Prosthesis having a sleeve valve

Abstract

Disclosed is a pressure sensitive prosthesis ( 10 ) that includes a tubular member ( 11 ) having a passageway ( 12 ) extending therethrough and a sleeve ( 13 ) attached about one end of the tubular member. The sleeve functions as a one-way valve to permit fluid flowing through the sleeve lumen ( 15 ) in a first direction ( 17 ) and under a first pressure, while collapsing in response to fluid flowing in a second direction 18 where the pressure that exceeds that of the first direction or pressure. One aspect of the invention includes an esophageal anti-reflux expandable prosthesis wherein the sleeve is adapted to invert back through the tubular stent frame to permit belching or vomiting (fluid or materials under a third, significantly higher pressure). Another aspect of the invention includes a tubular drainage stent ( 60 ), such as a biliary or urethral stent in which the sleeve opens to permit passage of fluids, then collapses to prevent retrograde flow.

1 . A prosthesis for placement in a patient comprising: 
 a tubular drainage stent having a passage extending longitudinally therethrough; and    a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally therethrough and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.    
     
     
         2 . The prosthesis of  claim 1 , wherein a portion of the sleeve extends over an outer surface of the tubular drainage stent and is affixed thereto.  
     
     
         3 . The prosthesis of  claim 2 , wherein the sleeve includes an attachment member that affixes the sleeve to the tubular drainage stent.  
     
     
         4 . The prosthesis of  claim 3 , wherein the attachment member comprises a metal band.  
     
     
         5 . The prosthesis of  claim 1 , wherein the sleeve comprises a bile-resistant polymeric material.  
     
     
         6 . The prosthesis of  claim 5 , wherein the material comprises expanded polytetrafluoroethylene.  
     
     
         7 . The prosthesis of  claim 1 , wherein the material comprises polyurethane.  
     
     
         8 . The prosthesis of  claim 1 , wherein the sleeve has an average thickness in the range of approximately 0.001″ to 0.01″.  
     
     
         9 . The prosthesis of  claim 8 , wherein the sleeve has an average thickness of approximately 0.002″ to 0.005″.  
     
     
         10 . The prosthesis of  claim 9 , wherein the sleeve has a thickness of approximately 0.0025″.  
     
     
         11 . The prosthesis of  claim 1 , wherein the tubular drainage stent is sized and configured for placement in the biliary system such that the sleeve is extendable into the intestine of the patient such that bile travels in the first direction thereinto.  
     
     
         12 . The prosthesis of  claim 1 , wherein the prosthesis further includes a guiding catheter and pusher element having a distal end, the prosthesis being mounted over the guiding catheter such that the prosthesis is deliverable to a target site within the patient by way of the distal end of the pusher element urging the prosthesis distally and relative to the guiding catheter until the prosthesis is deployed therefrom.  
     
     
         13 . The prosthesis of  claim 1 , wherein the sleeve and tubular drainage stent comprise the same polymeric material, the sleeve representing an integral extension of the one end of the tubular drainage stent.  
     
     
         14 . The prosthesis of  claim 1 , wherein the sleeve is normally closed in the absence of the fluid applying a first pressure in a first direction.  
     
     
         15 . The prosthesis of  claim 1 , wherein the end form which the sleeve extends includes a pigtail configuration.  
     
     
         16 . A prosthesis for placement in a patient comprising: 
 a tubular drainage stent sized and configured for placement in the biliary system, the tubular drainage stent having a passage extending longitudinally therethrough; and    a sleeve comprising a polymeric material, the sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally therethrough and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.    
     
     
         17 . The prosthesis of  claim 16 , wherein the sleeve is normally closed in the absence of the fluid applying a first pressure in a first direction.  
     
     
         18 . The prosthesis of  claim 16 , wherein the material comprises expanded polytetrafluoroethylene.  
     
     
         19 . The prosthesis of  claim 16 , wherein the sleeve has an average thickness of approximately 0.002″ to 0.005″.  
     
     
         20 . The prosthesis of  claim 14 , wherein the prosthesis further includes a guiding catheter and pusher element having a distal end, the prosthesis being mounted over the guiding catheter such that the prosthesis is deliverable to a target site within the patient by way of the distal end of the pusher element urging the prosthesis distally and relative to the guiding catheter until the prosthesis is deployed therefrom.  
     
     
         21 . A prosthesis for placement in a patient comprising: 
 a tubular drainage stent sized and configured for placement in a bodily passageway, the tubular drainage stent having a passage extending longitudinally therethrough, and    a sleeve comprising a thin, flexible polymeric material, the sleeve attached about the tubular drainage stent and having a lumen extending longitudinally therethrough and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to either a fluid applying a second pressure in a second direction or the absence of the fluid applying a first pressure in a first direction.    
     
     
         22 . The prosthesis of  claim 21 , wherein the sleeve extends from an end of the tubular drainage stent.  
     
     
         23 . The prosthesis of  claim 21 , wherein one end of the sleeve is affixed within the lumen of the tubular drainage stent.  
     
     
         24 . The prosthesis of  claim 21 , wherein the sleeve resides completely within the lumen of the tubular drainage stent.  
     
     
         25 . (Cancelled)  
     
     
         26 . (Cancelled)  
     
     
         27 . (Cancelled)  
     
     
         28 . A prosthesis for placement in a patient comprising: 
 a tubular drainage stent having a passage extending longitudinally there through configured to pass only bodily matter;    a retention structure extending from an outer surface of the passage and comprising a flexible material configured to hold the tubular drainage stent within a vessel that conveys fluid without enlarging a diameter of the passage; and    a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.    
     
     
         29 . The prosthesis of  claim 28 , wherein the retention structure comprises a structure selected from the group consisting of a flap and a barb.  
     
     
         30 . The prosthesis of  claim 28 , wherein the tubular drainage stent is sized and configured for placement within a body passage selected from the group consisting essentially of a bile duct, a pancreatic duct, and a urethra.  
     
     
         31 . The prosthesis of  claim 28 , wherein the tubular drainage stent is sized and configured for placement within a body passage selected from the group consisting of a pancreatic duct and a urethra.  
     
     
         32 . (Cancelled)  
     
     
         33 . (Cancelled)  
     
     
         34 . A prosthesis for placement in a patient comprising: 
 a tubular drainage stent having a passage sized and configured for placement within a pancreatic duct;    a retention structure extending from an outer surface of the passage comprising a flexible material configured to expand without enlarging a diameter of the passage; and    a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.    
     
     
         35 . A prosthesis for placement in a patient comprising: 
 a tubular drainage stent having a passage sized and configured for placement within a urethra;    a retention structure extending from an outer surface of the passage comprising a flexible material configured to expand without enlarging a diameter of the passage; and    a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.    
     
     
         36 . A prosthesis for placement in a patient comprising: 
 a tubular drainage stent having a passage sized and configured for conveying a glandular secretion;    a retention structure extending from an outer surface of the passage comprising a flexible material configured to expand without enlarging a diameter of the passage; and    a sleeve extending from an end of the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to a fluid applying a second pressure in a second direction.    
     
     
         37 . A prosthesis for placement in a patient comprising: 
 a non-expanding tubular drainage stent sized and configured for placement in a bodily passageway, the tubular drainage stent having a passage extending longitudinally there through, and    a sleeve comprising a thin, flexible polymeric material, the sleeve attached about the tubular drainage stent and having a lumen extending longitudinally there through and communicating with the passage of the tubular drainage stent, the sleeve in response to a fluid applying a first pressure in a first direction passing the fluid through the lumen thereof, the sleeve collapsible to at least substantially close the lumen in response to either a fluid applying a second pressure in a second direction or the absence of the fluid applying a first pressure in a first direction.