Percutaneous valve prosthesis and system and method for implanting same

Abstract

A heart valve prosthesis includes a cylindrical valve cage stent constructed to be implanted percutaneously in the planar axis of a native valve annulus, an elastic and compressible, multi-leaflet valve insertable percutaneously into the body, and an attachment mechanism for attaching the valve to the superior rim of the valve cage stent. The valve can be of a bi-leaflet or a tri-leaflet type and includes a valve frame made from a memory metal and a tissue cover attached to the valve frame. The valve cage stent is self-expanding or balloon expandable, made respectively from memory metal or stainless steel but otherwise structurally the same.

1 . A heart valve prosthesis comprising:
 an expandable and compressible, cylindrical valve cage stent constructed to be implanted endovascularly in the planar axis of a native valve annulus, the valve cage stent having a superior rim;   an elastic and compressible, multi-leaflet valve insertable endovascularly into the body, the valve including an expandable and compressible valve frame and a tissue cover attached to the valve frame; and   attachment means for attaching the valve to the superior rim of the valve cage.   
   
   
       2 . The heart valve prosthesis of  claim 1 , wherein the valve frame is made from a memory metal. 
   
   
       3 . The heart valve prosthesis of  claim 1 , wherein:
 the valve cage stent has a fabric covering on the interior surfaces thereof and on parts of the exterior surfaces thereof to provide a complete seal and prevent leakage of blood when the valve cage stent is expanded; and   the valve cage stent has first, second, and third zones along its longitudinal axis, the first zone being between the second and third zones, the first zone being configured to connect the valve cage stent to the native valve annulus, the second zone being configured as the superior valve rim, and the third zone being configured as an inferior valve skirt for providing additional support and as an attachment area for the fabric covering and surrounding tissue to minimize leaking.   
   
   
       4 . The heart valve prosthesis of  claim 1 , wherein the valve is a bi-leaflet valve, the frame has two substantially semicircular, expandable, and compressible parts, and the tissue cover is configured to cover the two parts of the frame with the straight sides of the two parts in spaced-apart relation. 
   
   
       5 . The heart valve prosthesis of  claim 4 , wherein the tissue cover has a central aperture and the two parts of the frame have respective slots, and wherein the heart valve prosthesis further comprises a deformable hinge having oppositely extending arms extending through the slots and a stem received through the aperture, and
 wherein the attachment means comprises a valve mount affixed to the superior rim of the valve cage stent and a mating part on the hinge receivable in the valve mount.   
   
   
       6 . The heart valve prosthesis of  claim 5 , wherein the oppositely extending arms of the hinge have stops at the ends thereof for limiting movement of the leaflets. 
   
   
       7 . The heart valve prosthesis of  claim 5 , wherein the mating part on the hinge is removable from the valve mount, whereby the valve is replaceable. 
   
   
       8 . The heart valve prosthesis of  claim 1 , wherein the valve is a tri-leaflet valve, the frame is cylindrical and has three commissural posts mounted thereon, the tissue cover has three cusps fitted and sewn to the valve frames, the commissural posts being sized to maintain the commissural height of the cusps. 
   
   
       9 . The heart valve prosthesis of  claim 8 , wherein the valve cage stent has three commissural pins extending from the superior rim thereof, wherein the commissural posts of the frame are cannulated to receive the commissural pins of the valve cage stent, and wherein the commissural pins and the commissural posts define the attachment means. 
   
   
       10 . The heart valve prosthesis of  claim 8 , wherein the tissue cover comprises fabric and three substantially identical aortic cusps affixed to the fabric. 
   
   
       11 . A method for implanting the percutaneous valve prostheses of  claim 1  in a body, comprising the steps of:
 endovascularly inserting the valve cage stent in the planar axis of a native valve annulus; and   endovascularly attaching the valve to the superior rim of the valve cage stent so that the valve is in a supra annular position.   
   
   
       12 . The method of  claim 11 , wherein the valve cage stent and the valve are inserted using respective catheters, and wherein the valve is attached to the valve cage stent after they are discharged from their respective catheters. 
   
   
       13 . The method of  claim 11 , wherein the valve cage stent and the valve are inserted using the same catheter, and the valve is attached to the valve cage stent within the catheter.