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, 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.

Description

FIELD OF THE INVENTION [0001] The invention relates generally to implantable medical devices and in particular to implantable medical devices for treating urinary incontinence. BACKGROUND OF THE INVENTION [0002] Various implantable devices, such as distensible medical devices, are known in which the distensible medical devices are implanted into the tissue of a human to treat urinary incontinence. These devices have typically relied upon restricting or constricting the urethra of the patient to maintain continence. [0003] U.S. Pat. No. 4,733,393 to Haber et al. is an attempt at such a proposed device. U.S. Pat. No. 4,733,393 relates to a hypodermically implantable genitourinary prosthesis which provides an extensible, inflatable tissue expanding membrane to be located in proximal urethral tissue to add bulk to these tissues for overcoming urinary incontinence by localized increase in tissue volume. [0004] U.S. Pat. No. 4,802,479 to Haber et al. is an attempt at an instrument for dis...

AI Technical Summary

Benefits of technology

[0008] 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.

[0012] During the postoperative adjustments, the adjustable element is expanded or contracted (ie., the volume of the adjustable element is increased or decreased) due to fluid volume introduced into the chamber. In one embodiment, fluid volume is introduced into the chamber through a hollow non-coring needle, such as a hypodermic needle, inserted through the wall of the adjustable element. The self-sealing ability of the wall allows for such adjustments by needles during one or more postoperative occasions without compromising the pressure retaining ability of the wall of the adjustable element.

[0013] In an additional embodiment, the implantable device includes one or more reinforcing structures positioned between the inner surface and an outer surface of the continuous wall. In one embodiment, woven or layered fibers of polyester, nylon, polypropylene, polytetrafluoroethylene (such as TEFLON) or other polymers having a high durometer measure or high modulus constitute the reinforcing structures. The reinforcing structures help to maintain structural integrity and the shape of the adjustable element during the initial inflation and any postoperative adjustments made thereafter.

[0020] An important feature of the implantable device of the present invention relates to the adjustable element or membrane which is accessible for subsequent adjustment in volume through the rear port element located under a patient's skin, remotely from the adjustable element. Another important feature of the present invention over the prior art devices is the convenient in vivo postoperative adjustability of both pressure and size of the adjustable element.

Problems solved by technology

However, in the prior art devices any tissue change which may occur postoperatively such as a reduction in tissue edema associated with the procedure may cause a reduction in clinical effect because of the reduced coaptation and resistance after the swelling has subsided.

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