Dual-flange prosthetic valve frame

Abstract

An assembly includes a delivery apparatus and a self-expandable prosthetic heart valve including radially extendable atrial protrusions and radially extendable ventricular protrusions. The prosthetic valve further includes a valve member supported by an annular body having the atrial protrusions and the ventricular protrusions coupled thereto. The delivery apparatus includes a first (distal) capsule portion and a second (proximal) capsule portion for retaining the prosthetic valve in a radially compressed, delivery state. The first capsule portion can be moved distally to allow the ventricular protrusions to expand, and the second capsule portion can be proximally retracted to allow the atrial protrusions to expand and transition to prosthetic valve to a radially expanded state. When implanted, the atrial protrusions are configured to engage an atrial side of a native heart valve, and the ventricular protrusions are configured to engage the ventricular side of the native heart valve.

We claim: 
     
         1 . An assembly comprising:
 a self-expandable prosthetic heart valve for implantation within a native heart valve between an atrium and a ventricle, the prosthetic heart valve comprising:
 a radially collapsible and expandable annular body defining a central axis and a lumen extending therethrough from an inlet end to an outlet end of the annular body, the annular body comprising a network of struts interconnected at a plurality of nodes to form a plurality of open cells; 
 a plurality of radially extending atrial protrusions coupled to the annular body, wherein the atrial protrusions are sized and shaped to engage an atrial side of the native heart valve when the prosthetic heart is in a fully radially expanded state within the native heart valve; 
 a plurality of radially extending ventricular protrusions coupled to the annular body, wherein the ventricular protrusions are angularly offset from the atrial protrusions, wherein the ventricular protrusions are sized and shaped to engage a ventricular side of the native heart valve when the prosthetic heart is in the fully radially expanded state within the native heart valve; and 
 a valve member comprising three leaflets made of pericardium and disposed within the lumen of the annular body, the valve member configured to enable flow of blood in a direction from the inlet end toward the outlet end of the annular body, and prevent flow of blood in an opposing direction; and 
   a delivery apparatus comprising:
 a first capsule portion and a second capsule portion for retaining the prosthetic heart valve in a radially compressed state when the first and second capsule portions are in a closed, delivery configuration, wherein the first capsule portion is distal relative to the second capsule portion; 
   wherein the first capsule portion is configured to be distally extended relative to the second capsule portion to enable transition of the prosthetic heart valve from the radially compressed state to a partially radially expanded state;   wherein the second capsule portion is configured to be proximally retracted relative to the first capsule portion to enable transition of the prosthetic heart valve from the partially radially expanded state to the fully radially expanded state; and   wherein, when the prosthetic heart valve is in the partially radially expanded state, the ventricular protrusions are exposed from the first capsule portion and extend radially away from the annular body and the atrial protrusions are retained within the second capsule portion.   
     
     
         2 . The assembly of  claim 1 , wherein, when the prosthetic heart valve is in the fully radially expanded state, the ventricular protrusions and the atrial protrusions extend radially outward from the annular body and form a gap therebetween, the gap sized and shaped to retain a portion of a native annulus of the native heart valve therein. 
     
     
         3 . The assembly of  claim 1 , wherein the atrial protrusions are located closer to the inlet end than the outlet end of the annular body. 
     
     
         4 . The assembly of  claim 3 , wherein the ventricular protrusions are axially spaced from the atrial protrusions toward the outlet end of the annular body. 
     
     
         5 . The assembly of  claim 1 , wherein the plurality of atrial protrusions includes twelve atrial protrusions. 
     
     
         6 . The assembly of  claim 1 , wherein the plurality of ventricular protrusions includes twelve ventricular protrusions. 
     
     
         7 . The assembly of  claim 1 , wherein the prosthetic heart valve further comprises a first fabric layer, wherein the atrial protrusions are covered by the first layer of fabric and form an atrial flange. 
     
     
         8 . The assembly of  claim 7 , wherein the prosthetic heart valve further comprises a second fabric layer, the second fabric layer covering at least a portion of the annular body. 
     
     
         9 . The assembly of  claim 7 , wherein at least a portion of the atrial flange is orthogonal relative to the central axis. 
     
     
         10 . The assembly of  claim 1 , wherein, when the prosthetic heart valve is in the partially radially expanded state, the outlet end of the annular body is radially expanded and the inlet end of the annular body is retained within the second capsule. 
     
     
         11 . The assembly of  claim 1 , wherein the native heart valve is a native mitral valve. 
     
     
         12 . The assembly of  claim 1 , wherein the assembly is configured for transeptal delivery of the prosthetic heart valve. 
     
     
         13 . The assembly of  claim 1 , wherein the annular body is made from nitinol. 
     
     
         14 . An assembly comprising:
 a self-expandable prosthetic heart valve for implantation within a native heart valve between an atrium and a ventricle, the prosthetic heart valve comprising:
 a radially collapsible and expandable annular body defining a central axis and a lumen extending therethrough from an inlet end portion to an outlet end portion of the annular body, the annular body comprising a network of struts made from nitinol and interconnected at a plurality of nodes to form a plurality of open cells; 
 a plurality of radially extending atrial protrusions coupled to the annular body, wherein the atrial protrusions are connected to a first set of nodes of the plurality of nodes, wherein the first set of nodes are located at the inlet end portion of the annular body; 
 a plurality of radially extending ventricular protrusions coupled to the annular body, wherein the ventricular protrusions are connected to a second set of nodes of the plurality of nodes, and wherein the second set of nodes is axially spaced from the first set of nodes toward the outlet end portion of the annular body; 
 a valve member comprising three leaflets made of pericardium and disposed within the lumen of the annular body, the valve member configured to enable flow of blood in a direction from the inlet end portion toward the outlet end portion of the annular body, and prevent flow of blood in an opposing direction; and 
 a layer of fabric covering at least a portion of the annular body; and 
   a delivery apparatus comprising:
 a first capsule portion and a second capsule portion along a distal end portion of the delivery apparatus, wherein the first capsule portion is distal relative to the second capsule portion; 
 wherein the first capsule portion is configured to retain the ventricular protrusions in a radially compressed state for delivery of the prosthetic heart valve through a patient's vasculature and the second capsule portion is configured to retain the atrial protrusions in a radially compressed state for delivery of the prosthetic heart valve through the patient's vasculature; 
 wherein the first capsule portion is configured to be moved distally relative to the second capsule portion to allow the ventricular protrusions to expand from their radially compressed state to a radially expanded state; 
 wherein the second capsule portion is configured to be moved proximally relative to the first capsule portion to allow the atrial protrusions to expand from their radially compressed state to a radially expanded state. 
   
     
     
         15 . The assembly of  claim 14 , wherein the first and second capsule portions are moveable
 (i) from a closed, first state in which the first and second capsule portions retain the ventricular and atrial protrusions in their radially compressed states to a second state by moving the first capsule portion distally relative to the second capsule portion to allow the ventricular protrusions to radially expand, and   (ii) from the second state to a third state by moving the second capsule portion proximally relative to the first capsule portion to allow the atrial protrusions to radially expand.   
     
     
         16 . The assembly of  claim 15 , wherein the second capsule portion is configured to extend over and retain a portion of the annular body in a radially compressed state when the first and second capsule portions are in the closed, first state. 
     
     
         17 . The assembly of  claim 16 , wherein the plurality of atrial protrusions are covered by another layer of fabric to form an atrial sealing flange. 
     
     
         18 . An assembly comprising:
 a self-expandable prosthetic heart valve for implantation within a native heart valve between an atrium and a ventricle, the prosthetic heart valve comprising:
 a radially collapsible and expandable annular body defining a central axis and a lumen extending therethrough from an inlet end portion to an outlet end portion of the annular body, the annular body comprising a network of interconnected struts; 
 an atrial flange disposed at the inlet end portion of the annular body, the atrial flange comprising a plurality of radially extending atrial protrusions coupled to the annular body and covered by a first fabric layer; 
 a plurality of radially extending ventricular protrusions coupled to the annular body and axially spaced apart from the atrial flange toward the outlet end portion of the annular body; and 
 a valve member comprising three leaflets made of pericardium and disposed within the annular body, the valve member configured to enable flow of blood in a direction from the inlet end portion toward the outlet end portion of the annular body, and prevent flow of blood in an opposing direction; and 
   a delivery apparatus comprising:
 a first capsule portion and a second capsule portion for retaining the prosthetic heart valve in a radially compressed state when the first and second capsule portions are in a closed, delivery configuration, wherein the first capsule portion is distal relative to the second capsule portion; 
   wherein the first capsule portion is configured to be distally extended relative to the second capsule portion to enable transition of the prosthetic heart valve from the radially compressed state to a partially radially expanded state, wherein, when the prosthetic heart valve is in the partially radially expanded state, the outlet end portion of the annular body radially expands and the ventricular protrusions are exposed from the first capsule portion and extend radially away from the annular body, while the atrial protrusions and the inlet end portion of the annular body are retained within the second capsule portion; and   wherein the second capsule portion is configured to be proximally retracted relative to the first capsule portion to enable transition of the prosthetic heart valve from the partially radially expanded state to a fully radially expanded state, wherein, when the prosthetic heart is in the fully radially expanded state within the native heart valve, the atrial flange is configured to engage an atrial side of a native annulus the native heart valve and the ventricular protrusions are configured to engage a ventricular side of the native annulus, such that the native annulus is captured between the atrial flange and the ventricular protrusions.   
     
     
         19 . The assembly of  claim 18 , wherein the interconnected struts are joined at a plurality of nodes, wherein the atrial protrusions are connected to a first set of nodes of the plurality of nodes, and wherein the first set of nodes form inlet apices of the annular body. 
     
     
         20 . The assembly of  claim 18 , wherein the plurality of atrial protrusions includes twelve atrial protrusions, and wherein the plurality of ventricular protrusions includes twelve ventricular protrusions.