SELF-ACTUATING SEALING PORTIONS FOR PARAVALVULAR LEAK PROTECTION

• US 20140277423A1
• Filed: 03/12/2013
• Published: 09/18/2014
• 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
• Granted Patent: US 9,398,951 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/007 O-rings

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 plurality of elongated legs each with a first end coupled to the stent and a free end, the elongated legs being configured to transition from an extended configuration to a relaxed configuration. A sealing portion connected to the 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 plurality of elongated legs, each of the legs having a first end coupled to the stent and a second free end, the elongated legs being configured to transition from an extended configuration to a relaxed configuration; and

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

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

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

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

5. The prosthetic heart valve of claim 4, wherein the sealing ring is configured and arranged to be disposed below native leaflets of the native valve.

6. The prosthetic heart valve of claim 4, wherein the sealing ring is configured and arranged to be disposed within native leaflets of the native valve.

7. The prosthetic heart valve of claim 4, wherein the sealing ring is configured and arranged to be disposed above native leaflets of the native valve.

8. The prosthetic heart valve of claim 1, wherein the plurality of legs are coupled to the proximal end of the stent and the free ends of the legs extend toward the distal end of the stent in the extended configuration.

9. The prosthetic heart valve of claim 1, wherein the plurality of legs are coupled to the proximal end of the stent and the free ends of the legs extend away from the distal end of the stent in the extended configuration.

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

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

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

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

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

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

16. The prosthetic heart valve of claim 15, wherein the stent includes an annulus portion having a deployed diameter and the sealing portion forms a distended portion having an expanded diameter when the plurality of legs billow radially outwardly in the relaxed configuration, the expanded diameter being larger than the deployed diameter.

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

a second set 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 set of elongated legs and forming a sealing structure upon the transition of the first set of elongated legs from the extended configuration to the relaxed configuration; and

a second sealing portion connected to the second set of elongated legs and forming a sealing structure upon the transition of the second set 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 18, 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.

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 configured to transition 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 delivery system includes a core and a sheath disposed about the core, the heart valve being disposed about the core and within the sheath.

22. The method of claim 21, wherein the deploying step includes retracting the sheath to expose the heart valve.

23. The method of claim 21, wherein the plurality of legs are disposed substantially parallel to the sheath when loaded in the delivery system.

24. The method of claim 21, wherein the plurality of legs curl toward the distal end of the stent when exposed from the sheath.

25. The method of claim 21, wherein the plurality of legs axially collapse to form an undulating shape when exposed from the sheath.