Abstract: An implantable medical device and method for adjustably restricting a selected body lumen such as a urethra or ureter of a patient to treat urinary incontinence or ureteral reflux. The device includes an adjustable, self-sealing element having a continuous wall, including an inner surface defining a chamber. The adjustable element expands or contracts due to fluid volume introduced into the chamber for restricting a body lumen. After being implanted into a patient, the size of the adjustable element is altered by first locating the adjustable element implanted adjacent the body lumen, and then establishing fluid communication with the adjustable element. The volume of the adjustable element is then adjusted by either introducing or removing volume from the chamber of the adjustable element.

Abstract: An implantable medical device and method for adjustably restricting a selected body lumen such as a urethra or ureter of a patient to treat urinary incontinence or ureteral reflux. The device includes an adjustable element and a tubular elongate body, where the adjustable element includes a chamber and the tubular elongate body includes at least a first interior passageway which extends longitudinally in the tubular elongate body from a first opening at the proximal end to a second opening in fluid communication with the chamber. Fluid volume passed through the first passageway is used for adjustably expanding or contracting the adjustable element. The implantable medical device further includes a sheath and a sleeve, where the sheath includes a wall having an inner surface which defines a channel through which at least a portion of the implantable device and the sleeve can pass.

Abstract: A device and method for loading a self expanding stent into a deployment tool is disclosed. The device includes an outer tube and a constricting sheath having a stent delivery end and a stent receiving opening opposite thereto. The stent receiving opening is shaped and sized to receive a self expanding stent aligned along the axis and in its expanded state. A funnel, positioned within the constricting sheath, is shaped for collapsing the self expanding stent before loading the stent into the space of the outer tube. An inserter is used to engage and urge the expanded stent into the constricting sheath as the inserter moves towards and into the funnel of the constricting sheath.

Abstract: An implantable device and method for adjustably restricting a selected body lumen such as the urethra of a patient to treat urinary incontinence. The device includes an expandable element or membrane such as a balloon attached pressure-tightly to a flexible conduit at its forward end and includes a rear port portion containing an elastic septum and flow connected to the expandable element by a first passageway. The conduit contains a second passageway which allows it to be slid along an elongated guide probe initially inserted surgically into a patient's body adjacent the body lumen which is to be adjustably restricted. A suitable flowable material is injected from a syringe source into the device rear port sufficient to expand the membrane element and restrict the body lumen to the desired degree. The syringe and guide probe are removed and the skin incision is closed over the rear port end of the implanted device.

Abstract: An implantable medical device and method for adjustably restricting a selected body lumen such as a urethra or ureter of a patient to treat urinary incontinence or ureteral reflux. The device includes an adjustable, self-sealing element having a continuous wall, including an inner surface defining a chamber. The adjustable element expands or contracts due to fluid volume introduced into the chamber for restricting a body lumen. After being implanted into a patient, the size of the adjustable element is altered by first locating the adjustable element implanted adjacent the body lumen, and then establishing fluid communication with the adjustable element. The volume of the adjustable element is then adjusted by either introducing or removing volume from the chamber of the adjustable element.

Abstract: A surgically implantable prosthesis for the treatment of penile erectile impotence in male patients. The device comprises at least one elongated cylinder implanted within one of the corpora cavernosa of the penis. The flexible, distal end of the cylinder is adapted to rigidize upon being filled with pressurizing fluid. The rear tip or proximal end of the cylinder is formed to provide a chamber which serves as a fluid reservoir. Valve means contained within the cylinder controls fluid flow between the rear tip reservoir and the flexible, distal end of the cylinder. The prosthesis further includes a manually operable pump means utilized to transfer pressurized fluid from the rear tip reservoir to the distal end of the cylinder in order to achieve an erection. The walls of the rear tip reservoir itself may serve as the pump means; or a separate pump may be implanted within the scrotum.

Abstract: A prostatic stent and method of manufacture. The stent has an elongate body defining a passage therethrough and includes a distal section, a mid-section and a proximal section. The elongate body has a length sufficient to extend distally from a bladder neck to a position somewhat short of the external sphincter. The proximal section has a shape conforming to the neck of the urinary bladder.

Abstract: A device for dilating at least an obstructed portion of the urethra, includes a urinary catheter having a proximal portion and a distal portion; a dilation balloon capable of expanding radially outwardly disposed between the proximal and distal portion of the catheter; and a pressure source capable of sequentially contracting under pressure. The pressure source and dilation balloon are in fluid communication through a conduit which enables fluid to flow from the pressure source to the dilation balloon at a predetermined gradual rate when the pressure source is contracting, whereby the balloon expands gradually radially outwardly to effect the slow dilation of the urethra. A method for dilating the obstructed portion of the urethra and for treating prostatic hyperplasia is also provided.

Abstract: A device for dilating at least an obstructed portion of a urethra includes a hollow core member with opposed open ends permitting urination therethrough from the bladder, a confining covering disposed on the hollow member having a length of at least that of the obstructed portion and having hydrophilic means integrally associated therewith. The hydrophilic means is capable of absorbing water and gradually expanding for at least 30 minutes whereby the outer surface of the confining covering expands radially and outwardly, after insertion into the urethra, until dilation of the obstructed portion occurs to a desired diameter and configuration. Methods for dilating an obstructed portion of the urethra and for treating benign prostatic hyperplasia are also provided.

Abstract: An apparatus and method for treatment of conditions in which it is desired to simultaneously hyperthermally treat diseased target tissue in a patient and dilate a lumen of a patient which is compressed and/or obstructed by the diseased target tissue and/or surrounding tissue is disclosed.

Abstract: A stent for transluminal implantation comprising a single-piece tubular member having a fenestrated side wall exhibiting a pattern of uniformly spaced openings defined by intersecting strands where the strands are integrally joined together at their points of intersection whereby the tubular member can be radially compressed from a larger diameter to a smaller diameter by the application of a uniform inwardly directed radial force and which self-expands to a larger diameter when the radial compressive force is removed. The compression and subsequent self-expansion occurs without an appreciable change in the stent's length. By forming the stent from a thermoplastic material, it may later be resected by carving it up into small pieces preferably using an electrosurgical instrument.

Abstract: A rectal probe comprising a catheter having a longitudinal axis around which is mounted an inflatable, low pressure, compliant balloon having a temperature element associated with the wall thereof, means for holding the probe at a proper position within a patient's rectum and means for inflating the balloon when it is properly positioned to put the temperature element in intimate contact with the anterior side of the rectum. A method for monitoring a patient's rectal mucosal temperature during thermal treatment of the patient's prostate is also disclosed.

Abstract: An inflatable penile prosthesis having at least one inflatable cylinder or pressurizable chamber, a fluid reservoir, pump means, and valves for permitting the flow of fluid between said reservoir and cylinder or chamber as a consequence of pressure changes, wherein to prevent spontaneous inflation there is provided an additional lock-out valve disposed at a point between the reservoir and chamber, which will be opened only by the application of a suitable pressure or force exerted volitionally from without the prosthesis. In a preferred embodiment the prosthesis is of a non-unitary type in which the pump means is in the scrotum.

Abstract: A method and apparatus for valving body fluids involving a flexible tubular body with a drainage canal therethrough, including collapsible means for blocking the passageway and thereby preventing the flow of urine. The length of the device is such that one end protrudes into the bladder and the other end terminates interior of the meatus. The device includes a means for anchoring to secure it in place and a plug device for deflating and releasing the anchoring means and for collapsing the blocking means to facilitate removal of the device from the body. The device is manually actuable to an open position and means are provided to delay the closing of the device for a sufficient period of time to allow voiding of the bladder. The collapsible and expandable nature of the device facilitates its insertion and removal, particularly while passing through areas of restricted diameter.

Abstract: An instrument for the placement of a self-expanding stent in a body canal, which comprises an elongated inner tube having an outer tube disposed along its axis adapted to carry and retain a self-expanding stent adjacent its proximal end, and an arrangement for releasing the stent, in combination with at least one of the following components: (a) a location member for positioning and fixing the instrument so that the stent is released at a desired location in the body canal, and (b) a member for releasing the stent in a retrograde manner. A method for placing a self-expanding stent in a body canal is also disclosed.

Abstract: An instrument for the deployment or retraction of a self-expanding stent in a body canal, which comprises an elongated tubular outer sleeve having disposed therein an elongated core which is movable relative to said sleeve and has a grip member formed at or near its distal end, which grip member is adapted to releasably hold a self-expanding stent within said outer sleeve.

Abstract: An anchoring means for anchoring a suture in tissue comprises a housing, a substantially cylindrical means within said housing for receiving a suture, and an adjusting means. Another anchoring means comprises a housing, a rotating spool within said housing, a driving gear, and an adjusting means.

Abstract: A method for suspending the urethrovesical junction in females comprises inserting sutures through a puncture or incision in the suprapubic abdominal area or through a puncture or incision in the vaginal wall, suspending the urethrovesical junction with the sutures, and anchoring the sutures with an anchoring means at an anchoring site. The anchoring means is a relatively rigid helix having an attaching means to attach the suture, or a pad adapted to be delivered with a delivery means to the anchoring site, or a flip anchor in substantial axial alignment with a placement means and adapted to be flipped from the axial alignment to an angled position, or an adjustable tissue anchor having a means for adjustably attaching the sutures.

Abstract: A method and apparatus for valving body fluids involving a flexible tubular body with a drainage canal therethrough, including collapsible means for blocking the passageway and thereby preventing the flow of urine. The length of the device is such that one end protrudes into the bladder and the other end terminates interior of the meatus. The device includes a means for anchoring to secure it in place and a plug device for deflating and releasing the anchoring means and for collapsing the blocking means to facilitate removal of the device from the body. The device is manually actuable to an open position and means are provided to delay the closing of the device for a sufficient period of time to allow voiding of the bladder. The collapsible and expandable nature of the device facilitates its insertion and removal, particularly while passing through areas of restricted diameter.

Abstract: A semi-automatic functioning artificial sphincter including a means for occluding a body passage, a fluid reservoir, and a mechanism for transferring fluid between the occluding mechanism and the fluid reservoir, wherein the sphincter also includes a lock-out mechanism for occluding fluid flow between the fluid reservoir and the inflatable cuff and the occluding mechanism. The occluding mechanism is preferably a valve which is positioned in the fluid path between the reservoir and the occluding mechanism. The valve may be either manually or hydraulically actuated to control one or more aspects of fluid flow through the valve.