Prosthetic heart valves

• US 9,572,660 B2
• Filed: 06/04/2008
• Issued: 02/21/2017
• Est. Priority Date: 06/04/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Alkhatib, Yousef F.
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US12/451,678
• Publication Number:
  US 20100168839A1
• Time in Patent Office: 3,184 Days
• Field of Search: 623/2.1, 623/2.12
• US Class Current: 1/1
• 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, and (2) a ring that is substantially concentric with the stent and located downstream from the stent in the direction of blood flow when the valve is in use in a patient, the stent having a blood-outflow region that includes a plurality of annularly spaced commissure tips at which the stent is closest to the ring, the ring being connected to the stent substantially solely by flexible strut structures that extend from the stent to the ring adjacent to the commissure tips, each of the flexible strut structures starting from a respective point or points on the stent that are farther from the ring than the commissure tips; and

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

wherein the ring has a first resistance to annular compression, and the stent has a second resistance to annular compression, the first resistance being greater than the second resistance.

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

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

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 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.

10. The prosthetic heart valve defined in claim 9 wherein the strut structures are connected to the stent only via the first ring member and only at connection points that are upstream from the commissure tips.

11. The prosthetic heart valve defined in claim 9 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.

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

sheet material covering at least part of the stent.

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

sheet material covering at least part of the ring.

14. The prosthetic heart valve defined in claim 9 further comprising:

sheet material covering the first ring member.

15. The prosthetic heart valve defined in claim 11 further comprising:

sheet material covering the second ring member.

16. The prosthetic heart valve defined in claim 11 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.

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

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

18. The prosthetic heart valve defined in claim 17 wherein the ring 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.

19. The prosthetic heart valve defined in claim 18 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.

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

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

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

22. The prosthetic heart valve defined in claim 21 wherein each of the posts includes a plurality of apertures for suture attachment of other material to the stent.

23. 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 and the ring.

4. A prosthetic heart valve comprising:

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

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

wherein the ring has an expanded ring circumference, and the stent has a plurality of expanded stent circumferences ranging from a minimum stent circumference to a maximum stent circumference, the ring circumference being greater than the minimum stent circumference.

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

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

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