Apparatus and methods for closing septal defects and occluding blood flow

• US 6,712,836 B1
• Filed: 05/12/2000
• Issued: 03/30/2004
• Est. Priority Date: 05/13/1999
• Status: Expired due to Term

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories)
• Inventors: Peterson, Alex A., Swanson, William J., Berg, Todd A., Hindrichs, Paul J.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/570,358
• Time in Patent Office: 1,418 Days
• Field of Search: 606/213, 606/139
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2090/3941 Photoluminescent markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Plugs and methods for plugging septal defects and blood vessels are provided. Plugs are delivered via catheter to a septal defect or a location where it is desired to occlude blood flow in a blood vessel. The plugs are positioned and expanded at the treatment site. The expansion of the plugs can be accomplished passively by using a heat-treated elastic frame or actively by using a balloon to deform a plastically-deforming frame. Plugging structures mounted to the frame span the defect or lumen and prevent blood flow. The plugs described herein have small profiles, and are more reliable than preceding intraluminal transcatheter methods.

Claims

1. A plug for closing an aperture in a wall of a patient'"'"'s body cavity, said plug comprising:

a frame having a central axis comprising;

a first plurality of fingers configured to engage an interior surface of said wall of said body cavity;

a second plurality of fingers attached to said first plurality, wherein said second plurality is configured to engage an exterior surface of said wall of said body cavity, and wherein said pluralities of fingers are positioned substantially circumferentially with respect to said axis; and

a plugging structure that spans said aperture when said plug is inserted in said aperture, wherein said plugging structure is attached to said frame, and wherein any cross-section of said frame that lies in a plane substantially perpendicular to said axis is discontinuous.

2. The plug of claim 1 wherein said plug can be detected using fluoroscopy.

3. The plug of claim 1 wherein said first and second pluralities of fingers are formed from a unitary body.

4. The plug of claim 1 wherein said frame comprises an elastic material.

5. The plug of claim 4 wherein said frame comprises nitinol.

6. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers extends substantially radially away from said central axis.

7. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has a marker structure.

8. The plug of claim 7 wherein said marker structure is radiopaque.

9. The plug of claim 7 wherein said marker structure is a marker band.

10. The plug of claim 9 wherein said finger has an end portion and said marker band is crimped to said end portion.

11. The plug of claim 7 wherein said marker structure is a rivet.

12. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has a retention device receptacle.

13. The plug of claim 12 wherein said retention device receptacle is a locking pin aperture.

14. The plug of claim 12 wherein said retention device receptacle is a nose cone cover.

15. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has a pointed end portion located remotely from said central axis.

16. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has a barbed end portion located remotely from said central axis.

17. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers is curved, said curve being concave toward a plane perpendicular to said central axis and passing substantially between said first and second pluralities of fingers.

18. The plug of claim 1 wherein said fingers have end portions that are proximal to said central axis and said end portions define a substantially round cross section.

19. The plug of claim 1 wherein said fingers have end portions that are proximal to said central axis and said end portions define a substantially elliptical cross section.

20. The plug of claim 1 wherein substantially all of said fingers of at least one of said pluralities of fingers are of substantially the same length.

21. The plug of claim 1 wherein different fingers of at least one of said pluralities of fingers have different lengths.

22. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has a different flexural stiffness at different points along its length.

23. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has a different thickness at different points along its length.

24. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has a different width at different points along its length.

25. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has a free end portion comprising an end structure configured to facilitate releasable retention of said finger by a plug delivery device.

26. The plug of claim 1 further comprising an elastic web between adjacent ones of said fingers.

27. The plug of claim 26 wherein said web comprises silicone.

28. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has an end portion proximal to said central axis for supporting said plugging structure.

29. The plug of claim 28 wherein said end portions have support structures with which to affix said plugging structure.

30. The plug of claim 1 wherein at least one finger of at least one of said pluralities of fingers has an end portion remote from said central axis for supporting said plugging structure.

31. The plug of claim 30 wherein said end portion has a support structure with which to affix said plugging structure.

32. The plug of claim 1 wherein said plugging structure is elastic.

33. The plug of claim 1 wherein said plugging structure can be unfolded.

34. The plug of claim 1 wherein said plugging structure comprises polymeric material.

35. The plug of claim 1 wherein said plugging structure comprises DACRON®

.

36. The plug of claim 1 wherein said plugging structure comprises cloth.

37. The plug of claim 1 wherein said plugging structure is sewn to said frame.

38. The plug of claim 1 wherein said plugging structure has a guide wire aperture through which a guide wire can pass.

39. The plug of claim 38 wherein said guide wire aperture can substantially self close when said guide wire is removed from said guide wire aperture.

40. The plug of claim 1 wherein said frame is insertable into a delivery tube by positioning said fingers in a direction substantially parallel to said central axis.

41. The plug of claim 1 wherein said second plurality of fingers is integral with said first plurality of fingers.

42. The plug of claim 1 wherein said aperture has a perimeter and said frame can conform to said perimeter.

43. A plug comprising:

a perforated tubular portion having a longitudinal passage, wherein any cross-section of said perforated tubular portion in a plane perpendicular to said passage is discontinuous;

a plurality of fingers attached to said tubular portion and extending from an axial end of said perforated tubular portion, wherein any cross-scction of said plurality of fingers in a plane perpendicular to said passage is discontinuous; and

a plugging structure substantially occluding said passage.

44. The plug of claim 43 wherein said plug can be detected using fluoroscopy.

45. The plug of claim 43 wherein said perforated tubular portion and said plurality of fingers are formed from a unitary body.

46. The plug of claim 43 further comprising a second plurality of fingers attached to said tubular portion and extending from a second axial end of said perforated tubular portion.

47. The plug of claim 46 wherein said plug can be detected using fluoroscopy.

48. The plug of claim 46 wherein said perforated tubular portion and said first and second pluralities of fingers are formed from a unitary body.

49. The plug of claim 46 wherein said perforated tubular structure and said fingers comprise an elastic material.

50. The plug of claim 49 wherein said perforated tubular structure and said fingers frame comprise nitinol.

51. The plug of claim 46 wherein at least one finger of said pluralities of fingers can be positioned to extend substantially radially away from said longitudinal passage.

52. The plug of claim 46 wherein at least one finger of said plurality of fingers has a marker structure.

53. The plug of claim 52 wherein said marker structure is radiopaque.

54. The plug of claim 52 wherein said marker structure is a marker bands.

55. The plug of claim 54 wherein said finger has an end portion and said marker band is crimped to said end portion.

56. The plug of claim 52 wherein said marker structure is a rivet.

57. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers has a retention device receptacle.

58. The plug of claim 57 wherein said retention device receptacle is a locking pin aperture.

59. The plug of claim 58 wherein said retention device receptacle is a nose cone cover.

60. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers has a pointed end portion located remotely from said central axis.

61. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers has a barbed end portion located remotely from said central axis.

62. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers is curved, said curve being concave toward a plane perpendicular to said central axis and passing substantially between said first and second pluralities of fingers.

63. The plug of claim 46 wherein said perforated tubular portion defines a substantially round cross section as viewed in a direction of said longitudinal axis.

64. The plug of claim 46 wherein said perforated tubular portion defines a substantially elliptical cross section as viewed in a direction of said longitudinal passage.

65. The plug of claim 46 wherein substantially all of said fingers of at least one of said pluralities are of substantially similar length.

66. The plug of claim 46 wherein different ones of the fingers of at least one of said pluralities are of different lengths.

67. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers has different flexural stiffness along its length.

68. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers has different thickness along its length.

69. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers has different width along its length.

70. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers has a free end portion comprising an end structure configured to facilitate releasable retention of said finger by a plug delivery device.

71. The plug of claim 46 further comprising an elastic web between adjacent ones of said fingers.

72. The plug of claim 71 herein the web comprises silicone.

73. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers has an end portion proximal to said central axis for supporting said plugging structure.

74. The plug of claim 46 wherein at least one finger of at least one of said pluralities of fingers has an end portion remote from said central axis for supporting said plugging structure.

75. The plug of claim 74 wherein said end portion has a support structure with which to affix said plugging structure.

76. The plug of claim 46 wherein said perforated tubular portion has at least one support structure with which to affix said plugging structure.

77. The plug of claim 46 wherein said plugging structure is elastic.

78. The plug of claim 46 wherein said plugging structure can be unfolded.

79. The plug of claim 46 wherein said plugging structure comprises polymeric material.

80. The plug of claim 46 wherein said plugging structure comprises DACRON®

.

81. The plug of claim 46 wherein said plugging structure comprises cloth.

82. The plug of claim 46 wherein said plugging structure is sewn to said frame.

83. The plug of claim 46 wherein said plugging structure has a guide wire aperture through which a guide wire can pass.

84. The plug of claim 83 wherein said guide wire aperture can substantially self close after said guide wire is removed.

85. The plug of claim 46 wherein said frame may be inserted into a delivery tube by extending said fingers in a direction substantially parallel to said longitudinal passage.

86. The plug of claim 46 wherein said perforated tubular portion can conform to a perimeter of a hole in a wall of a patient'"'"'s body cavity.

87. The plug of claim 46 wherein said perforated tubular portion can contract longitudinally as it expands radially.

88. The plug of claim 46 wherein said perforated tubular portion is plastically deformable.

89. The plug of claim 88 wherein said perforated tubular portion comprises stainless steel.

90. The plug of claim 89 wherein said tubular portion comprises tantalum.

91. The plug of claim 88 wherein said perforated tubular portion can be conformed to a perimeter of a hole in a wall of a patient'"'"'s body cavity using a balloon to expand said perforated tubular portion.

92. The plug of claim 88 wherein said perforated tubular portion can contract longitudinally as it expands radially.

93. The plug of claim 43 wherein said perforated tubular portion and said fingers comprise an elastic material.

94. The plug of claim 93 wherein said perforated tubular portion and said fingers comprise nitinol.

95. The plug of claim 43 wherein at least one of said fingers extends substantially radially away from said central axis.

96. The plug of claim 43 wherein at least one of said fingers has a marker structure.

97. The plug of claim 96 wherein said marker structure is radiopaque.

98. The plug of claim 96 wherein said marker structure is a marker band.

99. The plug of claim 98 wherein said finger has an end portion and said marker band is crimped to said end portion.

100. The plug of claim 96 wherein said marker structure is a rivet.

101. The plug of claim 43 wherein at least one of said fingers has a pointed end portion located remotely from said central axis.

102. The plug of claim 43 wherein at least one of said fingers has a barbed end portion located remotely from said central axis.

103. The plug of claim 43 wherein at least one of said fingers is curved, said curve being concave toward a plane perpendicular to said central axis and passing through said perforated tubular portion.

104. The plug of claim 43 wherein said i perforated tubular portion defines a substantially round cross section as viewed in a direction of said longitudinal passage.

105. The plug of claim 43 wherein said perforated tubular portion defines a substantially elliptical cross section as viewed in a direction of said longitudinal passage.

106. The plug of claim 43 wherein substantially all of said fingers are of substantially similar length.

107. The plug of claim 43 wherein different ones of the fingers are of different lengths.

108. The plug of claim 43 wherein at least one of said fingers has different flexural stiffness along its length.

109. The plug of claim 43 wherein at least one of said fingers has different thickness along its length.

110. The plug of claim 43 wherein at least one of said fingers has different width along its length.

111. The plug of claim 43 wherein at least one of said fingers has a free end portion comprising an end structure configured to facilitate releasable retention of said finger by a plug delivery device.

112. The plug of claim 43 further comprising an elastic web between adjacent ones of said fingers.

113. The plug of claim 112 wherein the web comprises silicone.

114. The plug of claim 43 wherein at least one of said fingers has an end portion proximal to said central axis for supporting said plugging structure.

115. The plug of claim 114 wherein said end portion has a support structure with which to affix said plugging structure.

116. The plug of claim 43 wherein said perforated tubular portion has at least one support structure for supporting said plugging structure.

117. The plug of claim 43 wherein said plugging structure is elastic.

118. The plug of claim 43 wherein said plugging structure can be unfolded.

119. The plug of claim 43 wherein said plugging structure comprises polymeric material.

120. The plug of claim 43 wherein said plugging structure comprises DACRON®

.

121. The plug of claim 43 wherein said plugging structure comprises cloth.

122. The plug of claim 43 wherein said plugging structure is sewn to said frame.

123. The plug of claim 43 wherein said plugging structure has a guide wire aperture through which a guide wire can pass.

124. The plug of claim 123 wherein said guide wire aperture can substantially self close after said guide wire is removed.

125. The plug of claim 43 wherein said frame may be inserted into a delivery tube by extending said fingers in a direction substantially parallel to said longitudinal passage.

126. The plug of claim 43 wherein said perforated tubular portion can conform to a perimeter of a defect in a wall of a patient'"'"'s body cavity.

127. The plug of claim 43 wherein said perforated tubular portion can contract longitudinally as it expands radially.

128. The plug of claim 43 wherein said perforated tubular portion is plastically deformable.

129. The plug of claim 128 wherein said perforated tubular portion comprises stainless steel.

130. The plug of claim 128 wherein said perforated tubular portion comprises tantalum.

131. The plug of claim 128 wherein said perforated tubular portion can be conformed to a perimeter of a hole in a wall of a patient'"'"'s body cavity using a balloon to expand said perforated tubular portion.

132. The plug of claim 128 wherein said perforated tubular portion can contract longitudinally as it expands radially.

133. A method for plugging an aperture in a wall of a patient'"'"'s body cavity comprising:

positioning in said aperture a conformable plug having a first plurality of fingers, a second plurality of fingers, and a central axis, wherein said pluralities are arranged about said axis at opposite axial ends, and wherein said plug also has a plugging structure;

conforming said plug to said aperture; and

securing said plug in said aperture.

134. The method of claim 133 wherein said positioning comprises locating said plug using fluoroscopy.

135. The method of claim 133 wherein said positioning comprises providing a delivery structure for installing said plug.

136. The method of claim 135 wherein said positioning further comprises:

extending said fingers in a direction substantially parallel to said central axis; and

inserting said plug into a sleeve.

137. The method of claim 136 wherein said positioning further comprises engaging at least one of said fingers with a locking pin.

138. The method of claim 137 wherein said positioning further comprises releasing at least one finger from a locking pin.

139. The method of claim 135 wherein said positioning further comprises inserting said delivery structure through an insertion aperture in a patient'"'"'s body tissue.

140. The method of claim 135 wherein said positioning further comprises shifting said delivery structure relative to said plug and said aperture so that (1) said delivery structure is removed from said aperture but said plug extends through said aperture;

(2) said fingers extend out from said axis, wherein each of said first and second pluralities on opposite sides of said wall; and

(3) said plugging structure substantially occludes said aperture.

141. The method of claim 140 wherein said positioning further comprises allowing said fingers to engage said respective opposite sides of said wall.

142. The method of claim 140 wherein said conforming comprises allowing said plug to elastically expand in said aperture until said plug substantially conforms to a perimeter of said aperture.

143. The method of claim 140 wherein said positioning further comprises allowing said plug to elastically contract longitudinally to cause said fingers to engage said respective opposite sides of said wall.

144. The method of claim 143 wherein said allowing further comprises allowing said plug to substantially center itself with respect to said wall in a direction along said longitudinal passage.

145. A method for occluding blood flow in a tube of a patient'"'"'s circulatory system, said method comprising:

positioning in said tube a conformable plug having a first plurality of fingers, a tubular portion, a plugging structure, and a central axis, wherein said plurality of fingers is arranged circumferentially about said central axis and wherein said plugging structure spans across said tubular portion;

conforming said plug to said tube; and

securing said plug in said tube.

146. The method of claim 145 wherein said positioning comprises locating said plug using fluoroscopy.

147. The method of claim 145 wherein said positioning comprises providing a delivery balloon for installing said plug.

148. The method of claim 145 wherein said positioning further comprises:

inserting said delivery balloon in said tubular portion; and

delivering said plug through the patient'"'"'s body tissue to said tube.

149. The method of claim 148 wherein said delivering further comprises inserting said balloon and said plug through an insertion aperture in a patient'"'"'s body tissue.

150. The method of claim 148 wherein said positioning further comprises moving said plug mounted on said balloon through a patient'"'"'s existing body tubing so that said plug is positioned in said tube at a desired location.

151. The method of claim 150 wherein said conforming comprises:

expanding said balloon; and

radially enlarging said tubular portion until said tubular portion until said plurality of fingers engages with an inside surface of said tube, wherein said plugging structure substantially occludes said tube.

152. The method of claim 151 wherein said enlarging comprises plastically deforming said plug.

153. The method of claim 151 wherein said positioning further comprises allowing said plug to substantially center itself with respect to said wall in a direction along said longitudinal passage.