Abstract: The disclosure is directed to techniques for providing a visualization of efficacy ratings for a medical therapy. A graphical representation of weighted efficacy parameter values may be displayed to provide a visualization of efficacy for the patient. The graphical representation may include a boundary extending between the efficacy parameter values on multiple axes. If the representation includes three axes, the shape of the boundary may be substantially triangular. The graphical representation may simultaneously display multiple graphical representations. Each of the multiple multi-axis graphical representations corresponds to efficacy parameter values obtained for different sets of therapy parameters or to efficacy parameter values obtained at different times. The graphical representation may be modified so that the efficacy parameter values correspond to values relating to a time reference specified by a user.

Abstract: An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one electrode; a lead body; and at least one modifiable portion wherein the at least one modifiable portion can exist in both a deflated configuration and an inflated configuration, and wherein the inflated configuration exhibits a greater resistance to movement of the lead within the body tissue than does the deflated configuration. Kits, systems, and methods of using the leads are also included.

Abstract: The disclosure describes a method and system for applying electrical stimulation to an iliohypogastric nerve of a patient. The system includes electrical stimulators that apply electrical stimulation for alleviation of pelvic pain. The system may apply electrical stimulation for pelvic pain in men or women. The electrical stimulators may comprise various types of electrodes such as cuff electrodes, electrode leads, and microstimulators implanted at various locations proximate to a single or both iliohypogastric nerves of a patient. In particular, the electrode may be implanted proximate or adjacent to an anterior cutaneous branch of one or both iliohypogastric nerves, a lateral cutaneous branch of one or both iliohypogastric nerves, or one or both of iliohypogastric nerves above the branch point.

Abstract: The disclosure describes a method and system for applying electrical stimulation to a pudendal nerve of a patient via an implantable electrical stimulation device to treat a pelvic disorder in men or women. Pelvic disorders may include sexual dysfunction, urinary incontinence, pudendal nerve entrapment (PNE), and urogenital pain or other forms of pelvic pain, e.g., chronic pelvic pain and prostatitis-like pain. The electrical stimulation may be applied to one or both pudendal nerves and, more particularly, to at least one of a dorsal branch and a perineal branch of one or both pudendal nerves. In some embodiments, the electrical stimulation may be applied to at least one of the dorsal and perineal branches of a pudendal nerve via a pudendal canal of the patient. In further embodiments, drug therapy may be delivered alone or in combination with electrical stimulation to one or both pudendal nerves of a patient via an implantable drug delivery device.

Abstract: The disclosure describes a method and system for delivering a drug to an iliohypogastric nerve of a patient. The system includes drug delivery devices that deliver one or more drugs for alleviation of pelvic pain. The system may deliver drug therapy for pelvic pain in men or women. Drug therapy may made be delivered at various locations along a single or both iliohypogastric nerves of a patient via a fluid transfer device. In some embodiments, electrical stimulation may be applied in combination with drug therapy to one or both iliohypogastric nerves of a patient.

Abstract: The invention includes an implantable medical electrical lead for electrical stimulation of body tissue that includes at least one electrode; a lead body; and at least one modifiable portion that is coaxial with the lead body, wherein the at least one modifiable portion can exist in both a first configuration and a second configuration, wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration, and wherein the first configuration is exhibited when an external force is applied to the outer surface of the modifiable portion. Kits, systems and methods of implanting are also included in the invention.

Abstract: The disclosure describes an external sensor attached to an undergarment worn by a patient that detects voiding information. The sensor stores the voiding information in a voiding log and transmits the voiding log to an external device. The external device includes a user interface that displays the voiding log to the patient for review. The patient may correct any incorrect voiding information that was logged in error or due to a non-voiding event. A user, such as a clinician or the patient, may use the voiding information to diagnose a condition of the patient. In addition, the voiding information of the voiding log may be used by the user to adjust a stimulation therapy or the external device to automatically adjust stimulation therapy. The undergarment may be disposable or washable after patient use.

Abstract: The disclosure describes a method and system for delivering a drug to an ilioinguinal nerve of a patient. The system includes drug delivery devices that deliver one or more drugs for alleviation of pelvic pain. The system may deliver drug therapy for pelvic pain in men or women. Drug therapy may be delivered at various locations along a single or both ilioinguinal nerves of a patient via a fluid transfer device. In some embodiments, electrical stimulation may be applied in combination with drug therapy to one or both ilioinguinal nerves of a patient.

Abstract: The disclosure describes a method and system for applying electrical stimulation to a genitofemoral nerve or a genital branch of a genitofemoral nerve of a patient. The system includes electrical stimulators that apply electrical stimulation for alleviation of pelvic pain. The system may apply electrical stimulation for pelvic pain in men or women. The electrical stimulators may comprise various types of electrodes such as cuff electrodes, electrode leads, and microstimulators implanted at various locations proximate to a single or both genitofemoral nerves and the genital branch of a single or both genitofemoral nerves of a patient. When implanted proximate to a genital nerve branch, the electrode may be implanted proximate to the genital nerve branch. In a male patient stimulation may be delivered proximate to the spermatic cord, which contains a portion of the genital nerve branch.

Abstract: The disclosure describes a system that may be used to deliver ablation therapy to a target tissue within a patient. The system uses a flexible catheter to navigate through a passage and reach a target tissue. Once at the desired location, a side of the flexible catheter is forced against a wall of the passage to allow a needle to be extended from the side of the flexible catheter and into the target tissue. A pull-wire or inflatable balloon may be used as the control mechanism that forces the flexible catheter against the passage wall. In the case of the pull-wire, the flexible catheter may also be steered through the passage. As an example, the flexible catheter may be inserted into the urethra and the needle may be deployed into the prostate to treat benign prostatic hypertrophy (BPH).

Abstract: The disclosure is directed to a method and tool for implanting a stimulation lead or other medical device adjacent a pudendal nerve. The tool includes a shaped needle that enters a patient and passes through an obturator foramen passage in a pelvis. A physician places a tip of the tool at the pudendal nerve and performs test stimulation to confirm an effective stimulation location. A shape memory cannula initially covering the needle remains at the pudendal nerve when the physician removes the tool. The cannula deforms to follow the curve of the pudendal nerve once the needle is removed, and a lead is inserted into the cannula and secured at the pudendal nerve placement site. This method may provide an easier and more consistent procedure for implanting the stimulation lead near the pudendal nerve.

Abstract: An assembly fixture is used to hold the moveable mold half insert assembly (e.g. the insert, cores, lifters, ejector pins, etc.) in its correct working position and orientation. To spark erode the final geometric form onto a moveable mold half insert assembly, the assembly fixture can be placed in an electro or electrical discharge machine (EDM) with the moveable mold half insert assembly therein.

Abstract: The invention provides an implantable neurostimulator that includes a pulse generator to supply electrical stimulation through a lead having one or more electrodes, a memory storing at least one fluctuating neurostimulation therapy program, wherein the fluctuating neurostimulation therapy program includes frequency of stimulation, pulse width of stimulation, amplitude of stimulation, particular electrode(s) that is to be utilized, the on and off time, or some combination thereof, and a processor that controls the pulse generator to apply stimulation pulses according to the fluctuating neurostimulation therapy program.

Abstract: An implantable medical lead for stimulation of target sites, including nerves, organs, or tissue comprises a lead body having a distal electrode lead segment and a proximal connector lead segment. The electrode lead segment has at its distal end an electrode array including at least one stimulation electrode. The connector lead segment includes at least one common electrode. The proximal end of the connector lead segment may be coupled to a pulse generator, other stimulation device, or additional intermediate wiring.

Abstract: Systems that sense the volume, activity or other parameters of the urinary bladder are described. The systems include at least two electrodes that are implanted at respective locations proximate the wall of the bladder, and may be located substantially opposite each other with respect to a center of the bladder. At least one of the electrodes receives an electrical signal emitted by another of the electrodes. Systems according to the invention detect an impedance through the bladder based on the signal, e.g., based on one or both of the current or voltage of the signal. Based on the detected impedance, the systems sense one or more parameters of the bladder, such as volume, activity, or the like, which influence the impedance. The detected impedance, or bladder parameter information derived from the impedance, may be stored for short- or long-term monitoring, or used to control delivery of a therapy to a patient.

Abstract: The disclosure describes blood flow sensors for detecting penile tumescence. A system according to the invention may include at least one sensor for sensing blood flow into the penis, and one sensor for sensing blood flow away from the penis. Detecting penile tumescence may be accomplished by comparing the flow of blood into the penis to the blood flow out of the penis. A greater inflow of blood indicates an increasing tumescence whereas a greater outflow of blood indicates a decreasing tumescence. The sensors may be used for short- or long-term monitoring of penile tumescence, or as closed-loop feedback in a therapeutic penile tumescence control system, which may deliver electrical or chemical stimulation therapy to control a tumescence or erectile state, thus treating sexual dysfunction or, more specifically, erectile dysfunction.

Abstract: The disclosure describes techniques for sensing penile tumescence based on the impedance of tissue between two electrodes implanted in the penis, which may vary based on penile tumescence, e.g., penile length or circumference. One of the electrodes emits an electrical signal, and the other of the electrodes detects the emitted electrical signal. Information relating to the detected electrical signal, e.g., information indicating the degree of penile tumescence, may be used in a therapeutic penile tumescence control system. For example, such information may be used to control delivery of electrical stimulation of therapeutic substances to the pelvic floor nerves that stimulate erections. In addition, such information may be recorded and presented a physician.

Abstract: An implantable medical electrical lead particularly for stimulation of the sacral nerves comprises a lead body extending between a distal end and a proximal end, and the distal end having at least one electrode of an electrode array extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in and engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes. The fixation mechanism comprises a M tine elements arrayed in a tine element array along a segment of the lead proximal to the stimulation electrode array.

Abstract: The disclosure describes an implantable electrical lead with a conformable array of electrodes. The array of electrodes may be distributed across a convex or concaave surface to position the electrodes in various positions and orientations relative to a target stimulation site. The lead may be useful in a variety of applications such as spinal cord stimulation to alleviate chronic pain, gastrointestinal stimulation to alleviate gastroparesis or obesity, pelvic floor stimulation to alleviate incontinence or sexual dysfunction, or deep brain stimulation to alleviate neurological disorders.

Abstract: The disclosure describes an implantable bladder sensor that is attachable to an exterior surface of a urinary bladder to sense bladder condition or activity. The sensor may include a strain gauge that detects mechanical deformation of the bladder. Mechanical deformation may be indicative of a gradual filling of the bladder, or an instantaneous contraction indicating an imminent urine voiding event. Wireless telemetry circuitry within the sensor transmits information to implanted electrical stimulator that delivers electrical stimulation for alleviating urinary incontinence, or to an external programmer that controls the implanted stimulator.