Sinus-Engaging Valve Fixation Member

Abstract

A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

1 - 12 . (canceled) 
     
     
         13 . A prosthetic valve comprising:
 an inner support structure expandable from a compressed state to an expanded state;   a valve member positioned inside and coupled to the inner support structure; and   an outer support structure expandable from a compressed state to an expanded state, the outer support structure positioned around the inner support structure, a first end of the outer support structure coupled to the inner support structure and extending radially outward from the inner support structure such that, in the expanded state, a space exists between the outer support structure and the inner support structure, the outer support structure comprising a tissue engagement portion disposed radially outward of the inner support structure, the tissue engagement portion configured to engage a native valve from within the native valve.   
     
     
         14 . The prosthetic valve of  claim 13 , wherein the native valve is a mitral valve. 
     
     
         15 . The prosthetic valve of  claim 13 , wherein the native valve is an aortic valve. 
     
     
         16 . The prosthetic valve of  claim 13 , wherein the native valve is a tricuspid valve. 
     
     
         17 . The prosthetic valve of  claim 13 , wherein the native valve is a pulmonary valve. 
     
     
         18 . The prosthetic valve of  claim 13 , wherein the inner support structure is self-expanding. 
     
     
         19 . The prosthetic valve of  claim 13 , wherein the outer support structure is self-expanding. 
     
     
         20 . The prosthetic valve of  claim 13 , wherein the tissue engagement portion comprises one or more tissue piercing elements. 
     
     
         21 . The prosthetic valve of  claim 20 , wherein the one or more tissue piercing elements comprise barbs. 
     
     
         22 . The prosthetic valve of  claim 13 , wherein at least a portion of the outer support structure comprises a covering. 
     
     
         23 . The prosthetic valve of  claim 13 , wherein at least a portion of the inner support structure comprises a covering. 
     
     
         24 . The prosthetic valve of  claim 13 , wherein the first end of the outer support structure is coupled to a first end of the inner support structure. 
     
     
         25 . The prosthetic valve of  claim 13 , wherein a distal end of the outer support structure is coupled to a distal end of the inner support structure. 
     
     
         26 . The prosthetic valve of  claim 13 , wherein the prosthetic valve further comprises an upstream tissue engagement portion and a downstream tissue engagement portion, wherein the upstream tissue engagement portion is configured to engage an upstream surface of the native valve, and wherein the downstream tissue engagement portion is configured to engage a downstream surface of the native valve. 
     
     
         27 . The prosthetic valve of  claim 13 , wherein the outer support member extends in a lengthwise direction of the inner support member. 
     
     
         28 . The prosthetic valve of  claim 13 , wherein the prosthetic valve further comprises one or more arms configured to extend behind a native leaflet. 
     
     
         29 . The prosthetic valve of  claim 13 , wherein a second end of the outer support structure is not coupled to the inner support structure.