SELF-ACTUATING SEALING PORTIONS FOR A PARAVALVULAR LEAK PROTECTION

• US 20160030170A1
• Filed: 07/02/2013
• Published: 02/04/2016
• 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
• Granted Patent: US 9,867,697 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 (300) for replacing a native valve includes a collapsible and expandable stent (306) having a proximal end (302) and a distal end (304), and a valve assembly (308) including a plurality of leaflets (310), the valve assembly (308) being disposed within the stent. The heart valve (300) further includes a first plurality of elongated legs (320) coupled to the stent (306) and transitionable from an extended configuration to a relaxed configuration. A first sealing portion (322) connected to the first plurality of legs (320) forms a sealing structure (350) when the legs (320) 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 elongated legs coupled to the stent and transitionable from an extended configuration to a relaxed configuration; and

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

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

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

4. The prosthetic heart valve of claim 3, wherein the first sealing portion curls to form a sealing ring when the first plurality of legs transition from the extended configuration to the relaxed configuration.

5. The prosthetic heart valve of claim 4, wherein the prosthetic valve is configured and arranged to be disposed in an annulus of the native valve in a deployed condition, and the first sealing ring is disposed below leaflets of the native valve in the deployed condition.

6. The prosthetic heart valve of claim 1, wherein the first plurality of legs are coupled to the proximal end of the stent, each of the legs having a free end extending toward the distal end of the stent in the extended configuration.

7. The prosthetic heart valve of claim 1, wherein the first plurality of legs are coupled to the proximal end of the stent, each of the legs having a free end extending away from the distal end of the stent in the extended configuration.

8. 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.

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

10. The prosthetic heart valve of claim 11, wherein the first sealing portion is formed by enlarging the cuff and extending the cuff along the plurality of legs.

11. 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.

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

13. The prosthetic heart valve of claim 1, wherein the first plurality of legs billow radially outwardly in the relaxed configuration.

14. The prosthetic heart valve of claim 13, wherein the stent includes an annulus portion having a deployed diameter and the first sealing portion forms a distended portion having an expanded diameter when the first plurality of legs billow radially outwardly in the relaxed configuration, the expanded diameter being larger than the deployed diameter.

15. The prosthetic heart valve of claim 1, wherein each of the first plurality of legs is coupled to the stent at a corresponding plane of attachment and angled with respect to the corresponding plane of attachment in the relaxed configuration.

16. The prosthetic heart valve of claim 1, wherein each of the first plurality of legs has a corresponding longitudinal axis and is twisted with respect to the corresponding longitudinal axis in the relaxed configuration.

17. The prosthetic heart valve of claim 1, further comprising:

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

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

18. The prosthetic heart valve of claim 17, wherein the first sealing portion curls to form a first sealing ring when the first set of elongated legs transition from the extended configuration to the relaxed configuration, and the second sealing portion curls to form a second sealing ring when the second set of elongated legs transition from the extended configuration to the relaxed configuration.

19. The prosthetic heart valve of claim 17, wherein the prosthetic valve is configured and arranged to be disposed in an annulus of the native valve in a deployed condition, and the first sealing ring is disposed in a first position in the deployed condition, the first portion being selected from i) below leaflets of the native valve, ii) within leaflets of the native valve and iii) above leaflets of the native valve, and the second sealing ring is disposed in a second position in the deployed condition, the second position being selected from i) below leaflets of the native valve, ii) within leaflets of the native valve and iii) above leaflets of the native valve, the second position being different from the first position.

20. A method for implanting a prosthetic heart valve in a native valve annulus, the method comprising:

loading the heart valve in a delivery system, the heart valve including;

(a) a collapsible and expandable stent having a proximal end and a distal end, (b) a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets, (c) a plurality of elongated legs transitionable from an extended configuration to a relaxed configuration, and (d) a sealing portion connected to the plurality of legs, the heart valve being loaded in the delivery system with the plurality of legs in the extended configuration;

delivering the heart valve to the native valve annulus; and

deploying the heart valve within the native valve annulus, whereupon the plurality of elongated legs transition from the extended configuration to the relaxed configuration and the sealing portion forms a sealing structure.

21. The method of claim 20, wherein the plurality of legs are disposed substantially parallel to one another in the extended configuration.

22. The method of claim 20, wherein the plurality of legs curl toward the distal end of the stent in the relaxed configuration.

23. The method of claim 20, wherein the plurality of legs axially collapse to form an undulating shape in the relaxed configuration.

24. 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 plurality of elongated legs coupled to the stent and transitionable from an extended configuration to a relaxed configuration; and

a sealing element connected to the plurality of legs, the sealing element being spaced away from the valve assembly in the extended configuration of the elongated legs and being disposed radially outward of the valve assembly in the relaxed configuration of the elongated legs.

25. The prosthetic heart valve of claim 24, wherein the sealing element is toroid-shaped.

26. The prosthetic heart valve of claim 24, wherein the prosthetic valve is configured and arranged to be disposed in an annulus of the native valve in a deployed condition, and the sealing element is disposed within leaflets of the native valve in the deployed condition.

27. The prosthetic heart valve of claim 24, wherein the prosthetic valve is configured and arranged to be disposed in an annulus of the native valve in a deployed condition, and the sealing element is disposed above leaflets of the native valve in the deployed condition.

28. The prosthetic heart valve of claim 24, wherein the sealing element comprises a sealing cluster coupled to each of the plurality of elongated legs.

29. The prosthetic heart valve of claim 28, wherein the sealing cluster is spherical.

30. The prosthetic heart valve of claim 28, wherein the sealing cluster on each of the plurality of elongated legs is movable independently from the sealing clusters on the others of the plurality of elongated legs.