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 Apparatus and method for inserting an adjustable implantable genitourinary device

Details
Inventors: Burton, John H.; Noddin, Richard A.; Schreiner, Dale L.; Cook, Timothy C.;
Assignee: Uromedica, Inc. (Plymouth, MN)
Primary Examiner: Lacyk; John P.
Assistant Examiner:
Attorney, Agent or Firm: Schwegman, Lundberg, Woessner & Kluth, P.A.

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. Alternatively, the implantable medical device includes a tip suitable to penetrate tissue so that the implantable medical device can be implanted within the tissue of a patient.

DETAILED DESCRIPTION The present invention provides an implantable device and a method for its use in restricting a body lumen.
In one embodiment, the body lumen is a urethra, where the implantable device is used to coapt the urethra to assist the patient in urinary continence.
The implantable medical device has the advantage of being adjustable both at the time of implantation and postoperatively.
This postoperative adjustability of the implantable medical device allows a physician to regulate the amount of pressure applied to the urethra to ensure continence of the patient and to minimize iatrogenic effects.
In one embodiment, the present subject matter includes an implantable device assembly for controllable coaptation of a body lumen.
The implantable device assembly includes an implantable device which includes an adjustable element and a tubular elongate body.
The adjustable element includes a continuous wall, including an inner surface defining a chamber.
The tubular elongate body includes a peripheral surface, a proximal end and a distal end, where the peripheral surface is connected to and sealed to the adjustable element.
The tubular elongate body further 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 of the implantable device.
This allows for adjustably expanding or contracting the adjustable element by applied flowable material introduced through the first opening.
The implantable device assembly also includes a sheath, where the sheath includes a wall having an inner surface which defines a channel through which at least a portion of the implantable device can pass.
In one embodiment, the implanted device is inserted into body tissue by passing the device through the sheath.
The sheath is first inserted into the tissue of the patient and then the implanted device is moved through the channel of the sheath.
In one embodiment, the implanted device is moved through the sheath through the use of a push rod, where the push rod is inserted into the first interior passageway



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