Subcutaneous electrode with improved contact shape for transthoracic conduction

Abstract

One embodiment of the present invention provides a lead electrode assembly for use with an implantable cardioverter-defibrillator subcutaneously implanted outside the ribcage between the third and eighth ribs comprising an electrode.

What is claimed is:  
     
         1 . A lead electrode assembly for use with an implantable cardioverter-defibrillator subcutaneously implanted outside a patient's ribcage between the third and twelfth ribs, wherein the lead electrode assembly comprises an electrode.  
     
     
         2 . The lead electrode assembly of  claim 1 , wherein the electrode can emit an effective energy for shocking the patient's heart.  
     
     
         3 . The lead electrode assembly of  claim 2 , wherein the effective energy for shocking the patient's heart is approximately 25 J to approximately 50 J.  
     
     
         4 . The lead electrode assembly of  claim 2 , wherein the effective energy for shocking the patient's heart is approximately 50 J to approximately 75 J.  
     
     
         5 . The lead electrode assembly of  claim 2 , wherein the effective energy for shocking the patient's heart is approximately 75 J to approximately 100 J.  
     
     
         6 . The lead electrode assembly of  claim 2 , wherein the effective energy for shocking the patient's heart is approximately 100 J to approximately 125 J.  
     
     
         7 . The lead electrode assembly of  claim 2 , wherein the effective energy for shocking the patient's heart is approximately 125 J to approximately 150 J.  
     
     
         8 . The lead electrode assembly of  claim 2 , wherein the effective energy for shocking the patient's heart is approximately 150 J.  
     
     
         9 . The lead electrode assembly of  claim 2 , wherein the electrode can further receive physiological information from the patient through sensors.  
     
     
         10 . The lead electrode assembly of  claim 1 , wherein the electrode can receive physiological information from the patient through sensors.  
     
     
         11 . The lead electrode assembly of  claim 1 , wherein at least a portion of the electrode is non-planar.  
     
     
         12 . The lead electrode assembly of  claim 1 , wherein the electrode is substantially ellipsoidal in shape.  
     
     
         13 . The lead electrode assembly of  claim 1 , wherein the electrode is substantially thumbnail shaped.  
     
     
         14 . The lead electrode assembly of  claim 1 , wherein the electrode is substantially circular in shape.  
     
     
         15 . The lead electrode assembly of  claim 1 , wherein the electrode is substantially square in shape.  
     
     
         16 . The lead electrode assembly of  claim 15 , wherein the electrode comprises rounded corners.  
     
     
         17 . The lead electrode assembly of  claim 1 , wherein the electrode is substantially rectangular in shape.  
     
     
         18 . The lead electrode assembly of  claim 17 , wherein the electrode comprises rounded corners.  
     
     
         19 . The lead electrode assembly of  claim 1 , wherein the electrode is substantially triangular in shape.  
     
     
         20 . The lead electrode assembly of  claim 19 , wherein the electrode comprises rounded corners.  
     
     
         21 . The lead electrode assembly of  claim 1 , wherein the electrode is less than approximately 1000 square millimeters in area.  
     
     
         22 . The lead electrode assembly of  claim 21 , wherein the electrode is between approximately 750 square millimeters to approximately 1000 square millimeters in area.  
     
     
         23 . The lead electrode assembly of  claim 22 , wherein the electrode is between approximately 500 square millimeters to approximately 750 square millimeters in area.  
     
     
         24 . The lead electrode assembly of  claim 1 , wherein the electrode is between approximately 250 square millimeters to approximately 500 square millimeters in area.  
     
     
         25 . The lead electrode assembly of  claim 1 , wherein the electrode is between approximately 100 square millimeters to approximately 250 square millimeters in area.  
     
     
         26 . The lead electrode assembly of  claim 1 , wherein the electrode is positioned approximately in a posterior region of the patient's ribcage.  
     
     
         27 . The lead electrode assembly of  claim 1 , wherein the electrode is positioned approximately in a paraspinal region of the patient.  
     
     
         28 . The lead electrode assembly of  claim 1 , wherein the electrode is positioned approximately in a parascapular region of the patient.  
     
     
         29 . The lead electrode assembly of  claim 1 , wherein the electrode is positioned approximately posterior to a mid axillary line of the patient.  
     
     
         30 . The lead electrode assembly of  claim 1 , wherein the electrode is positioned approximately posterior and lateral to an anterior axillary line of the patient.  
     
     
         31 . The lead electrode assembly of  claim 1 , wherein lead electrode assembly further comprises a backing layer coupled to the electrode.  
     
     
         32 . The lead electrode assembly of  claim 31 , wherein the backing layer comprises a polymeric material.  
     
     
         33 . The lead electrode assembly of  claim 32 , 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.  
     
     
         34 . The lead electrode assembly of  claim 31 , wherein the backing layer is substantially planar.  
     
     
         35 . The lead electrode assembly of  claim 34 , wherein the backing layer is substantially parallel to the electrode.  
     
     
         36 . The lead electrode assembly of  claim 1 , wherein at least a portion of the electrode is covered by a skirt.  
     
     
         37 . The lead electrode assembly of  claim 1 , wherein the lead electrode assembly further comprises a molded cover coupled to the electrode.  
     
     
         38 . The lead electrode assembly of  claim 37 , wherein the molded cover partially covers the electrode  
     
     
         39 . The lead electrode assembly of  claim 38 , wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.  
     
     
         40 . The lead electrode assembly of  claim 37 , wherein the molded cover comprises a polymeric material.  
     
     
         41 . The lead electrode assembly of  claim 40 , 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.  
     
     
         42 . The lead electrode assembly of  claim 1 , wherein the electrode comprises a mesh of metallic material.  
     
     
         43 . The lead electrode assembly of  claim 42 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         44 . The lead electrode assembly of  claim 1 , wherein the electrode comprises a metallic material.  
     
     
         45 . The lead electrode assembly of  claim 44 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         46 . The lead electrode assembly of  claim 1 , wherein the electrode is substantially planar.  
     
     
         47 . The lead electrode assembly of  claim 1 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         48 . The lead electrode assembly of  claim 47 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         49 . The lead electrode assembly of  claim 1 , wherein the lead electrode assembly further comprises a lead coupled to the electrode.  
     
     
         50 . The lead electrode assembly of  claim 49 , wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.  
     
     
         51 . The lead electrode assembly of  claim 50 , wherein the lead further comprises an electrically insulating sheath enclosing the one or more electrical conductors.  
     
     
         52 . The lead electrode assembly of  claim 49 , wherein the lead electrode assembly further comprises a connector coupled to the lead.  
     
     
         53 . The lead electrode assembly of  claim 52 , wherein the connector is electrically coupled to the electrode.  
     
     
         54 . The lead electrode assembly of  claim 49 , wherein the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         55 . The lea d electrode assembly of  claim 54 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         56 . The lead electrode assembly of  claim 55 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         57 . The lead electrode assembly of  claim 54 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         58 . The lead electrode assembly of  claim 57 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         59 . The lead electrode assembly of  claim 49 , wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.  
     
     
         60 . The lead electrode assembly of  claim 59 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         61 . 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;    an electrical circuit located within the housing;    a first electrode coupled to the electrical circuit and located on the housing; and    a lead electrode assembly coupled to the housing, wherein the lead electrode assembly comprises: 
 a second electrode coupled to the electrical circuit.  
   
     
     
         62 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode can emit an effective energy for shocking the patient's heart.  
     
     
         63 . The implantable cardioverter-defibrillator of  claim 62 , wherein the effective energy for shocking the patient's heart is approximately 25 J to approximately 50 J.  
     
     
         64 . The implantable cardioverter-defibrillator of  claim 62 , wherein the effective energy for shocking the patient's heart is approximately 50 J to approximately 75 J.  
     
     
         65 . The implantable cardioverter-defibrillator of  claim 62 , wherein the effective energy for shocking the patient's heart is approximately 75 J to approximately 100 J.  
     
     
         66 . The implantable cardioverter-defibrillator of  claim 62 , wherein the effective energy for shocking the patient's heart is approximately 100 J to approximately 125 J.  
     
     
         67 . The implantable cardioverter-defibrillator of  claim 62 , wherein the effective energy for shocking the patient's heart is approximately 125 J to approximately 150 J.  
     
     
         68 . The implantable cardioverter-defibrillator of  claim 62 , wherein the effective energy for shocking the patient's heart is approximately 150 J.  
     
     
         69 . The implantable cardioverter-defibrillator of  claim 62 , wherein the second electrode can further receive physiological information from the patient through sensors.  
     
     
         70 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode can receive physiological information from the patient through sensors.  
     
     
         71 . The implantable cardioverter-defibrillator of  claim 61 , wherein at least a portion of the second electrode is non-planar.  
     
     
         72 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is substantially ellipsoidal in shape.  
     
     
         73 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is substantially thumbnail shaped.  
     
     
         74 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is substantially circular in shape.  
     
     
         75 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is substantially square in shape.  
     
     
         76 . The implantable cardioverter-defibrillator of  claim 75 , wherein the second electrode comprises rounded corners.  
     
     
         77 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is substantially rectangular in shape.  
     
     
         78 . The implantable cardioverter-defibrillator of  claim 77 , wherein the second electrode comprises rounded corners.  
     
     
         79 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is substantially triangular in shape.  
     
     
         80 . The implantable cardioverter-defibrillator of  claim 79 , wherein the second electrode comprises rounded corners.  
     
     
         81 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is less than approximately 1000 square millimeters in area.  
     
     
         82 . The implantable cardioverter-defibrillator of  claim 81 , wherein the second electrode is between approximately 750 square millimeters to approximately 1000 square millimeters in area.  
     
     
         83 . The implantable cardioverter-defibrillator of  claim 82 , wherein the second electrode is between approximately 500 square millimeters to approximately 750 square millimeters in area.  
     
     
         84 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is between approximately 250 square millimeters to approximately 500 square millimeters in area.  
     
     
         85 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is between approximately 100 square millimeters to approximately 250 square millimeters in area.  
     
     
         86 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is positioned approximately in a posterior region of the patient's ribcage.  
     
     
         87 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is positioned approximately in a paraspinal region of the patient.  
     
     
         88 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is positioned approximately in a parascapular region of the patient.  
     
     
         89 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is positioned approximately posterior to a mid axillary line of the patient.  
     
     
         90 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is positioned approximately posterior and lateral to an anterior axillary line of the patient.  
     
     
         91 . The implantable cardioverter-defibrillator of  claim 61 , wherein lead electrode assembly further comprises a backing layer coupled to the second electrode.  
     
     
         92 . The implantable cardioverter-defibrillator of  claim 91 , wherein the backing layer comprises a polymeric material.  
     
     
         93 . The implantable cardioverter-defibrillator 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 implantable cardioverter-defibrillator of  claim 92 , wherein the backing layer is substantially planar.  
     
     
         95 . The implantable cardioverter-defibrillator of  claim 94 , wherein the backing layer is substantially parallel to the second electrode.  
     
     
         96 . The implantable cardioverter-defibrillator of  claim 61 , wherein at least a portion of the second electrode is covered by a skirt.  
     
     
         97 . The implantable cardioverter-defibrillator of  claim 61 , wherein the lead electrode assembly further comprises a molded cover coupled to the second electrode.  
     
     
         98 . The implantable cardioverter-defibrillator of  claim 97 , wherein the molded cover partially covers the second electrode  
     
     
         99 . The implantable cardioverter-defibrillator of  claim 98 , wherein the molded cover comprises a skirt that partially covers a bottom surface of the second electrode.  
     
     
         100 . The implantable cardioverter-defibrillator of  claim 97 , wherein the molded cover comprises a polymeric material.  
     
     
         101 . The implantable cardioverter-defibrillator of  claim 100 , 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.  
     
     
         102 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode comprises a mesh of metallic material.  
     
     
         103 . The implantable cardioverter-defibrillator of  claim 102 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         104 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode comprises a metallic material.  
     
     
         105 . The implantable cardioverter-defibrillator of  claim 104 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         106 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode is substantially planar.  
     
     
         107 . The implantable cardioverter-defibrillator of  claim 61 , wherein the second electrode comprises a substantially flat sheet of metallic material.  
     
     
         108 . The implantable cardioverter-defibrillator of  claim 107 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         109 . The implantable cardioverter-defibrillator of  claim 61 , wherein the lead electrode assembly further comprises a lead coupled between the housing and the second electrode.  
     
     
         110 . The implantable cardioverter-defibrillator of  claim 109 , wherein the lead comprises one or more electrical conductors electrically coupled to the second electrode.  
     
     
         111 . The implantable cardioverter-defibrillator of  claim 110 , wherein the lead further comprises an electrically insulating sheath enclosing the one or more electrical conductors.  
     
     
         112 . The implantable cardioverter-defibrillator of  claim 109 , wherein the lead electrode assembly further comprises a connector coupled to the lead.  
     
     
         113 . The implantable cardioverter-defibrillator of  claim 112 , wherein the connector is electrically coupled to the second electrode.  
     
     
         114 . The implantable cardioverter-defibrillator of  claim 109 , wherein the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         115 . The implantable cardioverter-defibrillator of  claim 114 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         116 . The implantable cardioverter-defibrillator of  claim 115 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         117 . The implantable cardioverter-defibrillator of  claim 114 , wherein the lead length is one of a plurality of preset lengths.  
     
     
         118 . The implantable cardioverter-defibrillator of  claim 117 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         119 . The implantable cardioverter-defibrillator of  claim 109 , wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the second electrode.  
     
     
         120 . The implantable cardioverter-defibrillator of  claim 119 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the second electrode.  
     
     
         121 . 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.  
     
     
         122 . The lead electrode assembly of  claim 121 , wherein the electrode can emit an effective energy for shocking the patient's heart.  
     
     
         123 . The lead electrode assembly of  claim 122 , wherein the effective energy for shocking the patient's heart is approximately 25 J to approximately 50 J.  
     
     
         124 . The lead electrode assembly of  claim 122 , wherein the effective energy for shocking the patient's heart is approximately 50 J to approximately 75 J.  
     
     
         125 . The lead electrode assembly of  claim 122 , wherein the effective energy for shocking the patient's heart is approximately 75 J to approximately 100 J.  
     
     
         126 . The lead electrode assembly of  claim 122 , wherein the effective energy for shocking the patient's heart is approximately 100 J to approximately 125 J.  
     
     
         127 . The lead electrode assembly of  claim 122 , wherein the effective energy for shocking the patient's heart is approximately 125 J to approximately 150 J.  
     
     
         128 . The lead electrode assembly of  claim 122 , wherein the effective energy for shocking the patient's heart is approximately 150 J.  
     
     
         129 . The lead electrode assembly of  claim 122 , wherein the electrode can further receive physiological information from the patient through sensors.  
     
     
         130 . The lead electrode assembly of  claim 121 , wherein the electrode can receive physiological information from the patient through sensors.  
     
     
         131 . The lead electrode assembly of  claim 121 , wherein at least a portion of the electrode is non-planar.  
     
     
         132 . The lead electrode assembly of  claim 121 , wherein the electrode is substantially ellipsoidal in shape.  
     
     
         133 . The lead electrode assembly of  claim 121 , wherein the electrode is substantially thumbnail shaped.  
     
     
         134 . The lead electrode assembly of  claim 121 , wherein the electrode is substantially circular in shape.  
     
     
         135 . The lead electrode assembly of  claim 121 , wherein the electrode is substantially square in shape.  
     
     
         136 . The lead electrode assembly of  claim 135 , wherein the electrode comprises rounded corners.  
     
     
         137 . The lead electrode assembly of  claim 121 , wherein the electrode is substantially rectangular in shape.  
     
     
         138 . The lead electrode assembly of  claim 137 , wherein the electrode comprises rounded corners.  
     
     
         139 . The lead electrode assembly of  claim 121 , wherein the electrode is substantially triangular in shape.  
     
     
         140 . The lead electrode assembly of  claim 139 , wherein the electrode comprises rounded corners.  
     
     
         141 . The lead electrode assembly of  claim 121 , wherein the electrode is less than approximately 1000 square millimeters in area.  
     
     
         142 . The lead electrode assembly of  claim 141 , wherein the electrode is between approximately 750 square millimeters to approximately 1000 square millimeters in area.  
     
     
         143 . The lead electrode assembly of  claim 142 , wherein the electrode is between approximately 500 square millimeters to approximately 750 square millimeters in area.  
     
     
         144 . The lead electrode assembly of  claim 121 , wherein the electrode is between approximately 250 square millimeters to approximately 500 square millimeters in area.  
     
     
         145 . The lead electrode assembly of  claim 121 , wherein the electrode is between approximately 100 square millimeters to approximately 250 square millimeters in area.  
     
     
         146 . The lead electrode assembly of  claim 121 , wherein the electrode is positioned approximately in a posterior region of the patient's ribcage.  
     
     
         147 . The lead electrode assembly of  claim 121 , wherein the electrode is positioned approximately in a paraspinal region of the patient.  
     
     
         148 . The lead electrode assembly of  claim 121 , wherein the electrode is positioned approximately in a parascapular region of the patient.  
     
     
         149 . The lead electrode assembly of  claim 121 , wherein the electrode is positioned approximately posterior to a mid axillary line of the patient.  
     
     
         150 . The lead electrode assembly of  claim 121 , wherein the electrode is positioned approximately posterior and lateral to an anterior axillary line of the patient.  
     
     
         151 . The lead electrode assembly of  claim 121 , wherein lead electrode assembly further comprises a backing layer coupled to the electrode.  
     
     
         152 . The lead electrode assembly of  claim 151 , wherein the backing layer comprises a polymeric material.  
     
     
         153 . The lead electrode assembly of  claim 152 , 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.  
     
     
         154 . The lead electrode assembly of  claim 151 , wherein the backing layer is substantially planar.  
     
     
         155 . The lead electrode assembly of  claim 154 , wherein the backing layer is substantially parallel to the electrode.  
     
     
         156 . The lead electrode assembly of  claim 121 , wherein at least a portion of the electrode is covered by a skirt.  
     
     
         157 . The lead electrode assembly of  claim 121 , wherein the lead electrode assembly further comprises a molded cover coupled to the electrode.  
     
     
         158 . The lead electrode assembly of  claim 157 , wherein the molded cover partially covers the eletoctrode  
     
     
         159 . The lead electrode assembly of  claim 158 , wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.  
     
     
         160 . The lead electrode assembly of  claim 157 , wherein the molded cover comprises a polymeric material.  
     
     
         161 . The lead electrode assembly of  claim 160 , 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.  
     
     
         162 . The lead electrode assembly of  claim 121 , wherein the electrode comprises a mesh of metallic material.  
     
     
         163 . The lead electrode assembly of  claim 162 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         164 . The lead electrode assembly of  claim 121 , wherein the electrode comprises a metallic material.  
     
     
         165 . The lead electrode assembly of  claim 164 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         166 . The lead electrode assembly of  claim 121 , wherein the electrode is substantially planar.  
     
     
         167 . The lead electrode assembly of  claim 121 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         168 . The lead electrode assembly of  claim 167 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         169 . The lead electrode assembly of  claim 121 , wherein the lead electrode assembly further comprises a lead coupled to the electrode.  
     
     
         170 . The lead electrode assembly of  claim 169 , wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.  
     
     
         171 . The lead electrode assembly of  claim 170 , wherein the lead further comprises an electrically insulating sheath enclosing the one or more electrical conductors.  
     
     
         172 . The lead electrode assembly of  claim 169 , wherein the lead electrode assembly further comprises a connector coupled to the lead.  
     
     
         173 . The lead electrode assembly of  claim 172 , wherein the connector is electrically coupled to the electrode.  
     
     
         174 . The lead electrode assembly of  claim 169 , wherein the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         175 . The lead electrode assembly of  claim 174 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         176 . The lead electrode assembly of  claim 175 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         177 . The lead electrode assembly of  claim 174 , wherein the lead length is one of a plurality of pre-set lengths.  
     
     
         178 . The lead electrode assembly of  claim 177 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         179 . The lead electrode assembly of  claim 169 , wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.  
     
     
         180 . The lead electrode assembly of  claim 179 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.  
     
     
         181 . 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.  
   
     
     
         182 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode can emit an effective energy for shocking the patient's heart.  
     
     
         183 . The implantable cardioverter-defibrillator of  claim 182 , wherein the effective energy for shocking the patient's heart is approximately 25 J to approximately 50 J.  
     
     
         184 . The implantable cardioverter-defibrillator of  claim 182 , wherein the effective energy for shocking the patient's heart is approximately 50 J to approximately 75 J.  
     
     
         185 . The implantable cardioverter-defibrillator of  claim 182 , wherein the effective energy for shocking the patient's heart is approximately 75 J to approximately 100 J.  
     
     
         186 . The implantable cardioverter-defibrillator of  claim 182 , wherein the effective energy for shocking the patient's heart is approximately 100 J to approximately 125 J.  
     
     
         187 . The implantable cardioverter-defibrillator of  claim 182 , wherein the effective energy for shocking the patient's heart is approximately 125 J to approximately 150 J.  
     
     
         188 . The implantable cardioverter-defibrillator of  claim 182 , wherein the effective energy for shocking the patient's heart is approximately 150 J.  
     
     
         189 . The implantable cardioverter-defibrillator of  claim 182 , wherein the electrode can further receive physiological information from the patient through sensors.  
     
     
         190 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode can receive physiological information from the patient through sensors.  
     
     
         191 . The implantable cardioverter-defibrillator of  claim 181 , wherein at least a portion of the electrode is non-planar.  
     
     
         192 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is substantially ellipsoidal in shape.  
     
     
         193 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is substantially thumbnail shaped.  
     
     
         194 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is substantially circular in shape.  
     
     
         195 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is substantially square in shape.  
     
     
         196 . The implantable cardioverter-defibrillator of  claim 195 , wherein the electrode comprises rounded corners.  
     
     
         197 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is substantially rectangular in shape.  
     
     
         198 . The implantable cardioverter-defibrillator of  claim 197 , wherein the electrode comprises rounded corners.  
     
     
         199 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is substantially triangular in shape.  
     
     
         200 . The implantable cardioverter-defibrillator of  claim 199 , wherein the electrode comprises rounded corners.  
     
     
         201 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is less than approximately 1000 square millimeters in area.  
     
     
         202 . The implantable cardioverter-defibrillator of  claim 201 , wherein the electrode is between approximately 750 square millimeters to approximately 1000 square millimeters in area.  
     
     
         203 . The implantable cardioverter-defibrillator of  claim 202 , wherein the electrode is between approximately 500 square millimeters to approximately 750 square millimeters in area.  
     
     
         204 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is between approximately 250 square millimeters to approximately 500 square millimeters in area.  
     
     
         205 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is between approximately 100 square millimeters to approximately 250 square millimeters in area.  
     
     
         206 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is positioned approximately in a posterior region of the patient's ribcage.  
     
     
         207 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is positioned approximately in a paraspinal region of the patient.  
     
     
         208 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is positioned approximately in a parascapular region of the patient.  
     
     
         209 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is positioned approximately posterior to a mid axillary line of the patient.  
     
     
         210 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is positioned approximately posterior and lateral to an anterior axillary line of the patient.  
     
     
         211 . The implantable cardioverter-defibrillator of  claim 181 , wherein lead electrode assembly further comprises a backing layer coupled to the electrode.  
     
     
         212 . The implantable cardioverter-defibrillator of  claim 211 , wherein the backing layer comprises a polymeric material.  
     
     
         213 . The implantable cardioverter-defibrillator of  claim 212 , 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.  
     
     
         214 . The implantable cardioverter-defibrillator of  claim 211 , wherein the backing layer is substantially planar.  
     
     
         215 . The implantable cardioverter-defibrillator of  claim 214 , wherein the backing layer is substantially parallel to the electrode.  
     
     
         216 . The implantable cardioverter-defibrillator of  claim 181 , wherein at least a portion of the electrode is covered by a skirt.  
     
     
         217 . The implantable cardioverter-defibrillator of  claim 181 , wherein the lead electrode assembly further comprises a molded cover coupled to the electrode.  
     
     
         218 . The implantable cardioverter-defibrillator of  claim 217 , wherein the molded cover partially covers the electrode  
     
     
         219 . The implantable cardioverter-defibrillator of  claim 218 , wherein the molded cover comprises a skirt that partially covers a bottom surface of the electrode.  
     
     
         220 . The implantable cardioverter-defibrillator of  claim 217 , wherein the molded cover comprises a polymeric material.  
     
     
         221 . The implantable cardioverter-defibrillator of  claim 220 , 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.  
     
     
         222 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode comprises a mesh of metallic material.  
     
     
         223 . The implantable cardioverter-defibrillator of  claim 222 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         224 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode comprises a metallic material.  
     
     
         225 . The implantable cardioverter-defibrillator of  claim 224 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         226 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode is substantially planar.  
     
     
         227 . The implantable cardioverter-defibrillator of  claim 181 , wherein the electrode comprises a substantially flat sheet of metallic material.  
     
     
         228 . The implantable cardioverter-defibrillator of  claim 227 , wherein the metallic material is selected from the group consisting essentially of titanium, nickel alloys, stainless steel alloys, platinum, platinum iridium, and mixtures thereof.  
     
     
         229 . The implantable cardioverter-defibrillator of  claim 181 , wherein the lead electrode assembly further comprises a lead coupled between the electrode and the housing.  
     
     
         230 . The implantable cardioverter-defibrillator of  claim 229 , wherein the lead comprises one or more electrical conductors electrically coupled to the electrode.  
     
     
         231 . The implantable cardioverter-defibrillator of  claim 230 , wherein the lead further comprises an electrically insulating sheath enclosing the one or more electrical conductors.  
     
     
         232 . The implantable cardioverter-defibrillator of  claim 229 , wherein the lead electrode assembly further comprises a connector coupled to the lead.  
     
     
         233 . The implantable cardioverter-defibrillator of  claim 232 , wherein the connector is electrically coupled to the electrode.  
     
     
         234 . The implantable cardioverter-defibrillator of  claim 229 , wherein the lead is between approximately 5 cm and approximately 52 cm in length.  
     
     
         235 . The implantable cardioverter-defibrillator of  claim 234 , wherein the lead is between approximately 5 cm and approximately 30 cm in length.  
     
     
         236 . The implantable cardioverter-defibrillator of  claim 235 , wherein the lead is between approximately 10 cm and approximately 20 cm in length.  
     
     
         237 . The implantable cardioverter-defibrillator of  claim 234 , wherein the lead length is one of a plurality of preset lengths.  
     
     
         238 . The implantable cardioverter-defibrillator of  claim 237 , wherein the pre-set lengths vary by approximately 10 cm.  
     
     
         239 . The implantable cardioverter-defibrillator of  claim 229 , wherein the lead has a proximal end and a distal end and wherein the proximal end of the lead is coupled to the electrode.  
     
     
         240 . The implantable cardioverter-defibrillator of  claim 239 , wherein the lead electrode assembly further comprises a lead fastener coupled between the lead and the electrode.