Prosthetic heart valve having improved commissure supports

• US 10,363,132 B2
• Filed: 09/07/2017
• Issued: 07/30/2019
• Est. Priority Date: 12/09/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yohanan, Ziv, Levi, Tamir S., Benichou, Netanel, Bukin, Michael, Gurovich, Nikolay, Sherman, Elena
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/697,740
• Publication Number:
  US 20180021127A1
• Time in Patent Office: 691 Days
• Field of Search: 623 21- 219
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A prosthetic heart valve can comprise a radially collapsible and expandable annular frame and a leaflet structure comprising a plurality of leaflets mounted within the frame. The frame can have commissure attachment portions that are configured to support the commissures of the leaflets in unique ways. For example, commissure attachment portions can include at least two struts defining a gap therebetween. Additionally, angularly-spaced commissure attachment portions can comprise inner struts and outer struts. Adjacent side portions of leaflets can extend through a gap between the inner struts of a corresponding commissure attachment portion. Further features and arrangements are also possible.

Claims

1. A prosthetic valve comprising:

a radially collapsible and expandable annular frame, the frame comprising an inlet end and an outlet end, the frame comprising a plurality of angularly spaced, commissure attachment portions, each comprising two inner struts and two outer struts; and

a leaflet structure comprising a plurality of leaflets, each leaflet comprising opposing side portions, an upper edge extending between the side portions, and a lower edge extending between the side portions;

wherein each side portion of a leaflet is paired with an adjacent side portion of another leaflet to form commissures of the leaflet structure supported by respective commissure attachment portions, wherein each pair of adjacent side portions extends through a gap between the inner struts of a corresponding commissure attachment portion and one side portion of the pair is folded to form a first fold layer that extends through a gap between one of the inner struts and one of the outer struts of a corresponding commissure attachment portion and the other side portion of the pair is folded to form a second fold layer that extends through a gap between the other inner strut and the other outer strut of the corresponding commissure attachment portion;

wherein the leaflets are movable between an open position to allow blood to flow through the prosthetic valve from the inlet end to the outlet end and a closed position to inhibit the flow of blood through the prosthetic valve from the outlet end to the inlet end.

2. The prosthetic valve of claim 1, further comprising a suture loop wrapped around the inner struts and the outer struts of each corresponding commissure attachment portion, the suture loop causing the first and second fold layers of each commissure to be compressed between the inner and outer struts of the corresponding commissure attachment portion.

3. The prosthetic valve of claim 2, wherein the outer struts of each commissure attachment portion have notches and each suture loop is located within the notches of a corresponding commissure attachment portion.

4. The prosthetic valve of claim 2, wherein the suture loop at each commissure attachment portion is tightened around the outer struts, thereby drawing the outer struts toward each other.

5. The prosthetic valve of claim 1, wherein the inner and outer struts of each commissure attachment portion are cantilevered relative to each other and have respective upper ends that are unattached to each other.

6. The prosthetic valve of claim 1, wherein the commissure attachment portions extend radially inwardly toward a longitudinal flow axis of the prosthetic valve.

7. The prosthetic valve of claim 6, wherein the upper edges of the leaflets are spaced radially inwardly of an outlet portion of the frame when the leaflets are in the open position such that a gap is formed between the upper edge of each leaflet and the outlet portion of the frame.

8. The prosthetic valve of claim 1, wherein the frame comprises a plurality of struts connected to each other to define a plurality of cells arranged in circumferentially extending rows connected to each other along the length of the frame, and the commissure attachment portions extend from an uppermost row of the cells proximate the outlet end of the frame.

9. The prosthetic valve of claim 1, wherein the frame comprises a plurality of frame retaining arms between the commissure attachment portions at the outflow end of the frame, the frame retaining arms configured to form a releasable connection with a delivery catheter.

10. The prosthetic valve of claim 1, wherein the frame comprises an intermediate portion between an inlet portion of the frame and an outlet portion of the frame, the intermediate portion having an enlarged inlet end of a first diameter, a middle section having a second diameter less than the first diameter, and an enlarged outlet end of a third diameter greater than the second diameter.

11. A prosthetic valve comprising:

a radially collapsible and expandable annular frame, the frame comprising an inlet end and an outlet end, the frame comprising a plurality of angularly spaced, commissure attachment portions, each comprising at least two struts defining a gap therebetween;

a leaflet structure comprising a plurality of leaflets, each leaflet comprising opposing side portions, an upper edge extending between the side portions, and a lower edge extending between the side portions;

wherein each side portion of a leaflet is paired with an adjacent side portion of another leaflet to form commissures of the leaflet structure supported by respective commissure attachment portions, wherein each pair of adjacent side portions extends through a gap between the struts of a corresponding commissure attachment portion; and

a suture loop wrapped around the struts of each commissure attachment portion and tightened to draw the struts toward each other and pinch a corresponding pair of side portions of the leaflets that are between the struts;

wherein the leaflets are movable between an open position to allow blood to flow through the prosthetic valve from the inlet end to the outlet end and a closed position to inhibit the flow of blood through the prosthetic valve from the outlet end to the inlet end.

12. The prosthetic valve of claim 11, wherein the struts of each commissure attachment portion have notches and each suture loop is located within the notches of a corresponding commissure attachment portion.

13. The prosthetic valve of claim 11, wherein the at least two struts are cantilevered relative to each other and have respective upper ends that are unattached to each other.

14. The prosthetic valve of claim 11, wherein:

the at least two struts of each commissure attachment portion comprises two inner struts and two outer struts; and

each pair of adjacent side portions extends through a gap between the inner struts of a corresponding commissure attachment portion and one side portion of the pair is folded to form a first fold layer that extends through a gap between one of the inner struts and one of the outer struts of a corresponding commissure attachment portion and the other side portion of the pair is folded to form a second fold layer that extends through a gap between the other inner strut and the other outer strut of the corresponding commissure attachment portion.

15. A prosthetic valve comprising:

a radially collapsible and expandable annular frame, the frame comprising an inlet portion and an outlet portion, the frame comprising a plurality of struts connected to each other to define a plurality of cells arranged in circumferentially extending rows with the rows connected to each other along the length of the frame, the outlet portion of the frame comprising a plurality of angularly spaced commissure attachment portions and a plurality of angularly spaced frame retaining arms between the commissure attachment portions;

wherein the commissure attachment portions and the frame retaining arms extend from an uppermost row of the cells;

wherein the frame retaining arms are configured to form a releasable connection with a delivery apparatus;

a leaflet structure comprising a plurality of leaflets, each leaflet comprising opposing side portions, an upper edge extending between the side portions, and a lower edge extending between the side portions;

wherein each side portion is paired with an adjacent side portion of another leaflet to form commissures of the leaflet structure, each commissure being supported by one of the commissure attachment portions;

wherein the leaflets are movable between an open position to allow blood to flow through the prosthetic valve from the inlet portion to the outlet portion and a closed position to inhibit the flow of blood through the prosthetic valve from the outlet portion to the inlet portion.

16. The prosthetic valve of claim 15, wherein each commissure attachment portion comprises at least two parallel struts defining a leaflet-receiving gap therebetween through which a pair of side portions forming one of the commissures extends.

17. The prosthetic valve of claim 16, wherein the struts of each commissure attachment portion have respective lower ends connected to a common base, which is connected to a cell of the uppermost row of cells.

18. The prosthetic valve of claim 17, wherein the struts of each commissure attachment portion have respective upper ends that are unattached to each other.

19. The prosthetic valve of claim 16, further comprising a suture loop wrapped around the struts of each commissure attachment portion and tightened to draw the struts toward each other and pinch a corresponding pair of side portions of the leaflets that are between the struts.

20. The prosthetic valve of claim 15, wherein an inflow end portion of the frame tapers in diameter from an intermediate portion of the frame to an inlet end of the frame.