Mitral valve docking devices, systems and methods

• US 10,226,339 B2
• Filed: 01/31/2013
• Issued: 03/12/2019
• Est. Priority Date: 01/31/2012
• 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.
• Primary Examiner(s): Bui, Vy
• Application Number:
  US14/372,953
• Publication Number:
  US 20140379074A1
• Time in Patent Office: 2,231 Days
• Field of Search: 623 211, 623 2113, 623 214, 623 217, 623 236, 623 237
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 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 2/2436 Deployment by retracting a sheath
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• 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: A61M 25/0133 Tip steering devices

Abstract

Various systems, devices and methods associated with the placement of a dock or anchor (72) for a prosthetic mitral valve (120). The anchor (72) may take the form of a helical anchor having multiple coils (104, 108) and/or a stent-like structure. Various methods include different levels of minimal invasive procedures for delivering the prosthetic valve anchor (72) and prosthetic valve (120), as well as tissue anchors for plication or other purposes to the mitral valve position in the heart (14).

Claims

1. A system comprising:

a heart valve prosthesis that is radially expandable;

a helical anchor for docking the heart valve prosthesis, the helical anchor adapted to be held in a coil guide catheter in a straightened configuration and delivered from the coil guide catheter, and comprising;

a plurality of coils having a preformed, coiled configuration after being delivered from the coil guide catheter and adapted to support the heart valve prosthesis upon being fully delivered from the coil guide catheter and implanted with respective coil portions above and below a native heart valve annulus of a native heart valve, wherein the plurality of coils include at least one upper coil and a plurality of lower coils, wherein the at least one upper coil is adapted to be placed above the native heart valve annulus and wherein the plurality of lower coils are configured to encircle heart valve leaflets of the native heart valve and configured such that, when the heart valve prosthesis is docked within the helical anchor, the heart valve leaflets of the native heart are secured between the helical anchor and the heart valve prosthesis and the helical anchor is locked in place relative to the heart valve leaflets, wherein the at least one upper coil is larger than the plurality of lower coils, and further comprising a gap between the at least one upper coil and an adjacent coil, the gap large enough to span the native annulus upon implantation.

2. The system of claim 1, wherein at least one of the plurality of lower coils further comprises a distal end portion formed to extend downward and radially outward relative to a next adjacent coil of the helical anchor, such that the distal end portion is spaced from the next adjacent coil and is configured to be delivered between the commissures of the native heart valve.

3. The system of claim 1, further comprising an extension portion configured to engage the wall of the atrium and provide stabilization upon implantation in the heart.

4. The system of claim 1, wherein the at least one upper coil is adapted to be placed above the native heart valve annulus and extend upwardly to adjustably position the heart valve prosthesis at a desired height relative to the heart valve annulus.

5. The system of claim 4, wherein the plurality of lower-coils are configured to contain mitral valve leaflets therein and prevent obstruction of an aortic valve by an anterior mitral leaflet.

6. The system of claim 1, wherein the gap between the upper and lower coils creates a space prior to implantation of the coils.

7. The system of claim 1, wherein at least a portion of the first upper coil is spaced apart from the mitral valve leaflet tissue upon implantation.

8. The system of claim 1, wherein a distal tip at a distal end of the plurality of coils is blunt.

9. The system of claim 1,

comprising the coil guide catheter, wherein the coil guide catheter includes a stem portion and a distal portion connected to the stem portion at a first curved shape, the distal portion having a second curved shape configured to generally follow the curvature of the mitral valve annulus, said first and second curved portions capable of being delivered in straightened configurations and activated to the first and second curved shapes within the heart at a mitral valve position proximate the mitral valve.

10. The system of claim 9, wherein the heart valve prosthesis is capable of being delivered to the mitral valve position and expanded inside the multiple coils and into engagement with leaflets of the mitral valve.

11. The system of claim 1, wherein the heart valve prosthesis includes grooves configured to engage with the plurality of coils for coupling the heart valve prosthesis with the helical anchor.

12. The system of claim 9, wherein the helical anchor further comprises a shape memory material.

13. The system of claim 9, wherein the plurality of coils includes an end coil portion formed as an enlarged diameter coil relative to the next adjacent coil, the end coil portion configured to engage the left atrial wall of the heart when the multiple coils have been fully delivered from the coil guide catheter with the coil portions positioned above and below the mitral valve annulus.

14. The system of claim 9, further comprising:

a plurality of anchoring arms coupled with the helical anchor and configured to engage the mitral valve leaflets.

15. The system of claim 14, wherein the anchoring arms further comprise hook-like members.

16. The system of claim 9, further comprising:

a control catheter having connecting element configured to couple with the helical anchor for guiding the placement of the helical anchor relative to the mitral valve.

17. The system of claim 16, wherein the control catheter further comprises

a snare catheter.

18. The system of claim 16, wherein the control catheter further comprises a catheter with a grasping tool.

19. The system of claim 16, wherein the helical anchor further includes an engagement element configured to allow coupling of the connecting element therewith.

20. The system of claim 9, further comprising a positioning helix configured to be delivered from the coil guide catheter for assisting with positioning of the helical anchor.

21. The system of claim 9, further comprising an extension coupled with the second curved portion and configured to assist with positioning of the second curved portion on top of the mitral valve as the helical anchor is being delivered.

22. The system of claim 21, wherein the extension further comprises a flat membrane.

23. The system of claim 9, further comprising an anchor delivery catheter and an anchor, the anchor delivery catheter being coupled with the coil guide catheter for delivering the anchor into tissue at the mitral valve position.

24. The system of claim 9, wherein the helical anchor comprises a solid wire.

25. The system of claim 9, wherein the helical anchor further comprises a hollow wire configured to be delivered over a guide wire.

26. A system comprising:

a heart valve prosthesis that is radially expandable;

a helical anchor for docking the heart valve prosthesis, the helical anchor adapted to be held in a coil guide catheter in a straightened configuration and delivered from the coil guide catheter, and comprising;

a plurality of coils having a preformed, coiled configuration after being delivered from the coil guide catheter and adapted to support the heart valve prosthesis upon being fully delivered from the coil guide catheter and implanted in a native heart valve,

wherein the plurality of coils include an upper coil and a plurality of lower coils,

wherein a length of the upper coil is configured to extend from the native heart valve and contact an atrial wall,

wherein the upper coil is configured to be placed above a native heart valve annulus of the native heart valve in contact with the atrial wall, and wherein the plurality of lower coils is adapted to be placed below the native heart valve annulus such that the plurality of lower coils encircle native leaflets of the native heart valve and, when the heart valve prosthesis is docked within the plurality of lower coils, the native leaflets are secured between the plurality of lower coils and the heart valve prosthesis,

wherein the upper coil has a larger diameter than each of the plurality of lower coils.

27. The system of claim 26, wherein plurality of coils are configured such that the heart valve prosthesis can be adjustably positioned at a desired height relative to the native heart valve annulus.

28. The system of claim 26, wherein the native valve leaflets are native mitral valve leaflets of a native mitral valve and wherein the plurality of lower coils are configured to encircle the mitral valve leaflets such that the anterior leaflet is prevented from obstructing of the aortic valve.

29. The system of claim 26, further comprising a gap between the upper coil and an adjacent lower coil that creates a space therebetween prior to implantation of the coils.

30. The system of claim 26, wherein at least a portion of the upper coil is spaced apart from native heart valve leaflet tissue of the native heart valve upon implantation.

31. The system of claim 26, wherein a distal tip of the helical anchor turns downward and radially outward relative to an adjacent coil of the helical anchor such that the distal tip helps direct the helical anchor under the native leaflets.

32. The system of claim 26, wherein multiple coils of the plurality of lower coils has the same diameter.

33. The system of claim 26, wherein a lower-most coil of the helical anchor has a larger diameter than another coil of the helical anchor.