Prosthetic mitral valve with improved anchors and seal

Abstract

A method for replacing a native heart valve includes advancing a delivery catheter having a valve prosthesis disposed along a distal end portion thereof, wherein the valve includes an inner frame having an hourglass shape and an outer sealing frame connected to and surrounding the inner frame. A valve body is mounted within the inner frame and includes a plurality of leaflets. The leaflets have longitudinal curvatures when in an open position, wherein the curvatures are shaped for conforming to the curved interior surface of the inner frame. This combination of features reduces the possibility of blood stagnating between the leaflets and inner frame, which reduces the possibility of thrombus formation.

What is claimed is: 
     
         1 . A method of replacing a native mitral valve, the method comprising:
 advancing a delivery catheter through a patient's vasculature, the delivery catheter having a replacement valve prosthesis disposed along a distal end portion thereof and configured to transition between a compressed configuration and an expanded configuration, wherein the replacement valve prosthesis comprises:
 an inner frame having an hourglass shape when the prosthesis is in the expanded configuration; 
 an outer frame connected to the inner frame, 
 wherein, when the prosthesis is in the expanded configuration, a longitudinal length of the outer frame overlaps with at least an intermediate region of the inner frame; 
 a valve body coupled to a curved interior surface of the inner frame formed by the hourglass shape of the inner frame, the valve body comprising a plurality of leaflets arranged to allow blood flow in a first direction and prevent blood flow in a second direction opposite the first direction, 
 wherein, when the prosthesis is in the expanded configuration and the valve body is in the open configuration, the leaflets are adapted to have a longitudinal curvature that follows the curved hourglass shape of the inner frame such that the leaflets conform to and lie flush against the curved interior surface of the inner frame; 
   releasing the prosthesis from the delivery catheter so that the prosthesis expands from the compressed configuration to the expanded configuration within the native mitral valve; and   removing the delivery catheter from the patient's vasculature.   
     
     
         2 . The method of  claim 1 , wherein, when the valve body is in the open configuration, only a free edge at a distal end of each of the leaflets does not contact the inner frame. 
     
     
         3 . The method of  claim 1 , wherein an upper region of the inner frame and an upper region of the outer frame each comprises corresponding eyelets, and wherein the inner frame and the outer frame are attached via the corresponding eyelets of the inner frame and the outer frame. 
     
     
         4 . The method of  claim 1 , wherein, when the prosthesis is in the expanded configuration and when the valve body is in the open configuration, an intermediate portion of a longitudinal length of each of the leaflets contacts a waist of the intermediate region of the inner frame. 
     
     
         5 . The method of  claim 1 , wherein the inner frame further comprises a plurality of inner frame anchoring features extending radially outwardly and then proximally toward a proximal end of the prosthesis when the prosthesis is in the expanded configuration. 
     
     
         6 . The method of  claim 1 , wherein the outer frame has a bulbous shape. 
     
     
         7 . The method of  claim 1 , wherein the outer frame comprises a circumferential shoulder spaced from a proximal end of the outer frame and the distal end of the outer frame, the circumferential shoulder being a radially outermost portion of the outer frame. 
     
     
         8 . The method of  claim 1 , wherein the prosthesis further comprises a fabric skirt connected to an outer surface of a distal end of the inner frame. 
     
     
         9 . The method of  claim 8 , wherein the fabric skirt is held in tension between the outer frame and the inner frame. 
     
     
         10 . A method of replacing a native mitral valve, the method comprising:
 advancing a delivery catheter through a patient's vasculature, the delivery catheter having a replacement valve prosthesis disposed along a distal end portion thereof and configured to transition between a compressed configuration and an expanded configuration, wherein the replacement valve prosthesis comprises:
 an inner frame comprising an upper region, an intermediate region, and a lower region, 
 wherein, when the prosthesis is in the expanded configuration, the intermediate region has a narrower diameter than both the upper region and the lower region so as to form an interior surface that tapers radially inward from the upper region toward the intermediate region and tapers radially outward from the intermediate region to the lower region; 
 an outer frame connected to the inner frame, 
 wherein, when the prosthesis is in the expanded configuration, at least the intermediate region of the inner frame is positioned radially within a portion of a length of the outer frame; and 
 a valve body connected along the interior surface of the inner frame, the valve body comprising a plurality of leaflets arranged to allow blood flow in a first direction and prevent blood flow in a second direction, 
 wherein, when the prosthesis is in the expanded configuration, each of the leaflets has a longitudinal curvature that conforms to the interior surface of the inner frame; 
   releasing at least a portion of the prosthesis from the delivery catheter so that the prosthesis expands from the compressed configuration to the expanded configuration within the native mitral valve; and   removing the delivery catheter from the patient's vasculature.   
     
     
         11 . The method of  claim 10 , wherein the upper region of the inner frame and an upper region of the outer frame each comprises corresponding eyelets, and wherein the inner frame and the outer frame are coupled together via the corresponding eyelets of the inner frame and the outer frame. 
     
     
         12 . The method of  claim 10 , wherein, when the prosthesis is in the expanded configuration and when the valve body is in the open configuration, an intermediate portion of a longitudinal length of each of the leaflets contacts a waist of the intermediate region of the inner frame. 
     
     
         13 . The method of  claim 10 , wherein the outer frame comprises a circumferential shoulder spaced from a proximal end of the outer frame and a distal end of the outer frame, the circumferential shoulder being a radially outermost portion of the outer frame. 
     
     
         14 . The method of  claim 10 , wherein over 90% of a longitudinal length of each of the leaflets contacts the interior surface of the inner frame when the valve body is in the open configuration. 
     
     
         15 . The method of  claim 10 , wherein only a free edge at a distal end of each of the leaflets does not contact the inner frame when the valve body is in the open configuration. 
     
     
         16 . A method of replacing a native heart valve, the method comprising:
 advancing a delivery catheter through a patient's vasculature, the delivery catheter having a replacement valve prosthesis disposed along a distal end portion thereof and configured to transition between a compressed configuration and an expanded configuration, wherein the replacement valve prosthesis comprises:
 an inner frame comprising an upper region, an intermediate region, and a lower region, 
 wherein the intermediate region has a smaller diameter than the upper region and the lower region so as to form a first curved interior surface extending from the upper region to the intermediate region and a second curved interior surface extending from the lower region to the intermediate region; 
 an outer frame connected to the inner frame, and 
 a valve body positioned within the inner frame, the valve body comprising a plurality of leaflets arranged to allow blood flow in a first direction and prevent blood flow in a second direction, 
 wherein, when the prosthesis is in the expanded configuration and the valve body is in an open configuration, a longitudinal length of each leaflet is adapted to have a final curvature that conforms to the curved interior surface of the inner frame; 
   releasing at least a portion of the prosthesis from the delivery catheter so that the prosthesis expands from the compressed configuration to the expanded configuration within the native heart valve; and   removing the delivery catheter from the patient's vasculature.   
     
     
         17 . The method of  claim 16 , wherein the native heart valve is a mitral valve. 
     
     
         18 . The method of  claim 16 , wherein the native heart valve is a tricuspid valve. 
     
     
         19 . The method of  claim 16 , wherein over 90% of the longitudinal length of each leaflet contacts at least one of the first and second curved interior surfaces of the inner frame when the valve body is in the open configuration. 
     
     
         20 . The method of  claim 16 , wherein only a free edge at a distal end of each of the plurality of leaflets does not contact the inner frame when the valve body is in the open configuration.