Multi-portion replacement heart valve prosthesis

Abstract

A replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native mitral valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

What is claimed is: 
     
         1 . A replacement heart valve prosthesis comprising:
 a valve body including a plurality of flexible leaflets made from pericardium; and   a self-expanding, metallic support structure surrounding and supporting the valve body, the support structure sized for deployment in a native heart valve, the support structure comprising:
 a cylindrical valve frame comprising:
 an upper portion including tabs with enlarged heads, 
 an intermediate portion comprising at least two circumferential rows of closed cells, and 
 a lower portion comprising a plurality of anchors extending radially outwardly and upwardly and ending in a flared tip, at least some of the flared tips having cushions; and 
 
 a sealing frame separate from, coupled to by sutures, and disposed radially outwardly of the cylindrical valve frame, the sealing frame comprising:
 an upper portion including a plurality of struts having eyelets, 
 an intermediate portion, and 
 a lower portion, 
 
 wherein a clearance is provided between the sealing frame and the cylindrical valve frame when the prosthesis is in an expanded configuration, and 
 wherein the flared tips of the plurality of anchors of the cylindrical valve frame are disposed radially outwardly of the sealing frame when the prosthesis is in the expanded configuration. 
   
     
     
         2 . The prosthesis of  claim 1 , wherein the upper portion of the sealing frame is coupled to the upper portion of the cylindrical valve frame via the sutures. 
     
     
         3 . The prosthesis of  claim 1 , wherein the sealing frame is more flexible than the cylindrical valve frame for conforming to a heart valve annulus. 
     
     
         4 . The prosthesis of  claim 1 , wherein the support structure is adapted to capture native heart valve leaflets between the sealing frame and the anchors. 
     
     
         5 . The prosthesis of  claim 1 , wherein the intermediate portion of the sealing frame has a diameter in a range of 35 mm to 55 mm when the prosthesis is in the expanded configuration. 
     
     
         6 . The prosthesis of  claim 1 , wherein at least a portion of the sealing frame is covered by fabric. 
     
     
         7 . The prosthesis of  claim 6 , wherein at least a portion of the fabric extends along an exterior of the sealing frame and at least a portion of the fabric extends between the sealing frame and the cylindrical valve frame. 
     
     
         8 . The prosthesis of  claim 1 , wherein the lower portion of the sealing frame has a larger diameter than the upper portion of the sealing frame. 
     
     
         9 . The prosthesis of  claim 1 , wherein the self-expanding, metallic support structure comprises a shape-memory metal. 
     
     
         10 . The prosthesis of  claim 1 , wherein the intermediate portion of the sealing frame is spaced away from the intermediate portion of the cylindrical valve frame when the prosthesis is in the expanded configuration so as to provide the clearance. 
     
     
         11 . The prosthesis of  claim 1 , wherein the prosthesis is a replacement tricuspid valve. 
     
     
         12 . A replacement heart valve prosthesis comprising:
 a valve body including a plurality of flexible leaflets; and   a self-expanding support structure surrounding and supporting the valve body, the support structure sized for deployment in a native heart valve, the support structure comprising:
 a valve frame comprising:
 an upper portion including tabs with enlarged heads, 
 an intermediate portion comprising at least two circumferential rows of closed cells, and 
 a lower portion comprising a plurality of anchors extending radially outwardly and upwardly and ending in a flared tip; and 
 
 a sealing frame separate from and disposed radially outwardly of the valve frame, the sealing frame comprising:
 an upper portion including a plurality of struts having eyelets, 
 an intermediate portion, and 
 a lower portion, 
 
 wherein the upper portion of the sealing frame is sutured to the upper portion of the valve frame, 
 wherein a clearance is provided between the intermediate portion of the sealing frame and the intermediate portion of the valve frame when the prosthesis is in an expanded configuration, and 
 wherein the flared tip of each of the plurality of anchors of the valve frame is disposed radially outwardly of the sealing frame when the prosthesis is in the expanded configuration. 
   
     
     
         13 . The prosthesis of  claim 12 , wherein the flared tip of at least some of the plurality of anchors is covered by a cushion. 
     
     
         14 . The prosthesis of  claim 12 , wherein the upper portion of the sealing frame is sutured to the upper portion of the valve frame through the eyelets of the plurality of struts of the upper portion of the sealing frame. 
     
     
         15 . The prosthesis of  claim 12 , wherein the lower portion of the sealing frame has a larger diameter than the upper portion of the sealing frame. 
     
     
         16 . The prosthesis of  claim 12 , wherein the self-expanding support structure comprises a shape-memory metal. 
     
     
         17 . The prosthesis of  claim 1 , wherein the intermediate portion of the sealing frame has a diameter in a range of 35 mm to 55 mm when the prosthesis is in the expanded configuration. 
     
     
         18 . The prosthesis of  claim 1 , wherein at least a portion of the sealing frame is covered by fabric. 
     
     
         19 . A replacement heart valve prosthesis comprising:
 a valve body including a plurality of flexible leaflets; and   a self-expanding support structure surrounding and supporting the valve body, the support structure sized for deployment in a native heart valve, the support structure comprising:
 a valve frame comprising:
 an upper portion including tabs with enlarged heads, 
 an intermediate portion, and 
 a lower portion comprising a plurality of anchors extending radially outwardly and upwardly and ending in a flared tip; and 
 
 a sealing frame separate from and disposed radially outwardly of the valve frame, the sealing frame comprising:
 an upper portion including a plurality of struts having eyelets, 
 an intermediate portion, and 
 a lower portion, 
 
 wherein the upper portion of the sealing frame is sutured to the upper portion of the valve frame, and 
 wherein the flared tip of at least one of the plurality of anchors of the valve frame is disposed radially outwardly of the sealing frame when the prosthesis is in an expanded configuration. 
   
     
     
         20 . The prosthesis of  claim 19 , wherein the flared tip of at least some of the plurality of anchors is covered by a cushion, and wherein the upper portion of the sealing frame is sutured to the upper portion of the valve frame through the eyelets of the plurality of struts of the upper portion of the sealing frame.