Methods and devices for capturing and fixing leaflets in valve repair

• US 20020013571A1
• Filed: 06/27/2001
• Published: 01/31/2002
• 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 6,752,813 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• 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 method for repairing a cardiac valve having valve leaflets, said method comprising:

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

advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve; and

applying an upward force against a downstream surface of at least one leaflet with the capturing device to reposition at least one leaflet so as to reduce leakage through the valve during ventricular systole.

2. A method as in claim 1, further comprising observing flow through the leaflets to determine if regurgitation has been inhibited.

3. A method as in claim 2, further comprising fixing the leaflets together if regurgitation has been sufficiently inhibited.

4. A method as in claim 2, further comprising adjusting the application of upward force on at least one valve leaflet with the capturing device if the regurgitation has not been sufficiently inhibited.

5. A method as in claim 1, wherein the interventional tool comprises an elongate shaft having a proximal end and a distal end and the capture device is disposed near the distal end, wherein the capture device comprises at least one distal element capable of protruding radially outward from the shaft and wherein the applying step includes pressing the distal element against the downstream surface of the leaflet.

6. A method as in claim 5, further comprising adjusting the length of protrusion of the distal element from the shaft.

7. A method as in claim 6, wherein adjusting the length comprises retracting or extending the distal element.

8. A method as in claim 6, wherein the adjusting the length step is performed after the applying step which serves to adjust the position of the leaflet to which the distal element is applied.

9. A method as in claim 5, further comprising adjusting the curvature of the distal element.

10. A method as in claim 9, wherein adjusting the curvature comprises retracting or extending the distal element.

11. A method as in claim 9, wherein the adjusting the curvature step is performed after the applying step which serves to adjust the position of the leaflet to which the distal element is applied.

12. A method as in claim 5, wherein the capture device further comprises at least one proximal element capable of protruding radially outward from the shaft and wherein the method further comprises holding one or more leaflets between the proximal and distal elements.

13. A method as in claim 12, further comprising adjusting the length of protrusion of the proximal element from the shaft.

14. A method as in claim 13, wherein the adjusting the length step is performed after the applying step which serves to adjust the position of the leaflet.

15. A method as in claim 14, further comprising simultaneously adjusting the length of protrusion of the distal element from the shaft.

16. A method as in claim 12, further comprising interlocking the proximal and distal elements.

17. A method as in claim 12, further comprising detaching the capture tool from the interventional tool so that the capture tool serves as a fixation device.

18. A method for repairing a cardiac valve having valve leaflets, said method comprising:

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

advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve;

capturing at least one leaflet with the capturing device; and

repositioning the captured leaflets independently of each other.

19. A method as in claim 18, wherein the capture device comprises at least one distal element capable of protruding radially outward from the shaft and wherein the capturing step includes pressing the distal element against the leaflet.

20. A method as in claim 19, wherein the repositioning step comprises retracting or extending the distal element.

21. A method as in claim 18, wherein the capture device comprises at least one proximal element and at least one distal element each capable of protruding radially outward from the shaft and wherein the capturing step comprises holding the leaflet between the proximal and distal elements.

22. A method as in claim 21, wherein the proximal element has at least one friction accessory and the capturing step includes applying friction to the leaflet with the friction accessory.

23. A method as in claim 21, wherein the repositioning step comprises retracting or extending the proximal element.

24. A method as in claim 21, wherein the repositioning step comprises simultaneously retracting or extending the proximal element and distal element disposed on opposite sides of the leaflet.

25. A method as in claim 21, further comprising interlocking the proximal and distal elements.

26. A method as in claim 18, further comprising fixing the leaflets together.

27. A method for repairing a cardiac valve having valve leaflets, said method comprising:

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

advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve;

atraumatically capturing at least one leaflet with the capturing device independently of other leaflets.

28. A method as in claim 27, wherein the capture device comprises at least one distal element capable of protruding radially outward from the shaft and wherein the capturing step includes pressing the distal element against the leaflet.

29. A method as in claim 27, wherein the capture device comprises at least one proximal element and at least one distal element each capable of protruding radially outward from the shaft and wherein the atraumatically capturing step comprises holding the leaflet between the proximal and distal elements.

30. A method as in claim 29, further comprising interlocking the proximal and distal elements.

31. A method as in claim 27, further comprising repositioning the captured leaflets.

32. A method as in claim 27, further comprising fixing the leaflets together.

33. A method for repairing a cardiac valve having valve leaflets, each leaflet comprising a proximal side and a distal side, said method comprising:

penetrating a first leaflet from the proximal side to the distal side with a penetrating device;

deploying at least a portion of a first anchor having a first attached suture on the distal side of the first leaflet;

penetrating a second leaflet from the proximal side to the distal side with a penetrating device;

deploying at least a portion of a second anchor having a second attached suture on the distal side of the second leaflet;

securing the first suture and the second suture together.

34. A method as in claim 33, wherein the anchors are disposed on or in the penetrating devices and the deploying steps comprise releasing the anchors from the respective penetrating devices.

35. A method as in claim 34, wherein the deploying steps further comprise expanding the anchors.

36. A method as in claim 33, wherein the penetrations are located from 1 mm to 12 mm inward from a free edge of the valve leaflet.

37. A method as in claim 33, further comprising:

penetrating the first leaflet from the proximal side to the distal side with a penetrating device;

deploying a snare on the distal side of the leaflet so that the snare captures at least part of the first anchor; and

retracting the snare so that the anchor is drawn through the penetration of the snare.

38. A method as in claim 37, further comprising:

penetrating the second leaflet from the proximal side to the distal side with a penetrating device;

deploying a snare on the distal side of the leaflet so that the snare captures at least part of the second anchor; and

retracting the snare so that the anchor is drawn through the penetration of the snare.

39. A method as in claim 33, further comprising:

penetrating the second leaflet from the proximal side to the distal side with a penetrating device;

deploying a snare on the distal side of the leaflet so that the snare captures at least part of the first anchor; and

retracting the snare so that the anchor is drawn through the penetration of the snare.

40. A method as in claim 39, further comprising:

penetrating the first leaflet from the proximal side to the distal side with a penetrating device;

deploying a snare on the distal side of the leaflet so that the snare captures at least part of the second anchor; and

retracting the snare so that the anchor is drawn through the penetration of the snare.

41. A method as in claim 33, further comprising:

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

advancing an interventional tool having at least one guide conduit through the vasculature to a location near the cardiac valve; and

advancing the penetration devices through the guide conduits prior to the penetrating steps.

42. A method as in claim 41, further comprising extending the guide conduits to desired positions prior to the penetrating steps.

43. A method as in claim 41, wherein the interventional tool further comprises a capture device comprising at least one loop which is protrudable radially outward from a shaft, the method further comprising:

protruding the loop(s) radially outward from the shaft;

positioning the guide conduit(s) so that the conduit guides the penetration device through the loop upon advancement of the penetration device; and

advancing the penetration device so that the leaflet is penetrated within the loop.

44. A method as in claim 43, further comprising retracting one or more loops to radially translate the penetration devices and penetrated leaflets toward the shaft.

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

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

a capture device on the interventional catheter comprising at least one distal element, wherein the distal element is protrudable radially outward and has a loop shape configured for pressing against a downstream surface of at least one leaflet.

46. A device as in claim 45, wherein the interventional tool comprises a shaft having a proximal end and a distal end, and the capture device is disposed near the distal end of the shaft.

47. A device as in claim 45, wherein the length of protrusion of the distal element is adjustable.

48. A device as in claim 45, wherein the radius of curvature of the distal element is adjustable.

49. A device as in claim 47 or 48, wherein the distal element is extendable or retractable.

50. A device as in claim 45, wherein the capture device comprises two distal elements disposed on opposite sides of the shaft.

51. A device as in claim 45, wherein the capture device further comprises at least one proximal element disposed proximal to the distal element.

52. A device as in claim 51, wherein the proximal element is protrudable radially outward from the shaft.

53. A device as in claim 51, wherein the proximal or distal elements are made from a material comprising stainless steel, metals, nitinol, shape-memory alloy, polymer, silk, polyester, nylon or a combination of these.

54. A device as in claim 51, wherein the proximal element is interlockable with the distal element.

55. A device as in claim 51, wherein the capture device is detachable from the interventional tool.

56. A device as in claim 45, wherein the interventional tool further comprises at least one fixation tool for fixing the valve leaflet together.

57. A device as in claim 56, wherein the fixation tool is adapted for fastening, suturing, clipping, stapling, riveting, gluing, or fusing the leaflets together.

58. A device as in claim 56, wherein the fixation tool comprises a penetrating device.

59. A device as in claim 58, wherein the penetrating device has a suture and an anchor disposed at the distal end of the suture.

60. A device as in claim 59, wherein the anchor is mountable on or in the penetrating device.

61. A device as in claim 60, wherein the anchor is deployable from the penetrating device.

62. A device as in claim 59, wherein the anchor is expandable

63. A device as in claim 59, wherein the anchor comprises a wire curved into a ring shape.

64. A device as in claim 63, wherein the wire has a first end and a second end wherein the first end is disposed on top of the ring and the second end is disposed underneath the ring.

65. A device as in claim 58, wherein the penetrating device comprises a snare.

66. A device as in claim 58, wherein the penetrating device has a slot through which a suture is passable.

67. A device as in claim 45, wherein the interventional tool further comprises at least one guide conduit.

68. A device as in claim 67, wherein each guide conduit is capable of extending angularly outward from the shaft.

69. A device as in claim 67, wherein the guide conduit is positionable so that a tool advanced through the guide tube is directed toward the inside of the loop shaped distal element.

105. A device as in claim 45, wherein the capture device is detachable from the interventional tool.

106. A device as in claim 45, wherein the distal element has at least one friction accessory.

107. A device as in claim 106, wherein the friction accessory comprises prongs, windings, bands or barbs.

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

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

a capture device on the interventional catheter comprising at least one distal element, wherein the distal element is protrudable radially outward and configured to capture at least one leaflet and reposition the captured leaflet independently of the other leaflets.

71. A device as in claim 70, wherein the distal element is extendable or retractable to reposition the captured leaflet.

72. A device as in claim 70, wherein the capture device further comprises at least one proximal element disposed proximal to the distal element.

73. A device as in claim 72, wherein the proximal element is protrudable radially outward from the shaft.

74. A device as in claim 73, wherein the proximal element is extendable or retractable to reposition the captured leaflet.

75. A device as in claim 72, wherein the proximal element is interlockable with the distal element.

76. A device as in claim 72, wherein the capture device is detachable from the interventional tool.

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

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

a capture device on the interventional catheter comprising 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.

78. A device as in claim 77, wherein the superior loop and inferior loop are extendable or retractable to reposition the captured leaflet.

79. A device as in claim 78, wherein the superior loop and inferior loop are independently extendable or retractable.

80. A device as in claim 77, wherein the capture device is detachable from the interventional catheter.

81. A kit for repairing a cardiac valve having valve leaflets, said kit comprising:

an interventional catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve, said catheter having a capture device comprising at least one distal element; and

instructions for use setting forth a method comprising

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

advancing the interventional tool through the vasculature to a location near the cardiac valve, and

applying an upward force against a downstream surface of at least one leaflet with the capturing device to reposition at least one leaflet so as to reduce leakage through the valve during ventricular systole.

82. A kit as in claim 81, further comprising a guide catheter configured to pass from the remote vasculature to a position within the heart adjacent to the cardiac valve, said guide catheter having a lumen sized to accept the interventional catheter.

83. A kit as in claim 81, further comprising a fixation tool.

84. A kit as in claim 83, wherein the fixation tool comprises a penetrating device having a suture and an anchor disposed at the distal end of the suture.

85. A kit for repairing a cardiac valve having valve leaflets, said kit comprising:

an interventional catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve, said catheter having a capture device comprising at least one distal element; and

instructions for use setting forth a method comprising

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

advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve;

capturing at least one leaflet with the capturing device; and

repositioning the captured leaflets independently of each other.

86. A kit as in claim 85, further comprising a guide catheter configured to pass from the remote vasculature to a position within the heart adjacent to the cardiac valve, said guide catheter having a lumen sized to accept the interventional catheter.

87. A kit as in claim 85, further comprising a fixation tool.

88. A kit as in claim 87, wherein the fixation tool comprises a penetrating device having a suture and an anchor disposed at the distal end of the suture.

89. A kit for repairing a cardiac valve having valve leaflets, said kit comprising:

an interventional catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve, said catheter having a capture device comprising at least one distal element, wherein the distal element is protrudable radially outward and has a loop shape configured for pressing against a downstream surface of at least one leaflet; and

instructions for use.

90. A kit as in claim 89, further comprising a fixation tool.

91. A kit as in claim 89, wherein the fixation tool comprises a penetrating device having a suture and an anchor disposed at the distal end of the suture.

92. A method for repairing a cardiac valve having leaflets, said method comprising:

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

advancing an interventional tool having a detachable capturing device through the vasculature to a location near the cardiac valve;

atraumatically capturing the valve leaflets with the capture device; and

detaching the capture device to leave the valve leaflets permanently affixed.

93. A method as in claim 92, wherein the capture device comprises at least one radially deployable distal element and at least one radially deployable proximal element and wherein atraumatically capturing comprises capturing a portion of the leaflets between the elements.

94. A method as in claim 93, further comprising radially deploying the distal or proximal elements prior to capturing.

95. A method as in claim 93, further comprising radially expanding or retracting the distal or proximal elements after capturing to adjust the position of the leaflets.

96. A method as in claim 95, wherein radially expanding or retracting of the distal and proximal elements is achieved independently.

97. A fixation device for repairing a cardiac valve having valve leaflets, said device comprising:

a shaft having a proximal end and a distal end;

at least one distal element disposed near the distal end, the distal element capable of protruding radially outward and shaped to atraumatically contact a downstream surface of a leaflet; and

at least one proximal element disposed near the proximal end, the proximal element capable of protruding radially outward and shaped to atraumatically contact an upstream surface of a leaflet.

98. A fixation device as in claim 97, further comprising a coupling mechanism disposed near the proximal end for coupling with an interventional catheter.

99. A fixation device as in claim 97, wherein the length of protrusion of the distal element and/or proximal element is adjustable.

100. A fixation device as in claim 97, wherein the radius of curvature of the distal element and/or proximal element is adjustable.

101. A fixation device as in claim 97, comprising two distal elements disposed on opposite sides of the shaft.

102. A fixation device as in claim 97, comprising two proximal elements disposed on opposite sides of the shaft.

103. A fixation device as in claim 97, wherein the proximal or distal elements are made from a material comprising stainless steel, metals, nitinol, shape-memory alloy, polymer, silk, polyester, nylon or a combination of these.

104. A fixation device as in claim 97, wherein the proximal element is interlockable with the distal element.