METHODS AND DEVICES FOR CAPTURING AND FIXING LEAFLETS IN VALVE REPAIR

• US 20080183194A1
• Filed: 10/30/2007
• Published: 07/31/2008
• Est. Priority Date: 04/09/1999
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Raschdorf, Alfred H., Thornton, Troy L., Dell, Kent D., Goldfarb, Eric A., Powell, Ferolyn T., Fan, Sylvia Wen-Chin, Martin, Brian B.
• Granted Patent: US 8,029,518 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• 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 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• 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 for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00986 : Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0404 : Buttons
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 : 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 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• 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 J-shaped suture needles A61B2017/0608
• 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 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 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 for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/088 : Sliding fasteners
• CPC Class Codes: A61B 2017/2908 : Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 8/10 : Eye inspection
• 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 2/246 : Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 : Implants forming part of the valve leaflets

Abstract

The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Claims

1. A device for repairing a cardiac valve, said device comprising:

an interventional catheter adapted to pass from the remote vasculature of a patient to a position within a heart of the patient adjacent to the cardiac valve; and

a capture device on the interventional catheter comprising at least one distal element coupled to the catheter, wherein the distal element is protrudable radially outward and is adapted to press against a downstream surface of at least one leaflet,

wherein the interventional catheter further comprises at least one fixation tool for fixing the valve leaflet to a second valve leaflet,

the fixation tool comprising a penetrating device which has a suture and an anchor coupled with the suture, and

wherein the anchor has a first profile adapted to be housed at least partially within the penetrating device and a second profile larger than the first profile, the second profile adapted to engage the downstream surface of the at least one leaflet thereby anchoring the suture to the at least one leaflet.

2. The device as in claim 1, wherein the penetrating device is adapted to penetrate an atrial surface of the valve leaflet and pass therethrough so as to emerge on a ventricular surface of the valve leaflet.

3. The device of claim 1, wherein the second profile expands from the first profile which is in a compressed state.

4. The device of claim 1, wherein the anchor comprises a radiopaque marker.

5. The device of claim 1, wherein the anchor comprises one of a stainless steel, nitinol or a shape memory material.

6. The device of claim 1, wherein the anchor self-expands from the first profile to the second profile.

7. The device of claim 1, wherein the anchor is plastically deformed as it expands from the first profile to the second profile.

8. The device of claim 1, wherein the anchor comprises a wire with the first profile having a substantially linear configuration and the second profile having a curved ring shape.

9. The device of claim 1, wherein the anchor comprises two parts, the two parts positionable on opposite sides of the valve leaflet thereby capturing the valve leaflet therebetween.

10. The device of claim 9, wherein the first part comprises one or more spikes and the second part comprises one or more receptacles, the spikes penetrating the valve leaflet and interlocking with the receptacles.

11. The device of claim 1, wherein the anchor comprises a tubular structure adapted to radially expand upon delivery of the anchor through the valve leaflet.

12. The device of claim 11, wherein the tubular structure comprises a plurality of longitudinal slits.

13. The device of claim 11, wherein the tubular structure expands radially outward when axially compressed.

14. The device of claim 1, wherein the anchor comprises two or more beams, the beams adapted to expand radially outward.

15. The device of claim 1, wherein the anchor comprises a disk adapted to be rolled into a cylindrical shape.

16. The device of claim 1, wherein the anchor comprises a tubular structure having a plurality of axial arms adapted to bent outwardly.

17. The device of claim 1, wherein the anchor comprises a bar coupled to the suture and adapted to be substantially perpendicular to the suture after the bar has been deployed through the valve leaflet.

18. The device of claim 1, further comprising a second suture coupled to a second anchor in the penetrating device, the second anchor having a first profile adapted to be housed at least partially within the penetrating device and a second profile larger than the first profile, the second profile adapted to engage the downstream surface of the at least one leaflet thereby anchoring the second suture to the at least one leaflet.

19. A device for repairing a cardiac valve, said device comprising:

an interventional catheter adapted to pass from the remote vasculature of a patient to a position within a heart of the patient adjacent to the cardiac valve; and

a capture device on the interventional catheter comprising at least one distal element coupled to the catheter, wherein the distal element is protrudable radially outward and is adapted to press against a downstream surface of at least one leaflet,

wherein the capture device fixedly couples the valve leaflet to a second valve leaflet; and

a pledget adjacent the distal element, the pledget adapted to obstruct blood flow through a gap created by the device along a coaptation line between the at least one leaflet and a second leaflet.

20. The device of claim 19, wherein the pledget is disk shaped.

21. The device of claim 19, further comprising at least one proximal element disposed proximal to the distal element.

22. The device of claim 21, wherein the proximal element is protrudable radially outward.

23. The device of claim 21, wherein the pledget is positioned between the proximal and distal elements.

24. The device of claim 21, wherein the at least one leaflet is captured between the proximal and distal elements.

25. A device for repairing a cardiac valve, said device comprising:

an interventional catheter adapted to pass from the remote vasculature of a patient to a position within a heart of the patient adjacent to the cardiac valve; and

a capture device on the interventional catheter comprising at least one distal element coupled to the catheter, wherein the distal element comprises a block protrudable radially outward and is adapted to engage and press against a downstream surface of at least one leaflet,

wherein the interventional catheter further comprises at least one fixation tool for fixing the valve leaflet to a second valve leaflet, and

the fixation tool comprising a penetrating device which has a suture and an anchor coupled with the suture.

26. The device of claim 25, wherein the block is adapted to pivot about a pivot point.

27. The device of claim 25, wherein the block is a rod shaped or bar shaped.

28. The device of claim 25, wherein the catheter has a diameter and the distal element extends beyond the diameter.

29. The device of claim 26, further comprising a pull wire coupled to the block, the pull wire adapted to pivot the block about the pivot point.

30. The device of claim 26, wherein the distal element is pivotable about the pivot point to a position substantially perpendicular to the catheter.

31. The device of claim 25, wherein the block has one or more cutouts therein and the block is surrounded by one or more wire-like loops.

32. The device of claim 31, wherein the loops are adjustable thereby changing the engagement between the loops and downstream surface of the leaflet.

33. The device of claim 25, further comprising a second distal element coupled to the catheter and adapted to press against a downstream surface of at least a second leaflet.

34. The device of claim 33, wherein the first distal element is independently movable relative to the second distal element.

35. The device of claim 33, wherein the first distal element is extendable independently of the second distal element.

36. The device of claim 33, wherein the first distal element has a first angle of curvature and the second distal element has a second angle of curvature different than the first.

37. The device of claim 25, further comprising a cap near a distal end of the capture device.

38. The device of claim 37, wherein the cap has a blunt surface that facilitates atraumatic advancement of the capture device through the valve.

39. The device of claim 25, wherein moving the cap proximally toward the distal element facilitates grasping of the valve leaflet between the distal element and a distal end of the interventional catheter.

40. The device of claim 25, wherein the cap is positionable proximally toward the distal element thereby increasing the rigidity of the distal element.

41. A device for repairing a cardiac valve, said device comprising:

an interventional catheter adapted to pass from the remote vasculature of a patient to a position within a heart of the patient adjacent to the cardiac valve; and

a capture device on the interventional catheter comprising at least one distal element and one proximal element coupled to the catheter, wherein the distal element is protrudable radially outward and adapted to press against a downstream surface of at least one leaflet and the proximal element is adapted to press against an upstream surface of the at least one leaflet.

42. The device of claim 41, wherein the proximal and distal elements are formed by a continuous structure.

43. The device of claim 41, wherein the proximal and distal elements are formed from a wire-like filament.

44. The device of claim 41, wherein the proximal and distal elements are expandable into loops.

45. The device of claim 41, wherein the proximal and distal elements are collapsible into a helical shape.

46. A device for repairing a cardiac valve, said device comprising:

an interventional catheter adapted to pass from the remote vasculature of a patient to a position within a heart of the patient adjacent to the cardiac valve; and

a capture device on the interventional catheter comprising at least one distal element coupled to the catheter, wherein the distal element is protrudable radially outward and is adapted to press against a downstream surface of at least one leaflet,

wherein the interventional catheter further comprises at least one fixation tool for fixing the valve leaflet to a second valve leaflet, and

the fixation tool comprising a guide conduit adapted to house a penetrating device which has a suture and an anchor coupled with the suture.

47. The device of claim 46, wherein the guide conduit guides the penetrating device and suture through the at least one leaflet.

48. The device of claim 46, wherein the guide conduit is proximal to the at least one distal element.

49. The device of claim 46, wherein the guide conduit extends at an angle from the interventional catheter.

50. The device of claim 49, wherein the angle formed between the guide conduit and the interventional catheter ranges from about 0°

to about 90°

.

51. The device of claim 46, wherein the guide conduit is adapted to penetrate the valve leaflet.

52. The device of claim 46, wherein the guide conduit is extendable relative to the interventional catheter.

53. The device of claim 46, wherein the guide conduit is retractable relative to the interventional catheter.

54. The device of claim 46, wherein the guide conduit is adapted to deploy a snare on the ventricular side of the leaflet.

55. The device of claim 46, wherein the guide conduit comprises a suture holding feature.

56. The device of claim 55, wherein the suture holding feature comprises a notch.

57. The device of claim 55, wherein the guide conduit is adapted to capture suture on a ventricular side of the valve leaflet and to pull the suture to an atrial side of the valve leaflet.

58. The device of claim 46, wherein the fixation tool comprises a loop and a length of suture releasably coupled to the loop, and wherein the length of suture is adapted to be retracted away from the loop and passed through the valve leaflet.

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

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

a capture device comprising at least one distal element, wherein the distal element is protrudable radially outward and is adapted to press against a downstream surface of at least one leaflet,

wherein the system further comprises at least one fixation tool for fixing the valve leaflet to a second valve leaflet,

the fixation tool comprising a penetrating device which has a suture and an anchor coupled with the suture, and

wherein the capture device and the fixation tool are coupled to separate shafts disposed at least partially within the guide catheter.

60. The system of claim 59, further comprising a first catheter and a second catheter, wherein the capture device extends through the first catheter and the fixation tool extends through the second catheter.

61. The system of claim 59, wherein the penetrating device is adapted to penetrate an atrial surface of the valve leaflet and pass therethrough so as to emerge on a ventricular surface of the valve leaflet.

62. The system of claim 59, wherein the anchor comprises a radiopaque marker.

63. The system of claim 59, wherein the anchor comprises one of a stainless steel, nitinol or a shape memory material.

64. The system of claim 59, wherein the anchor self-expands from a first profile to a second profile larger than the first.

65. The system of claim 59, wherein the anchor is plastically deformed as it expands from a first profile to a second profile.

66. A method for repairing a cardiac valve having valve leaflets, the method comprising:

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

advancing a catheter having a capture device in an antegrade direction into the right atrium of the heart and to a location near the cardiac valve, wherein the capture device comprises at least one distal element adapted to independently protrude radially outward from the catheter;

capturing at least one leaflet with the capturing device by atraumatically pressing the at least one distal element against the leaflet;

repositioning the captured leaflets independently of each other by applying an upward force against a downstream surface of each leaflet; and

fixing the leaflets together.

67. The method of claim 66, wherein advancing the catheter comprises advancing the catheter through the inferior vena cava or the superior vena cava.

68. The method of claim 66, wherein advancing the catheter comprises advancing the catheter across an interatrial septum.

69. The method of claim 68, wherein advancing the catheter comprises advancing the catheter into a left atrium of the patient'"'"'s heart.

70. The method of claim 68, wherein advancing the catheter across an interatrial septum comprises piercing the interatrial septum with a needle.

71. The method of claim 66, wherein the cardiac valve is a mitral valve.

72. The method of claim 66, further comprising advancing a second catheter in a retrograde direction adjacent to the location.

73. A method for repairing a cardiac valve having valve leaflets, the method comprising:

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

advancing a catheter having a capture device in a retrograde direction into the left ventricle of the heart and to a location near the cardiac valve, wherein the capture device comprises at least one distal element adapted to independently protrude radially outward from the catheter;

capturing at least one leaflet with the capturing device by atraumatically pressing the at least one distal element against the leaflet;

repositioning the captured leaflets independently of each other by applying an upward force against a downstream surface of each leaflet; and

fixing the leaflets together.

74. The method of claim 73, wherein advancing the catheter comprises advancing the catheter through an aortic arch.

75. The method of claim 73, wherein advancing the catheter comprises advancing the catheter across an aortic valve.

76. The method of claim 73, wherein advancing the catheter comprises advancing the catheter into a left atrium of the heart.

77. The method of claim 73, wherein the cardiac valve is a mitral valve.

78. The method of claim 73, further comprising advancing a second catheter in antegrade direction adjacent to the location.