PFO closure devices and related methods of use

• US 20030208232A1
• Filed: 05/06/2002
• Published: 11/06/2003
• Est. Priority Date: 05/06/2002
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Velocimed LLC (Abbott Laboratories Incorporated)
• Inventors: Ressemann, Thomas V., Blaeser, David J., Keith, Peter T., Wahr, Dennis W., Grudem, Jerome K. Jr., Phillips, Joel D., Hackett, Steven S., Olson, Scott A., Christianson, Mark R.
• Granted Patent: US 7,976,564 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0458 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 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence

Abstract

Devices and methods for sealing a passageway formed by a patent foramen ovale (PFO track) in the heart are provided. One method includes providing an abrading device to the PFO track and abrading the tissue within the PFO track. The abraded tissue forming the PFO track is then held together under pressure, either via lowering right atrial pressure or via applying suction to the septum primum to pull it into apposition against the septum secundum. After a sufficient period of time, the pressure is released and the abraded tissue heals to form a robust seal over the PFO track. Additionally, several devices are provided which can be placed into the PFO track to apply adhesive to the walls of the PFO track. The devices may or may not be left within the PFO track. If the devices are not left within the PFO track, the walls of the PFO track, covered with adhesive, are brought into apposition with one another and adhered together. If the device is left within the PFO track, the device is flattened from an expanded configuration to a flattened configuration, and the walls of the PFO track, adhering to the outer surface of the device, are pulled toward each other as the device flattens. The device may also include interior structure to hold the device in a flattened configuration.

Claims

1. A method of sealing a passageway in a heart, comprising:

advancing an abrasion device into the passageway to be sealed;

abrading at least a portion of the tissue surfaces forming the passageway;

withdrawing the abrasion device from the passageway; and

forcing abraded portions of the tissue surfaces of the passageway against one another for a period of time.

2. The method of claim 1, wherein the forcing abraded portions of the tissue surfaces together includes reducing venous return to the right atrium.

3. The method of claim 2, wherein reducing venous return to the right atrium includes occluding the inferior vena cava.

4. The method of claim 3, wherein occluding the inferior vena cava includes positioning an inflatable balloon in the inferior vena cava.

5. The method of claim 1, wherein the forcing abraded portions of the tissue surfaces together includes applying a vacuum to the septum primum.

6. The method of claim 5, wherein applying a vacuum includes anchoring a catheter to the septum primum via the vacuum.

7. The method of claim 6, wherein anchoring a catheter to the septum primum includes creating the vacuum with a syringe in fluid communication with a lumen of the catheter.

8. The method of claim 1, further comprising providing an adhesive to at least a portion of the tissue surfaces forming the passageway prior to forcing the abraded portions together.

15. The method of claim 8, further comprising providing a catheter having a porous balloon.

16. The method of claim 15, wherein providing adhesive includes inflating the porous balloon with a liquid adhesive.

17. The method of claim 15, further comprising expanding an inner layer of the porous balloon within the passageway.

18. The method of claim 16, wherein providing adhesive includes filling an outer layer of the porous balloon with a liquid adhesive.

19. The method of claim 1, wherein the passageway is a patent foramen ovale.

9. The method of claim 9, wherein providing the adhesive includes advancing a closure device into the passageway subsequent to withdrawing the abrasion device.

10. The method of claim 9, further comprising supplying adhesive to the closure device.

11. The method of claim 9, wherein the closure device is self-flattening.

12. The method of claim 11, further comprising providing the closure device on a balloon catheter and expanding a balloon of the balloon catheter within the passageway to place the self-flattening closure device in an expanded configuration.

13. The method of claim 12, wherein supplying adhesive includes providing adhesive to hollow portions of the self-flattening closure device.

14. The method of claim 13, wherein supplying adhesive further includes passing the adhesive through holes in the self-flattening closure device to at least a portion of the tissue surfaces forming the passageway.

20. A device for sealing a passageway in a human body, the device comprising:

a catheter having an distal portion; and

at least one suture lumen, the at least one suture lumen containing a suture having an anchor at an end of the suture.

21. The device of claim 20, further comprising two suture lumens, wherein each suture lumen contains a suture having an anchor at an end of the suture.

22. The device of claim 20, wherein the anchor has a sharp tip.

23. The device of claim 20, wherein the anchor includes a barbed end.

24. The device of claim 21, wherein each anchor includes a barbed end.

25. The device of claim 21, wherein one of the at least two suture lumens is positioned on a first side of the catheter and wherein the other of the at least two suture lumens is positioned on an opposite side of the catheter.

26. The device of claim 25, wherein the at least two suture lumens are spaced approximately 180 degrees apart.

27. The device of claim 20, wherein the at least one suture lumen has an open distal end.

28. The device of claim 21, wherein each of the two suture lumens has an open distal end.

29. The device of claim 20, wherein the expandable distal portion includes a balloon.

30. An assembly for sealing a passageway in a human body, comprising:

a delivery catheter;

a suture connected to a barbed anchor; and

a support tube configured to surround and support the suture.

31. The assembly of claim 30, further comprising a lock device.

32. The assembly of claim 31, wherein the lock device is configured to engage the suture.

33. The assembly of claim 32, wherein the lock device is configured to move in only one direction along the suture.

34. The assembly of claim 30, wherein the anchor includes sharp tips.

35. The assembly of claim 30, wherein the anchor includes barbed portions.

36. The assembly of claim 35, wherein the barbed portions are moveable between an expanded configuration and a collapsed configuration.

37. The assembly of claim 30, wherein the support tube is positioned within the catheter.

38. A method of sealing a passageway in a heart, comprising:

advancing a hollow tubular structure into the passageway to be sealed;

engaging the walls of the passageway with the hollow tubular structure; and

flattening the hollow tubular structure.

39. The method of claim 38, wherein engaging the walls includes expanding the hollow tubular structure.

40. The method of claim 39, wherein engaging the walls further includes supplying an adhesive from the hollow tubular structure to the walls of the passageway.

41. The method of claim 40, wherein expanding the hollow tubular structure includes inflating a balloon.

42. The method of claim 41, wherein inflating the balloon includes supplying a liquid adhesive to inflate the balloon.

43. The method of claim 42, wherein supplying adhesive from the hollow tubular structure includes continuing to supply the liquid adhesive to the balloon until adhesive passes through pores of the balloon to an outer surface of the balloon.

44. The method of claim 41, wherein inflating the balloon includes supplying an inner layer of the balloon with a fluid.

45. The method of claim 44, wherein supplying the adhesive includes supplying an outer layer of the balloon with a liquid adhesive.

46. The method of claim 45, wherein supplying the adhesive further includes continuing to supply the liquid adhesive to the outer layer of the balloon until adhesive passes through pores of the outer layer of the balloon to an outer surface of the balloon.

47. The method of claim 40, further comprising allowing the adhesive to at least partially cure prior to flattening the hollow tubular structure.

48. The method of claim 47, wherein flattening the hollow tubular structure pulls the walls of the passageway toward each other.

49. The method of claim 47, wherein flattening the hollow tubular structure includes deflating a balloon.

50. The method of claim 49, wherein deflating the balloon includes deflating the balloon of a delivery catheter, and further comprising the step of removing the delivery catheter.

51. The method of claim 50, wherein deflating the balloon further includes allowing the hollow tubular structure comprising a shape memory alloy to flatten.

52. The method of claim 40, further comprising leaving the flattened hollow tubular structure within the passageway.

53. The method of claim 38, further comprising abrading at least a portion of the walls of the passageway prior to advancing the hollow tubular structure into the passageway.

54. The method of claim 53, further comprising forcing abraded portions of the tissue surfaces of the passageway against one another subsequent to flattening the hollow tubular structure.

55. The method of claim 54, wherein the forcing abraded portions of the tissue surfaces together includes reducing venous return to the right atrium.

56. The method of claim 54, wherein the forcing abraded portions of the tissue surfaces together includes applying a vacuum to the septum primum.

57. The method of claim 52, further comprising abrading at least a portion of the walls of the passageway prior to advancing the hollow tubular structure into the passageway.

58. The method of claim 57, further comprising forcing abraded portions of the tissue surfaces of the passageway against one another subsequent to flattening the hollow tubular structure.

59. The method of claim 58, wherein the forcing abraded portions of the tissue surfaces together includes reducing venous return to the right atrium.

60. The method of claim 58, wherein the forcing abraded portions of the tissue surfaces together includes applying a vacuum to the septum primum.

61. The method of claim 40, further comprising removing the flattened hollow tubular structure from the passageway.

62. The method of claim 61, further comprising abrading at least a portion of the walls of the passageway prior to advancing the hollow tubular structure into the passageway.

63. The method of claim 62, further comprising forcing abraded portions of the tissue surfaces of the passageway against one another subsequent to flattening the hollow tubular structure.

64. The method of claim 63, wherein the forcing abraded portions of the tissue surfaces together includes reducing venous return to the right atrium.

65. The method of claim 63, wherein the forcing abraded portions of the tissue surfaces together includes applying a vacuum to the septum primum.

66. The method of claim 41, wherein inflating the balloon includes expanding the balloon of a delivery catheter to expand a self-flattening closure device comprising a shape memory alloy.

67. The method of claim 66, wherein supplying the adhesive includes supplying adhesive from a supply lumen to a lumen within a longitudinal strut of the self-flattening closure device.

68. The method of claim 67, wherein supplying the adhesive further includes supplying the adhesive from the lumen of the longitudinal strut to a plurality of lumens in circumferential struts of the self-flattening closure device.

69. The method of claim 68, wherein supplying the adhesive further includes passing adhesive from the lumens of the circumferential struts through holes in the circumferential struts to an outer surface of the self-flattening closure device.

70. The method of claim 69, further comprising allowing the adhesive to at least partially cure prior to flattening the hollow tubular structure.

71. The method of claim 70, wherein flattening the hollow tubular structure pulls the walls of the passageway toward each other.

72. The method of claim 71, wherein flattening the hollow tubular structure includes allowing the self-flattening closure device to assume a flattened configuration.

73. The method of claim 72, further comprising leaving the self-flattening closure device in its flattened configuration within the passageway.

74. The method of claim 38, wherein the passage is a patent foramen ovale.

75. A method of sealing a passageway in a heart, comprising:

advancing a catheter into the passageway;

applying adhesive to the walls of the passageway;

withdrawing the catheter from the passageway; and

forcing portions of the walls of the passageway against one another for a period of time sufficient to allow the adhesive to at least partially cure.

76. The method of claim 75, wherein applying adhesive to the walls of the passageway includes expanding a porous balloon.

77. The method of claim 76, wherein expanding the porous balloon includes filling the balloon with a liquid adhesive until the adhesive passes through pores of the balloon to an outer surface of the balloon.

78. The method of claim 76, wherein expanding the balloon includes inflating an inner layer of the balloon.

79. The method of claim 78, wherein expanding the balloon further includes filling an outer layer of the balloon with a liquid adhesive until the adhesive passes through pores of the balloon to an outer surface of the balloon.

80. The method of claim 76, further comprising deflating the porous balloon prior to withdrawing the catheter.

81. The method of claim 75, further comprising abrading portions of the walls of the passageway prior to advancing the catheter into the passageway.

82. The method of claim 75, wherein forcing portions of the walls of the passageway together includes reducing venous return to the right atrium.

83. The method of claim 82, wherein reducing venous return to the right atrium includes occluding the inferior vena cava.

84. The method of claim 83, wherein occluding the inferior vena cava includes positioning an inflatable balloon in the inferior vena cava.

85. The method of claim 75, wherein forcing portions of the walls of the passageway together includes applying a vacuum to the septum primum.

86. The method of claim 85, wherein applying a vacuum includes anchoring a catheter to the septum primum via the vacuum.

87. The method of claim 86, wherein anchoring a catheter to the septum primum includes creating the vacuum with a syringe in fluid communication with a lumen of the catheter.

88. A method of sealing a passageway in a heart, comprising:

advancing a delivery device having an expandable end into the passageway, wherein the delivery device includes at least two suture lumens, each suture lumen having an open end positioned in the passageway when the delivery device is advanced into the passageway;

expanding the expandable end;

advancing a suture-anchor assembly out of the end of each suture lumen;

penetrating the tissue forming the passageway with an anchor of each suture-anchor assembly; and

pulling the passageway closed with the anchored sutures.

89. The method of claim 88, wherein pulling the passageway closed includes tying the sutures in a knot.

90. The method of claim 88, further comprising abrading portions of the tissue surfaces forming the passageway prior to advancing the delivery device.

91. The method of claim 88, wherein expanding the expandable end includes inflating a balloon.

92. A method of sealing a passageway between a septum primum and a septum secundum in a heart, comprising:

advancing a delivery catheter into the right atrium;

advancing an anchor and suture assembly out of the delivery catheter; and

passing the anchor and suture assembly through the septum secundum and through the septum primum.

93. The method of claim 92, wherein advancing the anchor and suture assembly includes advancing a support tube surrounding a suture of the anchor and suture assembly.

94. The method of claim 93, wherein passing the anchor and suture assembly through the septum secundum and through the septum primum includes passing the support tube surrounding the suture through the septum secundum and through the septum primum.

95. The method of claim 92, further comprising abrading the passageway prior to advancing the delivery catheter into the right atrium.

96. The method of claim 92, further comprising moving a locking device along a portion of the suture extending between the septum secundum and the delivery catheter.

97. The method of claim 96, wherein moving the locking device includes moving the locking device until the locking device is adjacent the septum secundum and the suture is taut.

98. The method of claim 97, further comprising cutting the suture between the locking device and the delivery catheter.