BOWED RUNNERS AND CORRESPONDING VALVE ASSEMBLIES FOR PARAVALVULAR LEAK PROTECTION

• US 20160361160A1
• Filed: 02/12/2015
• Published: 12/15/2016
• Est. Priority Date: 02/18/2014
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Braido, Peter N., Smith, Kent J., McCarthy, Andrea L.
• Granted Patent: US 9,949,825 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve for replacing a native valve includes a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition. At least one runner is coupled a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.

Claims

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

a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition;

at least one runner coupled to a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration; and

a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.

2. The prosthetic heart valve of claim 1, wherein the at least one runner is substantially linear in the first configuration.

3. The prosthetic heart valve of claim 1, wherein the at least one runner is bowed or curved in the second configuration.

4. The prosthetic heart valve of claim 1, wherein the cuff includes at least one flap configured to fold from the luminal surface to the abluminal surface of the stent to form the covering material.

5. The prosthetic heart valve of claim 4, wherein the flap folds over a selected strut from the distal end toward the proximal end of the stent.

6. The prosthetic heart valve of claim 4, wherein the flap folds over a selected strut from the proximal end toward the distal end of the stent.

7. The prosthetic heart valve of claim 4, wherein the flap folds diagonally over a selected strut.

8. The prosthetic heart valve of claim 1, wherein the at least one runner comprises multiple runners and wherein the covering material includes a plurality of individual panels, each of the plurality of individual panels being disposed over one of the multiple runners.

9. The prosthetic heart valve of claim 1, wherein the covering material includes at least one diamond-shaped panel disposed over at least one cell, the covering material further including at least one flap integrally formed with the cuff and configured to fold from he luminal surface to the abluminal surface of the stent.

10. The prosthetic heart valve of claim 1, wherein the stent further includes commissure features, and wherein the at least one runner is coupled to selected cells in a first row of cells proximal of the commissure features.

11. The prosthetic heart valve of claim 1, wherein the stent further includes commissure features, and wherein the at least one runner is coupled to selected cells in a second row of cells proximal of the commissure features.

12. The prosthetic heart valve of claim 1, further comprising a plurality of runners coupled to proximal-most struts of the stent and extending proximally of the proximal end of the stent.

13. The prosthetic heart valve of claim 12, wherein each of the plurality of runners extends from a first end joined to a strut to a free end.

14. The prosthetic heart valve of claim 13, wherein each free end has a horseshoe shape, the covering material being sutured to the horseshoe shape.

15. The prosthetic heart valve of claim 1, wherein the covering material includes a sheet of material circumferentially disposed on the abluminal surface of the stent so as to extend over a row of cells.

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

a stent extending between a proximal end and a distal end and including a plurality of struts forming cells and a plurality of runners, the stent having a collapsed condition and an expanded condition, the struts defining a first diameter and the runners defining a second diameter, the second diameter being greater than the first diameter; and

a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets and a cuff at least partially disposed on a luminal surface of the stent and partially disposed on an abluminal surface of the stent to cover the runners.

17. The prosthetic heart valve of claim 16, wherein the stent includes a plurality of commissure features and the cuff includes an upper portion and a lower portion, the upper portion being disposed on the luminal surface of the stent and coupled to the commissure features and the lower portion being disposed on the abluminal surface of the stent so as to cover the plurality of runners.

18. The prosthetic heart valve of claim 17, wherein the lower portion is divided into individual segments capable of passing through the cells from the luminal surface to the abluminal surface.

19. The prosthetic heart valve of claim 18, wherein the cuff transitions from the luminal surface to the abluminal surface distal to the plurality of runners.

20. The prosthetic heart valve of claim 18, wherein each of the individual segments is coupled to an adjacent segment and a runner.