Methods and apparatus for cardiac valve repair

• US 20040039442A1
• Filed: 08/07/2003
• Published: 02/26/2004
• Est. Priority Date: 04/09/1999
• Status: Abandoned Application

• Current Assignee: Evalve, Inc. (Abbott Laboratories)
• Original Assignee: Evalve, Inc. (Abbott Laboratories)
• Inventors: Gifford, Hanson S. III, Dell, Kent D., Goldfarb, Eric A., Deem, Mark E., Dieck, Martin S., Powell, Ferolyn T., Fan, Sylvia Wen-Chin, Fann, James I-Lin, St. Goar, Frederick G., Martin, Brain B.
• Application Number:
  US10/638,022
• Publication Number:
  US 20040039442A1
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• 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 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00243 : cardiac
• CPC Class Codes: A61B 2017/00575 : for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 : Barbed implements
• CPC Class Codes: A61B 2017/00588 : Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 : Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 : Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 : Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00783 : Valvuloplasty
• CPC Class Codes: A61B 2017/00867 : shape memory effect
• CPC Class Codes: A61B 2017/0404 : Buttons
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/0443 : the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/045 : snug fit within the anchor
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks
• 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
• CPC Class Codes: A61B 2017/06057 : Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06076 : helically or spirally coiled
• CPC Class Codes: A61B 2017/061 : hollow or tubular
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2017/088 : Sliding fasteners
• CPC Class Codes: A61B 2017/2906 : Multiple forceps
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 2017/2931 : with releasable head
• CPC Class Codes: A61B 2018/00291 : using suction
• CPC Class Codes: A61B 8/10 : Eye inspection
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 : Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 : Devices for obstructing a leak through a native valve in a closed condition

Abstract

The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.

Claims

1. A method for repairing an atrioventricular valve within a heart, said method comprising:

accessing a patient'"'"'s vasculature remote from the heart;

advancing an interventional catheter through the vasculature into the heart, the interventional catheter having an interventional tool at a distal end thereof;

orienting the interventional tool relative to a tissue structure on or near the atrioventricular valve by deflecting the distal end of the interventional catheter; and

implanting a portion of the interventional tool in engagement with the tissue structure to modify the tissue structure in a manner that reduces leakage through the valve during ventricular systole.

2. A method as in claim 1, wherein orienting further comprises positioning the tool relative to a line of coaptation of leaflets the atrioventricular valve.

3. A method as claim 2, wherein positioning comprises engaging positioning elements in at least one commissure of the valve.

4. A method as in claim 1, wherein the tissue structure is selected from the group consisting of valve leaflets, chordae, valve annulus, and papillary muscles.

5. A method as in claim 1, wherein the tissue structure comprises valve leaflets and the implanting step comprises attaching opposed points on or along the valve leaflets together.

6. A method as in claim 5, wherein attaching comprises suturing, clipping, stapling, riveting, gluing, or fusing said opposed points together.

7. A method as in claim 5, wherein the opposed points are located from 1 mm to 4 mm inward from the free edge of the valve leaflet.

8. A method as in claim 5, further comprising capturing the valve leaflets and holding the leaflets together prior to the implanting step.

9. A method as in claim 8, wherein the heart remains beating during the capturing and holding steps, the method further comprising observing flow through the held valve leaflets to determine if regurgitation has been inhibited.

10. A method as in claim 9, further comprising repositioning the held valve leaflets if the regurgitation has not been sufficiently inhibited.

11. A method as in claim 1, wherein the heart remains beating during the implanting step.

12. A method as in claim 1, further comprising stopping the heart beating so that the beating is stopped during the implanting step.

13. A method as in claim 12, wherein the patient is on cardiopulmonary bypass.

14. A method as in claim 12, wherein the beating is stopped temporarily.

15. A method as in claim 14, wherein the beating is stopped temporarily by drug administration.

16. A method as in claim 1, further comprising visualizing the tissue structure during the orienting and implanting steps.

17. A method as in claim 16, wherein visualization comprises trans-esophageal echocardiography, fluoroscopy, or angioscopy.

18. A system for repairing a cardiac valve, said system comprising:

a guide catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve;

an interventional catheter configured to pass through the guide catheter to a tissue location on or near the cardiac valve, the valve annulus, the papillary muscles, or the valve chordae;

means for orienting the interventional catheter so as to be in alignment with the tissue location;

an interventional tool on the interventional catheter, at least a portion of the interventional tool being deployable from the interventional catheter and adapted to modify the cardiac valve, the valve annulus, the papillary muscles, or the valve chordae to reduce regurgitation.

19. A system as in claim 18, wherein the means for orienting are disposed on the guide catheter.

20. A system as in claim 19, wherein the means for orienting comprises a steering mechanism.

21. A system as in claim 19, wherein the means for orienting comprises a preformation of shape of the guide catheter.

22. A system as in claim 18, further comprising an additional means for orienting the interventional catheter so as to be in alignment with the tissue location, wherein the additional means for orienting are disposed on the interventional catheter.

23. A system as in claim 18, wherein the means for orienting are disposed on the interventional catheter.

24. A system as in claim 23, wherein the means for orienting comprises a steering mechanism.

25. A system as in claim 23, wherein the means for orienting comprises a preformation of shape of the interventional catheter.

26. A system as in claim 18, wherein the guide catheter comprises a stabilizing mechanism for engaging a tissue structure within the heart to reduce relative movement between the guide catheter and the heart.

27. A system as in claim 26, wherein the stabilizing mechanism is adapted to engage at least one of the interatrial septum, the atrial wall, the valve annulus, and the valve commissures.

28. A system as in claim 26, wherein the stabilizing mechanism comprises an extensible wire that is deployed radially outward to engage the tissue structure.

29. A system as in claim 26, wherein the stabilizing mechanism comprises an expansible cage that occupies the atrium.

30. A system as in claim 21, wherein the stabilizing mechanism comprises a pair of spaced-apart inflatable balloons adapted to capture the interatrial septum therebetween.

31. A system as in claim 18, wherein the interventional tool is selected from the group consisting of suturing devices, stapling devices, clip-applying devices, radiofrequency electrodes, and annuloplasty ring-applying devices.

32. A system as in claim 18, further comprising a chordae capture catheter for repair of an atrioventricular valve.

33. A system for repairing a cardiac valve, said system comprising:

a guide catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve;

an interventional catheter configured to pass through the guide catheter to a tissue location on or near the cardiac valve, a valve annulus, a papillary muscle, or a valve chordae, the interventional catheter comprising a stabilizing mechanism for engaging a tissue structure within the heart to reduce relative motion between the interventional catheter and the heart; and

an interventional tool on the interventional catheter, at least a portion of the interventional tool being deployable from the interventional catheter and adapted to modify the cardiac valve, the valve annulus, the papillary muscle, or the valve chordae to reduce regurgitation.

34. A system as in claim 33, wherein the interventional tool comprises a valve leaflet capture device for temporarily holding valve leaflets prior to modification.

35. A system as in claim 34, wherein the valve leaflet capture device comprises at least two jaws which grasp the valve leaflets.

36. A system as in claim 34, wherein the valve leaflet capture device comprises at least one radially expansible superior loop and at least one radially expansible inferior loop, wherein the superior loop contacts a superior surface of the valve leaflet and the inferior loop contacts an inferior surface of the valve leaflet when the loops are in an expanded position to capture a portion of the valve leaflet between the loops.

37. A system as in claim 34, wherein the valve leaflet capture device comprises a pair of opposing coils, wherein each coil curves outwardly and upwardly to contact an inferior surface of a valve leaflet and capture the valve leaflets between the coils.

38. A system as in claim 34, wherein the valve leaflet capture device comprises at least two opposing prongs arranged to grasp a valve leaflet.

39. A system as in claim 38, wherein the opposing prongs are opened by retraction of a grasping sheath and closed by advancement of the grasping sheath over at least a portion of the prongs.

40. A system as in claim 34, wherein the valve leaflet capture device comprises a vacuum or suction applicator to capture the valve leaflet.

41. A method for treating an atrioventricular valve having a first valve leaflet and a second valve leaflet within a heart, said method comprising:

accessing a patient'"'"'s vasculature remote from the heart;

advancing an interventional tool through the vasculature to near the atrioventricular valve, the interventional tool comprising at least one capture element; and

capturing chordae attached to the first valve leaflet and chordae attached to the second valve leaflet with the at least one capture element; and

manipulating the captured chordae attached to the first valve leaflet or to the second valve leaflet in a manner that reduces leakage through the valve during ventricular systole.

42. A method as in claim 41, wherein the at least one capture element comprises a first capture coil used to capture chordae attached to the first valve leaflet and a second capture coil used to capture chordae attached to the second valve leaflet.

43. A method as in claim 42, wherein manipulating comprises drawing the coils laterally together to coapt the valve leaflets.

44. A method as in claim 41, wherein the at least one capture element comprises a single capture element used to capture chordae attached to the first valve leaflet and to the second valve leaflet.

45. A method as in claim 44, wherein manipulating comprises forming a loop with the single capture element and tightening the loop to coapt the valve leaflets.

46. A method as in claim 41, further comprising securing the at least one capture element to maintain reduced leakage through the valve during ventricular systole.

47. A method as in claim 41, further comprising fixing leaflets of the valve together to maintain reduced leakage through the valve during ventricular systole.

48. A method for stabilizing an atrioventricular valve within a heart, said method comprising:

accessing a patient'"'"'s vasculature remote from the heart;

advancing an interventional catheter through the vasculature into the heart, the interventional catheter having an interventional tool at a distal end thereof;

orienting the interventional tool relative to a chordae attached to at least one leaflet of the atrioventricular valve by deflecting the distal end of the interventional catheter; and

capturing chordae attached to at least one leaflet of the valve while the heart is beating; and

holding the chordae in a position that reduces leakage through the valve during ventricular systole.

49. A method as in claim 48, wherein capturing comprises capturing chordae attached to two different valve leaflets.

50. A method as in claim 49, wherein holding the chordae comprises affixing the chordae attached to two different valve leaflets together while the chordae remain captured.

51. A method as in claim 48, wherein holding includes shortening the valve chordae while the chordae remain captured.

52. A method as in claim 51, wherein shortening the valve chordae comprises positioning a stabilization coil in engagement with the chordae and actuating contraction of the coil which shortens the chordae.

53. A method as in claim 51, wherein shortening the valve chordae comprises positioning an energy-applying coil in engagement with the chordae and applying energy to the coil which shortens the chordae.

54. A method as in claim 51, wherein shortening the valve chordae comprises positioning mechanical plication devices in engagement with the chordae which shortens the chordae.

55. A method for stabilizing an atrioventricular valve, said method comprising:

capturing chordae attached to at least one leaflet of the valve while the heart is beating by surrounding the chordae with a capture device; and

repositioning or changing the shape of the capture device so as to tension at least a portion of the chordae to modify movement of the leaflet.

56. A chordae capture catheter comprising:

a catheter body having a proximal end and a distal end;

a capture device at the distal end of the catheter for capturing chordae; and

means for repositioning or reshaping the capture device so as to tension the chordae.

57. A catheter as in claim 56, wherein the capture device comprises a coil which is extensible from the distal end of the catheter body and which entangles the chordae when advanced therein.

58. A catheter as in claim 56, wherein the capture device comprises a loop element which is extensible from the distal end of the catheter body and which is preformed to pass through chordae and return to the catheter body to complete a loop.

59. A valve leaflet capture catheter, said catheter comprising:

a catheter body having a proximal end and a distal end; and

a leaflet grasper at the distal end of the catheter body, said grasper including a central member and at least two arms pivotable relative to the central member for capturing leaflets between the arms and the central member.

60. A catheter as in claim 59, further comprising means for affixing the valve leaflets after they are captured.

61. A catheter as in claim 60, wherein the affixing means comprises a clip-applier or stapler.

62. A catheter as in claim 59 wherein the leaflet grasper is detachable from the catheter body.

63. A catheter as in claim 59 wherein the central member has surface texture for frictionally engaging the leaflets.

64. A catheter as in claim 59 wherein the arms have surface texture for frictionally engaging the leaflets.

65. A catheter as in claim 59 wherein grasper is configured so that the leaflets are captureable in vertical opposition between the arms and the central member.

66. A catheter as in claim 59 wherein the grasper is configured so that the leaflets are clampable between the arms and the central member.

67. A catheter as in claim 59 wherein the central member is coupled to the catheter body and the arms are coupled to the central member.

68. A catheter as in claim 59 wherein the arms are openable and closeable in tandem.

69. A catheter as in claim 59 wherein the arms are openable and closeable independently.

70. A catheter as in claim 59 wherein the arms do not penetrate the leaflets.