Prosthetic heart valve with paravalvular leak mitigation features

• US 10,548,722 B2
• Filed: 08/25/2017
• Issued: 02/04/2020
• Est. Priority Date: 08/26/2016
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Morin, Kristen T., Erzberger, Gary, Hillukka, Brett A., Vietmeier, Kristopher H.
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US15/686,310
• Publication Number:
  US 20180055631A1
• Time in Patent Office: 893 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2210/0061 swellable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.

Claims

1. A prosthetic heart valve for replacing a native valve, comprising:

a stent having an inflow end, an outflow end, a plurality of cells formed by cell struts, a collapsed condition and an expanded condition;

a valve assembly disposed within the stent;

a first cuff annularly disposed adjacent the stent;

a second cuff having a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent radially outward of the first cuff and radially outward of the stent; and

a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end remote from the first end, the free end extending into a space formed by the corresponding cell, the distal edge of the second cuff being coupled to the free ends of the fingers at spaced locations around a circumference of the stent, the free ends of the fingers being spaced radially outward of the corresponding cell in the expanded condition of the stent to position the distal edge of the second cuff radially outward of the corresponding cells of the stent at the spaced locations.

2. The prosthetic heart valve of claim 1, wherein the cell struts have a strut thickness in a radial direction of the stent, and the fingers have a thickness in the radial direction of the stent that is less than the strut thickness.

3. The prosthetic heart valve of claim 1, wherein the free ends of the fingers are blunted.

4. The prosthetic heart valve of claim 1, wherein the free ends of the fingers include an eyelet.

5. The prosthetic heart valve of claim 1, wherein the free ends of the fingers include a cruciform structure.

6. The prosthetic heart valve of claim 1, wherein each of the fingers is formed of a single strut.

7. The prosthetic heart valve of claim 1, wherein each of the fingers includes first and second struts each having a first end coupled to one of the plurality of cell struts and a second end, the second ends being coupled to one another.

8. The prosthetic heart valve of claim 7, wherein the first and second struts of each finger collectively form a “

V”

shape.

9. The prosthetic heart valve of claim 8, wherein the distal edge of the second cuff is coupled to an apex of the “

V”

shape.

10. The prosthetic heart valve of claim 8, wherein each of the fingers further includes a third strut extending from an apex of the “

V”

shape, the distal edge of the second cuff being coupled to the third strut.

11. The prosthetic heart valve of claim 1, wherein each of the cell struts extends in an elongation direction, a first cell strut in each of the corresponding cells having a first width in a direction orthogonal to the elongation direction in first and second end portions of the first cell strut and a second width in the direction orthogonal to the elongation direction in a portion of the first cell strut intermediate the first and second end portions, the second width being less than the first width.

12. The prosthetic heart valve of claim 11, wherein each of the cell struts forming the corresponding cells has the first width in the direction orthogonal to the elongation direction in first and second end portions of the cell strut and the second width in the direction orthogonal to the elongation direction in a portion of the cell strut intermediate the first and second end portions.

13. The prosthetic heart valve of claim 11, wherein the stent includes a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts in the annulus section having the first width in the direction orthogonal to the elongation direction in first and second end portions of the cell strut and the second width in the direction orthogonal to the elongation direction in a portion of the cell strut intermediate the first and second end portions.

14. The prosthetic heart valve of claim 1, wherein the stent includes a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts extending in an elongation direction, each of the cell struts in the annulus section having a first width in a direction orthogonal to the elongation direction of the cell strut, and each of the cell struts in the aortic section having a second width in the direction orthogonal to the elongation direction of the cell strut, the second width being less than the first width.

15. The prosthetic heart valve of claim 1, wherein each of the fingers in the expanded condition of the stent curves toward the corresponding cell of the stent.

16. The prosthetic heart valve of claim 1, wherein the plurality of cells includes a first annular row of cells extending around a circumference of the stent adjacent the inflow end, each of the corresponding cells being in the first annular row of cells.

17. The prosthetic heart valve of claim 1, wherein the plurality of cells includes a first annular row of cells extending around a circumference of the stent adjacent the inflow end and a second annular row of cells extending around the circumference of the stent adjacent the first annular row of cells, each of the corresponding cells being in the second annular row of cells.

18. The prosthetic heart valve of claim 1, wherein the stent includes a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts in the aortic section extending in an elongation direction, selected ones of the cell struts in the aortic section having a first width in a direction orthogonal to the elongation direction in first and second end portions of the selected cell strut and a second width in the direction orthogonal to the elongation direction in a portion of the selected cell strut intermediate the first and second end portions, the second width being less than the first width.

19. The prosthetic heart valve of claim 18, wherein the plurality of cells are arranged in annular rows of cells extending around a circumference of the stent, each of the selected ones of the cell struts being positioned in a single one of the annular rows.

20. The prosthetic heart valve of claim 1, wherein the stent includes a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts in the annulus section extending in an elongation direction, a first group of the cell struts in the annulus section being connected to one of the commissure attachment features at an attachment point, each of the cell struts in the first group having a first width in a direction orthogonal to the elongation direction at a spaced distance from the attachment point and a second width in the direction orthogonal to the elongation direction at the attachment point, the second width being greater than the first width.

21. The prosthetic heart valve of claim 1, wherein the stent includes a plurality of commissure attachment features, an annulus section between the inflow end and the plurality of commissure attachment features, and an aortic section adjacent the outflow end, each of the cell struts in the aortic section extending in an elongation direction, a first group of the cell struts in the aortic section being connected to one of the commissure attachment features at an attachment point, each of the cell struts in the first group having a first width in a direction orthogonal to the elongation direction at a spaced distance from the attachment point and a second width in the direction orthogonal to the elongation direction at the attachment point, the second width being greater than the first width.