Prosthetic Heart 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 heart valve. In some embodiments, an apparatus includes an outer sheath, a tube member movably disposed within the outer sheath, a retention device coupled to the tube member, and a valve holder. A prosthetic heart valve is disposed within the outer sheath and includes an outer frame and an inner frame that is removably coupled to the valve holder. The outer frame is disposed in an inverted configuration relative to the inner frame. A first actuation wire is releasably coupled to a first portion of the outer frame and releasably coupled to the retention device at a first location on the retention device. A second actuation wire is releasably coupled to a second portion of the outer frame and releasably coupled to the retention device at a second location on the retention device.

What is claimed is: 
     
         1 . A method, comprising:
 inserting a distal end portion of a delivery sheath of a valve delivery device into a left atrium of a heart, the delivery sheath having a prosthetic heart valve disposed within a lumen of the delivery sheath, the prosthetic heart valve having an outer frame coupled to an inner frame, the outer frame being inverted relative to the inner frame, the prosthetic heart valve being releasably coupled to a retention device, the retention device including a proximal retention member defining a first opening, a center retention member including a first pin and a second pin, and a distal retention member defining a second opening, an actuation wire being coupled to the prosthetic heart valve and including a first loop secured to the retention device with the first pin and a second loop secured to the retention device with the second pin;   moving the prosthetic heart valve distally out of the distal end portion of the delivery sheath;   moving the retention device proximally such that the actuation wire pulls the outer frame of the prosthetic heart valve proximally and the outer frame is reverted relative to the inner frame;   actuating the retention device such that the distal retention member moves axially relative to the center retention member and the second pin releases the second loop of the actuation wire;   after actuating the retention device, moving the retention device proximally such that the actuation wire is pulled proximally and is uncoupled from the prosthetic heart valve; and   positioning the prosthetic heart valve within a mitral valve annulus of the heart.   
     
     
         2 . The method of  claim 1 , further comprising;
 after positioning the prosthetic heart valve within the mitral valve annulus of the heart, releasing the inner frame of the prosthetic heart valve from a valve holder of the delivery device.   
     
     
         3 . The method of  claim 1 , wherein the actuation wire includes a third loop secured to the retention device with a third pin of the retention device, and when the retention device is actuated and the distal retention member moves axially relative to the center retention member, the third pin releases the third loop of the actuation wire. 
     
     
         4 . The method of  claim 1 , further comprising:
 prior to actuating the retention device such that the distal retention member moves axially relative to the center retention member and the second pin releases the second loop of the actuation wire, moving the retention device further proximally such that outer open ends of the outer frame are pulled in closer to the retention device.   
     
     
         5 . The method of  claim 1 , further comprising loading the prosthetic heart valve into the delivery sheath prior to inserting the distal end portion of the delivery sheath of the valve delivery device into the left atrium of the heart, the loading comprising:
 placing the first loop of the actuation wire over the first pin of the retention device of the prosthetic heart valve delivery device;   passing a first portion of the actuation wire through a first frame loop on the outer frame of the prosthetic heart valve and passing a second portion of the actuation wire through a second frame loop on the outer frame of the prosthetic heart valve, the first portion of the actuation wire having the second loop disposed on a first end of the actuation wire and the second portion of the actuation wire having a third loop on a second end of the actuation wire;   placing the second loop and the third loop of the actuation wire over the second pin of the retention device;   actuating the retention member to move one of the center retention member and the proximal retention member axially such that the first pin is disposed in the first opening and the first loop of the actuation wire is secured to the retention device;   actuating the retention member to move the distal retention member axially such that the second pin is disposed in the second opening and the second loop and the third loop of the actuation wire are secured to the retention device;   placing the prosthetic heart valve within the lumen of the delivery sheath of the delivery device.   
     
     
         6 . The method of  claim 5 , further comprising:
 prior to placing the prosthetic heart valve within the lumen of the delivery sheath, moving the prosthetic heart valve from a first configuration in which the outer frame of the prosthetic heart valve is disposed substantially surrounding the inner frame of the prosthetic heart valve to a second configuration in which the outer frame is inverted relative to the inner frame and a free end portion of the outer frame points in a direction away from the inner frame.   
     
     
         7 . The method of  claim 6 , wherein the prosthetic heart valve is in the second configuration when placing the prosthetic heart valve within the lumen of the delivery sheath. 
     
     
         8 . The method of  claim 5 , further comprising:
 prior to placing the prosthetic heart valve within the lumen of the delivery sheath, releasably coupling a portion of the prosthetic heart valve to a valve holder of the prosthetic heart valve delivery device, the valve holder being movably disposed within a tube member, the tube member being fixedly coupled to the retention device.   
     
     
         9 . The method of  claim 8 , wherein prior to placing the prosthetic heart valve within the lumen of the delivery sheath, routing a portion of the actuation wire through an aperture defined by the valve holder. 
     
     
         10 . The method of  claim 5 , wherein the actuation wire is a first actuation wire, the method further comprising:
 placing a first loop of a second actuation wire over a third pin of the retention device, the center retention member including the third pin and a fourth pin, the distal retention member defining a third opening, the proximal retention member defining a fourth opening;   passing a first portion of the second actuation wire through a third frame loop on the outer frame of the prosthetic heart valve and passing a second portion of the second actuation wire through a fourth frame loop on the outer frame of the prosthetic heart valve, the first portion of the second actuation wire having a second loop disposed on a first end of the second actuation wire and the second portion of the second actuation wire having a third loop on a second end of the second actuation wire; and   placing the second loop and the third loop of the second actuation wire over the fourth pin of the retention device; wherein   when the retention member is actuated to move one of the center retention member and the proximal retention member axially, the third pin is disposed in the fourth opening and the first loop of the second actuation wire is secured to the retention device; and   when the retention member is actuated to move the distal retention member axially, the fourth pin is disposed in the third opening and the second loop and the third loop of the second actuation wire are secured to the retention device.   
     
     
         11 . The method of  claim 1 , wherein the second pin extends a first length from the center retention member and the center retention member includes a third pin extending toward the distal retention member having a second length greater than the first length, and wherein actuating the retention device such that the distal retention member moves axially includes disengaging the second pin from the second opening before disengaging the third pin from a third opening of the distal retention member. 
     
     
         12 . The method of  claim 11 , wherein actuating the retention device such that the distal retention member moves axially includes releasing the second loop from the second pin before releasing a third loop from the third pin. 
     
     
         13 . The method of  claim 1 , wherein positioning the prosthetic heart valve within the mitral valve annulus includes manipulating a tube member with the actuation wire pinned thereto to control the outer frame. 
     
     
         14 . The method of  claim 1 , wherein while actuating the retention device such that the distal retention member moves axially relative to the center retention member, the distal retention member is rotationally fixed to the center retention member. 
     
     
         15 . The method of  claim 14 , wherein the proximal retention member is rotationally fixed to the center retention member and the distal retention member. 
     
     
         16 . The method of  claim 1 , wherein prior to positioning the prosthetic heart valve within the mitral valve annulus, moving the retention device proximally to tension the actuation wire and pull outer free end portions of the outer frame, hinging the outer frame about the valve holder to reduce a profile of the prosthetic heart valve. 
     
     
         17 . The method of  claim 16 , wherein after moving the retention device proximally to tension the actuation wire, the positioning includes releasing the tension on the actuation wire to allow the outer frame to radially expand in the mitral valve annulus. 
     
     
         18 . The method of  claim 17 , wherein after releasing the tension on the actuation wire, the positioning includes reapplying the tension on the actuation wire to reposition the prosthetic heart valve within the mitral valve annulus. 
     
     
         19 . The method of  claim 1 , wherein the outer frame includes a first row of frame loops at a first longitudinal location and a second row of frame loops at a second longitudinal location, the actuation wire passing through at least one frame loop in each of the first and second rows such that tensioning the actuation wire causes an end portion of the outer frame to hinge about the first row of frame loops. 
     
     
         20 . The method of  claim 1 , wherein the actuation wire is passed through an aperture on a valve holder, the aperture surrounded by a ring providing a radiused smooth surface for the actuation wire to abut while the actuation wire is translated relative to the valve holder.