Collapsible prosthetic heart valves

• US 10,299,925 B2
• Filed: 07/05/2017
• Issued: 05/28/2019
• Est. Priority Date: 03/18/2003
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Iobbi, Mario
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/641,991
• Publication Number:
  US 20170296333A1
• Time in Patent Office: 692 Days
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A prosthetic heart valve includes a collapsible and expandable support frame extending between an inflow end and an outflow end and a plurality of commissures, wherein each commissure is formed with an elongate opening. A plurality of leaflets are supported inside the support structure and operative for allowing 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 includes tabs. The prosthetic heart valve includes at least a first panel of fabric covering the opening of a first commissure. The first panel of fabric is attached to a first tab of a first leaflet via a suture extending orthogonal to the first panel of fabric, wherein the first panel of fabric is positioned radially outwardly of the first tab.

Claims

1. A prosthetic heart valve, comprising:

a collapsible and expandable support frame extending between an inflow end and an outflow end and including a plurality of commissures, each commissure having two leaflet attachment portions and an elongate opening disposed between the leaflet attachment portions, wherein each leaflet attachment portion has a plurality of radially-extending assembly holes;

a plurality of leaflets disposed inside the support 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 including tabs, wherein the tabs of an adjacent pair of leaflets extends through the opening of a respective commissure; and

a first panel of fabric covering the opening of a first commissure, the first panel of fabric being attached to a first tab of a first leaflet via a suture extending orthogonal to the first panel of fabric and extending through one or more of the assembly holes, the first panel of fabric being disposed radially outwardly of the first tab.

2. The prosthetic heart valve of claim 1, wherein the first panel of fabric is further attached to a first tab of a second leaflet.

3. The prosthetic heart valve of claim 1, further comprising a second panel of fabric covering the opening of a second commissure, the second panel of fabric being attached to a second tab of the first leaflet.

4. The prosthetic heart valve of claim 1, wherein the first panel of fabric is disposed radially outwardly of a radially-inwardly facing surface of the support frame.

5. The prosthetic heart valve of claim 1, wherein the first panel of fabric overlaps the first tab of the first leaflet.

6. The prosthetic heart valve of claim 5, wherein the first panel of fabric also overlaps a first tab of a second leaflet.

7. The prosthetic heart valve of claim 1, further comprising a second panel of fabric covering an opening of a second commissure and a third panel of fabric covering an opening of a third commissure.

8. The prosthetic heart valve of claim 1, further comprising a fabric cover circumferentially disposed on a radially-outwardly facing surface of the support frame and attached to the support frame, wherein the first panel of fabric extends farther toward the outflow end of the support frame than the cover.

9. The prosthetic heart valve of claim 1, wherein each of the plurality of leaflets includes pericardium.

10. The prosthetic heart valve of claim 1, wherein the first panel of fabric is attached to at least one of the commissures.

11. The prosthetic heart valve of claim 1, wherein the first panel of fabric covers a single commissure.

12. A prosthetic heart valve, comprising:

a collapsible and expandable support structure extending between an inflow end and an outflow end and including three commissures, each commissure having two posts and an elongate opening that spans a length of the commissure between the posts;

a plurality of leaflets disposed inside the support 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 including tabs, and each tab extending through an opening of one of the commissures;

a plurality of panels of fabric, each covering an opening of one of the commissures, each of the panels of fabric being attached to adjacent tabs of adjacent leaflets via sutures, each suture being orthogonal to one of the panels of fabric, and each of the panels of fabric being disposed radially outwardly of corresponding adjacent tabs; and

a fabric cover circumscribing each post of the commissures, wherein the cover is disposed radially inwardly relative to the panels of fabric, and wherein the cover is coupled to the support structure via the sutures.

13. The prosthetic heart valve of claim 12, wherein the prosthetic heart valve comprises three panels of fabric and three leaflets.

14. The prosthetic heart valve of claim 13, wherein each of the three panels of fabric is disposed radially outwardly of a radially-inwardly facing surface of the support structure.

15. The prosthetic heart valve of claim 12, wherein each of the plurality of leaflets is coupled to two adjacent panels of fabric.

16. The prosthetic heart valve of claim 12, wherein the panels of fabric extend farther toward the outflow end of the support structure than the cover.

17. The prosthetic heart valve of claim 12, wherein each of the plurality of leaflets includes pericardium.

18. The prosthetic heart valve of claim 12, wherein the plurality of leaflets comprise a different material than the plurality of panels of fabric.

19. The prosthetic heart valve of claim 12, wherein each of the panels of fabric is coupled to a single commissure.

20. The prosthetic heart valve of claim 12, wherein each leaflet includes a first tab and a second tab, the first tab and second tab being coupled to different panels of fabric.

21. The prosthetic heart valve of claim 12, further comprising an equal number of leaflets, commissures, and panels of fabric.

22. A prosthetic heart valve, comprising:

a collapsible and expandable support structure extending between an inflow end and an outflow end, an inflow edge adjacent the inflow end, and including three commissures, each commissure having an elongate opening that spans a length of the commissure and a longitudinally-extending flange on each side of the elongate opening, wherein each flange includes a plurality of openings extending radially therethrough;

a plurality of leaflets disposed inside the support 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 including tabs, wherein adjacent tabs of adjacent leaflets extend through the elongate opening of a respective commissure and diverge from each other, wherein one tab of the adjacent tabs extends partially around a first flange of the respective commissure, and wherein another tab of the adjacent tabs extends partially around a second flange of the respective commissure;

a first fabric layer circumferentially disposed on a radially-inwardly facing surface of the support structure and attached to the support structure;

a second fabric layer circumferentially disposed on a radially-outwardly facing surface of the support structure and attached to the support structure; and

a plurality of panels of fabric, each of the panels of fabric being attached to adjacent tabs of adjacent leaflets and to the flanges of one of the commissures via sutures, each suture being orthogonal to a corresponding panel of fabric and extending through the tabs of the leaflets.

23. The prosthetic heart valve of claim 22, wherein the plurality of panels of fabric extend farther toward the outflow end of the support structure than the first fabric layer.

24. The prosthetic heart valve of claim 22, wherein each of the panels of fabric is coupled to a single commissure.

25. The prosthetic heart valve of claim 22, wherein each leaflet includes a first tab and a second tab, the first tab and the second tab being coupled to different panels of fabric.

26. The prosthetic heart valve of claim 22, wherein each leaflet includes a first tab and a second tab, the first tab and the second tab being coupled to different commissures.

27. The prosthetic heart valve of claim 22, wherein the plurality of leaflets comprise a different material than the plurality of panels of fabric.