Heart Occlusion Devices

• US 20120071918A1
• Filed: 08/15/2011
• Published: 03/22/2012
• Est. Priority Date: 03/07/2008
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Amin, Zahid, Cully, Edward, Shaw, Edward Emil, Cutright, Warren, Larsen, Coby, Masters, Steven
• Granted Patent: US 9,138,213 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• 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 2017/00597 Implements comprising a membrane
• 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 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection

Abstract

The disclosure is directed to a heart occlusion device and a method for occluding an aperture defect in a heart. The heart occlusion device includes two separate wires 12, 14. Each wire forms geometric shapes that together form a distal plate and a proximal plate. The first plate is disposed in a first plane. The second plate is disposed in a second plane that is parallel to and remote from the first plane. The distal plate and the proximal plate are separated by a self-centering waist. The proximal plate is attached to a hub. A similar hub is optional on the distal plate. The plates further include coverings which form a sealant to occlude an aperture in a tissue. The wires forming the plates have a shape-memory capability such that they can be collapsed and distorted in a catheter during delivery but resume and maintain their intended shape after delivery.

Claims

1. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire.

2. The device of claim 1, wherein the first geometric forms of the first and second wires are generally semi-circular.

3. The device of claim 1, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

4. The device of claim 1, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

5. The device of claim 1, wherein the waist is self-centering.

6. The device of claim 1, wherein the first geometric form and the second geometric form both comprise substantially identical geometric shapes.

7. The device of claim 1, wherein the first geometric form is generally oval.

8. The device of claim 1, wherein the first geometric form is generally triangular.

9. The device of claim 1, wherein the first geometric form is generally rectangular.

10. The device of claim 1, wherein the first geometric form is generally elliptical.

11. The device of claim 1, wherein the first geometric form is generally of a keyhole-type shape.

12. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, the first plate having a center, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire, and wherein the waist is offset from the center of the first plate.

13. The device of claim 12, wherein the first geometric forms of the first and second wires are generally semi-circular.

14. The device of claim 12, wherein:

the second plate has a center; and

the waist is aligned with the center of the second plate.

15. The device of claim 12, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

16. The device of claim 12, wherein the waist is self-centering.

17. The device of claim 12, wherein:

a first of the two portions of the first wire has a first surface area; and

a first of the two portions of the second wire has a second surface area that is substantially equal to the first surface area.

18. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms around an inner region such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire, the waist comprising a first portion and a second portion, the first portion being connected to the inner region by a first segment and the second portion being connected to the inner region by a second segment, the first segment having a first length, and the second segment having a second length that is greater than the first length.

19. The device of claim 18, wherein the first geometric forms of the first and second wires are generally semi-circular.

20. The device of claim 18, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

21. The device of claim 18, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

22. The device of claim 18, wherein the waist is self-centering.

23. The device of claim 18, wherein:

the first portion of the waist has a first surface area; and

the second portion of the waist has a second surface area that is substantially equal to the first surface area.

24. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire, the first and second geometric forms comprising;

a first segment formed from a first of the two portions of the first wire, the first segment having a first length;

a second segment formed from a first of the two portions of the second wire, the second segment having a second length that is substantially equal to the first length;

a third segment formed from a second of the two portions of the first wire, the third segment generally opposing the first segment and having a third length that is greater than the first length; and

a fourth segment formed from a second of the two portions of the second wire, the fourth segment generally opposing the first segment and having a fourth length that is substantially equal to the third length.

25. The device of claim 24, wherein at least one of the first segment, the second segment, the third segment, and the fourth segment comprises an arc segment.

26. The device of claim 24, wherein each of the first segment, the second segment, the third segment, and the fourth segment comprises an arc segment.

27. The device of claim 24, wherein the first geometric forms of the first and second wires are generally semi-circular.

28. The device of claim 24, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

29. The device of claim 24, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

30. The device of claim 24, wherein the waist is self-centering.

31. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire, the first and second geometric forms comprising;

a first segment formed from a first of the two portions of the first wire, the first segment having a first arm and a second arm, the first arm having a first length and the second arm having a second length, the second length being greater than the first length; and

a second segment formed from a first of the two portions of the second wire, the second segment having a third arm and a fourth arm, the third arm having the first length and the fourth arm having the second length.

32. The device of claim 31, wherein the first geometric forms of the first and second wires are generally semi-circular.

33. The device of claim 31, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

34. The device of claim 31, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

35. The device of claim 31, wherein the waist is self-centering.

36. The device of claim 31, wherein the first and second geometric forms further comprise:

a third segment formed from a second of the two portions of the first wire, the third segment having a fifth arm and a sixth arm, the fifth arm having the first length and the sixth arm having the second length; and

a fourth segment formed from a second of the two portions of the second wire, the fourth segment having a seventh arm and an eighth arm, the seventh arm having the first length and the eighth arm having the second length.

37. The device of claim 36, wherein the first segment, the second segment, the third segment, and the fourth segment each comprise arc segments.

38. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, the first plate having a first surface area, and the second plate having a second surface area that is greater than the first surface area, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire.

39. The device of claim 38, wherein the first geometric forms of the first and second wires are generally semi-circular.

40. The device of claim 38, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

41. The device of claim 38, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

42. The device of claim 38, wherein the waist is self-centering.

43. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire and a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire, the waist having a length that is greater than eight millimeters.

44. The device of claim 43, wherein the length is less than or equal to ten millimeters.

45. The device of claim 43, wherein the first geometric forms of the first and second wires are generally semi-circular.

46. The device of claim 43, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

47. The device of claim 43, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

48. The device of claim 43, wherein the waist is self-centering.

49. The device of claim 43, wherein the first plate comprises a distal disc and the second plate comprises a proximal disc, and wherein the distal disc comprises a plurality of hooks configured to grip the tissue.

50. The device of claim 43, wherein the aperture is in an artery.

51. The device of claim 43, wherein the aperture is in a vein.

52. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire and a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to the first plane and greater than eight millimeters from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire.

53. The device of claim 52, wherein the second plane is less than or equal to ten millimeters from the first plane.

54. The device of claim 52, wherein the first geometric forms of the first and second wires are generally semi-circular.

55. The device of claim 52, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

56. The device of claim 52, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

57. The device of claim 52, wherein the waist is self-centering.

58. The device of claim 52, wherein the first plate comprises a distal disc and the second plate comprises a proximal disc, and wherein the distal disc comprises a plurality of hooks configured to grip the tissue.

59. The device of claim 52, wherein the aperture is in an artery.

60. The device of claim 52, wherein the aperture is in a vein.

61. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire and a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire; and

a hook coupled to the first plate and configured for engagement with a positioning system.

62. The device of claim 61, further comprising:

a screw device coupled to the first plate and configured for further engagement with the positioning system.

63. The device of claim 61, wherein the positioning system comprises a deployment system.

64. The device of claim 61, wherein the positioning system comprises a retrieval system.

65. The device of claim 61, wherein the positioning system comprises a repositioning system.

66. The device of claim 61, wherein the first geometric forms of the first and second wires are generally semi-circular.

67. The device of claim 61, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

68. The device of claim 61, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

69. The device of claim 61, wherein the waist is self-centering.

70. A device for occluding an aperture in tissue comprising:

a first flexible wire and a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire overlaps with the first geometric form of the second wire to form a first plate in a first plane, and the second geometric form of the first wire overlaps with the second geometric form of the second wire to form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire.

71. The device of claim 70, wherein the first geometric forms of the first and second wires are generally semi-circular.

72. The device of claim 70, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

73. The device of claim 70, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

74. The device of claim 70, wherein the waist is self-centering.

75. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, and wherein each of the first and second wires is shaped into first and second geometric forms separated by a waist formed from two portions of the first wire and two portions of the second wire, such that;

the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane;

the first plane has a first quadrant, a second quadrant that is adjacent to the first quadrant, a third quadrant that is below the first quadrant, and a fourth quadrant that is below the second quadrant and adjacent to the third quadrant;

the first geometric form of the first wire extends through the first, second, and third quadrants of the first plane; and

the first geometric form of the second wire extends through the first, third, and fourth quadrants of the first plane.

76. The device of claim 75, wherein:

the second plane has a first quadrant, a second quadrant that is adjacent to the first quadrant, a third quadrant that is below the first quadrant, and a fourth quadrant that is below the second quadrant and adjacent to the third quadrant, the first quadrant of the first plane being closer to the first quadrant of the second plane than to the second, third, or fourth quadrants of the second plane, the second quadrant of the first plane being closer to the second quadrant of the second plane than to the first, third, or fourth quadrants of the second plane, the third quadrant of the first plane being closer to the third quadrant of the second plane than to the first, second, or fourth quadrants of the second plane, and the fourth quadrant of the first plane being closer to the fourth quadrant of the second plane than to the first, second, or third quadrants of the second plane; and

the second geometric form of the first wire extends through the first, second, and third quadrants of the second plane.

77. The device of claim 76, wherein:

the second geometric form of the second wire extends through the first, third, and fourth quadrants of the first plane.

78. The device of claim 75, wherein:

the second plane has a first quadrant, a second quadrant that is adjacent to the first quadrant, a third quadrant that is below the first quadrant, and a fourth quadrant that is below the second quadrant and adjacent to the third quadrant, the first quadrant of the first plane being closer to the first quadrant of the second plane than to the second, third, or fourth quadrants of the second plane, the second quadrant of the first plane being closer to the second quadrant of the second plane than to the first, third, or fourth quadrants of the second plane, the third quadrant of the first plane being closer to the third quadrant of the second plane than to the first, second, or fourth quadrants of the second plane, and the fourth quadrant of the first plane being closer to the fourth quadrant of the second plane than to the first, second, or third quadrants of the second plane;

the second geometric form of the first wire extends through the third, fourth, and first quadrants of the second plane.

79. The device of claim 78, wherein the second geometric form of the second wire extends through the first, second, and third quadrants of the first plane.

80. The device of claim 75, wherein the first geometric forms of the first and second wires are generally semi-circular.

81. The device of claim 75, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

82. The device of claim 75, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

83. The device of claim 75, wherein the waist is self-centering.

84. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire, the first plate and the second plate forming a non-zero angle with respect to one another.

85. The device of claim 84, wherein the angle is greater than five degrees.

86. The device of claim 84, wherein the angle is greater than ten degrees.

87. The device of claim 84, wherein the angle is approximately equal to twenty degrees.

88. The device of claim 84, wherein the first geometric forms of the first and second wires are generally semi-circular.

89. The device of claim 84, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

90. The device of claim 84, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

91. The device of claim 84, wherein the waist is self-centering.

92. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are not substantially parallel to one another and are separated by a waist formed from two portions of the first wire and two portions of the second wire.

93. The device of claim 92, wherein the first geometric forms of the first and second wires are generally semi-circular.

94. The device of claim 92, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

95. The device of claim 92, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

96. The device of claim 92, wherein the waist is self-centering.

97. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from a first waist component of the first wire and a second waist component of the second wire, the first and second waist components being of unequal sizes.

98. The device of claim 97, wherein:

the first waist component has a first length;

the second waist component has a second length; and

the second length is larger than the first length.

99. The device of claim 97, wherein:

the first waist component has a first surface area;

the second waist component has a second surface area; and

the second surface area is larger than the first surface area.

100. The device of claim 97, wherein:

the first waist component has a first radius;

the second waist component has a second radius; and

the second radius is larger than the first radius.

101. The device of claim 97, wherein the first geometric forms of the first and second wires are generally semi-circular.

102. The device of claim 97, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

103. The device of claim 97, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

104. The device of claim 97, wherein the waist is self-centering.

105. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire; and

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from a first waist component of the first wire and a second waist component of the second wire, the first and second waist components configured to generate a non-zero angle of curvature for the waist.

106. The device of claim 105, wherein the angle of curvature is not equal to zero.

107. The device of claim 105, wherein the angle of curvature is greater than five degrees.

108. The device of claim 105, wherein the angle of curvature is greater than ten degrees.

109. The device of claim 105, wherein the angle of curvature is approximately equal to twenty degrees.

110. The device of claim 105, wherein the first geometric forms of the first and second wires are generally semi-circular.

111. The device of claim 105, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

112. The device of claim 105, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

113. The device of claim 105, wherein the waist is self-centering.

114. A device for occluding an aperture in tissue, the device comprising:

a first flexible wire having a first end and a second end and a second flexible wire having a first end and a second end, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms between their respective first and second ends such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire, and wherein;

the first end of the first wire is disposed at a first hub; and

at least one of the second end of the first wire, the first end of the second wire, and the second end of the second wire is disposed at a second hub.

115. The device of claim 114, wherein the second end of the first wire is disposed at the second hub.

116. The device of claim 114, wherein the first end of the second wire is disposed at the second hub.

117. The device of claim 114, wherein the second end of the second wire is disposed at the second hub.

118. The device of claim 114, wherein the first geometric forms of the first and second wires are generally semi-circular.

119. The device of claim 114, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

120. The device of claim 114, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

121. The device of claim 114, wherein the waist is self-centering.

122. A device for occluding an aperture in tissue comprising:

a first flexible wire; and

a second flexible wire; and

a third flexible wire, wherein each of the first, second, and third wires is comprised of a shape memory material, wherein each of the first, second, and third wires is shaped into first and second geometric forms such that the first geometric form of the first wire, the first geometric form of the second wire, and the first geometric form of the third wire form a first plate, and the second geometric form of the first wire, the second geometric form of the second wire, and the second geometric form of the third wire form a second plate, and wherein the first and second plates are separated by a waist formed from two portions of the first wire, two portions of the second wire, and two portions of the third wire.

123. The device of claim 122, wherein the first and second geometric forms of the first, second, and third wires are curved.

124. The device of claim 122, wherein the first and second geometric forms of the first, second, and third wires each comprise an arch.

125. The device of claim 122, wherein:

the first plate is formed in a first plane having a first planar region, a second planar region that is adjacent to the first planar region, and a third planar region that is adjacent to both the first and second planar regions; and

the first geometric form of the first wire is disposed in the first planar region of the first plane;

the first geometric form of the second wire is disposed in the second planar region of the first plane; and

the first geometric form of the second wire is disposed in the third planar region of the first plane.

126. The device of claim 125, wherein:

the second plate is formed in a second plane that is parallel to and remote from the first plane, the second plane having a first planar region, a second planar region that is adjacent to the first planar region, and a third planar region that is adjacent to both the first and second planar regions; and

the second geometric form of the first wire is disposed in the first planar region of the second plane;

the second geometric form of the second wire is disposed in the second planar region of the second plane; and

the second geometric form of the third wire is disposed in the third planar region of the second plane.

127. The device of claim 122, wherein:

the first plate comprises a first disc; and

the second plate comprises a second disc.

128. The device of claim 122, further comprising:

a covering over the first plate, the second plate, or both that provides a seal to occlude the aperture.

129. The device of claim 122, wherein the waist is self-centering.

130. A method for occluding an aperture defect in a heart to prevent the flow of blood therethrough, the method comprising the steps of:

providing an occluder device comprising;

a first flexible wire;

a second flexible wire, wherein each of the first and second wires is comprised of a shape memory material, wherein each of the first and second wires is shaped into first and second geometric forms around an inner region such that the first geometric form of the first wire and the first geometric form of the second wire form a first plate in a first plane, and the second geometric form of the first wire and the second geometric form of the second wire form a second plate in a second plane that is parallel to and remote from the first plane, and wherein the first and second plates are separated by a waist formed from two portions of the first wire and two portions of the second wire; and

a sealed covering over at least one of the first and second plates, wherein the covering provides a seal for the aperture defect, wherein each of the first and second wires have a first and second end and wherein each of the first and second ends of the first and second wires are connected to a hub, wherein the hub further comprises a delivery attachment mechanism for attachment to a removable deployment cable;

attaching the occluder device to the removable deployment cable,

placing the occluder device within a flexible delivery catheter having an open channel;

feeding the catheter into a blood vessel system and advancing the catheter via the blood vessel system to the aperture defect in the heart;

advancing the catheter through the aperture defect;

withdrawing the catheter from the occluder device such that the first plate of the occluder device expands on a first side of the aperture defect;

further withdrawing the catheter from the occluder device such that the second plate of the occluder device expands on a second side of the aperture defect, such that the waist of the occluder device expands by memory retention within the aperture defect to self-center the occluder device;

further withdrawing the catheter from the blood vessel system; and

removing the deployment cable from the hub.

131. The method of claim 130, further comprising the steps of:

advancing a balloon into the heart through the open channel toward the occluder device at the aperture defect;

inserting the balloon into the waist of the occluder device; and

inflating the balloon.

132. The method of claim 131, further comprising the steps of:

deflating the balloon;

removing the balloon from the waist; and

removing the balloon from the heart via the open channel.

133. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first geometric forms of the first and second wires are generally semi-circular.

134. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein;

the first plate comprises a first disc; and

the second plate comprises a second disc.

135. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the waist is self-centering.

136. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first geometric form and the second geometric form both comprise substantially identical geometric shapes.

137. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first geometric form is generally oval.

138. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first geometric form is generally triangular.

139. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first geometric form is generally rectangular.

140. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first geometric form is generally elliptical.

141. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first geometric form is of a keyhole-type shape.

142. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein;

the first plate has a first center;

the second plate has a second center; and

the waist is offset from the first center.

143. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the waist comprises a first portion and a second portion, the first portion being connected to the inner region by a first segment and the second portion being connected to the inner region by a second segment, the first segment having a first length, and the second segment having a second length that is greater than the first length.

144. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first and second geometric forms comprise;

a first segment formed from a first of the two portions of the first wire, the first segment having a first length;

a second segment formed from a first of the two portions of the second wire, the second segment having a second length that is substantially equal to the first length;

a third segment formed from a second of the two portions of the first wire, the third segment generally opposing the first segment and having a third length that is greater than the first length; and

a fourth segment formed from a second of the two portions of the second wire, the fourth segment generally opposing the first segment and having a fourth length that is substantially equal to the third length.

145. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first and second geometric forms comprise;

a first segment formed from a first of the two portions of the first wire, the first segment having a first arm and a second arm, the first arm having a first length and the second arm having a second length, the second length being greater than the first length; and

a second segment formed from a first of the two portions of the second wire, the second segment having a third arm and a fourth arm, the third arm having the first length and the fourth arm having the second length.

146. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein;

the first plate has a first surface area; and

the second plate has a second surface area that is greater than the first surface area.

147. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the waist has a length that is greater than eight millimeters.

148. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the second plane is greater than eight millimeters from the first plane.

149. The method of claim 130, wherein the step of providing the occluder device comprises the step of comprising the occluder device wherein a hook is coupled to the first plate, and the method further comprises the step of:

engaging the hook with the delivery attachment mechanism.

150. The method of claim 149, further comprising the step of:

further engaging the hook to the delivery attachment mechanism via a screw system.

151. The method of claim 149, further comprising the step of:

manipulating the hook using the delivery attachment mechanism and repositioning the occluder device.

152. The method of claim 149, further comprising the step of:

exerting force on the delivery attachment mechanism and retrieving the occluder device from the aperture defect.

153. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein each of the first and second wires is shaped into the first and second geometric forms such that the first geometric form of the first wire overlaps with the first geometric form of the second wire to form the first plate in the first plane, and the second geometric form of the first wire overlaps with the second geometric form of the second wire to form the second plate in the second plane.

154. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein;

the first plane has a first quadrant, a second quadrant that is adjacent to the first quadrant, a third quadrant that is below the first quadrant, and a fourth quadrant that is below the second quadrant and adjacent to the third quadrant;

the first geometric form of the first wire extends through the first, second, and third quadrants of the first plane; and

the first geometric form of the second wire extends through the first, third, and fourth quadrants of the first plane.

155. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first plate and the second plate form a non-zero angle with respect to one another.

156. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the first and second plates are not substantially parallel to one another.

157. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the waist is formed from a first waist component of the first wire and a second waist component of the second wire, the first and second waist components being of unequal sizes.

158. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device wherein the waist is formed from a first waist component of the first wire and a second waist component of the second wire, the first and second waist components configured to generate a non-zero angle of curvature for the waist.

159. The method of claim 130, wherein the step of providing the occluder device comprises the step of:

providing the occluder device further comprising a third flexible wire comprised of the shape memory material and shaped into first and second geometric forms around the inner region such that the first plate is formed by the first geometric form of the third wire in addition to the first geometric form of the first wire and the first geometric form of the second wire and the second plate is formed by the second geometric form of the third wire in addition to the second geometric form of the first wire and the second geometric form of the second wire, and the waist is formed from two portions of the third wire in addition to the two portions of the first wire and the two portions of the second wire.