Subcutaneous electrode for transthoracic conduction with insertion tool

Abstract

One embodiment of the present invention provides a lead electrode assembly for subcutaneous implantation including an electrode; and a pocket 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; and    a pocket coupled to the electrode for positioning the lead electrode assembly.    
     
     
         2 . The lead electrode assembly of  claim 1 , wherein the pocket comprises a bounded region coupled to the electrode.  
     
     
         3 . The lead electrode assembly of  claim 2 , wherein the bounded region is contiguous.  
     
     
         4 . The lead electrode assembly of  claim 2 , wherein the bounded region has a curved shape.  
     
     
         5 . The lead electrode assembly of  claim 2 , wherein the pocket further comprises a center and wherein the bounded region is disposed around the center without entirely enclosing the center.  
     
     
         6 . The lead electrode assembly of  claim 2 , wherein the bounded region forms part of a circumference of a circle.  
     
     
         7 . The lead electrode assembly of  claim 1 , wherein the pocket comprises a polymeric material.  
     
     
         8 . The lead electrode assembly of  claim 7 , 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.  
     
     
         9 . The lead electrode assembly of  claim 1 , wherein the pocket is substantially planar.  
     
     
         10 . The lead electrode assembly of  claim 1 , wherein the pocket is substantially parallel to the electrode.  
     
     
         11 . The lead electrode assembly of  claim 1 , wherein the lead electrode assembly further comprises a rigid backing layer coupled between the pocket and the electrode.  
     
     
         12 . The lead electrode assembly of  claim 1 , wherein the lead electrode assembly further comprises an appendage positioned between the pocket and the electrode.  
     
     
         13 . The lead electrode assembly of  claim 12 , wherein the appendage is fin-shaped.  
     
     
         14 . The lead electrode assembly of  claim 12 , wherein the appendage is loop-shaped.  
     
     
         15 . The lead electrode assembly of  claim 12 , wherein the appendage is tube-shaped.  
     
     
         16 . The lead electrode assembly of  claim 1 , wherein the pocket comprises a periphery and a middle portion surrounded by the periphery.  
     
     
         17 . The lead electrode assembly of  claim 16 , wherein the bounded region of the pocket comprises a portion of the periphery.  
     
     
         18 . The lead electrode assembly of  claim 16 , wherein the electrode is positioned substantially under the pocket.  
     
     
         19 . The lead electrode assembly of  claim 18 , wherein the electrode comprises at least one edge and wherein the at least one edge of the electrode is positioned substantially under a portion of the periphery of the pocket.  
     
     
         20 . The lead electrode assembly of  claim 1 , wherein the lead electrode assembly further comprises a molded cover coupled between the pocket and the electrode.  
     
     
         21 . The lead electrode assembly of  claim 18 , wherein the electrode comprises at least one edge and wherein at least a portion of the bounded region of the pocket is positioned substantially over the at least one edge of the electrode.  
     
     
         22 . The lead electrode assembly of  claim 1 , wherein a first side and a second side of the pocket are substantially straight.  
     
     
         23 . The lead electrode assembly of  claim 22 , wherein the pocket is substantially rectangular in shape.  
     
     
         24 . The lead electrode assembly of  claim 1 , wherein the pocket is substantially rectangular in shape.  
     
     
         25 . The lead electrode assembly of  claim 1 , wherein a first side and a second side of the pocket are substantially curved in shape.  
     
     
         26 . The lead electrode assembly of  claim 25 , wherein the pocket is substantially triangular in shape.  
     
     
         27 . The lead electrode assembly of  claim 1 , wherein the pocket is substantially triangular in shape.  
     
     
         28 . The lead electrode assembly of  claim 2 , wherein the bounded region of the pocket is attached directly to the electrode.  
     
     
         29 . The lead electrode assembly of  claim 2 , wherein the lead electrode assembly further comprises a molded cover coupled to the electrode.  
     
     
         30 . The lead electrode assembly of  claim 29 , wherein the molded cover is coupled to the bounded region of the pocket.  
     
     
         31 . The lead electrode assembly of  claim 29 , wherein the molded cover partially covers the electrode  
     
     
         32 . The lead electrode assembly of  claim 31 , wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.  
     
     
         33 . The lead electrode assembly of  claim 29 , wherein the pocket comprises at least a portion of the molded cover.  
     
     
         34 . The lead electrode assembly of  claim 29 , wherein the molded cover comprises a polymeric material.  
     
     
         35 . The lead electrode assembly of  claim 34 , 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.  
     
     
         36 . The lead electrode assembly of  claim 1 , wherein the electrode comprises a mesh of metallic material.  
     
     
         37 . The lead electrode assembly of  claim 36 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         38 . The lead electrode assembly of  claim 1 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         39 . The lead electrode assembly of  claim 38 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         40 . The lead electrode assembly of  claim 1 , wherein the electrode is substantially planar.  
     
     
         41 . The lead electrode assembly of  claim 1 , wherein the electrode comprises at least one substantially planar surface.  
     
     
         42 . The lead electrode assembly of  claim 41 , wherein the at least one substantially planar surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.  
     
     
         43 . The lead electrode assembly of  claim 1 , wherein the electrode is thumbnail shaped.  
     
     
         44 . The lead electrode assembly of  claim 1 , wherein the lead electrode assembly further comprises a lead coupled to the electrode.  
     
     
         45 . The lead electrode assembly of  claim 44 , wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.  
     
     
         46 . The lead electrode assembly of  claim 45 , wherein the lead further comprises an electrically insulating sheath enclosing the one or more electrical conductors.  
     
     
         47 . The lead electrode assembly of  claim 44 , wherein the lead electrode assembly further comprises a connector coupled to the lead.  
     
     
         48 . The lead electrode assembly of  claim 47 , wherein the connector is electrically coupled to the electrode.  
     
     
         49 . The lead electrode assembly of  claim 44 , wherein the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         50 . The lead electrode assembly of  claim 49 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         51 . The lead electrode assembly of  claim 50 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         52 . The lead electrode assembly of  claim 49 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         53 . The lead electrode assembly of  claim 52 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         54 . The lead electrode assembly of  claim 44 , wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.  
     
     
         55 . The lead electrode assembly of  claim 54 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         56 . The lead electrode assembly of  claim 1 , wherein the length of the electrode is not equal to the length of the pocket.  
     
     
         57 . The lead electrode assembly of  claim 56 , wherein the length of the electrode is less than the length of the pocket.  
     
     
         58 . The lead electrode assembly of  claim 1 , wherein the length of the electrode is equal to the length of the pocket.  
     
     
         59 . 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    a pocket coupled to the electrode for positioning the lead electrode assembly.    
     
     
         60 . The lead electrode assembly of  claim 59 , wherein the pocket comprises a bounded region coupled to the electrode.  
     
     
         61 . The lead electrode assembly of  claim 60 , wherein the bounded region is contiguous.  
     
     
         62 . The lead electrode assembly of  claim 60 , wherein the bounded region has a curved shape.  
     
     
         63 . The lead electrode assembly of  claim 60 , wherein the pocket further comprises a center and wherein the bounded region is disposed around the center without entirely enclosing the center.  
     
     
         64 . The lead electrode assembly of  claim 60 , wherein the bounded region forms part of a circumference of a circle.  
     
     
         65 . The lead electrode assembly of  claim 59 , wherein the pocket comprises a polymeric material.  
     
     
         66 . The lead electrode assembly of  claim 65 , 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.  
     
     
         67 . The lead electrode assembly of  claim 59 , wherein the pocket is substantially planar.  
     
     
         68 . The lead electrode assembly of  claim 59 , wherein the pocket is substantially parallel to the electrode.  
     
     
         69 . The lead electrode assembly of  claim 59 , wherein the lead electrode assembly further comprises a rigid backing layer coupled between the pocket and the electrode.  
     
     
         70 . The lead electrode assembly of  claim 59 , wherein the lead electrode assembly further comprises an appendage positioned between the pocket and the electrode.  
     
     
         71 . The lead electrode assembly of  claim 70 , wherein the appendage is fin-shaped.  
     
     
         72 . The lead electrode assembly of  claim 70 , wherein the appendage is loop-shaped.  
     
     
         73 . The lead electrode assembly of  claim 70 , wherein the appendage is tube-shaped.  
     
     
         74 . The lead electrode assembly of  claim 59 , wherein the pocket comprises a periphery and a middle portion surrounded by the periphery.  
     
     
         75 . The lead electrode assembly of  claim 74 , wherein the bounded region of the pocket comprises a portion of the periphery.  
     
     
         76 . The lead electrode assembly of  claim 74 , wherein the electrode is positioned substantially under the pocket.  
     
     
         77 . The lead electrode assembly of  claim 76 , wherein the electrode comprises at least one edge and wherein the at least one edge of the electrode is positioned substantially under a portion of the periphery of the pocket.  
     
     
         78 . The lead electrode assembly of  claim 59 , wherein the lead electrode assembly further comprises a molded cover coupled between the pocket and the electrode.  
     
     
         79 . The lead electrode assembly of  claim 76 , wherein the electrode comprises at least one edge and wherein at least a portion of the bounded region of the pocket is positioned substantially over the at least one edge of the electrode.  
     
     
         80 . The lead electrode assembly of  claim 59 , wherein a first side and a second side of the pocket are substantially straight.  
     
     
         81 . The lead electrode assembly of  claim 80 , wherein the pocket is substantially rectangular in shape.  
     
     
         82 . The lead electrode assembly of  claim 59 , wherein the pocket is substantially rectangular in shape.  
     
     
         83 . The lead electrode assembly of  claim 59 , wherein a first side and a second side of the pocket are substantially curved in shape.  
     
     
         84 . The lead electrode assembly of  claim 83 , wherein the pocket is substantially triangular in shape.  
     
     
         85 . The lead electrode assembly of  claim 59 , wherein the pocket is substantially triangular in shape.  
     
     
         86 . The lead electrode assembly of  claim 60 , wherein the bounded region of the pocket is attached directly to the electrode.  
     
     
         87 . The lead electrode assembly of  claim 60 , wherein the lead electrode assembly further comprises a molded cover coupled to the electrode.  
     
     
         88 . The lead electrode assembly of  claim 87 , wherein the molded cover is coupled to the bounded region of the pocket.  
     
     
         89 . The lead electrode assembly of  claim 87 , wherein the molded cover partially covers the electrode  
     
     
         90 . The lead electrode assembly of  claim 89 , wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.  
     
     
         91 . The lead electrode assembly of  claim 87 , wherein the pocket comprises at least a portion of the molded cover.  
     
     
         92 . The lead electrode assembly of  claim 87 , wherein the molded cover comprises a polymeric material.  
     
     
         93 . The lead electrode assembly of  claim 92 , 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.  
     
     
         94 . The lead electrode assembly of  claim 59 , wherein the electrode comprises a mesh of metallic material.  
     
     
         95 . The lead electrode assembly of  claim 94 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         96 . The lead electrode assembly of  claim 59 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         97 . The lead electrode assembly of  claim 96 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         98 . The lead electrode assembly of  claim 59 , wherein the electrode is substantially planar.  
     
     
         99 . The lead electrode assembly of  claim 59 , wherein the electrode comprises at least one substantially planar surface.  
     
     
         100 . The lead electrode assembly of  claim 99 , wherein the at least one substantially planar surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.  
     
     
         101 . The lead electrode assembly of  claim 59 , wherein the electrode is thumbnail shaped.  
     
     
         102 . The lead electrode assembly of  claim 59 , wherein the lead electrode assembly further comprises a lead coupled to the electrode.  
     
     
         103 . The lead electrode assembly of  claim 102 , wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.  
     
     
         104 . The lead electrode assembly of  claim 103 , wherein the lead further comprises an electrically insulating sheath enclosing the one or more electrical conductors.  
     
     
         105 . The lead electrode assembly of  claim 102 , wherein the lead electrode assembly further comprises a connector coupled to the lead.  
     
     
         106 . The lead electrode assembly of  claim 105 , wherein the connector is electrically coupled to the electrode.  
     
     
         107 . The lead electrode assembly of  claim 102 , wherein the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         108 . The lead electrode assembly of  claim 107 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         109 . The lead electrode assembly of  claim 108 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         110 . The lead electrode assembly of  claim 107 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         111 . The lead electrode assembly of  claim 110 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         112 . The lead electrode assembly of  claim 102 , wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.  
     
     
         113 . The lead electrode assembly of  claim 112 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         114 . The lead electrode assembly of  claim 59 , wherein the length of the electrode is not equal to the length of the pocket.  
     
     
         115 . The lead electrode assembly of  claim 114 , wherein the length of the electrode is less than the length of the pocket.  
     
     
         116 . The lead electrode assembly of  claim 59 , wherein the length of the electrode is equal to the length of the pocket.  
     
     
         117 . 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; and    a pocket coupled to the electrode for positioning the lead electrode assembly.    
     
     
         118 . The lead electrode assembly of  claim 117 , wherein the pocket comprises a bounded region coupled to the electrode.  
     
     
         119 . The lead electrode assembly of  claim 118 , wherein the bounded region is contiguous.  
     
     
         120 . The lead electrode assembly of  claim 118 , wherein the bounded region has a curved shape.  
     
     
         121 . The lead electrode assembly of  claim 118 , wherein the pocket further comprises a center and wherein the bounded region is disposed around the center without entirely enclosing the center.  
     
     
         122 . The lead electrode assembly of  claim 118 , wherein the bounded region forms part of a circumference of a circle.  
     
     
         123 . The lead electrode assembly of  claim 117 , wherein the pocket 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 117 , wherein the pocket is substantially planar.  
     
     
         126 . The lead electrode assembly of  claim 117 , wherein the pocket is substantially parallel to the electrode.  
     
     
         127 . The lead electrode assembly of  claim 117 , wherein the lead electrode assembly further comprises a rigid backing layer coupled between the pocket and the electrode.  
     
     
         128 . The lead electrode assembly of  claim 117 , wherein the lead electrode assembly further comprises an appendage positioned between the pocket and the electrode.  
     
     
         129 . The lead electrode assembly of  claim 128 , wherein the appendage is fin-shaped.  
     
     
         130 . The lead electrode assembly of  claim 128 , wherein the appendage is loop-shaped.  
     
     
         131 . The lead electrode assembly of  claim 128 , wherein the appendage is tube-shaped.  
     
     
         132 . The lead electrode assembly of  claim 117 , wherein the pocket comprises a periphery and a middle portion surrounded by the periphery.  
     
     
         133 . The lead electrode assembly of  claim 132 , wherein the bounded region of the pocket comprises a portion of the periphery.  
     
     
         134 . The lead electrode assembly of  claim 132 , wherein the electrode is positioned substantially under the pocket.  
     
     
         135 . The lead electrode assembly of  claim 134 , wherein the electrode comprises at least one edge and wherein the at least one edge of the electrode is positioned substantially under a portion of the periphery of the pocket.  
     
     
         136 . The lead electrode assembly of  claim 117 , wherein the lead electrode assembly further comprises a molded cover coupled between the pocket and the electrode.  
     
     
         137 . The lead electrode assembly of  claim 134 , wherein the electrode comprises at least one edge and wherein at least a portion of the bounded region of the pocket is positioned substantially over the at least one edge of the electrode.  
     
     
         138 . The lead electrode assembly of  claim 117 , wherein a first side and a second side of the pocket are substantially straight.  
     
     
         139 . The lead electrode assembly of  claim 138 , wherein the pocket is substantially rectangular in shape.  
     
     
         140 . The lead electrode assembly of  claim 117 , wherein the pocket is substantially rectangular in shape.  
     
     
         141 . The lead electrode assembly of  claim 117 , wherein a first side and a second side of the pocket are substantially curved in shape.  
     
     
         142 . The lead electrode assembly of  claim 141 , wherein the pocket is substantially triangular in shape.  
     
     
         143 . The lead electrode assembly of  claim 117 , wherein the pocket is substantially triangular in shape.  
     
     
         144 . The lead electrode assembly of  claim 118 , wherein the bounded region of the pocket is attached directly to the electrode.  
     
     
         145 . The lead electrode assembly of  claim 118 , wherein the lead electrode assembly further comprises a molded cover coupled to the electrode.  
     
     
         146 . The lead electrode assembly of  claim 145 , wherein the molded cover is coupled to the bounded region of the pocket.  
     
     
         147 . The lead electrode assembly of  claim 145 , wherein the molded cover partially covers the electrode  
     
     
         148 . The lead electrode assembly of  claim 147 , wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.  
     
     
         149 . The lead electrode assembly of  claim 145 , wherein the pocket comprises at least a portion of the molded cover.  
     
     
         150 . The lead electrode assembly of  claim 145 , wherein the molded cover comprises a polymeric material.  
     
     
         151 . The lead electrode assembly of  claim 150 , 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.  
     
     
         152 . The lead electrode assembly of  claim 117 , wherein the electrode comprises a mesh of metallic material.  
     
     
         153 . The lead electrode assembly of  claim 152 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         154 . The lead electrode assembly of  claim 117 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         155 . The lead electrode assembly of  claim 154 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         156 . The lead electrode assembly of  claim 117 , wherein the electrode is substantially planar.  
     
     
         157 . The lead electrode assembly of  claim 117 , wherein the electrode comprises at least one substantially planar surface.  
     
     
         158 . The lead electrode assembly of  claim 157 , wherein the at least one substantially planar surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.  
     
     
         159 . The lead electrode assembly of  claim 117 , wherein the electrode is thumbnail shaped.  
     
     
         160 . The lead electrode assembly of  claim 117 , wherein the lead electrode assembly further comprises a lead coupled to the electrode.  
     
     
         161 . The lead electrode assembly of  claim 160 , wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.  
     
     
         162 . The lead electrode assembly of  claim 161 , wherein the lead further comprises an electrically insulating sheath enclosing the one or more electrical conductors.  
     
     
         163 . The lead electrode assembly of  claim 160 , wherein the lead electrode assembly further comprises a connector coupled to the lead.  
     
     
         164 . The lead electrode assembly of  claim 163 , wherein the connector is electrically coupled to the electrode.  
     
     
         165 . The lead electrode assembly of  claim 160 , wherein the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         166 . The lead electrode assembly of  claim 165 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         167 . The lead electrode assembly of  claim 166 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         168 . The lead electrode assembly of  claim 165 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         169 . The lead electrode assembly of  claim 168 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         170 . The lead electrode assembly of  claim 160 , wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.  
     
     
         171 . The lead electrode assembly of  claim 170 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         172 . The lead electrode assembly of  claim 117 , wherein the length of the electrode is not equal to the length of the pocket.  
     
     
         173 . The lead electrode assembly of  claim 172 , wherein the length of the electrode is less than the length of the pocket.  
     
     
         174 . The lead electrode assembly of  claim 117 , wherein the length of the electrode is equal to the length of the pocket.  
     
     
         175 . 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  
 a pocket coupled to the electrode for positioning the lead electrode assembly.  
   
     
     
         176 . The implantable cardioverter-defibrillator of  claim 175 , wherein the pocket comprises a bounded region coupled to the electrode.  
     
     
         177 . The implantable cardioverter-defibrillator of  claim 176 , wherein the bounded region is contiguous.  
     
     
         178 . The implantable cardioverter-defibrillator of  claim 176 , wherein the bounded region has a curved shape.  
     
     
         179 . The implantable cardioverter-defibrillator of  claim 176 , wherein the pocket further comprises a center and wherein the bounded region is disposed around the center without entirely enclosing the center.  
     
     
         180 . The implantable cardioverter-defibrillator of  claim 176 , wherein the bounded region forms part of a circumference of a circle.  
     
     
         181 . The implantable cardioverter-defibrillator of  claim 175 , wherein the pocket 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 175 , wherein the pocket is substantially planar.  
     
     
         184 . The implantable cardioverter-defibrillator of  claim 175 , wherein the pocket is substantially parallel to the electrode.  
     
     
         185 . The implantable cardioverter-defibrillator of  claim 175 , wherein the lead electrode assembly further comprises a rigid backing layer coupled between the pocket and the electrode.  
     
     
         186 . The implantable cardioverter-defibrillator of  claim 175 , wherein the lead electrode assembly further comprises an appendage positioned between the pocket and the electrode.  
     
     
         187 . The implantable cardioverter-defibrillator of  claim 186 , wherein the appendage is fin-shaped.  
     
     
         188 . The implantable cardioverter-defibrillator of  claim 186 , wherein the appendage is loop-shaped.  
     
     
         189 . The implantable cardioverter-defibrillator of  claim 186 , wherein the appendage is tube-shaped.  
     
     
         190 . The implantable cardioverter-defibrillator of  claim 175 , wherein the pocket comprises a periphery and a middle portion surrounded by the periphery.  
     
     
         191 . The implantable cardioverter-defibrillator of  claim 190 , wherein the bounded region of the pocket comprises a portion of the periphery.  
     
     
         192 . The implantable cardioverter-defibrillator of  claim 190 , wherein the electrode is positioned substantially under the pocket.  
     
     
         193 . The implantable cardioverter-defibrillator of  claim 192 , wherein the electrode comprises at least one edge and wherein the at least one edge of the electrode is positioned substantially under a portion of the periphery of the pocket.  
     
     
         194 . The implantable cardioverter-defibrillator of  claim 175 , wherein the lead electrode assembly further comprises a molded cover coupled between the pocket and the electrode.  
     
     
         195 . The implantable cardioverter-defibrillator of  claim 192 , wherein the electrode comprises at least one edge and wherein at least a portion of the bounded region of the pocket is positioned substantially over the at least one edge of the electrode.  
     
     
         196 . The implantable cardioverter-defibrillator of  claim 175 , wherein a first side and a second side of the pocket are substantially straight.  
     
     
         197 . The implantable cardioverter-defibrillator of  claim 196 , wherein the pocket is substantially rectangular in shape.  
     
     
         198 . The implantable cardioverter-defibrillator of  claim 175 , wherein the pocket is substantially rectangular in shape.  
     
     
         199 . The implantable cardioverter-defibrillator of  claim 175 , wherein a first side and a second side of the pocket are substantially curved in shape.  
     
     
         200 . The implantable cardioverter-defibrillator of  claim 199 , wherein the pocket is substantially triangular in shape.  
     
     
         201 . The implantable cardioverter-defibrillator of  claim 175 , wherein the pocket is substantially triangular in shape.  
     
     
         202 . The implantable cardioverter-defibrillator of  claim 176 , wherein the bounded region of the pocket is attached directly to the electrode.  
     
     
         203 . The implantable cardioverter-defibrillator of  claim 176 , wherein the lead electrode assembly further comprises a molded cover coupled to the electrode.  
     
     
         204 . The implantable cardioverter-defibrillator of  claim 203 , wherein the molded cover is coupled to the bounded region of the pocket.  
     
     
         205 . The implantable cardioverter-defibrillator of  claim 203 , wherein the molded cover partially covers the electrode  
     
     
         206 . The implantable cardioverter-defibrillator of  claim 205 , wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.  
     
     
         207 . The implantable cardioverter-defibrillator of  claim 203 , wherein the pocket comprises at least a portion of the molded cover.  
     
     
         208 . The implantable cardioverter-defibrillator of  claim 203 , wherein the molded cover comprises a polymeric material.  
     
     
         209 . The implantable cardioverter-defibrillator of  claim 208 , 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.  
     
     
         210 . The implantable cardioverter-defibrillator of  claim 175 , wherein the electrode comprises a mesh of metallic material.  
     
     
         211 . The implantable cardioverter-defibrillator of  claim 210 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         212 . The implantable cardioverter-defibrillator of  claim 175 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         213 . The implantable cardioverter-defibrillator of  claim 212 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         214 . The implantable cardioverter-defibrillator of  claim 175 , wherein the electrode is substantially planar.  
     
     
         215 . The implantable cardioverter-defibrillator of claim wherein the electrode comprises at least one substantially planar surface.  
     
     
         216 . The implantable cardioverter-defibrillator of  claim 215 , wherein the at least one substantially planar surface has a surface area between approximately 100 square millimeters and approximately 2000 square millimeters.  
     
     
         217 . The implantable cardioverter-defibrillator of  claim 175 , wherein the electrode is thumbnail shaped.  
     
     
         218 . The implantable cardioverter-defibrillator of  claim 175 , wherein the lead electrode assembly further comprises a lead coupled between the electrode and the housing.  
     
     
         219 . The implantable cardioverter-defibrillator of  claim 218 , wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.  
     
     
         220 . The implantable cardioverter-defibrillator of  claim 219 , wherein the lead further comprises an electrically insulating sheath enclosing the one or more electrical conductors.  
     
     
         221 . The implantable cardioverter-defibrillator of  claim 218 , wherein the lead electrode assembly further comprises a connector coupled to the lead.  
     
     
         222 . The implantable cardioverter-defibrillator of  claim 221 , wherein the connector is electrically coupled to the electrode.  
     
     
         223 . The implantable cardioverter-defibrillator of  claim 218 , wherein the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         224 . The implantable cardioverter-defibrillator of  claim 223 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         225 . The implantable cardioverter-defibrillator of  claim 224 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         226 . The implantable cardioverter-defibrillator of  claim 223 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         227 . The implantable cardioverter-defibrillator of  claim 226 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         228 . The implantable cardioverter-defibrillator of  claim 218 , wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.  
     
     
         229 . The implantable cardioverter-defibrillator of  claim 228 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         230 . The implantable cardioverter-defibrillator of  claim 175 , wherein the length of the electrode is not equal to the length of the pocket.  
     
     
         231 . The implantable cardioverter-defibrillator of  claim 230 , wherein the length of the electrode is less than the length of the pocket.  
     
     
         232 . The implantable cardioverter-defibrillator of  claim 175 , wherein the length of the electrode is equal to the length of the pocket.  
     
     
         233 . A lead electrode assembly manipulation tool comprising: 
 a paddle; and    a rod connected to the paddle.    
     
     
         234 . The lead electrode assembly manipulation tool of  claim 223 , wherein the paddle is substantially planar.  
     
     
         235 . The lead electrode assembly manipulation tool of  claim 233 , wherein the paddle has a substantially circular shape.  
     
     
         236 . The lead electrode assembly manipulation tool of  claim 233 , wherein the paddle has a proximal end and a distal end and wherein the proximal end of the paddle is attached to the rod.  
     
     
         237 . The lead electrode assembly manipulation tool of  claim 233 , wherein the rod has a first end and a second end and wherein the first end of the rod is connected to the paddle.  
     
     
         238 . The lead electrode assembly manipulation tool of  claim 237 , wherein lead electrode assembly manipulation tool further comprises a handle connected to the second end of the rod.  
     
     
         239 . The lead electrode assembly manipulation tool of  claim 233 , wherein the rod is curved.  
     
     
         240 . The lead electrode assembly manipulation tool of  claim 233 , wherein the paddle comprises a metallic material.  
     
     
         241 . The lead electrode assembly manipulation tool of  claim 240 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         242 . The lead electrode assembly manipulation tool of  claim 233 , wherein the paddle comprises a polymeric material.  
     
     
         243 . The lead electrode assembly manipulation tool of  claim 242 , 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.  
     
     
         244 . The lead electrode assembly manipulation tool of  claim 233 , wherein the rod comprises a metallic material.  
     
     
         245 . The lead electrode assembly manipulation tool of  claim 244 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         246 . The lead electrode assembly manipulation tool of  claim 233 , wherein the rod comprises a polymeric material.  
     
     
         247 . The lead electrode assembly manipulation tool of  claim 246 , 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.  
     
     
         248 . 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 lead and a pocket;    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.    
     
     
         249 . The method of  claim 248 , 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.    
     
     
         250 . The method of  claim 249 , 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.    
     
     
         251 . The method of  claim 249 , 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.    
     
     
         252 . The method of  claim 249 , wherein the incision in the thoracic region of the patient is in the anterior of the thorax.  
     
     
         253 . The method of  claim 249 , wherein the lead electrode assembly manipulation tool comprises a rod and a paddle.  
     
     
         254 . The method of  claim 253 , wherein the step of capturing the lead electrode assembly with the lead electrode assembly manipulation tool further comprises the step of: 
 sliding the paddle of the lead electrode assembly into the pocket of the lead electrode assembly manipulation tool.    
     
     
         255 . The method of  claim 253 , 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.    
     
     
         256 . The method of  claim 253 , 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.    
     
     
         257 . The method of  claim 253 , 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.    
     
     
         258 . 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 pocket stored in the tray.    
     
     
         259 . The subcutaneous implantable cardioverter-defibrillator kit of  claim 258 , wherein the subcutaneous implantable cardioverter-defibrillator kit further comprises a lead electrode assembly manipulation tool having a paddle, wherein the lead electrode assembly manipulation tool is stored in the tray.  
     
     
         260 . The subcutaneous implantable cardioverter-defibrillator kit of  claim 258 , wherein the subcutaneous implantable cardioverter-defibrillator kit further comprises a subcutaneous implantable cardioverter-defibrillator, wherein the subcutaneous implantable cardioverter-defibrillator is stored in the tray.  
     
     
         261 . The subcutaneous implantable cardioverter-defibrillator kit of  claim 258 , wherein the subcutaneous implantable cardioverter-defibrillator kit further comprises a medical adhesive, wherein the medical adhesive is stored in the tray.  
     
     
         262 . The subcutaneous implantable cardioverter-defibrillator kit of  claim 258 , wherein the subcutaneous implantable cardioverter-defibrillator kit further comprises an anesthetic, wherein the anesthetic is stored in the tray.  
     
     
         263 . The subcutaneous implantable cardioverter-defibrillator kit of  claim 258 , wherein the subcutaneous implantable cardioverter-defibrillator kit further comprises a tube of mineral oil, wherein the tube of mineral oil is stored in the tray.