Replacement heart valve apparatus and methods

• US 10,226,330 B2
• Filed: 08/14/2014
• Issued: 03/12/2019
• Est. Priority Date: 08/14/2013
• Status: Active Grant

• Current Assignee: Mitral Valve Technologies Sarl (Edwards Lifesciences Corporation)
• Original Assignee: Mitral Valve Technologies Sarl (Edwards Lifesciences Corporation)
• Inventors: Spence, Paul A., Tompkins, Landon H., Chau, Mark, Siegel, Alexander J.
• Primary Examiner(s): Stransky, Katrina M
• Application Number:
  US14/912,067
• Publication Number:
  US 20160184095A1
• Time in Patent Office: 1,671 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Systems and methods for replacing a heart valve. An expansible helical anchor is formed as multiple coils to support a valve prosthesis. At least one of the coils is expandable to a second, larger diameter upon application force from within the anchor. A gap is defined between adjacent coils sufficient to prevent engagement by at least one of the adjacent coils with the native heart valve. An expansible heart valve prosthesis is provided and is configured to be delivered into the anchor and expanded inside the coils into engagement. This moves the coil from the first diameter to the second diameter while securing the anchor and prosthesis together. The system further includes a seal on the expansible heart valve prosthesis configured to engage the helical anchor and prevent blood leakage past the heart valve prosthesis after implantation of the heart valve prosthesis in the helical anchor.

Claims

1. A system, comprising:

an expansible prosthetic heart valve comprising a stent structure and leaflets mounted to the stent structure;

an anchor comprising at least three coils configured to support the prosthetic heart valve and to encircle native tissue of a native heart valve;

wherein the prosthetic heart valve is capable of being delivered into the anchor and expanded inside the at least three coils to trap the native tissue between the anchor and the prosthetic heart valve; and

a seal structure on the prosthetic heart valve configured to inhibit blood leakage past the prosthetic heart valve after implantation of the prosthetic heart valve in the anchor, wherein the seal structure comprises a seal layer circumscribing the scent structure and a bumper region covering an end edge of an outflow end of the stent structure, the seal structure arranged such that the entire end edge of the outflow end of the stent structure is covered.

2. The system of claim 1, wherein a first coil of the at least three coils has a first diameter in an unstressed state that is expandable to a second, larger diameter as the prosthetic heart valve, and wherein a second coil of the at least three coils moves from a larger diameter to a smaller diameter as the prosthetic heart valve is expanded inside the multiple coils.

3. The system of claim 1, wherein the seal includes portions extending between adjacent coils for preventing blood leakage through the anchor and past the prosthetic heart valve.

4. The system of claim 1, wherein the seal comprises a biological material.

5. The system of claim 1, wherein at least a portion of the stent structure extends into an interior of the bumper region.

6. The system of claim 1, wherein the seal comprises at least two different materials.

7. The system of claim 6, wherein one of the at least two different materials is pericardium tissue.

8. The system of claim 6, wherein one of the at least two different materials is a foam material.

9. The system of claim 1, wherein the bumper region comprises a first material covering the end edge of the outflow end and a second material covering the first material.

10. The system of claim 1, wherein a gap is formed between two adjacent coil portions of the anchor by a portion of the anchor that extends non-parallel to the adjacent coil portions of the anchor.

11. The system of claim 1, wherein the stent structure is an open stent structure and the seal is configured to, cover openings in the open stent structure.

12. A system, comprising:

a prosthetic heart valve comprising a stent structure and a valve structure mounted to the stent structure, wherein the prosthetic heart valve is expandable from a compressed configuration to an expanded configuration;

an anchor comprising multiple coils configured to be implanted at a native heart valve and adapted to support the prosthetic heart valve, wherein the anchor is configured such that application of a radial outward force, by the prosthetic heart valve expanding from the compressed configuration to the expanded configuration within the anchor, can cause at least one coil of the multiple coils to expand from a first diameter to a second, larger diameter; and

a seal structure on the prosthetic heart valve, wherein the seal structure comprises a seal layer circumscribing the stent structure and a bumper covering the outflow end of the stent structure, the seal structure arranged such that the entire outflow end of the stent structure is covered by the seal structure; and

wherein the prosthetic heart valve and the anchor are configured such that, when the anchor is implanted at the native heart valve, the prosthetic heart valve can be delivered inside the multiple coils of the anchor and expanded such that native tissue of the native heart valve is trapped between the at least one coil and the prosthetic heart valve.

13. The system of claim 12, wherein the anchor includes a coil configured to transition from a larger diameter to a smaller diameter as the prosthetic heart valve is expanded inside the multiple coils.

14. The system of claim 12, wherein the outflow end is flared radially outward.

15. The system of claim 12, wherein a gap is formed between two adjacent coil portions by a region of the anchor that extends non-parallel to the adjacent coil portions of the anchor.

16. The system of claim 12, wherein the multiple coils comprise at least three full coils.

17. The system of claim 12, wherein at least a portion of the stent structure extends into a center of the bumper.

18. The system of claim 12, wherein the seal comprises at least two different materials.

19. The system of claim 18, wherein one of the at least two different materials is pericardium tissue.

20. The system of claim 12, wherein the bumper comprises a first material covering an end edge of the outflow end and a second material covering the first material.

21. The system of claim 12, wherein the stent structure is an open stent structure and the seal structure is configured to cover openings in the open stent structure.

22. The system of claim 12, wherein the anchor comprises a layer of foam material over a wire portion.

23. The system of claim 12, wherein the anchor comprises an upper anchor portion and a lower anchor portion that wind in opposite directions and are crimped together.