Abstract: The disclosure describes a wireless urodynamic monitoring system with an automated voiding diary feature. The system senses and records urodynamic information in response to a user command or in response to detection of the onset of a voiding event. The urodynamic information obtained over a series of voiding events forms an automated voiding diary that is useful in diagnosis of urological disorders. An implantable monitor obtains the urodynamic information and either records the information locally or transmits the information to an external controller via a wireless telemetry link. In some embodiments, the external controller may include a loop recorder for recording urodynamic information obtained by the implantable monitor over an extended period of time.

Abstract: Assembly and method for measuring the concentration of an analyte in a biological matrix. The assembly includes an implantable optical-sensing element that comprises a body, and a membrane mounted on the body in a manner such that the membrane and the body define a cavity. The membrane is permeable to the analyte, but is impermeable to background species in the biological matrix. A refractive element is positioned in the cavity. A light source transmits light of a first intensity onto the refractive element, and a light detector receives light of a second intensity that is reflected from the cavity. A controller device optically coupled to the detector compares the first and second light intensities, and relates the intensities to analyte concentration.

Abstract: Assembly and method for measuring the concentration of an analyte in a biological matrix. The assembly includes an implantable optical-sensing element that comprises a body, and a membrane mounted on the body in a manner such that the membrane and the body define a cavity. The membrane is permeable to the analyte, but is impermeable to background species in the biological matrix. A refractive, element is positioned in the cavity. A light source transmits light of a first intensity onto the refractive element, and a light detector receives light of a second intensity that is reflected from the cavity. A controller device optically coupled to the detector compares the first and second light intensities, and relates the intensities to analyte concentration.

Abstract: A device and method for transurethral needle ablation of prostate tissue to alleviate BPH uses bipolar ablation needles and a virtual electrode. To create the virtual electrode, a conductive fluid is delivered to the target site within the prostate tissue. Ablation energy is then delivered to the target tissue and the virtual electrode via a pair of bipolar ablation needles. The ablation energy flows between the bipolar ablation needles, throughout the virtual electrode and the prostate tissue to create ablation lesions within the prostate.

Abstract: An esophageal delivery system includes features that facilitate the precise positioning of a medical device within the gastrointestinal tract. The system supports indexed positioning without relying solely on endoscopic viewing or external imaging equipment to identify the location of the medical device. A fixation element holds an elongated delivery device at a selected position within the gastrointestinal tract. The medical device is carried at a position that is a fixed and known distance away from the fixation element. Once the fixation element is positioned at a known location, precise positioning of the medical device within the esophagus can be achieved with greater certainty. As an illustration, the fixation element may take the form of a balloon an expandable frame or other device capable of engaging the lower esophageal sphincter (LES) to provide a reference position for a medical device to be placed at a precise distance above the LES.

Abstract: Medical devices and methods are designed to bias stretch receptors in the stomach wall of a patient to treat obesity. Biasing of the stretch receptors by pre-stretching induces an early sensation of satiety, causing the patient to consume less food. Biasing of the stretch receptors can be achieved by the placement of bulking devices within the wall of the stomach, e.g., in the mucosa, submucosa or muscle layer. The bulking devices may be expandable and, in some embodiments, may take the form of a hydrogel prosthesis that expands following implantation in a wall of the stomach.

Abstract: Methods and apparatus for implanting a stimulation lead in a patient's sacrum to deliver neurostimulation therapy that can reduce patient surgical complications, reduce patient recovery time, and reduce healthcare costs. A surgical instrumentation kit for minimally invasive implantation of a sacral stimulation lead through a foramen of the sacrum in a patient to electrically stimulate a sacral nerve comprises a needle and a dilator and optionally includes a guide wire. The needle is adapted to be inserted posterior to the sacrum through an entry point and guided into a foramen along an insertion path to a desired location. In one variation, a guide wire is inserted through a needle lumen, and the needle is withdrawn. The insertion path is dilated with a dilator inserted over the needle or over the guide wire to a diameter sufficient for inserting a stimulation lead, and the needle or guide wire is removed from the insertion path.

Abstract: Assembly and method for measuring the concentration of an analyte in a biological matrix. The assembly includes an implantable optical-sensing element that comprises a body, and a membrane mounted on the body in a manner such that the membrane and the body define a cavity. The membrane is permeable to the analyte, but is impermeable to background species in the biological matrix. A refractive element is positioned in the cavity. A light source transmits light of a first intensity onto the refractive element, and a light detector receives light of a second intensity that is reflected from the cavity. A controller device optically coupled to the detector compares the first and second light intensities, and relates the intensities to analyte concentration.

Abstract: Described are implantable devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the pudendal or other nerves, and optional means for delivering drugs in association therewith. A method of precisely positioning and implanting a medical electrical lead so as to provide optimal stimulation of the pudendal nerve or a portion thereof is also described. Placement of a stimulation lead next to or on the pudendal nerve may be performed using conventional prior art techniques through gross anatomical positioning, but usually does not result in truly optimal lead placement. One method of the present invention utilizes neurophysiological monitoring to assess the evoked responses of the pudendal nerve, and thereby provide a method for determining the optimal stimulation site.

Abstract: Described are implantable devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the pudendal and sacral nerves, or portions thereof, and optional means for delivering drugs in association therewith. Two or more electrical stimulation regimes are applied on a continuous, alternating, intermittent or other basis to the sacral and pudendal nerves, and optionally one or more drugs are infused, injected or otherwise administered, to appropriate portions of a patient's pelvic floor and pudendal nerve and/or sacral nerve, or portions thereof, 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: An implantable electrical stimulation lead includes an integrated fixation mechanism that expands upon implantation of the lead to fix the lead relative to a target tissue site, such as tissue within the epidural region proximate the spine or the sacral foramen. The fixation mechanism may include one or more expandable wire-like elements, which may be configured in a substantial helical shape. The wire-like elements may be formed from an elastic or super-elastic material, and expand radially outward when a restraint mechanism is removed following implantation of the lead.

Abstract: The invention is directed to a technique for delivering a denervating agent to a patient's prostate gland. In particular, the invention is directed to a transurethral technique for delivering the denervating agent. Devices and systems are also described for use in implementing the technique.

Abstract: The invention is directed to techniques for providing electrical stimulation to the prostate gland of a patient. In particular, various techniques are described for providing such stimulation in order to treat sexual dysfunction, benign prostatic hyperplasia (BPH), or other disorders. In some embodiments, the stimulation may be provided to the prostate gland to cause erection or ejaculation in order to treat various sexual dysfunctions. In other embodiments, the stimulation may comprise a training sequence of pulses selected to train and modify the cellular structure of the prostate gland in order to treat BPH or similar prostate disorders.

Abstract: In general, the invention is directed to treatment of urinary incontinence by the implantation of one or more bulking prostheses proximate to a urethral sphincter. These bulking prostheses, which may include biocompatible hydrogel, are implanted into the tissue outside the urethra, proximate to a urethral sphincter. When implanted, the bulking prostheses are in a miniature state. Upon introduction into the body, the devices enter an enlarged state. In their enlarged state, the bulking prostheses supply extra bulk to the tissues proximate to the external urethral sphincter. With the extra bulk, the patient can exercise voluntary control over the external urethral sphincter to close or maintain closure of the urethra and maintain urinary continence.

Abstract: The invention is directed to a technique for delivering a denervating agent to a patient's prostate gland. In particular, the invention is directed to a transrectal technique for delivering the denervating agent. Devices and systems are also described for use in implementing the technique.

Abstract: The invention is directed to a technique for delivering a denervating agent to a patient's prostate gland. In particular, the invention is directed to a transperineal technique for delivering the denervating agent. Devices and systems are also described for use in implementing the technique.

Abstract: In general, the invention is directed to treatment of fecal incontinence by the implantation of one or more bulking prostheses proximate to an anal sphincter. These bulking prostheses, which may include biocompatible hydrogel, are inserted into the tissue near the anus through a small opening in the mucosa. When inserted, the bulking prostheses are in a miniature state. Upon introduction into the body, the devices enter an enlarged state. In their enlarged state, the bulking prostheses supply extra bulk to the tissues proximate to the anal sphincters. With the extra bulk, the patient can exercise voluntary control over the external sphincter to close the anus and maintain fecal continence.

Abstract: Described are devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the pudendal and sacral 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 and sacral 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: 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 various nerves or nerve portions, 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 one or more selected portions of a patient's pelvic floor 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.