Holder for flexible heart valve

Abstract

A holder for a highly flexible tissue-type heart valve is disclosed that maintains an implant shape to the valve. The holder may have cusp and commissure contacting supports, and may be attached at all six such supports, or only three. The holder may be flexible to permit inward flexing of the heart valve during implant for greater visibility when implanting using a running suture method. The holder may be formed of flexible wires such as Nitinol, and shaped to resist excessive axial and torsional deformation of the valve. A short handle connector suitable for manual grasping may be attached and stored with the valve, with the handle connector having a coupling for receiving a longer delivery handle. A two stage holder may be utilized to accommodate different implant methods.

1 . A holder for a heart valve, the 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, the valve commissures each being disposed between adjacent curvilinear valve cusps along the periphery of the valve, the holder comprising:
 a plurality of cusp supports connected to the heart valve generally along the valve cusps, wherein the heart valve is a flexible heart valve.   
   
   
       2 . The holder of  claim 1 , wherein the commissures are radially flexible enabling the valve commissures to be flexed inward while the holder is attached to the heart valve. 
   
   
       3 . The holder of  claim 2 , wherein the commissure are made of Nitinol. 
   
   
       4 . The holder of  claim 1 , wherein sutures connect the holder to the commissures. 
   
   
       5 . The holder of  claim 4 , wherein the cusp supports are connected to the heart valve with sutures. 
   
   
       6 . The holder of  claim 5 , wherein the sutures connecting the cusp supports to the heart valve are cut to release the holder from the heart valve. 
   
   
       7 . The holder of  claim 6 , wherein the sutures connecting the commissures to the holder are cut to release the holder from the heart valve. 
   
   
       8 . A holder for attaching to and holding a heart valve, the heart valve having multiple leaflets joined together at a periphery of the valve at valve commissures, the valve commissures each being disposed between adjacent curvilinear valve cusps about the periphery of the valve generally at an inflow end thereof, the holder comprising: a plurality of cusp supports arranged around a holder axis that coincides with the valve axis when the holder and valve are attached, the cusp supports being adapted to contact and attach to the heart valve along the valve cusps, wherein the valve commissures can be flexed inwards for increased visibility during implantation while the holder is attached to the valve cusps. 
   
   
       9 . The holder of  claim 8 , wherein the commissure are made of Nitinol. 
   
   
       10 . The holder of  claim 8 , wherein sutures connect the holder to the commissures. 
   
   
       11 . The holder of  claim 10 , wherein the cusp supports are connected to the heart valve with sutures. 
   
   
       12 . The holder of  claim 11 , wherein the sutures connecting the cusp supports to the heart valve are cut to release the holder from the heart valve. 
   
   
       13 . The holder of  claim 12 , wherein the sutures connecting the commissures to the holder are cut to release the holder from the heart valve.