Apparatus and method for inserting an adjustable implantable genitourinary 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 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.

1 . An implantable device assembly for controllable coaption of a body lumen, comprising:
 an implantable device including an adjustable element and a tubular elongate body, wherein the adjustable element includes a continuous wall, including an inner surface defining a chamber, and 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 including 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 for adjustably expanding or contracting the adjustable element by applied flowable material introduced through the first opening;   a sleeve, where the sleeve includes a wall having an inner surface which is positioned adjacent the implantable device; and   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 and the sleeve can pass.