Subcutaneous electrode for transthoracic conduction with improved installation characteristics

• US 20020035379A1
• Filed: 08/27/2001
• Published: 03/21/2002
• Est. Priority Date: 09/18/2000
• Status: Abandoned Application

• Current Assignee: Gary H. Sanders, Gust H. Bardy, Riccardo Cappato, William J. Rissmann
• Original Assignee: Gary H. Sanders, Gust H. Bardy, Riccardo Cappato, William J. Rissmann
• Inventors: Rissmann, William J., Bardy, Gust H., Sanders, Gary H., Cappato, Riccardo
• Application Number:
  US09/940,468
• Publication Number:
  US 20020035379A1
• Time in Patent Office: Days
• US Class Current: 607/4
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence

Abstract

One embodiment of the present invention provides a lead electrode assembly for subcutaneous implantation including an electrode; and an appendage coupled to the electrode for positioning the lead electrode assembly.

Claims

1. A lead electrode assembly for use with an implantable cardioverter-defibrillator subcutaneously implanted outside the ribcage between the third and twelfth ribs comprising:

an electrode; and

an appendage coupled to the electrode for positioning the lead electrode assembly.

2. The lead electrode assembly of claim 1, wherein the appendage is substantially fin-shaped.

3. The lead electrode assembly of claim 2, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom of the appendage.

4. The lead electrode assembly of claim 1, wherein the appendage is substantially planar.

5. The lead electrode assembly of claim 4, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

6. The lead electrode assembly of claim 4, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

7. The lead electrode assembly of claim 1, wherein the appendage has an eyelet therein.

8. The lead electrode assembly of claim 1, wherein the appendage is substantially loop-shaped.

9. The lead electrode assembly of claim 1, wherein the appendage is substantially tube-shaped.

10. The lead electrode assembly of claim 9, wherein a proximal end of the substantially tube-shaped appendage is closed.

11. The lead electrode assembly of claim 9, wherein the appendage is substantially cylindrical.

12. The lead electrode assembly of claim 1, wherein the appendage comprises a polymeric material.

13. The lead electrode assembly of claim 12, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.

14. The lead electrode assembly of claim 1, wherein the electrode is substantially planar.

15. The lead electrode assembly of claim 14, wherein the electrode is substantially rectangular in shape.

16. The lead electrode assembly of claim 15, wherein the electrode has rounded corners.

17. The lead electrode assembly of claim 14, wherein the electrode comprises a top surface, a bottom surface and at least one side.

18. The lead electrode assembly of claim 17, wherein the appendage is substantially fin-shaped.

19. The lead electrode assembly of claim 18, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

20. The lead electrode assembly of claim 17, wherein the appendage is substantially planar.

21. The lead electrode assembly of claim 20, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

22. The lead electrode assembly of claim 20, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

23. The lead electrode assembly of claim 20, wherein the appendage is substantially perpendicular to the top surface of the electrode.

24. The lead electrode assembly of claim 20, wherein the appendage is less than 10 mm in height.

25. The lead electrode assembly of claim 20, wherein the appendage is flexible.

26. The lead electrode assembly of claim 25, wherein the appendage is substantially perpendicular to the top surface of the electrode and wherein the appendage is capable of flexing when force is applied to it, so that the appendage is no longer substantially perpendicular to the top surface of the electrode.

27. The lead electrode assembly of claim 26, wherein the appendage is capable of flexing when force is applied to it, so that the appendage lies substantially parallel to the top surface of the electrode.

28. The lead electrode assembly of claim 23, wherein the appendage is rigid.

29. The lead electrode assembly of claim 28, wherein the lead electrode assembly further comprises flexible joining material, wherein the flexible joining material is coupled between the appendage and the electrode.

30. The lead electrode assembly of claim 29, wherein the flexible joining material is capable of allowing the appendage to fold such that the appendage lies parallel to the top surface of the electrode.

31. The lead electrode assembly of claim 20, wherein the appendage is coupled to the electrode and extends from the at least one side of the electrode.

32. The lead electrode assembly of claim 31, wherein the appendage is substantially parallel to the top surface of the electrode.

33. The lead electrode assembly of claim 1, wherein the electrode comprises a mesh of metallic material.

34. The lead electrode assembly of claim 33, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.

35. The lead electrode assembly of claim 1, wherein the electrode comprises a substantially flat sheet of metallic material.

36. The lead electrode assembly of claim 35, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.

37. The lead electrode assembly of claim 33, wherein the appendage is substantially fin-shaped.

38. The lead electrode assembly of claim 37, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

39. The lead electrode assembly of claim 33, wherein the appendage is substantially planar.

40. The lead electrode assembly of claim 39, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

41. The lead electrode assembly of claim 39, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

42. The lead electrode assembly of claim 39, wherein the appendage extends substantially perpendicular to the electrode.

43. The lead electrode assembly of claim 39, wherein the appendage extends substantially parallel to the electrode.

44. The lead electrode assembly of claim 33, wherein the appendage is substantially loop-shaped.

45. The lead electrode assembly of claim 33, wherein the appendage is substantially tube-shaped.

46. The lead electrode assembly of claim 45, wherein a proximal end of the substantially tube-shaped appendage is closed.

47. The lead electrode assembly of claim 45, wherein the tube is substantially cylindrical.

48. The lead electrode assembly of claim 1, wherein the lead electrode assembly further comprises a lead coupled to the electrode.

49. The lead electrode assembly of claim 48, wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.

50. The lead electrode assembly of claim 49, wherein the lead further comprises an electrically insulating sheath, enclosing the one or more electrical conductors.

51. The lead electrode assembly of claim 48, wherein the lead electrode assembly further comprises a connector coupled to the lead.

52. The lead electrode assembly of claim 51, wherein the connector is electrically coupled to the electrode.

53. The lead electrode assembly of claim 48, wherein the lead is between approximately 5 cm and approximately 52 cm in length.

54. The lead electrode assembly of claim 53, wherein the lead is between approximately 5 cm and approximately 30 cm in length.

55. The lead electrode assembly of claim 54, wherein the lead is between approximately 10 cm and approximately 20 cm in length.

56. The lead electrode assembly of claim 53, wherein the lead length is one of a plurality of pre-set lengths.

57. The lead electrode assembly of claim 56, wherein the pre-set lengths vary by approximately 10 cm.

58. The lead electrode assembly of claim 48, wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.

59. The lead electrode assembly of claim 58, wherein the lead electrode assembly further comprises a lead fastener coupled between the proximal end of the lead and the electrode.

60. The lead electrode assembly of claim 59, wherein the appendage is coupled to the electrode along an interface line intersecting the lead fastener.

61. The lead electrode assembly of claim 60, wherein the appendage is substantially fin-shaped.

62. The lead electrode assembly of claim 61, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

63. The lead electrode assembly of claim 60, wherein the appendage is substantially planar.

64. The lead electrode assembly of claim 63, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

65. The lead electrode assembly of claim 63, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

66. The lead electrode assembly of claim 63, wherein the appendage has an eyelet therein.

67. The lead electrode assembly of claim 63, wherein the appendage is substantially tube-shaped.

68. The lead electrode assembly of claim 67, wherein a proximal end of the substantially tube-shaped appendage is closed.

69. The lead electrode assembly of claim 67, wherein the tube is substantially cylindrical.

70. The lead electrode assembly of claim 59, wherein the appendage is coupled to the electrode along an interface line and wherein the lead is coupled to the lead fastener along a line of the lead that is substantially parallel to the interface line.

71. The lead electrode assembly of claim 70, wherein the appendage is substantially fin-shaped.

72. The lead electrode assembly of claim 71, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

73. The lead electrode assembly of claim 71, wherein the appendage is substantially planar.

74. The lead electrode assembly of claim 73, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

75. The lead electrode assembly of claim 73, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

76. The lead electrode assembly of claim 71, wherein the appendage has an eyelet therein.

77. The lead electrode assembly of claim 71, wherein the appendage is substantially tube-shaped.

78. The lead electrode assembly of claim 77, wherein a proximal end of the substantially tube-shaped appendage is closed.

79. The lead electrode assembly of claim 77, wherein the tube is substantially cylindrical.

80. The lead electrode assembly of claim 70, wherein the interface line and the line of the lead are the same line.

81. The lead electrode assembly of claim 80, wherein the appendage is substantially fin-shaped.

82. The lead electrode assembly of claim 81, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

83. The lead electrode assembly of claim 80, wherein the appendage is substantially planar.

84. The lead electrode assembly of claim 83, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

85. The lead electrode assembly of claim 83, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

86. The lead electrode assembly of claim 81, wherein the appendage has an eyelet therein.

87. The lead electrode assembly of claim 59, wherein the appendage is substantially tube-shaped.

88. The lead electrode assembly of claim 87, wherein a proximal end of the substantially tube-shaped appendage is closed.

89. The lead electrode assembly of claim 87, wherein the tube is substantially cylindrical.

90. The lead electrode assembly of claim 1, wherein the length of the appendage is between approximately 2 mm and approximately 6 cm.

91. The lead electrode assembly of claim 1, wherein the length of the appendage is less than the length of the electrode.

92. The lead electrode assembly of claim 91, wherein the appendage length is less than 6 cm.

93. The lead electrode assembly of claim 91, wherein the appendage is coupled to the electrode along an interface line and the length of the appendage and the length of the electrode are measured along the interface line.

94. The lead electrode assembly of claim 93, wherein the electrode has a proximal end and a distal end and wherein the appendage is closer to the proximal end of the electrode than the distal end of the electrode.

95. The lead electrode assembly of claim 94, wherein the lead electrode assembly further comprises a lead, wherein the lead is coupled to the electrode closer to the distal end of the electrode than the proximal end of the electrode.

96. The lead electrode assembly of claim 94, wherein the appendage is positioned less than 20 mm from the proximal end of the electrode.

97. The lead electrode assembly of claim 1, wherein the appendage is attached directly to the electrode.

98. The lead electrode assembly of claim 1, wherein the electrode is flexible.

99. The lead electrode assembly of claim 1, where in the lead electrode assembly further comprises a plurality of adjacent backing layers, wherein the plurality of adjacent backing layers includes a layer positioned furthest from the electrode and a layer positioned closest to the electrode, wherein the layer positioned furthest from the electrode is attached to the appendage and wherein the layer positioned closest to the electrode is attached to the electrode.

100. The lead electrode assembly of claim 1 further comprising a backing layer coupled between the appendage and the electrode.

101. The lead electrode assembly of claim 100, wherein the backing layer comprises a polymeric material.

102. The lead electrode assembly of claim 101, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.

103. The lead electrode assembly of claim 100, wherein the electrode is flexible and wherein the backing layer is flexible.

104. The lead electrode assembly of claim 100, wherein the backing layer comprises an inside face and an outside face, wherein the backing layer is coupled to the electrode such that at least part of the inside face of the backing layer faces and is parallel to the electrode, and wherein the appendage is coupled to the outside face of the backing layer.

105. The lead electrode assembly of claim 104, wherein the appendage is substantially planar.

106. The lead electrode assembly of claim 104, wherein the backing layer comprises a first section of material and a second section of material, wherein a portion of the inside face of the first section of material is coupled to the electrode, wherein a portion of the inside face of the second section of material is coupled to the electrode, and wherein a portion of the inside face of the first section of material is coupled to a portion of the inside face of the second section of material such that an appendage is formed.

107. The lead electrode assembly of claim 106, wherein the appendage is substantially fin-shaped.

108. The lead electrode assembly of claim 107, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

109. The lead electrode assembly of claim 104, wherein the appendage is attached to the backing layer by stitching.

110. The lead electrode assembly of claim 100, wherein the lead electrode assembly further comprises a molded cover covering the backing layer and appendage.

111. The lead electrode assembly of claim 110, wherein the molded cover comprises a polymeric material.

112. The lead electrode assembly of claim 111, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.

113. The lead electrode assembly of claim 110, wherein the electrode comprises a front face, a back face, a periphery and a center, wherein the front face faces away from the backing layer, wherein the molded cover covers the periphery of the front face and wherein the cover does not cover the center of the front face.

114. The lead electrode assembly of claim 1, wherein the electrode has a curved shape.

115. The lead electrode assembly of claim 114, wherein the electrode is curved with a radius between approximately 5 cm and approximately 35 cm.

116. The lead electrode assembly of claim 115, wherein the radius is one of a plurality of pre-set radii.

117. The lead electrode assembly of claim 116, wherein the pre-set radii vary by approximately 10 cm.

119. The implantable cardioverter-defibrillator of claim 118, wherein the appendage is substantially fin-shaped.

120. The implantable cardioverter-defibrillator of claim 119, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom of the appendage.

121. The implantable cardioverter-defibrillator of claim 118, wherein the appendage is substantially planar.

122. The implantable cardioverter-defibrillator of claim 121, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

123. The implantable cardioverter-defibrillator of claim 121, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

124. The implantable cardioverter-defibrillator of claim 118, wherein the appendage has an eyelet therein.

125. The implantable cardioverter-defibrillator of claim 118, wherein the appendage is substantially loop-shaped.

126. The implantable cardioverter-defibrillator of claim 118, wherein the appendage is substantially tube-shaped.

127. The implantable cardioverter-defibrillator of claim 126, wherein a proximal end of the substantially tube-shaped appendage is closed.

128. The implantable cardioverter-defibrillator of claim 126, wherein the appendage is substantially cylindrical.

129. The implantable cardioverter-defibrillator of claim 118, wherein the appendage comprises a polymeric material.

130. The implantable cardioverter-defibrillator of claim 129, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.

131. The implantable cardioverter-defibrillator of claim 118, wherein the electrode is substantially planar.

132. The implantable cardioverter-defibrillator of claim 131, wherein the electrode is substantially rectangular in shape.

133. The implantable cardioverter-defibrillator of claim 132, wherein the electrode has rounded corners.

134. The implantable cardioverter-defibrillator of claim 131, wherein the electrode comprises a top surface, a bottom surface and at least one side.

135. The implantable cardioverter-defibrillator of claim 134, wherein the appendage is substantially fin-shaped.

136. The implantable cardioverter-defibrillator of claim 135, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

137. The implantable cardioverter-defibrillator of claim 134, wherein the appendage is substantially planar.

138. The implantable cardioverter-defibrillator of claim 137, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

139. The implantable cardioverter-defibrillator of claim 137, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

140. The implantable cardioverter-defibrillator of claim 137, wherein the appendage is substantially perpendicular to the top surface of the electrode.

141. The implantable cardioverter-defibrillator of claim 137, wherein the appendage is less than 10 mm in height.

142. The implantable cardioverter-defibrillator of claim 137, wherein the appendage is flexible.

143. The implantable cardioverter-defibrillator of claim 142, wherein the appendage is substantially perpendicular to the top surface of the electrode and wherein the appendage is capable of flexing when force is applied to it, so that the appendage is no longer substantially perpendicular to the top surface of the electrode.

144. The implantable cardioverter-defibrillator of claim 143, wherein the appendage is capable of flexing when force is applied to it, so that the appendage lies substantially parallel to the top surface of the electrode.

145. The implantable cardioverter-defibrillator of claim 140, wherein the appendage is rigid.

146. The implantable cardioverter-defibrillator of claim 145, wherein the lead electrode assembly further comprises flexible joining material, wherein the flexible joining material is coupled between the appendage and the electrode.

147. The implantable cardioverter-defibrillator of claim 146, wherein the flexible joining material is capable of allowing the appendage to fold such that the appendage lies parallel to the top surface of the electrode.

148. The implantable cardioverter-defibrillator of claim 137, wherein the appendage is coupled to the electrode and extends from the at least one side of the electrode.

149. The implantable cardioverter-defibrillator of claim 148, wherein the appendage is substantially parallel to the top surface of the electrode.

150. The implantable cardioverter-defibrillator of claim 118, wherein the electrode comprises a mesh of metallic material.

151. The implantable cardioverter-defibrillator of claim 150, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.

152. The implantable cardioverter-defibrillator of claim 118, wherein the electrode comprises a substantially flat sheet of metallic material.

153. The implantable cardioverter-defibrillator of claim 152, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridiuma, and mixtures thereof.

154. The implantable cardioverter-defibrillator of claim 150, wherein the appendage is substantially fin-shaped.

155. The implantable cardioverter-defibrillator of claim 154, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

156. The implantable cardioverter-defibrillator of claim 150, wherein the appendage is substantially planar.

157. The implantable cardioverter-defibrillator of claim 156, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

158. The implantable cardioverter-defibrillator of claim 156, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

159. The implantable cardioverter-defibrillator of claim 156, wherein the appendage extends substantially perpendicular to the electrode.

160. The implantable cardioverter-defibrillator of claim 156, wherein the appendage extends substantially parallel to the electrode.

161. The implantable cardioverter-defibrillator of claim 150, wherein the appendage is substantially loop-shaped.

162. The implantable cardioverter-defibrillator of claim 150, wherein the appendage is substantially tube-shaped.

163. The implantable cardioverter-defibrillator of claim 162, wherein a proximal end of the substantially tube-shaped appendage is closed.

164. The implantable cardioverter-defibrillator of claim 162, wherein the tube is substantially cylindrical.

165. The implantable cardioverter-defibrillator of claim 118, wherein the lead electrode assembly further comprises a lead coupled between the electrode and the housing.

166. The implantable cardioverter-defibrillator of claim 165, wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.

167. The implantable cardioverter-defibrillator of claim 166, wherein the lead further comprises an electrically insulating sheath, enclosing the one or more electrical conductors.

168. The implantable cardioverter-defibrillator of claim 165, wherein the lead electrode assembly further comprises a connector coupled to the lead.

169. The implantable cardioverter-defibrillator of claim 168, wherein the connector is electrically coupled to the electrode.

170. The implantable cardioverter-defibrillator of claim 165, wherein the lead is between approximately 5 cm and approximately 52 cm in length.

171. The implantable cardioverter-defibrillator of claim 170, wherein the lead is between approximately 5 cm and approximately 30 cm in length.

172. The implantable cardioverter-defibrillator of claim 171, wherein the lead is between approximately 10 cm and approximately 20 cm in length.

173. The implantable cardioverter-defibrillator of claim 170, wherein the lead length is one of a plurality of pre-set lengths.

174. The implantable cardioverter-defibrillator of claim 173, wherein the pre-set lengths vary by approximately 10 cm.

175. The implantable cardioverter-defibrillator of claim 165, wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.

176. The implantable cardioverter-defibrillator of claim 175, wherein the lead electrode assembly further comprises a lead fastener coupled between the proximal end of the lead and the electrode.

177. The implantable cardioverter-defibrillator of claim 176, wherein the appendage is coupled to the electrode along an interface line intersecting the lead fastener.

178. The implantable cardioverter-defibrillator of claim 177, wherein the appendage is substantially fin-shaped.

179. The implantable cardioverter-defibrillator of claim 178, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

180. The implantable cardioverter-defibrillator of claim 177, wherein the appendage is substantially planar.

181. The implantable cardioverter-defibrillator of claim 180, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

182. The implantable cardioverter-defibrillator of claim 180, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

183. The implantable cardioverter-defibrillator of claim 180, wherein the appendage has an eyelet therein.

184. The implantable cardioverter-defibrillator of claim 180, wherein the appendage is substantially tube-shaped.

185. The implantable cardioverter-defibrillator of claim 184, wherein a proximal end of the substantially tube-shaped appendage is closed.

186. The implantable cardioverter-defibrillator of claim 184, wherein the tube is substantially cylindrical.

187. The implantable cardioverter-defibrillator of claim 176, wherein the appendage is coupled to the electrode along an interface line and wherein the lead is coupled to the lead fastener along a line of the lead that is substantially parallel to the interface line.

188. The implantable cardioverter-defibrillator of claim 187, wherein the appendage is substantially fin-shaped.

189. The implantable cardioverter-defibrillator of claim 188, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

190. The implantable cardioverter-defibrillator of claim 188, wherein the appendage is substantially planar.

191. The implantable cardioverter-defibrillator of claim 190, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

192. The implantable cardioverter-defibrillator of claim 190, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

193. The implantable cardioverter-defibrillator of claim 188, wherein the appendage has an eyelet therein.

194. The implantable cardioverter-defibrillator of claim 188, wherein the appendage is substantially tube-shaped.

195. The implantable cardioverter-defibrillator of claim 194, wherein a proximal end of the substantially tube-shaped appendage is closed.

196. The implantable cardioverter-defibrillator of claim 194, wherein the tube is substantially cylindrical.

197. The implantable cardioverter-defibrillator of claim 187, wherein the interface line and the line of the lead are the same line.

198. The implantable cardioverter-defibrillator of claim 197, wherein the appendage is substantially fin-shaped.

199. The implantable cardioverter-defibrillator of claim 198, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

200. The implantable cardioverter-defibrillator of claim 197, wherein the appendage is substantially planar.

201. The implantable cardioverter-defibrillator of claim 200, wherein the appendage comprises first face, a second face, a top and a bottom and wherein the first face and the second face are closer together at the top of the appendage than at the bottom of the appendage.

202. The implantable cardioverter-defibrillator of claim 200, wherein the appendage comprises first face, a second facea, a top and a bottom and wherein the first face and the second face are closer together at the bottom of the appendage than at the top of the appendage.

203. The implantable cardioverter-defibrillator of claim 198, wherein the appendage has an eyelet therein.

204. The implantable cardioverter-defibrillator of claim 176, wherein the appendage is substantially tube-shaped.

205. The implantable cardioverter-defibrillator of claim 204, wherein a proximal end of the substantially tube-shaped appendage is closed.

206. The implantable cardioverter-defibrillator of claim 204, wherein the tube is substantially cylindrical.

207. The implantable cardioverter-defibrillator of claim 118, wherein the length of the appendage is between approximately 2 mm and approximately 6 cm.

208. The implantable cardioverter-defibrillator of claim 118, wherein the length of the appendage is less than the length of the electrode.

209. The implantable cardioverter-defibrillator of claim 208, wherein the appendage length is less than 6 cm.

210. The implantable cardioverter-defibrillator of claim 208, wherein the appendage is coupled to the electrode along an interface line and the length of the appendage and the length of the electrode are measured along the interface line.

211. The implantable cardioverter-defibrillator of claim 210, wherein the electrode has a proximal end and a distal end and wherein the appendage is closer to the proximal end of the electrode than the distal end of the electrode.

212. The implantable cardioverter-defibrillator of claim 211, wherein the lead electrode assembly further comprises a lead, wherein the lead is coupled to the electrode closer to the distal end of the electrode than the proximal end of the electrode.

213. The implantable cardioverter-defibrillator of claim 211, wherein the appendage is positioned less than 20 mm from the proximal end of the electrode.

214. The implantable cardioverter-defibrillator of claim 118, wherein the appendage is attached directly to the electrode.

215. The implantable cardioverter-defibrillator of claim 118, wherein the electrode is flexible.

216. The implantable cardioverter-defibrillator of claim 118, where in the lead electrode assembly further comprises a plurality of adjacent backing layers, wherein the plurality of adjacent backing layers includes a layer positioned furthest from the electrode and a layer positioned closest to the electrode, wherein the layer positioned furthest from the electrode is attached to the appendage and wherein the layer positioned closest to the electrode is attached to the electrode.

217. The implantable cardioverter-defibrillator of claim 118 further comprising a backing layer coupled between the appendage and the electrode.

218. The implantable cardioverter-defibrillator of claim 217, wherein the backing layer comprises a polymeric material.

219. The implantable cardioverter-defibrillator of claim 218, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.

220. The implantable cardioverter-defibrillator of claim 217, wherein the electrode is flexible and wherein the backing layer is flexible.

221. The implantable cardioverter-defibrillator of claim 217, wherein the backing layer comprises an inside face and an outside face, wherein the backing layer is coupled to the electrode such that at least part of the inside face of the backing layer faces and is parallel to the electrode, and wherein the appendage is coupled to the outside face of the backing layer.

222. The implantable cardioverter-defibrillator of claim 221, wherein the appendage is substantially planar.

223. The implantable cardioverter-defibrillator of claim 221, wherein the backing layer comprises a first section of material and a second section of material, wherein a portion of the inside face of the first section of material is coupled to the electrode, where in a portion of the inside face of the second section of material is coupled to the electrode, and wherein a portion of the inside face of the first section of material is coupled to a portion of the inside face of the second section of material such that an appendage is formed.

224. The implantable cardioverter-defibrillator of claim 223, wherein the appendage is substantially fin-shaped.

225. The implantable cardioverter-defibrillator of claim 224, wherein the appendage comprises proximal edge, a distal edge, a top and a bottom and wherein the proximal edge is closer to the distal edge at the top of the appendage than at the bottom appendage.

226. The implantable cardioverter-defibrillator of claim 221, wherein the appendage is attached to the backing layer by stitching.

227. The implantable cardioverter-defibrillator of claim 217, wherein the lead electrode assembly further comprises a molded cover covering the backing layer and appendage.

228. The implantable cardioverter-defibrillator of claim 227, wherein the molded cover comprises a polymeric material.

229. The implantable cardioverter-defibrillator of claim 228, wherein the polymeric material is selected from the group consisting essentially of a polyurethane, a polyamide, a polyetheretherketone (PEEK), a polyether block amide (PEBA), a polytetrafluoroethylene (PTFE), a silicone, and mixtures thereof.

230. The implantable cardioverter-defibrillator of claim 227, wherein the electrode comprises a front face, a back face, a periphery and a center, wherein the front face faces away from the backing layer, wherein the molded cover covers the periphery of the front face and wherein the cover does not cover the center of the front face.

231. The implantable cardioverter-defibrillator of claim 118, wherein the electrode has a curved shape.

232. The implantable cardioverter-defibrillator of claim 231, wherein the electrode is curved with a radius between approximately 5 cm and approximately 35 cm.

233. The implantable cardioverter-defibrillator of claim 232, wherein the radius is one of a plurality of preset radii.

234. The implantable cardioverter-defibrillator of claim 233, wherein the pre-set radii vary by approximately 10 cm.

236. The method of claim 235, wherein the step of creating a subcutaneous path outside the ribcage further comprises the steps of:

creating an incision in the thoracic region of the patient; and

creating the subcutaneous path by moving the hemostat between the ribcage and the skin.

237. The method of claim 236, wherein the step of creating the subcutaneous path by moving the hemostat between the ribcage and the skin further comprises the step of:

moving the hemostat laterally and posteriorly around the side of the patient until the subcutaneous path terminates at a termination point such that if a straight line were drawn from the incision to the termination point, the line would intersect the heart of the patient.

238. The method of claim 236, wherein the step of creating the subcutaneous path by moving the hemostat between the ribcage and the skin further comprises the step of:

moving the hemostat laterally and posteriorly around the side of the patient until the subcutaneous path terminates at a termination point within 10 cm of the spine of the patient between the third and twelfth rib.

239. The method of claim 236, wherein the incision in the thoracic region of the patient is in the anterior of the thorax.

240. The method of claim 235, wherein the hemostat has a curved shape.

242. The method of claim 241, wherein the step of creating a subcutaneous path outside the ribcage further comprises the steps of:

creating an incision in the thoracic region of the patient;

introducing the hemostat into the incision;

creating the subcutaneous path by moving the hemostat between the ribcage and the skin; and

retracting the hemostat.

243. The method of claim 241, wherein the step of creating the subcutaneous path by moving the hemostat between the ribcage and the skin further comprises the step of:

moving the hemostat laterally and posteriorly around the side of the patient.

244. The method of claim 241, wherein the step of creating the subcutaneous path by moving the hemostat between the ribcage and the skin further comprises the step of:

moving the hemostat until the subcutaneous path terminates at a termination point such that if a straight line were drawn from the incision to the termination point, the line would intersect the heart of the patient.

245. The method of claim 241, wherein the step of creating the subcutaneous path by moving the hemostat between the ribcage and the skin further comprises the step of:

moving the hemostat until the subcutaneous path terminates at a termination point near the patient'"'"'s spine between the third and twelfth rib.

246. The method of claim 241, wherein the incision in the thoracic region of the patient is in the anterior of the thorax.

247. The method of claim 241, wherein the hemostat has a curved shape.

249. The method of claim 248, further comprising the step of:

releasing effective energy via the housing electrode and the lead electrode assembly electrode.

251. The subcutaneous implantable cardioverter-defibrillator kit of claim 250, further comprising a hemostat stored in the tray.

252. The subcutaneous implantable cardioverter-defibrillator kit of claim 250, further comprising a hemostat with two prongs comprising a pin on at least one prong stored in the tray.

253. The subcutaneous implantable cardioverter-defibrillator kit of claim 250, further comprising a subcutaneous implantable cardioverter-defibrillator stored in the tray.

254. The subcutaneous implantable cardioverter-defibrillator kit of claim 250, further comprising a medical adhesive stored in the tray.

255. The subcutaneous implantable cardioverter-defibrillator kit of claim 250, further comprising an anesthetic stored in the tray.

256. The subcutaneous implantable cardioverter-defibrillator kit of claim 250, further comprising a tube of mineral oil stored in the tray.

258. The lead electrode assembly manipulation tool of claim 257, wherein the first prong and the second prong are curved.

118. An implantable cardioverter-defibrillator for subcutaneous positioning between the third rib and the twelfth rib within a patient, the implantable cardioverter-defibrillator comprising:

a housing; and

a lead electrode assembly coupled to the housing,

wherein the lead electrode assembly comprises;

an electrode; and

an appendage coupled to the electrode for positioning the lead electrode assembly.

235. A method for surgically implanting a lead electrode assembly comprising an appendage for positioning the lead electrode assembly subcutaneously outside a patient'"'"'s ribcage, the method comprising the steps of:

providing a hemostat;

creating a subcutaneous path outside the ribcage;

grasping the appendage of the lead electrode assembly with the hemostat;

moving the lead electrode assembly through the path; and

releasing the appendage of the lead electrode assembly from the hemostat.

241. A method for surgically implanting a lead electrode assembly with a fin-shaped appendage comprising an eyelet for positioning the lead electrode assembly subcutaneously outside a patient'"'"'s ribcage, comprising the steps of:

providing a hemostat comprising two prongs and a pin on at least one prong;

creating a subcutaneous path outside the ribcage;

placing the pin on said at least one prong of the hemostat through the eyelet on the fin-shaped appendage of the lead electrode assembly;

moving the lead electrode through the path; and

moving the hemostat until the pin comes out of the eyelet in the fin-shaped appendage.

248. A method of providing effective energy via subcutaneous electrodes in the thorax of a patient, the method comprising the steps of:

providing an implantable cardioverter-defibrillator comprising;

a housing comprising a housing electrode, a lead comprising a proximal and distal end, and a lead electrode assembly comprising a lead electrode assembly electrode, wherein the housing is connected to the proximal end of the lead and the lead electrode assembly is connected to the distal end of the lead;

implanting the housing subcutaneously in the posterolateral thorax;

implanting the lead electrode assembly in a position approximately lateral to the tip of the left inferior portion of the scapula; and

implanting the lead circumferentially around the thorax.

250. A subcutaneous implantable cardioverter-defibrillator kit for use in surgically implanting a subcutaneous implantable cardioverter-defibrillator and lead electrode assembly within a patient comprising:

a tray; and

a lead electrode assembly comprising an appendage for positioning the lead electrode assembly within the patient stored in the tray.

257. A lead electrode assembly manipulation tool for use in surgically implanting a lead electrode assembly with an appendage containing an eyelet for positioning the lead electrode assembly within a patient comprising:

a hemostat comprising a first prong, a second prong and a pin attached to the first prong for hooking into the eyelet of the appendage.