Self-actuating sealing portions for paravalvular leak protection

• US 10,548,725 B2
• Filed: 12/08/2017
• Issued: 02/04/2020
• Est. Priority Date: 03/12/2013
• 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: Alkhatib, Yousef F., Eidenschink, Tracee, Khouengboua, Sounthara
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US15/835,964
• Publication Number:
  US 20180104053A1
• Time in Patent Office: 788 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly including a plurality of leaflets, the valve assembly being disposed within the stent. The heart valve further includes a first plurality of elongated legs coupled to the stent and transitionable from an extended configuration to a relaxed configuration. A first sealing portion connected to the first plurality of legs forms a sealing structure when the legs transition to the relaxed configuration to reduce perivalvular leakage between the implanted valve and surrounding tissue.

Claims

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

a collapsible and expandable stent having a proximal end and a distal end;

a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets;

a first plurality of legs coupled to the stent and transitionable from an extended configuration to a relaxed configuration, each of the first plurality of legs having a free end extending toward the distal end of the stent in the extended configuration and each free end positioned proximal to the distal end of the stent in the extended configuration;

a second plurality of legs coupled to the proximal end of the stent and transitionable from an extended configuration to a relaxed configuration;

a first sealing portion connected to the first plurality of legs and forming a sealing structure upon the transition of the first plurality of legs from the extended configuration to the relaxed configuration; and

a second sealing portion connected to the second plurality of legs and forming a sealing structure upon the transition of the second plurality of legs from the extended configuration to the relaxed configuration.

2. The prosthetic heart valve of claim 1, wherein the first sealing portion is configured to curl to form a first sealing ring when the first plurality of legs transition from the extended configuration to the relaxed configuration, and the second sealing portion is configured to curl to form a second sealing ring when the second plurality of legs transition from the extended configuration to the relaxed configuration.

3. The prosthetic heart valve of claim 2, wherein the first sealing ring is configured and arranged to be disposed in a first position selected from i) below native leaflets of the native valve, ii) within native leaflets of the native valve and iii) above native leaflets of the native valve, and the second sealing ring is configured and arranged to be disposed in a second position selected from i) below native leaflets of the native valve, ii) within native leaflets of the native valve and iii) above native leaflets of the native valve, the second position being different from the first position.

4. The prosthetic heart valve of claim 1, wherein each of the first plurality of legs is substantially linear in the extended configuration.

5. The prosthetic heart valve of claim 4, wherein each of the second plurality of legs is substantially linear in the extended configuration.

6. The prosthetic heart valve of claim 1, wherein each of the first plurality of legs is curled in the relaxed configuration.

7. The prosthetic heart valve of claim 6, wherein each of the second plurality of legs is curled in the relaxed configuration.

8. The prosthetic heart valve of claim 1, wherein the first plurality of legs are formed integrally with the stent.

9. The prosthetic heart valve of claim 1, wherein each of the second plurality of legs has a free end extending away from the distal end of the stent in the extended configuration.

10. The prosthetic heart valve of claim 9, wherein the free ends of the second plurality of legs terminate proximally of the proximal end of the stent in the extended configuration.

11. The prosthetic heart valve of claim 1, wherein the first sealing portion includes at least one of a metallic mesh, a shape-memory material, a polymeric material or a tissue material.

12. The prosthetic heart valve of claim 11, wherein the second sealing portion includes at least one of a metallic mesh, a shape-memory material, a polymeric material or a tissue material.

13. The prosthetic heart valve of claim 1, wherein the valve assembly further includes a cuff coupled to the stent, the second sealing portion and the cuff being made of the same material.

14. The prosthetic heart valve of claim 1, wherein each of the first plurality of legs includes an eyelet for attaching the first sealing portion to the leg.

15. The prosthetic heart valve of claim 14, wherein each of the second plurality of legs includes an eyelet for attaching the second sealing portion to the leg.

16. The prosthetic heart valve of claim 1, wherein the second plurality of legs are arranged in pairs of legs, each pair of legs being coupled to the stent at a common attachment end.

17. The prosthetic heart valve of claim 1, wherein each of the first plurality of legs is curled away from the distal end of the stent in the relaxed configuration.

18. The prosthetic heart valve of claim 17, wherein each of the second plurality of legs is curled toward the distal end of the stent in the relaxed configuration.