Collapsible-expandable prosthetic heart valves with structures for clamping native tissue

• US 20140155997A1
• Filed: 09/28/2007
• Published: 06/05/2014
• Est. Priority Date: 09/28/2007
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical LLC (Abbott Laboratories)
• Inventors: Braido, Peter Nicholas
• Granted Patent: US 9,532,868 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient'"'"'s native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Claims

1. A prosthetic heart valve comprising:

an annular structure that is annularly continuous and that has an annular perimeter that is changeable in length between (1) a first relatively small length suitable for delivery of the valve into a patient with reduced invasiveness, and (2) a second relatively large length suitable for use of the annular structure to engage tissue of the patient adjacent to the patient'"'"'s native valve annulus and thereby implant the valve in the patient; and

a flexible leaflet structure attached to the annular structure;

wherein the annular structure comprises an annular array of diamond-shaped cells, upstream apex portions of at least some of the cells being resiliently biased to deflect radially outwardly from at least some other portion of the annular structure forming a line circumscribing the annular structure, and downstream apex portions of at least some of the cells being resiliently biased to deflect radially outwardly from said at least some other portion of the annular structure forming the line circumscribing the annular structure;

whereby, in use, tissue of the patient adjacent to the patient'"'"'s native valve annulus is clamped between the upstream and downstream apex portions, with the upstream apex portions engaging tissue upstream from the annulus, and with the downstream apex portions engaging tissue downstream from the annulus.

2. The valve defined in claim 1 wherein the annular perimeter is elastically changeable in length between the first relatively small length and the second relatively large length.

4. The valve defined in claim 1 wherein the resiliently biased, radially outward deflection of each of the upstream apex portions includes a downstream component of motion by that upstream apex portion;

and

wherein the resiliently biased, radially outward deflection of each of the downstream apex portions includes and upstream component of motion by that downstream apex portion.

5. The valve defined in claim 1 further comprising at least one site for attachment to the valve of material functioning as chordae tendonae.

6. The valve defined in claim 5 wherein the located on the annular structure.

7. The valve defined in claim 5 wherein the located on the flexible leaflet structure.

8. The valve defined in claim 5 wherein the located on a commissure post member that is cantilevered from the annular structure.

9. The valve defined in claim 1 further comprising a plurality of commissure post members that are cantilevered from the annular structure.

3. (canceled)

10. A prosthetic aortic valve comprising:

an annular structure that is annularly continuous and that has an annular perimeter that is changeable in length between (1) a first relatively small length suitable for delivery of the valve into a patient with reduced invasiveness, and (2) a second relatively large length suitable for use of the annular structure to engage tissue of the patient adjacent to the patient'"'"'s native aortic valve annulus and also downstream from ostia of the patient'"'"'s coronary arteries to thereby implant the valve in the patient, the annular structure including an annularly continuous annulus portion adapted for implanting adjacent the patient'"'"'s native aortic valve annulus upstream from the ostia of the patient'"'"'s coronary arteries, and an annularly continuous aortic portion adapted for

implanting in the patient'"'"'s aorta downstream from the ostia of the patient'"'"'s coronary arteries, the annulus portion and the aortic portion being connected to one another only by a plurality of linking structures that are disposed to pass through at least a portion of the patient'"'"'s valsava sinus at locations that are spaced

from the ostia of the patient'"'"'s coronary arteries in a direction that extends annularly around the valsalva sinus; and

a flexible leaflet structure attached to the annulus portion;

wherein the annulus portion includes first and second tissue clamping structures that are spaced from one another along an axis that passes longitudinally through the valve, each of the clamping structures being resiliently biased to extend radially outwardly from the leaflet structure about a common pivot point, whereby, in use, tissue of the patient adjacent to the patient'"'"'s native aortic valve annulus is clamped between the first and second clamping structures, with the first clamping structure engaging tissue upstream from the annulus, and with the second clamping structure engaging tissue downstream from the annulus.

11. The valve defined in claim 10 wherein the annular perimeter is elastically changeable in length between the first relatively small length and the second relatively large length.

12. The valve defined in claim 10 further comprising a plurality of commissure post members connected to the annulus portion.

13. The valve defined in claim 12 wherein the linking structure consists essentially of a plurality of struts, each of which extends from a downstream end of a respective one of the commissure post members to the aortic portion.

14. The valve defined in claim 13 wherein each of the struts connects to the aortic portion at a axially aligned with the commissure post member from which that strut extends.

15. The valve defined in claim 12 wherein of the commissure post members includes a downstream end portion that is cantilevered from the annulus portion.

16. The valve defined in claim 15 wherein the linking structure consists essentially of a respective pair of strut members associated with each of the commissure post members, the strut members in each pair extending along respective opposite sides of the associated commissure post members to the aortic portion.

17. The valve defined in claim 16 wherein, at least at a transverse geometric plane across the valve at the ostia of the coronary arteries, circumferential spacing between the strut members in each pair is less than circumferential spacing between the pairs.

18. The valve defined in claim 12 wherein the commissure post members are spaced circumferentially around the annulus portion so that they can be aligned with respective commissures of the patient'"'"'s native aortic valve.

19. The valve defined in claim 10 wherein the annulus portion comprises an annular array of diamond-shaped cells.

20. The valve defined in claim 19 wherein the first clamping structure includes apex portions of at least some of the cells.

21. The valve defined in claim 20 wherein the second clamping structure includes other apex portions of at least some of the cells.

22. A prosthetic aortic valve comprising:

an annular structure that is annularly continuous and that has an annular perimeter that is changeable in length between (1) a first relatively small length suitable for delivery of the valve into a patient with reduced invasiveness, and (2) a second relatively large length suitable for use of the annular structure to engage tissue of the patient adjacent to the patient'"'"'s native aortic valve annulus and thereby implant the valve in the patient; and

a flexible leaflet structure attached to the annular structure;

wherein, when implanted in the patient, any non-leaflet part of the valve that is at the level of the patient'"'"'s native coronary artery ostia confined in a direction that is circumferential of the valve to areas that are adjacent to the patient'"'"'s aortic valve commissures or downstream projections of those commissures, each of said areas having an extent in the circumferential direction that less than the distance in the circumferential direction between circumferentially adjacent ones of those areas; and

wherein the annular structure includes first and second tissue clamping structures that are spaced from one another along an axis that passes longitudinally through the valve, each of the clamping structures being resiliently biased to extend radially outwardly from a common pivot point of the leaflet structure, whereby, in use, tissue of the patient adjacent to the patient'"'"'s native aortic valve annulus is clamped between the first and second clamping structures, with the first clamping structure engaging tissue upstream from the annulus, and with the second clamping structure engaging tissue downstream from the annulus.

23. The valve defined in claim 22 wherein the annular perimeter is elastically changeable in length between the first relatively small length and second relatively large length.

24. The valve defined in claim 22 further comprising a plurality of commissure post members connected to the annular structure.

25. The valve defined in claim 24 wherein each of the commissure posts members includes a downstream end portion that is cantilevered from the annular structure.

26. The valve defined in claim 24 wherein the commissure post members are spaced circumentially around the annular structure so that they can be aligned with respective commissures of the patient'"'"'s native aortic valve.

27. The valve defined in claim 22 wherein the annular structure comprises an annular array of diamond-shaped cells.

28. The valve defined in claim 27 wherein the first clamping structure includes apex portions of at least some of the cells.

29. The valve defined in claim 28 wherein the second clamping structure includes other apex portions of at least some of the cells.