Self-actuating sealing portions for paravalvular leak protection

• US 9,398,951 B2
• Filed: 03/12/2013
• Issued: 07/26/2016
• 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
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US13/797,418
• Publication Number:
  US 20140277423A1
• Time in Patent Office: 1,232 Days
• Field of Search: 623/1.24, 623/1.25, 623/1.26, 623/1.36, 623 212- 219, 623/2.38, 623/2.4
• US Class Current: 1/1
• 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 plurality of elongated legs, each of the legs having a first end coupled to the stent and a second free end, the legs being configured to transition from an extended configuration to a relaxed configuration;

a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets and a cuff disposed on a portion of the stent and about the plurality of leaflets; 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;

wherein the sealing portion includes a toroidal sealing ring coupled to the plurality of legs, the toroidal sealing ring being configured to move from a first position spaced away from the proximal end of the stent to a second position at least partially disposed over the valve assembly 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 plurality of legs are arranged in pairs of legs, each pair of legs being coupled to the stent at a common attachment end.

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

13. The prosthetic heart valve of claim 12, 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.

14. The prosthetic heart valve of claim 1, wherein the cuff and the sealing portion are both formed of a fluid-impermeable material.

15. The prosthetic heart valve of claim 1, wherein the plurality of leaflets and the cuff are formed of a same material.

17. The prosthetic heart valve of claim 1, wherein the cuff and the sealing portion are unitary.

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

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

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

a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets and a cuff disposed on a portion of the stent and about the plurality of leaflets; 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,

wherein the sealing portion includes a toroidal sealing ring that is spaced from the stent when the plurality of legs are in the extended configuration.