Connecting skirt for attaching a leaflet to a frame of a prosthetic heart valve

Abstract

Methods and assemblies for attaching leaflets to a frame of a prosthetic heart valve using a connecting skirt are disclosed. As one example, a prosthetic heart valve can include a frame, a valvular structure mounted within the frame and comprising a plurality of leaflets, each leaflet comprising tabs on opposite sides of the leaflet and a cusp edge portion, and a plurality of connecting skirts. Each connecting skirt comprises side base portions and a central portion connected to each of the cusp edge portion of a corresponding leaflet and struts of the frame, each connecting skirt further comprising side extension portions that extend away from the cusp edge portion along a length of the frame, where each side extension portion of each connecting skirt extends across struts of the frame, between cusp edge portions of adjacent leaflets and connects to an adjacent side extension portion of an adjacent connecting skirt.

We claim: 
     
         1 . A prosthetic heart valve comprising:
 an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises a plurality of struts;   a valvular structure mounted within the frame and comprising a plurality of leaflets, wherein each leaflet comprises opposing tabs on opposite sides of the leaflet and a cusp edge portion between the tabs, wherein each tab is paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are connected to the frame; and   a plurality of connecting skirts, each connecting skirt comprising side base portions and a central portion connected to each of the cusp edge portion of a corresponding leaflet of the plurality of leaflets and struts of the frame, each connecting skirt further comprising side extension portions that extend away from the cusp edge portion along a length of the frame, wherein each side extension portion of each connecting skirt extends across struts of the frame, between cusp edge portions of adjacent leaflets and connects to an adjacent side extension portion of an adjacent connecting skirt.   
     
     
         2 . The prosthetic heart valve of  claim 1 , wherein each side extension portion is sutured to an adjacent side extension portion of the adjacent connecting skirt from a strut junction to which a corresponding commissure of the plurality of commissures is connected, to the inflow end of the frame along a vertical seam. 
     
     
         3 . The prosthetic heart valve of  claim 2 , wherein the struts form a plurality of circumferentially extending rows of cells including a first row of cells defining the inflow end of the frame and a second row of cells downstream of the first row of cells, and wherein each side extension portion and an adjacent side extension portion of an adjacent connecting skirt completely cover two cells of the first row of cells and one cell of the second row of cells. 
     
     
         4 . The prosthetic heart valve of  claim 3 , wherein the connecting skirts do not occlude any cells of the frame downstream of the cusp edge portions of the leaflets. 
     
     
         5 . The prosthetic heart valve of  claim 1 , wherein each extension portion and an adjacent extension portion of an adjacent connecting skirt collectively form an isosceles triangle. 
     
     
         6 . The prosthetic heart valve of any one of  claim 1 , wherein each connecting skirt includes two side base portions, each arranged on an opposite side of the central portion, and two side extension portions, each side extension portion extending outward from a corresponding side base portion of the two side base portions. 
     
     
         7 . The prosthetic heart valve of  claim 6 , wherein each connecting skirt includes a plurality of rows of apertures in the central portion and two side base portions, and wherein each row of apertures includes a plurality of apertures spaced apart from one another and extending from a free end of one side base portion of the two side base portions to another side base portion of the two side base portions. 
     
     
         8 . The prosthetic heart valve of  claim 7 , wherein each connecting skirt is secured to the cusp edge portion of the corresponding leaflet via one or more sutures that extend through a first row of apertures of the plurality of rows of apertures. 
     
     
         9 . The prosthetic heart valve of  claim 8 , wherein each connecting skirt is secured to the struts of the frame via one or more sutures that extend through a second row of apertures of the plurality of rows of apertures. 
     
     
         10 . The prosthetic heart valve of  claim 6 , wherein each connecting skirt includes slits that partially separate the two side base portions from the central portion to allow the connecting skirt to be aligned along the cusp edge portion of the corresponding leaflet. 
     
     
         11 . The prosthetic heart valve of  claim 1 , wherein the central portion of each connecting skirt is rectangular. 
     
     
         12 . A prosthetic heart valve comprising:
 a radially collapsible and expandable frame comprising an inflow end and an outflow end, wherein the frame comprises a plurality of interconnected struts; and   a plurality of leaflets arranged within the frame, wherein each leaflet comprises two tabs disposed on opposite sides of the leaflet and a cusp edge portion extending between the two tabs;   wherein the cusp edge portion of each leaflet is connected to the frame by a connecting skirt, wherein each connecting skirt comprises a central portion and opposing side base portions on opposite sides of the central portion that are connected to each of and disposed between the frame and the cusp edge portion of the leaflet, and wherein each connecting skirt further comprises side extension portions that extend axially away from the cusp edge portion of the leaflet and across struts of the frame that are disposed between cusp edge portions of adjacent leaflets.   
     
     
         13 . The prosthetic heart valve of  claim 12 , wherein the plurality of interconnected struts form a plurality of apices at the inflow end and the outflow end of the frame, and wherein each side extension portion of each connecting skirt extends across the struts of the frame that are disposed between cusp edge portions of adjacent leaflets such that an inner surface of each apex of the plurality of apices that are disposed at the inflow end of the frame, between adjacent leaflets, is covered by a corresponding side extension portion of a corresponding connecting skirt. 
     
     
         14 . The prosthetic heart valve of  claim 12 , wherein each side extension portion is secured to an adjacent side extension portion of an adjacent connecting skirt. 
     
     
         15 . The prosthetic heart valve of  claim 12 , further comprising an outer sealing member mounted on an outer surface of the frame and secured to each connecting skirt. 
     
     
         16 . A method of assembling a prosthetic heart valve comprising a frame and a plurality of leaflets, the method comprising:
 forming a plurality of leaflet assemblies with the plurality of leaflets, wherein each leaflet assembly is formed by: 
 securing a central portion and two side base portions of a connecting skirt to a cusp edge portion of a leaflet, wherein each connecting skirt comprises two side portions, one arranged on either side of the central portion, and wherein each side portion comprises a corresponding side base portion of the two side base portions and a side extension portion extending outward and away from the corresponding side base portion; 
   securing each connecting skirt of each leaflet assembly to the frame of the prosthetic heart valve, the frame comprising a plurality of interconnected struts, the securing of each connecting skirt including: 
 securing the central portion and two side base portions of the connecting skirt to a first portion of struts of the plurality of interconnected struts; 
 extending each side extension portion of the connecting skirt across a second portion of struts of the plurality of interconnected struts that are disposed between cusp edge portions of adjacent leaflets; and 
 securing each side extension portion to an adjacent side extension portion of an adjacent connecting skirt. 
   
     
     
         17 . The method of  claim 16 , wherein each connecting skirt includes a plurality of rows of apertures extending along the central portion and side base portions, and wherein securing the central portion and two side base portions to the cusp edge portion of the leaflet includes extending one or more sutures through the cusp edge portion of the leaflet and a first row of apertures of the plurality of rows of apertures, along a length of the cusp edge portion, to secure the central portion and the two side base portions of the connecting skirt to the cusp edge portion of the leaflet. 
     
     
         18 . The method of  claim 17 , wherein securing the central portion and two side base portions of the connecting skirt to the first portion of struts includes securing the central portion and two side base portions of the connecting skirt to the first portion of struts via one or more sutures extending through a second row of apertures of the plurality of rows of apertures and around the first portion of struts, along a length of the cusp edge portion of the leaflet. 
     
     
         19 . The method of  claim 16 , wherein extending each side extension portion of the connecting skirt across the second portion of struts includes covering inner surfaces of the second portion of struts and an apex of the frame that is arranged at an inflow end of the frame with the side extension portion. 
     
     
         20 . The method of  claim 16 , wherein securing each side extension portion to the adjacent side extension portion of the adjacent connecting skirt includes securing overlapping portions of the side extension portion and the adjacent side extension portion together via one or more sutures.