COLLAPSIBLE/EXPANDABLE PROSTHETIC HEART VALVES WITH NATIVE CALCIFIED LEAFLET RETENTION FEATURES

• US 20100249923A1
• Filed: 09/26/2008
• Published: 09/30/2010
• 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: Girard, Michael J., Alkhatib, Yousef F.
• Granted Patent: US 8,784,481 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• 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 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 that annulus; and

a flexible leaflet structure disposed in the frame structure, wherein the frame structure includes 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 being cantilevered from an annulus portion of the frame structure, which is re-expanded in the annulus, to a free end of the leaflet restraining structure that is downstream from the annulus portion in the direction of blood flow through the prosthetic valve when the prosthetic valve is in use in the patient.

2. The prosthetic heart valve defined in claim 1 wherein the leaflet restraining structure is resiliently biased to incline radially outwardly from the annulus portion toward the free end of the leaflet restraining structure.

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

a plurality 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 and extending from the annulus portion in the direction of blood flow.

4. The prosthetic heart valve defined in claim 3 wherein each of the fingers has a free end that is remote from the annulus portion.

5. The prosthetic heart valve defined in claim 4 wherein all of the fingers extend to approximately the same distance downstream from the annulus portion in the direction of blood flow.

6. The prosthetic heart valve defined in claim 4 wherein a first of the fingers extends to a greater distance downstream from the annulus portion in the direction of blood flow than a second of the fingers.

7. The prosthetic heart valve defined in claim 6 wherein the annulus portion includes two circumferentially spaced commissure regions, wherein the fingers are circumferentially spaced from one another between the commissure regions, and wherein the first finger is circumferentially closer to one of the commissure regions than the second finger is to either of the commissure regions.

8. The prosthetic heart valve defined in claim 3 wherein the leaflet restraining structure further comprises:

a linking structure between two circumferentially adjacent ones of the fingers at a location that is downstream from the annulus portion in the direction of blood flow.

9. The prosthetic heart valve defined in claim 8 wherein the linking structure is collapsible and re-expandable in a direction that is circumferential around the annulus portion.

10. The prosthetic heart valve defined in claim 8 wherein the location is at ends of the two circumferentially adjacent fingers that are remote from the annulus portion.

11. The prosthetic heart valve defined in claim 1 wherein the annulus portion includes a plurality of circumferentially spaced commissure regions, and wherein the leaflet restraining structure is circumferentially spaced between two circumferentially adjacent ones of the commissure regions.

12. The prosthetic heart valve defined in claim 11 wherein the leaflet restraining structure is one of a plurality of leaflet restraining structures, each being as defined in claim 1, and wherein 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.

13. The prosthetic heart valve defined in claim 1 wherein the annulus is the patient'"'"'s native aortic valve annulus, and wherein the prosthetic heart valve further comprises:

a further frame structure that includes an annular aortic 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, the aortic portion being downstream from the free end of the leaflet restraining structure in the direction of blood flow, and the links being circumferentially spaced from the leaflet restraining structure.

14. The prosthetic heart valve defined in claim 13 wherein the annulus portion includes a plurality of circumferentially spaced commissure regions, and wherein the links connect to the annulus portion adjacent the commissure regions.

15. The prosthetic heart valve defined in claim 14 wherein the leaflet restraining structure is circumferentially spaced between first and second circumferentially adjacent ones of the links, and wherein the first and second links are respectively connected to the annulus portion adjacent respective first and second circumferentially adjacent ones of the commissure regions.