Clip apparatus for closing septal defects and methods of use

• US 7,740,640 B2
• Filed: 05/28/2004
• Issued: 06/22/2010
• Est. Priority Date: 09/06/2001
• Status: Expired due to Fees

• Current Assignee: Promed, Inc.
• Original Assignee: Ovalis, Inc.
• Inventors: Ginn, Richard S.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Severson; Ryan J
• Application Number:
  US10/856,493
• Publication Number:
  US 20040249398A1
• Time in Patent Office: 2,216 Days
• Field of Search: 606/213, 606/216, 606/219, 606/221, 606/151, 606/157, 606/142
• US Class Current: 606/142
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks

Abstract

A device for closing a septal defect, such as a patent foramen ovale, includes a clip formed from a superelastic material that is inserted into a septum wall of a heart. The clip is advanced through a patient'"'"'s vasculature, e.g., within a delivery apparatus, until the clip is disposed within a first chamber adjacent the septal defect. Tines of the clip are directed through a flap of tissue of the septal defect until the tines of the clip are disposed within a second opposing chamber. The clip then transforms into its relaxed state, wherein the tines of the clip engage with a surface of the second chamber, thereby substantially closing the septal opening.

Claims

1. A method of closing a septal defect within a patient'"'"'s heart comprising the steps of:

advancing an elongate delivery apparatus, adapted to carry a clip apparatus, through the patient'"'"'s vasculature and into a right atrial chamber of the heart, wherein the atrial septal wall of the heart has a patent foramen ovale characterized by a first tissue flap located mainly in the right atrial chamber and a second tissue flap located mainly in a left atrial chamber, at least a portion of the first tissue flap overlapping at least a portion of the second tissue flap to define a tunnel therebetween; and

advancing the clip apparatus from the right atrial chamber through the first tissue flap, then into and across the tunnel, then through the second tissue flap and into the left atrial chamber, such that at least part of the clip apparatus resides entirely through the first and second tissue flaps to at least partially close the tunnel.

2. The method of claim 1, wherein advancing the elongate delivery apparatus comprises advancing the distal end of the elongate delivery apparatus into the right atrial chamber until the distal end is disposed adjacent to the patent foramen ovale.

3. The method of claim 2, wherein advancing the clip apparatus comprises advancing a pusher member distally relative to the elongate delivery apparatus to advance the clip apparatus.

4. The method of claim 1, further comprising imaging a portion of the heart.

5. The method of claim 1, further comprising externally imaging the clip apparatus.

6. The method of claim 5, further comprising externally imaging the clip apparatus with ultrasound.

7. The method of claim 5, wherein the clip apparatus comprises a radiopaque marker and wherein externally imaging the clip apparatus comprises externally imaging the radiopaque marker with fluoroscopy.

8. The method of claim 1, wherein advancing the clip apparatus through the vasculature of a subject comprises advancing the clip apparatus through the vasculature while the clip apparatus is in a stressed state.

9. The method of claim 8, comprising allowing the clip apparatus to transition from the stressed, first state to a less stressed, second state.

10. The method of claim 9, wherein the less stressed, second state is a relaxed state with substantially no stress.

11. The method of claim 1, further comprising:

engaging a first septal surface exposed in the left atrial chamber with a first portion of the clip apparatus; and

engaging a second septal surface exposed in the right atrial chamber with a second portion of the clip apparatus.

12. The method of claim 11, wherein engaging the first septal surface exposed in the left atrial chamber with the first portion of the clip apparatus comprises allowing the first portion of the clip apparatus to transition from a stressed state to a less stressed state such that the first portion engages the first septal surface.

13. The method of claim 11, wherein the first portion of the clip apparatus comprises a plurality of deflectable members.

14. The method of claim 13, wherein engaging the first septal surface exposed in the left atrial chamber with the first portion of the clip apparatus comprises allowing the plurality of deflectable members to deflect laterally to engage the first septal surface.

15. The method of claim 14, wherein the plurality of deflectable members deflect laterally in directions generally away from each other.

16. The method of claim 11, wherein engaging the second septal surface exposed in the right atrial chamber with the second portion of the clip apparatus comprises allowing the second portion of the clip apparatus to transition from a stressed state to a less stressed state such that the second portion engages the second septal surface.

17. The method of claim 11, wherein the second portion of the clip apparatus comprises a fixed retaining end configured to abut the second septal surface.

18. The method of claim 11, wherein the clip apparatus is monolithic.

19. The method of claim 11, wherein the clip apparatus comprises a plurality of separate segments.

20. The method of claim 11, wherein the first and second septal surfaces are engaged such that the first tissue flap is held in contact with the second tissue flap.

21. The method of claim 20, wherein a part of the clip apparatus that resides within the first flap resides within a piercing in the portion of the first flap that overlaps the second flap.

22. The method of claim 21, wherein a part of the clip apparatus that resides within the second flap resides within a piercing in the portion of the second flap that overlaps the first flap.

23. The method of claim 20, wherein a part of the clip apparatus that resides within the second flap resides within a piercing in the portion of the second flap that overlaps the first flap.

24. The method of claim 23, wherein a part of the clip apparatus that resides within the first flap resides within a piercing in the portion of the first flap that overlaps the second flap.

25. The method of claim 1, wherein the clip apparatus comprises a tip configured to penetrate tissue and wherein advancing the clip apparatus comprises advancing the clip apparatus such that the tip penetrates the first tissue flap.

26. The method of claim 25, wherein advancing the clip apparatus comprises advancing the clip apparatus such that the tip penetrates the second tissue flap.

27. The method of claim 26, wherein the tip is on a tine.

28. The method of claim 26, wherein the clip apparatus comprises a plurality of tips configured to penetrate tissue.

29. The method of claim 26, wherein the tip is located on a first portion of the clip apparatus, the first portion being configured to transition from a first orientation, configured to allow penetration of the septal tissue during advancement of the clip apparatus, to a second orientation configured to engage a first septal surface exposed in the left atrial chamber after penetrating the second tissue flap.

30. The method of claim 29, wherein the tip inflects back towards the atrial septal wall in the second orientation.

31. The method of claim 29, wherein the second orientation has a hook-like configuration.

32. The method of claim 31, wherein the tip inflects back and penetrates the atrial septal wall.

33. The method of claim 29, wherein the second orientation is configured such that at least part of the first portion of the clip apparatus lies substantially flat against the atrial septal wall.

34. The method of claim 33, wherein the second orientation is configured such that the tip lies substantially flat against the septal wall.

35. The method of claim 33, wherein the second orientation is configured such that the majority of the first portion of the clip apparatus lies substantially flat against the septal wall after implantation.

36. The method of claim 29, wherein the first portion is biased to transition from the first orientation to the second orientation.

37. The method of claim 36, wherein the clip apparatus comprises a second portion configured to engage a second septal surface exposed in the right atrial chamber.

38. The method of claim 37, further comprising:

engaging the first septal surface exposed in the left atrial chamber with the first portion of the clip apparatus; and

engaging the second septal surface exposed in the right atrial chamber with the second portion of the clip apparatus.

39. The method of claim 38, wherein the second portion of the clip apparatus comprises a fixed retaining end.

40. The method of claim 38, wherein engaging the second septal surface exposed in the right atrial chamber with the second portion of the clip apparatus comprises allowing the second portion of the clip apparatus to transition from a stressed state to a less stressed state such that the second portion engages the second septal surface.

41. The method of claim 40, further comprising advancing the clip apparatus through a percutaneous entry site near a peripheral vessel to gain access to the vasculature of the subject.

42. The method of claim 41, wherein advancing the elongate delivery apparatus through the vasculature of the subject comprises advancing the elongate delivery apparatus through the inferior vena cava.

43. The method of claim 42, wherein the clip apparatus comprises NITINOL.

44. The method of claim 1, wherein the elongate delivery apparatus comprises a lumen with an open distal end.

45. The method of claim 44, wherein the clip apparatus is slidable within the lumen.

46. The method of claim 45, wherein advancing the clip apparatus comprises advancing the clip apparatus through the distal end of the elongate delivery apparatus with a distal end of an elongate pusher member.

47. The method of claim 46, further comprising advancing the pusher member with an actuator.

48. The method of claim 46, wherein the distal end of the pusher member is configured to engage the clip apparatus.

49. The method of claim 48, wherein the distal end of the pusher member is configured to allow rotational control of the clip apparatus.

50. The method of claim 49, wherein the distal end of the pusher member comprises a notch.

51. The method of claim 49, wherein the clip apparatus is held in a stressed state by the elongate delivery apparatus.

52. The method of claim 51, further comprising allowing at least a first portion of the clip apparatus to transition from the stressed state to a less stressed state after the clip apparatus is advanced from the distal end of the elongate delivery apparatus.

53. The method of claim 52, wherein the first portion of the clip apparatus is a distal portion.

54. The method of claim 53, wherein the first portion of the clip apparatus comprises a tip configured to penetrate tissue.

55. The method of claim 53, wherein advancing the clip apparatus further comprises allowing a second portion of the clip apparatus to transition from a stressed state to a less stressed state after the second portion exits the distal end of the elongate delivery apparatus.

56. The method of claim 48, wherein the inner surface the elongate delivery apparatus is configured to engage the clip apparatus.

57. The method of claim 56, wherein the inner surface of the elongate delivery apparatus comprises a groove.

58. The method of claim 46, wherein the pusher member comprises a radiopaque marker.

59. The method of claim 1, wherein the clip apparatus comprises a radiopaque marker.

60. The method of claim 1, wherein the elongate delivery apparatus comprises a radiopaque marker.

61. The method of claim 1, wherein the clip apparatus comprises stainless steel.

62. The method of claim 1, wherein the clip apparatus comprises NITINOL.

63. The method of claim 1, wherein the clip apparatus comprises a shape memory material.

64. The method of claim 1, wherein the clip apparatus comprises an elastic material.

65. The method of claim 1, wherein the clip apparatus comprises a superelastic material.

66. The method of claim 1, wherein advancing the elongate delivery apparatus through the vasculature of the subject comprises advancing the elongate delivery apparatus through the inferior vena cava.

67. The method of claim 1, wherein advancing the elongate delivery apparatus through the vasculature of the subject comprises advancing the elongate delivery apparatus through the superior vena cava.

68. The method of claim 1, wherein advancing the elongate delivery apparatus through the vasculature of the subject comprises advancing the elongate delivery apparatus through an artery.

69. The method of claim 1, further comprising introducing the elongate delivery apparatus into the vasculature of the patient at a percutaneous entry site to a peripheral vessel, prior to advancing the elongate delivery apparatus.

70. The method of claim 1, comprising orienting the elongate delivery apparatus with respect to the septal wall such as to allow advancement of the clip apparatus into a position suitable for the clip apparatus to close the tunnel.

71. The method of claim 1, further comprising orienting the elongate delivery apparatus perpendicularly with respect to the septal wall prior to advancing the clip apparatus.

72. The method of claim 1, wherein the clip apparatus comprises a central body member that resides through the first and second tissue flaps.

73. The method of claim 1, further comprising:

engaging a first septal surface exposed in the left atrial chamber with a first portion of the clip apparatus; and

engaging a second septal surface exposed in the right atrial chamber with a second portion of the clip apparatus.

74. The method of claim 1, wherein advancing the clip apparatus from the right atrial chamber through the first tissue flap comprises piercing through the first tissue flap with the clip apparatus.

75. The method of claim 1, wherein advancing the clip apparatus comprises piercing the first tissue flap with the clip apparatus.

76. The method of claim 75, wherein the piercing is the sole piercing entirely through the first tissue flap in which the clip apparatus resides.

77. The method of claim 76, wherein the part of the clip apparatus that resides within the piercing is the main body portion of the clip apparatus.

78. The method of claim 1, wherein the clip apparatus resides within a first opening through the first tissue flap and a second opening through the second tissue flap, wherein the first opening is in-line with the second opening.

79. The method of claim 78, further comprising removing the elongate delivery apparatus while leaving the clip apparatus implanted within the first and second openings, wherein the clip apparatus does not reside in any other openings entirely through the first tissue flap or the second tissue flap.

80. The method of claim 1, wherein first tissue flap is the septum secundum and the second tissue flap is the septum primum and the clip apparatus at least partially closes the tunnel by maintaining the left atrial side of the septum secundum in contact with the right atrial side of the septum primum.

81. A method of closing a septal defect within a patient'"'"'s heart comprising the steps of:

advancing an elongate delivery apparatus, adapted to carry an implantable device, through the patient'"'"'s vasculature and into a right atrial chamber of the heart, wherein the atrial septal wall of the heart has a patent foramen ovale characterized by a first tissue flap located mainly in the right atrial chamber and a second tissue flap located mainly in a left atrial chamber, at least a portion of the first tissue flap overlapping at least a portion of the second tissue flap to define a tunnel therebetween; and

advancing the implantable device from the right atrial chamber through the first tissue flap, then into and across the tunnel, then through the second tissue flap and into the left atrial chamber, such that at least part of the implantable device resides entirely through the first and second tissue flaps to at least partially close the tunnel.

82. The method of claim 81, wherein advancing the elongate delivery apparatus comprises advancing the distal end of the elongate delivery apparatus into the right atrial chamber until the distal end is disposed adjacent to the patent foramen ovale.

83. The method of claim 82, wherein advancing the implantable device comprises advancing a pusher member distally relative to the elongate delivery apparatus to advance the implantable device.

84. The method of claim 81, wherein the implantable device comprises a radiopaque marker, and further comprising externally imaging the radiopaque marker with fluoroscopy.

85. The method of claim 81, wherein advancing the implantable device through the vasculature of a subject comprises advancing the implantable device through the vasculature while the implantable device is in a stressed state.

86. The method of claim 85, comprising allowing the implantable device to transition from the stressed, first state to a less stressed, second state.

87. The method of claim 81, further comprising:

engaging a first septal surface exposed in the left atrial chamber with a first portion of the implantable device; and

engaging a second septal surface exposed in the right atrial chamber with a second portion of the implantable device.

88. The method of claim 87, wherein engaging the first septal surface exposed in the left atrial chamber with the first portion of the implantable device comprises allowing the first portion of the implantable device to transition from a stressed state to a less stressed state such that the first portion engages the first septal surface.

89. The method of claim 87, wherein engaging the second septal surface exposed in the right atrial chamber with the second portion of the implantable device comprises allowing the second portion of the implantable device to transition from a stressed state to a less stressed state such that the second portion engages the second septal surface.

90. The method of claim 87, wherein the second portion of the implantable device comprises a fixed retaining end configured to abut the second septal surface.

91. The method of claim 81, wherein advancing the elongate delivery apparatus through the vasculature of the subject comprises advancing the elongate delivery apparatus through the inferior vena cava.

92. The method of claim 81, wherein advancing the elongate delivery apparatus through the vasculature of the subject comprises advancing the elongate delivery apparatus through the superior vena cava.

93. The method of claim 81, further comprising introducing the elongate delivery apparatus into the vasculature of the patient at a percutaneous entry site to a peripheral vessel, prior to advancing the elongate delivery apparatus.

94. The method of claim 81, wherein advancing the implantable device from the right atrial chamber through the first tissue flap comprises piercing through the first tissue flap with the implantable device.

95. The method of claim 81, wherein advancing the implantable device comprises piercing the first tissue flap with the implantable device.

96. The method of claim 95, wherein the piercing is the sole piercing entirely through the first tissue flap in which the implantable device resides.

97. The method of claim 96, wherein the part of the implantable device that resides within the piercing is a main body portion of the implantable device.

98. The method of claim 81, wherein the implantable device resides within a first opening through the first tissue flap and a second opening through the second tissue flap, wherein the first opening is in-line with the second opening.

99. The method of claim 98, further comprising removing the elongate delivery apparatus while leaving the implantable device implanted within the first and second openings, wherein the implantable device does not reside in any other openings entirely through the first tissue flap or the second tissue flap.

100. The method of claim 81, wherein first tissue flap is the septum secundum and the second tissue flap is the septum primum and the implantable device at least partially closes the tunnel by maintaining the left atrial side of the septum secundum in contact with the right atrial side of the septum primum.