DEVICES, SYSTEMS, AND METHODS FOR CLOSING THE LEFT ATRIAL APPENDAGE

• US 20080243183A1
• Filed: 03/25/2008
• Published: 10/02/2008
• Est. Priority Date: 03/30/2007
• Status: Active Grant

• Current Assignee: SentreHeart, LLC (Atricure, Inc.)
• Original Assignee: SentreHEART Incorporated (Atricure, Inc.)
• Inventors: Fung, Gregory W., MILLER, Gary H., Seiber, Russell A.
• Granted Patent: US 8,771,297 B2
• Time in Patent Office: Days
• US Class Current: 606/228
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Described here are devices, systems and methods for closing the left atrial appendage. Some of the methods described here utilize one or more guide members having alignment members to aid in positioning of a closure device. In general, these methods include advancing a first guide having a first alignment member into the left atrial appendage, advancing a second guide, having a second alignment member, into the pericardial space, aligning the first and second alignment members, advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, and closing the left atrial appendage with the closure device. In these variations, the closure device typically has an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closure element comprises a loop defining a continuous aperture therethrough.

Claims

1. A method for closing a left atrial appendage comprising:

advancing a first guide into the left atrial appendage, the guide having a proximal end and a distal end, wherein the first guide comprises a first alignment member;

advancing a second guide into the pericardial space, the guide having a proximal end and a distal end, wherein the second guide comprises a second alignment member;

aligning the first and second alignment members;

advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, wherein the closure device comprises an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body, wherein the closure element comprises a loop defining a continuous aperture therethrough; and

closing the left atrial appendage with the closure device.

2. The method of claim 1, wherein the first guide, second guide, or both guides are advanced under visualization.

3. The method of claim 1, wherein the alignment members of the first and second guides are located at the distal ends of the first and second guides.

4. The method of claim 1, wherein the first and second alignment members are magnets.

5. The method of claim 1, wherein the first and second alignment members comprise radioopaque or echogenic markers.

6. The method of claim 1, wherein the first and second alignment members comprise interconnecting members.

7. The method of claim 1, wherein one of the first or second alignment members comprises a vacuum member.

8. The method of claim 1, wherein the first guide further comprises an expandable member.

9. The method of claim 8, wherein the expandable member is expanded within the left atrial appendage.

10. The method of claim 1, further comprising advancing a third guide into the left atrial appendage, wherein the third guide has a proximal end and a distal end and comprises an expandable member.

11. The method of claim 10, wherein the first and third guides are coupled together for at least a portion of the method.

12. The method of claim 8, wherein the expandable member comprises an expandable balloon.

13. The method of claim 12, wherein the balloon has one or more apertures therein

14. The method of claim 1, wherein the first guide, second guide, closure device, or a combination thereof, are advanced over a guidewire.

15. The method of claim 1, wherein the closure device and the second guide are coupled together for at least a portion of the method.

16. The method of claim 1, wherein the closure device further comprises a suture for encircling the left atrial appendage after it has been closed with the closure device, wherein the suture comprises a surgical slip knot.

17. The method of claim 16, wherein the suture is coupled to the closure element.

18. The method of claim 17, further comprising tensioning the suture.

19. The method of claim 18, further comprising releasing tension on the suture.

20. The method of claim 17, further comprising releasing the suture from the closure element.

21. The method of claim 16, further comprising severing the suture.

22. The method of claim 21, wherein the suture is severed with a cutting device.

23. The method of claim 21, wherein the suture is severed by the application of energy.

24. The method of claim 23, wherein the energy is selected from the group consisting of light energy, thermal energy, RF energy, electrical energy, magnetic energy, electromagnetic energy, kinetic energy, chemical energy and combinations thereof.

25. The method of claim 21, wherein the suture is severed with a cutting element on the closure device.

26. The method of claim 1, further comprising the step of confirming satisfactory closure of the left atrial appendage.

27. The method of claim 1, further comprising opening the left atrial appendage with the closure device.

28. The method of claim 27, further comprising repositioning the closure device.

29. A method for closing the left atrial appendage comprising;

advancing a closure device into the pericardial space and adjacent to the left atrial appendage;

closing the left atrial appendage with the closure device, wherein the closure device comprises an elongate body having a proximal end and a distal end, and a closure element that comprises a loop defining a continuous aperture therethrough;

securing the closed left atrial appendage with a suture; and

severing the suture.

30. The method of claim 29, wherein the suture is severed with a cutting device.

31. The method of claim 29, wherein the suture is severed by the application of energy.

32. The method of claim 31, wherein the energy is selected from the group consisting of light energy, thermal energy, RF energy, electrical energy, magnetic energy, electromagnetic energy, kinetic energy, chemical energy and combinations thereof.

33. The method of claim 29, wherein the suture is severed with a cutting element on the closure device.

34. The method of claim 29, wherein the closure device comprises one or more expandable elements.

35. The method of claim 29, wherein the closure device, the suture, or both comprise a radiopaque or echogenic material.

36. The method of claim 29, wherein the closure device is made from a shape-memory material.

37. The method of claim 29, wherein the suture is coupled to the closure device.

38. The method of claim 29, wherein the closure device is visualized while advanced.

39. The method of claim 38, wherein the closure device is visualized using fluoroscopy.

40. A device for closing the left atrial appendage comprising:

an elongate body having a proximal end and a distal end;

a closure element comprising a loop defining a continuous aperture therethrough, the closure element at least partially housed within the elongate body; and

a suture loop.

41. The device of claim 40, wherein the closure element is made from a shape-memory material.

42. The device of claim 41, wherein the closure element is made from a nickel titanium alloy.

43. The device of claim 40, wherein the suture loop is bioabsorbable.

44. The device of claim 40, wherein the suture loop is non-bioabsorbable.

45. The device of claim 40, further comprising a retention member, wherein the retention member is configured to retain the closure element and the suture loop.

46. The device of claim 45, wherein the retention member comprises first and second lumens, wherein the closure element is housed within the first lumen and the suture loop is housed within the second lumen.

47. The device of claim 46, wherein the second lumen has a weakened region configured to release the suture with the application of a force.

48. The device of claim 46, wherein the second lumen has a perforated region configured to release the suture with the application of force.

49. The device of claim 46, wherein the second lumen has a slit extending along at least a portion of the retention member

50. The device of claim 45, wherein the retention member comprises a first lumen and one or more releasable retention elements, wherein the closure element is housed within the first lumen and the suture loop is retained by the one or more releasable retention elements.

51. The device of claim 50, wherein at least one of the releasable retention elements is a polymer.

52. The device of claim 40, wherein the elongate body has one or more curves along its length.

53. The device of claim 40, wherein the elongate body is steerable.

54. The device of claim 40, wherein the elongate body is a catheter.

55. The device of claim 40, wherein the closure element, suture loop, or both comprise a radiopaque or echogenic material.

56. The device of claim 40, wherein the closure element and the suture loop are separately actuatable.

57. The device of claim 40, further comprising a cutting element.

58. A system for closing a left atrial appendage comprising:

a first guide having a size and length adapted for accessing the left atrial appendage through the vasculature, wherein the first guide comprises a first alignment member;

a second guide having a size and length adapted for accessing the pericardial space from a subthoracic region, wherein the second guide comprises a second alignment member; and

a closure device comprising an elongate body having a proximal end and a distal end, and a closure element housed therein, wherein the closure element comprises a loop defining a continuous aperture therethrough.

59. The system of claim 58, further comprising an expandable member.

60. The system of claim 59, wherein the expandable member has one or more apertures therein.

61. The system of claim 59, wherein the expandable member is couplable to the first guide.

62. The system of claim 59, wherein the expandable member is a balloon.

63. The system of claim 58, further comprising a suture.

64. The system of claim 63, wherein the suture is coupled to the closure device.

65. The system of claim 63, further comprising a device for severing the suture.

66. The system of claim 58, wherein the closure device is couplable to the second guide.

67. The system of claim 58, wherein the first and second alignment members are magnets.

68. The system of claim 67, wherein the magnets are located at the distal ends of the first and second guides.

69. The system of claim 58, wherein the first and second alignment members comprise radiopaque or echogenic markers.

70. The system of claim 58, wherein the first and second alignment members comprise interconnecting members.

71. The system of claim 58, wherein one of the first or second alignment members comprises a vacuum member.

72. The system of claim 58, further comprising instructions for using the first guide, second guide, closure device, or combination thereof.

73. The system of claim 58, wherein the elongate body of the closure device has one or more curves along its length.

74. The system of claim 73, further comprising a straightening tube, configured to temporarily straighten the one or more curves.

75. A method for closing a left atrial appendage comprising:

advancing a first guide having a proximal end and a distal end into the left atrial appendage, through the left atrial appendage, and out of the left atrial appendage, such that one of the proximal or distal ends is within the vasculature, and one of the proximal or distal ends is within a subthoracic space; and

advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, wherein the closure device comprises an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body, wherein the closure element comprises a loop defining a continuous aperture therethrough; and

closing the left atrial appendage with the closure device.

76. The method of claim 75, wherein the proximal end of the first guide is within the vasculature.

77. The method of claim 75, wherein the proximal end of the first guide is within the subthoracic space.

78. The method of claim 75, wherein the closure device is advanced into the pericardial space over the first guide.

79. The method of claim 75, wherein the first guide, closure device, or both are advanced under fluoroscopic visualization.

80. The method of claim 75, further comprising advancing a second guide into the left atrial appendage, wherein the second guide has a proximal end, a distal end, and comprises an expandable member.

81. The method of claim 80, further comprising expanding the expandable member.

82. The method of claim 80, wherein the first and second guides are coupled together for at least a portion of the method.