Heart valve assembly systems and methods

• US 9,011,515 B2
• Filed: 03/15/2013
• Issued: 04/21/2015
• Est. Priority Date: 04/19/2012
• Status: Active Grant

• Current Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Original Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Inventors: Schweich, Cyril J. Jr., Mortier, Todd J.
• Primary Examiner(s): Shay, Randy
• Application Number:
  US13/842,490
• Publication Number:
  US 20130282114A1
• Time in Patent Office: 767 Days
• Field of Search: 623/1.26, 623/2.1, 623/2.13, 623/2.14, 623/2.17, 623/2.18
• US Class Current: 623/1.26
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

Heart valve assembly systems and methods configured for medical interventional procedures. In one aspect, the methods and systems involve a modular approach to treatment.

Claims

1. A mitral heart valve assembly system configured for staged implantation at a native mitral valve site via an endovascular access to a heart, comprising:

an anchor to implant along a native mitral valve annulus while the native mitral valve remains functional, the anchor including;

a supra-annular structure configured to reside above the valve annulus of the native mitral valve and defining a first geometric interlock face at an uppermost portion of the anchor; and

a plurality of commissural projections that extend downwardly away from the supra-annular structure and that are sized and shaped to extend between the native mitral valve leaflets without interfering with the functionality of native mitral valve leaflets, wherein the commissural projections are configured to anchor along native heart tissue below the valve annulus of the native mitral valve without interfering with the functionality of native mitral valve leaflets; and

a valve assembly configured to subsequently implant after the anchor in the staged implantation via the endovascular access to the heart, wherein the valve assembly includes;

an occluder component having a plurality of leaflets formed from pericardial tissue and positioned to occlude blood flow during systole and open to blood flow during diastole;

a support component to maintain a portion of the occluder component in a supra-annular position above the valve annulus of the native mitral valve and further having a second geometric interlock face sized and shaped to lockingly and directly engage the first geometric interlock face of the supra-annular structure of the anchor; and

a lower contoured portion configured to engage with the native mitral valve, wherein at least a portion of the lower contoured portion is tapered inwardly and configured to extend below the valve annulus of the native mitral valve.

2. The system of claim 1, the valve assembly further comprising a plurality of annular ridges on said support component shaped to lockingly receive the anchor.

3. The system of claim 1, the valve assembly further comprising a generally cylindrical portion and the lower contoured portion extending from the generally cylindrical portion.

4. The system of claim 3, the valve assembly further comprising a surface configured for tissue ingrowth.

5. The system of claim 4, the valve assembly further comprising a projecting member extending beyond the lower contoured portion, the projecting member sized and shaped to engage native valve anatomy to offset rotational forces.

6. The system of claim 1, wherein the valve assembly is configured to present valve leaflet structure which is at an angle with respect to a native valve opening.

7. The system of claim 1, wherein said plurality of leaflets comprises five or more leaflets.

8. The system of claim 7, wherein one leaflet of the five or more leaflets is an envelope center valve bounded by four separate and distinct leaflets.

9. The system of claim 1, the support component including a crossing strut frame.

10. The system of claim 9, wherein the crossing strut frame supports three centrally located leaflets and three outer leaflets.

11. The system of claim 10, wherein the three centrally located leaflets together form a triangular shape when in a closed position.

12. The system of claim 10, wherein the three centrally located leaflet together form a generally circular shape when in a closed position.

13. The system of claim 1, said leaflets including leaflets which include non-coaptive tips which extend below the native valve leaflets.

14. The system of claim 1, said plurality of leaflets comprising a pair of laterally arranged tri-leaflet valves.

15. The system of claim 1, the valve assembly configured to be suspended within a coaptation line of a native valve.

16. The system of claim 15, wherein said plurality of leaflets open and close in response to functioning of native leaflets.

17. The system of claim 1, wherein said plurality of leaflets are flap-like leaflets.

18. The system of claim 17, wherein certain of the flap-like leaflets are arranged at different angles from other flap-like leaflets.

19. The system of claim 1, wherein the occluder component of the valve assembly comprises a tri-leaflet construction in which said plurality of leaflets comprise three centrally located leaflets together form a generally circular shape when in a closed position.

20. The system of claim 1, wherein the anchor is configured to seat along the native mitral valve annulus while the commissural wire projections extend between the native mitral valve leaflets to maintain pre-existing native valve function.

21. The system of claim 20, wherein the commissural projections include loop structures that are shaped to anchor along the native heart tissue below the valve annulus of the native mitral valve.

22. The system of claim 21, wherein two of the commissural wire projections have the wire loop structures that are shaped to anchor proximate to trigones along the native heart tissue of the native mitral valve without interfering with the functionality of native mitral valve leaflets.

23. The system of claim 22, wherein at least a portion of the anchor is covered with ePTFE material.

24. The system of claim 23, wherein the valve assembly includes attachment components extending from the support component to mechanically fasten with the anchor.

25. The system of claim 24, wherein the attachment components of the valve assembly extend from the support component to mechanically fasten with a portion of the anchor above the native mitral valve annulus.

26. The system of claim 25, wherein the valve assembly comprises a Nitinol frame and pericardial tissue material.

27. The system of claim 26, wherein the valve assembly is configured to geometrically interlock with the anchor while preserving subvalvular structural relationships.

28. The system of claim 27, wherein the valve assembly is adjustable from a compressed state during the staged implantation to a deployed state in the heart.