Methods and apparatus for atrioventricular valve repair

• US 9,763,658 B2
• Filed: 04/06/2012
• Issued: 09/19/2017
• Est. Priority Date: 08/02/2002
• Status: Active Grant

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Eigler, Neal L., Price, Matthew J., Siegel, Robert J.
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US13/441,308
• Publication Number:
  US 20120310331A1
• Time in Patent Office: 1,992 Days
• Field of Search: 606139, 623 211
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising

Abstract

Methods and devices are disclosed for minimally invasive procedures in the heart. In one application, a catheter is advanced from the left atrium through the mitral valve and along the left ventricular outflow tract to orient and stabilize the catheter and enable a procedure such as a “bow tie” repair of the mitral valve. Right heart procedures are also disclosed.

Claims

1. A method of performing a procedure in the heart, comprising the steps of:

providing a catheter having an elongate flexible body, a proximal end, a distal end, and a procedure zone, spaced proximally apart from the distal end;

advancing the catheter antegrade through the mitral valve, through the aortic valve and into the aorta, such that the procedure zone is positioned upstream from the aortic valve and a length of the catheter extending proximally of the distal end is positioned in the ascending aorta, the length of the catheter extending proximally of the distal end providing a fulcrum for manipulating the procedure zone by torqueing the proximal end, the length of the catheter extending proximally of distal end having a maximum outer periphery smaller than the inner periphery of the ascending aorta; and

performing a procedure on the mitral valve from the procedure zone while maintaining the maximum outer periphery of the length of the catheter extending proximally of the distal end smaller than the inner periphery of the ascending aorta to provide a flow path for blood ejected from the heart by contraction of the left ventricle around the distal end of the catheter during the procedure.

2. The method of performing a procedure in the heart as in claim 1, wherein the advancing step comprises advancing the catheter along a guidewire.

3. The method of performing a procedure in the heart as in claim 2, additionally comprising the steps of positioning a flow directed catheter through the mitral valve, through the aortic valve and into the aorta, advancing the guidewire through the flow directed catheter, and removing the flow directed catheter.

4. The method of performing a procedure in the heart as in claim 2, wherein the guidewire is a flow directed guidewire.

5. The method of performing a procedure in the heart as in claim 2, wherein the catheter comprises an opening in a side wall of the catheter.

6. The method of performing a procedure in the heart as in claim 2, wherein the catheter comprises an outer tubular wall having a central lumen, and an inner elongate flexible body extendable through the central lumen, and the procedure zone comprises an opening at a distal end of the outer tubular wall.

7. The method of performing a procedure in the heart as in claim 1, wherein the catheter is a flow directed catheter.

8. The method of performing a procedure in the heart as in claim 1, wherein the advancing step comprises advancing the catheter to position the procedure zone within a flow path between the mitral valve and the aortic valve.

9. The method of performing a procedure in the heart as in claim 1, wherein the procedure zone comprises an opening carried by the catheter.

10. The method of performing a procedure in the heart as in claim 1, wherein the procedure comprises a diagnostic procedure.

11. The method of performing a procedure in the heart as in claim 1, wherein the procedure comprises a therapeutic procedure.

12. The method of performing a procedure in the heart as in claim 1, wherein the procedure comprises an imaging procedure.

13. The method of performing a procedure in the heart as in claim 1, wherein the procedure comprises a hemodynamic monitoring procedure.

14. The method of performing a procedure in the heart as in claim 1, wherein the procedure comprises an ablation procedure.

15. The method of performing a procedure in the heart as in claim 1, wherein the procedure comprises an atrioventricular valve repair.

16. The method of performing a procedure in the heart as in claim 1, further comprising the step of transluminally advancing the catheter through the intra atrial septum prior to the advancing step.

17. The method of performing a procedure in the heart as in claim 1, wherein the procedure comprises grasping at least one leaflet of the mitral valve.

18. The method of performing a procedure in the heart as in claim 1, wherein the procedure comprises attaching the anterior leaflet of the mitral valve to the posterior leaflet of the mitral valve.

19. The method of performing a procedure in the heart as in claim 1, wherein performing a procedure on the mitral valve comprises attaching a clip to a first leaflet of the mitral valve.

20. A method of orienting a first and second tissue grasper with respect to the mitral valve, comprising the steps of:

providing a catheter having an elongate, flexible body, with a proximal end, a distal end and first and second tissue graspers spaced apart from the distal end;

transluminally advancing the distal end from the left atrium through the mitral valve and along the left ventricular outflow tract into the ascending aorta;

engaging the left ventricular outflow tract or ascending aorta with the distal end; and

positioning the catheter by way of torqueing the proximal end relative to a fulcrum established by the step of engaging such that the first and second tissue graspers are adjacent the mitral valve.

21. The method as in claim 20, further comprising the step of extending at least the first tissue grasper radially outwardly from the flexible body.

22. The method as in claim 21, wherein the extending step comprises advancing the first tissue grasper from a first position in which a longitudinal axis of the tissue grasper extends generally parallel with the flexible body, to a second position in which the axis is inclined with respect to the flexible body.

23. The method as in claim 21, wherein the extending step comprises advancing the first tissue grasper distally along a pathway which is inclined with respect to a longitudinal axis of the catheter.

24. The method of orienting a first and second tissue grasper with respect to the mitral valve as in claim 20, further comprising attaching a clip to a first leaflet of the mitral valve.

25. A method of grasping a mitral valve leaflet, comprising the steps of:

providing a catheter having an elongate, flexible body, with a proximal end and a distal end;

transluminally advancing the distal end from the left atrium through the mitral valve and along the left ventricular outflow tract into the ascending aorta;

deploying a tissue grasper from a position on the catheter spaced apart from the distal end;

positioning the tissue grasper by way of a fulcrum established at the distal end; and

grasping a mitral valve leaflet by advancing the tissue grasper toward the valve leaflet from a position downstream of the valve leaflet to initially grasp the valve leaflet.

26. The method of grasping a mitral valve leaflet as in claim 25, wherein the grasping step comprises piercing the leaflet.

27. The method of grasping a mitral valve leaflet as in claim 25, wherein the grasping step comprises trapping the leaflet.

28. The method of grasping a mitral valve leaflet as in claim 25, wherein the grasping step comprises applying suction to the leaflet.

29. The method of grasping a mitral valve leaflet as in claim 25, further comprising attaching a clip to a first leaflet of the mitral valve.

30. A method of performing an atrioventricular valve repair, comprising the steps of:

providing a catheter having an elongate, flexible body, with a proximal end, a distal end, and a first and second leaflet grasper thereon, the first leaflet grasper being asymmetric to the second leaflet grasper;

transluminally advancing the distal end from the left atrium through the mitral valve and along the left ventricular outflow tract into the ascending aorta such that a first lateral portion of the distal end braces against a medial wall of the ascending aorta and a second lateral portion opposite the first lateral portion is spaced away from a lateral wall of the ascending aorta, such that a flow path is provided between the second lateral portion and the lateral wall of the ascending aorta;

positioning the first and second leaflet grasper relative to the mitral valve by way of a fulcrum established at the first lateral portion of the distal end;

grasping at least a first leaflet of the mitral valve with the first leaflet grasper while maintaining blood flow ejected by the heart through the flow path and around the distal end during a beating hear procedure; and

securing the first leaflet to at least one other anatomical structure while maintaining blood flow ejected by the heart through the flow path and around the distal end during a beating heart procedure.

31. The method of performing an atrioventricular valve repair as in claim 30, wherein the securing step comprises securing the first leaflet to a second leaflet.

32. The method of performing an atrioventricular valve repair as in claim 30, wherein the securing step comprises securing the first leaflet to a valve annulus.

33. The method of performing an atrioventricular valve repair as in claim 30, wherein the securing step comprises advancing a suture through the first leaflet.

34. The method of performing an atrioventricular valve repair as in claim 30, wherein the securing step comprises attaching a clip to the first leaflet.

35. The method of performing an atrioventricular valve repair as in claim 30, wherein the securing step comprises attaching a tissue anchor to the first leaflet.

36. A method of orienting a catheter with respect to the mitral valve, comprising the steps of:

positioning a guidewire from the left atrium through the mitral valve and along the left ventricular outflow tract into the ascending aorta;

advancing a catheter along the guidewire, the catheter having an anchor and a procedure site, the procedure site comprising a leaflet grasper spaced proximally apart from the anchor; and

locating the anchor within the ascending aorta such that the leaflet grasper is at a predetermined orientation with respect to the mitral valve.

37. The method of orienting a catheter as in claim 36, wherein the positioning step includes the use of a flow directed structure.

38. The method of orienting a catheter as in claim 36, wherein the locating the anchor step comprises positioning a distal portion of the catheter within the ascending aorta.

39. The method of orienting a catheter as in claim 36, wherein the locating the anchor step comprises positioning the catheter such that it is approximately centered on the posterior leaflet of the mitral valve.

40. The method of orienting a catheter with respect to the mitral valve as in claim 36, further comprising attaching a clip to a first leaflet of the mitral valve.

41. A method of performing a procedure in the heart, comprising the steps of:

providing a catheter having an elongate flexible body, a proximal end, a distal end, and a procedure zone, spaced proximally apart from the distal end;

advancing the catheter through the right atrium, through the right ventricle and into the pulmonary artery, such that the procedure zone is positioned at a treatment site, a length of the catheter extending proximally of the distal end being positioned in the pulmonary artery to provide a fulcrum for manipulating the procedure zone by torqueing the proximal end;

performing a procedure on a tricuspid valve from the procedure zone;

removing the catheter from the patient after performing the procedure;

wherein the heart continues to beat from before the step of performing the procedure until after the step of removing the catheter.

42. The method of performing a procedure in the heart as in claim 41, wherein the advancing step comprises advancing the catheter along a guidewire.

43. The method of performing a procedure in the heart as in claim 42, wherein the procedure is performed on the tricuspid valve.

44. The method of performing a procedure in the heart as in claim 42, wherein the procedure is performed on the pulmonic valve.

45. The method of performing a procedure in the heart as in claim 41, wherein the advancing step comprises advancing the catheter to position the distal end in the right ventricle outflow tract of the pulmonary artery.

46. The method of performing a procedure in the heart as in claim 41, wherein the procedure comprises a valve repair.

47. The method of performing a procedure in the heart as in claim 41, wherein the procedure comprises grasping at least one leaflet of a valve.

48. The method of performing a procedure in the heart as in claim 41, wherein the procedure comprises attaching a first leaflet of a valve to a second leaflet of a valve.

49. The method of performing a procedure in the heart as in claim 41, wherein performing a procedure on a tricuspid valve from the procedure zone comprises attaching a clip to a first leaflet of the tricuspid valve.

50. A method of performing a procedure in the heart, comprising the steps of:

providing a catheter having an elongate flexible body, a proximal end, a distal end, and a procedure zone, the procedure zone comprising a leaflet grasper spaced proximally apart from the distal end;

advancing the catheter through at least two valves in the heart, through a first chamber in the heart and at least into a second chamber in the heart;

bracing the distal end of the catheter against tissue disposed downstream of the at least two valves such that a first manipulation of the proximal end induces translation of the procedure zone along a line of coaptation of one of the at least two valves and a second manipulation of the proximal end induces rotation of the procedure zone relative to at least two leaflets of the one of the at least two valves; and

performing a procedure on a heart valve from the procedure zone.

51. The method of performing a procedure in the heart as in claim 50, comprising advancing the catheter through the mitral valve and the aortic valve.

52. The method of performing a procedure in the heart as in claim 50, wherein the procedure comprises a valve repair.

53. The method of performing a procedure in the heart as in claim 50, wherein performing a procedure on a heart valve from the procedure zone comprises attaching a clip to a first leaflet of the heart valve.

54. A method for repairing a heart valve, the method comprising:

inserting a catheter proximal to first and second leaflets of a mitral valve, the catheter comprising an anchor zone spaced distally apart from a first leaflet immobilization support;

advancing the anchor zone into the ascending aorta to bring the first leaflet immobilization support into the left ventricle;

torqueing the anchor against an anatomical structure to position the first leaflet immobilization support over the first leaflet of the mitral valve;

engaging the first leaflet of the mitral valve with the first leaflet immobilization support;

engaging the second leaflet of the mitral valve with a second leaflet immobilization support;

advancing a first fixating member through the first leaflet immobilization support, engaging thereby a receptacle within the first leaflet immobilization support, wherein the receptacle is attached to a first end of fastening material;

advancing a second fixating member through the second leaflet immobilization support, engaging thereby a receptacle within the second leaflet immobilization support, wherein the receptacle is attached to a second end of fastening material;

retracting the fixating members, thereby pulling the fastening material through the leaflets;

withdrawing the catheter, the leaflet immobilization supports, and the fixating members; and

tying off the fastening material.

55. The method of claim 54, wherein the catheter further comprises an inflatable balloon, and the method further comprises inflating the balloon during the step of inserting the catheter proximal to the first and second leaflets of the heart valve.

56. The method of claim 55, wherein the inflated balloon rests in the aortic valve anchoring the catheter.

57. A method for repairing a cardiac atrioventricular valve comprising:

positioning a leaflet immobilization device across a mitral valve and an extension thereof into the ventricular outflow tract wherein the ventricular outflow tract and the extension orients the leaflet immobilization device so that immobilization of the leaflets will occur without interfering with papillary muscles, chordal structures, or other cardiac structures, wherein a distal end of the extension braces against a portion of the ascending aorta to create a fulcrum that assists with the positioning of the leaflet immobilization device.

58. The method for repairing a cardiac atrioventricular valve as in claim 57, further comprising attaching a clip to a first leaflet of the cardiac atrioventricular valve.