System, devices and methods for anchoring and/or sealing a heart valve prosthesis

Abstract

Methods, devices and systems for anchoring and/or sealing a heart valve prosthesis and, in particular, a mitral valve prosthesis (202). Inflatable elements (204, 206) are used to seal and anchor the mitral valve prosthesis (202) and/or other elements associated with repairing a native mitral valve.

1 - 93 . (canceled) 
     
     
         94 . A system for anchoring a mitral valve prosthesis, the system comprising:
 a first anchor formed in a generally annular or partially annular shape and configured for positioning below and in engagement with heart tissue including at least the lower surfaces of the native mitral valve leaflets, and wherein the first anchor includes at least one inflatable portion, and   a second anchor coupled adjacent to the first anchor and configured to be positioned above and in engagement with heart tissue including upper surfaces of the native mitral valve leaflets and/or the mitral annulus and/or the left atrial tissue,   wherein the first and second anchors securely engage heart tissue therebetween for supporting a prosthetic mitral valve which is either integrated and delivered with the first and second anchors to the native mitral valve or delivered separately to the native mitral valve after the first and second anchors have been implanted.   
     
     
         95 . The system of  claim 94 , further comprising a plurality of anchoring arms configured to engage the first anchor and/or the native mitral valve leaflets, wherein the arms comprise inflatable elements, super-elastic wires, or combinations of inflatable elements carried by one or more super-elastic wires. 
     
     
         96 . The system of  claim 94 , wherein one or more super-elastic wires carry the first anchor and/or the second anchor. 
     
     
         97 . The system of  claim 94 , wherein the second anchor further comprises an inflatable anchor. 
     
     
         98 . The system of  claim 94 , wherein the second anchor further comprises a flange configured to provide anchoring of the system in the left atrium. 
     
     
         99 . The system of  claim 94 , further comprising a ring element coupled to and spaced from the first and second anchors, wherein the ring element provides additional height support for a prosthetic mitral valve which is either integrated and delivered with the first and second anchors and the ring element to the native mitral valve or delivered separately to the native mitral valve after the first and second anchors and the ring element have been implanted. 
     
     
         100 . The system of  claim 99 , wherein the first and second anchors and the ring element are coupled by vertical support struts. 
     
     
         101 . The system of  claim 94 , further comprising one or more inflatable portions associated with or integrated into the first and/or second anchors which are inflatable to adjust to the size of the native mitral valve annulus of a patient. 
     
     
         102 . The system of  claim 94 , wherein the first and/or second anchor further comprises a commissural seal. 
     
     
         103 . The system of  claim 94 , further comprising an inflatable element configured to be located below the native mitral valve annulus and wrap around or restrict the movement of the native anterior mitral leaflet to prevent the native anterior mitral leaflet from obstructing blood outflow from the left ventricle through the aortic valve. 
     
     
         104 . The system of  claim 94 , wherein the first anchor further comprises a plurality of partially annular inflatable segments which may be delivered via the commissures and/or around the native mitral valve leaflets. 
     
     
         105 . The system of  claim 104  wherein a native valve commissure is sealed between segments of the first anchor, the second anchor or a combination of first and second anchor elements. 
     
     
         106 . The system of  claim 94 , further comprising:
 an expansible mitral valve prosthesis configured to be delivered through a catheter separately from the first and second anchors to the position of the native mitral valve of a patient, the prosthesis capable of being expanded into engagement with the first and second anchors such that the prosthesis is anchored and stabilized in the native mitral valve.   
     
     
         107 . The system of  claim 94 , further comprising:
 an expansible mitral valve prosthesis coupled with at least the first and second anchors to be delivered through a catheter to the position of the native mitral valve of a patient, the prosthesis capable of being expanded and stabilized in the native mitral valve with the first and second anchors.   
     
     
         108 . The system of  claim 107 , further comprising a plurality of anchoring arms connected to the prosthesis and configured to wrap around and trap the native mitral valve leaflets against the prosthesis and/or against at least one of the anchors, wherein the arms comprise inflatable elements, super-elastic wires, or combinations of inflatable elements carried by one or more super-elastic wires. 
     
     
         109 . A system for anchoring a mitral valve prosthesis, the system comprising:
 a first ring element formed in a generally annular or partially annular shape and configured for positioning in engagement with heart tissue,   a second ring element coupled adjacent to the first ring element and configured to be in engagement with heart tissue, the second ring element formed in a generally annular or partially annular shape, and   a third ring element coupled to and spaced from the first and second ring elements, wherein the third ring element provides additional height support for a prosthetic mitral valve which is either integrated and delivered with the first, second and third ring elements to the native mitral valve or delivered separately to the native mitral valve after the first, second and third ring elements have been implanted.   
     
     
         110 . The system of  claim 109 , wherein at least one of the first or second annular or partially annular ring elements and/or the third ring element further comprises a flange and the remainder of the first or second annular or partially annular ring elements and/or the third ring elements comprise inflatable elements. 
     
     
         111 . A system for anchoring a mitral valve prosthesis, the system comprising:
 a first ring element formed in a generally annular shape and configured for positioning adjacent the native mitral valve and in engagement with heart tissue,   a second ring element coupled adjacent to the first ring element and configured to be positioned in engagement with heart tissue, the second ring element formed in a plurality of partially annular segments, and   a third ring element coupled to and spaced from the first and second ring elements, wherein the third ring element provides additional height support for a prosthetic mitral valve which is either integrated and delivered with the first, second and third ring elements to the native mitral valve or delivered separately to the native mitral valve after the first, second and third ring elements have been implanted.   
     
     
         112 . The system of  claim 111 , wherein at least one of the first, second and/or third ring elements further includes at least one inflatable portion. 
     
     
         113 . A method for implanting an anchor or sealing member for sealing and/or stabilizing a mitral valve prosthesis at the location of the native mitral valve, comprising:
 directing an elongate inflatable element adjacent at least a portion of the native mitral valve, and   using a wire operatively coupled to the elongate inflatable element to guide the elongate inflatable element adjacent the portion of the native mitral valve.