Heart valve prosthesis and methods of manufacture and use

Abstract

A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

1 - 46 . (canceled) 
     
     
         47 . A valve prosthesis comprising:
 a frame comprising a terminal proximal end and a distal end, the frame comprising a plurality of rows of cells;   a valve body comprising a plurality of leaflets, adjoining leaflets affixed together to form commissures, the valve body coupled to the frame; and   a skirt attached to an interior surface of the frame;   wherein the plurality of leaflets are attached to the skirt along a curved joint line, the curved joint line curving towards and away from the terminal proximal end of the frame such that a base of the curved joint line is a distance within two rows of cells of the terminal proximal end of the frame.   
     
     
         48 . The valve prosthesis of  claim 47 , wherein the plurality of leaflets are formed from animal pericardial tissue and the skirt is formed of synthetic or polymer material. 
     
     
         49 . The valve prosthesis of  claim 48 , wherein the plurality of leaflets have a thickness between 0.008 inch and 0.016 inch. 
     
     
         50 . The valve prosthesis of  claim 49 , wherein the thickness is between 0.012 inch and 0.014 inch. 
     
     
         51 . The valve prosthesis of  claim 47 , wherein an inflow end of the skirt is sewn to the terminal proximal end of the frame. 
     
     
         52 . The valve prosthesis of  claim 47 , wherein the terminal proximal end of the frame is defined by a plurality of struts in a zig-zag pattern, wherein an inflow end of the skirt is sewn to the plurality of struts. 
     
     
         53 . The valve prosthesis of  claim 47 , wherein the curved joint line is affixed to and supported by the frame over most of the joint line. 
     
     
         54 . The valve prosthesis of  claim 47 , wherein the curved joint line is curved along a contour defined by struts of cells of the frame. 
     
     
         55 . A valve prosthesis comprising:
 a frame comprising an inflow section including a plurality of rows of cells defined by a plurality of rows of zig-zag struts, the inflow section including an inflow end defined by a proximal-most row of zig-zag struts of the plurality of rows of zig-zag struts;   a valve body comprising a plurality of leaflets, adjoining leaflets affixed together to form commissures coupled to the frame distal of at least two rows of the plurality of rows of cells, wherein the leaflets are formed from animal pericardium tissue with a thickness between 0.008 inch and 0.016 inch; and   a skirt attached to an interior surface of the frame, the skirt formed of synthetic or polymer material, wherein the skirt is sewn to the frame at least along the proximal-most row of zig-zag struts,   wherein the plurality of leaflets are attached to the skirt along a curved joint line, the curved joint line curving towards and away from the inflow end of the frame.   
     
     
         56 . The valve prosthesis of  claim 55 , wherein the thickness of the animal pericardium tissue is between 0.012 inch and 0.014 inch. 
     
     
         57 . The valve prosthesis of  claim 55 , wherein the skirt has a thickness of between 0.004 inch and 0.012 inch. 
     
     
         58 . The valve prosthesis of  claim 55 , wherein the curved joint line is affixed to and supported by the frame over most of the joint line. 
     
     
         59 . The valve prosthesis of  claim 55 , wherein the curved joint line is curved along a contour defined by struts of the cells of the frame. 
     
     
         60 . A valve prosthesis comprising:
 a frame having a radially compressed configuration and a radially expanded configuration, the frame including a plurality of cells having a plurality of cell sizes forming an inflow portion and an outflow portion, wherein the plurality of cells are disposed in a plurality of rows of cells including a first row of cells in the inflow portion, a second row of cells in the outflow portion, and a third row of cells disposed longitudinally between the first row of cells and the second row of cells, wherein each cell of the first row of cells has a first area and each cell of the second row of cells has a second area greater than the first area, and wherein the plurality of cell sizes vary along the length of the frame;   a valve body comprising a plurality of leaflets, the valve body coupled to the frame; and   a skirt attached to an interior surface of the frame.   
     
     
         61 . The valve prosthesis of  claim 60 , wherein the valve body includes a plurality of leaflets formed from animal pericardial tissue and the skirt is formed of synthetic or polymer material. 
     
     
         62 . The valve prosthesis of  claim 61 , wherein the plurality of leaflets have a thickness between 0.008 inch and 0.016 inch. 
     
     
         63 . The valve prosthesis of  claim 61 , wherein the plurality of leaflets are attached to the skirt along a curved joint line, the joint line curving towards and away from the inflow end of the frame. 
     
     
         64 . The valve prosthesis of  claim 60 , wherein each cell of the third row of cells has a third area smaller than the first area. 
     
     
         65 . The valve prosthesis of  claim 60 , wherein the first row of cells is the proximal-most row of cells of the frame. 
     
     
         66 . The valve prosthesis of  claim 60 , wherein in a radially expanded configuration, a terminal proximal end of the frame has a first diameter smaller than a second diameter of a distal terminal end of the frame.