Multiple Component Prosthetic Heart Valve Assemblies and Methods for Delivering Them

Abstract

Multiple component heart valves and apparatus and methods for implanting them are provided. The heart valve generally includes a first annular prosthesis and a second valve prosthesis. The first prosthesis includes an annular member compressible from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition. The first prosthesis also includes guide rails extending therefrom. The second prosthesis includes an annular frame, valve elements, and receptacles for receiving respective guide rails therethrough when the second prosthesis is directed towards the first prosthesis. In addition, a valve holder may releasably carry the valve prosthesis that includes channels for receiving respective guide rails therethrough when the guide rails are received through the valve prosthesis. A delivery tool is also provided that includes an actuator for selectively compressing the annular member into the contracted condition.

1 - 5 . (canceled) 
     
     
         6 . A method for delivering an annular first prosthesis into a biological annulus, the first prosthesis comprising a plurality of leaders extending therefrom, the method comprising: securing the leaders to a delivery tool such that the first prosthesis is disposed adjacent a distal end of the delivery tool;
 applying axial tension to the leaders to compress the first prosthesis inwardly to a contracted condition;   introducing the distal end of the delivery tool into a biological annulus with the first prosthesis in the contracted condition; and   deploying the first prosthesis in the biological annulus such that the prosthesis expands to an enlarged condition.   
     
     
         7 . The method of  claim 6 , further comprising securing the first prosthesis to tissue surrounding the biological annulus. 
     
     
         8 . The method of  claim 7 , further comprising securing a second valve prosthesis to the first prosthesis after deploying the first prosthesis in the biological annulus. 
     
     
         9 . The method of  claim 7 , further comprising advancing the second prosthesis over the leaders towards the first prosthesis before securing the second prosthesis to the first prosthesis. 
     
     
         10 . The method of  claim 6 , wherein tissue surrounding the biological annulus is dilated when the first prosthesis is deployed. 
     
     
         11 - 22 . (canceled)