Prosthetic heart valve having multi-level sealing member

Abstract

Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve may be radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The prosthetic valve may comprise an annular frame, a leaflet structure positioned within the frame and a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt comprising an inflow edge secured to the frame and an outflow edge secured at intervals to the frame. The plurality of outer skirts may include a first outer skirt and a second outer skirt, wherein in the expanded configuration the first and second outer skirts include openings unsecured to the frame between the intervals. The inflow edge of the first annular outer skirt may be secured to the frame with sutures including radiopaque material. The first annular outer skirt may include radiopaque dye.

We claim: 
     
         1 . An implantable prosthetic valve comprising:
 an annular frame;   a leaflet structure positioned within the frame; and   two or more annular outer skirts extending continuously and completely around an outer surface of the frame, the two or more outer skirts each comprising an inflow edge secured to the frame and an outflow edge, wherein the outflow edges of the two or more outer skirts define one or more upper openings allowing retrograde blood to flow between the outer surface of the frame and the two or more skirts to create a plurality of regions of turbulent blood flow along the prosthetic valve.   
     
     
         2 . The prosthetic valve of  claim 1 , wherein the inflow edge of at least one of the two or more outer skirts is secured to the frame with sutures including radiopaque material. 
     
     
         3 . The prosthetic valve of  claim 1 , wherein at least one of the two or more outer skirts comprises markings formed from radiopaque dye. 
     
     
         4 . The prosthetic valve of  claim 1 , wherein the outflow edges of the two or more outer skirts are secured at intervals to the frame, and wherein the upper openings are formed between the intervals. 
     
     
         5 . The prosthetic valve of  claim 1 , wherein the one or more openings do not lie flat against the outer surface of the frame in an expanded configuration of the prosthetic valve. 
     
     
         6 . The prosthetic valve of  claim 1 , wherein the outflow edge of at least one of the two or more outer skirts is unsecured to the frame. 
     
     
         7 . The prosthetic valve of  claim 1 , wherein the axial spacing between the two or more outer skirts is less than the axial height of a least one of the two or more outer skirts. 
     
     
         8 . The prosthetic valve of  claim 1 , wherein the two or more outer skirts are positioned in series along the length of the frame between an inflow edge of the frame and an outflow edge of the frame. 
     
     
         9 . The prosthetic valve of  claim 1 , wherein the inflow edge of at least one of the two or more outer skirt contacts the outflow edge of another one of the two or more outer skirts without any axial spacing between. 
     
     
         10 . An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve comprising:
 an annular frame;   a leaflet structure positioned within the frame; and   a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt comprising an inflow edge secured to and extending completely around the frame and an outflow edge unsecured to the frame along its entire length and extending completely around the frame to form an upper opening extending continuously around the frame to receive retrograde blood, the plurality of outer skirts including at least a first outer skirt and a second outer skirt.   
     
     
         11 . The prosthetic valve of  claim 10 , wherein when the prosthetic valve is radially expanded, each of the outer skirts flares outwardly away from the frame in a direction from the inflow edge to the outflow edge. 
     
     
         12 . The prosthetic valve of  claim 11 , further comprising a plurality of shape memory struts secured to the skirts that bias the outflow edges of the skirts away from the frame. 
     
     
         13 . The prosthetic valve of  claim 12 , wherein the shape memory struts have lower ends pivotably connected to the frame at the inflow edges of the skirts. 
     
     
         14 . The prosthetic valve of  claim 12 , wherein the shape memory struts are made from Nitinol. 
     
     
         15 . The prosthetic valve of  claim 10 , wherein the plurality of outer skirts further includes a third outer skirt. 
     
     
         16 . The prosthetic valve of  claim 10 , wherein the plurality of outer skirts are positioned in series along the length of the frame between an inflow edge of the frame and an outflow edge of the frame. 
     
     
         17 . The prosthetic valve of  claim 10 , wherein the second skirt is downstream of the first skirt, and the inflow edge of the second skirt is axially spaced from the outflow edge of the first skirt. 
     
     
         18 . An implantable prosthetic valve comprising:
 an annular frame having an inflow end and an outflow end;   a leaflet structure positioned within the frame;   an annular skirt mounted on the frame; and   a plurality of discrete radiopaque markings positioned at a plurality of circumferentially spaced locations on the skirt, wherein the radiopaque markings are positioned to indicate an orientation of the prosthetic valve relative to a native heart valve under fluoroscopy.   
     
     
         19 . The prosthetic valve of  claim 18 , wherein the radiopaque markings comprise radiopaque sutures. 
     
     
         20 . The prosthetic valve of  claim 18 , wherein the radiopaque markings comprise radiopaque dye.