Minimally-invasive heart valve with cusp positioners

Abstract

A prosthetic heart valve includes a support frame and a plurality of leaflets disposed inside the support frame. The support frame extends between an inflow end and an outflow end and includes a leaflet frame and a plurality of positioning members coupled to the leaflet frame. The leaflet frame has an undulating shape at the outflow end of the support frame and includes a plurality of commissure regions spaced apart from each other. The positioning members are disposed between the commissure regions of the leaflet frame and extend radially outwardly relative to the leaflet frame. The positioning members are configured to contact native tissue and anchor the support frame relative to the native tissue. The leaflets are coupled to the commissure regions of the leaflet frame. The leaflets are configured to allow flow in a first direction and to substantially block flow in an opposite direction.

What is claimed is: 
     
         1 . A prosthetic heart valve comprising:
 a support frame having an inflow end and an outflow end, the support frame arranged around a flow axis and including inflow apices spaced circumferentially apart from each other at the inflow end and outflow apices spaced circumferentially apart from each other at the outflow end, wherein the inflow apices and the outflow apices define a continuous, undulating pattern; and   a plurality of leaflets coupled to a first subset of the outflow apices and operative to allow flow in a first direction along the flow axis and to substantially block flow in an opposite direction along the flow axis,   wherein a second subset of the outflow apices flare radially outwardly relative to the first subset of the outflow apices and is configured to contact native tissue and anchor the prosthetic heart valve relative to the native tissue.   
     
     
         2 . The prosthetic heart valve of  claim 1 , wherein the second subset of the outflow apices include one or more barbs extending axially from each of the second subset of the outflow apices. 
     
     
         3 . The prosthetic heart valve of  claim 2 , wherein each of the barbs extend axially towards the inflow end of the support frame. 
     
     
         4 . The prosthetic heart valve of  claim 2 , wherein each of the barbs includes an elongated section and a rounded head. 
     
     
         5 . The prosthetic heart valve of  claim 1 , wherein the first subset of the outflow apices is covered with one or more panels of fabric, and wherein the second subset of the outflow apices is uncovered. 
     
     
         6 . The prosthetic heart valve of  claim 1 , wherein the first subset of the outflow apices includes every other one of the outflow apices. 
     
     
         7 . The prosthetic heart valve of  claim 1 , wherein the first subset of the outflow apices terminate at the outflow end and the second subset of the outflow apices terminate closer to the inflow end than the first subset of the outflow apices. 
     
     
         8 . The prosthetic heart valve of  claim 1 , wherein the continuous, undulating pattern includes a first undulating shape including the first subset of the outflow apices and a second undulating shape including the second subset of the outflow apices, and wherein the first undulating shape and the second undulating shape are offset 60° from each other about the flow axis. 
     
     
         9 . A prosthetic heart valve comprising:
 a collapsible and expandable support frame extending between an inflow end and an outflow end and including a plurality of positioning members spaced circumferentially apart from each other, wherein the positioning members are configured to contact native tissue and anchor the prosthetic heart valve relative to the native tissue, wherein each positioning member includes one or more anti-migration members extending axially from the positioning members; and   a plurality of leaflets disposed inside the support frame, wherein the leaflets are configured to allow flow in a first direction from the inflow end to the outflow end and to substantially block flow in an opposite direction from the outflow end to the inflow end.   
     
     
         10 . The prosthetic heart valve of  claim 9 , wherein each positioning member includes an apex positioned towards the outflow end, and each anti-migration member is cantilevered from the apex of a respective positioning member towards the inflow end. 
     
     
         11 . The prosthetic heart valve of  claim 9 , wherein each of the anti-migration members includes a first portion having a first circumferential width and a second portion having a second circumferential width that is larger than the first circumferential width. 
     
     
         12 . The prosthetic heart valve of  claim 9 , further comprising a fabric cover disposed between the leaflets and the support frame. 
     
     
         13 . The prosthetic heart valve of  claim 12 , wherein the fabric cover extends axially from the outflow end of the support frame to the inflow end of the support frame. 
     
     
         14 . The prosthetic heart valve of  claim 9 , wherein the support frame further includes commissure regions disposed between the plurality of positioning members, and wherein the plurality of leaflets is coupled to the commissure regions of the support frame. 
     
     
         15 . The prosthetic heart valve of  claim 14 , wherein the commissure regions are U-shaped, and wherein each commissure region extends from one positioning member to an adjacent positioning member of the support frame. 
     
     
         16 . The prosthetic heart valve of  claim 1 , wherein the support frame is self-expandable. 
     
     
         17 . A prosthetic heart valve comprising:
 a leaflet support frame having an inflow end and an outflow end, the leaflet support frame including three commissure regions and three struts disposed between the commissure regions of the leaflet support frame, wherein each commissure region has at least one attachment flange, wherein each strut is outwardly angled relative to the leaflet support frame, wherein the struts are configured to stabilize and anchor the prosthetic heart valve in its implant position;   one or more panels of fabric; and   three leaflets disposed inside the leaflet support frame and coupled to the at least one attachment flange of the commissure regions, the leaflets operative to allow flow in a first direction from the inflow end to the outflow end and to substantially block flow in an opposite direction from the outflow end to the inflow end,   wherein the commissure regions of the leaflet support frame are covered by the one or more panels of fabric, and   wherein at least one of the struts of the leaflet support frame is uncovered by the one or more panels of fabric.   
     
     
         18 . The prosthetic heart valve of  claim 17 , wherein each strut is U-shaped and includes an apex positioned towards the outflow end. 
     
     
         19 . The prosthetic heart valve of  claim 17 , wherein the one or more panels of fabric includes a fabric cover disposed radially between the leaflets and the leaflet support frame. 
     
     
         20 . The prosthetic heart valve of  claim 17 , wherein the leaflet support frame comprises nitinol.