Low profile transcatheter heart valve

Patent metadata

Field	Value
Publication number	US-11744701-B2
Application number	US-202017018258-A
Country	US
Kind code	B2
Filing date	Sep 11, 2020
Priority date	Jun 6, 2008
Publication date	Sep 5, 2023
Grant date	Sep 5, 2023

Abstract

A prosthetic heart valve comprises a radially collapsible and expandable annular frame and a leaflet structure comprising three leaflets. Each leaflet has an upper edge portion, a curved lower edge portion and two side flaps, wherein each side flap is connected to an adjacent side flap of another leaflet to form commissures of the leaflet structure, with each commissure being attached to the frame. An annular inner sleeve comprises three U-shaped portions positioned along the curved lower edge portions of the leaflets. An annular outer sleeve extends around are outer surface of the frame, wherein the outer sleeve is made of pericardium. The frame is made of Nitinol and the prosthetic valve can be radially crimped to a radially collapsed configuration inside a sheath for delivery into a patient's body and self-expand to a radially expanded configuration when released from the sheath inside the patient's body.

First claim

We claim:

1. A prosthetic heart valve comprising:
a radially collapsible and expandable annular frame, the frame having at least three circumferentially extending rows of angled struts arranged in a zig-zag pattern in each row, the at least three rows including a first row of angled struts defining an inflow end of the frame, a second row of angled struts defining an outflow end of the frame, a third row of angled struts positioned axially between the first and second rows of angled struts along a length of the frame;
wherein the frame comprises a circumferentially extending, upper row of closed cells defined between the second and third rows of angled struts, the cells defining openings in the frame;
wherein the frame comprises three commissure attachment posts;
a leaflet structure comprising three separate leaflets, wherein each leaflet comprises pericardial tissue, each leaflet having an upper edge portion, a curved lower edge portion and two side flaps, wherein each side flap has a height that is less than an overall height of the leaflet in a flattened state of the leaflet prior to assembly of the leaflet structure, wherein the curved lower edge portion extends from the lower end of one of the side flaps to the lower end of the other side flap, and wherein each side flap is connected to an adjacent side flap of another leaflet to form commissures of the leaflet structure, each commissure being attached to the frame;
wherein each commissure is connected to one of the commissure attachment posts with sutures extending through apertures in the commissure attachment posts only at locations along the commissure attachment posts between the outflow end of the frame and an upstream end of the upper row of closed cells;
an annular inner sleeve comprising three U-shaped portions positioned along the curved lower edge portions of the leaflets, wherein the inner sleeve is a separate piece of material from the leaflets and wherein each leaflet is sutured to the inner sleeve along the curved lower edge portion; and
an annular outer sleeve extending around an outer surface of the frame, wherein the outer sleeve is made of pericardium.

2. The prosthetic heart valve of claim 1 , wherein the outer sleeve has a height that is less than a height of the frame.

3. The prosthetic heart valve of claim 2 , wherein an inflow end portion of the outer sleeve covers the struts of the first row of struts.

4. The prosthetic heart valve of claim 1 , wherein the commissures of the leaflet structure are attached to the frame with sutures.

5. The prosthetic heart valve of claim 4 , wherein the zig-zag pattern of the second row of angled struts is opposite from the first and third rows.

6. The prosthetic heart valve of claim 1 , wherein the first and third rows of angled struts have parallel zig-zag patterns.

7. The prosthetic heart valve of claim 1 , wherein the first row of angled struts define a plurality of U-shaped crown structures that interconnect adjacent ends of two angled struts at the inflow end of the frame and the second row of angled struts define a plurality of U-shaped crown structures that interconnect adjacent ends of two angled struts at the outflow end of the frame.

8. The prosthetic heart valve of claim 7 , wherein the first row of angled struts forms exactly twelve crown structures at the inflow end of the frame.

9. The prosthetic heart valve of claim 1 , wherein the commissure attachment posts have cantilevered ends adjacent the outflow end of the frame.

10. A prosthetic heart valve comprising:
a radially collapsible and expandable annular frame, the frame having at least three circumferentially extending rows of angled struts arranged in a zig-zag pattern in each row, the at least three rows including a first row of angled struts defining an inflow end of the frame, a second row of angled struts defining an outflow end of the frame, a third row of angled struts positioned axially between the first and second rows of angled struts along a length of the frame, wherein the frame comprises a plurality of circumferentially extending rows of closed cells defined between adjacent rows of angled struts, including an upper row of closed cells defined between the second and third row of angled struts;
wherein the frame comprises three commissure attachment posts;
a leaflet structure comprising three separate leaflets, wherein each leaflet comprises pericardial tissue, each leaflet having an upper edge portion, a curved lower edge portion and two side flaps, wherein each side flap has a height that is less than an overall height of the leaflet in a flattened state of the leaflet prior to assembly of the leaflet structure, wherein the curved lower edge portion extends from the lower end of one of the side flaps to the lower end of the other side flap, and wherein each side flap is connected to an adjacent side flap of another leaflet to form commissures of the leaflet structure, each commissure being attached to the frame;
wherein each commissure is connected to one of the commissure attachment posts only at locations along the commissure attachment posts between the outflow end of the frame an upstream end of the upper row of closed cells;
an annular inner skirt member positioned against an inner surface of the frame, wherein the inner skirt member is a separate piece of material from the leaflets and wherein each leaflet is sutured to the inner skirt member along the curved lower edge portion; and
an annular outer sleeve extending around an outer surface of the frame wherein the outer sleeve is made of pericardium;
wherein the inner skirt member and the outer sleeve are separate pieces of material.

11. The prosthetic heart valve of claim 10 , wherein the inner skirt has a lower edge portion that is sutured to struts of the first row of angled struts.

12. The prosthetic heart valve of claim 11 , wherein the lower edge portion of the inner skirt extends below the lower edge portions of the leaflets in a direction toward the inflow end of the frame.

13. The prosthetic heart valve of claim 10 , wherein the outer sleeve has a lower edge portion that covers the struts of the first row of angled struts.

14. The prosthetic heart valve of claim 13 , wherein the outer sleeve covers two rows of closed cells closest to the inflow end of the frame.

15. The prosthetic heart valve of claim 14 , wherein the outer sleeve has a height that is less than a height of the frame.

16. The prosthetic heart valve of claim 10 , wherein the commissures of the leaflet structure are attached to the frame with sutures.

17. The prosthetic heart valve of claim 10 , wherein the first and third rows of angled struts have parallel zig-zag patterns.

18. The prosthetic heart valve of claim 17 , wherein the zig-zag pattern of the second row of angled struts is opposite from the first and third rows.

19. The prosthetic heart valve of claim 10 , wherein each commissure is connected to one of the commissure attachment posts with sutures extending through apertures in the commissure attachment posts only at locations downstream of the upstream end of the upper row of closed cells.

20. The prosthetic heart valve of claim 19 , wherein the sutures extend through the commissures and the apertures in the commissure attachment posts.

Assignees

• Edwards Lifesciences Corp

Inventors

• Hariton Ilia
• Benichou Netanel
• Nitzan Yaacov
• Felsen Bella
• Nguyen-Thien-Nhon Diana
• Khanna Rajesh A
• Nguyen Son V
• Levi Tamir S
• Pelled Itai

Classifications

• B05B1/185

  characterised by their outlet element; Mounting arrangements therefor · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2/2475

  Venous valves · CPC title