Collapsible/expandable prosthetic heart valves with native calcified leaflet retention features

• US 9,364,321 B2
• Filed: 08/12/2015
• Issued: 06/14/2016
• Est. Priority Date: 09/28/2007
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Alkhatib, Yousef F., Girard, Michael J.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/824,209
• Publication Number:
  US 20150342733A1
• Time in Patent Office: 307 Days
• Field of Search: 623 21- 219
• US Class Current: 1/1
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid

Abstract

A prosthetic heart valve is circumferentially collapsible for less invasive delivery into a patient. The valve re-expands to operating size at the implant site in the patient. A frame structure of the valve includes restraining structure that can help to push one or more of the patient'"'"'s native heart valve leaflets radially outwardly so that this native leaflet tissue does not interfere with the operation or service life of the prosthetic valve.

Claims

1. A prosthetic heart valve comprising:

an annular frame that is adapted for (1) delivery into a patient'"'"'s native heart valve annulus in a circumferentially collapsed condition, and (2) circumferential reexpansion when in the annulus, the frame having an inflow end having an inflow diameter adjacent an annulus portion and an outflow end having an outflow diameter greater than the inflow diameter, the annular frame further including a plurality of struts, at least some of the plurality of struts forming at least two rows of cells adjacent the annulus portion;

a leaflet structure disposed in the frame; and

at least two commissure members circumferentially spaced apart, each of the at least two commissure members having a first end coupled to two selected struts of one of the cells, and including three holes, the at least two commissure members being spaced apart from the inflow end and the outflow end.

2. The prosthetic heart valve of claim 1, wherein the at least two commissure members are equally spaced about a circumference of the frame.

3. The prosthetic heart valve of claim 1, wherein the leaflet structure includes a plurality of leaflets, and the at least two commissure members are configured and arranged to align with the plurality of leaflets.

4. The prosthetic heart valve of claim 1, wherein each of the at least two commissure members are the same length.

5. The prosthetic heart valve of claim 1, wherein the at least two commissure members includes three commissure members.

6. The prosthetic heart valve of claim 1, wherein the leaflet structure includes a plurality of leaflets, each of the leaflets extending between two of the at least two commissure members.

7. The prosthetic heart valve of claim 1, wherein the leaflet structure includes a plurality of leaflets, the sum of the plurality of leaflets being equal to the sum of the at least two commissure members.

8. The prosthetic heart valve of claim 1, wherein each of the at least two commissure members projects along a line that bisects the selected struts to which it is attached.

9. The prosthetic heart valve of claim 1, wherein the three holes are substantially circular.

10. A prosthetic heart valve comprising:

an annular frame that is adapted for (1) delivery into a patient'"'"'s native heart valve annulus in a circumferentially collapsed condition, and (2) circumferential reexpansion when in the annulus, the frame having an inflow end having an inflow diameter adjacent an annulus portion and an outflow end having an outflow diameter greater than the inflow diameter, the annular frame further including a plurality of struts, at least some of the plurality of struts forming at least two rows of cells adjacent the annulus portion;

a leaflet structure disposed in the frame; and

at least two commissure members circumferentially spaced apart, each of the at least two commissure members having a first end coupled to at least one strut of one of the cells, and including three equally-spaced holes, the at least two commissure members being spaced apart from the inflow end and the outflow end.

11. The prosthetic heart valve of claim 10, wherein the three holes are of the same size.

12. The prosthetic heart valve of claim 10, wherein the three holes are circular.

13. The prosthetic heart valve of claim 10, wherein the three holes are arranged in a column.

14. The prosthetic heart valve of claim 10, wherein the at least two commissure members are equally spaced about a circumference of the frame.

15. The prosthetic heart valve of claim 10, wherein the leaflet structure includes a plurality of leaflets, and the at least two commissure members are configured and arranged to align with the plurality of leaflets.

16. The prosthetic heart valve of claim 10, wherein each of the at least two commissure members are the same length.

17. The prosthetic heart valve of claim 10, wherein the at least two commissure members includes three commissure members.

18. The prosthetic heart valve of claim 10, wherein the leaflet structure includes a plurality of leaflets, each of the leaflets extending between two of the at least two commissure members.

19. The prosthetic heart valve of claim 10, wherein the leaflet structure includes a plurality of leaflets, the sum of the plurality of leaflets being equal to the sum of the at least two commissure members.

20. The prosthetic heart valve of claim 10, wherein each of the plurality of commissure members is coupled to an apex of one of the cells.

21. A prosthetic heart valve comprising:

an annular frame that is adapted for (1) delivery into a patient'"'"'s native heart valve annulus in a circumferentially collapsed condition, and (2) circumferential reexpansion when in the annulus, the frame having an inflow end having an inflow diameter adjacent an annulus portion and an outflow end having an outflow diameter greater than the inflow diameter, the annular frame further including a plurality of struts, at least some of the plurality of struts forming at least two rows of cells adjacent the annulus portion;

a leaflet structure disposed in the frame; and

at least two commissure members circumferentially spaced apart and coupled to an apex of one of the cells, each of the at least two commissure members including holes arranged in a column and being spaced apart from the inflow end and the outflow end.

22. The prosthetic heart valve of claim 21, wherein the holes include three holes of the same size.

23. The prosthetic heart valve of claim 21, wherein the holes are circular.

24. The prosthetic heart valve of claim 21, wherein the holes are arranged in a column.

25. The prosthetic heart valve of claim 21, wherein the at least two commissure members are equally spaced about a circumference of the frame.

26. The prosthetic heart valve of claim 21, wherein the leaflet structure includes a plurality of leaflets, and the at least two commissure members are configured and arranged to align with the plurality of leaflets.

27. The prosthetic heart valve of claim 21, wherein each of the at least two commissure members are the same length.

28. The prosthetic heart valve of claim 21, wherein the at least two commissure members includes three commissure members.

29. The prosthetic heart valve of claim 21, wherein the leaflet structure includes a plurality of leaflets, each of the leaflets extending between two of the at least two commissure members.

30. The prosthetic heart valve of claim 21, wherein the leaflet structure includes a plurality of leaflets, the sum of the plurality of leaflets being equal to the sum of the at least two commissure members.