Anti-Aspiration Prosthesis

Abstract

A prosthesis and a method of manufacturing the prosthesis for controlling flow through a bodily lumen are provided. The prosthesis includes a body having a proximal portion, a distal portion and a lumen extending therethrough. The prosthesis also includes a valve operably connected to the body. The valve has a proximal portion, a distal portion and a lumen extending through the valve, where the valve lumen is connected to the body lumen. The valve is configured to be closed in the absence of an antegrade pressure and a retrograde pressure, the retrograde pressure being greater than the antegrade pressure. The valve includes a material portion operably connected to the valve, the material portion providing increased stiffness to the valve relative to the valve alone, wherein the material portion is configured to facilitate self-reversion of the valve to the closed configuration.

1 . A prosthesis for controlling flow through a bodily lumen, the prosthesis comprising:
 a body having a proximal portion, a distal portion and a lumen extending therethrough; and   a valve operably connected to the body, the valve having a proximal portion, a distal portion and a lumen extending through the valve, the valve lumen connected to the body lumen; the valve being configured to be closed in the absence of an antegrade pressure and a retrograde pressure, the retrograde pressure being greater than the antegrade pressure, the valve comprising a material portion operably connected to the valve, the material portion providing increased stiffness to the valve relative to the valve alone, wherein the material portion is configured to facilitate self-reversion of the valve to the closed configuration.   
     
     
         2 . The prosthesis of  claim 1 , wherein the material portion comprises at least one material that is different from a valve material. 
     
     
         3 . The prosthesis of  claim 1 , wherein the material portion comprises nitinol. 
     
     
         4 . The prosthesis of  claim 3 , wherein the nitinol is heat set. 
     
     
         5 . The prosthesis of  claim 1 , wherein the material portion is connected to the distal portion of the body. 
     
     
         6 . The prosthesis of  claim 1 , wherein the material portion at least partially overlaps the body. 
     
     
         7 . The prosthesis of  claim 2 , wherein the material portion comprises one arm. 
     
     
         8 . The prosthesis of  claim 2 , wherein the material portion comprises one u-shaped arm. 
     
     
         9 . The prosthesis of  claim 2 , wherein the material portion comprises a coil. 
     
     
         10 . The prosthesis of  claim 1 , wherein the material portion comprises a proximal portion and a distal portion and the distal portion of the material portion is more flexible than the proximal portion of the material portion. 
     
     
         11 . The prosthesis of  claim 10 , wherein the distal portion of the material portion is electropolished, ground or chemically etched to provide flexibility. 
     
     
         12 . The prosthesis of  claim 2 , wherein the material portion comprises a first peak and a second peak and the first peak is positioned within second peak and extends in the same plane as the second peak. 
     
     
         13 . The prosthesis of  claim 2 , wherein the material portion includes a plurality of peaks positioned about a perimeter of the body. 
     
     
         14 . The prosthesis of  claim 12 , wherein each peak is independently operably connected to the body. 
     
     
         15 . The prosthesis of  claim 1 , wherein a distal end of the material portion is movable proximally in response to the retrograde pressure to facilitate opening the valve in response to the retrograde pressure. 
     
     
         16 . The prosthesis of  claim 1 , wherein the distal end of the material portion is movable to facilitate the return of the valve to a closed configuration after the retrograde pressure is removed. 
     
     
         17 . A method of manufacturing a prosthesis for controlling flow through a bodily lumen, the method comprising:
 forming a material portion of a valve on a first mandril;   heat setting the material portion;   forming an inner portion of the valve on a second mandril, the second mandril having a different shape than the first mandril;   curing the inner portion;   positioning the heat set material portion on the inner portion that is positioned on the second mandril; and   coating the inner portion and the material portion to form the outer portion of the valve.   
     
     
         18 . The method of  claim 17 , further comprising connecting the valve to a body to form the prosthesis. 
     
     
         19 . The method of  claim 17 , comprising forming the outer portion of the valve by dipping the inner portion and the material portion in a polymer dispersion. 
     
     
         20 . The method of  claim 17 , comprising providing a body having a first axis extending longitudinally along the body and providing the material portion having a helical pitch that is different from the first axis.