Prosthetic heart valve with reduced stitching

• US 10,575,944 B2
• Filed: 09/19/2017
• Issued: 03/03/2020
• Est. Priority Date: 09/22/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Saar, Tomer, Bukin, Michael, Sherman, Elena, Barash, Alexander, Mayatskaya, Yana
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/709,355
• Publication Number:
  US 20180078367A1
• Time in Patent Office: 896 Days
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame including a plurality of angled strut members, and a skirt member secured to the frame. The skirt member includes a plurality of extension portions wrapped around at least one strut member adjacent the extension portions. The prosthetic valve further includes a cord member threaded through at least a portion of the plurality of extension portions to secure the skirt member to the at least one strut member.

Claims

1. 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 including a plurality of angled strut members;

a skirt member disposed inside the frame and secured to the frame, the skirt member including a plurality of extension portions extending radially outwardly through the frame and wrapped around at least one strut member adjacent the extension portions, the extension portions defining respective openings, extension portions on opposite sides of the at least one strut member being wrapped around the at least one strut member in opposite directions such that the at least one strut member is outside the bounds of the openings defined by the extension portions; and

a cord member threaded through the openings of at least a portion of the plurality of extension portions in a longitudinal direction through the openings to secure the skirt member to the at least one strut member.

2. The prosthetic valve of claim 1, wherein the skirt member is secured to an edge portion of a valve leaflet to form a leaflet-skirt assembly, the leaflet-skirt assembly being situated within the frame.

3. The prosthetic valve of claim 2, wherein the skirt member comprises first and second longitudinal edge portions, and the plurality of extension portions are located on at least one of the longitudinal edge portions.

4. The prosthetic valve of claim 3, wherein the extension portions define tubular portions.

5. The prosthetic valve of claim 4, wherein a diameter of the tubular portions is less than or equal to a length of the extension portions.

6. The prosthetic valve of claim 3, wherein the skirt member is folded about the edge portion of the leaflet such that the first and second longitudinal edge portions extend radially outwardly from opposite sides of the leaflet.

7. The prosthetic valve of claim 2, further comprising an outer skirt extending around the circumference of the frame and secured to the frame with the cord member.

8. The prosthetic valve of claim 2, wherein the skirt member is secured to the valve leaflet by suturing.

9. The prosthetic valve of claim 2, wherein the skirt member is a first skirt member, and the prosthetic valve further comprises a second skirt member separate from the first skirt member and secured to the edge portion of the valve leaflet on the opposite side of the valve leaflet from the first skirt member.

10. The prosthetic valve of claim 2, further comprising two leaflet-skirt assemblies configured to collapse in a bicuspid arrangement.

11. The prosthetic valve of claim 2, further comprising three leaflet-skirt assemblies configured to collapse in a tricuspid arrangement.

12. The prosthetic valve of claim 1, wherein the extension portions are one or more threads formed into loop portions and inserted through openings defined in the skirt member.

13. The prosthetic valve of claim 12, wherein the loop portions are spaced apart from one another in a direction along a longitudinal axis of the at least one strut member.

14. The prosthetic valve of claim 12, wherein the loop portions are arranged in pairs, and the at least one strut member is located between the respective loop portions of at least one pair of loop portions.

15. The prosthetic valve of claim 1, wherein the skirt member is disposed about an interior of the frame.

16. The prosthetic valve of claim 1, wherein the skirt member is made from a natural or a synthetic woven fabric.

17. 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 including a plurality of angled strut members;

a skirt member secured to an edge portion of a valve leaflet to form a leaflet-skirt assembly, the leaflet-skirt assembly being disposed inside the frame and secured to the frame, the skirt member including first and second longitudinal edge portions and a plurality of extension portions extending from at least one of the longitudinal edge portions radially outwardly through the frame, the extension portions defining tubular portions, sequential extension portions along a longitudinal axis of the skirt member on opposite sides of at least one strut member being wrapped around the at least one strut member in opposite directions such that their respective tubular portions are coaxially aligned with each other on the outside of the frame; and

a cord member threaded through at least a portion of the plurality of extension portions to secure the skirt member to the at least one strut member.

18. 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 including a plurality of angled strut members;

a skirt member secured to an edge portion of a valve leaflet to form a leaflet-skirt assembly, the leaflet-skirt assembly being disposed inside the frame and secured to the frame, the skirt member including a plurality of extension portions extending radially outwardly through the frame and wrapped around at least one strut member adjacent the extension portions, extension portions on opposite sides of the at least one strut member being wrapped around the at least one strut member in opposite directions;

an outer skirt extending around the circumference of the frame, at least a portion of the plurality of extension portions being inserted through openings defined in the outer skirt; and

a cord member threaded through the extension portions inserted through the openings in the outer skirt to secure the outer skirt to the frame and to secure the skirt member to the at least one strut member.

19. A method, comprising:

situating a skirt member adjacent a strut member of a frame of a prosthetic valve, the skirt member including a plurality of extension portions defining respective openings, the skirt member being situated such that the plurality of extension portions extend radially outwardly through the frame, the prosthetic valve being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration;

wrapping at least a portion of the plurality of extension portions around the strut member such that extension portions on opposite sides of the strut member are wrapped around the strut member in opposite directions with the at least one strut member being outside the bounds of the openings defined by the wrapped extension portions; and

threading a cord member through the openings of the extension portions wrapped around the strut member in a longitudinal direction to secure the skirt member to the frame.

20. The method of claim 19, further comprising securing the skirt member to an edge of a valve leaflet to form a leaflet-skirt assembly, the skirt member including first and second longitudinal edge portions, and the plurality of extension portions being located along at least one of the longitudinal edge portions.

21. The method of claim 20, wherein:

The openings of the extension portions are tubular portions; and

the wrapping further comprises wrapping sequential extension portions around the strut member in opposite directions such that the respective tubular portions defined by the extension portions are coaxially aligned with one another on the outside of the frame.

22. The method of claim 21, further comprising threading a guide wire through the tubular portions to align the skirt member with the valve leaflet.

23. The method of claim 20, wherein securing the skirt member to the valve leaflet comprises suturing the skirt member to the valve leaflet.

24. The method of claim 20, further comprising securing an outer skirt to the frame with the cord member.

25. The method of claim 24, wherein securing the outer skirt further comprises threading the cord member through openings defined in the outer skirt, the openings in the outer skirt being positioned between respective extension portions of the skirt member when the outer skirt is situated around the frame.

26. The method of claim 24, wherein securing the outer skirt further comprises inserting at least a portion of the extension portions through openings defined in the outer skirt.

27. The method of claim 19, wherein:

the extension portions are loop portions formed from one or more suture threads threaded through openings defined in a main body of the skirt member;

the loop portions are arranged in pairs; and

situating the skirt member adjacent the strut member further comprises situating the skirt member such that the strut member is located between the respective loop portions of at least one pair of loop portions.

28. 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 including a plurality of angled strut members; and

a leaflet-skirt assembly situated within and secured to the frame, the leaflet-skirt assembly comprising;

a valve leaflet; and

a skirt member secured to an edge portion of the valve leaflet, the skirt member having first and second longitudinal edge portions and a plurality of extension portions on at least one of the longitudinal edge portions, the extension portions defining tubular portions and extending radially outward through the frame;

wherein at least a portion of the extension portions of the skirt member are wrapped around the strut members to secure the leaflet-skirt assembly to the frame, sequential extension portions on opposite sides of the strut members being wrapped around the strut members in opposite directions such that the tubular portions of the extension portions are coaxially aligned with each other on the outside of the frame.