Stented prosthetic heart valve having a paravalvular sealing wrap

• US 10,729,542 B2
• Filed: 10/25/2017
• Issued: 08/04/2020
• Est. Priority Date: 10/26/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Howard, Elliot, Hallak, Amy, Menk, Ana, Weston, Matthew, Racchini, Joel
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/792,991
• Publication Number:
  US 20180110617A1
• Time in Patent Office: 1,014 Days
• 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 2/243 Deployment by mechanical expansion
• 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 2250/0069 Sealing means

Abstract

Stented prosthetic heart valves including a stent frame having a plurality of stent frame support structures collectively defining an interior surface, an exterior surface and a plurality of cells. The stented prosthetic heart valve further including a valve structure including valve leaflets disposed within and secured to the stent frame and defining a margin of attachment. The stented prosthetic heart valve including one or both of an outer paravalvular leakage prevention wrap and an inner skirt for supporting the valve leaflets. In various embodiments, the outer wrap is positioned entirely on one side of the margin of attachment. In embodiments including an inner skirt, the outer wrap and the inner skirt are on opposite sides of the margin of attachment such that the inner skirt and the outer wrap do not overlap. In other embodiments, the outer wrap includes a plurality of zones having varying thickness.

Claims

1. A stented prosthetic heart valve comprising:

a tubular stent frame having a plurality of stent frame support structures collectively defining a plurality of cells, an interior surface and an exterior surface of the stent frame;

a valve structure including valve leaflets disposed within and secured to the stent frame, the valve leaflets defining a margin of attachment;

wherein the margin of attachment defines a boundary between an inflow side and an outflow side of the margin of attachment;

wherein the valve structure includes first, second and third commissure posts positioned between and supporting adjacent valve leaflets; and

an outer wrap generally encircling the exterior surface of the stent frame;

wherein the outer wrap is positioned entirely on the inflow side of the margin of attachment;

wherein the outer wrap has a U-shaped boundary that is aligned with the margin of attachment, the U-shaped boundary spanning from the first commissure post to the second commissure post.

2. The stented prosthetic heart valve of claim 1, further comprising an inner skirt supporting the valve leaflets on the interior surface of the stent frame.

3. The stented prosthetic heart valve of claim 2, wherein the inner skirt spans less than an area of one respective cell.

4. The stented prosthetic heart valve of claim 2, wherein the inner skirt and the outer wrap collectively span an area of one respective cell.

5. The stented prosthetic heart valve of claim 2, wherein the inner skirt is positioned entirely on the outflow side of the margin of attachment.

6. The stented prosthetic heart valve of claim 1, wherein the outer wrap includes at least two zones of varying thickness.

7. A stented prosthetic heart valve comprising:

a tubular stent frame having a plurality of stent frame support structures collectively defining a plurality of cells, an interior surface and an exterior surface of the stent frame;

valve leaflets disposed within and secured to the stent frame and defining a margin of attachment;

wherein the valve structure includes a plurality of commissure posts; and

an outer wrap generally encircling the exterior surface of the stent frame;

wherein the outer wrap has a U-shaped boundary that is aligned with the margin of attachment, the U-shaped boundary spanning from one of the plurality of commissure posts to one adjacent commissure post.

8. The stented prosthetic heart valve of claim 7, further comprising an inner skirt supporting the valve leaflets on the interior surface of the stent frame.

9. The stented prosthetic heart valve of claim 8, wherein the inner skirt spans less than an area of one respective cell.

10. The stented prosthetic heart valve of claim 8, wherein the inner skirt and the outer wrap collectively span an area of one respective cell.

11. The stented prosthetic heart valve of claim 8, wherein the margin of attachment defines a boundary between an inflow side and an outflow side of the margin of attachment;

wherein the inner skirt is positioned entirely on the outflow side of the margin of attachment.

12. The stented prosthetic heart valve of claim 11, wherein the inner skirt is aligned with the margin of attachment.

13. The stented prosthetic heart valve of claim 8, wherein the outer wrap has at least two zones of varying thickness.

14. The stented prosthetic heart valve of claim 7, wherein the outer wrap includes at least two zones of varying thickness.

15. A stented prosthetic heart valve comprising:

a tubular stent frame having a plurality of stent frame support structures collectively defining a plurality of cells, an interior surface and an exterior surface of the stent frame;

a valve structure including valve leaflets disposed within and secured to the stent frame and defining a margin of attachment;

an outer wrap generally encircling the exterior surface of the stent frame, the outer wrap having at least two zones of varying thickness; and

an inner skirt supporting the valve leaflets on the inside surface of the stent frame;

wherein the outer wrap and the inner skirt are positioned to not overlap along a length of the stent frame.

16. The stented prosthetic heart valve of claim 15, wherein the margin of attachment defines a boundary between an inflow side and an outflow side of the margin of attachment;

wherein the outer wrap has a boundary that is aligned with the margin of attachment.

17. The stented prosthetic heart valve of claim 15, wherein the inner skirt spans less than an area of one respective cell.

18. The stented prosthetic heart valve of claim 15, wherein the inner skirt and the outer wrap collectively span an area of one respective cell.

19. The stented prosthetic heart valve of claim 15, wherein one zone of varying thickness is a sinusoidal band extending around the outer wrap.

20. The stented prosthetic heart valve of claim 15, wherein the valve structure includes first, second and third commissure posts positioned between and supporting adjacent valve leaflets;

wherein the outer wrap has a U-shaped boundary that is aligned with the margin of attachment, the U-shaped boundary spanning from the first commissure post to the second commissure post.