Method of reconfiguring a mitral valve annulus

• US 10,136,985 B2
• Filed: 09/30/2015
• Issued: 11/27/2018
• Est. Priority Date: 07/17/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Millipede, Inc. (Boston Scientific Corporation)
• Inventors: Lashinski, Randall, Rust, Matthew, Macaulay, Patrick, Daniels, Terry Wayne, Kristoffersen, Kris
• Primary Examiner(s): McEvoy, Thomas
• Application Number:
  US14/870,481
• Publication Number:
  US 20160015515A1
• Time in Patent Office: 1,154 Days
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0662 : Guide tubes

Abstract

Disclosed are systems and methods relating to an implant configured for reshaping a mitral valve. The implant comprises a plurality of struts with anchors for tissue engagement. The implant is compressible to a first, reduced diameter for transluminal or transapical navigation and delivery to the left atrium of a heart. The implant may then expand to a second, enlarged diameter to embed its anchors to the tissue surrounding and/or including the mitral valve. The size and/or shape of the implant may then be adjusted, pulling mitral annulus tissue radially inwardly, and restrained in the adjusted configuration to improve mitral valve function.

Claims

1. A method of reconfiguring a mitral valve annulus, comprising:

positioning an implant having a first diameter into a left atrium, the implant comprising a frame having a proximal end, a distal end, a pair of struts joined at an apex, a restraint positioned on the pair of struts, and a plurality of anchors near the distal end;

expanding the positioned implant to a second diameter that is larger than the first diameter;

connecting the expanded implant to tissue surrounding a mitral valve by embedding the plurality of anchors into the tissue;

moving the restraint axially relative to the apex along the pair of struts by rotating a shaft in threaded engagement with the restraint to cause the restraint to move axially along the pair of struts thereby adjusting an angle between the pair of struts to contract the implant.

2. A method as in claim 1, wherein the connecting step comprises distally advancing the plurality of anchors relative to the frame.

3. A method as in claim 1, wherein the connecting step comprises rotating the plurality of anchors.

4. A method as in claim 3, wherein the plurality of anchors move axially relative to the frame in response to rotation of the plurality of anchors.

5. A method as in claim 3, wherein each of the plurality of anchors comprises a helical configuration which embeds into tissue in response to rotation of the plurality of anchors.

6. A method as in claim 1, wherein the moving the restraint step comprises rotating the restraint.

7. A method as in claim 1, wherein the moving the restraint step comprises distally moving the restraint relative to the pair of struts.

8. A method as in claim 1, wherein the moving the restraint step comprises moving the restraint relative to the pair of struts to change a distance between two anchors of the plurality of anchors.

9. A method as in claim 1, wherein the moving the restraint step changes a shape of the implant.

10. A method as in claim 1, wherein the positioning step is accomplished via a femoral artery access.

11. A method as in claim 1, wherein the positioning step is accomplished via a brachial artery access.

12. A method as in claim 1, wherein the positioning step is accomplished via a jugular vein access.

13. A method as in claim 1, wherein the positioning step is accomplished via a transapical access.

14. A method as in claim 1, wherein the moving the restraint step comprises sliding the restraint along the pair of struts.

15. A method of reconfiguring a cardiac valve annulus, comprising the steps of:

positioning an implant having a first diameter into an atrium of the heart, the implant comprising a frame having a proximal end, a distal end, a pair of adjacent struts joined at an apex, a restraint positioned around opposing circumferential sides of the adjacent pair of struts, and a plurality of anchors near the distal end;

expanding the positioned implant to a second diameter larger than the first diameter;

connecting the expanded implant to tissue surrounding a cardiac valve by embedding the plurality of anchors into the tissue; and

adjusting an angle between the adjacent pair of struts to contract the implant;

wherein the adjusting step comprises axially moving the restraint relative to the pair of adjacent struts to reduce the angle between the pair of adjacent struts.

16. A method as in claim 15, wherein the adjusting step comprises rotating a shaft in threaded engagement with the restraint to cause the restraint to move axially along the pair of struts to adjust the angle between the pair of adjacent struts.

17. A method as in claim 15, wherein the adjusting step comprises sliding the restraint along the pair of struts to adjust the angle between the pair of adjacent struts.

18. A method as in claim 17, wherein the adjusting step comprises rotating a shaft in threaded engagement with the restraint to cause the restraint to slide along the pair of struts.

19. A method as in claim 15, wherein the connecting step comprises rotating the plurality of anchors.

20. A method as in claim 15, wherein the positioning step is accomplished via a femoral artery access.

21. A method of reconfiguring a mitral valve annulus, comprising:

positioning an implant having a first diameter into a left atrium, the implant comprising a frame having a proximal end, a distal end, a pair of struts joined at an apex, a restraint positioned on the pair of struts, and a plurality of anchors near the distal end;

expanding the positioned implant to a second diameter that is larger than the first diameter;

connecting the expanded implant to tissue surrounding a mitral valve by embedding the plurality of anchors into the tissue;

moving the restraint axially relative to the apex along the pair of struts thereby adjusting an angle between the pair of struts to contract the implant;

wherein the moving the restraint step comprises retaining the angle by moving a collar along the pair of struts by rotating the collar in threaded engagement with the frame to prevent the angle between the pair of struts from increasing.

22. A method as in claim 21, wherein the connecting step comprises distally advancing the plurality of anchors relative to the frame.

23. A method as in claim 21, wherein the connecting step comprises rotating the plurality of anchors.

24. A method as in claim 23, wherein the plurality of anchors move axially relative to the frame in response to rotation of the plurality of anchors.

25. A method as in claim 23, wherein each of the plurality of anchors comprises a helical configuration which embeds into tissue in response to rotation of the plurality of anchors.

26. A method as in claim 21, wherein the moving the restraint step comprises distally moving the restraint relative to the pair of struts.

27. A method as in claim 21, wherein the moving the restraint step comprises moving the restraint relative to the pair of struts to change a distance between two anchors of the plurality of anchors.

28. A method as in claim 21, wherein the moving the restraint step changes a shape of the implant.

29. A method as in claim 21, wherein the positioning step is accomplished via a femoral artery access.

30. A method as in claim 21, wherein the positioning step is accomplished via a brachial artery access.

31. A method as in claim 21, wherein the positioning step is accomplished via a jugular vein access.

32. A method as in claim 21, wherein the positioning step is accomplished via a transapical access.

33. A method of reconfiguring a cardiac valve annulus, comprising the steps of:

positioning an implant having a first diameter into an atrium of the heart, the implant comprising a frame having a proximal end, a distal end, a pair of adjacent struts joined at an apex, a restraint positioned around opposing circumferential sides of the adjacent pair of struts, and a plurality of anchors near the distal end;

expanding the positioned implant to a second diameter larger than the first diameter;

connecting the expanded implant to tissue surrounding a cardiac valve by embedding the plurality of anchors into the tissue; and

adjusting an angle between the adjacent pair of struts to contract the implant;

wherein the adjusting step comprises rotating a shaft in threaded engagement with the restraint to cause the restraint to move axially along the pair of struts to adjust the angle between the pair of adjacent struts.

34. The method of claim 33, wherein the adjusting step comprises axially moving the restraint relative to the pair of adjacent struts to reduce the angle between the pair of adjacent struts.

35. A method as in claim 33, wherein the connecting step comprises rotating the plurality of anchors.

36. A method as in claim 33, wherein the positioning step is accomplished via a femoral artery access.

37. A method of reconfiguring a cardiac valve annulus, comprising the steps of:

positioning an implant having a first diameter into an atrium of the heart, the implant comprising a frame having a proximal end, a distal end, a pair of adjacent struts joined at an apex, a restraint positioned around opposing sides of the adjacent pair of struts, and a plurality of anchors near the distal end;

expanding the positioned implant to a second diameter larger than the first diameter;

connecting the expanded implant to tissue surrounding a cardiac valve by embedding the plurality of anchors into the tissue; and

adjusting an angle between the adjacent pair of struts to contract the implant;

wherein the adjusting step comprises sliding the restraint along the pair of struts to adjust the angle between the pair of adjacent struts.

38. The method of claim 37, wherein the adjusting step comprises axially moving the restraint relative to the pair of adjacent struts to reduce the angle.

39. A method as in claim 37, wherein the adjusting step comprises rotating a shaft in threaded engagement with the restraint to cause the restraint to move axially along the pair of struts to adjust the angle between the pair of adjacent struts.

40. A method as in claim 37, wherein the connecting step comprises rotating the plurality of anchors.

41. A method as in claim 37, wherein the positioning step is accomplished via a femoral artery access.

42. A method as in claim 37, wherein the positioning step is accomplished via a transapical access.

43. A method as in claim 37, wherein the positioning step is accomplished via a brachial artery access.

44. A method as in claim 37, wherein the positioning step is accomplished via a jugular vein access.