Subcutaneous electrode for transthoracic conduction with highly maneuverable insertion tool

Abstract

One embodiment of the present invention provides a lead electrode assembly for subcutaneous implantation including an electrode; at least two channel guides coupled to the electrode for positioning the lead electrode assembly.

What is claimed is:  
     
         1 . A lead electrode assembly for subcutaneous implantation comprising: 
 an electrode;    at least two channel guides coupled to the electrode for positioning the lead electrode assembly.    
     
     
         2 . The lead electrode assembly of  claim 1 , wherein the electrode is substantially planar.  
     
     
         3 . The lead electrode assembly of  claim 2 , wherein the at least two channel guides comprise a first channel guide and a second channel guide and wherein the first channel guide is coupled to a first side of the electrode and the second channel guide is coupled to a second side of the electrode.  
     
     
         4 . The lead electrode assembly of  claim 3 , wherein the first channel guide and the second channel guide each comprise a strip of material.  
     
     
         5 . The lead electrode assembly of  claim 4 , wherein the strip of material comprises a polymeric material.  
     
     
         6 . The lead electrode assembly of  claim 5 , 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.  
     
     
         7 . The lead electrode assembly of  claim 4 , wherein the strip of material is coupled to the electrode with stitching.  
     
     
         8 . The lead electrode assembly of  claim 4 , wherein the strip of material has a rectangular shape.  
     
     
         9 . The lead electrode assembly of  claim 4 , wherein an inner side of the strip of material is coupled to the electrode.  
     
     
         10 . The lead electrode assembly of  claim 9 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled between the inner side of the strip of material and the electrode.  
     
     
         11 . The lead electrode assembly of  claim 9 , wherein the electrode is substantially planar comprising a first side, a second side, a top surface and a bottom surface.  
     
     
         12 . The lead electrode assembly of  claim 11 , wherein the inner side of the strip of material is coupled to the top surface and the bottom surface of the electrode.  
     
     
         13 . The lead electrode assembly of  claim 11 , wherein the inner side of the strip of material comprising the first channel guide is coupled to the top surface and the bottom surface of the electrode on the first side of the electrode.  
     
     
         14 . The lead electrode assembly of  claim 13 , wherein the lead electrode assembly further comprises a backing layer, wherein the backing layer is coupled between the top surface of the first side of the electrode and the inner side of the strip of material comprising the first channel guide.  
     
     
         15 . The lead electrode assembly of  claim 14 , wherein the inner side of the strip of material comprising the second channel guide is coupled to the top surface and bottom surface of the electrode on the second side of the electrode.  
     
     
         16 . The lead electrode assembly of  claim 15 , wherein the backing layer is coupled between the top surface of the second side of the electrode and the inner side of the strip of material comprising the second channel guide.  
     
     
         17 . The lead electrode assembly of  claim 4 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled to the electrode.  
     
     
         18 . The lead electrode assembly of  claim 17 , wherein the strip of material is attached to the molded cover.  
     
     
         19 . The lead electrode assembly of  claim 18 , wherein the molded cover forms a skirt around the electrode.  
     
     
         20 . The lead electrode assembly of  claim 17 , wherein the molded cover is composed of a polymeric material.  
     
     
         21 . The lead electrode assembly of  claim 20 , 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.  
     
     
         22 . The lead electrode assembly of  claim 3 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled to the electrode.  
     
     
         23 . The lead electrode assembly of  claim 22 , wherein the molded cover partially covers the electrode.  
     
     
         24 . The lead electrode assembly of  claim 23 , wherein the molded cover forms a skirt around the electrode.  
     
     
         25 . The lead electrode assembly of  claim 22 , wherein the molded cover is composed of a polymeric material.  
     
     
         26 . The lead electrode assembly of  claim 25 , 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.  
     
     
         27 . The lead electrode assembly of  claim 22 , wherein the first channel guide and the second channel guide are formed as part of the molded cover.  
     
     
         28 . The lead electrode assembly of  claim 1 , wherein the electrode comprises a mesh of metallic material.  
     
     
         29 . The lead electrode assembly of  claim 28 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         30 . The lead electrode assembly of  claim 1 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         31 . The lead electrode assembly of  claim 30 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         32 . The lead electrode assembly of  claim 1 , wherein the electrode comprises at least one surface.  
     
     
         33 . The lead electrode assembly of  claim 32 , wherein the electrode is substantially planar.  
     
     
         34 . The lead electrode assembly of  claim 32 , wherein the said at least one surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.  
     
     
         35 . The lead electrode assembly of  claim 1 , wherein the lead electrode assembly further comprises a lead, wherein the lead is coupled to the electrode.  
     
     
         36 . The lead electrode assembly of  claim 35 , wherein the lead comprises one or more electrical conductors and an electrically insulating sheath, wherein the electrically insulating sheath encloses said one or more electrical conductors.  
     
     
         37 . The lead electrode assembly of  claim 35 , wherein the said one or more electrical conductors are electrically coupled to the electrode.  
     
     
         38 . The lead electrode assembly of  claim 35 , wherein the lead electrode assembly further comprises a connector, wherein the lead comprises a proximal end and a distal end and wherein the connector is physically connected to the distal end of the lead.  
     
     
         39 . The lead electrode assembly of  claim 38 , wherein the connector is electrically coupled to the electrode.  
     
     
         40 . The lead electrode assembly of  claim 35 , the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         41 . The lead electrode assembly of  claim 40 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         42 . The lead electrode assembly of  claim 41 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         43 . The lead electrode assembly of  claim 40 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         44 . The lead electrode assembly of  claim 43 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         45 . The lead electrode assembly of  claim 35 , wherein the lead has a proximal end and a distal end and further wherein the proximal end of the lead is physically connected to the electrode.  
     
     
         46 . The lead electrode assembly of  claim 45 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         47 . 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 first channel guide and a second channel guide coupled to the electrode for positioning the lead electrode assembly.    
     
     
         48 . The lead electrode assembly of  claim 47 , wherein the electrode is substantially planar.  
     
     
         49 . The lead electrode assembly of  claim 48 , wherein the at least two channel guides comprise a first channel guide and a second channel guide and wherein the first channel guide is coupled to a first side of the electrode and the second channel guide is coupled to a second side of the electrode.  
     
     
         50 . The lead electrode assembly of  claim 49 , wherein the first channel guide and the second channel guide each comprise a strip of material.  
     
     
         51 . The lead electrode assembly of  claim 50 , wherein the strip of material comprises a polymeric material.  
     
     
         52 . The lead electrode assembly of  claim 51 , 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.  
     
     
         53 . The lead electrode assembly of  claim 50 , wherein the strip of material is coupled to the electrode with stitching.  
     
     
         54 . The lead electrode assembly of  claim 50 , wherein the strip of material has a rectangular shape.  
     
     
         55 . The lead electrode assembly of  claim 50 , wherein an inner side of the strip of material is coupled to the electrode.  
     
     
         56 . The lead electrode assembly of  claim 55 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled between the inner side of the strip of material and the electrode.  
     
     
         57 . The lead electrode assembly of  claim 55 , wherein the electrode is substantially planar comprising a first side, a second side, a top surface and a bottom surface.  
     
     
         58 . The lead electrode assembly of  claim 57 , wherein the inner side of the strip of material is coupled to the top surface and the bottom surface of the electrode.  
     
     
         59 . The lead electrode assembly of  claim 57 , wherein the inner side of the strip of material comprising the first channel guide is coupled to the top surface and the bottom surface of the electrode on the first side of the electrode.  
     
     
         60 . The lead electrode assembly of  claim 59 , wherein the lead electrode assembly further comprises a backing layer, wherein the backing layer is coupled between the top surface of the first side of the electrode and the inner side of the strip of material comprising the first channel guide.  
     
     
         61 . The lead electrode assembly of  claim 60 , wherein the inner side of the strip of material comprising the second channel guide is coupled to the top surface and bottom surface of the electrode on the second side of the electrode.  
     
     
         62 . The lead electrode assembly of  claim 61 , wherein the backing layer is coupled between the top surface of the second side of the electrode and the inner side of the strip of material comprising the second channel guide.  
     
     
         63 . The lead electrode assembly of  claim 50 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled to the electrode.  
     
     
         64 . The lead electrode assembly of  claim 63 , wherein the strip of material is attached to the molded cover.  
     
     
         65 . The lead electrode assembly of  claim 64 , wherein the molded cover forms a skirt around the electrode.  
     
     
         66 . The lead electrode assembly of  claim 63 , wherein the molded cover is composed of a polymeric material.  
     
     
         67 . The lead electrode assembly of  claim 66 , 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.  
     
     
         68 . The lead electrode assembly of  claim 49 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled to the electrode.  
     
     
         69 . The lead electrode assembly of  claim 68 , wherein the molded cover partially covers the electrode.  
     
     
         70 . The lead electrode assembly of  claim 69 , wherein the molded cover forms a skirt around the electrode.  
     
     
         71 . The lead electrode assembly of  claim 68 , wherein the molded cover is composed of a polymeric material.  
     
     
         72 . The lead electrode assembly of  claim 71 , 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.  
     
     
         73 . The lead electrode assembly of  claim 68 , wherein the first channel guide and the second channel guide are formed as part of the molded cover.  
     
     
         74 . The lead electrode assembly of  claim 47 , wherein the electrode comprises a mesh of metallic material.  
     
     
         75 . The lead electrode assembly of  claim 74 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         76 . The lead electrode assembly of  claim 47 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         77 . The lead electrode assembly of  claim 76 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         78 . The lead electrode assembly of  claim 47 , wherein the electrode comprises at least one surface.  
     
     
         79 . The lead electrode assembly of  claim 78 , wherein the electrode is substantially planar.  
     
     
         80 . The lead electrode assembly of  claim 78 , wherein the said at least one surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.  
     
     
         81 . The lead electrode assembly of  claim 47 , wherein the lead electrode assembly further comprises a lead, wherein the lead is coupled to the electrode.  
     
     
         82 . The lead electrode assembly of  claim 81 , wherein the lead comprises one or more electrical conductors and an electrically insulating sheath, wherein the electrically insulating sheath encloses said one or more electrical conductors.  
     
     
         83 . The lead electrode assembly of  claim 81 , wherein the said one or more electrical conductors are electrically coupled to the electrode.  
     
     
         84 . The lead electrode assembly of  claim 81 , wherein the lead electrode assembly further comprises a connector, wherein the lead comprises a proximal end and a distal end and wherein the connector is physically connected to the distal end of the lead.  
     
     
         85 . The lead electrode assembly of  claim 84 , wherein the connector is electrically coupled to the electrode.  
     
     
         86 . The lead electrode assembly of  claim 81 , the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         87 . The lead electrode assembly of  claim 86 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         88 . The lead electrode assembly of  claim 87 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         89 . The lead electrode assembly of  claim 86 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         90 . The lead electrode assembly of  claim 89 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         91 . The lead electrode assembly of  claim 81 , wherein the lead has a proximal end and a distal end and further wherein the proximal end of the lead is physically connected to the electrode.  
     
     
         92 . The lead electrode assembly of  claim 91 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         93 . 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 first channel guide and a second channel guide coupled to the electrode for positioning the lead electrode assembly.    
     
     
         94 . The lead electrode assembly of  claim 93 , wherein the electrode is substantially planar.  
     
     
         95 . The lead electrode assembly of  claim 94 , wherein the at least two channel guides comprise a first channel guide and a second channel guide and wherein the first channel guide is coupled to a first side of the electrode and the second channel guide is coupled to a second side of the electrode.  
     
     
         96 . The lead electrode assembly of  claim 95 , wherein the first channel guide and the second channel guide each comprise a strip of material.  
     
     
         97 . The lead electrode assembly of  claim 96 , wherein the strip of material comprises a polymeric material.  
     
     
         98 . The lead electrode assembly of  claim 97 , 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.  
     
     
         99 . The lead electrode assembly of  claim 96 , wherein the strip of material is coupled to the electrode with stitching.  
     
     
         100 . The lead electrode assembly of  claim 96 , wherein the strip of material has a rectangular shape.  
     
     
         101 . The lead electrode assembly of  claim 96 , wherein an inner side of the strip of material is coupled to the electrode.  
     
     
         102 . The lead electrode assembly of  claim 101 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled between the inner side of the strip of material and the electrode.  
     
     
         103 . The lead electrode assembly of  claim 101 , wherein the electrode is substantially planar comprising a first side, a second side, a top surface and a bottom surface.  
     
     
         104 . The lead electrode assembly of  claim 103 , wherein the inner side of the strip of material is coupled to the top surface and the bottom surface of the electrode.  
     
     
         105 . The lead electrode assembly of  claim 103 , wherein the inner side of the strip of material comprising the first channel guide is coupled to the top surface and the bottom surface of the electrode on the first side of the electrode.  
     
     
         106 . The lead electrode assembly of  claim 105 , wherein the lead electrode assembly further comprises a backing layer, wherein the backing layer is coupled between the top surface of the first side of the electrode and the inner side of the strip of material comprising the first channel guide.  
     
     
         107 . The lead electrode assembly of  claim 106 , wherein the inner side of the strip of material comprising the second channel guide is coupled to the top surface and bottom surface of the electrode on the second side of the electrode.  
     
     
         108 . The lead electrode assembly of  claim 107 , wherein the backing layer is coupled between the top surface of the second side of the electrode and the inner side of the strip of material comprising the second channel guide.  
     
     
         109 . The lead electrode assembly of  claim 96 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled to the electrode.  
     
     
         110 . The lead electrode assembly of  claim 109 , wherein the strip of material is attached to the molded cover.  
     
     
         111 . The lead electrode assembly of  claim 110 , wherein the molded cover forms a skirt around the electrode.  
     
     
         112 . The lead electrode assembly of  claim 109 , wherein the molded cover is composed of 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 95 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled to the electrode.  
     
     
         115 . The lead electrode assembly of  claim 114 , wherein the molded cover partially covers the electrode.  
     
     
         116 . The lead electrode assembly of  claim 115 , wherein the molded cover forms a skirt around the electrode.  
     
     
         117 . The lead electrode assembly of  claim 114 , wherein the molded cover is composed of a polymeric material.  
     
     
         118 . The lead electrode assembly of  claim 117 , 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.  
     
     
         119 . The lead electrode assembly of  claim 114 , wherein the first channel guide and the second channel guide are formed as part of the molded cover.  
     
     
         120 . The lead electrode assembly of  claim 93 , wherein the electrode comprises a mesh of metallic material.  
     
     
         121 . The lead electrode assembly of  claim 120 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         122 . The lead electrode assembly of  claim 93 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         123 . The lead electrode assembly of  claim 122 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         124 . The lead electrode assembly of  claim 93 , wherein the electrode comprises at least one surface.  
     
     
         125 . The lead electrode assembly of  claim 124 , wherein the electrode is substantially planar.  
     
     
         126 . The lead electrode assembly of  claim 124 , wherein the said at least one surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.  
     
     
         127 . The lead electrode assembly of  claim 93 , wherein the lead electrode assembly further comprises a lead, wherein the lead is coupled to the electrode.  
     
     
         128 . The lead electrode assembly of  claim 127 , wherein the lead comprises one or more electrical conductors and an electrically insulating sheath, wherein the electrically insulating sheath encloses said one or more electrical conductors.  
     
     
         129 . The lead electrode assembly of  claim 127 , wherein the said one or more electrical conductors are electrically coupled to the electrode.  
     
     
         130 . The lead electrode assembly of  claim 127 , wherein the lead electrode assembly further comprises a connector, wherein the lead comprises a proximal end and a distal end and wherein the connector is physically connected to the distal end of the lead.  
     
     
         131 . The lead electrode assembly of  claim 130 , wherein the connector is electrically coupled to the electrode.  
     
     
         132 . The lead electrode assembly of  claim 127 , the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         133 . The lead electrode assembly of  claim 132 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         134 . The lead electrode assembly of  claim 133 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         135 . The lead electrode assembly of  claim 132 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         136 . The lead electrode assembly of  claim 135 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         137 . The lead electrode assembly of  claim 127 , wherein the lead has a proximal end and a distal end and further wherein the proximal end of the lead is physically connected to the electrode.  
     
     
         138 . The lead electrode assembly of  claim 137 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         139 . 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;  
 a first channel guide and a second channel guide coupled to the electrode for positioning the lead electrode assembly.  
   
     
     
         140 . The implantable cardioverter-defibrillator of  claim 139 , wherein the electrode is substantially planar.  
     
     
         141 . The implantable cardioverter-defibrillator of  claim 140 , wherein the at least two channel guides comprise a first channel guide and a second channel guide and wherein the first channel guide is coupled to a first side of the electrode and the second channel guide is coupled to a second side of the electrode.  
     
     
         142 . The implantable cardioverter-defibrillator of  claim 141 , wherein the first channel guide and the second channel guide each comprise a strip of material.  
     
     
         143 . The implantable cardioverter-defibrillator of  claim 142 , wherein the strip of material comprises a polymeric material.  
     
     
         144 . The implantable cardioverter-defibrillator of  claim 143 , 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.  
     
     
         145 . The implantable cardioverter-defibrillator of  claim 142 , wherein the strip of material is coupled to the electrode with stitching.  
     
     
         146 . The implantable cardioverter-defibrillator of  claim 142 , wherein the strip of material has a rectangular shape.  
     
     
         147 . The implantable cardioverter-defibrillator of  claim 142 , wherein an inner side of the strip of material is coupled to the electrode.  
     
     
         148 . The implantable cardioverter-defibrillator of  claim 147 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled between the inner side of the strip of material and the electrode.  
     
     
         149 . The implantable cardioverter-defibrillator of  claim 147 , wherein the electrode is substantially planar comprising a first side, a second side, a top surface and a bottom surface.  
     
     
         150 . The implantable cardioverter-defibrillator of  claim 149 , wherein the inner side of the strip of material is coupled to the top surface and the bottom surface of the electrode.  
     
     
         151 . The implantable cardioverter-defibrillator of  claim 149 , wherein the inner side of the strip of material comprising the first channel guide is coupled to the top surface and the bottom surface of the electrode on the first side of the electrode.  
     
     
         152 . The implantable cardioverter-defibrillator of  claim 151 , wherein the lead electrode assembly further comprises a backing layer, wherein the backing layer is coupled between the top surface of the first side of the electrode and the inner side of the strip of material comprising the first channel guide.  
     
     
         153 . The implantable cardioverter-defibrillator of  claim 152 , wherein the inner side of the strip of material comprising the second channel guide is coupled to the top surface and bottom surface of the electrode on the second side of the electrode.  
     
     
         154 . The implantable cardioverter-defibrillator of  claim 153 , wherein the backing layer is coupled between the top surface of the second side of the electrode and the inner side of the strip of material comprising the second channel guide.  
     
     
         155 . The implantable cardioverter-defibrillator of  claim 142 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled to the electrode.  
     
     
         156 . The implantable cardioverter-defibrillator of  claim 155 , wherein the strip of material is attached to the molded cover.  
     
     
         157 . The implantable cardioverter-defibrillator of  claim 156 , wherein the molded cover forms a skirt around the electrode.  
     
     
         158 . The implantable cardioverter-defibrillator of  claim 155 , wherein the molded cover is composed of a polymeric material.  
     
     
         159 . The implantable cardioverter-defibrillator of  claim 158 , 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.  
     
     
         160 . The implantable cardioverter-defibrillator of  claim 141 , wherein the lead electrode assembly further comprises a molded cover, wherein the molded cover is coupled to the electrode.  
     
     
         161 . The implantable cardioverter-defibrillator of  claim 160 , wherein the molded cover partially covers the electrode.  
     
     
         162 . The implantable cardioverter-defibrillator of  claim 161 , wherein the molded cover forms a skirt around the electrode.  
     
     
         163 . The implantable cardioverter-defibrillator of  claim 160 , wherein the molded cover is composed of a polymeric material.  
     
     
         164 . The implantable cardioverter-defibrillator of  claim 163 , 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.  
     
     
         165 . The implantable cardioverter-defibrillator of  claim 160 , wherein the first channel guide and the second channel guide are formed as part of the molded cover.  
     
     
         166 . The implantable cardioverter-defibrillator of  claim 139 , wherein the electrode comprises a mesh of metallic material.  
     
     
         167 . The implantable cardioverter-defibrillator of  claim 166 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         168 . The implantable cardioverter-defibrillator of  claim 139 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         169 . The implantable cardioverter-defibrillator of  claim 168 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         170 . The implantable cardioverter-defibrillator of  claim 139 , wherein the electrode comprises at least one surface.  
     
     
         171 . The implantable cardioverter-defibrillator of  claim 170 , wherein the electrode is substantially planar.  
     
     
         172 . The implantable cardioverter-defibrillator of  claim 170 , wherein the said at least one surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.  
     
     
         173 . The implantable cardioverter-defibrillator of  claim 139 , wherein the lead electrode assembly further comprises a lead, wherein the lead is coupled between the electrode and the housing.  
     
     
         174 . The implantable cardioverter-defibrillator of  claim 173 , wherein the lead comprises one or more electrical conductors and an electrically insulating sheath, wherein the electrically insulating sheath encloses said one or more electrical conductors.  
     
     
         175 . The implantable cardioverter-defibrillator of  claim 173 , wherein the said one or more electrical conductors are electrically coupled to the electrode.  
     
     
         176 . The implantable cardioverter-defibrillator of  claim 173 , wherein the lead electrode assembly further comprises a connector, wherein the lead comprises a proximal end and a distal end and wherein the connector is physically connected to the distal end of the lead.  
     
     
         177 . The implantable cardioverter-defibrillator of  claim 176 , wherein the connector is electrically coupled to the electrode.  
     
     
         178 . The implantable cardioverter-defibrillator of  claim 173 , the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         179 . The implantable cardioverter-defibrillator of  claim 178 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         180 . The implantable cardioverter-defibrillator of  claim 179 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         181 . The implantable cardioverter-defibrillator of  claim 180 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         182 . The implantable cardioverter-defibrillator of  claim 181 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         183 . The implantable cardioverter-defibrillator of  claim 173 , wherein the lead has a proximal end and a distal end and further wherein the proximal end of the lead is physically connected to the electrode.  
     
     
         184 . The implantable cardioverter-defibrillator of  claim 183 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         185 . A lead electrode assembly manipulation tool comprising: 
 a rod; and    a pair of tines for capturing a lead electrode assembly having a first channel guide and a second channel guide, wherein the pair of tines is coupled to the rod.    
     
     
         186 . The lead electrode assembly manipulation tool of  claim 185 , wherein each of the pair of tines is substantially parallel to the other.  
     
     
         187 . The lead electrode assembly manipulation tool of  claim 185 , wherein each of the pair of tines is separated from the other by a gap.  
     
     
         188 . The lead electrode assembly manipulation tool of  claim 185 , wherein the pair of tines is substantially straight.  
     
     
         189 . The lead electrode assembly manipulation tool of  claim 185 , wherein the lead electrode assembly manipulation tool further comprises a tine base, wherein the tine base is connected to the rod and further wherein the tine base is connected to the pair of tines.  
     
     
         190 . The lead electrode assembly manipulation tool of  claim 189 , wherein each of the pair of tines comprises a proximal end and a distal end and further wherein the proximal ends of the pair of tines are attached to the tine base.  
     
     
         191 . The lead electrode assembly manipulation tool of  claim 190 , wherein the distal end of each of the pair of tines is rounded.  
     
     
         192 . The lead electrode assembly manipulation tool of  claim 189 , wherein the rod has a proximal end and a distal end and wherein the distal end of the rod is connected to the tine base.  
     
     
         193 . The lead electrode assembly manipulation tool of  claim 192 , wherein the lead electrode assembly manipulation tool further comprises a handle, wherein the handle is coupled to the proximal end of the rod.  
     
     
         194 . The lead electrode assembly manipulation tool of  claim 185 , wherein the rod is curved.  
     
     
         195 . The lead electrode assembly manipulation tool of  claim 185 , wherein the pair of tines is composed a metallic material.  
     
     
         196 . The lead electrode assembly of  claim 195 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         197 . The lead electrode assembly manipulation tool of  claim 185 , wherein the pair of tines is composed of a polymeric material.  
     
     
         198 . The lead electrode assembly of  claim 197 , 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.  
     
     
         199 . The lead electrode assembly manipulation tool of  claim 185 , wherein the rod is composed a metallic material.  
     
     
         200 . The lead electrode assembly of  claim 199 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         201 . The lead electrode assembly manipulation tool of  claim 185 , wherein the rod is composed of a polymeric material.  
     
     
         202 . The lead electrode assembly of claim  201 , 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.  
     
     
         203 . A method for surgically implanting a lead electrode assembly subcutaneously outside a patient's ribcage, the method comprising the steps of: 
 providing a lead electrode assembly having a first channel guide and a second channel guide;    providing a lead electrode assembly manipulation tool;    creating a subcutaneous path outside the ribcage;    capturing the lead electrode assembly with the lead electrode assembly manipulation tool;    moving the lead electrode assembly through the path; and    releasing the lead electrode assembly from the lead electrode assembly manipulation tool.    
     
     
         204 . The method of claim  203 , wherein the step of creating a subcutaneous path outside the ribcage further comprises the steps of: 
 providing a hemostat;    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.    
     
     
         205 . The method of claim  204 , 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.    
     
     
         206 . The method of claim  204 , 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.    
     
     
         207 . The method of claim  204 , wherein the incision in the thoracic region of the patient is in the anterior of the thorax.  
     
     
         208 . The method of claim  204 , wherein the lead electrode assembly manipulation tool comprises a rod and a pair of tines.  
     
     
         209 . The method of claim  208 , wherein the step of capturing the lead electrode assembly with the lead electrode assembly manipulation tool further comprises the step of: 
 sliding one of the pair of tines of the lead electrode assembly manipulation tool into each of the first channel guide and second channel guide of the lead electrode assembly.    
     
     
         210 . The method of claim  208 , wherein the step of capturing the lead electrode assembly with the lead electrode assembly manipulation tool further comprises the step of: 
 holding the lead of the lead electrode assembly still relative to the rod of the lead electrode assembly manipulation tool.    
     
     
         211 . The method of claim  208 , wherein the step of capturing the lead electrode assembly with the lead electrode assembly manipulation tool further comprises the step of: 
 holding the lead of the lead electrode assembly against the rod of the lead electrode assembly manipulation tool.    
     
     
         212 . The method of claim  208 , wherein the step of releasing the lead electrode assembly from the lead electrode assembly manipulation tool further comprises the step of: 
 allowing the lead of the lead electrode assembly to move relative to the rod of the lead electrode assembly manipulation tool.    
     
     
         213 . A subcutaneous implantable cardioverter-defibrillator kit for use in surgically implanting a subcutaneous implantable cardioverter-defibrillator and a lead electrode assembly within a patient comprising: 
 a tray; and    a lead electrode assembly having a first channel guide and a second channel guide stored in the tray.    
     
     
         214 . The subcutaneous implantable cardioverter-defibrillator kit of claim  213 , further comprising a lead electrode assembly manipulation tool having a pair of tines, wherein the lead electrode assembly manipulation tool is stored in the tray.  
     
     
         215 . The subcutaneous implantable cardioverter-defibrillator kit of claim  213 , further comprising a subcutaneous implantable cardioverter-defibrillator, wherein the subcutaneous implantable cardioverter-defibrillator is stored in the tray.  
     
     
         216 . The subcutaneous implantable cardioverter-defibrillator kit of claim  213 , further comprising a medical adhesive, wherein the medical adhesive is stored in the tray.  
     
     
         217 . The subcutaneous implantable cardioverter-defibrillator kit of claim  213 , further comprising an anesthetic, wherein the anesthetic is stored in the tray.  
     
     
         218 . The subcutaneous implantable cardioverter-defibrillator kit of claim  213 , further comprising a tube of mineral oil, wherein the tube of mineral oil is stored in the tray.