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.

1 - 21 . (Cancelled).  
   
   
       22 . A device adapted for implantation in body tissue adjacent to a lumen, the device comprising: 
 an adjustable element adapted to coapt the lumen, the adjustable element including a continuous wall having an inner surface defining a chamber, wherein at least a portion of the continuous wall includes a porous structure allowing fluid to move across the continuous wall;    a hydrophilic material substantially encapsulated in the chamber;    a tubular elongate body having a proximal end and a distal end, the tubular elongate body including a first interior passageway extending longitudinally in the tubular elongate body from a first port at the proximal end to a second port in fluid communication with the chamber; and    a rear port element coupled to the proximal end of the tubular elongate body, the rear port element including a cavity in fluid communication with the first port of the first interior passageway and an elastic septum allowing access to the cavity by a needle.    
   
   
       23 . The device of  claim 22 , wherein the tubular elongate body further comprises a second interior passageway extending longitudinally in the tubular elongate body from a proximal opening positioned between the proximal end and the distal end of the tubular elongate body to a distal opening through the distal end of the tubular elongate body.  
   
   
       24 . The device of  claim 22 , wherein the hydrophilic material includes one or more of polyvinylpyrrolidone, polyethylene glycol, carboxy methyl cellulose, and hyaluronic acid.  
   
   
       25 . The device of  claim 22 , wherein the hydrophilic material includes a hydrophilic polymer in a form of discrete, individual polymeric units.  
   
   
       26 . The device of  claim 22 , further comprising a detectable marker imbedded in the continuous wall.  
   
   
       27 . The device of  claim 26 , wherein the detectable marker is opaque to x-ray or fluoroscopy.  
   
   
       28 . The device of  claim 22 , wherein the continuous wall is constructed of a biocompatible resiliently elastomeric polymer or polymer blend.  
   
   
       29 . The device of  claim 28 , wherein the continuous wall is constructed of one or more of polyurethane and silicone.  
   
   
       30 . The device of  claim 28 , wherein the adjustable element retains a general cross-section shape when being deflated.  
   
   
       31 . The device of  claim 22 , wherein the continuous wall is constructed of a biocompatible non-resilient polymer or polymer blend.  
   
   
       32 . The device of  claim 31 , wherein the continuous wall is constructed of one or more of polyethylene, polytetraflouroethylene, polystyrene, and polyesteretherketone.  
   
   
       33 . The device of  claim 31 , wherein the adjustable element has a folded structure when being deflated.  
   
   
       34 . The device of  claim 22 , wherein at least a portion of the continuous wall comprises at least one reinforcing structure.  
   
   
       35 . The device of  claim 34 , wherein the reinforcing structure comprises fibers constructed from one or more of polyester, nylon, polypropylene, and polytetrafluoroethylene.