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 that includes a chamber and a hydrophilic material substantially encapsulated in the chamber to expand the adjustable element by absorbing fluid entering the chamber.

1 . An implantable device for use in body tissue, comprising:
 an adjustable element including a continuous wall having an inner surface and an outer surface, the inner surface defining a chamber;   one or more reinforcing structures including fibers woven into a support structure positioned between the inner surface and the outer surface; and   a hydrophilic material substantially encapsulated in the chamber, the hydrophilic material having particles and absorbing fluid to expand the adjustable element.   
     
     
         2 . The implantable device of  claim 1 , wherein the continuous wall comprises a porous polymer structure that allows the fluid to pass through the continuous wall. 
     
     
         3 . The implantable device of  claim 2 , wherein the support structure is constructed to prevent the particles of the hydrophilic material from migrating out of the chamber. 
     
     
         4 . The implantable device of  claim 1 , wherein the fibers are constructed of one or more polymers having a high durometer measure or high modulus. 
     
     
         5 . The implantable device of  claim 4 , wherein the fibers are constructed of one or more of polyester, nylon, polypropylene, and polytetrafluoroethylene. 
     
     
         6 . The implantable device of  claim 1 , wherein the fibers are less elastic than the continuous wall. 
     
     
         7 . The implantable device of  claim 6 , wherein the fibers are substantially non-elastic. 
     
     
         8 . The implantable device of  claim 1 , wherein the support structure allows for rip-stop protection from tears in the continuous wall due to insertion and removal of a non-coring needle through the continuous wall. 
     
     
         9 . The implantable device of  claim 8 , wherein the continuous wall is constructed of a material that is substantially self-sealing material after the continuous wall is pierced by a non-coring needle. 
     
     
         10 . The implantable device of  claim 1 , wherein the continuous wall is constructed to be expandable to a predetermined shape. 
     
     
         11 . The implantable device of  claim 10 , wherein the outer surface generally defines a sphere. 
     
     
         12 . The implantable device of  claim 10 , wherein the outer surface generally defines an elongate body having semi-spherical end portions. 
     
     
         13 . The implantable device of  claim 10 , wherein the continuous wall is constructed of a biocompatible resiliently elastomeric polymer or polymer blend. 
     
     
         14 . The implantable device of  claim 10 , wherein the continuous wall is constructed of a biocompatible non-resilient polymer or polymer blend. 
     
     
         15 . The implantable device of  claim 1 , wherein the hydrophilic material comprises one or more of hyaluronic acid, polyvinylpyrrolidone, polyethylene glycol, carboxy methyl cellulose, or hyaluronic acid. 
     
     
         16 . The implantable device of  claim 1 , comprising a detectable marker allowing for the adjustable element to be visualized within the body tissue using electromagnetic energy. 
     
     
         17 . The implantable device of  claim 16 , comprising a detectable marker allowing for the adjustable element to be visualized within the body tissue using x-ray or fluoroscopy. 
     
     
         18 . The implantable device of  claim 16 , wherein the detectable marker in imbedded in the continuous wall. 
     
     
         19 . The implantable device of  claim 16 , wherein the detectable marker is constructed
 of tantalum.   
     
     
         20 . The implantable device of  claim 19 , wherein the one or more reinforcing structures are labeled with tantalum.