Apparatus and methods for implanting a replacement heart valve

• US 10,034,749 B2
• Filed: 08/11/2014
• Issued: 07/31/2018
• Est. Priority Date: 08/12/2013
• Status: Active Grant

• Current Assignee: Mitral Valve Technologies SA
• Original Assignee: Mitral Valve Technologies Sarl (Edwards Lifesciences Corporation)
• Inventors: Spence, Paul A., Tompkins, Landon H.
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca
• Application Number:
  US14/911,539
• Publication Number:
  US 20160199177A1
• Time in Patent Office: 1,450 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

Systems and methods for docking a heart valve prosthesis. A system includes a helical anchor (30) formed as multiple coils (32) adapted to support a heart valve prosthesis (10) with coil portions (32) positioned above and below the heart valve annulus (12). A seal (50) is coupled with the helical anchor (30) and includes portions extending between adjacent coils (32) for preventing blood leakage through the helical anchor (30) and past the heart valve prosthesis (10). An expansible helical anchor (30) is formed as multiple coils (32) adapted to support a heart valve prosthesis (10). At least one of the coils (32) is normally being at a first diameter, and is expandable to a second, larger diameter upon application of radial outward force from within the helical anchor (30).

Claims

1. A system for replacing a native heart valve, the system comprising:

an expansible helical anchor having at least three coils in an unconstrained state, wherein a first coil of the helical anchor has a first diameter in the unconstrained state, and is expandable to a second diameter larger than the first diameter upon application of radial outward force from within the first coil, and wherein the first coil is configured such that it can encircle native leaflets of the native heart valve while a second coil does not encircle the native leaflets; and

an expansible heart valve prosthesis capable of being delivered into the helical anchor and expanded inside the first coil to move the first coil from the first diameter to the second diameter while trapping at least a portion of the native leaflets between the first coil and the heart valve prosthesis.

2. The system of claim 1, wherein the helical anchor includes a third coil that moves from a larger diameter to a smaller diameter as the heart valve prosthesis is expanded inside the multiple coils.

3. The system of claim 2, wherein at least two adjacent coils of the helical anchor are spaced apart, and the adjacent coils move toward each other as the heart valve prosthesis is expanded inside the first coil.

4. The system of claim 1, wherein at least two adjacent coils of the helical anchor are spaced apart, and the adjacent coils move toward each other as the heart valve prosthesis is expanded inside the first coil.

5. The system of claim 1, wherein the helical anchor further comprises a plurality of fasteners, and the fasteners are moved from an undeployed state to a deployed state as the first coil moves from the first diameter to the second diameter.

6. The system of claim 5, further comprising a seal coupled with the helical anchor and including portions extending between adjacent coils for preventing blood leakage through the helical anchor and past the heart valve prosthesis, wherein the fasteners engage the seal in the deployed state.

7. The system of claim 1, further comprising at least one compressible element on the helical anchor, the compressible element being engaged by the heart valve prosthesis as the heart valve prosthesis is expanded inside the first coil to assist with affixing the heart valve prosthesis to the helical anchor.

8. The system of claim 7, wherein the at least one compressible element further comprises multiple compressible elements spaced along the helical anchor.

9. The system of claim 7, wherein the at least one compressible element further comprises a continuous compressible element extending along the helical anchor.

10. The system of claim 7, wherein the at least one compressible element further comprises a resilient element.

11. The system of claim 7, wherein the heart valve prosthesis further comprises an expansible structure including openings and the openings are engaged by the at least one compressible element as the heart valve prosthesis is expanded inside the first coil.

12. The system of claim 1, wherein the helical anchor includes at least two coils that cross over each other.

13. The system of claim 1, wherein the helical anchor further comprises a shape memory material.

14. The system of claim 1, further comprising a seal coupled with the helical anchor that includes portions extending between adjacent coils.

15. The system of claim 14, wherein the seal further comprises a membrane or panel extending over at least two coils of the helical anchor.

16. The system of claim 15, wherein the membrane or panel is moved between an undeployed state and a deployed state, the undeployed state being adapted for delivery to a site of implantation and the deployed state being adapted for implanting the system and anchoring the heart valve prosthesis.

17. The system of claim 16, wherein the undeployed state comprises a rolled up state on one of the coils of the helical anchor.

18. The system of claim 16, wherein the undeployed state comprises a collapsed state.

19. The system of claim 15, wherein the membrane or panel includes a support element affixed therewith.

20. The system of claim 14, wherein the seal further comprises one or more seal elements carried by the helical anchor and including overlapping portions configured to seal a space between adjacent coils of the helical anchor.

21. The system of claim 20, wherein the one or more seal elements each include a support element affixed therewith.

22. The system of claim 20, wherein the one or more seal elements are each generally circular in cross sectional shape.

23. The system of claim 20, wherein the one or more seal elements are each oblong in cross sectional shape.

24. The system of claim 20, wherein the one or more seal elements each have a connecting portion affixed to one of the coils and an extension portion extending toward an adjacent coil.

25. The system of claim 1, wherein, in the unconstrained state, the first coil has a different a radius of curvature than the second coil and a third coil of the helical anchor.

26. The system of claim 1, wherein, in the unconstrained state, the first coil of the helical anchor is positioned between the second coil and a lower end coil of the helical anchor, and wherein the first coil has a smaller radius of curvature than the second coil and the lower end coil.

27. A system for replacing a native heart valve, comprising:

a helical anchor having at least three coils in a relaxed state, the helical anchor being implantable at the native heart valve such that a first coil portion is positioned above a heart valve annulus and a second coil portion is positioned below the heart valve annulus such that it encircles native leaflets of the native heart valve, wherein, in the relaxed state, the first coil portion of the coils has a first radius of curvature that is different from a second radius of curvature of the second coil portion;

a cover disposed over at least some of the helical anchor and including a portion extending between at least two adjacent coils; and

a prosthetic heart valve capable of being positioned inside the helical anchor at the native heart valve and expanded inside the helical anchor such that at least a portion of native leaflets of the native heart valve are trapped between the helical anchor and the prosthetic heart valve.

28. The system of claim 27, wherein the second coil portion is positioned between the first coil portion and a third coil portion, and wherein the second radius of curvature is smaller than the first radius of curvature and a third radius of curvature of the third coil portion.

29. The system of claim 27, wherein the prosthetic heart valve comprises a seal.

30. The system of claim 29, wherein the seal of the prosthetic heart valve includes a fabric or polymeric covering.

31. The system of claim 29, wherein the seal includes a support element.

32. The system of claim 27, wherein the seal includes overlapping portions configured to seal a space between adjacent coils of the helical anchor.

33. The system of claim 27, wherein the seal is generally circular in cross sectional shape.

34. A system for replacing a native heart valve, the system comprising:

an anchor comprising;

a plurality of middle region coils in a relaxed state;

an upper coil extending from an upper end of the plurality of middle region coils;

a lower coil extending from a lower end of the plurality of middle region coils;

wherein, in the relaxed state, at least one of the plurality of middle coils has a first diameter and the lower coil has a second diameter that is greater than the first diameter; and

wherein, upon application of an outward radial force, the first diameter expands to a third diameter; and

a radially expanding replacement heart valve configured to be inserted within the plurality of middle coils;

wherein the upper coil is configured to remain in the atrium, and the lower coil is configured to encircle the mitral valve leaflets and the chordae in the left ventricle.

35. The system of claim 34, further comprising

a seal structure over at least a portion of the plurality of coils.