REPLACEMENT MITRAL VALVE WITH ANNULAR FLAP
A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity, and an annular flap positioned around an exterior of the expandable frame. In some embodiments, the annular flap can extend outward from the frame and have a collapsed configuration and an expanded configuration.
1 . A prosthesis for placement within a body cavity, the prosthesis configured to inhibit or reduce paravalvular leakage, the prosthesis comprising:
an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the frame configured to radially expand and contract for deployment within the body cavity;
an annular flap positioned around and secured to an exterior of the expandable frame, the annular flap having a distal edge secured at or near the distal end of the frame and extending to a proximal edge secured at an intermediate location on the frame between the proximal and distal ends; and
a valve body positioned within an interior of the expandable frame, wherein the valve body comprises:
an inner skirt secured to the interior of the expandable frame; and
a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second opposite direction;
wherein an opening is defined at or near the distal end of the frame between the annular flap and the valve body to provide access for fluid to flow into a space between the annular flap and the valve body, and wherein fluid flow into the space causes the annular flap to move from a first configuration wherein the flap is closer to the frame to a second configuration wherein the flap is spaced further away from the frame to increase the surface area of the prosthesis and create a barrier to fluid flow exterior to the frame when deployed within the body cavity.
2 . The prosthesis of claim 1 , further comprising a plurality of distal anchors each connected to the frame so that when the frame is in an expanded configuration an end of each distal anchor is positioned radially outward from the frame and extends generally proximally.
3 . The prosthesis of claim 2 , wherein at least some of the plurality of distal anchors comprise a cushion.
4 . The prosthesis of claim 1 , further comprising a plurality of proximal anchors each connected to the frame so that when the frame is in an expanded configuration an end of each proximal anchor is positioned radially outward from the frame and extends generally distally.
5 . The prosthesis of claim 1 , further comprising a band at or near the proximal end of the frame.
6 . The prosthesis of claim 1 , wherein the expandable frame comprises a plurality of struts defining a plurality of foreshortening cells.
7 . The prosthesis of claim 6 , wherein the distal edge of the annular flap is attached to undulating struts at the distal end of the frame.
8 . The prosthesis of claim 1 , wherein the intermediate location of the frame has a greater cross-sectional dimension than the proximal end and the distal end of the frame when the frame is in an expanded configuration.
9 . The prosthesis of claim 1 , wherein the plurality of leaflets are configured to allow flow from the proximal end to the distal end of the frame and prevent flow from the distal end to the proximal end.
10 . The prosthesis of claim 1 , wherein the annular flap comprises a first layer of resilient material extending radially outward away from the frame and a second layer of resilient material extending distally toward the distal end of the frame.
11 . The prosthesis of claim 1 , wherein at least a portion of the expandable frame is positioned within the space between the annular flap and the valve body.