Prosthetic valve with semi-rigid and flexible leaflets

Abstract

The invention relates to a prosthetic valve for regulating fluid flow through a body lumen. The valve includes a frame and a valve member comprising at least one semi-rigid leaflet and at least one flexible leaflet.

1 . A valve prosthesis for implantation within a lumen of a body vessel, said valve prosthesis comprising:
 a frame;   a semi-rigid leaflet attached to the frame and having a first free edge; and   a flexible leaflet attached to the frame and having a second free edge, the flexible leaflet being moveable between a first position that permits fluid flow through said prosthesis in a first direction and a second position in which at least a portion of the flexible leaflet coapts with at least a portion of the semi-rigid leaflet to substantially prevent fluid flow through said valve prosthesis in a second direction.   
   
   
       2 . The valve prosthesis of  claim 1 , wherein the semi-rigid leaflet and the flexible leaflet comprise different materials. 
   
   
       3 . The valve prosthesis of  claim 2 , wherein the semi-rigid leaflet further comprises reinforcing material selected from the group consisting of threads, fibers, meshes, and wires. 
   
   
       4 . The valve prosthesis of  claim 1 , wherein one of the flexible leaflet and the semi-rigid leaflet comprises a material selected from the group consisting of extracellular matrix material, xenogenic biomaterials, autologous tissue, allogeneic tissue, and polymeric materials. 
   
   
       5 . The valve prosthesis of  claim 1 , wherein one of the flexible leaflet and the semi-rigid leaflet comprises small intestine submucosa. 
   
   
       6 . The valve prosthesis of  claim 1 , wherein the first free edge comprises a curved free edge. 
   
   
       7 . The valve prosthesis of  claim 1 , wherein one of the semi-rigid leaflet and the flexible leaflet define a leaflet surface comprising a curvature. 
   
   
       8 . The valve prosthesis of  claim 7 , wherein the curvature comprises a convex or concave curvature. 
   
   
       9 . The valve prosthesis of  claim 1 , wherein the flexible leaflet comprises a surface having a curvature approximating the curvature of said body vessel. 
   
   
       10 . The valve prosthesis of  claim 1 , wherein each of the semi-rigid leaflet and the flexible leaflet has a curved surface adjacent the frame. 
   
   
       11 . The valve prosthesis of  claim 1 , wherein each of the semi-rigid leaflet and the flexible leaflet has a varying thickness. 
   
   
       12 . The valve prosthesis of  claim 1 , wherein one of the semi-rigid leaflet and the flexible leaflet comprises an opening that provides a passageway. 
   
   
       13 . The valve prosthesis of  claim 1 , wherein the semi-rigid leaflet comprises a first opening providing a first passageway and the flexible leaflet comprises a second opening providing a second passageway. 
   
   
       14 . The valve prosthesis of  claim 1 , wherein one of the semi-rigid leaflet and the flexible leaflet is adapted to cooperatively define an opening with said body vessel to provide a passageway. 
   
   
       15 . The valve prosthesis of  claim 1 , wherein the semi-rigid leaflet has a length that is between about 25% and about 60% of a diameter of said body vessel. 
   
   
       16 . The valve prosthesis of  claim 1 , wherein the flexible leaflet has a length that is between about 40% and about 75% of a diameter of said body vessel. 
   
   
       17 . The valve prosthesis of  claim 1 , wherein the frame is self-expanding. 
   
   
       18 . The valve prosthesis of  claim 1 , wherein the frame comprises stainless steel or nitinol. 
   
   
       19 . A valve prosthesis for implantation within a lumen of a body vessel, said valve prosthesis comprising:
 a frame;   a semi-rigid leaflet attached to the frame and having a first free edge, the semi-rigid leaflet comprising an opening providing a passageway; and   a flexible leaflet attached to the frame and having a second free edge, the flexible leaflet being moveable between a first position that permits fluid flow through said prosthesis in a first direction and a second position in which at least a portion of the flexible leaflet coapts with at least a portion of the semi-rigid leaflet to substantially prevent fluid flow through said valve prosthesis in a second direction;   wherein the semi-rigid leaflet has a length that is between about 25% and about 60% of a diameter of said body vessel.   
   
   
       20 . A valve prosthesis for implantation within a lumen of a body vessel, said valve prosthesis comprising:
 a frame;   a semi-rigid leaflet attached to the frame and having a first free edge, the semi-rigid leaflet adapted to cooperatively define an opening with said body vessel to provide a passageway disposed substantially opposite the first free edge; and   a flexible leaflet attached to the frame and having a second free edge, the flexible leaflet being moveable between a first position that permits fluid flow through said prosthesis in a first direction and a second position in which at least a portion of the flexible leaflet coapts with at least a portion of the semi-rigid leaflet to substantially prevent fluid flow through said valve prosthesis in a second direction;   wherein the semi-rigid leaflet has a length that is between about 25% and about 60% of a diameter of said body vessel.