Prosthetic Mitral Valves And Apparatus And Methods For Delivery Of Same

Abstract

Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when the valve is in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The distal end portion of the delivery sheath is inserted into a left atrium of a heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. In some embodiments, actuation wires are used to assist in the reversion of the outer frame. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.

What is claimed is: 
     
         1 . An apparatus, comprising:
 a delivery sheath defining a lumen;   a valve holder movably disposable within the lumen of the delivery sheath;   a prosthetic heart valve disposed at least partially within the lumen of the delivery sheath in a collapsed configuration, the prosthetic heart valve including an outer frame coupled to an inner frame, the inner frame being removably coupled to a distal end portion of the valve holder,   the outer frame being movable between a first configuration relative to the inner frame and a second configuration relative to the inner frame in which the outer frame is inverted relative to the inner frame, the prosthetic heart valve being disposed within the lumen of the delivery sheath with the outer frame in the second configuration;   a first actuation wire releasably coupled to a first portion of an open free end portion of the outer frame; and   a second actuation wire releasably coupled to a second portion of the open free end portion of the outer frame,   each of the first actuation wire and the second actuation wire having a first portion extending proximally from the outer frame and a second portion extending proximally from the outer frame, the first portion and the second portion of each of the first actuation wire and the second actuation wire configured to be pulled proximally to urge the outer frame from the second configuration towards the first configuration relative to the inner frame.   
     
     
         2 . The apparatus of  claim 1 , wherein the outer frame includes a plurality of loop members including at least a first loop member and a second loop member disposed at the open free end portion, the first actuation wire being inserted through at least the first loop member from the plurality of loop members to releasably couple the first actuation wire to the outer frame, the second actuation wire being inserted through at least the second loop member from the plurality of loop members to releasably couple the second actuation wire to the outer frame. 
     
     
         3 . The apparatus of  claim 1 , wherein the first portion of the first actuation wire and the second portion of the first actuation wire each extend proximally from the outer frame and through a first side aperture defined by a wall of the delivery sheath and within the lumen of the delivery sheath, and the first portion of the second actuation wire and the second portion of the second actuation wire each extend proximally from the outer frame and through a second side aperture defined by the wall of the delivery sheath and within the lumen of the delivery sheath. 
     
     
         4 . The apparatus of  claim 1 , further comprising:
 an outer sheath, the delivery sheath being movably disposed within a lumen defined by the outer sheath.   
     
     
         5 . The apparatus of  claim 1 , further comprising:
 an outer sheath, the delivery sheath being movably disposed within a lumen defined by the outer sheath,   the first portion of the first actuation wire and the second portion of the first actuation wire each extending proximally from the outer frame and through a distal opening defined by the delivery sheath and within the lumen of the delivery sheath, and the first portion of the second actuation wire and the second portion of the second actuation wire each extending proximally from the outer frame and through a distal opening defined by the delivery sheath and within the lumen of the delivery sheath.   
     
     
         6 . The apparatus of  claim 1 , further comprising:
 an outer sheath, the delivery sheath being movably disposed within a lumen defined by the outer sheath,   the first portion of the first actuation wire and the second portion of the first actuation wire each extending proximally from the outer frame and through the lumen of the outer sheath and along an outside wall of the delivery sheath, and the first portion of the second actuation wire and the second portion of the second actuation wire each extend proximally from the outer frame and through the lumen of the outer sheath and along an outside wall of the delivery sheath.   
     
     
         7 . The apparatus of  claim 3 , wherein the first portion of the first actuation wire and the second portion of the first actuation wire each extend from within the lumen of the delivery sheath through side apertures defined by the valve holder and within a lumen defined by the valve holder, and the first portion of the second actuation wire and the second portion of the second actuation wire each extend from within the lumen of the delivery sheath through side apertures defined by the valve holder and within the lumen of the valve holder. 
     
     
         8 . The apparatus of  claim 1 , wherein the inner frame includes a plurality of couplers, the valve holder defining a plurality of recesses, each coupler from the plurality of couplers configured to be received within a different recess from the plurality of recesses to releasably couple the inner frame to the valve holder. 
     
     
         9 . An apparatus, comprising:
 an outer sheath defining a lumen;   an inner sheath movably disposed within the lumen of the outer sheath and defining a lumen;   a tube member movably disposed within the lumen of the outer sheath and defining a lumen;   a valve holder movably disposed within the lumen of the inner sheath and within a lumen defined by the tube member;   a prosthetic heart valve disposed at least partially within the lumen of the outer sheath and at least partially within the lumen of the inner sheath,   the prosthetic heart valve including an outer frame coupled to an inner frame, the inner frame being removably coupled to a distal end portion of the valve holder,   the outer frame being movable between a first configuration relative to the inner frame and a second configuration relative to the inner frame in which the outer frame is inverted relative to the inner frame, the prosthetic heart valve being disposed within the lumen of the outer sheath and the lumen of the inner sheath with the outer frame in the second configuration;   a first actuation wire releasably coupled to a first portion of an open free end portion of the outer frame and releasably coupled to the tube member at a first location on the tube member; and   a second actuation wire releasably coupled to a second portion of the open free end portion of the outer frame and releasably coupled to the tube member at a second location on the tube member.   
     
     
         10 . The apparatus of  claim 9 , wherein the lumen of the tube member is a first lumen, the first actuation wire is coupled to the tube member with a first pinning member, and the second actuation wire is coupled to the tube member with a second pinning member, the first pinning member being movably disposed within a second lumen defined by the tube member, the second pinning member being movably disposed within a third lumen defined by the tube member. 
     
     
         11 . The apparatus of  claim 9 , wherein the outer frame includes a plurality of loop members including at least a first loop member and a second loop member disposed at the open free end portion, the first actuation wire being inserted through at least the first loop member from the plurality of loop members to releasably couple the first actuation wire to the outer frame, the second actuation wire being inserted through at least the second loop member from the plurality of loop members to releasably couple the second actuation wire to the outer frame. 
     
     
         12 . The apparatus of  claim 9 , wherein the inner frame includes a plurality of couplers, the valve holder defining a plurality of recesses, each coupler from the plurality of couplers configured to be received within a different recess from the plurality of recesses to releasably couple the inner frame to the valve holder. 
     
     
         13 . The apparatus of  claim 9 , wherein the first actuation wire extends between the first location on the outer frame and the first location on the tube member proximally from the outer frame through the lumen of the outer sheath and along an outside wall of the inner sheath,
 the second actuation wire extends between the second location on the outer frame and the second location on the tube member proximally from the outer frame through the lumen of the outer sheath and along an outside wall of the inner sheath.   
     
     
         14 . The apparatus of  claim 9 , wherein the first actuation wire includes a loop configured to be pinned by the first pinning member to releasably couple the first actuation wire to the tube member, the second actuation wire includes a loop configured to be pinned by the second pinning wire to releasably couple the second actuation wire to the tube member. 
     
     
         15 . The apparatus of  claim 9 , further comprising:
 a third actuation wire releasably coupled to a third portion of the open free end portion of the outer frame and releasably coupled to the tube member at a third location on the tube member; and   a fourth actuation wire releasably coupled to a fourth portion of the open free end portion of the outer frame and releasably coupled to the tube member at a fourth location on the tube member.   
     
     
         16 . The apparatus of  claim 10 , further comprising:
 a third actuation wire releasably coupled to a third portion of the open free end portion of the outer frame and releasably coupled to the tube member at a third location on the tube member; and   a fourth actuation wire releasably coupled to a fourth portion of the open free end portion of the outer frame and releasably coupled to the tube member at a fourth location on the tube member.   the third first pinning member being movably disposed within a third lumen defined by the tube member, the fourth pinning member being movably disposed within a fifth lumen defined by the tube member.   
     
     
         17 . A method, comprising:
 inserting a distal end portion of a delivery sheath into a left atrium of a heart, the delivery sheath having a prosthetic mitral valve disposed within a lumen of the delivery sheath, the prosthetic mitral valve having an outer frame coupled to an inner frame, the outer frame being movable between a first position relative to the inner frame and a second position relative to the inner frame in which the outer frame is inverted relative to the inner frame, the prosthetic mitral valve being disposed within the lumen of the delivery sheath with the outer frame in the second positon relative to the inner frame;   moving the prosthetic mitral valve distally out of the delivery sheath;   causing the outer frame of the prosthetic mitral valve to revert back to the first position relative to the inner frame such that the prosthetic mitral valve at least partially assumes a biased expanded configuration; and   positioning the prosthetic mitral valve within a mitral annulus of the heart.   
     
     
         18 . The method of  claim 17 , wherein the outer frame is coupled to the inner frame with a plurality of coupling joints such that the outer frame can be moved between the first position relative to the inner frame and the second position relative to the inner frame. 
     
     
         19 . The method of  claim 17 , wherein the causing the outer frame to revert back to the first position relative to the inner frame includes pulling proximally a first actuation wire and a second actuation wire, the first actuation wire being releasably coupled to a first portion of an open free end portion of the outer frame, the second actuation wire being releasably coupled to a second portion of the open free end portion of the outer frame. 
     
     
         20 . The method of  claim 17 , wherein the causing the outer frame to revert back to the first position relative to the inner frame includes pulling proximally a tube member movably disposed within the lumen of the delivery sheath, the tube member being coupled to the outer frame via a first actuation wire and a second actuation wire, the first actuation wire being releasably coupled to a first portion of an open free end portion of the outer frame and having a first portion releasably coupled to the tube member at a first location on the tube member and a second portion releasably coupled to the tube member at a second location on the tube member,
 the second actuation wire being releasably coupled to a second portion of the open free end portion of the outer frame and having a first portion releasably coupled to the tube member at a third location on the tube member and a second portion releasably coupled to the tube member at a fourth location on the tube member.   
     
     
         21 . The method of  claim 17 , wherein the moving the prosthetic mitral valve distally out of the delivery sheath includes at least in part, moving distally an inner sheath movably disposed within the delivery sheath, the prosthetic mitral valve being at least partially disposed with a lumen of the inner sheath. 
     
     
         22 . The method of  claim 17 , wherein the moving the prosthetic mitral valve distally out of the delivery sheath includes at least in part, moving distally a valve holder movably disposed within the delivery sheath, the valve holder being releasably coupled to the inner frame of the prosthetic mitral valve. 
     
     
         23 . The method of  claim 17 , further comprising:
 after causing the outer frame of the prosthetic mitral valve to revert back to the first position relative to the inner frame and prior to positioning the prosthetic mitral valve within a mitral annulus of the heart, releasing the first actuation wire from one of the first location on the tube member and the second location on the tube member;   releasing the second actuation wire from one of the third location on the tube member and the fourth location on the tube member; and   after releasing the first actuation wire and the second actuation wire, pulling the tube member proximally such that the first actuation wire and the second actuation wire are released from the outer frame.   
     
     
         24 . The method of  claim 19 , further comprising:
 after the causing the outer frame to revert back to the first position relative to the inner frame and the prosthetic mitral valve at least partially assumes the biased expanded configuration, pulling proximally on the first actuation wire and the second actuation wire to move the outer frame to at least a partially radially collapsed configuration outside of the delivery sheath.   
     
     
         25 . The method of  claim 19 , further comprising:
 after the causing the outer frame to revert back to the first position relative to the inner frame and the prosthetic mitral valve at least partially assumes the biased expanded configuration, pulling proximally on the tube member to move the outer frame to at least a partially radially collapsed configuration outside of the delivery sheath.