Granted Patent B2

US 12,357,452 · App. 18/542,482 · Granted Jul 15, 2025

Inventors: Lien Huong Thi Hoang (San Juan Capistrano, CA); Son V. Nguyen (Irvine, CA); Hien Tran Ngo (Irvine, CA); Vivian Tran (Santa Ana, CA); Russell T. Joseph (Las Flores, CA); Dinesh L Sirimanne (Irvine, CA); Kevin D. Rupp (Irvine, CA); Diana Nguyen-Thien-Nhon (Irvine, CA)

Assignee: EDWARDS LIFESCIENCES CORPORATION

A61F2/2409A61F2/2418A61F2230/0006A61F2230/0069A61F2230/0076

Abstract

Claims (37)

1. A prosthetic heart valve comprising:

an annular frame that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the frame having a plurality of circumferentially extending rows of angled struts, including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row, a third row of angled struts downstream of the second row, a fourth row of angled struts downstream of the third row, and a fifth row of angled struts downstream of the fourth row, each row of angled struts comprising angled struts arranged in a zig-zag pattern;

a leaflet structure comprising three leaflets forming three commissures of the leaflet structure, wherein the commissures are connected to the frame; and

an annular outer sealing member extending around an outer surface of the frame, the sealing member having an inflow edge portion secured to the struts of the first row with sutures and an outflow edge portion having a plurality of tapered projections secured with sutures to the struts of a selected one of the second, third, or fourth row of angled struts, wherein the projections are shaped to correspond to the zig-zag pattern of the selected row of struts;

wherein the outer sealing member is configured to stretch axially when the frame is radially compressed to the collapsed configuration;

wherein the outer sealing member comprises a fabric comprising an inner mesh layer and an outer pile layer, wherein the mesh layer comprises a plurality of circumferentially extending first rows of interlaced yarns alternating with a plurality of circumferentially extending second rows of interlaced yarns, wherein the first rows have a density greater than the second rows, and wherein the pile layer is formed from yarns extending from and interlaced with the mesh layer.

2. The prosthetic heart valve of claim 1 , wherein the frame is made of a plastically-expandable material.

3. The prosthetic heart valve of claim 2 , wherein the plastically-expandable material comprises a nickel cobalt chromium alloy.

4. The prosthetic heart valve of claim 1 , wherein the frame is made of nitinol.

5. The prosthetic heart valve of claim 1 , further comprising an annular inner skirt extending along an inner surface of the frame, wherein the inner skirt comprises an inflow edge portion and an outflow edge portion, wherein the inflow edge portion of the inner skirt is secured to the struts of the first row of angled struts with sutures.

6. The prosthetic heart valve of claim 5 , wherein the outflow edge portion of the inner skirt is secured with sutures to selected struts of the frame downstream of the outflow edge portion of the outer sealing member.

7. The prosthetic heart valve of claim 5 , wherein the outer sealing member has an outer surface and the inner skirt has an outer surface, wherein the outer surface of the outer sealing member has a different surface texture than the outer surface of the inner skirt.

8. A prosthetic heart valve comprising:

an annular frame that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the frame having a plurality of circumferentially extending rows of angled struts, each row of angled struts comprising angled struts arranged in a zig-zag pattern;

a leaflet structure comprising three leaflets forming three commissures of the leaflet structure, wherein the commissures are connected to the frame; and

an annular outer sealing member extending around an outer surface of the frame, the sealing member having an inflow edge portion and an undulating outflow edge portion that is connected to and shaped to correspond to the zig-zag pattern of one of the rows of angled struts, wherein the outflow edge portion defines a plurality of tapered projections;

wherein the outer sealing member comprises a mesh layer and a pile layer comprising a plurality of pile yarns extending outwardly from the mesh layer;

an annular inner skirt extending along an inner surface of the frame, wherein the inner skirt comprises an inflow edge portion and an outflow edge portion;

wherein the inflow edge portion of the inner skirt is wrapped around an inflow end of the frame and extends partially over an outer surface of the pile layer along the inflow edge portion of the outer sealing member, and wherein the inflow edge portion of the outer sealing member is stitched to the inflow end portion of the inner skirt at an inflow end of the frame such that the pile layer is compressed by the inflow edge portion of the inner skirt where it extends over the pile layer;

wherein the inner skirt extends axially further toward an outflow end of the frame than the outer sealing member, wherein the outflow end portion of the inner skirt is connected to and shaped to correspond to the zig-zag pattern of another one of the rows of angled struts downstream of the outflow end portion of the outer sealing member.

9. The prosthetic heart valve of claim 8 , wherein the sealing member is configured to stretch axially when the frame is radially compressed to the collapsed configuration.

10. The prosthetic heart valve of claim 8 , wherein the sealing member comprises a fabric.

11. The prosthetic heart valve of claim 8 , wherein the frame is made of nitinol and is self-expandable from the collapsed configuration to the expanded configuration.

12. The prosthetic heart valve of claim 8 , wherein the rows of angled struts include a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row, a third row of angled struts downstream of the second row, a fourth row of angled struts downstream of the third row, and a fifth row of angled struts downstream of the fourth row.

13. The prosthetic heart valve of claim 12 , wherein the outflow edge portion of the outer sealing member is attached to the struts of the third row with sutures.

14. The prosthetic heart valve of claim 13 , wherein the outflow edge portion of the inner skirt is secured to struts of the fifth row of angled struts with sutures.

15. A prosthetic heart valve comprising:

an annular frame that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the frame having a plurality of circumferentially extending rows of angled struts, including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row, a third row of angled struts downstream of the second row, a fourth row of angled struts downstream of the third row, and a fifth row of angled struts downstream of the fourth row, each row of angled struts comprising angled struts arranged in a zig-zag pattern;

a leaflet structure comprising three leaflets forming three commissures of the leaflet structure, wherein the commissures are connected to the frame; and

an annular outer sealing member extending around an outer surface of the frame, the sealing member having an inflow edge portion and an outflow edge portion having a plurality of tapered projections secured with sutures to the struts of the third row of angled struts, wherein the projections are shaped to correspond to the zig-zag pattern of the third row of struts, wherein each strut of the third row has an upper end connected to an upper end of an adjacent strut at a first junction and a lower end connected to a lower end of an adjacent strut at a second junction;

wherein each projection comprises two angled side edges that converge at a peak of the projection and each side edge converges with an adjacent side edge of an adjacent projection at a valley between adjacent projections, wherein each peak is positioned at a first junction and each valley is positioned at a second junction;

wherein each side edge of a projection is secured to an adjacent strut of the third row of angled struts with multiple stitches that extend around the adjacent strut at locations along a length of the strut between each first junction and an adjacent second junction such that each side edge is secured to an adjacent strut along an entire length of the side edge; and

an annular inner skirt extending along an inner surface of the frame, wherein the inner skirt comprises an inflow edge portion and an outflow edge portion, wherein the inflow edge portion of the inner skirt is secured to the struts of the first row of angled struts with sutures, wherein the inner skirt extends axially further toward an outflow end of the frame than the outer sealing member;

wherein the outer sealing member is configured to stretch axially when the frame is radially compressed to the collapsed configuration;

wherein the inflow edge portion of the outer sealing member is stitched to the inflow edge portion of the inner skirt at the inflow end of the frame;

wherein the outer sealing member comprises a knitted fabric comprising a plurality of circumferentially extending first rows of relatively higher-density stitching spaced apart by a plurality of circumferentially extending second rows of relatively lower-density stitching.

16. The prosthetic heart valve of claim 15 , wherein the outflow edge portion of the inner skirt is secured to struts of the fifth row of angled struts with sutures.

Assignments (1)

Continuity (5)

References Cited (400)