Prosthetic valve with anti-pivoting mechanism

Abstract

A prosthetic valve for implanting in a patient's native valve has a self-expanding frame that comprises a first end, a second end opposite the first end, an anterior portion, and a posterior portion. The self-expanding frame has an expanded configuration adapted to engage tissue at a treatment site, and a collapsed configuration adapted to be delivered to the treatment site. The expandable frame also comprises a self-expanding atrial skirt near the second end, a self-expanding ventricular skirt near the first end, a self-expanding annular region disposed between first and second ends, a first self-expanding anterior tab disposed on the anterior portion, and a self-expanding foot coupled to the posterior portion and extending radially outward. The foot has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.

1 .- 75 . (canceled) 
     
     
         76 . A prosthetic valve for implanting in a native valve of a patient, said prosthetic valve comprising:
 a self-expanding frame having a first end, a second end opposite the first end, an atrial region near the second end, a ventricular region near the first end, an anterior portion, and a posterior portion,   wherein the self-expanding frame has an expanded configuration and a collapsed configuration, the expanded configuration adapted to engage tissue at a treatment site, and wherein the self-expanding frame comprises:
 a self-expanding atrial skirt disposed in the atrial region; 
 a self-expanding ventricular skirt disposed in the ventricular region; 
 a self-expanding annular region disposed between the atrial region and the ventricular region; 
 a first self-expanding anterior tab disposed on the anterior portion of the self-expanding frame in the ventricular region; and 
 a self-expanding foot coupled to the ventricular region, wherein the self-expanding foot is disposed in the posterior portion and extends radially outward from the self-expanding frame and has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve to the posterior portion of the native valve, 
 wherein anchoring of the self-expanding foot to the tissue prevents or minimizes rotation of the prosthetic valve upstream toward or into a left atrium of the patient's heart. 
   
     
     
         77 . The prosthetic valve of  claim 76 , wherein the prosthetic valve is a prosthetic mitral valve. 
     
     
         78 . The prosthetic valve of  claim 76 , wherein the atrial skirt has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the treatment site, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to lie over a superior surface of the patient's native valve, thereby anchoring the atrial skirt against the superior surface of the native valve. 
     
     
         79 . The prosthetic valve of  claim 76 , wherein the atrial skirt comprises a plurality of axially oriented struts connected together with a connector element, the plurality of axially oriented connected struts forming a series of peaks and valleys. 
     
     
         80 . The prosthetic valve of  claim 76 , wherein after self-expansion of the atrial skirt, the atrial skirt forms a flanged region adjacent the second end of the self-expanding frame, and has an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a partially cylindrically shaped posterior portion. 
     
     
         81 . The prosthetic valve of  claim 76 , further comprising an alignment element coupled to an anterior portion of the atrial skirt, wherein the alignment element is adapted to be aligned with an aortic root of the patient's heart and adapted to be disposed between two fibrous trigones adjacent an anterior leaflet of the patient's mitral valve. 
     
     
         82 . The prosthetic valve of  claim 76 , wherein after self-expansion, the ventricular skirt comprises an asymmetrically D-shaped cross-section having a substantially flat anterior portion, and a partially cylindrically shaped posterior portion. 
     
     
         83 . The prosthetic valve of  claim 76 , wherein the ventricular skirt has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the treatment site, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to displace native mitral valve leaflets radially outward. 
     
     
         84 . The prosthetic valve of  claim 76 , wherein the ventricular skirt comprises a plurality of struts connected together with a connector element, the plurality of interconnected struts forming a series of peaks and valleys. 
     
     
         85 . The prosthetic valve of  claim 76 , wherein the annular region has a collapsed configuration and an expanded configuration, the collapsed configuration adapted for delivery to the treatment site, and the expanded configuration radially expanded relative to the collapsed configuration and adapted to conform with and engage an annulus of the native valve. 
     
     
         86 . The prosthetic valve of  claim 76 , wherein after self-expansion, the annular region has an asymmetrically D-shaped cross-section having a substantially flat anterior position, and a partially cylindrically shaped posterior portion. 
     
     
         87 . The prosthetic valve of  claim 76 , wherein the annular region comprises a plurality of axially oriented interconnected struts, the plurality of axially oriented interconnected struts forming a series of peaks and valleys. 
     
     
         88 . The prosthetic valve of  claim 76 , wherein the first self-expanding anterior tab has a tip portion adapted to engage a first fibrous trigone on a first side of an anterior leaflet of the patient's mitral valve, and wherein the anterior leaflet and adjacent chordae tendinae are disposed between the first self-expanding anterior tab and an outer anterior surface of the ventricular skirt. 
     
     
         89 . The prosthetic valve of  claim 89 , further comprising a second self-expanding anterior tab disposed on the anterior portion of the self-expanding frame in the ventricular region, and wherein the second self-expanding anterior tab has a tip portion adapted to engage a second fibrous trigone on a second side of the anterior leaflet of the patient's mitral valve opposite the first side of the anterior leaflet, and wherein the anterior leaflet and adjacent chordae tendinae are disposed between the second self-expanding anterior tab and the outer surface of the ventricular skirt. 
     
     
         90 . The prosthetic valve of  claim 76 , further comprising a covering disposed over a first or a second self-expanding anterior tab, the covering increasing contact surface area of the first or the second anterior tab with heart tissue. 
     
     
         91 . The prosthetic valve of  claim 76 , wherein rotation of the posterior portion is minimized or prevented relative to the anterior portion of the prosthetic valve. 
     
     
         92 . The prosthetic valve of  claim 76 , wherein the foot comprises a wedge shaped element extending radially outward from the self-expanding frame. 
     
     
         93 . The prosthetic valve of  claim 76 , wherein the foot comprises a central elongate element and a cover, wherein the cover is disposed over the central elongate element and the cover is coupled to a strut on either side thereof. 
     
     
         94 . The prosthetic valve of  claim 76 , further comprising a plurality of prosthetic valve leaflets, each of the plurality of prosthetic valve leaflets having a first end and a free end, wherein the first end is coupled with the self-expanding frame and the free end is opposite of the first end, wherein the plurality of prosthetic valve leaflets have an open configuration in which the free ends of the plurality of prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the plurality of prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. 
     
     
         95 . The prosthetic valve of  claim 76 , further comprising a posterior self-expanding anchor tab on the posterior portion of the self-expanding frame, wherein the posterior anchor tab is configured to expand radially outward without anchoring the posterior tab on the native.