Prosthetic heart valve and delivery apparatus

Abstract

Delivery assemblies including a prosthetic heart valve and a delivery apparatus are disclosed. The prosthetic heart valve includes a frame having posts extending from a terminal outflow end of the frame and a valve structure disposed within the frame. The delivery apparatus includes an inner shaft including a valve connection portion having recesses configured to receive the posts of the frame of the prosthetic heart valve, an outer shaft including a valve sheath for retaining the prosthetic valve in a radially compressed state and retaining the posts within the recesses, and a handle including a control knob for moving the valve sheath proximally and distally relative to the handle. The control knob is seated within the handle housing such that the housing partially covers a circumferentially extending outer surface of the control knob.

1 . An assembly comprising:
 a radially collapsible and self-expandable prosthetic heart valve comprising:
 an annular frame comprising a plurality of strut members interconnected to each other to form a plurality of rows of cells, the plurality of rows of cells including an outflow row of cells defining an outflow terminal end of the frame and an inflow row of cells defining an inflow terminal end of the frame, the frame further comprising a plurality of posts extending from the outflow terminal end, wherein each of the posts comprises a stem portion connected at a first end thereof to the outflow row of cells and a circular head portion connected to a second end of the stem portion; and 
 a valve structure disposed within an interior of the frame; and 
   a delivery apparatus comprising:
 an inner shaft comprising a valve connection portion that is releasably coupled to the posts of the prosthetic heart valve, wherein the valve connection portion comprises a plurality of recesses, wherein each of the posts is received in a respective one of the recesses; 
 an outer shaft positioned around the inner shaft, the outer shaft comprising a valve sheath, the valve sheath sized and shaped to be positioned around the prosthetic heart valve and the valve connection portion of the inner shaft, wherein the valve sheath maintains the prosthetic heart valve in a radially compressed state and maintains the posts within the recesses for delivery of the prosthetic heart valve to a native aortic heart valve region; and 
 a handle comprising a housing and a control knob that is rotatable relative to the housing, each of the inner shaft and the outer shaft extending distally from the handle, wherein rotation of the control knob in a first direction relative to the housing causes the valve sheath to move proximally relative the handle, and wherein rotation of the control knob in a second direction relative to the housing causes the valve sheath to move distally relative to the handle. 
   
     
     
         2 . The assembly of  claim 1 , wherein the control knob has a circumferentially extending outer surface forming a user-engagement surface for engaging and rotating the control knob by a user, wherein the control knob is seated within the housing such that the housing partially covers the outer surface of the control knob. 
     
     
         3 . The assembly of  claim 1 , wherein the control knob is rotatable around a longitudinal axis of the outer shaft and an outer surface of the control knob comprises a plurality of axial grooves that are parallel to the longitudinal axis. 
     
     
         4 . The assembly of  claim 1 , wherein each of the recesses comprises an axial recess portion that receives the stem portion of the respective post and a circular recess portion that receives the circular head portion of the respective post. 
     
     
         5 . The assembly of  claim 1 , wherein the valve sheath includes a radiopaque band at a distal tip thereof. 
     
     
         6 . The assembly of  claim 1 , wherein rotation of the control knob in the first direction to a first position causes the valve sheath to uncover a distal portion of the prosthetic heart valve, while covering the posts and maintaining the posts within the recesses, which allows the prosthetic heart valve to radially self-expand from the radially compressed state to a partially radially expanded state where the posts remain connected to the valve connection portion of the inner shaft. 
     
     
         7 . The assembly of  claim 6 , wherein further rotation of the control knob in the first direction from the first position to a second position causes the valve sheath to uncover the posts, which allows the prosthetic heart valve to radially self-expand from the partially radially expanded state to a fully radially expanded state, such that expansion of the prosthetic heart valve moves the posts radially out of the recesses, which releases the prosthetic heart valve from the delivery apparatus. 
     
     
         8 . The assembly of  claim 6 , wherein rotation of the control knob from the first position in a second direction opposite the first direction causes the valve sheath to recover the distal portion of the prosthetic heart valve while maintaining the posts within the recesses, which causes the distal portion of the prosthetic heart valve to radially compress from the partially radially expanded state to the radially compressed state. 
     
     
         9 . The assembly of  claim 1 , wherein the valve structure comprises an annular skirt and a plurality of leaflets made of pericardial tissue, each of the plurality of leaflets having an inflow end section and an outflow end section, the annular skirt disposed at the inflow end section of each of the plurality of leaflets. 
     
     
         10 . The assembly of  claim 9 , wherein the inflow end section of each of the plurality of leaflets is secured to the skirt by a suture line that extends across cells of the inflow row of cells, and wherein the inflow row of cells is formed by first and second rows of the strut members and the skirt is sutured to the strut members of the first and second rows of strut members. 
     
     
         11 . The assembly of  claim 1 , wherein the plurality of rows of cells includes exactly four rows of diamond-shaped cells. 
     
     
         12 . An assembly comprising:
 a radially collapsible and self-expandable prosthetic heart valve comprising:
 an annular frame comprising a plurality of strut members interconnected to each other to form a plurality of rows of cells, the plurality of rows of cells including an outflow row of cells defining an outflow terminal end of the frame and an inflow row of cells defining an inflow terminal end of the frame, the frame further comprising a plurality of retaining arm posts extending from the outflow terminal end; and 
 a valve structure disposed within an interior of the frame; and 
   a delivery apparatus comprising:
 an inner shaft comprising a valve connection portion, the valve connection portion comprising a plurality of recesses each sized and shaped to receive a respective one of a plurality of retaining arm posts extending from a proximal end of a frame of the prosthetic heart valve; 
 an outer shaft positioned around the inner shaft, the outer shaft comprising a valve sheath, the valve sheath sized and shaped to be positioned around the prosthetic heart valve and the valve connection portion for maintaining the prosthetic heart valve in a radially compressed state and maintaining the retaining arm posts within the recesses during delivery of the prosthetic heart valve to a native aortic heart valve region; and 
 a handle comprising a housing and a control knob that is rotatable relative to the housing, each of the inner shaft and the outer shaft extending distally from the handle, wherein rotation of the control knob in a first direction relative to the housing causes the valve sheath to move proximally relative to the handle, and wherein rotation of the control knob in a second direction relative to the housing causes the valve sheath to move distally relative to the handle; 
 wherein the control knob has a circumferentially extending outer surface forming a user-engagement surface for engaging and rotating the control knob by a user, wherein the control knob is seated within the housing such that the housing partially covers the outer surface of the control knob. 
   
     
     
         13 . The assembly of  claim 12 , wherein each of the retaining arm posts comprises a stem portion connected at a first end thereof to the outflow row of cells and a circular head portion connected to a second end of the stem portion and wherein each of the recesses comprises an axial recess portion that receives a stem portion of the respective retaining arm post and a circular recess portion that receives the circular head portion of the respective retaining arm post, wherein the axial recess portion is distal relative to circular recess portion. 
     
     
         14 . The assembly of  claim 12 , wherein the control knob is rotatable around a longitudinal axis of the outer shaft and the user-engagement surface comprises a plurality of axial grooves that are parallel to the longitudinal axis. 
     
     
         15 . The assembly of  claim 12 , wherein rotation of the control knob in the first direction to a first position causes the valve sheath to uncover a distal portion of the prosthetic heart valve, while covering the retaining arm posts and maintaining the retaining arm posts within the recesses, which allows the prosthetic heart valve to radially self-expand from the radially compressed state to a partially radially expanded state where the retaining arm posts remain connected to the valve connection portion of the inner shaft. 
     
     
         16 . The assembly of  claim 15 , wherein rotation of the control knob in the first direction from the first position to a second position causes the valve sheath to uncover the retaining arm posts, which allows the prosthetic heart valve to radially self-expand from the partially radially expanded state to a fully radially expanded state, such that expansion of the prosthetic heart valve moves the retaining arm posts radially out of the recesses, which releases the prosthetic heart valve from the delivery apparatus. 
     
     
         17 . The assembly of  claim 15 , wherein rotation of the control knob from the first position in a second direction opposite the first direction causes the valve sheath to recover the distal portion of the prosthetic heart valve while maintaining the retaining arm posts within the recesses, which causes the distal portion of the prosthetic heart valve to radially compress from the partially radially expanded state to the radially compressed state. 
     
     
         18 . An assembly for implanting a prosthetic heart valve within a native aortic valve, comprising:
 a radially collapsible and self-expandable prosthetic heart valve having an annular frame and a valve structure disposed within an interior of the frame, wherein the annular frame is formed with a plurality of interconnected strut members forming a plurality of rows of cells, the plurality of rows of cells including an outflow row of cells defining an outflow terminal end of the frame and an inflow row of cells defining an inflow terminal end of the frame, the frame further comprising a plurality of retaining arm posts extending from the outflow terminal end; and   a delivery apparatus comprising:
 an inner shaft having a valve connection portion, the valve connection portion formed with a plurality of recesses each sized and shaped to receive a respective one of the retaining arm posts; 
 an outer shaft positioned around the inner shaft, the outer shaft including a valve sheath sized and shaped to be positioned around the prosthetic heart valve and the valve connection portion for maintaining the prosthetic heart valve in a radially compressed state and maintaining the retaining arm posts within the recesses during delivery of the prosthetic heart valve; and 
 a handle including a housing, a rotatable control knob, and a latch, wherein the inner shaft and the outer shaft extend distally from the handle; 
 wherein rotation of the control knob in a first direction causes the valve sheath to move proximally relative to the handle and wherein rotation of the control knob in a second direction causes the valve sheath to move distally relative to the handle; and 
 wherein the latch is operatively coupled to the outer shaft such that, when the latch is in an engaged position, the prosthetic heart valve can be fully deployed from the valve sheath via rotation of the control knob in the first direction. 
   
     
     
         19 . The assembly of  claim 18 , wherein the control knob has a circumferentially extending outer surface forming a user-engagement surface for engaging and rotating the control knob by a user, wherein the control knob is seated within the housing such that the housing partially covers the outer surface of the control knob. 
     
     
         20 . The assembly of  claim 18 , wherein each of the retaining arm posts comprises a stem portion connected at a first end thereof to the outflow row of cells and a circular head portion connected to a second end of the stem portion and wherein each of the recesses comprises an axial recess portion that receives a stem portion of the respective retaining arm post and a circular recess portion that receives the circular head portion of the retaining arm respective post. 
     
     
         21 . The assembly of  claim 18 , wherein the delivery apparatus is sized to be inserted through a femoral artery and the aorta in a retrograde approach for delivering the prosthetic heart valve to the native aortic valve. 
     
     
         22 . The assembly of  claim 18 , wherein the valve sheath includes a radiopaque band along a distal end portion thereof.