Valve replacement systems and methods

• US 9,427,315 B2
• Filed: 03/15/2013
• Issued: 08/30/2016
• 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): LOUIS, RICHARD G
• Application Number:
  US13/842,206
• Publication Number:
  US 20130282110A1
• Time in Patent Office: 1,264 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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

Systems and methods for medical interventional procedures, including approaches to valve implant. In one aspect, the methods and systems involve a modular approach to treatment.

Claims

1. A method of replacing a valve, comprising:

implanting an anchoring structure adjacent a native mitral valve so that a supra-annular retention element of the anchoring structure is positioned above an annulus of the native mitral valve while a plurality of commissural wire structures of the anchoring structure extend downwardly through opposing commissures between native leaflets of the native mitral valve and sub-annular anchor feet of the anchoring structure directly engage commissural clefts below the annulus of the native mitral valve without disruption of native valve function of the native mitral valve; and

after implanting the anchoring structure adjacent to the native mitral valve, attaching an artificial valve to the anchoring structure by advancing the artificial valve out of a valve delivery catheter proximate to the native mitral valve and securing the artificial valve to the supra-annular retention element of the anchoring structure positioned above the annulus of the native mitral valve.

2. The method of claim 1, wherein said attaching the artificial valve to the anchoring structure includes mating an exterior periphery region of the artificial valve with the supra-annular retention element of the anchoring structure.

3. The method of claim 1, wherein the supra-annular retention element of the anchoring structure comprises a supra-annular ring.

4. The method of claim 1, wherein the plurality of commissural wire structures extend away from a plane defined by a generally circular body of the anchoring structure.

5. The method of claim 1, wherein each of the sub-annular anchoring feet comprise wire loop structures.

6. The method of claim 1, wherein the anchoring structure comprises a wire frame structure, and the anchoring structure includes a covering comprising a biocompatible material selected from PET and ePTFE.

7. The method of claim 1, wherein said attaching the artificial valve to the anchoring structure includes expanding the artificial valve from a delivery configuration to an implantation configuration.

8. The method of claim 1, further comprising:

after implanting the anchoring structure adjacent to the native mitral valve, advancing the valve delivery catheter into a heart so that a distal end is proximate to the native mitral valve.

9. The method of claim 8, further comprising:

before advancing the valve delivery catheter into the heart, providing tissue growth around the anchoring structure before implanting the artificial valve.

10. The method of claim 1, wherein the anchoring structure includes elements that promote tissue ingrowth.

11. The method of claim 1, said attaching the artificial valve to the anchoring structure includes positioning the artificial valve in a non-functional configuration by temporarily restraining the valve in the non-functional configuration.

12. The method of claim 1, further comprising axially aligning the artificial valve with the previously implanted anchoring structure.

13. The method of claim 12, wherein axially aligning the artificial valve includes aligning radiopaque elements of the artificial valve and anchor structure.

14. The method of claim 1, further comprising performing a procedure including an angiogram, wherein said implanting the anchoring structure occurs during the procedure including the angiogram.

15. The method of claim 1, wherein the native valve function of the native mitral valve is maintained after said implanting the anchoring structure adjacent to the native mitral valve and until the artificial valve is attached to the anchoring structure.

16. The method of claim 1, wherein said implanting the anchoring structure adjacent the native mitral valve includes engaging the plurality of commissural sub-annular anchoring feet of the anchoring structure with the commissural clefts below the annulus of the native mitral valve without interaction with chordae of the native mitral valve.

17. The method of claim 1, wherein said implanting the anchoring structure adjacent the native mitral valve includes deploying at least some of the sub-annular anchoring feet of the anchoring structure behind anterior and posterior leaflets of the native mitral valve in the commissural clefts where the anterior and posterior leaflets meet the annulus of the native mitral valve.

18. The method of claim 1, further comprising advancing a guide catheter into a heart having the native mitral valve.

19. The method of claim 18, further comprising advancing an anchor delivery catheter through the guide catheter and into the heart having so that a distal end of anchor delivery catheter is proximate to the native mitral valve.

20. The method of claim 19, further comprising advancing the anchoring structure out of the distal end of the anchor delivery catheter for said implanting the anchoring structure adjacent the native mitral valve.

21. The method of claim 1, wherein said attaching the artificial valve to the anchoring structure includes securing the artificial valve to the supra-annular retention element of the anchoring structure using a mechanical interlock mechanism at an interface between the anchoring structure and artificial valve.

22. The method of claim 21, wherein interface between the anchoring structure and artificial valve transfers a valve load acting upon the artificial valve to the anchoring structure.

23. The method of claim 2, wherein each of the sub-annular anchoring feet comprise wire loop structures.

24. The method of claim 2, wherein the anchoring structure comprises a wire frame structure, and the anchoring structure includes a covering comprising a biocompatible material selected from PET and ePTFE.

25. The method of claim 2, further comprising axially aligning the artificial valve with the previously implanted anchoring structure.

26. The method of claim 2, wherein said implanting the anchoring structure adjacent the native mitral valve includes directly contacting the sub-annular anchoring feet of the anchoring structure with the commissural clefts below the annulus of the native mitral valve.

27. The method of claim 2, wherein said the artificial valve is secured to the supra-annular retention element of the anchoring structure using a mechanical interlock mechanism at a mating interface between the supra-annular retention element of the anchoring structure and artificial valve.

28. The method of claim 17, wherein each of the sub-annular anchoring feet comprise wire loop structures.

29. The method of claim 17, wherein the anchoring structure comprises a wire frame structure, and the anchoring structure includes a covering comprising a biocompatible material selected from PET and ePTFE.

30. The method of claim 17, further comprising axially aligning the artificial valve with the previously implanted anchoring structure.

31. The method of claim 17, wherein said implanting the anchoring structure adjacent the native mitral valve includes directly contacting the plurality of sub-annular anchoring feet of the anchoring structure with the commissural clefts below the annulus of the native mitral valve.

32. The method of claim 17, wherein said the artificial valve is secured to the supra-annular retention element of the anchoring structure using a mechanical interlock mechanism at a mating interface between the supra-annular retention element of the anchoring structure and artificial valve.