Apparatus for transvascular implantation of neo chordae tendinae

• US 10,682,230 B2
• Filed: 10/31/2017
• Issued: 06/16/2020
• Est. Priority Date: 12/30/2016
• Status: Active Grant

• Current Assignee: Pipeline Medical Technologies, Inc.
• Original Assignee: Pipeline Medical Technologies, Inc.
• Inventors: Bishop, Gordon B., Lashinski, Randall T.
• Primary Examiner(s): Fishback, Ashley L
• Application Number:
  US15/799,585
• Publication Number:
  US 20180185150A1
• Time in Patent Office: 959 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2018/00369 Heart valves
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2457 : Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium, through the mitral valve, and into the left ventricle. A ventricular anchor is deployed from the catheter and into a wall of the left ventricle, leaving a ventricular suture attached to the ventricular anchor and extending proximally through the catheter. A leaflet anchor is deployed to secure a mitral valve leaflet to a leaflet suture, with the leaflet suture extending proximally through the catheter. The leaflet suture is secured to the ventricular suture to limit a range of travel of the leaflet in the direction of the left atrium. Also disclosed is an assembled in situ mitral valve leaflet restraint, having a neo papillary muscle and a neo chordae tendinea.

Claims

1. An assembled in situ mitral valve leaflet restraint, comprising:

an elongate, flexible neo papillary muscle, having a proximal end and a distal end;

a helical tissue anchor attached to the distal end of the neo papillary muscle;

an elongate, flexible neo chordae, extending proximally from the neo papillary muscle; and

a leaflet anchor attached to a proximal end of the neo chordae;

wherein the leaflet anchor is enlargeable from a first reduced cross section for advancing through a leaflet, to a second, enlarged cross section for contacting an atrial side of the leaflet, and

wherein the neo chordae is attached to a suture extending distally through the neo papillary muscle to the helical tissue anchor.

2. The assembled in situ mitral valve leaflet restraint as in claim 1, wherein the helical anchor comprises a laser cut hypotube.

3. The assembled in situ mitral valve leaflet restraint as in claim 1, wherein the helical anchor comprises a coiled round wire.

4. The assembled in situ mitral valve leaflet restraint as in claim 3, wherein the helical anchor comprises two coiled round wires.

5. The assembled in situ mitral valve leaflet restraint as in claim 1, wherein the leaflet anchor comprises a pledget.

6. The assembled in situ mitral valve leaflet restraint as in claim 5, wherein the pledget is configured to be collapsed by pulling a suture coupled to the pledget, the pledget assuming the second, enlarged cross section when collapsed.

7. The assembled in situ mitral valve leaflet restraint as in claim 5, wherein a suture is threaded through at least two apertures in the pledget.

8. The assembled in situ mitral valve leaflet restraint as in claim 7, wherein the suture is threaded through at least three apertures in the pledget, the apertures being substantially collinear.

9. The assembled in situ mitral valve leaflet restraint as in claim 1, wherein the helical anchor comprises a hub configured for receiving and frictionally securing a suture.

10. The assembled in situ mitral valve leaflet restraint as in claim 1, wherein the helical anchor comprises a loop for securing the neo papillary muscle to the helical anchor.

11. The assembled in situ mitral valve leaflet restraint as in claim 1, wherein the neo papillary muscle comprises a soft ribbon.

12. The assembled in situ mitral valve leaflet restraint as in claim 1, wherein the leaflet anchor comprises a T tag bar and wherein the T tag bar comprising a bar rotatably coupled to a suture such that rotation of the bar enlarges the leaflet anchor from the first reduced cross section to the second, enlarged cross section.

13. The assembled in situ mitral valve leaflet restraint as in claim 1, wherein the leaflet anchor comprises a hub, the hub comprising a plurality of flexible radially extending spokes, and wherein the spokes are configured to bend into alignment along a longitudinal axis so as to be confined within a delivery needle and biased to expand radially outward when unconfined to enlarge the leaflet anchor from the first reduced cross section to the second, enlarged cross section.

14. An assembled in situ mitral valve leaflet restraint, comprising:

an elongate, flexible neo papillary muscle, having a proximal end and a distal end;

a helical tissue anchor attached to the distal end of the neo papillary muscle;

an elongate, flexible neo chordae, extending proximally from the neo papillary muscle; and

a leaflet anchor attached to a proximal end of the neo chordae;

wherein the leaflet anchor is enlargeable from a first reduced cross section for advancing through the leaflet, to a second, enlarged cross section for contacting an atrial side of the leaflet; and

wherein the neo chordae is a suture extending from a proximal end of the neo papillary muscle through the neo papillary muscle to the helical tissue anchor.

15. The assembled in situ mitral valve leaflet restraint as in claim 14, wherein the helical anchor comprises a laser cut hypotube.

16. The assembled in situ mitral valve leaflet restraint as in claim 14, wherein the helical anchor comprises a coiled round wire.

17. The assembled in situ mitral valve leaflet restraint as in claim 16, wherein the helical anchor comprises two coiled round wires.

18. The assembled in situ mitral valve leaflet restraint as in claim 14, wherein the neo chordae comprises a first component extending proximally from the neo papillary muscle and a second component extending distally from the leaflet anchor, and wherein a proximal portion of the first component and a distal portion of the second component are joined together by a locking device.

19. The assembled in situ mitral valve leaflet restraint as in claim 18, wherein the locking device has a locked configuration and an unlocked configuration, and wherein the locking device is configured to be advanced over the first component and the second component when in an unlocked configuration and to fixedly clamp the first component and the second component when in a locked configuration.

20. The assembled in situ mitral valve leaflet restraint as in claim 14, wherein the leaflet anchor comprises a pledget.

21. The assembled in situ mitral valve leaflet restraint as in claim 20, wherein the pledget is configured to be collapsed by pulling a suture coupled to the pledget, the pledget assuming the second, enlarged cross section when collapsed.

22. The assembled in situ mitral valve leaflet restraint as in claim 20, wherein a suture is threaded through at least two apertures in the pledget.

23. The assembled in situ mitral valve leaflet restraint as in claim 22, wherein the suture is threaded through at least three apertures in the pledget, the apertures being substantially collinear.

24. The assembled in situ mitral valve leaflet restraint as in claim 14, wherein the helical anchor comprises a hub configured for receiving and frictionally securing a suture.

25. The assembled in situ mitral valve leaflet restraint as in claim 14, wherein the helical anchor comprises a loop for securing the neo papillary muscle to the helical anchor.

26. The assembled in situ mitral valve leaflet restraint as in claim 14, wherein the neo papillary muscle comprises a soft ribbon.

27. The assembled in situ mitral valve leaflet restraint as in claim 14, wherein the leaflet anchor comprises a T tag bar and wherein the T tag bar comprising a bar rotatably coupled to a suture such that rotation of the bar enlarges the leaflet anchor from the first reduced cross section to the second, enlarged cross section.

28. The assembled in situ mitral valve leaflet restraint as in claim 14, wherein the leaflet anchor comprises a hub, the hub comprising a plurality of flexible radially extending spokes, and wherein the spokes are configured to bend into alignment along a longitudinal axis so as to be confined within a delivery needle and biased to expand radially outward when unconfined to enlarge the leaflet anchor from the first reduced cross section to the second, enlarged cross section.

29. An assembled in situ mitral valve leaflet restraint, comprising:

an elongate, flexible neo papillary muscle, having a proximal end and a distal end;

a helical tissue anchor attached to the distal end of the neo papillary muscle;

an elongate, flexible neo chordae, extending proximally from the neo papillary muscle; and

a leaflet anchor attached to a proximal end of the neo chordae;

wherein the leaflet anchor is enlargeable from a first reduced cross section for advancing through the leaflet, to a second, enlarged cross section for contacting an atrial side of the leaflet, and

wherein the neo chordae comprises a first component extending proximally from the neo papillary muscle and a second component extending distally from the leaflet anchor, and wherein a proximal portion of the first component and a distal portion of the second component are joined together by a locking device.

30. The assembled in situ mitral valve leaflet restraint as in claim 29, wherein the helical anchor comprises a laser cut hypotube.

31. The assembled in situ mitral valve leaflet restraint as in claim 29, wherein the helical anchor comprises a coiled round wire.

32. The assembled in situ mitral valve leaflet restraint as in claim 31, wherein the helical anchor comprises two coiled round wires.

33. The assembled in situ mitral valve leaflet restraint as in claim 29, wherein the leaflet anchor comprises a pledget.

34. The assembled in situ mitral valve leaflet restraint as in claim 33, wherein the pledget is configured to be collapsed by pulling a suture coupled to the pledget, the pledget assuming the second, enlarged cross section when collapsed.

35. The assembled in situ mitral valve leaflet restraint as in claim 33, wherein a suture is threaded through at least two apertures in the pledget.

36. The assembled in situ mitral valve leaflet restraint as in claim 35, wherein the suture is threaded through at least three apertures in the pledget, the apertures being substantially collinear.

37. The assembled in situ mitral valve leaflet restraint as in claim 29, wherein the helical anchor comprises a hub configured for receiving and frictionally securing a suture.

38. The assembled in situ mitral valve leaflet restraint as in claim 29, wherein the helical anchor comprises a loop for securing the neo papillary muscle to the helical anchor.

39. The assembled in situ mitral valve leaflet restraint as in claim 29, wherein the neo papillary muscle comprises a soft ribbon.

40. The assembled in situ mitral valve leaflet restraint as in claim 29, wherein the leaflet anchor comprises a T tag bar and wherein the T tag bar comprising a bar rotatably coupled to a suture such that rotation of the bar enlarges the leaflet anchor from the first reduced cross section to the second, enlarged cross section.

41. The assembled in situ mitral valve leaflet restraint as in claim 29, wherein the leaflet anchor comprises a hub, the hub comprising a plurality of flexible radially extending spokes, and wherein the spokes are configured to bend into alignment along a longitudinal axis so as to be confined within a delivery needle and biased to expand radially outward when unconfined to enlarge the leaflet anchor from the first reduced cross section to the second, enlarged cross section.