SEALING STRUCTURES FOR PARAVALVULAR LEAK PROTECTION

• US 20150142104A1
• Filed: 11/19/2014
• Published: 05/21/2015
• Est. Priority Date: 11/19/2013
• 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: Braido, Peter N.
• Granted Patent: US 9,889,004 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• 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 disposed within the stent, the valve assembly including a plurality of leaflets and a cuff annularly disposed about the stent. The cuff includes a surplus portion capable of forming a sealing structure having a diameter greater than a diameter of the proximal end of the stent when deployed.

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; and

a cuff annularly disposed about the stent and having a surplus portion capable of forming a sealing structure at the proximal end of the stent, the sealing structure having a deployed condition with a diameter in the deployed condition greater than a diameter of the proximal end of the stent.

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

3. The prosthetic heart valve of claim 1, wherein the sealing structure comprises a toroid formed by rolling the surplus portion upon itself.

4. The prosthetic heart valve of claim 3, wherein the stent includes horseshoe-shaped ends and the toroid is coupled to at least some of the horseshoe-shaped ends via a plurality of locking sutures.

5. The prosthetic heart valve of claim 4, wherein the plurality of locking sutures includes three locking sutures.

6. The prosthetic heart valve of claim 3, wherein the stent includes an annulus section and the toroid is disposed proximal to the annulus section of the stent.

7. The prosthetic heart valve of claim 3, wherein the stent includes an annulus section and the toroid is disposed about the annulus section of the stent.

8. The prosthetic heart valve of claim 1, wherein the sealing structure comprises an undulating sealing ring having a plurality of alternating peaks and valleys.

9. The prosthetic heart valve of claim 8, wherein the stent includes a plurality of struts and the surplus portion is coupled to selected ones of the struts via terminal sutures to enable circumferential buckling of the surplus portion into the undulating sealing ring.

10. The prosthetic heart valve of claim 1, wherein the sealing structure comprises a flat sealing halo.

11. The prosthetic heart valve of claim 1, wherein the sealing structure comprises a body having a plurality of independently moveable limbs.

12. The prosthetic heart valve of claim 1, wherein the diameter of the sealing structure in the deployed condition has a diameter greater than the diameter of the proximal end of the stent by between about 2.0 mm and about 10.0 mm.

14. The prosthetic heart valve of claim 1, wherein the free end is configured to roll upon itself to create a toroid.

15. The prosthetic heart valve of claim 1, wherein the free end is configured to flare out radially to form a flattened halo adjacent the proximal end of the stent.

16. The prosthetic heart valve of claim 1, wherein the free end comprises a body having a plurality of independently moveable limbs.

13. 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; and

a cuff annularly disposed about the stent and having an attached end coupled to the stent and a free end extending past the proximal end of the strut and capable of forming a sealing structure for sealing gaps between the prosthetic heart valve and a native valve annulus.

17. A method of making a prosthetic heart valve for replacing a native valve, comprising:

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

coupling a valve assembly to the stent, the valve assembly including a plurality of leaflets;

coupling a cuff to the stent so that a surplus portion of the cuff extends beyond the proximal end of the strut; and

converting the surplus portion of the cuff into a sealing structure at the proximal end of the stent, the sealing structure having a diameter greater than a diameter of the proximal end of the stent.

18. The method of claim 17, wherein the converting step includes rolling the surplus portion of the cuff into a toroid shape.

19. The method of claim 18, further comprising securing the surplus portion to the stent via at least one suture to maintain the toroid shape.