Heart valve assembly systems and methods

• US 10,080,656 B2
• Filed: 12/14/2016
• Issued: 09/25/2018
• 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, Jr., Cyril J., Mortier, Todd J.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US15/378,737
• Publication Number:
  US 20170095327A1
• Time in Patent Office: 650 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 2/2445 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 co configured for staged implantation at a native mitral valve site via an endovascular access to a heart, comprising:

an anchor assembly to implant along a native mitral valve annulus while maintaining pre-existing native valve function, the anchor assembly including;

a supra-annular structure defining a first mating face at an upper portion of the anchor assembly configured to reside above the valve annulus of the native mitral valve;

a plurality of wire structures that extend downwardly away from the supra-annular structure and are sized and shaped to extend through commissures between the native mitral valve leaflets and into a sub-annular position; and

a plurality of sub-annular anchor projections connected to the wire structures and being sized and shaped to anchor into a sub-annular gutter along an underside of the valve annulus of the native mitral valve; and

a valve assembly configured to subsequently mate with the anchor assembly after implantation of the anchor assembly, wherein the valve assembly includes;

an occluder component having a plurality of leaflets 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 mating face sized and shaped to be positioned inwardly of and directly mate with the first mating face of the supra-annular structure of the anchor assembly; and

a lower peripheral portion that is sized and shaped to extend below the valve annulus of the native mitral valve while the support component maintains the portion of the occluder component in the supra-annular position above the valve annulus.

2. 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 define a generally circular periphery when in a closed position.

3. The system of claim 2, wherein the plurality of leaflets are formed from pericardial tissue.

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

5. The system of claim 4, wherein the sub-annular anchor projections include loop structures that are shaped to anchor along the native heart tissue below the valve annulus of the native mitral valve.

6. The system of claim 5, wherein two of the sub-annular anchor projections have the 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.

7. The system of claim 6, wherein at least a portion of the anchor assembly is covered with ePTFE material.

8. The system of claim 1, wherein valve assembly includes attachment components extending from the support component to mechanically fasten with the anchor assembly.

9. The system of claim 8, wherein the attachment components of the valve assembly extend from the support component to mechanically fasten with a portion of the anchor assembly above the native mitral valve annulus.

10. The system of claim 9, wherein the valve assembly comprises a Nitinol frame and pericardial tissue material.

11. The system of claim 1, wherein the valve assembly is configured to geometrically interlock with the anchor assembly while preserving subvalvular structural relationships.

12. The system of claim 11, wherein the valve assembly is adjustable from a compressed state during the staged implantation to a deployed state in the heart.

13. The system of claim 12, wherein the anchor assembly is configured to seat along the native mitral valve annulus while the plurality of wire structures extend between the native mitral valve leaflets to maintain pre-existing native valve function.

14. The system of claim 13, wherein the sub-annular anchor projections include loop structures that are shaped to anchor along the native heart tissue below the valve annulus of the native mitral valve.

15. The system of claim 14, wherein two of the sub-annular anchor projections have the 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.

16. The system of claim 15, wherein at least a portion of the anchor assembly is covered with ePTFE material.

17. The system of claim 16, wherein the lower peripheral portion of the valve assembly comprises a lower contoured peripheral wall configured to engage with the native mitral valve, wherein at least a portion of the lower contoured peripheral wall is tapered inwardly.

18. The system of claim 17, the valve assembly further comprising a generally cylindrical portion and the lower contoured peripheral wall extending from the generally cylindrical portion.

19. The system of claim 1, wherein the lower peripheral portion of the valve assembly comprises a lower contoured peripheral wall configured to engage with the native mitral valve, wherein at least a portion of the lower contoured peripheral wall is tapered inwardly.

20. The system of claim 19, the valve assembly further comprising a generally cylindrical portion and the lower contoured peripheral wall extending from the generally cylindrical portion.