Three dimensional spherical micro-coils manufactured from radiopaque nickel-titanium microstrand

• US 6,159,165 A
• Filed: 02/06/1998
• Issued: 12/12/2000
• Est. Priority Date: 12/05/1997
• Status: Expired due to Term

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Micrus Corporation (Johnson & Johnson)
• Inventors: Ferrera, David A., Ken, Christopher G. M.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): Marmor, II, Charles
• Application Number:
  US09/019,841
• Time in Patent Office: 1,040 Days
• Field of Search: 600/434, 600/435, 600/585, 606/191, 606/108, 606/200, 606/194, 604/52, 604/57
• US Class Current: 600/585
• 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 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12154 having stretch limiting means
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12072 the heat created by laser light
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/09191 made of twisted wires

Abstract

The three dimensional device is adapted to be inserted into a portion of a vasculature for occluding the portion of the vasculature for use in interventional therapy and vascular surgery. The device is formed from a multi-stranded microcable having a plurality of flexible strands of a shape memory material and at least one radiopaque strand. The flexible strands in a multi-stranded micro-cable of the device can be helically wound, or can be configured as parallel, longitudinal strands, and can also be formed to have a secondary, three dimensional therapeutic configuration, such as helical, conical, spherical, or other geometric shapes. The strands can be made of a shape memory nickel titanium alloy, that is highly flexible at a temperature appropriate for introduction into the body via a catheter, and that after placement will take on the therapeutic shape. The device can also include a therapeutic agent, and can be bundled by an outer cover to constrain the strands of the micro-cable about a longitudinal axis to produce a composite banded cable.

Claims

1. A device for use in interventional therapy and vascular surgery, adapted to be inserted into a portion of a vasculature, comprising:

at least one multi-stranded micro-cable having a collapsed primary coil configuration and an expanded secondary configuration with a three dimensional shape, each said multi-stranded micro-cable having a plurality of flexible strands of a shape memory material, and at least one radiopaque strand to provide a radiopaque marker of the deployed configuration of the device.

2. The device of claim 1, wherein said secondary three dimensional shape is generally spherical.

3. The device of claim 1, wherein said secondary three dimensional shape is generally helical.

4. The device of claim 1, wherein said secondary three dimensional shape is generally conical.

5. The device of claim 1, wherein said plurality of strands are helically wound.

6. The device of claim 1, wherein said plurality of flexible strands are parallel longitudinal strands.

7. The device of claim 1, wherein at least one of said plurality of strands comprises a super-elastic material.

8. The device of claim 1, wherein said plurality of strands are comprised of a super-elastic material.

9. The device of claim 8, wherein said super-elastic material comprises a nickel titanium alloy.

10. The device of claim 1, wherein said shape memory material comprises a nickel-titanium alloy.

11. The device of claim 10, wherein said shape memory nickel-titanium alloy is heat treated such that the alloy is highly flexible at a temperature appropriate for introduction into the body via a catheter, and after placement, the device will take on a shape designed to optimize the therapeutic purposes desired for the device.

12. The device of claim 1, wherein said shape memory material comprises a shape memory polymer.

13. The device of claim 1, wherein at least one of the strands comprises a therapeutic agent.

14. The device of claim 13, wherein said strand comprising a therapeutic agent is wound into said micro-cable so that at least a portion of said strand projects beyond the diameter of the other strands in said cable.

15. The device of claim 13, wherein said therapeutic agent comprises a metal wire selected from the group consisting of copper and copper alloys.

16. The device of claim 13, wherein said therapeutic agent comprises a fiber selected from the group consisting of polyester, polyglycolic acid, polylactic acid, fluoropolymers, nylons, polyaramid fiber and silk chosen for thrombogenicity.

17. The device of claim 13, wherein at least one of the strands is impregnated with said therapeutic agent.

18. The device of claim 13, wherein at least one of the strands is coated with said therapeutic agent.

19. The device of claim 13, wherein said therapeutic agent is selected from the group consisting of human growth hormone, genetic material, antigens and hydrogels.

20. The device of claim 13, wherein said therapeutic agent comprises at least one component selected from the group consisting of hydrogel, collagen, and bio-absorbable polymers including lactic acids, glycolic acids, caprolactam and microcellular foams.

21. The device of claim 15, wherein said therapeutic agent comprises means to conduct energy.

22. The device of claim 21, wherein said means to conduct energy comprises an optical fiber to conduct light energy.

23. The device of claim 21, wherein said therapeutic means comprises means to conduct electrical energy.

24. The device of claim 23, wherein said means to conduct electrical energy comprises means to conduct radio frequency energy.

25. The device of claim 13, wherein said therapeutic agent is disposed axially in a central core.

26. The device of claim 1, wherein said plurality of strands comprises a plurality of exterior strands surrounding at least one interior strand.

27. The device of claim 1, wherein said plurality of strands comprises a plurality of exterior strands surrounding a central core.

28. The device of claim 1, wherein said radiopaque strand comprises at least one centrally, axially disposed radiopaque wire.

29. The device of claim 1, wherein said radiopaque wire is made of platinum.

30. The device of claim 1, wherein said radiopaque wire is made of tungsten.

31. The device of claim 1, wherein said radiopaque wire is made of gold.

32. The device of claim 1, wherein said micro-cable comprises a plurality of radiopaque strands.

33. The device of claim 1, wherein said micro-cable comprises four radiopaque strands.

34. The device of claim 33, wherein said micro-cable comprises three shape memory material strands.

35. The device of claim 1, wherein said micro-cable includes a central core.

36. The device of claim 35, wherein said central core of said micro-cable comprises copper.

37. The device of claim 35, wherein said central core of said micro-cable comprises a copper alloy.

38. The device of claim 1, wherein said radiopaque wire is approximately 0.0005 to 0.0030 inches in diameter.

39. The device of claim 38, wherein said strands of the micro-cable are bundled by a plurality of bands disposed at intervals along said micro-cable to produce a composite banded cable.

40. The device of claim 39, wherein said composite cable comprises a single inner micro-cable.

41. The device of claim 38, further comprising at least one longitudinal element for sensing a parameter.

42. The device of claim 41, wherein said longitudinal element for sensing a parameter comprises an optical imaging element.

43. The device of claim 41, wherein said longitudinal element for sensing a parameter comprises an optical fiber.

44. The device of claim 41, wherein said longitudinal element for sensing a parameter comprises a thermal imaging element.

45. The device of claim 41, wherein said longitudinal element for sensing a parameter comprises an ultrasound imaging element.

46. The device of claim 1, wherein said strands of the micro-cable are bundled by at least one outer cover to produce a composite banded cable.

47. The device of claim 46, wherein said outer cover comprises a sheath to constrain said strands of said micro-cable about a longitudinal axis.

48. The device of claim 47, wherein said sheath comprises a containment strand wound about said longitudinal strands.

49. The device of claim 48, wherein said sheath is made of low friction material.

50. The device of claim 48, wherein said sheath is made of a fluoropolymer.

51. The device of claim 48, wherein said strands are laid parallel within the composite banded cable.

52. The device of claim 48, wherein said strands are twisted within the composite banded cable.

53. The device of claim 48, wherein the width of the outer cover is varied along the composite cable.

54. The device of claim 47, wherein said sheath comprises a heat shrinkable plastic tube.

55. The device of claim 47, wherein outer covering comprises a plurality of layers formed of different materials in order to provide a graduated bending and stiffness characteristic over the length of the cable.

56. The device of claim 46, wherein said outer cover comprises an outer sheath of material to provide bending stiffness and constrain said longitudinal strands about said longitudinal axis.

57. The device of claim 56, wherein said sheath comprises a plurality of heat shrink plastic covers placed to provide bending stiffness in said cable which varies with the position on said cable.

58. The device of claim 56, wherein said exterior wrapped cover is wound at varying intervals along the outside to provide variations in the torqueability and stiffness of the composite cable.

59. The device of claim 46, wherein said outer covering varies in cross section along its length to provide bending stiffness of said composite cable which varies along said composite cable.

60. The device of claim 46, wherein the number of strands and the degree to which they extend along said composite cable within the outer covering varies along said composite cable.

61. The device of claim 46, wherein said composite micro-cable comprises a plurality of micro-cables disposed within said outer cover in order to provide desired bending and strength characteristics.

62. The device of claim 61, wherein said plurality of micro-cables are helically wound within said outer cover.

63. The device of claim 61, wherein said plurality of micro-cables extend parallel and longitudinally within said outer cover.

64. The device of claim 61, wherein said composite cable has a collapsed primary configuration and an expanded secondary configuration with a secondary shape.

65. The device of claim 64, wherein said secondary shape is three dimensional.

66. The device of claim 64, wherein said secondary shape is spherical.

67. The device of claim 64, wherein said secondary shape is helical.

68. The device of claim 64, wherein said secondary shape is conical.

69. The device of claim 61, wherein said plurality of micro-cables are banded at intervals by a plurality of bands.

70. The device of claim 1, wherein said multi-stranded micro-cable is approximately 0.0021 to 0.0045 inches in diameter.

71. The device of claim 70, further comprising at least one longitudinal element for sensing a parameter.

72. The device of claim 1, further comprising at least one longitudinal element for sensing a parameter.

73. A composite device for use in interventional therapy and vascular surgery adapted to be inserted into a portion of a vasculature, comprising:

at least one multi-stranded micro-cable having a collapsed primary coil configuration and an expanded configuration with a secondary three dimensional shape, each said multi-stranded micro-cable having a plurality of flexible strands of a shape memory material, and at least one radiopaque strand to provide a radiopaque marker of the deployed configuration of a device made of the micro-cable; and

at least one outer cover disposed over each said multi-stranded micro-cable to produce a composite banded cable.

74. The composite device of claim 73, wherein said secondary three dimensional shape is generally spherical.

75. The composite device of claim 73, wherein said secondary three dimensional shape is generally helical.

76. The composite device of claim 73, wherein said secondary three dimensional shape is generally conical.

77. The composite device of claim 73, wherein said plurality of strands are helically wound.

78. The composite device of claim 73, wherein said plurality of flexible strands are parallel longitudinal strands.

79. The composite device of claim 73, wherein at least one of said plurality of strands comprises a super-elastic material.

80. The composite device of claim 79, wherein said super-elastic material comprises a nickel titanium alloy.

81. The composite device of claim 73, wherein a plurality of said flexible strands are comprised of a super-elastic material.

82. The composite device of claim 73, wherein said shape memory material comprises a nickel-titanium alloy.

83. The composite device of claim 82, wherein said shape memory nickel-titanium alloy is heat treated such that the alloy is highly flexible at a temperature appropriate for introduction into the body via a catheter, and after placement, the device will take on a shape designed to optimize the therapeutic purposes desired for the device.

84. The composite device of claim 73, wherein said shape memory material comprises a shape memory polymer.

85. The composite device of claim 73, wherein at least one of the strands comprises a metal wire selected from the group consisting of copper and copper alloys or other metal alloys.

86. The composite device of claim 73 wherein at least one strand comprises a fiber selected from the group consisting of polyester, polyglycolic acid, polylactic acid, fluoropolymers, nylons, polyaramid fiber and silk chosen for thrombogenicity.

87. The composite device of claim 86, wherein said fiber is wound into said cable so that said fiber projects beyond the diameter of the other strands in said cable.

88. The composite device of claim 73, wherein at least one of the strands comprises a therapeutic agent selected from the group consisting of human growth hormone;

genetic material;

antigens;

hydrogels;

a metal wire selected from the group consisting of copper and copper alloys; and

a fiber selected from the group consisting of polyester, polyglycolic acid, polylactic acid, fluoropolymers, nylons, polyaramid fiber and silk chosen for thrombogenicity.

89. The composite device of claim 88, wherein at least one of the strands is impregnated with said therapeutic agent.

90. The composite device of claim 86, wherein at least one of the strands is coated with said therapeutic agent.

91. The composite device of claim 86, wherein said therapeutic agent is disposed axially in a central core of said composite device.

92. The composite device of claim 73, wherein at least one of the strands comprises a therapeutic agent including at least one component selected from the group consisting of hydrogel, collagen, and bio-absorbable polymers including lactic acids, glycolic acids and caprolactam.

93. The composite device of claim 73, further comprising means to conduct energy.

94. The composite device of claim 93, wherein said means to conduct energy comprises an optical fiber to conduct light energy.

95. The composite device of claim 93, wherein said means to conduct energy comprises means to conduct electrical energy.

96. The composite device of claim 73, wherein said plurality of strands comprises a plurality of exterior strands surrounding at least one interior strand.

97. The composite device of claim 73, wherein said plurality of strands comprises a plurality of exterior strands surrounding a central core of said composite device.

98. The composite device of claim 73, wherein said radiopaque strand comprises at least one centrally, axially disposed radiopaque wire, and said radiopaque wire is formed from a metal selected from the group consisting of platinum, tungsten, and gold.

99. The composite device of claim 73, wherein said outer cover comprises a sheath to constrain said strands of said micro-cable about a longitudinal axis.

100. The composite device of claim 99, wherein said sheath comprises a containment strand wound about said longitudinal strands.

101. The composite device of claim 100, wherein said containment strand is wound at varying intervals along the outside to provide variations in the torqueability and stiffness of the composite cable.

102. The composite device of claim 100, wherein the width of the outer cover is varied along the composite cable.

103. The composite device of claim 99, wherein said sheath comprises a plurality of heat shrink plastic tubes placed to provide bending stiffness in said cable which varies with the position on said cable.

104. The composite device of claim 99, wherein outer cover comprises a plurality of layers formed of different materials in order to provide a graduated bending and stiffness characteristic over the length of the cable.

105. The composite device of claim 73, wherein said outer cover comprises an outer sheath of material to provide bending stiffness and constrain said longitudinal strands about said longitudinal axis, said sheath being formed of a low friction material selected from the group consisting of a fluoropolymer and a heat shrinkable plastic tube.

106. The composite device of claim 73, wherein said strands of the micro-cable are bundled by a plurality of bands disposed at intervals along said micro-cable to produce a composite banded cable.

107. The composite device of claim 106, wherein said strands are laid parallel within the composite banded cable.

108. The composite device of claim 106, wherein said strands are twisted within the composite banded cable.

109. The composite device of claim 106, wherein composite cable comprises a single inner micro-cable.

110. The composite device of claim 73, wherein said outer cover varies in cross section along its length to provide bending stiffness of said composite cable which varies along said composite cable.

111. The composite device of claim 73, wherein the number of strands and the degree to which they extend along said composite cable within the outer cover varies along said composite cable.

112. The composite device of claim 73, wherein said multi-stranded micro-cable is approximately 0.0021 to 0.0045 inches in diameter.

113. The composite device of claim 73, wherein said composite microcable comprises a plurality of micro-cables disposed within said outer cover in order to provide desired bending and strength characteristics.

114. The composite device of claim 113, wherein said plurality of micro-cables are helically wound within said outer cover.

115. The composite device of claim 113, wherein said plurality of micro-cables extend parallel and longitudinally within said outer cover.

116. The composite device of claim 113, wherein said composite cable has a collapsed primary configuration and an expanded secondary configuration with a secondary three dimensional shape selected from the group consisting of spherical, helical and conical shapes.

117. The composite device of claim 113, wherein said plurality of micro-cables are bundled by at least one outer cover to produce said composite banded cable.

118. The composite device of claim 113, wherein said plurality of micro-cables are banded at intervals by a plurality of bands.

119. The composite device of claim 73, further comprising at least one longitudinal element for sensing a parameter selected from the group consisting of an optical imaging element, an optical fiber, a thermal imaging element, and an ultrasound imaging element.

120. A three dimensional composite device having a collapsed coil configuration with a primary shape and an expanded coil configuration with a secondary three dimensional shape for use in interventional therapy and vascular surgery, the device adapted to be inserted into a portion of a vasculature for occluding the portion of the vasculature, comprising:

a plurality of multi-stranded micro-cables having a collapsed coil configuration with a primary shape and an expanded coil configuration with a secondary three dimensional shape, each said multi-stranded micro-cable having a plurality of flexible strands of a shape memory material, and at least one said strand being a radiopaque strand to provide a radiopaque marker of the deployed configuration of a device made of the cable during vascular surgery.

121. The device of claim 120, said micro-cable further comprising at least one outer cover disposed over at least a portion of said plurality of multi-stranded micro-cables to produce a composite banded cable.

122. The three dimensional composite device of claim 121, wherein said secondary three dimensional shape is selected from the group consisting of generally spherical, generally helical, and generally conical shapes.

123. The three dimensional composite device of claim 121, wherein said plurality of strands are helically wound.

124. The three dimensional composite device of claim 121, wherein said plurality of flexible strands are parallel longitudinal strands.

125. The three dimensional composite device of claim 121, wherein at least one of said plurality of strands comprises a super-elastic material.

126. The three dimensional composite device of claim 125, wherein said super-elastic material comprises a nickel titanium alloy.

127. The three dimensional composite device of claim 121, wherein a plurality of said flexible strands are comprised of a super-elastic material.

128. The three demensional composite device of claim 121, wherein at least one of the strands comprises a therapeutic agent selected from the group consisting of human growth hormone;

genetic material;

antigens;

hydrogels;

a metal wire selected from the group consisting of copper and copper alloys; and

a fiber selected from the group consisting of polyester, polyglycolic acid, polylactic acid, fluoropolymers, nylons, polyaramid fiber and silk chosen for thrombogenicity.

129. The device of claim 128, wherein at least a portion of said strand of therapeutic agent projects beyond the diameter of the remaining strands on said cable.

130. The three dimensional composite device of claim 128, wherein at least one of the strands is impregnated with said therapeutic agent.

131. The three dimensional composite device of claim 128, wherein at least one of the strands is coated with said therapeutic agent.

132. The three dimensional composite device of claim 128, wherein said therapeutic agent is disposed axially in a central core of said three dimensional composite device.

133. The three dimensional composite device of claim 121, wherein at least one of said strands comprises a therapeutic agent including at least one component selected from the group consisting of hydrogel, collagen, and bio-absorbable polymers including lactic acids, glycolic acids and caprolactam.

134. The three dimensional composite device of claim 121, further comprising means to conduct energy.

135. The three dimensional composite device of claim 134, wherein said means to conduct energy comprises an optical fiber to conduct light energy.

136. The three dimensional composite device of claim 121, wherein said plurality of strands comprises a plurality of exterior strands surrounding at least one interior strand.

137. The three dimensional composite device of claim 121, wherein said plurality of strands comprises a plurality of exterior strands surrounding a central core of said three dimensional composite device.

138. The three dimensional composite device of claim 121, wherein said radiopaque strand comprises at least one centrally, axially disposed radiopaque wire, and said radiopaque wire is formed from a metal selected from the group consisting of platinum, tungsten, and gold.

139. The three dimensional composite device of claim 121, wherein said outer cover comprises a sheath to constrain said strands of said micro-cable about a longitudinal axis.

140. The three dimensional composite device of claim 139, wherein said sheath comprises a containment strand wound about said longitudinal strands.

141. The three dimensional composite device of claim 140, wherein said containment strand is wound at varying intervals along the outside to provide variations in the torqueability and stiffness of the composite cable.

142. The three dimensional composite device of claim 140, wherein the width of the outer cover is varied along the composite cable.

143. The three dimensional composite device of claim 139, wherein said sheath comprises a plurality of heat shrink plastic tubes placed to provide bending stiffness in said cable which varies with the position on said cable.

144. The three dimensional composite device of claim 121, wherein said outer cover comprises an outer sheath of material to provide bending stiffness and constrain said longitudinal strands about said longitudinal axis, said sheath being formed of a low friction material selected from the group consisting of a fluoropolymer and a heat shrinkable plastic tube.

145. The three dimensional composite device of claim 144, wherein outer cover comprises a plurality of layers formed of different materials in order to provide a graduated bending and stiffness characteristic over the length of the cable.

146. The three dimensional composite device of claim 121, wherein said strands of the micro-cable are bundled by a plurality of bands disposed at intervals along said micro-cable to produce a composite banded cable.

147. The three dimensional composite device of claim 146, wherein said strands are laid parallel within the composite banded cable.

148. The three dimensional composite device of claim 146, wherein said strands are twisted within the composite banded cable.

149. The three dimensional composite device of claim 146, wherein composite cable comprises a single inner micro-cable.

150. The three dimensional composite device of claim 121, wherein said outer cover varies in cross section along its length to provide bending stiffness of said composite cable which varies along said composite cable.

151. The three dimensional composite device of claim 121, wherein the number of strands and the degree to which they extend along said composite cable within the outer cover varies along said composite cable.

152. The three dimensional composite device of claim 121, wherein said multi-stranded micro-cable is approximately 0.0021 to 0.0045 inches in diameter.

153. The three dimensional composite device of claim 121, wherein said composite microcable comprises a plurality of micro-cables disposed within said outer cover in order to provide desired bending and strength characteristics.

154. The three dimensional composite device of claim 153, wherein said plurality of micro-cables are helically wound within said outer cover.

155. The three dimensional composite device of claim 153, wherein said plurality of micro-cables extend parallel and longitudinally within said outer cover.

156. The three dimensional composite device of claim 153, wherein said composite cable has a collapsed primary configuration and an expanded secondary configuration with a secondary three dimensional shape selected from the group consisting of spherical, helical and conical shapes.

157. The three dimensional composite device of claim 153, wherein said plurality of micro-cables are bundled by at least one outer cover to produce said composite banded cable.

158. The three dimensional composite device of claim 153, wherein said plurality of micro-cables are banded at intervals by a plurality of bands.

159. The three dimensional composite device of claim 121, further comprising at least one longitudinal element for sensing a parameter selected from the group consisting of an optical imaging element, an optical fiber, a thermal imaging element, and an ultrasound imaging element.

160. The three dimensional composite device of claim 120, wherein said shape memory material comprises a nickel-titanium alloy.

161. The three dimensional composite device of claim 160, wherein said shape memory nickel-titanium alloy is heat treated such that the alloy is highly flexible at a temperature appropriate for introduction into the body via a catheter, and after placement, the device will take on a shape designed to optimize the therapeutic purposes desired for the device.

162. The three dimensional composite device of claim 120, wherein said shape memory material comprises a shape memory polymer.

163. A composite micro-cable for use in interventional therapy comprising:

at least one longitudinal strand made of a radiopaque material;

at least one longitudinal strand made of a flexible shape memory material; and

at least one strand of a therapeutic material which extends beyond the diameter of the other strands in the micro-cable along the length of the cable.