METHOD AND APPARATUS FOR REPAIRING A MITRAL VALVE

• US 20130211513A1
• Filed: 02/13/2013
• Published: 08/15/2013
• Est. Priority Date: 02/13/2012
• Status: Active Grant

• Current Assignee: MitraSpan, Inc.
• Original Assignee: MitraSpan, Inc.
• Inventors: Rourke, Jonathan M., Kyi, Stanley B.
• Granted Patent: US 9,011,531 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/06104 interconnected at their distal ends, e.g. two hollow needles forming a loop for passing a suture
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2/2466 Delivery devices therefor

Abstract

A method for repairing a mitral valve, the method comprising:

• • positioning a crossing guidewire across the mitral valve, the crossing guidewire passing through the annulus of the mitral valve at a first location and passing through the annulus of the mitral valve at a second location;
  • using the crossing guidewire to position a spanning implant across the mitral valve, with the spanning implant extending from the first location to the second location;
  • anchoring the spanning implant at the first location;
  • tensioning the spanning implant so as to draw the first location and the second location together; and
  • anchoring the spanning implant at the second location.

Claims

1. A method for repairing a mitral valve, the method comprising:

positioning a crossing guidewire across the mitral valve, the crossing guidewire passing through the annulus of the mitral valve at a first location and passing through the annulus of the mitral valve at a second location;

using the crossing guidewire to position a spanning implant across the mitral valve, with the spanning implant extending from the first location to the second location;

anchoring the spanning implant at the first location;

tensioning the spanning implant so as to draw the first location and the second location together; and

anchoring the spanning implant at the second location.

2. A method according to claim 1 wherein the mitral valve is accessed by penetrating the wall of the left ventricle in the vicinity of the apex.

3. A method according to claim 1 wherein the crossing guidewire is positioned by accessing the left ventricle of the heart;

passing a first guidewire from the left ventricle to the left atrium at the first location;

passing the first guidewire from the left atrium through the valve leaflets, through the left ventricle and out to an operative sterile field;

passing a second guidewire from the left ventricle to the left atrium at the second location;

passing the second guidewire from the left atrium through the valve leaflets, through the left ventricle and out to the operative sterile field;

terminating an end of the first guidewire to an end of the second guidewire at the operative sterile field so as to create the complete crossing guidewire; and

passing the termination from the operative sterile field, through the left ventricle, through the valve leaflets, to the left atrium.

4. A method according to claim 3 wherein the first guidewire is passed from the left ventricle to the left atrium at the first location by advancing a first positioning sheath through the left ventricle so that the distal end of the first positioning sheath is positioned against the annulus at the first location, advancing a first curved tube out of the first positioning sheath and through the annulus at that first location, and advancing the first guidewire through the first curved tube and into the left atrium.

5. A method according to claim 4 wherein the first curved tube has a sharp distal end so that it may be pushed through the annulus.

6. A method according to claim 4 wherein the first curved tube receives an RF wire therein, and further wherein the RF wire is used to create an opening in the annulus for receiving the first curved tube.

7. A method according to claim 3 wherein the first guidewire is passed from the left atrium through the valve leaflets, through the left ventricle and out to an operative sterile field by advancing a snare from the left ventricle, through the valve leaflets and into the left atrium, snaring the first guidewire with the snare, and retracting the snare from the left atrium, through the valve leaflets and through the left ventricle.

8. A method according to claim 3 wherein the second guidewire is passed from the left ventricle to the left atrium at the second location by advancing a second positioning sheath through the left ventricle so that the distal end of the second positioning sheath is positioned against the annulus at the second location, advancing a second curved tube out of the second positioning sheath and through the annulus at that second location, and advancing the second guidewire through the second curved tube and into the left atrium.

9. A method according to claim 8 wherein the second curved tube has a sharp distal end so that it may be pushed through the annulus.

10. A method according to claim 8 wherein the second curved tube receives an RF wire therein, and further wherein the RF wire is used to create an opening in the annulus for receiving the second curved tube.

11. A method according to claim 3 wherein the second guidewire is passed from the left atrium through the valve leaflets, through the left ventricle and out to an operative sterile field by advancing a snare from the left ventricle, through the valve leaflets and into the left atrium, snaring the second guidewire with the snare, and retracting the snare from the left atrium, through the valve leaflets and through the left ventricle.

12. A method according to claim 1 wherein the crossing guidewire is positioned by accessing the left ventricle of the heart;

passing the crossing guidewire from the left ventricle to the left atrium at the first location;

passing a funnel-shaped snare from the left ventricle to the left atrium at the second location;

capturing the crossing guidewire with the funnel-shaped snare in the left atrium;

retracting the funnel-shaped snare and captured crossing guidewire through the annulus at the second location and through the left ventricle.

13. A method according to claim 1 wherein the crossing guidewire is positioned by accessing the left ventricle of the heart;

passing the crossing guidewire from the left ventricle to the left atrium at the first location;

passing an inflatable funnel from the left ventricle to the left atrium at the second location while the inflatable funnel is in a deflated condition;

inflating the inflatable funnel;

advancing the crossing guidewire into the inflatable funnel and through the annulus at the second location, and through the left ventricle.

14. A method according to claim 1 wherein the spanning implant is positioned across the mitral valve by attaching the spanning implant to the crossing guidewire and using the crossing guidewire to pull the spanning implant into position.

15. A method according to claim 1 wherein the spanning implant comprises a suture having a first end and a second end, a first anchor secured to the first end of the suture, a second anchor slidably mounted to the second end of the suture, and a coaxial suture lock for locking the second anchor to the suture.

16. A method according to claim 15 wherein the spanning implant is anchored at the first location using the first anchor.

17. A method according to claim 15 wherein the first anchor is positioned on the ventricular side of the annulus.

18. A method according to claim 15 wherein the spanning implant is anchored at the second location using the second anchor.

19. A method according to claim 15 wherein the second anchor is positioned on the ventricular side of the annulus.

20. A method according to claim 1 wherein the spanning implant is dynamically tensioned while observing changes in the function of the mitral valve.

21. Apparatus for repairing a mitral valve, the apparatus comprising:

a suture having a first end and a second end, a first anchor secured to the first end of the suture, a second anchor slidably mounted to the second end of the suture, and a coaxial suture lock for locking the second anchor to the suture.

22. Apparatus according to claim 21 wherein the second end of the suture is configured to be secured to a guidewire.

23. Apparatus according to claim 21 wherein the first anchor comprises a T-bar anchor.

24. Apparatus according to claim 23 further comprising a control line releasably secured to the T-bar anchor.

25. Apparatus according to claim 21 wherein the second anchor comprise a T-bar anchor.

26. Apparatus according to claim 21 wherein the coaxial suture lock is configured to bind to the suture upon the application of a compressive radial force to the coaxial suture lock.

27. Apparatus for repairing a mitral valve, the apparatus comprising:

a crossing guidewire extending from the left ventricle, through the annulus at a first location, into the left atrium, through the annulus at a second location, and into the left ventricle.

28. Apparatus for repairing a mitral valve, the apparatus comprising:

a positioning sheath having a distal end, a proximal end, and a lumen extending therebetween, the positioning sheath being configured to extend across the left ventricle and contact the annulus of the mitral valve at a first location, with the distal end of the positioning sheath set so that the lumen of the positioning sheath is aimed into the left atrium; and

a curved tube having a distal end, a proximal end, and a lumen extending therebetween, the curved tube being configured to telescopically extend through the positioning sheath, across the annulus at the first location and present its distal end substantially parallel to the plane of the mitral valve annulus.

29. Apparatus according to claim 28 further comprising a guidewire sized to be telescopically disposed within the curved tube.

30. Apparatus according to claim 29 further comprising a snare for capturing the guidewire when the guidewire is telescopically advanced out of the distal end of the curved tube.

31. Apparatus according to claim 28 further comprising:

a second positioning sheath having a distal end, a proximal end, and a lumen extending therebetween, the second positioning sheath being configured to extend across the left ventricle and contact the annulus of the mitral valve at a second location, with the distal end of the second positioning sheath set so that the lumen of the second positioning sheath is aimed into the left atrium;

a second curved tube having a distal end, a proximal end, and a lumen extending therebetween, the second curved tube being configured to telescopically extend through the second positioning sheath, across the annulus at the second location and present its distal end substantially parallel to the plane of the mitral valve annulus; and

a guidewire extendable through the first curved tube and receivable within the second curved tube.

32. Apparatus according to claim 31 further comprising a suture having a first end and a second end, a first anchor secured to the first end of the suture, a second anchor slidably mounted to the second end of the suture, and a coaxial suture lock for locking the second anchor to the suture, and further wherein the second end of the suture is releasably secured to the guidewire.