Prosthetic cardiac and venous valves

Abstract

A prosthetic heart or venous valve, the valve including a central tissue structure with multiple tissue lobes extending from a common central area, wherein each of the lobes includes a longitudinal slot. The valve further includes a plurality of leaflets, each extending from the central tissue structure and positioned between two adjacent lobes, wherein each of the leaflets has a free end spaced from the central tissue structure, and also has a compressible and expandable stent frame with a plurality of extending arms, wherein each of the extending arms of the stent frame is positioned at least partially within one of the longitudinal slots of the central tissue structure.

1 . A prosthetic heart or venous valve, comprising: 
 a central tissue structure comprising multiple tissue lobes extending from a common central area, wherein each of the lobes includes a longitudinal slot;    a plurality of leaflets, each of which extends from the central tissue structure and is positioned between two adjacent lobes, wherein each of the leaflets comprises a free end spaced from the central tissue structure; and    a flexible stent frame comprising a plurality of extending arms, wherein each of the extending arms of the stent frame is positioned at least partially within one of the longitudinal slots of the central tissue structure.    
   
   
       2 . The valve of  claim 1 , wherein the central tissue structure comprises a native valve segment that has been inverted to provide the plurality of leaflets.  
   
   
       3 . The valve of  claim 2 , wherein the multiple tissue lobes are formed by folded portions of an aortic wall of the native valve segment.  
   
   
       4 . The valve of  claim 3 , wherein the native valve segment comprises a porcine valve segment.  
   
   
       5 . The valve of  claim 1 , wherein the plurality of extending arms are connected to each other at a common point that is positioned at an inflow end of the valve, wherein the stent frame comprises a distal portion that extends beyond the central tissue structure at an outflow end of the valve, and wherein the distal portion of the stent frame further comprises an anchoring mechanism.  
   
   
       6 . The valve of  claim 5 , wherein the anchoring mechanism comprises at least one connector extending from each of the extending arms that is engageable with a thickness of tissue.  
   
   
       7 . The valve of  claim 5 , wherein the anchoring mechanism comprises a compressible and expandable engagement structure extending from the stent frame.  
   
   
       8 . The valve of  claim 7 , wherein the engagement structure comprises a self-expanding material.  
   
   
       9 . The valve of  claim 1 , wherein the plurality of leaflets are moveable from a first position in which their free ends are spaced at a first distance from the central tissue structure to a second position in which their free ends are spaced at a second distance from the central tissue structure that is greater than the first distance, wherein the first position of the leaflets defines a plurality of channels between adjacent lobes of the central tissue structure and provides an open position of the valve.  
   
   
       10 . The valve of  claim 9 , wherein the second position of the leaflets eliminates the plurality of channels between adjacent lobes of the central tissue structure and provides a closed position of the valve.  
   
   
       11 . A prosthetic valve, comprising: 
 a flexible tube having an inflow end and a outflow end, wherein the inflow end of the tube is folded against and attached to itself and the outflow end of the tube is open; and    a stent having multiple longitudinally extending members located at least partially within the tube and extending to the open outflow end of the tube, wherein portions of the tube that are adjacent to the outflow end of the tube and between the longitudinally extending members of the stent are moveable toward and away from a central area of the valve to provide a plurality of valve leaflets.    
   
   
       12 . A prosthetic valve according to  claim 11 , wherein the stent comprises a distal portion that extends beyond the outflow end of the tube, and wherein the distal portion of the stent further comprises an anchoring mechanism.  
   
   
       13 . The valve of  claim 12 , wherein the anchoring mechanism comprises at least one connector extending from each of the extending members that is engageable with a thickness of tissue.  
   
   
       14 . The valve of  claim 12 , wherein the anchoring mechanism comprises a compressible and expandable engagement structure extending from the stent.  
   
   
       15 . The valve of  claim 14 , wherein the engagement structure comprises a self-expanding material.  
   
   
       16 . The valve of  claim 11 , further comprising at least one spacer positioned between portions of the tube that are adjacent the open outflow end of the tube.  
   
   
       17 . The valve of  claim 16 , wherein the at least one spacer extends from and is attached to the inflow end of the tube and extends generally along a central longitudinal axis of the tube.  
   
   
       18 . The valve of  claim 11 , wherein the stent comprises three longitudinally extending members and wherein the valve comprises three leaflets defined by the three extending members and the open outflow end of the tube.  
   
   
       19 . The valve of  claim 18 , wherein the stent and leaflets are sized to provide a central aperture that is open to the inside of the tube at the outflow end of the tube when the valve is in its open position and when the valve is in its closed position.  
   
   
       20 . The valve of  claim 11 , wherein the stent comprises two longitudinally extending members and the valve comprises two leaflets.