PARAVALVULAR LEAK PROTECTION

• US 20140277424A1
• 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)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Oslund, John
• Granted Patent: US 9,636,222 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a collapsible and expandable stent having a proximal end and a distal end, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to at least one of the stent and a cuff. The heart valve further includes a conformable band disposed about the perimeter of the stent near the proximal end for filling gaps between the collapsible prosthetic heart valve and a native valve annulus.

Claims

1. A prosthetic heart valve, comprising:

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

a cuff coupled to the stent;

a valve assembly including a plurality of leaflets coupled to at least one of the stent or the cuff; and

a conformable band having an inner surface disposed near the perimeter of the stent adjacent the plurality of leaflets and an outer surface adapted for contacting body tissue, the conformable band being configured to seal the valve assembly against leakage by filling gaps between the prosthetic heart valve and the body tissue.

2. The device of claim 1, wherein the conformable band comprises at least one of a metallic mesh, a braided nitinol mesh or a shape-memory material.

3. The device of claim 1, wherein the conformable band is constructed in the shape of a toroid.

4. The device of claim 1, wherein the conformable band further comprises polyester.

5. The device of claim 1, wherein the conformable band further comprises a polyester fabric intertwined with the metal mesh to increase density of the conformable band.

6. The device of claim 1, wherein the stent includes a plurality of struts and the conformable band is coupled to at least one of the plurality of the struts of the stent.

7. The device of claim 1, wherein the conformable band is coupled to an inner surface of the stent.

8. The device of claim 1, wherein the cuff has a lumenal surface and an ablumenal surface and the conformable band is coupled to the ablumenal surface of the cuff.

9. The device of claim 1, wherein the conformable band has a non-circular cross-section.

10. The device of claim 1, wherein the conformable band has varying heights along the perimeter.

13. The device of claim 1, wherein the conformable band is continuously formed about the perimeter of the stent.

14. The device of claim 1, wherein the conformable band comprises at least two rings formed about the stent.

15. The device of claim 1, wherein the conformable band is loaded with a hydrophobic filler.

11. The device of claim 11, wherein the conformable band comprises a biological agent for promoting tissue growth.

12. The device of claim 11, wherein the conformable band includes a plurality of beads joined together to form a chain.

16. A method of sealing a prosthetic heart valve in a patient, comprising:

positioning the prosthetic heart valve within body tissue, the prosthetic heart valve comprising (i) a collapsible and expandable stent, (ii) a valve assembly including a plurality of leaflets coupled to the stent and (iii) a conformable band having an inner surface disposed about the plurality of leaflets and an outer surface adapted for contacting body tissue;

expanding the stent until the conformable band is in sealing contact with the body tissue.

17. A prosthetic heart valve, comprising:

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

a valve assembly including a plurality of leaflets coupled to the stent; and

a conformable band disposed about the stent between the proximal and distal ends thereof, the band adapted for creating a fluid seal about the circumference of the stent with an adjacent body tissue.

18. The prosthetic heart valve of claim 17, wherein the conformable band is attached about an outer surface of the stent.

19. The prosthetic heart valve of claim 17, wherein the conformable band is attached about an inner surface of the stent.

20. The prosthetic heart valve of claim 17, wherein the conformable band is disposed adjacent the plurality of leaflets.

21. The device of claim 17, wherein the conformable band comprises at least two rings formed about the stent.

22. The device of claim 17, wherein the conformable band includes a plurality of beads joined together to form a chain.