Collapsible prosthetic heart valves

• US 9,693,859 B2
• Filed: 04/01/2016
• Issued: 07/04/2017
• Est. Priority Date: 09/26/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., McCarthy, Andrea L., Figueiredo, Rubem L., Schraut, Julia A.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US15/088,524
• Publication Number:
  US 20160213468A1
• Time in Patent Office: 459 Days
• Field of Search: 623 217- 219
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A prosthetic heart valve includes an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts, a plurality of leaflets disposed inside the supporting structure and 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, a sheet circumferentially disposed on an inner surface of the supporting structure and coupled to the supporting structure, a reinforcing core coupled to at least one of the plurality of leaflets, and a plurality of stitches coupling the reinforcing core to the sheet and one of the plurality of leaflets.

Claims

1. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts;

a plurality of leaflets disposed inside the supporting structure and 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;

a sheet circumferentially disposed on an inner surface of the supporting structure and coupled to the supporting structure;

a reinforcing core coupled to at least one of the plurality of leaflets; and

a plurality of stitches coupling the reinforcing core to the sheet and to the at least one leaflet;

wherein each of the plurality of leaflets includes a pair of flaps, a free edge, and a secured line portion extending between the flaps and opposite the free edge, and wherein at least some of the plurality of stitches pass through the sheet and the secured line portion of the at least one leaflet.

2. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts;

a plurality of leaflets disposed inside the supporting structure and 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;

a sheet circumferentially disposed on an inner surface of the supporting structure and coupled to the supporting structure;

a reinforcing core coupled to at least one of the plurality of leaflets; and

a plurality of stitches coupling the reinforcing core to the sheet and to the at least one leaflet;

wherein each of the plurality of leaflets includes a pair of flaps, a free edge, and a secured line portion extending between the flaps and opposite the free edge, and wherein at least some of the plurality of stitches wrap around a bottom edge of the at least one leaflet adjacent the secured line portion.

3. The prosthetic heart valve of claim 2, wherein at least some of the plurality of stitches further wrap around an edge of the reinforcing core.

4. The prosthetic heart valve of claim 2, wherein the reinforcing core wraps around a bottom edge of the at least one leaflet.

5. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts;

a plurality of leaflets disposed inside the supporting structure and 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;

a sheet circumferentially disposed on an inner surface of the supporting structure and coupled to the supporting structure;

a reinforcing core coupled to at least one of the plurality of leaflets; and

a plurality of stitches coupling the reinforcing core to the sheet and to the at least one leaflet, wherein at least some of the plurality of stitches pierce the reinforcing core.

6. The prosthetic heart valve of claim 5, wherein at least some of the plurality of stitches pierce through the reinforcing core, the sheet and the at least one leaflet.

7. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts;

a plurality of leaflets disposed inside the supporting structure and 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;

a sheet circumferentially disposed on an inner surface of the supporting structure and coupled to the supporting structure;

a reinforcing core coupled to at least one of the plurality of leaflets; and

a plurality of stitches coupling the reinforcing core to the sheet and to the at least one leaflet so that the at least one leaflet is disposed between the sheet and the reinforcing core.

8. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts;

three leaflets disposed inside the supporting structure and 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;

a sheet circumferentially disposed on an inner surface of the supporting structure and coupled to the supporting structure;

a reinforcing core coupled to at least one of the three leaflets, the at least one leaflet being disposed between the reinforcing core and the sheet; and

a plurality of stitches coupling the reinforcing core to the sheet and to the at least one leaflet, at least some of the plurality of stitches piercing through the reinforcing core.

9. The prosthetic heart valve of claim 8, wherein the reinforcing core and the sheet are formed of a same material.

10. The prosthetic heart valve of claim 8, wherein the sheet and the reinforcing core comprise a polymer.

11. The prosthetic heart valve of claim 8, wherein the plurality of leaflets comprises tissue and the reinforcing core comprises a polymer.

12. The prosthetic heart valve of claim 8, wherein the reinforcing core comprises a fabric.

13. The prosthetic heart valve of claim 8, wherein at least some of the plurality of stitches further wrap around an edge of the reinforcing core.

14. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts;

three leaflets disposed inside the supporting structure and 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;

a sheet circumferentially disposed on an inner surface of the supporting structure and coupled to the supporting structure;

a reinforcing core coupled to at least one of the three leaflets, the at least one leaflet being disposed between the reinforcing core and the sheet; and

a plurality of stitches coupling the reinforcing core to the sheet and to the at least one leaflet, wherein each of the three leaflets includes a pair of flaps, a free edge, and a secured line portion extending between the flaps and opposite the free edge.

15. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts;

three leaflets disposed inside the supporting structure and 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;

a sheet circumferentially disposed on an inner surface of the supporting structure and coupled to the supporting structure;

a reinforcing core coupled to at least one of the three leaflets, the at least one leaflet being disposed between the reinforcing core and the sheet; and

a plurality of stitches coupling the reinforcing core to the sheet and to the at least one leaflet, wherein at least some of the plurality of stitches pass through the sheet and the secured line portion of the at least one leaflet.

16. A prosthetic heart valve comprising:

an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts, and an inflow edge adjacent the inflow end;

a plurality of leaflets disposed inside the supporting structure and 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, each of the plurality of leaflets having a pair of flaps, a free edge, and a secured line portion extending between the flaps and opposite the free edge;

a first sheet circumferentially disposed on an inner surface of the supporting structure and coupled to the supporting structure;

a second sheet circumferentially disposed on an outer surface of the supporting structure and coupled to the first sheet adjacent the inflow edge of the supporting structure;

a reinforcing core coupled to the secured line portion of each of the leaflets; and

a plurality of stitches coupling the reinforcing core to the first sheet and to at least one of the plurality of leaflets.

17. The prosthetic heart valve of claim 16, wherein the first sheet comprises a polymer.

18. The prosthetic heart valve of claim 16, wherein each of the plurality of leaflets is attached to the first sheet.

19. The prosthetic heart valve of claim 16, wherein at least some of the plurality of stitches pierce through the reinforcing core.