Prosthesis intended for the treatment of a natural lumen or tract, in particular an endo-urethral prosthesis

Abstract

A prosthesis intended for the treatment of a natural lumen or tract of a human or animal body through which a flow is effected on either side of a sphincter is disclosed. The prosthesis comprises at least one tubular element, in particular of cylindrical shape which is sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain an artificial passage in the lumen, and is intended to be placed in the natural lumen. The wall of the tubular element comprises a relatively smooth and soft biocompatible material, such as silicone rubber, at least in its outer part.

1 . A prosthesis capable of being inserted in a biological lumen or tract, comprising: 
 first and second elements that are locatable on respective distal and proximal sides of a sphincter surrounding the lumen or tract, wherein the first element is sufficiently flexible to at least partially conform to the lumen or tract and sufficiently rigid to maintain a passage through the lumen or tract, and wherein the second element comprises a surface that abuts the proximal side of the sphincter; and    a connecting element interconnecting the first element and the second element, wherein the connecting element comprises a middle portion locatable in the sphincter that is deformable in response to pressure by the sphincter to allow the sphincter to close naturally and thereby close the lumen or tract to natural fluid flows.    
   
   
       2 . The prosthesis of  claim 1 , wherein the lumen or tract is the human male urethra.  
   
   
       3 . The prosthesis of  claim 2 , wherein the first element is tubular and traverses at least a portion of a segment of the male urethra extending between the bladder and the distal side of the sphincter.  
   
   
       4 . The prosthesis of  claim 3 , wherein the tubular element comprises a distal end and proximal end, and the distal end resides at least partially within the bladder when placed in the male urethra.  
   
   
       5 . The prosthesis of  claim 4 , wherein a tip of the distal end of the tubular element is closed and has a convex shape.  
   
   
       6 . The prosthesis of  claim 5 , wherein the proximal end of the tubular element comprises a proximal end opening, the distal end of the tubular element along a surface residing within the bladder comprises a side opening, and a lumen extends within the tubular element providing fluid communication between the proximal end opening and the side opening.  
   
   
       7 . The prosthesis of  claim 1 , wherein one or both of the first and second elements comprises silicone rubber.  
   
   
       8 . The prosthesis of  claim 1 , wherein the second element comprises a cross-sectional diameter along at least a portion of the second element that is larger than a cross-sectional diameter along at least a portion of the first element.  
   
   
       9 . The prosthesis of  claim 4 , wherein the second element comprises a cross-sectional diameter along at least a portion of the second element that is larger than a cross-sectional diameter along at least a portion of the tubular element.  
   
   
       10 . The prosthesis of  claim 9 , wherein the second element comprises an angulated exterior surface that extends along a longitudinal axis of the lumen.  
   
   
       11 . The prosthesis of  claim 3 , wherein the abutting surface counters upward migration of the tubular segment further into the bladder once the prosthesis is deployed.  
   
   
       12 . The prosthesis of  claim 3 , wherein the second element is locatable within a bulbar urethral segment extending from the proximal side of the sphincter.  
   
   
       13 . The prosthesis of  claim 12 , wherein the second element comprises a surface that conforms to a surface of the bulbar urethral segment.  
   
   
       14 . A method of treating an obstruction of a male urethra, comprising: 
 supporting said male urethra at a site of said obstruction with the prosthesis of  claim 1  by inserting said prosthesis into said male urethra so that said first element supports said male urethra at said site of said obstruction.    
   
   
       15 . A prosthesis capable of being inserted in a biological lumen or tract, comprising: 
 first and second elements that are locatable on either side of a sphincter surrounding the lumen or tract, wherein at least one of said first and second elements is sufficiently flexible to conform to the lumen or tract and sufficiently rigid to maintain a passage through the lumen or tract against a force that tends to obstruct the lumen or tract; and    a connecting element comprising at least one thread, wherein the thread traverses the sphincter and interconnects the first and second elements.    
   
   
       16 . The prosthesis of  claim 15 , wherein abutment of the second element against the sphincter can inhibit upward migration of the first element.  
   
   
       17 . The prosthesis of  claim 15 , wherein said connecting element comprises a plurality of threads.  
   
   
       18 . A method of treating an obstruction of a male urethra, comprising: 
 supporting said male urethra at a site of said obstruction with the prosthesis of  claim 15  by inserting said prosthesis into said male urethra so that said first element supports said male urethra at said site of said obstruction.    
   
   
       19 . A prosthesis for implanting in a lumen, comprising a first tubular element, a second element, and a connecting element, said connecting element comprising a plurality of threads, wherein the first and second elements are locatable on either side of a sphincter surrounding the lumen and the plurality of threads traverse the sphincter and interconnect said first and second elements.  
   
   
       20 . A method of treating an obstruction of a male urethra, comprising: 
 supporting said male urethra at a site of said obstruction with the prosthesis of  claim 19  by inserting said prosthesis into said male urethra so that said first element supports said male urethra at said site of said obstruction.    
   
   
       21 . An intraurethral device, comprising: 
 (i) a first tubular element comprising a flexible, biocompatible material, and comprising a proximal portion and a distal portion, and a central portion with a substantially constant outer diameter, wherein said proximal portion comprises an end opening to allow passage of fluid and said distal portion comprises an opening to allow urine to enter said first tubular element from the bladder;    (ii) a second element comprising a flexible, biocompatible material, and comprising a proximal end and a distal end, wherein a width dimension along at least a portion of the second element is greater than the outer diameter of the central portion of the first tubular element; and    (iii) a connecting element comprising at least one thread connecting said proximal portion of said first element to said distal end of said second element.    
   
   
       22 . A method of treating an obstruction of a male urethra, comprising: 
 supporting said male urethra at a site of said obstruction with the prosthesis of  claim 21  by inserting said prosthesis into said male urethra so that said first element supports said male urethra at said site of said obstruction.