COLLAPSIBLE AND RE-EXPANDABLE PROSTHETIC HEART VALVE CUFF DESIGNS AND COMPLEMENTARY TECHNOLOGICAL APPLICATIONS

• US 20140350667A1
• Filed: 08/06/2014
• Published: 11/27/2014
• Est. Priority Date: 07/15/2008
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Ashworth, Paul Edward, Schraut, Julia Ann
• Granted Patent: US 9,220,594 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Claims

1. (canceled)

2. A prosthetic heart valve, comprising:

(a) a stent that is collapsible for mounting on a delivery device;

(b) a valve element mounted within the stent; and

(c) a cuff around the periphery of the stent, the cuff including at least one pocket sized, shaped and positioned on the stent for engagement within the native valve annulus to impede perivalvular leakage.

3. The prosthetic heart valve according to claim 2, wherein the stent includes a downstream collapsible and expandable ring portion and an upstream collapsible and expandable ring portion that is annularly expandable within the native valve annulus.

4. The prosthetic heart valve according to claim 3, wherein the cuff is disposed around the upstream ring portion.

5. The prosthetic heart valve according to claim 3, wherein the upstream ring portion includes a flared region.

6. The prosthetic heart valve according to claim 2, wherein the at least one pocket has an outer surface that is biased outwardly into engagement with the native valve annulus by retrograde blood flow.

7. The prosthetic heart valve according to claim 2, wherein the at least one pocket has an outer surface that is biased outwardly into engagement with the native valve annulus by antegrade blood flow.

8. The prosthetic heart valve according to claim 2, wherein the cuff includes a plurality of pockets.

9. The prosthetic heart valve according to claim 2, wherein the stent is self-expanding.

10. The prosthetic heart valve according to claim 2, wherein the stent is balloon expandable.

11. An assembly for delivering a prosthetic heart valve to a target site in a patient, comprising:

(a) a delivery device having a retractable sheath; and

(b) a prosthetic heart valve mounted on the delivery device and covered by the sheath, the prosthetic heart valve including a collapsible and expandable stent, a valve element mounted within the stent, and a cuff around the periphery of the stent, the cuff including at least one pocket sized, shaped and positioned on the stent for engagement within the native annulus to impede perivalvular leakage.

12. The assembly according to claim 11, wherein the at least one pocket has an open side adapted to face in a direction of antegrade blood flow, the pocket being sized and shaped to impede perivalvular leakage around the outside of the stent.

13. The assembly according to claim 11, wherein the at least one pocket has an open side adapted to face in a direction of retrograde blood flow, the pocket being sized and shaped to impede perivalvular leakage around the outside of the stent.

14. The assembly according to claim 11, wherein the delivery device includes an expandable member for moving the stent from a collapsed condition to an expanded condition.

15. The assembly according to claim 14, wherein the expandable member is a balloon.

16. A prosthetic heart valve, comprising:

(a) a stent that is collapsible for mounting on a delivery device having a sheath for covering the stent;

(b) a valve element mounted within the stent; and

(c) a cuff around the periphery of the stent, the cuff including at least one pocket having an outer surface, the pocket being sized and shaped to fill with blood by blood flow around the stent to bias the outer surface outwardly into engagement within the valve annulus.

17. The prosthetic heart valve according to claim 16, wherein the stent includes a downstream collapsible and expandable ring portion and an upstream collapsible and expandable ring portion that is annularly expandable within the native valve annulus.

18. The prosthetic heart valve according to claim 17, wherein the cuff is disposed around the upstream ring portion.

19. The prosthetic heart valve according to claim 17, wherein the upstream ring portion includes a flared region.

20. The prosthetic heart valve according to claim 16, wherein the at least one pocket has an open side adapted to face in a direction of antegrade blood flow, the pocket being sized and shaped to impede perivalvular leakage around the outside of the stent.

21. The prosthetic heart valve according to claim 16, wherein the at least one pocket has an open side adapted to face in a direction of retrograde blood flow, the pocket being sized and shaped to impede perivalvular leakage around the outside of the stent.

22. The prosthetic heart valve according to claims 16, wherein the stent is self-expanding.

23. The prosthetic heart valve according to claim 16, wherein the stent is balloon expandable.

24. An assembly for delivering a prosthetic heart valve to a target site in a patient, comprising:

(a) a delivery device; and

(b) a prosthetic heart valve mounted on the delivery device, the prosthetic heart valve including a stent, a valve element mounted within the stent, and a cuff around the periphery of the stent, the cuff including at least one pocket having an outer surface, the pocket being sized and shaped to fill with blood by blood flow around the stent to bias the outer surface outwardly into engagement within the valve annulus.

25. The assembly according to claim 24, wherein the pocket has an open side adapted to face in a direction of antegrade blood flow, the pocket being sized and shaped to impede perivalvular leakage around the outside of the stent.

26. The assembly according to claim 24, wherein the pocket has an open side adapted to face in a direction of retrograde blood flow, the pocket being sized and shaped to impede perivalvular leakage around the outside of the stent.

27. The assembly according to claim 24, wherein the delivery device includes an expandable member for moving the stent from a collapsed condition to an expanded condition.

28. The assembly according to claim 27, wherein the expandable member is a balloon.

29. The assembly according to claim 24, wherein the delivery device includes a retractable sheath, and the prosthetic heart valve is covered by the sheath.