Subcutaneous electrode for transthoracic conduction with low-profile installation appendage and method of doing same

US 6,937,907 B2
Filed: 08/27/2001
Issued: 08/30/2005
Est. Priority Date: 09/18/2000
Status: Expired due to Term

First Claim

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1. A lead electrode assembly for subcutaneous implantation comprising:

an electrode;

a riser coupled to the electrode; and

a head coupled to the riser;

wherein the riser comprises a proximal end, a distal end, a top and a bottom and wherein the proximal end is closer to the distal end at the top of the riser than at the bottom of the riser.

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Abstract

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

203 Citations

238 Claims

1. A lead electrode assembly for subcutaneous implantation comprising:
- an electrode;
  
  a riser coupled to the electrode; and
  
  a head coupled to the riser;
  
  wherein the riser comprises a proximal end, a distal end, a top and a bottom and wherein the proximal end is closer to the distal end at the top of the riser than at the bottom of the riser.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60)
- - 2. The lead electrode assembly of claim 1, wherein the riser comprises a metallic material.
  - 3. The lead electrode assembly of claim 2, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 4. The lead electrode assembly of claim 1, wherein the riser comprises a polymeric material.
  - 5. The lead electrode assembly of claim 4, 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.
  - 6. The lead electrode assembly of claim 1, wherein the head comprises a metallic material.
  - 7. The lead electrode assembly of claim 6, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 8. The lead electrode assembly of claim 1, wherein the head comprises a polymeric material.
  - 9. The lead electrode assembly of claim 8, 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.
  - 10. The lead electrode assembly of claim 1, wherein the riser is substantially planar.
  - 11. The lead electrode assembly of claim 1, wherein the riser is substantially perpendicular to the electrode.
  - 12. The lead electrode assembly of claim 1, wherein the riser is substantially centered over the electrode.
  - 13. The lead electrode assembly of claim 1, wherein the head is substantially planar.
  - 14. The lead electrode assembly of claim 1, wherein the head is substantially perpendicular to the riser.
  - 15. The lead electrode assembly of claim 1, wherein the riser is between approximately 1 mm and approximately 10 mm in height.
  - 16. The lead electrode assembly of claim 1, wherein the electrode comprises a mesh of metallic material.
  - 17. The lead electrode assembly of claim 16, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 18. The lead electrode assembly of claim 1, wherein the electrode comprises a substantially flat sheet of metallic material.
  - 19. The lead electrode assembly of claim 18, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 20. The lead electrode assembly of claim 1, wherein the electrode is substantially planar.
  - 21. The lead electrode assembly of claim 1, wherein the electrode comprises at least one substantially planar surface.
  - 22. The lead electrode assembly of claim 21, wherein the at least one substantially planar surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.
  - 23. The lead electrode assembly of claim 1, wherein the lead electrode assembly further comprises a lead coupled to the electrode.
  - 24. The lead electrode assembly of claim 23, wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.
  - 25. The lead electrode assembly of claim 24, wherein the lead further comprises an electrically insulating sheath, enclosing the one or more electrical conductors.
  - 26. The lead electrode assembly of claim 23, wherein the lead electrode assembly further comprises a connector coupled to the lead.
  - 27. The lead electrode assembly of claim 26, wherein the connector is electrically coupled to the electrode.
  - 28. The lead electrode assembly of claim 23, wherein the lead is between approximately 5 cm and approximately 52 cm in length.
  - 29. The lead electrode assembly of claim 28, wherein the lead is between approximately 5 cm and approximately 30 cm in length.
  - 30. The lead electrode assembly of claim 29, wherein the lead is between approximately 10 cm and approximately 20 cm in length.
  - 31. The lead electrode assembly of claim 28, wherein the lead length is one of a plurality of pre-set lengths.
  - 32. The lead electrode assembly of claim 31, wherein the pre-set lengths vary by approximately 10 cm.
  - 33. The lead electrode assembly of claim 23, wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.
  - 34. The lead electrode assembly of claim 33, wherein the lead electrode assembly further comprises a lead fastener coupled between the proximal end of the lead and the electrode.
  - 35. The lead electrode assembly of claim 34, wherein the riser is coupled to the electrode along an interface line intersecting the lead fastener.
  - 36. The lead electrode assembly of claim 34, wherein the riser 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.
  - 37. The lead electrode assembly of claim 36, wherein the interface line and the line of the lead are the same line.
  - 38. The lead electrode assembly of claim 1, wherein the length of the riser is between approximately 2 mm and approximately 6 cm.
  - 39. The lead electrode assembly of claim 1, wherein the length of the riser is less than the length of the electrode.
  - 40. The lead electrode assembly of claim 39, wherein the riser is coupled to the electrode along an interface line and the length of the riser and the length of the electrode are measured along the interface line.
  - 41. The lead electrode assembly of claim 40, wherein the electrode has a proximal end and a distal end and wherein the riser is closer to the proximal end of the electrode than the distal end of the electrode.
  - 42. The lead electrode assembly of claim 41, 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.
  - 43. The lead electrode assembly of claim 42, wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.
  - 44. The lead electrode assembly of claim 1, wherein the lead electrode assembly further comprises a foundation.
  - 45. The lead electrode assembly of claim 44, wherein a top surface of the foundation is coupled to a bottom of the riser.
  - 46. The lead electrode assembly of claim 44, wherein a bottom surface of the foundation is coupled to and faces a top surface of the electrode.
  - 47. The lead electrode assembly of claim 44, wherein the lead electrode assembly further comprises a backing layer coupled between the foundation and the electrode.
  - 48. The lead electrode assembly of claim 47, wherein the backing layer comprises a polymeric material.
  - 49. The lead electrode assembly of claim 48, 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.
  - 50. The lead electrode assembly of claim 44, wherein the lead electrode assembly further comprises a molded cover coupled to the foundation and the electrode.
  - 51. The lead electrode assembly of claim 50, wherein the molded cover at least partially covers a top surface of the foundation.
  - 52. The lead electrode assembly of claim 50, wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.
  - 53. The lead electrode assembly of claim 50, wherein the molded cover comprises a polymeric material.
  - 54. The lead electrode assembly of claim 53, 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.
  - 55. The lead electrode assembly of claim 44, wherein the foundation is substantially planar.
  - 56. The lead electrode assembly of claim 44, wherein the foundation is substantially parallel to the electrode.
  - 57. The lead electrode assembly of claim 44, wherein the foundation comprises a metallic material.
  - 58. The lead electrode assembly of claim 57, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 59. The lead electrode assembly of claim 44, wherein the foundation comprises a polymeric material.
  - 60. The lead electrode assembly of claim 59, 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.

61. 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;
  
  a foundation;
  
  a backing layer disposed between the foundation and the electrode;
  
  a riser coupled to the electrode; and
  
  a head coupled to the riser.
- View Dependent Claims (62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119)
- - 62. The lead electrode assembly of claim 61, wherein the riser comprises a metallic material.
  - 63. The lead electrode assembly of claim 62, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 64. The lead electrode assembly of claim 61, wherein the riser comprises a polymeric material.
  - 65. The lead electrode assembly of claim 64, 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.
  - 66. The lead electrode assembly of claim 61, wherein the head comprises a metallic material.
  - 67. The lead electrode assembly of claim 66, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 68. The lead electrode assembly of claim 61, wherein the head comprises a polymeric material.
  - 69. The lead electrode assembly of claim 68, 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.
  - 70. The lead electrode assembly of claim 61, wherein the riser is substantially planar.
  - 71. The lead electrode assembly of claim 61, wherein the riser is substantially perpendicular to the electrode.
  - 72. The lead electrode assembly of claim 61, wherein the riser is substantially centered over the electrode.
  - 73. The lead electrode assembly of claim 61, wherein the head is substantially planar.
  - 74. The lead electrode assembly of claim 61, wherein the head is substantially perpendicular to the riser.
  - 75. The lead electrode assembly of claim 61, wherein the riser is between approximately 1 mm and approximately 10 mm in height.
  - 76. The lead electrode assembly of claim 75, wherein the riser comprises a proximal end, a distal end, a top and a bottom and wherein the proximal end is closer to the distal end at the top of the riser than at the bottom of the riser.
  - 77. The lead electrode assembly of claim 61, wherein the electrode comprises a mesh of metallic material.
  - 78. The lead electrode assembly of claim 77, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 79. The lead electrode assembly of claim 61, wherein the electrode comprises a substantially flat sheet of metallic material.
  - 80. The lead electrode assembly of claim 79, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 81. The lead electrode assembly of claim 61, wherein the electrode is substantially planar.
  - 82. The lead electrode assembly of claim 61, wherein the electrode comprises at least one substantially planar surface.
  - 83. The lead electrode assembly of claim 82, wherein the at least one substantially planar surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.
  - 84. The lead electrode assembly of claim 61, wherein the lead electrode assembly further comprises a lead coupled to the electrode.
  - 85. The lead electrode assembly of claim 84, wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.
  - 86. The lead electrode assembly of claim 85, wherein the lead further comprises an electrically insulating sheath, enclosing the one or more electrical conductors.
  - 87. The lead electrode assembly of claim 84, wherein the lead electrode assembly further comprises a connector coupled to the lead.
  - 88. The lead electrode assembly of claim 87, wherein the connector is electrically coupled to the electrode.
  - 89. The lead electrode assembly of claim 84, wherein the lead is between approximately 5 cm and approximately 52 cm in length.
  - 90. The lead electrode assembly of claim 89, wherein the lead is between approximately 5 cm and approximately 30 cm in length.
  - 91. The lead electrode assembly of claim 90, wherein the lead is between approximately 10 cm and approximately 20 cm in length.
  - 92. The lead electrode assembly of claim 89, wherein the lead length is one of a plurality of pre-set lengths.
  - 93. The lead electrode assembly of claim 92, wherein the pre-set lengths vary by approximately 10 cm.
  - 94. The lead electrode assembly of claim 84, wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.
  - 95. The lead electrode assembly of claim 94, wherein the lead electrode assembly further comprises a lead fastener coupled between the proximal end of the lead and the electrode.
  - 96. The lead electrode assembly of claim 95, wherein the riser is coupled to the electrode along an interface line intersecting the lead fastener.
  - 97. The lead electrode assembly of claim 95, wherein the riser 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.
  - 98. The lead electrode assembly of claim 97, wherein the interface line and the line of the lead are the same line.
  - 99. The lead electrode assembly of claim 61, wherein the length of the riser is between approximately 2 mm and approximately 6 cm.
  - 100. The lead electrode assembly of claim 61, wherein the length of the riser is less than the length of the electrode.
  - 101. The lead electrode assembly of claim 100, wherein the riser is coupled to the electrode along an interface line and the length of the riser and the length of the electrode are measured along the interface line.
  - 102. The lead electrode assembly of claim 101, wherein the electrode has a proximal end and a distal end and wherein the riser is closer to the proximal end of the electrode than the distal end of the electrode.
  - 103. The lead electrode assembly of claim 102, 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.
  - 104. The lead electrode assembly of claim 103, wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.
  - 105. The lead electrode assembly of claim 61, wherein a top surface of the foundation is coupled to a bottom of the riser.
  - 106. The lead electrode assembly of claim 61, wherein a bottom surface of the foundation is coupled to and faces a top surface of the electrode.
  - 107. The lead electrode assembly of claim 61, wherein the backing layer comprises a polymeric material.
  - 108. The lead electrode assembly of claim 107, 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.
  - 109. The lead electrode assembly of claim 61, wherein the lead electrode assembly further comprises a molded cover coupled to the foundation and the electrode.
  - 110. The lead electrode assembly of claim 109, wherein the molded cover at least partially covers a top surface of the foundation.
  - 111. The lead electrode assembly of claim 109, wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.
  - 112. The lead electrode assembly of claim 109, wherein the molded cover comprises a polymeric material.
  - 113. The lead electrode assembly of claim 112, 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.
  - 114. The lead electrode assembly of claim 61, wherein the foundation is substantially planar.
  - 115. The lead electrode assembly of claim 61, wherein the foundation is substantially parallel to the electrode.
  - 116. The lead electrode assembly of claim 61, wherein the foundation comprises a metallic material.
  - 117. The lead electrode assembly of claim 116, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 118. The lead electrode assembly of claim 61, wherein the foundation comprises a polymeric material.
  - 119. The lead electrode assembly of claim 118, 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.

120. A lead electrode assembly for subcutaneous implantation in a patient'"'"'s posterior thorax from an incision in the skin covering the patient'"'"'s anterior thorax comprising:
- an electrode;
  
  a foundation coupled to the electrode;
  
  a riser coupled to the foundation; and
  
  a head coupled to the riser;
  
  wherein a bottom surface of the head is coupled to a top surface of the riser, a bottom surface of the riser is coupled to a top surface of the foundation, and a bottom surface of the foundation is coupled to a top surface of the electrode.
- View Dependent Claims (121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177)
- - 121. The lead electrode assembly of claim 120, wherein the riser comprises a metallic material.
  - 122. The lead electrode assembly of claim 121, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 123. The lead electrode assembly of claim 120, wherein the riser comprises a polymeric material.
  - 124. The lead electrode assembly of claim 123, 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.
  - 125. The lead electrode assembly of claim 120, wherein the head comprises a metallic material.
  - 126. The lead electrode assembly of claim 125, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 127. The lead electrode assembly of claim 120, wherein the head comprises a polymeric material.
  - 128. The lead electrode assembly of claim 127, 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.
  - 129. The lead electrode assembly of claim 120, wherein the riser is substantially planar.
  - 130. The lead electrode assembly of claim 120, wherein the riser is substantially perpendicular to the electrode.
  - 131. The lead electrode assembly of claim 120, wherein the riser is substantially centered over the electrode.
  - 132. The lead electrode assembly of claim 120, wherein the head is substantially planar.
  - 133. The lead electrode assembly of claim 120, wherein the head is substantially perpendicular to the riser.
  - 134. The lead electrode assembly of claim 120, wherein the riser is between approximately 1 mm and approximately 10 mm in height.
  - 135. The lead electrode assembly of claim 134, wherein the riser comprises a proximal end, a distal end, a top and a bottom and wherein the proximal end is closer to the distal end at the top of the riser than at the bottom of the riser.
  - 136. The lead electrode assembly of claim 120, wherein the electrode comprises a mesh of metallic material.
  - 137. The lead electrode assembly of claim 136, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 138. The lead electrode assembly of claim 120, wherein the electrode comprises a substantially flat sheet of metallic material.
  - 139. The lead electrode assembly of claim 138, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 140. The lead electrode assembly of claim 120, wherein the electrode is substantially planar.
  - 141. The lead electrode assembly of claim 120, wherein the electrode comprises at least one substantially planar surface.
  - 142. The lead electrode assembly of claim 141, wherein the at least one substantially planar surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.
  - 143. The lead electrode assembly of claim 120, wherein the lead electrode assembly further comprises a lead coupled to the electrode.
  - 144. The lead electrode assembly of claim 143, wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.
  - 145. The lead electrode assembly of claim 144, wherein the lead further comprises an electrically insulating sheath, enclosing the one or more electrical conductors.
  - 146. The lead electrode assembly of claim 143, wherein the lead electrode assembly further comprises a connector coupled to the lead.
  - 147. The lead electrode assembly of claim 146, wherein the connector is electrically coupled to the electrode.
  - 148. The lead electrode assembly of claim 143, wherein the lead is between approximately 5 cm and approximately 52 cm in length.
  - 149. The lead electrode assembly of claim 148, wherein the lead is between approximately 5 cm and approximately 30 cm in length.
  - 150. The lead electrode assembly of claim 149, wherein the lead is between approximately 10 cm and approximately 20 cm in length.
  - 151. The lead electrode assembly of claim 148, wherein the lead length is one of a plurality of pre-set lengths.
  - 152. The lead electrode assembly of claim 151, wherein the pre-set lengths vary by approximately 10 cm.
  - 153. The lead electrode assembly of claim 143, wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.
  - 154. The lead electrode assembly of claim 153, wherein the lead electrode assembly further comprises a lead fastener coupled between the proximal end of the lead and the electrode.
  - 155. The lead electrode assembly of claim 154, wherein the riser is coupled to the electrode along an interface line intersecting the lead fastener.
  - 156. The lead electrode assembly of claim 154, wherein the riser 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.
  - 157. The lead electrode assembly of claim 156, wherein the interface line and the line of the lead are the same line.
  - 158. The lead electrode assembly of claim 120, wherein the length of the riser is between approximately 2 mm and approximately 6 cm.
  - 159. The lead electrode assembly of claim 120, wherein the length of the riser is less than the length of the electrode.
  - 160. The lead electrode assembly of claim 159, wherein the riser is coupled to the electrode along an interface line and the length of the riser and the length of the electrode are measured along the interface line.
  - 161. The lead electrode assembly of claim 160, wherein the electrode has a proximal end and a distal end and wherein the riser is closer to the proximal end of the electrode than the distal end of the electrode.
  - 162. The lead electrode assembly of claim 161, 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.
  - 163. The lead electrode assembly of claim 162, wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.
  - 164. The lead electrode assembly of claim 120, wherein the lead electrode assembly further comprises a backing layer coupled between the foundation and the electrode.
  - 165. The lead electrode assembly of claim 164, wherein the backing layer comprises a polymeric material.
  - 166. The lead electrode assembly of claim 165, 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.
  - 167. The lead electrode assembly of claim 120, wherein the lead electrode assembly further comprises a molded cover coupled to the foundation and the electrode.
  - 168. The lead electrode assembly of claim 167, wherein the molded cover at least partially covers a top surface of the foundation.
  - 169. The lead electrode assembly of claim 167, wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.
  - 170. The lead electrode assembly of claim 167, wherein the molded cover comprises a polymeric material.
  - 171. The lead electrode assembly of claim 170, 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.
  - 172. The lead electrode assembly of claim 120, wherein the foundation is substantially planar.
  - 173. The lead electrode assembly of claim 120, wherein the foundation is substantially parallel to the electrode.
  - 174. The lead electrode assembly of claim 120, wherein the foundation comprises a metallic material.
  - 175. The lead electrode assembly of claim 174, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 176. The lead electrode assembly of claim 120, wherein the foundation comprises a polymeric material.
  - 177. The lead electrode assembly of claim 176, 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.

178. An implantable cardioverter-defibrillator for subcutaneous positioning between the third rib and the twelfth rib within a patient, the implantable cardioverter-defibrillator comprising:
- a biocompatible housing sized and configured for subcutaneous implantation in the patient; and
  
  a lead electrode assembly coupled to the housing, wherein the lead electrode assembly comprises;
  
  an electrode;
  
  a riser coupled to the electrode; and
  
  a head coupled to the riser.
- View Dependent Claims (179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217, 218, 219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 233, 234, 235, 236, 237, 238)
- - 179. The implantable cardioverter-defibrillator of claim 178, wherein the riser comprises a metallic material.
  - 180. The implantable cardioverter-defibrillator of claim 179, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 181. The implantable cardioverter-defibrillator of claim 178, wherein the riser comprises a polymeric material.
  - 182. The implantable cardioverter-defibrillator of claim 181, 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.
  - 183. The implantable cardioverter-defibrillator of claim 178, wherein the head comprises a metallic material.
  - 184. The implantable cardioverter-defibrillator of claim 183, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 185. The implantable cardioverter-defibrillator of claim 178, wherein the head comprises a polymeric material.
  - 186. The implantable cardioverter-defibrillator of claim 185, 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.
  - 187. The implantable cardioverter-defibrillator of claim 178, wherein the riser is substantially planar.
  - 188. The implantable cardioverter-defibrillator of claim 178, wherein the riser is substantially perpendicular to the electrode.
  - 189. The implantable cardioverter-defibrillator of claim 178, wherein the riser is substantially centered over the electrode.
  - 190. The implantable cardioverter-defibrillator of claim 178, wherein the head is substantially planar.
  - 191. The implantable cardioverter-defibrillator of claim 178, wherein the head is substantially perpendicular to the riser.
  - 192. The implantable cardioverter-defibrillator of claim 178, wherein the riser is between approximately 1 mm and approximately 10 mm in height.
  - 193. The implantable cardioverter-defibrillator of claim 192, wherein the riser comprises a proximal end, a distal end, a top and a bottom and wherein the proximal end is closer to the distal end at the top of the riser than at the bottom of the riser.
  - 194. The implantable cardioverter-defibrillator of claim 178, wherein the electrode comprises a mesh of metallic material.
  - 195. The implantable cardioverter-defibrillator of claim 194, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 196. The implantable cardioverter-defibrillator of claim 178, wherein the electrode comprises a substantially flat sheet of metallic material.
  - 197. The implantable cardioverter-defibrillator of claim 196, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 198. The implantable cardioverter-defibrillator of claim 178, wherein the electrode is substantially planar.
  - 199. The implantable cardioverter-defibrillator of claim 178, wherein the electrode comprises at least one substantially planar surface.
  - 200. The implantable cardioverter-defibrillator of claim 199, wherein the at least one substantially planar surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.
  - 201. The implantable cardioverter-defibrillator of claim 178, wherein the lead electrode assembly further comprises a lead coupled between the electrode and the housing.
  - 202. The implantable cardioverter-defibrillator of claim 201, wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.
  - 203. The implantable cardioverter-defibrillator of claim 202, wherein the lead further comprises an electrically insulating sheath, enclosing the one or more electrical conductors.
  - 204. The implantable cardioverter-defibrillator of claim 201, wherein the lead electrode assembly further comprises a connector coupled to the lead.
  - 205. The implantable cardioverter-defibrillator of claim 204, wherein the connector is electrically coupled to the electrode.
  - 206. The implantable cardioverter-defibrillator of claim 201, wherein the lead is between approximately 5 cm and approximately 52 cm in length.
  - 207. The implantable cardioverter-defibrillator of claim 206, wherein the lead is between approximately 5 cm and approximately 30 cm in length.
  - 208. The implantable cardioverter-defibrillator of claim 207, wherein the lead is between approximately 10 cm and approximately 20 cm in length.
  - 209. The implantable cardioverter-defibrillator of claim 206, wherein the lead length is one of a plurality of pre-set lengths.
  - 210. The implantable cardioverter-defibrillator of claim 209, wherein the pre-set lengths vary by approximately 10 cm.
  - 211. The implantable cardioverter-defibrillator of claim 201, wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.
  - 212. The implantable cardioverter-defibrillator of claim 211, wherein the lead electrode assembly further comprises a lead fastener coupled between the proximal end of the lead and the electrode.
  - 213. The implantable cardioverter-defibrillator of claim 212, wherein the riser is coupled to the electrode along an interface line intersecting the lead fastener.
  - 214. The implantable cardioverter-defibrillator of claim 212, wherein the riser 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.
  - 215. The implantable cardioverter-defibrillator of claim 214, wherein the interface line and the line of the lead are the same line.
  - 216. The implantable cardioverter-defibrillator of claim 178, wherein the length of the riser is between approximately 2 mm and approximately 6 cm.
  - 217. The implantable cardioverter-defibrillator of claim 178, wherein the length of the riser is less than the length of the electrode.
  - 218. The implantable cardioverter-defibrillator of claim 217, wherein the riser is coupled to the electrode along an interface line and the length of the riser and the length of the electrode are measured along the interface line.
  - 219. The implantable cardioverter-defibrillator of claim 218, wherein the electrode has a proximal end and a distal end and wherein the riser is closer to the proximal end of the electrode than the distal end of the electrode.
  - 220. The implantable cardioverter-defibrillator of claim 219, 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.
  - 221. The implantable cardioverter-defibrillator of claim 220, wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.
  - 222. The implantable cardioverter-defibrillator of claim 178, wherein the lead electrode assembly further comprises a foundation.
  - 223. The implantable cardioverter-defibrillator of claim 222, wherein a top surface of the foundation is coupled to a bottom of the riser.
  - 224. The implantable cardioverter-defibrillator of claim 222, wherein a bottom surface of the foundation is coupled to and faces a top surface of the electrode.
  - 225. The implantable cardioverter-defibrillator of claim 222, wherein the lead electrode assembly further comprises a backing layer coupled between the foundation and the electrode.
  - 226. The implantable cardioverter-defibrillator of claim 225, wherein the backing layer comprises a polymeric material.
  - 227. The implantable cardioverter-defibrillator of claim 226, 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.
  - 228. The implantable cardioverter-defibrillator of claim 222, wherein the lead electrode assembly further comprises a molded cover coupled to the foundation and the electrode.
  - 229. The implantable cardioverter-defibrillator of claim 228, wherein the molded cover at least partially covers a top surface of the foundation.
  - 230. The implantable cardioverter-defibrillator of claim 228, wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.
  - 231. The implantable cardioverter-defibrillator of claim 228, wherein the molded cover comprises a polymeric material.
  - 232. The implantable cardioverter-defibrillator of claim 231, 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.
  - 233. The implantable cardioverter-defibrillator of claim 222, wherein the foundation is substantially planar.
  - 234. The implantable cardioverter-defibrillator of claim 222, wherein the foundation is substantially parallel to the electrode.
  - 235. The implantable cardioverter-defibrillator of claim 222, wherein the foundation comprises a metallic material.
  - 236. The implantable cardioverter-defibrillator of claim 235, wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.
  - 237. The implantable cardioverter-defibrillator of claim 235, wherein the foundation comprises a polymeric material.
  - 238. The implantable cardioverter-defibrillator of claim 237, 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 a silicone, and mixtures thereof.

Specification

Resources

Litigation Campaign Assessment

Current Assignee
Cameron Incorporated (Schlumberger NV)
Original Assignee
Cameron Incorporated (Schlumberger NV)
Inventors
Rissmann, William J., Bardy, Gust H., Sanders, Gary H., Cappato, Riccardo
Primary Examiner(s)
Schaetzle, Kennedy

Application Number

US09/940,340
Publication Number

US 20020052636A1
Time in Patent Office

1,464 Days
Field of Search

607/116, 607/119, 607/115, 607/129, 607/130, 607/149, 607/152, 607/5
US Class Current

607/116
CPC Class Codes

A61N 1/375   Constructional arrangements...

A61N 1/3756   Casings with electrodes the...

A61N 1/3906   characterised by the form o...

A61N 1/3956   Implantable devices for app...

A61N 1/39622   Pacing therapy

A61N 1/3968   Constructional arrangements...

A61N 1/3975   Power supply A61N1/378 take...

Subcutaneous electrode for transthoracic conduction with low-profile installation appendage and method of doing same

First Claim

3 Assignments

0 Petitions

Accused Products

Abstract

203 Citations

238 Claims

Specification

Solutions

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Subcutaneous electrode for transthoracic conduction with low-profile installation appendage and method of doing same

First Claim

3 Assignments

Subscription Required

Subscription Required

0 Petitions

Subscription Required

Accused Products

Subscription Required

Abstract

203 Citations

238 Claims

Specification

Subscription Required

Solutions

Use Cases

Quick Links