Abstract: The disclosure describes a sensing device that is implantable to sense bladder conditions, as well as a neurostimulation system and method that make use of such a sensor for alleviation of urinary incontinence. The sensing device is implantable outside the bladder, but includes a lead that penetrates the bladder wall to deployed a sensor within the bladder. Using the sensor on the lead, the sensing device outside the bladder is able to detect a condition within the interior of the bladder. In this sense, the sensing device provides transmembrane sensing of internal bladder conditions. The condition may be indicative of bladder filling or bladder contraction, and may be used to control electrical stimulation applied to the patient to alleviate urinary incontinence.

Abstract: The disclosure describes an implantable electrical lead with a rounded array of electrodes. The array of electrodes may be distributed across a rounded 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 a tube pressure sensor to measure penile tumescence which may be used in a therapeutic penile tumescence control system. The system senses penile pressure and sends the information to a stimulator that is capable of stimulation therapy to control an erectile state, thus treating sexual dysfunction or, more specifically, erectile dysfunction. Measuring penile tumescence pressure is accomplished through the use of a tube placed within the urethra of the penis and attached to a module implanted within the bladder. Pressure on the tube generates an electrical signal that is sent wirelessly to an implanted stimulator connected to a lead positioned near pelvic floor nerves that stimulate erections. An external device may be used to wirelessly send information to the implanted stimulator to start or stop stimulation in order for the patient to conduct normal sexual activity.

Abstract: The disclosure describes a therapeutic sphincter control system with a fluid tube pressure sensor. The system senses sphincter pressure and sends the information to a stimulator that is capable of stimulation therapy to control sphincter contractility, thus reducing unwanted urinary incontinence. Measuring sphincter pressure is accomplished through the use of a fluid-filled tube placed through the sphincter and attached to a module implanted within the bladder. Pressure within the tube is transduced to generate an electrical signal that is sent wirelessly to an implanted stimulator connected to a lead positioned near pelvic floor nerves. An external device may be used to wirelessly send information to the implanted stimulator and inhibit stimulation in order for the patient to empty the bladder. Pressure information and stimulation information may be recorded and reviewed for continued patient monitoring. In addition, the system may only include the pressure sensor to monitor patient pressure information.

Abstract: The disclosure describes an optical fiber pressure sensor to measure sphincter pressure which may be incorporated into a therapeutic sphincter control system. The system senses sphincter pressure and sends the information to a stimulator that is capable of stimulation therapy to control sphincter contractility, thus reducing unwanted urinary incontinence. Measuring sphincter pressure is accomplished through the use of an optical fiber connected to flexible tube section placed through the sphincter, where properties of the emitted light are changed proportional to the pressure on the tube section. The light is returned to a light detector to measure light properties and create an electrical signal representative of the pressure on the tube section. The signal may then be sent by wireless telemetry to an implanted stimulator or external programmer.

Abstract: The disclosure describes a multi-tube pressure sensor to measure the pressure at two sites that may be used in a therapeutic incontinence control system. The system senses urinary sphincter pressure and urethral pressure and sends the information to a stimulator that is capable of stimulation therapy to control sphincter contractility, thus reducing unwanted urinary incontinence. Measuring sphincter pressure is accomplished through the use of a tube placed through the sphincter and urethral pressure is measured by a second tube placed within the urethra, both tubes may be attached to a single module implanted within the bladder. Pressure within the tube generates an electrical signal that is sent wirelessly to an implanted stimulator connected to a lead positioned near pelvic floor nerves. An external device may be used to wirelessly send information to the implanted stimulator and inhibit stimulation in order for the patient to empty the bladder.

Abstract: The disclosure is directed to a chronic implantable neurostimulator that supports trial and chronic modes of operation. The implantable neurostimulator can alternatively include one or more sensors that may or may not function differently in trial and chronic modes. In particular, the device is designed to be used as both a trial neurostimulator and a permanent, or chronic, neurostimulator. A trial neurostimulation period is generally desired to evaluate the efficacy of the therapy. A percutaneous or implantable trial neurostimulator is used for the trial neurostimulation period. In most cases, the trial period is successful, in which case the trial stimulator is explanted and replaced with a permanent, i.e., “chronic,” implantable stimulator. In accordance with the disclosure, an implantable neurostimulator supports both trial neurostimulation and chronic neurostimulation in the event trial stimulation is successful.

Abstract: The disclosure is directed to a chronic implantable neurostimulator that supports trial and chronic modes of operation. The implantable neurostimulator can alternatively include one or more sensors that may or may not function differently in trial and chronic modes. In particular, the device is designed to be used as both a trial neurostimulator and a permanent, or chronic, neurostimulator. A trial neurostimulation period is generally desired to evaluate the efficacy of the therapy. A percutaneous or implantable trial neurostimulator is used for the trial neurostimulation period. In most cases, the trial period is successful, in which case the trial stimulator is explanted and replaced with a permanent, i.e., “chronic,” implantable stimulator. In accordance with the disclosure, an implantable neurostimulator supports both trial neurostimulation and chronic neurostimulation in the event trial stimulation is successful.

Abstract: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Abstract: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate fecal or urinary incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Abstract: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Abstract: Described are implantable devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the left and right sacral nerves, or portions thereof. Two or more electrical stimulation regimes are applied on a continuous, alternating, intermittent or other basis to the left and right sacral nerves or nerve portions in an amount and manner effective to treat a number of disorders, including, but not limited to, urinary and/or fecal voiding dysfunctions such as constipation, incontinence disorders such as urge frequency and urinary retention disorders, sexual dysfunctions such as orgasmic and erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

Abstract: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate urinary or fecal incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Abstract: A medical electrical lead, a system for providing electrical stimulation or sensing using such a lead, and methods of implanting, making and using same are described. The lead includes a rapidly connectable and/or interchangeable distal line that may be attached to a connector located distally from a distal end of a stimulating electrode. The rapidly connectable or interchangeable line may be sutured to a patient's muscle or other tissue. A physician may select a distal suture line of the present invention on the basis of the desired characteristics of the line, and then connect, secure or attach same to the lead body just prior to the surgical operation in which the stimulating or sensing medical electrical lead of the present invention is to be employed. The desired characteristics of the suture line may relate to thickness or diameter, length, the material from which the line is made, biodegradability, and the like.

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: Described are devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the pudendal nerves, and means for delivering one or more drugs in association with such electrical stimulation therapies. One or more electrical stimulation signals are applied, and one or more drugs are infused, injected or otherwise administered, to appropriate portions of a patient's pelvic floor and the pudendal nerves or portions thereof in an amount and manner effective to treat a number of disorders, including, but not limited to, urinary voiding dysfunction, fecal voiding dysfunction, constipation, stress incontinence, urge incontinence, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

Abstract: In general, the invention is directed to devices and methods for use in sub-mucosal implantation of medical devices such as electrical stimulators and physiological sensors. An implantation instrument includes a probe defining a cavity, and a vacuum channel to apply vacuum pressure to draw tissue into the cavity. Once the tissue is captured within the cavity, a needle is advanced through the probe to define an implantation pocket. Then, a medical device, such as an electrical stimulator or sensor, is advanced through the probe and into the pocket. In this manner, a medical device can be quickly and securely implanted at a desired tissue site within a patient.

Abstract: In general, invention is directed to devices and methods for use in laparoscopic surgical procedures in which a medical implant is affixed to or implanted within an exterior surface of a body organ. A system, for example, is described that includes a laparoscopic cannula and a delivery instrument disposed within the cannula to fix a medical implant to an exterior surface of an organ. The delivery instrument has a distal end including a cavity and a vacuum port to draw a portion of the exterior surface of the organ into the cavity. The medical implant is affixed to the portion of the exterior surface drawn into the cavity of the delivery instrument.

Abstract: A device and method for transurethral needle ablation (TUNA) of prostate tissue to alleviate BPH provides ultrasound visualization and/or measurement of the urethra, the prostrate, the ablation lesions and/or other pertinent structures. An ultrasound transducer is positioned at the distal tip of the transurethral needle ablation catheter. The ultrasound transducer provides measurements of the target prostrate tissue in each imaging plane before deployment of the ablation needles. The device may also display the imaged tissue for visualization by a physician.

Abstract: The disclosure is directed to a neurostimulation system and method that make use of remote, distributed stimulators implanted at selected positions within a patient. Each stimulator is capable of independently delivering neurostimulation energy to a patient. A master controller communicates with the stimulator by wireless telemetry, and controls and synchronizes the operation of the stimulators on a selective basis to deliver a desired mode of neurostimulation energy to the patient. The distributed stimulators function as remote “slave” stimulators that can be used to selectively stimulate various nerves. In this manner, the stimulators can be selectively activated and used in a coordinated manner to provide a multi-function stimulation generator or a multi-site stimulator.