Flexible Heart Valve and Holder Therefor

Abstract

A highly flexible tissue-type heart valve is disclosed having a structural stent in a generally cylindrical configuration with cusps and commissures that are permitted to move radially. The stent commissures are constructed so that the cusps are pivotably or flexibly coupled together at the commissures to permit relative movement therebetween. The stent may be cloth-covered and may be a single element or may be made in three separate elements for a three cusp valve, each element having a cusp portion and two commissure portions; adjacent commissure portions for each pair of adjacent stent element combining to form the stent commissures. If the stent has separate elements their commissure portions may be pivotably or flexible coupled, or may be designed to completely separate into independent leaflets at bioresorbable couples. The cloth covering may have an outwardly projecting flap that mates with valve leaflets (e.g., pericardial leaflets) along the cusps and commissures. A connecting band may be provided that follows the cusps and commissures and extends outwardly. The valve is connected to the natural tissue along the undulating connecting band using conventional techniques, such as sutures. The connecting band may be a cloth-covered silicon member and attaches to the underside of the valve at the cusps to provide support to the stent and to the outer side of the valve at the commissures. The connecting band includes commissure portions defining generally axial gaps that help permit flexing of the valve.

1 . A heart valve and holder combination, comprising:
 a flexible heart valve having multiple leaflets joined together at a periphery of the valve at valve commissures that are generally axially aligned and evenly disposed about a valve axis and project toward an outflow end of the heart valve, the valve commissures each being disposed between adjacent curvilinear valve cusps that are convex toward an inflow end of the heart valve and also arranged around the periphery of the valve;   a valve holder having a plurality of straight legs that extend at an outward angle from a central hub to terminate in cusp supports, the holder being attached to the heart valve such that the central hub is positioned along the valve axis on the outflow side of the valve and the legs extend toward the inflow direction between adjacent commissures and the cusp supports contact the heart valve cusps; and   a suture securing each holder cusp support against a respective heart valve cusp, the suture extending up the leg to an exposed location adjacent the central hub to enable severing by a sharp.   
     
     
         2 . The combination of  claim 1 , wherein the valve commissures are radially flexible enabling them to be flexed inward while the holder is attached to the heart valve. 
     
     
         3 . The combination of  claim 2 , wherein the commissures are made of Nitinol. 
     
     
         4 . The combination of  claim 1 , wherein sutures also connect the holder to the valve commissures. 
     
     
         5 . The combination of  claim 4 , wherein the sutures connecting the commissures to the holder permit the commissures to flex. 
     
     
         6 . The combination of  claim 4 , wherein the holder further includes a plurality of radially extending legs between adjacent cusp support legs and terminating in commissure supports, and the sutures connecting the commissures to the holder secure the commissure supports to the valve commissures. 
     
     
         7 . The combination of  claim 1 , wherein the cusp supports each include a concavity on an inflow side for conforming to the respective valve cusp. 
     
     
         8 . A heart valve and holder combination, comprising:
 a heart valve having multiple leaflets joined together at a periphery of the valve at valve commissures that are generally axially aligned and evenly disposed about a valve axis and project toward an outflow end of the heart valve, the valve commissures are located between adjacent curvilinear valve cusps that are convex toward an inflow end of the heart valve and also arranged around the periphery of the valve; and   a valve holder having a handle socket and plurality of legs that flare outward at angles therefrom and terminate in cusp supports, the holder being attached to the heart valve such that the handle socket is positioned on the outflow side of the valve and the legs extend toward the inflow direction between adjacent commis sures and the cusp supports contact the heart valve cusps;   a suture securing each holder cusp support against a respective heart valve cusp; and   at least one suture securing each valve commissure to the handle socket.   
     
     
         9 . The combination of  claim 8 , wherein the valve commissures are radially flexible enabling them to be flexed inward while the holder is attached to the heart valve. 
     
     
         10 . The combination of  claim 9 , wherein the commissures are made of Nitinol. 
     
     
         11 . The combination of  claim 8 , wherein the sutures connecting the commissures to the holder permit the commissures to flex. 
     
     
         12 . The combination of  claim 8 , wherein the holder further includes a plurality of radially extending legs between adjacent cusp support legs and terminating in commissure supports, and the sutures connecting the commissures to the holder secure the commissure supports to the valve commissures. 
     
     
         13 . The combination of  claim 8 , wherein the cusp supports each include a concavity on an inflow side for conforming to the respective valve cusp. 
     
     
         14 . The combination of  claim 8 , wherein the suture securing each holder cusp support against a respective heart valve cusp extends up the leg to an exposed location adjacent the handle socket to enable severing by a sharp. 
     
     
         15 . A heart valve and holder combination, comprising:
 a flexible heart valve having three leaflets joined together at a periphery of the valve at three valve commissures that are generally axially aligned and evenly disposed about a valve axis and project toward an outflow end of the heart valve, the valve commissures each being disposed between adjacent curvilinear valve cusps that are convex toward an inflow end of the heart valve and also arranged around the periphery of the valve, at least a portion of the heart valve being covered by fabric;   a valve holder having a central hub and legs that radiate at an angle outward therefrom; and   sutures securing the valve holder to the heart valve, wherein the sutures pass through the heart valve fabric at six locations, one at each valve cusp and one at each valve commissure, wherein the legs extend into contact with the valve cusps and stabilize movement thereby while the valve commissures are permitted to flex radially relative to the central hub.   
     
     
         16 . The combination of  claim 15 , wherein the valve commissures are made of Nitinol. 
     
     
         17 . The combination of  claim 15 , wherein the valve holder legs comprise a plurality of cusp support legs that extend at an outward angle from the central hub to terminate in cusp supports, the holder being attached to the heart valve such that the central hub is positioned along the valve axis on the outflow side of the valve and the legs extend toward the inflow direction between adjacent commissures and the cusp supports contact and conform to the heart valve cusps. 
     
     
         18 . The combination of  claim 17 , wherein the valve holder further includes a plurality of radially extending legs between adjacent cusp support legs and terminating in commissure supports, and the sutures connecting the commissures to the holder secure the commissure supports to the valve commissures. 
     
     
         19 . The combination of  claim 17 , wherein the cusp supports each include a concavity on an inflow side for conforming to the respective valve cusp. 
     
     
         20 . The combination of  claim 17 , wherein the suture securing each holder cusp support against a respective heart valve cusp extends up the leg to an exposed location adjacent the handle socket to enable severing by a sharp.