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

• US 8,784,481 B2
• Filed: 09/26/2008
• Issued: 07/22/2014
• Est. Priority Date: 09/28/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Alkhatib, Yousef F., Girard, Michael J.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/733,763
• Publication Number:
  US 20100249923A1
• Time in Patent Office: 2,125 Days
• Field of Search: 623 123- 219
• US Class Current: 623/2.18
• 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 structure that is adapted for (1) delivery into a patient'"'"'s native heart valve annulus in a circumferentially collapsed condition, and (2) circumferential re-expansion when in the annulus, the frame structure having a first end including an annulus portion and a second end;

a flexible leaflet structure disposed in the frame structure; and

a leaflet restraining structure for pushing radially outwardly on a patient'"'"'s native heart valve leaflets when the frame structure is re-expanded, the leaflet restraining structure having a first end connected at a junction to the annulus portion of the frame structure and a free end disposed between the junction and the second end of the frame structure, the leaftlet restraining structure including a plurality of fingers that are spaced from one another in a direction that is circumferential around the annulus portion, each of the fingers being cantilevered from the annulus portion.

2. The prosthetic heart valve defined in claim 1 wherein each of the fingers has a free end that is remote from the annulus portion.

3. The prosthetic heart valve defined in claim 2 wherein all of the fingers extend approximately the same distance from the annulus portion toward the second end of the frame structure.

6. The prosthetic heart valve defined in claim 1 wherein the leaflet restraining structure further comprises:

a linking structure between two circumferentially adjacent ones of the fingers at a location that is spaced from the annulus portion.

7. The prosthetic heart valve defined in claim 6 wherein the linking structure is collapsible and re-expandable in a direction that is circumferential around the annulus portion.

8. The prosthetic heart valve defined in claim 6 wherein the location is at the free ends of the two circumferentially adjacent fingers.

9. The prosthetic heart valve defined in claim 1 wherein the annulus portion includes a plurality of circumferentially spaced commissure regions, and the plurality of fingers are circumferentially spaced from one another between two circumferentially adjacent ones of the commissure regions.

10. The prosthetic heart valve defined in claim 9 wherein the leaflet restraining structure is one of a plurality of leaflet restraining structures, and each of the leaflet restraining structures is circumferentially spaced between a respective one of a plurality of pairs of circumferentially adjacent ones of the commissure regions.

11. The prosthetic heart valve defined in claim 1 wherein the annular frame structure further includes an annular aortic portion spaced from the annular portion and a plurality of links between the aortic portion and the annulus portion, the aortic portion being adapted for (1) delivery into a patient'"'"'s native aorta in a circumferentially collapsed condition, and (2) circumferential re-expansion when in the aorta disposed between the free ends of the fingers and the second end of the frame structure, and the links being circumferentially spaced from each of the fingers.

12. The prosthetic heart valve defined in claim 11 wherein the annulus portion includes a plurality of circumferentially spaced commissure regions, and the links connect to the annulus portion adjacent the commissure regions.

13. The prosthetic heart valve defined in claim 12 wherein plurality of fingers are circumferentially spaced between first and second circumferentially adjacent ones of the links, and first and second ones of the links are respectively connected to the annulus portion adjacent respective first and second circumferentially adjacent ones of the commissure regions.

14. The prosthetic heart valve defined in claim 1 wherein the annulus portion includes two circumferentially spaced commissure regions, and the leaflet restraining structure comprises a plurality of fingers circumferentially spaced from one another between the commissure regions.

15. The prosthetic heart valve defined in claim 14, wherein the plurality of fingers are capable of independent radial expansion.

4. A collapsible and re-expandable prosthetic heart valve comprising:

an annular frame structure that is adapted for (1) delivery into a patient'"'"'s native heart valve annulus in a circumferentially collapsed condition, and (2) circumferential re-expansion when in the annulus, the frame structure having a first end including an annulus portion and a second end;

a flexible leaflet structure disposed in the frame structure; and

a leaflet restraining structure for pushing radially outwardly on a patient'"'"'s native heart valve leaflet when the frame structure is re-expanded, the leaflet restraining structure including a plurality of fingers that are spaced from one another in a direction that is circumferential around the annulus portion of the frame structure, each of the fingers being cantilevered from the annulus portion to a free end of the finger spaced from the annulus portion,

wherein the free end of a first of the fingers extends closer to the second end of the frame structure than the free end of a second of the fingers.

5. The prosthetic heart valve defined in claim 4 wherein:

the annulus portion includes two circumferentially spaced commissure regions,

the fingers are circumferentially spaced from one another between the commissure regions, and

the first finger is circumferentially closer to one of the commissure regions than the second finger is to either of the commissure regions.

16. A collapsible and re-expandable prosthetic heart valve comprising:

an expandable annular frame structure having a first end including an annulus portion and a second end, the annulus portion having a series of alternating peaks and valleys;

a flexible leaflet structure disposed in the frame structure; and

a leaflet restraining structure for pushing radially outwardly on a patient'"'"'s native heart valve leaflet when the frame structure is re-expanded, the leaflet restraining structure having a first end connected to at least one of the valleys at a point closest to the first end of the frame structure and extending toward the second end of the frame structure.