PROSTHETIC HEART VALVES

• US 20100168839A1
• Filed: 06/04/2008
• Published: 07/01/2010
• Est. Priority Date: 06/04/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Alkhatib, Yousef F.
• Granted Patent: US 9,572,660 B2
• Time in Patent Office: Days
• US Class Current: 623/1.260
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

A prosthetic heart valve (10) (e.g., a prosthetic aortic valve) is designed to be somewhat circumferentially collapsible and then re-expandable. The collapsed condition may be used for less invasive delivery of the valve into a patient. When the valve reaches the implant site in the patient, it re-expands to normal operating size, and also to engage surrounding tissue of the patient. The valve includes a stent portion (200) and a ring portion (100) that is substantially concentric with the stent portion but downstream from the stent portion in the direction of blood flow through the implanted valve. When the valve is implanted, the stent portion engages the patient'"'"'s tissue at or near the native valve annulus, while the ring portion engages tissue downstream from the native valve site (e.g., the aorta).

Claims

1. A prosthetic heart valve comprising:

an annular supporting structure including (1) an annular stent portion, and (2) a ring portion that is substantially concentric with the stent portion but that is downstream from the stent portion in the direction of blood flow when the valve is in use in a patient, the stent portion having a blood-outflow region that includes a plurality of annularly spaced commissure tips at which the stent portion is closest to the ring portion, the ring portion being connected to the stent portion substantially solely by flexible strut structures that extend from the stent portion to the ring portion adjacent to the commissure tips, each of the strut structures starting from a respective point or points on the stent structure that are farther from the ring portion than the commissure tips; and

a plurality of valve leaflets supported by the stent portion, the ring portion being downstream from the stent portion sufficiently far that the leaflets cannot contact the ring portion.

2. The prosthetic heart valve defined in claim 1 wherein the ring portion is integrally connected to the stent portion via the strut structures.

3. The prosthetic heart valve defined in claim 1 wherein the ring portion and the stent portion are annularly compressible to substantially the same circumference.

4. The prosthetic heart valve defined in claim 3 wherein the ring portion is re-expandable to a circumferential size that is greater than the circumferential size of at least a part of the stent portion when the stent portion is re-expanded.

5. The prosthetic heart valve defined in claim 4 wherein the stent portion includes a skirt portion that is adjacent the blood inflow end of the valve when the valve is in use in a patient, and wherein the skirt portion re-expands to flare radially out from a remainder of the stent portion.

6. The prosthetic heart valve defined in claim 5 wherein the skirt portion is scalloped in an annular direction around the heart valve to reduce interference with an anatomical constraint in the heart of the patient who is receiving the prosthetic heart valve.

7. The prosthetic heart valve defined in claim 6 wherein the skirt portion is scalloped by being recessed in a direction toward one of the commissure tips relative to extent of the skirt portion upstream from others of the commissure tips.

8. The prosthetic heart valve defined in claim 1 wherein the supporting structure includes barbs that engage tissue of the patient when the valve is in use.

9. The prosthetic heart valve defined in claim 1 wherein the ring portion is more resistant to annular compression than the stent portion.

10. The prosthetic heart valve defined in claim 1 wherein the blood outflow region includes a first ring member that extends annularly around the valve in a serpentine pattern, the commissure tips being points along the first ring member.

11. The prosthetic heart valve defined in claim 10 wherein the strut structures are connected to the stent portion only via the first ring member and only at connection points that are upstream from the commissure tips.

12. The prosthetic heart valve defined in claim 10 wherein parts of the strut structures form portions of a second ring member that follows the first ring member annularly around the valve and that is spaced downstream from the first ring member, and wherein portions of each of the leaflets are inserted between the first and second ring members.

13. The prosthetic heart valve defined in claim 1 further comprising:

sheet material covering at least part of the stent portion.

14. The prosthetic heart valve defined in claim 1 further comprising:

sheet material covering at least part of the ring portion.

15. The prosthetic heart valve defined in claim 10 further comprising:

sheet material covering the first ring member.

16. The prosthetic heart valve defined in claim 12 further comprising:

sheet material covering the second ring member.

18. The prosthetic heart valve defined in claim 1 wherein the ring portion comprises:

a serpentine ring that undulates alternately upstream and downstream relative to the direction of blood flow as one proceeds annularly around the valve.

19. The prosthetic heart valve defined in claim 18 wherein the ring portion further comprises:

a second serpentine ring that is downstream from the serpentine ring and that also undulates alternately upstream and downstream relative to the direction of blood flow as one proceeds annularly around the valve; and

a plurality of links between the serpentine ring and the second serpentine ring.

20. The prosthetic heart valve defined in claim 19 wherein each of the links is serpentine by undulating transverse to the direction of blood flow as one proceeds between the serpentine ring and the second serpentine ring.

21. The prosthetic heart valve defined in claim 1 further comprising:

a plurality of apertures in the stent portion for suture attachment of other material to the stent portion.

22. The prosthetic heart valve defined in claim 1 wherein the stent portion includes only a single post extending to each commissure tip from other structure of the stent portion.

23. The prosthetic heart valve defined in claim 22 wherein each of the posts includes a plurality of apertures for suture attachment of other material to the stent portion.

24. The prosthetic heart valve defined in claim 1 wherein each of the strut structures includes a serpentine portion that undulates transverse to the direction of blood flow as one proceeds between the stent portion and the ring portion.

17. The prosthetic heart valve defined in 12 further comprising:

first sheet material interposed between each of the leaflets and the first ring member; and

second sheet material interposed between each of the leaflets and the second ring member.

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

a stent structure including (1) a plurality of commissure post members that are spaced from one another in a circumferential direction around the valve and that each extend in a direction of blood flow through the valve when it is implanted and in use in a patient, and (2) an inter-commissure structure that extends in the circumferential direction between each circumferentially adjacent pair of the commissure posts and that is collapsible and re-expandable in the circumferential direction;

a web of flexible sheet material secured to the stent structure and extending in the circumferential direction around the stent structure; and

a plurality of flexible leaflets that are initially separate from the stent structure and the sheet material, but that are each secured to the stent structure and the sheet material along an entire periphery of the leaflet except for one edge of each leaflet that remains free for meeting a similarly free edge of another of the leaflets in an interior of the valve.

26. The valve defined in claim 25 wherein the inter-commissure structure comprises:

a plurality of closed-perimeter cells disposed in a circumferentially extending row, each of which cells has an open center.

27. The valve defined in claim 25 wherein each of the leaflets has two side edge portions that are at respective opposite ends of the free edge of that leaflet, and wherein each of the side edge portions is secured to a respective one of the commissure posts by stitching that passes through the side edge portion directly to the commissure post.

28. The valve defined in claim 27 wherein each of the leaflets has a secured edge portion that is opposite the free edge of that leaflet, and wherein the secured edge portion is secured to the sheet material by stitching between the secured edge portion and the sheet material.

29. The valve defined in claim 25 wherein each of the commissure posts has a free end portion that is cantilevered from locations at which the commissure post is attached to the inter-commissure structure, the free end portion extending in the direction of blood flow through the valve in use.

30. The valve defined in claim 29 wherein opposite ends of the free edge of each leaflet are respectively secured to the free end portion of a respective one of the commissure posts.

31. The valve defined in claim 25 wherein a diameter of the valve is collapsible to a size that is in a range from about 20% to about 50% of that diameter when the valve is fully expanded.