantable device is controlled in response to sensed information of the patient.

[0033] 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.

[0034] 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 internal orifice of the urethra 14. The IUS 32 is located at 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 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 the micturition reflex. 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.

[0035] 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 is generally reflected in FIG. 2 by reference to a pelvic1618.332 1115nerve 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.

[0036] 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 complete emptying of the bladder. 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) is 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 as in the normal, non-disordered case. 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 to describe a combination of both overactive bladder and stress incontinence.

[0037] Internal and external sphincters are similarly utilized to control the flow of fecal matterand gas through the anus 16 (i.e., the internal anal sphincter and the external anal sphincter), acting to keep the anal canal and orifice closed. Action1618.332 1116of the internal anal sphincter (IAS) is entirely involuntary, and it is 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 sphincters. 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 innervation 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.

[0038] 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.

[0039] 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 of1618.332 1117urinary 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. WO 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.

[0040] 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, electrical voltage 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 power and / or 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 external device 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 may1618.332 1118receive sensing signals from external sensor, receive sensing signals from one or more implanted portions 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 provide 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.

[0041] 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 / control1618.332 1119elements (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.

[0042] 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 be referred to as, a care engine, sensing engine, monitoring engine, and / or treatment engine.

[0043] 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 related1618.332 11110elements, devices, user interfaces, instructions, information, engines, functions, actions, and / or method, etc. as described throughout examples of the present disclosure.

[0044] 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 processor-executable 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 with machine 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.

[0045] In some examples, the control portion 70 may be entirely implemented within or by a stand-alone device.

[0046] In some examples, the control portion 70 may be partially implemented in the IPG 64 and partially implemented in a computing resource separate from, and1618.332 11111independent 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.

[0047] 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).

[0048] The systems and methods of the present disclosure are in no way limited to 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 between FIGS. 1-3, the system 50 can be configured and implanted to provide stimulation therapy to at least the external urethral sphincter 34 and optionally 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 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 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 and1618.332 11112implanted to deliver stimulation to two (or more) target sites (e.g., two or more of the external urethral sphincter 34, the pudendal nerve 44, the pelvic nerve 40, 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. WO 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.

[0049] 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 of ring electrodes, segmented electrodes, partial ring electrodes, electrode arrays, paddle leads, etc. In some examples, the stimulation element(s) may be, include, or be provided as 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. WO 2020 / 243104 (Rondoni, et al.) and PCT Publication No.1618.332 11113WO 2022 / 192726 (Rondoni, et al.) the entire teachings of each of which are incorporated herein by reference.

[0050] 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. Some aspects of the present disclosure provide for devices, 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(s) 66 (provided, for example, as part of a lead, a cuff electrode, a microstimulator, etc.) at an intended target site, such as near or on or in the external urethral sphincter (EUS) 34. As a point of reference and as mentioned above, the EUS 34 is a muscular organ located approximately in the middle of the urethra and can be a key structure in maintaining bladder continence. At the EUS target locations of some embodiments of the present disclosure, a plethora of stimulation delivery protocols can be implemented. Unless stated otherwise, the systems and methods are not limited to a particular stimulation therapy regimen and / or algorithms. In more general terms, studies have shown that electrical stimulation of the EUS 34 can be a successful therapy for improving the function of the EUS 34 and a reduction in stress incontinence episodes. In some non-limiting examples, a mechanism of the therapies provided by some systems and methods of the present disclosure can entail low level chronic electrical stimulation protocols that serve to improve the tone and strength of the EUS 34 and the associated pelvic floor musculature and / or promote neuroplastic regeneration of damaged nerves. Alternatively or in addition, a boost of electrical stimulation applied as a closed loop response to an abdominal pressure rise (or other surrogate indicator of a urine leak-inducing event) can be used to cause a maximal contraction of the EUS 34 to prevent bladder leaks.

[0051] By way of further background, various aspects of the female anatomy of the periurethral space are shown in FIG. 4A, including the urethra 14, the EUS 34 and vagina 80. FIG. 4B is a stylized representation of portions of the same anatomy, and further reflects a hip bone or pelvis 90 that forms two obturator foramen or windows 92 (the obturator membrane and other anatomy is not shown for ease of understanding). As a point of reference, only a portion the EUS 34 structure is shown in the stylized representation of FIG. 4B. It will be understood1618.332 11114that the native EUS 34 is annular, concentrically surrounding the urethra 34; a thickness of the EUS 34 can vary about a circumference of the urethra 34, and is typically thicker in a lateral direction as generally reflected by FIG. 4B. FIG. 4C is a highly simplified end view of the urethra 14 as surrounded by the EUS 34, along with the vagina 80. With some systems and methods of the present disclosure, it can be beneficial to locate one or more stimulation elements in, on or along the EUS 34. The anatomical constraints of, and proximate to, an EUS target site (e.g., generally designated at “T1” and at “T2” in FIGS. 4A-4C) can make delivery and chronic retention of a stimulation element-carrying lead challenging.

[0052] In some embodiments, systems and methods of the present disclosure entail placement of a neuromodulation lead in or near the EUS 34, with the lead extending generally transversely or laterally relative to the urethra 14. As a point of reference, FIG. 5A illustrates, in simplified form, one example of a lead 100 having been placed between the urethra 14 and the vagina 80 at a level of the EUS 34 (e.g., EUS target site T1) and extending generally transversely relative to the urethra 14. FIG. 5B illustrates, in simplified form, one example of a lead 110 having been placed “above” the urethra 14 (or opposite the vagina 80) at a level of the EUS 34 (e.g., EUS target site T2) and extending generally transversely relative to the urethra 14. With this in mind, some aspects of the present disclosure relate to lead configurations conducive to one or more of capturing the EUS 34 via unique positioning near the urethra 14 and / or EUS 34 structures and fixation (acute and / or chronic) when deployed to the arrangement of FIG. 5A or FIG. 5B in which the lead 100, 110 generally follows or conforms to a curvature of the EUS 34. The lead 100, 110 can be in casual contact with the EUS 34 muscular structures, nerves innervating the EUS 34, etc.Leads

[0053] Leads of the present disclosure, including any of the leads of FIGS. 5A-15, 19 and 20, can have a wide variety of sizes (lengths, widths, etc.) and can be used as a general design or to offer different options based on patient-specific anatomy. Further, leads of the present disclosure, including any of the leads of FIGS. 5A-15, 19 and 20, can be formed of a material (or combination of materials) that range from more rigid to softer and / or flexible to better shape to targeted anatomy and accommodate tissue movement. To the extent not otherwise made1618.332 11115clear by the stylized representations of the EUS in one or more of the figures of the present disclosure, in general term with any of the leads and methods of the figures of the present disclosure, the lead (and / or electrodes carried thereby) can be in contact with the EUS. This can occur via being in the EUS, in direct contact to the posterior of the EUS, etc. In some embodiments, the figures of the present disclosure are intended to reflect contact between the lead in question and the EUS is provided or achieved on the bulk portion of the EUS (and not necessarily on the urethral distal (with respect to the bladder) to the EUS).

[0054] FIG. 6 illustrates portions of one example of a lead 150 in accordance with principles of the present disclosure and useful for placement or deployment at a level of the EUS 34. Some leads of the present disclosure, for example the lead 150, can be a percutaneous lead. 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 sheath or needle) and carrying one or more stimulation elements or electrodes (it being understood that in some embodiments simulation elements or electrodes can also serve as sensing electrodes and / or the leads of the present disclosure can include one or more sensing electrodes in addition to stimulation element(s) or electrode(s)). With this in mind, the lead 150 includes a lead body 160 carrying one or more stimulation elements or electrodes 162. In addition, one or more fixation features 164 can optionally be carried or formed by the lead body 160. Alternatively or in addition, fixation features can be provided apart from the lead 150. Regardless, the lead body 160 is configured to maintain the electrodes 162 (as well as other optional electrical components) in an electrically isolated manner, and defines a distal end 170, a first shelf region 172, a saddle region 174, a second shelf region 176, and a proximal region 178. Internal, electrically isolated wiring (hidden) within a structure of the lead body 160 is electrically connected to and extends from each of the stimulation elements 162, respectively, along the proximal region 178 for connection to a power source (not shown) as is known in the art.

[0055] The saddle region 174 is formed or provided between the first and second shelf regions 172, 176, and is generally sized and shaped for placement about a urethra. For example, the saddle region 174 can have the generally curved shape1618.332 11116as shown (e.g., a C-like shape or ll-like shape is defined in the longitudinal direction). The first and second shelf regions 172, 176 are each sized and shaped to support and maintain at least one of the electrodes 162. Further, the first and second shelf regions 172, 176 extend linearly from opposing sides of the saddle region 174, arranged opposite an apex of a curvature defined by the saddle region 174. In some examples, the first and second shelf regions 172, 176 are optionally substantially co-axial (i.e., a central axis of the lead body 160 along the first shelf region 172 is within 10% of being truly co-axial with a central axis of the lead body 160 along the second shelf region 176).

[0056] In some examples, the curved shape of the saddle region 174, the linear shape of the shelf regions 172, 176, as well as shapes at transitions from the saddle region 174 to each of the shelf regions 172, 176 are imparted and relatively rigidly maintained by one or more shape memory elements (not shown), such as a polymer or metal shape memory element, carried within and / or embedded within a thickness of the lead body 160. With these and similar constructions, the saddle region 174 can readily assume or be forced to a more flattened or linear shape when passed through an introducer sheath for delivery to a target site, and then self-assume or self-revert to the curved shape implicated by FIG. 6 when deployed from the confines of the sheath. In other embodiments, the lead 150 can include one or more features that can be actuated to force the saddle region 174 to, and retain, the curved shape implicated by FIG. 6. For example, one or more wires or strings can be secured to and / or embedded within a thickness of the lead body 160 at or along the saddle region 174 that extend along at least a portion of the length thereof. During delivery to a target site, the saddle region 174 is permitted to assume any desired shape conducive to delivery. Once the lead body 160 has been located at the target site, the wire(s), string(s), or similar feature is then actuated (e.g., pulled), forcing the saddle region 174 to assume and retain the curved shape. Other techniques or assemblies can alternatively be employed to selectively arrange the saddle region 174 to the curved shaped and / or to retain one or both of the shelf regions 172, 176 to extend relatively linearly from the saddle region 174.

[0057] The electrode(s) 162 can assume a wide variety of forms appropriate for applying stimulation energy to an EUS target site (e.g., ring electrodes) and / or for1618.332 11117sensing purposes, and can be maintained at various locations along a length of the lead body 160. While FIG. 6 generally implicates the electrodes 162 being located proximate opposing ends of the saddle region 174 on the shelf regions 172, 176, other locations are also acceptable, including one or more electrodes being located along the saddle region 174. Further, the lead 150 can include any number of electrodes 162, and is not limited to the two electrode configuration of FIG. 6. In addition to the electrode(s) 162, the lead 150 can optionally include visualization members (not shown), such as bands or other guides (e.g., radiopaque bands) carried by the lead body 160, that aid in visualization lead features during or after an implant procedure.

[0058] The fixation feature(s) 164, where provided, can assume various forms appropriate for promoting fixation of the lead 150 following implant. In some nonlimiting examples, the fixation feature(s) 164 can include tine structures configured to self-deploy, or to be actuated to, the arrangement of FIG. 6 that are located along the proximal region 178. In other examples, the fixation feature(s) 164 can be located elsewhere along a length of the lead body 160 and can be or include holes for tissue ingrowth, deployable tip barbs, suturable sleeves, ribs, serpentine shape, etc.

[0059] FIG. 7 illustrates the lead 150 following implantation to a target site in which the electrode(s) 162 are positioned highly proximate and / or in contact with the EUS 34. Various techniques and tools for delivering and placing the lead 150 to the arrangement of FIG. 7 are provided below, and can generally include guiding the lead 150 through a trans obturator, retropubic, prepubic, transvaginal, transvulvar, etc., approach, with the saddle region 174 self-assuming, or being actuated to assume, the curved shape upon final deployment. With the arrangement of FIG. 7, a segment of the urethra 14 is within the curved shape of the saddle region 174; at this location, a shape and arrangement of the shelf regions 172, 176 relative to the saddle region 174 inherently locates the corresponding electrode(s) 162 in close proximity to the EUS 34. With the one example of FIG. 7, the lead 150 is arranged such that the saddle region 174 is positioned between the urethra 14 and the vagina 80; with other embodiments or delivery techniques, the lead 150 can be arranged such that the saddle region 174 is positioned “above” the urethra 14 (or opposite the vagina 80). Regardless,1618.332 11118an interface between the saddle region 174 and the urethra 14 promotes locating the lead 150 at the urethra 14 and can assist in preventing migration of the lead 150. A shape of the saddle region 174 can further facilitate a spatial relationship between the electrodes 162 relative to the EUS 34 that mitigates the need for implant of two separate leads to get the same coverage when separated by a structure the EUS 34 / urethra 14. Acute and / or chronic fixation is provided by engagement of the fixation feature(s) 164 with native tissue. Upon final implantation to the arrangement of FIG. 7, stimulation energy delivered by the electrode(s) 162 will readily capture the EUS 34.

[0060] FIG. 8 illustrates portions of another example lead 200 in accordance with principles of the present disclosure and useful for placement or deployment at a level of the EUS 34. The lead 200 includes a lead body 210 carrying one or more stimulation elements or electrodes 212. In addition, one or more fixation features 214 can optionally be carried or formed by the lead body 210. The lead body 210 is configured to maintain the electrodes 212 (as well as other optional electrical components) in an electrically isolated manner, and defines a distal end 220, an overlap region 222, a first shelf region 224, a saddle region 226, a second shelf region 228, and a proximal region 230.

[0061] The saddle region 226 can be akin to the saddle region 174 (FIG. 6) described above, generally sized and shaped for placement about a urethra. For example, the saddle region 226 can have the generally curved shape as shown (e.g., a C-like or U-like shape in the longitudinal direction). The first and second shelf regions 224, 228 are each sized and shaped to support and maintain at least one of the electrodes 212. Further, the first and second shelf regions 224, 228 extend linearly from opposing sides of the saddle region 226, arranged opposite an apex of a curvature defined by the saddle region 226. In some examples, the first shelf region 224 defines a linear shape in extension from the saddle region 226 to the overlap region 222 and can be generally perpendicular to a linear shape of the second shelf region 228 (e.g., a central axis of the lead body 210 along the first shelf region 224 is substantially perpendicular to the central axis of the lead body 210 along the second shelf region 228). The overlap region 222 projects linearly from first shelf region 224 to the distal end 220 in a direction of the proximal region 230, and is generally perpendicular to an1618.332 11119orientation of the first shelf region 224. For example, an approximately 90 degree bend can be formed between the overlap region 222 and the first shelf region 224. With this configuration, shapes and spatial orientations of the first shelf region 224 and the overlap region 222 effectively combine to “aim” the distal end 220 in a direction of the proximal region 230; dimensions or geometries of the retention region 222 and the saddle region 224 are such that a gap 232 is maintained or established between the distal end 220 and other portions of the lead body 210.

[0062] In some examples, the shapes and spatial relationships of the overlap region 222, the first shelf region 224, the saddle region 226 and the second shelf region 228 are imparted and relatively rigidly maintained by one or more shape memory elements (not shown), such as a polymer or metal shape memory element, carried within and / or embedded within a thickness of the lead body 210. With these and similar constructions, the regions 222-228 can collectively assume or be forced to a more flattened or linear shape when passed through an introducer sheath for delivery to a target site, and then self-assume or self-revert to the shapes implicated by FIG. 8 when deployed from the confines of the sheath. In other embodiments, the lead 200 can include one or more features that can be actuated to force one or more of the regions 222-228 to, and retain, the shapes and spatial relationships implicated by FIG. 8 as described above.

[0063] The electrode(s) 212 can assume a wide variety of forms appropriate for applying stimulation energy to an EUS target site (e.g., ring electrodes), and can be maintained at various locations along a length of the lead body 210. While FIG. 8 generally implicates the electrodes 212 being located proximate opposing ends of the saddle region 226 on the shelf regions 224, 228, other locations are also acceptable. Further, the lead 210 can include any number of electrodes 212, and is not limited to the two electrode configuration of FIG. 8. In addition to the electrode(s) 212, the lead 200 can optionally include visualization members (not shown), such as bands or other guides (e.g., radiopaque bands) carried by the lead body 210, that aid in visualization lead features during or after an implant procedure.

[0064] The fixation feature(s) 214, where provided, can assume various forms appropriate for promoting fixation of the lead 200 following implant. In some non-1618.332 11120limiting examples, the fixation feature(s) 214 can include tine structures configured to self-deploy, or to be actuated to, the arrangement of FIG. 8 that are located along the proximal region 230. In other examples, the fixation feature(s) 214 can be located elsewhere along a length of the lead body 210 and can be or include holes, mesh or the like for tissue ingrowth, deployable tip barbs, suturable sleeves, etc.

[0065] FIG. 9 illustrates the lead 200 following implantation to a target site in which the electrode(s) 212 are positioned highly proximate and / or in contact with the EUS 34. Various techniques and tools for delivering and placing the lead 200 to the arrangement of FIG. 9 are provided below, and can generally include guiding the lead 200 through a trans obturator, retropubic, prepubic, transvaginal, transvulvar, etc., approach, with the regions 222-228 self-assuming, or being actuated to assume, the shapes or geometries shown upon final deployment. With the arrangement of FIG. 9, the urethra 14 is surrounded by or captured within a region collectively defined by the overlap region 222, the first shelf region 224, and the saddle region 226. With the one example of FIG. 9, the lead 200 is arranged such that the saddle region 226 is positioned between the urethra 14 and the vagina 80; with other embodiments or delivery techniques, the lead 200 can be arranged such that the saddle region 226 is positioned “above” the urethra 14 (or opposite the vagina 80). Regardless, an interface between the saddle region 226 and the urethra 14 promotes locating the lead 200 at the urethra 14, with the overlap region 222 and the first shelf region 224 assisting to prevent migration of the lead 200. Acute and / or chronic fixation is provided by engagement of the fixation feature(s) 214 with native tissue. Upon final implant to the arrangement of FIG. 9, stimulation energy delivered by the electrode(s) 212 will readily capture the EUS 34.

[0066] While some examples of the present disclosure entail a single lead body being arranged at or along the EUS 34, other configurations are also acceptable. For example, FIG. 10 illustrates portions of a lead assembly 250 implanted to the patient. The lead assembly 250 includes first and second lead sections 260, 262. The lead sections 260, 262 can be similar or substantially identical in construction, and in some embodiments can be akin to the lead 150 (FIG. 6) described above (e.g., each including a lead body carrying one or more1618.332 11121electrodes and defining a saddle region). In some embodiments, the lead sections 260, 262 can be entirely separate from one another. In other embodiments, the lead sections 260, 262 can be extensions from a common base section (e.g., the lead assembly 250 can be a bifurcated lead). Regardless, the lead sections 260, 262 can be placed between the urethra 14 and the vagina 80 at the level of the EUS 34 as shown, with fixation features (e.g., tines) provided with each of the lead sections 260, 262 providing acute and / or chronic fixation. Alternatively, the lead sections 260, 262 can be positioned “above” the urethra 14 (or opposite the vagina 80). Commensurate with the descriptions above, electrodes provided with the lead sections 260, 262 are arranged and maintained in highly close proximity to the EUS 34. FIG. 10 further reflects that in some embodiments, the leads of the present disclosure (e.g., the lead sections 260, 262) can optionally be arranged (e.g., tunneled) through the obturator foramen or window 92 and then up to the patient’s abdomen for connection to an IPG (not shown).

[0067] FIG. 11 illustrates portions of another example lead 300 in accordance with principles of the present disclosure and useful for placement or deployment at a level of the EUS 34. The lead 300 includes a lead body 310 carrying one or more stimulation elements or electrodes 312. In addition, one or more fixation features (not shown) can optionally be carried or formed by the lead body 310. The lead body 310 is configured to maintain the electrodes 312 (as well as other optional electrical components) in an electrically isolated manner, and defines a distal region 320, a saddle region 322, an intermediate region 324, and a proximal region 326. As a point of reference, the regions 320-326 are illustrated in a deployed state in the view of FIG. 11. The distal region 320 includes or defines first and second arms 330, 332 each extending distally from the saddle region 322. More particularly, the first and second arms 330, 332 splay away from one another in the deployed state such that a spacing is defined between a distal end 334 of the first arm 330 and a distal end 336 of the second arm 332. The saddle region 322 extends between and interconnects the distal and intermediate regions 320, 324, and can be, or can be akin to, the saddle region 174 (FIG. 6) described above, generally sized and shaped for placement about a urethra (e.g., can define a C-like or U-like shape in the longitudinal direction). The intermediate region 324 includes or defines first and second legs 340, 342. The legs 340, 3421618.332 11122are connected to one another at opposing ends thereof (i.e. , point of intersection with the saddle region 322 and point of intersection with the proximal region 326). In the deployed state of FIG. 11 , the legs 340, 342 extend or expand away from one another in extension between the saddle region 322 and the proximal region 326 to define an opening 344 for reasons made clear below.

[0068] In some examples, the shapes, spatial orientations, and / or structures of one or more of the distal region 320, the saddle region 322, and the intermediate region 324 in the deployed state are imparted and maintained by one or more shape memory elements (not shown), such as a polymer or metal shape memory element, carried within and / or embedded within a thickness of the lead body 310. With these and similar constructions, the distal region 320, the saddle region 322, and the intermediate region 324 can readily assume or be forced to a more linear shape (generally represented by dashed lines 350 in FIG. 11) when passed through an introducer sheath for delivery to a target site, and then self-assume or self-revert to the shapes implicated by FIG. 11 when deployed from the confines of the sheath. In other embodiments, the lead 300 can include one or more features that can be actuated to force one or more of the distal region 320, the saddle region 322, and the intermediate region 324 to the shape(s) implicated by FIG. 11. For example, a line 360 (e.g., a suture cord) can optionally be provided that is connected to the lead body 310 near the intersection of the distal region 320 and the saddle region 322. When a pulling force is applied to the line 360 in the proximal direction, the arms 330, 332 of the distal region 320 and / or the legs 340, 342 of the intermediate region 324 are caused to expand or splay to the deployed arrangement of FIG. 11. Other constructions and / or devices can be utilized to facilitate transitioning of the lead body 310 from a relatively straight or linear shape to the shapes of the deployed state.

[0069] The electrode(s) 312 can assume a wide variety of forms appropriate for applying stimulation energy to an EUS target site, and can be maintained at various locations along a length of the lead body 310. In some non-limiting examples, at least one of the electrodes 312 is provided along each of the arms 330, 332 and the legs 340, 342. Other electrode locations and numbers are also acceptable. In addition to the electrode(s) 312, the lead 300 can optionally include visualization members (not shown), such as bands or other guides (e.g.,1618.332 11123radiopaque bands) carried by the lead body 310, that aid in visualization lead features during or after an implant procedure.

[0070] FIG. 12 illustrates the lead 300 following implantation to a target site in which the electrode(s) 312 are positioned highly proximate and / or in contact with the EUS 34. Various techniques and tools for delivering and placing the lead 300 to the arrangement of FIG. 12 are provided below, and can generally include guiding the lead 200 through a trans obturator, retropubic, prepubic, transvaginal, transvulvar, etc., approach, with the distal region 320, the saddle region 322, and the intermediate region 324 self-assuming, or being actuated to assume, the shapes or geometries shown upon final deployment. With the arrangement of FIG. 12, the urethra 14 is received within the saddle region 322 (positioned between the urethra 14 and the vagina 80; positioned “above” the urethra 14 (or opposite the vagina 80)). An interface between the saddle region 322 and the urethra 14 promotes locating the lead 300 at the urethra 14. Fixation features (e.g., tines) 370 can engage native tissue to promote acute and / or chronic fixation. Further, and with additional reference to FIG. 11, the arms 330, 332 effectively act as self-deploying fixation features, serving to limit or prevent forward migration of the lead 300. In the location of FIG. 12, the intermediate region 324 is proximate or extends over the perineal membrane or other tissue and provides a viable surface for optional sutures (not shown) securing one or both of the legs 340, 342 to the tissue for acute lead fixation. The mechanism used to splay open the intermediate region 324 (e.g., the line 360) can also be fixated at the proximal end of the lead 300 to keep tension in the intermediate region 324, providing both acute and chronic fixation. Further, tissue ingrowth or encapsulation at the opening 344 of the intermediate region 324 can serve to chronically lock the lead 300 in place. Upon final implant to the arrangement of FIG. 12, stimulation energy delivered by the electrode(s) 312 will readily capture the EUS 34. In this regard, the spread apart arrangement of the electrodes 312 on the arms 330, 332 and the legs 340, 342 can provide an enhance electric field coverage.

[0071] In some embodiments, the lead 300 can incorporate one or more features that facilitate removal of the lead 300 following chronic fixation. For example, a longitudinal central portion of the saddle region 322 can be formed as a thin web1618.332 11124(referenced generally at 362 in FIG. 11). The thin web 362 can be easily torn, for example by applying opposing direction forces to the arms 330, 332 and / or to the legs 340, 342; once the saddle region 322 has been longitudinally split, the lead 300 can more easily be removed. Alternatively or in addition, with embodiments in which the mechanism used to splay open the intermediate region 324 (e.g., the line 360) is fixated at the proximal end of the lead 300 to keep tension in the intermediate region 324, this tension can be replaced to promote ease of repositioning or removal.

[0072] FIGS. 13A and 13B illustrate portions of another example lead 400 in accordance with principles of the present disclosure and useful for placement or deployment at a level of the EUS 34. The lead 400 includes lead body 410 carrying one or more stimulation elements or electrodes 412. The lead body 410 defines or includes a head or paddle 414 and a proximal region 416 extending from the head 414. In addition, one or more fixation features (not shown) can optionally be carried or formed by one or both of the head 414 and the proximal region 416. Regardless, the head 414 is configured to maintain the electrodes 412 (as well as other optional electrical components) in an electrically isolated manner, with electrical conductors (e.g., wires) for each of the electrodes 412 extending through a thickness of head 414 to the proximal region 416. The head 414 can be an enlarged, elongated body. More particularly, the head 414 can have a generally rectangular or oval perimeter shape, defining a width that is greater than a diameter (or other outer dimension) of the proximal region 416. As compared to a percutaneous lead, then, a face 418 of the head 414 provides an enlarged surface area at which the electrodes 412 are maintained, allowing for implementation of larger and / or more electrodes.

[0073] Extension of the head 414 from the proximal region 416 forms or defines a first shelf region 420, a saddle region 422, and a second shelf region 424. The saddle region 422 is generally sized and shaped for placement about a urethra, and can thus have the generally curved shape as shown (e.g., a C-like shape or U-like shape is defined in the longitudinal direction). In other embodiments, the head 410 can have a flattened shape (e.g., a curvature of the saddle region 422 can be omitted). The first and second shelf regions 420, 424 are each sized and shaped to support and maintain at least one of the electrodes 412. The shelf1618.332 11125regions 420, 424 can each have or define the substantially flat or linear shape as shown, extending from opposing sides of the saddle region 422 at a spatial location opposite of an apex of the curve defined by a shape of the saddle region 422. In some examples, a material and construction of the head 414 self-retains the shapes and spatial relationships of the first shelf region 420, the saddle region 422, and the second shelf region 420. In other embodiments, one or more shape memory elements (not shown), such as a polymer or metal shape memory element, can be carried by and / or embedded within a thickness of the head 414. In other embodiments, the lead 400 can include one or more features that can be actuated to force, for example, the saddle region 422 to (and retain) the shape implicated by FIG. 13A as described above.

[0074] The electrode(s) 412 can assume a wide variety of forms appropriate for applying stimulation energy to an EUS target site, and can be maintained at various locations along a length and width of the head 414. While FIGS. 13A and 13B generally reflect the electrodes 412 as being generally flat and rectangular, other configurations are also acceptable (e.g., hemispherical or other profile). In some examples, one or more of the electrodes 412 are maintained along both of the shelf regions 420, 424 proximate opposing sides of the saddle region 422. Other locations and / or orientations are also acceptable. Further, the lead 400 can include any number of electrodes 412, and is not limited to the four electrode configuration of FIGS. 13A and 13B. For example, FIG. 13C illustrates portions of another lead 400’ highly akin to the lead 400, and includes stimulation elements or electrodes 412’. As compared to the configuration of FIGS. 13A and 13B, an elongate shape of the electrodes 412’ can be oriented to extend longitudinally along the head 414 and arranged in two (or more) rows. Returning to FIGS. 13A and 13B, in addition to the electrodes 412, the lead 400 can optionally include visualization members (not shown), such as bands or other guides (e.g., radiopaque bands) carried by the head 414, that aid in visualization lead features during or after an implant procedure. Further, one or more fixation features can be carried or formed by the head 414 (e.g., suture holes or points, self-deploying tines, etc.).

[0075] FIG. 14 illustrates the lead 400 following implantation to a target site in which the electrode(s) 412 are positioned highly proximate and / or in contact with1618.332 11126the EUS 34. Various techniques and tools for delivering and placing the lead 400 to the arrangement of FIG. 14 are provided below, and can generally include guiding the lead 400 through a trans obturator, retropubic, prepubic, transvaginal, transvulvar, etc., approach, with the saddle region 422 self-assuming, or being actuated to assume, the shape shown upon final deployment. With the arrangement of FIG. 14, a segment of the urethra 14 is within the curved shape of the saddle region 422, and the electrodes 412 are oriented toward the EUS 34. With the one example of FIG. 14, the lead 400 is arranged such that the saddle region 422 is positioned between the urethra 14 and the vagina 80; with other embodiments or delivery techniques, the lead 400 can be arranged such that the saddle region 422 is positioned “above” the urethra 14 (or opposite the vagina 80). Regardless, an interface between the saddle region 422 and the urethra 14 promotes locating the lead head 414 at the urethra 14, assists in desired electrode placement relative to the EUS 34, and can assist in preventing migration of the lead 400. Acute and / or chronic fixation be enhanced with one or more fixation features, such as tines. Upon final implant to the arrangement of FIG. 14, stimulation energy delivered by the electrodes 412 will readily capture the EUS 34.

[0076] With the optional constructions of FIGS. 13A and 13C, upon final placement of the head 414 at the urethra 14, the electrodes 412, 412’ are arranged relative to one another in a pattern that is generally perpendicular to a centerline of the urethra 14 (e.g., as generally represented by the view of FIG.14). In other embodiments, a more parallel relationship can be provided. For example, FIG. 13D illustrates portions of another lead 400” akin to the leads 400, 400’. The lead 400” includes a lead body 410” carrying a plurality of electrodes 412”. The lead body 410” include a head 414” forming a saddle region 422”. As compared to the embodiments of FIGS. 13A and 13C, the head 414” can be slightly wider so as to provide sufficient surface area for supporting an array of the electrodes 412” at either side of the saddle region 422”. The electrodes 412” are arranged relative to one another in each array to establish a pattern that is generally perpendicular to a centerline of the urethra 14 upon final placement of the saddle region 422” at the urethra 14. This more parallel relationship may be beneficial for targeting and chronic adjustability. Any of the other leads of present1618.332 11127disclosure can be modified to promote or provide electrodes arranged to be more parallel to the urethra 14 upon final implant.

[0077] With some systems and methods of the present disclosure, one or more of the leads can be utilized or provided with additional devices or features that enhance continence and / or provide other anchoring mechanisms (e.g., mesh tissue ingrowth, obturator puncture, etc.). For example, urethral slings are commonly used to treat stress incontinence. In some embodiments, a paddletype lead of the present disclosure, for example a lead akin to or the same as the lead 400, could be provided as an additional feature with or incorporated into a urethral sling. FIG. 15 reflects one embodiment in which the lead 400 is implanted as described above, along with a urethral sling 450. In other examples, a combination lead and urethral sling device can be provided in which a lead akin to the lead 400 incorporates features that replace or mimic materials and features of a conventional urethral sling (or other sling design, such as a retropubic sling, a single incision sling, etc.), or can be built into an existing sling design. FIG. 16 illustrates one example of a lead sling device 460 that includes a sling body 462, a head or paddle 464 carrying electrodes 466, and an energy supply 468. The head 464 can be akin to the head 410 (FIG. 13A) described above, and includes or forms features configured to receive and support a segment of the urethra 14 and position the electrodes 466 in close proximity to the EUS 34. The energy supply 468 is electrically connected to the electrodes 466 and is carried by the sling body 462. The energy supply 468 can assume various forms appropriate for delivering stimulation energy to the electrodes 466, for example a small rechargeable IPG (that can be charged by a charging device located at the skin or in a body cavity (e.g., vagina, rectum, etc.) of the patient, or an externally powered IPG. Upon final implant, the sling body 462 supports and / or lifts the urethra 14 (akin to a conventional urethral sling), and the electrodes 466 are selectively energized to apply simulation energy to the EUS 34 to assist in maintaining continence as desired by the patient (e.g., operable to deliver “on demand” continence therapy, muscular strengthening therapy, OAB-reducing neuromodulation, etc.).Delivery Methods and Tools1618.332 11128

[0078] Returning to FIGS. 5A and 5B, other aspects of the present disclosure relate to tools and / or techniques for attaining the lead arrangement of FIG. 5A or FIG. 5B (e.g., useful with any of the lead configurations of the present disclosure), for example via a trans obturator, retropubic, prepubic, transvaginal, transvulvar, etc., approach. The tools and / or methods of the present disclosure can be employed or performed directly by a clinician or can be provided as part of a robotically performed or assisted procedure. Thus, in the descriptions below, while reference may be made to a clinician manually or directly performing a particular action, task, decision, etc., the tools and / or techniques of the present disclosure are not so-limited and instead can be utilized or performed with or as part of a robotically performed or assisted procedure.

[0079] Some methods of the present disclosure include creating a lead delivery or tunneling path to or from an EUS target site via one of the obturator foramen or windows 92 (FIG. 4B) of the patient. For example, FIGS. 17Aand 17B illustrate a passer tool 500 having been manipulated or deployed to access a target site near or on the EUS 34, for example between the urethra 14 and the vagina 80. The passer tool 500 can take various forms, and in some embodiments includes an elongated shaft 510 extending from a handle 512. The shaft 510 can be hollow, defining a lumen or internal channel that is open at a distal end 520; in other embodiments, the shaft 510 can have a more solid construction. The distal end 520 can be configured to facilitate tunneling through tissue (e.g., a sharpened tip). In some embodiments, the shaft 510 is formed of a rigid material (e.g., surgical grade stainless steel) and robustly maintains a curved shape (e.g., a single radius curve, a multi-radius curve, etc.) as reflected by the views. In other embodiments, the shaft 510 can have a malleable construction. The passer tool 500, as well as other passer tools of the present disclosure, can include or carry one or more additional features as described below.

[0080] A size, shape, and geometry of the shaft 510 can be selected in accordance with an expected anatomy of the patient so as to readily achieve the arrangement of FIGS. 17A and 17B in which the handle 512 has been manipulated to direct the distal end 520 through an initial insertion site in the patient’s skin at or proximate one of the obturator foramen or windows 92 (i.e., one of two large openings in the hip bone or pelvis), then through the foramen 921618.332 11129(e.g., piercing the obturator membrane), and finally to a location of the EUS 34 between the urethra 14 and the vagina 80 on a minimally invasive basis. With this non-limiting example tunneling approach, the distal end 520 does not pierce the vagina 80. It can be useful for the clinician to ensure a desired location of the distal end 520 relative to the EUS 34 has been attained. In some embodiments, correct placement is aided by palpation using a finger in the vagina 80; the distal end 520 is directed to clinician’s finger and thus the desired location of the EUS 34. In other embodiments, these same general techniques can be used to locate the distal end 520 at a location of the EUS 34 “above” the urethra 14, and thus opposite the vagina 80 (e.g., the location T2 of FIG. 4A). In related embodiments, the shaft 510 can form or carry a palpable element (e.g. , ball or rounded body) at or near a location relative to the distal end 520 corresponding with an expected location of one or more electrodes provided with the lead that will be placed following tunneling; the palpable element can be palpated by the clinician to better confirm desired electrode placement. In yet other embodiments, the passer tools of the present disclosure can be configured to emit light from the distal end 520; during use the emitted light can pass through the urethra of the patient for visualization via urethroscopy.

[0081] With the distal end 520 at the location of FIGS. 17A and 17B, the passer tool 500 can be utilized to place or deploy a lead at a location of the EUS 34, for example any of the leads of the present disclosure, although any other lead configuration is also acceptable. Regardless of an exact format of the lead, some methods of the present disclosure can include the lead being disposed within, or distally advanceable through, the lumen of the shaft 510. In other embodiments, the lead can be pulled or dragged by the shaft 510 to the target location during the tunneling procedure (e.g., the lead can be directly connected to the shaft 510, the lead can be disposed within a cover that is connected to the shaft 510, etc.). In yet other embodiments, an introducer sheath sized and shaped to receive the lead can be disposed within, or is distally advanceable through, the lumen of the shaft 510. With these and related embodiments, the introducer sheath extends to, or is advanced toward, the distal end 520, followed by removal of the shaft 510 from the patient. For example, the passer tool 500 can be arranged as shown in FIGS. 17Aand 17B and then employed to locate the introducer sheath between1618.332 11130the vagina 80 and the urethra 14 at the level of the EUS 34. The shaft 510 can then be removed, leaving the introducer sheath in place. The lead can then be placed through the introducer sheath between the urethra 14 and the vagina 80. In yet other embodiments, a guidewire can be distally advanced through the lumen of the shaft 510 to the distal end 520, followed by removal of the shaft 510 from patient. One or more other tools or devices (e.g., sheath, dilator, etc.) can then be delivered over the guidewire to complete the lead implant procedure.

[0082] In some examples, the passer tool 500 and corresponding clinician handling techniques for arranging the distal end 520 at the location of FIGS. 17A and 17B can be akin to tools and techniques oftentimes used with trans obturator urethral sling procedures. As a point of reference, urethra sling procedures are commonly used to treat stress incontinence. With these procedures, slings are placed between the urethra and the vagina, and are tensioned to support the urethra and provide more structure to the pelvic floor so as to improve the function of the EUS 34. The trans obturator sling procedure uses tools that tunnel the sling bilaterally between the vagina 80 and the obturator foramen or window 92 in the pelvis. With some systems and methods of the present disclosure (e.g., as facilitated by use of the passer tool 500 or similar device), unlike conventional trans obturator sling procedures, only a single trans obturator tunneling pass is used, and there may not be a need for a vaginal incision.

[0083] As an alternative to the trans obturator techniques described above, other methods of the present disclosure utilize a retropubic approach to the EUS 34. As a point of reference, some urethral sling procedures locate the sling via retropubic paths so that corresponding tunneling / delivery tools and techniques are familiar to many clinicians. One example of a sling 550 that has been placed to support the urethra 14 on a retropubic basis is shown in FIG. 18. Some examples of the present disclosure can use the same or similar retropubic sling procedure tools and techniques to place a lead proximate the urethra 14 at a level of the EUS 34. For example, FIG. 19 illustrates, in simplified form, a treatment system 600 of the present disclosure implanted to the patient in accordance with principles of the present disclosure. The system 600 includes at least the IPG 64 and a lead 610. The lead 610 can have any of the configurations of the present disclosure, and includes a lead body 620 carrying one or more stimulation1618.332 11131elements or electrodes 622 and forming a saddle region 630 generally configured for placement about a portion of the urethra 14. The lead 610 has been routed to the urethra 14 via a retropubic approach. The retropubic path facilitates a more direct routing of the lead 610 to the IPG 64 that is otherwise implanted in a location of the patient’s abdomen. The retropubic techniques of the present disclosure do not entail an obturator puncture; it has been observed that some patients experience prolonged pain from the obturator punctures associated with trans obturator sling procedures. FIG. 19 also highlights that with a retropubic approach, a more direct path to a location “above” the urethra 14 and close to the EUS 34 can be achieved in a relatively straightforward manner. With some retropubic-based techniques of the present disclosure, the urethra 14 can be displaced laterally with a catheter and a passer tool is tunneled from a vaginal insertion to above the pubis bone. The tunneling path can be created to a location above or below the urethra 14 (as compared to retropubic sling procedures that tunnel to a location below the urethra 14).

[0084] With some lead delivery procedures of the present disclosure, a vaginal incision is not required (e.g., some of the trans obturator procedures described above). In other examples, techniques are provided that can deliver leads of the present disclosure to the EUS 34 via a vaginal incision. In some instances, a vaginal incision entry point may offer better procession for locating the lead at the EUS 34. For example, and with reference to FIGS. 17A and 17B, the trans obturator procedures mentioned above can entail a passer tool (e.g., the passer tool 500) being manipulated to create a tunnel from an incision at the vagina 80 to the obturator window or foramen 92. Additionally, some blunt dissection at the urethra 14 may ensure proper lead placement and / or offer additional lead fixation techniques. A vaginal incision initiating point may also be beneficial with the retropubic lead tunneling approaches described above with respect to FIGS. 18 and 19 (where the tunneling path exits above the pubis bone instead of the obturator window as with the trans obturator approach). Moreover, some lead configurations of the present disclosure may be better suited for delivery to the EUS 34 via a vaginal incision (e.g. , the paddle-type leads 400 implicated by FIGS.13A, 13B, and 13D).1618.332 11132

[0085] The shaft provided with passer tools of the present disclosure, such as the shaft 510 of the passer tool 500), can assume various shapes or geometries commensurate with the particular surgical / tunneling approach to the EUS 34. That is to say, the particular passer tool shaft can exhibit a curvature or geometry to accommodate one (or more) of trans obturator placement (starting at a vaginal incision, starting at a location lateral to the obturator window), retropubic placement (starting at a vaginal incision, starting at external skin at or near the vulva, starting at a location superior to the pubic symphysis, etc.), or prepubic placement (starting at a vaginal incision, starting at external skin at or near the vulva, starting at a location superior to the pubic symphysis, etc.). Regardless of an exact shape or geometry, the passer tool shafts of the present disclosure can form or define a sharpened distal tip for tunneling through tissue. Further, the passer tools of the present disclosure can incorporate one or more features that facilitate delivery of a lead via the tunneled path. For example, an actuatable grabbing element can be associated with the shaft that is configured to hold the lead. The lead is pulled through the tunnel with the shaft. Once a desired location is attained, the grabbing element is actuated to release the lead. Alternatively, the passer tool shaft can be hollow, defining a lumen through which the lead is passed. In yet other embodiments, an introducer sheath sized and shaped to receive the lead can be disposed within, or is distally advanceable through, the lumen of the shaft. The passer tool is used to deliver the introducer sheath and then is removed, leaving the introducer sheath in place. The lead can then be placed through the introducer sheath. In yet other embodiments, a guidewire can be distally advanced through the lumen of the shaft, followed by removal of the shaft from patient. One or more other tools or devices (e.g., sheath, dilator, etc.) can then be delivered over the guidewire to complete the lead implant procedure. In yet other embodiments, the lead can contain a removable guidewire for imparting stiffness to the lead during placement.

[0086] In some embodiments, the passer tools of the present disclosure can be configured to facilitate delivery of stimulation energy as part of a tunneling procedure allowing a clinician to, for example, confirm capture or location of the EUS 34. For example, one or more electrodes can be provided near or at a distal tip of the passer tool shaft. Alternatively or in addition, one or more holes can be1618.332 11133formed in the passer tool shaft at locations corresponding with stimulation electrode(s) provided with a lead disposed within the shaft. With these and related embodiments, the stimulation energy provided to the lead electrodes can emit through shaft (holes) for evaluating proximity to the EUS 34 (or other anatomy).

[0087] Several of the leads described above optionally include or carry fixation features (e.g., tines, etc.) that assist in anchoring the lead to native anatomy upon final deployment. Other anchoring techniques and / or devices can alternatively be employed, for example anchoring a distal region of the lead to the obturator facia / muscle. For example, FIG. 20 illustrates portions of a lead 650 implanted to the patient, with the lead 650 including a saddle region 652 having any of the formats of the present disclosure and terminating at a distal region 654. A first anchor device 660 anchors the distal region 654 to obturator facia 670 (referenced generally). Optionally, a second anchor device 660 can be provided that extends in an opposite direction. Regardless, the anchor device 660 includes a line 662 and a locking assembly 664 (referenced generally). In general terms, the locking assembly 664 secures the line 662 to the obturator facia 670, with tension in the so-secured line 662 maintaining the distal region 654 in close proximity to the urethra 14.

[0088] The line 662 can assume various forms, and in some examples is, or is akin to, a suture. In other embodiments, such as with the non-limiting example of FIG. 20, at least a portion of the line 662 can be formed to a designated longitudinal shape selected to permit some longitudinal expansion or strain relief. For example, the line 662 can have the sigmoid or zig-zag shape as shown. With these and similar constructions, the line 662 keeps the distal region 654 close to the urethra 14 during tissue movements until the lead 650 is encapsulated.

[0089] One non-limiting example of the locking assembly 664 is shown in greater detail in FIG. 21. In the view, the line 662 extends from the distal region 654 of the lead 650 to the obturator facia 670. The locking assembly 664 can include a fixation unit 666 and a lock unit 668. The fixation unit 666 is generally configured to robustly engage with tissue of the obturator facia 670, and can include one or more tines that pierce into tissue. The lock unit 668 is generally configured for assembly to the fixation unit 666 and to selectively secure the line 662. With the arrangement of FIG. 21, the fixation unit 666 is located outside the pelvis and1618.332 11134engages through the obturator facia 670. The lock unit 668 is secured to the fixation unit 666 at an opposite side of the obturator facia 670 and is connected to the line 662. The line 662 goes through the lock unit 668 and is attached thereto. Once a desired tension in the line 662 has been achieved and the line 662 secured to the lock unit 668, a remainder of the line 662 distal the lock unit 668 can be accessed (e.g., via vaginal incision) and trimmed.

[0090] In some examples, the anchor device 660 can be useful with bifurcated leads. FIG. 22 illustrates a bifurcated lead 680 deployed to a patient that includes a first lead segment 682 and a second lead segment 684 each carrying one or more electrodes 686. The lead segments 682, 684 are arranged to extend in opposite directions, locating the corresponding electrodes 686 on and / or in close proximity to the EUS 34. A first anchor device 660A is arranged to anchor the first lead segment 682 to obturator facia at one side of the patient, and a second anchor device 660B is arranged to anchor the second lead segment 684 to obturator facia at the other side of the patient, commensurate with the descriptions above. With some techniques of the present disclosure, a catheter (not shown) can be placed in the urethra 14, allowing a clinician to move the urethra 14 laterally (first to one side, and then to the other). In this way, both of the lead segments 682, 684 can be brought to the vaginal incision. The distal region of each of the lead segments 682, 684 can then be anchored to the corresponding obturator window and tensioned via the corresponding anchoring device 660A, 660B. With these and similar arrangements, the bifurcation and the electrodes 686 are caused to be brought on top of the urethra 14 and in close contact with the EUS 34.

[0091] The present disclosure is not limited to any particular delivery approach or corresponding delivery tool(s). In general terms, however, a location of the EUS 34 along the urethra 14 is desirably determined for proper final placement of the lead. In some examples, the location may be approximated by referencing distances from the urethral meatus (e.g., the EUS 34 can be assumed to be located at 1.5 - 2.5 centimeters from the urethral meatus). Other anatomical reference points can alternatively be utilized, such as the bladder neck. Various imaging techniques may also be employed. In other embodiments, one or more additional tools can be provided. For example, FIG. 23 illustrates portions of a1618.332 11135probe unit 700 that can optionally be utilized with systems and methods of the present disclosure. The probe unit 700 includes a catheter 710 carrying one or more electrodes 720 and one or more sensors 722 along a distal region 724 thereof. A longitudinal distance between the electrode(s) 720 and locations proximal the electrode(s) 720 are known or determinable (e.g., incremental distance markings on an exterior of the catheter 710; radiopaque marker at each of the electrode(s) 720). In some embodiments, the one or more sensors 722 can be configured to sense a parameter indicative of pressure (e.g., pressure sensor, strain gage, etc.); in other embodiments, the one or more sensors can be configured to sense another parameter of interest, such as electromyography (EMG). The catheter 710 is sized for insertion into the urethra 14. The electrode(s) 720 are electrically connected to a power source (not shown). With the distal region 724 inserted within the urethra 14, stimulation energy is delivered to the electrode(s) 720 sufficient to stimulate the EUS 34 through the urethral wall. This stimulation contracts the urethra 14 and there is an associated localized change (e.g., urethral pressure rise, EMG), with the localized change being detected by the sensor(s) 722). Thus, a maximal change (e.g., maximal urethral pressure) can be identified that otherwise directly implicates a location of the EUS 34 or other target location (e.g., nerve), and helps determine a specific definitive electrode target location. For example, where the catheter 710 includes or displays markings or the like that reflect a distance to between the marking and the electrode(s) 720, when the catheter 710 is positioned relative to the urethra 14 at the location producing maximal urethral pressure, the distance marking observed to be at an anatomical reference point (e.g., the urethral meatus, the bladder neck, etc.) identifies the distance from the anatomical reference point to the electrode(s) 720, and thus to the EUS 34 or other target site such as a nerve entry site. Other EUS location techniques based upon measured maximal urethral pressure can also be employed. The probe unit 700 can also be employed for other procedures, such as a screening tool / method for determining suitability of a particular patient. If, for example, insufficient pressure increase is observed with targeted stimulation levels, the patient may not be a good candidate for EUS stimulation-based incontinence therapies.1618.332 11136

[0092] In some examples, the sensor 722 can be a balloon pressure sensor (although other configurations are also acceptable such a single or circumferential solid state pressure sensors). Alternatively, a separate balloon structure can optionally be provided with the catheter 710 along the distal region 724. With either approach, the balloon device can be located along the catheter 710 opposite the electrode(s) 720. With these and related embodiments, the balloon (e.g., the balloon pressure sensor 722) can, upon inflation, be palpated from the vagina 80 through the vaginal wall. This allows a clinician the ability to digitally locate an exact location where the stimulation lead should be placed between the vagina 80 and the urethra 14 at the level of the EUS 34. Alternatively or in addition, the balloon structure can be located at a distal-most end of the catheter 710. With these and related embodiments, the ballon structure could be used for determining the urethral length and electrode positions (e.g., the ballon structure is inflated in the patient’s bladder and is positioned against the bladder neck). In other embodiments, the probe unit 700 need not include a balloon. Sensors

[0093] Returning to FIGS. 1 -3, the treatment systems 50 of the present disclosure can include any of the lead configurations described above as carrying or supporting the stimulation element(s) 66. In some related embodiments, one or more of the sensors 62 can optionally be incorporated into the lead. The so-provided sensor(s) 62 can have a variety of forms and can be positioned at various locations along a length of the lead appropriate for sensing a parameter(s) of interest. By way of non-limiting example, some possible sensor locations are identified at 800 in FIG. 10, such as along the lead track near the abdomen (e.g., for electromyography (EMG) sensing), near the urethra 14 (e.g., for bioimpedance sensing, flow sensing, EMG sensing, etc.).

[0094] As a point of reference, and returning to FIGS. 1-3, chronic intermittent stimulation protocols applied to the EUS 34 with some embodiments of the present disclosure may prove completely therapeutic for stress continence as can other scheduled stimulation protocols (e.g., a scheduled patient-controlled dosage such as “stim for 20 minutes a day when convenient for you”). However, some patients may benefit from additional boost intervention of stimulation therapy during physical events such as a cough or sneeze. These and similar1618.332 11137events are characterized as producing an increase in abdominal and / or bladder pressure that can overcome the EUS’s capacity to prevent urine leakage. With this in mind, some lead systems of the present disclosure can incorporate sensors and / or devices configured and located to detect pressure rises or their surrogates, with the control portion 70 being programmed to initiate stimulation of the EUS 34 to maximally contract the EUS 34 in response, for example, to elevated detected pressures and / or rapid increases in pressure. In some embodiments, the control portion 70 can operate one or more triggering algorithms that are formatted to trigger or prompt stimulation when one or more designated sensor signals meet designated criteria (e.g., exceed a threshold).

[0095] In some embodiments, the leads of the present disclosure can include one or more piezoelectric-type elements or sensors. Piezoelectricity is a property of certain materials where they generate an electrical change when subjected to mechanical stress (e.g., pressure or deformation). Piezoelectric polymers are carbon-based materials that exhibit a piezoelectric effect due to their molecular structure and orientation. Polymers with semi-crystalline structure have microscopic crystals randomly distributed within an amorphous bulk. Some examples include polyvinylidene fluoride (PVDF), polyvinylidene fluoride-trifluoro ethylene (P(VDF-TrFE), liquid crystal polymers, polyamides, etc. Piezoelectricity is observed in amorphous or non-crystalline polymers when its molecular structure contains dipoles. The dipoles are aligned by poling at temperatures higher than the polymer’s glass transition temperature (Tg). Against this background, some leads of the present disclosure can include piezoelectric polymers (or piezoelectric elements) along portions or an entire length of the lead body. With these and similar configurations, a cough, sneeze or similar event with accompany strain can be detected by the piezoelectric polymers or elements embedded in the lead body.

[0096] In some embodiments, the leads of the present disclosure and / or other components of the system 50 (e.g., the IPG 64) can include one or more microelectromechanical system (MEMS)-type sensors. A ME MS-type sensor is a miniature device that has both mechanical and electrical components. The physical dimension of a MEMS can be extremely small (in the range of microns) and can easily be incorporated into a lead. Alternatively or in addition, a MEMS-1618.332 11138type sensor can be incorporated into the IPG 64 (e.g., the IPG header or inside a hermetic can of the IPG, etc.). The so-provided ME MS-type sensor(s) can be configured to operate as a strain gauge, a pressure sensor, an accelerometer, a microphone, a flow sensor (e.g., detecting presence of fluid in the urethra 14 during voiding or during leaking), etc. In other embodiments, the MEMS-type sensor(s) can be formatted and arranged to serve as a bioimpedance device. For example, a dedicated electrode at or near a distal tip of the lead could be used for bioimpedance of the urethra 14 (e.g., to detect a change during fluid flow or a leak), bioimpedance between the IPG and the electrode (e.g., to detect a changes in bladder fullness), muscular contraction of the EUS 34 or pelvic floor, etc. With any of these or related embodiments, additional sensor(s) (e.g., sensing electrode(s)) can be located some distance (e.g., 1-15 cm) proximal from the lead tip to enable a wider field, and conversely extend the tip of the lead beyond the target (e.g., with lead orientations that are transverse to the urethra 14) to position electrodes on the opposite side and enable a broaderfield for EMG / bioimpedance sensing.

[0097] In some embodiments, the leads of the present disclosure can include one or more electromyography-type sensors. Electromyography (EMG) is a technique for evaluating and recording the electrical activity produced by skeletal muscles. Where provided, the EMG sensor(s) can be located along a length of the lead (or other tool, such as the probe unit 700 (FIG. 23)) so as to be appropriately located (upon final implant) to detect EMG of one or more of the patient’s abdominal muscles, EUS, and / or other pelvic floor muscles. Alternatively or in addition, the leads of the present disclosure can include one or more electroneurography-type sensors. Electroneurography (ENG) is a technique for evaluating the function or integrity of a peripheral nerve, for example by stimulating the nerve and measuring the electrical activity of the muscle(s) it innervates. Where provided, the ENG sensor(s) can be located along a length of the lead (or other tool, such as the probe unit 700 (FIG. 23)) to facilitate detecting and triggering stimulation based on activation of target nerve(s).ASPECTS1618.332 11139

[0098] Various Aspects are described below. It is to be understood that any one or more of the features recited in the following Aspect(s) can be combined with any one or more of other Aspect(s).

[0099] Aspect 1. A method of treating a bladder dysfunction of a patient, the method comprising: placing at least one stimulation element of a lead proximate an external urethral sphincter (EUS) of the patient; and applying stimulation energy to the EUS via the stimulation element.

[0100] Aspect 2. The method of Aspect 1, wherein the at least one stimulation element is carried by a lead body of the lead, and further wherein the step of placing includes arranging the lead body to extend between a urethra and a vagina of the patient.

[0101] Aspect 3. The method of Aspect 1, wherein the at least one stimulation element is carried by a lead body of the lead, and further wherein the step of placing includes arranging the lead body to extend across next to a urethra of the patient at a location opposite a vagina of the patient.

[0102] Aspect 4. The method as in any of Aspects 1-3, wherein the at least one stimulation element is carried by a lead body of the lead, the lead body defining a saddle region, and further wherein the step of placing further includes locating the saddle region at a urethra of the patient at a level of the EUS.

[0103] Aspect 5. The method of Aspect 4, wherein in at least a deployed state of the lead, the saddle region defines a curvature configured to be received across at least a segment of the urethra.

[0104] Aspect 6. The method of Aspect 5, wherein the step of placing includes confirming placement of the lead relative to the urethra by palpating the urethra within the curvature of the saddle region.

[0105] Aspect 7. The method of Aspect 5 or 6, wherein the lead is configured to provide a delivery state in which the saddle region is substantially linear, the saddle region being transitionable from the delivery state to the deployed state.

[0106] Aspect 8. The method as in any of Aspects 5-7, wherein the at least one stimulation element includes a stimulation element carried by the saddle region.

[0107] Aspect 9. The method as in any of Aspects 5-8, wherein the body further defines first and second shelf regions extending from opposite sides of the saddle region, respectively.1618.332 11140

[0108] Aspect 10. The method of Aspect 9, wherein the at least one stimulation element includes a first stimulation element carried by the first shelf region and a second stimulation element carried by the second shelf region.

[0109] Aspect 11. The method of Aspect 10, wherein in at least a deployed state of the lead, the first and second shelf regions locate the first and second stimulation elements, respectively, spatially away from an apex of the curvature of the saddle region.

[0110] Aspect 12. The method of Aspect 11 , wherein the step of placing includes the first and second shelf regions maintaining the first and second stimulation elements, respectively, proximate the EUS.

[0111] Aspect 13. The method as in any of Aspects 9-12, wherein the first shelf region extends distally from the saddle region, and further wherein the body further defines an overlap region extending distally from the first shelf region, and even further wherein the step of placing includes arranging the urethra between the saddle region and the overlap region.

[0112] Aspect 14. The method as in any of Aspects 5-13, wherein the lead body further defines a distal region distal the saddle region, the distal region including first and second arms.

[0113] Aspect 15. The method of Aspect 14, wherein the at least one stimulation element includes a first stimulation element carried by the first arm and a second stimulation element carried by the second arm.

[0114] Aspect 16. The method of Aspect 15, wherein the step of placing includes locating at least one of the first and second stimulation elements proximate the EUS.

[0115] Aspect 17. The method of Aspect 16, wherein in at least the deployed state of the lead, the first and second arms splay away from one another in extension from the saddle region.

[0116] Aspect 18. The method of Aspect 17, wherein the step of placing includes the first and second arms limiting migration of the body.

[0117] Aspect 19. The method as in any of Aspects 15-18, wherein the lead body further defines an intermediate region proximal the saddle region, the intermediate region including first and second legs.1618.332 11141

[0118] Aspect 20. The method of Aspect 19, wherein the at least one stimulation element further includes a third stimulation element carried by the first leg and a fourth stimulation element carried by the second leg.

[0119] Aspect 21. The method of Aspect 20, wherein the step of placing includes locating at least one of the third and fourth stimulation elements proximate the EUS.

[0120] Aspect 22. The method of Aspect 20 or 21 , wherein in at least the deployed state of the lead, the first and second legs combine to define an opening.

[0121] Aspect 23. The method of Aspect 22, wherein the step of placing includes locating the first and second legs over tissue of the patient, the method further comprising securing at least one of the first and second legs to the tissue with a suture.

[0122] Aspect 24. The method of Aspect 22 or 23, wherein the step of placing includes locating the first and second legs over tissue of the patient, the method further comprising tissue ingrowth occurring at the opening.

[0123] Aspect 25. The method as in any of Aspects 5-24, wherein the lead body is cylindrical.

[0124] Aspect 26. The method of Aspect 25, wherein the lead is a percutaneous lead.

[0125] Aspect 27. The method as in any of Aspects 5-26, wherein the lead body includes a head defining an elongated shape having a length greater than a width, and the width greater than a thickness.

[0126] Aspect 28. The method of Aspect 27, wherein the lead is a paddle lead.

[0127] Aspect 29. The method of Aspect 28, wherein the paddle lead is provided as part of a sling device.

[0128] Aspect 30. The method of Aspect 29, wherein the sling device includes a sling body, and further wherein the step of placing includes securing the sling body to anatomy of the patient such that the sling body supports the urethra of the patient.

[0129] Aspect 31 . The method as in any of Aspects 1 -30, wherein the at least one stimulation element is a first stimulation element carried by a first body, the method further comprising: placing a second stimulation element carried by a1618.332 11142second body proximate the EUS; and applying stimulation energy to the EUS via the second stimulation element.

[0130] Aspect 32. The method of Aspect 31 , wherein each of the first and second bodies define a saddle region configured to receive a segment of a urethra of the patient.

[0131] Aspect 33. The method of Aspect 31 or 32, wherein the first body is provided as part of a first lead and the second body is provided as part of a second lead.

[0132] Aspect 34. The method as in any of Aspects 31-33, wherein the first and second bodies are provided as part of a bifurcated lead.

[0133] Aspect 35. The method as in any of Aspects 1-34, wherein the step of placing includes tunneling a delivery path to a urethra of the patient at a location proximate the EUS.

[0134] Aspect 36. The method of Aspect 35, wherein the delivery path is one of a trans obturator path, a retropubic path, and a prepubic path.

[0135] Aspect 37. The method of Aspect 35 or 36, wherein the delivery path extends through an obturator foramen or window of the patient.

[0136] Aspect 38. The method of Aspect 37, wherein the delivery path initiates at an incision lateral to the obturator foramen and does not include a vaginal incision.

[0137] Aspect 39. The method of Aspect 38, wherein the step of placing includes tunneling a single delivery path.

[0138] Aspect 40. The method of Aspect 37, wherein the delivery path initiates at a vaginal incision.

[0139] Aspect 41. The method of Aspect 35, wherein the delivery path is a retropubic path initiated at one of a vaginal incision, external skin of or near a vulva of the patient, and superior to a pubic symphysis of the patient.

[0140] Aspect 42. The method of Aspect 35, wherein the delivery path is a prepubic path initiated at one of a vaginal incision, a vaginal sulcus, and superior to a pubic symphysis.

[0141] Aspect 43. The method of Aspect 35, wherein the step of tunneling includes directing a distal end of a shaft of a passer tool through tissue of the patient to form the delivery path.1618.332 11143

[0142] Aspect 44. The method of Aspect 43, wherein the shaft defines a curvature.

[0143] Aspect 45. The method of Aspect 44, wherein the shaft is one of rigid and malleable.

[0144] Aspect 46. The method as in any of Aspects 43-45, wherein the step of placing includes connecting the lead to the shaft such that the lead is pulled with the shaft during the step of tunneling.

[0145] Aspect 47. The method of Aspect 46, wherein the step of placing includes the lead being disposed within a cover and the cover is pulled with the shaft during the step of tunneling.

[0146] Aspect 48. The method as in any of Aspects 43-45, wherein the step of placing includes passing the lead through a lumen of the shaft.

[0147] Aspect 49. The method as in any of Aspects 43-45, wherein the step of placing includes locating an introducer sheath along the delivery path, removing the shaft from the patient, and delivering the lead through the introducer sheath.

[0148] Aspect 50. The method as in any of Aspects 43-49, wherein the step of tunneling further includes emitting stimulation energy from a location proximate the distal end of the shaft to evaluate a current location of the distal end relative to the EUS.

[0149] Aspect 51. The method of Aspect 50, wherein the passer tool further includes at least one shaft electrode located proximate the distal end of the shaft, and further wherein the step of emitting stimulation energy includes delivering energy to the shaft electrode.

[0150] Aspect 52. The method of Aspect 50, wherein the shaft defines a lumen and at least one opening through a thickness of the shaft that is open to the lumen, and further wherein the step of emitting stimulation energy includes disposing the lead within the lumen such that the at least one stimulation element of the lead is aligned with the opening.

[0151] Aspect 53. The method as in any of Aspects 43-52, wherein the step of tunneling further includes emitting light from the distal end of the shaft, the emitted light passing through the urethra for visualization via urethroscopy.1618.332 11144

[0152] Aspect 54. The method as in any of Aspects 43-53, wherein the shaft forms or carries a palpable element, and wherein the step of tunneling include palpating the palpable element by a clinician.

[0153] Aspect 55. The method as in any of Aspects 1-54, wherein the step of placing includes locating the EUS along a urethra of the patient.

[0154] Aspect 56. The method of Aspect 55, wherein the step of locating includes approximating a distance of a target site from an anatomical reference point of the patient.

[0155] Aspect 57. The method of Aspect 56, wherein the target site is one of the EUS and a nerve entry site.

[0156] Aspect 58. The method of Aspect 56 or 57, wherein the anatomical reference point is one of a urethral meatus and a bladder neck of the patient.

[0157] Aspect 59. The method as in any of Aspects 55-58, wherein the step of locating includes obtaining images of an anatomy of the patient.

[0158] Aspect 60. The method as in any of Aspects 55-59, wherein the step of locating includes: applying stimulation energy to the EUS through a wall of the urethra from a plurality of different locations along a length of the urethra; measuring a localized response to the applied stimulation at each of the different locations; and identifying a maximum of the measured localized responses.

[0159] Aspect 61. The method of Aspect 60, wherein the localized response is one of urethral pressure rise and electromyography (EMG).

[0160] Aspect 62. The method of Aspect 60 or 61, wherein the step of applying stimulation energy to the EUS through a wall of the urethra include inserting a catheter carrying at least one electrode into the urethra.

[0161] Aspect 63. The method of Aspect 62, wherein the step of measuring includes operating a sensor carried by the catheter and configured to sense a parameter indicative of pressure.

[0162] Aspect 64. The method of Aspect 63, wherein a balloon device is further carried by the catheter, and wherein the step of locating further includes: inflating the balloon device following insertion of the catheter into the urethra; and palpating the inflated balloon device.1618.332 11145

[0163] Aspect 65. The method as in any of Aspects 1-64, wherein the step of applying stimulation energy to the EUS includes delivering stimulation energy to the stimulation element on a chronic intermittent basis.

[0164] Aspect 66. The method as in any of Aspects 1-65, wherein the step of applying stimulation energy to the EUS includes applying stimulation energy in response to information from a sensor positioned to sense at least one parameter of the patient indicative of a potential incontinence event.

[0165] Aspect 67. The method of Aspect 66, wherein the sensor is one of carried by and formed by the lead.

[0166] Aspect 68. The method of Aspect 67, wherein the sensor is an electromyography (EMG) sensor.

[0167] Aspect 69. The method of Aspect 68, wherein upon final implant of the lead, the sensor is located to detect EMG of at least one of an abdominal muscle, the EUS, and a pelvic floor muscle.

[0168] Aspect 70. The method of Aspect 67, wherein the sensor includes a piezoelectric element.

[0169] Aspect 71. The method of Aspect 70, wherein the piezoelectric element is provided by a piezoelectric polymer incorporated into the lead.

[0170] Aspect 72. The method of Aspect 71, wherein upon final implant of the lead, the piezoelectric element is positioned to detect strain indicative of a potential incontinence event.

[0171] Aspect 73. The method of Aspect 67, wherein the sensor is a microelectromechanical system (MEMS) device.

[0172] Aspect 74. The method of Aspect 73, wherein the MEMS device is configured to operate as at least one of: strain gauge; pressure sensor; accelerometer; microphone; flow sensor; and bioimpedance sensor.

[0173] Aspect 75. A device configured to perform at least one step of the method of any one of Aspects 1 -74.

[0174] Aspect 76. A lead comprising one or more stimulation elements and a lead body, wherein the lead body is configured such that, when the lead is implanted in a patient, at least one of the one or more stimulation elements is positioned proximate an external urethral sphincter (EUS). In some embodiments, the geometry, flexibility profile, and stimulation element placement along the lead1618.332 11146body are selected such that, upon implantation using standard implantation techniques, the lead self-orients or conforms to patient anatomy to position at least one stimulation element adjacent to a target tissue, such as the external urethral sphincter, without requiring precise intraoperative localization.

[0175] Aspect 77. The lead of Aspect 76, wherein the at least one stimulation element is carried by the lead body, the lead body defining a saddle region, and further wherein the saddle region is configured to for placement at a urethra of the patient at a level of the EUS.

[0176] Aspect 78. The lead of Aspect 77, wherein in at least a deployed state of the lead, the saddle region defines a curvature configured to be received across at least a segment of the urethra.

[0177] Aspect 79, The lead of Aspect 77 or 78, wherein the lead is configured to provide a delivery state in which the saddle region is substantially linear, the saddle region being transitionable from the delivery state to the deployed state.

[0178] Aspect 80. The lead as in any of Aspects 77-79, wherein the at least one stimulation element includes a stimulation element carried by the saddle region.

[0179] Aspect 81. The lead as in any of Aspects 77-80, wherein the body further defines first and second shelf regions extending from opposite sides of the saddle region, respectively.

[0180] Aspect 82. The lead of Aspect 81, wherein the at least one stimulation element includes a first stimulation element carried by the first shelf region and a second stimulation element carried by the second shelf region.

[0181] Aspect 83. The lead of Aspect 82, wherein in a deployed state of the lead, the first and second shelf regions locate the first and second stimulation elements, respectively, spatially away from an apex of the curvature of the saddle region.

[0182] Aspect 84. The lead of Aspect 81 , wherein the first shelf region extends distally from the saddle region, and further wherein the body further defines an overlap region extending distally from the first shelf region.

[0183] Aspect 85. The lead as in any of Aspects 78-84, wherein the lead body further defines a distal region distal the saddle region, the distal region including first and second arms.1618.332 11147

[0184] Aspect 86. The lead of Aspect 85, wherein the at least one stimulation element includes a first stimulation element carried by the first arm and a second stimulation element carried by the second arm.

[0185] Aspect 87. The lead of Aspect 86, wherein in at least the deployed state of the lead, the first and second arms splay away from one another in extension from the saddle region.

[0186] Aspect 88. The lead of Aspect 86 or 87, wherein the body further defines an intermediate region proximal the saddle region, the intermediate region including first and second legs.

[0187] Aspect 89. The lead of Aspect 88, wherein the at least one stimulation element further includes a third stimulation element carried by the first leg and a fourth stimulation element carried by the second leg.

[0188] Aspect 90. The lead as in any of Aspects 76-89, wherein the lead body is cylindrical.

[0189] Aspect 91 . The lead of Aspect 90, wherein the lead is a percutaneous lead.

[0190] Aspect 92. The lead as in any of Aspects 76-89, wherein the lead body includes a head defining an elongated shape having a length greater than a width, and the width greater than a thickness.

[0191] Aspect 93. The lead of Aspect 92, wherein the lead is a paddle lead.

[0192] Aspect 94. The lead of Aspect 93, wherein the paddle lead is provided as part of a sling device.1618.332 11148

[0193] 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. Any of the systems, methods, and algorithms of the present disclosure can be utilized for the treatment of other medical conditions.

Claims

1618.332 11149CLAIMS1. A method of treating a bladder dysfunction of a patient, the method comprising:placing at least one stimulation element of a lead proximate an external urethral sphincter (EUS) of the patient; andapplying stimulation energy to the EUS via the stimulation element.

2. The method of claim 1, wherein the at least one stimulation element is carried by a lead body of the lead, and further wherein the step of placing includes arranging the lead body to extend between a urethra and a vagina of the patient.

3. The method of claim 1 , wherein the at least one stimulation element is carried by a lead body of the lead, and further wherein the step of placing includes arranging the lead body to extend across next to a urethra of the patient at a location opposite a vagina of the patient.

4. The method of claim 1 , wherein the at least one stimulation element is carried by a lead body of the lead, the lead body defining a saddle region, and further wherein the step of placing further includes locating the saddle region at a urethra of the patient at a level of the EUS.

5. The method of claim 4, wherein in at least a deployed state of the lead, the saddle region defines a curvature configured to be received across at least a segment of the urethra.

6. The method of claim 5, wherein the step of placing includes confirming placement of the lead relative to the urethra by palpating the urethra within the curvature of the saddle region.

7. The method of claim 5, wherein the lead is configured to provide a delivery state in which the saddle region is substantially linear, the saddle region being transitionable from the delivery state to the deployed state.1618.332 111508. The method of claim 5, wherein the at least one stimulation element includes a stimulation element carried by the saddle region.

9. The method of claim 5, wherein the body further defines first and second shelf regions extending from opposite sides of the saddle region, respectively.

10. The method of claim 9, wherein the at least one stimulation element includes a first stimulation element carried by the first shelf region and a second stimulation element carried by the second shelf region.

11. The method of claim 10, wherein in at least a deployed state of the lead, the first and second shelf regions locate the first and second stimulation elements, respectively, spatially away from an apex of the curvature of the saddle region.

12. The method of claim 11 , wherein the step of placing includes the first and second shelf regions maintaining the first and second stimulation elements, respectively, proximate the EUS.

13. The method of claim 9, wherein the first shelf region extends distally from the saddle region, and further wherein the body further defines an overlap region extending distally from the first shelf region, and even further wherein the step of placing includes arranging the urethra between the saddle region and the overlap region.

14. The method of claim 5, wherein the lead body further defines a distal region distal the saddle region, the distal region including first and second arms.

15. The method of claim 14, wherein the at least one stimulation element includes a first stimulation element carried by the first arm and a second stimulation element carried by the second arm.1618.332 1115116. The method of claim 15, wherein the step of placing includes locating at least one of the first and second stimulation elements proximate the EUS.

17. The method of claim 16, wherein in at least the deployed state of the lead, the first and second arms splay away from one another in extension from the saddle region.

18. The method of claim 17, wherein the step of placing includes the first and second arms limiting migration of the body.

19. The method of claim 15, wherein the lead body further defines an intermediate region proximal the saddle region, the intermediate region including first and second legs.

20. The method of claim 19, wherein the at least one stimulation element further includes a third stimulation element carried by the first leg and a fourth stimulation element carried by the second leg.

21. The method of claim 20, wherein the step of placing includes locating at least one of the third and fourth stimulation elements proximate the EUS.

22. The method of claim 20, wherein in at least the deployed state of the lead, the first and second legs combine to define an opening.

23. The method of claim 22, wherein the step of placing includes locating the first and second legs over tissue of the patient, the method further comprising securing at least one of the first and second legs to the tissue with a suture.

24. The method of claim 22, wherein the step of placing includes locating the first and second legs over tissue of the patient, the method further comprising tissue ingrowth occurring at the opening.

25. The method of claim 5, wherein the lead body is cylindrical.1618.332 1115226. The method of claim 25, wherein the lead is a percutaneous lead.

27. The method of claim 5, wherein the lead body includes a head defining an elongated shape having a length greater than a width, and the width greater than a thickness.

28. The method of claim 27, wherein the lead is a paddle lead.

29. The method of claim 28, wherein the paddle lead is provided as part of a sling device.

30. The method of claim 29, wherein the sling device includes a sling body, and further wherein the step of placing includes securing the sling body to anatomy of the patient such that the sling body supports the urethra of the patient.

31. The method of claim 1, wherein the at least one stimulation element is a first stimulation element carried by a first body, the method further comprising:placing a second stimulation element carried by a second body proximate the EUS; andapplying stimulation energy to the EUS via the second stimulation element.

32. The method of claim 31 , wherein each of the first and second bodies define a saddle region configured to receive a segment of a urethra of the patient.

33. The method of claim 31 , wherein the first body is provided as part of a first lead and the second body is provided as part of a second lead.

34. The method of claim 31 , wherein the first and second bodies are provided as part of a bifurcated lead.

35. The method of claim 1, wherein the step of placing includes tunneling a delivery path to a urethra of the patient at a location proximate the EUS.1618.332 1115336. The method of claim 35, wherein the delivery path is one of a trans obturator path, a retropubic path, and a prepubic path.

37. The method of claim 35, wherein the delivery path extends through an obturator foramen or window of the patient.

38. The method of claim 37, wherein the delivery path initiates at an incision lateral to the obturator foramen and does not include a vaginal incision.

39. The method of claim 38, wherein the step of placing includes tunneling a single delivery path.

40. The method of claim 37, wherein the delivery path initiates at a vaginal incision.

41. The method of claim 35, wherein the delivery path is a retropubic path initiated at one of a vaginal incision, external skin of or near a vulva of the patient, and superior to a pubic symphysis of the patient.

42. The method of claim 35, wherein the delivery path is a prepubic path initiated at one of a vaginal incision, a vaginal sulcus of the patient, and superior to a pubic symphysis of the patient.

43. The method of claim 35, wherein the step of tunneling includes directing a distal end of a shaft of a passer tool through tissue of the patient to form the delivery path.

44. The method of claim 43, wherein the shaft defines a curvature.

45. The method of claim 44, wherein the shaft is one of rigid and malleable.1618.332 1115446. The method of claim 43, wherein the step of placing includes connecting the lead to the shaft such that the lead is pulled with the shaft during the step of tunneling.

47. The method of claim 46, wherein the step of placing includes the lead being disposed within a cover and the cover is pulled with the shaft during the step of tunneling.

48. The method of claim 43, wherein the step of placing includes passing the lead through a lumen of the shaft.

49. The method of claim 43, wherein the step of placing includes locating an introducer sheath along the delivery path, removing the shaft from the patient, and delivering the lead through the introducer sheath.

50. The method of claim 43, wherein the step of tunneling further includes emitting stimulation energy from a location proximate the distal end of the shaft to evaluate a current location of the distal end relative to the EUS.

51. The method of claim 50, wherein the passer tool further includes at least one shaft electrode located proximate the distal end of the shaft, and further wherein the step of emitting stimulation energy includes delivering energy to the shaft electrode.

52. The method of claim 50, wherein the shaft defines a lumen and at least one opening through a thickness of the shaft that is open to the lumen, and further wherein the step of emitting stimulation energy includes disposing the lead within the lumen such that the at least one stimulation element of the lead is aligned with the opening.

53. The method of claim 43, wherein the step of tunneling further includes emitting light from the distal end of the shaft, the emitted light passing through the urethra for visualization via urethroscopy.1618.332 1115554. The method of claim 43, wherein the shaft forms or carries a palpable element, and wherein the step of tunneling include palpating the palpable element by a clinician.

55. The method of claim 1, wherein the step of placing includes locating the EUS along a urethra of the patient.

56. The method of claim 55, wherein the step of locating includes approximating a distance of a target site from an anatomical reference point of the patient.

57. The method of claim 56, wherein the target site is one of the EUS and a nerve entry site.

58. The method of claim 56, wherein the anatomical reference point is one of a urethral meatus and a bladder neck of the patient.

59. The method of claim 55, wherein the step of locating includes obtaining images of an anatomy of the patient.

60. The method of claim 55, wherein the step of locating includes:applying stimulation energy to the EUS through a wall of the urethra from a plurality of different locations along a length of the urethra; measuring a localized response to the applied stimulation at each of the different locations; andidentifying a maximum of the measured localized responses.

61. The method of claim 60, wherein the localized response is one of urethral pressure rise and electromyography (EMG).1618.332 1115662. The method of claim 60, wherein the step of applying stimulation energy to the EUS through a wall of the urethra include inserting a catheter carrying at least one electrode into the urethra.

63. The method of claim 62, wherein the step of measuring includes operating a sensor carried by the catheter and configured to sense a parameter indicative of pressure.

64. The method of claim 63, wherein a balloon device is further carried by the catheter, and wherein the step of locating further includes:inflating the balloon device following insertion of the catheter into the urethra; andpalpating the inflated balloon device.

65. The method of claim 1 , wherein the step of applying stimulation energy to the EUS includes delivering stimulation energy to the stimulation element on a chronic intermittent basis.

66. The method of claim 1 , wherein the step of applying stimulation energy to the EUS includes applying stimulation energy in response to information from a sensor positioned to sense at least one parameter of the patient indicative of a potential incontinence event.

67. The method of claim 66, wherein the sensor is one of carried by and formed by the lead.

68. The method of claim 67, wherein the sensor is an electromyography (EMG) sensor.

69. The method of claim 68, wherein upon final implant of the lead, the sensor is located to detect EMG of at least one of an abdominal muscle, the EUS, and a pelvic floor muscle.1618.332 1115770. The method of claim 67, wherein the sensor includes a piezoelectric element.

71. The method of claim 70, wherein the piezoelectric element is provided by a piezoelectric polymer incorporated into the lead.

72. The method of claim 71, wherein upon final implant of the lead, the piezoelectric element is positioned to detect strain indicative of a potential incontinence event.

73. The method of claim 67, wherein the sensor is a micro-electromechanical system (MEMS) device.

74. The method of claim 73, wherein the MEMS device is configured to operate as at least one of:strain gauge;pressure sensor;accelerometer;microphone;flow sensor; andbioimpedance sensor.

75. A lead comprising one or more stimulation elements and a lead body, wherein the lead body is configured such that, when the lead is implanted in a patient, at least one of the one or more stimulation elements is positioned proximate an external urethral sphincter (EUS).

76. The lead of claim 75, wherein a geometry, flexibility profile, and stimulation element placement along the lead body are selected such that, upon implantation using standard implantation techniques, the lead self-orients or conforms to patient anatomy to position at least one stimulation element adjacent to a target tissue, such as the external urethral sphincter, without requiring precise intraoperative localization.1618.332 1115877. The lead of claim 75, wherein the at least one stimulation element is carried by the lead body, the lead body defining a saddle region, and further wherein the saddle region is configured to for placement at a urethra of the patient at a level of the EUS78. The lead of claim 77, wherein in at least a deployed state of the lead, the saddle region defines a curvature configured to be received across at least a segment of the urethra.

79. The lead of claim 77, wherein the lead body further defines first and second shelf regions extending from opposite sides of the saddle region, respectively.

80. The lead of claim 79, wherein the at least one stimulation element includes a first stimulation element carried by the first shelf region and a second stimulation element carried by the second shelf region.

81. The lead of claim 80, wherein in at least a deployed state of the lead, the first and second shelf regions locate the first and second stimulation elements, respectively, spatially away from an apex of the curvature of the saddle region.

82. The lead of claim 79, wherein the first shelf region extends distally from the saddle region, and further wherein the body further defines an overlap region extending distally from the first shelf region.

83. The lead of claim 77, wherein the lead body further defines a distal region distal the saddle region, the distal region including first and second arms.

84. The lead of claim 83, wherein the at least one stimulation element includes a first stimulation element carried by the first arm and a second stimulation element carried by the second arm.1618.332 1115985. The lead of claim 84, wherein in at least the deployed state of the lead, the first and second arms splay away from one another in extension from the saddle region.

86. The lead of claim 85, wherein the lead body further defines an intermediate region proximal the saddle region, the intermediate region including first and second legs.

87. The lead of claim 86, wherein the at least one stimulation element further includes a third stimulation element carried by the first leg and a fourth stimulation element carried by the second leg.

Images